Fundamentals of randomized clinical trials in wound care: reporting standards

Brolmann, Fleur E., Eskes, Anne M., Bauer, E. Sumpio, Mayer, Dieter O., Moore, Zena, Agren, Magnus S., Hermans, Michel, Cutting, Keith, Legemate, Dink A., Vermeulen, Hester and Ubbink, Dirk T. (2013) Fundamentals of randomized clinical trials in wound care: reporting standards. Wound Repair and Regeneration, 21 (5). pp. 641-647. ISSN 1524-475X

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Abstract

In wound care research, available high-level evidence according to the evidencepyramid is rare, and is threatened by a poor study design and reporting. Without comprehensive and transparent reporting, readers will not be able to assess the strengths and limitations of the research performed. Randomized clinical trials (RCTs) are universally acknowledged as the study design of choice for comparing treatment effects. To give high-level evidence the appreciation it deserves in wound care, we propose a step-by-step reporting standard for comprehensive and transparent reporting of RCTs in wound care. Critical reporting issues (e.g., wound care terminology, blinding, predefined outcome measures, and a priori sample size calculation) and wound-specific barriers (e.g., large diversity of etiologies and comorbidities of patients with wounds) that may prevent uniform implementation of reporting standards in wound care research are addressed in this article. The proposed reporting standards can be used as guidance for authors who write their RCT, as well as for peer reviewers of journals. Endorsement and application of these reporting standards may help achieve a higher standard of evidence and allow meta-analysis of reported wound care data. The ultimate goal is to help wound care professionals make better decisions for their patients in clinical practice.

Item Type:	Article
Divisions:	?? BucksNewUniversity ??
Depositing User:	ULCC Admin
Date Deposited:	30 Aug 2013 11:34
Last Modified:	11 Dec 2017 19:17
URI:	https://bnu.repository.guildhe.ac.uk/id/eprint/9559

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