Policies and Procedures

for Thesis and Dissertation Preparation and Filing

TABLE OF CONTENTS

INTRODUCTION 3

Chapter I. MANUSCRIPT CONSTRUCTION: TYPING, ILLUSTRATIONS AND

REPRODUCTION 5

A. MATERIALS 5

Paper 5

Bond for Oversize Pages 5

Graph Paper 5

B. PREPARING THE ORIGINAL COPY 5

Appearance 5

Typeface 5

Size 5

Captions and Footnotes 5

Font 5

Italics 6

Non-typed Material 6

Spacing 6

Formatting the Manuscript 6

Margins 6

Manuscript and Figure Layout 7

Using Reprints or Versions of Manuscripts 7

Page Numbers 7

Pagination 8

C. COPIES SUBMITTED FOR FILING 8

Computer Printers 8

D. OVERSIZE, ILLUSTRATIVE AND SPECIAL MATERIAL 8

Wide Margins 8

Reducing Oversize to Standard Required Margins 8

Oversize Material To Be Folded 9

“Pocket” Oversized Material 9

Very Large Oversized Material 9

Color in Maps and Illustrations 9

Photographs 9

Reproduced Published Material 10

Music Composition 10

Reproduction of Music Composition 10

E. TYPIST AND REPRODUCTION SERVICES 11

1

Chapter II. THE MANUSCRIPT 13

A. FORMAT 13

B. ARRANGEMENT 13

C. PRELIMINARY PAGES 14

Title Page 14

Copyright Page or Blank Page (no sample pages) 15

Signature Page 15

Dedication Page (no sample pages) 16

Table of Contents and Lists (no sample pages) 16

Acknowledgments (no sample pages) 16

Vita, Publications, and Presentations 17

Abstract 17

Sample Preliminary Pages

DOCTORATE:

Title Page 19

Signature Page 20

Vita 21

Abstract 22

MASTER’S:

Title Page 23

Signature Page 24

Abstract 25

D. TEXT 26

E. COPYRIGHT PERMISSIONS 26

Chapters as Reprints 26

Chapters Based on Published or About-to-be-Published Articles or Chapters Based on Papers in

Progress 26

Reproducing Copyrighted Material in a Manuscript 26

Permissions Letters 26

Determining if the Material is Copyrighted 27

Permission to Reproduce from Private or Museum Collections 27

F. REFERENCE SECTION 27

Chapter III. FILING THE MANUSCRIPT 29

A. LAST DAY FOR FILING 29

B. FILING PROCEDURES FOR THE MASTER’S THESIS 29

C. FILING PROCEDURES FOR THE DOCTORAL DISSERTATION 30

Chapter IV. MISCELLANY 33

A. MICROFILMING AND ORDERING COPIES 33

Master’s Thesis 33

Doctoral Dissertation 33

B. REGISTRATION OF COPYRIGHT 33

Master’s Thesis 33

Doctoral Dissertation 33

IMPORTANT REFERENCE NUMBERS 35

October 2004

INTRODUCTION

The submission of a thesis or dissertation is the last step in a program leading to the award of a graduate degree. The manuscript is a scholarly statement of the results of the student’s research and related preparation. It is made available for public use in the University Library, microfilmed for archival preservation and, if a dissertation, published by ProQuest (formerly University Microfilms International).

The UCLA Graduate Division and University Archives established this policy and procedure for uniformity in the physical format of the manuscript. The student’s faculty committee supervises the intellectual content and may specify certain aspects of style, such as footnote style and placement, and the manner in which references are cited and listed. Students are urged to consult with their chairs regarding style preferences early in the preparation of the manuscript. Style manuals are available in several UCLA libraries, and for purchase at the UCLA Store. The regulations included here supersede any style manual instructions regarding format. Format includes manuscript arrangement, organization of specific preliminary pages, spacing, typeface, margins, page number order, page number placement, and the requirement for permission to reproduce copyrighted material. A student should not use theses or dissertations previously filed or past UCLA regulations for format examples because changes are made periodically, and candidates are responsible for following the requirements in effect when the manuscript is filed.

The Graduate Council, in general, does not endorse classified or confidential research in the University. In instances where this is approved, the end result must be an academically acceptable thesis or dissertation that can be deposited at the University in an unclassified version.

Questions that arise in the preparation of final manuscript copies, but which are not covered in this publication, may be discussed with the theses and dissertations advisor, 21560 Young Research Library, (310) 825-3625. The office hours for the theses and dissertations advisor are 12:00 p.m. until 4:00 p.m. Monday through Friday. Early consultation with the theses and dissertations advisor is particularly helpful if, after a student reads the regulations carefully, the student has questions about special material or about the need for permission to reproduce copyrighted material.

Students should address questions regarding the completion of academic requirements for advanced degrees to their department or to the Graduate Admissions/Student and Academic Affairs Office, 1255 Murphy Hall.

Orientation meetings on the preparation and filing of theses and dissertations are normally held the third week of classes each regular academic term (not during summer). Students are encouraged to attend these meetings.

A list of related offices with addresses and telephone numbers can be found at the end of this manual.

3

4

Chapter I

MANUSCRIPT CONSTRUCTION: TYPING, ILLUSTRATIONS AND

REPRODUCTION

A. MATERIALS

Paper

The two manuscript copies submitted to the Theses and Dissertations Office may be either photocopies or printouts. The paper used for the copies must be at least 20-pound, 25% cotton bond. This is not special or unusual paper; it is available at all campus bookstores. Higher cotton content (50% or more) and heavier weight papers (e.g., 24-pound, 25% cotton bond) are also acceptable. Standard xerographic bond is not acceptable.

Bond for Oversize Pages

Bond measuring 11 x 17 inches may be used in preparing oversize pages (see Oversize Material to Be Folded, page 9).

Graph Paper

Drawings, text, and gridlines must be kept within the UCLA required margins. The gridlines on blue grid tracing paper usually do not reproduce; green gridlines reproduce lightly, and red gridlines reproduce as dark lines. Visible gridlines are acceptable.

B. PREPARING THE ORIGINAL COPY

Appearance

The manuscript must be typed or machine-printed, neat in appearance, and without error. Strikeovers, handwritten corrections, or interlineations are not accepted. Corrections may be made on the original manuscript only (not on the copy being submitted for filing). Any process may be used (fluid, tape, eraser) that will not reproduce. The manuscript can be printed on only one side of each page. Music composition on heavyweight paper is the only thesis or dissertation submission where both sides of a page may be used (see Music Composition, page 10, and Reproduction of Music Composition, page 10).

Typeface

SIZE. The University does not require an absolute character and space count per inch of text because many manuscripts are now produced using laser printers with proportional spacing and letters. For the basic manuscript text, most fonts in 12-point or larger should be acceptable. Ten-point or smaller type cannot be used for the basic text.

Fonts vary in size depending on the software used. The decision of the theses and dissertations advisor is final concerning acceptable fonts and type sizes.

CAPTIONS AND FOOTNOTES Type sizes may be smaller for footnotes, captions, and for information in figures and tables. Ten-point is a good standard type size for print outside of the basic text.

FONT Only nonitalic type fonts may be used for the core manuscript text. A student who has any questions about a type font should bring in a sample of the type to the Theses and Dissertations Office for approval. The Times font in 12-point is a standard type and size that can be used as a rule of thumb.

5

ITALICS may be used for headings, labels, foreign words, book titles or occasional emphasis. The use of underlining and bold face in the text of headings and titles is at the discretion of the student’s committee.

Non-typed Material

Signatures on the signature page (page ii of the preliminary pages of the manuscript) and other non-typed matter, such as line drawings, handwritten symbols, formulae, and diacritical marks should be in black ink for clear reproduction.

Spacing

Unless otherwise noted the manuscript must be double-spaced throughout. Acceptable double spacing means no more than 3 type lines and 3 space lines per vertical inch of text, i.e., 6 lines per inch maximum.

Footnotes, bibliographic entries, long quoted passages, figure and table captions, and items in lists and tables may be single-spaced. If individual footnote or bibliographic entries are single-spaced, there must be double-spacing between entries.

There are special spacing requirements for some of the preliminary pages (see sample pages for the doctorate, pages 19-22; sample pages for the master’s, pages 23-25). The layout for these pages must be followed carefully as departures from the standard format are not acceptable.

FORMATTING THE MANUSCRIPT

Margins

NOTE: Copy machines may shift text on a page. Therefore the following are minimum margins. The student may set larger margins but must be sure that the final text lies well within these guidelines.

LEFT = 1.5” (this margin is wide for binding requirements)

TOP LINE OF TYPE = 1” from top of paper

RIGHT = 1”

BOTTOM LINE OF TYPE = 1.5” from bottom of paper

FOOTER MARGIN FOR PAGE NUMBER = .75” from bottom of paper

Aside from page numbers, all other manuscript material must fit within these margin requirements (including tables, figures, graphs). When oversized pages are used, the same margin measurements are maintained (see pages 8-10).

6

Manuscript and Figure Layout

The required order of pages for the manuscript is described on p. 13. Especially note that a bibliography is always the last section of a manuscript. The last page of a manuscript should be the last page of the bibliography. If students in the biological sciences choose to have a bibliography for each individual chapter of the manuscript, that bibliography must be the last pages of the chapter: All figures, tables, appendices, etc., come before the bibliography. Students following this style must remember to list each chapter’s bibliography in the Table of Contents with the appropriate page number.

All other questions regarding the layout of the manuscript — how to subdivide chapters, whether to center a heading, whether to use bold in a title, where to place footnotes, figures, or tables, etc., or what footnote or reference format to use — come under the rubric of “text” and are decided by the student’s committee chair.

No matter where figures or tables are placed, the student should not include the printer’s instruction “place Table X here” in brackets in the text. The student should remember that there is no printer to “place” the table, so such instructions are not necessary.

Layout of figures and tables can be the most bothersome aspect of the manuscript. A student should remember that 11 x 17” paper solves many problems (see page 9). Laying out the table horizontally to the page (landscaping) can also be helpful, as can using the page facing the figure for the caption. For questions about table and figure layout, the student should consult the chair or bring in samples to the theses and dissertations adviser.

Using Reprints or Versions of Manuscripts in Preparation as Dissertation Chapters

If students use an actual reprint of a published article, i.e., a copy of the article as it appears in a journal, as a chapter of the manuscript, the student must reduce the article to fit the UCLA margin requirements, remove the original page numbers and paginate the article appropriately, and request permission from the article’s publisher to include the article in the manuscript. In most cases the article has been copyrighted, and the student must request permission to reprint it even if the student is an author.

If students do not use a reprint, then they may be using a VERSION of an article that may have been published or submitted for publication or in preparation for submission. If this is the case, then the student must remove all of the heading material—the addresses of the authors, grant numbers, journal addresses, etc., — from the source manuscript before using the material as a chapter of the dissertation. All Figures and Tables in the chapters must be numbered consecutively, i.e., 1-x or according to chapter, i.e., 1-1, 2-1, etc. A Figure or Table number cannot be repeated. The only exception is if the student is using a reprint; we do not require students to renumber Figures or Tables in reprints. Also, if the source manuscript of a chapter had individual acknowledgements, these must be deleted from the chapter and added to the general dissertation Acknowledgements at the front of the manuscript. See the discussion under

Acknowledgements on page 16, for further details, or phone the Dissertations Advisor with any questions. See also page 26.

Page Numbers

Page numbers must be centered to the text, not the paper, must be at least .75” from the bottom of the paper, and must not be closer than .75” to the last line of type (in other words halfway between the bottom of the paper and the last line of type). Most word processing programs have a page numbering default that sets the number too close to the last line of type for UCLA requirements. If this is the case, the student must paginate the manuscript using the Footer margin of the program (instructions are in the manual for the word processing program).

7

Pagination

Every sheet of paper in the manuscript must be numbered except for two: the title page is counted but not numbered, and the copyright page (or blank page, if the copyright is not registered) is neither counted nor numbered.

ROMAN NUMERALS are used for the preliminary pages (title page through last abstract page). Because the title page is counted but not numbered, “ii” is the first number used and appears on the signature page.

ARABIC NUMERALS are used for all pages following the last page of the abstract. The next sheet of paper in the manuscript following the last abstract page, no matter what is printed there, is numbered “1” and so on to the last sheet of paper. If material appears on paper (e.g., appendices, facing pages, tables, figures), the piece of paper is a page and must be counted and numbered. If the student has a piece of paper in the manuscript and it comes after the abstract, it is a page; if it does not have a number, then the student has made a mistake. Correct pagination — no missing pages, no duplicate numbers or pages — is required for the manuscript to be acceptable. If the student has any questions about this issue, the student should not guess, refer to old manuscripts, or ask anyone for assistance other than the theses and dissertations advisor who is available by telephone or walk-in visit.

C. COPIES SUBMITTED FOR FILING

The student is required to submit two copies of the manuscript for filing. The submitted copies of the manuscript, whether computer-printed or photocopied, must conform to paper, margin, and pagination requirements as stated in this manual. Note: Photocopying may shift the image; the student must be sure that the margins used on the original will still correspond to margin requirements on any photocopies. Submitted copies must be neat, clean, and legible; new ribbons or high quality photocopiers must be used. Copies with postcopy corrections cannot be accepted.

Computer Printers

Only letter quality computer printing is acceptable. If a non-laser printer — dot matrix, jetstream, etc. — is used, a sample of the generated print must be submitted to the Theses and Dissertations Office for approval. If the student has any questions about copies or printers, the student should present a sample of the final product to the Theses and Dissertations Office for approval.

D. OVERSIZE, ILLUSTRATIVE, AND SPECIAL MATERIAL

UCLA margin requirements (see Margins, page 6) are to be observed for all oversize, illustrative, and special material described in the following paragraphs, unless an exception is noted.

Wide Margins

Where computer output, tables, or other illustrative materials with wide margins are turned on the page to fit within required margins, the top of the material should run along the left side of the paper at the 1.5 inch margin. Placement of the page number is always at least .75” inch from the bottom of the page (see Margins, page 6).

Reducing Oversize to Standard Required Margins

Copy that has been reduced on photocopying machines to fit within required margins for an 8-1/2 x 11 inch page must be legible. The easiest method is to reduce the material to the appropriate size, trim the page, and mount it on a separate page to fit within the required margins. This “pasted up” version serves as the original from which the copy is made for filing.

8

Oversize Material to Be Folded

Some oversize material does not lend itself to reduction to standard-page margin requirements, and must be submitted on a larger-than-standard page. Paper measuring 11 x 17 inches may be included in the manuscript by converting the page to manuscript size with pleat-like folds. With these pages, the left (11 inch) edge will have a 1-1/2 inch margin, the top (17 inch) edge will have a 1 inch margin, the right (11inch) edge will have a 1 inch margin, and the bottom edge will have a 1-1/2 inch margin. The page number is placed .75” inch from the bottom edge of the page, and about 4 inches from the right-side paper edge. The folds of the 17 inch wide paper must be at least 1-1/2 inches from the edges of the page to assure the illustration is not cut when the edge of the page is trimmed in the binding process. When the oversize page is properly folded, the page number will appear in the position where it appears on the standard-size page. When submitted, the oversized page must be one continuous sheet, with nothing glued or taped.

“Pocket” Oversized Material

Oversized material larger than 11 x 17 inches is either bound at the end of the manuscript or folded by the bindery for insertion into a special pocket that will be supplied when the manuscript is bound. The oversized page is filmed in segments at the end of the microfilm. The student’s name should be typed or neatly block-lettered within the text area (not in the margins) in the lower right-hand portion of the oversized page. Such material is to be referred to in the text, and noted in the Table of Contents or List of Figures or Tables (e.g., “Plates 1 through 7 in pocket”). When filing the manuscript, the student should present “pocket” oversized pages wrapped around a cardboard tube (or rolled inside a map tube) with an extra copy of the title page on the outside.

Very Large Oversized Material

Very large maps and other very large submitted pages should be presented in the manner described for “pocket” oversized material, rolled, not folded, and labeled with an additional copy of the title page. The student’s name must be typed or neatly block-lettered in the lower right portion of the oversized page (not in the margins).

Color in Maps and Illustrations

Both black and white and color illustrations are acceptable. However, the student must remember that the manuscript will be microfilmed in black and white. Therefore, the student should not use color as the key to a graph or map, etc. If the student chooses to use color reproductions, standard color copying paper is acceptable. The student must also remember that glossy prints, whether black and white or color, are not acceptable.

Photographs

There are two ways to include photos in the manuscript. Actual photos printed on 8-1/2 x 11 inch matte or pearl finish paper may be substituted as pages if the image size conforms to margin requirements. If the photo has been printed onto paper smaller than 8-1/2 x 11, the student should glue, paste, or somehow affix the photo to a standard sheet of paper, according to margin requirements, photocopy the paste-up either in black and white or color as appropriate, and submit the photocopy as the manuscript page. The student must not submit pasted-up pages in the manuscript; pasted-up pages will be rejected. Photo page-number placement follows standard requirements (see page 7). Photo captions may be placed on the subject and shot as part of the original negative or captions may be typed on the page facing the photo.

The student is strongly encouraged to use a high quality, high contrast copying machine to reproduce photographic material for submission in lieu of photographs.

9

Reproduced Published Material

Photocopies of previously published material must be legible and conform to margin and page numbering requirements (see pages 6-7). When published material, including material authored or co-authored by the student, is included in the master’s thesis or doctoral dissertation, it is essential that the student follow instructions for permission to reproduce copyrighted material (see page 26).

Music Composition

If the manuscript consists of an oversize music composition only, preliminary pages are reproduced on the same oversized pages as the composition. UCLA margin and page number requirements must be observed on all oversized pages. Page numbers may be typed or neatly handwritten in black ink.

When an oversized music composition is included as a part of the manuscript, the manuscript is submitted in two volumes, Volume I includes all the preliminary pages (see pages 13-16) and the text, and is submitted on 8-1/2 x 11 inch paper. The title page includes titles for both Volume I and Volume II, and both volumes will be listed in the Table of Contents.

Volume II includes the oversized music composition and will have a separate set of oversized preliminary pages:

(a ) Title page (identical to Volume I, showing titles for both volumes)

(b ) Copyright (or blank) page

(c ) Title page for Volume II (does not include Volume I title); this page is numbered Roman numeral ii

(d ) Dedication page (optional)

(e ) Table of Contents, if needed

(f ) Performing notes, lists or other notations (e.g., placement of instruments, instrumentation, explanation of notation), if needed

If the composition in Volume II needs to be turned lengthwise on the page to accommodate the width of the score, all pages of Volume II are to be turned lengthwise. The top and bottom margins will then be along the long sides of the page and the top and bottom margins will each equal 1.5”. The side margins will be along the short sides of the paper and will each equal 1”. The page number will appear at the bottom of the composition and will follow standard page margin requirements (see pages 6-7).

Reproduction of Music Composition

If the manuscript is photocopied on 60-pound bond paper, the manuscript may be printed on both sides of the page. The music manuscript on overweight paper is the only thesis or dissertation submission where both sides of the page may be used. If 20-pound bond paper is used, the student must print on one side of the paper only. If both sides of the page are printed, the student should reverse the margins on the left-side page to allow for binding; that is, the left margin of the left-side page will be 1 inch, the right margin will be 1 1/2 inches, and the page number will be centered to the text. (When the composition is turned on the page, observe the margins described above.)

10

E. TYPIST AND REPRODUCTION SERVICES

University policy prohibits the theses and dissertations advisor from recommending typists, editors, or computer or reproduction services.

Reproduction services are available on-campus and off-campus through a number of vendors. Cost and quality vary among vendors, and the student is cautioned to check carefully each page of the copy to be submitted to insure margins and page number placement requirements are maintained and that the appearance meets University requirements.

11

12

Chapter II

THE MANUSCRIPT

A. FORMAT

The student should consult with the committee chair regarding an acceptable manuscript style before preparing the final copy of the thesis or dissertation. UCLA Policies and Procedures for Thesis and Dissertation Preparation Filing supersedes manuals of style if there is a conflict in the instructions regarding format.

B. ARRANGEMENT

The order for the preliminary pages is listed below. A student must follow this order; no exceptions are allowed. Starting with the signature page (ii), each page must be counted and numbered. The student must use lower case Roman numerals on preliminary pages and Arabic numerals on text pages. The text starts with the first piece of paper after the abstract and uses Arabic numeral 1.

Examples of the title, signature, vita, and abstract pages for both dissertations and theses follow page 18. The manuscript is arranged in the following sequence:

1. THE PRELIMINARY PAGES

a) TITLE PAGE (counted but not numbered)

b) BLANK PAGE or (if there is to be registration of copyright) the COPYRIGHT PAGE (neither counted nor numbered)

c) Copy of SIGNATURE PAGE with signatures (page ii, the first page on which a number appears)

d) DEDICATION PAGE (optional)

e) TABLE OF CONTENTS (containing page numbers)

f) LIST OF FIGURES, LIST OF TABLES, LIST OF SYMBOLS, ETC. (if applicable, and containing page numbers)

g) ACKNOWLEDGMENTS (usually optional; see Copyright Permissions, page 26)

h) VITA (required for all dissertations) Articles under review cannot be listed as publications. Only accepted, in-press articles may be listed as publications. (A master’s candidate does not submit a vita with a thesis.)

i) ABSTRACT (the final item in the preliminary pages and the final item with Roman numerals)

2. THE TEXT

(the first page following the abstract is the first page of the text and is numbered with an Arabic number 1)

13

    a) PREFACE or INTRODUCTION (if any)

    b) TEXT, divided into chapters or sections

    c) APPENDICES (if any)

    d) ADDENDA (if applicable)

    e) REFERENCES/BIBLIOGRAPHY (last pages of a chapter or of the manuscript; see page 7.) C. PRELIMINARY PAGES

The information on the preliminary pages and the format for these pages are standardized and the student must follow the samples and instructions presented in this manual.

The student should note that page numbers in parentheses at the bottom of the sample pages refer to the order of those pages in this manual and should not be copied. The signature page is always numbered “ii”, so the Roman numeral “ii” appears above the page number of this booklet on the sample page, at least .75” above the bottom of the paper.

The general format for capitalization and spacing is to be followed for all preliminary pages for which a sample is provided (e.g., where groups of lines are double-spaced on the sample pages, the student must be sure to double-space. The student must balance the spaces between groups of lines to present a balanced appearance). There must be consistency among approval forms and all preliminary pages with respect to the student’s name, major field, committee chair’s name (or co-chairs’ names), title of thesis or dissertation, and year the degree is granted.

Title Page

(Doctoral sample page, p. 19; Master’s sample page, p.23)

1. UNIVERSITY OF CALIFORNIA appears in full capital letters at the top of the page, Los Angeles in upper and lower case letters. The student should follow the spacing on the sample page.

2. The TITLE for the thesis or dissertation should include meaningful key words descriptive of the subject and content. This is particularly important for doctoral candidates, because titles are the basis for computer searches from which subject lists of dissertations are prepared by ProQuest’s Datrix reference service. Formulae, symbols, superscripts, Greek letters, acronyms, and abbreviated forms in general are to be spelled out (e.g., K3 Mn(CN)6 is written Potassium Manganicyanide; MMPI is written Minnesota Multiphasic Personality Inventory; TESL is written Teaching English as a Second Language). For music manuscripts that include an oversize composition volume, see page 10, Music Composition.

3. The MAJOR in which the student is earning the degree must be written exactly as it is approved by the Academic Senate Graduate Council. A student can verify the official name of the major by looking at his or her official transcript or by consulting the list of official majors at the Registrar’s Office site on the World Wide Web at www.registrar.ucla.edu/Dept/major.htm. Unofficial specializations may not be included. For example, UCLA awards a graduate degree in Education, not Educational Psychology. If there is any question about the degree major, the student should consult his or her transcript or the listing in the UCLA General Catalog or the Web site noted above.

4. The NAME used on the title page must be the name under which the student is registered at UCLA and must match the name that appears on the approval forms, copyright page (if the copyright is being registered), signature page and abstract. If the student wishes to change the name of record, the student should file a change of name petition in the Registrar’s Office. If the student is unsure about what

14

form of his or her name is on record, this information may be obtained through URSA, the Registrar’s Office or Graduate Admissions/Student and Academic Affairs.

5. The DATE at the bottom of the title page is the year in which the degree is awarded. This is the same year in which the manuscript is filed, except when the manuscript is filed with the theses and dissertations adviser after the published last day to file for the Fall Quarter; in this case, the degree will be awarded in the Winter Quarter of the following year, and should be dated accordingly.

There is no page number on the title page (it is counted as the first preliminary page, but is not numbered).

If a thesis or dissertation exceeds 2-1/2 inches in thickness, it may be divided into two parts with a title page for each part.

Copyright Page or Blank Page

(no sample pages)

The student must include either a blank sheet of paper or a completed copyright page. This page is not counted or numbered. Whether the student intends to file for copyright at the time of filing or at a later date, the student must complete a copyright page with the information listed below, centered, double spaced, and ending at the bottom text margin. The information and layout are the same for both theses and dissertations.

© Copyright by (copyright notice)

Jane Arlene Brown (name of author)

2002 (year degree is awarded)

DOCTORAL CANDIDATES ONLY — If the student intends to file for copyright at the time of filing, the student must sign the copyright-filing line on the ProQuest Agreement form (see page 28) and bring a certified check or money order for the amount specified on the ProQuest Agreement form. A student cannot use personal checks to pay for any ProQuest charges — copyright, ordering copies, etc.

Signature Page

(Doctoral sample page, p. 20; Master’s sample page, p. 24)

The formal signature page, which contains the signatures of the certifying members of the committee, should not be confused with the approval forms, which are simply record-keeping forms. (See page 29 [Master’s] or page 30 [Doctoral] for a discussion of approval forms.)

The student’s name as recorded by the UCLA Registrar appears on the signature page. The name should be the same as that which appears on the title page, copyright page (if the copyright is being registered), first page of the abstract, and approval forms.

The name of each signing committee member should be typed under the appropriate signature. No titles or degree designations should be used (no “Professor,” no Ph.D., no MD, etc.) The typed name of the chair (or co-chairs) must match the version of the name used on the approval forms. On the signature page, the title “Committee” Chair or (Co-chair) follows each chair’s name (compare this form with the abstract page). The student should adjust the spacing between listed names according to how many committee members there are. There is no required order for the names of the committee members except the name of the chair (or co-chairs), which appears as the last name(s) on the page.

Signatures should be in black ink for best reproduction. If a member signs in blue ink, obtain the clearest copy possible.

15

A very common error is inconsistency among names, especially between signature and abstract pages. A student must insure that the form of the student’s name is consistent on the manuscript title page, the signature page, the abstract page, and the approval forms and that the form of the chair’s or co-chairs’ name(s) is consistent in all of these places as well (except the title page). A rule of thumb — once the signature page is typed, the chair’s name is now set. That form of the name should be used on the abstract and approval forms.

The date at the bottom of the page is the year in which the degree is awarded and is the same as the year on the title page.

The signature page is always page ii of the manuscript, and is the first page on which a number appears (ii appears .75” from the bottom of the paper). Every page after this page is numbered; the preliminary pages in Roman numerals and the text in Arabic numerals.

Dedication Page

(no sample pages)

OPTIONAL. If included, this will always be numbered page iii, and should be typed double-spaced.

Table of Contents and Lists

(no sample pages)

The format for the table of contents and the lists of figures, tables, symbols, or other items is left to the student’s judgment; however, if figures or tables appear in the manuscript, the student must include the appropriate list(s) with page numbers following the Table of Contents.

Acknowledgments

(See also page 26.)

(no sample pages)

Acknowledgments may be optional except in either of the following circumstances:

1. The student reproduces/reprints copyrighted material requiring permission to be reprinted/reproduced in which case the student is responsible for acquiring and acknowledging each permission to reprint/ reproduce in accordance with the instructions of the individuals/institutions/publishers granting the permission (see Copyright Permissions on page 26).

2. The student uses as text in a chapter either material based on co-authored published or about to be published articles or material based on co-authored papers in progress. If a chapter is based on a coauthored published or about to be published article a sentence such as, “Chapter Five is a version of

where the student fills in the formal bibliographic article citation is sufficient. In this way the student has identified all co-authors, the journal where the article can be found and the journal publisher. If a chapter is based on a co-authored paper in progress, the student must identify and acknowledge the individuals contributing to the chapter/paper. Finally, if the student is using as a chapter a version of an article that has its own acknowledgments, those acknowledgments should appear in the manuscript Acknowledgments identified by chapter. In each case the student should always identify and acknowledge the director of the research that forms the basis of a chapter.

16

Vita, Publications and Presentations

(Doctoral sample page, p. 21; not used for Master’s thesis)

VITA—The vita is required for the doctoral dissertation. (A master’s candidate does not submit a vita with the thesis.) The vita provides a brief biographical background of the candidate; it is not intended to be a comprehensive resume. The heading, VITA, is centered, in full capitals, and is not underlined. All vita entries are to be listed in strict chronological order, with no subcategories or subheadings. The vita includes the date (may be omitted if the student prefers) and place of the student’s birth, dates of degrees and names of colleges or universities (exclude the degree for which this dissertation is written), academic or professional employment, and may, if the student wishes, include military service, honors, awards and distinctions.

PUBLICATIONS AND PRESENTATIONS—The appropriate heading should be used: PUBLICATIONS, PRESENTATIONS, or PUBLICATIONS AND PRESENTATIONS; only these headings are acceptable. Publications and Presentations should not be broken into two separate categories. The heading should be in full capitals, centered, and not underlined. All entries should be listed in strict alphabetical order by first author’s last name. Presentation entries should be listed using a standard citation format. If a presentation paper has not been subsequently published and the student is uncertain about citation format, the student should consult a style manual for correct formats for unpublished presentation papers.

Abstract

(Doctoral sample page, p. 22; master’s sample page, p.25)

The words ABSTRACT OF THE DISSERTATION (doctorate) or ABSTRACT OF THE THESIS (master’s) appear in full capital letters beneath the top margin. The student should follow the sample-page spacing. The version of the title, student’s name, degree being awarded, year of degree, and name of the chair or co-chairs must match the versions used on other preliminary pages and the approval forms. The title “Professor” precedes the chair’s name (no matter what the individual’s normal title). The title “Chair” or “Co-chair” follows the name; “committee” is dropped (NOTE: This style does not match the signature-page style.) If there are co-chairs, a separate line is used for each name.

The abstract consists of:

* a brief statement of the problem;

* a brief exposition of the method or procedures used;

* a condensed summary of the findings of the study.

The abstract is published without further editing or revisions and special care must be taken in its preparation.

The abstract for the master’s thesis must not exceed 250 words.

The abstract for the doctoral dissertation is published by ProQuest in Dissertation Abstracts International and must not exceed 350 words or 35 lines (or 2,450 characters counting spaces and punctuation). If the abstract is more than two pages long, the student must be prepared to demonstrate that it is not more than 350 words long.

The last page of the abstract is the last page of the preliminary pages; it is the last page numbered with Roman numerals. Any other item in a manuscript that has not been specifically listed and discussed above must not be included in the preliminary pages. With the next sheet of paper following the last abstract page, page numbering is done with Arabic numerals, beginning with “1” and so on to the last sheet of paper.

17

18

UNIVERSITY OF CALIFORNIA

Los Angeles

The Effect of Urbanization

on Socialization Practices and Personality Development

in Guajiro Society

A dissertation submitted in partial satisfaction of the

requirements for the degree Doctor of Philosophy

in Anthropology

by

Richard Smith Roe

2004

19

The dissertation of Richard Smith Roe is approved.

George A. Brown

Jane Marie Smith

B. Joseph Jones

Gerald B. Greene

Katherine Doe, Committee Chair

University of California, Los Angeles

2004

ii

VITA

April 6, 1977 Born, Bangor, Maine

1999 B. A., Psychology

Harvard University

Cambridge, Massachusetts

1998- 2000 Peace Corps, Peru

2001 M. S., Anthropology

University of Chicago

Chicago, Illinois

2000-2001 Teaching Assistant

Department of Anthropology

Chicago, Illinois

2001 Teaching Assistant of the Year Award

University of Chicago

Chicago, Illinois

2001-02 Teaching Assistant

Department of Anthropology

University of California, Los Angeles

2001-02 Field Work, Peru, under National

Institute of Mental Health Grant

PUBLICATIONS AND PRESENTAIONS

Roe, R. S (October, 1999). The etiology of emotional distress among tribe members in the Peruvian Andes. Paper presented at the meeting of the American Psychological Association, Toronto, Canada.

—, Jones, B.J., and Doe, K. (2002). Research design for a study in urbanization. American Anthropologist, 77 (3):440-467.

21

ABSTRACT OF THE DISSERTATION

The Effect of Urbanization

on Socialization Practices and Personality Development

In Guajiro Society

by

Richard Smith Roe

Doctor of Philosophy in Anthropology

University of California, Los Angeles, 2004

Professor Katherine Doe, Chair

(The student begins typing the abstract here, double-spaced.) The body of the abstract is limited to 350 words, with a maximum of 2,450 characters allowed. Spaces and punctuation are counted as characters for this purpose. To get an estimate of the count, the student should count the characters (including spaces and punctuation) of A line of average length, and multiply by the number of lines.

If the abstract is longer than 35 lines, it is important to check the number of characters.

22

UNIVERSITY OF CALIFORNIA

Los Angeles

Equipotential Surfaces

for Earth-Pointing Satellites

A thesis submitted in partial satisfaction

of the requirements for the degree Master of Science

in Aerospace Engineering

by

John Smith Doe

2004

23

The thesis of John Smith Doe is approved.

Howard L. Jones

Patricia Anne Brown

Richard W. Roe, Committee Chair

University of California, Los Angeles

2004

ii

ABSTRACT OF THE THESIS

Equipotential Surfaces

for Earth-Pointing Satellites

by

John Smith Doe

Master of Science in Aerospace Engineering

University of California, Los Angeles, 2004

Professor Richard W. Roe, Chair

(The student begins typing the abstract here, double-spaced. Limited to 250 words.)

25

D. TEXT

The student should consult with the committee to determine the preferred textual arrangement and style, including footnote style and the manner in which references are cited and listed. Techniques for managing reproduction of oversize, illustrative, and special material are described on pages 8-10. Regulations regarding the use of published and other special material that may require special permission or acknowledgment are presented in the following section.

E. COPYRIGHT PERMISSIONS Using Reprints, Modified Published/About-to-be Published or Unpublished Material, or Reproduced Copyrighted Material in the Manuscript (see also page 16)

Permission to reprint/reproduce copyrighted material in a manuscript will often be required, depending on what material is used and how it is reproduced. If a student does not have the appropriate copyright permissions at the time the manuscript is filed, the student will still be allowed to file. However, the student should note that if the necessary copyright permissions are not ready, public access to the manuscript will be affected.

CHAPTERS AS REPRINTS. If approved by the candidate’s committee a master’s thesis or doctoral dissertation may include reprints of previously published articles where the student is a co-author. A reprint is a direct copy of a published article. To be acceptable in a thesis or dissertation the reprint must be reduced to fit manuscript margin requirements, paginated appropriately, and the original page numbers blocked out. A reprint is copyrighted material. If a reprint is used, the student must obtain the publisher’s permission to reprint and acknowledge the permission in the manuscript Acknowledgments. The student must also identify the author who directed the research that forms the basis of the article/chapter. (See page 16 [Acknowledgments].)

CHAPTERS BASED ON PUBLISHED OR ABOUT TO BE PUBLISHED ARTICLES OR CHAPTERS BASED ON PAPERS IN PROGRESS. If a student uses a modified version of a published/about to be published article or a paper in progress as a chapter in the manuscript, the student is not using a reprint, so copyright permission to reprint will not be required. However, please note that if the student reprints actual copies of published figures or tables as part of the chapter, permission to reprint those figures or tables is required. All non-reprinted text must be formatted according to UCLA requirements, all cover pages containing co-authors, grants, addresses, etc., and individual acknowledgments removed, and tables, figures, etc., numbered consecutively. (See pages 7, 10 and especially 16 [Acknowledgments, item 2].)

REPRODUCING COPYRIGHTED MATERIAL IN A MANUSCRIPT. If the student reproduces or reprints a complete, single, copyrighted image or work such as, e.g., a table, figure, poem, picture, map, or song, permission to reproduce or reprint the image or work should be obtained from the individual or concern which was the source of the image used in the manuscript: a publisher, institution, or individual. If the student reproduces in the manuscript an excerpt or excerpts of copyrighted material not longer than one single-spaced manuscript page and from a single source, the student will not need to ask copyright permission from a publisher, institution, or individual. If the student reproduces more copyrighted material from a single source than fits on one single-spaced manuscript page, the student should obtain permission to reproduce the copyrighted material from the individual or concern that was the source of the material.

PERMISSIONS LETTERS. If the student believes that permissions letters may be necessary, the request should be mailed as early as possible, using one of the following as a return address. ProQuest makes the final decision as to whether a DISSERTATION requires a permission letter; the Theses and Dissertations Office decides if a THESIS requires a letter. For both types of manuscripts, if the required letters are not received within sixty (60) days of filing, the filed manuscript will be microfilmed, but access to the film will be restricted to the student and UCLA. When contacting publishers, the time limits and restriction information should be included in the permission request. Also, the permission request should not be left open-ended. The publishers should be asked for a response, whether the answer is yes or no.

26

When contacting publishers for permissions letters, the student should use his or her home or department as a return address if he or she is writing early enough to receive replies before filing the manuscript. If the student waits until the last minute before sending out permission-request letters, he or she should use either the ProQuest or Powell Library addresses given below.

DISSERTATIONS. Permission answers for dissertations should be mailed directly to:

Manuscript Supervisor

ProQuest

300 North Zeeb Road

Ann Arbor, MI 48106-1346

THESES. Permission answers for theses should be mailed directly to:

Theses and Dissertations Office

21560 Young Research Library

University of California

Los Angeles, CA 90095-1575

DETERMINING IF THE MATERIAL IS COPYRIGHTED. The student should check the front of the material, looking for the publishing history and the international copyright sign: “©” Normally, whatever appears after “© by” identifies who holds the copyright. Some general rules of thumb: professional journals hold the copyrights on all articles they publish; magazines and newspapers hold the copyrights on everything they publish; publishing houses hold the copyright on all books, whether collections, editions, translations, etc. that the house produces. Foreign copyrights are as valid as U.S. copyrights: foreign publishers must provide permission letters for any copyrighted material taken from books, journals, music collections, newspapers, etc.

Material published in the U.S. before 1978 and that is more than 75 years old is in the public domain. Material published outside the U.S. does not have clear-cut rules. Some authorities advise that it is not safe to assume that a foreign work copyrighted in the last 200 years is in the public domain. Especially for non-U.S. copyrighted material, a student should always err on the side of supposing that copyright permission is necessary.

When using an old text — Tacitus, Diderot, Lord Acton, etc. — the student always should check the edition date (found on the publishing page). Just because the text is old does not mean that the edition being used is old or out of copyright.

If it is certain that a permission letter is not required, a student must provide a letter when filing the manuscript that indicates why the permission is not needed and proving that the material in question is in the public domain.

PERMISSION TO REPRODUCE FROM PRIVATE OR MUSEUM COLLECTIONS. Permission is required for the use of materials from certain private collections and museums without respect to copyright. The student is responsible for determining if permission is needed, and if it is, to submit letters of permission when the manuscript is filed with the theses and dissertations advisor.

F. REFERENCE SECTION

The reference section is always the last subsection of the manuscript (see pages 13-14). The style used for the reference section is determined by the student in consultation with the faculty committee. If the bibliographic citations are single-spaced, however, there should be double-spacing between citations. If references are needed at the end of each chapter, as is often the case in the sciences, this format is acceptable.

27

28

Chapter III

FILING THE MANUSCRIPT

A. LAST DAY FOR FILING

The deadline for filing the thesis or dissertation in final form is ten days to two weeks before the degree date. The exact date for each quarter is printed in the General Catalog Calendar and the Schedule of Classes. Students are encouraged to file as early in a quarter as possible. The manuscript must be filed in person, either by the student or a representative. Under no circumstances will a manuscript be accepted through the mail.

B. FILING PROCEDURES FOR THE MASTER’S THESIS

1) The student obtains two Thesis Approval forms, which are available in PDF format on the Graduate Division’s website at http://www.gdnet.ucla.edu/gasaa/library/masapprvl.pdf. The forms are also available at 1255 Murphy Hall, or from the Office of the Theses and Dissertations Adviser, University Archives, 21560 Young Research Library.

2) The student completes the Thesis Approval Forms (must be typed or completed in interactive PDF format on the website listed above and printed out). The name, degree title, degree major, chair or co-chairs, and thesis title on the approval forms must match the information on the preliminary pages of the thesis. The student must be sure to use the same name under which he or she is registered, and that the degree major is listed exactly as approved by the Graduate Council (e.g., Education, not Higher Education). The student must be sure to sign the approval forms, noting options available.

3) A registered student proceeds to Step 4. A student who is not registered follows these steps for using the Filing Fee:

a) Obtains the Filing Fee Application from Graduate Admissions/Student and Academic Affairs.

b) Has the application signed by the department chair and the committee chair.

c) Submits the completed application to Graduate Admissions/Student and Academic Affairs. If approved, the fee is billed through the Billing and Receivables System (BAR).

4) On the day that the thesis is filed, the student brings the two copies of the thesis and first goes to Graduate Admissions/Student and Academic Affairs to submit the following items:

a) Two Thesis Approval Forms (typed)

b) Title Page

c) Signature Page (with all signatures included)

Checking these documents takes only a few minutes. The two Thesis Approval Forms will be signed, dated, and returned to the student to submit to the theses and dissertations adviser. The title page and the signature page are returned to the student to keep; they will not be needed again for the filing procedure.

5) On the same day the student submits the required items in Step (4) to Graduate Admissions/Student and Academic Affairs, 1255 Murphy Hall, and is cleared by that office, the student then submits the following items to the theses and dissertations adviser, 21560 Young Research Library:

a) Two typed Thesis Approval Forms (stamped and dated by Graduate Division) (Step 4).

29

b) Two complete copies of the thesis, including copies of the signed signature page, each in a separate manila envelope with an extra title page taped on the outside. Copies must be submitted in final form (no further corrections, substitutions, additions, or deletions) and not bound, stapled, folded, or punched.

c) Any letters concerning permission to reproduce copyrighted materials or to use privately owned or museum materials.

6) If the manuscript is acceptable, the student takes an approved copy, with an order for microfilming, from the theses and dissertations adviser downstairs to the Cashier’s window on the first floor of Young Research Library.

A student may pay for the microfilming by check, cash or credit card (27 cents a page, plus tax). This microfilm is the required archival copy of the thesis. The student receives a receipt for payment, and returns to room 21560 where the theses and dissertations adviser records the receipt number. Presentation of the receipt and the recording of its number complete the steps for filing. The Graduate Division will be notified that the Thesis is accepted.

C. FILING PROCEDURES FOR THE DOCTORAL DISSERTATION

1) The student obtains the following forms from either Graduate Admissions/Student and Academic Affairs, 1255 Murphy Hall, or from the Office of the Theses and Dissertations Adviser, University Archives, 21560 Young Research Library.

a) Two Dissertation Approval Forms (typed) — these forms are also available in PDF format on the Graduate Division’s website at http://www.gdnet.ucla.edu/gasaa/library/docapprvl.pdf.

b) ProQuest Agreement Form

c) Survey of Earned Doctorates http://www.gdnet.ucla.edu/gasaa/library/sedsurvey.pdf

d) UCLA Doctoral Exit Survey http://www.gdnet.ucla.edu/gasaa/library/docexitsurvey.pdf

2) The student completes the Dissertation Approval Forms (must be typed or completed in interactive PDF format on the website listed above and printed out). The name, degree title, degree major, chair or co-chairs, and dissertation title on the approval forms must match the information on the preliminary pages of the dissertation. The student must be sure to use the same name under which he or she is registered, and that the degree major is listed exactly as approved by the Graduate Council (e.g., Education, not Higher Education).

3) Students are required to complete and sign the ProQuest Agreement form regardless of whether they do or do not copyright the dissertation. Signing the form does not affect control of the manuscript; it simply allows ProQuest to microfilm the manuscript for UCLA.

4) Students who are registered for the term in which the manuscript is filed proceed to Step 5. Students who are not registered follow the steps below to determine eligibility to use the Filing Fee in lieu of registering:

a) A doctoral candidate must be registered for the immediately preceding term in order to be eligible to pay the filing fee in lieu of registering for the current term (note: Spring term is considered to be the term which immediately precedes both summer and fall terms). Candidates who were not registered for the immediately preceding term must register for the current term in order to file the dissertation. Registration and enrollment in four units during a summer session counts for being registered in a term.

b) A student who was registered for the immediately preceding term and who does not need to be registered for the current term for any other reason (e.g., an academic apprentice personnel appointment), obtains the Filing Fee Application form Graduate Admissions/Student and Academic Affairs, 1255 Murphy Hall at http://www.gdnet.ucla.edu/gasaa/library/docffee.pdf.

30

c) The application must be signed by the department chair and the committee chair.

d) The student submits the completed application to Graduate Admissions/Student and Academic Affairs. If approved, the fee is billed through the Billing and Receivables System (BAR).

5) On the day the dissertation is to be filed, the student brings the two copies of the dissertation and first goes to Graduate Admissions/Student and Academic Affairs to submit the following items:

a) Report on the Final Oral Examination (defense of the dissertation), if required, or a waiver of final oral examination, if the committee decides to change to a waiver of the requirement. (Waiving the Final Oral Examination is an option on the Report on the Oral Qualifying Examination and Request for Advancement to Doctoral Candidacy form and on the green form used to reconstitute a doctoral committee). If the Final Oral Examination is required, either the report or the waiver must be in the Graduate Division before a student is permitted to file. The student should bring the report if it was not previously sent to the Graduate Division.

b) Survey of Earned Doctorates and UCLA Doctoral Exit Survey (completed forms)

c) Two Dissertation Approval Forms (typed, and with the student’s signature) These will be signed and dated by the Graduate Division and returned to the student.

d) Title page

e) Signature page (with all required signatures included)

Checking these documents takes only a few minutes. The two Dissertation Approval Forms will be signed, dated, and returned to the student to be submitted to the theses and dissertations adviser.

6) On the same day the student submits the required items in Step (5) to Graduate Admissions/Student and Academic Affairs and is cleared by that office, the student then submits the following items to the theses and dissertations adviser, University Archives, 21560 Young Research Library:

a) Two complete, unbound copies of the dissertation, including copies of the signed signature page, each in a manila envelope with an extra title page taped at corners to the outside of each envelope. (If the dissertation is longer than 500 pages, the student may wish to submit two envelopes; each additional envelope should contain an extra title page on the inside and be labeled with an extra title page on the outside.) The dissertation must be in final form (no further corrections, substitutions, additions, or deletions), and not bound, stapled, folded, or punched.

b) A third manila envelope, labeled with a title page on the outside, in which is included:

i) Two typed Dissertation Approval Forms, signed and dated by the Graduate Division (Step 4).

ii) ProQuest Agreement Form (completed and signed on the back).

iii) One copy of the title page and one copy of the abstract for ProQuest.

iv) Students who request ProQuest to register copyrights on their behalf (optional), must bring a certified check or money order made payable to ProQuest in the amount specified on the ProQuest Agreement Form (no personal checks, credit cards or cash are accepted for the copyright fee).

v) If ordering abstracts, copies, or films from ProQuest (optional), a separate certified check, money order, or credit card number (see form). Cash is not accepted.

31

NOTE: There is no charge for microfilming the dissertation, and there is no requirement for registering copyright or for ordering copies; all fees payable to ProQuest are for services provided at the student’s option.

vi) Any letters concerning permission to reproduce copyrighted materials or to use privately owned or museum collections.

NOTE: All fees are subject to change without notice.

No changes in the manuscript are allowed after the manuscript is accepted and filed in archives.

32

Chapter IV

MISCELLANY

A. MICROFILMING AND ORDERING COPIES

Master’s Thesis

The master’s thesis in microfilmed through UCLA Reprographic Services (see Filing, Step 6, page 30.) The University frequently receives requests for copies of theses and fills such orders at cost. Students who intend to publish the manuscript may request that the University withhold reproduction for a period up to three years. A student indicates the desire to withhold publication by signing both Thesis Approval Forms in the space provided, giving a permanent address, and noting the date within the three-year period on which permission to publish is to be granted. Request for copies of master’s theses should be addressed to UCLA Reprographic Services, 2801 Engineering I.

Doctoral Dissertations

ProQuest publishes UCLA doctoral dissertations in microfilm form and in paper copies from the microfilm. Braille editions and special sound recordings of nondramatic literary works are provided for the blind and physically handicapped with the student’s permission (see item 15 on the ProQuest Agreement form). The abstract of the dissertation is published in Dissertations Abstracts International. Copies of the abstract, and copies of the dissertation in soft cover, hard cover, microfiche or rolifilm may be ordered at the time of filing through ProQuest, at a discounted rate, using the agreement form. A student should allow about five months from the time of filing for the request to be processed and the copies delivered.

B. REGISTRATION OF COPYRIGHT

The need to register copyright depends on the nature of the materials and on plans for the future publication or revision of the manuscript. Under present law, the works of an author are protected from the date of creation and on throughout the life of the author, plus another fifty years thereafter (Public Law 94-553, The Copyright Act 1976, effective January 1, 1978). Whether the thesis or dissertation copyright is registered or not, the author retains the right to publish all or any part of the manuscript by any means at any time, except, in the case of the doctoral dissertation, as described in the ProQuest Agreement. Registration of the copyright puts on public record the exact details of a copyright claim. In order to bring suit against an infringer, registration is necessary.

Further information about copyright may be obtained at www.loc.gov/copyright.

If a registration of copyright is desired, the student prepares the copyright page (instructions on page 15) for notification of copyright in the thesis or dissertation.

Master’s Thesis

Master’s candidates are responsible for registering the thesis and may do so by applying directly to the Registrar of Copyright, Copyright Office, Library of Congress, 101 Independence Avenue S.E., Washington, D. C. 20559-6000, (202) 707-9100.

Doctoral Dissertations

ProQuest will file the application for registration of a claim of copyright on behalf of a doctoral candidate. The candidate completes the appropriate section of the ProQuest form, signs the authorization on the back of the form, and submits the required fee in a certified check or money order (made payable to ProQuest) as

33

part of the filing process. ProQuest pays the registration fee, prepares the application, and deposits the copies required by the Copyright Office. The Copyright Office mails the certificate of registration to the candidate approximately five months after ProQuest receives the manuscript.

34

                   IMPORTANT REFERENCE NUMBERS

Questions regarding manuscript format:

Theses and Dissertations Adviser (310) 825-3625

21560 Young Research Library

Office hours: 12:00 PM - 4:00 PM, Monday through Friday

      www.library.ucla.edu/welcome/services/thesis.htm

Questions regarding completion of academic requirements:

Graduate Division: Graduate Admissions/Student and Academic Affairs (310) 825-3819

1255 Murphy Hall

Office hours: 9:00 AM - 5:00 PM, Monday through Friday

www.gdnet.ucla.edu

Questions regarding degree certification and diplomas:

Registrar’s Office Certificates of Completion

1105 Murphy Hall

Doctoral and Master’s Candidates (310) 825-3248

Student Services, Verification and Transcripts

1134 Murphy Hall

   For confirmation of candidate’s name and major (310) 206-0482 Office hours: 9:00 AM - 5:00 PM, Monday through Friday

Questions regarding copyright and publications:

Copyright Information and Registration Forms*

Copyright Office

Library of Congress

Washington, D.C. 20559 (202) 707-9100

www.loc.gov/copyright

ProQuest (formerly UMI)

300 North Zeeb Road

Ann Arbor, Michigan 48106 (800) 521-0600

ext. 7020

http://proquest.com/proquest/

*Master’s degree candidates may find this information helpful if they wish to register copyright of their theses. Doctoral candidates may instruct ProQuest to register copyright for them.

Questions regarding computer word processing:

http://computerlabs.clicc.ucla.edu

http://computerlabs.clicc.ucla.edu/Info.asp?LabID=4

35

AAO-HNSF Call for Science

INSTRUCTION COURSE

About the Annual Meeting & OTO EXPOSE

The AAO-HNSF Annual Meeting & OTO EXPOSM is the premier education and networking event for the otolaryngologist-head and neck surgery community. More than 5,500 of the brightest and most talented medical experts from around the globe will convene for this unique once-a-year opportunity to share practical and comprehensive knowledge to advance the specialty.

Each year, the AAO-HNSF receives and reviews hundreds of abstracts and proposals submitted by otolaryngologists and healthcare professionals. If accepted, your education session proposal or abstract will be presented live during the event.

Instruction Courses

Instruction Course sessions are one- or two-hour sessions that address current diagnostic, therapeutic, and practice

management topics.

Eligibility Requirements

* Members and non-members of the AAO-HNS are eligible to submit an abstract or proposal.

* NEW RULE: A presenter may only four (4) times during the conference.

* Abstracts addressing one or more of the identified Clinical Topics will be given special consideration during the review and selection process.

* All submissions must be made online by the deadline. Changes to proposals may not be made once the deadline passes. Submission Deadline: Monday, December 14, 2015 at 11:59 pm EST – no exceptions. You will not be able to submit proposals after midnight on Monday, December 14, 2015.

* Be sure to follow all the procedures posted on the submission site. Failure to complete all the required fields will result in the proposal not being successfully submitted.

* Submission of a proposal constitutes a commitment by the presenter(s) to present if selected. Failure to present will result in exclusion from the program for up to two years.

* All presenters are required to register for the Annual Meeting and pay all applicable fees. An exception to this rule will only be made for non-otolaryngologists who are also NON-AAO-HNSF members. Please contact programs@entnet.org for details.

* The Academy will notify presenters of the acceptance or rejection status of submitted proposals via email.

Instruction Course Guidelines

* Instruction Courses are limited to two instructors for a one-hour course and up to four instructors for a two-hour course.

* It is preferred that ALL instruction Course presenters be a minimum of five-years out of residency/fellowship training.

1

New Course: Course is being submitted for the FIRST time for consideration in the Academy's Instruction Course program.

Previously Offered Course:

* The course has been offered within the last three years.

* All selected courses will be offered for one year. If a course has been offered previously it will be reviewed by the Annual Meeting Program Committee to determine if:

o it is continuing to fulfill the needs of the Academy's Annual Meeting attendees

o it is attracting reasonably-sized audiences;

o there is meeting room space available.

Submission Dates

Instruction Course

Submission Dates

Review Process

November 9-December 14, 2015 January 4- February 8, 2016

Submission Review Process

After the submission deadline, completed abstracts and proposals will be peer-reviewed. “Incomplete” abstracts or proposals are considered incomplete and will not be reviewed. To ensure the integrity of the review process, revisions to abstracts and proposals will not be accepted after the submission deadline – no exceptions. Abstracts will be peer-reviewed by the responsible committee according to subject categories.

Notification

The AAO-HNSF will notify the Lead Instructor of the status of their submissions upon the final review and decision of the committee and Program Chair. The AAO-HNSF graciously requests that all interested parties please refrain from directly contacting the AAO-HNSF to obtain information regarding abstract status, notification distribution and/or publication dates. Please check the Annual Meeting website regularly for the most up-to-date information.

Proposal Components

SESSION TITLE (limited to 10 words)

Make sure your title is listed as you would like it to be published on the Convention website (if selected), including correct grammar, capitalization, and punctuation. While a catchy session title can attract the attention of meeting attendees, the proposal itself should be clear and complete in order to be favorably viewed by the Program Committee.

SPECIALTY AREA

Select one of the listed categories for your proposed session. The Committee has the right to reassign the specialty area

if deemed appropriate.

* Business of Medicine/Practice Management

* Endocrine Surgery

* Facial Plastic and Reconstructive Surgery

* General Otolaryngology

* Head and Neck Surgery

* Laryngology/Broncho-Esophagology

* Maintenance of Certification

* Otology/Neurotology

* Pediatric Otolaryngology

2

* Rhinology/Allergy

* Sleep Medicine

DESCRIPTION

Provide a concise description that will explain the focus and significance of your proposed session. You should provide a succinct description of the relevance of this program to the practice of otolaryngology and the purpose (goals) of the presentation. If selected, your description will be published online to help attendees choose among sessions.

OUTCOME OBJECTIVES

Objectives focus participant’s attention on the expected outcome of the presentation. You should state clearly what attendees can expect to learn during the session. Begin each statement as if it was preceded by "Upon completion of this session, participants should be able to." Follow a numbered structure and start with a verb (i.e. analyze, compare, demonstrate, examine, explain, implement, interpret, recognize, etc.). We recommend that you provide at least two objectives. If selected, your objectives will be published online to help attendees choose among sessions.

PRESENTATION FORMAT

Instruction Courses are offered in the following formats:

* Didactic Lecture – Course will be presented in a large-audience lecture setting.

* Audience Polling – Presentations include the opportunity for audience members to respond to polling questions. Please consider this option only if your presentation is suited to audience participation in the discussion.

* Hands-On – Hands-On courses are classroom set and limited to 40 participants.

* Mini-Course – Mini-Courses are conference set promoting informal discussion and the exchange of information. These courses will be limited to 25 participants.

LENGTH REQUESTED

* One-Hour

* Two-Hour

AUDIENCE

What audience segment would benefit most from this session? (check all that apply)

* Residents

* Young Physicians

* Internationals Physicians

* Researchers

* Academic Physicians

* Private Practitioners

CLINICAL TOPICS

The following topics were identified in a comprehensive gap analysis conducted by the Foundation education committees. A clear learning need has been identified for each of these topics. Abstracts addressing one or more of these topics will be given special consideration during the review and selection process.

* Chronic Rhinosinusitis

* Complications of Chemoradiotherapy

* Dizzy Patient

* Emerging Role of HPV

* Endoscopic Skull Base Surgery

* 

Facial Trauma

* Healthcare Reform, Managed Care, Reimbursement

* Immunotherapy

* Laryngeal Laser Surgery

* Nasal Valve Problems 

* 

Non-Allergic Rhinitis

* OSA Surgical Treatment Options

* Otitis Media and Ear Tubes

* Patient Satisfaction and Compliance

3

* Pediatric OSA

* Pediatric Postoperative

Pain Management

* Reflux: GERD And LPR

* Sialoendoscopy

* Soft Tissue Engineering And Application to the Head and Neck

* Stroboscopy

* Sudden Hearing Loss

* Thyroid Carcinoma

* Tinnitus

* Vocal Fold Paralysis and Injection

* Not Applicable

PROFESSIONAL PRACTICE GAP AND NEEDS STATEMENT

Please indicate which Practice Gap this live education event serves to fill:

* Patient Safety, related to:

* Clinical research, related to:

* Basic science research, related to:

* Technology and technique, related to:

* Education research, related to:

* Clinical Practice, related to:

* Other:

* Not Applicable

EDUCATIONAL NEEDS

Regarding the educational need above – participants need (check all that apply).

* More information about the subject (knowledge)

* More strategies or skills to apply their knowledge to practiced (competence)

* To actually do something differently in practice (performance)

* Not Applicable

LANGUAGE

Will your presentation be presented in a language other than English?

AAO-HNS/F OTHER EDUCATION OFFERINGS

AAO-HNS/F members have access to a catalog of education offerings and resources. If accepted, would you be willing to

contribute content in any of these areas:

* Online Courses and Lectures

* Otolaryngology-Head and Neck Surgery Journal

* AAO-HNS/F Bulletin article

* Clinical Practice Guidelines

* Not at this Time

SPEAKER INFORMATION

All correspondences from the AAO-HNSF regarding this submission will be directed to the LEAD INSTRUCTOR. All fields

are required for all presenters. Please do not use the same email address for additional presenters.

* Lead Instructor: Instruction Courses are meant to be presented by experts in our field and so higher priority will be given to courses presented by seasoned instructors. If you intend to be the lead instructor, you must select yourself in this step and enter the information in all required fields. An Instruction Course presenter may only present up to three (3) instruction courses or five (5) hours during the Annual Meeting.

* Co-Instructor(s): The number of co-instructors that may participate depends on the duration of the course requested. You may identify up to one co-instructor for a one-hour course and up to three co-instructors for a two-hour course. The Committee reserves the right to adjust the number of hours when a course is accepted. In all cases, the first instructor listed is considered the lead instructor. An Instruction Course presenter may present up to three (3) instruction courses or five (5) hours during the Annual Meeting.

4

QUESTIONS?

For general inquiries regarding the submission process: Contact us by email at programs@entnet.org.

For technical assistance regarding the submission site: Contact CadmiumCD technical support by phone at (410) 638

9239 or by e-mail at support@ConferenceAbstracts.com, Monday through Friday, between 9:00 am and 6:00 pm,

Eastern Standard Time.

5

Health and Human Performance Exit Exam Study Guide

The questions for the HHP exit exam were selected from the major course content and from content that the instructors of the course feel will be repeated in subsequent classes. It is not the intention of the HHP faculty to submit questions that are misleading or confusing. The following is a list of topics, by course, that you can use to study. The object is to look at the topic and realize that you need to fully understand that topic and not just a definition of what it “is”.

HPER 207

1. Physical Activity Guidelines

2. Physiological benefits of exercise

3. The five health related components of fitness

4. Assessing the five health related components of fitness

5. Creating a balanced physical activity and exercise program

6. Aerobic activity workout components

7. Resistance Training Programming and Components

8. Flexibility Training and Components

9. Principles of exercising for Weight Management

10. Behavioral Techniques associated with Exercise Adherence

HPER 350

1. Motor Behavior and Related Fields

2. One-Dimension Motor Skill Classification Systems

3. Gentile’s Two-Dimensions Taxonomy

4. Fundamental Motor Skills

5. Motor Abilities

6. Motor Learning and Performance

7. Stages of Learning

8. Transfer of Learning

9. Motor Development

10. Motor Development Constraints

HPER 432

1. Motivation

2. Arousal and Anxiety

3. Intrinsic Motivation and Flow

4. Personality

5. Group Cohesion

6. Arousal Regulation

7. Imagery

8. Self-Confidence

9. Goal Setting

10. Concentration

Health and Human Performance Exit Exam Study Guide

HPER 435

1. Carbohydrate, fat, protein use and storage in the body

2. What are the primary macronutrients and energy supplied by each

3. Types of carbohydrates, their use and function

4. Vitamin use in the general population

5. Nutrition and exercise on bone health

6. Calorie intake and expenditure in weight loss

7. Diet and exercise in resistance to illness and disease

8. RDA of macronutrients and the daily reference value for daily intake

HPER 440

1. Variables (dependent and independent) how they are used in research

2. How data is displayed on various graphs

3. What are the types of statistical tests to research relationships vs. differences

4. Why we collect data, how we use the results

5. Probability of error (alpha level) or confidence level

6. Inferential and descriptive statistics, what they are and how they are used

7. Subjective and objective evaluation of skills

8. Types of validation and reliability

HLTH 111

1. What is good health

2. What is a Behavior Change model

3. What is stress and how does a person cope

4. Know good fitness practices and weight loss practices

5. What are macronutrients and what are their purpose

6. The effects of tobacco and alcohol

7. Safe and safer sex practices, including disease prevention

8. Leading causes of death in the United States

9. Self-care

HLTH 220

1. Identify how to make appropriate decision and to prioritize those decisions when administering first aid.

2. Recognize the treatment and demonstrate the care of life-threatening emergencies: breathing, choking, and cardiac arrest for infants, small children, and adults. (CPR)

3. Identify the variables that must be controlled when treating bleeding, wounds, and shock victims.

Health and Human Performance Exit Exam Study Guide

4. Describe and demonstrate the care for the following medical emergencies: poisoning,

bites, stings, heat and cold exposure, burns, diabetes and seizures, eye, nose, jaw, mouth,

and tooth injuries.

5. Describe principles of cold application, elevation, and compression in treatment of sprains, strains, fractures and dislocations.

6. Recognize signs and symptoms of head trauma, and changes in neurological assessment.

7. Recognize signs and symptoms of trauma to the spinal cord and identify cervical stabilization device.

8. Recognize signs and symptoms of shock.

9. Become familiar with the procedures concerning Automated External Defibrillator. (AED)

10. Describe his/her role as a citizen responder in the Emergency Medical Service System.

HLTH 330

1. Key Characteristics of Epidemiology

2. Interrelationship between Disease Incidence and Prevalence

3. Vital Statistics

4. Prevention

5. Morbidity and Mortality Rates

6. Epidemiologic Study Design

7. Descriptive Epidemiology

8. Analytical Epidemiology

9. Behavioral Epidemiology

10. Epidemiologic Triangle and Web of Causation

HLTH 351

1. Substance Abuse versus Substance Dependence

2. Physical versus Psychological Dependence

3. Drug Interactions

4. Tolerance

5. Substance Abuse Prevention

6. Ergogenic Drugs

7. Drug Administration

8. Drug Metabolism

9. Substance Use/Abuse Effect on Neurotransmitters

10. Substance Abuse/Dependence Treatment

HLTH 410

1. Health Education and Promotion

2. Levels of Prevention

Health and Human Performance Exit Exam Study Guide

3. Generalized Model of Program Planning

4. Process of Identifying Health Needs in a Population

5. Prioritizing Needs

6. Components and types of Program Objectives

7. Link between theories and Interventions

8. Types of Intervention Strategies

9. Components of Logic Models

10. Framework for Evaluation

EXSC 305

1. Types of muscle contraction and the effect on joint movement

2. Planes of movement and types of movements within those planes

3. Major muscle groups and their actions

4. Anatomical positioning and types of joint movement (flexion, extension, etc.)

5. Characteristics of mobility vs. stability

EXSC 430

Cardiorespiratory adaptations: 

Understand how we adapt to aerobic and anaerobic exercise as it relates to:

HR

Stroke volume

Q

BP (systolic/diastolic)

Ventilation

Muscular adaptations: 

Understand how we adapt to aerobic and anaerobic exercise as it relates to:

Muscle size

Muscle contraction

Neurological response

SO

FG

FOG

Metabolism: 

Understand the three energy systems as it relates to:

Fuel source

Intensity

Duration

Key enzymes

Aerobic/anaerobic activity

Health and Human Performance Exit Exam Study Guide

Terms:

ATP ATPpcr Enzyme Substrate PFK Lactate

Aerobic Anaerobic ETS Kreb cycle lactate threshold Atrophy

Frank Starling mechanism MET MHR Local control of blood flow

F.I.T. DOMS Eccentric Concentric Action potential Hypertrophy

Hyperplasia Isokinetic Isotonic Isometric Peripheral fatigue Central

fatigue Task-Dependency Model Accumulation Hypothesis Depletion Hypothesis

All or none principal NADH FADH ATPase Isocitrate dehydrogenase

LDH PC Oxygen debt Oxygen deficit EPOC

Dissociation curve RER Vo2Max Overload Specificity Progression

Avo2 difference Aerobic glycolysis Anaerobic glycolysis

EXSC 431

1. Health assessment

2. Risk stratification

3. Metabolic equations

4. Rx

5. Criteria for risk stratification

6. Criteria for health assessment

Sport Management 305 Introduction to Sport Management and Administration

1. Understand, describe, and apply basic administrative principles as applied to sport organizations and industry.

2. Identify and explain administrative/organizational theories, terminology, and structure as they exist in sport settings.

3. Understand, describe, and apply basic principles regarding management, marketing and finance for sport organizations.

4. Understand, describe, and apply basic legal and ethical principles as applied to sport organizations.

5. Design and implement programs utilizing organizational principles for the administration of sport related programs.

Sport Management 406 Advanced Sport Management and Administration

1. Articulate thoughtful positions on several current issues facing the sport industry today and in the near future.

2. Indentify and describe several theories relating to sport management and administration.

3. Feel more comfortable presenting sport management academic contents and current issues in sport.

4. Demonstrate effective communication and presenting skills.

5. Prepare future career in sport.

Sport Management 413Event and Facility Planning

1. Recognize the necessary steps in managing a facility.

2. Discuss the similarities and differences between event and facility management

Health and Human Performance Exit Exam Study Guide

3. Demonstrate an understanding of the procedures, principles, and current trends in planning and managing an event or facility

4. Explain the need for effective risk management of facilities and events.

5. Knowledge of venue and event management.

6. An understanding of the importance of customer service.

7. Importance of economic impact of venues and events.

8. Understand the unique situations involved in running international events.

The

International

Journal of Tuberculosis

and Lung Disease

Guidelines for preparing manuscripts on qualitative

research in the IJTLD

Ellen M. H. Mitchell, Ian Harper & Sally Theobald, Associate Editors, IJTLD

Introduction

There is debate about how to ensure quality in qualitative research, which is shaped by different theoretical positions. While there is no agreed checklist for qualitative research quality, there are quality standards that are maintained by the major biomedical journals and to which IJTLD adheres.1 These guidelines are intended to improve the quality of qualitative manuscript submissions to the Journal.

Scope

Qualitative manuscripts are sought that shed light on why particular TB control and lung care efforts are successful or unsuccessful and how they can be improved. Research that focuses on experiences of diverse actors and their implications are welcome. Qualitative research that helps to overcome challenges of health care delivery (for example, TB prevention, access to services, diagnosis and adherence) are preferable to those that simply analyse problems and dilemmas.

Rationale and specific aims

Although qualitative studies may ask broad, exploratory and inter-connected questions that are not always pre-specifiable as conventional hypotheses, it is necessary to offer a cogent and well-reasoned justification or rationale for your inquiry.2 These might be construed as broad research issues to be investigated, rather than pre-determined hypotheses.

Background and significance

Rather than a mere summary of what has been written before, the introduction should display a broad understanding of how the literature fits together and leads to the current inquiry.3 Introductions should include relevant qualitative and quantitative literature on your topic. It is sometimes appropriate to adopt a critical stance towards what exists and highlight any gaps or methodological limitations of previous research, and at other times to stress the importance of previous work in informing your own study design.3

Setting and context

Qualitative findings are generally expected to be more context-driven, relational and reflexive

than quantitative findings.4 A concise description of the setting(s) where the research took

2

place is essential. A common weakness in qualitative manuscripts submitted to the IJTLD has been a tendency to offer only a national or regional overview of notified cases and estimated prevalence, while neglecting the social, cultural, gender, economic or political context in which TB control is embedded. Good qualitative articles will illuminate the social, gender, cultural, economic, or political dynamics that shape transmission, case-finding, diagnosis and treatment outcomes.3

Theoretical frameworks

Transparency about the conceptual framework(s) and theoretical perspectives applied is important.1 The point of departure of most IJTLD manuscripts is cosmopolitan biomedicine. In qualitative research, the assumptions of cosmopolitan biomedicine may be treated as one of several aetiological frames that may be operating in a particular setting.4

Methodology

There should be a logical relationship between the research questions, the methods selected and the analytical approach chosen. It is important to avoid jargon. A lack of understanding of qualitative concepts among IJTLD audiences obliges authors be particularly explicit with the rationale behind their methodological choices. Many concepts (e.g., sampling, reliability, coding and observation) have different meanings in quantitative and qualitative research, so you need to be specific. There should be consistency in the ways in which key concepts are defined, used and subsequently applied throughout the manuscript. Table 1 offers some examples of how particular methodologies offer advantages for certain research aims.

Table 1 Illustrative examples of qualitative methods suitable for specific topics

Method

Good for the study of

Not ideal for the study of

Interviews

Experiences, perceptions, beliefs, attitudes, private discourses

Clinical practices

Focus groups

Group dynamics, public discourses, community norms,

Stigmatised behaviours, sensitive issues

Ethnography

Sub-cultures, organisational cultures and practices, inter-cultural interactions, habits, non-adherence, enacted stigma,

Time-sensitive issues

Structured observation

Clinical practices, quality of care, infection control, etc.

Attitudes, perceptions

Textual

analysis

Policies, messaging, framing and representation

Policy implementation

Well-written manuscripts will convince the reader that the methodology(ies) employed was/were the most appropriate by, crucially, linking it to the research question, and being transparent about the logic behind adaptations.

3

As with quantitative manuscripts, it is critical to address issues of access, consent, language, translation, recruitment, refusal, reimbursement and retention. In particular, if translation is undertaken, it may be necessary to describe this process, and explore the possible multiple meanings of words and phrases. In trying to interpret the experiences and meanings attributed to particular groups and cultures it is important that manuscripts do not reinforce stereotypes or use judgmental language. Always describe what quality controls were used to assess the validity or trustworthiness of the findings (e.g., piloting, triangulation, participant checking, etc.).5,6

Sampling

Avoid generalities. It is not sufficient to simply say that ‘purposive sampling’ was used without defining the purpose behind it. Reviewers will want to know why certain characteristics were deemed important enough to guide selection and see these characteristics used in the analysis.

Sample size

There are multiple approaches to sample size determination in qualitative methods, and you can make reference to considerations including redundancy, saturation, stratification and range. A scientific (or at least credible) rationale for the sample size is required.1 In ethnography and participant observation, samples might be quite small (n < 20), but the richness of the data set should compensate for the narrowness. It is a fallacy that sampling and sample size are unimportant in qualitative research.7

Data collection

Simply naming the data collection technique is insufficient (e.g., semi-structured interviews). Data collection might be done using recording devices or in extensive field notes. This should be detailed appropriately.1 Authors should indicate how potential threats to validity, such as social desirability bias or the Hawthorne effect, were addressed and discuss implications for the analysis. It is important to highlight steps the research team has undertaken to enhance the trustworthiness or rigour of the research approach, for example, participant checking, prolonged engagement or triangulation.8-10 This should include disclosure of the linguistic, cultural, methodological competencies of the research team members.1,3

Data analysis

Simply saying ‘a qualitative approach to analysis was undertaken’ is not sufficient. Specify if codes or themes were developed a priori or ad hoc (during the processing of data).3 Unlike quantitative methods, in qualitative research, data collection and analysis are often concurrent. It is not essential to imply that they were linear or sequential if they were not.11

Be clear and accountable about who participated in the analysis and what approach to analysis was undertaken, with links to the literature as appropriate. If multiple analysts coded the data, indicate whether and how inter-coder reliability was assured. If qualitative software was used, fully describe the ways it was employed and any issues that may have restricted its utility.12

4

Data interpretation

Interpretation of data will depend on the questions asked, and on the theoretical and methodological approaches taken.13 Historically, the audience of the IJTLD can be described as sceptical of and somewhat unfamiliar with qualitative methods, and it is therefore important to offer compelling proof that analytical methods are rigorous and transparent, yielding both fascinating and useful results.

In qualitative research, there is a logical emphasis on the nature and quality of rapport between the research team and the participants. It is common practice to address the social position of the researcher (through taking a reflexive approach) in the manuscript and to scrutinise how this may influence the data gathered.1,10

In quantitative work there is a tendency to strenuously defend one’s method due to the inability to make mid-course corrections. However, a good qualitative study may, and some argue should, evolve over time and generate unexpected findings. It is often difficult to determine in advance who holds the answer to the question and how best to get it. Therefore it is vital to describe what was done and any refinements of the research question or method in the course of the project.11 This methodological flexibility is often mistaken for an acceptance of data collection that is driven by convenience or whimsy as opposed to a logical flow from theoretical imperatives.3 The manuscript should offer a cogent rationale for why methods or instruments evolved.

Quotations and thick description

The use of quotes should be judicious and used to emphasise the main thrust of the analytical argument and interpretation being developed.14 While the identities of participants are normally concealed, it is expected that some relevant descriptors are provided to enhance the interpretation of quotations. The voices of the participants and those of the researchers should be readily distinguishable.10,12

Qualitative findings can also be well summarised in diagrammatic, tabular and numerical form if the pitfalls are avoided.15

Limitations

It is not essential that qualitative study results be representative or broadly generalisable, but it is essential to critically discuss the usefulness of findings that are not.3,10In some cases the theoretical implications of the study might be important. Consider the effect of relationships, cultural, class or gender disparities, limited access and other factors that impact the quality of the data collected. Share your manuscript with critical colleagues to anticipate reviewers’ concerns and discuss them.3

5

Implications

Authors are invited to place special emphasis on the utility of their findings and to emphasise

how they should inform tuberculosis and lung health policy and practice.

A note on length

Because much social science research may involve quoting from participants, reflection on process, detailed description of context, and is less readily summarised in tabular form, it may require a higher word count than quantitative articles.2,3 Therefore, the word count for a qualitative manuscript may be as high as 3,500 words. For ethnographies and case studies with extensive quotation or discourse analysis, we recommend that authors consider submission to our sister journal, Public Health Action, which accepts qualitative submissions of up to 8,000 words.

Protecting human participants

Qualitative manuscripts should be explicit about steps taken to shield participants from social and physical risks. When research involves hidden, stigmatised or marginalised populations, it is important to be clear and concise as to the procedures used to protect both privacy and confidentiality, prevent coercion, and uphold ethical principles of justice and beneficence. Similarly it is important to relate the responsibilities of the researchers to the relevant ethical guidelines (for example, those of the respective anthropological and sociological associations). The safety issues are frequently significantly different to those of quantitative research and should not be entirely over-determined by medical ethics in isolation.13 The justification for what was done, and how this was guided by certain ethical principles, may require reflection in the final article (rather than just a statement saying that relevant clearance has been achieved). Any queries can be directed to the Union’s Ethics Advisory Group.

Special topics:

Literature reviews

Literature reviews are welcome, particularly scoping reviews of qualitative research on particular issues of relevance to the Journal readership. These can be complex, however, and should address questions of comparability.16-18 Pre-submission queries are required for all review articles submitted to the IJTLD (see Instructions to Authors).

Combining quantitative and qualitative methods

Authors of mixed-method manuscripts must make a very concise, yet compelling, case for how both methods mutually inform the study.19 Mixed methods papers often require lengthy descriptions of study procedures, offering little space for discussion and conclusions. A common weakness is mixed-method manuscripts is that one methodology is described comprehensively and the other is superficially developed. If both methods are used, it is essential to describe the relationship between the data collected.20

Recommended resources for methodological guidance qualitative research 

1. The Robert Wood Johnson Foundation has sponsored the Qualitative Research Guidelines Project t. This website is useful for people developing, evaluating and engaging in qualitative research projects in healthcare

settings. https://c28lmydqm3bt4o2die.sec.amc.nl/ 

2. For reporting of interview and focus groups data, the COREQ checklist is recommended: Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care 2007; 19: 349-357.

3. British Medical Journal Qualitative Research Checklist

http://resources.bmj.com/bmj/authors/checklists-forms/editors-checklists 

4. Qualitative Methods in Health Research: Opportunities and Considerations in Application and Review. Office of Behavioral and Social Sciences Research National Institutes of Health.

References

1. Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care 2007; 19: 349-357.

2. Kitto S C, Chesters J, Grobich C. Quality in qualitative research. Med J Austr 2008; 188: 243-246.

3. Lamont M. Workshop on interdisciplinary standards for systematic qualitative research. Washington, DC, USA: National Science Foundation, 2009 http://www.nsf.gov/sbe/ses/soc/ISSQR_workshop_rpt.pdf Accessed November 2011.

4. Horsburgh D. Evaluation of qualitative research. J Clin Nurs 2003; 12: 307-312.

5. Collingridge D S, Gantt E E. The quality of qualitative research. Am J Med Qual 2008; 23: 389-395.

6. Mays N, Pope C. Qualitative research in health care: assessing quality in qualitative research. Brit Med J 7226; 320: 50-52.

7. Sandelowski M. Sample size in qualitative research. Res Nurs Health 1995; 18: 179-183.

8. Sandelowski M. Rigor or rigor mortis: the problem of rigor in qualitative research revisited. ANS. Adv Nurs Sci 1993; 16: 1-8.

9. Tuckett A G. Part II. Rigour in qualitative research: complexities and solutions. Nurse Res 2005; 13: 29-42.

10. Malterud K. Qualitative research: standards, challenges, and guidelines. The Lancet 2001; 358: 483-488.

11. Forman J, Creswell J W, Damschroder L, Kowalski C P, Krein S L. Qualitative research methods: key features and insights gained from use in infection prevention research. Am J Infect Control 2008; 36: 764-771.

12. Sandelowski M. On the aesthetics of qualitative research. Image J Nursing Schol 1995; 27: 205-209.

13. Stige B, Malterud K, Midtgarden T. Toward an agenda for evaluation of qualitative research. Qual Health Res 2009; 19: 1504-1516.

14. Sandelowski M. The use of quotes in qualitative research. Res Nurs Health 1994; 17: 479-482.

15. Sandelowski M. Real qualitative researchers do not count: the use of numbers in qualitative research. Res Nurs Health 2001; 24: 230-240.

16. Sandelowski M, Voils C I, Barroso J, Lee E J. 'Distorted into clarity': a methodological case study illustrating the paradox of systematic review. Res Nurs Health 2008; 31: 454-465.

17. Sandelowski M. Docherty S, Emden C. Focus on qualitative methods. Qualitative metasynthesis: issues and techniques. Res Nurs Health 1997; 20: 365-371.

18. Sandelowski M. Reading, writing and systematic review. J Adv Nurs 2008; 64: 104-110.

19. Morse J M. Serving two masters: the qualitatively-driven, mixed-method proposal. Qual Health Res 2008; 18: 1607-1608.

20. Sandelowski M. Combining qualitative and quantitative sampling, data collection, and analysis techniques in mixed-method studies. Res Nurs Health 2000; 23: 246-255.

Applying for a stay abroad at ETH Zurich, academic year 2018/19: Instructions for regular visiting students

Preparation (before online application) and application deadlines 2

1. Rules and Conditions 2

Admission Requirements 2

Language 2

Admission decision 3

Time Frame 3

2. Important information about visiting studies at ETH Zurich 3

Semester dates 3

Visa and residence permit 3

Health Insurance 4

Studying with a disability: Where can I get help and advice? 4

Accommodation 4

Living costs in Zurich 4

German courses 4

Arrival and enrolment at ETH Zurich 4

Department of Biosystems Science and Engineering (D-BSSE) in Basel 4

Living/Studying outside of the canton of Zurich 4

3. Documents required for online application 5

Study plan 5

Letter of recognition from your home university 5

Transcript of records 5

Grading Key 5

List of courses to be completed prior to mobility studies 5

Language skills 5

Passport 5

Photo 5

CV 5

Motivation Letter 5

Students of Architecture: Portfolio 5

4. Visiting Students: Invoices and fees 6

Application and Tuition Fees 6

Application fee 6

Invoicing of tuition fees 6

5. Preparing a Study Plan 6

6. Application procedure 6

Application form 6

Login 6

Adding data 7

Study plan 7

Projects (if applicable) 8

Documents 8

Submitting the application 8

Next steps 8

Version 1.0

1 / 8

Preparation (before online application) and application deadlines

The application deadlines at ETH Zurich are as follows:

4 For the Autumn Semester: 15 April

    (online application completed and submitted, including all documents) 4 For the Spring Semester: 15 October

(online application completed and submitted, including all documents)

1. Rules and Conditions

Students from a university that has no exchange agreement with ETH Zurich may apply as visiting students. If you plan to attend courses at ETH Zurich, you must apply as a regular visiting student.

Visiting students may study at ETH Zurich for a maximum of two semesters. Your home university must recognise and credit the results of your visiting studies at ETH Zurich. Your curriculum will therefore be drawn up in accordance with the requirements of your home university. You will not receive an ETH degree for your visiting studies.

Only students matriculated/enrolled at universities are accepted as visiting students. Students from non-university colleges or universities of applied sciences are not admitted. Please contact us if you are unsure whether your university fulfils these criteria. Please note that regular visiting students will not be accepted from partner universities that already have an exchange agreement with the department in question.

Regular visiting students must pay the regular tuition fees as ETH students, amounting to a maximum of CHF 580 per semester (in addition to the mandatory fees of CHF 69 per semester enrolment). Please note that visiting students are not eligible for tuition fee waivers. Please also see below for further details on invoices and fees.

Please note that the application is binding.

Admission Requirements

* You must be matriculated at a university or a technical university as a Bachelor, Master or Diploma student (doctoral students are usually registered with a different status).

* You can only be admitted as a visiting student if you are enrolled in a university or technical university that has the right to award doctorates (universities of applied sciences are thus not eligible). Please contact the Student Exchange Office of ETH Zurich if you are not sure about the status of your home university. As a rule, Colleges and Liberal Arts Colleges that do not award doctorates do not meet the above-mentioned criteria because their curriculum has a different structure. Exceptions may be made on an individual case-by-case basis only and require students to get in touch with the Student Exchange Office at an early stage before their application.

* You must have passed the first-year/preliminary exams, have earned 120 ECTS credits, or have successfully completed at least two years of study at a university or a technical university until the start of your potential stay at ETH Zurich.

* You must have a very good academic record (as proven by your transcript of records).

* Your home university must recognise and credit your stay at ETH Zurich. Your curriculum will therefore be drawn up in accordance with the requirements of your home university.

* Visiting students must respect the official semester and examination dates, i.e. you must plan your mobility period to ensure your presence at ETH Zurich during the examination sessions. Visiting students are not  allowed to shift their examinations (neither preponement nor distance examinations are allowed).

* You must have sufficient language skills, see below.

Language

A good knowledge of German is recommended for all students and is a requirement if you plan to attend courses in German. A good knowledge of English is equally important, as many courses are given in English.

Students whose native language is not German or English must prove that they know sufficient German and/or English in order to act in an academic context (level C1 of the Common European Framework of Reference for Languages is recommended, level B2 is the minimum requirement). You need to provide a confirmation only for the language(s) in which you plan to take courses. We accept all well-established language certificates or a confirmation from a supervisor/language teacher at your home university.

2 / 8

Admission decision

The Student Exchange Office cannot answer any academic questions or make any assessment of an application’s chances of success. The decision about admission as a visiting student is made by the department to which you apply. This decision is based on your grades and study achievements, your letter of motivation, your study plan for ETH Zurich, and the capacity of the department to accommodate visiting students related to the number of applications received. In Architecture, students must also submit a portfolio with the application. The portfolio plays an important part in the department's decision.

Time Frame

Applicants are usually informed about the admission decision via e-mail a few weeks after the application deadline - irrespective of whether they submitted their application earlier or not (i.e. no rolling admission).

2. Important information about visiting studies at ETH Zurich Semester dates

Autumn semester 2018

Spring semester 2019

Official semester dates

17.09.2018

– 15.02.2019

18.02.2019

– 30.08.2019

Lectures

17.09.2018

– 21.12.2018

18.02.2019

– 31.05.2019

End-of-semester exams

10.12.2018

07.01.2019

– 21.12.2018 and

– 18.01.2019

20.05.2019

– 14.06.2019

Session exams

21.01.2019

– 15.02.2019

05.08.2019

– 30.08.2019

When planning your stay at ETH Zurich, be aware of the semester dates and examination periods as you cannot shift any exams! See website on study planning for further details about the examinations.

Visa and residence permit

Citizens of the European Union or EFTA states do not require a visa for Switzerland and therefore need do nothing in this regard before their arrival. Citizens of other countries must check with the Swiss Embassy whether they need a visa for Switzerland. You are responsible for determining whether you need an entry visa and, if applicable, for obtaining the visa; you will receive detailed information about the visa application

process and the necessary official confirmation from us if your application to ETH Zurich is successful. Please note that the process of obtaining a student visa will take up to 3 months, so timely application for your visa is essential! Do not enter Switzerland with a tourist visa or with a Schengen residence permit: these allow you to travel to Switzerland as a tourist, but not to study there! Any questions regarding the visa requirements or process must be addressed directly to the respective Swiss embassy/consulate abroad.

Regardless of your nationality, to obtain a residence permit you must register with the appropriate authority within 14 days of your arrival in Switzerland. You will find more information about this procedure in your ETH Zurich letter of acceptance.

Proof of sufficient financial means:

Visiting students must produce evidence of sufficient financial means to support their stay in Switzerland. You can do so by providing bank statements, scholarship awards, or (if you are an EU/EFTA citizen) a letter of your parents – see below for more information. Any questions regarding the proof of sufficient financial means must be addressed directly to the respective Swiss embassy/consulate abroad.

For bank statements: The Immigration Office requires confirmation from a bank with a branch in Switzerland (foreign bank with a branch in Switzerland or a Swiss bank). In the Canton of Zurich, as a rule, you must be able to provide evidence of having CHF 1'750 per month during your visiting studies, including the examination period at ETH Zurich. The account must be registered in your own name and the currency must be Swiss Francs, Euros or US Dollars. No other currencies are accepted! Important: Even big and internationally well-known banks are not accepted if they do not have a branch in Switzerland. See this list of accepted banks for more information.

For EU/EFTA Citizens only: Instead of providing a bank statement and/or scholarship award, you may also hand in a letter of your parents confirming that they will support you with CHF 1750 per month.

When you need to provide the proof of financial means depends on whether you require a visa:

- Visiting students who require a visa for Switzerland must furnish proof of financial means together with their visa application.

- Visiting students who do not require a visa for Switzerland will need to furnish proof of financial means only when applying for their residence permit.

3 / 8

Health Insurance

Everyone who lives in Switzerland for at least three months (90 days) is required by law to have health and accident insurance coverage from a Swiss insurance company. Additional information is listed on our website.

- Students from EU and EFTA countries: In the framework of the Bilateral Agreements between the EU and Switzerland, visiting students from EU and EFTA countries can get exempted from Swiss compulsory health insurance, provided that they obtain the ‘European Health Insurance Card’ from their health insurance in their home country.

- Students from other countries: If your insurer is acknowledged by the Swiss authorities, you may be exempted from having to take out compulsory health insurance in Switzerland. If you are not exempted, which will most likely be the case, some Swiss insurance companies offer special packages for foreign students, see also our website.

Studying with a disability: Where can I get help and advice?

Please contact the Disability advisory service at an early stage for information on support options and procedures. This is particularly important with regard to study conditions, examination arrangements and the housing situation in Zurich.

Accommodation

Visiting students are obliged to find accommodation on their own. Finding accommodation in Zurich is difficult and time-consuming. In the Spring Semester the availability of student housing is usually slightly better than in the Autumn Semester. You will receive detailed information about accommodation in Zurich with your letter of acceptance. Please see our website for information on accommodation for exchange and visiting students in Zurich and its surroundings.

Living costs in Zurich

Please be aware that living costs in Switzerland are very high, and especially so in Zurich. The Immigration Authorities identify a sum of CHF 1750.- per month as necessary to support oneself financially. The actual amount needed may be slightly lower; this will depend largely on your monthly rent. Finding cheap housing in Zurich is difficult. For more information see the information on our website.

German courses

The joint Language Center of the University and ETH Zurich offers semester courses in ‘German as a foreign  language’ for all levels of proficiency, as well as intensive German courses for three levels of proficiency in Spring and Autumn (in the two weeks before the respective semester starts). Mobility students may take the intensive German course plus one semester course. Pre-registration on the website of the Language Center is necessary and course fees apply. In addition, there may be a charge for copies and other course materials.

Arrival and enrolment at ETH Zurich

Students need to register at the helpdesk of the Student Exchange Office after arrival. There is also an official welcome and information event on the first Monday of the semester in week 38 (Autumn) or the Friday just before the semester starts in week 7 (Spring). Its exact time and location will be specified at a later stage.

Department of Biosystems Science and Engineering (D-BSSE) in Basel

Note that certain conditions and services differ substantially for students applying for the department of Biosystems Sciences and Engineering (D-BSSE) which is located in Basel. Refer to the separate factsheet of D-BSSE for important details on immigration policies, housing, catering, sports facilities, etc. If you wish to do a small research project/thesis in D-BSSE, note also the special information on projects in the section ‘application procedure’.

Living/Studying outside of the canton of Zurich

Information provided by the Student Exchange Office concerning visa, residence permit and health insurance only applies to mobility students who live and study in the canton of Zurich. Mobility students in D-BSSE in Basel (canton Basel-Stadt) should consult the separate fact sheet. Mobility students with a place of residence or place of study in another canton are responsible on their own to clarify the necessary conditions, carry out the respective formalities and respect the regulations that are applicable. The Student Exchange Office cannot assist mobility students not living in the canton of Zurich or the canton of Basel-Stadt with respective questions.

4 / 8

3. Documents required for online application

ETH Zurich uses the ‘Mobility-Online’ tool to manage its applications. See the chapter on the application procedure for information on how to start your online application. All documents except the photo should be uploaded as PDFs.

Study plan

Please read the information on preparing a study plan carefully. Any changes to the study plan need to be made online at the start of the semester and need to be re-approved by your department at ETH Zurich.

Letter of recognition from your home university

In this letter your home university needs to confirm that they will recognize the majority of courses you take during your stay at ETH Zurich and credit them towards your degree programme. Your home university may use the template provided, but they may also use a form of their own, as long as the content is similar. We also accept a Learning Agreement as a letter of recognition.

Transcript of records

You must upload a complete, official transcript of records in English or German of all your studies to date, i.e. including your Bachelor’s degree studies if you are already a Master’s degree student.

Grading Key

You need to upload a grading key/legend explaining the grading system of your home university or any other previous universities you attended to. If your transcript of records already includes a grading key, you may also upload the transcript once again – or you may choose to upload a separate grading key.

List of courses to be completed prior to mobility studies

You are required to upload a list of the courses that you plan to take at your home university before your stay at ETH Zurich and which are not yet listed on your transcript of records. You may make your own list or use the template here.

Language skills

To be active in an academic context, you will need at least a B2 language level as defined by the Common European Framework of Reference for Languages; however, we strongly recommend that you have a C1 level. Depending on the language of instruction of your choice of courses, you must have these language skills in English and/or German.

You need to provide a confirmation only for the language(s) in which you plan to take courses. We accept all well-established language certificates or a confirmation from a supervisor/language teacher at your home university confirming your language level B2 or higher.

Passport

You will also be required to upload a scan of your passport: page(s) with your photo and personal details (name, date of birth) only.

Photo

You must upload a photo which will be used for your ETH student card. Make sure that the picture quality is good and that you are recognisable in the photo (full-face, well-lit, neutral background, etc.). The photo may be no larger than 800x600 pixels (height x width) and 1 MB maximum.

CV

You are required to upload a curriculum vitae (CV) in English or German. Please make sure that it is up-to-date.

Motivation Letter

You must upload a motivation letter in which you state your motivation for a mobility stay at ETH Zurich. Maximum 1 page (A4), in English or German.

Students of Architecture: Portfolio

Applicants in architecture must submit with their application a portfolio. The portfolio must be uploaded in electronic form on Mobility-Online. Note the requirements for the portfolio of the department of architecture outlined on their website which are binding.

5 / 8

4. Visiting Students: Invoices and fees

Application and Tuition Fees

Application processing fee (to be paid with application): CHF 150.

Tuition fees (per weekly hour, i.e. CHF 50.- for a course taking place each week

for one hour for the duration of the whole semester): CHF 50.

Maximum tuition fees per semester (for students taking courses for more than

12 weekly hours): CHF 580.

Mandatory semester fees for all students (for use of sports facilities, etc.): CHF 69.

Application fee

When applying in Mobility-Online for a stay as regular visiting student you will be requested to pay the application processing fee (CHF 150.-) by credit card. Note that you must have a valid credit card.

Invoicing of tuition fees

A few weeks after the semester commences, students will automatically receive an invoice from ETH Zurich for their tuition and mandatory fees, based on the selection of courses/project work. Please note that you will not be able to attend any courses you have not signed up for, nor will you be able to take exams or receive any kind of confirmation. The invoice will be sent out electronically by email to your nethz-account. It can be paid in cash at any post office or at the ETH cash desk. For detailed information on how to pay your semester invoice consult the student portal.

It is very important to always update your valid postal address, so that any postal correspondence is sent to the correct place.

5. Preparing a Study Plan

The study plan is the list of courses you plan on taking at ETH Zurich. It is an essential part of your application and determines which department you are applying to.

In order to prepare your study plan you must read the following information thoroughly and carefully:

==> Study Plan Guidelines 

==> Conditions set by the departments

6. Application procedure

Begin your application process by clicking here (for the German version of the search portal, please click here) and follow the procedure outlined below.

Application form

Enter the required information and submit the form. As your email address it is preferable to give your student email address from the home university (universities are normally less restrictive in sorting potential spam than private providers) and/or to set the domain ethz.ch on your whitelist, so that you are sure to receive ETH Zurich emails.

After submitting your form you will receive an email which details how to set up a user account. After setting it up you will receive a further email with details of how to log in to Mobility-Online to complete your application. You may only submit the application when you have completed all the necessary steps! Please note that you must submit it by the given deadline.

Login

Always enter Mobility-Online by entering your details in the upper half of the login page (even after you begin your stay at ETH Zurich):

6 / 8

Note for Mac users: Please first activate the ‘Always show scrollbar’ setting; otherwise, depending on your browser setting, the scrollbar function may be deactivated and you may not be able to view your workflow correctly.

Logging in will call up your workflow with all pending steps. Complete these steps by clicking on the link to the corresponding step on the right. The compulsory steps must be completed in the designated order:

Adding data

Add a contact person in case of emergencies. Click on the ‘edit’ button to make changes.

Study plan

The next step is to enter the study plan. Your Departmental Exchange Coordinator will check it after you submit your application; it is an important part of the application. Be sure to adhere to the study plan guidelines and to the conditions set by the departments.

First select your courses in the ETH Zurich Course Catalogue, where you will find detailed descriptions, information about prerequisites, etc. Add each of the chosen courses to your study plan in Mobility-Online by clicking on “Enter further courses”. You only need to type or copy/paste the course number from the Course Catalogue and autocomplete will fill in the rest (title and number of credits). A search function is also available.

You must, however, enter in full any courses of other institutions (e.g. the University of Zurich): these are not automatically linked. You must enter them manually in the study plan: Click on “Enter further courses” and add the title of the course, the amount of ECTS and if known the course number.

7 / 8

Projects (e.g. Bachelor’s or Master’s thesis) must also be entered as course units! If you do not find a suitable course unit for your project, please enter manually the title and previewed number of ECTS you are expected to earn (see below for further information).

Projects (if applicable)

4 All projects must be entered in the study plan as course units (see above). In a separate step, also enter the exact details of the project. Check with your home university whether you are expected to earn a certain number of ECTS for the project and if yes, make sure that your ETH Zurich supervisor understands and agrees with this requirement (which may be different from the standard at ETH Zurich). The number of ECTS can be 0 if there are no specific requirements from your home university.

Important: As a regular visiting student, you apply for coursework at ETH Zurich. Should you also wish to do a project it must not exceed 10 ECTS, otherwise you would have to apply as an invited visiting student instead.

The confirmation of the ETH Zurich supervisor must be uploaded to the documents, completing the application. You are responsible for finding a project supervisor. Please apply directly with professors of ETH Zurich.

Special conditions as outlined in the separate factsheet apply for students undertaking a research project/thesis in the department of Biosystems Science and Engineering (D-BSSE) in Basel. Projects in Basel have to be a compulsory part of your study programme at your home university (particularly applicable to students from non-EU/EFTA countries) and must be declared from the very beginning of your application process. If you plan on undertaking a research project in the department of Biosystems Science and Engineering (D-BSSE) in Basel you need to confirm that your project is a compulsory part of your study programme at your home university (particularly applicable to students from non-EU/EFTA countries). During your application process in Mobility-Online, a specific form will be provided which you will need to download, fill in and sign. Note that this information also applies for small research projects such as semester projects.

Documents

Depending on the mobility programme, different documents should be uploaded: see the information above.

4 Only PDF documents are accepted, no images (exception: photo for student card). Ensure that the

resolution is good and that scans are high-quality.

Upload the documents according to the respective step in the application procedure.

If you wish to submit more than one document in one category, you may upload the second (and any following) document by clicking on the paper icon on the top left in the workflow step: 

A template for the list of courses planned before the stay abroad may be found here. Alternatively, depending on when the stay abroad will begin, you may upload a view of your courses from your home university’s electronic course management system.

Submitting the application

After entering all of your information and uploading the documents, finish the application by confirming that it is complete and submitting it. You will receive an automatic confirmation by email. It normally takes a few weeks for the Student Exchange Office and the responsible person in the department to process your application.

Next steps

Your application will be perused in form and content after the application deadline. If it is accepted you will receive an email which states that ETH Zurich has officially admitted you for your mobility period. Depending on the programme, there will be various further steps; you will receive a corresponding email which describes them. You may log in to Mobility-Online at any time to view what information has already been sent, and which step comes next.

8 / 8

The Emerald Research Register for this journal is available at The current issue and full text archive of this journal is available at

www.emeraldinsight.com/researchregister www.emeraldinsight.com/1741-038X.htm

Use of AHP in decision-making

for flexible manufacturing

systems

Ozden Bayazit

Central Washington University, Washington, USA

Abstract

Purpose – To provide a good insight into the use of analytic hierarchy process (AHP) that is a multiple criteria decision-making methodology in evaluating flexible manufacturing systems (FMSs).

Design/methodology/approach – In this study AHP is used to the decision by a tractor manufacturing plant to implement FMS. Also sensitivity analysis is conducted to see how realistic the final outcome is.

Findings – Information on the use of AHP in assessing advanced manufacturing technologies is provided and an AHP model is proposed to guide the management of tractor manufacturing plant. Most important factors, and their relative importance and influences on the objective of the decision-making model are found. By performing a sensitivity analysis, it is also found that the final outcome remained stable in all cases when the weights of the main criteria affecting the decision are varied up and down by 5 percent in all possible combinations.

Research limitations/implications – When there are dependencies and interactions among the criteria in a decision-making model, analytic network process is more appropriate methodology; yet AHP assumes linear independence of criteria and alternatives.

Originality/value – Proposes a decision-making model to guide managers for assessing advanced manufacturing technologies such as FMS. Also sensitivity analysis conducted in this study is very important for practical decision-making.

Keywords Analytical hierarchy process, Decision making, Flexible manufacturing systems, Advanced manufacturing technologies

Paper type Research paper

Introduction

Flexible manufacturing system (FMS) has received considerable attention in the literature over the last several decades. Hence there is literally a huge amount of published literature on FMS. A dominant theme in these writings is that FMS is a highly automated production system consisting of automated material-handling and transferring machines working together under a comprehensive computer control system (Inman, 1991; Boer and Krabbendam, 1992a, b; Evans and Haddock, 1992; Maccarthy and Liu, 1993; Rao and Deshmukh, 1994; Kaighobadi and Venkatesh, 1994; Maffei and Meredith, 1995; Lee, 1998; Koltai et al., 2000; Mohamed et al., 2001; Shamsuzzaman et al., 2003; Fan and Wong, 2003).

  Several studies are devoted to examining the potential benefits of FMS implementation. The common conclusion of these studies is that the advantages associated with the FMS implementation are numerous. Successful implementation of FMS could generate reduced labor costs, increased flexibility and product variety, productivity improvement, improved responsiveness, and increased machinery

utilization (Inman, 1991; Boer and Krabbendam, 1992a, b; Evans and Haddock, 1992; Kaighobadi and Venkatesh, 1994; Maffei and Meredith, 1995). Many firms have installed FMSs and gained such benefits. However, many other firms have failed because of successful FMS implementation require effective operation. A number of studies have addressed the issues related to the success of an FMS installation and implementation, since FMSs are highly capital intensive and installation may take several years. According to those studies, management commitment, people involvement, technological changes, and organizational requirements are critical issues to the success of FMS implementation (Inman, 1991; Boer and Krabbendam, 1992a, b; Evans and Haddock, 1992; Kaighobadi and Venkatesh, 1994; Lee, 1998).

   The analytic hierarchy process (AHP) technique is one of the approaches used in determining the relative importance of a set of attributes or criteria. AHP is designed to solve complex multi-criteria problems. Many quantitative methods have been in an attempt to evaluate new technology implementation. The AHP has previously been used in evaluating advanced technology by Shang and Sueyoshi (1995), San and Tabucanon (1994), Albayrakoglu (1996), Shamsuzzaman et al. (2003) and Chan et al. (2000).

   In this study, a very comprehensive application of AHP in a real-world case for assessing FMS is presented along with sensitivity analysis. The objective of this paper is to determine whether Turkish Tractor Manufacturing (TTM) should implement FMS throughout the plant by utilizing the AHP. This paper is organized into six sections. First, the research carried out at TTM and then the attributes affecting the decision are presented. The third section introduces the application of the AHP and describes its application in TTM whereas the fourth section introduces the sensitivity analysis and application for checking the authenticity of results obtained by AHP. Finally, the overall conclusion is given in sensitivity analysis section with future scope of further research.

Research methodology

TTM was established in 1948 located in Ankara, Turkey as a main tractor manufacturer. It has continued to be the industry leader in the manufacture of tractors in Turkey. In the last six years TTM has invested $100,000,000 in acquiring the latest technologies such as computer aided design (CAD), computer numerically controlled machines (CNC), and FMSs. TTM is currently one of few companies that partially implements FMS in Turkey. Seven flexible manufacturing lines have been established in TTM.

   TTM is now considering the implementation of FMS throughout the organization. Although, considerable benefits were gained by having an FMS such as reducing set-up time, increasing customer satisfaction, increasing flexibility, etc. they had also had some difficulties during the FMS implementation. Therefore, the management of TTM wanted to find out whether they should implement FMS in entire plant. We ran an AHP study on the problem in order to provide a systematic approach. We met with the managers of the company for several hours to decide on the best alternative. A team of TTM decision makers consisted of quality control manager, production manager, operations manager, purchasing manager, sales manager and plant manager. First, the AHP methodology was presented to the decision-making team since the decision-making team was not familiar with the approach. Then we

JMTM formulated the model and determined the criteria. Thirty-nine criteria were initially

identified. However, after further evaluation decision-making team has eliminated insignificant ones to the problem and considered 28 factors as the primary ones. Also, two alternatives were identified:

(1) implementing flexible FMS; and

(2) not implementing FMS.

After deciding the criteria, pairwise comparisons were performed including all the combinations of criteria/sub-criteria/alternatives relationships by the decision-making team. Since the decision concerns FMS implementation in the entire plant, the criteria were determined based on the decision makers’ experience on partial FMS implementation. Hence, the criteria shown in Table I for evaluating the decision were identified and used in the AHP model.

Analytic hierarchy process

The AHP is based on the innate human ability to make sound judgments about small problems. It facilitates decision-making by organizing perceptions, feelings, judgments and memories into a framework that exhibits the forces that influence a decision. The AHP is normally implemented in conjunction with the use of Expert Choice q and it has been applied in a variety of decisions and planning projects in nearly 20 countries (Saaty, 1990).

Three steps of AHP methodology

The AHP methodology is explained in Saaty’s (1990) book. Below we give enough of the general approach to enable the reader to follow the paper with ease.

   Step 1 (structuring the hierarchy). Group related components and arrange them into a hierarchical order that reflects functional dependence of one component or a group of components on another. The approach of the AHP involves the structuring of any complex problem into different hierarchy levels with a view to accomplishing the stated objective of a problem.

   Step 2 (performing paired comparisons between elements/decision alternatives). Construct a matrix of pairwise comparisons of elements where the entries indicate the strengths with which one element dominates another using a method for scaling of weights of the elements in each of the hierarchy levels with respect to an element of the next higher level. Use these values to determine the priorities of the elements of the hierarchy reflecting the relative importance among entities at the lowest levels of the hierarchy that enables the accomplishment of the objective of the problem (Albayrakoglu, 1996; Chan et al., 2000). The scale used for comparisons in AHP enables the decision maker to incorporate experience and knowledge intuitively (Harker and Vargas, 1990) and indicates how many times an element dominates another with respect to the criterion. The decision maker can express his preference between each pair of elements verbally as equally important, moderately more important, strongly more important, very strongly more important, and extremely more important. These descriptive preferences would then be translated into numerical values 1, 3, 5, 7, 9, respectively, with 2, 4, 6 and 8 as intermediate values for comparisons between two successive qualitative judgments. Reciprocals of these values are used for the corresponding transposed judgments.

 Use of AHP in decision-making

811

Criteria Definition

Quality improvement Because of the ability to make things that could not be made by hand (e.g. microprocessors) and because of improved inspection capabilities, quality is improved

Faster delivery The managers pointed out that the firm delivered its

products to the market just in time. On-time delivery frequency is increased remarkably

Product variety Product variety is increased due to scope economies as a

result of implementing FMS

Customer satisfaction Because of product variety, improved quality, and the

ability to produce in small quantities, customer satisfaction is also increased

Set-up time The managers pointed out that they have achieved zero

set-up time

Cutting speed The managers emphasized that cutting speed, which

reduces cutting times, is much better than before. They increased cutting speed 1,000 percent

Production time Because machining times went down from 410,240 to

352,402 minutes, reduction in production times was achieved

Labor cost The managers pointed out that they have been provided

with a significant cost reduction because of decrease in the number of operators

Number of operators Since both machining and material-handling are under computer control, operators are needed only to perform necessary loading and unloading operations. The managers reported that the number of operators went down from 23 to 12

Number of operations The managers pointed out that the number of operations

went down from 30 to 10 after FMS implementation

Number of machine tools The managers pointed out that the number of machine

tools went down from 32 to 12 after FMS implementation

Productivity Productivity is increased by reducing the non-productive

time on a part spent on the shop floor

Machine utilization They have achieved higher machine utilization because of

reduced set-up times, efficiently handled parts, and simultaneously produced several parts

Profitability All these advantages achieved in TTM Plant may help to

increase profitability in the long-term

Long-term competitive power All these advantages achieved in TTM Plant may

help to increase its competitive power in the long-term

Top management commitment The managers pointed out that FMS begins with top management’s commitment and involvement. FMS requires a high degree of management commitment and effort. Many problems on the managerial side result from a lack of top management support. Management may not be willing to adopt new technology. On the other hand, managers may quickly abandon the current technology when there are short-term failures

Table I.

Decision criteria

(continued)

Criteria Definition

Training employees Owing to timing delays for comprehensive training program including programming, technical, operating training, there were some difficulties in training personnel as to how to use new machine tools

Unstable conditions Turkey is a dynamic country with ups and downs in its

economy. The managers emphasized that because of these unstable conditions, they are very afraid to try new things

Workers involvement The managers pointed out that there might be silent resistance from the workers against the new system. Even if there is support from the workers initially, workers support might be lost later on as the study progresses

Delivery dependability Until there is some experience in how to maintain machine tools, they had to work with the service team of the supplier company. As a result of this, there were delays in delivering parts and materials

Material availability Since they did not have sufficient information about the

material they will need, they had some difficulties to procure such materials

Delays in the entire There were certain shortcomings occurring during the

production process implementation of synchronized activities of FMS. These

shortcomings caused delays in the entire production process

High initial costs The managers pointed out that FMS required large capital

investments that exceed $10 million

Necessity of developing FMS must be custom-designed to a company’s specific

company-specific models needs. The managers emphasized that they had difficulties

when they were developing their own model

Table I.

Space requirements The managers pointed out that installing FMS increased

space requirements in the entire plant

Long implementation lead-time The managers emphasized that installing and running FMS

took several years

Labor requirements The managers pointed out that the company needed experts

and qualified employees during the implementation process of FMS

Central computer control Since a comprehensive computer control system is used to run the entire system, if the computer breaks down, the production line would stop and delays and errors would occur in the production process

Step 3 (synthesizing results). Synthesize these priorities to obtain the each alternative’s

overall priority. Select the alternative with the highest priority.

AHP in TTM

In this section, the work carried out to use AHP for assessing importance priority of

“implementing FMS” over “not implementing FMS” in TTM is briefed.

Structuring the hierarchy

In using AHP to model a decision problem, the first step is to structure the hierarchy. The goal of our model was to determine whether TTM should implement FMS in the entire plant. We placed this goal at the top of the hierarchy. The hierarchy descended

from the more general criteria in the second level to sub-criteria in the third level to tertiary sub-criteria in the fourth level on to the alternatives at the bottom or fifth level. The general criteria level involved four major criteria: advantages, opportunities, risks and disadvantages. We located advantages to customer and advantages to company under advantages criterion in the third level of the hierarchy. Each of these in turn needed further decomposition into specific items in the fourth level. As an example, advantages to customer were decomposed into four criteria, which are quality improvement, faster delivery, product variety and customer satisfaction. We also located profitability and long-term competitive power in the third level of the hierarchy under opportunities. The seven sub-criteria were included for risks in the third level. These are top management commitment, training employees, unstable conditions, workers involvement, delivery dependability, materials availability and delays in the entire production process. The decision-making team decomposed disadvantages into six criteria: high initial costs, necessity of developing country specific models, space requirements, long implementation lead-time, labor requirements and central computer control. The decision-making team considered two decision alternatives, and located them on the bottom level of the hierarchy. Figure 1 shows a hierarchical representation of the selecting best production system decision-making model.

Performing pairwise comparisons

Pairwise comparisons were performed systematically to include all the combinations of criteria/sub-criteria/tertiary sub-criteria/alternatives relationships. The decision-making team compared the criteria and sub-criteria according to their relative importance with respect to the parent element in the adjacent upper level. We have first entered the judgments for four major criteria in level 2. We concluded that advantages are the most important factor of assessing the FMS implementation with a priority of 0.328. Disadvantages are also a major factor with an importance priority of 0.248. Figure 2 shows the pairwise comparison matrix for the major criteria.

   After comparing the major criteria, we have evaluated the sub-criteria and tertiary sub-criteria. As an example, for advantages to customer criterion customer satisfaction received the highest priority with 0.436, followed by quality improvement with 0.247.

JMTM

16,7

814

Figure 2.

Comparing major criteria-preferences and weights of major criteria

Figure 3 shows the judgments obtained and importance matrix for advantages to customer.

The Figure 4 shows the priorities of all criteria under advantages hierarchy.

   Finally, we compared each pair of alternative with respect to each criterion. In comparing the two alternatives, we asked which alternative decision-making team preferred with respect to each of the main criterion in level 2, each sub-criterion in level 3, each tertiary sub-criterion in level 4. For example, for the sub-criterion competitive power (located under opportunities), we obtained a matrix of paired comparisons (Figure 5) in which alternative 1 (implementing FMS) is preferred over alternative 2 (not implementing FMS). As a result of it, implementing FMS came out as the top choice with a preference rating of 0.890.

Synthesizing the results

After deriving the local priorities for the criteria and the alternatives through pairwise comparisons, the priorities of the criteria were synthesized to calculate the overall priorities for the decision alternatives. As shown in Figure 6, implementing FMS received the highest ranking with 54.6 percent, indicating that the organization should install and implement FMS in entire plant.

   Use of AHP in decision-making

815

Figure 4.

The advantages hierarchy

Figure 5. Comparing alternatives based on competitive power

Sensitivity analysis

A series of sensitivity analyses were conducted to investigate the impact of changing the priority of the criteria on the alternatives’ ranking. Dynamic sensitivity of Expert Choiceq was performed to see how realistic the final outcome is. Dynamic sensitivity analysis is used to dynamically change the priorities of the criteria to determine how these changes affect the priorities of the alternative choices (Saaty, 2001). We investigated the impact of changing the priority of four main criteria on overall results. As shown in Figures 7-10, the results indicated that the alternatives’ ratings are not sensitive to changes in the importance of the advantages, while it is sensitive to

JMTM changes in the importance of disadvantages and risks and a little sensitive to changes

in the importance of opportunities. When the importance of advantages was increased up to 0.623, overall rank of the final outcome was preserved. When the importance of disadvantages was increased from 0.248 to 0.461, not implementing FMS became the best alternative. We performed a third sensitivity analysis where the relative importance of risks was increased to 0.438. Similarly in this analysis, not implementing

816

Figure 7.

First scenario

Figure 8.

Second scenario

Figure 9.

Third scenario

Figure 10.

Fourth scenario

FMS became the most preferable one. In the fourth scenario, only when the importance of opportunities was increased from 0.207 to 0.567, not implementing FMS turned out to be the best one.

   The sensitivity analysis indicated that when the importance of the main criteria was changed up and down by 5 percent in all possible combinations, the ranks of the alternatives remained stable in all cases. In this respect TTM should choose implementing FMS as the best alternative for the decision.

Conclusion

Since FMSs are highly capital intensive and installation may take several years, only a limited percentage of companies have made a serious attempt to install FMS in Turkey. TTM is one of the companies which have achieved a successful partial implementation of FMS. In this study, we proposed an AHP model to guide the management of TTM who are contemplating a decision about whether FMS should be implemented in the entire plant. We found most important factors, and their relative importance and influences on the objective of our decision-making model. To invest in FMS is a complex decision involving many criteria. The AHP enabled us to incorporate 28 factors that were both qualitative and quantitative to assess the FMS implementation. We concluded that implementing FMSs is the most preferable alternative with an overall priority score of 0.546. This alternative is not as overwhelmingly preferable to other alternative as we expected prior to our study, which was a surprising outcome. In our judgment the main reason for this is, in spite of advantages and opportunities to be gained by implementing FMS, there are numerous risks and disadvantages.

Further discussion

Our literature search indicated that most studies found the best solution and ignored sensitivity analysis. The sensitivity analysis is very important for practical decision-making. We performed sensitivity analysis to see how realistic the final outcome is. The sensitivity analysis indicated that when we varied the weights of the main criteria up and down by 5 percent in all possible combinations, the ranks of the alternatives remained stable in all cases. It also indicated that the alternatives’ ratings are not sensitive to changes in the importance of the advantages; while it is sensitive to changes in the importance of disadvantages and risks and a little sensitive to changes in the importance of opportunities. When we increased or decreased the importance of disadvantages and risks, not implementing FMS became the most preferable alternative. We attribute this result to FMS’s high risks and disadvantages.

   The actual process of conducting this analysis helped us prioritize the criteria in a manner that otherwise might not be possible. The decision-making team was far more confidant with their decision as this study showed them, even if the importance of certain criteria changes, overall ranking does not change; even though the degree of preference rating is strengthened or weakened. Bounded rationality and limited cognitive processes make it impossible for the decision maker to adequately consider all of the factors involved in a complex screening decision. Without decision support methodologies such as AHP, managers might base their decisions on only a subset of important criteria while not understanding their relative importance and interactions.

   AHP has some limitations. AHP assumes linear independence of criteria and alternatives. If there is dependence among the criteria, analytic network process (ANP)

(Saaty, 2001) is more appropriate; yet ANP requires far more comparisons which may be formidable in practical decision environment. We were able to acquire the cooperation of the decision-making team to structure the model and apply it. We attribute our success mainly to the ease of use of AHP and the existence of easy-to-use commercial software Expert Choice.

  We needed a methodology that is well supported with powerfully developed software conducive to real-life applications easily understandable by the managers. AHP would be appropriate whenever a goal is clearly stated and a set of relevant criteria and alternatives are available. When there are numerous criteria involved, AHP is one of the very few multiple criteria approaches capable of handling so many criteria, especially if some of the criteria are qualitative. With Expert Choice software, AHP enables sensitivity analysis of results which is very important in practical decision-making. This study showed the researchers that AHP can be used to manage complex problems to evaluate advanced manufacturing technologies. For future research it would be interesting to see comparative evaluations of ANP and AHP.

References

Albayrakoglu, M. (1996), “Justification of new manufacturing technology: a strategic approach using the analytic hierarchy process”, Production and Inventory Management Journal, Vol. 37 No. 1, pp. 71-7.

Boer, H. and Krabbendam, K. (1992a), “The effective implementation and operation of flexible manufacturing systems”, International Studies of Management & Organization, Vol. 22 No. 4, pp. 33-48.

Boer, H. and Krabbendam, K. (1992b), “Organizing for manufacturing innovation: the case of flexible manufacturing systems”, International Journal of Operations & Production Management, Vol. 12 Nos 7/8, pp. 41-56.

Chan, F.T.S., Bing, J. and Nelson, T.K.H. (2000), “The development of intelligent decision support tools to aid the design of flexible manufacturing systems”, International Journal of Production Economics, Vol. 65 No. 1, pp. 73-82.

Evans, G.W. and Haddock, J. (1992), “Modeling tools for flexible manufacturing systems”, Production Planning & Control, Vol. 3 No. 2, pp. 158-67.

Fan, C.K. and Wong, T.N. (2003), “Agent-based architecture for manufacturing systems control”, Integrated Manufacturing Systems, Vol. 14 No. 7, pp. 599-609.

Harker, P.T. and Vargas, L.G. (1990), “Reply to remarks on the analytic hierarchy process”, Management Science, Vol. 36, pp. 269-73.

Inman, A.R. (1991), “Flexible manufacturing systems: issues and implementation”, Industrial Management, Vol. 7, pp. 7-11.

Kaighobadi, M. and Venkatesh, K. (1994), “Flexible manufacturing systems: an overview”, International Journal of Operations & Production Management, Vol. 14 No. 4, pp. 26-49.

Koltai, T., Lozano, S. and Onieva, L. (2000), “A flexible costing systems for flexible manufacturing systems using activity based costing”, International Journal of Production Research, Vol. 38 No. 7, pp. 1615-30.

Lee, H.F. (1998), “Production planning for flexible manufacturing systems with multiple machine types: a practical method”, International Journal of Production Research, Vol. 36 No. 10, pp. 2911-27.

Maccarthy, B.L. and Liu, J. (1993), “A new classification scheme for flexible manufacturing systems”, International Journal of Production Research, Vol. 31 No. 2, pp. 299-309.

Maffei, M.J. and Meredith, J. (1995), “Infrastructure and flexible manufacturing technology: theory development”, Journal of Operations Management, Vol. 13, pp. 273-98.

Mohamed, Z.M., Youssef, M.A. and Huq, F. (2001), “The impact of machine flexibility on the performance of flexible manufacturing systems”, International Journal of Operations & Production Management, Vol. 21 Nos 5/6, pp. 707-27.

Rao, S.K.V. and Deshmukh, S.G. (1994), “Strategic framework for implementing flexible manufacturing systems in India”, International Journal of Operations & Production Management, Vol. 14 No. 4, pp. 50-63.

Saaty, T.L. (1990), The Analytic Hierarchy Process, McGraw-Hill, RWS Publications, Pittsburgh, PA.

Saaty, T.L. (2001), Decision Making with Dependence and Feedback the Analytic Network Process, 2nd ed., RWS Publications, Pittsburgh, PA.

San, M. and Tabucanon, M.T. (1994), “A multiple-criteria approach to machine selection for flexible manufacturing systems”, International Journal of Production Economics, Vol. 33 Nos 1/3, pp. 121-32.

Shamsuzzaman, M., Ullah, A.M.M. and Bohez, E. (2003), “Applying linguistic criteria in FMS selection: fuzzy-set AHP approach”, Integrated Manufacturing Systems, Vol. 14 No. 3, pp. 247-58.

Shang, J. and Sueyoshi, T. (1995), “A unified framework for the selection of a flexible manufacturing system”, European Journal of Operational Research, Vol. 85 No. 2, pp. 297-316.

 Use of AHP in decision-making

819

SPEAK TRUTH

TO POWER

EDUCATOR GUIDE

RIGHTS AT RISK IN A

PUBLIC HEALTH CRISIS

OVERVIEW

The following lessons are presented as in-class activities. During the COVID-19 pandemic and other public health crises, we recognize that teachers are likely to engage in virtual or online learning exercises. You can adapt any of the following class activities to be assigned to individuals or groups online with the opportunity for virtual discussion.

During a public health crisis, there are many rights at risk. One of these is UDHR Article 19: the right to seek, receive, and impart information and ideas through any media and regardless of frontiers. Because of this, encourage and facilitate the use of trustworthy news sources and other data among students based upon current best practices

UNIVERSAL DECLARATION OF HUMAN RIGHTS

* Article 19: Everyone has the right to freedom of opinion and expression

* Article 22: Everyone, has the right to social security

* Article 25: Everyone has the right to a standard of living adequate for their health and well-being

* Article 26: Everyone has the right to education

* Article 29: Everyone has duties to the community

HUMAN RIGHTS ISSUES

Health, Adequate Standard of Living, Social Security, Education, and Personal Duty and Responsibility

ACTIVITY DURATION

1–5 30 minute lessons with additional time for work beyond the classroom

SPEAK TRUTH DEFENDERS | RIGHTS AT RISK IN A PUBLIC HEALTH CRISIS

TO POWER

TARGET AUDIENCE

Grades 9-12, ELA and Social Studies Courses

ESSENTIAL QUESTIONS

* What factors need to be present for a health crisis to become a pandemic?

* What role should the government (local, state, national, and international) play in preventing, addressing and stopping a health crisis?

* How is the interdependent and interrelated characteristic of human rights evidenced during a public health crisis?

* What role does the individual play during a health crisis or pandemic?

STUDENT SKILLS

* Critical thinking and problem solving

* Comparing and contrasting

* Researching and analyzing information

* Drawing inferences and making conclusions

VOCABULARY

* Pandemic

* Public Health

* Mitigation

* Social Distancing

* Virus

* World Health Organization

* Center for Disease Control

* Infectious Disease

* COVID-19

* Coronavirus Disease

CONCEPTS

* Individuals, Groups, and Institutional Social Responsibility

* Public Health Care

* Social Connectedness

SPEAK TRUTH DEFENDERS | RIGHTS AT RISK IN A PUBLIC HEALTH CRISIS

TO POWER

TECHNOLOGY REQUIRED

* Internet Access

* Computer Access

MATERIALS

* Video of Dr. Fauci testifying to the House Oversight and Reform Committee Hearing on Coronavirus Response, Day 1

* News article of Dr. Fauci testifying to before Congress

* Video of the World Health Organization’s (WHO) Media Briefing on COVID-19 with Dr. Tedros

* World Health Organization Situation Dashboard 

BACKGROUND INFORMATION

The Universal Declaration of Human Rights (UDHR) was created in the aftermath of World War II in an effort to ensure that the atrocities committed by Nazi Germany would not be repeated. Representatives from all regions of the world, who symbolized a variety of legal traditions and cultural backgrounds, came together to codify a list of human rights to which all people around the globe should be entitled. The drafting committee, known as the UN Commission on Human Rights, was chaired by Eleanor Roosevelt, widow of American President Franklin D. Roosevelt and a long-time advocate on behalf of minorities, refugees, women, and the working class. The final document, containing 30 articles, was recognized as a common standard by the United Nations General Assembly on December 10, 1948. Since that date, the document has been translated into over 500 languages.

The Commission’s work did not end with the approval of the declaration. The treaty still needed to be ratified by nations, with the expectation that every nation that signed on “would then be obligated to change its laws wherever they did not conform to the points contained in the covenant.” The Commission was optimistic that this work could be completed within a few years. However, the challenge was far greater than they realized. Today, advocates continue to fight to secure the human rights of citizens around the globe

SPEAK TRUTH DEFENDERS | RIGHTS AT RISK IN A PUBLIC HEALTH CRISIS

TO POWER

ANTICIPATORY SET

* Organize students into three groups.

* In their groups, ask students to research public health crises.

* Some examples of public health crises and pandemics to research include: Ebola Virus Disease (EVD), H1N1 (Swine Flu), H5N1 (Bird Flu), HIV/AIDS and SARS coronavirus (SARS-CoV). For each group, students should answer the following questions:

* What was the health concern?

* How did it spread?

* Did it affect certain populations more than others? (male vs. female, age, ethnicity, etc.)

* How did the government(s) respond to this health concern?

* Ask students to compare and contrast Coronavirus Disease 2019 (COVID-19) with the public health crisis they have researched. If they have not already, ask students to consider the questions they answered for the public health crisis and compare those answers to the circumstances of COVID-19.

NOTE TO TEACHERS

Based upon current pandemic conditions, the term “coronavirus” will be used exclusively and interchangeably to

describe COVID-19 in the following lessons. Adapt based upon the classroom environment as necessary.

STUDENT ACTIVITIES

Activity 1

* Each group should have one sheet of flip chart paper. The paper should be held lengthwise and divided into four columns. The columns should be headed: Local, State, Federal, and Intergovernmental.

* Students should be answering the question:

* What is the role and responsibility of the Local, State, Federal, and Intergovernmental (international) levels of government when it comes to protecting and promoting public health?

* Students should consider the following in developing their chart:

* Legislation passed or proposed by the government jurisdiction.

* The influence of agencies or actors, such as the U.S. Department of Health and Human Services (HHS), the Centers for Disease Control and Prevention (CDC), or elected officials.

* Public statements and information released by the governmental administration, including press conferences and releases, media briefings, official statements, and social media.

* The present political and cultural climate.

* Each group should try to reach a consensus. When all the columns have been filled, the flip charts can be taped in place in the classroom.

* Groups should be allowed time to look at each other’s finished charts and to identify differences in roles and responsibilities (of the government jurisdictions) as perceived by other groups.

SPEAK TRUTH DEFENDERS | RIGHTS AT RISK IN A PUBLIC HEALTH CRISIS

TO POWER

* As a class, have the students share their outcomes and respond to the following questions:

* What (if anything) did all groups agree are the roles and responsibilities that should be upheld by the government (Local, State, Federal, and Intergovernmental) when protecting and promoting public health?

* Did a group identify a role or responsibility of the government jurisdiction that other groups did not? Discuss.

* In addition to taking action, what is the responsibility of the government as it pertains to dissemination of information (regarding public health)?

Activity 2

* Break students into two groups.

* One group will watch the video of Dr. Fauci testifying to the House Oversight and Reform Committee Hearing on Coronavirus Response, Day 1 or read “8 key exchanges from the testimony”

* Video of Dr. Fauci testifying to the House Oversight and Reform Committee Hearing on Coronavirus Response, Day 1

* News article of Dr. Fauci testifying to before Congress

* Ask students to discuss their reactions to the testimony. Have students discuss and/or write about how Dr. Fauci perceives the role and responsibility of different levels of government as it pertains to protection and promotion of public health (as perceived by the testimony and other background research). Ask students how this approach affects the individual.

* The other group will watch the video of the World Health Organization’s (WHO) Media Briefing on COVID-19 with Dr. Tedros or read the transcript

* Video of the World Health Organization’s (WHO) Media Briefing on COVID-19

* Ask students to discuss their reactions to the briefing. Have students discuss and/or write about how Dr. Tedros perceives the role and responsibility of different levels of government as it pertains to protection and promotion of public health (as perceived by the briefing and other background research). Ask students how this approach affects the individual.

* Ask each group to pick volunteers to summarize the video/information and discussion and report orally to the class.

* As a class, debrief the outcomes of the group discussions. Examine the similarities and differences between the views of Dr. Fauci and Dr. Tedros as it pertains to the government’s role in protection and promotion of public health. Students should consider the information that was provided by Dr. Fauci and Dr. Tedros to the national and international community and how governments responded to them.

SPEAK TRUTH DEFENDERS | RIGHTS AT RISK IN A PUBLIC HEALTH CRISIS

TO POWER

NOTE TO TEACHERS

The full video will give the most vast perspective on the United States governmental and intergovernmental response to

a public health crisis. Adjust viewing time of the testimony and briefing videos for your class needs.

* Dr. Fauci testifying to the House Oversight and Reform Committee Hearing on Coronavirus Response, Day 1

* Dr. Fauci’s opening statement on the coronavirus and timeline for vaccines begins at 13:54.

* Dr. Fauci’s discussion of lack of containment and testing of coronavirus within the United States at 35:01.

* Representative Stephen Lynch (D-Massachusetts) discusses the response of President Trump to the coronavirus outbreak and Dr. Fauci replies in regards to the data he has provided at 49:14.

* Dr. Robert Redfield (CDC) and Dr. Fauci discuss the lack of and possibilities for testing at 58:08.

* Dr. Fauci says “We need to do a lot more” at the national level and in response to travel restrictions at 1:02:23.

* Dr. Fauci refutes the comparison between coronavirus and other viruses including the “common flu [and cold]” and warns the Committee against inaction and complacency at 1:14:04, at 1:30:11, and at 1:35:58.

* Dr. Fauci talks about the importance of data and science (when questioned about speaking out in politically charged times) at 1:16:55.

* Dr. Fauci talks about the necessity for quick response and mitigation strategies by the United States. with the coronavirus at 1:47:58 and at 1:51:46.

* Dr. Fauci responds to questions about what the health sector needs from Congress and the government to address public health concerns at 1:58:36.

* World Health Organization’s (WHO) Media Briefing on COVID-19 with Dr. Tedros

* Dr. Tedros speaks to breaking the chains of transmission and the necessity of testing at 2:32.

* Dr. Tedros discusses the joint call to action of the global business community from the WHO and the International Chamber of Commerce at 10:05.

* Dr. Tedros speaks of the need for political commitment at all levels of government (including the highest levels) at 17:51.

* Dr. Tedros promotes “a whole of government and the whole of society approach” to combatting coronavirus at 37:49.

Activity 3

* Organize students in groups of two.

* Ask each group to select a country (besides the United States) that they want to focus on for this project.

* Show students the World Health Organization Situation Dashboard 

* Ask students to compare the graphs, speed of spread, and numbers between the United States and their country of choice.

SPEAK TRUTH DEFENDERS | RIGHTS AT RISK IN A PUBLIC HEALTH CRISIS

TO POWER

* After examining the WHO data, ask students to research the public response of their chosen country to local, national, and global coronavirus outbreaks. Have students answer the following questions:

* What tactics, if any, did your country use to mitigate and control the coronavirus? In what time frame did these actions take place?

* If applicable, what role did the Local, State (or Provincial), Federal (or National), and Intergovernmental jurisdictions take to address the coronavirus? What information did they or did they not share with their population and when?

* Were they successful? Why? Why not?

* Did the government response (at any level) align more with the position of Dr. Fauci, Dr. Tedros, or neither? How did they align? How did they differ?

* Ask students to compare and contrast the government response of their country to those actions of the United States. Students should answer how the United States statistics relate to that of their chosen country.

* To what extent do the countries reveal commonalities (or differences) in the spread of the coronavirus? Can you identify any patterns consistent between the two?

* In your opinion, has one of the countries been more successful at controlling the coronavirus? Why and how? What has the government’s role been?

* Have students report the findings of their country to the class.

* As a class, debrief the outcomes of their research session with their country. Ask students if it was easy or difficult to find data or information outside of the WHO statistics.

* Have the groups merge all research into a Comprehensive Global Coronavirus Response Document.

Culminating Activity

In their groups, ask students to consider the contexts which they have been researching and generate a list of rights that have been protected or denied by the government due to their management (or mismanagement) of the coronavirus public health crisis.

UNIVERSAL DECLARATION OF HUMAN RIGHTS 

* Article 19: Everyone has the right to freedom of opinion and expression

* Article 22: Everyone, has the right to social security

* Article 25: Everyone has the right to a standard of living adequate for their health and well-being

* Article 26: Everyone has the right to education

* Article 29: Everyone has duties to the community

SPEAK TRUTH DEFENDERS | RIGHTS AT RISK IN A PUBLIC HEALTH CRISIS

TO POWER

TEACHER TIP

Students may automatically recognize that their right to a standard of living adequate for their health and well-being (Article 25) is impacted, protected, or denied during the pandemic or public health crisis. Ask students if there are any interdependent or interrelated rights that have been impacted. For example, has the public health crisis resulted in a change in way of life? Has this change in life protected or denied a right guaranteed to them previously?

* Using the information in the previous activity, have each group write a Rights Action Plan to address these rights within the Comprehensive Global Coronavirus Response Document. Students should include at least three government actions that can be taken to protect or promote these rights. Within their plans, students should discuss which level of government will be involved and what actions they will take.

* Students should refer to their chart from Activity 1 and consider how the following could be used in their plans:

* Legislation passed or proposed by the government jurisdiction.

* The influence of agencies or actors, such as the U.S. Department of Health and Human Services (HHS), the Centers for Disease Control and Prevention (CDC), or elected officials.

* Public statements and information released by the governmental administration, including press conferences and releases, media briefings, official statements, and social media.

* The present political and cultural climate.

* Ask students to reflect back on the discussion from Activity 1 and consider the responsibility of the government as it pertains to dissemination of information during a public health crisis or pandemic. Students should consider these responsibilities when developing action items for their Plan.

* Students should also consider local individuals and human rights defenders in their community who are taking action to protect or promote human rights. If applicable, students should include actions that could be taken by these or other individuals in their plan.

* Ask each group to present their plan either through a PowerPoint, flip chart or oral presentation.

BECOME A DEFENDER

We are in very unprecedented times as the world navigates how to deal with the spread of the Coronavirus (COVID-19). What we also know is that human rights should and must be considered in all the efforts to help contain this from becoming worse. Your students might be asking, what can we do to help uphold and protect human rights during this challenging time? While most of our students are being asked to stay home indefinitely, how can they affect change from home? Below are some immediate things all young people can do RIGHT NOW!

For all students, we encourage students to leverage technology and help organize virtual meetings to collaborate and brainstorm ways in which they can all help during this global challenge. Please encourage your students to self-organize themselves into groups to brainstorm ways in which they can advance the following recommendations for taking action and more!

Right to Access to Information and Duty to Community

* Social Media: Right now, many of us are at home and have a ton of time to be on social media, but how are we using it for good in the midst of all this challenge? Students can:

* Make PSA’s and share information: There are a lot of helpful educational materials out there that students can share via social media to help spread very tangible ways people can stop the spread of

SPEAK TRUTH DEFENDERS | RIGHTS AT RISK IN A PUBLIC HEALTH CRISIS

TO POWER

this virus. For example, the notion of Social Distancing has been thoughtfully articulated on multiple platforms, and students can begin to share. For example, the following link from the Washington Post serves as a great tool to educate the public on the need for social distancing and what your personal duty is to the global community: https://www.washingtonpost.com/graphics/2020/world/corona-simulator/ 

Right to Health and Well-being

Ask students to research and find local food banks in their immediate community or around the world that could help vulnerable demographics. Students can compile their findings, and create a PSA to encourage folks to donate, or even create a crowdfunding campaign themselves for a local food bank. For example, Feeding America has a large reach and they can encourage folks to donate here.

ADDITIONAL RESOURCES

WORLD HEALTH ORGANIZATION (WHO)

https://www.who.int/emergencies/diseases/novel-coronavirus-2019

Live updates, reports, and research from the global outbreak

CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)

https://www.cdc.gov/coronavirus/2019-ncov/index.html 

Information regarding symptoms, prevention, and preparation

RECENT NEWS

NEW YORK TIMES

https://www.nytimes.com/interactive/2020/world/coronavirus-maps.

html?action=click&module=RelatedLinks&pgtype=Article 

Coronavirus Map: Tracking the Spread of the Outbreak

https://www.nytimes.com/2012/07/15/sunday-review/the-ecology-of-disease. 

html?fbclid=IwAR1SfPAdr6jlVBe6TqqXlVs7V1dw275PXaHX7nozcA9VJFG 8qroBuuTpLU 

The Ecology of Disease by Jim Robbins

POLITICO

https://www.politico.eu/article/coronavirus-italy-doctors-tough-calls-survival/?fbclid=IwAR276hojcWWd15vVkkGB0WB QWdUUTG aAhYpM LrBYQoE9I4BLa9 

Italian doctors on coronavirus frontline face tough calls on whom to save by Greta Privitera

SPEAK TRUTH DEFENDERS | RIGHTS AT RISK IN A PUBLIC HEALTH CRISIS

TO POWER

NATIONAL STANDARDS

COLLEGE, CAREER & CIVIC LIFE (C3) FRAMEWORK FOR SOCIAL STUDIES STANDARDS

* D1.5.9-12 Determine the kinds of sources that will be helpful in answering compelling and supporting questions, taking into consideration multiple points of view represented in the sources, the types of sources available, and the potential uses of the sources.

* D2.Civ.7.9-12 Apply civic virtues and democratic principles when working with others.

* D2.Civ.10.9-12 Analyze the impact and the appropriate roles of personal interests and perspectives on the application of civic virtues, democratic principles, constitutional rights, and human rights.

* D2.Civ.12.9-12 Analyze how people use and challenge local, state, national, and international laws to address a variety of public issues.

* D2.Civ.14.9-12 Analyze historical, contemporary, and emerging means of changing societies, promoting the common good, and protecting rights.

* D2.Geo.5.9-12 Evaluate how political and economic decisions throughout time have influenced cultural and environmental characteristics of various places and regions.

* D3.1.9-12 Gather relevant information from multiple sources representing a wide range of views while using the origin, authority, structure, context, and corroborative value of the sources to guide the selection.

* D4.6.9-12 Use disciplinary and interdisciplinary lenses to understand the characteristics and causes of local, regional, and global problems; instances of such problems in multiple contexts; and challenges and opportunities faced by those trying to address these problems over time and place.

* D4.7.9-12 Assess options for individual and collective action to address local, regional, and global problems by engaging in self-reflection, strategy identification, and complex causal reasoning.

COMMON CORE STATE STANDARDS FOR ENGLISH LANGUAGE ARTS

* RI.11-12.1 Cite strong and thorough textual evidence to support analysis of what the text says explicitly as well as inferences drawn from the text, including determining where the text leaves matters uncertain

* W.11-12.7 Conduct short as well as more sustained research projects to answer a question (including a self-generated question) or solve a problem; narrow or broaden the inquiry when appropriate; synthesize multiple sources on the subject, demonstrating understanding of the subject under investigation

* W.11-12.9 Draw evidence from literary or informational texts to support analysis, reflection, and research.

SPEAK TRUTH

TO POWER

DEFENDERS | RIGHTS AT RISK IN A PUBLIC HEALTH CRISIS

DR. ANTHONY FAUCI

Dr. Fauci was appointed Director of National Institute of Allergy and Infectious Diseases (NIAID) in 1984. He oversees an extensive portfolio of basic and applied research to prevent, diagnose, and treat established infectious diseases such as HIV/AIDS, respiratory infections, diarrheal diseases, tuberculosis and malaria as well as emerging diseases such as Ebola and Zika. NIAID also supports research on transplantation and immune-related illnesses, including autoimmune disorders, asthma and allergies. The NIAID budget for fiscal year 2020 is an estimated $5.9 billion.

Dr. Fauci has advised six presidents on HIV/AIDS and many other domestic and global health issues. He was one of the principal architects of the President’s Emergency Plan for AIDS Relief (PEPFAR), a program that has saved millions of lives throughout the developing world.

Dr. Fauci also is the longtime chief of the Laboratory of Immunoregulation. He has made many contributions to basic and clinical research on the pathogenesis and treatment of immune-mediated and infectious diseases. He helped pioneer the field of human immunoregulation by making important basic scientific observations that underpin the current understanding of the regulation of the human immune response. In addition, Dr. Fauci is widely recognized for delineating the precise ways that immunosuppressive agents modulate the human immune response. He developed effective therapies for formerly fatal inflammatory and immune-mediated diseases such as polyarteritis nodosa, granulomatosis with polyangiitis (formerly Wegener's granulomatosis), and lymphomatoid granulomatosis. A 1985 Stanford University Arthritis Center Survey of the American Rheumatism Association membership ranked Dr. Fauci’s work on the treatment of polyarteritis nodosa and granulomatosis with polyangiitis among the most important advances in patient management in rheumatology over the previous 20 years.

Dr. Fauci has made seminal contributions to the understanding of how HIV destroys the body's defenses leading to its susceptibility to deadly infections. Further, he has been instrumental in developing treatments that enable people with HIV to live long and active lives. He continues to devote much of his research to the immunopathogenic mechanisms of HIV infection and the scope of the body's immune responses to HIV.

SPEAK TRUTH DEFENDERS | DR. ANTHONY FAUCI

TO POWER

In a 2019 analysis of Google Scholar citations, Dr. Fauci ranked as the 41st most highly cited researcher of all time. According to the Web of Science, he ranked 8th out of more than 2.2 million authors in the field of immunology by total citation count between 1980 and January 2019.

Dr. Fauci has delivered major lectures all over the world and is the recipient of numerous prestigious awards, including the Presidential Medal of Freedom (the highest honor given to a civilian by the President of the United States), the National Medal of Science, the George M. Kober Medal of the Association of American Physicians, the Mary Woodard Lasker Award for Public Service, the Albany Medical Center Prize in Medicine and Biomedical Research, the Robert Koch Gold Medal, the Prince Mahidol Award, and the Canada Gairdner Global Health Award. He also has received 45 honorary doctoral degrees from universities in the United States and abroad.

Dr. Fauci is a member of the National Academy of Sciences, the National Academy of Medicine, the American Academy of Arts and Sciences, and the American Philosophical Society, as well as other professional societies including the American College of Physicians, the American Society for Clinical Investigation, the Association of American Physicians, the Infectious Diseases Society of America, the American Association of Immunologists, and the American Academy of Allergy, Asthma & Immunology. He serves on the editorial boards of many scientific journals; as an editor of Harrison's Principles of Internal Medicine; and as author, coauthor, or editor of more than 1,300 scientific publications, including several textbooks

SPEAK TRUTH

TO POWER

DEFENDERS | RIGHTS AT RISK IN A PUBLIC HEALTH CRISIS

DR. TEDROS ADHANOM

GHEBREYESUS

“I envision a world in which everyone can live healthy, productive lives, regardless of who they are or where they live. I believe the global commitment to sustainable development—enshrined in the Sustainable Development Goals—offers a unique opportunity to address the social, economic and political determinants of health and improve the health and wellbeing of people everywhere. Achieving this vision will require a strong, effective WHO that is able to meet emerging challenges and achieve the health objectives of the Sustainable Development Goals. We need a WHO— fit for the 21st century—that belongs to all, equally. We need a WHO that is efficiently managed, adequately resourced and results driven, with a strong focus on transparency, accountability and value for money.”

—Dr. Tedros Adhanom Ghebreyesus, Director-General WHO

Dr Tedros Adhanom Ghebreyesus was elected as WHO Director-General for a five-year term by WHO Member States at the Seventieth World Health Assembly in May 2017.

He is the first WHO Director-General to have been elected from multiple candidates by the World Health Assembly, and is the first person from the WHO African Region to serve as WHO's chief technical and administrative officer.

Immediately after taking office on 1 July 2017 Dr Tedros outlined five key priorities for the Organization: universal health coverage; health emergencies; women’s, children’s and adolescents’ health; health impacts of climate and environmental change; and a transformed WHO.

Prior to his election as WHO Director-General, Dr Tedros served as Ethiopia’s Minister of Foreign Affairs from 2012–2016. In this role he led efforts to negotiate the Addis Ababa Action Agenda, in which 193 countries committed to the financing necessary to achieve the Sustainable Development Goals.

SPEAK TRUTH DEFENDERS | DR. TEDROS ADHANOM GHEBREYESUS

TO POWER

Dr Tedros served as Ethiopia’s Minister of Health from 2005–2012, where he led a comprehensive reform of the country’s health system. All roads lead to universal health coverage for Dr Tedros, and he has demonstrated what it takes to expand access to health care with limited resources.

The transformation he led as Ethiopia’s Minister of Health improved access to health care for millions of people. Under his leadership Ethiopia invested in critical health infrastructure, expanded its health workforce, and developed innovative health financing mechanisms.

Beyond Ethiopia, Dr Tedros’ global leadership on malaria, HIV/AIDS, and maternal and child health has been immensely impactful. He was elected as Chair of the Global Fund to Fight AIDS, Tuberculosis, and Malaria Board in 2009, and previously served as Chair of the Roll Back Malaria Partnership Board, and Co-chair of the Partnership for Maternal, Newborn and Child Health Board.

Born in the city of Asmara, Eritrea, Dr Tedros holds a Doctorate of Philosophy (PhD) in Community Health from the University of Nottingham and a Master of Science (MSc) in Immunology of Infectious Diseases from the University of London. Dr Tedros is globally recognised as a health scholar, researcher, and diplomat with first-hand experience in research, operations, and leadership in emergency responses to epidemics.

Throughout his career Dr Tedros has published numerous articles in prominent scientific journals, and received awards and recognition from across the globe. He received the Decoration of the Order of Serbian Flag in 2016, and was awarded the Jimmy and Rosalynn Carter Humanitarian Award in recognition of his contributions to the field of public health in 2011.

The World Journal of Biological Psychiatry, 2011; 12: 2–32

GUIDELINES

World Federation of Societies of Biological Psychiatry (WFSBP) Guidelines for the Biological Treatment of Alzheimer ’ s disease and other dementias

RALF IHL 1 , LUTZ FR Ö LICH 2 , BENGT WINBLAD 3 , LON SCHNEIDER 4 , ALISTAIR BURNS 5 , HANS-J Ü RGEN M Ö LLER 6 & WFSBP TASK FORCE ON TREATMENT GUIDELINES FOR ALZHEIMER’S DISEASE AND

OTHER DEMENTIAS *

1 Alexian Hospital Krefeld and Department of Psychiatry, University of Duesseldorf, Germany, 2 Division of Geriatric Psychiatry Central Institute of Mental Health Mannheim University of Heidelberg, Mannheim, Germany, 3 Karolinska

Institute, Neurotec, Huddinge, Sweden, 4 University of Southern California Keck School of Medicine, Los Angeles, CA, USA, 5 Psychiatry Research Group, University of Manchester, Manchester, UK, and 6 Department of Psychiatry and

Psychotherapy, University of Munich, Munich, Germany

Abstract

Objectives. To define a practice guideline for biological treatment of dementia and to make transparent the development of the guideline connecting the original data with the resulting recommendations. Methods. This guideline includes pharma-cologic treatment considerations for patients with Alzheimer’s disease, vascular dementia, DLB, and fronto-temporal dementia. Studies were selected that represent double-blind placebo-controlled trials of at least 3 months duration in patients with a diagnosis of dementia according to accepted international diagnostic criteria (for example the NINCDS/ ADRDA or NINDS/AIREN criteria). Moreover, to be included studies had to fulfill a restrictive set of methodological criteria. Original studies and not meta-analyses determined the evaluation and the development of recommendations. Results. Antidementia pharmaceuticals neither cure nor arrest the disease. A modest effect of improvement of symptoms compared with placebo can be observed. Antidementia pharmaceuticals show different efficacy and side effect profiles. The type of dementia, the individual symptom constellation and the tolerability should determine what medication should be used. There are hints that combination therapy of drugs with different therapeutic mechanisms might improve the efficacy. In treating neuropsychiatric symptoms (NPS), psychosocial intervention should be the treatment of first choice. Pharmaceuticals can only be recommended when psychosocial interventions is not adequate. However, even then the side effects of pharmaceuticals limit their use. Conclusions. Depending on the diagnostic entity and the pathology treated different anti-dementia drugs can be recommended to improve symptoms. In the management of NPS, side effects limit the use of medications even when psychosocial interventions have failed. Thus, there is an urgent need to develop more efficacious medications for the treatment of dementia.

Key words: Dementia , guidelines , Alzheimer , vascular dementia , Lewy body disease , fronto-temporal dementia , anti-dementia pharmaceuticals , neuropsychiatric symptoms , NPS , biological , treatment

* Bengt Winblad (Chairman; Sweden), Lon Schneider (Co-Chairman; USA), Alistair Burns (Co-Chairman; UK), Lutz Fr ö lich (Secretary; Ralf Ihl (Co-secretary), Germany); Hans-J ü rgen M ö ller (Chairman of the WFSBP Committee on Scientific Publications; Germany); Rafael Blesa (Spain); Henry Brodaty (Australia); Jean-Francois Dartigues (France); Istwan Degrell (Hungary); Steve DeKosky (USA); Hidetoshi Endo (Japan); Timo Erkinjjuntti (Finland); Hans F ö rstl (Germany); Giovanni Frisoni (Italy); Serge Gauthier (Canada); Ezio Giacobini (Switzerland); Teresa Gomez-Isla (Spain); Carl-Gerhard Gottfries (Sweden); Michael Grundman (USA); Changsu Han (Korea); Christoph Hock (Switzerland); Josef Marksteiner (Austria); Colin Masters (Australia); Ian McKeith (UK); Maria Olofsdottir (Iceland); Jean-Marc Orgogozo (France); Michael Rainer (Austria); Barry Reisberg (USA); Peter Riederer (Germany); Martin Rossor (UK); Bernd Saletu (Austria); Eric Salmon (Belgium); Trey Sunderland (USA); Masatoshi Takeda (Japan); Bruno Vellas (France); Frans Verhey (Netherlands); Gunhild Waldemar (Denmark); Peter Whitehouse (USA).

Correspondence: Ralf Ihl, MD, Head of the Clinic of Geriatric Psychiatry and Psychotherapy Alexian Hospital, Oberdiessemer Str. 136, 47504 Krefeld, Germany. Tel: + 49 21513 47904. Fax: + 49 21513 47901. E-mail: ralf.ihl@alexianer-krefeld.de

ISSN 1562-2975 print/ISSN 1814-1412 online © 2011 Informa Healthcare

DOI: 10.3109/15622975.2010.538083

WFSBP Guidelines for Alzheimer’s disease and other dementias 3

Preface and disclosure statement

Like with the preceding guidelines of this series (Bauer et al. 2002, Bandelow et al. 2008b), these practice guidelines for the pharmacological treatment of Alzheimer’ s disease and other dementias(AD) were developed by an international Task force of the World Federation of Societies of Biological Psychiatry (WFSBP). Their purpose is to provide expert guidance on the pharmacological treatment of dementia based on a systematic overview of all available scientific evidence pertaining to the phar-macologic treatment of AD and other disorders associated with dementia. These guidelines are intended for use by all physicians seeing and treating patients with dementia. Some medications recommended in the present guideline may not be available in all countries.

  The preparation of these guidelines has not been financially supported by any commercial organization. This practice guideline has been developed mainly by psychiatrists who are in active clinical practice. In addition, some contributors are primarily involved in research or other academic endeavours. It is possible that through such activities some contributors have received income related to medicines discussed in this guideline (See disclosure). A number of mechanisms are in place to minimize the potential for producing biased recommendations due to conflicts of interest.

Levels of evidence

The scientific rigor of the data was categorised according to the evidence categories of the World

Table I. Evidence levels of the WFSBP.

Federation of Societies of Biological Psychiatry (WFSBP, Bandelow et al. 2008a, Table I). Whenever a level of evidence is referred to herein it will be consistent with Table I.

Grade of recommendation

In the current literature, several different “ scales ” to grade recommendations are used. None of the scales offers any validation data. The grading scale used here was developed and used by the WFSBP (Ban-delow et al. 2008b, Table II). To develop recommendations, scientific evidence was taken into account as well as side effects and the highest possible outcome of therapy. For the following recommendations, it is important to remember that available anti-dementia medications neither cure nor arrest the disease. Even the effect on symptoms is modest. For NPS accompanying the disease, treatments following these recommendations might mitigate or even eliminate a particular NPS without influencing the underlying disease.

Introduction

Dementia is a syndrome of acquired cognitive deficits sufficient to interfere with social or occupational functioning, which results from various central brain pathological processes. It is defined by the existence of deficits in episodic memory and in other cognitive domains. The syndrome is diagnosed in association with behavioural assessment, neuroimaging and laboratory investigations. Deficits in cognitive domains include global cognitive

A Full Evidence From Controlled Studies is based on: two or more double-blind, parallel-group, randomized controlled studies (RCTs) showing superiority to placebo (or in the case of psychotherapy studies, superiority to a ‘ ‘ psychological placebo ’ ’ in a study with adequate blinding) and one or more positive RCT showing superiority to or equivalent efficacy compared with established comparator treatment in a three-arm study with placebo control or in a well-powered non-inferiority trial (only required if such a standard treatment exists) In the case of existing negative studies (studies showing non-superiority to placebo or inferiority to comparator treatment), these must be outweighed by at least two more positive studies or a meta-analysis of all available studies shows superiority to placebo and non-inferiority to an established comparator treatment. Studies must fulfill established methodological standards. The decision is based on the primary efficacy measure .

B Limited Positive Evidence From Controlled Studies is based on: one or more RCTs showing superiority to placebo (or in

the case of psychotherapy studies, superiority to a ‘ ‘ psychological placebo ’ ’ ) ora randomized controlled comparison with a standard treatment without placebo control with a sample size sufficient for a non-inferiority trial andno negative studies exist

C Evidence from Uncontrolled Studies or Case Reports/Expert Opinion

C1 Uncontrolled Studies is based on: one or more positive naturalistic open studies (with a minimum of five evaluable patients) or a comparison with a reference drug with a sample size insufficient for a non-inferiority trial and no negative controlled studies exist

C2 Case Reports is based on: one or more positive case reports andno negative controlled studies exist

C3 Based on the opinion of experts in the field orclinical experience

D Inconsistent Results. Positive RCTs are outweighed by an approximatelyequal number of negative studies

E Negative Evidence. The majority of RCTs studies shows no superiority to placebo (or in the case of psychotherapy studies,

superiority to a ‘ ‘ psychological placebo ’ ’ ) or inferiority to comparator treatment

F Lack of Evidence. Adequate studies proving efficacy or non-efficacy are lacking

4 R. Ihl et al.

Table II. The level of evidence determines the grade of recommendation. Depending on the frequency and severity of side effects it may be altered by one step in category A. A precondition is to recognize that the highest possible treatment outcome herein referred to will be a modest decrease of symptoms over a limited period in the course of the disease.

Recommendation

grade Based on

1 Category A evidence and good risk-benefit ratio

2 Category A evidence and moderate

risk-benefit ratio

3 Category B evidence

4 Category C evidence

5 Category D evidence

function, orientation, memory impairment (e.g., episodic memory), language, visuoperceptual skills and executive functions. Dementia may be diagnosed according to the criteria of the International Classification of Diseases, 10th Revision (ICD-10) (World Health Organisation 1992), or the Diagnostic and Statistical Manual, 3rd ed. (DSM-III) or 4th ed. (DSM-IV) (American Psychiatric Association 1994). The prevalence of dementia may vary with the diff erent diagnostic criteria. Erkinjuntti et al. (1997) compared six commonly used classification schemes (DSM-III, DSM-III-R, DSM-IV, ICD-9, ICD-10, and the Cambridge Examination for Mental Disorders in the Elderly (CAMDEX)). They showed that the prevalence of dementia can differ by a factor of 10 depending on the diagnostic criteria used. Moreover, there are no data on inter-rater-reliability. Two other studies demonstrated that the pre valence of vascular dementia (VD) varies with the classification system and therefore the criteria for diagnosis are not interchangeable. Table III gives an overview of different types of dementia.

  International consensus criteria have been developed for several causes of dementia. Alzheimer ’ s disease (AD), the commonest cause of dementia, is diagnosed according to the National Institute of Neurological and Communicative Disorders and Stroke – Alzheimer’s Disease and Related Disorders Association criteria (NINCDS/ADRDA, McKhann et al. 1984). Lewy body dementia, which was recognized about a decade ago as possibly the second most frequent cause of neurodegenerative dementia in the elderly, is commonly diagnosed according to the third revision of McKeith criteria (McKeith et al. 2005). The former entities of Pick ’ s disease, frontal lobe dementia, semantic dementia etc. have been combined into the group of fronto-temporal degeneration (FD). Consensus criteria have first been defined by (Neary et al. 1998). Criteria for vascular dementia (VD) have been established by 

the National Institute of Neurological Disorders and Stroke (NINDS) and the Association Internationale pour la Recherche et l’Enseignement en Neurosci-ences (AIREN) workshop (Rom á n et al. 1993). These criteria comprise three entities of cerebrovas-cular disease: small-vessel disease with extensive leukoencephalopathy (Binswanger ’ s disease), small vessel disease with multiple lacunae (affecting predominantly the basal ganglia and frontal white matter), or large infarcts in strategic locations of large-vessel territories locations.

  These subtypes can be distinguished using structural neuroimaging, but almost never occur in pure form (Guermazi et al. 2007). Therefore, it is not surprising that the sensitivity of the NINDS-AIREN criteria is low (about 40% at 95% specificity) at autopsy (Holmes et al. 1999). More than one third of patients with the clinical diagnosis of dementia had the diagnosis of mixed dementia (AD plus cere-brovascular disease) at autopsy (Holmes et al. 1999; Galasko et al. 1994). Vice versa cerebrovascular dysfunction might aggravate the deleterious effects of AD (Iadecola, 2010). These observations might contribute to the explanation of results from clinical studies in vascular dementia using medications for AD (Morris et al. 1988; Tierney et al. 1988; McKhann et al. 1984; Galasko et al. 1994; Nolan et al. 1998; Lim et al. 1999; Rom á n et al. 2010).

  The discovery that a long pre-clinical period precedes AD has led to the development of early diagnostic indices of dementia. This border zone between normality and dementia has been given numerous names and definitions, which include: benign senescent forgetfulness (BSF), age associated memory impairment (AAMI), age-consistent memory impairment (ACMI), age-associated cognitive decline (AACD), mild cognitive impairment (MCI), cognitive loss no dementia (CLOND), and cognitive impairment but not dementia (CIND). The prevalence for this pre-clinical or mild form of cognitive decline varies with the classification system used (Schroder et al. 1998). Originally described by Reis-berg as a stage in the Global Deterioration Scale (GDS Stage 3, Reisberg et al. 1987) and proven in a study by Flicker et al. (1991) MCI is emerging as the preferred term for this condition. Criteria were published by Peterson et al. (1997) and consensus criteria by Winblad et al. (2004). Ritchie et al. (2001) estimated the prevalence of MCI in the general population to be 3.2% with an 11.1% conversion rate to dementia within a 3-year period. Other studies have found higher rates of conversion (Geslani et al. 2005; Amieva et al. 2004), probably related to the exact definition of MCI and population sampled. Recently, the criteria of MCI have been refined into single domain and multiple domain MCI (one or several

Table III. Comparison of diagnostic criteria (for biomarkers see Wiltfang et al. 2005; for CT/MR Frisoni et al. 2010; for PET Nordberg et al. 2010; for EEG Rossini et al. 2007).

AD

VD

LBD

FD

CJD

Special aspects of symptomatology besides the dementia syndrome

Only 50 % show memory deficit early in the course, preserved facade

Early gait disturbance, bladder dysfunction without urologic reason, falls, focal neurological signs

Fluctuation of vigilance, paranoid and hallucinatory symptoms, Parkinsonian rigidity, oversensitivity to neuroleptics, REM sleep disturbance

Euphoria, emotional flattening, disinhibition, coarsening of social behaviour, visuo-spatial functions preserved in the beginning

Visual and cerebellar disturbances, pyramidal and extrapyramidal symptoms, myoclonus, akinetic mutism

Course

Slow progression

Step-wise progression with possible partial compensation after a step

As AD

As AD but in comparison faster

Rapid progression, most

often less than 1 year duration

EEG

Slowing of electric wave activity related to severity, decreased fast alpha activity associated with faster progression, no alterations also possible

Often focal alterations

Slowing related to severity

(as in AD)

No characteristic alterations

Periodic sharp waves (triphasic waves often present), not with the new variant

Biomarker

Increased tau and phospho-tau, and decreased A ? in the CSF

None

None

None

Increased protein 14-3-3 in the CSF

Structural Imaging CT/MRI

Atrophy (medial temporal in the beginning, later temporo-parietal, frontal and finally generalized; hippocampal atrophy related to severity

Multiple infarcts, single strategic infarcts, extensive white matter lesions

Relatively less severe medial temporal atrophy as compared to AD

Lobar frontal and/or temporal

atrophy, often asymmetric

Unspecific

Functional Imaging

In the beginning temporo

In ischemic areas

Predominantly in visual

Frontal and temporal cortex

Variable

Glucose

hypomeatbolism on PET

parietal and posterior cingulate, later frontal, finally generalized

association cortex

often asymmetric

Neuropathology

Plaques, fibrillary tangles,

congophil angiopathy

Ischemic lesions

Lewy bodies

Astrocytosis, atrophy of lamina I-III in the frontal cortex, microvascualisation neuropil, alterations in tau and TDP43

Spongiform encephalopathy (increased amyloidosis and microvesicles)

6 R. Ihl et al.

cognitive domains are impaired), and amnestic and non-amnestic MCI (primary memory impairment vs. primary impairment of non-memory cognitive functions, Petersen et al. 2001; Petersen, 2004). With the exception of multiple-domain non-amnestic MCI, all other MCI subtypes showed the highest association with AD in a population based study (Busse et al. 2006). The clinical entity of MCI is still not satisfactorily defined. This entity, however, plays a major role in the evaluation of secondary preventive treatments that may have the potential to attenuate or stop the conversion from MCI into dementia. It may be necessary in the future to include neuroimaging and CSF/blood biomarkers to define persons with MCI as at risk for dementia, particularly for AD. However, for clinical studies, the definitions of the concept are often not operationalised robust enough to identify reproducible groups. These aspects may account for the observed variability between samples with MCI (Arn á iz et al. 2004).

  Dementia has become a major public health problem due to its increasing prevalence accompanying the aging of the population, long duration, caregiver burden, and high financial cost of care. The prevalence of dementia in Europe increases continuously with age and has been estimated to be about 1% in the group aged 65 – 69 years and 29% at age 90 years and older (Lobo et al. 2000). The most frequent underlying neurobiological cause of a dementia syndrome is Alzheimer ’ s disease (AD), accounting for at least 60% of dementia in patients older than 65. Presently, it is estimated that 7.21 million patients in Europe and 3.1 million in North America suffer from mild to severe AD. This number is projected to increase to 16.51 million in Europe and 8.85 million in North America until in the year 2050 (Brookmeyer 2007). In Asia, South America and Africa, the numbers although lower than in Europe and North America now, will quintuple by 2050.

  From a clinical perspective, dementia predominately affects cognition, behavior/mood, physical functions, activities of daily living and caregiver burden. Most therapeutic interventions for dementia aim to affect these domains. From a pharmacological perspective, all interventions for dementia try to target at least one of the following broad therapeutic goals.

Prevention of onset of dementia

In the context of this review, this applies to those at greatest risk (such as those with a clinical diagnosis of MCI) of progression to a dementia syndrome.

Symptomatic treatment of dementia

Symptomatic benefit can be described as maintenance (or stabilization) or improvement of the current cog 

nitive, behavioural, functional, or caregiver status only while on active treatment with the pharmacological intervention. Withdrawal of the pharmacological therapy may result in a decline towards baseline or placebo levels of relevant outcomes.

Delay in the progression of dementia

A therapeutic intervention that brings about delay in the progression of the disease can be described as either (1) one that maintains (or stabilizes) or improves current cognitive, behavioural, functional, or caregiver status, which is sustained even when the drug is withdrawn, or (2) one that can be shown to alter the rate of decline of the disease progression, even when the drug is withdrawn.

  However, only for the symptomatic treatment of dementia are sufficient data available. In the first section of this guideline, the criteria for the evaluation of studies are described. In the second part, the evidence for the pharmacological treatment options is reviewed and the levels of evidence for the available treatment options evaluated. Finally, on the basis of this evidence, guidelines will be suggested.

Methods

The data used for this guideline have been extracted from a Medline and Embase search, from recent proceedings of key conferences, from meta-analyses and reviews on the efficacy of anti-dementia medications including Cochrane-Reviews, from conclusions of national authorities like National Institute for Clinical Excellence (NICE, United Kingdom) and Institut f ü r Qualit ä t und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Economics in Public Health, IQWIG, Germany) and from various national and international treatment guidelines (last guideline included was the German so called S3-Guideline “ Dementia ” of the Association of Scientific Medical Societes in Germany, 11/2009). The keywords were (dementia or Alzheimer

or FTD, Pick ’ s disease, frontal lobe dementia,

semantic dementia, or vascul ? or LBD and therapy and/or guideline).

  This review considers different dementia populations and subjects from both community and institutional settings. Subjects in the studies had to be > 18 years of age. This guideline includes pharma-cologic treatment considerations for patients with Alzheimer’s disease, vascular dementia, DLB, and fronto-temporal dementia. For the most part, when referring to Alzheimer’s disease within the context of treatment, we are referring to probable or possible Alzheimer’s disease or dementia of the Alzheimer ’ s type, as diagnosed by NINCDS-ADRDA criteria (McKhann et al. 1984), or DSM-III-R or DSM-IV

WFSBP Guidelines for Alzheimer’s disease and other dementias 7

criteria (American Psychiatric Association 1994). Vascular dementia refers to NINCDS-AIREN criteria (Rom á n et al. 1993), including dementia occurring soon after a stroke, multi-infarct dementia as defined by DSM-III-R and DSM-IV (American Psychiatric Association 1994), and chronic leukenceph-alopathy. Dementia with Lewy Bodies is based on the Newcastle criteria McKeith criteria (McKeith et al. 2005), fronto-temporal degeneration to Lund-Manchester criteria (Neary et al. 1998). For the diagnosis of mild cognitive impairment (MCI), each study tends to construct its own set of criteria, but those are mostly based on Mayo criteria (Petersen 2004) with more or less variation (Anonymous 1989; World Health Organization 1992; American Psychiatric Association, 1980, 1987, 1994, McKhann et al. 1984; Roman et al. 1993; Petersen 2001; Graham et al. 1997; Graham et al. 1996; Folstein et al. 1975; Hachinski et al. 1975). Studies were selected that represent double-blind placebo-controlled trials of at least 3 months duration in patients with a diagnosis of dementia according to the diagnostic criteria described in Table III.

  The potential for risk, or adverse events, was an important component to consider with respect to efficacy. The Jadad scale for quality (Oremus et al. 2001) does not take into account factors associated with adequate collection and reporting of adverse events as detailed by (Ioannidis and Lau 2002). Therefore, a summary checklist was used to determine the potential quality in the collection and reporting of adverse events.

Meta-analyses and guidelines

Scientific articles bear a high potential of methodological pitfalls. The reviewer system does only detect a minor number of faults in a publication. Even if rigourously evaluated many conclusions of studies remain arbitrary (see Excursus section). Thus, it is important to make the basis of conclusions transparent. In meta-analyses, these problems are even greater. Rosenthal and diMatteo (2001) and M ö ller and Maier (2007) have described the advantages and disadvantages of meta-analyses. In most meta-analyses the reviewer or reader must trust in the veracity of the content. Thus, meta-analyses are not transparent and they may, or may not, be scientific. Most guidelines include both articles and meta-analyses, making it difficult to determine the overall quality of the data. The present guideline of the WFSBP seeks to overcome this methodological flaw by reference to the underlying data base. For anti-dementia drugs the underlying database is attached. For NPS, the underlying database is described by Gauthier et al. (2010).

  

To double check flaws and shortcomings of studies, meta-analyses, Cochrane reviews, guidelines and independent reports are useful and were used. The cues on flaws and shortcomings in studies were used to optimize the selection of studies. For the studies included, tables for each intervention summarise the key data (see online Tables 1 – 10 and the resulting overview in Table VII). A list of studies excluded due to pitfalls and failures is not given but can be found in Cochrane reviews, guidelines and independent reports.

 The field of dementia in medicine is a research area with a leading highly sophisticated methodology. The following differentiated excursus exemplarily will describe a part of the aspects that determine the outcome of studies not only in dementia.

Excursus: Methodological aspects of clinical trials in dementia

Study design

In clinical research on dementia treatment there are neither uniformly accepted criteria for disease progression nor a consensus regarding the magnitude of clinically important changes (Whitehouse et al. 1998; Rockwood and McKnight 2001). With respect to the therapeutic aims stated above, the practical consequences of these unresolved issues are that the same efficacy variables have been used to both show evidence of symptomatic benefit and demonstrate the effects on disease progression. Thus, the design of a clinical trial (rather than the outcome) is critical to demonstrating which of these two therapeutic outcomes (symptomatic benefit or delay in progression) is being achieved with the pharmacological agent (Leber 1997). Irrespective of which therapeutic goal is targeted by the pharmacological agent, the lack of consensus on these two issues has even more important implications when considering the definition of “ efficacy ” . To base efficacy solely on statistical significance has long been recognized as problematic. A clinically relevant pharmacological treatment is seen as one that makes a “ real difference ” , where the change is both relevant and important to the patient or to their families. This shows the difference between clinically significant (relevant and important) versus statistically significant (associated with probabilities), where the latter determines that the results are not due to chance or confounders. Moreover, a clinically important change will vary depending on whether importance is defined from the patient, family caregiver or clinician perspective. Clinically meaningful change reflects a different level of“ significance ” , which may require a consensus among experts within the field to establish what magnitude of change is

8 R. Ihl et al.

regarded as important (Rockwood and McKnight 2001).

 Accepting the criteria of the SIGN50 group (Wells et al. 2008) requires acceptance that between groups the only difference allowed as a pivotal outcome is the treatment under investigation. Comparing different trials requires the same restriction. However, RCTs fulfilling the inclusion criteria differ in many aspects (for instance age, stage of severity, diseases included, selection of patients, spectra of symptoms). Each of these aspects can be divided into a number of subcategories. Division into categories does not follow a common rule (for instance by using the same categorical meassure to assess the stage of severity). This situation becomes more complex when factors like doses of drugs used in a trial form new categories. The resulting picture can best be described as a multidimensional grid with at least three axes: diagnostic group, stage of severity, age of patients. Studies cover only a small part of the number of possible “ study-boxes ” . In most of the boxes no study or only one study is presently available. So verification of the first result is often missing. This limits the possibility of a generalisation of the results to more areas than the one covered. For every area of interest, the multidimensional grid would have to be replicated. Although some studies include several outcome criteria the number of criteria differs. This leads to an unmanageable number of possible studies (for instance in measuring cognition, behaviour, activities of daily living, clinical impression etc.). For an evaluation, the conservative strategy of dimensional boxes would limit possible statements to a very narrow part of medical treatment. To allow for exact statements, studies in every box would be needed. Due to limited economical as well as scientific resources, it will be impossible to run the possible number of studies. Thus, strategies to reach conclusions on areas that are not precisely covered have to be accepted. One solution could be to permit conclusions based on age groups that were far removed from the mean age of the available studies and, thus, were only investigated in a smaller number of patients ( “ extrapolations ” , Oxford Centre for Evidence Based Medicine 2009).

 A second source of study diversity stems from the particular tests employed. In all areas apart from cognition there is no standardized procedure or test and the validation of the tests is in an evolving stage (for instance the version of ADAS-cog used differs from study to study in the method of item administration or even in the number of items used). For rater training, no common rules are described. This means, if studies are comparable in the inclusion categories and more than one tester fills in a box 

incompatible test results might make a comparison or verification almost impossible.

  A third major source of diversity results from different developments in the group of patients investigated. This is demonstrated by the alteration of test values of the placebo group that may have worsened dramatically or conversily improved after a 6 month trial period, for instance Kanowski et al. (1996) in comparison with Corey-Bloom et al. (1998). The rate of progression might also have had an effect on the study outcome, explaining these divergent results.

Relevant efficacy

The United States Food and Drug Administration (FDA) has established criteria for efficacy of anti-dementia (specifically for AD) drug interventions (Leber 1990) which require the following: (1) a double-blind, placebo-controlled trial, (2) subjects who meet established criteria for AD, (3) sufficient length of follow-up to appreciate a meaningful effect of the drug on cognition, and (4) a clinical change of sufficient magnitude to be recognized by a clinician. In establishing these criteria, it was assumed that the outcome measuring cognition was the primary change of interest, and that the global clinical evaluation would mirror the changes in the primary variable (Rockwood and Joffres 2002). In 1997, the European Medicine Evaluation Agency (EMEA) issued new guidelines that incorporated two new concepts for the treatment of AD (European Medicine Evaluation Agency (EMEA) 1997). Firstly, the EMEA guidelines suggested a measure of functional abilities in addition to a global measure, and noted that behavioural outcomes were important from a clinical perspective. Secondly, a definition of “ responders ” should be included in all trials, such that the degree of improvement in their cognition (or stabilization) was pre-specified. Nevertheless, these approaches with up to three criteria do not represent the symptom spectrum of dementia and moreover, do not cover other factors that also might contribute to the evaluation of a drug (i.e. quality of life, institutionalization, mortality, time spent caring etc.).

  Moreover, the magnitude of the change reflecting a clinically meaningful improvement was not specifically stated in any of these guidelines (Table IV). Sufficient magnitude of the change would reflect a clinically important difference, and this would vary with the type of outcome selected. Several authors have attempted to define “ clinically ” relevant change. Gutzmann et al. (2002) developed an Efficacy Index Score (EIS), which is a checklist that combines dropout as well as the relevant improvements individually across three levels of assessment (cognitive function,

WFSBP Guidelines for Alzheimer’s disease and other dementias 9

Table IV. Methods proposed to determine the outcome of clinical studies.

Author Gutzmann et al. 2002, EIS Mayeux and Sano 1999 Burns et al. 2008

Dropouts Evaluating dropouts percent of dropouts related to

adverse events

Cognitive function Improvement of cognitive

function

Other domains Improvement of activities of

daily living

Global function Improvement of global function

in cognition

percent of the change in the treatment group relative to baseline (corrected for any change in the placebo group)

Improvement/stabilization/less than expected decline by < or = 2 or < or = 4 or < or = 6 points on the ADAS-cog. plus one other domain

Improvement or improvement/ no change in global response

activities of daily living and global function). Although, this summary score has not been validated relative to other traditional outcomes, it does present a unique example of determining efficacy in the context of anti-dementia drug interventions. Mayeux and Sano (1999) in reviewing drug interventions for dementia, evaluated efficacy as a percent of the change in the treatment group relative to baseline (corrected for any change in the placebo group) and contrasted this with the percentage of dropouts related to adverse events. Disease progression was considered with respect to the outcomes of (1) time until death, (2) nursing home placement, (3) loss of ability to perform Activities of Daily Living (ADL), or (4) severe dementia. In the context of clinical trials seeking to establish efficacy of pharmacological interventions, the latter outcomes may be problematic to ascertain. For a clinically relevant change, Burns et al. (2008) introduced cut-off criteria. None of the methods covers the whole spectrum of a dementia. The methods used determine and limit the interpretability of results. However for the patient suffering from a disease that progressively worsens, as long as the opposite is not demonstrated every improvement should be defined as clinically relevant (for ethical considerations see Katona et al. 2009).

Measuring efficacy with tests

EMEA guidelines acknowledge that no single test encompasses the broad range of disease characteristics associated with AD; nor has there been convincing evidence that an ideal (or reference) instrument exists to capture cognitive, behavioural, functional, or caregiver status (European Medicine Evaluation Agency (EMEA) 1997). Given the current state of research on outcome measures used in dementia trials for determining efficacy, a further dilemma is at hand. Ideally, all outcomes used to evaluate efficacy should have demonstrated acceptable psychometric properties, such as reliability, validity (construct), and responsiveness. The literature evaluating outcome 

measures in dementia trials suggests that most instruments have some limitations or at least more data are required to establish the properties for acceptability of the scales. However, since none of the presently used outcomes has been accepted as standard, the selection of the most appropriate outcome is arbitrary. Similarly, establishing a rationale to exclude studies based on a specific type of outcome measure would also be arbitrary. To minimize measuring failures, the degree of validation should be taken into account (i.e. objectivity, test-retest reliability, inter-rater reliability, construct validity, convergent validity, scope of application – for instance stage of severity, norm values available for the group of interest, defined sensitivity to detect change).

Rater training. For assessing test values, experienced raters are needed. Unfortunately, there is no standardised rater training available. If ever mentioned, studies merely state that there was rater training. This methodological flaw leads to a low inter-rater-reliability and poor test-retest-reliability. It increases the probability that an existing efficacy will not be detected.

Limitations of tests. Moreover, frequently used outcome measures have limitations such as bottom and ceiling effects, low sensitivity, and poor objectivity that undermine their validity. Some aspects of the most often used scales have even more influence on the interpretability of results.

  To measure cognition, the Alzheimer ’ s Disease Assessment Scale-Cognitive Section is used (ADAS-cog, Rosen et al. 1984). A basic quality aspect of a test is that it will be the same test in every study (example: if an inch is used, it should always have the same length). Yet, in most studies using the ADAS-cog different items are used. Due to manufacturing problems with the object naming task, it is not possible to use the same set of objects. As a result in some studies pictures of objects are used.

10 R. Ihl et al.

Moreover, the length of the test varies between 11 and 13 items also influencing results. Nevertheless, Rosen demonstrated that a decline of 1.28 points occurred within 12 weeks, a decline of 3.5 points within 6 months, and Stern et al. (1994) showed a decline of 9 – 11 points by 1 year. However, so far such alterations are not seen in the placebo groups of drug studies. After 6 months, in placebo groups of methodologically sufficient studies, the mean points of alteration lay between an improvement of 1.6 points and a worsening of more than 4 points. Without further explanatory statement for study duration of half a year, the magnitude of “ relevant benefit ” on the ADAS-cog was set as 4 points at endpoint in treatment over placebo (Food and Drug Administration 1989). Most of the studies demonstrate a mean improvement of below 4 points. It is self-evident that the decline will depend on the stage of a patient at the beginning of the evaluation. Thus, the real decline might have a much higher variability. The characteristics of the natural history of AD and other dementia types are best derived from longitudinal studies. However, the natural history of AD itself shows an enormous heterogeneity. This diversity of the natural history of disease has a negative impact on comparisons of drug efficacy across trials (Demers et al. 2000).

 The Mini-Mental-Status-Examination (Folstein et al. 1975) has even more flaws. Many different versions are used leading to different results (Kaiser et al. 2009). To detect early stage of dementia, the sensitivity is as low as 20% (Blessed et al. 1991; Ihl et al. 1992, 2005; White et al. 2002; Wind et al. 1997). To measure the course of the disease as well as treatment effects, it is not precise enough (Clark et al. 1999). The recommendation is not to use it (Grade 1, Wilcock et al. 1994). The high variability of the MMSE makes finding efficacy more difficult. Bottom and ceiling effects as well as low consistency and curvilinear relations to severity over the course of the disease accompany the tests.

 Measuring other variables like behaviour might be even more difficult. Symptoms occur and disappear in the natural course of the disease and the relation to the stage of severity is variable. Due to low validity, results concerning activities of daily living (ADL), quality of life and clinical global impression have to be interpreted with much more caution. Further, measures of these variables are obtained by proxy i.e. from reports from caregivers whose accuracy may be variable.

Problems of alternative measures. To overcome disadvantages of poorly validated tests, measuring mortality and time to nursing home placement are 

recommended (IQWiG 2007). These parameters are also arbitrary. For instance depending on the actual symptoms, nursing home placement can be seen as a positive as well as a negative outcome.

  Presently, we lack generally accepted designs to test drugs that would modify the underlying disease (compared to attenuating the clinical symptom course). Therefore, the regulatory authorities such as EMEA and FDA have expressed an increasing interest in the development and use of potential surrogate markers of disease modification in secondary preventive trials on AD and risk stages of AD (Broich 2007). Biomarkers derived from CSF, blood or neuroimaging might play an important role in this respect. These markers will only be useful if applied in combination with clinical and neu-ropsychological measures of change, but might particularly be helpful to discriminate symptomatic from disease modifying effects. Nevertheless, as long as we do not know the cause of the underlying diseases the interpretations of biomarkers remains difficult.

Statistical aspects of evaluating trials

To exclude unwanted intervening variables, studies need to be carfully designed. Failures are observed in design and methods and statistics (Altmann 1994). A number of factors may prohibit any conclusion being reached. However, reviewers do not detect the failures, even with training (Schroter et al. 2008). Thus, improving the quality of reports has been recommended (Hopewell et al. 2008; Zwarenstein et al. 2009).

  Especially in dementia trials, the JADAD scale (Jadad et al. 1996) or the CONSORT questionnaire (Moher et al. 2001) will not cover all relevant criteria. The “ SIGN 50 ” (Wells et al. 2008) meets the most important aspects. However, it asks for a deep understanding of methods and details of a study. Moreover, inter-rater-reliability and validation data are lacking. A selection of important factors to look for is summarised in Table V.

  Many other factors are discussed but the possible size of an effect is rarely defined. Determining efficacy in dementia trials evaluating pharmacological interventions may vary depending on the selection of the analysis type. In general, the types of analyses of primary data in trials fall into two main categories: (1) intention to treat analyses (ITT) with the method of ’ last observation carried forward ’ (LOCF) to substitute for drop-outs, and (2) observed case (OC) or completed trial (CT). The advantages of ITT over OC analyses have been well explained (Fergusson et al. 2002), however, the LOCF method to replace

WFSBP Guidelines for Alzheimer’s disease and other dementias 11

Table V. Examples of factors limiting conclusions in dementia trials.

Failure Limited conclusions because of

Power too low An existing effect might not be found

Heterogeneous groups An existing effect might not be found

Groups differ in more than the variable investigated Intervening variable occurs

Randomization inadequate or not done Intervening variable occurs

Blinding inadequate or not done Intervening variable occurs

Diagnostics do not follow the international criteria High variability

Unknown disease severity High variability

Low number of patients per centre (i.e. < 4) High variability

Unknown number of centres Self-evident

Psychometric tests not valid High variability

Limitations of a test not taken into account Self-evident

No specified rater training Measurement corrupted

Failures in statistical evaluation Self-evident

Overestimation of failures Self-evident

Missing ? - adjustment Pretends significance

Use of other anti-dementia drugs Increases noise

Use of other psychoactive drugs Increases noise

Differential attrition Confounds results

Use of Last Observation Carried Forward Overestimates effect of drug

drop-outs may not be the most appropriate in the case of a chronic progressive disease, where ’ return to normal ’ is not the expected outcome, but ’ worsen

ing from baseline ’ . It is well recognized that

non-compliance is not a random event; thus, ITT analyses should be used to base principal conclusions of efficacy (Pocock and Abdallah 1998). In the context of some anti-dementia drug therapies, where dropout rates due to adverse events in general and other non-compliance reasons may be high, the ITT analysis minimizes bias over the OC analysis and the potential for type I errors when considering treatment efficacy. However, the ITT/LOCF analysis does tend to favour treatment effects, if dropouts due to adverse events are more likely under active treatment and if the likelihood for favourable outcome is higher the earlier the last ’ real ’ observation is made. Both conditions are generally true for anti-dementia drug therapies. Thus, the optimal analysis, when there is a large loss to follow-up, is to conduct the analysis both ways and look for consistency. However, compared to failures done in the trial itself flaws in the statistical analysis are happening ex-post-facto. This means, in contrast to failures made in processing the trial, failures in statistics can be minimised by recalculation and a more exact result will be possible.

  The current designs of clinical trials do not allow for the collection of adverse events whose rates may generalize to the population as a whole. It is misleading to assume that drugs shown to be safe and effective in trials are safe and effective in all other circumstances (Lasagna 1998). The nature of pre-market clinical trials makes it difficult to evaluate the benefits of drugs for the entire population of 

potential users, as criteria restricting entry into the trial do not necessarily reflect dementia patients in general. By their nature, some adverse events are not easily anticipated, and therefore are not screened for in some trials. The implementation of pharmaco-vigilance systems attests to the need for further capture of potential adverse events not captured in trials. Adverse events may be hard to predict or anticipate and are captured only if a trial protocol was designed to measure these events. A limited number of standardized instruments exist to capture these events reliably. Unique to individuals with cognitive decline is the potential problem of validity of the self-report instrument. Subjectivity needs to be recognised for reports completed by the caregiver. Furthermore, many trials may be underpowered to detect adverse events with an incidence of 1/1000 and lower.

Flaws in the interpretation of results

To exclude “ euphoric over-interpretations ” , acceptance of the conclusions and language of authors ’ reports needs care and caution (Gilstad and Finu-cane 2008).

Results

Clinical trials fulfilling the suggested methodological criteria are available for five drugs (Table VI). The five anti-dementia pharmaceuticals belong to three different substance classes, i.e. cholinesterase-inhibitors, NMDA-receptor modulator and phyto-therapy. Donepezil, galantamine and rivastigmine

12 R. Ihl et al.

Table VI. Doses of drugs with methodologically adequate RCTs.

Generic name

(alphabetic order)

Functional classification

primary pharmacological action

Starting dose (mg/day)

Standard dose (mg/day)

Donepezil

Cholinesterase inhibitor

5 for at least 4 weeks

10

Galantamine

Cholinesterase inhibitor

8 for four weeks

16 – 24

Ginkgo biloba EGb761

Free radical scavenger, mitochondrial protection

240

240

Memantine

Glutamate-receptor-modulator

5 (weekly increase by 5 mg)

20

Rivastigmine

Cholinesterase inhibitor

3 (2 X 1.5) minimally for 2 weeks

12

4.6 mg Patch

9.2

are cholinesterase inhibitors. Memantine is a NMDA-channel modulator and Ginkgo biloba a phytopharmacon.

  In Supplementary Tables 1 – 10 (available online) an extensive description of all meaningful studies can be found including a rating of evidence that let to the following conclusions. An overview of all studies included is provided in Table VII.

  With respect to the results demonstrated in Table VII, there are no hints that parameters such as the origin of the data and the number of centers influence the outcome. Most studies were funded by the vendor of a substance. The selection criteria took care of including only studies with reasonable methodology.

  Most studies investigated age groups with a mean age between 70 and 80 years. The standard deviation of close to 10 years limits conclusions. Evidence decreases with the distance of the age of a patient from the mean age in trials. In most studies the severity level of the disease lay between Global Deterioration Scale (GDS) 3 – 5. With respect to all studies investigating dementia no significant difference in efficacy could be detected between AD and VD. Thus from a data point of view, the same recommendations will cover both diseases. This outcome might also be supported by recent pathological considerations (see above). However, authorities differentiate between the two indications and often only license the use in AD.

  When all areas of efficacy are observed, every anti-dementia drug showed an individual evidence profile. In at least one parameter investigated according to the methodological criteria outlined above, all substances demonstrated statistical efficacy. This means all drugs demonstrate a modest benefit (i.e. no cure, no arrest, just symptom improvement for a limited time in a part of the patients). For each individual symptom profile, the efficacy data would allow to select the best available substance. However, the pharmaceuticals differ in side effects (Table VIII). For treatment, side effects and efficacy will have to be taken into account.

Side effects

Frequent (i.e. higher than 1/100 patients) and very frequent (i.e. higher than 1/10 patients) side effects of these substances are shown in Table VIII. The studies give no hint of other side effects or of a higher probability for a particular side effect.

Comparison of results with recent reviews and meta-analyses

Cholinesterase inhibitors

Physostigmine demonstrated efficacy in treating dementia (see review in M ö ller et al. 1999). Further substances were developed that could be taken orally. The three cholinesterase inhibitors used in the treatment of dementia: donepezil, galantamine, and rivastigmine, are generally started at a low dose and increased when no side effects appear. Reviews underline the described efficacy of cholinesterase inhibitors (Clegg et al. 2001; Birks et al. 2009; IQWiG 2007; Prvulovic et al. 2010) . For cholinesterase inhibitors, basic scientific studies show that there is an individual dose-response relationship. Every individual has a dose that is too low to cause any effect. In a higher dose cognitive function will improve. However, if this dose is increased further no improvement but side effects can be seen (Ihl et al. 1989). For each patient, from a biological point of view to titrate the necessary dose would be useful. In clinical studies the dose is increased slowly but not titrated. Moreover, the studies did not systematically exclude all substances with anti-cholinergic side effects. Thus, a part of the results might be ascribed to extinguishing side effects.

Memantine. For memantine in “ moderate to severe ” dementia, recent reviews and meta-analyses support the findings (Gauthier et al. 2008; Ferris et al. 2009).

Ginkgo biloba extract. For Ginkgo biloba extract, independent meta-analyses in addition to the data

Table VII. Data of anti-dementia drug studies are compared. For details see data of attachment Tables 1 – 10.

Drug/

Parameter Donepezil Galantamine Rivastigmine Memantine Ginkgo Biloba extract

Description

Derivate of piperidine and a selective and specific cholinesterase inhibitor.

Location of studies

6 USA

1 Europe

2 intercontinental.

Funding

Uncompetitive N -methyl-D-aspartate (NMDA) receptor antagonist modulating the glutamate receptor.

5 USA

1 UK

1 Europe

1 China

1 International.

Standardised plant extract (EGb761) of the Ginkgo leave with a strong antioxidant capacity

2 USA

2 Ukraine

1 Bulgaria,

1 Germany

24 month in Bullock et al. (2005) 6 month in the other studies. One study investigated 24 and 36 mg/d (B304, 1998). The two other studies compared a low dose group with 1 – 4 mg/d, with a medium dose group of 6 – 12 mg/d and placebo.

3 probable AD exclusively. MMSE inclusion criterion was 10 – 26 in all three studies. Corey-Bloom et al. (1998) also assessed the GDS stage. Study

Recommended dose is 240 mg/d.

2 studies investigated 120 mg/d 4 240 mg/d. Thus, evaluation has to be done depending on the dose.

One 3-arm trial investigated Ginkgo biloba, donepezil and a combination of both. No significant difference was found.

6 probable AD or VD

For inclusion in 3 of the studies, the NPI value had to be > 4.The severity range of the patients was 9 – 26

(Continued)

investigating probable AD (Tariot et al. 2001) included patients in nursing homes. It also had to be observed separately. One of the probable (Seltzer et al. 2004) and one of the possible AD group (Gauthier et al. 2002 a, b) used an aberrant stage of severity (Table I). Studies with aberrant stage of severity also need separate evaluation.

10 – 25 points, i. e. GDS 3 – 6. As no staging was done in the studies GDS staging was estimated from MMSE score. The nursing home study of Burns et al. (2009) included patients with values of 5 – 12 points (i.e. GDS 6 – 7). The other studies used an additional criterion of a minimal ADAS-cog score of > 11 (3 studies) or 17 (2 studies). Studies with a higher ADAS-cog criterion comprised more severe patients. 

duration was 6 month. Data were collected in 22 – 94 study centres. Approximately, the mean number of patients per centre lay between 10 and 32. 

in the MMSE (i.e. GDS 2 – 6).

Studies did not allow

accompanying anti-dementia medication as well as other psychoactive drugs. This qualifies for separate evaluation.

Patient characteristics

There was no difference in age of placebo and treatment groups. In one of the studies the mean age was at least 10 years higher than in the others (Mohs et al. 2001). This also qualifies for separate evaluation. The proportion of females investigated was 10 and more percent higher in two (Winblad et al. 2001, Gauthier et al. 2002 a, b) and ten percent lower in one study (Seltzer et al. 2004). The baseline values in the NPI between treatment and placebo group were comparable for three studies but not for the Tune et al. study (2003).

The mean age lay between 72 and 78 years. The range of the female ratio was 48 – 73 percent. The mean MMSE score lies between 7.7 and 18.9 points. In the baseline values of three memantine studies there is a tendency for a worse NPI score. For the SIB and the ADL, no obvious difference occurred between treatment and placebo groups.

The mean age was between 63 and 70 for all but one study. In the Schneider et al. study (2005) the mean age was 10 years higher. There was no obvious difference between treatment and placebo groups. 54 to 84 % of the patients were female. No obvious difference occurred between placebo and treatment group. Between placebo and treatment groups there were also no significant differences in the other baseline parameters investigated.

Possible statement area ( Studies are allocated to an area when the parameter named was investigated as primary efficacy variable. The tables named can be found in the attachement. Outside the statement areas no data are available ( Level F ).

An overview of the field that the studies cover is given in table 2. Tariot et al. 2003 is included although the place of recruitment was nursing homes. Groups with a mean age below 70 years were not investigated. One study in probable AD included patients with higher age. Severity levels differ between studies and between parameters investigated.

For further analysis, the studies were included in a grid of possible studies that was developed from the main areas of interest (table 4). By contrast to table 2, stage as well as age was not used as a criterion because all but one study investigated the same stage and the same age groups. This means that reliable conclusions can be drawn on age groups with a mean of 70 – 80 years and on stages 3 – 5 in the GDS and might only be extrapolated on a group with a higher mean age (Burns et al. 2009).

All shown rivastigmine studies investigated patients with the same diagnosis (probable AD), the same age group (mean 71 – 75 years, std. 8 years), severity stage (i.e. GDS 3 – 5) and duration (6 months).

Four memantine studies investigated cognition and ADL in probable AD patients with the same degree of severity (GDS 5 – 6, mean MMSE 7.8 – 11.8) and comparable mean age (72 – 78). Two studies investigated cognition and clinical global impression in VD. Three studies investigated cognition and clinical

For probable AD, VD and AD/ VD with NPS data are available. Part of the studies investigated 120 mg others 240 mg. Data are available for cognition, behaviour, ADL and CGI. GDS 3 – 6 was included in the studies. The LeBars study had lasted 12 month all the other studies 6 month. None of the studies investigated patients with a mean age of above 79 years.

global impression in probable AD with a severity stage of GDS 3 – 5 (mean MMSE 16.718.9). The heterogeneity of groups investigated limits the conclusions as well as unexplained extraordinary placebo group responses.

Four studies investigating cognition in probable AD found an improvement of 2.9 – 3.9 points in the ADAS-cog when comparing placebo and treatment group (Raskind et al. 2000, Tariot et al. 2000, Wilcock et al. 2000, Brodaty et al. 2005). In the nursing home study a significant improvement of 4.9 points was found in the SIB (Burns et al. 2009). In groups with probable AD and a mean age between 72 and 78 years, galantamine demonstrated efficacy ( Level B ).

In one study, investigating patients with a mean age of 84 a comparable efficacy was found (Erkinjuntti et al. 2002; Level B ).

Three studies B304 (1998, IQWIG data), Corey-Bloom et al. (1998) R ö sler et al. (1999) in AD found a significant improvement of rivastigmine over placebo in patients with a mean age of 71 – 75 and a severity level of GDS 3 – 5 ( Level B ).

For the primary efficacy parameter cognition in moderate to severe probable AD, the studies 10116 (2006) and van Dyck et al. (2007) could not find any significant result. For the same parameters, the results of the Cummings et al. study (2006) were significant and so were the results of Reisberg et al. (2003). Thus, the results of the Memantine studies in probable AD on cognition are inconclusive. When severity was mild to moderate 2 of three studies could not find significance (Bakchine and Loft 2007, 2008, Porsteinsson et al. 2008). However, study groups differed in the acceptance of concomitant medication and unexplained extraordinary placebo group reactions. A recent secondary analysis confirmed superiority of memantine in AD compared to

Four of five studies investigating cognition found a significant superiority of treatment over placebo Only Schneider et al. (2005) could not replicate the findings. However, in a subanalysis of patients with NPS a significant improvement was found too (Level B).

(Continued)

significant improvement of 2.1 points in the MMSE was seen. This underlines efficacy in a group with higher age ( Level B ). Mohs et al. (2001) as well as Winblad et al. (2001) also found superiority of the treatment group over placebo group after a longer investigation time of 13.5 or 12 month duration ( Level B).

Possible AD In the primary efficacy variable cognition the study of Winblad et al. (2001) demonstrated superiority of donepezil over placebo ( Level B ).

VD For vascular dementia, 3 studies,

demonstrated superiority of donepezil over placebo (Black et al. 2003, Wilkinson et al. 2003, Roman et al. 2010; Level B). 

placebo (Ferris et al. 2009, Level D ).

No data ( Level F ). No data ( Level F ). Studies investigating VD

found superiority of Memantine over Placebo in cognition. Thus, in VD Memantine is superior to placebo. ( Level B ).

Others No data ( Level F ) For groups with higher stages of

severity no data are available

( Level F ).

Behaviour

Probable AD No data ( Level F ) Tariot et al. (2000) found significant superiority of galantamine over placebo in patients with a mean age of 76 years and GDS stage 3 – 5. In a pooled analysis this finding was supported (Cummings et al. 2004) ( Level B )

Possible AD Two studies included the NPI to measure behaviour as primary efficacy parameter. Gauthier et al. (2002 a, b) found a significant superiority of treatment over placebo in their trial. One study included patients from nursing homes (Tariot et al. 2001). This study could not find a significant difference between treatment and placebo treatment. Thus,

Erkinjuntti et al. (2002) found significant superiority of galantamine over placebo in patients with a mean age of 78 years and GDS stage 3 – 5( Level B )

No data ( Level F ) No data ( Level F ) No data ( Level F )

no reliable conclusions on the

efficacy on behaviour can be

drawn ( Level D ).

VD No data ( Level F ) No data ( Level F ) No data ( Level F ) No data ( Level F ) Same as probable AD Level B ).

Others No data ( Level F ) For other age groups and higher stages

of severity no data are available ( Level F ).

Two RCTs in Lewy body dementia had measured behaviour with the NPI as primary efficacy variable and found a significant improvement with rivastigmine compared to placebo (McKeith et al. 2000, Wesnes et al. 2002, Level B ).

No data ( Level F ) No data ( Level F )

Activities of Daily Living

Probable AD Only results of secondary efficacy analyses exist. Two of the studies show improvement, two do not. Thus for ADL, efficacy of donepezil is inconclusive ( Level D ).

Clinical Global Impression

Probable AD Two studies used the CIBICplus scale as primary outcome parameter in probable Alzheimer dementia and

Two of three studies measuring ADL as primary efficacy variable showed a significant improvement in AD in doses above 6 mg per day (Level B). Higher or lower doses did not show a significant effect ( Level E) .

Rivastigmine was significantly superior to placebo in the two studies investigating Clinical Global Impression in probable

For the primary efficacy parameter ADL in probable AD, the studies 10116 (2006) and van Dyck et al. (2007) could not find any significant result. For the same parameters, the results of the Cummings et al. study (2006) were significant and so were the results of Reisberg et al. (2003). Thus, the results of the Memantine studies in moderate to severe probable AD on cognition are inconclusive ( Level D ).

2 studies in mild to moderate AD could not demonstrate superiority of Memantine one did.

ADL were investigated in 5 studies (Kanowski et al. 1996, Le Bars et al. 1997, Schneider et al. 2005, Napryeyenko et al. 2007, Ihl et al., 2010). All but the study of Schneider et al. found a significant improvement under Ginkgo compared to placebo

(Level B).

Two of three studies investigated clinical global impression as primary efficacy variable. Only Kanowski et al. (1996)

severity stages between 0.5 – 2 CDR (2 – 5 GDS). Both found a significant improvement with treatment compared to placebo ( Level B ). For patients with more severe stages, no data are available ( Level F ).

2000). All three studies found significant superiority of galantamine over placebo ( Level B ).

AD (Corey-Bloom et al. 1998, R ö sler, 1999; Level B ).

For clinical global impression. Data are inconclusive ( Level D ). 

could demonstrate superiority over placebo. Le Bars et al. (2000) and Schneider et al. (2005) failed to replicate the finding. For clinical global impression, no superiority resulted (Level E).

Possible AD No data ( Level F ). No data ( Level F ). No data ( Level F ). No data ( Level F ). No data ( Level F ).

VD Black et al. (2003) and Wilkinson

et al. 2003 found an improvement, Roman et al. (2010) could not find an improvement ( Level D ).

No data ( Level F ). No data ( Level F ). 2 negative studies

( Level E )

Same as probable AD

(Level E).

Others No data ( Level F ). No data ( Level F ). No data ( Level F ). No data ( Level F ). No data ( Level F ).

Further Parameters

No data ( Level F ) No data ( Level F ) No data ( Level F ) No data ( Level F ) No data ( Level F )

Combination studies and comparability

A three armed study of Yancheva et al. (2007) in 94 patients showed improvement of a standardized Ginkgo extract, donepezil and a combination of both after 6 month compared to baseline values. With this size of groups no difference between treatments was observed. This does not exclude every possible difference between treatments. However, when more patients are needed to demonstrate significant differences this means that an ever existing statistical difference would be smaller ( Level C1 ). Due to different rates of drop outs, data of the comparison study between Donepezil and Rivastigmin of Bullock et al. (2005) are inconclusive

(Level D).

Side effects/adverse events

Studies did neither uncover another rate of side effects than described in table 6 of the paper nor other adverse events.

WFSBP Guidelines for Alzheimer’s disease and other dementias 19

support the findings (IQWiG 2008; Kasper and Schubert 2009; Wang et al. 2010).

Comparison studies

Although there are many methodological issues, there is a consistency in the data which is similar to other fields of treatment with psychopharmaceu-ticals. There are no studies demonstrating superiority of cholinesterase inhibitors over memantine or ginkgo biloba or vice versa.

Cost effectiveness

From a costs perspective, treatment with anti-dementia pharmaceuticals will reduce costs (Wimo et al. 2003).

Other anti-dementia pharmaceuticals

A wide group of other agents with diverse mechanisms of action have been tested in at least one randomized controlled clinical trial, but there is incomplete or conflicting evidence for these agents. In particular, intravenous cerebrolysin, a neurotrophic brain extract, improved global functioning and activities of daily living in one trial. For treatment in AD, several negative studies have been reported including an ACTH analog, DGAVP; the nootropics anirac-etam, BMY21, 50139 and piracetam; and two trials of phosphatidyl serine. Other negative randomized controlled clinical studies include the NMDA receptor stimulator cycloserine, besipiridine, and milace-mide. Hydergine was ineffective at 3 mg per day and showed slight memory improvement at 6 mg day, but did not meet a priori benefit standards. Patients receiving acetyl-L-carnitine, a membrane-stabilizing agent, showed less decline over one year on 4 of 14 neuropsychologic measures, but the drug was ineffective in a second study. Idebenone, a coenzyme Q analog, showed mild improvement in some neurop-sychologic tests and produced a significant drug – - placebo difference on a global neuropsychologic instrument, but in separate studies. Selegiline produced a modest drug – placebo difference in cognition in a 3-month trial of 136 patients with mild to moderate AD, but not in a 6-month trial with 60 patients. A low dose of nimodipine (30 mg TID) improved memory (but not other measures) but not at a higher dose (90 mg TID). In one large, 2-year trial, selegiline (5 mg BID) and vitamin E (1000 IU [ ? -tocopherol] BID) significantly delayed the time to a composite outcome of primary measures indicative of clinical worsening, and fewer patients treated with vitamin E were institutionalized. Importantly,

20 R. Ihl et al.

there was no additive effect from selegiline plus vitamin E, neither agent improved cognitive function (ADAS-cog) compared with baseline values, and those on drug did not decline less than those on placebo on these types of measures. Although epide-miologic data suggest that anti-inflammatory drugs may be protective against the development of AD, few anti-inflammatory drug trials have been reported. In one 6-month trial of indomethacin, stabilization of cognition was suggested, although the authors reported a 44% dropout rate. A 6-month trial of diclofenac for treatment of AD reported slightly slower decline (not significant) and a 50% dropout rate because of adverse events. Investigating celecoxib and naproxen natrium, the ADAPT trial failed to demonstrate any positive effect on cognition. There was weak evidence for a detrimental effect of naproxen and concerns with cardiovascular safety (ADAPT Research Group 2008, 2009).

 A recent trial of prednisone for the treatment of AD was negative. Epidemiological studies suggest that estrogen may be protective against the development of AD, and from this observation, the possibility that it also might have a therapeutic effect in AD has been suggested. To date, two clinical trials examining the ability of Premarin ® to slow the rate of decline in women with AD were negative. Since neither of these agents fulfils the requirements set out by the WFSBP task force, they are not considered as treatment options.

Future drug development

For the three main anti-dementia classes, new substances are under development (for instance ZT-1 as cholinesterase-inhibitor and Huperzine A as cholinesterase-inhibitor and phytopharmacon, MEM 1003 as NMDA-channel modulator). Due to the fact that we do not know the cause of the disease many other attempts are speculatively investigated. One particular area of focus has been to decrease the amount of plaques in the brain, e.g., by immunisation. Substances and immunisation was developed to clean the brain from plaques. However, there is an opinion that the brain may be cleaned of plaques but the disease remains unchanged (Holmes et al. 2008). An overview of new attempts to develop anti-dementia pharmaceuticals can be found by Riederer (2009). So far none of the attempts demonstrates a potential to cure or stop the disease. Thus, new approaches will have to show superior efficacy or at least fewer side effects.

 Developing drugs to treat dementia was guided by hypotheses on the cause of dementia. To explain all the alterations of dementia an integrative theory has been developed by the Hoyer group (Hoyer 2002; 

Salkovic-Petrisic et al. 2009). The hypotheses were deduced from pathological, biochemical and patho-physiological alterations found in the brain of patients with dementia. For future drug development, this model could be useful.

Behavioral disturbances in dementia

Often dementia is accompanied by neuropsychiatric symptoms (Alzheimer, 1906). In the literature these symptoms are also addressed as behavioral problems or behavioral and psychological symptoms of dementia (BPSD) or neuropsychiatric symptoms (NPS). An overview of symptoms included in the definition is demonstrated in Table IX.

  Different tests are used to measure neuropsychiat-ric symptoms. Initially the ADAS-noncog (Rosen et al. 1984), the Behavioural Pathology in Alzheimer ’ s disease rating scale (BEHAVE-AD, Reisberg et al. 1987), the Cohen-Mansfield Agitation Inventory (CMAI, Cohen-Mansfield, 1986; Cohen-Mansfield and Billig, 1986) and the Neuropsychiatric Inventory (NPI, Cummings et al. 1994) were developed. A variety of new tests was published without demonstrating superiority over existing tests and scales. Various scales are currently used in different studies. The spectrum of symptoms covered by the various tests is not congruent. Moreover, definitions for the symptoms differ. Thus, when neurosychiatric symptoms are measured results will not always be comparable. Most frequently in recent studies the NPI has been used and recommendations as to how to use it published (Gauthier et al. 2010).

  In a further step attempts were made to find symptom clusters to define specific syndromes. As an example using the NPI four syndromes were differentiated (Aalten et al. 2007, 2008):

- hyperactivity (agitation, aggression, disinhibi-tion, irritability, aberrant motor behaviour, euphoria);

Table IX. Examples of neuropsychiatric symptoms in dementia ( “ Hyperactivity ” , “ psychosis ” and “ affective symptoms ” are seen as syndromes and not separately named here).

Agitation Delusions Aberrant motor behavior

Aggression Hallucinations Pacing and wandering

Disinhibition Nocturnal Appetite change

confusion

Irritability Tearfulness Eating alterations

Eupohria Repetitive Uncooperativeness

activities

Depression Inappropriate Behavior dangerous to self

activities or others

Anxiety Apathy Fear of being left alone

Phobias Personality Alterations in sexual

changes behavior

WFSBP Guidelines for Alzheimer’s disease and other dementias 21

- affective symptoms (depression, anxiety);

- psychosis (delusions, hallucinations);

- apathy (apathy, appetite and eating abnor

malities).

  When more specific scales like the CMAI are used a more subtle differentiation may appear (Rabinowitz et al. 2005). However, the syndromes may allow for a more practical recommendation of treatment strategies.

  Concerning frequency and appearance of symptoms several studies have been carried out. They show that frequency and severity of symptoms depend on the kind of symptom as well as on the stage of the disease (see reviews: O ’ Connor et al, 2009a,b; Gauthier et al. 2010).

Contributing factors to the development of neuropsychiatric symptoms (NPS)

Not all patients experience NPS and only a part of symptoms of NPS will affect a single patient. Besides pathology causing dementia further causative factors are discussed. The efficacy of anti-dementia pharmaceuticals is described above. However, causative factors of NPS partially differ from dementia causes. Thus, they need reference.

Biological factors. Dementia pathology affects the whole brain. The regional development varies between different types of dementia. Nevertheless, all symptoms may appear in every type of dementia at a point in time. From a biological point of view several associations of symptoms and biological alterations have been reported. Again syndroms were measured with several different tests. Thus, although symptoms are named identically they may mean different behaviours and the study results can not be compared easily. An overview of a selection of possible associations between biological and behavioural alterations can be found in Gauthier et al. (2010). So far for the different results, an integrative hypothesis is missing. It is not ruled out that the underlying pathology or cause of dementia will also determine the type of behavioral symptoms. However, using other scales than the NPI to investigate the effect of dementia subtype and severity, Thompson et al. (2010) found no significant difference between AD and VD. Before drug treatment of behavioural symptoms on a biological basis is taken into account some very frequent causes of deteriorations have to be ruled out.

Diseases and side effects of drugs as contributing factors. Somatic diseases and conditions as well as side 

effects of drugs given for somatic diseases contribute to behavioural symptoms. Anticholinergic side effects of a broad spectrum of drugs or side effects of corticoids are examples.

Psychosocial factors. Three psychosocial theories describe possible causes of NPS (Gauthier et al. 2010). The first theory, Progressively Lowered Threshold, deals with the neuron loss in dementia. Inhibitory neurons get lost at first. It is proposed that inhibitory neurons are lost first and this is leading to reduced stress tolerance.

 The second theory describes unmet needs like hunger, thirst or missing attention as cause of NPS. Healthy individuals usually have capacities to satisfy the need. In dementia a loss of connections in the brain might prohibit the combination of perception, interpretation of a perception and necessary behaviour to achieve the solution.

 Behaviour theory is the basis of the third possible explanation of NPS. For example screaming as a stimulus might lead to social attention. It would act as positive reinforcement and increase the probability of the appearance of screaming.

Environmental factors. Environmental factors also may influence the probability of NPS (i.e. darkness, superheating or supercooling, off odour, loudness).

Treatment of NPS in dementia

Defining evidence of treatment in environmental as well as psychosocial treatment will have to employ the same methodological considerations as in drug therapy. However, the absence of severe side effects may reduce the requirements for a recommendation. Nevertheless, several studies investigated these aspects (see Livingston et al. 2005; O ’ Connor et al. 2009a,b; Gauthier et al. 2010, for reviews). These evaluations are the basis for and determine the following conclusions.

Elimination of causal factors. At first, modifiable causal factors (see above) have to be identified and addressed. Thus, disease states or side effects will have to be ruled out. Often environmental factors may be changed easily. This may also hold true for needs like hunger and thirst. Other needs like social attention will require more specific psychosocial intervention.

Psychosocial intervention. To define the further procedure, after diagnosis of dementia all available caregivers should be seen by the practitioner (family

22 R. Ihl et al.

counsellor). All necessary information should be given. Moreover, possible support should be explained and a training on psychosocial aspects of caring should be recommended.

Drug treatment. Only when psychosocial intervention and exclusion of other factors fail may drug treatment be necessary. Exceptions may occur when the behaviour requires urgent attention such as dangerous aggression and drug treatment may need to be started in tandem with other measures. Treatment with anti-dementia drugs is seen as a standard therapy in dementia. The evaluation above has already described the effect of anti-dementia drugs on behaviour. For this and further drug therapy, Gauthier et al. (2010) additionally have published a “ background paper ” .

Hyperactivity. To treat hyperactivity with drugs neu-roleptics often are used. There are results that can be interpreted as a hint to use drugs like risperidone (Brodaty et al. 2003; Katz et al. 1999; De Deyn and Rabheru 1999, AD, PDD, VD, mixed dementia) and olanzapine (Street et al. 2000; Clark et al. 2001; De Deyn et al. 2004; Sink et al. 2005). In some nations quetiapine often is used. However, methodological problems like low study size limit the evidence of efficacy of quetiapine treatment (Tariot et al. 2006; Kurlan et al. 2007; Rainer et al. 2007; Zhong et al. 2007; Paleacu et al. 2008; Shotbolt et al. 2009, Level F ). The risk of side effects of neuroleptics is comparable to other drugs in used this indication (Finkel et al. 2005). Nevertheless, neuroleptics are accompanied by a high rate of side effects possibly including an increased mortality rate (Haddad and Dursun 2008; Schneider et al. 2006; Sultzer et al. 2008). Moreover, the result of neuroleptic treatment often is a symptom shift leading to new unsolved problems like extrapyramidal syndromes, falls and fractures (Haddad and Sharma 2007; Kamble et al. 2008; Liperoti et al. 2007).

 In the literature, the efficacy of benzodiazepines to sedate an individual is broadly described. However, the half-life of benzodiazepines is prolonged with increasing age. Frequent paradoxical reactions, muscle relaxation, respiratory depression and a potential for dependency limit their usefulness in hyperactivity. Withdrawal symptoms including delirium are common. As an example in the US from 1998 to 2005 benzodiazepines were responsible of 15.2% of drug-induced delirium hospitalizations (Lin et al. 2010). Falls and fractures are often associated with the use of benzodiazepines.

 Lithium does not have a positive effect in AD (Hampel et al. 2009).

   

Anti-epileptic treatment with valproate is ineffective (Lonergan et al. 2004, Herrmann and Lanct ô t 2007) although positive results from mice results are reported (Qing et al. 2008). By contrast, carbamazepine may be of benefit for the behavioural disturbances in dementia (Herrmann and Lanct ô t 2007; Pinheiro et al. 2008; Warner et al. 2008). The recommendation is based on a series of studies of the Tariot group. Starting with an observational study in two patients with positive outcome (Leibovici and Tariot 1988) a preliminary study underlined the results (Tariot et al. 1994) that finally were supported in a randomized clinical trial (Tariot et al. 1998). A further analysis supported the results after a wash out period (Tariot et al. 1999). However, the spectrum of side effects of carbamazepine needs close surveillance (Table X) and studies on a possible efficacy of new substances with lower side effects like eslicarbazepine are so far not available.

Affective symptoms

Depression in dementia has been investigated in several studies. For fluoxetine and sertraline, studies could not demonstrate efficacy (Auchus and Bissey-Black 1997; Petracca et al. 2001; Magai et al. 2000; Rosenberg et al. 2010; Weintraub et al. 2010). For citalopram, efficacy is reported (Nyth and Gottfries 1990; Nyth et al. 1992) and it is recommended in the review of Herrmann and Lanct ô t (2007). Karlsson et al. (2000) saw comparable efficacy of citalopram and mianserin in a further trial. Trazodone was investigated by two research groups. Lebert et al. found efficacy to treat behavioural symptoms in dementia in a pilot study in 1994 and in a double blind trial in FTD in 2004 (Leber t et al. 1994, 2004). Sultzer et al. (1997) also found efficacy in a double blind trial and in a secondary analysis they stated that mild depressive symptoms and agitated behaviour respond to trazodone treatment (Sultzer et al. 2001). However, there is a need for further studies.

Psychosis and apathy

For psychosis, practice treatment most often includes neuroleptics. However, side effects of these substances require specific caution (see above and Schneider et al. 2006; Gauthier et al. 2010). For efficacy of cipramil as an alternative treatment, an indication can be found (Pollock et al. 2002, 2007). For drug treatment of apathy, no RCTs were found. However, one RCT favors an individualized functional training program (Lam et al. 2010).

Table X. Overview of frequent side effects of pharmaceuticals used in the treatment of behavioural disturbances in dementia.

Generic name

Contraindications

Nausea/

gastro-intestinal

Cardio-vascular

Neurological

Others

Citalopram

10 – 20 mg in the

morning

Trazodone

Simultaneous intake of MAO-inhibitors or pimozide. Severe disturbance of renal function

Acute Intoxication withhypnotika, analg

Nausea, obstipation, loss of appetite, diarrhoea,vomiting, gastro-intestinal complaints, vermehrter Speichelflussloss of weight, weight gain

Gastro-intestinal

Tachycardia, palpitations,

Cardiac

Tiredness, sleeplessness headache, tremor, try mouth, increased sweating, asthenia, agitation, anxiousness, nervosity, confusion, abnormal treams, disturbance of concentration, dysgeusia, paraesthesia, extrapyramidal symptoms, visual disturbances, tinnitus, yawning, rhinitis, pruritus, eczema, myalgia, arthralgia, dizziness, gest ö rtes Allgemein-befinden, apathia,

tremor, tiredness, dizziness, headache,

Reduced libido, female orgasm disturbance, impotence, disturbance of ejaculation, orthostatic hypotoniaurinary retention,

Withdrawal syndrome,

50 mg at night

etics,psychopharmaca,carcinoid syndrome, alcohol intoxication, cardiac arrhytmia, Decompnsated cardio vascular insufficiency

complaints

arrythmia, orthostatic dysregulation

confusion, sleep disorders, agitation, visual disturbances

priapism

Risperidone

0, 25 – 2 mg in

Hyperprolactinaemia independent of drug intake

Gastro-intestinal complaints, weight

Hypotonia, orthostatic

Provocation of epileptiform seizures, extrapyramidal symptoms, disturbed gait

Death

the morning

gain

dysregulation; stroke

and falls

Olanzapine

2, 5 mg in the

morning

Known risk of glaucoma

Weight gain,

metabolic syndrome

QTc-prolongation Orthostatic hypotonia

Tiredness, extrapyramidal symptoms, disturbed gait and falls

Pneumonia, increased temperature, lethargia, erythema, visual hallucinations, incontince of the bladder

Carbamazepine 50 – 100 mg retarded at night

Hypersensitivity to tricyclic anti-depressives, history of bone marrow impairment or depression, atrio-ventricular block, acute intermittend porphyria, combination with MAO-inhibitors (14 days period without MAO-inhibitors before beginning of treatment), combination with voriconazol (no treatment effect)

None

Tiredness

Altered blood count, hyponatraemia, increased lever enzymes, many drug interactions (decreased blood level and increased risk of side effects)

24 R. Ihl et al.

Conclusions

Dementia diseases are an interdisciplinary challenge, where psychiatrists and neurologists have equal importance in the neuropsychiatric centers in the treatment of dementia. Multi-level guidelines consider the family doctors care as well as the requirements for specialized centers for dementia treatment.

 In most cases, drug treatment with anti-dementia drugs preferably combined with non-pharmacological treatments may substantially provide benefits and improve quality of life in patients and their carers with this disorder. However, so far dementia can not be cured or arrested.

 When neuropsychiatric symptoms appear, psy-chosocial intervention is the treatment of first choice. For efficacy of drug treatment in NPS, the evidence is limited. Moreover, possible side effects often prohibit the use of pharmaceuticals.

Treatment recommendations for Alzheimer ’ s disease and other disorders associated with a dementia syndrome

The data based analysis (see Supplementray Tables 1 – 10 (available online) and Table VII in the text as well as Gauthier et al. 2010) considering the methodological aspects described let to the following treatment guidelines.

The use of anti-dementia pharmaceuticals

Prevention. For prevention under the age of 70 years, there are no data for donepezil, galantamine, rivastig-mine, memantine and Ginkgo biloba extract ( Level F ). For prevention over the age of 70 years first hints of efficacy of Ginkgo biloba were found accidentally by Andrieux et al. (EPIDOS, 2003). One confirmation study with Ginkgo biloba extract with a low transition rate to dementia in both groups and insufficient drug intake rate failed to demonstrate efficacy (GEM, DeKosky et al. 2008). A second confirmation study presently becomes evaluated and first positive results were presented (GUIDAGE, Vellas et al. 2006; Ipsen, 2010, Level D ). For other anti-dementia pharmaceuticals and for other types of dementia in both age groups, no data exist ( Level F ). Thus, for prevention anti-dementia pharmaceuticals so far cannot be recommended .

 Methodological limitations of studies in the prevention of so called “ MCI ” do not allow conclusion on preventive effects. Thus, anti-dementia pharmaceuticals cannot be recommended in MCI.

Indication of treatment. For curing or arresting of AD or VD or any other type of degenerative dementias no drugs can be recommended.

  

For the symptomatic treatment of AD, donepezil, galantamine, memantine, ginkgo biloba extract, rivastigmine show a modest, over a limited time, effect in a part of the patients (Level B). Donepezil, galantamine, rivastigmine show reasonable, meman-tine and ginkgo biloba extract less side effects (Level B). For symptomatic treatment of AD, these pharmaceuticals can be recommended ( Grade 3 ). For VD, in several nations anti-dementia pharmaceuticals are not licensed. However, the scientific data are also convincing and anti-dementia pharmaceuticals should be recommended too ( Grade 3 ). For Lewy body dementia, rivastigmine can be recommended ( Grade 3 ). For other drugs in Lewy body dementia and frontal lobe dementia, data are lacking. Nevertheless, treatment with anti-dementia pharmaceuticals should be a treatment option ( Level C3, Grade 4 ).

 Methodological inadaequatnesses prohibit a systematic recommendation of pharmaceuticals related to specific severity levels (see excursus Level F ).

Selection of drugs. Every substance has its own efficacy spectrum and its own side effect profile (see Tables VII and VIII, Level B ). For a patient, the individual symptom constellation and the probability of side effects and the stage of the disease should determine the selection of the drug ( Level C3, Grade 4 ).

Dose. For treatment, the following target daily doses are recommended: donepezil 10 mg, galantamine 24 mg, rivastigmine 12 mg (rivastigmine patch 9.2), memantine 20 mg, Ginkgo biloba extract 240 mg ( Grade 3 ). Side-effects may prohibit use of the recommended dose ( Level C3, Grade 4 ).

Effect size. Over all substances the median improvement in 6 month is 2.3 points in the ADAS-cog-scale ( Level B ). This effect is classified as a modest symptom improvement over a limited time in a part of the patients.

Beginning and end of treatment, surveillance. The treatment should start after diagnosis with clearly defined treatment goals ( Level C3, Grade 4 ). The end of treatment should depend on an individual decision ( Level C3, Grade 4 ). It should be discontinued if there are significant adverse effects or after consensus with patients and relatives/caregivers/legal representatives ( Level C3, Grade 4 ).

 Patients should particularly be monitored for adverse effects in the first 6 weeks after commencing treatment or after dosage adjustment ( Level C3, Grade 4 ). Patient status should be documented after 3 – 6 months of treatment at the highest tolerated recommended dosage ( Level C3, Grade 4 ).

WFSBP Guidelines for Alzheimer’s disease and other dementias 25

Any significant deterioration in the patient ’ s condition should lead to a rigorous re-assessment of the diagnosis and a work-up on potential intercurrent disases, but not automatically to discontinuation of anti-dementia drugs. All patients on long-term treatment should be reassessed at least every 6 months ( Level C3, Grade 4 ).

Combination therapy

There are findings showing that combination therapy of drugs with different modes of action might have a synergistic effect ( Level C ). With respect to the importance of the disease combination therapy should be a treatment option ( Level C3, Grade 4 ).

Additional recommendations: vascular dementia

Risk factors for VD are high blood pressure, cardiac disorders, hematocrit over 45% and diabetes mellitus, which are also risk factors for stroke. Obviously, if underlying vascular disease or strokes are leading to dementia, any primary or secondary prevention of cerebrovascular disease would seem to be a reasonable therapy (Qizilbash 2002, Grade 4 ).

 The most promising approach to VD is secondary prevention of cerebrovascular disease besides symptom management ( Grade 4 ). Although there is evidence to support the use of aspirin to prevent stroke in patients, no stroke prevention trial has been confined to patients with VD (Rands et al. 2004). No unconfounded, randomized controlled trials of blood pressure reduction in established VD were found ( Level F).

Management of behavioural and psychological aspects of Alzheimer ’ s disease and other disorders associated with dementia

For the following recommendations, it is assumed and recommended that treatment with anti-dementia pharmaceuticals is sufficiently done as recommended ( Grade 3 , see above).

 When behavioural disturbances like hyperactivity or depressed mood accompany the disease possible other causes have to be ruled out (i.e. other diseases, physiological needs like hunger and thirst as well as psychosocial causes like missing attention and environmental factors like temperature and odor, Grade 3 ). Elimination of causative factors and psychosocial intervention are the treatment of choice ( Grade 3 ).

 When all attempts fail, drug treatment will be the last option ( Level C3, Grade 4 ). However, the high 

rate of partially severe side effects should limit the use of drugs ( Level A, Grade 1 ).

   For the hyperactivity syndrome, there are indications that drugs like the following substances could be a last option when side effects are monitored, the dose is kept low and the duration of the treatment is as short as possible ( Level C3, Grade 4 ): risperi-done, olanzapine, quetiapine, aripiprazol, citalopram, trazodone and carbamazepine. In practice, the hyperactivity syndrome including for instance screaming and aggression often is accompanied by insufficient drug response ( Level C3 ). Valproic acid as well as lithium should not be used ( Level E ). For depression, there is no RCT demonstrating that antidepres-sives do not work in dementia with depression ( Grade 5 ). For psychosis, the same restrictions as for hyperactivity apply. For apathy, no data do exist ( Level F ).

General management principles for dementia

The physician in charge of the treatment and care of the patient should schedule regular follow-up visits (American Psychiatric Association 2002; Rosen et al. 2002). The purposes of planning systematic follow-up include (Waldemar et al. 2000):

* To ensure identification and appropriate treatment of concomitant conditions and of complications of the primary dementia disorder.

* To assess cognitive, emotional and behavioral symptoms.

* To evaluate treatment indications and to monitor pharmacological and non-pharmacological treatment effects.

* To assess caregiver burden and needs.

* To assess sources of care and support.

* To provide continuous advice and guidance to patients and caregivers on health and psychological issues.

* To administer appropriate caregiver interventions.

   It is important to follow legal requirements for informed consent in prescribing medications. For persons with dementia unable to give informed consent, proxy consent should be obtained from their family caregiver or other appropriate person as required by local legislation. Several further questions appear relevant for practice guidelines, but are as yet unresolved due to a lack of evidence.

Acknowledgements

The authors want to thank Martin Rossor for his skillful editorial support.

26 R. Ihl et al.

Statement of interest

Prof. Dr. Ralf Ihl received grants/research support or was involved as consultant, speaker or in advisory boards or received authors honoraria within the last three years from APK, Austroplant, BDI, Beltz Test, BOD, Caritas Siegen, Double Helix Development, Eisai, Friedrichverlag, GE Healthcare, Hogrefe, IFE, Janssen, KDA, Landesinitiative Demenz Service NRW, LVR D ü ren, Lundbeck, Medical Tribune, Med. Komm., Novartis, Pfizer, Pfrimmer Nutritia, Pierrel, Schwabe, Thieme, Urban & Vogel, Wester-mayer.

 Prof. Dr. Moeller has received grants or is a consultant for and on the speakership bureaus of Astra-Zeneca, Bristol-Myers Squibb, Eisai, Eli Lilly, GlaxoSmithKline, Janssen Cilag, Lundbeck, Merck, Novartis, Organon, Pfizer, Sanofi-Aventis, Schering-Plough, Schwabe, Sepracor, Servier and Wyeth.

 Prof. Dr. Lon Schneider , Prof. Dr. Bengt Winblad , Prof. Dr. Alistair Burns and Prof. Dr. Lutz Fr ö lich are None declared.

References

Aalten P, Verhey FR, Boziki M, Bullock R, Byrne EJ, Camus V, Caputo M, et al. 2007. Neuropsychiatric syndromes in dementia. Results from the European Alzheimer Disease Consortium: part I. Dement Geriatr Cogn Disord. 24:457 – 463.

Aalten P, Verhey FR, Boziki M, Brugnolo A, Bullock R, Byrne EJ, et al. 2008. Consistency of neuropsychiatric syndromes across dementias: results from the European Alzheimer Disease Consortium. Part II. Dement Geriatr Cogn Disord 25:1 – 8.

ADAPT Research Group, Martin BK, Szekely C, Brandt J, Piantadosi S, Breitner JC, Craft S, et al. 2008. Cognitive function over time in the Alzheimer’s Disease Anti-inflammatory Prevention Trial (ADAPT): results of a randomized, controlled trial of naproxen and celecoxib. Arch Neurol 65:896 – 905 (Epub May 12 2008).

ADAPT Research Group, Meinert CL, McCaffrey LD, Breitner JC. 2009. Alzheimer’s Disease Anti-inflammatory Prevention Trial: design, methods, and baseline results. Alzheimers Dement 5:93 – 104.

Altmann DG. 1994. The scandal of poor medical research. Br Med J 308:283 – 284.

Alzheimer A. 1906. Ueber einen eigenartigen schweren Erkrankung-sprozess der Hirnrinde. Neurol Centralblatt 25:1134.

American Psychiatric Association. 1980. Diagnostic and statistical manual of mental disorders. 3rd ed. Washington, DC: American Psychiatric Association.

American Psychiatric Association. 1987. Diagnostic and statistical manual of mental disorders. 3rd ed. rev. DSM-III-R. Washington, DC: American Psychiatric Association.

American Psychiatric Association. 1994. Diagnostic criteria from DSM-IV. Washington, DC: American Psychiatric Association.

American Psychiatric Association. 2002. Practice guideline development process. In: American Psychiatric Association, editors. Guidelines for the Treatment of Psychiatric Disorders: Compendium 2002 Washington, DC: American Psychiatric Press. p. 857 – 863.

Amieva H, Letenneur L, Dartigues JF, Rouch-Leroyer I, Sourgen C, D’Alch é e-Bir é e F, et al. 2004. Annual rate and predictors 

of conversion to dementia in subjects presenting mild cognitive impairment criteria defined according to a population-based study. Dement Geriatr Cogn Disord 18:87 – 93 (Epub 14April 2004).

Andrieu S, Gillette S, Amouyal K, Nourhashemi F, Reynish E, Ousset PJ, et al. 2003. Association of Alzheimer’s disease onset with ginkgo biloba and other symptomatic cognitive treatments in a population of women aged 75 years and older from the EPIDOS study. J Gerontol A Biol Sci Med Sci 58:372 – 377.

Anonymous. 1989. The International Classification of Diseases. 9th rev. Clinical modification: ICD-9-CM. 3rd ed. Washington, DC: US Department of Health and Human Services.

Arn á iz E, Almkvist O, Ivnik RJ, Tangalos EG, Wahlund LO, Winblad B, Petersen RC. 2004. Mild cognitive impairment: a cross-national comparison. J Neurol Neurosurg Psychiatry 75: 1275 – 1280.

Auchus AP, Bissey-Black C. 1997. Pilot study of haloperidol, fluoxetine, and placebo for agitation in Alzheimer’s disease. J Neuropsychiatry Clin Neurosci 9:591 – 593.

Bakchine S, Loft H. 2007. Memantine treatment in patients with mild to moderate Alzheimer’s disease: results of a randomised, double-blind, placebo-controlled 6-month study. J Alzheimers Dis 11:471 – 479. Corrected and republished in: J Alzheimers Dis 2008;13:97 – 107.

Bandelow B, Zohar J, Kasper S, Moeller HJ. 2008a. How to grade categories of evidence. The World Journal of Biological Psychiatry 9:242 – 247.

Bandelow B, Zohar J, Hollander E, Kasper S, Moeller HJ & WFSBP Task Force on Treatment of Obsessive-Compulsive Post-Traumatic Stress Disorder Guidelines. 2008b. World Federation of Societies of Biological Psychiatry (WFSBP) Guidelines for the Pharmacological Treatment of Anxiety, Obsessive-Compulsive and Post-Traumatic Stress Disorders. 1st rev. World J Biol Psychiatry 9:248 – 312.

Bauer M, Whybrow PC, Angst J, Versiani M, M ö ller HJ, World Federation of Societies of Biological Psychiatry (WFSBF) Task Force on Treatment Guidelines for Unipolar Depressive Disorders. 2002. World Federation of Societies of Biological Psychiatry (WFSBP) Guidelines for Biological Treatment of Unipolar Depressive Disorders, Part 2: Maintenance treatment of major depressive disorder and treatment of chronic depressive disorders and subthreshold depressions. World J Biol Psychiatry 3:69 – 86.

Birks J, Grimley Evans J, Iakovidou V, Tsolaki M, Holt FE. 2009. Rivastigmine for Alzheimer’s disease. Cochrane Database Syst Rev 15:CD001191.

Black S, Rom á n GC, Geldmacher DS, Salloway S, Hecker J, Burns A, et al. 2003. Efficacy and tolerability of donepezil in vascular dementia: positive results of a 24-week, multicenter, international, randomized, placebo-controlled clinical trial. Stroke 34:2323 – 2330.

Blessed G, Black SE, Butler T, Kay DV. 1991. The diagnosis of dementia in the elderly. A comparison of CAMCOG (the cognitive section of CAMDEX] the AGECAT program, DSM-III, the Mini-Mental State Examination and some short rating scales. Br J Psychiatry 159:193 – 198.

Brodaty H, Ames D, Snowdon J, Woodward M, Kirwan J, Clarnette R, et al. 2003. A randomized placebo-controlled trial of risperidone for the treatment of aggression, agitation, and psychosis of dementia. J Clin Psychiatry 64:134 – 143.

Brodaty H, Corey-Bloom J, Potocnik FC, Truyen L, Gold M, Damaraju CR. 2005. Galantamine prolonged-release formulation in the treatment of mild to moderate Alzheimer’s disease. Dement Geriatr Cogn Disord 20:120 – 132.

Broich K. 2007. Outcome measures in clinical trials on medicinal products for the treatment of dementia: a European regulatory perspective. Int Psychogeriatr 19:509 – 524 (Epub 16 April 2007).

WFSBP Guidelines for Alzheimer’s disease and other dementias 27

Brookmeyer R, Johnson E, Ziegler-Graham K, Arrighi HM. 2007. Forecasting the global burden of Alzheimer’s disease. Alzheim-ers Dement 3:186 – 191.

Bullock R, Touchon J, Bergman H, Gambina G, He Y, Rapatz G, et al. 2005. Rivastigmine and donepezil treatment in moderate to moderately-severe Alzheimer’s disease over a 2-year period. Curr Med Res Opin 21:1317 – 1327.

Burns A, Rossor M, Hecker J, Gauthier S, Petit H, M ö ller HJ, et al. 1999. The effects of donepezil in Alzheimer’s disease – results from a multinational trial. Dement Geriatr Cogn Disord 10:237 – 244.

Burns A, Yeates A, Akintade L, Del Valle M, Zhang RY, Schwam EM, Perdomo CA. 2008. Defining treatment response to donepezil in Alzheimer’s disease: responder analysis of patient-level data from randomized, placebo-controlled studies. Drugs Aging 25:707 – 714.

Burns A, Bernabei R, Bullock R, Cruz Jentoft AJ, Fr ö lich L, Hock C, et al. 2009. Safety and efficacy of galantamine (Reminyl) in severe Alzheimer’s disease (the SERAD study): a randomised, placebo-controlled, double-blind trial. Lancet Neurol 8:39 – 47.

Busse A, Hensel A, G ü hne U, Angermeyer MC, Riedel-Heller SG. 2006. Mild cognitive impairment: long-term course of four clinical subtypes. Neurology 67:2176 – 2185.

Choi SH, Lee BH, Kim S, Hahm DS, Jeong JH, Yoon SJ, et al. 2003. Interchanging scores between clinical dementia rating scale and global deterioration scale. Alzheimer Dis Assoc Disord 17:98 – 105.

Clark SM, Sheppard L, Fillenbaum GG, Galasko D, Morris JC, Koss E, et al. 1999. Variability in annual Mini-Mental State Examination score in patients with probable Alzheimer disease: a clinical perspective of data from the consortium to establish a registry for Alzheimer ’ s disease. Arch Neurol 56: 857 – 862.

Clark WS, Street JS, Feldman PD, Breier A. 2001. The effects of olanzapine in reducing the emergence of psychosis among nursing home patients with Alzheimer’s disease. J Clin Psychiatry 62:34 – 40.

Clegg A, Bryant J, Nicholson T, McIntyre L, De Broe S, Gerard K, et al. 2001. Clinical and cost-effectiveness of donepezil, rivastigmine and galantamine for Alzheimer’s disease: a rapid and systematic review. Health Technol Assess 5:1 – 137.

Corey-Bloom JR, Anand JV, Veach J for the ENA 713 B352 Study Group. 1998. A randomized trial evaluating the efficacy and safety of ENA 713 (rivastigmine tartrate), a new acetyl-cholinesterase inhibitor, in patients with mild to moderately severe Alzheimer’s disease. Int J Geriatr Psychopharmacol 1:55 – 65.

Cohen-Mansfield J, Billig N. 1986. Agitated behaviors in the elderly. I. A conceptual review. J Am Geriatr Soc 34:711 – 721.

Cohen-Mansfield J. 1986. Agitated behaviors in the elderly. II. Preliminary results in the cognitively deteriorated. J Am Geriatr Soc 34:722 – 727.

Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. 1994. The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology 44:2308 – 2314.

Cummings JL, Schneider L, Tariot PN, Kershaw PR, Yuan W. 2004. Reduction of behavioral disturbances and caregiver distress by galantamine in patients with Alzheimer ’ s disease. Am J Psychiatry 161:532 – 538.

Cummings JL, Schneider E, Tariot PN, Graham SM; Memantine MEM-MD-02 Study Group. 2006. Behavioral effects of memantine in Alzheimer disease patients receiving donepezil treatment Neurology 67:57 – 63.

Dantoine T, Auriacombe S, Sarazin M, Becker H, Pere JJ, Bourdeix I. 2006. Rivastigmine monotherapy and combination therapy with memantine in patients with moderately severe Alzheimer’s 

disease who failed to benefit from previous cholinesterase inhibitor treatment. Int J Clin Pract 60:110 – 118.

De Deyn PP, Rabheru K. 1999. A randomized trial of risperidone, placebo, and haloperidol for behavioral symptoms of dementia. Neurology 53:946 – 955.

De Deyn PP, Carrasco MM, Deberdt W, Jeandel C, Hay DP, Feldman PD, et al. 2004. Olanzapine versus placebo in the treatment of psychosis with or without associated behavioral disturbances in patients with Alzheimer’s disease. Int J Geriatr Psychiatry 19:115 – 126.

DeKosky ST,Williamson JD, Fitzpatrick AL, Kronmal RA, Ives DG, Saxton JA, et al. 2008. Ginkgo Evaluation of Memory (GEM) Study Investigators. Ginkgo biloba for prevention of dementia: a randomized controlled trial. J Am Med Assoc 300:2253 – 2262.

Demers L, Oremus M, Perrault A, Champoux N, Wolfson C. 2000. Review of outcome measurement instruments in Alzhe-imer’s disease drug trials: Psychometric properties of functional and quality of life scales. J Geriatr Psychiatry Neurol 13: 170 – 180.

Erkinjuntti T, Ostbye T, Steenhuis R, Hachinski V. 1997. The effect of different diagnostic criteria on the prevalence of dementia. New Engl J Med 337:1667 – 1674.

Erkinjuntti T, Kurz A, Gauthier S, Bullock R, Lilienfeld S, Dama-raju CV. 2002. Efficacy of galantamine in probable vascular dementia and Alzheimer’s disease combined with cerebrovas-cular disease: A randomised trial. Lancet 359:1283 – 1290.

European Medicine Evaluation Agency (EMEA). 1997. Note for guidance on medicinal products in the treatment of Alzheimer’s disease. London: EMEA.

Fergusson D, Aaron SD, Guyatt G, H é bert P. 2002. Post-randomisation exclusions: the intention to treat principle and excluding patients from analysis. Br Med J 325:652 – 654.

Ferris S, Ihl R, Robert P, Winblad B, Gatz G, Tennigkeit F, Gauthier S. 2009. Treatment effects of memantine on language in moderate to severe Alzheimer’s disease patients. 2009. Alzheimer s Dement 5:369 – 374.

Finkel S, Kozma C, Long S, Greenspan A, Mahmoud R, Baser O, Engelhart L. 2005. Risperidone treatment in elderly patients with dementia: relative risk of cerebrovascular events versus other antipsychotics. Int Psychogeriatr 17:617 – 629.

Flicker C, Ferris SH, Reisberg B. 1991. Mild cognitive impairment in the elderly: Predictors of dementia. Neurology.;41: 1006–1009.

Folstein MF, Folstein SE, McHugh PR. 1975. “Mini-mental state”. A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res 12:189 – 198.

Food and Drug Administration. 1989. Peripheral and Central Nervous System Drugs Advisory Committee Meeting, July 7, 1989. Rockville, MD: Department of Health and Human Services, Public Health Service. p. 227.

Frisoni GB, Fox NC, Jack CR Jr, Scheltens P, Thompson PM. 2010. The clinical use of structural MRI in Alzheimer disease. Nat Rev Neurol 6:67 – 77.

Galasko D, Hansen LA, Katzman R, Wiederholt W, Masliah E, Terry R, et al. 1994. Clinical-neuropathological correlations in Alzheimer’s disease and related dementias. Arch Neurol 51:888 – 895.

Gauthier S, Loft H, Cummings J. 2008. Improvement in behavioural symptoms in patients with moderate to severe Alzhe-imer’s disease by memantine: a pooled data analysis. Int J Geriatr Psychiatry 23:537 – 545.

Gauthier S, Feldman H, Hecker J, Vellas B, Emir B, Subbiah P; Donepezil MSAD Study Investigators ’ Group. 2002a. Functional, cognitive and behavioral effects of donepezil in patients with moderate Alzheimer’s disease. Curr Med Res Opin 18: 347 – 354.

28 R. Ihl et al.

Gauthier S, Feldman H, Hecker J, Vellas B, Ames D, Subbiah P, et al. 2002b. Efficacy of donepezil on behavioral symptoms in patients with moderate to severe Alzheimer’s disease. Int Psy-chogeriatr 14:389 – 404.

Gauthier S, Cummings J, Ballard C, Brodaty H, Grossberg G, Robert P, Lyketsos C. 2010. Management of behavioral problems in Alzheimer’s disease. Int Psychogeriatr 22:346 – 372.

Geslani DM, Tierney MC, Herrmann N, Szalai JP. 2005. Mild cognitive impairment: an operational definition and its conversion rate to Alzheimer’s disease. Dement Geriatr Cogn Disord 19:383 – 389 (Epub 30 March 2005).

Gilstad JR, Finucane TE. 2008. Results, rhetoric, and randomized trials: the case of donepezil. J Am Geriatr Soc 56:1556 – 1562.

Graham JE, Rockwood K, Beattie BL, Eastwood R, Gauthier S, Tuokko H, McDowell I. 1997. Prevalence and severity of cognitive impairment with and without dementia in an elderly population Lancet 349:1793 – 1796.

Graham JE, Rockwood K, Beattie BL, McDowell I, Eastwood R, Gauthier S. 1996. Standardization of the diagnosis of dementia in the Canadian Study of Health and Aging. 1996. Neuroepi-demiology 15:246 – 256.

Guermazi A, Miaux Y, Rovira-Ca ñ ellas A, Suhy J, Pauls J, Lopez R, Posner H. 2007. Neuroradiological findings in vascular dementia. Neuroradiology 49:1 – 22 (Epub 18 November 2006).

Gutzmann H, Kuhl KP, Hadler D, Rapp MA. 2002. Safety and efficacy of idebenone versus tacrine in patients with Alzheimer’s disease: Results of a randomized, double-blind, parallel-group multicenter study. Pharmacopsychiatry 35:12 – 18.

Hachinski VC, Iliff LD, Zilhka E, Du Boulay GH, McAllister VL, Marshall J, et al. 1975. Cerebral blood flow in dementia. Arch Neurol 32:632 – 637.

Haddad PM, Dursun SM. 2008. Neurological complications of psychiatric drugs: clinical features and management. Hum Psy-chophar macol 23(Suppl 1):15 – 26.

Haddad PM, Sharma SG. 2007. Adverse effects of atypical antip-sychotics: differential risk and clinical implications. CNS Drugs 21:911 – 913.

Hampel H, Ewers M, B ü rger K, Annas P, M ö rtberg A, Bogstedt A, et al. 2009. Lithium trial in Alzheimer’s disease: a randomized, single-blind, placebo-controlled, multicenter 10-week study J Clin Psychiatry 70:922 – 931.

Herrmann N, Lanctot KL, Rothenburg LS, Eryavec G. 2007. A placebo-controlled trial of valproate for agitation and aggression in Alzheimer’s disease. Dement Geriatr Cogn Disord 23: 116 – 119.

Herrmann N, Lanct ô t KL. 2007. Pharmacologic management of neuropsychiatric symptoms of Alzheimer disease. Can J Psychiatry 52:630 – 646.

Holmes C, Cairns N, Lantos P, Mann A. 1999. Validity of current clinical criteria for Alzheimer’s disease, vascular dementia and dementia with Lewy bodies. Br J Psychiatry 174:45 – 50.

Holmes C, Boche D, Wilkinson D, Yadegarfar G, Hopkins V, Bayer A, et al. 2008. Long-term effects of Abeta42 immunisation in Alzheimer’s disease: follow-up of a randomised, placebo-controlled phase I trial. Lancet 372(9634):216 – 223.

Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, et al. 2008. CONSORT for reporting randomised trials in journal and conference abstracts. Lancet 371:281 – 283.

Hoyer S. 2002. The aging brain. Changes in the neuronal insulin/ insulin receptor signal transduction cascade trigger late-onset sporadic Alzheimer disease (SAD). A mini-review. J Neural Transm 109:991 – 1002.

Iadecola C. 2010. The overlap between neurodegenerative and vascular factors in the pathogenesis of dementia. Acta Neuropathol. 120:287–96.

Ihl R, Biesenbach A, Brieber S, Grass-Kapanke B, Salamon T. 2005. A head-to-head comparison of the sensitivity of two 

screening tests for dementia Mini-Mental-State-Examination (MMSE) and the Test for the Early Detection of Dementia with Discrimination from Depression (TE4D). Psychogeriatr Pol 2:263 – 272.

Ihl R, Fr ö lich L, Dierks T, Martin EM, Maurer K. 1992. Differential validity of psychometric tests in dementia of the Alzheimer type. Psychiatry Res 44:93 – 106.

Ihl R, Fr ö lich L, Dierks T, Maurer K. 1989. Influence of phys-ostigmine on cognitive processing of the brain. In: Basar E, Bullock TH, editors. Brain dynamics progress and perspectives. Berlin, Heidelberg, New York: Springer. p. 429 – 435.

Ihl R, Tribanek M, Bachinskaya N . 2010. Baseline neuropsychi-atric symptoms are effect modifiers in Ginkgo biloba extract (EGb 761 ® ) treatment of dementia with neuropsychiatric features. Retrospective data analyses of a randomized controlled trial. J Neurol Sci 299:184–7.

Ihl R, Bachinskaya N, Korczyn AD, Vakhapova V, Tribanek M, Hoerr R, et al. 2010. In press. Efficacy and safety of a once-daily formulation of Ginkgo biloba extract EGb 761 in dementia with neuropsychiatric features. A randomized controlled trial. Int J Geriatr Psychiatry 25:1 – 10.

Ioannidis JP, Lau J. 2002. Improving safety reporting from randomised trials. Drug Saf 25:77 – 84.

Ipsen. 2010. Press release 23 June 2010 (http://www.medicalnew-stoday.com/articles/192581.php).

IQWiG. 2007. Cholinesterasehemmer bei Alzheimer Demenz. Abschlussbericht A05 – 19A. K ö ln: Institut f ü r Qualit ä t und Wirtschaftlichkeit im Gesundheitswesen (IQWiG), February 2007.

IQWiG. 2008. Ginkgohaltige Pr ä parate bei der Alzheimerdemenz Abschlussbericht A05 – 19B. K ö ln: Institut f ü r Qualit ä t und Wirtschaftlichkeit im Gesundheitswesen (IQWiG), September 2008.

Jadad AR , Moore RA, Carroll D, Jenkinson C, Reynolds DJM, Gavaghan DJ, McQuay HJ. 1996. Assessing the quality of reports of randomized clinical trials: Is blinding necessary? Control Clin Trials 17:1 – 12.

Kaiser A, Gusner-Pfeiffer R, Griesenberger H, Iglseder B. 2009. Mini-Mental-State – Screening instrument with variations. Z Gerontopsychiatr Psychother 22:11 – 16.

Kamble P, Chen H, Sherer J, Aparasu RR. 2008. Antipsychotic drug use among elderly nursing home residents in the United States. Am J Geriatr Pharmacother 6:187 – 197.

Kanowski S, Herrmann WM, Stephan K, Wierich W, H ö rr R. 1996. Proof of efficacy of the Ginkgo biloba special extract EGb 761 in outpatients suffering from mild to moderate primary degenerative dementia of the Alzheimer type or multi-infarct dementia. Pharmacopsychiatry 29:47 – 56.

Karlsson I, Godderis J, Augusto De Mendon ç a Lima C, Nygaard H, Sim á nyi M, Taal M, Eglin M. 2000. A randomised, double-blind comparison of the efficacy and safety of citalopram compared to mianserin in elderly, depressed patients with or without mild to moderate dementia. Int J Geriatr Psychiatry 15:295 – 305.

Kasper S, Schubert H. 2009. [Ginkgo biloba extract EGb 761 in the treatment of dementia: evidence of efficacy and tolerability]. Fortschr Neurol Psychiatr 77:494 – 506 (Epub 20 July 2009).

Katona C, Chiu E, Adelman S, Baloyannis S, Camus V, Firmino H, et al. 2009. World psychiatric association section of old age psychiatry consensus statement on ethics and capacity in older people with mental disorders. Int J Geriatr Psychiatry 24: 1319 – 1324.

Katz IR, Jeste DV, Mintzer JE, Clyde C, Napolitano J, Brecher M. 1999. Comparison of risperidone and placebo for psychosis and behavioral disturbances associated with dementia: A randomized, double-blind trial. J Clin Psychiatry 60:107 – 115.

WFSBP Guidelines for Alzheimer’s disease and other dementias 29

Kornhuber J, Schmidtke K, Frolich L, Perneczky R, Wolf S, Hampel H, et al. 2009. Early and differential diagnosis of dementia and mild cognitive impairment: design and cohort baseline characteristics of the German Dementia Competence Network. Dement Geriatr Cogn Disord 27:404 – 417 (Epub 1 April 2009).

Krishnan KR, Charles HC, Doraiswamy PM, Mintzer J, Weisler R, Yu X, et al. 2003. Randomized, placebo-controlled trial of the effects of donepezil on neuronal markers and hippocam-pal volumes in Alzheimer’s disease. Am J Psychiatry 160: 2003 – 2011.

Kurlan R, Cummings J, Raman R, Thal L, Alzheimer’s Disease Cooperative Study Group. 2007. Quetiapine for agitation or psychosis in patients with dementia and parkinsonism. Neurology 24(68):1356 – 1363.

Lam LC, Lui VW, Luk DN, Chau R, So C, Poon V, et al. 2010. Effectiveness of an individualized functional training program on affective disturbances and functional skills in mild and moderate dementia – a randomized control trial. Int J Geriatr Psychiatry 25:133 – 141.

Lasagna L. 1998. Balancing risks versus benefits in drug therapy decisions. Clin Ther 20(Suppl C):C72 – 79.

Le Bars PL, Kieser M, Itil KZ. 2000. A 26 week analysis of a double-blind, placebo-controlled trial of the Ginkgo biloba extract Egb 761 in dementia. Dement Geriatr Cogn Disord 11:230 – 237.

Le Bars PL, Katz MM, Berman N, Itil TM, Freedman AM, Schatzberg AF. 1997. A placebo-controlled, double-blind, randomized trial of an extract of Ginkgo biloba for dementia. J Am Med Assoc 16:1327 – 1332.

Leber P. 1990. Guidelines for the clinical evaluation of anti-dementia drugs First draft. Rockville, MD: US Food and Drug Administration (available: http://rain.he.net/ ? harmon2/guide-lines/usa.pdf).

Leber P. 1997. Slowing the progression of Alzheimer disease: methodologic issues. Alzheimer Dis Assoc Disord 11(Suppl 5):S10 – 21, discussion S37 – 39, S10 – 21.

Lebert F, Stekke W, Hasenbroekx C, Pasquier F. 2004. Fronto-temporal dementia: a randomised, controlled trial with trazo-done Dement Geriatr Cogn Disord 17:355 – 359.

Lebert F, Pasquier F, Petit H. 1994. Behavioral effects of trazo-done in Alzheimer’s disease. J Clin Psychiatry 55:536 – 538.

Leibovici A, Tariot PN. 1988. Carbamazepine treatment of agitation associated with dementia. J Geriatr Psychiatry Neurol 1:110 – 112.

Lim A, Tsuang D, Kukull W, Nochlin D, Leverenz J, McCormick W, et al. 1999. Clinico-neuropathological correlation of Alzhe-imer’s disease in a community-based case series. J Am Geriatr Soc 47:564 – 569.

Lin RY, Heacock LC, Fogel JF. 2010. Drug-induced, dementia-associated and non-dementia, non-drug delirium hospitalizations in the United States, 1998 – 2005: an analysis of the national inpatient sample. Drugs Aging 27:51 – 61.

Liperoti R, Onder G, Lapane KL, Mor V, Friedman JH, Bernabei R, Gambassi G. 2007. Conventional or atypical antipsychotics and the risk of femur fracture among elderly patients: results of a case-control study. J Clin Psychiatry 68:929 – 934.

Livingston G, Johnston K, Katona C, Paton J, Lyketsos CG, Old Age Task Force of the World Federation of Biological Psychiatry. 2005. Systematic review of psychological approaches to the management of neuropsychiatric symptoms of dementia. Am J Psychiatry 162:1996 – 2021.

Lobo A, Launer LJ, Fratiglioni L, Andersen K, Di Carlo A, Breteler MM, et al. 2000. Prevalence of dementia and major subtypes in Europe: A collaborative study of population-based cohorts Neurologic Diseases in the Elderly Research Group. Neurology 54(11 Suppl 5):S4 – 9.

Lonergan E, Luxenberg J, Colford J. 2004. Haloperidol for agitation in dementia (Cochrane Review). In: The Cochrane Library, Issue 2. Chichester: John Wiley.

Magai C, Kennedy G, Cohen CI, Gomberg D. 2000. A controlled clinical trial of sertraline in the treatment of depression in nursing home patients with late-stage Alzheimer’s disease. Am J Geriatr Psychiatry 8:66 – 74.

Mayeux R, Sano M. 1999. Drug therapy: Treatment of Alzhe-imer’s disease. New Engl J Med 341:1670 – 1679.

McKeith IG, Fairbairn A, Perry RH, Thompson P. 2005. Neu-roleptic sensitivity in patients with senile dementia of Lewy body type. Br Med J 305:673 – 678.

McKeith I, Del Ser T, Spano P, Emre M, Wesnes K, Anand R, et al. 2000. Efficacy of rivastigmine in dementia with Lewy bodies: A randomised, double-blind, placebo-controlled international study. Lancet 356:2031 – 2036.

McKhann G, Drachman D, Folstein M, Katzman R, Price D, Stadlan EM. 1984. Clinical diagnosis of Alzheimer’s disease: Report of the NINCDS-ADRDA Work Group under the auspices of Department of Health and Human Services Task Force on Alzheimer’s Disease. Neurology 34:939 – 944.

Moher D, Schulz KF, PhD, Altman DG, for the CONSORT Group. 2001. The CONSORT Statement: Revised Recommendations for Improving the Quality of Reports of Parallel-Group Randomized Trials. Ann Intern Med 134:657 – 662.

Mohs RC, Doody RS, Morris JC, Ieni JR, Rogers SL, Perdomo CA, Pratt RD. 2001. “312” Study Group. A 1-year, placebo-controlled preservation of function survival study of donepezil in AD patients. Neurology 57:481 – 488.

M ö ller HJ, Hampel H, Hegerl U, Schmitt W, Walter K. 1999. Double-blind, randomized, placebo-controlled clinical trial on the efficacy and tolerability of a physostigmine patch in patients with senile dementia of the Alzheimer type. Pharmacopsychia-try 32:99 – 106.

M ö ller HJ, Maier W. 2007. [Problems of evidence-based medicine in psychopharmacotherapy: problems of evidence grading and of the evidence basis for complex clinical decision making]. Nervenarzt 78:1014 – 1027.

Morris JC, McKeel DW Jr, Fulling K, Torack RM, Berg L. 1988. Validation of clinical diagnostic criteria for Alzheimer’s disease. Ann Neurol 24:17 – 22.

Napryeyenko O, Borzenko I, for the GINDEM-NP Study Group. 2007. Ginkgo biloba special extract in dementia with neuropsy-chiatric features. A randomised, placebo-controlled, double-blind clinical trial. Arzneim Forsch (Drug Res) 57:4 – 11.

Neary D, Snowden JS, Gustafson L, Passant U, Stuss D, Black S, et al. 1998. Frontotemporal lobar degeneration: a consensus on clinical diagnostic criteria. Neurology 51:1546 – 1554.

Nolan KA, Lino MM, Seligmann AW, Blass JP. 1998. Absence of vascular dementia in an autopsy series from a dementia clinic. J Am Geriatr Soc 46:597 – 604.

Nordberg A, Rinne JO, Kadir A, L å ngstr ö m B. 2010. The use of PET in Alzheimer disease. Nat Rev Neurol 6:78 – 87.

Nyth AL, Gottfries CG. 1990. The clinical efficacy of citalopram in treatment of emotional disturbances in dementia disorders A Nordic multicentre study. Br J Psychiatry 157:894 – 901.

Nyth AL, Gottfries CG, Lyby K, Smedegaard-Andersen L, Gylding-Sabroe J, Kristensen M, et al. 1992. A controlled multicenter clinical study of citalopram and placebo in elderly depressed patients with and without concomitant dementia. Acta Psychiatr Scand 86:138 – 145.

O’Connor DW, Ames D, Gardner B, King M. 2009a. Psychoso-cial treatments of behavior symptoms in dementia: a systematic review of reports meeting quality standards. Int Psychogeriatr 21:225 – 240.

O’Connor DW, Ames D, Gardner B, King M. 2009b. Psychoso-cial treatments of psychological symptoms in dementia: a

30 R. Ihl et al.

systematic review of reports meeting quality standards. Int Psy-chogeriatr 21:241 – 51.

Oremus M, Wolfson C, Perrault A, Demers L, Momoli F, Moride Y. 2001. Interrater reliability of the modified Jadad quality scale for systematic reviews of Alzheimer’s disease drug trials. Dement Geriatr Cogn Disord 12:232 – 236.

Orgogozo JM, Rigaud AS, Stoffler A, Mobius HJ, Forette F. 2002. Efficacy and safety of memantine in patients with mild to moderate vascular dementia: a randomized, placebo-controlled trial (MMM 300). Stroke 33:1834 – 1839.

Oxford Centre for Evidence-based Medicine. 2009. (http://www. cebm.net) (original work of Phillips B, Ball C, Sackett D, Bad-enoch D, Straus S, Haynes B, Dawes M, 1998, updated by Howick J, March 2009).

Paleacu D, Barak Y, Mirecky I, Mazeh D. 2008. Quetiapine treatment for behavioural and psychological symptoms of dementia in Alzheimer’s disease patients: a 6-week, double-blind, placebo-controlled study. Int J Geriatr Psychiatry 23:393 – 400.

Peskind ER, Potkin SG, Pomara N, Ott BR, Graham SM, Olin JT, McDonald S. 2006. Memantine treatment in mild to moderate Alzheimer disease: a 24-week randomized, controlled trial. Am J Geriatr Psychiatry 14:704 – 715.

Petersen RC. 2001. Mild cognitive impairment: transition between aging and Alzheimer’s disease. Neurologia 5:93 – 101.

Petersen RC. 2004. Mild cognitive impairment as a diagnostic entity. J Intern Med 256:183 – 194.

Petersen RC, Smith GE, Waring SC, Ivnik RJ, Kokmen E, Tangelos EG. 1997. Aging, memory, and mild cognitive impairment. Int Psychogeriatr 9(Suppl 1):65 – 69.

Petersen RC, Stevens JC, Ganguli M, Tangalos EG, Cummings JL, DeKosky ST. 2001. Practice parameter: early detection of dementia: mild cognitive impairment (an evidence-based review). Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology 56:1133 – 1142.

Petracca GM, Chemerinski E, Starkstein SE. 2001. A double-blind, placebo-controlled study of fluoxetine in depressed patients with Alzheimer’s disease. Int Psychogeriatr 13:233 – 240.

Pinheiro D. 2008. [Anticonvulsant mood stabilizers in the treatment of behavioral and psychological symptoms of dementia (BPSD)]. Encephale 34:409 – 415.

Pocock SJ, Abdalla M. 1998. The hope and the hazards of using compliance data in randomized controlled trials. Stat Med 17:303 – 317.

Pollock BG, Mulsant BH, Rosen J, Sweet RA, Mazumdar S, Bharucha A, et al. 2002. Comparison of citalopram, per phena-zine, and placebo for the acute treatment of psychosis and behavioral disturbances in hospitalized, demented patients. Am J Psychiatry 159:460 – 465.

Pollock BG, Mulsant BH, Rosen J, Mazumdar S, Blakesley RE, Houck PR, Huber KA. 2007. A double-blind comparison of citalopram and risperidone for the treatment of behavioral and psychotic symptoms associated with dementia Am J Geriatr Psychiatry 15:942 – 952.

Porsteinsson AP, Grossberg GT, Mintzer J, Olin JT, Meman-tine MEM-MD-12 Study Group. 2008. Memantine treatment in patients with mild to moderate Alzheimer’s disease already receiving a cholinesterase inhibitor: a randomized, double-blind, placebo-controlled trial. Curr Alzheimer Res 5:83 – 89.

Prvulovic D, Hampel H, Pantel J, Tariot P, Brodaty H, Kaye J, Erkinjuntti T. 2010. Galantamine for Alzheimer’s disease. Expert Opin Drug Metab Toxicol 6:345 – 354.

Qing H, He G, Ly PT, Fox CJ, Staufenbiel M, Cai F, Tariot P, Brodaty H, Kaye J, Erkinjuntti T. 2008. Valproic acid inhibits Abeta production, neuritic plaque formation, and behavioral deficits in Alzheimer’s disease mouse models. J Exp Med 205:2781 – 2789.

Qizilbash N, Schneider LS, Chui H, et al. 2002. Evidence-based dementia practice. Oxford: Blackwell Science Ltd. p. 604.

Rabinowitz J, Davidson M, De Deyn PP, Katz I, Brodaty H, Cohen-Mansfield J. 2005. Factor analysis of the Cohen-Mansfield Agitation Inventory in three large samples of nursing home patients with dementia and behavioral disturbance. Am J Geriatr Psychiatry 11:991 – 998.

Rainer M, Haushofer M, Pfolz H, Struhal C, Wick W. 2007. Quetiapine versus risperidone in elderly patients with behavioural and psychological symptoms of dementia: efficacy, safety and cognitive function. Eur Psychiatry 22:395 – 403.

Rands G, Orrel M, Spector A, Williams P. 2004. Aspirin for vascular dementia (Chochrane review): In: The Cochrane Library, Issue 2. Chichester: John Wiley.

Raskind MA, Peskind ER, Wessel T, Yuan W. 2000. Galantamine in AD: A 6-month randomized, placebo-controlled trial with a 6-month extension. The Galantamine USA-1 Study Group. Neurology 54:2261 – 2268.

Reisberg B, Borenstein J, Salob SP, Ferris SH, Franssen E, Georgotas A. 1987. Behavioral symptoms in Alzheimer’s disease: phenomenology and treatment. J Clin Psychiatry 48(Suppl):9 – 15.

Reisberg B, Doody R, St ö ffler A, Schmitt F, Ferris S, M ö bius HJ. 2003. Memantine Study Group Memantine in moderate-to-severe Alzheimer’s disease. New Engl J Med 348: 1333 – 1341.

Riederer P. Endbericht zum Projekt Medikamentenentwicklung f ü r Demenzen in Deutschland (MED-D), GESENT. W ü rz-burg 2009 Available via internet: http://www.bundesgesund-heitsministerium.de/cln_151/nn_1168300/SharedDocs/ Publikationen/DE/Fors chungsberichte/Medikamentenent-wicklung-fuer-Demenzen,templateId=raw,proper ty=publicat ionFile.pdf/Medikamentenentwicklung-fuer-Demenzen.pdf

Ritchie K, Artero S, Touchon J. 2001. Classification criteria for mild cognitive impairment: a population-based validation study. Neurology 56:37 – 42.

Rockwood K, Joffres C. 2002. Improving clinical descriptions to understand the effects of dementia treatment: Consensus recommendations. Int J Geriatr Psychiatry 17:1006 – 1011.

Rockwood K, MacKnight C. 2001. Assessing the clinical importance of statistically significant improvement in anti-dementia drug trials. Neuroepidemiology 20:51 – 56.

Rogers SL, Farlow MR, Doody RS, Mohs R, Friedhoff LT. 1998. A 24-week, double-blind, placebo-controlled trial of donepezil in patients with Alzheimer’s disease. Donepezil Study Group. Neurology 50:136 – 145.

Rom á n GC, Tatemichi TK, Erkinjuntti T, Cummings JL, Masdeu JC, Garcia JH, et al. 1993. Vascular dementia: diagnostic criteria for research studies. Report of the NINDS-AIREN International Workshop. Neurology 43:250 – 260.

Rom á n GC, Salloway S, Black SE, Royall DR, Decarli C, Weiner MW, et al. 2010. Randomized, placebo-controlled, clinical trial of donepezil in vascular dementia: differential effects by hip-pocampal size. Stroke 41:1213 – 1221 (Epub 15 April 2010).

Rosen CS, Chow HC, Greenbaum MA, Finney JF, Moos RH, Sheikh JI, Yesavage JA. 2002. How well are clinicians following dementia practice guidelines? Alzheimer Dis Assoc Disord 16:15 – 23.

Rosen WG, Mohs RC, Davis KL. 1984. A new rating scale for Alzheimer’s disease. Am J Psychiatry 141:1356 – 1364.

Rosenthal R, DiMatteo MR. 2001. Meta-analysis: recent developments in quantitative methods for literature reviews. Annu Rev Psychol 52:59 – 82.

Rosenberg PB, Drye LT, Martin BK, Frangakis C, Mintzer JE, Weintraub D, et al. 2010. Sertraline for the treatment of depression in Alzheimer disease. Am J Geriatr Psychiatry 18: 136 – 145.

WFSBP Guidelines for Alzheimer’s disease and other dementias 31

Rosler M, Anand R, Cicin-Sain A, Gauthier S, Agid Y, Dal-Bianco P, et al. 1999. Efficacy and safety of rivastigmine in patients with Alzheimer’s disease: International randomised controlled trial. Br Med J 318(7184):633 – 638.

Rossini PM, Rossi S, Babiloni C, Polich J. 2007. Clinical neuro-physiology of aging brain: from normal aging to neurodegen-eration. Prog Neurobiol 83:375 – 400.

S3-Guideline. 2009. “ Dementia ” (S3-Leitlinie “ Demenzen ” ) of the Association of Scientific Medical Societes in Germany (AWMF), November 2009 (http://leitlinien.net/).

Salkovic-Petrisic M, Osmanovic J, Gr ü nblatt E, Riederer P, Hoyer S. 2009. Modeling sporadic Alzheimer’s disease: The Insulin Resistant Brain State Generates Multiple Long-Term Morpho-biological Abnormalities Inclusive Hyperphosphorylated Tau Protein and Amyloid-beta. A Synthesis. J Alzheimers Dis 18: 1184.

Schneider LS, DeKosky ST, Farlow MR, Tariot PN, Hoerr R, Kieser M. 2005. A randomized, double-blind, placebo-controlled trial of two doses of Ginkgo biloba extract in dementia of the Alzheimer’s type. Curr Alzheimer Res 2: 541 – 551.

Schneider LS, Tariot PN, Dagerman KS, Davis SM, Hsiao JK, Ismail MS, et al. 2006. Effectiveness of atypical antipsychotic drugs in patients with Alzheimer’s disease. New Engl J Med 355:1525 – 1538.

Schroder J, Kratz B, Pantel J, Minnemann E, Lehr U, Sauer H. 1998. Prevalence of mild cognitive impairment in an elderly community sample J Neural Transm Suppl 54:51 – 59.

Schroter S, Black N, Evans S, Godlee F, Osorio L, Smith R. 2008. What errors do peer reviewers detect, and does training improve their ability to detect them? J R Soc Med 101: 507 – 514.

Seltzer B, Zolnouni P, Nunez M, Goldman R, Kumar D, Ieni J, et al. 2004. Efficacy of donepezil in early-stage Alzheimer disease: a randomized placebo-controlled trial. Arch Neurol 61:1852 – 1856.

Shotbolt P, Samuel M, Fox C, David AS. 2009. A randomized controlled trial of quetiapine for psychosis in Parkinson’s disease. Neuropsychiatr Dis Treat 5:327 – 332.

Sink KM, Holden KF, Yaffe K. 2005. Pharmacological treatment of neuropsychiatric symptoms of dementia: a review of the evidence. J Am Med Assoc 293:596 – 608.

Stern RG, Mohs RC, Davidson M, Schmeidler J, Silverman J, Kramer-Ginsberg E, et al. 1994. A longitudinal study of Alzhe-imer’s disease: measurement, rate, and predictors of cognitive deterioration. Am J Psychiatry 151:390 – 396.

Street JS, Clark WS, Gannon KS, Cummings JL, Bymaster FP, Tamura RN, et al. 2000. Olanzapine treatment of psychotic and behavioral symptoms in patients with Alzheimer disease in nursing care facilities: A double-blind, randomized, placebo-controlled trial. The HGEU Study Group. Arch Gen Psychiatry 57:968 – 976.

Sultzer DL, Gray KF, Gunay I, Berisford MA, Mahler ME. 1997. A double-blind comparison of trazodone and haloperidol for treatment of agitation in patients with dementia. Am J Geriatr Psychiatry 5:60 – 69.

Sultzer DL, Gray KF, Gunay I, Wheatley MV, Mahler ME. 2001. Does behavioral improvement with haloperidol or trazodone treatment depend on psychosis or mood symptoms in patients with dementia? J Am Geriatr Soc 49:1294 – 1300.

Sultzer DL, Davis SM, Tariot PN, Dagerman KS, Lebowitz BD, Lyketsos CG, et al. 2008. Clinical symptom responses to atypical antipsychotic medications in Alzheimer’s disease: phase 1 outcomes from the CATIE-AD effectiveness trial. Am J Psychiatry 165:844 – 854.

Tariot PN, Erb R, Leibovici A, Podgorski CA, Cox C, Asnis J, et al. 1994. Carbamazepine treatment of agitation in nursing 

home patients with dementia: a preliminary study. J Am Geriatr Soc 42:1160 – 1166.

Tariot PN, Erb R, Podgorski CA, Cox C, Patel S, Jakimovich L, Irvine C. 1998. Efficacy and tolerability of carbamazepine for agitation and aggression in dementia. Am J Psychiatry 155:54 – 61.

Tariot PN, Jakimovich LJ, Erb R, Cox C, Lanning B, Irvine C, Podgorski CA. 1999. Withdrawal from controlled carbamazepine therapy followed by further carbamazepine treatment in patients with dementia J Clin Psychiatry 60:684 – 689.

Tariot PN, Solomon PR, Morris JC, Kershaw P, Lilienfeld S, Ding C. 2000. A 5-month, randomized, placebo-controlled trial of galantamine in AD The Galantamine USA-10 Study Group. Neurology 54:2269 – 2276.

Tariot PN, Cummings JL, Katz IR, Mintzer J, Perdomo CA, Schwam EM, Whalen E. 2001. A randomised, double-blind, placebo-controlled study of the efficacy and safety of Donepe-zil in patients with Alzheimer’s disease in the nursing home setting. J Am Geriatr Soc 49:1590 – 1599.

Tariot P, Farlow M, Grossberg G, Graham SM, McDonald S, Gergel I; Memantine Study Group. 2004. Memantine treatment in patients with moderate to severe Alzheimer disease already receiving donepezil. J Am Med Assoc 291:317 – 324.

Tariot PN, Schneider L, Katz IR, Mintzer JE, Street J, Copen-haver M, Williams-Hughes C. 2006. Quetiapine treatment of psychosis associated with dementia: a double-blind, randomized, placebo-controlled clinical trial. Am J Geriatr Psychiatry 14:767 – 776 (Epub 11 August 2006).

Thompson C, Brodaty H, Trollor J, Sachdev P. 2010. Behavioral and psychological symptoms associated with dementia subtype and severity. Int Psychogeriatr 22:300 – 305.

Tierney MC, Fisher RH, Lewis AJ, Zorzitto ML, Snow WG, Reid DW, Nieuwstraten P. 1988. The NINCDS-ADRDA Work Group criteria for the clinical diagnosis of probable Alzheimer’s disease: a clinicopathologic study of 57 cases. Neurology 38:359 – 364.

Tune L, Tiseo PJ, Ieni J, Perdomo C, Pratt RD, Votaw JR, et al. 2003. Donepezil HCl (E2020) maintains functional brain activity in patients with Alzheimer disease: results of a 24-week, double-blind, placebo-controlled study. Am J Geriatr Psychiatry 11:169 – 177.

Van Dyck CH, Tariot PN, Meyers B, Malca Resnick E; for the Memantine MEM-MD-01 Study Group. 2007. A 24-week randomized, controlled trial of memantine in patients with moderate-to-severe Alzheimer disease. Alzheimer Dis Assoc Disord 21:136 – 143.

Vellas B, Andrieu S, Ousset PJ, Ouzid M, Mathiex-For tunet H, for the GuidAge Study Group . 2006. The GuidAge study Methodological issues. A 5-year double-blind randomized trial of the efficacy of EGb 761 ® for prevention of Alzheimer disease in patients over 70 with a memory complaint. Neurology 67:S6 – 11.

Waldemar G, Dubois B, Emre M, Scheltens P, Tariska P, Rossor M. 2000. Diagnosis and management of Alzheimer’s disease and other disorders associated with dementia. The role of neurologists in Europe European Federation of Neurological Societies Scientist Panel on Dementia. Eur J Neurol 7:133 – 144.

Wang BS, Wang H, Song YY, Qi H, Rong ZX, Wang BS, et al. 2010. Effectiveness of standardized ginkgo biloba extract on cognitive symptoms of dementia with a six-month treatment: a bivariate random effect meta-analysis Pharmacopsychiatry 43:86 – 91 (Epub 26 January 2010).

Warner J, Butler R, Wuntakal B. 2008. Dementia. In: BMJ Clinical Evidence Handbook. London: BMJ.

Weintraub D, Rosenberg PB, Drye LT, Martin BK, Frangakis C, Mintzer JE, et al. 2010. Sertraline for the treatment of depression in Alzheimer disease: week-24 outcomes. Am J Geriatr Psychiatry 18:332 – 340.

32 R. Ihl et al.

Wells G, Shukla VK, Bai A, Milne S. 2008. Review of quality assessment instruments for randomized controlled trials. Canadian Cochrane Symposium, Edmonton, AB, Canada.

Wesnes KA, McKeith IG, Ferrera R, Emre M, Del Ser T, Spano PF, et al. 2002. Effects of Rivastigmine on cognitive function in Dementia with Lewy Bodies: A randomised placebo-controlled international study using the cognitive drug research computerised assessment system. Dement Geriatr Cog Disord 13: 183 – 192.

Whitehouse PJ, Kittner B, Roessner M, Rossor M, Sano M, Thal L, Winblad B. 1998. Clinical trial designs for demonstrating disease-course-altering effects in dementia. Alzheimer Dis Assoc Disord 12:281 – 294.

White N, Scott A, Woods RT, Wenger G-C, Keady J-D, Devaku-mar M. 2002. The limited utility of the Mini-Mental State Examination in screening people over the age of 75 years for dementia in primary care. Br J Gen Pract 52:1002 – 1003.

Wilcock GK, Ashworth DL, Langfield JA, Smith PM. 1994. Detecting patients with Alzheimer ’ s disease suitable for drug treatment: comparison of three methods of assessment. Br J Gen Pract 44:30 – 33.

Wilcock G, Mobius HJ, Stoffler A. 2002. A double-blind, placebo-controlled multicentre study of memantine in mild to moderate vascular dementia (MMM500). Int Clin Psychopharmacol 17:297 – 305.

Wilcock GK, Lilienfeld S, Gaens E. 2000. Efficacy and safety of galantamine in patients with mild to moderate Alzheimer’s disease: Multicentre randomised controlled trial. Galantamine International-1 Study Group. Br Med J 321:1445 – 1449.

Wilkinson D, Doody R, Helme R, Taubman K, Mintzer J, Kertesz A, et al. 2003. Donepezil in vascular dementia: a randomized, placebo-controlled study. Neurology 61:479 – 486.

Wiltfang J, Lewczuk P, Riederer P, Gr ü nblatt E, Hock C, Scheltens P, et al. 2005. Consensus paper of the WFSBP Task Force on Biological Markers of Dementia: the role of CSF and blood

Supplementary material available online

The data base of RCTs that fulfilled the methodological criteria of the work group (Tables 1 – 10).

analysis in the early and differential diagnosis of dementia. World J Biol Psychiatry 6:69 – 84.

Wimo A, Winblad B, Stoffler A, Wirth Y, Möbius HJ. 2003. Resource utilisation and cost analysis of memantine in patients with moderate to severe Alzheimer ’ s disease. Pharmacoeco-nomics 21:327 – 340.

Winblad B, Engedal K, Soininen H, Wirth Y, M ö bius HJ. 2001. A 1-year, randomized, placebo-controlled study of donepezil in patients with mild to moderate AD. Neurology 57:489 – 495.

Winblad B, Palmer K, Kivipelto M, Jelic V, Fratiglioni L, Wahlund LO, et al. 2004. Mild cognitive impairment – beyond controversies, towards a consensus: report of the International Working Group on Mild Cognitive Impairment. J Intern Med 256: 240 – 246.

Wind AW, Schellevis F-G, Van Staveren G, Scholten RP, Jonker C, Van Eijk J-T. 1997. Limitations of the Mini-Mental State Examination in diagnosing dementia in general practice. Int J Geriatr Psychiatry 12:101 – 108.

World Health Organization. 1992. The tenth revision of the International Classification of Diseases and relative health problems (ICD-10). Geneva: WHO.

Yancheva S, Ihl R, Nikolova G, Panayotov C, Schlaefke S, Hoerr R, for the GINDON Study Group. 2009. Ginkgo biloba extract EGb 761 ® , donepezil or both combined in the treatment of Alzheimer’s disease with neuropsychiatric features: A randomised, double-blind, exploratory trial. Aging Ment Health 13:183 – 190.

Zhong KX, Tariot PN, Mintzer J, Minkwitz MC, Devine NA. 2007. Quetiapine to treat agitation in dementia: a randomized, double-blind, placebo-controlled study Curr Alzheimer Res 2007 4:81 – 93.

Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, et al. 2008. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. Br Med J 337:2390.

DigitalPersona® White Paper

Guide to Fingerprint Recognition

DigitalPersona, Inc.

650.474.4000

www.digitalpersona.com

DigitalPersona

Guide to Fingerprint Recognition

All fingerprints are unique. The critical issue is whether we can get to the information that

is unique and express it in a way that meets the objective of positive identification.

Getting to and expressing the unique information in the fingerprint biometric is the

mission of DigitalPersona and its Fingerprint Recognition Engine.

Introduction

      When we interact with others we are used to identifying them by their physical appearance, their voice, or other sensory data. When we need proof of identity beyond physical appearance we obtain a signature or we look at a photo identification card. In Cyberspace, where people need to interact with digital systems or with one another remotely, we do not have these tried and true means of identification available. In almost all cases we cannot see, hear, or obtain a signature from the person with whom we are interacting.

      Biometrics, the measurement of a unique physical characteristic, is an ideal solution to the problem of digital identification. Biometrics makes it possible to identify ourselves to digital systems, and through these systems identify ourselves to others in Cyberspace. With biometrics we create a digital persona that makes our transactions and interactions in Cyberspace convenient and secure. Of all the biometrics available, including face, iris and retina scanning, voice identification, and others, the fingerprint is one of the most convenient and foolproof.

DigitalPersona – Fingerprint Recognition Page 1

  The advantages of fingerprint biometrics for the purpose of personal digital identification include:

* Each and every one of our ten fingerprints is unique, different from one another and from those of every other person. Even identical twins have unique fingerprints.

* Unlike passwords, PIN codes, and smartcards that we depend upon today for identification, our fingerprints are impossible to lose or forget, and they can never be stolen.

* We have ten fingerprints as opposed to one voice, one face or two eyes.

* Fingerprints have been used for centuries for identification, and we have a substantial body of real world data upon which to base our claim of the uniqueness of each fingerprint. Iris scanning, for instance, is an entirely new science for which there is little or no real world data.

  In the DigitalPersona Guide to Fingerprint Identification we explain how we know that the likelihood of two fingerprints being alike is so infinitesimal as to be impossible, how much unique information is available in each print, how fingerprints have been used over the centuries as proof of identity, and how DigitalPersona is adapting this standard of identification for the digital age.

DigitalPersona – Fingerprint Recognition Page 2

The Basics of Fingerprint Identification

Ridges

      The skin on the inside surfaces of our hands, fingers, feet, and toes is “ridged” or covered with concentric raised patterns. These ridges are called friction ridges and they serve the useful function of making it easier to grasp and hold onto objects and surfaces without slippage. It is the many differences in the way friction ridges are patterned, broken, and forked which make ridged skin areas, including fingerprints, unique.

Fingerprint Identification Terminology

      Fingerprints are extremely complex. In order to “read” and classify them, certain defining characteristics are used, many of which have been established by law enforcement agencies as they have created and maintained larger and larger databases of prints. Even though biometrics companies like DigitalPersona do not save images of fingerprints and do not use the same manual process to analyze them, many of the methodologies that have been established over the years in law enforcement are useful for digital algorithms as well.

Global Versus Local Features

   We make use of two types of fingerprint characteristics for use in identification of individuals: Global Features and Local Features. Global Features are those characteristics that you can see with the naked eye. Global Features include:

* Basic Ridge Patterns

* Pattern Area

DigitalPersona – Fingerprint Recognition Page 3

* Core Area

* Delta

* Type Lines

* Ridge Count

  The Local Features are also known as Minutia Points. They are the tiny, unique characteristics of fingerprint ridges that are used for positive identification. It is possible for two or more individuals to have identical global features but still have different and unique fingerprints because they have local features - minutia points - that are different from those of others.

Global Features

* Pattern Area – The Pattern Area is the part of the fingerprint that contains all

the global features. Fingerprints can be read and classified based on the information in the Pattern Area. Certain minutia points that are used for final identification might be outside the Pattern Area. One significant difference between DigitalPersona’s fingerprint recognition algorithm and those of competing companies is that DigitalPersona uses the entire fingerprint for

DigitalPersona – Fingerprint Recognition Page 4

analysis and identification, not just the Pattern Area. While other companies’ devices require users to line up their fingerprints on the fingerprint reader, DigitalPersona acquires a greater amount of information over the entire fingerprint, and can obtain enough information to "read" a print even if only part of the print is placed on the fingerprint reader.'

* Core Point -- The Core Point, located at the approximate center of the finger impression, is used as a reference point for reading and classifying the print.

* Type Lines – Type Lines are the two innermost ridges that start parallel, diverge, and surround or tend to surround the pattern area. When there is a definite break in a type line, the ridge immediately outside that line is considered to be its continuation.

* Delta – The Delta is the point on the first bifurcation, abrupt ending ridge, meeting of two ridges, dot, fragmentary ridge, or any point upon a ridge at or

nearest the center of divergence of two type lines, located at or directly in front of their point of divergence. It is a definite fixed point used to facilitate ridge counting and tracing.'

* Ridge Count – The Ridge Count is most commonly the number of ridges between the Delta and the Core. To establish the ridge count, an imaginary

DigitalPersona – Fingerprint Recognition Page 5

line is drawn from the Delta to the Core and each ridge that touches this line is counted.

Basic Ridge Patterns

      Over the years those who work with fingerprints have defined groupings of prints based on patterns in the fingerprint ridges. This categorization makes it easier to search large databases of fingerprints and identify individuals. The basic ridge patterns are not sufficient for identification but they help narrow down the search.

      Certain products base identification on "optical correlation" of global ridge patterns, or matching one fingerprint pattern image to another. DigitalPersona believes that positive identification must be based on verification of minutia points in addition to global features.

   The new digital paradigm for fingerprint identification uses many elements of the categorization process that has been in place for years, as well as some newer concepts for understanding and categorizing global features. In addition to defining ridge patterns, DigitalPersona has determined that there are certain ways that ridges can flow around on a fingerprint, and that the constraints on flow behavior can be exploited for identification. The DigitalPersona Recognition Engine makes use of the characteristics of global ridge patterns and flow characteristics to identify individuals.

   There are a number of basic ridge pattern groupings which have been defined. Three of the most common are loop, arch, and whorl.

DigitalPersona – Fingerprint Recognition Page 6

1. LOOP

The loop is the most common type of fingerprint pattern and accounts for about

65% of all prints.'

2. ARCH

The Arch pattern is a more open curve than the Loop. There are two types of

arch patterns – the Plain Arch and the Tented Arch.'

DigitalPersona – Fingerprint Recognition Page 7

3. WHORL

Whorl patterns occur in about 30% of all fingerprints and are defined by at least

one ridge that makes a complete circle.1

Minutia Points

Fingerprint ridges are not continuous, straight ridges. Instead they are broken, forked, changed directionally, or interrupted. The points at which ridges end, fork, and change are called minutia points, and these minutia points provide unique, identifying information.

There are five characteristics of minutia points in fingerprints:

1. Type – There are a number of types of minutia points. The most common are ridge endings and ridge bifurcations.

* Ridge Ending -- occurs when a ridge ends abruptly.

* Ridge Bifurcation -- the point at which a ridge divides into two or more branches.

* Ridge Divergence – the spreading apart of two lines which have been running parallel or nearly parallel.

DigitalPersona – Fingerprint Recognition Page 8

* Dot or Island – a ridge that is so short it appears as a dot.

* Enclosure –a ridge that divides into two and then re-unites to create an enclosed area of ridge-less skin.

* Short Ridge – an extremely short ridge, but not so short that it appears as a Dot or Island

2. Orientation – Each minutia point faces a particular direction. This is the Orientation of the minutia point.

3. Spatial Frequency – Spatial frequency refers to how far apart the ridges are in the neighborhood of the minutia point.

4. Curvature –The curvature refers to the rate of change of ridge orientation.

5. Position – The position of the minutia point refers to its x, y location, either in an absolute sense or relative to fixed points like the Delta and Core points.

DigitalPersona – Fingerprint Recognition Page 9

Advantages of the DigitalPersona Fingerprint Recognition Algorithm

      The DigitalPersona Fingerprint Recognition Algorithm was developed by leading researchers in the field of fingerprint biometrics to overcome the new issues and constraints the digital world imposes on standards of identification. It incorporates traditional fingerprint identification methodologies into creating each user’s unique identifying information for Cyberspace. The result of years of study, extensive researching, and testing, DigitalPersona’s recognition engine is the most robust recognition algorithm available today.

      The performance of fingerprint algorithms is measured as a tradeoff between two attributes:

False Acceptance Rate (FAR) which is the probability that an intruder will be accepted by the system

False Rejection Rate (FRR) which is the probability that a legitimate person will be rejected by the system

   By adjusting the threshold of acceptance, the FAR can be lowered at the expense of the FRR, and vice versa. In some installations, such as a highly confidential site, a higher FRR and a lower FAR are required. In other installations where security is not as significant an issue and the system is used primarily for the convenience it provides, it may be preferable to decrease the FRR and increase FAR.

   DigitalPersona is continuously improving both the FAR and FRR of its algorithm. The goal is to increase the overall robustness of the algorithm as

DigitalPersona – Fingerprint Recognition Page 10

measured by the reliability of the verification over time for different users, at different times, and under different conditions.

   FAR and FRR offset one another and can be stated only in terms that are relative to one another. Currently the DigitalPersona algorithm provides an FAR of 0.01% at an FRR of 1.4%.

   The above FAR and FRR rates and the accuracy of the system are a direct result of the quality of the fingerprint of the individual user. Testing with large groups of people over an extended period has shown that 80% of all users have such feature-rich fingerprints that they will virtually always be recognized accurately by DigitalPersona and never obtain a false acceptance or a false rejection. Of the remaining 20%, about 15% of users have less information in their prints. They will have to place their finger onto the fingerprint reader twice to obtain secure system access. About 5% of all users have poor-quality prints and might have to try a second and third time to obtain an accurate reading.

   The DigitalPersona Recognition Engine is optimized to recognize prints of poor quality. However, a very small number of fingerprints are either worn from manual labor or have unreadable ridge lines and are impossible to scan. Even DigitalPersona will not register prints of exceptionally low quality.

   Many digital recognition systems rely upon what is called a “Skeleton Model” as its basis. This is a line drawing derived from the image provided by the fingerprint reader that includes the basic ridge lines and minutia points on the fingerprint. The problem is that in addition to the basic information, the Skeleton Model also includes a great deal of spurious skeleton lines that do not

DigitalPersona – Fingerprint Recognition Page 11

correspond to real minutia points at all. This is particularly the case with poor-quality prints. A major advantage of the DigitalPersona algorithm over those of its competitors is that it employs an enhanced version of the raw image that comes from the fingerprint reader. It extracts the minutia points directly from this representation rather than attempting to impose an unrealistic and highly lossy skeleton model. This provides an inherently more reliable result.

   In addition to making better use of the scan provided by the fingerprint reader, the DigitalPersona algorithm benefits from proprietary machine-learning techniques. This improves the results obtained from poor-quality dry, damaged, and minutia-impoverished prints, and blurred or skewed print images. It also eliminates “latent” prints that are left on the platen from the previous time it was used. It is this ability that truly sets the DigitalPersona Recognition Engine apart and makes it clearly superior to a traditional Skeleton Model algorithm.

   The key benefit of the DigitalPersona system is that it brings together ease of use and reliability. The system is entirely rotation-invariant, meaning that the user can put his\her fingerprint onto the fingerprint reader at any angle. It also provides extremely low FAR and FRR as described above – the ultimate test of the system.

Are All Fingerprints Really Unique?

   Underlying all methods of fingerprint identification is the assertion that no two fingerprints are alike. DigitalPersona’s belief in this assertion is based on two fundamental principles:

DigitalPersona – Fingerprint Recognition Page 12

* We know how much information is included in one fingerprint and we can create statistical models around this. There are up to 70 minutia points on each print, and each of these points has 5 characteristics as described above. The chance of finding sets of minutia points that are alike with respect to these characteristics is so small as to be negligible.

* We have almost a century of real-world fingerprint data available to us. F.B.I. files alone contain over 200 million fingerprints, each of which is unique from all the rest. In all the data that has been collected over the past hundred years, using the classification methodologies described above, there have never been two prints that were classified exactly the same.

    Even though we feel confident making the claim of the uniqueness of each fingerprint, there are certain conditions that make it impossible to state with absolute certainty that this is true:

* Every fingerprint is directly affected by the mechanism that is used to collect the print. Even with a manual system of inking the print and physically pressing it onto paper, the degree of pressure, amount of ink and other factors having nothing to do with the print itself affect the information that is gathered. The same holds true for electronic collection mechanisms.

* Because fingerprints are part of living organisms, the biological process is always at work. The physiological characteristics of skin differ depending on race, gender, and life-style. Skin changes over time depending on the lifestyle and activities of the individual.

DigitalPersona – Fingerprint Recognition Page 13

Still, with all these caveats, fingerprints are extremely reliable biometrics which have stood up to the claim of uniqueness for over one hundred years and will continue to do so for as far into the future as we need to project.

History of Fingerprint Identification

   One of the reasons fingerprint identification is so promising is that, unlike iris scanning or other relatively untested biometrics, the U.S. and other countries have extensive real-world experience with fingerprint identification. We are all aware of the use of fingerprint identification in law enforcement. Less well known is the ancient history of fingerprint identification for commerce, and the long history of the “science” of fingerprints in the U.S. and western Europe.

* Pre-historic picture writing found in Nova Scotia shows a hand with ridge patterns.

* In ancient China thumbprints were used on clay seals to prove identity in financial transactions.

1686 Marcello Malpighi, a professor of anatomy at the University of Bologna, wrote about ridges, loops, and spirals in fingerprints.

1823 Professor Purkinji from the University of Breslau described nine basic fingerprint patterns. These pattern descriptors are still used today.

1823 Dr. Henry Faulds wrote an article describing fingerprints as a means of personal identification. He is credited with the first fingerprint identification in law enforcement by obtaining a conviction based on correctly identifying a greasy print left on an alcohol bottle.

DigitalPersona – Fingerprint Recognition Page 14

1882 Gilbert Thompson of the U.S. Geological Survey used his own fingerprint on a document to prevent forgery.

1892 Sir Francis Galton, a British anthropologist, published the first fingerprint classification system and established the individuality and permanence of

fingerprints. The “minutia points” Galton identified are still used today.

1901 Scotland Yard adopted the Galton-Henry fingerprint identification system,

an adaptation of Galton’s observations by Sir Edward Henry, chief

commissioner of the London metropolitan police.

1903 The New York State prison system began the first systematic use of fingerprints in the U.S. for identifying known criminals.

1904 The U.S. Army first began using fingerprints to identify enlisted personnel. 1904 Juan Vucetich of the Buenos Aires police published his system of

fingerprint identification, which helped him identify a murderer by studying

fingerprints left on a door-post. His method is still used today.

1905-1930

Law enforcement agencies across the U.S. turned to fingerprints for personal identification. Many began to send copies of their fingerprint cards to the National Bureau of Criminal Identification established by the International Association of Police Chiefs.

1919 Congress established the Identification Division of the F.B.I. The National Bureau and Leavenworth consolidated their files to form the nucleus of the

DigitalPersona – Fingerprint Recognition Page 15

current F.B.I. fingerprint files. By 1946 the F.B.I had processed 100 million fingerprint cards, and by 1971 it had processed 200 million.

1 Illustrations: J Edgar Hoover, Federal Bureau of Investigation, Department of Justice, Classification of Fingerprints, US Government Printing Office 1939

DigitalPersona – Fingerprint Recognition Page 16

Human Resource Development

Review

http://hrd.sagepub.com/

A Review of Cross-Cultural Training: Best Practices, Guidelines, and Research Needs

Lisa N. Littrell and Eduardo Salas

Human Resource Development Review 2005 4: 305

DOI: 10.1177/1534484305278348

The online version of this article can be found at:

http://hrd.sagepub.com/content/4/3/305

Published by:

http://www.sagepublications.com

On behalf of:

Academy of Human Resource Development

Additional services and information for Human Resource Development Review can be found at:

Email Alerts: http://hrd.sagepub.com/cgi/alerts

Subscriptions: http://hrd.sagepub.com/subscriptions

Reprints: http://www.sagepub.com/journalsReprints.nav

Permissions: http://www.sagepub.com/journalsPermissions.nav

Citations: http://hrd.sagepub.com/content/4/3/305.refs.html

>> Version of Record - Aug 3, 2005

What is This?

Downloaded from hrd.sagepub.com at UNIV DE SAO PAULO BIBLIOTECA on February 21, 2012

Integrative Literature Reviews

A Review of Cross-Cultural Training: Best Practices, Guidelines, and Research Needs

LISA N. LITTRELL

EDUARDO SALAS

University of Central Florida

The purpose of this article is to present the best practices of cross-cultural training (CCT) in terms of what organizations are doing and what they should be doing. In presenting the best practices, the following questions will be investigated: (a) why is CCT an important research domain, (b) what is the general purpose of CCT, (c) how is CCT designed and delivered, (d) which CCT strategies are organizations currently implementing, (e) what guidelines can be offered to organizations offering CCT, and (f) what additional research is needed. This article contributes to existing CCT research by providing a condensed set of guidelines instructing organizations on the techniques necessary for maximizing the benefits of CCT.

Keywords: cross-cultural training; intercultural training; cross-cultural adjustment; expatriate adjustment; expatriate training

During the 1960s and 1970s, cross-cultural research examined multiple-cultural phenomena, covering topics such as expatriate employment, differences between national cultures, and the relationship between culture and motivation. However, although cross-cultural research continued throughout the 1980s, the 1990s saw a surge in the amount of research devoted to cross-cultural training (CCT; Bhawuk & Brislin, 2000). The increasing globalization of the economy was one catalyst for the increased interest in CCT. In addition, research dedicated to cross-cultural issues in the workplace has risen in importance because researchers have been unable to translate their research advances into practice. Specifically, multinational corporations (MNCs) have not yet adopted many of the CCT strategies that researchers propose because cross-cultural researchers have not successfully resolved the controversies surrounding the goals, content, effective

This article was supported in part by a contract from the Leadership Development Research Unit of the U.S. Army Research Institute (Contract# DASW01-03-P-0182) awarded to Aptima and the University of Central Florida.

Human Resource Development Review Vol. 4, No. 3 September 2005 305-334

DOI: 10.1177/1534484305278348

© 2005 Sage Publications

Downloaded from hrd.sagepub.com at UNIV DE SAO PAULO BIBLIOTECA on February 21, 2012

306 Human Resource Development Review / September 2005

ness, implementation, and processes of CCT (Baumgarten, 1995; Brewster, 1995; Selmer, 2001; Selmer, Torbiörn, & de Leon, 1998; Tung, 1982). More important, for today’s MNCs, a condensation of the literature detailing the best practices of CCT, such as what organizations are doing and how their practices can be improved upon, is not yet available.

  Thus, the purpose of this review is fivefold. First, based on a comprehensive literature review of the past 25 years of CCT research, we describe how CCT is typically delivered in organizations. Second, we document the strategies that organizations are currently implementing. Third, we highlight why CCT is still an important research domain. Fourth, the best practices of CCT are presented in terms of what organizations are doing and how it can be done better. Finally, we propose additional research that is needed.

  Ultimately, this article contributes to existing research on CCT by providing practitioners and researchers with a condensed set of research-based guidelines regarding how CCT should be conducted if organizations want to maximize the benefits of CCT. In the past, many suggestions have been offered regarding the design and delivery of CCT. However, these recommendations are often limited in that they usually address only one facet of CCT and are not supported by empirical research. In addition, the past recommendations have been based primarily upon anecdotal information or CCT successes observed in one organization. In combining research from both researchers and practitioners, the research-based guidelines in this article extend existing CCT research.

  In conducting this review, research on CCT, cross-cultural adjustment, and expatriate performance was gathered. Various social-science databases (e.g., PsychInfo, ABI-Inform) were used to conduct searches using the following keywords: cross-cultural training, expatriate training, intercultural training, cross-cultural adjustment, and expatriate adjustment. To be included in the review, the article must have been published within the past 25 years; addressed issues regarding the design, delivery, evaluation, or effectiveness of CCT; or discussed the performance and adjustment issues faced by expatriates. Both theoretical and empirical articles were included. Articles from the domestic training literature were also incorporated. Articles that addressed multicultural training, defined here as training conducted in the home country to make all employees more aware of cultural differences, were excluded.

Why Is CCT Still Important for Organizations?

  Many reasons have been provided over the years as to why research on CCT is still in demand. We focus our discussion on three arguments: the financial loss associated with expatriate assignments, the lack of a conclusive answer regarding the effectiveness of CCT, and the continuing evolution of the workplace toward increased diversity.

Downloaded from hrd.sagepub.com at UNIV DE SAO PAULO BIBLIOTECA on February 21, 2012

Littrell, Salas / BEST PRACTICES 307

  In the past few decades, the number of MNCs has risen, and the number of employees, primarily managers, sent overseas has increased. Although some researchers have argued that expatriate employment has decreased following the events of September 11th, survey results indicate that expatriate employment is continuing to increase (GMAC Global Relocation Services, 2003). Despite the increased use of expatriate employees (Eschbach, Parker, & Stoeberl, 2001; Mervosh & McCleniahan, 1997), expatriates continue to experience difficulties on these foreign assignments, ranging from problems associated with inadequate transfer of managerial practices (Selmer, 2001) to concerns surrounding adjustment to the foreign culture (Caligiuri, Phillips, Lazarova, Tarique, & Bürgi, 2001). The culmination of these difficulties often results in the expatriate’s early return from the assignment. With 10% to 50% of expatriates returning early from their assignments (Eschbach et al., 2001), these difficulties are costly for MNCs, ranging from $250,000 to $1 million (Eschbach et al., 2001; Mervosh & McCleniahan, 1997). Furthermore, expatriate assignments can be viewed as failures even if the expatriate remains in the foreign locale for the duration. For instance, lost opportunities, delayed productivity, and damaged relations may also result in the expatriate assignment being viewed as a failure from the organization’s perspective (R. Bennett, Aston, & Colquhoun, 2000; Selmer et al., 1998). According to the Global Relocation Trends Survey Report (2002), the problem is typically even more disastrous because many expatriates decide to leave their organization within one year of returning to the home country. Thus, more work needs to be done on CCT in an effort to ameliorate the financial ramifications associated with losing an estimated quarter to a million dollars per failure (Mervosh & McCleniahan, 1997; Morris & Robie, 2001) and to reduce the loss of a significant proportion of organizational talent (Gomez-Me jia & Balkin, 1987).

  For decades, cross-cultural researchers have attempted to illustrate to MNCs the role that CCT plays in facilitating the success of an expatriate (Black & Mendenhall, 1990; Tung, 1982). Past estimates of CCT use indicated that the majority of MNCs ignored this advice. For instance, researchers estimated that 70% of U.S. MNCs did not provide their employees with any form of CCT (Black & Mendenhall, 1990). However, the number of companies offering CCT is on the rise in that current estimates indicate that more than 60% of companies offer some form of CCT (R. Bennett et al., 2000). Nonetheless, of those that do offer training, most CCT programs are comprised of one-day debriefing sessions (Bhagat & Prien, 1996; Black, 1988; Deshpande & Viswesvaran, 1992). Many reasons have been offered to explain the neglect or insufficient application of preparatory training, including the short length of time between selection and expatriate departure, the belief that technical competence is the main factor in determining success, the opinion that managers who operate well will be effective

Downloaded from hrd.sagepub.com at UNIV DE SAO PAULO BIBLIOTECA on February 21, 2012

308 Human Resource Development Review / September 2005

regardless of location, the costs associated with training, and the lack of a conclusive answer in regard to the effectiveness of CCT (Baumgarten, 1995; Black & Mendenhall, 1990; Deshpande & Viswesvaran, 1992; Kealey & Protheroe, 1996; Selmer, 2001). Thus, additional CCT research is desperately needed because a definitive answer to the question regarding the effectiveness of CCT has not yet been reached, and the advent of new technology and learning strategies might provide a much-needed infusion of new and more effective delivery methods.

  Finally, the changing nature of the workplace illustrates the need for additional CCT research. Increased organizational diversity, use of multicultural teams, and internationalization of the economy concretely demonstrate the manner in which the world is becoming more cross-cultural. Culture plays a major role in organizational life, from the corner shop to the branch office to world conflict. Culture plays a major role in our lives and our world—it cannot be ignored. To identify, address, and resolve the challenges that will stem from this increasing internationalization of the work environment, business, government, and industry, additional research on CCT is critical.

What Is the Purpose of CCT?

  CCT has been defined as an educative process focused on promoting intercultural learning through the acquisition of behavioral, cognitive, and affective competencies required for effective interactions across diverse cultures (Landis & Brislin, 1996; Morris & Robie, 2001). CCT has been identified as a major technique for improving the cross-cultural effectiveness of managers (Bhagat & Prien, 1996; Bhawuk & Brislin, 2000; Deshpande & Viswesvaran, 1992). CCT differs from traditional training in that the focus is on attitudinal changes rather than on the acquisition of information (Bhagat & Prien, 1996).

  Researchers have agreed that three components are indicative of success on an international assignment: the degree of personal adjustment to the new host environment, the degree of professional effectiveness in accomplishing business responsibilities, and the degree of interpersonal adjustment (Baumgarten, 1995; R. Bennett et al., 2000). Thus, the overall purpose of CCT is to improve an expatriate’s probability of success on the foreign assignment (Baumgarten, 1995; Black & Mendenhall, 1990; Forster, 2000) by equipping the expatriate with the knowledge, skills, and attitudes needed for cross-cultural adjustment, effective on-the-job performance, and interaction with the host nationals (Baumgarten, 1995; R. Bennett et al., 2000; Forster, 2000). More specifically, the ability of a CCT program to facilitate the success of an expatriate assignment requires the development of three types of skills—self-maintenance, interpersonal, and cognitive.

Downloaded from hrd.sagepub.com at UNIV DE SAO PAULO BIBLIOTECA on February 21, 2012

Littrell, Salas / BEST PRACTICES 309

  Because CCT cannot prepare individuals for every situation that they are likely to encounter, one of the primary responsibilities of CCT is to aid the expatriate in learning how to learn (J. Bennett, 1986; Brislin & Bhawuk, 1999). Learning how to learn means that the individual is taught the meta-cognitive strategies needed to engage in self-development processes and continuous learning (J. Bennett, 1986). That is, the individual will need to develop approaches for obtaining information from new stimuli. Essentially, by teaching the expatriate how to learn and acquire information about another culture, the trainee will be able to better understand how to derive information from new situations and respond accordingly (J. Bennett, 1986). Essentially, CCT creates adaptable people by teaching global skills that can be adapted to more specific situations. These individuals are able to take the knowledge learned from the training program and apply it to the multiple-novel situations that are encountered in the daily life of an expatriate.

  In addition to learning how to learn, Brislin and Bhawuk (1999) also advocate that enabling the expatriate to make isomorphic attributions and to handle disconfirmed expectations should be additional goals of a training program. With respect to aiding the expatriate’s ability to make isomorphic attributions, CCT programs aim to teach expatriates how to make approximately the same judgments as host nationals regarding the causes of behavior. Disconfirmed expectations refers to situations in which expatriates expect the host national to engage in a certain form of behavior and then observe an entirely different form of behavior from the host national (Brislin & Bhawuk, 1999). Thus, CCT aims to enable the individual to contemplate why the host nationals did not behave in a certain manner and make isomorphic attributions, rather than making hurried conclusions regarding host national behavior that are often incorrect.

What Components Make Up the Design

and Delivery of Typical CCT Programs?

  In the past, cross-cultural researchers divided training programs into two categories: didactic (information-giving) and experiential learning activities (Kea ley & Protheroe, 1996). However, additional categories are now used to divide CCT activities: didactic, attribution, culture awareness, experiential, cognitive-behavior modification, interaction, and language training (Bhawuk & Brislin, 1999; Kealey & Protheroe, 1996). We examine these next (see Table 1).

Attribution Training

  Expatriate employees often encounter difficulties in the host culture when they attempt to understand the meaning of host national behavior.

Downloaded from hrd.sagepub.com at UNIV DE SAO PAULO BIBLIOTECA on February 21, 2012

310 Human Resource Development Review / September 2005

TABLE 1: Summary of Delivery Strategies

Focus of Training Intervention Potential Strategies

Developing the skills required to make isomorphic Attribution training attributions

Imparting the knowledge needed to understand Culture awareness training cultural differences

Assisting in the development of host-culture Cognitive-behavior

appropriate behaviors modification training

Promoting successful adjustment via on-the-job Interaction training training

Developing the language skills required for everday Language training interactions

Providing the expatriate with information regarding Didactic training living and working conditions

Giving the expatriate the opportunity to practice Experiential training

potential situations to be encountered in the

host culture

Specifically, these expatriates use attribution techniques from their home country in the assignment of meaning to host national behavior. This practice is problematic because behavior is often interpreted differently in different cultures. Thus, attribution training focuses on the development of the attitude and skills necessary for comprising explanations of host national behavior from the host-culture point of view (Befus, 1988). Essentially, the goal of attribution training is to teach expatriates how to make isomorphic attributions that are similar to the attributions made by individuals in the host culture. Thus, the expatriates would be better equipped to interpret behavior in a manner similar to that of host nationals (Bhawuk, 2001; Brislin & Bhawuk, 1999).

Cultural Awareness Training

 Cultural awareness training is based on the assumption that an individual who has a better understanding of his own culture will be more effective in an overseas assignment (J. Bennett, 1986). Thus, the focus of this training strategy is on educating the individual about his or her own culture so that he or she will appreciate the differences between his or her own culture and the culture of the host country (Befus, 1988). By participating in culture-awareness training, expatriates learn to recognize their own values and culture and the contrasts between their own culture and other cultures. Furthermore, expatriates learn how to apply what was learned in an effort to improve the outcomes of their interactions with host nationals (J. Bennett, 1986).

Downloaded from hrd.sagepub.com at UNIV DE SAO PAULO BIBLIOTECA on February 21, 2012

Littrell, Salas / BEST PRACTICES 311

Cognitive-Behavior Modification Training

  Proposed by Black and Mendenhall (1990), cognitive-behavior modification seeks to assist the expatriate in developing the habitual behaviors desired in the host culture (Bhawuk & Brislin, 2000; Brislin & Bhawuk, 1999). Specifically, the training focuses on helping the expatriate to not only identify and avoid the behaviors that will be deemed inappropriate in the host culture but also to teach them behaviors that are typically rewarded in the host culture (Befus, 1988).

Interaction Training

  With interaction training, the incoming expatriate learns from the expatriate whom he or she is replacing (Befus, 1988). These situations are more commonly known as overlaps, and they are a form of on-the-job training. Overlaps are the most popular interactional training strategy used in expatriate preparation. Essentially, the incoming expatriate is sent to the foreign country prior to the departure of the incumbent expatriate (Brewster, 1995). During the time frame in which both expatriates are working in the host country, the experienced expatriate facilitates hands-on training regarding business practices, introduces the new expatriate to key people at work and within the community, and attempts to make the new expatriate’s transition into the host culture easier by showing him how to carry out daily-life tasks.

Language Training

  Language training is not relevant in every assignment, but for those assignments in which the individual is immersed in a culture speaking a foreign language, this type of training is crucial for intercultural adjustment. Although ideal, it is not critical that the individual become fluent in the language. Rather, the training focuses on providing expatriates with the ability to exchange common courtesies in the host language. Host nationals will appreciate these small efforts at speaking the language because it is a demonstration of interest in the host nationals and in the culture in general (Gudykunst, Guzley, & Hammer, 1996). This training is also advantageous because it will improve the expatriate’s on-the-job performance. Learning the host-culture language is crucial because relying on one’s native language reduces the speed with which the individual can process data written in the foreign language, and the expatriate may miss out on crucial pieces of work-related information published in the host-country language (Ashamalla & Crocitto, 1997). Thus, individuals that have at least a rudimentary grasp of the language will be more effective in the new work environment.

Downloaded from hrd.sagepub.com at UNIV DE SAO PAULO BIBLIOTECA on February 21, 2012

312 Human Resource Development Review / September 2005 Didactic

  Didactic, or information-giving, training is one of the most common CCT strategies, and it involves the provision of factual information regarding working conditions, living conditions, and cultural differences (J. Bennett, 1986). Didactic training interventions target many diverse topics, including travel arrangements, job characteristics, shopping, and appropriate dress requirements for work. In addition, information about the political, economic, and cultural conditions of the country is provided in the form of area studies (Kealey & Protheroe, 1996; Morris & Robie, 2001). The enhancement of the cognitive skills that will enable the expatriate to understand the host culture and to possess a framework within which to evaluate the new situations that will be encountered is the main goal of didactic training. Many training techniques are classified as didactic-training activities, but informal briefings, traditional formal educational activities, and culture assimilators are the most popular strategies (Brewster, 1995).

Experiential

  The final CCT strategy to be discussed is experiential training. The main premise of experiential training is that the individual “learn by doing.” Essentially, the expatriate learns by participating in activities that are likely to be encountered during the foreign assignment. For example, an expatriate participates in experiences such as simulations of critical incidents in order to practice alternative responses to situations that are likely to be encountered during the overseas assignments. Experiential learning activities focus on the expatriate developing the skills necessary for performing work functions effectively, for interacting positively with host nationals, and for acquiring the cognitive skills needed to make correct attributions (Kealey & Protheroe, 1996; Morris & Robie, 2001). The intended outcome of this experiential-training intervention will be the improvement of the cross-cultural communication skills necessary for adjustment and the possession of the cross-cultural knowledge needed to determine which option for dealing with various situations will be the most culture-appropriate response (Kealey & Protheroe, 1996; Morris & Robie, 2001). Furthermore, at the conclusion of experiential training, the expatriate should be able to take on a host national’s viewpoint and respond to situations as if he were a member of that culture (Morris & Robie, 2001). A wider variety of training techniques are available for experiential learning, which include look-see visits, role-plays, intercultural workshops, and simulations (Grove & Torbiörn, 1993; Kealey & Protheroe, 1996; Morris & Robie, 2001). However, it is important to note that simulation is merely a tool—a tool for training (Salas, Cannon-Bowers, Rhodenizer, & Bowers, 1999). A number of instructional features need to be embedded in the simulation (Salas, Priest, Wilson

Downloaded from hrd.sagepub.com at UNIV DE SAO PAULO BIBLIOTECA on February 21, 2012

Littrell, Salas / BEST PRACTICES 313

Donnelly, & Burke, in press). Learning will not simply occur by using experiential techniques in training. Thus, practitioners must supplement this tool with appropriate instruction, practice, and feedback techniques.

How Well Do Traditional CCT Practices

Support Expatriates?

  As can be seen from the previous section, many training strategies can be used to deliver CCT. However, the jury is still out regarding whether the CCT strategies that organizations are implementing facilitate expatriate success. Although many training techniques are available and most researchers assert that CCT is a critical component in preparing expatriates for overseas assignments, very little empirical evidence exists to support their claims (Bhagat & Prien, 1996; Black & Mendenhall, 1990; Deshpande & Viswesvaran, 1992; Selmer, 2001).

  Of the few empirical studies that address the effectiveness of CCT, most provide support for the belief that CCT facilitates an expatriate’s success on a foreign assignment (Selmer et al., 1998). For example, cross-cultural adjustment to the host environment has been found to have an impact on the success of the global assignment (Brewster, 1995; Caligiuri et al., 2001). Specifically, research indicates that CCT positively affects adjustability, and that cross-cultural adjustment in turn has a positive relationship with performance and a negative relationship with early return rates (Caliguiri et al., 2001; Deshpande & Viswesvaran, 1992). Thus, this link between CCT and increased cross-cultural adjustment during a foreign assignment provides support for the thesis that CCT is a mechanism for facilitating the effectiveness of expatriate assignments.

  Additional evidence supporting the effectiveness of CCT was provided by a meta-analysis on intercultural training conducted by Black and Mendenhall (1990). A total of 29 studies were examined to determine whether CCT was effective in developing the skills related to maintenance of the self, the skills necessary for interacting with host nationals, and the cognitive skills necessary for cultural awareness. In the studies that addressed self-maintenance skills, all found a positive relationship between CCT and the development of self-confidence and overall feelings of wellbeing. In regard to the studies pertaining to interpersonal skills, a positive relationship was found to exist in all of the studies. Last, of the 16 studies that assessed cognitive perception, a positive relationship between CCT and cognitive skill development was observed in all 16.

  Furthermore, evidence from a more recent meta-analysis conducted by Morris and Robie (2001) provided additional support for the argument that CCT is effective in enhancing the performance of expatriates. Specifically, they investigated the relationship between CCT and the performance. In this

Downloaded from hrd.sagepub.com at UNIV DE SAO PAULO BIBLIOTECA on February 21, 2012

314 Human Resource Development Review / September 2005

study, performance was measured using ratings of cross-cultural skill development, early return rates, and supervisor ratings. In addition, they examined the relationship between CCT and adjustment, which included both work adjustment and general adjustment to the culture. Significant positive relationships were observed between CCT and expatriate performance (r = .26) and between CCT and adjustment (r = .13) (Morris & Robie, 2001). Thus, the results from these two meta-analyses are encouraging. They appear to indicate that CCT is an effective tool for facilitating expatriate success.

CCT “Best Practices”

  As noted earlier, researchers estimate that only 30% of U.S. MNCs provide their employees with CCT (Bhagat & Prien, 1996; Black, 1988; Deshpande & Viswesvaran, 1992). However, this figure may be misleading because the Global Relocation Trends 2002 Survey Report (GMAC Global Relocation Services, 2003) reported that 64% of MNCs deploying expatriates offer some form of CCT. For example, Shell is an organization that has a large expatriate population with an estimated 5,000 expatriates worldwide (Barham, 1991). In Shell’s CCT programs, expatriates undergo a week-long training course upon arrival in the host country. The CCT focuses on assisting the expatriates in understanding the social and business customs (Barham, 1991). Foseco, a subsidiary of Burma h-Castrol, is a large MNC that offers CCT. Foseco offers a variety of workshop sessions covering topics such as multinational team building (Hurn & Jenkins, 2000). Motorola, Inc,. is another organization that offers CCT. In fact, Motorola, Inc., has a special center for CCT that was opened in an effort to make all of its managers multiculturally competent (Harrison, 2002). Furthermore, other companies, such as Du Pont, Ford, Intel, Kodak, Procter & Gamble, and Pharmacia, have introduced CCT to combat the difficulties associated with conducting business in Japan (Barham, 1991). These are just a few examples of the types of organizations offering CCT and of the content of those programs.

  However, upon closer examination of the CCT practices of actual organizations, it has become apparent that the literature regarding what organizations are actually doing in terms of CCT is scarce (see Table 2). Nevertheless, in this section of the article, successful techniques adopted by organizations offering CCT are discussed. The discussion is subdivided into the following sections: design, delivery, and evaluation. After each section, the current CCT best practices extracted from the literature are highlighted.

Downloaded from hrd.sagepub.com at UNIV DE SAO PAULO BIBLIOTECA on February 21, 2012

Littrell, Salas / BEST PRACTICES 315

TABLE 2: Summary of Best Practices

Design Adjust the length of training based upon the unique features of the assignment.

Determine according to organizational and expatriate needs whether cross-cultural training (CCT) should be culture-general or culture-specific.

Offer CCT to expatriates and accompanying family members.

Have the human resource department play a large role in planning and implementing the CCT intervention.

Delivery Use multiple delivery strategies within one training program.

Tailor the delivery strategy according to the goals of the training.

Provide expatriates with online real-time support materials.

Keep international staff members up to date on home organization

issues by bringing them home for periodic meetings.

Provide the expatriate with personalized coaches.

Offer CCT prior to departure, immediately following arrival in the host

country, or at both times.

Evaluation Evaluate the CCT program each time it is implemented.

Use numerous criteria to evaluate success and/or failure.

Conduct surveys to assess the expatriate’s satisfaction with the training

and the overall assignment.

Design

  Organizations have many crucial decisions to make when designing CCT programs. For instance, they must decide whether to offer culture-specific or culture-general training. For example, a large number of expatriates embarking for various destinations can be trained using the culture-general approach. However, many researchers argue that tailoring the CCT for each individual expatriate’s experience is the better approach (Bhawuk, 2001; Brislin & Bhawuk, 1999). Furthermore, organizations must decide which individuals should receive the CCT. For instance, research has revealed that spousal adjustment and satisfaction can influence the expatriate’s satisfaction (Takeuchi, Yun, & Tesluk, 2002; Tung, 1987). Thus, organizations with successful expatriate employment records are offering CCT to the accompanying family members.

  Still other practices pertaining to the design of CCT can be classified as best practices. For instance, organizations whose expatriates are successful compensate their expatriates well (Blassingame, 2001). Corporations offer the expatriate hardship grants, additional paid time off, performance bonuses, overseas differential premiums, moving reimbursements, and automobile and home assistance as a comprehensive compensation plan (Blassingame, 2001; Klaus, 1995). Also, organizations with effective CCT programs involve the human resource department in nearly all levels of the

Downloaded from hrd.sagepub.com at UNIV DE SAO PAULO BIBLIOTECA on February 21, 2012

316 Human Resource Development Review / September 2005

planning and implementation (Halcrow, 1999; Inkson, Arthur, Pringle, & Barry, 1997; Scullion & Brewster, 2001). Furthermore, successful organizations pay close attention to the selection process. Finally, organizations that are typically more successful with expatriate employment convey to their employee that expatriate assignments are valuable to the organization (Scullion & Brewster, 2001). Successful design practices, which are based upon the above-mentioned examples, are listed below.

Design—Best Practices

1. Adjust the length of training based upon the unique features of the assignment.

2. Determine according to organizational needs and expatriate needs whether CCT should be culture-general or culture-specific.

3. Offer CCT to expatriates and to accompanying family members.

4. Have the human resource department play a large role in planning and implementing the CCT intervention.

Delivery

   As illustrated in previous sections, organizations have a wide variety of delivery mechanisms at their disposal. For example, researchers have identified seven approaches to CCT: didactic, attribution, culture awareness, experiential, cognitive-behavior modification, interaction, and language training (Bhawuk & Brislin, 2000; Kealey & Protheroe, 1996). Organizations that have experienced success with CCT programs do not limit themselves to one specific technique. Rather, they employ a variety of techniques within one CCT program. Also, trainers use multiple media for delivery. Specifically, CCT can be provided via written media, via video, or via CD-ROM. Moreover, organizations can offer predeparture, postarrival, or sequential CCT. In addition, organizations with successful CCT programs offer online support for their expatriates so that they can have instant access to information and to boost efficiency while cutting costs (Greengard, 1999). Furthermore, international staff members from organizations with successful CCT programs are kept in the organizational loop by frequently visiting the home office and by being visited by executives from the home office. For instance, Coca Cola flies its international human resources staff to its company headquarters twice a year to provide the employees with updates on philosophies, programs, and policies (Ashamalla, 1998). Finally, CCT can be delivered in tandem with executive coaching for the expatriate. For example, Motorola EMEA has been using executive coaching for certain expatriates for more than 8 years (Garcia, 2003). Coaching is advantageous because it is personalized and because the individual can contact the coach about specific difficulties that he or she is encountering (Mendenhall & Stahl, 2000). Based upon these examples, the delivery best practices are listed below.

Downloaded from hrd.sagepub.com at UNIV DE SAO PAULO BIBLIOTECA on February 21, 2012

Littrell, Salas / BEST PRACTICES 317

Delivery—Best Practices

1. Use multiple delivery strategies within one training program.

2. Tailor the delivery strategy to the goals of the training.

3. Provide expatriates with online real-time support materials.

4. Keep international staff members up to date on home organization issues by bringing them home for periodic meetings.

5. Provide the expatriate with personalized coaches.

6. Offer CCT either prior to departure, immediately following arrival in the host country, or at both times.

Evaluation

   Most CCT evaluation efforts consist solely of identifying whether the expatriate returned early from the assignment. However, companies that have more successful CCT programs use additional criteria for success and failure. For example, delayed productivity and start-up time, disruption of the relationship between the expatriate and host nationals, damage to the MNC’s image, lost opportunities, and problematic repatriation resulting in high turnover rates are all criteria used by organizations offering successful CCT programs (R. Bennett et al., 2000). Furthermore, organizations that implement successful CCT learn from past mistakes. That is, these organizations take the time to evaluate their CCT programs and to look for ways in which they can be improved.

Evaluation—Best practices

1. Evaluate the CCT program each time it is implemented.

2. Use numerous criteria to evaluate success and/or failure.

3. Conduct surveys to assess the expatriate’s satisfaction with the training and the overall assignment.

What Are Organizations Not Doing

That They Should Be Doing?

   Although much progress has been made with respect to CCT, deficiencies still exist and result in ineffective CCT programs. Thus, in the next section, the discussion will center on what organizations are not doing with respect to CCT and what they should be doing. In addition, a set of guidelines regarding the effective implementation of CCT programs will be provided.

Design

   Many difficulties associated with design still plague CCT programs. The effectiveness of CCT programs is often marred by a failure to adequately

Downloaded from hrd.sagepub.com at UNIV DE SAO PAULO BIBLIOTECA on February 21, 2012

318 Human Resource Development Review / September 2005

assess the needs of expatriates (R. Bennett et al., 2000; Bhagat & Prien, 1996; Brewster, 1995; Caligiuri et al., 2001), by the lack of communication regarding the value of culture to other organizational members (Estienne, 1997), by failing to offer CCT to accompanying family members (Black, Gregerson, & Mendenhall, 1992; Takeuchi et al., 2002), by ignoring the requisite knowledge, skills, and abilities (KSAs) (C. Burke et al., in press), and by failing to utilize the vast knowledge domain related to the science of training. Thus, several guidelines can be offered for improving the design of CCT programs.

Guideline 1: CCT Should Be Customized to Match the Expatriate’s Needs

  As argued by Salas and colleagues (1999), the needs-assessment phase of training serves as the foundation of the entire program and thus must focus on analyzing training needs at multiple levels, one of those being a person analysis. The conduction of a needs assessment should be the first step in designing a CCT program. More specifically, the needs assessment should be directed at the needs of the individual expatriate employee. Thus, the strengths and weaknesses with respect to the individual’s interpersonal, cognitive, and self-maintenance skills must be assessed. In addition, other factors that could potentially affect the expatriate’s likelihood of success, such as job characteristics (Black et al., 1992; Ronen, 1989), past international experience (Takeuchi, Tesluk, Yun, & Lepak, 2005), and spousal accompaniment (Birdseye & Hill, 1995) should be identified. Based upon the findings from the needs assessment, the training program should be customized to meet the individual expatriate’s needs (R. Bennett et al., 2000; Caligiuri et al., 2001).

Guideline 2: CCT Should Not Stand Alone

  Training alone is not sufficient for ensuring the success of expatriates. In surveys conducted to identify factors that influence expatriate satisfaction, results have revealed that expatriates and accompanying family members often desire assistance outside the realm of traditional CCT programs (Eschbach et al., 2001). Because training is not the only option for improving expatriate performance, destination services, competitive compensation, and performance-management systems promoting intercultural-competency development are just some of the human resource interventions that could be paired with CCT (R. Bennett et al., 2000). For instance, organizations that have been classified as successfully conducting CCT hire relocation specialists to assist the expatriate with details such as finding a home in the overseas country. Furthermore, successful organizations require future expatriates to meet with tax consultants to cover the company’s tax

Downloaded from hrd.sagepub.com at UNIV DE SAO PAULO BIBLIOTECA on February 21, 2012

Littrell, Salas / BEST PRACTICES 319

reimbursement procedures (Klaus, 1995; Oddou, 1991). However, future research is needed to examine how these interventions should be designed and how they should be coupled with CCT programs.

Guideline 3: Training Rigor Should Be Tailored

to the Cultural Toughness of the Destination Country

  Cultural toughness and training rigor have also been identified as factors that may have an impact upon the relationship between CCT and overseas performance. Cultural toughness pertains to the notion that it is much more difficult to adjust to certain countries than it is to adjust to other countries (Black et al., 1992). Cultural toughness hinders cross-cultural adjustment in that the greater the cultural differences between the country of origin and the destination location, the greater the difficulty the expatriate will experience when interacting and working in the new environment (Bhagat & Prien, 1996).

  Training rigor is related to cultural toughness because training rigor refers to the degree of mental involvement and effort that must be expended in learning the training materials (Black et al., 1992; Chadwin, Rogers, & Kim, 1995). Training rigor influences the training method and the amount of time spent on training. If CCT programs tailor the training rigor to the cultural toughness of the destination country, the likelihood of the expatriate performing effectively on the overseas assignment will be improved.

Guideline 4: MNCs Should Develop a Global Mindset

  CCT is embedded in an organization. Research from the domestic training literature has revealed that training is one component of a larger organizational system. Specifically, Kozlowski and Salas (1997) argue that organizations are open to external influences and thus subsystems within the organization are also vulnerable to these influences. Thus, it is important to remember that CCT is part of a larger framework that is susceptible to both organizational and external factors.

  In addition, researchers have argued that expatriates fail on overseas assignments because culture is seen as something separate from the organization (Estienne, 1997). However, if organizations wish to maximize the success of their CCT endeavors, then it is critical that they create a global mindset for the entire organization, not just for the future expatriates. Estienne (1997) defines a global mindset as “a willingness to learn and an ability to adapt” (p. 15). An international mindset is beneficial to CCT programs for two reasons. First, the idea of cultural diversity will not be an entirely new phenomenon to the expatriates, and they will have already developed skills necessary for successful interaction in a culturally diverse

Downloaded from hrd.sagepub.com at UNIV DE SAO PAULO BIBLIOTECA on February 21, 2012

320 Human Resource Development Review / September 2005

work environment. Second, the host country subsidiary will also have a global mindset, and they will be more likely to accept the expatriate and understand that differences in behavior can be attributed to cultural differences. A company-wide international mindset can be accomplished through multicultural training. For instance, Elashmawi (2000) argues that organizations that are successful in administering CCT provide all employees with multicultural training.

Guideline 5: Organizations Must Use a Skill-Based

Approach When Designing CCT

  Few CCT-tra in in g programs are skill-based; instead, they are focused on building awareness of the expatriate’s own culture and the culture of the host country. Although building cultural awareness is crucial for familiarization with the new culture, Burke and colleagues (in press) illustrate that building cultural awareness may not be a strong enough intervention to ensure that expatriates will have the tools necessary for cross-cultural interaction. The acquisition of knowledge does not guarantee that the expatriate will apply the appropriate principles, and expatriates need to be provided with the skills that enable them to interact effectively in the host country.

  Designing a skill-based model of CCT requires that the organization first conduct a cognitive task analysis (CTA). The aim of a CTA is to identify the mental activities that are needed to successfully perform a given task (Schraagen, Chipman, & Shalin, 2000; Wei & Salvendy, 2004). The CTA will enable the organization to identify the competencies required for successful performance in all facets of the overseas assignment. Once these critical competencies have been identified, CCT can be structured so that the learning objectives focus on developing the identified requisite KSAs.

Guideline 6: MNCs Should Apply and Use Strategies Based

on the Science of Training in Designing CCT Programs

  In a recent article, Salas and Cannon-Bowers (2001) argued that training of any kind must be based in science. They posit that the learning that has resulted from the past two decades of training research can be organized around four crucial training elements: tools, competencies, methods, and instructional strategies. This framework should be used in designing CCT programs in order to ensure that CCT is conducted in a systematic and scientific manner. Although most CCT programs address one of these four critical elements, the effectiveness of CCT programs will be maximized if all elements are included in the design and delivery of CCT.

Downloaded from hrd.sagepub.com at UNIV DE SAO PAULO BIBLIOTECA on February 21, 2012

Littrell, Salas / BEST PRACTICES 321

Guideline 7: Scenario-Based Training Should Be Implemented

  Scenario-based training is a training strategy that would be beneficial to CCT practitioners. Developing expert performers is the goal of scenario-based training. Controlled exercises are used to provide trainees with cues similar to those likely to be encountered in a real-world environment (Salas, Cannon-Bowers, & Kozlowski, 1997). Specifically, scenario-based techniques are used to design training opportunities through the systematic identification and introduction of events within training exercises that provide known opportunities to observe trainee behavior (Fowlkes, Dwyer, Oser, & Salas, 1998). Then, the trainees are given feedback regarding their responses to these cues (Cannon-Bowers, Burns, Salas, & Pruitt, 1998).

  The addition of scenario-based training to CCT programs would be beneficial because it is both theory- and practice-based and offers trainers more control over what is being trained and how it is being presented (Oser, Gualtieri, Cannon-Bowers, & Salas, 1999). This practice-based intervention may be particularly beneficial in overcoming cross-cultural issues, such as culture shock, because participants can practice interacting with individuals from other cultures and receive focused feedback on their training performance. Furthermore, numerous opportunities for practice are offered that can be used to provide trainees with multiple learning opportunities. Thus, scenario-based training should be used in CCT programs to provide trainees with multiple, scripted opportunities to practice and learn from cross-cultural situations likely to be encountered on the foreign assignment.

Delivery

  As illustrated in the above-section, many design problems undermine the success of CCT programs. The problems associated with the delivery of CCT are much less numerous. The main difficulty associated with CCT delivery pertains to the timing of CCT. In fact, a current debate exists in the expatriation literature as to whether predeparture or postarrival training will be most effective in fostering the development of the skills required for success (R. Bennett et al., 2000; Black & Mendenhall, 1990; Selmer, 2001).

Guideline 8: Training Delivery Should Correspond

to the Dynamic Adjustment Process

  Predeparture training is the CCT practice that most MNCs adopt (Forster, 2000; Rahim, 1983; Selmer, 2001; Selmer et al., 1998). Proponents of predeparture CCT assert that training is most effective when conducted prior to departure for the foreign locale (Caligiuri et al., 2001; Forster, 2000) because the expatriate is able to form more realistic expectations of

Downloaded from hrd.sagepub.com at UNIV DE SAO PAULO BIBLIOTECA on February 21, 2012

322 Human Resource Development Review / September 2005

the host culture and work environment. On the other side of the debate stand the researchers who argue that postarrival training will be more effective. They prefer postarrival training because the training programs can address real-time issues—the issues that are prompted by experiences in the actual culture (R. Bennett et al., 2000). Unfortunately, it is unclear as to whether predeparture or postarrival is the best method for administering CCT programs.

  A new model of CCT has been proposed to encompass the advantages of both predeparture and postarrival training—the sequential model of adjustment (Selmer et al., 1998). These researchers proposed that CCT training programs should be structured to correspond to the cycle of adjustment that most individuals progress through in foreign cultures. The model is based on the assumption that the impact of training differs throughout the various phases of the foreign assignment in that the individual will be more psychologically receptive to training interventions at certain stages in the expatriate assignment (Selmer et al., 1998). Thus, training should not be solely offered predeparture or postarrival. Rather, it should be offered predeparture, postarrival, and after return to the home country.

Guideline 9: The Difficulties Surrounding Repatriation Should Be Addressed

  Repatriation refers to the experiences surrounding the return of an expatriate to his or her home environment following the completion of an overseas assignment. Repatriation is a critical factor in measuring the success or failure of a CCT program (Gomez-Me jia & Balkin, 1987; Martin & Harrell, 1996) because turnover rates indicate that many expatriates that complete their entire foreign assignment leave the organization within one year (GMAC Global Relocation Trends Survey Report, 2002). Many reasons are cited as influencing the decision to leave the organization. Lower levels of responsibility, less prestige, feelings of alienation, restricted career opportunities, and salary reductions play critical roles in determining the level of satisfaction and overall adjustment that the expatriate experiences (Gomez-Me jia & Balkin, 1987; Martin & Harrell, 1996). Individuals leaving the organization following the completion of an expatriate assignment are costly to the organization because the MNC loses its top executives, the expertise that the individual gained by working overseas, and the money attributed to training and turnover. Therefore, a successful CCT program should include measures, such as offering position choices upon return and family repatriation support, which facilitate the repatriation process (Gomez-Me jia & Balkin, 1987; Martin & Harrell, 1996).

Downloaded from hrd.sagepub.com at UNIV DE SAO PAULO BIBLIOTECA on February 21, 2012

Littrell, Salas / BEST PRACTICES 323

Guideline 10: Multiple Media Strategies Should Be Used to Deliver CCT

  Using multiple-delivery strategies was listed as one of the best practices regarding the delivery of CCT because different training approaches may be more appropriate for delivering certain types of CCT. The use of multiple media in conjunction with multiple-delivery strategies (e.g., didactic, attribution, experiential) should further increase the effectiveness of CCT. Multiple media refers to the many tools that are available for delivering CCT. For example, CCT can be delivered using written media, video, CD-ROM, or the Internet. Each type of media may be more or less suitable for delivering certain aspects of the training. For instance, the written and video media may be the best tools for providing information to expatriates about the characteristics of the host country culture (i.e., didactic and culture-awareness training). However, CD-ROM s (e.g., Bridging Cultures, The Culture Compass) may be more appropriate for the self-development portion of training (Mendenhall & Stahl, 2000). These CD-ROM s give expatriates the opportunity to practice in simulated intercultural situations and receive feedback on their performances, and they may be more suitable for experiential and attribution training. Furthermore, online, real-time Internet-training programs may be most beneficial for answering questions that arise in everyday interactions. Rather than attempting to get in touch with a former trainer or current expatriate coach via e-mail or telephone, the expatriate can peruse the site to look for answers to his questions or chat live with an expert on intercultural sojourns. Thus, the success of a CCT program would be enhanced if the most suitable media were used to deliver different portions of the training.

Evaluation

  Another major shortcoming of CCT research and practice is that CCT programs are not adequately evaluated. With the many potential moderators that may influence the relationship between CCT and expatriate performance, the failure to evaluate CCT programs will hinder the improvement of CCT programs.

Guideline 11: Organizations Must Establish Success Criteria for CCT Programs

  Inconsistencies in classifying effective performance make it difficult to evaluate the success of CCT programs. No one definition of what constitutes success on an expatriate assignment exists (Brislin, 1999; Church, 1982; Deshpande & Viswesvaran, 1992). Although most measures of success and/ or failure in expatriate assignments are based upon the expatriate’s early return to the home country, several other indications of failure exist (R. Bennett et al., 2000): inadequate transfer of managerial practices (Earley &

Downloaded from hrd.sagepub.com at UNIV DE SAO PAULO BIBLIOTECA on February 21, 2012

324 Human Resource Development Review / September 2005

Peterson, 2004; Rahim, 1983; Selmer, 2001); adjustment difficulties (Caligiuri et al., 2001); lost opportunities, delayed productivity, and damaged relations (R. Bennett et al., 2000; Selmer et al., 1998); and leaving the organization following return (Gomez-Me jia & Balkin, 1987). With the many operational definitions regarding success and failure, it has been difficult for researchers to compare results across studies and to compile studies for use in meta-analyses. Furthermore, it has been difficult for organizations to evaluate the success of their CCT programs. Thus, MNCs must establish during the design phase the criteria that are indicative of either success or failure on an expatriate’s assignment.

Guideline 12: Organizations Must Evaluate Whether

the Learning from CCT has Transferred to the Job

  Transfer of training is defined as the degree to which trainees effectively apply the KSAs gained in training when they return to the job (Baldwin & Ford, 1988). A training program cannot be viewed as successful unless the trainees are able to bring their newly acquired KSAs back to the workplace. For instance, even if an expatriate learns the skills that he needs for interacting in novel cultural situations, he must apply those skills on the job and during interactions with host nationals. If he is unable to apply these new skills, his performance and adjustment will be hindered. Thus, not only must organizations assess what the expatriate learned at the end of training, they must also assess whether the expatriate applied the learning. That is, organizations must discern whether unsuccessful overseas performance is due to inadequate preparation or to unsuccessful application of the KSAs acquired in training. If the unsuccessful performance is deemed to be the result of inadequate application of training, then the organization must examine the environmental constraints that prevented the transfer of training.

Guideline 13: Organizations Must Assess Whether the Investment in CCT Yields Positive Organizational Outcomes

  Goldstein (1991) stated that the training evaluation process is comprised of two key procedures—establishing criteria for success and determining what change the training program has brought about. Thus, the final guideline to be offered with respect to training pertains to whether CCT resulted in some sort of benefit for the organization. Recent meta-analyses have provided empirical evidence indicating that CCT is an effective form of preparation for enhancing an expatriate’s success on overseas assignments (Black & Mendenhall, 1990; Deshpande & Viswesvaran, 1992; Morris & Robie, 2001). However, the correlations found in these meta-analyses were small, and thus, it would benefit organizations to examine whether CCT is effective for them. For instance, organizations need to assess whether the training

Downloaded from hrd.sagepub.com at UNIV DE SAO PAULO BIBLIOTECA on February 21, 2012

Littrell, Salas / BEST PRACTICES 325

is in fact resulting in increased performance and adjustment. In addition, they should conduct a return-on-investment (ROI) analysis of the impact of training (Kealey & Protheroe, 1996). Information from the ROI analysis could be used to identify problems within the training program and be used to redesign training. Furthermore, a positive ROI analysis could be used to convince organizational stakeholders and future expatriates of the value of CCT (see Table 3).

Implications for Future Research

  Although a great deal of CCT research has been conducted, the synthesis of this research revealed that CCT research opportunities are abundant. In the remainder of this article, we focus on three areas that need research.

Multicultural Team Training

  Multicultural teams consist of two or more individuals from different national cultures that interact interdependently and adaptively while working toward a common goal (Salas, Burke, Fowlkes, & Wilson, 2004). These individuals may be colocated in the same office, or the team members may be distributed all around the world. Multicultural teams face unique challenges because they make decisions in complex and uncertain environments (Burke et al., in press). Specifically, lower levels of cohesion and trust, misinterpretation and loss of communication, and increased use of inappropriate stereotypes in assigning attributes have all been offered as difficulties contributing to the experienced process loss of multicultural teams (Bing & Bing, 2001; Burke et al., in press; Burns, 2002; Laroche, 2001; Salas et al., 2004).

  Therefore, the need for intercultural training is not unique to expatriate employees. Organizations are consistently finding themselves in situations in which they must deploy a team with individuals from diverse cultural backgrounds to solve problems or accomplish objectives. Given the difficulties team members face when interacting with individuals from one national culture, it is likely that individuals on multicultural teams will face additional challenges. Thus, cultural training research must broaden its scope to include an investigation into training requirements of diverse teams.

  Training for multicultural teams is one solution that may alleviate the frustrations and problems associated with multicultural teamwork. A vast amount of research is available on domestic and cross-cultural training for expatriates, but the research on training for multicultural teams is sparse. Thus, additional research on intercultural training is necessary to not only improve the performance of individuals but is also needed to identify the training strategies and interventions that would be most beneficial for preparing multicultural teams to interact effectively in uncertain environments.

Downloaded from hrd.sagepub.com at UNIV DE SAO PAULO BIBLIOTECA on February 21, 2012

TABLE 3: Summary of Guidelines

#2: CCT should not stand alone. Include destination services, competitive compensation, and performance management systems Evaluate the benefits associated with the combination of supplemental efforts and CCT

#3: Training rigor should be tailored Cultural toughness—more difficult to adjust to certain

to the cultural toughness of the countries.

destination country. Training rigor—effort that must be expended

Provide more rigorous training for more culturally tough destinations

#4: Multinational Corporations CCT influenced by internal and external factors.

(MNCs) should develop a global Culture should not be separate from the organization.

mindset. Provide all employees with multicultural training

#5: Organizations must use a skill-based approach when designing CCT.

#6: MNCs should use strategies from the science of training in designing CCT programs.

#7: Scenario-based training should be implemented.

Delivery

#8: Training delivery should correspond to the dynamic adjustment process.

#9: The difficulties surrounding repatriation should be addressed.

#10: Multiple media should be used to deliver CCT.

Cognitive task analysis must be conducted.

Learning objectives focused on developing requisite knowledge, skills, and abilities (KSAs).

Training of any kind must be based in science. Training objectives drive all aspects of the training.

Expert performance is characterized by the reliance on situational cues to trigger well-organized memories. Scenario-based training systematically links all aspects of scenario design, implementation, and analysis.

Scenario-based training offers numerous opportunities for practice.

Training is a process.

Link training delivery with the cycle of adjustment

High turnover rates upon return.

Pay attention to career advancements and expatriate

responsibility.

Provide repatriation support for family.

Written media, video, CD-ROM, Internet.

Match media to training type.

(continued)

TABLE 3 (continued)

Guidelines Key Points Sources

Evaluation

#11: Organizations must establish success criteria for CCT programs.

#12: Organizations must evaluate whether learning from CCT is transferred to the job.

#13: Organizations must assess whether the investment in CCT yields positive organizational outcomes.

Inconsistencies in classifying effective performance

 make it difficult to evaluate CCT programs. MNCs must establish criteria that are indicative of

either success of failure.

Involves the application of KSAs acquired in CCT. May provide clue regarding expatriate performance. May reveal environmental constraints

Assess whether CCT works for own organization. Use return-on-investment analysis to convince organizational stakeholders of the value of CCT.

Littrell, Salas / BEST PRACTICES 329

Adaptability

  Adaptability is another topic that is on the frontier of CCT research. Research is needed on what makes individuals adaptable. How people adapt and what cues they use or what variables influence whether they will adapt to novel environments is needed. We need better and richer theories on not only individual but team adaptation to develop more adaptable people.

Culture and Personality

  In the course of this review, it became obvious that the trends in CCT research are shifting. In the past, research efforts were aimed at investigating whether CCT is effective and identifying the best strategies for designing and delivering it. However, researchers have begun to explore the links between individual differences, cross-cultural adjustment, and CCT and the manner in which this information can be used to improve the delivery of CCT. For example, researchers have recently begun to draw on personality research to explain why some expatriates adjust more successfully to cross-cultural environments and exhibit higher levels of overseas performance. For instance, results from a concurrent validity study revealed that conscientiousness, extraversion, emotional stability, openness to experience, and agreeableness were negatively related to an expatriate’s desire to prematurely return to his home country (Caligiuri, 2000). In addition, Lievens, Harris, Van Keer, and Bisqueret (2003) observed that openness to experience was significantly related to CCT performance, and cognitive ability was significantly related to language acquisition. Recent empirical research has also revealed that additional individual differences variables, such as self-monitoring (Harrison, Chadwick, & Scales, 1996), self-efficacy (Black, Mendenhall, & Oddou, 1991; Mak & Tran, 2001), and cultural sensitivity (Paige, Jacobs-Cass uto, Yershova, & DeJaeghere, 2003) may be related to cross-cultural performance and adjustment. Based upon the above-mentioned research, it appears that individual-differences variables account for some of the differences in expatriate performance in CCT and in the overseas environment. Additional research in this area is needed to identify whether individual differences interact with training to influence expatriate performance. That is, researchers must examine whether expatriates with certain personalities will benefit more from one type of training or delivery strategy. Furthermore, researchers must identify why individuals with certain personality traits are more successful on overseas assignments. If the processes that successful expatriates engage in are identified, training content and delivery can be tailored to facilitate the development of the skills and behaviors related to these processes.

Downloaded from hrd.sagepub.com at UNIV DE SAO PAULO BIBLIOTECA on February 21, 2012

330 Human Resource Development Review / September 2005

Conclusion

  It is apparent that a vast quantity of research has been conducted on CCT in the past 25 years. It is evident that researchers thus far have done an excellent job in presenting the features of CCT, in examining the various types of delivery mechanisms, and in suggesting theoretical frameworks for explaining how and why CCT works. However, it is apparent that the research has not been synthesized and thus CCT has not provided practitioners and MNCs with a great quantity of new recommendations. This lack of synthesis in the area of CCT research has made it difficult for practitioners to pick out concise, complete recommendations regarding how CCT should be implemented.

  Thus, this article contributes to the existing literature on CCT by providing researchers and practitioners with a detailed synthesis of the best practices of CCT in terms of what organizations can do, what they are doing, and how it can be done better. In addition, research-based guidelines were offered as to how MNCs can enhance the success of their CCT programs via selection, design, and delivery. Furthermore, suggestions for future research in the areas of multicultural-team training, adaptability, and individual differences were offered.

References

Ashamalla, M. H. (1998). International human resource management practices: The challenge of expatriation. Competitiveness Review, 8, 54-65.

Ashamalla, M. H., & Crocitto, M. (1997). Easing entry and beyond: Preparing expatriates and patriates for foreign assignment success. International Journal of Commerce & Management, 2, 106-114.

Baldwin, T. T., & Ford, J. K. (1988). Transfer of training: A review and directions for future research. Personnel Psychology, 41, 63-105.

Barham, K. (1991). Developing the international manger. Journal of European Industrial Training, 15, 12-16.

Baumgarten, K. (1995). Training and development of international staff. In A. W. Harzing & J. Van

   Ruysseveldth (Eds.), International Human Resource Management (pp. 205-228). London: Sage. Befus, C. P. (1988). A multilevel treatment approach for culture shock experience by sojourners.

International Journal of Intercultural Relations, 12, 381-400.

Bennett, J. M. (1986). Modes of cross-cultural training: Conceptualizing cross-cultural training as education. International Journal of Intercultural Relations, 10, 117-134.

Bennett, R., Aston, A., & Colquhoun, T. (2000). Cross-cultural training: A critical step in ensuring the success of international assignments. Human Resource Management, 39, 239-250.

Bhagat, R., & Prien, K. O. (1996). Cross-cultural training in organizational contexts. In D. Landis & R. S. Bhagat (Eds.), Handbook of intercultural training (2nd ed., pp. 216-230). Thousand Oaks, CA: Sage.

Bhawuk, D.P.S. (2001). Evolution of culture assimilators: Toward theory-based assimilators. International Journal of Intercultural Relations, 25, 141-163.

Bhawuk, D.P.S., & Brislin, R. W. (2000). Cross-cultural training: A review. Applied Psychology: An International Review, 49, 162-191.

Downloaded from hrd.sagepub.com at UNIV DE SAO PAULO BIBLIOTECA on February 21, 2012

Littrell, Salas / BEST PRACTICES 331

Bing, J. W., & Bing, C. W. (2001). Helping global teams compete. Training and Development, 55, 70-71.

Birdseye, M. G., & Hill, J. S. (1995). Individual, organizational/work, and environmental influences on expatriate turnover tendencies: An empirical study. Journal of International Business Studies, 26, 787-813.

Black, J. S. (1988). Work role transitions: A study of American expatriate mangers in Japan. Journal of International Business Studies, 19, 277-294.

Black, J. S., Gregersen, H. B., & Mendenhall, M. E. (1992). Global assignments: Successfully expatriating and repatriating international managers. San Francisco: Jossey-Bass.

Black, J. S., & Mendenhall, M. E. (1990). Cross-cultural training effectiveness: A review and a theoretical framework for future research. Academy of Management Review, 15, 113-136.

Black, J. S., Mendenhall, M., & Oddou, G. (1991). Toward a comprehensive model of international adjustment: An integration of multiple theoretical perspectives. Academy of Management Review, 16, 291-317.

Blassingame, K. M. (2001). ‘C’ change recommended for expat management. Employee Benefit News, 15, 11-14.

Brewster, C. (1995). Effective expatriate training. In J. Selmer (Ed.), Expatriate management: New ideas for international business (pp. 57-71). Westport, CT: Quorem.

Brislin, R. (1999). Communicating information about culture and personality in formal cross-cultural training programs. In Y. T. Lee, C. R. McCauley, & J. G. Draguns (Eds.), Personality and person perception across cultures (pp. 255-277). Mahwah, NJ: Lawrence Erlbaum.

Brislin, R. W., & Bhawuk, D.P.S. (1999). Cross-cultural training: Research and innovations. In J. Adamopoulos & Y. Kashima (Eds.), Social psychology and cultural context (pp. 205-216). Thousand Oaks, CA: Sage.

Burke, C. S., Hess, K., Salas, E., Priest, H., Paley, M., & Riedel, S. (in press). Preparing leaders for complex environments: The leadership of multicultural teams. In R. Hoffman (Ed.), Expertise out of context. Mahwah, NJ: Lawrence Erlbaum.

Burns, P. (2002). Communication training for IT intercultural work groups: The significance of prepositions. Information Executive, 6, 4-13.

Caliguiri, P. M. (2000). The big five personality characteristics as predictors of expatriate’s desire to terminate the assignment and supervisor-rated performance. Personnel Psychology, 53, 67-88.

Caligiuri, P., Phillips, J., Lazarova, M., Tarique, I., & Bürgi, P. (2001). The theory of met expectations applied to expatriate adjustment: The role of cross-cultural training. International Journal of Human Resource Management, 12, 357-372.

Cannon-Bowers, J. A., Burns, J. J., Salas, E., & Pruitt, J. S. (1998). Advanced technology in

scenario-based training. In J. A. Cannon-Bowers & E. Salas (Eds.), Making decisions under

   stress: Implications for individual and team training (pp. 365-374). Washington, DC: APA. Church, A. T. (1982). Sojourner adjustment. Psychological Bulletin, 91, 540-572.

Deshpande, S. P., & Viswesvaran, C. (1992). Is cross-cultural training of expatriate managers effective: A meta analysis. International Journal of Intercultural Relations, 16, 295-310.

Earley, P. C., & Peterson, R. S. (2004). The elusive cultural chameleon: Cultural intelligence as a new approach to intercultural training for the global manager. Academy of Management Learning and Education, 3, 100-115.

Elashmawi, F. (2000). How to manage across cultures. People Management, 30, 52-53.

Eschbach, D. M., Parker, G. E., & Stoeberl, P. A. (2001). American repatriate employees’retrospec-tive assessments of the effects of cross-cultural training on their adaptation to international assignments. International Journal of Human Resource Management, 12, 270-287.

Estienne, M. (1997). The art of cross-cultural management: An alternative approach to training and development. Journal of European Industrial Training, 21, 14-18.

Forster, N. (2000). Expatriates and the impact of cross-cultural training. Human Resource Management Journal, 10, 63-78.

Downloaded from hrd.sagepub.com at UNIV DE SAO PAULO BIBLIOTECA on February 21, 2012

332 Human Resource Development Review / September 2005

Fowlkes, J., Dwyer, D. J., Oser, R. L., & Salas, E. (1998). Event-based approach to training. The International Journal of Aviation Psychology, 8, 209-221.

Garcia, K. (2003). Coaching for expats: The latest trend? Retrieved March 12, 2003, from http:// www.expatica.com

GMAC Global Relocation Services, National Foreign Trade Council, & SHRM Global Forum. (2003). Global relocation trends 2002 survey report. Woodridge, IL: Author.

Goldstein, I. L. (1991). Training in work organizations. In M. D. Dunnette, & L. M. Hough (Eds.), Handbook of industrial and organizational psychology (Vol. 2). Palo Alto, CA: Consulting Psychologists Press.

Gomez-Mejia, L., & Balkin, D. B. (1987). The determinants of managerial satisfaction with the expatriation and repatriation process. Journal of Management Development, 6, 7-17.

Greengard, S. (1999). Technology is changing expatriate training. Workforce, 78, 106-107.

Grove, C., & Torbiörn, I. (1993). A new conceptualization of intercultural adjustment and the goals of training. In R. M. Paige, Education for the intercultural experience. Yarmouth, ME: Intercultural Press.

Gudykunst, W. B., Guzley, R. M., & Hammer, M. R. (1996). Designing intercultural training. In D. Landis & R. W. Brislin (Eds.), Handbook of intercultural training (2nd ed., pp. 61-80). Thousand Oaks, CA: Sage.

Halcrow, A. (1999). Expats: The squandered resource. Workforce, 78, 42-48.

Harrison, J. K. (2002). Developing successful expatriate managers: A framework for the structural design and strategies alignment of cross-cultural training programs. Human Resource Planning, 17, 17-35.

Harrison, J. K., Chadwick, M., & Scales, M. (1996). The relationship between cross-cultural adjustment and the personality variables of self-efficacy and self-monitoring. International Journal of Intercultural Relations, 20, 167-188.

Hurn, B. J., & Jenkins, M. (2000). International peer group development. Industrial and Commercial Training, 32, 128-131.

Inkson, K., Arthur, M. B., Pringle, J., & Barry, S. (1997). Expatriate assignment versus overseas experience: Contrasting models of international human resource development. Journal of World Business, 32, 351-368.

Kealey, D. J., & Protheroe, D. R. (1996). The effectiveness of cross-cultural training for expatriates: An assessment of the literature on the issue. International Journal of Intercultural Relations, 20, 141-165.

Klaus, K. J. (1995). How to establish an effective expatriate program—Best practices in international assignment administration. Employment Relations Today, 22, 59-70.

Kozlowski, S.W.J., & Salas, E. (1997). A multilevel organizational systems approach for the implementation and transfer of training. In J. K. Ford & Associates (Eds.), Improving training effectiveness in work organizations (pp. 247-287). Hillsdale, NJ: LEA.

Landis, D., & Brislin, R. W. (Eds.). (1996). Handbook of intercultural training (2nd ed.). Thousand Oaks, CA: Sage.

Laroche, L. (2001). Teaming up. CMA Management, 75, 22-25.

Lievens, F., Harris, M. M., Van Keer, E., & Bisqueret, C. (2003). Predicting cross-cultural training performance: The validity of personality, cognitive ability, and dimensions measured by an assessment center and a behavior description interview. Journal of Applied Psychology, 88,476489.

Mak, A. S., & Tran, C. (2001). Big five personality and cultural relocation factors in Vietnamese Australian students’ intercultural social self-efficacy. International Journal of Intercultural Relations, 25, 181-201.

Martin, J. N., & Harrell, T. (1996). Reentry training for intercultural sojourners. In D. Landis, & R. W. Brislin (Eds.), Handbook of intercultural training (2nd ed., pp. 307-326). Thousand Oaks, CA: Sage.

Downloaded from hrd.sagepub.com at UNIV DE SAO PAULO BIBLIOTECA on February 21, 2012

Littrell, Salas / BEST PRACTICES 333

Mendenhall, M. E., & Stahl, G. K. (2000). Expatriate training and development: Where do we go from here? Human Resource Management, 39, 251-265.

Mervosh, E. M., & McCleniahan, J. S. (1997, December). The care and feeding of expats. Industry Week, 69-72.

Morris, M. A., & Robie, C. (2001). A meta-analysis of the effects of cross-cultural training on expatriate performance and adjustment. International Journal of Training and Development, 5,112125.

Oddou, G. R. (1991). Managing your expatriates: What the successful firms do. Human Resource Planning, 14, 301-309.

Oser, R. L., Cannon-Bowers, J. A., Salas, E., & Dwyer, D. J. (1999). Enhancing human performance in technology-rich environments: Guidelines for scenario-based training. Human/Technology Interaction in Complex Systems, 9, 175-202.

Oser, R. L., Gualtieri, J. W., Cannon-Bowers, J. A., & Salas, E. (1999). Training team problem solving skills: An event-based approach. Computers in Human Behavior, 15, 441-462.

Paige, R. M., Jacobs-Cassuto, M., Yershova, Y. A., & DeJaeghere, J. (2003). Assessing intercultural sensitivity: An empirical analysis of the Hammer and Bennett Intercultural Development Inventory. International Journal of Intercultural Relations, 27, 467-486.

Rahim, A. (1983). A model for developing key expatriate executives. Personnel Journal, 62, 312317.

Ronen, S. (1989). Training the international assignee. In R. A. Katzell (Ed.), Training and development in organizations (pp. 417-453). San Francisco: Jossey-Bass.

Salas, E., Burke, C. S., Fowlkes, J. E., & Wilson, K. A. (2004). Challenges and approaches to understanding leadership efficacy in multi-cultural teams. Cultural ergonomics: Advances in human performance and cognitive engineering research, 4, 341-384.

Salas, E., & Cannon-Bowers, J. A. (2001). The science of training: A decade of progress. Annual Review of Psychology, 52, 471-499.

Salas, E., Cannon-Bowers, J. A., & Kozlowski, S.W.J. (1997). The science and practice of training— Current trends and emerging themes. In J. K. Ford, S.W.J. Dozlowski, K. Kraiger, E. Salas, & M. S. Teachout (Eds.), Improving training effectiveness in work organizations (pp.357-367). Mahwah, NJ: Lawrence Erlbaum.

Salas, E., Cannon-Bowers, J. A., Rhodenizer, L., & Bowers, C. A. (1999). Training in organizations: Myths, misconceptions, and mistaken assumptions. Personnel and Human Resources Management, 17, 123-161.

Salas, E., Priest, H. A., Wilson-Donnelly, K. A., & Burke, C. S. (in press). Scenario-based training: Improving mission performance and adaptability. In T. W. Britt, A. B. Adler, & C. A. Castro (Eds.), Studies in military psychology (Vol. 4). Westport, CT: Praeger Press.

Schraagen, J. M., Chipman, S. F., & Shalin, V. L. (2000). Cognitive task analysis. London: Lawrence Erlbaum.

Scullion, H., & Brewster, C. (2001). The management of expatriates: Messages from Europe? Journal of World Business, 36, 346-365.

Selmer, J. (2001). The preference for predeparture or postarrival cross-cultural training: An exploratory approach. Journal of Managerial Psychology, 16, 50-58.

Selmer, J., Torbiörn, I., & de Leon, C. T. (1998). Sequential cross-cultural training for expatriate business managers: Pre-departure and post-arrival. International Journal of Human Resource Management, 9, 831-840.

Takeuchi, R., Tesluk, P. E., Yun, S., & Lepak, D. P. (2005). An integrative review of international experience. Academy of Management Journal, 48, 85-100.

Takeuchi, R., Yun, S., & Tesluk, P. E. (2002). An examination of crossover and spillover effects of spousal and expatriate cross-cultural adjustment on expatriate outcomes. Journal of Applied Psychology, 87, 655-666.

Tung, R. L. (1982). Selection and training procedures of U.S., European, and Japanese multinationals. California Management Review, 25, 57-71.

Downloaded from hrd.sagepub.com at UNIV DE SAO PAULO BIBLIOTECA on February 21, 2012

334 Human Resource Development Review / September 2005

Tung, R. L. (1987). Expatriate assignments: Enhancing success and minimizing failure. Academy of Management Executive, 1, 117-126.

Wei, J., & Salvendy, G. (2004). The cognitive task analysis methods for job and task design: Review and reappraisal. Behaviour & Information Technology, 23, 273-299.

Lisa N. Littrell is a doctoral student in the Industrial and Organizational Psychology program at the University of Central Florida.

Eduardo Salas is a professor of Industrial/Organizational and Human Factors Psychology at the University of Central Florida.

Downloaded from hrd.sagepub.com at UNIV DE SAO PAULO BIBLIOTECA on February 21, 2012

Mendeley is a free cross-platform tool that helps you organize, manage, and share you research papers (in PDF format) on your computer and via a web interface. This tools allows for you to index your PDFs from your computer in an easy to search system.

Downloading Mendeley Desktop on Your Computer

To download Mendeley Desktop for your computer, go to http://www.mendeley.com Click on the Sign up and Download button. You will then fill in your name, email address, and password. Once you sign up, you can choose the operating system your are running on your computer and install the application.

Opening Up Mendeley Desktop and Adding Documents

To open Mendeley Desktop, you will want to go to the folder you installed the software. Double click on the icon to start the application.

To add a document to Mendeley, click on the Add Document button, or you can drag and drop your PDF files into the application window. To delete a document from Mendeley, click on Delete Document button.

Adding Tags and Metadata to Documents

To organize your documents. Mendeley allows you add tags, notes, meta-data, and view references of each PDF. To add tags, click on the article. On the right hand side, Click on the Tags and Notes tab. Fill in any keywords (tags) to help you organize this document. Tags can also help you with searching for a document. You can add notes too about the document. To review and add/edit metadata, click on the Metadata tab. If you make changes to the metadata, click the save button. To view information about references for the article, click on the References tab. Here you will see information on the references of that article (to help you find and read it for research).

Searching For Documents in Mendeley

You can search for documents in Mendeley. To search for document in Mendeley, click in the search space at the top right of the application and type in a keyword. Mendeley will search for the keyword in the title, author field, etc. The search bar only works on the folder you are currently in. For example, if I type a word and I am currently in My Publications, it will only search My Publications, even though there may be a match under the Recently Added folder.

In conjunction with using the search bar, you can also use filters to find documents you are looking for in Mendeley. On the left side on the document, you can filter out the documents based off of the tags you added, by the author (s), authors keywords, or by the publications.

Another quick way to sort through your PDF documents is to click on the titles at the top of the Mendeley applications (just like an email) to sort via author name, title name, date, etc.

Exporting Files from Mendeley

You can export a PDF file from Mendeley as a BibTeX (.bib) file, an RIS file (.ris), or an Endnote XML file (.xml).

Saving Your Documents to Your Account on Mendeley.com

Mendeley gives you the option of syncing up your document library with your online account. Now, if you need to access a document and you’re not at your computer, you can get it through the web. To sync up your Mendeley Desktop with Mendeley.com, simply click the Sync Library button. Then, log into http://www.mendeley.com to view your library.

Sharing Your Documents in Mendeley Desktop with Others

Mendeley allows you to create groups of Mendeley members you can share certain documents with through the Mendeley Desk application. Click on the Add Group button. Give the group a name. Then click on the link titles Members (located at the right of the group name)/ Now when you sync your library with Mendeley.com, this will also send any documents you added to this group to other group members.

Finding Other Documents and Researchers at Mendeley.com

Mendeley.com is like a social network for researchers. When you go on the site, you can search for other researchers by their interests, disciplines, location, and their publications. You can find other people to consult with through the Mendeley network and find more resources and materials for your class and research. The website is also another way to build a network and create groups in your Mendeley desktop application to share and exchange information over long distances and keep research documents organized.

Department Information: Degrees Offered, Acceptable Text Formats, Style Guides, and Copy Requirements

Department, School, or Program

Degrees Offered

Approved Text Formats1

Department

Style Guide

Copy

Requirements

Aerospace Engineering and Engineering Mechanics

* Master of Science in Aerospace Engineering

Chapter/Technical

AIAA Journal2 or Chicago

Author/Number3

Dept library - hardbind, chair - hardbind

Anthropology

* Master of Arts in Anthropology

Chapter/Section/Technical

American Anthropologist2, American Journal of Physical Anthropologists2, or APA

None

Art and Design

* Master of Arts in Art

* Master of Fine Arts in Art

Chapter/Section/Technical

Art History: Turabian; MFA & Studio Arts Projects: MLA

Dept library -

either bind

Asia Pacific

Studies

* Master of Arts in Asian Studies

Chapter/Technical

Turabian or Ask Advisor

None

Astronomy

* Master of Science in Astronomy

Chapter/Section/Technical

Astrophysical

Journal2

Dept library - hardbind, chair - softbind

Bioengineering

* Master of Science in Bioengineering

Chapter/Technical

Journal5 or Chicago Author/Number3

Dept library - hardbind

Bioinformatics & Medical

Informatics

* Master of Science in Bioinformatics & Medical Informatics

Chapter/Section/Technical

All, Journal5 (Nature see advisor)

Dept library -

either bind

Biology

* Master of Arts in

Biology

* Master of Science in Biology

* Master of Science in Microbiology

Chapter/Section/Technical

Journal5

None

Business Administration, College of (all departments)

* Master of Science in Accountancy

* Master of Science in Business Administration

* Master of Business Administration (MBA)

* MBA and MA in Latin American Studies6

* MBA and Juris Doctor6

Chapter/Section/Technical

Journal5 or APA

Ask Advisor

Chemistry

* Master of Arts in Chemistry

* Master of Science in Chemistry

Chapter/Technical

Journal5 and either ACS2 or Department

Dept library - hardbind

Department, School, or Program

Degrees Offered

Approved Text Formats1

Department

Style Guide

Copy

Requirements

Chicano Studies

* Master of Arts in Chicana and Chicano Studies

Ask Advisor

Ask Advisor

Ask Advisor

Child & Family Development

* Master of Science in Child Development

Chapter/Section

APA

Ask Advisor

Civil & Environ. Engineering

* Master of Science in Civil Engineering

Chapter/Technical

Chicago Author/Year

Dept library - hardbind

Communication

* Master of Arts in Communication

Chapter/Section/Technical

APA

Dept library - hardbind, Chair hardbind, 2nd 3rd comm. softbind

Communicative Disorders

See Speech, Language, & Hearing Services

Computational Science

* Master of Science in Computational Science

Chapter/Technical

Ask Advisor

Ask Advisor

Computer Science

* Master of Science in Computer Science

Chapter/Technical

LATEX4

Ask Advisor

Counseling and School

Psychology

* Master of Science in Counseling

Chapter/Section

APA

Ask Advisor

Creative Writing

See English & Comparative Literature

Economics

* Master of Arts in Economics

Chapter

APA, MLA, or Chicago

None

Education (all

departments,

except

Counseling)

* Master of Arts in Education

* Doctor of Education7

Chapter

APA (exceptions to APA for the Ed.D must be approved by the dissertation chair)

None

Electrical and Computer Engineering

* Master of Science in Electrical Engineering

Chapter/Technical

Any IEEE Journal2 or Chicago

Author/Number3

Ask Advisor

English and Comparative Literature

* Master of Arts inEnglish

* Master of Fine Arts inCreative Writing

Chapter/Section

MLA

None

Exercise and

Nutritional

Sciences

* Master of Science in Kinesiology

* Master of Science in Exercise Physiology

* Master of Science in Nutritional Science

* Master of Science in Nutritional Science and Master of Science in Exercise Physiology6

Chapter/Section

APA or Journal5

Chair - either

bind

European Studies

* Master of Arts in French

Chapter/Technical

MLA

Ask Advisor

Geography

* Master of Arts in Geography

* Master of Science in Geography

Ask Advisor

Ask Advisor

None

Department, School, or Program

Degrees Offered

Approved Text Formats1

Department

Style Guide

Copy

Requirements

Geological

Sciences

* Master of Science in Geological Sciences

Chapter/Section

GSA Journals2, AAPG Bulletin2, Journal5, or APA

Dept library - either bind, chair - ask preference

Gerontology

* Master of Science in Gerontology

Chapter/Technical

APA

Ask Advisor

History

* Master of Arts in

History

Chapter

Ask Advisor

None

Homeland

Security

* Master of Science in Homeland Security

Chapter

All - see chair

Dept library – black hardbind

Interdisciplinary Studies

* Master of Arts in Interdisciplinary Studies

* Master of Science in Interdisciplinary Studies

Follow style of committee chair’s department.

Ask Advisor

Latin American Studies

* Master of Arts in Latin American Studies

Ask Advisor

Ask Advisor

* Master of Business Administration and Master of Arts in Latin American Studies6

* Master of Latin American Studies and Master of Public Health6

Chapter/Section/Technical

APA (preferred), or BA department

Ask Advisor

Liberal Arts and Sciences

* Master of Arts in Liberal Arts and Sciences

Chapter/Section/Technical

MLA, Chicago, or APA

Ask Advisor

Linguistics and Asian/Middle Eastern Languages

* Master of Arts in Linguistics

Chapter/Section/Technical

APA or LSA

None

Mathematics and Statistics

* Master of Arts in Mathematics •Master of Science in Statistics

Chapter/Technical

APA or LATEX4

None

* Master of Science in Applied Mathematics

* Master of Science in Biostatistics

Chapter/Technical

LATEX4

None

Mechanical Engineering

* Master of Science in Mechanical Engineering

* Master of Engineering in Manufacturing and Design

Chapter/Technical

Chicago

Author/Number3

Dept library - hardbind

Microbiology

See Biology

Music and Dance

* Master of Arts in Music

* Master of Music

Chapter

Turabian

Ask Advisor

Nursing

* Master of Science in Nursing

Chapter

APA (Turabian for historical theses)

Dept library - hardbind, chair - ask preference

Nutritional

Sciences

See Exercise and Nutritional Sciences

Department, School, or Program

Degrees Offered

Approved Text Formats1

Department

Style Guide

Copy

Requirements

Philosophy

Master of Arts in Philosophy

Chapter/Section/Technical

Chicago

None

Phys

Ed/Kinesiology

See Exercise and Nutritional Sciences

Physics

* Master of Arts in

Physics

* Master of Science in Physics

* Master of Science in Medical Physics

Chapter/Technical

AIP or LATEX4

Dept library - hardbind

Political Science

* Master of Arts in

Political Science

Chapter

APSA Style Manual for Political Science

Ask Advisor

Psychology

* Master of Arts in Psychology

* Master of Science in Psychology

Chapter/Section

APA

Ask Advisor

Public Affairs

* Master of City Planning

* Master of Public Administration

Chapter

APA or MLA

Dept library - hardbind

* Master of Science in Criminal Justice and Criminology

Chapter

APA or ASA

Dept library - hardbind

Public Health

* Master of Science in Public Health

* Master of Public Health

* Master of Public Health and Master of Social Work6

Chapter/Technical

APA

Ask Advisor

Regulatory

Affairs

* Master of Science in Regulatory Affairs

Technical

APA, MLA, or Chicago

Dept library - hardbind

Rhetoric and Writing Studies

* Master of Arts in Rhetoric and Writing Studies

Thesis – Chapter

Project – Section

MLA or APA

Chair - softbind

Social Work

* Master of Social Work

* Master of Social Work and Juris Doctor6

Chapter/Technical

APA

None

Sociology

* Master of Arts in Sociology

Chapter/Technical

ASA or APA

Dept library -

either bind

* Master of Science in Criminal Justice and Criminology

Chapter

APA or ASA

Dept library -

either bind

Spanish

* Master of Arts in

Spanish

Chapter

MLA or Turabian

Ask Advisor

Speech, Language and Hearing Sciences

* Master of Arts in Speech, Language, and Hearing Science

Chapter

APA

Dept library - hardbind

Statistics

See Mathematics and Statistics

Department, School, or Program

Degrees Offered

Approved Text Formats1

Department

Style Guide

Copy

Requirements

Theatre,

Television and Film

* Master of Arts in

Theatre Arts

* Master of Fine Arts in Theatre Arts

* Master of Fine Arts in Theatre Arts with a Concentration in Musical Theatre

Chapter/Technical

MLA

Dept library - hardbind

* Master of Arts in Television, Film, and New Media Production

Chapter/Section/Technical

MLA

Digital copy to be provided by the student

Women's Studies

* Master of Arts in

Women's Studies

Chapter/Section/Technical

All – see chair

Dept library - softbind

1 Bold designates the preferred format. See Chapter 2, Section 2.6 for descriptions of these formatting styles.

2 Some departments offer students a choice between formal style guides and the use of journals as style guides. When you have these options, select and use only one guide. If there is a style question not addressed by your chosen guide or the MP Thesis Manual, the other style guide could be used as an alternate source.

3 Author-number system of referencing based on the Chicago style manual. Brackets [ ] used in text. Please see the Appendix of this manual for details and examples.

4 The style guide contained in the pdf file, "Sample Thesis," is downloadable from the Dept. of Mathematics & Statistics’ web page under Dept. Resources. There is also a thesis template (programmed in LATEX) from that site. Some faculty prefer that students use the LATEX program (vs. M.S. Word, e.g.).

5 Relevant refereed journal approved by the thesis chair. (A copy of the journal’s Notes to Authors and a published article must be submitted with the thesis.)

6 Concurrent Degree. In the case of the concurrent MSW/Juris Doctor degree program, the Juris Doctor will be awarded by California Western School of Law.

7 Doctoral degree granted jointly with the University of San Diego.

Guidelines for a Seminar Work and Bachelor/Master Thesis at the Chair of Information Systems II

These guidelines give a general overview on requirements of a seminar work or Bachelor/Master thesis (called thesis ongoing) at the Chair of Information Systems II. However, this introduction does not relieve you from your responsibility to inform yourself about requirements of a scientific work and requirement regarding your exam regulations (“Prüfungsordnung”). The objective of a seminar work or Bachelor/Master thesis is to elaborate a predefined topic. The student has to prepare a written report and give a talk on his/her topic.

1. Course

This section explains the process of a seminar work respectively a Bachelor/Master thesis starting with the preliminary discussion to the final presentation. The section is divided in:

1. General remarks (valid for all kind of scientific work),

2. Procedure seminar (Bachelor and Master seminar),

3. Procedure theses and

4. Procedure Bachelor thesis BWL/WiPäd.

1.1. General remarks

The following remarks regarding supervising of the work and the written part of the work are valid for all types of scientific work.

1.1.1. Meeting your supervisor

Together with your topic, you are assigned to a supervisor. The supervisor can help you in the case of questions regarding your topic or the formal regulations. Furthermore, the supervisor encourages the student in independent working. It is not the in the responsibility of the supervisor to check every partly result and to confirm every progress. This is not in the sense of independent working of a student. You are responsible for arranging meetings with your supervisor. Your supervisor is not in charge of informing you or making meeting arrangements with you. If you have any need for support please arrange a meeting with your supervisor in advance and inform him/her about what you want to talk about (best is to send questions in advance).

1.1.2. Hand-in your document

You have to hand in your work in time at the chair (secretary office or at your supervisor’s office) as a printed version and additionally a digital one as .docx/.tex and .pdf file via email until 12:00 noon of the closing date. The exact date is written in the slide of the introductory session.

The printed version must be bound in spiral binding or adhesive binding. The binding should not allow the possibility to exchange pages. For seminar papers one copy is enough. For Bachelor/Master theses two copies must be handed in.

An additional CD must contain a digital copy of the work as .docx/.tex and .pdf file, digital copies of the sources (especially of web pages!) used in the work and source code of the implementation (if there is any implementation done). In the case of an implementation part there should be a manual how to use it.

1.2. Course of seminar works

In this section the procedure of writing a seminar work at the Chair of Information Systems 2 is given.

1.2.1. Introductory Session

Topics will be presented in the introductory session at the beginning of the semester. Students have to register in adavance. Please inform yourself one to two months before the semester starts on the chair’s web site.

1.2.2. Topic allocation

After the introductory session, the topic bidding procedure starts. You can choose three topics you are interested in. The seminar’s coordination person will assign the topics according to the students’ preferences.

1.2.3. Hand-In Slides for Presentation

The slides for the final presentation of the seminar ha to be hand in as digital copy as .ppt and .pdf file until 12:00 noon of the closing date via email to your seminar supervisor. The exact date is written in the slide of the introductory session.

1.2.4. Final Presentation

You have to present your work at the seminar day. The exact way of presentation is specified in the introduction session of the seminar. You should be prepared to answer questions not only related to the content of the presentation but to your seminar paper in general. The final grading is based on the presentation, discussion and participation in discussion of the other seminar participants’ discussions.

1.3. Course of the Thesis (except B.Sc. Business Administration/ Business Education)

This section describes the course of writing a thesis (except B.Sc. Business Administration/ Business Education) at the Chair of Information Systems II.

1.3.1. Topic

If you are interested in writing your thesis at our chair, you should first get familiar with our current research topics. You can find an overview on our webpage. Then contact the respective staff member that is responsible for the project and arrange an appointment, in which possible thesis topics can be discussed.

We are also open to topic suggestions. In this case, we expect a short proposal (1-2 pages) describing the thesis, including its relevance to our research areas.

1.3.2. Preliminary Outline

Before you can start working on your thesis, you may be required to write a short outline that specifies the topic and shows a preliminary structure of the thesis. It is meant to clarify the expectations of both you and your supervisor towards the deliverables of the thesis – comparable to a contract. The necessity of such an outline is decided by your supervisor.

1.3.3. Registration

After the topic and outline of the thesis have been agreed on, the chair will officially inform the university administration. For this, we need the following information: full name, address, date of birth, place of birth, field of study, student ID number, e-mail address, phone number.

1.3.4. Timeline and Abstract

As soon as your topic is fixed, you are expected to provide a timeline and abstract (1 page) of your thesis during the first week. These should depict the various work packages you have identified. You should especially consider the time you will need to work yourself into the topic, for your literature research, as well as for writing the actual thesis. In the

abstract, specify the research question you want to answer. Please discuss the timeline with your advisor as soon as possible.

1.3.5. Presentation

After completing your thesis, you have to present your findings to the chair, its current thesis students, as well as possibly other interested parties. The colloquium consists of a presentation and a subsequent discussion of your work (Bachelor: 20+10 minutes, Master: 30+15 minutes). The specific details regarding duration, etc. are discussed with your advisor. Both presentation and discussion are considered in your final grade. For Business Informatics students, your colloquium performance is specifically graded by itself.

In case of a master’s thesis, you are also required to present the current state of your work and your final timeline at the half mark, in order to discuss and/ or avoid possible problems, as well as to make sure you are on track. The half mark presentation is informal and not graded.

1.4.Course of the Thesis for B.Sc. Business Administration/ Business Education

This section describes the course of writing a thesis for B.Sc. Business Administration/ Business Education at the Chair of Information Systems II. The theses are coordinated centrally by the Business School. Each student applies for a thesis at the Business School (optionally specifying a list of chairs/ areas), and is subsequently assigned to one. The chairs then appoint topics by drawing lots.

The Chair of Information Systems II proceeds according to the rules set by the Business School.

2. Format of the written report:

* Extent: exclusive all indexes, exclusive appendix:

Seminar: presented in the introductory session,

20 pages (Bachelor thesis BWL/WiPäd),

30-40 pages (Bachelor thesis Wirtschaftsinformatik),

40-60 pages (Bachelor thesis BWL) und

60-80 pages (Master thesis Wirtschaftsinformatik).

A variance must be clarified with the supervisor.

* Font: Font with serifs (in all part of the report: headings, text, figures etc.)

* Font size: 12 pt. in text, 14 pt. bold headings (1st order), 12 pt. bold heading (2nd and 3rd order), 10pt in figures and tables

* Format: Justification, 1.5 line space. Aargin left, top and right 3cm, margin bottom, 4cm. Paragraphs are divided by an additional empty line

* Numbering: Continuing numbering of the text pages with Arabic numbers. Numbering of indexes with Roman number and appendix with Capital letters.

On the chair’s website you can find templates for Word and Latex satisfying the requirements regarding formatting. In case of problems with the templates (e.g. in style of citation) leading to the need for deviation from the template, please discuss this with your supervisor. The seminar is an exceptional case. The format is presented in the corresponding introductory session.

3. Structure of a scientific paper

3.1. Title page

The title page should include the following information:

* Name of the University

* Chair

* Full name and title of the examiner and the advisor

* Type of the paper (seminar paper, bachelor thesis, master thesis)

* Topic (Title, Subtitle)

* First name and surname of the author

* Matriculation number and course of study

* Date

3.2. List of contents

The list of contents represents the logical structure of a scientific paper. The depth of the structure should be in an appropriate relation to the requirements and the scope of the text. The chapters must be continuously enumerated and the page number for each chapter must be declared. The hierarchical structure of the list of contents must be clearly visible through indenting the chapters. Each section should have none or at least two subsections.

3.3. List of figures

This list contains the number, the caption and the page number of each figure.

3.4. List of tables

(Similar to the list of figures)

3.5. List of abbreviations

Here all acronyms and their meanings are listed that are used in the text, for instance: DFS: Depth-First Search.

(List of figures, list of tables and list of abbreviations are not necessarily required for a seminar paper or a bachelor thesis. These lists should only be included if they are actually needed.)

3.6. Text

Different aspects should be considered for writing a scientific paper/ thesis. Besides the scientific demands, the linguistic presentation and the comprehensibility are very important and these aspects are also grading criterions. The text should be objective and neutral. The first person should generally be avoided. Expressions like: “we have ... made”, “I think...” should not be used and nested sentences/ footnotes should be avoided. Short and concise sentences make the paper easier to understand and more comprehensible. Spelling and punctuation errors can negatively affect the grading and should be avoided. Spell checking and proofreading by a third person is therefore recommended. The level of abstraction is important as well. The level of detail must be appropriate for the topic and the scope of the paper/ thesis. With regards to the content the paper should be objectively presented and also the topic should be discussed critically. Potential advantages and disadvantages should be considered. Technical terms should be explained after their first appearance and then consistently used.

3.7. List of appendices

Here, all appendices should be listed.

3.8. Appendix

The appendix of a paper/ thesis consists of figures, tables, etc. that are not required for the general comprehension. The appendix is optional.

3.9. Bibliography

For a scientific paper it is important to know the state of the art literature. In some cases the advisor recommends one or two papers as a starting point for the literature review.

Researching new papers is an important part of the work and should be done with care. In the bibliography all the references that are used must be given.

3.10. Affidavit

Each candidate has to make the affidavit to affirm that the paper/thesis is self-penned:

„Hiermit versichere ich, dass diese Arbeit von mir persönlich verfasst wurde und dass ich keinerlei fremde Hilfe in Anspruch genommen habe. Ebenso versichere ich, dass diese Arbeit oder Teile daraus weder von mir selbst noch von anderen als Leistungsnachweise andernorts eingereicht wurden. Wörtliche oder sinngemäße Übernahmen aus anderen Schriften und Veröffentlichungen in gedruckter oder elektronischer Form sind gekennzeichnet. Sämtliche Sekundärliteratur und sonstige Quellen sind nachgewiesen und in der Bibliographie aufgeführt. Das Gleiche gilt für graphische Darstellungen und Bilder sowie für alle Internet-Quellen.

Ich bin ferner damit einverstanden, dass meine Arbeit zum Zwecke eines Plagiatsabgleichs in elektronischer Form anonymisiert versendet und gespeichert werden kann. Mir ist bekannt, dass von der Korrektur der Arbeit abgesehen werden kann, wenn diese Erklärung nicht erteilt wird.“

4. References and Bibliography

This section provides information about how to find literature for a thesis or a seminar paper, how to cite scientific sources and how to create a bibliography.

4.1. Information about literature research

Literature research is a substantial part of the work when writing a thesis or a seminar paper. Thus, it is of highest importance to dedicate sufficient time for it and perform the literature research accurately. One of the major sources of information, for sure, is the Internet. However, not all sources are reputable and can be cited in a scientific work. Although scientific papers are in general preferred over company publications, there are cases where citing so-called ‘white papers’ or product descriptions are useful to present the state-of-the-art.

4.2 How to find good sources

Digital libraries such as ACM [Liba], IEEE [Libb] and Springer [Lin] provide good sources in the area of computer science and business informatics. The University of Mannheim has the licenses to access major parts of these libraries. Publications can be accessed free of charge via the Intranet of the university (using the VPN client). Publications can be either

found directly on the libraries’ websites or via a search engine. You can also find online sources on the website of the university library [dBUM].

4.3 Quotations

Quotations are, for example, other peoples’ thoughts, ideas, results, and opinions, which are either recited word by word or referenced inside a text. Each quotation needs to be verifiable. Hence, it is indispensable to add the reference to each quotation. Parts of the text that have no references are considered to be the original work of the author. Each proposition in a thesis or a paper needs to be proved by a reference to a public source or by the work of the author itself. The bibliography contains the details of all sources which were used in the process of the scientific work.

4.3.1. Literal/Direct citations

When a part of a text is used word by word from a source, the quotation is to be marked with quotation marks at the beginning and the end. The reference including the page number is stated right after the quotation. The quoted text is recited word by word, including spelling and punctuation. The usage of literal quotations is rather uncommon. If possible, references to the context of a text is preferred.

Example: 

Tanenbaum et al. defines a distributed system as ‘[...] a collection of independent

computers that appears to its users as a single coherent system.’ [TS02, p.2]

4.3.2. Omissions in literal citations

When only a part of a text is cited and another part is skipped, the symbol [...] indicates the position in the text where a part of the original text is omitted. [MSU11]

Example: 

Obviously, strong robustness means that the system will continue to satisfy the evaluation criteria [...], whereas weakly robust systems might show an acceptable deviation from an ideal behavior [MSU11, p17].

4.3.3. Indirect citations

Quotations of ideas need to be identified as such by stating the original source as well. These quotations are used to integrate ideas from published texts into the own work. If the reference of the quotation is a long text such as a whole book, the page number is required. If the reference is a research paper, the page number can be omitted.

Example:

BASE [SCGR03] is a middleware that was developed for the requirements of ubiquitous

systems.

4.4. Bibliography

The sources which are referenced in the thesis or paper need to be listed in the bibliography. In the text, the citation is comprised of the author(s) and the year of the publication. The bibliography contains the complete information of the source. There are many ways to organize a bibliography. The references need to be sorted by the last name of the first author.

* One author

[Per01] Charles E. Perkins. Ad Hoc Networking. Addison-Wesley, 2001.

* Two authors

[RC00] Manuel Roman and Roy H. Campbell. GAIA: Enabling active spaces. In Proceedings of the 9th ACM SIGOPS European

Workshop. ACM, ACM Press, September 2000.

* Three authors

[SBR04] Gregor Schiele, Christian Becker, and Kurt Rothermel. Energy-efficient cluster-based service discovery. In Proceedings of the 11th ACM SIGOPS European Workshop, September 2004.

* Four authors

[HLMW02] Polly Huang, Vincent Lenders, Philipp Minnig, and Mario Widmer. Mini: A minimal platform comparable to Jini for Ubiquitous Computing. In Proceedings of the International Symposium on Distributed Objects and Applications (DOA 02), October 2002.

* More than four authors

[MPPS+08] Justin Mazzola Paluska, Hubert Pham, Umar Saif, Grace Chau, Chris Terman, and Steve Ward. Structured decomposition of adaptive applications. Pervasive Mobile Computing, 4(6):791-806, 2008.

* Multiple references of the same authors in the same year

In cases where the notation shown above is ambiguous, lower case letters can be

used to distinguish both sources.

[DS01a] Steffen Deter and Karsten Sohr. Pini – a Jini-like plug&play technology for the KVM/CLDC. In Proceedings of the International Workshop on Innovative Internet Computing Systems (I2CS 2001), pages 53 – 67, June 2001.

[DS01b] Steffen Deter and Karsten Sohr. Here comes the title of the second paper. In Proceedings of the International Workshop on Innovative Internet Computing Systems (I2CS 2001), pages 68 – 75, June 2001.

* Online sources

Online sources can be referenced as well. In addition to other references, online resources require the URL and the date they were accessed.

[Mic00] Microsoft Corporation. Universal plug and play device architecture, version 1.0. online publication, June 2000.

Url: http://www.upnp.org/download/UPnPDA1020000613.htm  Accessed: 01.01.2001

It is not guaranteed that online resources are available after the date they were accessed. The URL might change or the website might be shut down. Thus, online resources must be downloaded and be made available offline. PostScript and PDF files can be saved in their respective format. HTML documents need to be downloaded completely, including the associated graphics, styles, etc. The files have to be handed in together with the printed version of the thesis or the paper on a CD/DVD or a USB stick. The files should be names according to the reference with ‘author(s) year – title’, for example:

BS02 –MiddlewareApplicationAdaptionRequirements.pdf.

5. Table and Figures

Figure 1: System Model - Referring to [Sch07]

Tables and figures are consecutively numbered in the order in which they are referred to. Using a table or figure is only recommended if it is also described in the text. In general, a figure is only useful if it is often and clearly referred to its elements in the text. If a figure has been adopted from a source as it stands or an existing figure has been modified, it has to be stated accordingly (see label of Figure 1). A marking of own figures is not required. Tables are cited in the text in an analogous manner as figures. Tables as well as figures have their own numbering.

6. Summary

General conditions and requirements for completion of a (seminar) thesis at the Chair of Information Systems II are explained in this document. The presented guidelines are binding. If your thesis differs from the guidelines, please coordinate the changes with your advisor.

7. References

[dBdUM] Databases of the library of the University of Mannheim.

Url: http://www.bib.unimannheim.de/bib-digital/dbfachmathinfo.html,

Accessed: 01.01.2001.

[DS01a] Steffen Deter and Karsten Sohr. Pini – a Jini-like plug&play technology for the KVM/CLDC. In Proceedings of the International Workshop on Innovative Internet Computing Systems (I2CS 2001), pages 53 – 67, June 2001.

[DS01b] Steffen Deter and Karsten Sohr. Here comes the title of the second paper.

In Proceedings of the International Workshop on Innovative Internet

Computing Systems (I2CS 2001), pages 68 – 75, June 2001.

[HLMW02] Polly Huang, Vincent Lenders, Philipp Minnig, and Mario Widmer.

Mini: A minimal platform comparable to Jini for Ubiquitous Computing.

In Proceedings of the International Symposium on Distributed

Objects and Applications (DOA 02), October 2002.

[Liba] ACM Digital Library. Url: http://portal.acm.org/dl.cfm, Accessed: 01.01.2001.

[Libb] IEEE Computer Society Digital Library. Url:

http://www.computer.org/publications/dlib/, Accessed: 01.01.2013.

[Lin] Springer Link. Url: http://www.springerlink.de, Accessed: 01.01.2001.

[Mic00] Microsoft Corporation. Universal plug and play device architecture, version 1.0. online publication, June 2000.

http://www.upnp.org/download/UPnPDA10 20000613.htm, Accessed: 01.01.2013.

[MPPS+08] Justin Mazzola Paluska, Hubert Pham, Umar Saif, Grace Chau,

Chris Terman, and Steve Ward. Structured decomposition of adaptive

applications. Pervasive Mobile Computing, 4(6):791-806, 2008.

[MSU11] Christian Müller-Scholer, Hartmut Schmeck, and Theo Ungerer, eds. Organic computing--a paradigm shift for complex systems. Vol. 1. Springer, 2011.

[Per01] Charles E. Perkins. Ad Hoc Networking. Addison-Wesley, 2001.

[RC00] Manuel Roman and Roy H. Campbell. GAIA: Enabling active spaces. In Proceedings of the 9th ACM SIGOPS European Workshop. ACM, ACM Press, September 2000.

[SBR04] Gregor Schiele, Christian Becker, and Kurt Rothermel. Energy-efficient

cluster-based service discovery. In Proceedings of the 11th

ACM SIGOPS European Workshop, September 2004.

[SCGR03] Christian Becker, Gregor Schiele, Holger Gubbels, and Kurt Rothermel: ‘BASE – A Micro-broker-based Middleware For Pervasive Computing,‘ in Proceedings of the International IEEE Conference on Pervasive Computing and Communication (PerCom), 2003

[Sch07] Gregor Schiele: System Support for Spontaneous Pervasive Computing Environments. In Dissertation zur Erlangung des PhD in Computer Science. 2007.

[TS02] Andrew S. Tanenbaum and Maarten Van Steen. Distributed systems. Vol. 2. Prentice Hall, 2002.

ERA-NETs

SUSFOOD2 and CORE Organic Cofunds

Joint Call 2019

“Towards sustainable and organic food systems”

Evaluation Guidelines

November 2019

These projects have received funding from the European Union’s Horizon 2020 research and Innovation programme under grant agreement No 727473 and 727495, respectively.

Content

1. General information and background of the Joint Call 3

2. Time schedule 4

3. Call Office 4

4. The Evaluation procedure after submission of research proposals 5

4.1 Pre-proposals 5

4.2 Full proposals 5

5. Expert Panel 6

5.1 Constitution of the EP 6

6. Performing the evaluation 6

6.1 The online evaluation tool 6

6.2 Conflict of Interest, confidentiality and code of conduct 6

6.3 Tasks of the EP 6

6.4 Evaluation criteria (pre-proposals and full proposals) 7

6.5 Evaluation scores 8

6.6 Ethics assessment 8

6.7 Evaluation reports 9

7. Evaluation meeting 9

8. Compensation 10

ANNEX A Confidentiality NON-Disclosure Agreement 11

ANNEX B Declaration of Conflict of Interest 13

Definitions

Call Board (CB): the decision making body consisting of one representative of each funding body participating to the Joint Call

Call Office: central contact point for all issues around the evaluation procedures of the call (as well as the application procedure)

Expert Panel (EP): group of experts who will peer-review the submitted proposals in the framework of the Joint Call. The EP will be composed of international experts based on their acknowledged expertise in the research areas covered by the submitted proposals.

Rapporteur: member of the EP who shall report on a proposal during the evaluation procedure (by writing an evaluation summary and by presenting the

evaluation results during the evaluation meeting).

EP Chair: EP person, nominated by the CB and Call Office among the experts, who will assist the experts, in case of need, all along the evaluation period. S/he will chair the full proposals’ evaluation meeting of the EP and could be invited to attend the final CB selection meeting.

1. General information and background of the Joint Call

The ERA-NET SUSFOOD2 and CORE Organic Cofunds (SF/CO) have launched a Joint Call for transnational research project proposals on 2nd September based on the funding from participating countries of both networks and international partner countries. The commitment of the participating 21 funding bodies from 18 countries/regions is 9.585.000 € in total. With this, research should be supported that creates added value for sustainable and organic food systems in line with the objectives of both ERA-NETs and the scope of the Joint Call.

The Evaluation Guidelines provide information regarding the evaluation process, tasks and conditions within the framework of the Joint Call, which is following a two-step procedure with a first step for pre-proposal submission and evaluation and a second step for full proposal submission and evaluation.

Applications have been submitted under the four Call topics

Topic 1: Resource-efficient, circular and zero-waste food systems

Topic 2: Diversity in food from field to plate

Topic 3: Mild food processing

Topic 4: Sustainable and smart packaging

Cross-cutting issues (multi-actor-/ multi-disciplinary-/ system approach) had to be taken into account

by the applicants across all topics and be individually adapted to each project.

For information on the Joint Call the Call Announcement and Guidelines (https://www.submission-susfood-era.net/sf-co-jointcall) should be consulted with special emphasis on the sections 1. “Background of the Joint Call”, 2. “Joint Call topics and cross-cutting issues” and Annex A “Call Topics”.

3

2. Time schedule

The envisaged time schedule for the evaluation process of the Joint Call is indicated in the table below:

Action

Schedule

Step 1

Submission of pre-proposals

2 September - 4 November 2019

Nomination of experts for the EP

2 September – 4 November 2019

Assignment of proposals to experts and

submission of Confidentiality non-disclosure agreement/ Code of conduct agreement as well as Conflict of Interest

4 November – 18 November 2019

Evaluation of pre-proposals (remote)

18 November – 13 January 2020

Preparation of evaluation summaries by

rapporteurs

Until 15 January 2020

Selection of pre-proposals by CB

End of January 2020

Step 2

Submission of full proposals

3 February - 27 March 2020

Evaluation of full-proposals (remote)

30 March – 22 May 2020

Preparation of evaluation summaries by

rapporteurs

Until 27 May 2020

Evaluation meeting of EP

First week of June 2020

Revision of evaluation summaries by

rapporteurs

Asap after the evaluation meeting

Selection of full-proposals by CB

Mid June 2020

3. Call Office

The Call Office will provide administrative and technical (online tool) support to the experts during the evaluation process. It is the primary point of contact between the Expert Panel (EP) members and the Joint Call funding bodies (Call Board) for all general matters in relation to the peer-review evaluation.

Contact persons:

Elena Capolino Nikola Hassan

Ministry of Agricultural, Food and Forestry Project Management Juelich (DE) Policies (IT)

Tel. +39 0552492220 Tel. +49 2461 6196787

E-mail: e.capolino@politicheagricole.it E-mail: n.hassan@fz-juelich.de 

4

4. The Evaluation procedure after submission of research proposals

The assessment of the submitted proposals (eligibility checks, evaluation by the EP members) will be

carried out using the Call submission tool https://www.submission-susfood-era.net/sf-co-jointcall.

4.1 Pre-proposals

Submitted research proposals must be written in English and need to provide information mainly about: topic addressed, partners of the project consortium (coordinator and co-applicants), project budget (with explanations about the envisaged costs), description of planned work (relevance, approach, impact), ethical issues (see the Call Announcement at section 7.1 Pre-proposal submission). They consist of approx. 10 pages with 5 pages of project description.

The Call Office will firstly perform an eligibility check of the pre-proposals against general criteria listed at section 7.2 of the Call Announcement (maximum duration of the project, max budget request, minimum number of countries participating in the proposal, etc.).

Each Funding Body (CB members) will check the eligibility of the national applicants against the national/ regional criteria published in Annex D of the Call Announcement (project partners who will be selected for funding will receive the grant directly from their national funding bodies according to their terms and conditions, following the principles of the ERA-Net scheme1).

Eligible pre-proposals in terms of general and national/regional eligibility criteria will be peer-reviewed by 3 experts selected from the Expert Panel. The outcome of the experts‘ evaluation will be a ranking list of projects per topic with scores and a written evaluation reports which will enable the CB to shortlist the applying research consortia.

4.2 Full proposals

Research consortia selected by the Call Board based on the EP evaluation results and recommendations, and the available funding, will be invited to submit full proposals (approx. 25 pages with 20 pages of project description). These will be checked again by the Call Office and the Call Board (general and national/regional eligibility) and reviewed by the EP members (3 experts per proposal), who will provide scores and a written evaluation. Experts could also be asked to assess the fulfilment of conditions and recommendations indicated by the CB at the stage of pre-proposals’ selection and outlined in the invitations to submit a full proposal (if any, the letters will be made available). EP members will meet face-to-face in order to share and discuss their reports and to find a common agreement on a ranking list (one per each of the four Call topics). The EP panel chair will facilitate the discussion. The evaluation outputs, finalized after the meeting, will be used by the CB for the final funding decision.

1 ERA-Nets are Public-Public Partnerships (P2Ps) in research and innovation. The networks gather public organisations (Ministries, funding agencies, programme managers) from interested EU countries and beyond, that join forces to support research activities under an agreed vision or research and innovation agenda. In this way, these partnerships align national strategies, helping to overcome fragmentation of public research effort. ERA-Nets are supported by the European Commission.

5

5. Expert Panel

5.1 Constitution of the EP

The Expert Panel (EP) for evaluation is constituted of internationally recognised Experts chosen for their scientific / technical expertise and knowledge of the sectors covered in the Call.

The members of the EP have been proposed and nominated by the CB members and the Call Office, thereby, existing contacts of both networks have been taken into account. The European Commission database of experts has also been consulted. Potential Experts have been invited to become members of the EP and have sent their application to the Call Office. The selection of Expert Panel members is made by the Call Office and the complete EP list is then sent to the CB for final approval.

Experts are contacted by the Call Office for confirmation of availability and the assignment of proposals. An expert can only become a member of the EP if s/he has no conflict of interest and is available during the evaluation process. The final number of experts to build the EP depends on the number of pre-proposals submitted, the topics addressed and the expertise of the evaluators. Experts are asked to contact the Call Office in case they do not feel their area of expertise matches the assigned proposals.

The names of EP members will be kept anonymous for the applicants through the whole procedure.

6. Performing the evaluation

6.1 The online evaluation tool

The evaluation at both steps of the call (pre- and full proposals) can only be done using the online evaluation tool, accessible under https://www.submission-susfood-era.net/sf-co-jointcall. All assigned experts will receive an e-mail invitation with log-in details and instructions how to access the tool. At the stage of pre-proposal evaluation, experts will only be able to read the assigned applications, while at the 2nd stage there will be no restriction regarding the download of all submitted full proposals (when there is no conflict of interest).

6.2 Conflict of Interest, confidentiality and code of conduct

Before performing an evaluation, the confidentiality NON-disclosure agreement and Code of Conduct (Annex A) need to be downloaded, printed, signed and uploaded once. For each proposal, the assigned expert will then need to decide on possible Conflict of Interest (Annex B), based on a visible summary and research consortium information of the proposal. Full access to a proposal will only be granted when no conflict of interest exists.

6.3 Tasks of the EP

The EP shall peer review pre-proposals (step 1) and full proposals (step 2) and provide consolidated evaluation feedback for both evaluation steps considering the given timeframes (see table at chapter 2). Thereby, each proposal is evaluated by three experts. In case of highly contradictory evaluations an additional expert or the EP chair could be invited to a further evaluation.

6

If possible, the experts assigned for the evaluation of full proposals will be the same as in the pre-proposals. At the stage of full proposal evaluation, it is suggested (but not required) that experts read all proposals in order to have a complete overview of all applications.

One of the 3 experts evaluating a proposal will be appointed as rapporteur, which means s/he will prepare an evaluation summary report based on the single evaluations. All experts will be required to act as rapporteur in 2-4 proposals, prepare and submit a consolidated and mutually agreed evaluation summary report and, at full proposal stage, present the proposal and evaluation results during the step 2 evaluation meeting. In case of strong disagreement on the evaluation, the rapporteur should inform the Call Office to seek a solution (e.g. involving an additional expert or the EP chair).

An overall EP chair person will be nominated among the experts (by the CB and Call Office). Tasks of the chair include assistance in case of disagreements among experts, chairing of the evaluation meeting of the EP (only for step 2) and to attend the CB selection meeting (step 2) to explain the evaluation results if needed.

6.4 Evaluation criteria (pre-proposals and full proposals)

All eligible pre-proposals will be evaluated by 3 experts according to the following three criteria:

* Relevance: coherence and pertinence of the objectives, contribution to the scope of the Joint Call and the selected topic,

* Quality of the research approach: appropriateness and soundness of the research approach and methodology, feasibility, complementarity of partners, adequacy of the budget,

* Potential Impact: potential to reach expected impact and innovate/ implement, embracing of cross-cutting issues2, added value of transnational cooperation and geographical coverage.

Full proposals will be evaluated by 3 experts against the following three criteria:

* Excellence of the research proposal: scientific quality of objectives, ambition in relation to the call scope and topic addressed and innovative progress beyond the state-of-the-art

* Quality and efficiency of the implementation: appropriateness and soundness of the research approach and methodology, feasibility, effectiveness of the work plan, complementarity/ competences/ diversity of partners and disciplines, adequacy of the budget and balance between partners in terms of activities, risk management, capacity building activities, communication and dissemination

* Potential Impact: contribution towards sustainable and organic food systems, potential to innovate/ implement, embracing of cross-cutting issues2, transnational added value

2 The cross-cutting issues should be taken into account across all topics and be individually adapted to each project in order to increase projects’ value and impact:

* Multi-actor-approach: Involve different actors and stakeholders in your research project from the outset (by means of participation as well as transparent communication),

* Multi-disciplinary approach: Take account of different viewpoints and involve actors from the disciplines beyond your existing network,

* System approach: Consider interconnections, synergies or trade-offs between different aspects or actors that directly or indirectly affect your field of research on a systems level (e.g. economic, environmental, social, legislative, geographical, behavioural, business environment, etc.)

7

The result of the evaluation will be one ranking list per topic based on the final scores, resulting from the sum of the mean scores for each criterion.

6.5 Evaluation scores

For each evaluation criterion, scores from 0 to 5 (half points allowed) are awarded. A threshold of 3/5 will be applied for each criterion, i.e. proposals with a mean score < 3 in any criterion will not be recommended for funding. The overall score will be the sum of the mean scores of the 3 evaluation criteria and will include one decimal behind the comma (min 0.0, max 15.0).

The following scoring scheme should be applied:

0

Weak

The proposal shows severe flaws that are intrinsic to the proposed project. The criterion under examination is not addressed or cannot be judged due to missing or incomplete information.

1

Poor

The proposal addresses the criterion unsatisfactorily or in an inadequate manner. It shows serious inherent weaknesses resulting in the need of substantial modification or improvement.

2

Fair

The proposal broadly addresses the criterion; however, it contains some weaknesses and elements that can be improved.

3

Good

The proposal addresses the criterion well; however, it contains few elements that could be improved.

4

Very

Good

The proposal is really good in international comparison and contains no significant elements to be improved. It addresses the criterion very well, although certain improvements are still possible.

5

Excellent

The proposal stands out with exceptional novelty, innovation and progress of science at global level. It successfully addresses all relevant aspects of the criterion in question. Any shortcomings are minor

Besides the scores, the written statements (evaluation reports) should reflect the score, be sufficiently detailed and comprehensible.

6.6 Ethics assessment

Experts’ evaluation will include the check of Ethical issues using the information provided by the applicants, as explained at section 9 of the Call Announcement.

The assessment has to refer to the criteria published by the Commission in its guidelines for the Horizon 2020 Framework Programme, also listed in the self-assessment applicants are invited to

perform (see

http://ec.europa.eu/research/participants/data/ref/h2020/grants_manual/hi/ethics/h2020_hi_ethics-self-assess_en.pdf).

Additional ethical assessment on the national level can be performed by the funding bodies on optional basis.

Any proposal, which seems to contravene fundamental ethical principles, may be excluded from selection.

8

6.7 Evaluation reports

All experts will provide a written evaluation report on strengths and weaknesses of each proposal. The report has to be sufficiently detailed and in line with the given score. In case of a proposal failing to reach the threshold, a clear and consistent justification should be given.

Rapporteurs will write a summary evaluation report (ca. half a page) for the proposals assigned. The rapporteurs should contact the other two evaluators (pre-proposal phase only) in order to achieve a consensus regarding the evaluation summaries: these discussions have to be organized by the experts themselves, by e-mail, web or telephone meetings (the Call Office will provide email addresses, if experts agree, but will not be involved in the discussion). In case of strongly contradictory reviews among the 3 evaluators, the rapporteur should contact the Call Office and an additional expert might be involved.

Pre-proposal summary evaluation reports will be directly communicated to the applicants.

Full proposal summary evaluation reports will be discussed during the step 2 evaluation meeting, and finalized in a very short delay after the meeting. They will be communicated to the applicants as part of the notification letter.

7. Evaluation meeting

A physical Expert Panel meeting covering all topics will take place during the first week of June 2020 (further details will be communicated in due time). All experts will receive the draft evaluation reports before the meeting.

All Expert Panel members are welcome to take part in the discussions during the Panel meeting, if they do not have conflict of interest.

The Expert Panel a) will discuss projects where scores between experts are still diverging, b) will align the scoring between proposals and c) will agree on a ranking list per thematic research area.

The Expert Panel will be chaired by the EP chair, who will moderate the discussion but will not influence the evaluation.

The meeting will start by taking one Call topic at a time, and will be followed by a general discussion:

1. Each project will be introduced and commented on by the assigned rapporteur (one expert per proposal). In case a proposal fails the threshold, the draft evaluation report will have to be agreed upon and will be shortly discussed, unless there are strong objections against the presented overall score.

2. The Panel Experts will discuss each project and agree on an overall score and the evaluation report. The overall score shall have one decimal behind the comma (min 0.0, max 15.0).

3. The proposals will be ranked in one list for each research topic. A discussion among all the experts will ensure that the ranking list reflects a linear progression of quality among all proposals. Scores may be modified in this process with due justification and in case of unanimous decision.

9

4. In addition, evaluators will be asked to give a clear recommendation for funding (green/yellow/red or A/B/C). The direct outcome of the meeting will thus be four ranking lists with proposals grouped in categories of comparable quality.

After the meeting the Expert Panel members will finalize the evaluation reports as soon as possible. The EP’s ranking and recommendations will form the basis for the CB final funding decision.

8. Compensation

Expert Panel members will be entitled to a general compensation of 50 euros per pre-proposal evaluation, 100 per full proposal evaluation, and 250 euros for the participation in the 1 1/2-days Expert Panel meeting. Travel and subsistence will be reimbursed. The EP Chair needs to be available during the whole time of evaluation process and will be reimbursed with 1.000 €. Each expert will be asked to evaluate between 1 and 8 applications, and act as rapporteurs of 1 to 4 applications.

10

ANNEX A

EVALUATOR: EVALUATOR´S DATA

CALL OFFICE NIKOLA HASSAN

Project Management Juelich GmbH

52425 Juelich, Germany

Email: n.hassan@fz-juelich.de

ERA-NETS SUSFOOD2 AND CORE ORGANIC COFUND- JOINT CALL FOR PROPOSALS 2019

CONFIDENTIALITY NON-DISCLOSURE AGREEMENT

DATE (set placeholder, position must not be changed)

I hereby undertake to treat as confidential all and any information that I receive while participating in the work of the joint call Expert Panel (EP) and evaluating project proposals, to use this information solely for the purpose of evaluation of the proposals, not to disclose it to any third party and not to make it publicly available or accessible in any way, except with the prior written consent of the joint call consortium.

I understand that this confidentiality non-disclosure agreement is binding towards the joint call network, who has appointed me as an evaluator and towards (and for the benefit of) any applicant submitting the project proposal to the SUSFOOD2-CORE Organic call for proposals. Furthermore, I understand that this confidentiality non-disclosure agreement concerns all and any information in any form that comes to my knowledge during my participation in the work of the joint call Expert Panel and evaluating

respective project proposals.

I understand that I shall be bound by this confidentiality non-disclosure agreement as on the date of receipt of this signed letter by the Call Office, and that this confidentialy should be maintained even after the Expert Panel has performed its duties or after my participation in the work of the Expert Panel has ended.

I will not identify myself as a reviewer to the applicant(s) or to any third party, while the Call Office will ensure confidentiality concerning my role as reviewer as well.

I will only address any questions concerning a proposal to the Call Office and not to the applicant(s).

CODE OF CONDUCT AGREEMENT

Fundamental principles of good research practice and peer-review are essential for research integrity. All parties involved directly or indirectly in the evaluation must ensure the transparency and fairness of the process, the evaluation criteria published are respected equally for all proposals, and public funds are well used:

1. Experts as members of the EP are chosen for their technical or scientific or industrial expertise to cover the topics addressed by the submitted proposals. They should perform their work to the best of their abilities, professional skills, knowledge and applying the highest ethical and moral standards.

2. All parties involved directly or indirectly in the evaluation must act objectively, with no self-interested motives. They do not represent their company, organisation or establishment.

11

3. The reviewers shall evaluate the proposals based solely upon the information contained in the proposals and in accordance with the Evaluation Guidelines.

4. The experts must immediately inform the Call Office if they cannot fulfill their obligations.

5. The reviewers shall finish the individual written assessment for pre-proposals by 13.01.2020, at the latest and by 22.05.2020 for full-proposals; shall be available for discussions with other evaluators for the consolidation of the consensus report and agree to provide contact details to other evaluators.

6. The rapporteurs shall finish the consensus pre-proposals evaluation reports by 15.01.2020, at the latest and by 27.05.2020 for draft consensus full-proposals evaluation reports; they shall be available to moderate the discussions; they shall finish the final consensus evaluation reports after the EP meeting.

7. At the EP meeting, decisions must be taken collectively by the EP members after all arguments have been heard. Furthermore, decisions must be substantiated.

8. Opinions expressed during EP meetings as well as information which parties are the first to obtain have to be kept confidential. The substance of the EP debates must remain secret and the individual positions must not be divulged.

9. Minutes will be kept for those meetings during which decisions are reached. These minutes will be circulated to EP members and observers for verification and approval.

10. EP members should refrain in all cases from identifying external experts to third parties, and from divulging any other information which could compromise their anonymity. Likewise, reviewers cannot contact the applicants nor the other reviewers during the individual evaluation of proposals.

11. If any reviewer is subject to any pressure whatsoever from a project partner, she or he must immediately notify the Call Office.

12. If there is a conflict of interest, the concerned person must inform the Call Office as soon as finding that a conflict exists. The necessary measures will be taken to ensure that the related decision and discussion will not be biased, or suspected to be so (e.g. in requesting the concerned person to leave the room when the project in question is being discussed durng the EP meeting).

13. The chairperson may, on his or her own initiative, consult the Call Office in respect to a real or possible conflict of interests, which has been brought to his or her attention by any means whatsoever.

14. Compensations will be paid only if tasks were accomplished in accordance with the provisions of the Evaluation guidelines, within the given deadlines and in high quality after approval by the Call Board. Compensations may not be payed in case of breach of obligations relating to this Code of Conduct.

I agree to the rules of the confidentiality NON-disclosure agreement,

I undertake to abide by the Code of Conduct for Reviewers of the SUSFOOD2-CORE Organic Cofund joint Call:

No Yes

This agreement enters into force on the date of receipt of this signed letter by the Call Office.

ANNEX B

Declaration of Conflict of Interest

I declare that I will independent, impartial and objective in the evaluation of the assigned proposals.

I will refrain from reviewing the proposal if a conflict of interest exists or could be perceived to exist. I understand that there is a conflict of interest if I stand to profit professionally, financially or personally from approval or rejection of the proposal; if in the past three years I have published with, cooperated with or worked at the same company or research unit as the applicant or any of the project workers; if I have fundamental differences of scientific opinion with any applicant; or if I’m a friend or relative of the applicant or any of the co-workers.

If any such conflict of interest exists or arises, I will inform the Call Office as soon as possible. The Call Office takes the last decision about conflicts of interest and disqualifications.

During the Expert Panel meeting, even if I have not evaluated a specific proposal, in case of a possible conflict of interest with it, I will leave the room during the discussion of this proposal. I will follow the indications given by the Call Office aiming at reaching an impartial evaluation of the proposals.

13