Core concepts in pharmacoepidemiology: Measurement of medication exposure in routinely collected healthcare data for causal inference studies in pharmacoepidemiology.
bias
exposure measurement
misclassification
nonexperimental studies
pharmacoepidemiology
real world data
real world evidence
routinely collected healthcare data
Journal
Pharmacoepidemiology and drug safety
ISSN: 1099-1557
Titre abrégé: Pharmacoepidemiol Drug Saf
Pays: England
ID NLM: 9208369
Informations de publication
Date de publication:
26 Sep 2023
26 Sep 2023
Historique:
revised:
09
08
2023
received:
13
04
2023
accepted:
11
08
2023
pubmed:
27
9
2023
medline:
27
9
2023
entrez:
27
9
2023
Statut:
aheadofprint
Résumé
Observational designs can complement evidence from randomized controlled trials not only in situations when randomization is not feasible, but also by evaluating drug effects in real-world, considering a broader spectrum of users and clinical scenarios. However, use of such real-world scenarios captured in routinely collected clinical or administrative data also comes with specific challenges. Unlike in trials, medication use is not protocol based. Instead, exposure is determined by a multitude of factors involving patients, providers, healthcare access, and other policies. Accurate measurement of medication exposure relies on a similar broad set of factors which, if not understood and appropriately addressed, can lead to exposure misclassification and bias. To describe core considerations for measurement of medication exposure in routinely collected healthcare data. We describe the strengths and weaknesses of the two main types of routinely collected healthcare data (electronic health records and administrative claims) used in pharmacoepidemiologic research. We introduce key elements in those data sources and issues in the curation process that should be considered when developing exposure definitions. We present challenges in exposure measurement such as the appropriate determination of exposure time windows or the delineation of concomitant medication use versus switching of therapy, and related implications for bias. We note that true exposure patterns are typically unknown when using routinely collected healthcare data and that an in-depth understanding of healthcare delivery, patient and provider decision-making, data documentation and governance, as well as pharmacology are needed to ensure unbiased approaches to measuring exposure. Various assumptions are made with the goal that the chosen exposure definition can approximate true exposure. However, the possibility of exposure misclassification remains, and sensitivity analyses that can test the impact of such assumptions on the robustness of estimated medication effects are necessary to support causal inferences.
Sections du résumé
BACKGROUND
BACKGROUND
Observational designs can complement evidence from randomized controlled trials not only in situations when randomization is not feasible, but also by evaluating drug effects in real-world, considering a broader spectrum of users and clinical scenarios. However, use of such real-world scenarios captured in routinely collected clinical or administrative data also comes with specific challenges. Unlike in trials, medication use is not protocol based. Instead, exposure is determined by a multitude of factors involving patients, providers, healthcare access, and other policies. Accurate measurement of medication exposure relies on a similar broad set of factors which, if not understood and appropriately addressed, can lead to exposure misclassification and bias.
AIM
OBJECTIVE
To describe core considerations for measurement of medication exposure in routinely collected healthcare data.
METHODS
METHODS
We describe the strengths and weaknesses of the two main types of routinely collected healthcare data (electronic health records and administrative claims) used in pharmacoepidemiologic research. We introduce key elements in those data sources and issues in the curation process that should be considered when developing exposure definitions. We present challenges in exposure measurement such as the appropriate determination of exposure time windows or the delineation of concomitant medication use versus switching of therapy, and related implications for bias.
RESULTS
RESULTS
We note that true exposure patterns are typically unknown when using routinely collected healthcare data and that an in-depth understanding of healthcare delivery, patient and provider decision-making, data documentation and governance, as well as pharmacology are needed to ensure unbiased approaches to measuring exposure.
CONCLUSIONS
CONCLUSIONS
Various assumptions are made with the goal that the chosen exposure definition can approximate true exposure. However, the possibility of exposure misclassification remains, and sensitivity analyses that can test the impact of such assumptions on the robustness of estimated medication effects are necessary to support causal inferences.
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2023 John Wiley & Sons Ltd.
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