Control yourself: ISPE-endorsed guidance in the application of self-controlled study designs in pharmacoepidemiology

Suzanne M. Cadarette, Malcolm Maclure, J. A.Chris Delaney, Heather Whitaker, Kaleen N. Hayes, Shirley V. Wang, Mina Tadrous, Joshua J. Gagne, Giulia P. Consiglio, Jesper Hallas

Research output: Contribution to journalReview articlepeer-review

1 Citation (Scopus)

Abstract

Purpose: 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. 

Methods: 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. 

Results: 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. 

Conclusions: 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.

Original languageEnglish
Pages (from-to)671-684
Number of pages14
JournalPharmacoepidemiology and Drug Safety
Volume30
Issue number6
Early online date13 Mar 2021
DOIs
Publication statusPublished - 2 May 2021

Keywords

  • design
  • pharmacoepidemiology
  • research
  • self-controlled

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