Methods for the Clinical Validation of Digital Endpoints

Detalhes bibliográficos
Autor(a) principal: Rego, Sílvia
Data de Publicação: 2023
Outros Autores: Oliveira Henriques, Ana Rita, Silvério Serra, Sofia, Costa, Teresa, Maria Rodrigues, Ana, Nunes, Francisco
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: http://hdl.handle.net/10362/160053
Resumo: ©Sílvia Rego, Ana Rita Henriques, Sofia Silvério Serra, Teresa Costa, Ana Maria Rodrigues, Francisco Nunes. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 26.10.2023.
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spelling Methods for the Clinical Validation of Digital EndpointsProtocol for a Scoping Review Abstractdigital biomarkerdigital endpointmHealthmobile healthmobile health technologiesoutcome measureremote monitoringreview methodscoping reviewsensorvalidatevalidationwearablewearable technology©Sílvia Rego, Ana Rita Henriques, Sofia Silvério Serra, Teresa Costa, Ana Maria Rodrigues, Francisco Nunes. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 26.10.2023.BACKGROUND: Clinical trials often use digital technologies to collect data continuously outside the clinic and use the derived digital endpoints as trial endpoints. Digital endpoints are also being developed to support diagnosis, monitoring, or therapeutic interventions in clinical care. However, clinical validation stands as a significant challenge, as there are no specific guidelines orienting the validation of digital endpoints. OBJECTIVE: This paper presents the protocol for a scoping review that aims to map the existing methods for the clinical validation of digital endpoints. METHODS: The scoping review will comprise searches from the electronic literature databases MEDLINE (PubMed), Scopus (including conference proceedings), Embase, IEEE (Institute of Electrical and Electronics Engineers) Xplore, ACM (Association for Computing Machinery) Digital Library, CENTRAL (Cochrane Central Register of Controlled Trials), Web of Science Core Collection (including conference proceedings), and Joanna Briggs Institute Database of Systematic Reviews and Implementation Reports. We will also include various sources of gray literature with search terms related to digital endpoints. The methodology will adhere to the Joanna Briggs Institute Scoping Review and the Guidance for Conducting Systematic Scoping Reviews. RESULTS: A search for reviews on the existing evidence related to this topic was conducted and has shown that no such review was previously undertaken. This review will provide a systematic assessment of the literature on methods for the clinical validation of digital endpoints and highlight any potential need for harmonization or reporting of methods. The results will include the methods for the clinical validation of digital endpoints according to device, digital endpoint, and clinical application goal of digital endpoints. The study started in January 2023 and is expected to end by December 2023, with results to be published in a peer-reviewed journal. CONCLUSIONS: A scoping review of methodologies that validate digital endpoints is necessary. This review will be unique in its breadth since it will comprise digital endpoints collected from several devices and not focus on a specific disease area. The results of our work should help guide researchers in choosing validation methods, identify potential gaps in the literature, or inform the development of novel methods to optimize the clinical validation of digital endpoints. Resolving these gaps is the key to presenting evidence in a consistent way to regulators and other parties and obtaining regulatory acceptance of digital endpoints for patient benefit. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/47119.NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)RUNRego, SílviaOliveira Henriques, Ana RitaSilvério Serra, SofiaCosta, TeresaMaria Rodrigues, AnaNunes, Francisco2023-11-16T22:10:02Z2023-10-262023-10-26T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10362/160053eng1929-0748PURE: 75305026https://doi.org/10.2196/47119info:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2024-03-11T05:42:36Zoai:run.unl.pt:10362/160053Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-20T03:57:50.379094Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse
dc.title.none.fl_str_mv Methods for the Clinical Validation of Digital Endpoints
Protocol for a Scoping Review Abstract
title Methods for the Clinical Validation of Digital Endpoints
spellingShingle Methods for the Clinical Validation of Digital Endpoints
Rego, Sílvia
digital biomarker
digital endpoint
mHealth
mobile health
mobile health technologies
outcome measure
remote monitoring
review method
scoping review
sensor
validate
validation
wearable
wearable technology
title_short Methods for the Clinical Validation of Digital Endpoints
title_full Methods for the Clinical Validation of Digital Endpoints
title_fullStr Methods for the Clinical Validation of Digital Endpoints
title_full_unstemmed Methods for the Clinical Validation of Digital Endpoints
title_sort Methods for the Clinical Validation of Digital Endpoints
author Rego, Sílvia
author_facet Rego, Sílvia
Oliveira Henriques, Ana Rita
Silvério Serra, Sofia
Costa, Teresa
Maria Rodrigues, Ana
Nunes, Francisco
author_role author
author2 Oliveira Henriques, Ana Rita
Silvério Serra, Sofia
Costa, Teresa
Maria Rodrigues, Ana
Nunes, Francisco
author2_role author
author
author
author
author
dc.contributor.none.fl_str_mv NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)
RUN
dc.contributor.author.fl_str_mv Rego, Sílvia
Oliveira Henriques, Ana Rita
Silvério Serra, Sofia
Costa, Teresa
Maria Rodrigues, Ana
Nunes, Francisco
dc.subject.por.fl_str_mv digital biomarker
digital endpoint
mHealth
mobile health
mobile health technologies
outcome measure
remote monitoring
review method
scoping review
sensor
validate
validation
wearable
wearable technology
topic digital biomarker
digital endpoint
mHealth
mobile health
mobile health technologies
outcome measure
remote monitoring
review method
scoping review
sensor
validate
validation
wearable
wearable technology
description ©Sílvia Rego, Ana Rita Henriques, Sofia Silvério Serra, Teresa Costa, Ana Maria Rodrigues, Francisco Nunes. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 26.10.2023.
publishDate 2023
dc.date.none.fl_str_mv 2023-11-16T22:10:02Z
2023-10-26
2023-10-26T00:00:00Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://hdl.handle.net/10362/160053
url http://hdl.handle.net/10362/160053
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv 1929-0748
PURE: 75305026
https://doi.org/10.2196/47119
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.source.none.fl_str_mv reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron:RCAAP
instname_str Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron_str RCAAP
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reponame_str Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
collection Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
repository.name.fl_str_mv Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
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