Extreme restriction design as a method for reducing confounding by indication in pharmacoepidemiologic research.
Adult
Adverse Drug Reaction Reporting Systems
Aged
Aged, 80 and over
Confounding Factors, Epidemiologic
Female
Gastroesophageal Reflux
/ drug therapy
Humans
Male
Middle Aged
Pharmacoepidemiology
Pneumonia
/ epidemiology
Proton Pump Inhibitors
/ adverse effects
Risk Factors
United Kingdom
/ epidemiology
confounding
methodology
methods
pharmacoepidemiology
restriction
study design
Journal
Pharmacoepidemiology and drug safety
ISSN: 1099-1557
Titre abrégé: Pharmacoepidemiol Drug Saf
Pays: England
ID NLM: 9208369
Informations de publication
Date de publication:
01 2020
01 2020
Historique:
received:
26
06
2018
revised:
27
09
2018
accepted:
14
11
2018
pubmed:
11
1
2019
medline:
17
12
2020
entrez:
11
1
2019
Statut:
ppublish
Résumé
Confounding by indication is a concern in observational pharmacoepidemiologic studies, including those that use active comparator, new user (ACNU) designs. Here, we present a method of restriction to an indication, which we call "extreme restriction," to reduce confounding in such studies. As a case study, we evaluated the effect of proton pump inhibitors (PPIs) on hospitalization for community-acquired pneumonia (HCAP). PPI use has been associated with increased HCAP risk, but this association likely results from confounding by indication due to gastroesophageal reflux disease (GERD). Using the UK's Clinical Practice Research Datalink, we compared the risk of HCAP within 180 days between PPI users and histamine-2 receptor antagonist (H2RA) users in an ACNU cohort using Cox proportional hazard models with a time-fixed exposure definition adjusted for high-dimensional propensity score deciles. We then performed the same analysis on an "extremely-restricted" cohort of incident nonsteroidal anti-inflammatory drug (NSAID) users, some of whom received PPIs for prophylaxis. Because PPIs were given as prophylaxis in this population, confounding due to GERD should be limited. We compared effect estimates between ACNU and restricted cohorts to evaluate confounding in both analyses. In the ACNU cohort, PPIs were associated with an increased risk of HCAP (hazard ratio [HR]: 1.25; 95% confidence interval [CI]: 1.05, 1.47), but this association was not present in the restricted cohort (HR: 1.06; 95% CI: 0.75, 1.49). Restriction to a single indication for treatment may reduce confounding by indication in studies conducted in distributed data networks and other large databases.
Substances chimiques
Proton Pump Inhibitors
0
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
26-34Subventions
Organisme : CIHR
ID : DSE-146021
Pays : Canada
Informations de copyright
© 2019 John Wiley & Sons, Ltd.
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