Self-controlled designs in pharmacoepidemiology involving electronic healthcare databases: a systematic review

N Gault, J Castañeda-Sanabria, Y De Rycke… - BMC medical research …, 2017 - Springer
Background Observational studies are widely used in pharmacoepidemiology. Several
designs can be used, in particular self-controlled designs (case-crossover and self …

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

SM Cadarette, M Maclure, JAC Delaney… - … and Drug Safety, 2021 - Wiley Online Library
Purpose Consensus is needed on conceptual foundations, terminology and relationships
among the various self‐controlled “trigger” study designs that control for time‐invariant …

A comparison of estimators from self-controlled case series, case-crossover design, and sequence symmetry analysis for pharmacoepidemiological studies

Y Takeuchi, T Shinozaki, Y Matsuyama - BMC medical research …, 2018 - Springer
Background Despite the frequent use of self-controlled methods in
pharmacoepidemiological studies, the factors that may bias the estimates from these …

Case-only designs in pharmacoepidemiology: a systematic review

S Nordmann, L Biard, P Ravaud, M Esposito-Farèse… - PloS one, 2012 - journals.plos.org
Background Case-only designs have been used since late 1980's. In these, as opposed to
case-control or cohort studies for instance, only cases are required and are self-controlled …

Use of self‐controlled designs in pharmacoepidemiology

J Hallas, A Pottegård - Journal of internal medicine, 2014 - Wiley Online Library
Self‐controlled observational study designs, such as the case–crossover design and the self‐
controlled case series, are reviewed, and their respective rationale, strengths and limitations …

Introduction to self-controlled study design

M Iwagami, Y Takeuchi - Annals of Clinical Epidemiology, 2021 - jstage.jst.go.jp
Self-controlled study designs, also known as case-only designs or Self-controlled Crossover
Observational PharmacoEpidemiologic (SCOPE) studies, include case-crossover (CCO) …

When should case‐only designs be used for safety monitoring of medical products?

M Maclure, B Fireman, JC Nelson… - … and drug safety, 2012 - Wiley Online Library
Purpose To assess case‐only designs for surveillance with administrative databases.
Methods We reviewed literature on two designs that are observational analogs to crossover …

The use of active comparators in self-controlled designs

J Hallas, H Whitaker, JA Delaney… - American Journal of …, 2021 - academic.oup.com
For self-controlled studies of medication-related effects, time-varying confounding by
indication can occur if the indication varies over time. We describe how active comparators …

A simulation study to compare three self‐controlled case series approaches: correction for violation of assumption and evaluation of bias

W Hua, G Sun, CN Dodd, SA Romio… - … and drug safety, 2013 - Wiley Online Library
Purpose The assumption that the occurrence of outcome event must not alter subsequent
exposure probability is critical for preserving the validity of the self‐controlled case series …

“First-wave” bias when conducting active safety monitoring of newly marketed medications with outcome-indexed self-controlled designs

SV Wang, S Schneeweiss, M Maclure… - American journal of …, 2014 - academic.oup.com
Large health care databases are used extensively for pharmacoepidemiologic studies.
Unique methodological issues arise when applying self-controlled designs (ie, using within …