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

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.

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

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. 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 ANALYSIS: This 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 DISSEMINATION: This 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 NUMBER: Open Science Framework (https://doi.org/10.17605/OSF.IO/69T3V).

Reinfection rate in a cohort of healthcare workers over 2 years of the COVID-19 pandemic.

In this large cohort of healthcare workers, we aimed to estimate the rate of reinfections by SARS-CoV-2 over 2 years of the COVID-19 pandemic. We investigated the proportion of reinfections among all the cases of SARS-CoV-2 infection from March 10, 2020 until March 10, 2022. Reinfection was defined as the appearance of new symptoms that on medical evaluation were suggestive of COVID-19 and confirmed by a positive RT-PCR. Symptoms had to occur more than 90 days after the previous infection. These 2 years were divided into time periods based on the different variants of concern (VOC) in the city of São Paulo. There were 37,729 medical consultations due to COVID-19 at the hospital's Health Workers Services; and 25,750 RT-PCR assays were performed, of which 23% (n = 5865) were positive. Reinfection by SARS-CoV-2 was identified in 5% (n = 284) of symptomatic cases. Most cases of reinfection occurred during the Omicron period (n = 251; 88%), representing a significant increase on the SARS-CoV-2 reinfection rate before and during the Omicron variant period (0.8% vs. 4.3%; p < 0.001). The mean interval between SARS-CoV-2 infections was 429 days (ranged from 122 to 674). The Omicron variant spread faster than Gamma and Delta variant. All SARS-CoV-2 reinfections were mild cases.

Systematic review of economic evaluations on stereotactic ablative radiotherapy (SABR) compared to other radiotherapy techniques or surgical procedures for early-stage non-small cell lung cancer.

BACKGROUND: Stereotactic ablative radiotherapy (SABR) is recommended as first-choice treatment to inoperable early-stage non-small cell lung cancer (NSCLC). However, it is not widely adopted in developing countries, and its cost-effectiveness is unclear. We aimed to perform a systematic review of full economic evaluations (EE) that compared SABR with other radiotherapy or surgical procedures to assess the results and methodological approach. METHODS: The protocol was registered on PROSPERO (CRD42021241640). We included full EE studies with early-stage NSCLC in which one group was submitted to SABR. Studies that were partial EE, included advanced NSCLC or other neoplasm were excluded. We performed the last search on June 2021 in Medline, EMBASE and other databases. The reporting quality were assessed by CHEERS checklist. The main characteristics of each study were tabulated, and the results were presented by a narrative synthesis. RESULTS: We included nine studies. Three compared radiotherapy techniques, in which SABR was found to be dominant or cost-effective. Six compared SABR with surgery, and in this group, there was not a unanimous decision. All included only direct healthcare costs but varied about categories included. The parameters used in the model-based studies were highly heterogeneous using mixed data from various sources. The items properly reported varied from 29 to 67%. CONCLUSIONS: The studies were all from developed countries and lacked in reporting quality. We recommend that developing countries produce their own studies. More strict alignment to reporting guidelines and use of robust evidence as model parameters are also advised.

The Impact of Artificial Intelligence on Waiting Time for Medical Care in an Urgent Care Service for COVID-19: Single-Center Prospective Study.

BACKGROUND: To demonstrate the value of implementation of an artificial intelligence solution in health care service, a winning project of the Massachusetts Institute of Technology Hacking Medicine Brazil competition was implemented in an urgent care service for health care professionals at Hospital das Clínicas of the Faculdade de Medicina da Universidade de São Paulo during the COVID-19 pandemic. OBJECTIVE: The aim of this study was to determine the impact of implementation of the digital solution in the urgent care service, assessing the reduction of nonvalue-added activities and its effect on the nurses' time required for screening and the waiting time for patients to receive medical care. METHODS: This was a single-center, comparative, prospective study designed according to the Public Health England guide "Evaluating Digital Products for Health." A total of 38,042 visits were analyzed over 18 months to determine the impact of implementing the digital solution. Medical care registration, health screening, and waiting time for medical care were compared before and after implementation of the digital solution. RESULTS: The digital solution automated 92% of medical care registrations. The time for health screening increased by approximately 16% during the implementation and in the first 3 months after the implementation. The waiting time for medical care after automation with the digital solution was reduced by approximately 12 minutes compared with that required for visits without automation. The total time savings in the 12 months after implementation was estimated to be 2508 hours. CONCLUSIONS: The digital solution was able to reduce nonvalue-added activities, without a substantial impact on health screening, and further saved waiting time for medical care in an urgent care service in Brazil during the COVID-19 pandemic.

Pre and postnatal diagnosis of a third branchial cleft cyst by sonography and magnetic resonance imaging with three-dimensional virtual reconstruction.

Branchial cleft cysts (BCCs) are common causes of cervical tumors in children and adulthood; however, prenatal diagnosis of BCC is rare. In neonates, these cysts can suddenly increase in size, causing airway obstruction and becoming a life-threatening condition. In this case report, we describe the prenatal diagnosis of a third BCC at the 25th week of pregnancy using ultrasound, magnetic resonance imaging, and three-dimensional virtual models, as well as the perinatal outcomes of this rare condition.

Cardiovascular damage associated with subchronic exposure to the glyphosate herbicide in Wistar rats.

Glyphosate is the most widely used herbicide in the world. Although some studies have shown cardiac electrophysiological changes associated to glyphosate, the histopathological changes that this herbicide may cause in the cardiovascular system are not yet established. The aim of this study was to evaluate the cardiovascular effects of subchronic oral and inhalation exposure to the glyphosate herbicide in rats. Eighty albino Wistar rats were distributed into eight groups (five males and five females/group): inhalation control: nebulization with sodium chloride solution (NaCl); oral control: nebulized feed with NaCl; low inhalation concentration: nebulization with 3.71 × 10-3 grams of active ingredient per hectare (g.a.i./ha) of glyphosate; low oral concentration: nebulized feed with 3.71 × 10-3 g.a.i./ha of glyphosate; medium inhalation concentration: nebulization with 6.19 × 10-3 g.a.i./ha of glyphosate; medium oral concentration: nebulized feed with 6.19 × 10-3 g.a.i./ha of glyphosate; high inhalation concentration: nebulization with 9.28 × 10-3 g.a.i./ha of glyphosate; and high oral concentration: nebulized feed with 9.28 × 10-3 g.a.i./ha of glyphosate. After 75 days of exposure, the animals were euthanized, and aortas and hearts were collected for histopathological analysis. Fatty streaks were observed in most animals exposed to glyphosate and were more prevalent in male rats, regardless of the route of exposure (p < 0.05). There were no differences in the measurements of the thickness of the right and left ventricle or in the collagen density of both ventricles in any of the groups evaluated (p > 0.05). Our study suggests that glyphosate has atherogenic potential, regardless of the concentration and route of exposure.

Virtual navigation for the improvement of parents counseling and the planning of fetal endoscopic myelomeningocele repair.

BACKGROUND: Myelomeningocele (MMC) is the most severe form of spina bifida with intrauterine repairs becoming more prevalent. The development of three-dimensional ultrasound (3DUS) and magnetic resonance imaging (MRI) has drastically improved the visualization of fetal anatomy. METHODS: Virtual Navigation (VN) results from a technology that uses software generated realistic images to replicate the immersive feeling of a real environment. CONCLUSION: This report aims to demonstrate VN in a Chiari II malformation case, obtained from 3DUS and MRI files, comparing this with the fetal endoscopic surgery for MMC.

Introdução ao Modelo de Atenção às Condições Crônicas

Aula em powerpoint narrado que aborda uma introdução ao Modelo de Atenção às Condições Crônicas (MACC)CHRONIC CARE MODEL

Introdução ao Modelo de Atenção às Condições Crônicas [exercício]

Exercício de relacionar colunas, elaborado com base no material da aula da Unidade 3 - Você faz uma clínica adequada para estimular o autocuidado? Introdução ao Modelo de Atenção às Condições Crônicas (MACC)

Caso Silvana [exercício]

Avaliação Somativa com questões objetivas de múltipla escolha que avaliam as competências em Atenção às Condições Crônicas e o Chronic Care Model (CCM).

Caso Silvana [exercício]

Questões objetivas de múltipla escolha que avaliam as competências em Atenção às Condições Crônicas e o Chronic Care Model (CCM).

Nem só de falta de recursos padece o SUS: uma crítica à tomada de decisöes clínicas / Not all that hampers the unified health system is money shortage: a criticism on clinical decision taking

Os autores relatam o trajeto de um paciente através do Sistema Público de Saúde em Juiz de Fora - Brasil, até o diagnóstico final de Diabetes Mellitus tipo 1. Decisöes clínicas näo adequadas nos diferentes níveis de atençäo säo realçadas como um fator contribuinte para a baixa resolutividade do sistema.