EPIC overview

Carrol Gamble
Jenny Newman
Heather Bagley
Bec Hanley
Why this project?
Project phases and aims
Project model of PPI
Experience of applying for clinical trials
What do we expect PPI to bring?
What role can/should CTUs play in optimising
To really understand how to optimise PPI we need
to understand current PPI processes to determine
whether there is overall impact.
There is a need to link levels and quality of
involvement to impact.
The assessment of impact is difficult due to the
complexity of PPI.
Establish empirical evidence on how PPI was
actually implemented in its broadest form.
◦ Selective reporting of PPI aimed to ‘make the case’ or
‘convince the sceptics’ about PPI
Full title of project: An evidence base to optimise
Aims : To increase knowledge of PPI within RCTs
Our overall aim is to provide an evidence base
that will inform the optimisation of PPI.
methods for involving patient and public
representatives in clinical trials: a systematic
investigation of a cohort of Health Technology
Assessment funded clinical trials.
by systematically describing and critically
evaluating the process and impact of PPI from the
perspectives of the PPI representative, chief
investigator and clinical trials unit (CTU) staff. To
analyse features of RCTs and the processes of PPI
associated with PPI impact.
Systematically review PPI as it is described in
RCT applications funded by the Health
Technology Assessment (HTA).
Determine whether peer reviewers of HTA
applications comment on proposed PPI by
examining reviewers’ and Board comments
and subsequent responses.
Extracting data from HTA funded applications
between 2006-2010
◦ PPI and trial descriptors
Survey of PPI representatives, Chief Investigators, trial
How PPI rep identified. Characteristics
Ongoing PPI process. Have plans changed?
Previous experience of providing PPI
Training and support given to PPI rep and measure of
its usefulness
Views on the areas of the trial that PPI impacted
◦ design, conduct, analysis and dissemination. Including
specification of the research question and comparators,
outcomes, data collection procedures, consent process and
patient information sheets, visit schedules and length and
nature of follow up.
Purposive sample based on Phases 1 and 2
◦ RCTs with contrasting features;
◦ PPI representatives and CIs with different
experiences of PPI;
◦ Triangulate the accounts at a trio level (TC, CI and
PPI) and participant group level regarding the PPI
process and impact.
Does PPI differ from that planned, in what ways and why?
◦ Investigate researchers’ views and experiences of PPI, including how they selected PPI
reps to be involved, which aspects of the trial they sought PPI input on, which areas
of the trial had been influenced as a result of PPI.
◦ Explore PPI reps views and experiences of involvement in research within the HTA
cohort, including the ways in which they perceive their contribution to RCTs and
whether their involvement led to changes in design (including outcome
measurement), conduct, analysis or dissemination plans.
◦ identify perceived barriers to PPI and impact of PPI on trial design.
Explore PPI reps prior experience of contributing to research, and
whether this influences their views of their impact on the trial
Ascertain what training or support is offered to PPI representatives and
its value, including whether they are provided with INVOLVE guidance
documents or other materials. Use this information to establish a
minimum core set of materials to facilitate PPI.
Trials coordinated by a RCTU flagged in Phase 1
Identify current RCTU approach to PPI in terms of the
level of PPI, identification of PPI reps, support
offered, and costing models used
Trials grouped by RCTU to look for commonality or
differences of approaches used across trials within a
◦ Is the level of PPI in response to a risk assessment of the trial
◦ RCTU has a policy on PPI
Working group to strengthen the role RCTUs
undertake in PPI in the trials they coordinate and
identify training needs within RCTUs to facilitate PPI
PPI Coordinator
Jenny Newman
Project Management
Dr Carrol Gamble; Prof
Paula Williamson; Prof
Bridget Young; Jenny
Newman; Heather Bagley
PPI Project Advisors
Project Steering Group
Bec Hanley; Heather
Bagley; Gill Gyte
Prof Ann Jacoby; Prof Jennie
Popay; 2 PPI Reps; CTU
Director; Clinician
PPI Advisory Group
Heather Bagley (Chair) 5
PPI Reps
Phase 1 –The study
•Meet the team
•Learn about the project and look at a selection of Health Technology Assessment (HTA)
Applications and yearly reports focusing on PPI progress within studies
•Comment on the framework for analysis of PPI
•Consider how PPI in this project should be evaluated
Phase 2- questionnaire survey
•Help develop content of the survey
•Comment on analysis
Phase 3 – qualitative exploration of PPI with sample of respondents
•Comment on interview schedule
•Comment on analysis
Phase 4-current and future role of CTU’s in supporting PPI
•Map PPI activities in CTU’s/strategies/remit etc
•Attend CTU meetings
•Review CTU reports on PPI
•Key role in the dissemination event
Regular emails and teleconferences held to
discuss project and set up of PPI Advisory
Remit & Role Description developed for PPI
Advisory Group
Currently recruiting for PPI Advisory Group
INVOLVE/HSR EPIC Project: Exploring the evidence base for Patient and public
involvement Impact on Clinical trials
Member of the Patient and Public Advisory Group
The EPIC study aims to explore the impact of patient and public involvement (PPI) in clinical
trials. We will be looking at trials that have been funded by the NIHR Health Technology
Assessment Programme to see what PPI was planned and then what actually took place.
We’ll be asking researchers and patients/members of the public who were involved for their
views. We will also be whether and how clinical trials units support PPI. Finally, we’ll be
looking at the impact of PPI in deciding which outcomes trials should measure.
The EPIC team are currently looking for five members to join this Advisory Group. We are
particularly interested in receiving applications from patients, service users or carers with
experience of being actively involved in clinical trials – for example as a member of a trial
management group or clinical studies group.
Members of the Advisory Group will play a key role in shaping and informing each phase of
study design, working alongside the already established Patient and Public Involvement
(PPI) team.
All members are required to have:
Current knowledge and understanding of clinical trials
Experience of active involvement in a trial (e.g. as a member of a trial management
An understanding of confidentiality in relation to research
Ability to travel to Liverpool for five meetings during the lifetime of the project (it will
finish at the end of 2013)
Ability to work effectively in a group situation
A willingness to act as an ambassador for the project (includes being named on the
project website and a willingness to tell others about the project, where appropriate)
Good communication skills with an ability to listen to others and constructively
express a lay view beyond their own personal experience
For full details of the role and project description please download the role description and
application form. (form)
If you are interested in applying to join this group please email Jenny Newman:
[email protected] or alternatively call 0151 282 4534.
The deadline for applications is 23rd March 2012. Successful applicants will be invited for a
telephone interview on the 5th April.

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