PDF(Pubmed)
Abstract：
OBJECTIVE: Inhalation exposure to humidifier disinfectants has resulted to various types of health damages in Korea. To determine the epidemiological correlation necessary for presuming the legal causation, we aimed to develop a method to synthesize the entire evidence.
METHODS: Epidemiological and toxicological studies are systematically reviewed. Target health problems are selected by criteria such as frequent complaints of claimants. Relevant epidemiologic studies are reviewed and the risk of bias and confidence level of the total evidence are evaluated. Toxicological literature reviews are conducted on three lines of evidence including hazard information, animal studies, and mechanistic studies, considering the source-to-exposure-to-outcome continuum. The confidence level of the body of evidence is then translated into the toxicological evidence levels for the causality between humidifier disinfectant exposure and health effects. Finally, the levels of epidemiological and toxicological evidence are synthesized.
RESULTS: Under the Special Act revised in 2020, if the history of exposure and the disease occurred/worsened after exposure were approved, and the epidemiological correlation between the exposure and disease was verified, the legal causation is presumed unless the company proves the evidence against it. The epidemiological correlation can be verified through epidemiological investigations, health monitoring, cohort investigations and/or toxicological studies. It is not simply as statistical association as understood in judicial precedents, but a general causation established by the evidence as a whole, i.e., through weight-of-the-evidence approach.
CONCLUSIONS: The weight-of-the-evidence approach differs from the conclusive single study approach and this systematic evidence integration can be used in presumption of causation.
METHODS: Epidemiological and toxicological studies are systematically reviewed. Target health problems are selected by criteria such as frequent complaints of claimants. Relevant epidemiologic studies are reviewed and the risk of bias and confidence level of the total evidence are evaluated. Toxicological literature reviews are conducted on three lines of evidence including hazard information, animal studies, and mechanistic studies, considering the source-to-exposure-to-outcome continuum. The confidence level of the body of evidence is then translated into the toxicological evidence levels for the causality between humidifier disinfectant exposure and health effects. Finally, the levels of epidemiological and toxicological evidence are synthesized.
RESULTS: Under the Special Act revised in 2020, if the history of exposure and the disease occurred/worsened after exposure were approved, and the epidemiological correlation between the exposure and disease was verified, the legal causation is presumed unless the company proves the evidence against it. The epidemiological correlation can be verified through epidemiological investigations, health monitoring, cohort investigations and/or toxicological studies. It is not simply as statistical association as understood in judicial precedents, but a general causation established by the evidence as a whole, i.e., through weight-of-the-evidence approach.
CONCLUSIONS: The weight-of-the-evidence approach differs from the conclusive single study approach and this systematic evidence integration can be used in presumption of causation.
摘要：
目的：吸入湿化消毒剂对韩国的健康造成了各种损害。为了确定假定法律因果关系所必需的流行病学相关性，我们的目标是开发一种综合整个证据的方法。
方法：系统综述了流行病学和毒理学研究。目标健康问题是根据索赔人的频繁投诉等标准选择的。回顾了相关的流行病学研究，并评估了总体证据的偏倚风险和置信水平。毒理学文献综述是针对三行证据进行的，包括危害信息，动物研究,和机械研究，考虑来源到暴露到结果的连续体。然后，将证据体的置信水平转化为加湿器消毒剂暴露与健康影响之间因果关系的毒理学证据水平。最后,流行病学和毒理学证据的水平是综合的。
结果：根据2020年修订的《特别法》，如果暴露史和疾病在暴露后发生/恶化被批准，并且证实了暴露与疾病之间的流行病学相关性，除非公司证明反对它的证据，否则法律因果关系是推定的。流行病学相关性可以通过流行病学调查来验证,健康监测,队列调查和/或毒理学研究。它不仅仅是司法先例所理解的统计关联，而是由整个证据确定的一般因果关系，即，通过证据权重法。
结论：证据权重方法不同于结论性的单一研究方法，这种系统的证据整合可用于因果关系的推定。
方法：系统综述了流行病学和毒理学研究。目标健康问题是根据索赔人的频繁投诉等标准选择的。回顾了相关的流行病学研究，并评估了总体证据的偏倚风险和置信水平。毒理学文献综述是针对三行证据进行的，包括危害信息，动物研究,和机械研究，考虑来源到暴露到结果的连续体。然后，将证据体的置信水平转化为加湿器消毒剂暴露与健康影响之间因果关系的毒理学证据水平。最后,流行病学和毒理学证据的水平是综合的。
结果：根据2020年修订的《特别法》，如果暴露史和疾病在暴露后发生/恶化被批准，并且证实了暴露与疾病之间的流行病学相关性，除非公司证明反对它的证据，否则法律因果关系是推定的。流行病学相关性可以通过流行病学调查来验证,健康监测,队列调查和/或毒理学研究。它不仅仅是司法先例所理解的统计关联，而是由整个证据确定的一般因果关系，即，通过证据权重法。
结论：证据权重方法不同于结论性的单一研究方法，这种系统的证据整合可用于因果关系的推定。
