약물역학에서 자기-대조군 연구 설계 적용에 대한 국제약물역학회 승인 지침

초록

This Study aimed to establish consensus on conceptual foundations, terminology, and methodological relationships among self-controlled “trigger” study designs, which inherently control for time-invariant confounding and assess associations between transient exposures (potential triggers) and acute outcomes. Supported by the International Society for Pharmacoepidemiology (ISPE), a working group developed standardized guidance comparable to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). Based on a systematic review of existing literature collectively termed Self-controlled Crossover Observational PharmacoEpidemiologic (SCOPE) studies, the paper clarifies methodological distinctions between outcomeanchored designs (case-crossover [CCO], case-time control [CTC], case-case-time control [CCTC]) and exposure-anchored designs (self-controlled case-series [SCCS]). Key methodological considerations related to exposure, outcome, and timing are outlined, along with standardized terminology and a practical worksheet to facilitate study design. Achieving consensus in these foundational elements will improve clarity, enable critical appraisal, and promote rigorous implementation of future SCOPE studies. Additionally, this abstract was translated and paraphrased into Korean to assist Korean authors in clearly understanding and applying these concepts. This work is endorsed by ISPE.

키워드