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
- Institución
- Consejo Nacional de Investigaciones Científicas y Técnicas
- OAI Identificador
- oai:ri.conicet.gov.ar:11336/266081
Ver los metadatos del registro completo
id |
CONICETDig_45d290d26e4f7f11601546ac82a72c29 |
---|---|
oai_identifier_str |
oai:ri.conicet.gov.ar:11336/266081 |
network_acronym_str |
CONICETDig |
repository_id_str |
3498 |
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) |
collection |
CONICET Digital (CONICET) |
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 |
_version_ |
1846083123622707200 |
score |
13.22299 |