Shi Jiyuan, Gao Ya, Si Liangliang, Ma Xinping, Liu Ming, Liao Xiang, Zhang Junmei
Evidence-based Nursing Center, School of Nursing.
Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University.
Medicine (Baltimore). 2020 Feb;99(9):e19311. doi: 10.1097/MD.0000000000019311.
A core outcome set (COS) is an agreed minimum set of outcomes that should be reported in all clinical trials in specific areas of health care. A considerable amount of trials did not report essential outcomes or outcomes measurement methods, which makes it challenging to evaluate the efficacy and safety of treatment strategies for pressure injury (PI) and produced significant heterogeneity of reported outcomes. It is necessary to develop a COS, which can be used for clinical trials in PI treatment.
METHODS/DESIGN: The development of this COS will be guided by an advisory group composed of clinicians, senior nurses, patients, and methodologists. We will search six databases and 2 registry platforms to identify currently reported PI treatment outcomes and outcome measurement instruments in randomized controlled trials, meta-analysis, and systematic reviews. We will also conduct a semi-structured interview with clinicians, nurses, and adult PI patients to collect their opinions on important outcomes. Each outcome of the initial list generated from systematic review and interviews will be scored and reach a consensus through two rounds of international Delphi survey with all key stakeholders. A face-to-face consensus meeting with key stakeholders will be conducted to finish a final COS and recommend measurement instruments for each outcome.
We will develop a COS that should be reported in future clinical trials to evaluate the effectiveness of PI treatment.
The COS will follow current guidance to develop a high-quality COS in the field of PI treatment to reduce heterogeneity in trial reporting, facilitate valid comparisons of new therapies, and improve the quality of clinical trials.
核心结局集（COS）是在特定医疗保健领域的所有临床试验中应报告的一组商定的最小结局。相当数量的试验未报告基本结局或结局测量方法，这使得评估压力性损伤（PI）治疗策略的疗效和安全性具有挑战性，并导致所报告结局存在显著异质性。有必要制定一个可用于PI治疗临床试验的COS。
方法/设计：该COS的制定将由一个由临床医生、高级护士、患者和方法学家组成的咨询小组指导。我们将检索六个数据库和两个注册平台，以识别随机对照试验、荟萃分析和系统评价中目前报告的PI治疗结局和结局测量工具。我们还将对临床医生、护士和成年PI患者进行半结构化访谈，以收集他们对重要结局的意见。通过两轮与所有关键利益相关者的国际德尔菲调查，对系统评价和访谈产生的初始列表中的每个结局进行评分并达成共识。将与关键利益相关者举行面对面的共识会议，以完成最终的COS并为每个结局推荐测量工具。
我们将制定一个应在未来临床试验中报告的COS，以评估PI治疗的有效性。
该COS将遵循当前指南，在PI治疗领域制定高质量的COS，以减少试验报告中的异质性，促进新疗法的有效比较，并提高临床试验的质量。
