对医学研究中来自随机对照试验和队列研究的证据合并的影响场景的实证评估。
An empirical evaluation of the impact scenario of pooling bodies of evidence from randomized controlled trials and cohort studies in medical research.
机构信息
Institute for Evidence in Medicine, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Institute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center - University of Freiburg, Freiburg, Germany.
出版信息
BMC Med. 2022 Oct 24;20(1):355. doi: 10.1186/s12916-022-02559-y.
BACKGROUND
Randomized controlled trials (RCTs) and cohort studies are the most common study design types used to assess treatment effects of medical interventions. We aimed to hypothetically pool bodies of evidence (BoE) from RCTs with matched BoE from cohort studies included in the same systematic review.
METHODS
BoE derived from systematic reviews of RCTs and cohort studies published in the 13 medical journals with the highest impact factor were considered. We re-analyzed effect estimates of the included systematic reviews by pooling BoE from RCTs with BoE from cohort studies using random and common effects models. We evaluated statistical heterogeneity, 95% prediction intervals, weight of BoE from RCTs to the pooled estimate, and whether integration of BoE from cohort studies modified the conclusion from BoE of RCTs.
RESULTS
Overall, 118 BoE-pairs based on 653 RCTs and 804 cohort studies were pooled. By pooling BoE from RCTs and cohort studies with a random effects model, for 61 (51.7%) out of 118 BoE-pairs, the 95% confidence interval (CI) excludes no effect. By pooling BoE from RCTs and cohort studies, the median I was 48%, and the median contributed percentage weight of RCTs to the pooled estimates was 40%. The direction of effect between BoE from RCTs and pooled effect estimates was mainly concordant (79.7%). The integration of BoE from cohort studies modified the conclusion (by examining the 95% CI) from BoE of RCTs in 32 (27%) of the 118 BoE-pairs, but the direction of effect was mainly concordant (88%).
CONCLUSIONS
Our findings provide insights for the potential impact of pooling both BoE in systematic reviews. In medical research, it is often important to rely on both evidence of RCTs and cohort studies to get a whole picture of an investigated intervention-disease association. A decision for or against pooling different study designs should also always take into account, for example, PI/ECO similarity, risk of bias, coherence of effect estimates, and also the trustworthiness of the evidence. Overall, there is a need for more research on the influence of those issues on potential pooling.
背景
随机对照试验（RCTs）和队列研究是评估医学干预治疗效果最常用的研究设计类型。我们旨在假设从同一系统评价中包含的 RCT 和队列研究中汇集证据体（BoE）。
方法
考虑了来自发表在影响因子最高的 13 种医学期刊的 RCT 和队列研究系统评价的 BoE。我们通过使用随机和共同效应模型从 RCT 中汇集 BoE 并从队列研究中汇集 BoE 来重新分析纳入系统评价的效应估计值。我们评估了统计异质性、95%预测区间、RCT 产生的 BoE 在汇总估计值中的权重，以及是否从队列研究中整合 BoE 会改变来自 RCT 的 BoE 的结论。
结果
总体而言，基于 653 项 RCT 和 804 项队列研究，共汇集了 118 对 BoE。通过使用随机效应模型从 RCT 和队列研究中汇集 BoE，对于 118 对 BoE 中的 61 对（51.7%），95%置信区间（CI）不排除无效应。通过汇集 RCT 和队列研究的 BoE，I 的中位数为 48%，RCT 对汇总估计值的贡献权重中位数为 40%。RCT 的 BoE 和汇总效应估计值之间的效应方向主要一致（79.7%）。在 118 对 BoE 中，有 32 对（27%）通过检查 95%CI，从 RCT 的 BoE 中整合 BoE 会改变结论，但效应方向主要一致（88%）。
结论
我们的研究结果为系统评价中汇集 BoE 的潜在影响提供了见解。在医学研究中，通常需要依靠 RCT 和队列研究的证据来全面了解所研究的干预-疾病关联。是否选择汇集不同的研究设计也应始终考虑 PI/ECO 相似性、偏倚风险、效应估计值的一致性以及证据的可信度等因素。总体而言，需要更多的研究来探讨这些问题对潜在汇集的影响。
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