Guidelines for reporting embedded recruitment trials

Abstract

Background: Recruitment to clinical trials is difficult with many trials failing to recruit to target and within time. Embedding trials of recruitment interventions within host trials may provide a successful way to improve this. There are no guidelines for reporting such embedded methodology trials. As part of the Medical Research Council funded Systematic Techniques for Assisting Recruitment to Trials (MRC START) programme designed to test interventions to improve recruitment to trials, we developed guidelines for reporting embedded trials.

Methods: We followed a three-phase guideline development process: (1) pre-meeting literature review to generate items for the reporting guidelines; (2) face-to-face consensus meetings to draft the reporting guidelines; and (3) post-meeting feedback review, and pilot testing, followed by finalisation of the reporting guidelines.

Results: We developed a reporting checklist based on the Consolidated Standards for Reporting Trials (CONSORT) statement 2010. Embedded trials evaluating recruitment interventions should follow the CONSORT statement 2010 and report all items listed as essential. We used a number of examples to illustrate key issues that arise in embedded trials and how best to report them, including (a) how to deal with description of the host trial; (b) the importance of describing items that may differ in the host and embedded trials (such as the setting and the eligible population); and (c) the importance of identifying clearly the point at which the recruitment interventions were embedded in the host trial.

Conclusions: Implementation of these guidelines will improve the quality of reports of embedded recruitment trials while advancing the science, design and conduct of embedded trials as a whole.

Fig. 1

Example abstract for an embedded recruitment trial [17]

Fig. 2

Flow chart illustrating intervention and control sites and route of additional communication strategy

Fig. 3

A flow chart illustrating the focal point(s) of the host trial recruitment pathway targeted by embedded recruitment trial interventions

Fig. 4

Recruitment flowchart

Fig. 5

Recruitment flowchart

Fig. 6

Recruitment flowchart

Fig. 7

CONSORT diagram showing the flow of participants through each stage of the randomised trial (enrolment, intervention allocation, follow-up and data analysis)