Cited by 739Advanced Causal Inference TechniquesStatistical Methods in EpidemiologyStatistical Methods in Clinical Trials

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The active comparator, new user study design in pharmacoepidemiology: historical foundations and contemporary application.

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Lund, Jennifer L., Richardson, David B., Stürmer, Til·2015·Current Epidemiology Reports

DOI 10.1007/s40471-015-0053-5PMC PMC4778958

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Abstract

Better understanding of biases related to selective prescribing of, and adherence to, preventive treatments has led to improvements in the design and analysis of pharmacoepidemiologic studies. One influential development has been the "active comparator, new user" study design, which seeks to emulate the design of a head-to-head randomized controlled trial. In this review, we first discuss biases that may affect pharmacoepidemiologic studies and describe their direction and magnitude in a variety of settings. We then present the historical foundations of the active comparator, new user study design and explain how this design conceptually mitigates biases leading to a paradigm shift in pharmacoepidemiology. We offer practical guidance on the implementation of the study design using administrative databases. Finally, we provide an empirical example in which the active comparator, new user study design addresses biases that have previously impeded pharmacoepidemiologic studies.

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Authors: Lund, J. L., Richardson, D. B., & Stürmer, T.
Affiliations: University of North Carolina at Chapel Hill (US)
Corresponding author: Lund, Jennifer L.
ORCID: Lund, Jennifer L.
Richardson, David B.
Venue: Current Epidemiology Reports
Publisher: Springer Science and Business Media LLC
Published: 2015-09-30
Volume: 2
Issue: 4
Pages: 221-228
ISSN: 2196-2995 (ISSN-L)
DOI: 10.1007/s40471-015-0053-5
PMC: PMC4778958
OpenAlex: W1849521086
Cited by: 739
References: 42
Citations by year: 2026: 103 · 2025: 125 · 2024: 94 · 2023: 79 · 2022: 98 · 2021: 72 · 2020: 61 · 2019: 44 · 2018: 34 · 2017: 19 · 2016: 10
FWCI: 18.69
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.springer.com/tdm (tdm)
Locations: Current Epidemiology Reports (publishedVersion)
PubMed (publishedVersion)
PubMed Central (acceptedVersion)
Funders: National Institutes of Health (2k12ca120780-16)
National Institute on Aging (R01AG023178)
National Cancer Institute (K12-CA120780)
National Institute of Diabetes and Digestive and Kidney Diseases (P30DK124723)
Topics: Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Keywords: bias in observational studies, head-to-head comparison, administrative databases

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The active comparator, new user study design in pharmacoepidemiology: historical foundations and contemporary application.

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