Methodological guidelines and publications of benefit-risk assessment for health technology assessment: a scoping review protocol

Página do item simplificado
dc.contributorSistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP
dc.contributor.authorASCEF, Bruna De Oliveira
dc.contributor.authorGABRIEL, Franciele Cordeiro
dc.contributor.authorSUZUMURA, Erica Aranha
dc.contributor.authorMAIA, Fernando Henrique de Albuquerque
dc.contributor.authorBORTOLUZZI, Aline Frossard Ribeiro
dc.contributor.authorFARIAS, Natalia Santos
dc.contributor.authorJAHN, Beate
dc.contributor.authorSIEBERT, Uwe
dc.contributor.authorSOAREZ, Patricia Coelho De
dc.date.accessioned2024-04-05T19:34:30Z
dc.date.available2024-04-05T19:34:30Z
dc.date.issued2023
dc.description.abstractBackgroundBenefit-risk assessment (BRA) is used in multiple phases along the health technology's life-cycle to evaluate the balance between the benefits and risks, as it is fundamental to all stakeholders. BRA and its methodological approaches have been applied primarily in the context of regulatory agencies. However, BRA's application and extent in the context of health technology assessment (HTA) bodies remain less clear. Our goal is to perform a scoping review to identify and map methodological guidelines and publications on methods of BRA. This will be done considering the different phases of the life-cycle of health technologies to underline both the depth and extent of research concerning BRA, especially in the context of HTA. Methods and analysisThis scoping review protocol was developed following the framework proposed by Arksey and O'Malley, and the updated guidelines by the Joanna Briggs Institute. We will include methodological publications that provide recommendations or guidelines on methods for BRA. We will conduct electronic searches on Medline (PubMed) and EMBASE (Ovid) databases; manual searches on the main websites of HTA bodies and drug regulatory organisations; and contact experts in the field. Systematic extraction forms will be used to screen and assess the identified publications by independent assessors. We will provide a qualitative synthesis using descriptive statistics and visual tools. Results will be summarised in systematic evidence tables and comparative evidence scoping charts. Ethics and disseminationThis review will use data publicly available and does not require ethics approval. The results of this scoping review will contribute to scientific knowledge and act as a basis for methodologists, guideline developers and researchers for the development of BRA to inform regulatory decisions, reimbursement and coverage decision making. The results will be disseminated through peer-reviewed articles, conferences, policy briefs and workshops. Trial registration numberOpen Science Framework (https://doi.org/10.17605/OSF.IO/69T3V).eng
dc.description.indexMEDLINE
dc.description.indexPubMed
dc.description.indexScopus
dc.description.indexDimensions
dc.description.indexWoS
dc.description.sponsorshipRede Brasileira de Avaliao de Tecnologias em Sade - REBRATS
dc.identifier.citationBMJ OPEN, v.13, n.12, article ID e075333, 8p, 2023
dc.identifier.doi10.1136/bmjopen-2023-075333
dc.identifier.issn2044-6055
dc.identifier.urihttps://observatorio.fm.usp.br/handle/OPI/58975
dc.language.isoeng
dc.publisherBMJ PUBLISHING GROUPeng
dc.relation.ispartofBMJ Open
dc.rightsopenAccesseng
dc.rights.holderCopyright BMJ PUBLISHING GROUPeng
dc.subjectdecision makingeng
dc.subjectpublic healtheng
dc.subjectstatistics & research methodseng
dc.subjecthealth policyeng
dc.subject.otherframeworkseng
dc.subject.othermedicineseng
dc.subject.otherguidanceeng
dc.subject.wosMedicine, General & Internaleng
dc.titleMethodological guidelines and publications of benefit-risk assessment for health technology assessment: a scoping review protocoleng
dc.typearticleeng
dc.type.categoryrevieweng
dc.type.versionpublishedVersioneng
dspace.entity.typePublication
hcfmusp.affiliation.countryÁustria
hcfmusp.affiliation.countryisoat
hcfmusp.author.externalGABRIEL, Franciele Cordeiro:Univ Sao Paulo, Fac Med FMUSP, Dept Med Prevent, Sao Paulo, SP, Brazil
hcfmusp.author.externalJAHN, Beate:Univ Hlth Sci & Technol, Inst Publ Hlth Med Decis Making & Hlth Technol Ass, Dept Publ Hlth Hlth Serv Res & Hlth Technol Assess, UMIT TIROL, Hall In Tirol, Austria
hcfmusp.author.externalSIEBERT, Uwe:Univ Hlth Sci & Technol, Inst Publ Hlth Med Decis Making & Hlth Technol Ass, Dept Publ Hlth Hlth Serv Res & Hlth Technol Assess, UMIT TIROL, Hall In Tirol, Austria
hcfmusp.citation.scopus0
hcfmusp.contributor.author-fmusphcBRUNA DE OLIVEIRA ASCEF
hcfmusp.contributor.author-fmusphcERICA ARANHA SUZUMURA
hcfmusp.contributor.author-fmusphcFERNANDO HENRIQUE DE ALBUQUERQUE MAIA
hcfmusp.contributor.author-fmusphcALINE FROSSARD RIBEIRO BORTOLUZZI
hcfmusp.contributor.author-fmusphcNATALIA SANTOS FARIAS
hcfmusp.contributor.author-fmusphcPATRICIA COELHO DE SOAREZ
hcfmusp.description.articlenumbere075333
hcfmusp.description.issue12
hcfmusp.description.volume13
hcfmusp.origemWOS
hcfmusp.origem.dimensionspub.1166848513
hcfmusp.origem.pubmed38072481
hcfmusp.origem.scopus2-s2.0-85179648293
hcfmusp.origem.wosWOS:001171115000116
hcfmusp.publisher.cityLONDONeng
hcfmusp.publisher.countryENGLANDeng
hcfmusp.relation.reference[Anonymous], 2010, Rev. Saúde Pública, V44, P381eng
hcfmusp.relation.referenceArksey H., 2005, INT J SOC RES METHOD, V8, P19, DOI [10.1080/1364557032000119616, DOI 10.1080/1364557032000119616]eng
hcfmusp.relation.referenceBerntgen M, 2014, VALUE HEALTH, V17, P634, DOI 10.1016/j.jval.2014.04.006eng
hcfmusp.relation.referenceBujar M, 2017, FRONT PHARMACOL, V8, DOI 10.3389/fphar.2017.00189eng
hcfmusp.relation.referenceCADTH, 2018, Grey Matters: A Practical Tool for Search Health-Related Grey Literature (Internet)eng
hcfmusp.relation.referenceCADTH, 2022, SR / MA / HTA / ITC-MEDLINE, Embase, PsycInfoeng
hcfmusp.relation.referenceDurán CE, 2021, REV PANAM SALUD PUBL, V45, DOI 10.26633/RPSP.2021.10eng
hcfmusp.relation.referenceEuropean network for Health Technology Assessment (EUnetHTA), 2016, Report on the implementation of the EMA-Eunethta Threeyear work plan 2012-2015eng
hcfmusp.relation.referenceGuo JJ, 2010, VALUE HEALTH, V13, P657, DOI 10.1111/j.1524-4733.2010.00725.xeng
hcfmusp.relation.referenceHallgreen CE, 2016, PHARMACOEPIDEM DR S, V25, P238, DOI 10.1002/pds.3880eng
hcfmusp.relation.referenceHughes D, 2016, PHARMACOEPIDEM DR S, V25, P251, DOI 10.1002/pds.3958eng
hcfmusp.relation.referenceJansen E, 2022, VALUE HEALTH, V25, P1726, DOI 10.1016/j.jval.2022.01.026eng
hcfmusp.relation.referenceJuhaeri J., 2012, Pharmacoepidemiological research on outcomes of Therapeutics by a European consortiumeng
hcfmusp.relation.referenceJuhaeri J, 2019, THER ADV DRUG SAF, V10, DOI 10.1177/2042098619871180eng
hcfmusp.relation.referenceMaloney MA, 2019, INT J TECHNOL ASSESS, V35, P384, DOI 10.1017/S026646231900062Xeng
hcfmusp.relation.referenceMcGowan J, 2016, J CLIN EPIDEMIOL, V75, P40, DOI 10.1016/j.jclinepi.2016.01.021eng
hcfmusp.relation.referenceMoher D, 2015, SYST REV-LONDON, V4, DOI [10.1186/2046-4053-4-1, 10.1016/j.ijsu.2010.07.299, 10.1136/bmj.b2700, 10.1371/journal.pmed.1000097, 10.1016/j.ijsu.2010.02.007, 10.1136/bmj.b2535, 10.1136/bmj.i4086]eng
hcfmusp.relation.referenceMt-Isa S, 2016, PHARM STAT, V15, P324, DOI 10.1002/pst.1690eng
hcfmusp.relation.referenceMt-Isa S, 2014, PHARMACOEPIDEM DR S, V23, P667, DOI 10.1002/pds.3636eng
hcfmusp.relation.referenceMunn Zachary, 2018, BMC Med Res Methodol, V18, P143, DOI 10.1186/s12874-018-0611-xeng
hcfmusp.relation.referenceNemzoff C, 2023, VALUE HEALTH, V26, P1549, DOI 10.1016/j.jval.2023.05.017eng
hcfmusp.relation.referenceNixon R, 2016, BIOMETRICAL J, V58, P8, DOI 10.1002/bimj.201300248eng
hcfmusp.relation.referenceOfori-Asenso R, 2020, FRONT MED-LAUSANNE, V7, DOI 10.3389/fmed.2020.582634eng
hcfmusp.relation.referenceOuzzani M, 2016, SYST REV-LONDON, V5, DOI 10.1186/s13643-016-0384-4eng
hcfmusp.relation.referencePeters MDJ., 2020, JBI Manual for Evidence Synthesis, DOI [10.46658/JBIMES-20-12, DOI 10.46658/JBIMES-20-12]eng
hcfmusp.relation.referencePeters MDJ, 2020, JBI EVID SYNTH, V18, P2119, DOI 10.11124/JBIES-20-00167eng
hcfmusp.relation.referencePignatti F, 2015, CLIN PHARMACOL THER, V98, P522, DOI 10.1002/cpt.203eng
hcfmusp.relation.referencePollock D, 2023, JBI EVID SYNTH, V21, P520, DOI 10.11124/JBIES-22-00123eng
hcfmusp.relation.referencePuhan MA, 2012, BMC MED RES METHODOL, V12, DOI 10.1186/1471-2288-12-173eng
hcfmusp.relation.referenceSengar G., Pharmaceutical Regulatory Agencies and Organizations around the World: Scope and Challenges in Drug Developmenteng
hcfmusp.relation.referenceSmith MY, 2021, THER INNOV REGUL SCI, V55, P415, DOI 10.1007/s43441-020-00230-3eng
hcfmusp.relation.referenceSR / MA / HTA / ITC, 2022, CADTHeng
hcfmusp.relation.referenceTervonen T, 2019, CLIN PHARMACOL THER, V106, P955, DOI 10.1002/cpt.1447eng
hcfmusp.relation.referenceThe European Medicines Agency, 2011, Benefit-risk methodology project Work package 2 report: Applicability of current tools and processes for regulatory benefit-risk assessmenteng
hcfmusp.relation.referenceTricco AC, 2018, ANN INTERN MED, V169, P467, DOI 10.7326/M18-0850eng
hcfmusp.scopus.lastupdate2024-05-17
relation.isAuthorOfPublication147db607-694d-4ee9-849c-5538d30960a3
relation.isAuthorOfPublication51bf7376-6c9b-4558-bbd7-37e1cd88fdfa
relation.isAuthorOfPublication77794c61-b6be-4cf3-b4bf-fc1e6ca953b4
relation.isAuthorOfPublicationd2470a53-dc23-4385-8c96-5f99c125fdc5
relation.isAuthorOfPublicatione8bf6d9a-0ff0-4e66-918e-59401db82191
relation.isAuthorOfPublication81a16aff-8fa9-4477-b854-dafea8aced9d
relation.isAuthorOfPublication.latestForDiscovery147db607-694d-4ee9-849c-5538d30960a3
Arquivos
Coleções
Artigos e Materiais de Revistas Científicas - FM/MPR