Guidelines for reporting embedded recruitment trials

Trials
Vichithranie W Madurasinghe, Sandra Eldridge on behalf of MRC START Group and Gordon Forbes on behalf of the START Expert Consensus Group

Abstract

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. 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. 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 d...Continue Reading

Associated Clinical Trials

Dec 24, 2020·MICHELLE Y MARTIN

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Jan 10, 2017·Clinical Trials : Journal of the Society for Clinical Trials·Hopin LeeJames H McAuley
Feb 23, 2018·The Cochrane Database of Systematic Reviews·Shaun TreweekHeidi Gardner
Sep 1, 2018·Clinical Trials : Journal of the Society for Clinical Trials·Anna KearneyCarrol Gamble
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Mar 7, 2021·The Cochrane Database of Systematic Reviews·Katie GilliesMagaly Aceves-Martins
Sep 21, 2021·JAMA Internal Medicine·Scott D HalpernAlisa J Stephens-Shields

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Clinical Trials Mentioned

NCT01206738

Software Mentioned

CONSORT
EQUATOR

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