Publications by authors named "Bruna De Oliveira Ascef"
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.
Background: Benefit-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.
View Article and Find Full Text PDFImpact of switching between reference biologics and biosimilars of tumour necrosis factor inhibitors for rheumatoid arthritis: a systematic review and network meta-analysis.
Sci Rep
August 2023
Article Synopsis
- * Data from 17 randomized trials involving 6,562 patients indicated that a single switch to biosimilars produced comparable results in treatment effectiveness, measured by ACR20 and HAQ-DI outcomes.
- * The research found no significant increase in adverse effects, treatment discontinuation, or anti-drug antibodies post-switching; however, safety data was limited and not definitive for long-term outcomes.
Therapeutic Equivalence of Biosimilar and Reference Biologic Drugs in Rheumatoid Arthritis: A Systematic Review and Meta-analysis.
JAMA Netw Open
May 2023
Article Synopsis
- Biosimilar drugs offer lower-cost alternatives to biologics, potentially improving access to treatment for rheumatoid arthritis (RA), yet there's a scarcity of systematic reviews verifying their efficacy.
- The study aimed to evaluate the effectiveness, safety, and immune response of biosimilars for adalimumab, etanercept, and infliximab against their original biologics in RA patients through randomized clinical trials.
- Findings from 25 trials involving over 10,000 patients indicated that biosimilars were equivalent to the reference drugs in terms of treatment efficacy, safety, and immunogenicity.
Background: Health technology assessment (HTA) should provide an assessment of a technology's effects on health and of the related social, economic, organisational and ethical issues. HTA reports on biosimilars can specifically assess their immunogenicity, their extrapolation to one or more conditions, and the risks of interchangeability and substitution. We aimed to complete a scoping review within the context of HTA organisations to synthesise HTA reports on biosimilars and to map the extension, scope and methodological practices.
View Article and Find Full Text PDFObjective: To assist clinicians to make adequate interpretation of scientific evidence from studies that evaluate diagnostic tests in order to allow their rational use in clinical practice.
Methods: This is a narrative review focused on the main concepts, study designs, the adequate interpretation of the diagnostic accuracy data, and making inferences about the impact of diagnostic testing in clinical practice.
Results: Most of the literature that evaluates the performance of diagnostic tests uses cross-sectional design.
Objective: To evaluate the access to medicines in primary health care of the Brazilian Unified Health System (SUS), from the patients' perspective.
Methods: This is a cross-sectional study that used data from the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos - Services, 2015 (PNAUM - National Survey on Access, Use and Promotion of Rational Use of Medicines), conducted by interviews with 8,591 patients in cities of the five regions of Brazil. Evaluation of access to medicines used concepts proposed by Penshansky and Thomas (1981), according to the dimensions: availability, accessibility, accommodation, acceptability, and affordability.
Objective: To analyze the Health-Related Quality of Life (HRQoL) of patients of the primary health care of the Brazilian Unified Health System (SUS) and its associated factors.
Methods: This is a cross-sectional study with data from the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos - Serviços, 2015 (PNAUM - National Survey on Access, Use and Promotion of Rational Use of Medicines - Services, 2015). Data were collected with a questionnaire that included the EuroQol 5 Dimensions (EQ-5D) instrument.