Producing precise outcomes in randomized, controlled trials and clinical studies
Gottrup, F.; Apelqvist, J.; Price, P.
Wounds a Compendium of Clinical Research and Practice 24(1): 3-9
2012
ISSN/ISBN: 1044-7946 PMID: 25875946 Document Number: 662635
Evidence-based medicine (EBM) uses the current best evi- dence 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 interven- tion 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.