{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,13]],"date-time":"2025-05-13T15:49:16Z","timestamp":1747151356660,"version":"3.40.5"},"reference-count":36,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2021,10,29]],"date-time":"2021-10-29T00:00:00Z","timestamp":1635465600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100000864","name":"Michael J. 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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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We present a transparent, step\u2010by\u2010step 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>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\u2010varying, cumulative 6\u2010month exposure to tamsulosin (a drug used to treat prostate hyperplasia).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The proposed approach links exposure specifications to four major concepts in drug safety and effectiveness studies. Formulating subject\u2010matter knowledge about these major concepts provides an avenue to develop the rationale and specifications for the exposure measure.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.5372","type":"journal-article","created":{"date-parts":[[2021,10,19]],"date-time":"2021-10-19T13:50:44Z","timestamp":1634651444000},"page":"13-21","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["A systematic, concept\u2010based method of developing the exposure measure for drug safety and effectiveness studies"],"prefix":"10.1002","volume":"31","author":[{"given":"Lisa K.","family":"Kuramoto","sequence":"first","affiliation":[{"name":"Centre for Clinical Epidemiology &amp; Evaluation, Vancouver Coastal Health Research Institute University of British Columbia  Vancouver British Columbia Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Boris G.","family":"Sobolev","sequence":"additional","affiliation":[{"name":"Centre for Clinical Epidemiology &amp; Evaluation, Vancouver Coastal Health Research Institute University of British Columbia  Vancouver British Columbia Canada"},{"name":"School of Population and Public Health University of British Columbia  Vancouver British Columbia Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jan","family":"Rosner","sequence":"additional","affiliation":[{"name":"Collaboration for Outcomes Research and Evaluation (CORE), Faculty of Pharmaceutical Sciences University of British Columbia  Vancouver British Columbia Canada"},{"name":"Department of Neurology University Hospital Bern, Inselspital, University of Bern  Bern Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Penelope M. 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