Patient engagement and shared decision-making in trial recruitment intervention studies: a systematic review.

backgroundSupporting participation decisions and experiences in clinical trials is a persistent challenge that could be improved by two areas: patient engagement (PE), which involves actively collaborating with patients to enhance research relevance and value, and shared decision-making (SDM), which involves helping individuals make evidence-informed, values-based decisions about participation. The extent to which PE and SDM have informed trial recruitment interventions has not been synthesized.

objectivesWe aimed to explore (1) how PE informed recruitment interventions, both in general and among equity-deserving populations, and whether demographic differences existed between studies using and not using PE, and (2) how SDM has informed recruitment interventions, both in general and among equity-deserving populations.

methodsWe identified randomized and quasi-randomized recruitment intervention studies from a prior Cochrane review and the Online Resource for Research in Clinical triAls database. We assessed recruitment interventions for reporting of PE and coded the level at which PE occurred ('substantive engagement', 'limited engagement', 'both', 'unclear', or 'no engagement') and the areas in which PE occurred (development of the research question, intervention design, selecting outcomes, dissemination/implementation, or 'other'). We coded SDM across six domains: providing information about options, probabilities, clarifying outcomes, guidance in deliberation, using evidence, and disclosure and transparency.

resultsOf the 122 recruitment intervention studies included, 37 (30.3%) reported PE, although limited engagement was most common (n = 22; 59.5%). PE was most often used in designing the recruitment intervention (n = 32; 86.5%) followed by 'other' (n = 11; 29.7%; e.g., PE supporting participant recruitment efforts), developing the research question (n = 2; 5.4%), selecting outcomes (n = 3; 8.1%), and dissemination/implementation (n = 3; 8.1%). SDM was occasionally reported (n = 25; 20.5%), most commonly as 'providing information about options' (n = 11; 9.0%). Equity-deserving populations were the focus of 24 studies (19.7%); 11 of these also used PE (9.0%).

conclusionsEfforts to improve trial participation have not been informed by literature around patient lived experiences. Recruitment interventions infrequently reported any PE and occasionally mentioned SDM. When PE was mentioned, it was usually limited. These results hold among studies involving equity-deserving populations. Greater consideration of PE and SDM could enhance trial recruitment, research impact, trial participation experiences, and equity in trial recruitment.