Impact of patient and public involvement on enrolment and retention in clinical trials: systematic review and meta-analysis [患者和公众参与对临床试验中登记和保留的影响：系统综述和荟萃分析]

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BMJ 2018; 363 doi: https://doi.org/10.1136/bmj.k4738 (Published 28 November 2018)
Cite this as: BMJ 2018;363:k4738

Linked opinion
Time to embrace patient involvement in clinical trials?
“Researchers don’t know what they’re missing”—the impact of patient involvement in research

Authors
Joanna C Crocker, Ignacio Ricci-Cabello, Adwoa Parker, Jennifer A Hirst, Alan Chant, Sophie Petit-Zeman, David Evans, Sian Rees

Abstract
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.