Stratégies internationales et francophones pour la révision et le développement de la CIM-11...
-
Upload
anna-chapman -
Category
Documents
-
view
216 -
download
0
description
Transcript of 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
3 | Lille, France | 29 January 2014
Traduction pour les études en ligne
4 | Lille, France | 29 January 2014
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
5 | Lille, France | 29 January 2014
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
6 | Lille, France | 29 January 2014
Translation Coordinators
Coordination of French Translation:
–Dre. Anne-Claire Stona (CCOMS, Lille)
–Dr. Cary Kogan (OMS, Gèneve)
7 | Lille, France | 29 January 2014
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).
8 | Lille, France | 29 January 2014
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)
9 | Lille, France | 29 January 2014
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
10 | Lille, France | 29 January 2014
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.”
11 | Lille, France | 29 January 2014
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.
12 | Lille, France | 29 January 2014
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.”
13 | Lille, France | 29 January 2014
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.
14 | Lille, France | 29 January 2014
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.
15 | Lille, France | 29 January 2014
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.
16 | Lille, France | 29 January 2014
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.
17 | Lille, France | 29 January 2014
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.
18 | Lille, France | 29 January 2014
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
19 | Lille, France | 29 January 2014
Déploiement des études en ligne
20 | Lille, France | 29 January 2014
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)
21 | Lille, France | 29 January 2014
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)
22 | Lille, France | 29 January 2014
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
23 | Lille, France | 29 January 2014
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%
25 | Lille, France | 29 January 2014
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%
30 | Lille, France | 29 January 2014
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
31 | Lille, France | 29 January 2014
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%
32 | Lille, France | 29 January 2014
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
33 | Lille, France | 29 January 2014
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%
34 | Lille, France | 29 January 2014
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
35 | Lille, France | 29 January 2014
Internet-Based Field Study onDisorders Specifically Associated with Stress
36 | Lille, France | 29 January 2014
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
37 | Lille, France | 29 January 2014
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?
38 | Lille, France | 29 January 2014
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
39 | Lille, France | 29 January 2014
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
41 | Lille, France | 29 January 2014
Step 1
Random assignment to ICD-10 or ICD-11
Included ICD-10 as baseline comparison
42 | Lille, France | 29 January 2014
Step 2
Counterbalanced the presentation of the two vignettes
Controls for order effects
43 | Lille, France | 29 January 2014
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
44 | Lille, France | 29 January 2014
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.
45 | Lille, France | 29 January 2014
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.
46 | Lille, France | 29 January 2014
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
47 | Lille, France | 29 January 2014
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
48 | Lille, France | 29 January 2014
Step 4
Provides information on clinicians’ decision-making process, e.g., if they do not give the diagnosis we thought they should, why not?
49 | Lille, France | 29 January 2014
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
50 | Lille, France | 29 January 2014
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
51 | Lille, France | 29 January 2014
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
52 | Lille, France | 29 January 2014
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
53 | Lille, France | 29 January 2014
Disorders Specifically Related to Stress
Example of Preliminary Results
54 | Lille, France | 29 January 2014
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
55 | Lille, France | 29 January 2014
Participants
3%
14%
17%
3%29%
5%
27%
1% 0%
Region
AFROAMRO-NAMRO-SEMROEUROSEAROWPRO-AsiaWPRO-OceaniaOther
56 | Lille, France | 29 January 2014
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)
57 | Lille, France | 29 January 2014
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
58 | Lille, France | 29 January 2014
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
59 | Lille, France | 29 January 2014
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
60 | Lille, France | 29 January 2014
Functional Impairment PTSD
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
61 | Lille, France | 29 January 2014
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
62 | Lille, France | 29 January 2014
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
63 | Lille, France | 29 January 2014
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
64 | Lille, France | 29 January 2014
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.
65 | Lille, France | 29 January 2014
Psychotic Disorders
Study under Development
66 | Lille, France | 29 January 2014
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
67 | Lille, France | 29 January 2014
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
68 | Lille, France | 29 January 2014
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
69 | Lille, France | 29 January 2014
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?
70 | Lille, France | 29 January 2014
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)
71 | Lille, France | 29 January 2014
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
72 | Lille, France | 29 January 2014
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)
73 | Lille, France | 29 January 2014
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
74 | Lille, France | 29 January 2014
Example
Which of the following were present in the vignette?Absent Sub Mild Moderate Severe
Positive
Negative
Depressive
Manic
Psychomotor
Cognitive
75 | Lille, France | 29 January 2014
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
76 | Lille, France | 29 January 2014
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
77 | Lille, France | 29 January 2014
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
78 | Lille, France | 29 January 2014
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.
79 | Lille, France | 29 January 2014
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?
80 | Lille, France | 29 January 2014
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)
81 | Lille, France | 29 January 2014
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
82 | Lille, France | 29 January 2014
Déploiement des études sur le terrain
83 | Lille, France | 29 January 2014
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?
84 | Lille, France | 29 January 2014
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)
85 | Lille, France | 29 January 2014
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)
86 | Lille, France | 29 January 2014
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
87 | Lille, France | 29 January 2014
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
88 | Lille, France | 29 January 2014
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