Assessing Real-World Data From Electronic Health Records for Health Technology Assessment: The SUITABILITY Checklist: A Good Practices Report of an ISPOR Task Force

Autores
Fleurence, Rachael L.; Kent, Seamus; Adamson, Blythe; Tcheng, James; Balicer, Ran; Ross, Joseph S.; Haynes, Kevin; Muller, Patrick; Campbell, Jon; Bouée-Benhamiche, Elsa; García Martí, Sebastián; Ramsey, Scott
Año de publicación
2024
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
This ISPOR Good Practices report provides a framework for assessing the suitability of electronic health records data for use in health technology assessments (HTAs). Although electronic health record (EHR) data can fill evidence gaps and improve decisions, several important limitations can affect its validity and relevance. The ISPOR framework includes 2 components: data delineation and data fitness for purpose. Data delineation provides a complete understanding of the data and an assessment of its trustworthiness by describing (1) data characteristics; (2) data provenance; and (3) data governance. Fitness for purpose comprises (1) data reliability items, ie, how accurate and complete the estimates are for answering the question at hand and (2) data relevance items, which assess how well the data are suited to answer the particular question from a decision-making perspective. The report includes a checklist specific to EHR data reporting: the ISPOR SUITABILITY Checklist. It also provides recommendations for HTA agencies and policy makers to improve the use of EHR-derived data over time. The report concludes with a discussion of limitations and future directions in the field, including the potential impact from the substantial and rapid advances in the diffusion and capabilities of large language models and generative artificial intelligence. The report's immediate audiences are HTA evidence developers and users. We anticipate that it will also be useful to other stakeholders, particularly regulators and manufacturers, in the future.
Fil: Fleurence, Rachael L.. National Institutes of Health; Estados Unidos
Fil: Kent, Seamus. Erasmus University;
Fil: Adamson, Blythe. Flatiron Health; Estados Unidos
Fil: Tcheng, James. University of Duke; Estados Unidos
Fil: Balicer, Ran. Clalit Health Services; Israel
Fil: Ross, Joseph S.. University of Yale; Estados Unidos
Fil: Haynes, Kevin. Janssen Research And Development; Estados Unidos
Fil: Muller, Patrick. National Institute For Health And Care Excellence; Reino Unido
Fil: Campbell, Jon. National Pharmaceutical Council; Estados Unidos
Fil: Bouée-Benhamiche, Elsa. Institut National Du Cancer; Francia
Fil: García Martí, Sebastián. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina
Fil: Ramsey, Scott. Fred Hutchinson Cancer Center; Estados Unidos
Materia
REAL-WORLD EVIDENCE
HEALTH TECHNOLOGY ASSESSMENT
ISPORT GOOD PRACTICES REPORT
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/266081

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network_name_str CONICET Digital (CONICET)
spelling Assessing Real-World Data From Electronic Health Records for Health Technology Assessment: The SUITABILITY Checklist: A Good Practices Report of an ISPOR Task ForceFleurence, Rachael L.Kent, SeamusAdamson, BlytheTcheng, JamesBalicer, RanRoss, Joseph S.Haynes, KevinMuller, PatrickCampbell, JonBouée-Benhamiche, ElsaGarcía Martí, SebastiánRamsey, ScottREAL-WORLD EVIDENCEHEALTH TECHNOLOGY ASSESSMENTISPORT GOOD PRACTICES REPORThttps://purl.org/becyt/ford/3.3https://purl.org/becyt/ford/3This ISPOR Good Practices report provides a framework for assessing the suitability of electronic health records data for use in health technology assessments (HTAs). Although electronic health record (EHR) data can fill evidence gaps and improve decisions, several important limitations can affect its validity and relevance. The ISPOR framework includes 2 components: data delineation and data fitness for purpose. Data delineation provides a complete understanding of the data and an assessment of its trustworthiness by describing (1) data characteristics; (2) data provenance; and (3) data governance. Fitness for purpose comprises (1) data reliability items, ie, how accurate and complete the estimates are for answering the question at hand and (2) data relevance items, which assess how well the data are suited to answer the particular question from a decision-making perspective. The report includes a checklist specific to EHR data reporting: the ISPOR SUITABILITY Checklist. It also provides recommendations for HTA agencies and policy makers to improve the use of EHR-derived data over time. The report concludes with a discussion of limitations and future directions in the field, including the potential impact from the substantial and rapid advances in the diffusion and capabilities of large language models and generative artificial intelligence. The report's immediate audiences are HTA evidence developers and users. We anticipate that it will also be useful to other stakeholders, particularly regulators and manufacturers, in the future.Fil: Fleurence, Rachael L.. National Institutes of Health; Estados UnidosFil: Kent, Seamus. Erasmus University;Fil: Adamson, Blythe. Flatiron Health; Estados UnidosFil: Tcheng, James. University of Duke; Estados UnidosFil: Balicer, Ran. Clalit Health Services; IsraelFil: Ross, Joseph S.. University of Yale; Estados UnidosFil: Haynes, Kevin. Janssen Research And Development; Estados UnidosFil: Muller, Patrick. National Institute For Health And Care Excellence; Reino UnidoFil: Campbell, Jon. National Pharmaceutical Council; Estados UnidosFil: Bouée-Benhamiche, Elsa. Institut National Du Cancer; FranciaFil: García Martí, Sebastián. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; ArgentinaFil: Ramsey, Scott. Fred Hutchinson Cancer Center; Estados UnidosElsevier2024-06info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/266081Fleurence, Rachael L.; Kent, Seamus; Adamson, Blythe; Tcheng, James; Balicer, Ran; et al.; Assessing Real-World Data From Electronic Health Records for Health Technology Assessment: The SUITABILITY Checklist: A Good Practices Report of an ISPOR Task Force; Elsevier; Value In Health; 27; 6; 6-2024; 692-7011098-3015CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/https://linkinghub.elsevier.com/retrieve/pii/S109830152400069Xinfo:eu-repo/semantics/altIdentifier/doi/10.1016/j.jval.2024.01.019info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-10-15T14:58:19Zoai:ri.conicet.gov.ar:11336/266081instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-10-15 14:58:20.269CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Assessing Real-World Data From Electronic Health Records for Health Technology Assessment: The SUITABILITY Checklist: A Good Practices Report of an ISPOR Task Force
title Assessing Real-World Data From Electronic Health Records for Health Technology Assessment: The SUITABILITY Checklist: A Good Practices Report of an ISPOR Task Force
spellingShingle Assessing Real-World Data From Electronic Health Records for Health Technology Assessment: The SUITABILITY Checklist: A Good Practices Report of an ISPOR Task Force
Fleurence, Rachael L.
REAL-WORLD EVIDENCE
HEALTH TECHNOLOGY ASSESSMENT
ISPORT GOOD PRACTICES REPORT
title_short Assessing Real-World Data From Electronic Health Records for Health Technology Assessment: The SUITABILITY Checklist: A Good Practices Report of an ISPOR Task Force
title_full Assessing Real-World Data From Electronic Health Records for Health Technology Assessment: The SUITABILITY Checklist: A Good Practices Report of an ISPOR Task Force
title_fullStr Assessing Real-World Data From Electronic Health Records for Health Technology Assessment: The SUITABILITY Checklist: A Good Practices Report of an ISPOR Task Force
title_full_unstemmed Assessing Real-World Data From Electronic Health Records for Health Technology Assessment: The SUITABILITY Checklist: A Good Practices Report of an ISPOR Task Force
title_sort Assessing Real-World Data From Electronic Health Records for Health Technology Assessment: The SUITABILITY Checklist: A Good Practices Report of an ISPOR Task Force
dc.creator.none.fl_str_mv Fleurence, Rachael L.
Kent, Seamus
Adamson, Blythe
Tcheng, James
Balicer, Ran
Ross, Joseph S.
Haynes, Kevin
Muller, Patrick
Campbell, Jon
Bouée-Benhamiche, Elsa
García Martí, Sebastián
Ramsey, Scott
author Fleurence, Rachael L.
author_facet Fleurence, Rachael L.
Kent, Seamus
Adamson, Blythe
Tcheng, James
Balicer, Ran
Ross, Joseph S.
Haynes, Kevin
Muller, Patrick
Campbell, Jon
Bouée-Benhamiche, Elsa
García Martí, Sebastián
Ramsey, Scott
author_role author
author2 Kent, Seamus
Adamson, Blythe
Tcheng, James
Balicer, Ran
Ross, Joseph S.
Haynes, Kevin
Muller, Patrick
Campbell, Jon
Bouée-Benhamiche, Elsa
García Martí, Sebastián
Ramsey, Scott
author2_role author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv REAL-WORLD EVIDENCE
HEALTH TECHNOLOGY ASSESSMENT
ISPORT GOOD PRACTICES REPORT
topic REAL-WORLD EVIDENCE
HEALTH TECHNOLOGY ASSESSMENT
ISPORT GOOD PRACTICES REPORT
purl_subject.fl_str_mv https://purl.org/becyt/ford/3.3
https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv This ISPOR Good Practices report provides a framework for assessing the suitability of electronic health records data for use in health technology assessments (HTAs). Although electronic health record (EHR) data can fill evidence gaps and improve decisions, several important limitations can affect its validity and relevance. The ISPOR framework includes 2 components: data delineation and data fitness for purpose. Data delineation provides a complete understanding of the data and an assessment of its trustworthiness by describing (1) data characteristics; (2) data provenance; and (3) data governance. Fitness for purpose comprises (1) data reliability items, ie, how accurate and complete the estimates are for answering the question at hand and (2) data relevance items, which assess how well the data are suited to answer the particular question from a decision-making perspective. The report includes a checklist specific to EHR data reporting: the ISPOR SUITABILITY Checklist. It also provides recommendations for HTA agencies and policy makers to improve the use of EHR-derived data over time. The report concludes with a discussion of limitations and future directions in the field, including the potential impact from the substantial and rapid advances in the diffusion and capabilities of large language models and generative artificial intelligence. The report's immediate audiences are HTA evidence developers and users. We anticipate that it will also be useful to other stakeholders, particularly regulators and manufacturers, in the future.
Fil: Fleurence, Rachael L.. National Institutes of Health; Estados Unidos
Fil: Kent, Seamus. Erasmus University;
Fil: Adamson, Blythe. Flatiron Health; Estados Unidos
Fil: Tcheng, James. University of Duke; Estados Unidos
Fil: Balicer, Ran. Clalit Health Services; Israel
Fil: Ross, Joseph S.. University of Yale; Estados Unidos
Fil: Haynes, Kevin. Janssen Research And Development; Estados Unidos
Fil: Muller, Patrick. National Institute For Health And Care Excellence; Reino Unido
Fil: Campbell, Jon. National Pharmaceutical Council; Estados Unidos
Fil: Bouée-Benhamiche, Elsa. Institut National Du Cancer; Francia
Fil: García Martí, Sebastián. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina
Fil: Ramsey, Scott. Fred Hutchinson Cancer Center; Estados Unidos
description This ISPOR Good Practices report provides a framework for assessing the suitability of electronic health records data for use in health technology assessments (HTAs). Although electronic health record (EHR) data can fill evidence gaps and improve decisions, several important limitations can affect its validity and relevance. The ISPOR framework includes 2 components: data delineation and data fitness for purpose. Data delineation provides a complete understanding of the data and an assessment of its trustworthiness by describing (1) data characteristics; (2) data provenance; and (3) data governance. Fitness for purpose comprises (1) data reliability items, ie, how accurate and complete the estimates are for answering the question at hand and (2) data relevance items, which assess how well the data are suited to answer the particular question from a decision-making perspective. The report includes a checklist specific to EHR data reporting: the ISPOR SUITABILITY Checklist. It also provides recommendations for HTA agencies and policy makers to improve the use of EHR-derived data over time. The report concludes with a discussion of limitations and future directions in the field, including the potential impact from the substantial and rapid advances in the diffusion and capabilities of large language models and generative artificial intelligence. The report's immediate audiences are HTA evidence developers and users. We anticipate that it will also be useful to other stakeholders, particularly regulators and manufacturers, in the future.
publishDate 2024
dc.date.none.fl_str_mv 2024-06
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://purl.org/coar/resource_type/c_6501
info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/266081
Fleurence, Rachael L.; Kent, Seamus; Adamson, Blythe; Tcheng, James; Balicer, Ran; et al.; Assessing Real-World Data From Electronic Health Records for Health Technology Assessment: The SUITABILITY Checklist: A Good Practices Report of an ISPOR Task Force; Elsevier; Value In Health; 27; 6; 6-2024; 692-701
1098-3015
CONICET Digital
CONICET
url http://hdl.handle.net/11336/266081
identifier_str_mv Fleurence, Rachael L.; Kent, Seamus; Adamson, Blythe; Tcheng, James; Balicer, Ran; et al.; Assessing Real-World Data From Electronic Health Records for Health Technology Assessment: The SUITABILITY Checklist: A Good Practices Report of an ISPOR Task Force; Elsevier; Value In Health; 27; 6; 6-2024; 692-701
1098-3015
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/url/https://linkinghub.elsevier.com/retrieve/pii/S109830152400069X
info:eu-repo/semantics/altIdentifier/doi/10.1016/j.jval.2024.01.019
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Elsevier
publisher.none.fl_str_mv Elsevier
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
instname:Consejo Nacional de Investigaciones Científicas y Técnicas
reponame_str CONICET Digital (CONICET)
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instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
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