{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,9,27]],"date-time":"2025-09-27T09:10:11Z","timestamp":1758964211766,"version":"3.44.0"},"reference-count":54,"publisher":"Elsevier BV","issue":"10","license":[{"start":{"date-parts":[[2020,10,1]],"date-time":"2020-10-01T00:00:00Z","timestamp":1601510400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2020,10,1]],"date-time":"2020-10-01T00:00:00Z","timestamp":1601510400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2020,8,31]],"date-time":"2020-08-31T00:00:00Z","timestamp":1598832000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100003032","name":"Association Nationale de la Recherche et de la Technologie","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100003032","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004330","name":"GlaxoSmithKline","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004330","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["clinicalkey.com","clinicalkey.com.au","clinicalkey.es","clinicalkey.fr","clinicalkey.jp","clinicaltherapeutics.com","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Clinical Therapeutics"],"published-print":{"date-parts":[[2020,10]]},"DOI":"10.1016\/j.clinthera.2020.08.013","type":"journal-article","created":{"date-parts":[[2020,9,25]],"date-time":"2020-09-25T11:27:16Z","timestamp":1601033236000},"page":"1983-1991.e2","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":3,"title":["Using Discretely Integrated Condition Event Simulation To Construct Quantitative Benefit\u2013Risk Models: The Example of Rotavirus Vaccination in France"],"prefix":"10.1016","volume":"42","author":[{"given":"Hugo","family":"Arlegui","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ga\u00eblle","family":"Nachbaur","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nicolas","family":"Praet","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bernard","family":"B\u00e9gaud","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J. Jaime","family":"Caro","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"78","reference":[{"key":"10.1016\/j.clinthera.2020.08.013_bib1","doi-asserted-by":"crossref","first-page":"393","DOI":"10.1016\/j.biologicals.2012.07.007","article-title":"Current status and future directions of post-marketing vaccine safety monitoring with focus on USA and Europe","volume":"40","author":"Bonhoeffer","year":"2012","journal-title":"Biologicals"},{"key":"10.1016\/j.clinthera.2020.08.013_bib2","doi-asserted-by":"crossref","first-page":"176","DOI":"10.1080\/21645515.2015.1075679","article-title":"Perspectives on benefit-risk decision-making in vaccinology: conference report","volume":"12","author":"Greenberg","year":"2016","journal-title":"Hum Vaccin Immunother"},{"key":"10.1016\/j.clinthera.2020.08.013_bib3","doi-asserted-by":"crossref","first-page":"203","DOI":"10.1159\/000048910","article-title":"Risk\/benefit evaluation of drugs: the role of the pharmaceutical industry in Germany","volume":"34","author":"Schosser","year":"2002","journal-title":"Eur Surg Res"},{"key":"10.1016\/j.clinthera.2020.08.013_bib4","doi-asserted-by":"crossref","first-page":"667","DOI":"10.1002\/pds.3636","article-title":"Balancing benefit and risk of medicines: a systematic review and classification of available methodologies","volume":"23","author":"Mt-Isa","year":"2014","journal-title":"Pharmacoepidemiol Drug Saf"},{"key":"10.1016\/j.clinthera.2020.08.013_bib5","doi-asserted-by":"crossref","first-page":"26","DOI":"10.1016\/j.fct.2011.06.008","article-title":"State of the art in benefit-risk analysis: medicines","volume":"50","author":"Luteijn","year":"2012","journal-title":"Food Chem Toxicol"},{"key":"10.1016\/j.clinthera.2020.08.013_bib6","doi-asserted-by":"crossref","first-page":"324","DOI":"10.1002\/pst.1690","article-title":"Structured benefit-risk assessment: a review of key publications and initiatives on frameworks and methodologies","volume":"15","author":"Mt-Isa","year":"2016","journal-title":"Pharm Stat"},{"key":"10.1016\/j.clinthera.2020.08.013_bib7","doi-asserted-by":"crossref","first-page":"654","DOI":"10.1002\/cpt.507","article-title":"Benefit-risk analysis for decision-making: an approach","volume":"100","author":"Raju","year":"2016","journal-title":"Clin Pharmacol Ther"},{"year":"2012","series-title":"Benefit\u2013risk Methodology Project Work Package 2 Report: Applicability of Current Tools and Processes for Regulatory Benefit\u2013Risk Assessment","author":"Phillips","key":"10.1016\/j.clinthera.2020.08.013_bib8"},{"key":"10.1016\/j.clinthera.2020.08.013_bib9","doi-asserted-by":"crossref","first-page":"268","DOI":"10.1002\/pds.3559","article-title":"Estimating the incremental net health benefit of requirements for cardiovascular risk evaluation for diabetes therapies","volume":"23","author":"Chawla","year":"2014","journal-title":"Pharmacoepidemiol Drug Saf"},{"key":"10.1016\/j.clinthera.2020.08.013_bib10","doi-asserted-by":"crossref","first-page":"674","DOI":"10.1093\/eurpub\/ckt006","article-title":"Modelling the risk-benefit impact of H1N1 influenza vaccines","volume":"23","author":"Phillips","year":"2013","journal-title":"Eur J Public Health"},{"key":"10.1016\/j.clinthera.2020.08.013_bib11","doi-asserted-by":"crossref","first-page":"817","DOI":"10.1016\/j.vaccine.2009.10.050","article-title":"MCV vaccination in the presence of vaccine-associated Guillain-Barre syndrome risk: a decision analysis approach","volume":"28","author":"Cho","year":"2010","journal-title":"Vaccine"},{"key":"10.1016\/j.clinthera.2020.08.013_bib12","doi-asserted-by":"crossref","first-page":"3604","DOI":"10.1016\/j.vaccine.2014.04.082","article-title":"Evaluating the potential risks and benefits of infant rotavirus vaccination in England","volume":"32","author":"Clark","year":"2014","journal-title":"Vaccine"},{"key":"10.1016\/j.clinthera.2020.08.013_bib13","doi-asserted-by":"crossref","first-page":"5","DOI":"10.1186\/1471-2431-6-5","article-title":"The benefits and risks of Bacille Calmette-Guerin vaccination among infants at high risk for both tuberculosis and severe combined immunodeficiency: assessment by Markov model","volume":"6","author":"Clark","year":"2006","journal-title":"BMC Pediatr"},{"key":"10.1016\/j.clinthera.2020.08.013_bib14","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1097\/INF.0b013e318270362c","article-title":"Potential intussusception risk versus benefits of rotavirus vaccination in the United States","volume":"32","author":"Desai","year":"2013","journal-title":"Pediatr Infect Dis J"},{"key":"10.1016\/j.clinthera.2020.08.013_bib15","doi-asserted-by":"crossref","first-page":"1172","DOI":"10.1002\/pds.1994","article-title":"A\u00a0quantitative evaluation of the regulatory assessment of the benefits and risks of rofecoxib relative to naproxen: an application of the incremental net-benefit framework","volume":"19","author":"Lynd","year":"2010","journal-title":"Pharmacoepidemiol Drug Saf"},{"key":"10.1016\/j.clinthera.2020.08.013_bib16","doi-asserted-by":"crossref","first-page":"411","DOI":"10.1111\/j.1524-4733.2009.00595.x","article-title":"Using the incremental net benefit framework for quantitative benefit-risk analysis in regulatory decision-making\u2014a case study of alosetron in irritable bowel syndrome","volume":"13","author":"Lynd","year":"2010","journal-title":"Value Health"},{"key":"10.1016\/j.clinthera.2020.08.013_bib17","doi-asserted-by":"crossref","first-page":"e115553","DOI":"10.1371\/journal.pone.0115553","article-title":"Responding to vaccine safety signals during pandemic influenza: a modeling study","volume":"9","author":"Maro","year":"2014","journal-title":"PLoS One"},{"issue":"8778","key":"10.1016\/j.clinthera.2020.08.013_bib18","doi-asserted-by":"crossref","first-page":"1309","DOI":"10.1016\/0140-6736(91)92601-W","article-title":"Vaccine safety versus vaccine efficacy in mass immunisation programmes","volume":"338","author":"Nokes","year":"1991","journal-title":"Lancet"},{"year":"1998","series-title":"Benefit\u2013Risk Balance for Marketed Drugs. Evaluating Safety Signals","key":"10.1016\/j.clinthera.2020.08.013_bib19"},{"issue":"Suppl 2","key":"10.1016\/j.clinthera.2020.08.013_bib20","first-page":"3","article-title":"A\u00a0systematic review of methodological approaches for benefit-risk assessment of vaccines","volume":"26","author":"Arlegui","year":"2017","journal-title":"Pharmacoepidemiol Drug Saf"},{"key":"10.1016\/j.clinthera.2020.08.013_bib21","doi-asserted-by":"crossref","first-page":"ofaa087","DOI":"10.1093\/ofid\/ofaa087","article-title":"Quantitative benefit-risk models used for rotavirus vaccination: a systematic review","volume":"7","author":"Arlegui","year":"2020","journal-title":"Open Forum Infect Dis"},{"key":"10.1016\/j.clinthera.2020.08.013_bib22","doi-asserted-by":"crossref","first-page":"665","DOI":"10.1007\/s40273-016-0394-z","article-title":"Discretely integrated condition event (DICE) simulation for pharmacoeconomics","volume":"34","author":"Caro","year":"2016","journal-title":"Pharmacoeconomics"},{"year":"2016","series-title":"Excel","key":"10.1016\/j.clinthera.2020.08.013_bib23"},{"key":"10.1016\/j.clinthera.2020.08.013_bib24","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0215761","article-title":"Treatment sequences for advanced renal cell carcinoma: a health economic assessment","volume":"14","author":"Deniz","year":"2019","journal-title":"PLoS One"},{"key":"10.1016\/j.clinthera.2020.08.013_bib25","doi-asserted-by":"crossref","first-page":"1101","DOI":"10.1007\/s40273-018-0657-y","article-title":"Smoking cessation: a comparison of two model structures","volume":"36","author":"Pennington","year":"2018","journal-title":"Pharmacoeconomics"},{"year":"2019","series-title":"Health Economic Evaluation of Biological Treatments in the Management of Rheumatoid Arthritis","key":"10.1016\/j.clinthera.2020.08.013_bib26"},{"key":"10.1016\/j.clinthera.2020.08.013_bib27","doi-asserted-by":"crossref","first-page":"235","DOI":"10.1177\/0272989X17715636","article-title":"Adding events to a Markov model using DICE simulation","volume":"38","author":"Caro","year":"2018","journal-title":"Med Decis Making"},{"key":"10.1016\/j.clinthera.2020.08.013_bib28","doi-asserted-by":"crossref","first-page":"1103","DOI":"10.1007\/s40273-017-0534-0","article-title":"Validation of a DICE simulation against a discrete event simulation implemented entirely in code","volume":"35","author":"Moller","year":"2017","journal-title":"Pharmacoeconomics"},{"year":"2016","series-title":"Visual Basic for Applications (VBA)","key":"10.1016\/j.clinthera.2020.08.013_bib29"},{"key":"10.1016\/j.clinthera.2020.08.013_bib30","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0183392","article-title":"Estimating global, regional and national rotavirus deaths in children aged <5 years: current approaches, new analyses and proposed improvements","volume":"12","author":"Clark","year":"2017","journal-title":"PLoS One"},{"key":"10.1016\/j.clinthera.2020.08.013_bib31","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0072788","article-title":"Global causes of diarrheal disease mortality in children <5 years of age: a systematic review","volume":"8","author":"Lanata","year":"2013","journal-title":"PLoS One"},{"key":"10.1016\/j.clinthera.2020.08.013_bib32","doi-asserted-by":"crossref","first-page":"958","DOI":"10.1001\/jamapediatrics.2018.1960","article-title":"Rotavirus vaccination and the global burden of rotavirus diarrhea among children younger than 5 years","volume":"172","author":"Troeger","year":"2018","journal-title":"JAMA Pediatr"},{"year":"2019","series-title":"Summary of Key Characteristics of Currently WHO-Pre-Qualified Rotavirus Vaccines","key":"10.1016\/j.clinthera.2020.08.013_bib33"},{"key":"10.1016\/j.clinthera.2020.08.013_bib34","doi-asserted-by":"crossref","first-page":"495","DOI":"10.1080\/21645515.2017.1403705","article-title":"Improving rotavirus vaccine coverage: can newer-generation and locally produced vaccines help?","volume":"14","author":"Deen","year":"2018","journal-title":"Hum Vaccin Immunother"},{"key":"10.1016\/j.clinthera.2020.08.013_bib35","doi-asserted-by":"crossref","first-page":"11","DOI":"10.1056\/NEJMoa052434","article-title":"Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis","volume":"354","author":"Ruiz-Palacios","year":"2006","journal-title":"N\u00a0Engl J Med"},{"key":"10.1016\/j.clinthera.2020.08.013_bib36","doi-asserted-by":"crossref","first-page":"23","DOI":"10.1056\/NEJMoa052664","article-title":"Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine","volume":"354","author":"Vesikari","year":"2006","journal-title":"N\u00a0Engl J Med"},{"issue":"Suppl 1","key":"10.1016\/j.clinthera.2020.08.013_bib37","doi-asserted-by":"crossref","first-page":"S282","DOI":"10.1086\/605051","article-title":"Assessment of postlicensure safety of rotavirus vaccines, with emphasis on intussusception","volume":"200","author":"Bines","year":"2009","journal-title":"J\u00a0Infect Dis"},{"key":"10.1016\/j.clinthera.2020.08.013_bib38","article-title":"Childhood intussusception: a literature review","volume":"8","author":"Jiang","year":"2013","journal-title":"PLoS One"},{"key":"10.1016\/j.clinthera.2020.08.013_bib39","doi-asserted-by":"crossref","first-page":"763","DOI":"10.1097\/INF.0000000000000715","article-title":"Risk of intussusception after rotavirus vaccination: meta-analysis of postlicensure studies","volume":"34","author":"Rosillon","year":"2015","journal-title":"Pediatr Infect Dis J"},{"key":"10.1016\/j.clinthera.2020.08.013_bib40","first-page":"1306","article-title":"Risk of intussusception after rotavirus vaccination: a meta-analysis","volume":"9","author":"Dong","year":"2016","journal-title":"Int J Clin Exp Med"},{"key":"10.1016\/j.clinthera.2020.08.013_bib41","doi-asserted-by":"crossref","first-page":"1339","DOI":"10.1586\/14760584.2014.942223","article-title":"Intussusception following rotavirus vaccination: an updated review of the available evidence","volume":"13","author":"Rha","year":"2014","journal-title":"Expert Rev Vaccin"},{"key":"10.1016\/j.clinthera.2020.08.013_bib42","doi-asserted-by":"crossref","first-page":"3684","DOI":"10.1016\/j.vaccine.2016.04.050","article-title":"The risk of intussusception following monovalent rotavirus vaccination in England: a self-controlled case-series evaluation","volume":"34","author":"Stowe","year":"2016","journal-title":"Vaccine"},{"year":"2015","series-title":"Rotavirus Infections: Suspension of Infant Vaccination Recommendations","key":"10.1016\/j.clinthera.2020.08.013_bib43"},{"year":"2015","series-title":"Meeting Report, Meeting of the Pharmacovigilance Technical Committee","key":"10.1016\/j.clinthera.2020.08.013_bib44"},{"key":"10.1016\/j.clinthera.2020.08.013_bib45","unstructured":"European Medicines Agency. Rotarix: a summary of the European public assessment report. Available at: http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/medicines\/human\/medicines\/000639\/human_med_001043.jsp&mid=WC0b01ac058001d124. [Accessed 24 July 2020]"},{"key":"10.1016\/j.clinthera.2020.08.013_bib46","doi-asserted-by":"crossref","first-page":"139","DOI":"10.1007\/s40259-018-0273-6","article-title":"Benefit versus risk assessment of rotavirus vaccination in France: a simulation and modeling analysis","volume":"32","author":"Ledent","year":"2018","journal-title":"BioDrugs"},{"year":"2018","series-title":"Committee for Medicinal Products for Human Use (CHMP). Work Plan 2018. Benefit\/Risk Methodology","key":"10.1016\/j.clinthera.2020.08.013_bib47"},{"year":"2018","series-title":"Benefit-Risk Assessment in Drug Regulatory Decision-Making. Draft PDUFA VI Implementation Plan (FY 2018-2022)","key":"10.1016\/j.clinthera.2020.08.013_bib48"},{"key":"10.1016\/j.clinthera.2020.08.013_bib49","doi-asserted-by":"crossref","first-page":"327","DOI":"10.1586\/14737167.2016.1165608","article-title":"Advantages and disadvantages of discrete-event simulation for health economic analyses","volume":"16","author":"Caro","year":"2016","journal-title":"Expert Rev Pharmacoecon Outcomes Res"},{"key":"10.1016\/j.clinthera.2020.08.013_bib50","doi-asserted-by":"crossref","first-page":"379","DOI":"10.1177\/0272989X03256883","article-title":"The impact of ignoring population heterogeneity when Markov models are used in cost-effectiveness analysis","volume":"23","author":"Zaric","year":"2003","journal-title":"Med Decis Making"},{"key":"10.1016\/j.clinthera.2020.08.013_bib51","doi-asserted-by":"crossref","first-page":"e82","DOI":"10.1097\/INF.0b013e3182720b71","article-title":"Rotavirus vaccine effectiveness and case-control study on risk factors for breakthrough infections in Germany, 2010-2011","volume":"32","author":"Adlhoch","year":"2013","journal-title":"Pediatr Infect Dis J"},{"key":"10.1016\/j.clinthera.2020.08.013_bib52","doi-asserted-by":"crossref","first-page":"574","DOI":"10.1186\/s12879-014-0574-4","article-title":"Acute diarrhea in adults consulting a general practitioner in France during winter: incidence, clinical characteristics, management and risk factors","volume":"14","author":"Arena","year":"2014","journal-title":"BMC Infect Dis"},{"key":"10.1016\/j.clinthera.2020.08.013_bib53","doi-asserted-by":"crossref","first-page":"e1125","DOI":"10.1542\/peds.2007-1590","article-title":"Trends in intussusception hospitalizations among US infants, 1993-2004: implications for monitoring the safety of the new rotavirus vaccination program","volume":"121","author":"Tate","year":"2008","journal-title":"Pediatrics"},{"key":"10.1016\/j.clinthera.2020.08.013_bib54","doi-asserted-by":"crossref","first-page":"31","DOI":"10.1007\/s40121-015-0099-1","article-title":"Medium- to long-term impact of rotavirus vaccination on hospital care in Belgium: a 7-year follow-up of the rotavirus Belgium impact study (RotaBIS)","volume":"5","author":"Standaert","year":"2016","journal-title":"Infect Dis Ther"}],"container-title":["Clinical Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0149291820304197?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0149291820304197?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2025,9,27]],"date-time":"2025-09-27T08:54:19Z","timestamp":1758963259000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0149291820304197"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,10]]},"references-count":54,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2020,10]]}},"alternative-id":["S0149291820304197"],"URL":"https:\/\/doi.org\/10.1016\/j.clinthera.2020.08.013","relation":{},"ISSN":["0149-2918"],"issn-type":[{"type":"print","value":"0149-2918"}],"subject":[],"published":{"date-parts":[[2020,10]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Using Discretely Integrated Condition Event Simulation To Construct Quantitative Benefit\u2013Risk Models: The Example of Rotavirus Vaccination in France","name":"articletitle","label":"Article Title"},{"value":"Clinical Therapeutics","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.clinthera.2020.08.013","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2020 GlaxoSmithKline Biologicals SA. Published by Elsevier Inc.","name":"copyright","label":"Copyright"}]}}