stratégies internationales et francophones pour la révision et le développement de la cim-11...

Stratégies internationales et francophones pour la révision et le

développement de la CIM-11

Geoffrey M. ReedDepartment of Mental Health and Substance Abuse

ICD-11 Francophone Network Meeting29 January 2014

Lille, France

2 | Lille, France | 29 January 2014

Overview

Traduction pour les études en ligne

Déploiement des études en ligne

Déploiement des études sur le terrain


Traduction pour les études en ligne


Translation Process

The translation process consists of the following 8 steps:1. Forward translation by two independent bilingual

mental health professionals2. Reconciliation of the two forward translations3. Review by expert(s) & clinicians4. Revision of the draft translation5. Back translation6. Comparison of the original and back translation7. Pilot testing/proofreading by clinicians8. Proofreading by expert


Translation: Personnel Needed Per Study

Role # of professionals Requirements

Coordinator 1 - 2 Bilingual, Mental Health (MH) professional

Forward translators 2 Bilingual, MH professional

Back Translator 1 Bilingual, MH professional

Clinicians 5 MH professional (junior), native speakers of target language (may be monolingual)

Experts 2* Bilingual, MH professional (senior)

WHO/FSCG/WG representative 1 English-speaking, thoroughly familiar with the

study design and study material


Translation Coordinators

Coordination of French Translation:

–Dre. Anne-Claire Stona (CCOMS, Lille)

–Dr. Cary Kogan (OMS, Gèneve)


Forward Translation

Coordinator(s) identify two forward translators and have them produce forward translations independently.

Forward translators independently produce forward translations, i.e., translate the source material into the target language.

– Forward translation needs to be semantically and conceptually equivalent to the original.

– Since French is spoken in widely diverse geographic regions and there are substantial variations in words and word usage by country/region, it is advisable to have the two forward translators be from different geographic regions (e.g., Canada & France).

– Notes made regarding challenges encountered and provide alternative expressions if applicable (with the goal of semantic and conceptual equivalence).


Field Study on Eating Disorders

First French Internet-Based Field Study: Feeding and Eating Disorders

– Forward translators:

• Drs. Steiger and Israël, Programme des troubles de l’alimentation, Douglas Institut Universitaire Santé Mentale (McGill), Canada

• Dr. Abdelbaky, NSW Institute of Psychiatry Fellow, School of Medicine, University of Western Sydney, Australia (from Lebanon)


Reconciliation of forward translations

Coordinator produces a draft version by reconciling the two versions of forward translation.

– Translation is a subjective undertakingConsult the forward translators as necessary

– Coordinator makes notes of any unresolved issues or concerns– Discrepancies in word or language usage by country/region

resolved – Consult WHO/FSCG/WG representative for clarification about

issues/concerns– Consultation can be done either over the phone or via emails.– Communications need to be recorded

WHO/FSCG/WG representative provides assistance and feedback to coordinator as needed


Reconciliation of forward translations

Example from Feeding and Eating Disorders:

D2 Bulimia Nervosa: – English: “Preoccupation with body weight and shape that

excessively influences self-evaluation.”

– Translator 1: “Préoccupation avec le poids corporel et la forme qui influence excessivement l’autoévaluation.”

– Translator 2: “Des préoccupations du poids et de la forme qui influencent excessivement l’estime de soi.”

– Reconciliation: “Préoccupations concernant le poids et la silhouette qui influencent excessivement l’auto-perception.”


Review of Translation

Coordinator identifies two bilingual content experts (considering geographic variation in French) to provide technical review.

Experts compare the English original and the draft translation and identify discrepancies.

Identify two reviewer clinicians (no need to be bilingual). Clinicians are expected to identify and indicate words/sentences

that are confusing, difficult to understand, misleading, or ambiguous.

Clinicians also identify technical expressions that are overly technical, outdated, or otherwise inappropriate for general clinicians, as experts may not be able to identify these accurately due to their level of detailed knowledge.


Review: Feeding and Eating Disorders

Example from Feeding and Eating Disorders:D2 Bulimia Nervosa: – English: “Preoccupation with body weight and shape that

excessively influences self-evaluation.”– Reconciliation: “Préoccupations concernant le poids et la

silhouette qui influencent excessivement l’auto-perception.”– Expert reviewer 1: “Des préoccupations concernant le poids et

formes corporelles ayant une influence excessive sur la perception que l’individu a de lui-même.”

– Expert reviewer 2 agreed with the reconciliation.– Clinician 1: “Des préoccupations concernant le poids et la

silhouette ayant une influence excessive sur l’auto-perception.”


Revision of the draft

Coordinator evaluates feedback from the experts and implements necessary changes.

– When making changes that pertain to the content of translation, provide explanation and the English equivalent of the newly introduced translation.

– English changes can be made if required, but must be well justified.

Evaluate the feedback from clinicians and implement necessary changes.

– Changes to improve readability should be noted, but providing the English equivalent for the newly introduced translation is not necessary as long as the meaning remains the same.

– To evaluate feedback pertaining to the content, experts consulted before making changes. When making such changes, provide explanation and the English equivalent of the newly introduced translation.


Back translation

Coordinator identifies a back translator. If possible, it is preferable that the back translator’s first language be English. The back translator should also be fluent in the target language.

Back translator produces back translations, i.e., translate the draft back into English.

– The back translator should complete the back translation without reading the original English document.

– The purpose of the back translation is to provide as literal a translation as possible, not to make the language sound good.


Comparison of original and back translation

Point of comparison is to examine conceptual and semantic equivalence of the two versions.

Coordinator prepares an interim report to the WHO/FSCG/WG representative.

WHO/FSCG/WG representative reviews the interim report and identifies remaining discrepancies between the original and back translation.

Coordinator and WHO/FSCG/WG representative discuss discrepancies identified up to this point and decide whether the suggested changes are appropriate.


Pilot testing/proofreading by clinicians

Coordinator identifies three additional clinicians to the two that participated in the Review step (no need to be bilingual).

Clinicians use the latest version in a pilot study and identify any problems.


Proofreading by expert

Coordinator asks expert from review process to proof the final draft.

Expert reviews the final draft and confirm that it is error-free.


Geographically Diverse Content Expert Translators and Reviewers Needed

Feeding and Eating Disorders (in process)

Psychotic Disorders

Paraphilic Disorders

Obsessive-Compulsive and Related Disorders

Mood Disorders

Anxiety Disorders


Déploiement des études en ligne


Experimental Question

Do the changes to ICD-11 (both in individual diagnostic guidelines and the addition of new categories) improve diagnostic clarity over ICD-10?

To answer this question, we need a controlled stimulus (i.e., a vignette) that can be manipulated to either represent or not represent particular changes.

Two examples presented: – Disorders Specifically Related to Stress (with results)

– Psychotic Disorders (in the pipeline)


Mechanism for Internet-Based Field Studies

Global Clinical Practice Network for internet-based field studies:

www.globalclinicalpractice.net

Participants are invited to participate in no more than one study per month (average time commitment of 30 mins)


9,649 GCPN Registrants Globally(As of 1 January 2014)

Americas North: 1,014

South & Central: 1,060 Europe3,459

Africa158

Eastern Mediterranean

281

Southeast Asia456

Western Pacific Asia: 2,924Oceania: 255


Global Registrants:Demographic information

Gender composition: Male = 52.6%; Female = 47.3Other = 0.1%

Mean age: 44.3 years (SD = 11.7; range = 21 – 89)

Mean years of professional experience: 13.7 (SD=10.4; range = 0 – 61)

94.8% currently see patients

60.9% currently supervise others

Global Registrants:Regional Distribution of GCPN

EURO36%

WPRO-Asia30%

AMRO-South11%

AMRO-North11%

SEARO5%

EMRO3%

WPRO-Oceania3% AFRO

2%


Global Mental Health Professionals by Region

MH ATLAS

GCPN

AFRO AMRO EMRO EURO SEARO WPRO0%

5%

10%

15%

20%

25%

30%

35%

40%

1%

13%

5%

37%

9%

34%

2%

22%

3%

36%

5%

33%

Global Registrants:Distribution by Country Income Level

High59%

Upper-middle33%

Lower-middle7%

Low1%

Global Registrants:Disciplinary Distribution of GCPN

Medicine60%

Psychology29%

Counseling4%

Other4%

Nursing2%

Social Work1%

Sex Therapy0.4%

Speech Therapy0.2%

Global Registrants:Language of Registration

English39%

Chinese20%

Spanish11%

Japanese10%

French8%

Russian7%

German3%

Portuguese1% Arabic

1%

Global Registrants:Primary Language

English25%

Chinese20%

Spanish11%

Other10%

Japanese9%

French8%

Russian7%

German4%

Portuguese3%

Arabic2% Not Specified

1%


900 Francophone GCPN Registrants(As of 1 January 2014)

51.7% male, 48.3% female

Mean current age = 46.0 (SD = 12.5)

Mean years of experience = 15.9 (SD = 11.1)

96.0% currently seeing patients

63.2% providing direct supervision

67.1% often/routinely use ICD-10; 48.6% use DSM-IV


Francophone GCPN Registrants:Regional distribution

EURO; 78%

EMRO; 8%

AMRO-North; 7%

AFRO; 3%AMRO-South; 3% WPRO-Oceania; 0.2%

WPRO-Asia; 0.1%


FranceSwitzerland

CanadaTunisia

Lebanon

BelgiumMorocco

SpainAlgeria

United StatesUnited Kingdom

Brazil

Haiti

0 100 200 300 400 500 600567

7558

2928

17131110986

6

Francophone GCPN RegistrantsCountry of Residence

N = 5: Germany, RussiaN = 4: Argentina, Madagascar, Netherlands N = 3: Burkina Faso, Cameroon, Germany, Mexico, RussiaN = 2: Benin, Brazil, China, Colombia, DRC, MauritaniaN = 1: Albania, Australia, CAR, Croatia, Guatemala, Luxembourg, New Zealand, Senegal, Somalia, Sweden, Syria, Togo, Turkey, Venezuela


Francophone GCPN Registrants:Mental Health Disciplines

What is your clinical profession?

Medicine Psychology Other Nursing Counseling Social Work

0%

10%

20%

30%

40%

50%

60%

70% 65.7%

25.3%

4.0% 2.6% 1.6% 0.9%


Francophone GCPN Registrants:Area of Expertise

Mood DisordersSchizophrenia and Related Disorders

Anxiety DisordersPersonality Disorders

Autism Spectrum Disorders Attention Deficit and Conduct Disorders

Substance Abuse and Addictive DisordersStress-Related Disorders

Dementia, Delirium, and Related DisordersIntellectual Disabilities

Eating DisordersOther

Sexual DisordersObsessive-Compulsive and Related Disorders

NeuroscienceSomatoform Disorders

Public HealthSleep Disorders

Epidemiology

0 100 200 300 400 500 600477

361302

244150

138121118

10181

6257

4643

383636

1816


Internet-Based Field Study onDisorders Specifically Associated with Stress


Disorders Specifically Associated with Stress

New proposed grouping for ICD-11, part of ‘Neurotic, stress-related and somatoform disorders’ in ICD-10

PTSD diagnosis based on presence of specific, positive symptoms

Addition of new categories of Complex Post-Traumatic Stress Disorder and Prolonged Grief Disorder

Adjustment Disorder defined based on explicit set of essential features rather than being a diagnosis of exclusion

Reactive Attachment Disorder and Disinhibited Social Engagement Disorder included in grouping instead of in separate grouping of childhood disorders


Possible Field Trial Questions for Disorders Specifically Associated with Stress

Does greater specification of Adjustment Disorder lead to more reliability in determining threshold with normality?

Can clinicians distinguish between Prolonged Grief Disorder and normal bereavement?

Can Complex PTSD be reliably distinguished from PTSD and from other disorders (e.g., Personality Disorder) based on symptoms?

Is threshold for PTSD diagnosis consistent across global clinicians in spite of dramatic differences in exposure to potentially traumatic events across populations?


Methodology Development

A draft methodology document is prepared by WHO that identifies the comparisons that appear to be of clinical interest (e.g., to see if clinicians can reliably use a new diagnostic category)

The Working Group provides feedback indicating which comparisons are clinically meaningful and relevant

Methodology is refined and study is programmed in Qualtrics software


Vignette Development

Working Group is given the methodology document and assigned to write multiple examples for each vignette.

WHO combines the elements of each that work best.

Working Group then is asked to rate the presence of features we think are in the vignette (e.g., re-experiencing in the present)

If experts disagree, we clarify the feature or wording

Study Flow: Stress Disorders


Step 1

Random assignment to ICD-10 or ICD-11

Included ICD-10 as baseline comparison


Step 2

Counterbalanced the presentation of the two vignettes

Controls for order effects


Step 3

Randomly assigned to one of 8 comparisons:1. PTSD redefining re-experiencing2. PTSD adding functional impairment3. Defining PTSD as symptoms vs. stressor4. PTSD vs. Complex PTSD5. Complex stressor but just PTSD symptoms6. Prolonged Grief Disorder vs. Normal bereavement7. Adjustment Disorder symptoms vs. stressor8. Adjustment adding preoccupation and impairment


Step 3

Compare vignettes with a single factor manipulated that isolates the concern raised. Gives us information about the effect of that single change to the system.


Example

Question 1: Compare a case with re-experiencing in the present to a case with only remembered events that otherwise experiences similar avoidance and hyperarousal symptoms.

Under ICD-10, both vignettes would most likely be diagnosed as PTSD; under ICD-11, only the first should be diagnosed PTSD with the second receiving some other diagnosis.


Example

Truck driver in bad accident

Jumps at loud noises

Avoids going to work

Feels like his rib cage is crushing when he gets back in a car

Post worker gets mugged carrying packages

Panics when he goes by that place and now avoids it

Spends a lot of time wondering why it happened to him

Re-experiencing Vignette Remembering Vignette


Step 4

Participants reviewed the clinical descriptions and diagnostic guidelines for the system they are randomly assigned to use.

They provided a diagnosis for the vignette and answered a set of additional questions for each.

– Evaluated the presence of each guideline– Evaluated goodness of fit/ease of use– Evaluated vignette severity/impairment


Step 4

Provides information on clinicians’ decision-making process, e.g., if they do not give the diagnosis we thought they should, why not?


Example

Which of the following diagnostic conclusions best corresponds to the person described in the vignette?

– PTSD– Complex PTSD– Adjustment Disorder– Prolonged Grief– Acute Stress Reaction– Other Disorder Specifically Associated with Stress– Other Diagnosis– No Diagnosis


Example

Which of the following diagnostic conclusions best corresponds to the person described in the vignette?

– PTSD– Complex PTSD– Adjustment Disorder– Prolonged Grief– Acute Stress Reaction– Other Disorder Specifically Associated with Stress– Other Diagnosis– No Diagnosis

Follow-up Questions


Example

Which of the following were present in the vignette?Yes No Not Sure

Exposed to Trauma

Re-experiencing

Avoidance

Arousal/Hypervigilance

Symptoms develop after traumaFunctional impairment

Symptoms last several weeksNot Complex PTSD


Final Purpose

This sort of design allows for: – finely tuned examinations of specific changes in the

diagnostic system

– Determination of clinicians’ ability to discriminate amongst similar conditions

Desired goals are increased diagnostic clarity and specificity, and increased clinical utility


Disorders Specifically Related to Stress

Example of Preliminary Results


Participants

3631 GCPN members qualified for study– Self-rated proficiency either advanced or fluent in one of

the languages of the study– Current patient contact or supervision

2084 (57.4%) responded to link

1661 (79.7%) passed all validation checks and completed enough of survey for data analysis


Participants

3%

14%

17%

3%29%

5%

27%

1% 0%

Region

AFROAMRO-NAMRO-SEMROEUROSEAROWPRO-AsiaWPRO-OceaniaOther


Participants

English Spanish JapaneseTotal N 875 347 439Gender (%) Male 471 (53.8) 178 (51.3) 358 (81.5) Female 397 (45.4) 168 (48.4) 81 (18.5)Profession (%) Counseling 83 (9.5) 4 (1.2) 1 (0.2) Medicine 307 (35.1) 141 (40.6) 409 (93.2) Nursing 10 (1.1) 0 4 (0.9) Psychology 435 (49.7) 179 (51.6) 17 (3.9) Social work 10 (1.1) 3 (0.9) 1 (0.2) Sex Therapy 2 (0.2) 0 0 Other 23 (2.6) 19 (5.5) 7 (1.6)Age (SD) 46.71 (10.74) 45.56 (11.42) 46.66 (10.79)Years of Experience (SD) 15.30 (10.10) 15.91 (10.51) 14.71 (10.40)


Comparison: Requiring Functional Impairment in PTSD

2. Adding requirement of functional impairment for PTSD

– Vignette 1A met all ICD-11 requirements for PTSD, including functional impairment

– Vignette 1C had all the same symptoms except for no evidence of functional impairment

– Under ICD-10, both are PTSD

– Under ICD-11, only 1A should be PTSD


Functional Impairment PTSD

PTSD Other0

102030405060708090

100

Vig 1AVig 1C

ICD-11

Freq

uenc

y

Freq

uenc

y

ICD-10

PTSD Other0

102030405060708090

100

Vig 1AVig 1C



PTSD Other0

102030405060708090

100

Vig 1AVig 1C

ICD-11

Freq

uenc

y

Freq

uenc

y

ICD-10

PTSD Other0

102030405060708090

100

Vig 1AVig 1C



Yes No Not Sure

Exposed to trauma 100% 0% 0%

Re-experiencing in present 100% 0% 0%

Avoidance 93% 7% 0%

Arousal/hypervigilance 94% 1% 5%

Symptoms develop after trauma 97% 1% 2%

Functional impairment 69% 9% 22%

Symptoms last several weeks 99% 0% 1%

Complex PTSD 15% 76% 9%

Endorsement of PTSD guidelines


Comparison: Adding Complex PTSD to ICD-11

Complex PTSD is added as a new category. Can clinicians differentiate it (and its additional symptoms) from regular PTSD?

– Vignette 1A is PTSD

– Vignette 2A is Complex PTSD and includes enduring changes in affect regulation, beliefs about the world, and interpersonal functioning


Complex PTSD

ICD-11

Freq

uenc

y

Freq

uenc

y

ICD-10

PTSD Complex PTSD

0102030405060708090

Vig 1AVig 2A

PTSD

Enduring P

ersonali

ty Chan

ge0

20

40

60

80

Vig 1AVig 2A


Complex PTSD

ICD-11

Freq

uenc

y

Freq

uenc

y

ICD-10

PTSD Complex PTSD

0102030405060708090

Vig 1AVig 2A

PTSD

Enduring P

ersonali

ty Chan

ge0

20

40

60

80

Vig 1AVig 2A

G2(4) = 182.94, p < .0001


Summary

UNEXPECTED

– Comparison: Functional Impairment in PTSD – Clinicians did not differentiate PTSD with or without functional impairment; in practical application the distinction may not be necessary.

EXPECTED– Comparison: Complex PTSD – Complex PTSD clarified the

diagnostic landscape relative to Enduring Personality Change in Response to a Catastrophic Experience.


Psychotic Disorders

Study under Development


Psychotic Disorders Overview

1. Phase 1: Consistency and discriminability of ICD-11 psychotic disorders

2. Phase 2: Pretesting symptom specifier rating scale options

3. Phase 3: Use of symptom specifiers versus subtypes

4. Phase 4: Effect of training on use of symptom specifiers


ICD-11 Schizophrenia Spectrum and Other Primary Psychotic Disorders - I Elimination of classical schizophrenia subtypes Replaced by rating of symptom descriptors for Schizophrenia

and Schizoaffective Disorder:– With positive symptoms– With negative symptoms– With depressive symptoms– With manic symptoms– With psychomotor symptoms– With cognitive symptoms

Introduction of distinction between ‘First Episode’ and recurrent or multiple episodes


Other Proposed Changes for ICD-11 Psychotic Disorders

Simplification of Acute and Transient Psychotic Disorder (ATPD)

– Elimination of ICD-10 Types– Essential features include rapid onset, polymorphic

presentation– Single episode and Recurrent

Deletion of Induced Delusional DisorderAddition of separate diagnostic grouping for Catatonia:

– Associated with other mental disorder,– Due to disorder classified elsewhere– Unknown


Possible Field Trial Questions for Psychotic Disorders

Do clinicians find deletion of traditional subtypes of schizophrenia problematic?

Are symptom ratings likely to be clinically useful? Are they feasible in global settings (e.g., assessment of cognitive symptoms)?

Can clinicians reliably distinguish a first episode, and is this clinically useful in terms of management?

Is anything lost by deletion of various acute and transient psychotic disorder categories?


Phase 1

Similar to Stress Disorders designs

Series of paired vignette comparisons across ICD-10 versus ICD-11

Examines clinicians’ ability to discriminate among similar conditions and normality, as well as between disorders in this cluster and other disorders with psychotic presentations (e.g., depressive and bipolar disorders)


Phase 1

1. Schizophrenia vs. Schizoaffective disorder2. Schizoaffective vs. Depressive episode with psychotic

features3. Schizoaffective vs. Manic episode with psychotic

features4. Schizotypal vs. Schizophrenia5. Delusional disorder vs. Schizophrenia6. Delusional disorder vs. normality7. Acute & transient psychotic disorder vs. Acute stress

reaction8. Acute & transient psychotic disorder vs. schizophrenia

of too short duration


Phase 2

Moving towards specifying individual symptoms across 6 domains (positive, negative, depressive, manic, psychomotor, cognitive)

What rating method is more consistently used by clinicians and reported as more clinically useful?

– Dichotomous (present/absent)– Polytomous (absent, subthreshold, mild, moderate,

severe)


Phase 2

Intro

Ran

dom

izat

ion

Ran

dom

izat

ion

Counterbalance

Di then Poly

Poly then Di

First Rating Second Rating

Vig 1 Vig 1

Vig 2 Vig 2

Vig 3 Vig 3

Vig 4 Vig 4

Vig 5 Vig 5


Example

Which of the following were present in the vignette?Absent Sub Mild Moderate Severe

Positive

Negative

Depressive

Manic

Psychomotor

Cognitive


Phase 2

Can determine accuracy and reliability for clinicians’ use of each kind of scale

Best method across all vignettes will be used for further studies (Phases 3 & 4) and potentially adopted for ICD-11


Phase 3

ICD-10 included subtypes for Schizophrenia

ICD-11 will use rating scales instead

Do the symptom specifier scales capture more of the variability seen in cases of schizophrenia than subtypes?

– 6 clear-cut cases of subtypes– 6 unclear cases of subtypes that blend across areas

Can also test DSM-5 rating scale which uses slightly different domains


Phase 3

Intro

Ran

dom

izat

ion

Ran

dom

izat

ion

Pair 1

Pair 2

Pair 3

Pair 4

Pair 5

Pair 6

Ran

dom

izat

ion

CounterbalanceICD 10

ICD 11

DSM 5

Forward

Back


Phase 3

Clear-cut cases should have equivalent reliability and goodness of fit across diagnostic systems.

ICD-11 (and DSM-5) should have superior reliability and goodness of fit over ICD-10 on unclear cases.


Phase 4

In Phase 3, participants receive no special training in how to use the new symptom specifier rating scales

Is training necessary in the new system? Would it improve clinicians’ use of the system?


Phase 4

Participants would walk through a training program (offering them feedback on their ratings)

Could test them on the most and least reliable cases from Phase 3 or on all cases

Participants from Phase 3 that completed ICD-11 condition would act as control group (no training)


Psychotic Disorders Summary

Electronic survey vignette methodology is able to answer a wide variety of questions

For Psychotic Disorders, can answer:– Discriminability across Psychotic Disorders (and normality)– Reliability and accuracy of new symptom specifiers– Diagnostic clarification of unclear presentations– Effect of training in new system

Time

End Start

Phase 1

N = 1015

Phase 2

N = 330Phase 3

N = 972

Phase 4

N = 105

Total N = 2422


Déploiement des études sur le terrain


Clinic-Based Field Studies

Important to evaluate proposed diagnostic guidelines within contexts in which they will be used and with real patients:

Do proposals for ICD-11 fulfill quality criteria related to clinical utility, reliability and validity in real-life clinical settings?


Examples of Field Study Research Questions

Are the proposed diagnostic guidelines easy to understand and use? (utility – feasibility)

Do the proposed diagnostic guidelines accurately reflect or capture patients’ symptom presentations? (utility – goodness of fit)

Are the proposed diagnostic guidelines and specifiers useful/ helpful in formulating of treatment plans for patients? (utility)


Examples of Field Study Research Questions

Do the proposed diagnostic criteria capture the patients’ symptom presentation consistently over time and across clinicians? (test-retest reliability; inter-rater reliability)

Is there convergent validity of diagnoses with expert panel reviews, or with other available external criteria? (validity)


Clinic-Based Field Studies:How will they work?

Participating International Field Study Centers (IFSCs) will receive complete protocols, describing all procedures for each study, including settings, required number of patients, all procedures and measures, timeline

Separate protocols for different types of studies (e.g., psychotic disorders, substance use disorders, disorders specifically associated with stress)

Protocols will emphasize use in regular clinical practice Participating network not be expected to participate in

every study, only those for which they have capacity and interest


Clinic-Based Field Studies Currently Underway

Primary Health Care study examining the validity of Mixed Depression and Anxiety Disorder as well as Body Stress Disorder among primary care populations

– Data collection underway in Hong Kong and Mexico– Study will also be conducted in Spain, Pakistan, Tanzania, and

possibly other countries

Studies on Sexual Disorders and Sexual Health– To be conducted in Brazil, India, Lebanon (+ Bahrain and Jordan),

Mexico, South Africa, Germany, Netherlands and UK– To examine impact of proposed changes in categories related to

gender identity, sexual dysfunctions, and paraphilic disorders– Will be accompanied by legal and policy analyses in each country


Field Studies Timeline

Protocols for clinic-based field studies in other areas will be developed and made available to participating Centers beginning Q3 2014

Internet-based data collection to be completed by end of 2014

Clinic-based data collection to be completed by end of 2015

Proposals will be revised based on field study data in time for submission for World Health Assembly approval in May, 2017

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