BACKGROUND AND AIMS Heart failure endpoints in cardiovascular outcome trials are commonly identified through centralized adjudication of investigator-reported events. It remains unclear whether central adjudication improves the accuracy of treatment effect estimates in terms of log[hazard ratios (HR)]. METHODS Data from seven cardiovascular outcome trials with >1000 patients that included centrally adjudicated heart failure outcomes were utilized to assess (i) the concordance between investigator-reported and centrally adjudicated heart failure and cardiovascular death events; (ii) rates of subsequent all-cause mortality following positively vs. negatively adjudicated heart failure events; and (iii) the correlation of log(HR) based on centrally adjudicated vs. investigator-reported events. RESULTS Positive adjudication rates for investigator-reported events varied widely across trials, but were generally higher for cardiovascular death (range: 87.9%-99.2%) than for heart failure hospitalization (range: 61.6%-88.0%). The risk for subsequent all-cause death was similar for positively and negatively adjudicated heart failure hospitalizations. Log(HR) correlated well for cardiovascular death [R2 = .80, 95% credible interval (CrI): 0.53-0.93] and the composite of cardiovascular death or heart failure hospitalization (R2 = .79, 95% CrI: 0.46-0.93), but less for heart failure hospitalization (R2 = .57, 95% CrI: 0.10-0.83). CONCLUSIONS Positive adjudication rates were lower for heart failure events than cardiovascular death, but even negatively adjudicated heart failure events are prognostically important. Central adjudication of events did not alter the results (precision or estimated log(HR)), though some variation was observed, depending on the indication. The results suggest that the decision to pursue centralized adjudication of heart failure events in a specific trial may need to be individualized.

中文翻译：

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随机心力衰竭试验中集中裁决的结果与研究者报告的结果。


背景和目的 心血管结局试验中的心力衰竭终点通常是通过对研究者报告的事件进行集中裁决来确定的。目前尚不清楚中央裁决是否提高了对数 [风险比 （HR）] 治疗效果估计的准确性。方法 来自七项心血管结局试验的数据，涉及 >1000 名患者，其中包括集中裁决的心力衰竭结局，用于评估 （i） 研究者报告和集中裁决的心力衰竭与心血管死亡事件之间的一致性;（ii） 阳性与阴性心力衰竭事件后后续全因死亡率;（iii） 基于集中裁决事件与研究者报告事件的 log（HR） 相关性。结果 研究者报告的事件的阳性裁决率在试验中差异很大，但心血管死亡（范围：87.9%-99.2%）通常高于心力衰竭住院率（范围：61.6%-88.0%）。阳性和阴性心力衰竭住院治疗的后续全因死亡风险相似。Log（HR） 与心血管死亡 [R2 = .80,95% 可信区间 （CrI）：0.53-0.93] 和心血管死亡或心力衰竭住院的复合 （R2 = .79,95% CrI：0.46-0.93） 密切相关，但与心力衰竭住院 （R2 = .57,95% CrI： 0.10-0.83） 的相关性较低。结论 心力衰竭事件的阳性判定率低于心血管死亡，但即使是阴性判定的心力衰竭事件也具有预后重要性。事件的集中裁决不会改变结果（精确度或估计对数 （HR）），尽管观察到一些变化，具体取决于适应症。 结果表明，在特定试验中对心力衰竭事件进行集中裁决的决定可能需要个体化。