How public involvement work is valued by Chief Investigators

Report
Prof Carrol Gamble
Dept Biostatistics
University of Liverpool

Qualitative team

Clinical trials team &/or quantitative analysis

Professional PPI representatives

Patient and Public Advisory Group
◦ Prof Bridget Young
◦ Louise Dudley
◦ Deborah Buck
◦ Carrol Gamble
◦ Paula Williamson
◦ Barbara Arch
◦ Jennifer Preston
◦ Bec Hanley
◦ Heather Bagley
◦
◦
◦
◦
◦
Alison Allam
Philip Bell
Heather Goodare
Alison Walker
Neil Formstone

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



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.
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
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



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
Subject 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

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
52%
PPI can be beneficial but is not always
necessary
43%
I am not convinced of the benefits of PPI 5%

During the preparation of your grant application,
when did you consider PPI?
 Immediately - before contact with the
53%
 When prompted by the clinical trials
unit (if involved)
10%
 When I read the relevant questions on
the funding application form
11%
clinical trials unit (if involved)
 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
 No

94%
6%
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
67%
59%
50%
5%
13%

Which PPI reps did you involve?






Patient
Carer
Parent
Charity member
Medical staff
Other
Most common ways identified
 Charity
 Patient support groups & voluntary
organisations
 Patient, parent, carer known to me
 Previous involvement in the trial
Uncommon
 Advertising
 PPI Network leads
 NHS Patient Advisory Liaison
67%
59%
50%
5%
13%
29%
30%
22%
46%
25%
0%
3%
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
TSC
Trial Management group
DMC
Separate PPI Advisory Group
26%
83%
30%
13%
20%

Frequency of contact with PPI rep?
Once a month
Once every 6 months
Once a year
Less than once a year
Other*
*

16%
51%
1%
1%
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
* 1 answered yes but did not complete impact question









Designing/commenting on PIS
Considering patient burden of participation
Determining outcomes to be measured
Considering visit schedules
Contributing to the recruitment process
Helping to pilot assessments
Considering length and nature of follow-up
Helping to develop research question
Other
84%
80%
46%
43%
41%
38%
36%
27%
23%
Trouble shooting recruitment issues
Advertising to raise trial profile
Actively involved in recruitment/
consent process
Data collection
Participant identification
Other*
* Meeting attendance e.g. TSC, TMG n=25
*revising documentation n=6
57%
27%
7%
7%
5%
53%

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

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
1%
4%
79%
13%
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 Investigator
 CTUs
 Advertising
 NIHR HTA email to TSC chairs
Number completed=31 respondents to 28 trials
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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

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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