Brölmann, Fleur E3; Eskes, Anne M4; Sumpio, Bauer E4; Mayer, Dieter O4; Moore, Zena4; Ågren, Sven Per Magnus1; Hermans, Michel4; Cutting, Keith4; Legemate, Dink A4; Vermeulen, Hester4; Ubbink, Dirk T4
1 Digestive Diease Center, Bispebjerg and Frederiksberg Hospital, The Capital Region of Denmark2 Dermato-Venerologisk Afdeling og Videncenter for Sårheling (D/S), Bispebjerg and Frederiksberg Hospital, The Capital Region of Denmark3 Department of Quality Assurance and Process Innovation, Amsterdam, The Netherlands.4 unknown
In wound care research, available high-level evidence according to the evidence pyramid 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.
Wound Repair and Regeneration : Official Publication of the Wound Healing Society [and] the European Tissue Repair Society, 2013, Vol 21, Issue 5, p. 641-647