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Index: WOUNDS 2012;24(1):3–9

  Abstract: Evidence-based medicine (EBM) uses the current best evidence to inform decisions about care of individual patients, healthcare procedures, and technologies. The “gold standard” for optimal evidence in the Cochrane system is Level I randomized, controlled trials (RCTs) and meta-analyses of several RCTs. In order to achieve this level of evidence, one of the most important measures is the use of outcomes/endpoints. This article will provide, in short form, recommendations on how to achieve rigorous endpoints or outcomes in studies on wound management. Consistency in measuring endpoints/outcomes improves quality of care. To achieve such consistency it is important to 1) use predefined and robust outcomes; 2) adapt outcomes to the intervention under investigation; and 3) use the best evidence available. Also, it is emphasized that the use of complete wound closure or healing as an outcome measure is not always possible or suitable. Remaining patient-focused clarifies which other endpoints are relevant. Finally, “basic care” must be clearly defined and standardized when used as a comparative intervention in a RCT. In conclusion, the use of correct, clinically relevant outcomes or endpoints is of vital importance when establishing optimal evidence in wound healing and care.

Introduction

  Nonhealing wounds are a significant problem for healthcare systems all over the world. In the industrialized world, almost 1%–1.5% of the population has a problem wound at any one time and accounts for 2%–4% of the healthcare budget—a figure that is likely to rise with an increasing elderly and diabetic populations.^1–3

  For these reasons, there is an urgent need to review wound strategies and treatments in order to reduce the burden of care in an efficient and cost-effective way. A primary question is which of the available interventions, technologies, and dressing materials achieve the best outcomes for the best value? Ongoing controversy surrounds the value of various approaches to wound management and care. Evidence-based clinical practice is difficult to achieve due to confusion about the value of the various approaches to wound management. To address this, the European Wound Management Association (EWMA) set up a Patient Outcome Group.⁴ The first document identifies criteria for producing precise outcomes in both RCTs and clinical studies, and describes how to ensure that studies are consistent and reproducible.⁵ This review will highlight the principles in the EWMA document.

  Systematic reviews have indicated that there are substantial deficiencies in the quality of clinical research (eg, www.cochrane.org, www.nice.org.uk). Wound management has a paucity of high quality evidence, as the studies are often based on inadequate sample size, short follow up, nonrandom allocation to treatment arms, nonblinded assessment of outcomes, and poor description of control and concurrent intervention(s).

  Quality of evidence in wound management is interesting from different perspectives:
    1. From the clinical perspective the question is which interventions, technologies, and dressing materials are the best from the point of view of a single patient or group of patients, where the primary focus is healing and the absence of complications.

    2. From the policy maker and healthcare system perspectives two issues arise: A) Whether or not a particular product or intervention is safe and effective when used as indicated—this is a question of regulatory approval, and B) whether or not the product or intervention represents a cost-effective use of funds.