E vidence-base for - PowerPoint Presentation

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Evidence-base for Public Involvement in Clinical trials (EPIC)

Carrol Gamble

Jenny Newman

Heather Bagley

Bec HanleySlide2

Why this project?Project phases and aimsProject model of PPI OutlineSlide3

Experience of applying for clinical trials fundingWhat do we expect PPI to bring?What role can/should CTUs play in optimising PPI?Why this project?Slide4

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

An evidence base to optimise methods for involving patient and public representatives in clinical trialsSlide5

Full title of project: An evidence base to optimise methods for involving patient and public representatives in clinical trials: a systematic investigation of a cohort of Health Technology Assessment funded clinical trials.Aims : To increase knowledge of PPI within RCTs 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.

Our overall aim is to provide an evidence base that will inform the optimisation of PPI. Slide6

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 2006-2010PPI and trial descriptors

Phase 1: Systematic investigation of levels of PPI planned in trials funded by the Health Technology AssessmentSlide7

Survey of PPI representatives, Chief Investigators, trial coordinatorsHow PPI rep identified. CharacteristicsOngoing PPI process. Have plans changed?Previous experience of providing PPITraining and support given to PPI rep and measure of its usefulnessViews on the areas of the trial that PPI impacted upon

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.

Phase 2: Questionnaire SurveySlide8

Purposive sample based on Phases 1 and 2RCTs 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.

Phase 3-InterviewsSlide9

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 concerned.

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.

Phase 2 and 3 Slide10

Trials coordinated by a RCTU flagged in Phase 1Identify current RCTU approach to PPI in terms of the level of PPI, identification of PPI reps, support offered, and costing models usedTrials grouped by RCTU to look for commonality or differences of approaches used across trials within a RCTU.Is the level of PPI in response to a risk assessment of the trial characteristicsRCTU has a policy on PPIWorking group to strengthen the role RCTUs undertake in PPI in the trials they coordinate and identify training needs within RCTUs to facilitate PPI

Phase 4: Examining the existing role and identifying future role of RCTUs in identifying and supporting PPI needsSlide11

PPI Structure

Project Management Group

Dr Carrol Gamble; Prof Paula Williamson; Prof Bridget Young; Jenny Newman; Heather Bagley

PPI Project Advisors

Bec Hanley; Heather Bagley; Gill Gyte

PPI Advisory Group

Heather Bagley (Chair) 5 PPI Reps

Project Steering Group

Prof Ann Jacoby; Prof Jennie Popay; 2 PPI Reps; CTU Director; Clinician

PPI Coordinator

Jenny Newman Slide12

Proposed roles of the PPI Advisory Group

Phase 1

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The study

Meet the team

Learn about the project and look at a selection of Health Technology Assessment (HTA) Applications and

y

early 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

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qualitative exploration of PPI with sample of respondents

Comment on interview schedule

Comment on analysis

Phase 4-current and future role of CTU

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s in supporting PPI

Map PPI activities in CTU

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s/strategies/remit etc

Attend CTU meetings

Review CTU reports on PPI

Key role in the dissemination eventSlide13

Regular emails and teleconferences held to discuss project and set up of PPI Advisory GroupRemit & Role Description developed for PPI Advisory GroupCurrently recruiting for PPI Advisory GroupProgress so farSlide14