英国常规数据中主要出血事件的可靠性与临床试验裁定随访数据的比较。
Reliability of major bleeding events in UK routine data versus clinical trial adjudicated follow-up data.
机构信息
Medical Research Council Population Health Research Unit at the University of Oxford, Nuffield Department of Population Health (NDPH), University of Oxford, Oxford, UK.
Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU), NDPH, University of Oxford, Oxford, UK.
出版信息
Heart. 2023 Sep 13;109(19):1467-1472. doi: 10.1136/heartjnl-2023-322616.
OBJECTIVE
To assess how reliable UK routine data are for ascertaining major bleeding events compared with adjudicated follow-up.
METHODS
The ASCEND (A Study of Cardiovascular Events iN Diabetes) primary prevention trial randomised 15 480 UK people with diabetes to aspirin versus matching placebo. The primary safety outcome was major bleeding (including intracranial haemorrhage, sight-threatening eye bleeding, serious gastrointestinal bleeding and other major bleeding (epistaxis, haemoptysis, haematuria, vaginal and other bleeding)) ascertained by direct-participant mail-based follow-up, with >90% of outcomes undergoing adjudication. Nearly all participants were linked to routinely collected hospitalisation and death data (ie, routine data). An algorithm categorised bleeding events from routine data as major/minor. Kappa statistics were used to assess agreement between data sources, and randomised comparisons were re-run using routine data.
RESULTS
When adjudicated follow-up and routine data were compared, there was agreement for 318 major bleeding events, with routine data identifying 281 additional-potential events, and not identifying 241 participant-reported events (kappa 0.53, 95% CI 0.49 to 0.57). Repeating ASCEND's randomised comparisons using routine data only found estimated relative and absolute effects of allocation to aspirin versus placebo on major bleeding similar to adjudicated follow-up (adjudicated follow-up: aspirin 314 (4.1%) vs placebo 245 (3.2%); rate ratio (RR) 1.29, 95% CI 1.09 to 1.52; absolute excess +6.3/5000 person-years (mean SE±2.1); vs routine data: 327 (4.2%) vs 272 (3.5%); RR 1.21, 95% CI 1.03 to 1.41; absolute excess +5.0/5000 (±2.2)).
CONCLUSIONS
Analyses of the ASCEND randomised trial found that major bleeding events ascertained via UK routine data sources provided relative and absolute treatment effects similar to adjudicated follow-up.
TRIAL REGISTRATION NUMBER
ISRCTN60635500; NCT00135226.
目的
评估英国常规数据在确定主要出血事件方面的可靠性，与裁定后的随访相比。
方法
ASCEND（糖尿病心血管事件研究）一级预防试验将 15480 名英国糖尿病患者随机分为阿司匹林组和匹配安慰剂组。主要安全性结局是主要出血（包括颅内出血、视力威胁性眼出血、严重胃肠道出血和其他主要出血（鼻出血、咯血、血尿、阴道和其他出血）），通过直接参与者的邮件随访确定，其中超过 90%的结果经过裁定。几乎所有参与者都与常规收集的住院和死亡数据（即常规数据）相关联。一种算法将常规数据中的出血事件分类为主要/次要。kappa 统计用于评估数据源之间的一致性，并使用常规数据重新运行随机比较。
结果
当比较裁定后的随访和常规数据时，有 318 例主要出血事件的一致性，常规数据确定了 281 例潜在事件，而没有确定 241 例参与者报告的事件（kappa 0.53，95%CI 0.49 至 0.57）。仅使用常规数据重复 ASCEND 的随机比较发现，与安慰剂相比，分配给阿司匹林的主要出血的相对和绝对效果与裁定后的随访相似（裁定后的随访：阿司匹林 314（4.1%）与安慰剂 245（3.2%）；率比（RR）1.29，95%置信区间（CI）1.09 至 1.52；绝对过量+6.3/5000 人年（平均 SE±2.1）；与常规数据相比：327（4.2%）与 272（3.5%）；RR 1.21，95%CI 1.03 至 1.41；绝对过量+5.0/5000（±2.2））。
结论
ASCEND 随机试验的分析发现，通过英国常规数据源确定的主要出血事件提供了与裁定后的随访相似的相对和绝对治疗效果。
试验注册
ISRCTN60635500；NCT00135226。
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