Evidence map›Paper›PMID 26767365›Full record

ArticleTrials2016

Guidelines for reporting embedded recruitment trials.

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

Registry-linked trialAbstract read
In one paragraph

Article in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04683510 (Increasing Recruitment of Underrepresented Cancer Survivors With Awareness Enhancing Interventions), which is not on this map. Cited by 42 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 9 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04683510 nacompletednot on this mapstarted 2021, after this paper: background citation

Increasing Recruitment of Underrepresented Cancer Survivors With Awareness Enhancing Interventions

TypeinterventionalSponsorUniversity of TennesseeRan2021 to 2025Enrolled4,451ConditionsResearch AwarenessArmsNavigation - Study Specific - Researcher Voice, Navigation - Study Specific - Cancer Survivor Voice, Navigation - Research General - Researcher Voice, Navigation - Research General - Cancer Survivor Voice, Brochure - Study Specific - Researcher Voice
3 · Its place in the literature

Who cites it

42 citing papers in PubMed, 9 syntheses or guidelines pooled it.

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  7. Strategies to improve retention in randomised trials.The Cochrane database of systematic reviews · 2021
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  8. Strategies to improve recruitment to randomised trials.The Cochrane database of systematic reviews · 2018
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors.

Vichithranie W MadurasinghePragmatic Clinical Trials Unit (PCTU), Centre for Primary Care and Public Health, Blizard Institute, Yvonne Carter Building, 58 Turner Street, London, E1 2AB, UK. v.madurasinghe@qmul.ac.uk.
Sandra Eldridge on behalf of MRC START Group and Gordon Forbes on behalf of the START Expert Consensus Group

Funding

Chief Scientist Office HSRU1Department of Health DRF-2012-05-128Medical Research Council G1002325
6 · The paper itself

Abstract

backgroundRecruitment 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.

methodsWe 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.

resultsWe 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.

conclusionsImplementation 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.

Indexed as

Clinical Trials as TopicGuidelines as TopicPatient SelectionHumansRandom Allocation

Identifiers

PMID26767365
PMCPMC4714476

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.