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Open Access Research

Funding source and the quality of reports of chronic wounds trials: 2004 to 2011

Robert Hodgson1, Richard Allen1, Ellen Broderick1, J Martin Bland1, Jo C Dumville2*, Rebecca Ashby1, Sally Bell-Syer1, Ruth Foxlee1, Jill Hall1, Karen Lamb3, Mary Madden1, Susan O’Meara4, Nikki Stubbs3 and Nicky Cullum2

Author Affiliations

1 Department of Health Sciences, University of York, Seebohm Rowntree Building, YO10 5DD Heslington, England

2 School of Nursing, Midwifery and Social Work, University of Manchester, Jean McFarlane Building, Oxford Road, M13 9PL Manchester, England

3 NHS Leeds Community Health Care, St Mary’s Hospital, Green Hill Road, Leeds, UK, England

4 School of Healthcare, Baines Wing, University of Leeds, Leeds, UK, England

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Trials 2014, 15:19  doi:10.1186/1745-6215-15-19

Published: 14 January 2014

Abstract

Background

Critical commentaries suggest that wound care randomised controlled trials (RCTs) are often poorly reported with many methodological flaws. Furthermore, interventions in chronic wounds, rather than being drugs, are often medical devices for which there are no requirements for RCTs to bring products to market. RCTs in wounds trials therefore potentially represent a form of marketing. This study presents a methodological overview of chronic wound trials published between 2004 and 2011 and investigates the influence of industry funding on methodological quality.

Methods

A systematic search for RCTs for the treatment of chronic wounds published in the English language between 2004 and 2011 (inclusive) in the Cochrane Wounds Group Specialised Register of Trials was carried out.

Data were extracted on aspects of trial design, conduct and quality including sample size, duration of follow-up, specification of a primary outcome, use of surrogate outcomes, and risks of bias. In addition, the prevalence of industry funding was assessed and its influence on the above aspects of trial design, conduct and quality was assessed.

Results

A total of 167 RCTs met our inclusion criteria. We found chronic wound trials often have short durations of follow-up (median 12 weeks), small sample sizes (median 63), fail to define a primary outcome in 41% of cases, and those that do define a primary outcome, use surrogate measures of healing in 40% of cases. Only 40% of trials used appropriate methods of randomisation, 25% concealed allocation and 34% blinded outcome assessors. Of the included trials, 41% were wholly or partially funded by industry, 33% declared non-commercial funding and 26% did not report a funding source. Industry funding was not statistically significantly associated with any measure of methodological quality, though this analysis was probably underpowered.

Conclusions

This overview confirms concerns raised about the methodological quality of RCTs in wound care and illustrates that greater efforts must be made to follow international standards for conducting and reporting RCTs. There is currently minimal evidence of an influence of industry funding on methodological quality although analyses had limited power and funding source was not reported for a quarter of studies.

Keywords:
Wound care; Randomised controlled trials; Bias; Industry funding