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Fundamentals of randomized clinical trials in wound care: Design and conduct
Author(s) -
Eskes Anne M.,
Brölmann Fleur E.,
Sumpio Bauer E.,
Mayer Dieter,
Moore Zena,
Ågren Magnus S.,
Hermans Michel,
Cutting Keith,
Legemate Dink A.,
Ubbink Dirk T.,
Vermeulen Hester
Publication year - 2012
Publication title -
wound repair and regeneration
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.847
H-Index - 109
eISSN - 1524-475X
pISSN - 1067-1927
DOI - 10.1111/j.1524-475x.2012.00799.x
Subject(s) - blinding , randomized controlled trial , medicine , wound care , psychological intervention , clinical trial , intensive care medicine , clinical study design , randomization , health care , research design , risk analysis (engineering) , nursing , surgery , social science , pathology , sociology , economics , economic growth
The care for chronic and acute wounds is a substantial problem around the world. This has led to a plethora of products to accelerate healing. Unfortunately, the quality of studies evaluating the efficacy of such wound care products is frequently low. Randomized clinical trials are universally acknowledged as the study design of choice for comparing treatment effects, as they eliminate several sources of bias. We propose a framework for the design and conduct of future randomized clinical trials that will offer strong scientific evidence for the effectiveness of wound care interventions. While randomization is a necessary feature of a robust comparative study, it is not sufficient to ensure a study at low risk of bias. Randomized clinical trials should also ensure adequate allocation concealment and blinding of outcome assessors, apply intention‐to‐treat analysis, and use patient‐oriented outcomes. This article proposes strategies for improving the evidence base for wound care decision making.