Why this project? Project phases and aims Project model of PPI
Experience of applying for clinical trials funding What do we expect PPI to bring? What role can/should CTUs play in optimising PPI?
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 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.
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 ◦ PPI and trial descriptors
Survey of PPI representatives, Chief Investigators, trial coordinators 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 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.
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 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.
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 RCTU. ◦ Is the level of PPI in response to a risk assessment of the trial characteristics ◦ 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
Project Management Group Dr Carrol Gamble; Prof Paula Williamson; Prof Bridget Young; Jenny Newman; Heather Bagley 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 Project Advisors Bec Hanley; Heather Bagley; Gill Gyte PPI Advisory Group Heather Bagley (Chair) 5 PPI Reps PPI Advisory Group Heather Bagley (Chair) 5 PPI Reps Project Steering Group Prof Ann Jacoby; Prof Jennie Popay; 2 PPI Reps; CTU Director; Clinician Project Steering Group Prof Ann Jacoby; Prof Jennie Popay; 2 PPI Reps; CTU Director; Clinician PPI Coordinator Jenny Newman PPI Coordinator Jenny Newman
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 s and teleconferences held to discuss project and set up of PPI Advisory Group Remit & Role Description developed for PPI Advisory Group Currently recruiting for PPI Advisory Group