Soni-Jaiswal Archana, Lakhani Raj, Hopkins Claire
Guys and St Thomas's Hospital, London, UK.
George's Hospital, London, UK.
Trials. 2017 Jul 11;18(1):320. doi: 10.1186/s13063-017-2060-y.
A core outcome set (COS) is an agreed standardised collection of outcomes that should be measured and reported by all trials for a specific clinical area, in this case chronic rhinosinusitis. These are not restrictive and researchers may continue to explore other outcomes alongside these that they feel are relevant to their intervention. The aim of this systematic review was to identify the need for a COS for chronic rhinosinusitis.
A sensitive search strategy was used to identify all published Cochrane systematic reviews and randomised control trials of intervention for adult patients with chronic rhinosinusitis. Two independent authors reviewed these to obtain a list of outcomes and outcome measures reported by each clinical trial.
Sixty-nine randomised control trials and eight Cochrane systematic reviews were included in this study. They reported 68 individual outcomes and outcome measures, with an average of four to ten outcomes per clinical trial. These outcomes were mapped to 23 subcategories belonging to eight core categories.
The key finding of this review was the heterogeneity of outcomes reported and measured by clinical trials of patients with chronic rhinosinusitis, precluding meaningful meta-analysis of data. This review supports the need for development of a COS, to be used in future trials on adult patients with chronic rhinosinusitis.
核心结局集（COS）是一组达成共识的标准化结局，所有针对特定临床领域（在本案例中为慢性鼻-鼻窦炎）的试验都应测量并报告这些结局。这些并非限制性要求，研究人员可以在这些结局之外继续探索他们认为与干预措施相关的其他结局。本系统评价的目的是确定慢性鼻-鼻窦炎核心结局集的必要性。
采用敏感的检索策略，识别所有已发表的针对成年慢性鼻-鼻窦炎患者干预措施的Cochrane系统评价和随机对照试验。两位独立作者对这些进行了审查，以获取每项临床试验报告的结局和结局测量指标列表。
本研究纳入了69项随机对照试验和8篇Cochrane系统评价。它们报告了68项个体结局和结局测量指标，每项临床试验平均有4至10项结局。这些结局被映射到属于8个核心类别的23个子类别中。
本评价的关键发现是慢性鼻-鼻窦炎患者临床试验报告和测量的结局存在异质性，这使得对数据进行有意义的荟萃分析变得不可能。本评价支持开发一个核心结局集的必要性，该核心结局集将用于未来针对成年慢性鼻-鼻窦炎患者的试验。
