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Jan Apelqvist

Physician

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Producing Precise Outcomes in Randomized, Controlled Trials and Clinical Studies

Author

  • Finn Gottrup
  • Jan Apelqvist
  • Patricia Price

Summary, in 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.

Department/s

  • Genomics, Diabetes and Endocrinology

Publishing year

2012

Language

English

Pages

41342-41342

Publication/Series

Wounds

Volume

24

Issue

1

Document type

Journal article

Publisher

HMP Communications

Topic

  • Endocrinology and Diabetes

Status

Published

Research group

  • Genomics, Diabetes and Endocrinology

ISBN/ISSN/Other

  • ISSN: 1044-7946