A systematic, concept-based method of developing the exposure measure for drug safety and effectiveness studies.

Kuramoto, Lisa K; Sobolev, Boris G; Rosner, Jan; Brasher, Penelope M A; Azoulay, Laurent; Cragg, Jacquelyn J (2022). A systematic, concept-based method of developing the exposure measure for drug safety and effectiveness studies. Pharmacoepidemiology and drug safety, 31(1), pp. 13-21. Wiley-Blackwell 10.1002/pds.5372

[img] Text
Kuramoto__2021__A_systematic_concept_based_method_of_developing_the_exposure_measure.pdf - Published Version
Restricted to registered users only
Available under License Publisher holds Copyright.

Download (669kB)

PURPOSE

In drug safety and effectiveness studies based on secondary data, the choice of an appropriate exposure measure for a given outcome can be challenging. Different measures of exposure can yield different estimates of treatment effect and safety. There is a knowledge gap with respect to developing and refining measures of drug exposure, to ensure that the exposure measure addresses the study question and is suitable for statistical analysis.

METHODS

We present a transparent, step-by-step approach to the development of drug exposure measures involving secondary data. This approach would be of interest to students and investigators with initial training in pharmacoepidemiology. We illustrate the approach using a study about Parkinson's disease.

RESULTS

We described the exposure specifications according to the study question. Next, we refined the exposure measure by linking it to knowledge about four major concepts in drug safety and effectiveness studies: drug use patterns, duration, timing, and dose. We then used this knowledge to guide the ultimate choice of exposure measure: time-varying, cumulative 6-month exposure to tamsulosin (a drug used to treat prostate hyperplasia).

CONCLUSIONS

The proposed approach links exposure specifications to four major concepts in drug safety and effectiveness studies. Formulating subject-matter knowledge about these major concepts provides an avenue to develop the rationale and specifications for the exposure measure.

Item Type:

Journal Article (Review Article)

Division/Institute:

04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Neurology

UniBE Contributor:

Rosner, Jan

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1053-8569

Publisher:

Wiley-Blackwell

Language:

English

Submitter:

Chantal Kottler

Date Deposited:

08 Dec 2021 16:19

Last Modified:

05 Dec 2022 15:55

Publisher DOI:

10.1002/pds.5372

PubMed ID:

34657356

Uncontrolled Keywords:

Parkinson disease drug evaluation drug utilization pharmacoepidemiology

BORIS DOI:

10.48350/161682

URI:

https://boris.unibe.ch/id/eprint/161682

Actions (login required)

Edit item Edit item
Provide Feedback