SUMMARY OBJECTIVE: 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. Randomized clinical trials, in which diagnostic strategies are compared, are scarce. Cross-sectional studies measure diagnostic accuracy outcomes that are considered indirect and insufficient to define the real benefit for patients. Among the accuracy outcomes, the positive and negative likelihood ratios are the most useful for clinical management. Variations in the study's cross-sectional design, which may add bias to the results, as well as other domains that contribute to decreasing the reliability of the findings, are discussed, as well as how to extrapolate such accuracy findings on impact and consequences considered important for the patient. Aspects of costs, time to obtain results, patients’ preferences and values should preferably be considered in decision making. CONCLUSION: Knowing the methodology of diagnostic accuracy studies is fundamental, but not sufficient, for the rational use of diagnostic tests. There is a need to balance the desirable and undesirable consequences of tests results for the patients in order to favor a rational decision-making approach about which tests should be recommended in clinical practice.
Background Biologic drugs such as adalimumab, etanercept, and infliximab represent major first-line and second-line treatments for rheumatoid arthritis (RA) patients. However, their high cost poses a massive burden on healthcare systems worldwide. The expiration of patents for these biologics has driven the production of biosimilar drugs, which are potentially less costly and remarkably similar, albeit not identical to the reference molecules. This paper aims to outline the protocol of a systematic review that will investigate the efficacy and safety profile of biosimilars compared to biologics (objective 1) and the impact of switching between biosimilar drugs and reference biologics on the management of RA patients (objective 2). Methods We will investigate the effects of any biosimilars of adalimumab, etanercept, and infliximab on RA patients. We will include randomized controlled trials (RCTs) or quasi-RCTs to assess efficacy and safety outcomes and RCTs with two- or multiple-part designs to evaluate the consequences of switching from reference biologics to biosimilar drugs (and vice-versa). Electronic searches will be performed through MEDLINE (via PubMed), EMBASE, LILACS, and CENTRAL (from inception to April 2021). Two independent reviewers will screen studies, extract data, and evaluate the risk of bias. The latter will be carried out considering specific domains from equivalence trials and switching studies. Random-effects models will be fitted to obtain summary estimates using either relative risk or standardized mean difference as a metric. The primary outcome will be the rate of treatment success according to the American College of Rheumatology 20 (ACR20), and the co-primary outcome will be the Health Assessment Questionnaire—Disability Index (HAQ-DI). Conclusions will be based on equivalence hypothesis testing using predefined margins of equivalence elicited from a group of experienced rheumatologists and prior studies. The overall certainty of the evidence will be assessed based on the GRADE system. Discussion The present investigation proposes a comprehensive, clinician-oriented approach to assess the equivalence and the impact of switching between biosimilars and biologics on the management of patients with RA. Our results will elucidate the efficacy, safety, immunogenicity of biosimilars, and the clinical consequences of substituting biologics with biosimilars in the management of RA. Systematic review registration PROSPERO CRD42019137152 and CRD42019137155
Objetivo: analisar o perfil situacional dos bloqueios de valores decorrentes do descumprimento de decisões judiciais em assistência à saúde, no Estado de Santa Catarina. Métodos: foram considerados os processos com determinação de bloqueio nas contas do Estado de Santa Catarina, nos meses de dezembro de 2015 e dezembro de 2016, em que os autores requereram medicamentos, insumos e nutrição. Resultados: a maioria das ações são ajuizadas individualmente e por escritórios de advocacia particulares. Medicamentos configuraram como o objeto mais solicitado, prescritos em sua maioria pelo nome comercial e não padronizados em listas oficiais em mais de 70% dos casos. Em 2015, o gasto mensal foi de R$ 135.549,39, e, caso o Estado tivesse realizado a aquisição, o gasto mensal seria de R$ 82.016,29. Em dezembro de 2016, o gasto com bloqueio foi de R$ 833.634,88, enquanto por meio de compra administrativa seria de R$ 447.357,68. Observou-se um crescimento de 858,82% dos gastos com bloqueios, do ano de 2015 para 2016. Conclusões: os resultados obtidos podem contribuir para o melhor planejamento do cumprimento das decisões judiciais em saúde, evitando que não onerem ainda mais os cofres públicos e prejudiquem o orçamento da saúde pública.
Introduction Mini health technology assessment (HTA) reports have been used to support policy makers and health systems by providing a timely summary of scientific evidence. The objective of this meta-epidemiologic study was to evaluate the quality of reporting of mini-HTA reports published in Brazil. Methods An electronic search for all mini-HTA reports published between 2014 and March 2019 was conducted in the SISREBRATS and CONITEC databases. The study selection and data extraction were performed by two independent assessors. The following data were extracted: bibliographic data; research question; characteristics of the population, health technologies and outcomes assessed; eligibility criteria; information about searches and study selection; risk of bias assessment; quality of evidence assessment; synthesis of results; and recommendation about the technology evaluated. A descriptive analysis was used to summarize the information retrieved from all the included mini-HTA reports. Results We included 103 mini-HTA reports, the great majority of which (92.3 percent) focused on the coverage of the technologies in the healthcare system, with more than 60 percent being about drugs. Only five mini-HTA reports (4.8 percent) gave reasons for the choice of outcomes, and fifteen (14.5 percent) discriminated between primary and secondary outcomes. All mini-HTAs reported the databases searched and 99 percent of them reported using Medline. Sixty percent of the mini-HTA reported assessing the risk of bias, and 52 percent reported assessing the quality of evidence. Conclusion The quality of reporting of the mini-HTA reports performed in Brazil is insufficient and needs to be improved to guarantee transparency and replicability.
Background Biologic drugs such as adalimumab, etanercept, and infliximab represent major first-line and second-line treatments for rheumatoid arthritis (RA) patients. However, their high cost poses a massive burden on healthcare systems worldwide. The expiration of patents for these biologics has driven to the production of biosimilar drugs, which are potentially less costly and remarkably similar, albeit not identical to the reference molecules. These two systematic reviews aim to investigate the efficacy and safety profile of biosimilars compared to biologics (systematic review 1) and the impact of switching between biosimilar drugs and reference biologics on the management of RA patients (systematic review 2).Methods Electronic searches will be performed through MEDLINE (via Pubmed), EMBASE, LILACS, and CENTRAL (from inception to September 2020). Risk of bias assessments will be carried out with the Cochrane risk of bias tool, supplemented with specific domains from equivalence trials. Random-effects models will be fitted to obtain summary estimates using either relative risk or standardized mean difference as a metric. Between-trial heterogeneity will be tested and quantified with the Q-test and I2 metric, respectively, whereas assessment of small-study bias will be examined through contour-enhanced funnel plots and Egger and Harbord's tests. Meta-regression models will be fitted when appropriate. The primary outcome will be the rate of treatment success according to the American College of Rheumatology 20 (ACR20) and the co-primary outcome will be the Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index). Conclusions will be based on equivalence hypothesis testing using predefined margins of equivalence elicited from a group of experienced rheumatologists and prior studies. The overall certainty of evidence will be assessed based on the GRADE system.Discussion The two systematic reviews described here, to the best of our knowledge, are the first ones proposing a comprehensive, clinician-oriented approach to assess the equivalence and the impact of switching between biosimilars and biologics on the management of patients with RA. The results will elucidate the efficacy, safety, immunogenicity of biosimilars, and the clinical consequences of substituting biologics with biosimilars in the management of RA. Systematic Review Registration Protocol synopses were previously registered on PROSPERO (CRD42019137152 and CRD42019137155).
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