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

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dc.contributor.author Eskes, Anne M
dc.contributor.author Brölmann, Fleur E
dc.contributor.author Sumpio, Bauer E
dc.contributor.author Mayer, Dieter
dc.contributor.author Moore, Zena
dc.contributor.author Ågren, Magnus S
dc.contributor.author Hermans, Michel
dc.contributor.author Cutting, Keith
dc.contributor.author Legemate, Dink A
dc.contributor.author Ubbink, Dirk T
dc.contributor.author Vermeulen, Hester
dc.date.accessioned 2012-06-28T08:58:48Z
dc.date.available 2012-06-28T08:58:48Z
dc.date.issued 2012-06-28
dc.identifier.uri http://hdl.handle.net/123456789/639
dc.description.abstract Wound Rep Reg (2012) DOI:10.1111/j.1524-475X.2012.00799.x Reprint requests: Dr. D. T. Ubbink, Department of Quality Assurance and Process Innovation, A3-503, Academic Medical Center, Meibergdreef 9, PO Box 22700, 1100 DE Amsterdam, the Netherlands. Tel: +31 20 566 6892; Fax: +31 20 566 4440 Email: d.ubbink@amc.nl Manuscript received: May 5, 2011 Accepted in final form: February 27, 2012The 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. en_US
dc.subject Wound care en_US
dc.subject Clinical trials en_US
dc.subject Radnomized clinical trials en_US
dc.subject Clinical trial design en_US
dc.subject Clinical trial conduct en_US
dc.subject Wound care product evaluation en_US
dc.subject Evidence base for wound care decision making en_US
dc.title Fundamentals of randomized clinical trials in wound care: design and conduct en_US
dc.type Article en_US

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