Pacqué-Margolis S, Pacqué M, Dukuly Z, Boateng J, Taylor H R
Dana Center for Preventive Ophthalmology, Wilmer Institute, Johns Hopkins University School of Medicine, Baltimore, MD 21205.
Soc Sci Med. 1990;31(5):585-91. doi: 10.1016/0277-9536(90)90094-9.
During a community-based treatment trial of onchocerciasis with ivermectin, verbal autopsies were employed as one method to assess the safety of the drug. The verbal autopsy questionnaire was designed to determine causes of death and mortality differentials in the treated population. During the 8 months of surveillance here reported, 25 individuals died, yet only 9 of these deaths were certified. Seven of the deaths occurred to individuals who had been treated with ivermectin and the majority of the deaths occurred to children under 5, who were excluded from treatment. The verbal autopsy method was evaluated and validated by comparing the verbal autopsy diagnosis of cause of death to death certificate diagnosis, when available. In addition, verbal autopsies were retrospectively performed for all deaths which had occurred at the hospital during the 6 months preceding the start of the study, if these deaths were traceable to households in the surveillance population. We found that in 80% of the adult deaths, the verbal autopsy and death certificate diagnoses of underlying cause of death agreed. The verbal autopsy was less accurate in diagnosing child deaths which we attribute to the design of the verbal autopsy (being to detect potential drug related deaths in adults) and to the delay between death and interview. We conclude that verbal autopsies are an important addition to surveillance systems in remote areas where the absence or inadequacy of health information systems does not allow a thorough follow-up of all subjects in drug studies.
在一项使用伊维菌素进行盘尾丝虫病社区治疗试验期间，采用了死因推断作为评估该药物安全性的一种方法。死因推断调查问卷旨在确定治疗人群中的死亡原因和死亡率差异。在本报告的8个月监测期内，有25人死亡，但其中只有9人的死亡得到了认证。7例死亡发生在接受伊维菌素治疗的个体中，且大多数死亡发生在5岁以下儿童，这些儿童被排除在治疗之外。通过将死因推断诊断的死亡原因与死亡证明诊断（如有）进行比较，对死因推断方法进行了评估和验证。此外，对于研究开始前6个月在医院发生的所有可追溯到监测人群家庭的死亡病例，进行了回顾性死因推断。我们发现，在80%的成人死亡病例中，死因推断和死亡证明对根本死因的诊断是一致的。死因推断在诊断儿童死亡方面不太准确，我们将其归因于死因推断的设计（旨在检测成人中潜在的药物相关死亡）以及死亡与访谈之间的延迟。我们得出结论，在偏远地区，由于卫生信息系统缺失或不完善，无法对药物研究中的所有受试者进行全面随访，死因推断是监测系统的一项重要补充。
