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Cited by 255Pharmacovigilance and Adverse Drug ReactionsStatistical Methods in Clinical TrialsData-Driven Disease Surveillance

The DOI matches its Crossref record; 6 of the 6 references it cites were found in a registry or an index.

A basic study design for expedited safety signal evaluation based on electronic healthcare data

Open access
Schneeweiss, Sebastian·2010·Pharmacoepidemiology and Drug Safety
DOI 10.1002/pds.1926PMC PMC2917262
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Abstract

Active drug safety monitoring based on longitudinal electronic healthcare databases (a Sentinel System), as outlined in recent FDA-commissioned reports, consists of several interlocked processes, including signal generation, signal strengthening, and signal evaluation. Once a signal of a potential drug safety issue is generated, signal strengthening and signal evaluation have to follow in short sequence in order to quickly provide as much information about the triggering drug-event association as possible. This paper proposes a basic study design based on the incident user cohort design for expedited signal evaluation in longitudinal healthcare databases. It will not resolve all methodological issues nor will it fit all study questions arising within the framework of a Sentinel System. It should rather be seen as a guidance that will fit the majority of situations and serve as a starting point for adaptations to specific studies. Such an approach will expedite and structure the process of study development and highlight specific assumptions, which is particularly valuable in a Sentinel System where signals are by definition preliminary and evaluation of signals is time critical.

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  • Adjusting for time varying confounders is difficult in a matched case-control study.

    “Adjusting for time varying confounders is difficult in a matched case-control study.31 46”

    From Anticholinergic drugs and risk of dementia: case-control study (2018) · cites this paper as [31]

    The Incident user design section says case-control studies are prone to errors in confounder adjustment. It does not specify matched case-control studies or say that adjusting for time-varying confounders is difficult in that design. The Sources of exposure variation section discusses confounding as health status changes over time, but in a case-crossover design. (LLM, conf=0.84)

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Citations

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Research works printed but not linked: 30

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Metadata

Authors
Schneeweiss, S.
Affiliations
Brigham and Women's Hospital (US)
Corresponding author
Schneeweiss, Sebastian
ORCID
Schneeweiss, Sebastian
Venue
Pharmacoepidemiology and Drug Safety
Publisher
Wiley
Published
2010-05-17
Volume
19
Issue
8
Pages
858-868
ISSN
1053-8569 (ISSN-L)
DOI
10.1002/pds.1926
PMC
PMC2917262
OpenAlex
W2001727746
Cited by
255
References
6
Citations by year
2026: 8 · 2025: 5 · 2024: 10 · 2023: 6 · 2022: 18 · 2021: 19 · 2020: 17 · 2019: 29 · 2018: 22 · 2017: 14 · 2016: 10 · 2015: 13 · 2014: 16 · 2013: 17 · 2012: 35
FWCI
25.65
Type
journal article
Language
en
Open access
Licence
Locations
  • Pharmacoepidemiology and Drug Safety (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
Funders
  • National Library of Medicine (RO1-LM010213, RC1-LM010351)
  • National Center for Research Resources (RC1-RR028231)
Topics
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
  • Health Sciences › Medicine › Epidemiology › Data-Driven Disease Surveillance
Keywords
drug safety signals, signal evaluation, Sentinel System, research design
MeSH terms
Delivery of Health Care, Female, Humans, Male, Primary Health Care, Cohort Studies, Databases, Factual, Drug Monitoring, Adverse Drug Reaction Reporting Systems, Prescription Drugs, Propensity Score, Drug-Related Side Effects and Adverse Reactions

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