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Protocol for a qualitative study exploring perspectives on the INternational CLassification of Diseases (11th revision); Using lived experience to improve mental health Diagnosis in NHS England: INCLUDE study
  1. Corinna Hackmann1,
  2. Amanda Green1,
  3. Caitlin Notley2,
  4. Amorette Perkins1,
  5. Geoffrey M Reed3,
  6. Joseph Ridler1,
  7. Jon Wilson1,2,
  8. Tom Shakespeare2
  1. 1 Department of Research and Development, Norfolk and Suffolk NHS Foundation Trust, Hellesdon Hospital, Norwich, UK
  2. 2 Department of Clinical Psychology, Norwich Medical School, University of East Anglia, Norwich, UK
  3. 3 Department of Psychiatry, Global Mental Health Program, Columbia University Medical Centre, New York, New York, USA
  1. Correspondence to Dr Corinna Hackmann; Corinna.hackmann{at}


Introduction Developed in dialogue with WHO, this research aims to incorporate lived experience and views in the refinement of the International Classification of Diseases Mental and Behavioural Disorders 11th Revision (ICD-11). The validity and clinical utility of psychiatric diagnostic systems has been questioned by both service users and clinicians, as not all aspects reflect their lived experience or are user friendly. This is critical as evidence suggests that diagnosis can impact service user experience, identity, service use and outcomes. Feedback and recommendations from service users and clinicians should help minimise the potential for unintended negative consequences and improve the accuracy, validity and clinical utility of the ICD-11.

Methods and analysis The name INCLUDE reflects the value of expertise by experience as all aspects of the proposed study are co-produced. Feedback on the planned criteria for the ICD-11 will be sought through focus groups with service users and clinicians. The data from these groups will be coded and inductively analysed using a thematic analysis approach. Findings from this will be used to form the basis of co-produced recommendations for the ICD-11. Two service user focus groups will be conducted for each of these diagnoses: Personality Disorder, Bipolar I Disorder, Schizophrenia, Depressive Disorder and Generalised Anxiety Disorder. There will be four focus groups with clinicians (psychiatrists, general practitioners and clinical psychologists).

Ethics and dissemination This study has received ethical approval from the Coventry and Warwickshire HRA Research Ethics Committee (16/WM/0479). The output for the project will be recommendations that reflect the views and experiences of experts by experience (service users and clinicians). The findings will be disseminated via conferences and peer-reviewed publications. As the ICD is an international tool, the aim is for the methodology to be internationally disseminated for replication by other groups.

Trial registration number NCT03131505.

  • International Classification of Diseases
  • ICD-11
  • Personality Disorders
  • Anxiety Disorders

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  • Contributors CH is the chief investigator for this project and wrote the protocol. TS is supervising the project and helped to develop all aspects of the project. AG is the expert by experience on the research team, and led on developing the co-production, and the public and patient involvement. CN led the development of the methodology. AP had a specific contribution to the literature review. GMR is the WHO consultant for the project. GMR developed the original idea for the project and has had input into the development of the lay criteria. JR provided input to ethical considerations and the lay criteria. JW led on the development of the lay criteria. All authors supported the development and critical review of the protocol.

  • Competing interests None declared.

  • Ethics approval Coventry and Warwickshire HRA Research Ethics Committee (16/WM/0479).

  • Provenance and peer review Not commissioned; externally peer reviewed.

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