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Producing Precise Outcomes in Randomized, Controlled Trials and Clinical Studies

  • Finn Gottrup
  • Jan Apelqvist
  • Patricia Price
Publishing year: 2012
Language: English
Pages: 41342-41342
Publication/Series: Wounds
Volume: 24
Issue: 1
Document type: Journal article
Publisher: HMP Communications

Abstract english

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.


  • Endocrinology and Diabetes


  • Genomics, Diabetes and Endocrinology
  • ISSN: 1044-7946
E-mail: jan [dot] apelqvist [at] med [dot] lu [dot] se


Genomics, Diabetes and Endocrinology

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Lund University Diabetes Centre, CRC, SUS Malmö, Jan Waldenströms gata 35, House 91:12. SE-214 28 Malmö. Telephone: +46 40 39 10 00