Liu Zhenmi, Saldanha Ian J, Margolis David, Dumville Jo C, Cullum Nicky A
Division of Nursing, Midwifery and Social Work, University of Manchester, Manchester, Greater Manchester, United Kingdom.
Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Wound Repair Regen. 2017 Apr;25(2):292-308. doi: 10.1111/wrr.12519. Epub 2017 May 12.
The choice of outcomes in systematic reviews of the effects of interventions is crucial, dictating which data are included and analyzed. Full prespecification of outcomes in systematic reviews can reduce the risk of outcome reporting bias but, this issue has not been widely investigated. This study is the first to analyze the nature and specification of outcomes used in Cochrane Wounds (CW) systematic reviews. Adequacy of outcome specification was assessed using a five-element framework of key outcome components: outcome domain, specific measurement, specific metric, method of aggregation, and time points. We identified all CW review titles associated with a protocol published on or before October 1, 2014. We categorized all reported outcome domains and recorded whether they were primary or secondary outcomes. We explored outcome specification for outcome domains reported in 25% or more of the eligible protocols. We included 106 protocols and 126 outcome domains; 24.6% (31/126) domains were used as primary outcomes at least once. Eight domains were reported in ≥25% of protocols: wound healing, quality of life, costs, adverse events, resource use, pain, wound infection, and mortality. Wound healing was the most completely specified outcome domain (median 3; interquartile range [IQR] =1-5) along with resource use (median 3; IQR 2-4). Quality of life (median 1; IQR 1-3), pain (median 1; IQR 1-3), and costs (median 1; IQR 1-4) were the least completely specified outcome domains. Outcomes are frequently poorly prespecified and the elements of metric, aggregation, and time-point are rarely adequately specified. We strongly recommend that reviewers be more vigilant about prespecifying outcomes, using the five-element framework. Better prespecification is likely to improve review quality by reducing bias in data abstraction and analysis, and by reducing subjectivity in the decision of which outcomes to extract; it may also improve outcome specification in clinical trial design and reporting.
在对干预措施效果进行系统评价时，结局的选择至关重要，它决定了哪些数据会被纳入和分析。在系统评价中对结局进行充分的预先设定可以降低结局报告偏倚的风险，但是，这个问题尚未得到广泛研究。本研究首次分析了Cochrane伤口（CW）系统评价中使用的结局的性质和设定情况。使用关键结局组成部分的五要素框架评估结局设定的充分性：结局领域、具体测量方法、具体指标、汇总方法和时间点。我们识别了所有与2014年10月1日或之前发布的方案相关的CW评价标题。我们对所有报告的结局领域进行分类，并记录它们是主要结局还是次要结局。我们对在25%或更多符合条件的方案中报告的结局领域的结局设定进行了探究。我们纳入了106个方案和126个结局领域；24.6%（31/126）的领域至少有一次被用作主要结局。在≥25%的方案中报告了八个领域：伤口愈合、生活质量、成本、不良事件、资源使用、疼痛、伤口感染和死亡率。伤口愈合是设定最完整的结局领域（中位数为3；四分位间距[IQR]=1-5），资源使用情况也是如此（中位数为3；IQR为2-4）。生活质量（中位数为1；IQR为1-3）、疼痛（中位数为1；IQR为1-3）和成本（中位数为1；IQR为1-4）是设定最不完整的结局领域。结局通常预先设定不佳，指标、汇总和时间点等要素很少得到充分设定。我们强烈建议评价者使用五要素框架，更加警惕结局的预先设定。更好的预先设定可能会通过减少数据提取和分析中的偏倚，以及减少在决定提取哪些结局时的主观性来提高评价质量；它还可能改善临床试验设计和报告中的结局设定。
