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BMJ Open. 2016 Feb 21;6(2):e010329. doi: 10.1136/bmjopen-2015-010329.

Professional medical writing support and the quality of randomised controlled trial reporting: a cross-sectional study.

Author information

1
Research Evaluation Unit, Oxford PharmaGenesis Ltd, Oxford, UK Department of Mechanical Engineering and Mathematical Sciences, Oxford Brookes University, Oxford, UK.
2
Oxford Clinical Trials Research Unit, University of Oxford, Oxford, UK.
3
Research Evaluation Unit, Oxford PharmaGenesis Inc, Newtown, Pennsylvania, USA.
4
Research Evaluation Unit, Oxford PharmaGenesis Ltd, Oxford, UK.
5
Sideview, Princes Risborough, UK University of Split School of Medicine, Split, Croatia.
6
Research Evaluation Unit, Oxford PharmaGenesis Ltd, Oxford, UK School of Medicine, Pharmacy and Health, Durham University, University Boulevard, Stockton-on-Tees, UK.

Abstract

OBJECTIVES:

Authors may choose to work with professional medical writers when writing up their research for publication. We examined the relationship between medical writing support and the quality and timeliness of reporting of the results of randomised controlled trials (RCTs).

DESIGN:

Cross-sectional study.

STUDY SAMPLE:

Primary reports of RCTs published in BioMed Central journals from 2000 to 16 July 2014, subdivided into those with medical writing support (n=110) and those without medical writing support (n=123).

MAIN OUTCOME MEASURES:

Proportion of items that were completely reported from a predefined subset of the Consolidated Standards of Reporting Trials (CONSORT) checklist (12 items known to be commonly poorly reported), overall acceptance time (from manuscript submission to editorial acceptance) and quality of written English as assessed by peer reviewers. The effect of funding source and publication year was examined.

RESULTS:

The number of articles that completely reported at least 50% of the CONSORT items assessed was higher for those with declared medical writing support (39.1% (43/110 articles); 95% CI 29.9% to 48.9%) than for those without (21.1% (26/123 articles); 95% CI 14.3% to 29.4%). Articles with declared medical writing support were more likely than articles without such support to have acceptable written English (81.1% (43/53 articles); 95% CI 67.6% to 90.1% vs 47.9% (23/48 articles); 95% CI 33.5% to 62.7%). The median time of overall acceptance was longer for articles with declared medical writing support than for those without (167 days (IQR 114.5-231 days) vs 136 days (IQR 77-193 days)).

CONCLUSIONS:

In this sample of open-access journals, declared professional medical writing support was associated with more complete reporting of clinical trial results and higher quality of written English. Medical writing support may play an important role in raising the quality of clinical trial reporting.

KEYWORDS:

CONSORT; Medical writing; Peer review; Quality; Randomised controlled trials

PMID:
26899254
PMCID:
PMC4762118
DOI:
10.1136/bmjopen-2015-010329
[Indexed for MEDLINE]
Free PMC Article

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