{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2023,10,6]],"date-time":"2023-10-06T05:43:01Z","timestamp":1696570981689},"reference-count":28,"publisher":"Wiley","issue":"19","license":[{"start":{"date-parts":[[2014,4,1]],"date-time":"2014-04-01T00:00:00Z","timestamp":1396310400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2015,9,1]],"date-time":"2015-09-01T00:00:00Z","timestamp":1441065600000},"content-version":"tdm","delay-in-days":518,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["wiley.com"],"crossmark-restriction":true},"short-container-title":["Statistics in Medicine"],"published-print":{"date-parts":[[2014,8,30]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Various recently developed sequential methods have been used to detect signals for post\u2010marketing surveillance in drug and vaccine safety. Among these, the maximized sequential probability ratio test (MaxSPRT) has been used to detect elevated risks of adverse events following vaccination using large healthcare databases. However, a limitation of MaxSPRT is that it only provides a time\u2010invariant flat boundary. In this study, we propose the use of time\u2010varying boundaries for controlling how type I error is distributed throughout the surveillance period. This is especially useful in two scenarios: (i) when we desire generally larger sample sizes before a signal is generated, for example, when early adopters are not representative of the larger population; and (ii) when it is desired for a signal to be generated as early as possible, for example, when the adverse event is considered rare but serious. We consider four specific time\u2010varying boundaries (which we call critical value functions), and we study their statistical power and average time to signal detection. The methodology we present here can be viewed as a generalization or flexible extension of MaxSPRT. Published 2014. This article is a US Government work and is in the public domain in the USA.<\/jats:p>","DOI":"10.1002\/sim.6161","type":"journal-article","created":{"date-parts":[[2014,4,2]],"date-time":"2014-04-02T02:16:38Z","timestamp":1396404998000},"page":"3387-3397","update-policy":"http:\/\/dx.doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Continuous sequential boundaries for vaccine safety surveillance"],"prefix":"10.1002","volume":"33","author":[{"given":"Rongxia","family":"Li","sequence":"first","affiliation":[{"name":"Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases Centers for Disease Control and Prevention  Atlanta GA U.S.A."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brock","family":"Stewart","sequence":"additional","affiliation":[{"name":"Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases Centers for Disease Control and Prevention  Atlanta GA U.S.A."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eric","family":"Weintraub","sequence":"additional","affiliation":[{"name":"Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases Centers for Disease Control and Prevention  Atlanta GA U.S.A."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael M.","family":"McNeil","sequence":"additional","affiliation":[{"name":"Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases Centers for Disease Control and Prevention  Atlanta GA U.S.A."}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2014,4]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"crossref","first-page":"284","DOI":"10.1002\/sim.3780","article-title":"A conditional maximized sequential probability ratio test for pharmacovigilance","volume":"29","author":"Li L","year":"2009","journal-title":"Statistics in Medicine"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1080\/07474946.2011.539924"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1214\/aoms\/1177731118"},{"key":"e_1_2_10_5_1","volume-title":"Sequential Analysis","author":"Wald A","year":"1947"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.ede.0000155506.05636.a4"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2010-0665"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1093\/aje\/kwp345"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.amepre.2011.04.004"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1097\/INF.0b013e3181af8605"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.2133"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1093\/biomet\/64.2.191"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.2307\/2530245"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0197-2456(84)80014-8"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.2307\/2531959"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1038\/bjc.1976.220"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.2307\/2336502"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.0006-341X.1999.00874.x"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.4780131308"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1007\/978-1-4615-2009-2_1"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.4036"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1023\/A:1009954810211"},{"key":"e_1_2_10_23_1","volume-title":"Algorithms for Minimization Without Derivatives","author":"Brent R","year":"1973"},{"key":"e_1_2_10_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2012.01.027"},{"key":"e_1_2_10_25_1","doi-asserted-by":"publisher","DOI":"10.1097\/MLR.0b013e3180616c0a"},{"key":"e_1_2_10_26_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2011.08.106"},{"key":"e_1_2_10_27_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.2320"},{"key":"e_1_2_10_28_1","first-page":"1","article-title":"Statistical performance of group sequential methods for observational post\u2010licensure medical product safety surveillance: a simulation study","volume":"0","author":"Zhao S","year":"2008","journal-title":"Statistics and its Interface"},{"key":"e_1_2_10_29_1","doi-asserted-by":"publisher","DOI":"10.1093\/aje\/kws317"}],"container-title":["Statistics in Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fsim.6161","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/sim.6161","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,5]],"date-time":"2023-10-05T18:45:54Z","timestamp":1696531554000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/sim.6161"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2014,4]]},"references-count":28,"journal-issue":{"issue":"19","published-print":{"date-parts":[[2014,8,30]]}},"alternative-id":["10.1002\/sim.6161"],"URL":"https:\/\/doi.org\/10.1002\/sim.6161","archive":["Portico"],"relation":{},"ISSN":["0277-6715","1097-0258"],"issn-type":[{"value":"0277-6715","type":"print"},{"value":"1097-0258","type":"electronic"}],"subject":[],"published":{"date-parts":[[2014,4]]},"assertion":[{"value":"2014-04-01","name":"published_online","label":"Published Online","group":{"name":"publication_history","label":"Publication History"}}]}}