Development of a framework to improve the process of recruitment to randomised controlled trials (RCTs): the SEAR (Screened, Eligible, Approached, Randomised) framework

Abstract

BackgroundResearch has shown that recruitment to trials is a process that stretches from identifying potentially eligible patients, through eligibility assessment, to obtaining informed consent. The length and complexity of this pathway means that many patients do not have the opportunity to consider participation. This article presents the development of a simple framework to document, understand and improve the process of trial recruitment.MethodsEight RCTs integrated a QuinteT Recruitment Intervention (QRI) into the main trial, feasibility or pilot study. Part of the QRI required mapping the patient recruitment pathway using trial-specific screening and recruitment logs. A content analysis compared the logs to identify aspects of the recruitment pathway and process that were useful in monitoring and improving recruitment. Findings were synthesised to develop an optimised simple framework that can be used in a wide range of RCTs.ResultsThe eight trials recorded basic information about patients screened for trial participation and randomisation outcome. Three trials systematically recorded reasons why an individual was not enrolled in the trial, and further details why they were not eligible or approached, or declined randomisation. A framework to facilitate clearer recording of the recruitment process and reasons for non-participation was developed: SEAR – Screening, to identify potentially eligible trial participants; Eligibility, assessed against the trial protocol inclusion/exclusion criteria; Approach, the provision of oral and written information and invitation to participate in the trial, and Randomised or not, with the outcome of randomisation or treatment received.ConclusionsThe SEAR framework encourages the collection of information to identify recruitment obstacles and facilitate improvements to the recruitment process. SEAR can be adapted to monitor recruitment to most RCTs, but is likely to add most value in trials where recruitment problems are anticipated or evident. Further work to test it more widely is recommended.

Optimising recruitment to the HAND-1 RCT feasibility study: integration of the QuinteT Recruitment Intervention (QRI)

“…All centres were encouraged to keep detailed screening logs of their recruitment activities, including numbers of patients screened, eligible, approached and recruited (SEAR framework) [ 20 ], and reasons for non-participation. Centres received training on completing the logs and were sent reminders every two weeks to complete them in full and upload them to the trial database.…”

Overcoming difficulties with equipoise to enable recruitment to a randomised controlled trial of partial ablation vs radical prostatectomy for unilateral localised prostate cancer

“…Screening logs from all centres were examined regularly for information on the number of patients screened, eligible, approached, and randomised , to provide contextual information about recruitment in clinical centres and across the study.…”

Breaking through the barriers to recruit research participants in community settings: a qualitative exploration using the Theoretical Domains Framework and Behaviour Change Wheel

“…Recruitment to research involves three stages: (i) identi cation of eligible service users (ii) approaching them about the study (iii) seeking their agreement to participate and gaining their consent [2]. There is potential for loss of participants at any of these stages, but the stage where most potential participants are lost [3,4] and about which least is known [5] is the approach, in which eligible people are told about the study and invited to take part. The NHS Constitution for England [6] pledges to inform patients of research studies in which they may be eligible to participate.…”