Control yourself: ISPE-endorsed guidance in the application of self-controlled study designs in pharmacoepidemiology.
Control yourself: ISPE-endorsed guidance in the application of self-controlled study designs in pharmacoepidemiology.
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自我控制：ISPE认可的药物流行病学自我控制研究设计应用指南。
DOI：
10.1002/pds.5227
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发表时间：
2021-06
影响因子：
2.6
通讯作者：
Hallas J
中科院分区：
文献类型：
--
作者：
Cadarette SM;Maclure M;Delaney JAC;Whitaker HJ;Hayes KN;Wang SV;Tadrous M;Gagne JJ;Consiglio GP;Hallas J
需要就概念基础、术语和各种自控“触发”研究设计之间的关系达成共识，这些设计控制时间不变的混杂因素，并针对瞬时暴露(潜在触发)和突然结果之间的关联。国际药物流行病学学会(ISPE)资助了一个由ISPE成员组成的工作组，以开发应用和报告自身对照研究设计的指导材料，类似于报告观察流行病学的标准(STROBE)。第一篇文章关注于自主控制设计的类型之间的导航，以便对指导原则有一个基本的理解。我们对这些设计的应用进行了系统的回顾，我们称之为自身对照交叉观察性药物流行病学(SCOPE)研究。从基本原理出发，使用病例实例，我们回顾了结果锚定(病例交叉[CCO]、病例-时间对照[CTC]、病例-病例-时间对照[CCTC])和暴露锚定(自身对照病例系列[SCCS])研究设计。阐明了与暴露、结果和与时间有关的问题有关的主要方法特点，并介绍了一种促进范围研究设计的通用语言和工作表。就概念基础、术语和范围设计之间的关系达成共识，将有助于理解和批判性地评价已发表的研究，并有助于设计、分析和审查新的范围研究。这份手稿得到了ISPE的认可。
Consensus is needed on conceptual foundations, terminology and relationships among the various self‐controlled “trigger” study designs that control for time‐invariant confounding factors and target the association between transient exposures (potential triggers) and abrupt outcomes. The International Society for Pharmacoepidemiology (ISPE) funded a working group of ISPE members to develop guidance material for the application and reporting of self‐controlled study designs, similar to Standards of Reporting Observational Epidemiology (STROBE). This first paper focuses on navigation between the types of self‐controlled designs to permit a foundational understanding with guiding principles. We leveraged a systematic review of applications of these designs, that we term Self‐controlled Crossover Observational PharmacoEpidemiologic (SCOPE) studies. Starting from first principles and using case examples, we reviewed outcome‐anchored (case‐crossover [CCO], case‐time control [CTC], case‐case‐time control [CCTC]) and exposure‐anchored (self‐controlled case‐series [SCCS]) study designs. Key methodological features related to exposure, outcome and time‐related concerns were clarified, and a common language and worksheet to facilitate the design of SCOPE studies is introduced. Consensus on conceptual foundations, terminology and relationships among SCOPE designs will facilitate understanding and critical appraisal of published studies, as well as help in the design, analysis and review of new SCOPE studies. This manuscript is endorsed by ISPE.
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影响因子：
2.9
作者：
CLEOPHAS, TJM
通讯作者：
CLEOPHAS, TJM
影响因子：
13.6
作者：
Hallas, Jesper;Wang, Shirley V.;Pottegard, Anton
通讯作者：
Pottegard, Anton
影响因子：
5
作者：
Baker, Meghan A.;Lieu, Tracy A.;Nguyen, Michael D.
通讯作者：
Nguyen, Michael D.
影响因子：
2.6
作者：
Li, Lingling;Kulldorff, Martin;Hua, Wei
通讯作者：
Hua, Wei
影响因子：
5.3
作者：
Lustig, Andrew J.;Kurdyak, Paul A.;Redelmeier, Donald A.
通讯作者：
Redelmeier, Donald A.