1. Developing User-Valued Outcome Measures in Mental Heath Diana Rose, PhD Co-Director Service User Research Enterprise (SURE) Institute of Psychiatry Kings College London

2. The claim of neutrality in RCTs RCTs considered the gold standard in medicine Neutrality depends on blinding But is everything in an RCT neutral? Outcome measures are devised by clinicians and academics May not be the outcomes that matter to service users Try to develop measures that are valued by service users (and others) in mental health

3. What is special about mental health? Uniquely in medicine, people with mental health problems may be detained and treated against their will Has led to strong service user input to research as well as service development General medicine – outcomes agreed –as between patients and clinicians – survival rates and quality of life Mental health service users may not agree on either outcomes or methods in research For example, symptom relief Prized by academics and clinicians May not be for service users

4. The Service User Research Enterprise (SURE) Team of 10 people located at the Institute of Psychiatry, Kings College London Majority are or have been mental health service users – insider knowledge IoP not an easy place to be although more welcoming than the warnings I got before I went there Aims to do research from the service user perspective and to bring about change in treatments and services

5. SUREs New Methods Consumer-centred systematic reviews Electroconvulsive shock therapy (ECT) New anti-depressant medication Participatory research To reduce the power relations between researcher and researched Researchers are service users This method used to develop user-valued outcome measures – many examples now Jo and Caroline will describe the most recent in the poster session Acute care study used the method with nurses as well

6. Attitude measures in social sciences Begin with focus groups Stratified sampling Market research agencies find participants Fairly low status in the development of an attitude scale Different to the use of focus groups in user-focused research

7. Overview of methods to develop user-valued outcome measures All involved are service users including the researchers Reference group - some research expertise Focus groups – but sampled from people who have experience of the treatment or service under investigation Expert panels Feasibility Psychometric testing

8. Focus Groups Made up of participants who have experienced the treatment or service in question Reference group drafts topic guide Pilot: to refine topic guide Main groups meet twice Wave 1: discuss own experience facilitated by the topic guide Transcribed and analysed with Nvivo Wave 2: respondent validation and further discussion

9. User Researchers Role Full qualitative analysis Inter-rater reliability Generate draft questionnaire Use own experience

10. Expert Panels One comprising people who had been in the focus groups and one independent All have received the treatment or service we are investigating Experts in their own experience Role of Expert Panels is to comment on draft measure, add or delete items Close attention to the language used – is it the language of service users? Can be quite a lot of changes made at this stage

11. Feasibility Draft measure tested with ~ 40 people to see if it is; Easy to complete In their language Comprehensive for them Usually still some changes eg to wording Feasibility study makes changes to the measure as it proceeds

12. Reference Group Reference group meets for the second time at the conclusion of measure construction Opportunity to make final changes

13. Psychometrics from field trial samples The measure is now considered complete and ready for psychometric testing Use the criteria developed by HTA (Fitzpatrick et al) as more comprehensive than traditional psychometrics Qualitative as well as quantitative Test on a field trial sample usually recruited from other parts of large projects

14. Test-retest reliability Independent sample of service users ~ 50 people Complete measure twice with 1 or 2 week interval between T1 and T2 Mostly our measures found to be reliable Might think too difficult, for example, for people with psychoses But does seem to work

15. Criterion validity Usually no gold standard because our measures have been generated in a novel way Compare our measures with others to identify points of similarity and difference For example, continuity of care – peer support

16. HTA – Qualitative criteria Acceptability (to users and as a measure itself) Asked: Is it easy to complete? Was it upsetting to fill in? Did you enjoy filling it in? Generally our measures are acceptable to our respondents

17. More on participation For most research, participants never know what happens to the information they give We feed back results Presentations to groups of participants / user groups A newsletter The little things Thank you cards Christmas cards Ask people if they are proud of the results of their efforts – almost always say yes.

18. Examples of studies where this methodology has been used Continuity of care (in press) Satisfaction with Cognitive Remediation Therapy for People with Schizophrenia (published) Satisfaction with CBT for Psychosis Experiences of acute in-patient care – ongoing – poster presentation this afternoon The acute care study also used the same method with nurses

19. Challenges to user-led research 1 Frank Scepticism Peter Tyrer, editor of the British Journal of Psychiatry, writes: The engine of user involvement, while welcome in principle,……….may drive mental health research into the sand.

20. Challenges 2 - Power Most of the projects we have been involved with are collaborative Nearly always headed up by professor(s) of psychiatry Can undermine user researchers Are you a researcher or are you a patient?

21. Challenges 3 – the charge of bias Said, mostly implicitly, that user-research is biased, anecdotal and carried out by people who are over- involved – ENMESH conference We make no pretence of neutrality But all research comes from a certain standpoint User researchers more explicit about this than mainstream researchers In my opinion the word bias should be banished from research discourse and all researchers should clearly say where they are coming from.

22. Conclusion It is possible to develop psychometrically robust measures completely from the perspective of service users This is a form of participatory research – rarely used in mental health New in participatory research itself as the researchers belong to the same community as the participants – they too are mental health service users.