A concept analysis of 'trial recruitment' using the hybrid model

Abstract

Background: The International Committee of Medical Journal Editors (ICMJE) requires trials submitted for publication to be registered before recruitment of the first participant; however, there is ambiguity around the definition of recruitment and in anchoring the trial start date, end date, and recruitment, or as often interchangeably referred to, enrolment, temporally to trial processes. There is potential for variation in how recruitment is reported and understood in trial protocols and trial reports. We report on a concept analysis of 'trial recruitment' and develop an operational definition of 'trial recruitment'. Methods: A concept analysis using the hybrid model. In Phase 1 we examined randomised and non-randomised trial reports (n=150) published between January 2018 and June 2019 to conceptually explore how recruitment was temporally aligned to the four time-points of screening/eligibility, consent, randomisation and allocation. A preliminary operational definition of 'trial recruitment' was determined. This definition was further explored, refined and finalised in Phase 2 (field work), through an interactive, discussion-focused workshop with trial recruiters and trial participants. Results: Of the 150 trial reports analysed, over half did not identify a clear time point of when recruitment took place and varying terminology is used when reporting on trial recruitment. In Phase 2, the workshop attendees agreed that the proposed definition of 'trial recruitment' offers an acceptable definition that provides a standardised approach of how trial recruitment may be temporally understood as part of overall trial processes. Conclusion: There is ambiguity around temporal descriptions of 'trial recruitment' in health care journals. Informed by the findings of this concept analysis we propose a temporal operational definition of trial recruitment based on i) trial recruitment of an individual or cluster and ii) the trial recruitment period.

Keywords: Concept analysis; Trial enrolment; Trial recruitment; Trial report.

Figure 1.. Phases of the hybrid model of concept analysis .

Figure 2.. CONSORT flow diagram - edited to include the four time points analysed for this study.

Figure 3.. PRISMA flow diagram .

Figure 4.. At what time point is recruitment defined?