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.
| Original language | English |
|---|---|
| Article number | 27 |
| Journal | Trials |
| Volume | 17 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 14 Jan 2016 |
Bibliographical note
Funding Information:The authors give special thanks to Charles Weijer, David Collier, Anne Kennedy, Peter Knapp, Chris Salisbury, David Torgerson and David Reeves for their valuable contributions in developing this guidelines document.
The authors wish to acknowledge the MRC Methodology Research Programme which funded the MRC START embedded trials programme (MRC Grant Ref: G1002325). The MRC has no role in study design; collection, management, analysis and interpretation of data; writing of the report; or the decision to submit the report for publication. The Health Services Research Unit is funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates. The views expressed are those of the authors alone.
Publisher Copyright:
© 2016 Madurasinghe.
VM and SE participated in meetings and regular conference calls, planned the consensus meetings at Manchester, developed the agenda, prepared background research and initial criteria, identified and invited participants, contributed to the consensus meetings, drafted the manuscript, and, after critical review by the MRC START Group, finalised the text of the manuscript. GF contribute to the background literature review and participated in consensus meetings. GF, PB, JR, NS, JG, AH, ST, AM, CD, DRS, JC, MC and VB contributed to consensus meetings and discussions, reviewed and commented on the checklist and drafts of the manuscript. NS, JR and AH also contributed to organising consensus meetings. All authors commented on drafts of the paper.
The following are members of the MRC START Group: Peter Bower (PB); David Collier (DC); Sandra Eldridge (SE); Jonathan Graffy (JG); Adwoa Hughes-Morley (AH); Anne Kennedy (AK); Peter Knapp (PK); Vichithranie Madurasinghe (VM); Jo Rick (JR); Chris Salisbury (CS); Nicola Small (NS); David Torgerson (DT); and Shaun Treweek (ST). All authors read and approved the final manuscript.
Keywords
- Embedded randomised controlled trial
- Methodology
- Primary care
- Recruitment
- Reporting guidelines