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 …

[HTML][HTML] 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 …

[HTML][HTML] 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 …

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 …

[HTML][HTML] 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 …

“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 …

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 …

Empirical performance of a self-controlled cohort method: lessons for developing a risk identification and analysis system

PB Ryan, MJ Schuemie, D Madigan - Drug safety, 2013 - Springer
Background Observational healthcare data offer the potential to enable identification of risks
of medical products, but appropriate methodology has not yet been defined. The self …

Multiple self-controlled case series for large-scale longitudinal observational databases

SE Simpson, D Madigan, I Zorych, MJ Schuemie… - …, 2013 - academic.oup.com
Characterization of relationships between time-varying drug exposures and adverse events
(AEs) related to health outcomes represents the primary objective in postmarketing drug …

[图书][B] Self-controlled case series studies: a modelling guide with R

P Farrington, H Whitaker… - 2018 - library.oapen.org
Self-Controlled Case Series Studies: A Modelling Guide with R provides the first
comprehensive account of the self-controlled case series (SCCS) method, a statistical …