How public involvement work is valued by Chief Investigators & Public and Patient Involvement representatives

1. How public involvement work is valued by Chief Investigators & Public and Patient Involvement representatives Prof Carrol Gamble Dept Biostatistics University of Liverpool

2. EPIC Research Team • Qualitative team • Prof Bridget Young • Louise Dudley • Deborah Buck • Clinical trials team &/or quantitative analysis • Carrol Gamble • Paula Williamson • Barbara Arch • Professional PPI representatives • Jennifer Preston • Bec Hanley • Heather Bagley • Patient and Public Advisory Group • Alison Allam • Philip Bell • Heather Goodare • Alison Walker • Neil Formstone

3. Evidence-base for Public Involvement in Clinical trials • Jointly funded by NIHR HS&DR and INVOLVE • Aims : To increase knowledge of PPI within RCTs • Systematically describe and critically evaluate the process and impact of PPI from the perspectives of • the PPI representative(s) • chief investigator • clinical trials unit (CTU) staff • To analyse features of RCTs and the processes of PPI associated with PPI impact • To provide an evidence base to inform the optimisation of PPI

4. Evidence-base for Public Involvement in Clinical trials • To really understand how to optimise PPI we need to understand current PPI processes to determine whether there is overall impact. • Establish empirical evidence on how PPI was actually implemented in its broadest form. • A systematic investigation of a cohort of Health Technology Assessment funded clinical trials.

5. Phases • Cohort examination of planned PPI in trials funded by the Health Technology Assessment (HTA) (2006-2010) as described within applications for funding • Questionnaire Survey (CI, PPI)- opinions & what actually happened • Interviews- purposive sample • Examining the existing role and future role of RCTUs in identifying and supporting PPI needs

6. Phase 1: Cohort examination of planned PPI in trials funded by the Health Technology Assessment (HTA) • Systematically review PPI as it is described in RCT applications funded by the HTA. • Determine whether peer reviewers of HTA applications comment on proposed PPI by examining reviewers’ and Board comments and subsequent responses. • Extract data from 111 HTA funded applications between 2006-2010 • PPI and trial descriptors

7. Phase 1:summary of 1st stage of application • Approx 50% consider PPI within the early stages of the development of the research, • Only a 25% described PPI within the development of the 1st stage application itself • Evidence of risk-based approach • particular conditions, and design considerations, impact on whether PPI is likely to be considered within the early stages of development • Insufficient consideration of PPI at the early stages by funding Boards

8. Phase 2: Questionnaire surveys • Survey of Chief Investigators & PPI representatives • Opinions • Methods of engagement • Views on the areas of the trial that PPI impacted upon

9. Preliminary results Subject to change

10. CI Survey- 81repondents (73%) • In general what is your personal view on patient and public involvement (PPI),irrespective of funding requirements? • PPI should always be incorporated in a research study • PPI can be beneficial but is not always necessary • I am not convinced of the benefits of PPI

11. CI Survey- 81repondents (73%) • In general what is your personal view on patient and public involvement (PPI),irrespective of funding requirements? • PPI should always be incorporated 52% in a research study • PPI can be beneficial but is not always 43% necessary • I am not convinced of the benefits of PPI 5%

12. During the preparation of your grant application, when did you consider PPI? • Immediately - before contact with the 53% clinical trials unit (if involved) • When prompted by the clinical trials 10% unit (if involved) • When I read the relevant questions on 11%the funding application form • Cannot remember when I considered PPI 9% • Did not consider PPI as far as I can remember 4% • Other 14%

13. Did you include PPI at any stage of the trial (from design to dissemination)? • Yes • No • What motivated you to include PPI? • It is the right thing to do • Previous experience of the benefits • Requirement of funding • PPI rep offered their help • Other

14. Did you include PPI at any stage of the trial (from design to dissemination)? • Yes 94% • No 6% • What motivated you to include PPI? • It is the right thing to do 67% • Previous experience of the benefits 59% • Requirement of funding 50% • PPI rep offered their help 5% • Other 13%

15. Which PPI reps did you involve? • Patient67% • Carer 59% • Parent50% • Charity member5% • Medical staff13% • Other 29% Most common ways identified • Charity 30% • Patient support groups & voluntary organisations 22% • Patient, parent, carer known to me 46% • Previous involvement in the trial 25% Uncommon • Advertising 0% • PPI Network leads 3% • NHS Patient Advisory Liaison 1%

16. Did you provide a clear description to the PPI rep outlining role & expectations?

17. Did you provide a clear description to the PPI rep outlining role & expectations? • Yes 71% • In what capacity was the PPI rep associated with trial? • Co-applicant 26% • TSC 83% • Trial Management group 30% • DMC 13% • Separate PPI Advisory Group 20%

18. Frequency of contact with PPI rep? • Once a month 16% • Once every 6 months 51% • Once a year 1% • Less than once a year 1% • Other* 29% * often describing variability in frequency • Do you feel training should be given to researchers to help them to support PPI reps? • Yes 79%

19. CI opinion on level of impact of PPI * 1 answered yes but did not complete impact question

20. How PPI was involved in trial setup • Designing/commenting on PIS 84% • Considering patient burden of participation 80% • Determining outcomes to be measured 46% • Considering visit schedules 43% • Contributing to the recruitment process 41% • Helping to pilot assessments 38% • Considering length and nature of follow-up 36% • Helping to develop research question 27% • Other 23%

21. How PPI involved in trial conduct • Trouble shooting recruitment issues 57% • Advertising to raise trial profile 27% • Actively involved in recruitment/ 7% consent process • Data collection 7% • Participant identification 5% • Other* 53% *Meeting attendance e.g. TSC, TMG n=25 *revising documentation n=6

22. Do you advertise to potential trial participants that PPI reps have contributed to the trial? • Yes 22% • As a result of your experience with PPI in this trial, would you want to include PPI again in future trials? • Yes, but only if it was a requirement of funding • Yes, if adequate resources are available • Yes PPI makes a valuable contribution to the research process • If it was considered appropriate, I don’t believe it is always necessary • No

23. Do you advertise to potential trial participants that PPI reps have contributed to the trial? • Yes 22% • As a result of your experience with PPI in this trial, would you want to include PPI again in future trials? • Yes, but only if it was a requirement of funding 1% • Yes, if adequate resources are available 4% • Yes PPI makes a valuable contribution to the 79% research process • If it was considered appropriate, I don’t believe 13% it is always necessary • No 1%

24. Problem • Have you contacted your PPI rep for this trial and asked them to contact us so they maybe sent information about taking part in EPIC? • Yes 24% (n=19) • Approaches to contact • Chief Investigator • CTUs • Advertising • NIHR HTA email to TSC chairs Number completed=31 respondents to 28 trials

25. EPIC Event • 28th February 2014 (provisional) • Dissemination of EPIC results • Key note presentations from other key PPI projects • Target audience- all stakeholders • Funders, trialists, CTU staff, PPI reps

26. Funding Acknowledgement:This project was funded by the National Institute for Health Research HS&DR (project number 10/2001/29) Department of Health Disclaimer:The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HS&DR programme, NIHR, NHS or the Department of Health