Clarostat Consulting Limited, Cheshire, UK.
Roche, Basel, Switzerland.
Res Synth Methods. 2018 Sep;9(3):352-360. doi: 10.1002/jrsm.1301. Epub 2018 May 31.
In studies with time-to-event data, outcomes may be reported as hazard ratios (HR) or binomial counts/proportions at a specific time point. If the intent is to synthesise evidence by performing a meta-analysis or network meta-analysis (NMA) using the HR as the measure of treatment effect, studies that only report binomial data cannot be included in the network. Methods for converting binomial data to HRs were investigated, so that studies reporting binomial data only could be included in a network of HR data. Estimating the log HR is relatively straightforward under the assumptions of proportional hazards and minimal censoring at the binomial data time point. Estimating the standard error of the log HR is harder, but a simple method based on using a Taylor series expansion to approximate the variance is proposed. Thus, we have 2 easy-to-calculate equations for the log HR and variance. The performance of the method was assessed using simulations and data from a NMA of multiple sclerosis treatments. In the simulation, our binomial method produced very similar HRs to those from survival analysis when censoring rates were low, and also when censoring rates were high but the event rate was low. In all situations, it outperformed using relative risk to approximate the HR. In the NMA, results were consistent between reported HRs and HRs derived from binomial data for studies that reported both types of data. This method may be useful for easily incorporating trials reporting binomial data into an evidence synthesis of HR data, under certain assumptions.
在以时间事件数据为研究结果的研究中,结果可能以风险比 (HR) 或特定时间点的二项式计数/比例报告。如果意图通过使用 HR 作为治疗效果的衡量标准来进行荟萃分析或网络荟萃分析 (NMA) 来综合证据,则只能报告二项式数据的研究不能包含在网络中。研究了将二项式数据转换为 HR 的方法,以便仅报告二项式数据的研究可以包含在 HR 数据的网络中。在比例风险和二项式数据时间点最小截尾的假设下,估计 HR 的对数相对简单。估计 HR 的对数标准误差更难,但提出了一种基于使用泰勒级数展开近似方差的简单方法。因此,我们有 2 个易于计算的 HR 和方差的对数方程。使用模拟和多发性硬化症治疗的 NMA 数据评估了该方法的性能。在模拟中,当截尾率较低且当截尾率较高但事件率较低时,我们的二项式方法产生的 HR 与生存分析的 HR 非常相似。在所有情况下,它都优于使用相对风险来近似 HR。在 NMA 中,对于同时报告这两种类型数据的研究,报告的 HR 与从二项式数据中得出的 HR 之间的结果是一致的。在某些假设下,该方法可能有助于轻松将报告二项式数据的试验纳入 HR 数据的综合证据中。