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

Hodgson, Robert, Allen, Richard, Broderick, Ellen, Bland, J. Martin, Dumville, Jo C., Ashby, Rebecca, Bell-Syer, Sally, Foxlee, Ruth, Hall, Jill, Lamb, Karen, Madden, Mary, O'Meara, Susan, Stubbs, Nikki and Cullum, Nicky (2014) Funding source and the quality of reports of chronic wounds trials: 2004 to 2011. Trials, 15 1: 19.1-19.10. doi:10.1186/1745-6215-15-19

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Author Hodgson, Robert
Allen, Richard
Broderick, Ellen
Bland, J. Martin
Dumville, Jo C.
Ashby, Rebecca
Bell-Syer, Sally
Foxlee, Ruth
Hall, Jill
Lamb, Karen
Madden, Mary
O'Meara, Susan
Stubbs, Nikki
Cullum, Nicky
Title Funding source and the quality of reports of chronic wounds trials: 2004 to 2011
Journal name Trials   Check publisher's open access policy
ISSN 1745-6215
1468-6708
Publication date 2014-01-14
Year available 2014
Sub-type Critical review of research, literature review, critical commentary
DOI 10.1186/1745-6215-15-19
Open Access Status DOI
Volume 15
Issue 1
Start page 19.1
End page 19.10
Total pages 10
Place of publication London, United Kingdom
Publisher BioMed
Collection year 2015
Language eng
Formatted 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.
Keyword Wound care
Randomised controlled trials
Bias
Industry funding
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ
Additional Notes Article number 19.

Document type: Journal Article
Sub-type: Critical review of research, literature review, critical commentary
Collections: Official 2015 Collection
School of Nursing, Midwifery and Social Work Publications
 
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Created: Thu, 22 May 2014, 13:36:20 EST by Vicki Percival on behalf of School of Nursing, Midwifery and Social Work