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Prof Carrol Gamble Dept Biostatistics University of Liverpool.

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Presentation on theme: "Prof Carrol Gamble Dept Biostatistics University of Liverpool."— Presentation transcript:

1 Prof Carrol Gamble Dept Biostatistics University of Liverpool

2  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  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  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 1.Cohort examination of planned PPI in trials funded by the Health Technology Assessment (HTA) ( ) as described within applications for funding 2.Questionnaire Survey (CI, PPI)- opinions & what actually happened 3.Interviews- purposive sample 4.Examining the existing role and future role of RCTUs in identifying and supporting PPI needs

6  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 ◦ PPI and trial descriptors Phase 1: Cohort examination of planned PPI in trials funded by the Health Technology Assessment (HTA)

7  Approx 50% consider PPI within the early stages of the development of the research,  Only a 25% described PPI within the development of the 1 st 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  Survey of Chief Investigators & PPI representatives ◦ Opinions ◦ Methods of engagement ◦ Views on the areas of the trial that PPI impacted upon

9 Subject to change

10  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  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%  No6%  What motivated you to include PPI?  It is the right thing to do67%  Previous experience of the benefits59%  Requirement of funding50%  PPI rep offered their help 5%  Other 13%

15  Which PPI reps did you involve?  Patient67%  Carer59%  Parent50%  Charity member 5%  Medical staff13%  Other29% 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  Yes 71%  In what capacity was the PPI rep associated with trial?  Co-applicant26%  TSC83%  Trial Management group30%  DMC13%  Separate PPI Advisory Group20%

18  Frequency of contact with PPI rep?  Once a month16%  Once every 6 months51%  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 Stage of involvementYes % nHigh % Moderate % Low % None % Trial set up Trial conduct Data analysis75* Dissemination * 1 answered yes but did not complete impact question

20  Designing/commenting on PIS84%  Considering patient burden of participation80%  Determining outcomes to be measured46%  Considering visit schedules43%  Contributing to the recruitment process41%  Helping to pilot assessments38%  Considering length and nature of follow-up36%  Helping to develop research question27%  Other23%

21  Trouble shooting recruitment issues57%  Advertising to raise trial profile27%  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  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 to TSC chairs Number completed=31 respondents to 28 trials

25  28 th 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


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