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Incidence in pharmacoepidemiology-Basic definitions and types of misclassification.

Mikael Hoffmann¹, Henrik Støvring²

¹Health Care Analysis, Division of Society and Health, Linköping University, Sweden & The NEPI Foundation, Stockholm, Sweden.

Basic & Clinical Pharmacology & Toxicology

|March 31, 2022

Summary

Defining new drug use cases is crucial for incidence studies. Study shows run-in periods impact new drug use definitions and misclassification rates in pharmacoepidemiology.

Keywords:

incidence misclassification pharmacoepidemiology run-in statins

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Area of Science:

Pharmacoepidemiology
Biostatistics
Drug Utilization Research

Background:

Accurate definition of new drug use cases is essential for incidence studies in epidemiology and pharmacoepidemiology.
Methodologies differ significantly between general epidemiology and pharmacoepidemiology regarding new case definitions.
Misclassification errors can arise from the choice of run-in period, affecting incidence estimates.

Purpose of the Study:

To define and apply a framework for two distinct types of new drug use cases: first-ever and recurrent.
To quantify misclassification errors associated with different run-in period lengths using the positive predictive value (PPV).
To analyze the impact of run-in period selection on incidence proportions of statin use in a real-world population.

Main Methods:

Utilized individual-level statin dispensation data from Sweden (2006-2019) for over 1 million individuals.
Defined and applied a framework for first-ever and recurrent new drug use cases.
Calculated incidence proportions and positive predictive values (PPV) for various run-in period lengths (8 months, 5 years, 10 years).

Main Results:

Incidence proportion of statin use in Sweden (2019) varied significantly with run-in period: 17.4/1000 (8 months), 9.45/1000 (5 years), and 8.4/1000 (10 years).
Positive Predictive Value (PPV) was 49% for an 8-month run-in and 89% for a 5-year run-in, using a 10-year run-in as the gold standard.
Demonstrated that misclassification rates are directly influenced by the chosen run-in period length.

Conclusions:

The interpretation of incidence and the selection of an appropriate run-in period in pharmacoepidemiology are contingent on the research question (first-ever use, recurrent treatment, or both).
At least five distinct misclassification types can be introduced based on the definition of incidence.
Careful consideration of run-in period is necessary to minimize misclassification and ensure accurate pharmacoepidemiological research findings.