Supporting evidence-based judicial decisions on health care in Brazil: an experience report / Apoio técnico-científico à tomada de decisão judicial em saúde no Brasil: um relato de experiência / Apoyo técnico-científico a la toma de decisiones judiciales en salud en Brasil: un relato de experiencia

Objective: The main objective of this study is to report on the implementation and results of the "Supporting Health-Related Judicial Decisions in Brazil" project conducted at the Health Technology Assessment Center, Hospital Sírio-Libanês through the "Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde", in Brazil. Methods: This study is an experience report of a project conducted at the Health Technology Assessment Center, Hospital Sírio-Libanês. Results: The activities of the project occurred in 2023 and included two online training courses on primary studies and systematic reviews, 11 one-day workshops with technical-scientific content for members of the Technical Support Centers for the Judiciary (NATJus), 40 online technical-scientific consultations for magistrates on a digital platform, 11 technical-scientific reports addressing the most legally claimed technologies in Brazil; two methodological tools, a national forum (hybrid event), 10 chat-based mentorships for NATJus members; and the maintenance of an open-access blog, by publishing news on relevant topics on law and health. Discussion and conclusion: This project has contributed to the improvement of the judicial decision-making process by providing a range of activities aimed at aiding the prioritization of health technologies that are clearly effective and safe over those that are ineffective, harmful, or have uncertain effects.

Objetivo: O objetivo principal deste estudo é relatar a implementação e os resultados do projeto "Apoio técnico-científico à tomada de decisão judicial em Saúde no Brasil" realizado no Hospital Sírio-Libanês por meio do "Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde". Métodos: Este estudo é um relato de experiência de um projeto realizado no Núcleo de Avaliação de Tecnologias em Saúde do Hospital Sírio-Libanês. Resultados: As atividades do projeto ocorreram em 2023 e incluíram dois cursos de formação online sobre estudos primários e revisões sistemáticas, 11 oficinas de um dia com conteúdo técnico-científico para membros dos Núcleos de Apoio Técnico ao Judiciário (NATJus), 40 consultas on-line técnico-científicas para magistrados em plataforma digital, 11 relatórios técnico-científicos abordando as tecnologias mais reivindicadas judicialmente no Brasil; duas ferramentas metodológicas, um fórum nacional (evento híbrido), 10 mentorias via chat para membros do NATJus; e a manutenção de um blog de acesso aberto, com publicação de notícias sobre temas relevantes de direito e saúde. Discussão e conclusão: Este projeto contribuiu para a melhoria do processo de tomada de decisão judicial, fornecendo uma série de atividades destinadas a ajudar na priorização de tecnologias de saúde que sejam claramente eficazes e seguras em detrimento daquelas que são ineficazes, prejudiciais ou têm efeitos incertos.

Objetivo: El objetivo principal de este estudio es informar sobre la implementación y los resultados del proyecto "Apoyo a las Decisiones Judiciales Relacionadas con la Salud en Brasil" realizado en el Centro de Tecnología en Salud del Hospital Sírio-Libanês a través del "Programa de Apoio ao Desenvolvimento Institucional do Sistema Único de Saúde", en Brasil. Métodos: Este estudio es un informe de experiencia de un proyecto realizado en el Centro de Tecnología en Salud del Hospital Sírio-Libanês. Resultados: Las actividades del proyecto ocurrieron en 2023 e incluyeron dos cursos de capacitación en línea sobre estudios primarios y revisiones sistemáticas, 11 talleres de un día de contenido técnico-científico para miembros de los Centros de Apoyo Técnico al Poder Judicial (NATJus), 40 consultas técnico-científicas en línea para magistrados en plataforma digital, 11 informes técnico-científicos que abordan las tecnologías más reclamadas legalmente en Brasil; dos herramientas metodológicas, un foro nacional (evento híbrido), 10 mentorías basadas en chat para miembros de NATJus; y el mantenimiento de un blog de acceso abierto, mediante la publicación de noticias sobre temas relevantes en derecho y salud. Discusión y conclusión: Este proyecto ha contribuido a mejorar el proceso de toma de decisiones judiciales proporcionando actividades para priorizar las tecnologías sanitarias claramente eficaces y seguras frente a aquellas que son ineficaces, nocivas o de efectos inciertos.

Health care transition models in spina bifida care: evidence-based lessons in support of neurosurgical practice.

OBJECTIVE: The purpose of this study was to conduct a literature review on transition programs from pediatric to adult care and the role of neurosurgery as individuals with spina bifida (SB) transition, and to provide a framework for neurosurgical providers to assist in the transition to adult-centered care. METHODS: A comprehensive literature review was conducted according to the PRISMA statement, with a search in Medline and Embase to identify US clinical programs reporting on their experiences establishing a transition program for adolescents and young adults with SB. Data were collected for authors, year, transition clinic location, model of care for transition clinic, ages served, and specialty clinical team. RESULTS: The literature search yielded 698 articles, 5 of which met the inclusion criteria. These 5 studies included 4 transition programs for which models of care and approach to transition, clinical services involved, establishment of goals, and age of initiation and transition were identified. All programs described setting transition goals, ranging from community services, to self-management, to health care navigation, to patient-driven goals, with 1 program reporting a quality-of-life measurement component to their model. CONCLUSIONS: Robust SB transition programs can be established by applying the expanded chronic care model, reviewing lessons learned by other programs, advocating at the institutional level, and seeking support via professional organizations. While the comprehensive role of neurosurgical providers in these programs is still being defined, a shared vision of enhancing the health and quality of life for individuals with SB and their families is needed by all subspecialists involved.

What do Brazilian paediatric dentists know about bruxism in children? Cross-sectional study.

PURPOSE: Little is known about the knowledge of paediatric dentists on bruxism in children. The aim of this cross-sectional study was to assess the knowledge of paediatric dentists on the concept, associated factors of bruxism and management of sleep bruxism (SB) in children'. METHODS: An electronic questionnaire was sent to paediatric dentists in the state of Goiás, Brazil. Information was collected on (1) characteristics of the participants; (2) the concept of bruxism; (3) diagnosis; (4) associated factors; (5) strategies for the management of SB; and (6) updated knowledge on bruxism in children. The data were analysed descriptively. RESULTS: Fifty-seven paediatric dentists participated (10.7% of the total number of professionals). A high level of agreement was found with statements on the concepts of SB (94.7%) and awake bruxism (96.5%). The main strategy for the diagnosis was the combination of a parental report and a clinical examination (79.0%). Most participants indicated that bruxism is associated with anxiety/stress (96.5%), screen use (93%), airway obstruction (91.2%), and sleep apnoea (91.2%). In suspected cases of bruxism, the dentists would send the child for assessment by other health care providers (87.7%). The management options frequently indicated were the use of an occlusal splint, aromatherapy, and homeopathy. More than 70% of them considered themselves to be updated on the issue and sought information through scientific articles and discussions with colleagues. CONCLUSION: Paediatric dentists have knowledge on the concept of bruxism and associated factors. However, further information is needed on the management of this condition in children.

Development of Automated Triggers in Ambulatory Settings in Brazil: Protocol for a Machine Learning-Based Design Thinking Study.

BACKGROUND: The use of technologies has had a significant impact on patient safety and the quality of care and has increased globally. In the literature, it has been reported that people die annually due to adverse events (AEs), and various methods exist for investigating and measuring AEs. However, some methods have a limited scope, data extraction, and the need for data standardization. In Brazil, there are few studies on the application of trigger tools, and this study is the first to create automated triggers in ambulatory care. OBJECTIVE: This study aims to develop a machine learning (ML)-based automated trigger for outpatient health care settings in Brazil. METHODS: A mixed methods research will be conducted within a design thinking framework and the principles will be applied in creating the automated triggers, following the stages of (1) empathize and define the problem, involving observations and inquiries to comprehend both the user and the challenge at hand; (2) ideation, where various solutions to the problem are generated; (3) prototyping, involving the construction of a minimal representation of the best solutions; (4) testing, where user feedback is obtained to refine the solution; and (5) implementation, where the refined solution is tested, changes are assessed, and scaling is considered. Furthermore, ML methods will be adopted to develop automated triggers, tailored to the local context in collaboration with an expert in the field. RESULTS: This protocol describes a research study in its preliminary stages, prior to any data gathering and analysis. The study was approved by the members of the organizations within the institution in January 2024 and by the ethics board of the University of São Paulo and the institution where the study will take place. in May 2024. As of June 2024, stage 1 commenced with data gathering for qualitative research. A separate paper focused on explaining the method of ML will be considered after the outcomes of stages 1 and 2 in this study. CONCLUSIONS: After the development of automated triggers in the outpatient setting, it will be possible to prevent and identify potential risks of AEs more promptly, providing valuable information. This technological innovation not only promotes advances in clinical practice but also contributes to the dissemination of techniques and knowledge related to patient safety. Additionally, health care professionals can adopt evidence-based preventive measures, reducing costs associated with AEs and hospital readmissions, enhancing productivity in outpatient care, and contributing to the safety, quality, and effectiveness of care provided. Additionally, in the future, if the outcome is successful, there is the potential to apply it in all units, as planned by the institutional organization. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/55466.

Domains and Methods of Medical Device Technology Evaluation: A Systematic Review.

Objectives: Identify, through a systematic review, the main domains and methods to support health technology assessment of Medical Devices (MD) from the perspective of technological incorporation into healthcare systems. Methods: Performed structured searches in MEDLINE, Embase, BVS, Cochrane Library, and Web of Science for full studies published between 2017 and May 2023. Selection, extraction, and quality assessment were performed by two blinded reviewers, and discrepancies were resolved by a third reviewer. Results: A total of 5,790 studies were retrieved, of which 41 were included. We grouped the identified criteria into eight domains for the evaluations. Conclusion: Overall, studies discuss the need to establish specific methods for conducting HTA in MD. Due to the wide diversity of MD types, a single methodological guideline may not encompass all the specificities and intrinsic characteristics of the plurality of MD. Studies suggest using clustering criteria through technological characterization as a strategy to make the process as standardized as possible.

Closing the gap: prognostic and predictive biomarker validation for personalized care in a Latin American hormone-dependent breast cancer cohort.

BACKGROUND: Several guidelines recommend the use of different classifiers to determine the risk of recurrence (ROR) and treatment decisions in patients with HR+HER2- breast cancer. However, data are still lacking for their usefulness in Latin American (LA) patients. Our aim was to evaluate the comparative prognostic and predictive performance of different ROR classifiers in a real-world LA cohort. METHODS: The Molecular Profile of Breast Cancer Study (MPBCS) is an LA case-cohort study with 5-year follow-up. Stages I and II, clinically node-negative HR+HER2- patients (n = 340) who received adjuvant hormone therapy and/or chemotherapy, were analyzed. Time-dependent receiver-operator characteristic-area under the curve, univariate and multivariate Cox proportional hazards regression (CPHR) models were used to compare the prognostic performance of several risk biomarkers. Multivariate CPHR with interaction models tested the predictive ability of selected risk classifiers. RESULTS: Within this cohort, transcriptomic-based classifiers such as the recurrence score (RS), EndoPredict (EP risk and EPClin), and PAM50-risk of recurrence scores (ROR-S and ROR-PC) presented better prognostic performances for node-negative patients (univariate C-index 0.61-0.68, adjusted C-index 0.77-0.80, adjusted hazard ratios [HR] between high and low risk: 4.06-9.97) than the traditional classifiers Ki67 and Nottingham Prognostic Index (univariate C-index 0.53-0.59, adjusted C-index 0.72-0.75, and adjusted HR 1.85-2.54). RS (and to some extent, EndoPredict) also showed predictive capacity for chemotherapy benefit in node-negative patients (interaction P = .0200 and .0510, respectively). CONCLUSION: In summary, we could prove the clinical validity of most transcriptomic-based risk classifiers and their superiority over clinical and immunohistochemical-based methods in the heterogenous, real-world node-negative HR+HER2- MPBCS cohort.

Models and frameworks for assessing the implementation of clinical practice guidelines: a systematic review.

BACKGROUND: The implementation of clinical practice guidelines (CPGs) is a cyclical process in which the evaluation stage can facilitate continuous improvement. Implementation science has utilized theoretical approaches, such as models and frameworks, to understand and address this process. This article aims to provide a comprehensive overview of the models and frameworks used to assess the implementation of CPGs. METHODS: A systematic review was conducted following the Cochrane methodology, with adaptations to the "selection process" due to the unique nature of this review. The findings were reported following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) reporting guidelines. Electronic databases were searched from their inception until May 15, 2023. A predetermined strategy and manual searches were conducted to identify relevant documents from health institutions worldwide. Eligible studies presented models and frameworks for assessing the implementation of CPGs. Information on the characteristics of the documents, the context in which the models were used (specific objectives, level of use, type of health service, target group), and the characteristics of each model or framework (name, domain evaluated, and model limitations) were extracted. The domains of the models were analyzed according to the key constructs: strategies, context, outcomes, fidelity, adaptation, sustainability, process, and intervention. A subgroup analysis was performed grouping models and frameworks according to their levels of use (clinical, organizational, and policy) and type of health service (community, ambulatorial, hospital, institutional). The JBI's critical appraisal tools were utilized by two independent researchers to assess the trustworthiness, relevance, and results of the included studies. RESULTS: Database searches yielded 14,395 studies, of which 80 full texts were reviewed. Eight studies were included in the data analysis and four methodological guidelines were additionally included from the manual search. The risk of bias in the studies was considered non-critical for the results of this systematic review. A total of ten models/frameworks for assessing the implementation of CPGs were found. The level of use was mainly policy, the most common type of health service was institutional, and the major target group was professionals directly involved in clinical practice. The evaluated domains differed between the models and there were also differences in their conceptualization. All the models addressed the domain "Context", especially at the micro level (8/12), followed by the multilevel (7/12). The domains "Outcome" (9/12), "Intervention" (8/12), "Strategies" (7/12), and "Process" (5/12) were frequently addressed, while "Sustainability" was found only in one study, and "Fidelity/Adaptation" was not observed. CONCLUSIONS: The use of models and frameworks for assessing the implementation of CPGs is still incipient. This systematic review may help stakeholders choose or adapt the most appropriate model or framework to assess CPGs implementation based on their specific health context. TRIAL REGISTRATION: PROSPERO (International Prospective Register of Systematic Reviews) registration number: CRD42022335884. Registered on June 7, 2022.

Research evidence communication for policy-makers: a rapid scoping review on frameworks, guidance and tools, and barriers and facilitators.

BACKGROUND: Communication is a multifaceted process, ranging from linear, one-way approaches, such as transmitting a simple message, to continuous exchanges and feedback loops among stakeholders. In particular the COVID-19 pandemic underscored the critical need for timely, effective and credible evidence communication to increase awareness, levels of trust, and evidence uptake in policy and practice. However, whether to improve policy responses in crises or address more commonplace societal challenges, comprehensive guidance on evidence communication to decision-makers in health policies and systems remains limited. Our objective was to identify and systematize the global evidence on frameworks, guidance and tools supporting effective communication of research evidence to facilitate knowledge translation and evidence-informed policy-making processes, while also addressing barriers and facilitators. METHODS: We conducted a rapid scoping review following the Joanna Briggs Manual. Literature searches were performed across eight indexed databases and two sources of grey literature, without language or time restrictions. The methodological quality of included studies was assessed, and a narrative-interpretative synthesis was applied to present the findings. RESULTS: We identified 16 documents presenting either complete frameworks or framework components, including guidance and tools, aimed at supporting evidence communication for policy development. These frameworks outlined strategies, theoretical models, barriers and facilitators, as well as insights into policy-makers' perspectives, communication needs, and preferences. Three primary evidence communication strategies, comprising eleven sub-strategies, emerged: "Health information packaging", "Targeting and tailoring messages to the audience", and "Combined communication strategies". Based on the documented barriers and facilitators at micro, meso and macro levels, critical factors for successful communication of evidence to policy-makers were identified. CONCLUSIONS: Effective communication is indispensable for facilitating knowledge translation and evidence-informed policy-making. Nonetheless gaps persist in frameworks designed to enhance research communication to policy-makers, particularly regarding the effectiveness of multiple communication strategies. To advance in this field, the development of comprehensive frameworks incorporating implementation strategies is warranted. Additionally, barriers and facilitators to implementing effective communication must be recognized and addressed taking diverse contexts into consideration. Registration https://zenodo.org/record/5578550.

La Pregunta de Investigación y su Asociación con los Niveles de Evidencia y Grados de Recomendación en Estudios de Investigación Clínica / The Research Question and its Association with the Levels of Evidence and Grades of Recommendation in Clinical Research Studies

La mayoría de las preguntas de investigación (PI), conducirán a un proyecto que apunta a generar nuevo conocimiento, sin embargo el escenario, la población a estudio y la metodología pueden ser muy diferentes, lo que determinará que los resultados obtenidos y por ende, el nivel de evidencia (NE) y el grado de recomendación (GR) puedan variar notablemente. El objetivo de este artículo fue proporcionar recomendaciones para formular una PI asociada al NE y respectivos GR que se pueden desprender a partir de los resultados generados. Este artículo entregará algunos conocimientos sobre la PI y su relación con los NE y GR de la evidencia generada a partir de resultados obtenidos por un proceso de investigación en diferentes escenarios de investigación.

SUMMARY: Most research questions (RQ) will lead to a project that aims to generate new knowledge. However, the setting, study population and methodology may be very different, which will determine the results obtained and therefore, the level of evidence (LOE) and the grade of recommendation (GOR) may vary significantly. The aim of this study was to provide recommendations to formulate a RQ associated with the LOE and respective GOR that can be derived from the generated results. This article will provide some knowledge about the RQ and its relationship with the LEO and GOR of the generated evidence from results obtained by a research process in different research scenarios.

The COVID-19 pandemic in Brazil: space-time approach of cases, deaths, and vaccination coverage (February 2020 - April 2024).

OBJECTIVE: To assess the evolution of the COVID-19 pandemic in Brazil and its macro-regions, considering disease incidence and mortality rates, as well as identifying territories with still rising disease indices and evaluating vaccine coverage and population adherence to COVID-19 immunization. METHODS: An ecological study conducted in Brazil with COVID-19 cases and deaths reported between February 2020 and April 2024, obtained through the Coronavirus Panel. Historical series were constructed from incidence and mortality rates to assess the pandemic's evolution, and temporal trends were estimated using the Seasonal Trend Decomposition using Loess (STL) method. The Spatial Variation in Temporal Trends (SVTT) technique was employed to identify clusters with significant variations in temporal trends. Vaccination was analyzed considering the percentage of vaccinated and unvaccinated population in each municipality of the country. RESULTS: Brazil recorded a total of 38,795,966 cases and 712,038 deaths from COVID-19 during the study period. Incidence and mortality rates showed three waves of the disease, with a fourth wave of smaller amplitude. Four clusters with significant case growth and two with increased deaths were identified. Vaccine coverage varied among municipalities, with some regions showing low vaccination rates and others with high immunization adherence. CONCLUSION: The study provided a comprehensive overview of coronavirus behavior in Brazil, and its results highlight the ongoing importance of vaccination and the need to direct efforts and resources to areas of higher risk.

Status of the national immunization technical advisory groups in the Americas: recommendations for improvement.

Objectives: To evaluate the structure and operation of national immunization technical advisory groups (NITAGs) in Latin America and the Caribbean and to make recommendations for improvement. Methods: A convenience sample of six current and eight former NITAG members representing 12 countries in the region were invited in 2022 to answer a web-based questionnaire on NITAG structure, organization, and procedures. The questionnaire used indicators similar to those in the Joint Reporting Form on Immunization. Participants were also asked about the role their NITAGs played in coronavirus disease 2019 (COVID-19) immunization policies. Results: Brazil, Dominican Republic, and Venezuela (Bolivarian Republic of) reported not having an active NITAG. The nine active NITAGs are structured and organized according to World Health Organization and Pan American Health Organization recommendations, with variations between countries. Most NITAGs include representatives of the five recommended medical specialties with the participation of additional members possible. Only Bolivia (Plurinational State of) and Mexico have no explicit policy for managing members' potential conflicts of interest. All NITAGs have an exclusively technical advisory role and generally meet once a quarter. Usually, NITAGs are asked by health ministries to analyze issues and make recommendations. All NITAGs, except for Peru's, actively participated in supporting decision-making for immunization policy on COVID-19. Conclusions: NITAGs have successfully supported vaccine policy-making through evidence-based recommendations. However, improvement in their structure, operation, and transparency is needed to help them keep up with the rapidly evolving field of immunization. Research on the impact of NITAGs is important to support the development of recommendations for improvement.

Methodology for the Differential Classification of Dengue and Chikungunya According to the PAHO 2022 Diagnostic Guide.

Arboviruses such as dengue, Zika, and chikungunya present similar symptoms in the early stages, which complicates their differential and timely diagnosis. In 2022, the PAHO published a guide to address this challenge. This study proposes a methodological framework that transforms qualitative information into quantitative information, establishing differential weights in relation to symptoms according to the medical evidence and the GRADE scale based on recommendation 1 of the said guide. To achieve this, common variables from the dataset were identified using the PAHO guide, and quality rules were established. A linear interpolation function was then parameterised to assign weights to the symptoms according to the evidence. Machine learning was used to compare the different models, achieving 99% accuracy compared with 79% without the methodology. This proposal represents a significant advancement, allowing the direct application of the PAHO recommendations to the dataset and improving the differential classification of arboviruses.

Bridging Real-World Data Gaps: Connecting Dots Across 10 Asian Countries.

The economic trend and the health care landscape are rapidly evolving across Asia. Effective real-world data (RWD) for regulatory and clinical decision-making is a crucial milestone associated with this evolution. This necessitates a critical evaluation of RWD generation within distinct nations for the use of various RWD warehouses in the generation of real-world evidence (RWE). In this article, we outline the RWD generation trends for 2 contrasting nation archetypes: "Solo Scholars"-nations with relatively self-sufficient RWD research systems-and "Global Collaborators"-countries largely reliant on international infrastructures for RWD generation. The key trends and patterns in RWD generation, country-specific insights into the predominant databases used in each country to produce RWE, and insights into the broader landscape of RWD database use across these countries are discussed. Conclusively, the data point out the heterogeneous nature of RWD generation practices across 10 different Asian nations and advocate for strategic enhancements in data harmonization. The evidence highlights the imperative for improved database integration and the establishment of standardized protocols and infrastructure for leveraging electronic medical records (EMR) in streamlining RWD acquisition. The clinical data analysis and reporting system of Hong Kong is an excellent example of a successful EMR system that showcases the capacity of integrated robust EMR platforms to consolidate and produce diverse RWE. This, in turn, can potentially reduce the necessity for reliance on numerous condition-specific local and global registries or limited and largely unavailable medical insurance or claims databases in most Asian nations. Linking health technology assessment processes with open data initiatives such as the Observational Medical Outcomes Partnership Common Data Model and the Observational Health Data Sciences and Informatics could enable the leveraging of global data resources to inform local decision-making. Advancing such initiatives is crucial for reinforcing health care frameworks in resource-limited settings and advancing toward cohesive, evidence-driven health care policy and improved patient outcomes in the region.

International Society on Thrombosis and Haemostasis clinical practice guideline for treatment of congenital hemophilia A and B based on the Grading of Recommendations Assessment, Development, and Evaluation methodology.

BACKGROUND: Hemophilia is a rare congenital bleeding disorder that results from complete or partial deficiency of blood coagulation factor (F)VIII (hemophilia A) or FIX (hemophilia B) due to pathogenic variants in their coding genes. Hemophilia requires complex management. To date, there is no evidence-based clinical practice guideline on hemophilia treatment based on the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. OBJECTIVES: This evidence-based clinical practice guideline from the International Society on Thrombosis and Haemostasis aims to provide an overview of evidence and support patients, caregivers, hematologists, pediatricians, other clinicians, researchers, and stakeholders in treatment decisions about congenital hemophilia A and B. METHODS: The International Society on Thrombosis and Haemostasis formed a multidisciplinary guideline panel of physicians and patients with global representation, balanced to minimize potential bias from conflicts of interest. The panel prioritized a set of clinical questions and outcomes according to their importance for clinicians and patients. A methodological team supported the guideline development process, including searching for evidence and performing systematic reviews. The GRADE approach was used, including GRADE Evidence to Decision frameworks. The recommendations were subject to public comment. RESULTS: The panel selected 13 questions, of which 11 addressed the treatment of hemophilia A and 2 the treatment of hemophilia B. Specifically, the panel addressed questions on prophylactic and episodic treatment with FVIII concentrates, bypassing agents, and nonfactor therapy (emicizumab) for hemophilia A (with and without inhibitors) as well as immune tolerance induction for hemophilia A. For hemophilia B, the panel addressed questions on prophylactic and episodic treatment of bleeding events with FIX concentrates. Agreement was reached for all 13 recommendations, of which 7 (54%) were based on evidence from randomized clinical trials, 3 (23%) on observational studies, and 3 (23%) on indirect comparisons. CONCLUSION: Strong recommendations were issued for prophylactic over episodic treatment for severe and moderately severe hemophilia A and B. Only conditional recommendations were issued for the remaining questions. Future research should focus on direct treatment comparisons and the treatment of hemophilia B with and without inhibitors. Future updates of this guideline will provide an updated evidence synthesis on the current questions and focus on new FVIII and FIX concentrates, novel nonfactor therapies, and gene therapy for severe and nonsevere hemophilia A and B.

SARS-CoV-2 reinfection rate before and after VOC Omicron emergence: a retrospective study in Brazil.

SARS-COV-2 reinfection has been reported worldwide, although its rate remains unclear. VOC Omicron's emergence and its sub-variants led to an unprecedented number of COVID-19 cases in several countries, raising concerns regarding reinfection rates. 324,979 RT-qPCR-confirmed positive cases (72.57% from Minas Gerais State) diagnosed between April 1, 2020, and August 31, 2022, at the Hermes Pardini, Grupo Fleury (Brazil) were used to estimate the reinfection rate. Instances of reinfection were characterized by two positive tests occurring with a minimum interval of 60 days. We identified 11,669 cases of reinfection. The states of Minas Gerais, São Paulo, Rio de Janeiro and Goiás represented almost 41% of the reinfections. Up until epidemiological week 46 of 2020, only 14 cases of reinfection were recorded. The majority of reinfections, totalling 6,316 cases, were detected during the circulation period of the Omicron and its sublineages BA.1 and BA.2. Another 4,273 reinfections occurred during the circulation period of sublineages BA.4 and BA.5, revealing two distinct groups of observations. The first group comprised cases of reinfection with a shorter time interval (two infections within a period of up to 200 days), while the second group was associated with a longer time interval (two infections within a period of more than 500 days). The reinfection rate during this period was nearly 8%, which is six times higher than the rate observed at the beginning of the study. In conclusion, our study underscores the dynamic nature of SARS-CoV-2 reinfections and their correlation with emerging variants such as Omicron.

Which are the clinical consequences of Molar Incisor hypomineralization (MIH) in children and adolescents? Systematic review and meta-analysis.

OBJECTIVE: This systematic review was conducted to address the following research question: "What are the clinical consequences (outcome) of Molar Incisor Hypomineralization (MIH) (exposure) in children and adolescents (population/patient)?". MATERIAL AND METHODS: After defining the strategy, a search was performed in different databases (MEDLINE via Pubmed, Cochrane Library, BBO, LILACS, Scopus, Web of Science, Embase) and Grey literature in August 2023. Cross-sectional observational studies that identified clinical consequences of MIH (dental caries, post-eruptive structural loss, atypical restorations, hypersensitivity and tooth extraction) were included. The risk of bias was assessed following the Joanna Briggs Institute protocol for cross-sectional studies. Meta-analyses were conducted for each outcome, taking into account the number of patients and teeth. The effect measure considered was the prevalence; random-effects model was adopted. Heterogeneity was assessed using I2 statistics and prediction intervals (PI). RESULTS: A total of 903 studies were identified; 41 were selected for qualitative analysis and 38 for quantitative analysis. Twenty eight studies were classified as presenting uncertain risk of bias, 11 as low risk and 3 as high risk of bias. The prevalence levels, ranked from highest to lowest and considering the tooth and patient units, respectively, were: caries lesions (0.252 - 95% CI 0.158-0.375; 0.512 - 95% CI 0.385-0.639); hypersensitivity (0.286 - 95% CI 0.190-0.407; 0.417 - 95% CI 0.197-0.674), post-eruptive fracture (0.125 - 95% CI 0.099-0.158; 0.257 - 95% CI 0.145-0.412); atypical restorations (0.048 - 95% CI 0.030-0.077; 0.167 - 95% CI 0.096 - 0.274); tooth extraction (0.012 - 95% CI 0.007-0.019; 0.090 - 95% CI 0.019 - 0.331). All meta-analyses resulted in heterogeneity greater than 85%, with the exception of the outcome "tooth extraction" according to the tooth unit (I2 = 57.83). This heterogeneity may be attributed to factors such as differences in the location where the study was realized, the socioeconomic conditions of the studied population, the asymmetric nature of MIH, and patient age. CONCLUSION: The most common consequences of MIH are caries lesions, hypersensitivity, and post-eruptive breakdown. (PROSPERO:CRD42020201410).

Intake Characteristics as Predictors of Psychotherapy Outcome in a Practice Research Network in Argentina.

There are few studies exploring intake diagnostic characteristics as predictors of change in integrative naturalistic settings. The aim of this study is to explore baseline variables at the intake process and establish the predictive value of the individual trajectories of the patients. We recruited 259 patients undergoing an integrative psychotherapy network of psychotherapists from Buenos Aires, Argentina. Every therapist completed the intake form of each patient involved in the routine outcome monitoring. Thereafter step-wise regressions based on forward selection strategies were used, in order to identify meaningful baseline predictors of patients' clinical evolution, derived from the intake process. The selected predictors were social support network, subjective distress, the initial measure of clinical distress, unemployment, sociocultural status and reactance. When including those six variables in a multilevel model, the results indicate that social support network, subjective distress, and the initial measure of clinical distress were significant predictors of the trajectories of OQ-30, whereas unemployment, sociocultural status and reactance were not significant. The results regarding social support network are in line with the literature, while results of socioeconomic status (unemployment and sociocultural level) move in an opposite direction in comparison to the available evidence. Moreover, the mental health findings (initial OQ-30 and subjective distress) confirm the contradictory body of literature produced in this domain. Finally, reactance seems to be a significant predictor in previous study in contradiction of our results. Overall, this endeavor constitutes important but preliminary evidence to enhance the production of bottom-up science within practice research networks in the global south.

Malignant melanoma in Portuguese adult population: a scoping review of the real-world evidence.

PURPOSE: Malignant melanoma is an aggressive cancer, and there is a notable dearth on epidemiology, clinical and treatment characterization within the Portuguese population. We performed a scoping review to identify real-world evidence studies focused in Portuguese adult patients with malignant melanoma. METHODS: A comprehensive search was conducted. After screening, we described the studies by design, sample size, geographics, setting, population, and outcomes reported. RESULTS: The search yielded 54 studies, mainly retrospective (79.6%). The population assessed was heterogeneous varying from patients with melanoma in general to specific types of melanoma, or even more restricted to patients with specific conditions. The evidence found was mostly concerning clinical outcomes (n=46), patients' clinical profile (n=44) and demographic characterization (n=48). Treatment information was described in 30 studies whereas only 18 reported epidemiological parameters. Studies were mainly performed by the major oncology centers in Lisbon, Oporto and Coimbra, and only two evaluated the entire Portuguese population. To allow comparability, only studies including patients with cutaneous malignant melanoma were considered (13 of the 54) for outcomes evaluation analysis. Median OS varied from 18 to 36 months, assessed after melanoma treatment. Incidence was the most reported epidemiological parameter, confirming the increasing number of cutaneous malignant melanoma patients over the years. Only one study reported prevalence and four reported mortality rates. CONCLUSIONS: The evidence found confirms the lack of information about malignant melanoma in Portugal, highlighting the need of real-world studies to assess melanoma prevalence and incidence rates, current treatment approaches, and clinical characterization of these patients.

Comparison of factors associated with the evidence-practice gap as perceived by Japanese and Brazilian dentists.

OBJECTIVES: To identify 1) factors of the evidence-practice gap (EPG) in Japan and Brazil as perceived by dentists and compare these factors between two countries, and 2) mechanisms to close this EPG. METHODS: The study employed a cross-sectional design by administering a web-based questionnaire to 136 Japanese and 110 Brazilian dentists. The survey queried dentists' reports of which factors possibly cause an EPG, using a newly developed 20-item questionnaire. RESULTS: An international comparison of 20 items related to factors of the EPG between Japan and Brazil revealed that "Dentists' own experiences are sometimes given priority over evidence" and "Dentists' own thoughts are sometimes given priority over evidence" were common factors to both countries, with over 80 % agreement. In logistic regression, "Insufficient opportunity to learn about evidence in dental education at universities", "Evidence-based treatments are sometimes not covered by the dental insurance system", and "Insufficient evidence which helps dentists choose an appropriate treatment for a patient after careful consideration of his/her own background" were significantly associated with the EPG in Japan (p < 0.05). In Brazil, "Insufficient case reports in which evidence-based dentistry (EBD) is applied to clinical practice" and "Image-based information and devices used for diagnosis vary depending on individual dentists" were significantly associated with the EPG (p < 0.05). CONCLUSIONS: This study suggests that EPG could be improved in Japan: by promoting EBD education at universities, improving the dental insurance system, and accumulating evidence according to patient background; and in Brazil: by promoting EBD case reports and standardizing diagnostic information and devices. CLINICAL SIGNIFICANCE: Two factors of EPG common to Japan and Brazil, namely the prioritization of dentists' own "experiences" and "thoughts" over evidence, are urgent issues for improving EPG. In addition, it will be necessary to address the country-specific factors of EPG that were identified in this study.