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June 27, 2018Pharmacoepidemiology and Drug Safety

Ascertainment and validation of major bleeding events in a primary care database

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Why the study?

Does manual validation of read codes improve the accuracy of identifying major bleeding events in patients receiving anticoagulant therapy in a primary care database?

Population

Patients aged 2 to 89 years with a first prescription for an anticoagulant between 2012 and 2015 in The…

Design

Cohort

Authors

ARAna RuigómezGBGunnar BrobertKSKiliana Suzart‐Woischnik

Discussion

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Overview

Unvalidated read codes overestimate GI/UG bleed incidence; supports mandatory validation in future observational anticoagulant safety studies.

Structured PICO

Does manual validation of read codes improve the accuracy of identifying major bleeding events in patients receiving anticoagulant therapy in a primary care database?

P
Population
Patients aged 2 to 89 years with a first prescription for an anticoagulant (rivaroxaban or warfarin) between 2012 and 2015 in The Health Improvement Network (THIN) database.
I
Intervention
Identification of major bleeding events using read codes alone versus a 2-step validation process requiring manual review of patients' records.
O
Outcome
Positive predictive value and incidence rates of major bleeding events (intracranial, gastrointestinal, urogenital).safety

Major gastrointestinal and urogenital bleeding events identified using read codes in primary care databases require manual validation to prevent overestimation of incidence rates.

Cite This Study

Ruigómez et al. (2018) studied this question.

synapsesocial.com/papers/6a82b5ce8ddd99b9b523a88dhttps://doi.org/10.1002/pds.4580
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