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

Autor:	Suzumura EA; Departamento de Medicina Preventiva, Faculdade de Medicina - FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, Brazil esuzumura@yahoo.com.br.; Institute of Public Health, Medical Decision Making and Health Technology Assessment, Department of Public Health, Health Services Research and Health Technology Assessment, UMIT TIROL - University for Health Sciences and Technology, Hall in Tirol, Austria., de Oliveira Ascef B; Departamento de Medicina Preventiva, Faculdade de Medicina - FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, Brazil., Maia FHA; Departamento de Medicina Preventiva, Faculdade de Medicina - FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, Brazil., Bortoluzzi AFR; Departamento de Medicina Preventiva, Faculdade de Medicina - FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, Brazil., Domingues SM; Departamento de Medicina Preventiva, Faculdade de Medicina - FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, Brazil., Farias NS; Departamento de Medicina Preventiva, Faculdade de Medicina - FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, Brazil., Gabriel FC; Departamento de Ciências Farmacêuticas, Universidade de Sao Paulo, Sao Paulo, SP, Brazil., Jahn B; Institute of Public Health, Medical Decision Making and Health Technology Assessment, Department of Public Health, Health Services Research and Health Technology Assessment, UMIT TIROL - University for Health Sciences and Technology, Hall in Tirol, Austria., Siebert U; Institute of Public Health, Medical Decision Making and Health Technology Assessment, Department of Public Health, Health Services Research and Health Technology Assessment, UMIT TIROL - University for Health Sciences and Technology, Hall in Tirol, Austria.; Division of Health Technology Assessment, ONCOTYROL - Center for Personalized Cancer Medicine, Innsbruck, Austria.; Center for Health Decision Science, Departments of Epidemiology and Health Policy & Management, Harvard T.H. Chan School of Public Health, Boston, MA, USA.; Program on Cardiovascular Research, Institute for Technology Assessment and Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA., de Soarez PC; Departamento de Medicina Preventiva, Faculdade de Medicina - FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2024 Jun 08; Vol. 14 (6), pp. e086603. Date of Electronic Publication: 2024 Jun 08.
DOI:	10.1136/bmjopen-2024-086603
Abstrakt:	Objectives: To map the available methodological guidelines and documents for conducting and reporting benefit-risk assessment (BRA) during health technologies' life cycle; and to identify methodological guidelines for BRA that could serve as the basis for the development of a BRA guideline for the context of health technology assessment (HTA) in Brazil. Design: Scoping review. Methods: Searches were conducted in three main sources up to March 2023: (1) electronic databases; (2) grey literature (48 HTA and regulatory organisations) and (3) manual search and contacting experts. We included methodological guidelines or publications presenting methods for conducting or reporting BRA of any type of health technologies in any context of the technology's life cycle. Selection process and data charting were conducted by independent reviewers. We provided a structured narrative synthesis of the findings. Results: From the 83 eligible documents, six were produced in the HTA context, 30 in the regulatory and 35 involved guidance for BRA throughout the technology's life cycle. We identified 129 methodological approaches for BRA in the documents. The most commonly referred to descriptive frameworks were the Problem, Objectives, Alternatives, Consequences, Trade-offs, Uncertainty, Risk and Linked decisions and the Benefit-Risk Action Team. Multicriteria decision analysis was the most commonly cited quantitative framework. We also identified the most cited metric indices, estimation and utility survey techniques that could be used for BRA. Conclusions: Methods for BRA in HTA are less established. The findings of this review, however, will support and inform the elaboration of the Brazilian methodological guideline on BRA for HTA. Trial Registration Number: https://doi.org/10.17605/OSF.IO/69T3V. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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