Centre for Evidence-Based Medicine, Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, United Kingdom; Department for Continuing Education, University of Oxford, Rewley House, 1 Wellington Square, Oxford, OX1 2JA, United Kingdom.
Nuffield Department of Population Health, University of Oxford, Richard Doll Building, Old Road Campus, Oxford, OX3 7LF, United Kingdom.
J Clin Epidemiol. 2021 May;133:111-120. doi: 10.1016/j.jclinepi.2021.01.016. Epub 2021 Jan 27.
To evaluate design, methods, and reporting of impact studies of cardiovascular clinical prediction rules (CPRs).
We conducted a systematic review. Impact studies of cardiovascular CPRs were identified by forward citation and electronic database searches. We categorized the design of impact studies as appropriate for randomized and nonrandomized experiments, excluding uncontrolled before-after study. For impact studies with appropriate study design, we assessed the quality of methods and reporting. We compared the quality of methods and reporting between impact and matched control studies.
We found 110 impact studies of cardiovascular CPRs. Of these, 65 (59.1%) used inappropriate designs. Of 45 impact studies with appropriate design, 31 (68.9%) had substantial risk of bias. Mean number of reporting domains that impact studies with appropriate study design adhered to was 10.2 of 21 domains (95% confidence interval, 9.3 and 11.1). The quality of methods and reporting was not clearly different between impact and matched control studies.
We found most impact studies either used inappropriate study design, had substantial risk of bias, or poorly complied with reporting guidelines. This appears to be a common feature of complex interventions. Users of CPRs should critically evaluate evidence showing the effectiveness of CPRs.
评估心血管临床预测规则（CPR）影响研究的设计、方法和报告。
我们进行了系统评价。通过向前引用和电子数据库搜索，确定了心血管 CPR 的影响研究。我们将影响研究的设计分为适合随机和非随机实验的设计，不包括未经对照的前后研究。对于具有适当研究设计的影响研究，我们评估了方法和报告的质量。我们比较了影响研究和匹配对照研究的方法和报告质量。
我们发现了 110 项心血管 CPR 的影响研究。其中，65 项（59.1%）使用了不适当的设计。在 45 项具有适当设计的影响研究中，有 31 项（68.9%）存在较大的偏倚风险。具有适当研究设计的影响研究遵守的报告领域数量平均值为 21 个领域中的 10.2 个（95%置信区间，9.3 和 11.1）。具有适当研究设计的影响研究的方法和报告质量与匹配对照研究之间没有明显差异。
我们发现大多数影响研究要么使用了不适当的研究设计，要么存在较大的偏倚风险，要么报告规范遵守得很差。这似乎是复杂干预措施的一个共同特征。CPR 的使用者应批判性地评估显示 CPR 有效性的证据。
