Susan O’Meara

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

BackgroundCritical 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.MethodsA 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.ResultsA 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.ConclusionsThis 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.

Letter: Evidence‐Based Wound Care in the UK: A Response to David Leaper's Editorial in International Wound Journal April 2009 6 (2)

In David Leaper’s editorial published in April 2009 (1), some important points are made. These include the necessity for evidence-based practice and standards, the limited evidence for some wound care management strategies, and the difficulty this poses for making recommendations for clinical practice. However, other points made about the usefulness of observational evidence for the evaluation of interventions and that in the field of wound care ‘further Cochrane systematic reviews are not likely to achieve much’ (p. 90) are debatable (1). Professor Leaper confuses the primary functions of Cochrane reviews and clinical guidelines, the former being to address the question of the effectiveness of particular interventions and the latter being to provide recommendations to guide clinical practice. He criticises Cochrane reviews for failing to admit all the available (experimental and observational) evidence, unlike guidelines, and then producing recommendations that further research is needed, while failing to provide clinical guidance. Professor Leaper also argues that Cochrane reviews do not benefit from the input of an expert panel and that review authors have scientific skills with no topic-related knowledge. The Cochrane Collaboration is an organisation in large part driven by the efforts of those carrying out systematic reviews on a voluntary (unpaid) basis. Many of these volunteer review authors are clinicians who are very keen to further the evidence base in topic areas where they have a high level of knowledge, experience and expertise. In reviews of wound management, these people include physicians, surgeons, nurses and podiatrists. In addition, each Cochrane review is subject to a very rigorous peer review process by both clinical and methodological experts, and so overall there is ample opportunity for clinical input, helping to ensure that Cochrane reviews are methodologically sound but also relevant in terms of topic coverage and interpretation of findings. In commenting on a systematic review on antibiotics and antiseptics used with venous leg ulcers, Professor Leaper describes ‘the lack of expertise on the panel’. We are pleased to confirm that this review team represented a wealth of clinical knowledge and experience including medicine, nursing, pharmacology and clinical research (2). Cochrane reviews in the field of wound care (and other areas) are important because in addition to summarising the evidence on the effectiveness of interventions for the benefit of patients, health care practitioners and policymakers, they highlight gaps in the evidence,

Topical and systemic antimicrobial therapy for venous leg ulcers.

CLINICAL QUESTION Is treatment with topical or systemic antimicrobial agents associated with better venous leg ulcer healing compared with usual care (dressings and bandages without antimicrobials) or an alternative topical or systemic antimicrobial agent? BOTTOM LINE Available evidence, from underpowered pooled data, neither supports nor refutes an association of systemic antibiotic therapy with improved venous leg ulcer healing. Among topical antimicrobials, cadexomer iodine may be associated with better healing compared with usual care.