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Version 2. F1000Res. 2017 Aug 16 [revised 2017 Sep 14];6:1489. doi: 10.12688/f1000research.12268.2. eCollection 2017.

Professional medical writing support and the reporting quality of randomized controlled trial abstracts among high-impact general medical journals.

Author information

1
PAREXEL International, Hackensack, NJ, 07601, USA.
2
Department of Archaeology and Anthropology, University of Bristol, Bristol, BS8 1TH, UK.
3
Department of Medicine, Uniformed Services University, Bethesda, MD, 20814, USA.
4
School of Medicine, Pharmacy and Health, Durham University, Stockton on Tees, TS17 6BH, UK.
5
Research Evaluation Unit, Oxford PharmaGenesis Ltd, Oxford, OX13 5QJ, UK.
6
Oxford Brookes University, Oxford, OX3 0BP, UK.
7
Ipsen Pharma, Abingdon, OX14 4RL, UK.

Abstract

Background: In articles reporting randomized controlled trials, professional medical writing support is associated with increased adherence to Consolidated Standards of Reporting Trials (CONSORT). We set out to determine whether professional medical writing support was also associated with improved adherence to CONSORT for Abstracts. Methods: Using data from a previously published cross-sectional study of 463 articles reporting randomized controlled trials published between 2011 and 2014 in five top medical journals, we determined the association between professional medical writing support and CONSORT for Abstracts items using a Wilcoxon rank-sum test. Results: The mean proportion of adherence to CONSORT for Abstracts items reported was similar with and without professional medical writing support (64.3% vs 66.5%, respectively; p=0.30). Professional medical writing support was associated with lower adherence to reporting study setting (relative risk [RR]; 0.40; 95% confidence interval [CI], 0.23-0.70), and higher adherence to disclosing harms/side effects (RR 2.04; 95% CI, 1.37-3.03) and funding source (RR 1.75; 95% CI, 1.18-2.60). Conclusions: Although professional medical writing support was not associated with increased overall adherence to CONSORT for Abstracts, important aspects were improved with professional medical writing support, including reporting of adverse events and funding source. This study identifies areas to consider for improvement.

KEYWORDS:

CONSORT guidelines; abstracts; adherence; adverse events; funding source; medical writing; randomized controlled trials

Conflict of interest statement

Competing interests: Mills I is an employee of PAREXEL International. Sheard C, Hays M, and Douglas K have no disclosures to report. Gattrell WT is an employee of Ipsen Biopharma. Winchester CC is an employee and Director of Oxford PharmaGenesis Ltd, and a Director and shareholder of Oxford PharmaGenesis Holdings Ltd.

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