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The presentation explains population-level effect estimation using causal inference criteria, then introduces the self-controlled case series (SCCS) design that compares outcomes within individuals under differing exposure. It details replication study specification for influenza, defining exposure and risk intervals, and assessing multiple negative control outcomes. Results include reported IRRs for diabetes and acute myocardial infarction plus a replication estimate for acute myocardial infarction.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":40,"@type":76,"position":81},"https://docshare.wps.com/document/research-report/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/ohdsi-symposium-lightning-talk-negative-controls-for-self-controlled-case-series-design-james-weaver/144471/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/ohdsi-symposium-lightning-talk-negative-controls-for-self-controlled-case-series-design-james-weaver/144471.png","ImageObject",300,407,{"name":92,"@type":93},"wps_ap_test_251126_0180","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-17","2026-08-26",true,{"@type":102,"interactionType":103,"userInteractionCount":52},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What is the self-controlled case series (SCCS) design comparing?","Question",{"text":112,"@type":113},"SCCS compares outcomes within the same person during periods with different exposure status. This enables within-person comparisons across risk and non-risk intervals.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"Which key criteria are listed for causal effect identification in the talk?",{"text":117,"@type":113},"The talk highlights consistency, positivity, and exchangeability as causal effect identification criteria for estimating unbiased average effects of exposure on outcomes.",{"name":119,"@type":110,"acceptedAnswer":120},"How are risk intervals and exposure defined in the influenza replication specification?",{"text":121,"@type":113},"The exposure is defined using an influenza diagnosis code and lab result at an appropriate visit setting, with risk intervals from one day after the influenza visit end date to seven days before the visit start date. Additional rules exclude prior influenza and outcomes during the exposure visit.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},144471,1787702961,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":39,"category_name":40,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":52,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":139,"language":140,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":67,"update_tm":129,"read_time":144},8796095027276,"https://avatar.qwps.com/avatar/d3BzX2FwX3Rlc3RfMjUxMTI2XzAxODA=","The value of nega-ve controls for  \nthe self-­‐controlled case series  \ndesign  \nJames Weaver  \nEpidemiology Analy-cs, Janssen R&D  \nObserva-onal Health Data Sciences and Informa-cs Symposium  \nBethesda, MD  \n12 October 2018  \nThe purpose of OHDSI  \n• To generate  reliable evidence for the benefit of pa-ents, providers, researchers, health care systems, industry, and government agencies  \nThe purpose of OHDSI  \n• To generate  reliable evidence for the benefit of pa-ents, providers, researchers, health care systems, industry, and government agencies  \nThe purpose of OHDSI  \n• To generate  reliable evidence for the benefit of pa-ents, providers, researchers, health care systems, industry, and government agencies  \nIRR: 6.05 (95% CI 3.86, 9.50)  \n Popula-on-­‐level effect es-ma-on  \n• Methods for iden-fying causal rela-onships  \n• AYempts to es-mate unbiased, average effect of an exposure on an outcome  \n• Compares outcome occurrence between comparable popula-ons  \n• Causal effect iden-fica-on criteria  \n• Consistency  \n• Posi-vity  \n• Exchangeability  \nSelf-­‐controlled case series design (SCCS)  \n• Compares outcomes within persons during-me periods of differing exposure status  \n• Consistency:  \n• Time-­‐stamped risk intervals and outcome events  \n• Posi-vity:  \n• Pa-ents must have both exposed-me and unexposed-me  \n• Exchangeability:  \n• Unexposed-me = counterfactual approxima-on  \nReplica-on study specifica-on  \n• Exposure (influenza)  \n• Dx code, +lab result  \n• OP, any visit  \n• No influenza past 60 days, no outcome during visit  \n• Risk interval  \n• Influenza visit end date +1 day to visit start date +7 days  \n• Outcomes (first MI + 31 nega-ve control outcomes )  \n• IP, any visit  \n• Primary posi-on  \n• Analy-c variants  \n• Simple SCCS  \n• Pre-­‐exposure window  \n• Age and seasonality adjustment  \n• Event-­‐dependent observa-on period correc-on  \n Nega-ve control outcomes  \n\n| Lung cancer | Inflammatory disorder of diges4ve system |\n| --- | --- |\n| HIV | Infec4ous disease of genitourinary system |\n| Depression | Infec4ous disease of abdomen |\n| Ingrowing nail | Func4onal finding of gastrointes4nal tract |\n| So@ 4ssue lesion | Edema |\n| Skin or mucosa lesion | Diabetes mellitus |\n| Organic mental disorder | Chronic inflammatory disorder |\n| Observa4on of colon | Chronic disease of genitourinary system |\n| Neoplas4c disease | Bleeding |\n| Musculoskeletal and connec4ve 4ssue disorder | Acute genitourinary disorder |\n| Mass of trunk | Abscess |\n| Mass of respiratory structure | Schizophrenia |\n| Mass of lymphore4cular structure | Bipolar disorder |\n| Lymphoprolifera4ve disorder | Substance abuse |\n| Lesion of brain | Trauma4c injury |\n| Inflammatory disorder of extremity |  |\n\nNEJM results  \nDiabetes mellitus  \nIRR: 1.35 (95% CI 0.50, 3.62)  \nAcute myocardial infarc4on IRR: 6.05 (95% CI 3.86, 9.50)  \nReplica-on results  \nInfluenza diagnosis code (any visit), outcome (IP)  \nAcute myocardial infarc4on IRR: 4.85 (95% CI 4.06, 5.74)","cbCaijJAaLv5kRAO","https://ap.wps.com/l/cbCaijJAaLv5kRAO","pdf",1278041,14,"English","# Purpose of OHDSI\n# Causal effect identification and population-level effects\n# Self-controlled case series (SCCS) design\n## Assumptions: consistency, positivity, exchangeability\n# Replication study specification\n## Exposure and risk intervals\n## Outcomes and negative control outcomes\n# Results and replication findings","[{\"question\":\"What is the self-controlled case series (SCCS) design comparing?\",\"answer\":\"SCCS compares outcomes within the same person during periods with different exposure status. This enables within-person comparisons across risk and non-risk intervals.\"},{\"question\":\"Which key criteria are listed for causal effect identification in the talk?\",\"answer\":\"The talk highlights consistency, positivity, and exchangeability as causal effect identification criteria for estimating unbiased average effects of exposure on outcomes.\"},{\"question\":\"How are risk intervals and exposure defined in the influenza replication specification?\",\"answer\":\"The exposure is defined using an influenza diagnosis code and lab result at an appropriate visit setting, with risk intervals from one day after the influenza visit end date to seven days before the visit start date. Additional rules exclude prior influenza and outcomes during the exposure visit.\"}]","OHDSI Symposium Lightning Talk - Nega-ve Controls for Self-Controlled Case Series Design - James Weaver | PDF",35]