Impact of patient and public involvement on enrolment and retention in clinical trials: systematic review and meta-analysis.

OBJECTIVE: To investigate the impact of patient and public involvement (PPI) on rates of enrolment and retention in clinical trials and explore how this varies with the context and nature of PPI. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Ten electronic databases, including Medline, INVOLVE Evidence Library, and clinical trial registries. ELIGIBILITY CRITERIA: Experimental and observational studies quantitatively evaluating the impact of a PPI intervention, compared with no intervention or non-PPI intervention(s), on participant enrolment and/or retention rates in a clinical trial or trials. PPI interventions could include additional non-PPI components inseparable from the PPI (for example, other stakeholder involvement). DATA EXTRACTION AND ANALYSIS: Two independent reviewers extracted data on enrolment and retention rates, as well as on the context and characteristics of PPI intervention, and assessed risk of bias. Random effects meta-analyses were used to determine the average effect of PPI interventions on enrolment and retention in clinical trials: main analysis including randomised studies only, secondary analysis adding non-randomised studies, and several exploratory subgroup and sensitivity analyses. RESULTS: 26 studies were included in the review; 19 were eligible for enrolment meta-analysis and five for retention meta-analysis. Various PPI interventions were identified with different degrees of involvement, different numbers and types of people involved, and input at different stages of the trial process. On average, PPI interventions modestly but significantly increased the odds of participant enrolment in the main analysis (odds ratio 1.16, 95% confidence interval and prediction interval 1.01 to 1.34). Non-PPI components of interventions may have contributed to this effect. In exploratory subgroup analyses, the involvement of people with lived experience of the condition under study was significantly associated with improved enrolment (odds ratio 3.14 v 1.07; P=0.02). The findings for retention were inconclusive owing to the paucity of eligible studies (odds ratio 1.16, 95% confidence interval 0.33 to 4.14), for main analysis). CONCLUSIONS: These findings add weight to the case for PPI in clinical trials by indicating that it is likely to improve enrolment of participants, especially if it includes people with lived experience of the health condition under study. Further research is needed to assess which types of PPI work best in particular contexts, the cost effectiveness of PPI, the impact of PPI at earlier stages of trial design, and the impact of PPI interventions specifically targeting retention. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42016043808.

Patients/carers and clinicians can set joint priorities for research in cleft lip and palate.

The James Lind Alliance is a not-for-profit organisation that was established in 2004 in the United Kingdom with financial support from the Medical Research Council and the Department of Health. It brings together patients, carers and clinicians to identify and prioritise the uncertainties, or 'unanswered questions,' about the effects of treatments that they agree are most important. This information helps to ensure that those who fund health research are aware of what matters to both patients and clinicians. The James Lind Alliance has now facilitated these "priority setting partnerships" in several conditions as diverse as asthma and schizophrenia, and recently completed a partnership to gather and prioritise unanswered questions relating to clefts of the lip and/or palate, working with those affected, their parents/carers and healthcare professionals. As the James Lind Alliance prepares to transfer to a new home within the National Institute for Health Research Evaluation, Trials and Studies Coordinating Centre, this article tells the story of the James Lind Alliance based on a presentation given by Lester Firkins at the European Society of Paediatric Otolaryngology in Amsterdam, May 2012, entitled "Who's life is it anyway?" and the completion of the James Lind Alliance Priority Setting Partnership in cleft lip and palate research.

"Natural ground" for medical research charities: public and patient involvement in research funding.

Improving patient and public involvement in research is now an established goal of UK science policy. With many medical research charities often representing distinct patient groups as part of their broader charitable role, or having strong patient groups allied to them, patient and public involvement would seem "natural ground" for them. The Association of Medical Research Charities Natural Ground project brought together a learning set of staff and volunteers from member organizations to discuss current activities and share best practice. This article identifies 5 areas where medical research charities involve patients and discusses some of the methods used.