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.

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.

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.

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.

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.

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.

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).

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.

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.

Necrotizing sialometaplasia: systematic review and meta analyses over the past 46 years

Objectives: The aim of this study was to characterize the main characteristics of this disease in relation to diagnosis, clinical aspects, progression and treatment as well as correlating them with remission time. Material and Methods: A systematic search was performed following the guidelines given by PRISMA and the Joanna Briggs Institute. PubMed, Web of Science and Scopus were the databases used. Results: The final analysis resulted in 108 articles with 173 clinical cases. The longest remission time for signs and symptoms (>7 weeks) was registered among male patients (p = 0.02) and outside the oral cavity; however no significant correlation was observed (p>0.05). A high risk of bias was the most common rating among the articles analyzed (55%); followed by moderate (27%) and low (18%). The lack of standardization in clinical case report descriptions made it difficult to gain a thorough knowledge of the essential characteristics of the NS patho-logical processes. Conclusion: It is recommended that publications follow the standards recommended by the literature; in addition, studies using advanced technologies to better understand NS's pathological path are recommended so as to propose effective treatments for this disease. (AU)

Nonpharmacological Interventions for Treating Breastfeeding Nipple Pain: Systematic Review and Meta-Analysis.

Objective: To evaluate the efficacy and safety of nonpharmacological topical interventions for treating breastfeeding nipple pain. Methods: Randomized clinical trials (RCTs) assessing lactating women suffering from breastfeeding painful nipples were included. Primary outcomes were pain, healing process, and adverse events. A comprehensive search was conducted on June 02, 2023, without date or language restrictions. Methodological quality was assessed using the Cochrane risk of bias tool and the certainty of the evidence, the GRADE approach. Results: Nineteen RCTs with unclear to high risk of bias were included. There was uncertain evidence regarding the effects of photobiomodulation versus placebo on pain reduction (mean difference [MD] -0.15; 95% confidence interval [95% CI] -1 0.49 to 1.19; 139 participants, 2 RCTs). There are uncertainties concerning the effects of lanolin versus breast milk on pain (MD -1.80; 95% CI -2.43 to -1.17; 1 RCT; 180 participants), wound healing (MD 0.10; 95% CI -0.26 to -0.46; 1 RCT; 180 participants), and any adverse events (zero events in both groups). Similar effects were observed by the other interventions assessed. Conclusion: The evidence of nonpharmacological topical interventions for painful nipples is imprecise, and future RCTs with higher methodological quality are needed to support recommendations. Considering the accessibility and low cost of these alternative treatments, the findings of this evidence synthesis could support clinical decision-making and guide future research. PROSPERO CRD42020170320.

Effect of laser-microtextured abutments on peri-implant outcomes: a systematic review and meta-analysis.

OBJECTIVES: To evaluate the potential of laser-microtextured abutments (LMAs) compared to machined abutments (MAs) in peri-implant clinical and radiographic outcomes. MATERIALS AND METHODS: Eligible studies consisted of randomized clinical trials (RCTs) retrieved from MEDLINE, Web of Science, Scopus, and Embase databases. The study adhered to the PRISMA statement, and the protocol was registered at the PROSPERO (registration number CRD42023443112). The risk of bias was evaluated according to version 2 of the Cochrane risk of bias tool (RoB 2). Meta-analyses were performed using random effect models. Afterward, the GRADE approach was used to determine the certainty of evidence. RESULTS: Four RCTs were included from a total of 2,876 studies. LMAs had lower peri-implant sulcus depth at 6-8 weeks (WMD: -0.69 mm; 95% CI: -0.97, -0.40; p = 0.15, I2 = 53%) and at one year (WMD: -0.75 mm; 95% CI: -1.41, -0.09; p = 0.09, I2 = 65%), but the certainty of evidence was low. In addition, the marginal bone loss favored the LMAs group (WMD: -0.29 mm; 95% CI: -0.36, -0.21; p = 0.69, I2 = 0%) with moderate evidence. There were fewer sites with bleeding on probing in the LMAs group (WMD: -1.10; 95% CI: -1.43, -0.77; p = 0.88, i2 = 0%). There was no statistical difference between groups for the modified gingival index and modified plaque index. Furthermore, all studies were classified as having some concerns risk of bias. CONCLUSIONS: There was low to moderate certainty evidence that LMAs can favor peri-implant clinical and radiographic parameters compared to MAs. CLINICAL RELEVANCE: Laser-microtextured abutments may benefit peri-implant clinical and radiographic outcomes.

Clinical guidelines for herpes labialis: recommendations and quality evaluation according to AGREE II.

Cold sores require Healthcare professionals to employ specific approaches for prevention and management, with the need for effective therapeutic guidelines and ongoing improvement in patient care. AIM: To evalúate the methodological quality of Clinical Guidelines (CG), clinical guides and manuals for care of the population affected by herpes labialis, to verify their compliance with evidence-based health standards. MATERIALS AND METHOD: A search was conducted for CG on labial herpes in the MedicalLiteratureAnalysis andRetrieval System Online (Medline) database, Google Scholar, Brazilian Virtual Health Library (BVS), and sites of institutions/professional categories, using the descriptors "herpes labialis" or "oral herpes". Document quality was assessed using the Appraisal of Guidelines for Research & Evaluation Instrument (AGREE II). The Kappa test was used to avoid randomness or poor agreement between results. RESULTS: Analysis of the 12 selected publications on the management of labial herpes revealed flaws in quality, as the publications did not follow a quality standard. The main quality flaws identified were in "rigor in development" and "applicability. ". CONCLUSIONS: Priorities need to be redefined in the development of CG for clinical practice related to fever blisters to reduce the variability of the quality standard, and generate reliable, applicable recommendations.

A Herpes labial requer dos profissionais abordagens específicas para prevenido e manejo, com a ne-cessidade de diretrizes terapéuticas eficazes e continuo aprimoramento do cuidado ao paciente. OBJETIVO: avaliar a qualidade metodológica de documentos que abordaram Diretrizes Clínicas (DC), guias clínicos e manuais para o cuidado da populando afetada pelo herpes labial, verificando sua conformidade com padroes de saúde baseados em evidencias. MATERIAIS E MÉTODO: As DC sobre herpes labial foram pesquisadas na base de dados Medical Literature Analysis and Retrieval System Online (Medline), Google Académico, Biblioteca Virtual em Saúde (BVS) e em sites de instituigoes/categorias profissionais, utilizando os descritores "herpes labial" ou "herpes oral". Utilizamos aferramenta The Appraisal of Guidelines for Research & Evaluation Instrument (AGREE II) para a avaliagdo da qualidade. O teste Kappa também foi utilizado para evitar aleatoriedade ou baixa concordáncia entre os resultados. RESULTADOS: Na análise das 12 publicagoes selecionadas sobre o manejo do herpes labial, foram identificadas falhas na qualidade dos documentos, que ndo seguiram um padrdo de qualidade. As principais falhas de qualidade identificadas foram em "rigor no desenvolvimento" e "aplicabilida-de". CONCLUSÃO: é necessário um reenfoque para definir prioridades no desenvolvimento de DC para a prática clínica do herpes labial, a fim de reduzir a variabilidade do padrdo de qualidade e gerar recomendagoes que possam ser confiáveis e aplicáveis.

The impact of an online course on agreement rates of the certainty of evidence assessment using Grading of Recommendations, Assessment, Development, and Evaluation Approach: a before-and-after study.

BACKGROUND AND OBJECTIVE: The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach is a systematic method for assessing the certainty of evidence (CoE) and strength of recommendations in health care. We aimed to verify the effects of an online-based GRADE course on multirater consistency in the evaluation of the CoE in systematic reviews (SRs) analysis. STUDY DESIGN AND SETTINGS: Sixty-five Brazilian methodologists and researchers participated in an online course over 8 weeks. Asynchronous lessons and weekly synchronous meetings addressed the GRADE system in the context of CoE assessment. We asked participants to evaluate the CoE of random SRs (two before and another two after the course). Analyzes focused on the multirater agreement with a standard response, in the interrater agreement, and before-after changes in the proportion of participants that rated down the domains. RESULTS: 48 individuals completed the course. Participants presented improvements in the raters' assessment of the CoE using the GRADE approach after the course. The multirater consistency of indirectness, imprecision, and the overall CoE increased after the course, as well as the agreement between raters and the standard response. Furthermore, interrater reliability increased for risk of bias, inconsistency, indirectness, publication bias, and overall CoE, indicating progress in between-raters consistency. After the course, approximately 78% of individuals rated down the overall CoE to a low/very low degree, and participants presented more explanations for the judgment of each domain. CONCLUSION: An online GRADE course improved the consistency and agreement of the CoE assessment by Brazilian researchers. Online training courses have the potential to improve skills in guideline methodology development.

Efficiency and comparability of using new evidence platforms for updating recommendations: Experience with a type-2 diabetes guideline in Colombia.

Introduction: Updating recommendations for guidelines requires a comprehensive and efficient literature search. Although new information platforms are available for developing groups, their relative contributions to this purpose remain uncertain. Methods: As part of a review/update of eight selected evidence-based recommendationsfor type 2 diabetes, we evaluated the following five literature search approaches (targeting systematic reviews, using predetermined criteria): PubMed for MEDLINE, Epistemonikos database basic search, Epistemonikos database using a structured search strategy, Living overview of evidence (L.OVE) platform, and TRIP database. Three reviewers independently classified the retrieved references as definitely eligible, probably eligible, or not eligible. Those falling in the same "definitely" categories for all reviewers were labelled as "true" positives/negatives. The rest went to re-assessment and if found eligible/not eligible by consensus became "false" negatives/positives, respectively. We described the yield for each approach and computed "diagnostic accuracy" measures and agreement statistics. Results: Altogether, the five approaches identified 318 to 505 references for the eight recommendations, from which reviewers considered 4.2 to 9.4% eligible after the two rounds. While Pubmed outperformed the other approaches (diagnostic odds ratio 12.5 versus 2.6 to 5.3), no single search approach returned eligible references for all recommendations. Individually, searches found up to 40% of all eligible references (n = 71), and no combination of any three approaches could find over 80% of them. Kappa statistics for retrieval between searches were very poor (9 out of 10 paired comparisons did not surpass the chance-expected agreement). Conclusion: Among the information platforms assessed, PubMed appeared to be more efficient in updating this set of recommendations. However, the very poor agreement among search approaches in the reference yield demands that developing groups add information from several (probably more than three) sources for this purpose. Further research is needed to replicate our findings and enhance our understanding of how to efficiently update recommendations.

Introducción: La actualización de recomendaciones de las guías de práctica clínica requiere búsquedas bibliográficas exhaustivas y eficientes. Aunque están disponibles nuevas plataformas de información para grupos desarrolladores, su contribución a este propósito sigue siendo incierta. Métodos: Como parte de una revisión/actualización de 8 recomendaciones basadas en evidencia seleccionadas sobre diabetes tipo 2, evaluamos las siguientes cinco aproximaciones de búsqueda bibliográfica (dirigidas a revisiones sistemáticas, utilizando criterios predeterminados): PubMed para MEDLINE; Epistemonikos utilizando una búsqueda básica; Epistemonikos utilizando una estrategia de búsqueda estructurada; plataforma (L.OVE) y TRIP . Tres revisores clasificaron de forma independiente las referencias recuperadas como definitivamente o probablemente elegibles/no elegibles. Aquellas clasificadas en las mismas categorías "definitivas" para todos los revisores, se etiquetaron como "verdaderas" positivas/negativas. El resto se sometieron a una nueva evaluación y, si se consideraban por consenso elegibles/no elegibles, se convirtieron en "falsos" negativos/positivos, respectivamente. Describimos el rendimiento de cada aproximación, junto a sus medidas de "precisión diagnóstica" y las estadísticas de acuerdo. Resultados: En conjunto, las cinco aproximaciones identificaron 318-505 referencias para las 8 recomendaciones, de las cuales los revisores consideraron elegibles el 4,2 a 9,4% tras las dos rondas. Mientras que Pubmed superó a las otras aproximaciones (odds ratio de diagnóstico 12,5 versus 2,6 a 53), ninguna aproximación de búsqueda identificó por sí misma referencias elegibles para todas las recomendaciones. Individualmente, las búsquedas identificaron hasta el 40% de todas las referencias elegibles (n=71), y ninguna combinación de cualquiera de los tres enfoques pudo identificar más del 80% de ellas. Las estadísticas Kappa para la recuperación entre búsquedas fueron muy pobres (9 de cada 10 comparaciones pareadas no superaron el acuerdo esperado por azar). Conclusiones: Entre las plataformas de información evaluadas, Pubmed parece ser la más eficiente para actualizar este conjunto de recomendaciones. Sin embargo, la escasa concordancia en el rendimiento de las referencias exige que los grupos desarrolladores incorporen información de varias fuentes (probablemente más de tres) para este fin. Es necesario seguir investigando para replicar nuestros hallazgos y mejorar nuestra comprensión de cómo actualizar recomendaciones de forma eficiente.

¿Qué condiciones deben reunir las guías de diagnóstico y tratamiento para ser verdaderas guías de práctica clinica basadas en la evidencia? / What conditions should the diagnosis and treatment guidelines meet, to be true clinical practice guidelines based on evidence?

Resumen Las guías de diagnóstico y tratamiento elaboradas por las sociedades científicas médicas, constituyen una herramienta muy útil para el ejercicio profesional de la especialidad. Sustentadas en bibliografía actualizada, representan un material de enorme valor con reco mendaciones de los expertos en los diversos temas de la especialidad. En el presente artículo se intenta determinar si las mismas podrían ser diseñadas acercándolas lo más estrechamente posible al formato de las Guías de Práctica Clínica Basadas en la Evidencia (GPC-BE), para lo cual se revisan las etapas en su elaboración y los requisitos que deberían cumplir para ser conside radas como tales. Las GPC-BE son un "conjunto de recomendaciones elaboradas de forma sistemática para ayudar a los profe sionales y a los pacientes en la toma de decisiones sobre la atención sanitaria más apropiada, seleccionando las opciones diagnósticas y/o terapéuticas más adecuadas en el abordaje de un problema de salud o una condición clínica específica". Su objetivo es mejorar la efectividad, la eficiencia y la seguridad de las decisiones clínicas, y pueden servir de base para la elaboración de políticas de salud. La elaboración de las GPC representa un proceso complejo, que requiere conocimientos, experiencia y re cursos tanto en tiempo como en dinero. Su robustez no depende de quienes la realizan, sino de cómo es realiza da. Ello implica la participación de técnicos que aporten la evaluación de la evidencia por el método GRADE, y la consideración de aspectos de costo-efectividad.

Abstract The guides for diagnosis and treatment prepared by scientific medical societies constitute a very useful tool for the professional practice of the specialty. Supported by an updated bibliography, they represent material of enormous value with recommendations from experts on the various topics of the specialty. This article attempts to determine if they could be designed as "Evidence - Based Clinical Practice Guide lines" (CPG BE), for which the stages in their develop ment and the requirements that they reviewed. The CPG BE are a "set of recommendations prepared systematically to help professionals and patients in making decisions about the most appropriate health care, selecting the most appropriate diagnostic and/or therapeutic options to address a problem of health or a specific clinical condition". Their objective is to improve the effectiveness, efficiency and safety of clinical deci sions, and they can serve a basis for the development of health policies. The preparation of CPGs represents a complex pro cess, which requires knowledge, experience and re sources, both in time and money. Its robustness does not depend on who does it, but on how it is done. This implies the participation of technicians who provide the evaluation of the evidence using the GRADE method and the consideration of cost-effectiveness aspects.

Consideraciones bioéticas en el manejo de la esclerosis lateral amiotrófica: Una aproximación al quehacer fonoaudiológico

Introducción: La esclerosis lateral amiotrófica (ELA) es la forma más común de enfermedad degenerativa de motoneurona en la edad adulta y es considerada una enfermedad terminal. Por lo mismo, el accionar del fonoaudiólogo debe considerar el respeto a los principios bioéticos básicos para garantizar una asistencia adecuada. Objetivo: Conocer aquellas consideraciones bioéticas relacionadas al manejo y estudio de personas con ELA para luego brindar una aproximación hacia el quehacer fonoaudiológico. Método: Se efectuó una búsqueda bibliográfica en las bases de datos PubMed, Scopus y SciELO. Se filtraron artículos publicados desde 2000 hasta junio de 2023 y fueron seleccionados aquellos que abordaban algún componente bioético en población con ELA. Resultados: Aspectos relacionados al uso del consentimiento informado y a la toma de decisiones compartidas destacaron como elementos esenciales para apoyar la autonomía de las personas. Conclusión: Una correcta comunicación y una toma de decisiones compartida son claves para respetar la autonomía de las personas. A su vez, la estandarización de procedimientos mediante la investigación clínica permitirá aportar al cumplimiento de los principios bioéticos de beneficencia y no maleficencia, indispensables para la práctica profesional.

Introduction: Amyotrophic lateral sclerosis (ALS) is the most common form of degenerative motor neuron disease in adulthood and is considered a terminal disease. For this reason, the actions of the speech therapist must consider respect for basic bioethical principles to guarantee adequate assistance. Objective: To know those bioethical considerations related to the management and study of people with ALS to then provide an approach to speech therapy. Methodology: A bibliographic search was carried out in the PubMed, Scopus, and SciELO databases. Articles published from 2000 to June 2023 were filtered and those that addressed a bioethical component in the population with ALS were selected. Results: Aspects related to the use of informed consent and shared decision-making stood out as essential elements to support people's autonomy. Conclusion: Proper communication and shared decision-making are key to respecting people's autonomy. In turn, the standardization of procedures through clinical research will contribute to compliance with the bioethical principles of beneficence and non-maleficence, essential for professional practice.

Outcomes of a Community of Practice on Quebec Speech Language Pathologists' Voice Assessment Practices and Professional Identity

In a context where different protocols for recommended practices in clinical voice assessment exist, while there are gaps in the literature regarding the evidence base supporting assessment procedures and measures, clinicians from regions where a strong community holding expertise in clinical and scientific voice practices lack can struggle to confidently develop their voice assessment practices. In an effort to improve voice assessment practices and strengthen professional identity among speech-language pathologists in Quebec, Canada, a community of practice (CoP) was established, with the aim of promoting knowledge sharing, implementing change in clinical practice, and improving professional identity. Thirty-nine participants took part in the CoP activities conducted over a four-month period, including virtual meetings and in-person workshops. Participants had a high rate of attendance (> 74% participation rate in virtual meetings), and were highly satisfied with their participation and intended to remain involved after the project's end. Statistically significant changes in voice assessment practices were observed post-CoP, regarding probability of performing assessments (p < .001), and perceived importance of assessment for evaluative purposes (p <.001), as well as improvements in assessment specific confidence, specifically for procedure of auditory-perceptual assessment (p < .001) and purpose of aerodynamic assessment (p = .05). Moreover, there was an increase in professional identity post-CoP (p < .001) and participants felt they made significant learnings. The present study highlighted the need to involve SLPs in future research to identify assessments that are relevant to the specific evaluative objectives of SLPs working with voice, and suggests CoPs are an efficient tool for that purpose.

En un contexto en el que existen diferentes protocolos para las prácticas recomendadas en la evaluación vocal clínica, y en el que se presentan vacíos en la literatura respecto a la base de evidencia que respalda los procedimientos y medidas de evaluación, los profesionales de regiones donde no hay una comunidad sólida con experiencia en prácticas vocales clínicas y científicas pueden enfrentar dificultades para desarrollar con confianza sus prácticas de evaluación vocal. Con el propósito de mejorar las prácticas de evaluación vocal y fortalecer la identidad profesional entre los logopedas de Quebec, Canadá, se estableció una comunidad de práctica (CdP). Esta tenía como objetivo fomentar el intercambio de conocimientos, implementar cambios en la práctica clínica y mejorar la identidad profesional. Un total de treinta y nueve participantes se involucraron en las actividades de la CdP, llevadas a cabo durante un período de cuatro meses, que incluyeron reuniones virtuales y talleres presenciales. Los participantes tuvieron una alta tasa de asistencia (> 74% de participación en las reuniones virtuales) y expresaron un alto grado de satisfacción con su participación, manifestando su intención de continuar involucrados después de la finalización del proyecto. Se observaron cambios estadísticamente significativos en las prácticas de evaluación vocal posterior a la CdP, en lo que respecta a la probabilidad de llevar a cabo evaluaciones (p < .001) y la percepción de la importancia de la evaluación con fines evaluativos (p < .001), así como mejoras en la confianza específica en la evaluación, particularmente en el procedimiento de evaluación auditivo-perceptual (p < .001) y el propósito de la evaluación aerodinámica (p = .05). Además, se registró un aumento en la identidad profesional posterior a la CdP (p < .001) y los participantes sintieron que obtuvieron aprendizajes significativos. El presente estudio destacó la necesidad de involucrar a los logopedas en investigaciones futuras, para identificar evaluaciones pertinentes a los objetivos evaluativos específicos de los logopedas que trabajan con la voz, y sugiere que las CdP son una herramienta eficiente con ese propósito.

Efficiency and comparability of using new evidence platforms for updating recommendations: experience with a type-2 diabetes guideline in Colombia / Eficiencia y comparabilidad del uso de nuevas plataformas de evidencia para la actualización de recomendaciones: experiencia con una guía de diabetes tipo 2 en Colombia

INTRODUCTION: Updating recommendations for guidelines requires a comprehensive and efficient literature search. Although new information platforms are available for developing groups, their relative contributions to this purpose remain uncertain. METHODS: As part of a review/update of eight selected evidence-based recommendationsfor type 2 diabetes, we evaluated the following five literature search approaches (targeting systematic reviews, using predetermined criteria): PubMed for MEDLINE, Epistemonikos database basic search, Epistemonikos database using a structured search strategy, Living overview of evidence (L.OVE) platform, and TRIP database. Three reviewers independently classified the retrieved references as definitely eligible, probably eligible, or not eligible. Those falling in the same "definitely" categories for all reviewers were labelled as "true" positives/negatives. The rest went to re-assessment and if found eligible/not eligible by consensus became "false" negatives/positives, respectively. We described the yield for each approach and computed "diagnostic accuracy" measures and agreement statistics. RESULTS: Altogether, the five approaches identified 318 to 505 references for the eight recommendations, from which reviewers considered 4.2 to 9.4% eligible after the two rounds. While Pubmed outperformed the other approaches (diagnostic odds ratio 12.5 versus 2.6 to 5.3), no single search approach returned eligible references for all recommendations. Individually, searches found up to 40% of all eligible references (n = 71), and no combination of any three approaches could find over 80% of them. Kappa statistics for retrieval between searches were very poor (9 out of 10 paired comparisons did not surpass the chance-expected agreement). CONCLUSION: Among the information platforms assessed, PubMed appeared to be more efficient in updating this set of recommendations. However, the very poor agreement among search approaches in the reference yield demands that developing groups add information from several (probably more than three) sources for this purpose. Further research is needed to replicate our findings and enhance our understanding of how to efficiently update recommendations.

INTRODUCCIÓN: La actualización de recomendaciones de las guías de práctica clínica requiere búsquedas bibliográficas exhaustivas y eficientes. Aunque están disponibles nuevas plataformas de información para grupos desarrolladores, su contribución a este propósito sigue siendo incierta. MÉTODOS: Como parte de una revisión/actualización de 8 recomendaciones basadas en evidencia seleccionadas sobre diabetes tipo 2, evaluamos las siguientes cinco aproximaciones de búsqueda bibliográfica (dirigidas a revisiones sistemáticas, utilizando criterios predeterminados): PubMed para MEDLINE; Epistemonikos utilizando una búsqueda básica; Epistemonikos utilizando una estrategia de búsqueda estructurada; plataforma (L.OVE) y TRIP . Tres revisores clasificaron de forma independiente las referencias recuperadas como definitivamente o probablemente elegibles/no elegibles. Aquellas clasificadas en las mismas categorías "definitivas" para todos los revisores, se etiquetaron como "verdaderas" positivas/negativas. El resto se sometieron a una nueva evaluación y, si se consideraban por consenso elegibles/no elegibles, se convirtieron en "falsos" negativos/positivos, respectivamente. Describimos el rendimiento de cada aproximación, junto a sus medidas de "precisión diagnóstica" y las estadísticas de acuerdo. RESULTADOS: En conjunto, las cinco aproximaciones identificaron 318-505 referencias para las 8 recomendaciones, de las cuales los revisores consideraron elegibles el 4,2 a 9,4% tras las dos rondas. Mientras que Pubmed superó a las otras aproximaciones (odds ratio de diagnóstico 12,5 versus 2,6 a 53), ninguna aproximación de búsqueda identificó por sí misma referencias elegibles para todas las recomendaciones. Individualmente, las búsquedas identificaron hasta el 40% de todas las referencias elegibles (n=71), y ninguna combinación de cualquiera de los tres enfoques pudo identificar más del 80% de ellas. Las estadísticas Kappa para la recuperación entre búsquedas fueron muy pobres (9 de cada 10 comparaciones pareadas no superaron el acuerdo esperado por azar). CONCLUSIONES: Entre las plataformas de información evaluadas, Pubmed parece ser la más eficiente para actualizar este conjunto de recomendaciones. Sin embargo, la escasa concordancia en el rendimiento de las referencias exige que los grupos desarrolladores incorporen información de varias fuentes (probablemente más de tres) para este fin. Es necesario seguir investigando para replicar nuestros hallazgos y mejorar nuestra comprensión de cómo actualizar recomendaciones de forma eficiente.