Epidemiology and Health

Special Article

Evidence integration on health damage for humidifier disinfectant exposure and legal presumption of causation: Mina Ha, Taehyun Park, Jong-Hyun Lee, Younghee Kim, Jungyun Lim, Yong-Wook Baek, Sol Yu, Hyen-Mi Chung, Kyu Hyuck Chung, Hae-Kwan Cheong, Review Committee for the Epidemiological Correlations between Humidifier Disinfectants Exposure and Health Effects; Epidemiol Health. 2023;45:e2023095. Published online October 24, 2023; DOI: https://doi.org/10.4178/epih.e2023095

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Abstract Summary PDF Supplementary Material

Abstract

OBJECTIVES
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.

Summary

Korean summary
저자들은 가습기살균제 노출로 인한 건강피해의 법적 인과관계 추정요건인 역학적 상관관계를 확인하기 위한 과정으로서 체계적 문헌고찰과 역학과 독성학의 전체 과학적 근거를 체계적으로 종합하는 방법을 제시하였다. 이것은 법적 증거 방법에서 개별 연구가 가지는 제한점이나 불확실성을 이유로 배척하지 않고, 전체 증거의 부분으로서 종합적으로 접근하는 것을 통해 사실 관계에 도달하는 방법이다. 이 전체증거접근법은 향후 인과관계 추정에서 전범(model)이 될 수 있다.

Key Message
We establish a systematic method for integrating a body of scientific evidence of epidemiology and toxicology to verify the epidemiological correlation, which is essential for presuming legal causation of health damages due to exposure to humidifier disinfectants. In terms of a legal proof, this method does not exclude individual studies due to their limitations or uncertainty but integrates them as part of a body of evidence to arrive at a conclusion that better reflects the truth of the evidence. This weight-of-the-evidence approach can be a model for future causal inference.

Citations

Citations to this article as recorded by

A systematic review and BMD modeling approach to develop an AOP for humidifier disinfectant-induced pulmonary fibrosis and cell death
Donghyun Kim, Yusun Shin, Jong-In Park, Donghyeon Lim, Hyunjoon Choi, Seongwon Choi, Yong-Wook Baek, Jungyun Lim, Younghee Kim, Ha Ryong Kim, Kyu Hyuck Chung, Ok-Nam Bae
Chemosphere.2024; 364: 143010. CrossRef

Brief Communication

Prevalence and methodological quality of systematic reviews in Korean medical journals: Seong Jung Kim, Mi Ah Han, Jae Hung Jung, Eu Chang Hwang, Hae Ran Kim, Sang Eun Yoon, Seo-Hee Kim, Pius Kim, So-Yeong Kim; Epidemiol Health. 2023;45:e2023017. Published online February 6, 2023; DOI: https://doi.org/10.4178/epih.e2023017

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Abstract Summary PDF Supplementary Material

Abstract

This study aimed to assess and evaluate the prevalence and methodological quality of systematic reviews (SRs) published in major Korean medical journals (KMJs). The top 15 journals with the highest Korean Medical Citation Index, published between 2018 to 2021, were selected. We assessed the methodological quality of SRs using A Measurement Tool to Assess Systematic Reviews 2 (AMSTAR 2). In total, 126 SRs were included, with an average of 32 SRs being reported annually. The overall prevalence of SRs in KMJs was 2.8%, with an increase from 2.6% in 2018 to 3.4% in 2021. Overall, the methodological quality of SRs was low (9.5% low, 90.5% critically low). More than 80% of the studies adhered to critical domain items such as a comprehensive literature search and risk of bias assessment, but for items such as protocol registration and listing excluded studies and the justification for exclusion, the adherence rate was less than 15%. While the number of SRs in KMJs steadily increased, the overall confidence in the methodological quality was low to critically low. Therefore, in order to provide the best evidence for decision-making in clinical and public health areas, editors, reviewers, and authors need to pay more attention to improving the quality of SRs.

Summary

Korean summary
한국의학저널에서 체계적 문헌고찰의 수는 꾸준히 증가했지만 방법론적 품질은 전반적으로 낮았다. 임상 및 공중 보건 분야에서 의사 결정을 위한 최상의 근거를 제공하기 위해 편집자, 심사자 및 저자는 체계적 문헌고찰의 품질을 개선하는 데 더 많은 관심을 기울여야 할 것이다.

Key Message
While the number of systematic reviews in Korean medical journals steadily increased, the overall confidence of methodological quality was low to critically low. Therefore, in order to provide the best evidence for decision-making in clinical and public health areas, editors, reviewers, and authors need to pay more attention to improving the quality of systematic reviews.

Citations

Citations to this article as recorded by

A methodological framework for rigorous systematic reviews: Tailoring comprehensive analyses to clinicians and healthcare professionals
Stefano Mancin, Marco Sguanci, Giuliano Anastasi, Lea Godino, Alessio Lo Cascio, Emanuela Morenghi, Michela Piredda, Maria Grazia De Marinis
Methods.2024; 225: 38. CrossRef
The status quo of systematic reviews published in high-impact journals in Korea: a study focused on protocol registration and GRADE use
Mi Ah Han, Seong Jung Kim, Eu Chang Hwang, Jae Hung Jung
Epidemiology and Health.2022; 44: e2022108. CrossRef

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