@article{RN316,
   author = {Gauffin, O. and Brand, J. S. and Vidlin, S. H. and Sartori, D. and Asikainen, S. and Català, M. and Chalabi, E. and Dedman, D. and Danilovic, A. and Duarte-Salles, T. and García Morales, M. T. and Hiltunen, S. and Jödicke, A. M. and Lazarevic, M. and Mayer, M. A. and Miladinovic, J. and Mitchell, J. and Pistillo, A. and Ramírez-Anguita, J. M. and Reyes, C. and Rudolph, A. and Sandberg, L. and Savage, R. and Schuemie, M. and Spasic, D. and Trinh, N. T. H. and Veljkovic, N. and Vujovic, A. and de Wilde, M. and Zekarias, A. and Rijnbeek, P. and Ryan, P. and Prieto-Alhambra, D. and Norén, G. N.},
   title = {Supporting Pharmacovigilance Signal Validation and Prioritization with Analyses of Routinely Collected Health Data: Lessons Learned from an EHDEN Network Study},
   journal = {Drug Saf},
   volume = {46},
   number = {12},
   pages = {1335-1352},
   note = {1179-1942 Gauffin, Oskar Orcid: 0000-0003-1593-356x Brand, Judith S Orcid: 0000-0002-3720-1274 Vidlin, Sara Hedfors Orcid: 0000-0003-1619-3751 Sartori, Daniele Orcid: 0000-0003-3634-0317 Asikainen, Suvi Català, Martí Chalabi, Etir Dedman, Daniel Danilovic, Ana Duarte-Salles, Talita García Morales, Maria Teresa Hiltunen, Saara Jödicke, Annika M Lazarevic, Milan Mayer, Miguel A Miladinovic, Jelena Mitchell, Joseph Pistillo, Andrea Ramírez-Anguita, Juan Manuel Reyes, Carlen Rudolph, Annette Sandberg, Lovisa Savage, Ruth Schuemie, Martijn Spasic, Dimitrije Trinh, Nhung T H Veljkovic, Nevena Vujovic, Ankica de Wilde, Marcel Zekarias, Alem Rijnbeek, Peter Ryan, Patrick Prieto-Alhambra, Daniel Norén, G Niklas Orcid: 0000-0002-4595-230x No 806968/Innovative Medicines Initiative (IMI)/ Journal Article New Zealand 2023/10/07 Drug Saf. 2023 Dec;46(12):1335-1352. doi: 10.1007/s40264-023-01353-w. Epub 2023 Oct 7.},
   abstract = {INTRODUCTION: Individual case reports are the main asset in pharmacovigilance signal management. Signal validation is the first stage after signal detection and aims to determine if there is sufficient evidence to justify further assessment. Throughout signal management, a prioritization of signals is continually made. Routinely collected health data can provide relevant contextual information but are primarily used at a later stage in pharmacoepidemiological studies to assess communicated signals. OBJECTIVE: The aim of this study was to examine the feasibility and utility of analysing routine health data from a multinational distributed network to support signal validation and prioritization and to reflect on key user requirements for these analyses to become an integral part of this process. METHODS: Statistical signal detection was performed in VigiBase, the WHO global database of individual case safety reports, targeting generic manufacturer drugs and 16 prespecified adverse events. During a 5-day study-a-thon, signal validation and prioritization were performed using information from VigiBase, regulatory documents and the scientific literature alongside descriptive analyses of routine health data from 10 partners of the European Health Data and Evidence Network (EHDEN). Databases included in the study were from the UK, Spain, Norway, the Netherlands and Serbia, capturing records from primary care and/or hospitals. RESULTS: Ninety-five statistical signals were subjected to signal validation, of which eight were considered for descriptive analyses in the routine health data. Design, execution and interpretation of results from these analyses took up to a few hours for each signal (of which 15-60 minutes were for execution) and informed decisions for five out of eight signals. The impact of insights from the routine health data varied and included possible alternative explanations, potential public health and clinical impact and feasibility of follow-up pharmacoepidemiological studies. Three signals were selected for signal assessment, two of these decisions were supported by insights from the routine health data. Standardization of analytical code, availability of adverse event phenotypes including bridges between different source vocabularies, and governance around the access and use of routine health data were identified as important aspects for future development. CONCLUSIONS: Analyses of routine health data from a distributed network to support signal validation and prioritization are feasible in the given time limits and can inform decision making. The cost-benefit of integrating these analyses at this stage of signal management requires further research.},
   keywords = {Humans
*Pharmacovigilance
Adverse Drug Reaction Reporting Systems
*Drug-Related Side Effects and Adverse Reactions/epidemiology
Databases, Factual
Netherlands ,
ISSN = 0114-5916 (Print) 0114-5916 ,
DOI = 10.1007/s40264-023-01353-w},
   year = {2023},
   type = {Journal Article}
}

{"_id":"uvXzKdYihntPvFnZX","bibbaseid":"gauffin-brand-vidlin-sartori-asikainen-catal-chalabi-dedman-etal-supportingpharmacovigilancesignalvalidationandprioritizationwithanalysesofroutinelycollectedhealthdatalessonslearnedfromanehdennetworkstudy-2023","author_short":["Gauffin, O.","Brand, J. S.","Vidlin, S. H.","Sartori, D.","Asikainen, S.","Català, M.","Chalabi, E.","Dedman, D.","Danilovic, A.","Duarte-Salles, T.","García Morales, M. T.","Hiltunen, S.","Jödicke, A. M.","Lazarevic, M.","Mayer, M. A.","Miladinovic, J.","Mitchell, J.","Pistillo, A.","Ramírez-Anguita, J. M.","Reyes, C.","Rudolph, A.","Sandberg, L.","Savage, R.","Schuemie, M.","Spasic, D.","Trinh, N. T. H.","Veljkovic, N.","Vujovic, A.","de Wilde, M.","Zekarias, A.","Rijnbeek, P.","Ryan, P.","Prieto-Alhambra, D.","Norén, G. N."],"bibdata":{"bibtype":"article","type":"Journal Article","author":[{"propositions":[],"lastnames":["Gauffin"],"firstnames":["O."],"suffixes":[]},{"propositions":[],"lastnames":["Brand"],"firstnames":["J.","S."],"suffixes":[]},{"propositions":[],"lastnames":["Vidlin"],"firstnames":["S.","H."],"suffixes":[]},{"propositions":[],"lastnames":["Sartori"],"firstnames":["D."],"suffixes":[]},{"propositions":[],"lastnames":["Asikainen"],"firstnames":["S."],"suffixes":[]},{"propositions":[],"lastnames":["Català"],"firstnames":["M."],"suffixes":[]},{"propositions":[],"lastnames":["Chalabi"],"firstnames":["E."],"suffixes":[]},{"propositions":[],"lastnames":["Dedman"],"firstnames":["D."],"suffixes":[]},{"propositions":[],"lastnames":["Danilovic"],"firstnames":["A."],"suffixes":[]},{"propositions":[],"lastnames":["Duarte-Salles"],"firstnames":["T."],"suffixes":[]},{"propositions":[],"lastnames":["García","Morales"],"firstnames":["M.","T."],"suffixes":[]},{"propositions":[],"lastnames":["Hiltunen"],"firstnames":["S."],"suffixes":[]},{"propositions":[],"lastnames":["Jödicke"],"firstnames":["A.","M."],"suffixes":[]},{"propositions":[],"lastnames":["Lazarevic"],"firstnames":["M."],"suffixes":[]},{"propositions":[],"lastnames":["Mayer"],"firstnames":["M.","A."],"suffixes":[]},{"propositions":[],"lastnames":["Miladinovic"],"firstnames":["J."],"suffixes":[]},{"propositions":[],"lastnames":["Mitchell"],"firstnames":["J."],"suffixes":[]},{"propositions":[],"lastnames":["Pistillo"],"firstnames":["A."],"suffixes":[]},{"propositions":[],"lastnames":["Ramírez-Anguita"],"firstnames":["J.","M."],"suffixes":[]},{"propositions":[],"lastnames":["Reyes"],"firstnames":["C."],"suffixes":[]},{"propositions":[],"lastnames":["Rudolph"],"firstnames":["A."],"suffixes":[]},{"propositions":[],"lastnames":["Sandberg"],"firstnames":["L."],"suffixes":[]},{"propositions":[],"lastnames":["Savage"],"firstnames":["R."],"suffixes":[]},{"propositions":[],"lastnames":["Schuemie"],"firstnames":["M."],"suffixes":[]},{"propositions":[],"lastnames":["Spasic"],"firstnames":["D."],"suffixes":[]},{"propositions":[],"lastnames":["Trinh"],"firstnames":["N.","T.","H."],"suffixes":[]},{"propositions":[],"lastnames":["Veljkovic"],"firstnames":["N."],"suffixes":[]},{"propositions":[],"lastnames":["Vujovic"],"firstnames":["A."],"suffixes":[]},{"propositions":["de"],"lastnames":["Wilde"],"firstnames":["M."],"suffixes":[]},{"propositions":[],"lastnames":["Zekarias"],"firstnames":["A."],"suffixes":[]},{"propositions":[],"lastnames":["Rijnbeek"],"firstnames":["P."],"suffixes":[]},{"propositions":[],"lastnames":["Ryan"],"firstnames":["P."],"suffixes":[]},{"propositions":[],"lastnames":["Prieto-Alhambra"],"firstnames":["D."],"suffixes":[]},{"propositions":[],"lastnames":["Norén"],"firstnames":["G.","N."],"suffixes":[]}],"title":"Supporting Pharmacovigilance Signal Validation and Prioritization with Analyses of Routinely Collected Health Data: Lessons Learned from an EHDEN Network Study","journal":"Drug Saf","volume":"46","number":"12","pages":"1335-1352","note":"1179-1942 Gauffin, Oskar Orcid: 0000-0003-1593-356x Brand, Judith S Orcid: 0000-0002-3720-1274 Vidlin, Sara Hedfors Orcid: 0000-0003-1619-3751 Sartori, Daniele Orcid: 0000-0003-3634-0317 Asikainen, Suvi Català, Martí Chalabi, Etir Dedman, Daniel Danilovic, Ana Duarte-Salles, Talita García Morales, Maria Teresa Hiltunen, Saara Jödicke, Annika M Lazarevic, Milan Mayer, Miguel A Miladinovic, Jelena Mitchell, Joseph Pistillo, Andrea Ramírez-Anguita, Juan Manuel Reyes, Carlen Rudolph, Annette Sandberg, Lovisa Savage, Ruth Schuemie, Martijn Spasic, Dimitrije Trinh, Nhung T H Veljkovic, Nevena Vujovic, Ankica de Wilde, Marcel Zekarias, Alem Rijnbeek, Peter Ryan, Patrick Prieto-Alhambra, Daniel Norén, G Niklas Orcid: 0000-0002-4595-230x No 806968/Innovative Medicines Initiative (IMI)/ Journal Article New Zealand 2023/10/07 Drug Saf. 2023 Dec;46(12):1335-1352. doi: 10.1007/s40264-023-01353-w. Epub 2023 Oct 7.","abstract":"INTRODUCTION: Individual case reports are the main asset in pharmacovigilance signal management. Signal validation is the first stage after signal detection and aims to determine if there is sufficient evidence to justify further assessment. Throughout signal management, a prioritization of signals is continually made. Routinely collected health data can provide relevant contextual information but are primarily used at a later stage in pharmacoepidemiological studies to assess communicated signals. OBJECTIVE: The aim of this study was to examine the feasibility and utility of analysing routine health data from a multinational distributed network to support signal validation and prioritization and to reflect on key user requirements for these analyses to become an integral part of this process. METHODS: Statistical signal detection was performed in VigiBase, the WHO global database of individual case safety reports, targeting generic manufacturer drugs and 16 prespecified adverse events. During a 5-day study-a-thon, signal validation and prioritization were performed using information from VigiBase, regulatory documents and the scientific literature alongside descriptive analyses of routine health data from 10 partners of the European Health Data and Evidence Network (EHDEN). Databases included in the study were from the UK, Spain, Norway, the Netherlands and Serbia, capturing records from primary care and/or hospitals. RESULTS: Ninety-five statistical signals were subjected to signal validation, of which eight were considered for descriptive analyses in the routine health data. Design, execution and interpretation of results from these analyses took up to a few hours for each signal (of which 15-60 minutes were for execution) and informed decisions for five out of eight signals. The impact of insights from the routine health data varied and included possible alternative explanations, potential public health and clinical impact and feasibility of follow-up pharmacoepidemiological studies. Three signals were selected for signal assessment, two of these decisions were supported by insights from the routine health data. Standardization of analytical code, availability of adverse event phenotypes including bridges between different source vocabularies, and governance around the access and use of routine health data were identified as important aspects for future development. CONCLUSIONS: Analyses of routine health data from a distributed network to support signal validation and prioritization are feasible in the given time limits and can inform decision making. The cost-benefit of integrating these analyses at this stage of signal management requires further research.","keywords":"Humans *Pharmacovigilance Adverse Drug Reaction Reporting Systems *Drug-Related Side Effects and Adverse Reactions/epidemiology Databases, Factual Netherlands , ISSN = 0114-5916 (Print) 0114-5916 , DOI = 10.1007/s40264-023-01353-w","year":"2023","bibtex":"@article{RN316,\r\n author = {Gauffin, O. and Brand, J. S. and Vidlin, S. H. and Sartori, D. and Asikainen, S. and Català, M. and Chalabi, E. and Dedman, D. and Danilovic, A. and Duarte-Salles, T. and García Morales, M. T. and Hiltunen, S. and Jödicke, A. M. and Lazarevic, M. and Mayer, M. A. and Miladinovic, J. and Mitchell, J. and Pistillo, A. and Ramírez-Anguita, J. M. and Reyes, C. and Rudolph, A. and Sandberg, L. and Savage, R. and Schuemie, M. and Spasic, D. and Trinh, N. T. H. and Veljkovic, N. and Vujovic, A. and de Wilde, M. and Zekarias, A. and Rijnbeek, P. and Ryan, P. and Prieto-Alhambra, D. and Norén, G. N.},\r\n title = {Supporting Pharmacovigilance Signal Validation and Prioritization with Analyses of Routinely Collected Health Data: Lessons Learned from an EHDEN Network Study},\r\n journal = {Drug Saf},\r\n volume = {46},\r\n number = {12},\r\n pages = {1335-1352},\r\n note = {1179-1942 Gauffin, Oskar Orcid: 0000-0003-1593-356x Brand, Judith S Orcid: 0000-0002-3720-1274 Vidlin, Sara Hedfors Orcid: 0000-0003-1619-3751 Sartori, Daniele Orcid: 0000-0003-3634-0317 Asikainen, Suvi Català, Martí Chalabi, Etir Dedman, Daniel Danilovic, Ana Duarte-Salles, Talita García Morales, Maria Teresa Hiltunen, Saara Jödicke, Annika M Lazarevic, Milan Mayer, Miguel A Miladinovic, Jelena Mitchell, Joseph Pistillo, Andrea Ramírez-Anguita, Juan Manuel Reyes, Carlen Rudolph, Annette Sandberg, Lovisa Savage, Ruth Schuemie, Martijn Spasic, Dimitrije Trinh, Nhung T H Veljkovic, Nevena Vujovic, Ankica de Wilde, Marcel Zekarias, Alem Rijnbeek, Peter Ryan, Patrick Prieto-Alhambra, Daniel Norén, G Niklas Orcid: 0000-0002-4595-230x No 806968/Innovative Medicines Initiative (IMI)/ Journal Article New Zealand 2023/10/07 Drug Saf. 2023 Dec;46(12):1335-1352. doi: 10.1007/s40264-023-01353-w. Epub 2023 Oct 7.},\r\n abstract = {INTRODUCTION: Individual case reports are the main asset in pharmacovigilance signal management. Signal validation is the first stage after signal detection and aims to determine if there is sufficient evidence to justify further assessment. Throughout signal management, a prioritization of signals is continually made. Routinely collected health data can provide relevant contextual information but are primarily used at a later stage in pharmacoepidemiological studies to assess communicated signals. OBJECTIVE: The aim of this study was to examine the feasibility and utility of analysing routine health data from a multinational distributed network to support signal validation and prioritization and to reflect on key user requirements for these analyses to become an integral part of this process. METHODS: Statistical signal detection was performed in VigiBase, the WHO global database of individual case safety reports, targeting generic manufacturer drugs and 16 prespecified adverse events. During a 5-day study-a-thon, signal validation and prioritization were performed using information from VigiBase, regulatory documents and the scientific literature alongside descriptive analyses of routine health data from 10 partners of the European Health Data and Evidence Network (EHDEN). Databases included in the study were from the UK, Spain, Norway, the Netherlands and Serbia, capturing records from primary care and/or hospitals. RESULTS: Ninety-five statistical signals were subjected to signal validation, of which eight were considered for descriptive analyses in the routine health data. Design, execution and interpretation of results from these analyses took up to a few hours for each signal (of which 15-60 minutes were for execution) and informed decisions for five out of eight signals. The impact of insights from the routine health data varied and included possible alternative explanations, potential public health and clinical impact and feasibility of follow-up pharmacoepidemiological studies. Three signals were selected for signal assessment, two of these decisions were supported by insights from the routine health data. Standardization of analytical code, availability of adverse event phenotypes including bridges between different source vocabularies, and governance around the access and use of routine health data were identified as important aspects for future development. CONCLUSIONS: Analyses of routine health data from a distributed network to support signal validation and prioritization are feasible in the given time limits and can inform decision making. The cost-benefit of integrating these analyses at this stage of signal management requires further research.},\r\n keywords = {Humans\r\n*Pharmacovigilance\r\nAdverse Drug Reaction Reporting Systems\r\n*Drug-Related Side Effects and Adverse Reactions/epidemiology\r\nDatabases, Factual\r\nNetherlands ,\r\nISSN = 0114-5916 (Print) 0114-5916 ,\r\nDOI = 10.1007/s40264-023-01353-w},\r\n year = {2023},\r\n type = {Journal Article}\r\n}\r\n\r\n","author_short":["Gauffin, O.","Brand, J. S.","Vidlin, S. H.","Sartori, D.","Asikainen, S.","Català, M.","Chalabi, E.","Dedman, D.","Danilovic, A.","Duarte-Salles, T.","García Morales, M. T.","Hiltunen, S.","Jödicke, A. M.","Lazarevic, M.","Mayer, M. A.","Miladinovic, J.","Mitchell, J.","Pistillo, A.","Ramírez-Anguita, J. M.","Reyes, C.","Rudolph, A.","Sandberg, L.","Savage, R.","Schuemie, M.","Spasic, D.","Trinh, N. T. H.","Veljkovic, N.","Vujovic, A.","de Wilde, M.","Zekarias, A.","Rijnbeek, P.","Ryan, P.","Prieto-Alhambra, D.","Norén, G. 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