Vlaanderen Jelle, Vermeulen Roel, Heederik Dick, Kromhout Hans
Institute for Risk Assessment Sciences, Division Environmental Epidemiology, Utrecht University, Jenalaan 18d, Utrecht, the Netherlands.
Environ Health Perspect. 2008 Dec;116(12):1700-5. doi: 10.1289/ehp.11530. Epub 2008 Aug 12.
Careful evaluation of the quality of human observational studies (HOS) is required to assess the suitability of HOS for quantitative risk assessment (QRA). In particular, the quality of quantitative exposure assessment is a crucial aspect of HOS to be considered for QRA.
We aimed to develop guidelines for the evaluation of HOS for QRA and to apply these guidelines to case-control and cohort studies on the relation between exposure to benzene and acute myeloid leukemia (AML).
We developed a three-tiered framework specific for the evaluation of HOS for QRA and used it to evaluate HOS on the relation between exposure to benzene and AML.
The developed framework consists of 20 evaluation criteria. A specific focus of the framework was on the quality of exposure assessment applied in HOS. Seven HOS on the relation of benzene and AML were eligible for evaluation. Of these studies, five were suitable for QRA and were ranked based on the quality of the study design, conduct, and reporting on the study.
The developed guidelines facilitate a structured evaluation that is transparent in its application and harmonizes the evaluation of HOS for QRA. With the application of the guidelines, it was possible to identify studies suitable for QRA of benzene and AML and rank these studies based on their quality. Application of the guidelines in QRA will be a valuable addition to the assessment of the weight of evidence of HOS for QRA.
需要对人类观察性研究（HOS）的质量进行仔细评估，以评估HOS用于定量风险评估（QRA）的适用性。特别是，定量暴露评估的质量是HOS中QRA需要考虑的关键方面。
我们旨在制定用于评估HOS以进行QRA的指南，并将这些指南应用于关于苯暴露与急性髓系白血病（AML）之间关系的病例对照研究和队列研究。
我们开发了一个专门用于评估HOS以进行QRA的三层框架，并使用它来评估关于苯暴露与AML之间关系的HOS。
所开发的框架由20条评估标准组成。该框架的一个特别重点是HOS中应用的暴露评估质量。七项关于苯与AML关系的HOS符合评估条件。在这些研究中，五项适合进行QRA，并根据研究设计、实施和报告的质量进行了排名。
所制定的指南有助于进行结构化评估，其应用具有透明度，并使HOS用于QRA的评估更加统一。通过应用这些指南，可以识别出适合苯与AML的QRA的研究，并根据其质量对这些研究进行排名。在QRA中应用这些指南将是对HOS用于QRA的证据权重评估的宝贵补充。
