Food and Drug Administration, Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology, Divisions of Epidemiology I and II, Silver Spring, MD, USA.
Int J Epidemiol. 2019 Oct 1;48(5):1636-1649. doi: 10.1093/ije/dyz038.
Suicidal outcomes, including ideation, attempt, and completed suicide, are an important drug safety issue, though few epidemiological studies address the accuracy of suicidal outcome ascertainment. Our primary objective was to evaluate validated methods for suicidal outcome classification in electronic health care database studies.
We performed a systematic review of PubMed and EMBASE to identify studies that validated methods for suicidal outcome classification published 1 January 1990 to 15 March 2016. Abstracts and full texts were screened by two reviewers using prespecified criteria. Sensitivity, specificity, and predictive value for suicidal outcomes were extracted by two reviewers. Methods followed PRISMA-P guidelines, PROSPERO Protocol: 2016: CRD42016042794.
We identified 2202 citations, of which 34 validated the accuracy of measuring suicidal outcomes using International Classification of Diseases (ICD) codes or algorithms, chart review or vital records. ICD E-codes (E950-9) for suicide attempt had 2-19% sensitivity, and 83-100% positive predictive value (PPV). ICD algorithms that included events with 'uncertain' intent had 4-70% PPV. The three best-performing algorithms had 74-92% PPV, with improved sensitivity compared with E-codes. Read code algorithms had 14-68% sensitivity and 0-56% PPV. Studies estimated 19-80% sensitivity for chart review, and 41-97% sensitivity and 100% PPV for vital records.
Pharmacoepidemiological studies measuring suicidal outcomes often use methodologies with poor sensitivity or predictive value or both, which may result in underestimation of associations between drugs and suicidal behaviour. Studies should validate outcomes or use a previously validated algorithm with high PPV and acceptable sensitivity in an appropriate population and data source.
自杀结局，包括意念、企图和完成自杀，是一个重要的药物安全问题，尽管很少有流行病学研究涉及自杀结局确定的准确性。我们的主要目的是评估电子医疗保健数据库研究中用于自杀结局分类的验证方法。
我们通过系统检索 PubMed 和 EMBASE，以确定 1990 年 1 月 1 日至 2016 年 3 月 15 日发表的验证自杀结局分类方法的研究。两位评审员使用预设标准筛选摘要和全文。两位评审员提取自杀结局的敏感性、特异性和预测值。方法遵循 PRISMA-P 指南，PROSPERO 方案：2016：CRD42016042794。
我们共确定了 2202 篇参考文献，其中 34 篇验证了使用国际疾病分类（ICD）代码或算法、病历或生命记录测量自杀结局的准确性。自杀未遂的 ICD E 码（E950-9）的敏感性为 2-19%，阳性预测值（PPV）为 83-100%。包含“不确定”意图事件的 ICD 算法的 PPV 为 4-70%。三种性能最佳的算法的 PPV 为 74-92%，与 E 码相比，敏感性有所提高。读取代码算法的敏感性为 14-68%，PPV 为 0-56%。研究估计，病历审查的敏感性为 19-80%，生命记录的敏感性为 41-97%，PPV 为 100%。
测量自杀结局的药物流行病学研究通常使用敏感性或预测值较差或两者兼有的方法，这可能导致药物与自杀行为之间的关联被低估。研究应在适当的人群和数据源中验证结局或使用具有高 PPV 和可接受敏感性的先前验证算法。
