Department of Quality Assurance and Process Innovation, Amsterdam, The Netherlands.
Wound Repair Regen. 2013 Sep-Oct;21(5):641-7. doi: 10.1111/wrr.12087. Epub 2013 Aug 12.
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.
在伤口护理研究中，根据证据金字塔，可用的高级别证据很少，并且受到研究设计和报告不佳的威胁。如果没有全面透明的报告，读者将无法评估所进行研究的优缺点。随机临床试验 (RCT) 被普遍认为是比较治疗效果的首选研究设计。为了使伤口护理中的高级别证据得到应有的重视，我们提出了一个用于全面和透明报告伤口护理 RCT 的逐步报告标准。本文讨论了可能阻碍伤口护理研究中统一实施报告标准的关键报告问题（例如伤口护理术语、盲法、预设的结局测量以及事先的样本量计算）和伤口特异性障碍（例如伤口患者的病因和合并症存在较大的多样性）。提出的报告标准可作为撰写 RCT 的作者以及期刊同行评审者的指南。这些报告标准的认可和应用可能有助于提高证据水平，并允许对报告的伤口护理数据进行荟萃分析。最终目标是帮助伤口护理专业人员在临床实践中为患者做出更好的决策。
