Real-time evaluation and adaptation to facilitate rapid recruitment in a large cohort

ABSTRACT Objectives Recruiting large, diverse cohorts efficiently can speed the translation of findings into care across a range of scientific disciplines and medical specialties. Yet, efficient recruitment can be hampered by factors such as financial barriers, logistical concerns, and lack of resources for patients and clinicians. Here we use a case study of a large, prospective trial of a multi-cancer early detection test to describe how the study team tracked enrollment, protocol fidelity, and participant experience and iteratively adapted procedures. Methods While conducting a large, prospective trial of a multi-cancer early detection blood test at Geisinger, an integrated health system in central Pennsylvania, we monitored recruitment progress, fidelity to protocol procedures, and participants’ satisfaction. Tracking mechanisms such as paper records, electronic health records, research databases, dashboards, and electronic files were utilized to measure each outcome. We then reviewed study procedures and timelines to list the implementation strategies that were used to address barriers to recruitment, protocol fidelity and participant satisfaction. Results We enrolled 10,006 women ages 65-75 over 22 months. Adaptations to recruitment and enrollment methods that contributed to achieving the enrollment goal included adopting group consenting, improving visit convenience, increasing electronic capture and tracking of data and source documents, staffing optimization via leveraging resources external to the study team when appropriate, and integrating the disclosure of study results into routine clinical care without adding unfunded work for physicians. We maintained high protocol fidelity and positive participant experience as exhibited by a very low protocol deviation rate and a low number of participant complaints. Conclusion Recruiting rapidly for large studies – and thereby facilitating clinical translation – requires a nimble, creative approach that marshals available resources and changes course according to data. Planning a rigorous assessment of a study’s implementation outcomes prior to study recruitment can further ground study adaptations and facilitate translation into practice. This can be accomplished by proactively and continuously assessing and revising implementation strategies. Strengths and limitations of this study Synthesis and tracking of various data Real-time identification of necessary adaptations Mapping of adaptations to problems and consequences Analysis of results post-hoc Inability to analyze the value or impact of a single adaptation