{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T15:28:13Z","timestamp":1788967693030,"version":"build-2803163510"},"reference-count":23,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2021,6,7]],"date-time":"2021-06-07T00:00:00Z","timestamp":1623024000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2021,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>There is an increased use in the (prescription) sequence symmetry analysis (PSSA); however, limited studies have incorporated a negative control, and no study has formally quantified and controlled for within\u2010patient time\u2010varying bias using a negative control. Our aim was to develop a process to incorporate the effect of negative controls into the main analysis of a PSSA.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Using a previously assessed dihydropyridine calcium channel blocker (DH\u2010CCB) and loop diuretic PSSA, we directly compared the adjusted sequence ratios (aSRs) of DH\u2010CCBs to each of the two negative control index drugs (levothyroxine and angiotensin converting enzyme [ACE] inhibitor\/angiotensin\u20102 receptor blocker [ARB]) using the ratio of the aSRs to estimate a relative aSR with a Z test. Further, we utilized the relative aSR in stratum\u2010specific analyses and varying exposure windows.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The relative aSR of DH\u2010CCBs decreased from 1.87 to 1.72 (95% CI 1.66\u20131.78) using levothyroxine as a negative control index drug. ACE inhibitor\/ARB negative control index drug resulted in an aSR of 1.27 thus reducing the relative aSR for DH\u2010CBB from 1.84 to 1.45 (95% CI 1.41\u20131.49). When restricting the exposure window to 180 and 90\u2009days, the relative aSR of DH\u2010CCBs increased to 1.68 (95% CI 1.62\u20131.74) and 1.86 (95% CI 1.78\u20131.94), respectively, relative to the ACE inhibitor\/ARB negative control index drug.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>We illustrated how to incorporate negative control index drugs into a PSSA and generate relative aSRs. Stratum\u2010specific assessments and varying the exposure windows while using negative control index drugs can yield more informative results.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.5293","type":"journal-article","created":{"date-parts":[[2021,5,16]],"date-time":"2021-05-16T09:08:25Z","timestamp":1621156105000},"page":"1192-1199","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Use of negative controls in a prescription sequence symmetry analysis to reduce <scp>time\u2010varying<\/scp> bias"],"prefix":"10.1002","volume":"30","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0411-2160","authenticated-orcid":false,"given":"Scott Martin","family":"Vouri","sequence":"first","affiliation":[{"name":"Department of Pharmaceutical Outcomes &amp; Policy University of Florida\u2014College of Pharmacy  Gainesville Florida USA"},{"name":"University of Florida\u2014Center for Drug Evaluation and Safety (CoDES)  Gainesville Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9097-2641","authenticated-orcid":false,"given":"Xinyi","family":"Jiang","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Outcomes &amp; Policy University of Florida\u2014College of Pharmacy  Gainesville Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6092-8906","authenticated-orcid":false,"given":"Earl J.","family":"Morris","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Outcomes &amp; Policy University of Florida\u2014College of Pharmacy  Gainesville Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Babette A.","family":"Brumback","sequence":"additional","affiliation":[{"name":"University of Florida\u2014Center for Drug Evaluation and Safety (CoDES)  Gainesville Florida USA"},{"name":"Department of Biostatistics University of Florida\u2014College of Public Health &amp; Health Professions College of Medicine  Gainesville Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6518-5961","authenticated-orcid":false,"given":"Almut G.","family":"Winterstein","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Outcomes &amp; 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