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

Patient Involvement representatives Prof Carrol Gamble

Dept BiostatisticsUniversity of Liverpool

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

EPIC Research Team

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

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.

Evidence-base for Public Involvement in Clinical trials

1. Cohort examination of planned PPI in trials funded by the Health Technology Assessment (HTA) (2006-2010) 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

Phases

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

Phase 1: Cohort examination of planned PPI in trials funded by the Health Technology Assessment (HTA)

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

Survey of Chief Investigators & PPI representatives

◦ Opinions

◦ Methods of engagement

◦ Views on the areas of the trial that PPI impacted upon

Phase 2: Questionnaire surveys

Preliminary resultsSubject to change

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

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%

CI Survey- 81repondents (73%)

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%

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

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%

Which PPI reps did you involve? Patient 67% Carer 59% Parent 50% Charity member 5% Medical staff 13% 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%

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

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%

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%

Stage of involvement Yes%

n High%

Moderate%

Low%

None%

Trial set up 74 56 27 54 18 2

Trial conduct 82 62 15 44 39 3

Data analysis 7 5* 20 40 20 0

Dissemination 37 28 18 50 25 7

CI opinion on level of impact of PPI

* 1 answered yes but did not complete impact question

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-up36% Helping to develop research question

27% Other

23%

How PPI was involved in trial setup

Trouble shooting recruitment issues 57%Advertising to raise trial profile 27%Actively involved in recruitment/

7% consent processData collection 7%Participant identification 5%Other*

53%

* Meeting attendance e.g. TSC, TMG n=25*revising documentation n=6

How PPI involved in trial conduct

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 processIf it was considered appropriate, I don’t believe it is always necessaryNo

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 processIf it was considered appropriate, I don’t believe

13% it is always necessaryNo 1%

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 InvestigatorCTUsAdvertisingNIHR HTA email to TSC chairs

Number completed=31 respondents to 28 trials

Problem

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

EPIC Event

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