Models and impact of patient and public involvement in studies carried out by the Medical Research Council Clinical Trials Unit at University College London: findings from ten case studies

Abstract

BackgroundPatient and public involvement (PPI) in studies carried out by the UK Medical Research Council Clinical Trials Unit (MRC CTU) at University College London varies by research type and setting. We developed a series of case studies of PPI to document and share good practice.MethodsWe used purposive sampling to identify studies representing the scope of research at the MRC CTU and different approaches to PPI. We carried out semi-structured interviews with staff and patient representatives. Interview notes were analysed descriptively to categorise the main aims and motivations for involvement; activities undertaken; their impact on the studies and lessons learned.ResultsWe conducted 19 interviews about ten case studies, comprising one systematic review, one observational study and 8 randomised controlled trials in HIV and cancer. Studies were either open or completed, with start dates between 2003 and 2011. Interviews took place between March and November 2014 and were updated in summer 2015 where there had been significant developments in the study (i.e. if the study had presented results subsequent to the interview taking place). A wide range of PPI models, including representation on trial committees or management groups, community engagement, one-off task-focused activities, patient research partners and participant involvement had been used. Overall, interviewees felt that PPI had a positive impact, leading to improvements, for example in the research question; study design; communication with potential participants; study recruitment; confidence to carry out or complete a study; interpretation and communication of results; and influence on future research.ConclusionsA range of models of PPI can benefit clinical studies. Researchers should consider different approaches to PPI, based on the desired impact and the people they want to involve. Use of multiple models may increase the potential impacts of PPI in clinical research.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1488-9) contains supplementary material, which is available to authorized users.

Stakeholder engagement to inform HIV clinical trials: a systematic review of the evidence

“…In contrast, fewer studies conducted stakeholder engagement in middle‐ (30 studies; 27.8%) 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100 and low‐income (nine studies; 8.3%) 101, 102, 103, 104, 105, 106, 107, 108, 109 countries. The location of stakeholder engagement could not be discerned in six studies (5.6%) 110, 111, 112, 113, 114, 115, and fifteen studies (13.9%) 16, 24, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128 conducted stakeholder engagement in multiple countries at different income levels.…”

Priorities for methodological research on patient and public involvement in clinical trials: A modified Delphi process

“…Although not all reviews focus specifically on clinical trials, trials are regarded as particularly likely to benefit from PPI by helping to address the many methodological issues that arise within trials . Most reviews of PPI echo similar concerns to those identified in the above paragraph, pointing to the need for: agreed tools for measuring PPI and its impact across the different phases of research, for investigations of how best to support PPI and for optimal models of implementing PPI . However, many of these topics have been identified by PPI researchers and it is unclear whether these priorities are shared by the wider community of trialists and PPI stakeholders.…”

“…Several of the top 10 prioritized research topics address concepts that are fundamental to PPI in clinical trials, such as productive working relationships, resources and how to adapt PPI models to avoid a one size fits all approach . Previous studies of PPI in clinical trials have particularly highlighted the importance of productive working relationships in creating the sort of environment to enable contributors to make a difference to research, whilst Barber et al., recommended considering PPI as a dynamic partnership rather than a procedural activity .…”

“…5 Most reviews of PPI echo similar concerns to those identified in the above paragraph, pointing to the need for: agreed tools for measuring PPI and its impact across the different phases of research, 15,24,26,27 for investigations of how best to support PPI 6,23,28 and for optimal models of implementing PPI. 29,30 However, many of these topics have been identified by PPI researchers and it is unclear whether these priorities are shared by the wider community of trialists and PPI stakeholders. Given the diversity of stakeholders involved in PPI, there is considerable potential for divergence in the prioritization of topics to investigate, and therefore for dilution of research efforts in investigating how to improve PPI in research.…”

Patient and public involvement facilitators: Could they be the key to the NHS quality improvement agenda?

“…Research into PPI has mainly focused on the mechanisms of PPI, the varying perspectives on PPI and the motivations of the patients and public involved . A large body of research focuses on PPI in health research, particularly in more recent years. However, the specific role of patient and public involvement facilitators (PPIFs) remains under‐researched.…”