ICD11 Francophone Network Meeting 29 January 2014 Lille

ICD-11 Francophone Network Meeting 29 January 2014 Lille, France Stratégies internationales et francophones pour la révision et le développement de la CIM-11 Geoffrey M. Reed Department of Mental Health and Substance Abuse

Overview l Traduction pour les études en ligne l Déploiement des études sur le terrain 2 | Lille, France | 29 January 2014

Traduction pour les études en ligne 3 | 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 professionals 2. Reconciliation of the two forward translations 3. Review by expert(s) & clinicians 4. Revision of the draft translation 5. Back translation 6. Comparison of the original and back translation 7. Pilot testing/proofreading by clinicians 8. Proofreading by expert 4 | Lille, France | 29 January 2014

Translation: Personnel Needed Per Study # of professionals Role Coordinator 1 -2 Requirements 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 5 | Lille, France | 29 January 2014

Translation Coordinators l Coordination of French Translation: – Dre. Anne-Claire Stona (CCOMS, Lille) – Dr. Cary Kogan (OMS, Gèneve) 6 | Lille, France | 29 January 2014

Forward Translation l Coordinator(s) identify two forward translators and have them produce forward translations independently. l 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). 7 | Lille, France | 29 January 2014

Field Study on Eating Disorders l 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 (Mc. Gill), Canada • Dr. Abdelbaky, NSW Institute of Psychiatry Fellow, School of Medicine, University of Western Sydney, Australia (from Lebanon) 8 | Lille, France | 29 January 2014

Reconciliation of forward translations l Coordinator produces a draft version by reconciling the two versions of forward translation. – Translation is a subjective undertaking l Consult 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 l WHO/FSCG/WG representative provides assistance and feedback to coordinator as needed 9 | Lille, France | 29 January 2014

Reconciliation of forward translations l Example from Feeding and Eating Disorders: D 2 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. ” 10 | Lille, France | 29 January 2014

Review of Translation l Coordinator identifies two bilingual content experts (considering geographic variation in French) to provide technical review. l Experts compare the English original and the draft translation and identify discrepancies. l Identify two reviewer clinicians (no need to be bilingual). l Clinicians are expected to identify and indicate words/sentences that are confusing, difficult to understand, misleading, or ambiguous. l 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. 11 | Lille, France | 29 January 2014

Review: Feeding and Eating Disorders l Example from Feeding and Eating Disorders: D 2 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. ” 12 | Lille, France | 29 January 2014

Revision of the draft l 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. l 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. 13 | Lille, France | 29 January 2014

Back translation l 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. l 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. 14 | Lille, France | 29 January 2014

Comparison of original and back translation l Point of comparison is to examine conceptual and semantic equivalence of the two versions. l Coordinator prepares an interim report to the WHO/FSCG/WG representative. l WHO/FSCG/WG representative reviews the interim report and identifies remaining discrepancies between the original and back translation. l Coordinator and WHO/FSCG/WG representative discuss discrepancies identified up to this point and decide whether the suggested changes are appropriate. 15 | Lille, France | 29 January 2014

Pilot testing/proofreading by clinicians l Coordinator identifies three additional clinicians to the two that participated in the Review step (no need to be bilingual). l Clinicians use the latest version in a pilot study and identify any problems. 16 | Lille, France | 29 January 2014

Proofreading by expert l Coordinator asks expert from review process to proof the final draft. l Expert reviews the final draft and confirm that it is error-free. 17 | Lille, France | 29 January 2014

Geographically Diverse Content Expert Translators and Reviewers Needed l Feeding and Eating Disorders (in process) l Psychotic Disorders l Paraphilic Disorders l Obsessive-Compulsive and Related Disorders l Mood Disorders l Anxiety Disorders 18 | Lille, France | 29 January 2014

Déploiement des études en ligne 19 | Lille, France | 29 January 2014

Experimental Question l Do the changes to ICD-11 (both in individual diagnostic guidelines and the addition of new categories) improve diagnostic clarity over ICD-10? l 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. l Two examples presented: – Disorders Specifically Related to Stress (with results) – Psychotic Disorders (in the pipeline) 20 | Lille, France | 29 January 2014

Mechanism for Internet-Based Field Studies l Global Clinical Practice Network for internet-based field studies: www. globalclinicalpractice. net l Participants are invited to participate in no more than one study per month (average time commitment of 30 mins) 21 | Lille, France | 29 January 2014

9, 649 GCPN Registrants Globally (As of 1 January 2014) Americas Europe North: 1, 014 South & Central: 1, 060 3, 459 Western Pacific Asia: 2, 924 Oceania: 255 Africa 158 Eastern Mediterranean 281 22 | Lille, France | 29 January 2014 Southeast Asia 456

Global Registrants: Demographic information l Gender composition: Male = 52. 6%; Female = 47. 3 Other = 0. 1% l Mean age: 44. 3 years (SD = 11. 7; range = 21 – 89) l Mean years of professional experience: 13. 7 (SD=10. 4; range = 0 – 61) l 94. 8% currently see patients l 60. 9% currently supervise others 23 | Lille, France | 29 January 2014

Global Registrants: Regional Distribution of GCPN WPRO-Oceania EMRO AFRO 3% 3% 2% SEARO 5% AMRO-North 10% AMRO-South 11% WPRO-Asia 30% EURO 36%

Global Mental Health Professionals by Region 40% 37% 36% MH ATLAS 35% 34% 33% GCPN 30% 25% 22% 20% 13% 15% 9% 10% 5% 5% 1% 2% 5% 3% 0% AFRO 25 | Lille, France AMRO | EMRO 29 January 2014 EURO SEARO WPRO

Global Registrants: Distribution by Country Income Level Lower-middle 7% Upper-middle 33% Low 1% High 59%

Global Registrants: Disciplinary Distribution of GCPN Social Work Sex Therapy 1% 0, 4% Nursing 2% Other 4% Counseling 4% Psychology 29% Medicine 60% Speech Therapy 0, 2%

Global Registrants: Language of Registration Russian 7% German Portuguese Arabic 1% 3% 1% French 8% English 39% Japanese 10% Spanish 11% Chinese 20%

Global Registrants: Primary Language Arabic Portuguese 2% Not Specified 3% German 1% 4% Russian 7% French 8% Japanese 9% Other 10% Spanish 11% English 25% Chinese 20%

900 Francophone GCPN Registrants (As of 1 January 2014) l 51. 7% male, 48. 3% female l Mean current age = 46. 0 (SD = 12. 5) l Mean years of experience = 15. 9 (SD = 11. 1) l 96. 0% currently seeing patients l 63. 2% providing direct supervision l 67. 1% often/routinely use ICD-10; 48. 6% use DSM-IV 30 | Lille, France | 29 January 2014

Francophone GCPN Registrants: Regional distribution WPROAMRO-South; Oceania; 0, 2% 3% WPRO-Asia; AFRO; 3% 0, 1% AMRO-North; 7% EMRO; 8% EURO; 78% 31 | Lille, France | 29 January 2014

Francophone GCPN Registrants Country of Residence 0 100 200 300 400 500 France 567 Switzerland 75 Canada 58 Tunisia 29 Lebanon 28 Belgium 17 Morocco 13 Spain 11 Algeria 10 United States 9 United Kingdom 8 Brazil 6 Haiti 6 32 | 600 Lille, France N = 5: Germany, Russia N = 4: Argentina, Madagascar, Netherlands N = 3: Burkina Faso, Cameroon, Germany, Mexico, Russia N = 2: Benin, Brazil, China, Colombia, DRC, Mauritania N = 1: Albania, Australia, CAR, Croatia, Guatemala, Luxembourg, New Zealand, Senegal, Somalia, Sweden, Syria, Togo, Turkey, Venezuela | 29 January 2014

Francophone GCPN Registrants: Mental Health Disciplines 80% What is your clinical profession? 65, 7% 60% 40% 25, 3% 20% 4, 0% 2, 6% Other Nursing 0% Medicine 33 | Lille, France Psychology | 29 January 2014 1, 6% 0, 9% Counseling Social Work

Francophone GCPN Registrants: Area of Expertise 0 Mood Disorders Schizophrenia and Related Disorders Anxiety Disorders Personality Disorders Autism Spectrum Disorders Attention Deficit and Conduct Disorders Substance Abuse and Addictive. . . Stress-Related Disorders Dementia, Delirium, and Related. . . Intellectual Disabilities Eating Disorders Other Sexual Disorders Obsessive-Compulsive and Related. . . Neuroscience Somatoform Disorders Public Health Sleep Disorders Epidemiology 34 | Lille, France | 100 200 300 400 500 477 361 302 244 150 138 121 118 101 81 62 57 46 43 38 36 36 18 16 29 January 2014 600

Internet-Based Field Study on Disorders Specifically Associated with Stress 35 | Lille, France | 29 January 2014

Disorders Specifically Associated with Stress l New proposed grouping for ICD-11, part of ‘Neurotic, stressrelated and somatoform disorders’ in ICD-10 l PTSD diagnosis based on presence of specific, positive symptoms l Addition of new categories of Complex Post-Traumatic Stress Disorder and Prolonged Grief Disorder l Adjustment Disorder defined based on explicit set of essential features rather than being a diagnosis of exclusion l Reactive Attachment Disorder and Disinhibited Social Engagement Disorder included in grouping instead of in separate grouping of childhood disorders 36 | Lille, France | 29 January 2014

Possible Field Trial Questions for Disorders Specifically Associated with Stress l Does greater specification of Adjustment Disorder lead to more reliability in determining threshold with normality? l Can clinicians distinguish between Prolonged Grief Disorder and normal bereavement? l Can Complex PTSD be reliably distinguished from PTSD and from other disorders (e. g. , Personality Disorder) based on symptoms? l Is threshold for PTSD diagnosis consistent across global clinicians in spite of dramatic differences in exposure to potentially traumatic events across populations? 37 | Lille, France | 29 January 2014

Methodology Development l 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) l The Working Group provides feedback indicating which comparisons are clinically meaningful and relevant l Methodology is refined and study is programmed in Qualtrics software 38 | Lille, France | 29 January 2014

Vignette Development l Working Group is given the methodology document and assigned to write multiple examples for each vignette. l WHO combines the elements of each that work best. l Working Group then is asked to rate the presence of features we think are in the vignette (e. g. , reexperiencing in the present) l If experts disagree, we clarify the feature or wording 39 | Lille, France | 29 January 2014

Study Flow: Stress Disorders

Step 1 l Random assignment to ICD-10 or ICD-11 l Included ICD-10 as baseline comparison 41 | Lille, France | 29 January 2014

Step 2 l Counterbalanced the presentation of the two vignettes l Controls for order effects 42 | Lille, France | 29 January 2014

Step 3 l Randomly assigned to one of 8 comparisons: 1. PTSD redefining re-experiencing 2. PTSD adding functional impairment 3. Defining PTSD as symptoms vs. stressor 4. PTSD vs. Complex PTSD 5. Complex stressor but just PTSD symptoms 6. Prolonged Grief Disorder vs. Normal bereavement 7. Adjustment Disorder symptoms vs. stressor 8. Adjustment adding preoccupation and impairment 43 | Lille, France | 29 January 2014

Step 3 l 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. 44 | Lille, France | 29 January 2014

Example l 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. l 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. 45 | Lille, France | 29 January 2014

Example Re-experiencing Vignette Remembering Vignette l Truck driver in bad accident l Post worker gets mugged carrying packages l Jumps at loud noises l Panics when he goes by l Avoids going to work that place and now avoids it l Feels like his rib cage is crushing when he gets back in a car 46 | Lille, France | 29 January 2014 l Spends a lot of time wondering why it happened to him

Step 4 l Participants reviewed the clinical descriptions and diagnostic guidelines for the system they are randomly assigned to use. l 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 47 | Lille, France | 29 January 2014

Step 4 l Provides information on clinicians’ decision-making process, e. g. , if they do not give the diagnosis we thought they should, why not? 48 | Lille, France | 29 January 2014

Example l Which of the following diagnostic conclusions best corresponds to the person described in the vignette? – – – – 49 | PTSD Complex PTSD Adjustment Disorder Prolonged Grief Acute Stress Reaction Other Disorder Specifically Associated with Stress Other Diagnosis No Diagnosis Lille, France | 29 January 2014

Example l Which of the following diagnostic conclusions best corresponds to the person described in the vignette? – – – – 50 | PTSD Complex PTSD Follow-up Questions Adjustment Disorder Prolonged Grief Acute Stress Reaction Other Disorder Specifically Associated with Stress Other Diagnosis No Diagnosis Lille, France | 29 January 2014

Example l Which of the following were present in the vignette? Yes Exposed to Trauma Re-experiencing Avoidance Arousal/Hypervigilance Symptoms develop after trauma Functional impairment Symptoms last several weeks Not Complex PTSD 51 | Lille, France | 29 January 2014 No Not Sure

Final Purpose l 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 l Desired goals are increased diagnostic clarity and specificity, and increased clinical utility 52 | Lille, France | 29 January 2014

Disorders Specifically Related to Stress Example of Preliminary Results 53 | Lille, France | 29 January 2014

Participants l 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 l 2084 (57. 4%) responded to link l 1661 (79. 7%) passed all validation checks and completed enough of survey for data analysis 54 | Lille, France | 29 January 2014

Participants Region 1%0% 3% AFRO AMRO-N 14% AMRO-S 27% EMRO 17% SEARO 5% WPRO-Asia 29% 55 | Lille, France | EURO 29 January 2014 3% WPRO-Oceania Other

Participants Total N Gender (%) Male Female Profession (%) Counseling Medicine Nursing Psychology Social work Sex Therapy Other Age (SD) Years of Experience (SD) 56 | Lille, France | English 875 Spanish 347 Japanese 439 471 (53. 8) 397 (45. 4) 178 (51. 3) 168 (48. 4) 358 (81. 5) 81 (18. 5) 83 (9. 5) 307 (35. 1) 10 (1. 1) 435 (49. 7) 10 (1. 1) 2 (0. 2) 23 (2. 6) 46. 71 (10. 74) 15. 30 (10. 10) 4 (1. 2) 141 (40. 6) 0 179 (51. 6) 3 (0. 9) 0 19 (5. 5) 45. 56 (11. 42) 15. 91 (10. 51) 1 (0. 2) 409 (93. 2) 4 (0. 9) 17 (3. 9) 1 (0. 2) 0 7 (1. 6) 46. 66 (10. 79) 14. 71 (10. 40) 29 January 2014

Comparison: Requiring Functional Impairment in PTSD 2. Adding requirement of functional impairment for PTSD 57 | – Vignette 1 A met all ICD-11 requirements for PTSD, including functional impairment – Vignette 1 C had all the same symptoms except for no evidence of functional impairment – Under ICD-10, both are PTSD – Under ICD-11, only 1 A should be PTSD Lille, France | 29 January 2014

58 100 90 80 70 60 50 40 30 20 10 0 | ICD-11 Vig 1 A Vig 1 C PTSD Lille, France Other | 29 January 2014 Frequency Functional Impairment PTSD 100 90 80 70 60 50 40 30 20 10 0 ICD-10 Vig 1 A Vig 1 C PTSD Other

59 100 90 80 70 60 50 40 30 20 10 0 | ICD-11 Vig 1 A Vig 1 C PTSD Lille, France Other | 29 January 2014 Frequency Functional Impairment PTSD 100 90 80 70 60 50 40 30 20 10 0 ICD-10 Vig 1 A Vig 1 C PTSD Other

Functional Impairment PTSD Endorsement of PTSD guidelines 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% 60 | Lille, France | 29 January 2014

Comparison: Adding Complex PTSD to ICD -11 l Complex PTSD is added as a new category. Can clinicians differentiate it (and its additional symptoms) from regular PTSD? – Vignette 1 A is PTSD – Vignette 2 A is Complex PTSD and includes enduring changes in affect regulation, beliefs about the world, and interpersonal functioning 61 | Lille, France | 29 January 2014

62 90 80 70 60 50 40 30 20 10 0 | ICD-11 ICD-10 80 70 60 Vig 1 A Vig 2 A Frequency Complex PTSD 50 40 Vig 1 A 30 Vig 2 A 20 10 PTSD Lille, France Complex PTSD | 29 January 2014 0 PTSD Enduring Personality Change

63 90 80 70 60 50 40 30 20 10 0 | ICD-11 G 2(4) = 182. 94, p <. 0001 ICD-10 80 70 60 Vig 1 A Vig 2 A Frequency Complex PTSD 50 40 Vig 1 A 30 Vig 2 A 20 10 PTSD Lille, France Complex PTSD | 29 January 2014 0 PTSD Enduring Personality Change

Summary l 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. l EXPECTED – Comparison: Complex PTSD – Complex PTSD clarified the diagnostic landscape relative to Enduring Personality Change in Response to a Catastrophic Experience. 64 | Lille, France | 29 January 2014

Psychotic Disorders Study under Development 65 | 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 66 | Lille, France | 29 January 2014

ICD-11 Schizophrenia Spectrum and Other Primary Psychotic Disorders - I l Elimination of classical schizophrenia subtypes l 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 l Introduction of distinction between ‘First Episode’ and recurrent or multiple episodes 67 | Lille, France | 29 January 2014

Other Proposed Changes for ICD-11 Psychotic Disorders l Simplification of Acute and Transient Psychotic Disorder (ATPD) – Elimination of ICD-10 Types – Essential features include rapid onset, polymorphic presentation – Single episode and Recurrent l Deletion of Induced Delusional Disorder l Addition of separate diagnostic grouping for Catatonia: – Associated with other mental disorder, – Due to disorder classified elsewhere – Unknown 68 | Lille, France | 29 January 2014

Possible Field Trial Questions for Psychotic Disorders l Do clinicians find deletion of traditional subtypes of schizophrenia problematic? l Are symptom ratings likely to be clinically useful? Are they feasible in global settings (e. g. , assessment of cognitive symptoms)? l Can clinicians reliably distinguish a first episode, and is this clinically useful in terms of management? l Is anything lost by deletion of various acute and transient psychotic disorder categories? 69 | Lille, France | 29 January 2014

Phase 1 l Similar to Stress Disorders designs l Series of paired vignette comparisons across ICD-10 versus ICD-11 l 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) 70 | Lille, France | 29 January 2014

Phase 1 1. Schizophrenia vs. Schizoaffective disorder 2. Schizoaffective vs. Depressive episode with psychotic features 3. Schizoaffective vs. Manic episode with psychotic features 4. Schizotypal vs. Schizophrenia 5. Delusional disorder vs. Schizophrenia 6. Delusional disorder vs. normality 7. Acute & transient psychotic disorder vs. Acute stress reaction 8. Acute & transient psychotic disorder vs. schizophrenia of too short duration 71 | Lille, France | 29 January 2014

Phase 2 l Moving towards specifying individual symptoms across 6 domains (positive, negative, depressive, manic, psychomotor, cognitive) l What rating method is more consistently used by clinicians and reported as more clinically useful? – Dichotomous (present/absent) – Polytomous (absent, subthreshold, mild, moderate, severe) 72 | Lille, France | 29 January 2014

Phase 2 73 | Lille, France Vig 1 Di then Poly Vig 2 Vig 3 Vig 4 Vig 5 Poly then Di | Second Rating Counterbalance 29 January 2014 Randomization Intro Randomization First Rating

Example l Which of the following were present in the vignette? Absent Positive Negative Depressive Manic Psychomotor Cognitive 74 | Lille, France | 29 January 2014 Sub Mild Moderate Severe

Phase 2 l Can determine accuracy and reliability for clinicians’ use of each kind of scale l Best method across all vignettes will be used for further studies (Phases 3 & 4) and potentially adopted for ICD-11 75 | Lille, France | 29 January 2014

Phase 3 l ICD-10 included subtypes for Schizophrenia l ICD-11 will use rating scales instead l 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 l Can also test DSM-5 rating scale which uses slightly different domains 76 | Lille, France | 29 January 2014

Phase 3 Pair 1 Counterbalance DSM 5 Forward Back Pair 2 Randomization ICD 11 Randomization Intro Randomization ICD 10 Pair 3 Pair 4 Pair 5 Pair 6 77 | Lille, France | 29 January 2014

Phase 3 l Clear-cut cases should have equivalent reliability and goodness of fit across diagnostic systems. l ICD-11 (and DSM-5) should have superior reliability and goodness of fit over ICD-10 on unclear cases. 78 | Lille, France | 29 January 2014

Phase 4 l In Phase 3, participants receive no special training in how to use the new symptom specifier rating scales l Is training necessary in the new system? Would it improve clinicians’ use of the system? 79 | Lille, France | 29 January 2014

Phase 4 l Participants would walk through a training program (offering them feedback on their ratings) l Could test them on the most and least reliable cases from Phase 3 or on all cases l Participants from Phase 3 that completed ICD-11 condition would act as control group (no training) 80 | Lille, France | 29 January 2014

Psychotic Disorders Summary l Electronic survey vignette methodology is able to answer a wide variety of questions l For Psychotic Disorders, can answer: End Start 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 – – 81 | Lille, France | Phase 1 Phase 2 N = 1015 N = 330 Phase 3 N = 972 Total N = 2422 29 January 2014 Phase 4 N = 105

Déploiement des études sur le terrain 82 | Lille, France | 29 January 2014

Clinic-Based Field Studies l 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? 83 | Lille, France | 29 January 2014

Examples of Field Study Research Questions l Are the proposed diagnostic guidelines easy to understand use? (utility – feasibility) l Do the proposed diagnostic guidelines accurately reflect or capture patients’ symptom presentations? (utility – goodness of fit) l Are the proposed diagnostic guidelines and specifiers useful/ helpful in formulating of treatment plans for patients? (utility) 84 | Lille, France | 29 January 2014

Examples of Field Study Research Questions l Do the proposed diagnostic criteria capture the patients’ symptom presentation consistently over time and across clinicians? (test-retest reliability; inter-rater reliability) l Is there convergent validity of diagnoses with expert panel reviews, or with other available external criteria? (validity) 85 | Lille, France | 29 January 2014

Clinic-Based Field Studies: How will they work? l 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 l Separate protocols for different types of studies (e. g. , psychotic disorders, substance use disorders, disorders specifically associated with stress) l Protocols will emphasize use in regular clinical practice l Participating network not be expected to participate in every study, only those for which they have capacity and interest 86 | Lille, France | 29 January 2014

Clinic-Based Field Studies Currently Underway l 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 l 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 87 | Lille, France | 29 January 2014

Field Studies Timeline l Protocols for clinic-based field studies in other areas will be developed and made available to participating Centers beginning Q 3 2014 l Internet-based data collection to be completed by end of 2014 l Clinic-based data collection to be completed by end of 2015 l Proposals will be revised based on field study data in time for submission for World Health Assembly approval in May, 2017 88 | Lille, France | 29 January 2014