Bentouhami Hayat, Casas Lidia, Weyler Joost
University of Antwerp, Social Epidemiology and Health Policy, Wilrijk, 2610, Belgium.
Clin Epidemiol. 2021 Aug 27;13:755-767. doi: 10.2147/CLEP.S318287. eCollection 2021.
"Theoretical design" comprises the development of an occurrence relation and the specification of the study domain. In explanatory research, the occurrence relation causally relates one determinant to the occurrence (of an event or a state) taking into account other relevant characteristics (confounders and modifiers). Conflicting results in explanatory research might be (partially) explained by differences in the "theoretical design" or by a mismatch between the "theoretical design" and the "design of data collection". In this critical review, the reporting of "theoretical design" is assessed in articles on the association between early life antibiotic use and the occurrence of asthma. Articles investigating a relationship between early life antibiotic use and the occurrence of asthma were searched in PubMed and systematically selected for critical review. The full text was read and important elements of study design were extracted (the research question/hypothesis, seven key elements of "theoretical design" (measure of occurrence, case (event or state) definition, conceptualization (and operationalization) of the exposure, temporal relation between outcome and exposure, confounders and effect modifiers taken into account and the domain of the study), the method of data collection and the method of data processing). A comparison was made between articles published before and after the publication of the "Strengthening the Reporting of Observational Studies in Epidemiology" (STROBE) statement (2007). Sixty-three articles were included for review. Thirteen articles reported the seven key elements of "theoretical design" that were questioned. No marked differences in reporting were observed pre- and post-STROBE. All articles reported some key elements of "theoretical design"; however, the reporting is not structured and not linked to the concept of "theoretical design". Conceptualizing, delineating and explicit reporting of "theoretical design" is quintessential for the quality and transparency of explanatory research.
“理论设计”包括建立一种发生关系以及明确研究领域。在解释性研究中，发生关系从因果关系上将一个决定因素与（事件或状态的）发生联系起来，同时考虑其他相关特征（混杂因素和修饰因素）。解释性研究中相互矛盾的结果可能（部分地）归因于“理论设计”的差异，或者“理论设计”与“数据收集设计”之间的不匹配。在这篇批判性综述中，对关于早期使用抗生素与哮喘发生之间关联的文章中“理论设计”的报告情况进行了评估。在PubMed中搜索了调查早期使用抗生素与哮喘发生之间关系的文章，并系统地挑选出来进行批判性综述。阅读了全文并提取了研究设计的重要要素（研究问题/假设、“理论设计”的七个关键要素（发生的衡量指标、病例（事件或状态）定义、暴露的概念化（及操作化）、结局与暴露之间的时间关系、考虑到的混杂因素和效应修饰因素以及研究领域）、数据收集方法和数据处理方法）。对《加强流行病学观察性研究报告规范》（STROBE）声明（2007年）发布之前和之后发表的文章进行了比较。纳入63篇文章进行综述。13篇文章报告了受到质疑的“理论设计”的七个关键要素。STROBE声明发布前后在报告方面未观察到明显差异。所有文章都报告了“理论设计”的一些关键要素；然而，报告没有结构化，也未与“理论设计”的概念相联系。对“理论设计”进行概念化、界定和明确报告对于解释性研究的质量和透明度至关重要。
