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Fundamentals of randomized clinical trials in wound care: design and conduct


Eskes, Anne M; Brölmann, Fleur E; Sumpio, Bauer E; Mayer, Dieter; Moore, Zena; Agren, Magnus S; Hermans, Michel; Cutting, Keith; Legemate, Dink A; Ubbink, Dirk T; Vermeulen, Hester (2012). Fundamentals of randomized clinical trials in wound care: design and conduct. Wound Repair and Regeneration, 20(4):449-455.

Abstract

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.

Abstract

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.

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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Clinic for Cardiovascular Surgery
Dewey Decimal Classification:610 Medicine & health
Language:English
Date:2012
Deposited On:15 Feb 2013 11:50
Last Modified:07 Dec 2017 19:15
Publisher:Wiley-Blackwell
ISSN:1067-1927
Publisher DOI:https://doi.org/10.1111/j.1524-475X.2012.00799.x
PubMed ID:22642397

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