{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,9,7]],"date-time":"2024-09-07T06:36:16Z","timestamp":1725690976543},"reference-count":22,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2015,10,13]],"date-time":"2015-10-13T00:00:00Z","timestamp":1444694400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Department of Health and Human Services, for the Mini-Sentinel and PRISM programs","award":["223200910006I"],"award-info":[{"award-number":["223200910006I"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2015,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>The self\u2010controlled risk interval design is commonly used to assess the association between an acute exposure and an adverse event of interest, implicitly adjusting for fixed, non\u2010time\u2010varying covariates. Explicit adjustment needs to be made for time\u2010varying covariates, for example, age in young children. It can be performed via either a fixed or random adjustment. The random\u2010adjustment approach can provide valid point and interval estimates but requires access to individual\u2010level data for an unexposed baseline sample. The fixed\u2010adjustment approach does not have this requirement and will provide a valid point estimate but may underestimate the variance. We conducted a comprehensive simulation study to evaluate their performance.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We designed the simulation study using empirical data from the Food and Drug Administration\u2010sponsored Mini\u2010Sentinel Post\u2010licensure Rapid Immunization Safety Monitoring Rotavirus Vaccines and Intussusception study in children 5\u201336.9\u2009weeks of age. The time\u2010varying confounder is age. We considered a variety of design parameters including sample size, relative risk, time\u2010varying baseline risks, and risk interval length.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The random\u2010adjustment approach has very good performance in almost all considered settings. The fixed\u2010adjustment approach can be used as a good alternative when the number of events used to estimate the time\u2010varying baseline risks is at least the number of events used to estimate the relative risk, which is almost always the case.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>We successfully identified settings in which the fixed\u2010adjustment approach can be used as a good alternative and provided guidelines on the selection and implementation of appropriate analyses for the self\u2010controlled risk interval design. Copyright \u00a9 2015 John Wiley &amp; Sons, Ltd.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.3885","type":"journal-article","created":{"date-parts":[[2015,10,14]],"date-time":"2015-10-14T03:08:49Z","timestamp":1444792129000},"page":"1304-1312","source":"Crossref","is-referenced-by-count":7,"title":["Quantifying the impact of time\u2010varying baseline risk adjustment in the self\u2010controlled risk interval design"],"prefix":"10.1002","volume":"24","author":[{"given":"Lingling","family":"Li","sequence":"first","affiliation":[{"name":"Department of Population Medicine Harvard Pilgrim Health Care Institute and Harvard Medical School  Boston MA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martin","family":"Kulldorff","sequence":"additional","affiliation":[{"name":"Department of Population Medicine Harvard Pilgrim Health Care Institute and Harvard Medical School  Boston MA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Estelle","family":"Russek\u2010Cohen","sequence":"additional","affiliation":[{"name":"Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research Food and Drug Administration  Silver Spring MD USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alison Tse","family":"Kawai","sequence":"additional","affiliation":[{"name":"Department of Population Medicine Harvard Pilgrim Health Care Institute and Harvard Medical School  Boston MA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wei","family":"Hua","sequence":"additional","affiliation":[{"name":"Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research Food and Drug Administration  Silver Spring MD USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2015,10,13]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1093\/aje\/kwp345"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1093\/aje\/kws195"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1093\/aje\/kwu322"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1198\/jasa.2011.ap10108"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.2302"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2005.11.012"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1303164"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1001\/archpedi.158.11.1031"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1001\/archfami.9.7.617"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2011-1111"},{"issue":"5","key":"e_1_2_8_12_1","first-page":"110","article-title":"Advisory Committee on Immunization Practices (ACIP), ACIP Child\/Adolescent Immunization Work Group. advisory committee on immunization practices recommended immunization \u2013 schedules for persons aged 0 through 18 Years \u2013 United States, 2014","volume":"63","author":"Akinsanya\u2010Beysolow I","year":"2014","journal-title":"MMWR"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2012.01.027"},{"key":"e_1_2_8_14_1","doi-asserted-by":"crossref","unstructured":"KawaiAT MartinDB KulldorffM et al.Febrile seizures following 2010\u201311 trivalent inactivated influenza vaccine.2015. 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