A systematic review of non-randomised evaluations of strategies to improve participant recruitment to randomised controlled trials [version 1; peer review: 1 approved, 2 approved with reservations]

Background: Recruitment to trials can be challenging. Currently, non-randomised evaluations of trial recruitment interventions are rejected due to poor methodological quality, but systematic assessment of this substantial body of work may inform trialists’ decision-making about recruitment methods. Our objective was to quantify the effects of strategies to improve participant recruitment to randomised trials evaluated using non-randomised study designs. Methods: We searched relevant databases for non-randomised studies that included two or more interventions evaluating recruitment to trials. Two reviewers screened abstracts and full texts for eligible studies, then extracted data on: recruitment intervention, setting, participant characteristics, number of participants in intervention and comparator groups. The ROBINS-I tool was used to assess risk of bias. The primary outcome was the number of recruits to a trial. Results: We identified 92 studies for inclusion; 90 studies aimed to improve the recruitment of participants, one aimed to improve the recruitment of GP practices, and one aimed to improve recruitment of GPs. Of the 92 included studies, 20 were at high risk of bias due to confounding; the remaining 72 were at high risk of bias due to confounding and at least one other category of the ROBINS-I tool. The 20 studies at least risk of bias were synthesised narratively based on seven broad categories; Face to face recruitment initiatives, postal invitations and responses, language adaptations, randomisation methods, trial awareness strategies aimed at the recruitee, trial awareness strategies aimed at the recruiter, and use of networks and databases. The utility of included studies is substantially limited due to small sample sizes, inadequate reporting, and a lack of coordination around deciding what to evaluate and how. Conclusions: Careful thought around planning, conduct, and reporting of non-randomised evaluations of recruitment interventions is required to prevent future non-randomised studies contributing to research waste. Registration: PROSPERO CRD42016037718