RESUMEN
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.
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Medicina Basada en la Evidencia , Hemofilia A , Hemofilia B , Humanos , Coagulantes/uso terapéutico , Consenso , Medicina Basada en la Evidencia/normas , Factor VIII/uso terapéutico , Factor VIII/genética , Hemofilia A/sangre , Hemofilia A/genética , Hemofilia A/terapia , Hemofilia A/diagnóstico , Hemofilia B/sangre , Hemofilia B/terapia , Hemofilia B/diagnóstico , Hemofilia B/genética , Hemorragia/sangre , Hemostasis , Sociedades Médicas , Resultado del Tratamiento , Hematología/métodos , Hematología/normasRESUMEN
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.
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Medicina Basada en la Evidencia , Humanos , Brasil , Medicina Basada en la Evidencia/normas , Variaciones Dependientes del Observador , Femenino , Masculino , Internet , Adulto , Educación a Distancia/normas , Educación a Distancia/métodos , Reproducibilidad de los ResultadosRESUMEN
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 Guidelines" (CPG BE), for which the stages in their development 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 decisions, and they can serve a basis for the development of health policies. The preparation of CPGs represents a complex process, which requires knowledge, experience and resources, 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.
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 recomendaciones 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 consideradas como tales. Las GPC-BE son un "conjunto de recomendaciones elaboradas de forma sistemática para ayudar a los profesionales 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 recursos tanto en tiempo como en dinero. Su robustez no depende de quienes la realizan, sino de cómo es realizada. 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.
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Medicina Basada en la Evidencia , Guías de Práctica Clínica como Asunto , Humanos , Medicina Basada en la Evidencia/normasRESUMEN
Las altas tasas de letalidad y mortalidad a causa del paro cardiorespiratorio por fibrilación ventricular son considerados un problema de salud pública, cobrando gran relevancia la posibilidad de que sean revertidos rápidamente con la presencia de profesionales capacitados o por personal "lego" actualizados en reanimación cardiopulmonar. El objetivo del presente artículo de revisión fue analizar las nuevas recomendaciones de la American Heart Association para reanimación cardiopulmonar y atención cardiovascular de emergencia para el año 2020.
High rates of lethality and mortality due to ventricular fibrillation cardiorespiratory arrest are considered a public health problem, Thus, the possibility of reversed quickly by trained professionals or updated "lego" staff in cardiopulmonary resuscitation is taking great relevance. The objective of this review article was to discuss the New Recommendations of the American Heart Association for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care for 2020.
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Humanos , Recién Nacido , Niño , Adulto , Cardiología/normas , Reanimación Cardiopulmonar/normas , Servicio de Cardiología en Hospital/normas , Servicio de Urgencia en Hospital/normas , Paro Cardíaco/terapia , Factores de Riesgo , Resultado del Tratamiento , Reanimación Cardiopulmonar/efectos adversos , Medicina Basada en la Evidencia/normas , Apoyo Vital Cardíaco Avanzado/normas , American Heart Association , Paro Cardíaco/diagnóstico , Paro Cardíaco/fisiopatologíaAsunto(s)
Procedimientos Quirúrgicos Cardíacos/normas , Cardiología/normas , Recuperación Mejorada Después de la Cirugía/normas , Cardiopatías Congénitas/cirugía , Pediatría/normas , Factores de Edad , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Consenso , Técnica Delphi , Medicina Basada en la Evidencia/normas , Humanos , Recuperación de la Función , Factores de Tiempo , Resultado del TratamientoRESUMEN
The A.A.E.E.H has developed this guideline for the best care of patients with hepatocellular carcinoma (HCC) from Argentina. It was done from May 2018 to March 2020. Specific clinical research questions were systematically searched. The quality of evidence and level of recommendations were organized according to GRADE. HCC surveillance is strongly recommended with abdominal ultrasound (US) every six months in the population at risk for HCC (cirrhosis, hepatitis B or hepatitis C); it is suggested to add alpha-feto protein (AFP) levels in case of inexeperienced sonographers. Imaging diagnosis in patients at risk for HCC has high specificity and tumor biopsy is not mandatory. The Barcelona Clinic Liver Cancer algorithm is strongly recommended for HCC staging and treatment-decision processes. Liver resection is strongly recommended for patients without portal hypertension and preserved liver function. Composite models are suggested for liver transplant selection criteria. Therapies for HCC with robust clinical evidence include transarterial chemoembolization (TACE) and first to second line systemic treatment options (sorafenib, lenvatinib, regorafenib, cabozantinib and ramucirumab). Immunotherapy with nivolumab and pembrolizumab has failed to show statistical benefit but the novel combination of atezolizumab plus bevacizumab has recently shown survival benefit over sorafenib in frontline.
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Carcinoma Hepatocelular/terapia , Técnicas de Apoyo para la Decisión , Neoplasias Hepáticas/terapia , Oncología Médica/normas , Estadificación de Neoplasias/normas , Algoritmos , Argentina , Biopsia/normas , Carcinoma Hepatocelular/diagnóstico por imagen , Carcinoma Hepatocelular/mortalidad , Carcinoma Hepatocelular/patología , Toma de Decisiones Clínicas , Consenso , Medicina Basada en la Evidencia/normas , Humanos , Neoplasias Hepáticas/diagnóstico por imagen , Neoplasias Hepáticas/mortalidad , Neoplasias Hepáticas/patología , Valor Predictivo de las Pruebas , Medición de Riesgo , Factores de Riesgo , Resultado del Tratamiento , Ultrasonografía/normasRESUMEN
BACKGROUND: Medical meetings are a tool to help physicians advance and update their medical knowledge. Their quality is the responsibility of colleges and institutions. OBJECTIVE: To assess and compare the academic level of four different annual rheumatology meetings. MATERIAL AND METHODS: As a source of information, we used the abstracts published in the supplements of the journal Reumatología Clínica, SE1 Vol. 12, issued in February 2016, SE 1 Vol. 13 issued in February 2017, the electronic application of the 2016 ACR/ARHP of the 2016 American Congress of Rheumatology, devoted to the works presented at the 44th Mexican Congress of Rheumatology (CMR 44), the 45th Mexican Congress of Rheumatology (CMR 45), and the 2016 ACR/ARHP Annual Meeting (ACR 2016), as well as the Web page on the files and abstracts of EULAR 2017, respectively; from each work we compiled information on the major disease being referred to, the type of information provided and the type of report. We should point out that some were combined conditions or designs, from which we selected that which we considered to be the most important. RESULTS: In all, 275, 340, 3275 and 4129 studies were submitted to the XLIV Mexican Congress of Rheumatology, XLV Mexican Congress of Rheumatology, the 2016 ACR/ARHP Annual Meeting and EULAR 2017, respectively. Rheumatoid arthritis was the most common disorder, dealt with in 23%, 26%, 21% and 27% in CMR 44, CMR 45, 2016 ACR and EULAR 2017, respectively, followed by systemic lupus erythematosus; in third place, Mexican congresses reported trials related to systemic vasculitis, whereas spondylitis was the main subject of international congresses. In the case of rheumatoid arthritis, clinical topics accounted for 30% in the Mexican congresses and ACR, and nearly 20% in EULAR. Observational studies accounted for 40% in the Mexican congresses vs. 33% in 2016 ACR and 55% in EULAR 2017. Studies on basic science were minimal in the Mexican congress, whereas in 2016 ACR, they represented 21% and 12% in EULAR 2017. CONCLUSION: Rheumatology meetings constitute a tool to obtain adequate evidence-based medical knowledge in this important branch of medicine. For our Mexican Congress, we should encourage collaborative efforts between institutions, which will result in a greater number of controlled studies, clinical trials and basic studies that support the quality of the congress. We wish to emphasize that a greater diffusion of other musculoskeletal diseases is needed, not only autoimmune diseases, since the former represent an important percentage of the daily practice.
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Investigación Biomédica/normas , Congresos como Asunto/normas , Enfermedades Reumáticas , Reumatología/normas , Sociedades Médicas/normas , Investigación Biomédica/estadística & datos numéricos , Congresos como Asunto/estadística & datos numéricos , Europa (Continente) , Medicina Basada en la Evidencia/normas , Humanos , México , Garantía de la Calidad de Atención de Salud , Enfermedades Reumáticas/diagnóstico , Enfermedades Reumáticas/terapia , Reumatología/estadística & datos numéricos , Sociedades Médicas/estadística & datos numéricos , Estados UnidosRESUMEN
Diabetes is a major and costly health concern worldwide, with high morbidity, disability, mortality, and impaired quality of life. The vast majority of people living with diabetes have type 2 diabetes. Historically, the main strategy to reduce complications of type 2 diabetes has been intensive glycemic control. However, the body of evidence shows no meaningful benefit of intensive (compared with moderate) glycemic control for microvascular and macrovascular outcomes important to patients, with the exception of reduced rates of non-fatal myocardial infarction. Intensive glycemic control does, however, increase the risk of severe hypoglycemia and incurs additional burden by way of polypharmacy, side effects, and cost. Additionally, data from cardiovascular outcomes trials showed that cardiovascular, kidney, and mortality outcomes may be improved with use of specific classes of glucose lowering drugs largely independently of their glycemic effects. Therefore, delivering evidence based, patient centered care to people with type 2 diabetes requires a paradigm shift and departure from the predominantly glucocentric view of diabetes management. Instead of prioritizing intensive glycemic control, the focus needs to be on ensuring access to adequate diabetes care, aligning glycemic targets to patients' goals and situations, minimizing short term and long term complications, reducing the burden of treatment, and improving quality of life.
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Complicaciones de la Diabetes/prevención & control , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Hipoglucemia/epidemiología , Hipoglucemiantes/administración & dosificación , Calidad de Vida , Glucemia/análisis , Glucemia/efectos de los fármacos , Complicaciones de la Diabetes/sangre , Diabetes Mellitus Tipo 2/sangre , Diabetes Mellitus Tipo 2/complicaciones , Medicina Basada en la Evidencia/métodos , Medicina Basada en la Evidencia/normas , Humanos , Hiperglucemia/sangre , Hiperglucemia/tratamiento farmacológico , Hipoglucemia/inducido químicamente , Hipoglucemiantes/efectos adversos , Incidencia , Metaanálisis como Asunto , Atención Dirigida al Paciente/métodos , Atención Dirigida al Paciente/normas , Guías de Práctica Clínica como Asunto , Revisiones Sistemáticas como Asunto , Resultado del TratamientoRESUMEN
INTRODUCTION: This study evaluated and compared the completeness of reporting of abstracts of orthodontics systematic reviews before and after the publication of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) extension for Abstracts Checklist (PRISMA-A). METHODS: Abstracts of systematic reviews and meta-analyses in orthodontics published in PubMed, Latin American and Caribbean Health Sciences Literature, and the Cochrane Database of Systematic Reviews databases before March 23, 2018, that met the predefined inclusion and exclusion criteria, were evaluated using the 12 items of PRISMA-A, scoring each item from 0 to 2. Abstracts were classified into 2 groups: before and after publication of the PRISMA-A checklist. Three calibrated evaluators (intraclass correlation coefficient and kappa > 0.8) assessed the scores for compliance with the checklist. The number of authors, country of affiliation of the first author, performance of meta-analysis, and topic of the article were recorded. A regression analysis was performed to assess the associations between abstract characteristics and the PRISMA-A scores. RESULTS: Of 1034 abstracts evaluated, 389 were included in the analysis. The mean PRISMA-A score was 53.39 (95% CI, 51.83-54.96). The overall score for studies published after the publication of the checklist was significantly higher than for studies published before (P ≤ 0.0001). The components returning significantly higher scores after publication of PRISMA-A were title (P = 0.024), information from databases (P = 0.026), risk of bias (P ≤ 0.0001), included studies (P ≤ 0.0001), synthesis of results (P ≤ 0.0001), interpretation of results (P = 0.035), financing and conflict of interest (P ≤ 0.0001), and registration (P ≤ 0.0001). These results showed the positive effect of PRISMA-A had on the quality of reporting of orthodontics systematic reviews. Nevertheless, the poor adherence revealed that there is still need for improvement in the quality of abstract reporting. CONCLUSIONS: The quality of reporting of abstracts of orthodontic systematic reviews and meta-analyses increased after the introduction of PRISMA-A.
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Medicina Basada en la Evidencia/normas , Ortodoncia/normas , Publicaciones Periódicas como Asunto/normas , Edición/normas , Revisiones Sistemáticas como Asunto , Bibliometría , Lista de Verificación , Humanos , Control de CalidadAsunto(s)
Medicina Basada en la Evidencia/normas , Comunicación en Salud/normas , Disparidades en Atención de Salud/estadística & datos numéricos , Neoplasias/prevención & control , Región del Caribe/epidemiología , Países en Desarrollo , Etnicidad/estadística & datos numéricos , Humanos , Incidencia , Agencias Internacionales , América Latina/epidemiología , Neoplasias/epidemiología , Neoplasias/etnologíaAsunto(s)
Medicina Basada en la Evidencia/normas , Gastroenterólogos/normas , Gastroenterología/normas , Adhesión a Directriz/normas , Guías de Práctica Clínica como Asunto/normas , Pautas de la Práctica en Medicina/normas , Consenso , Conferencias de Consenso como Asunto , Técnica Delphi , Humanos , América LatinaRESUMEN
OBJECTIVES: This study aimed to provide evidence for understanding how to treat osteoarthritis (OA) in our country. Therefore, it was necessary to match information and investigations related to the treatment of the disease from the three main types of specialists involved: physiatrists, orthopedists and rheumatologists. METHODS: The authors acted as a scientific advisory committee. From the initial discussions, a structured questionnaire was developed for use with a group of specialists on OA using the Delphi technique. The questionnaire was sent to 21 experts appointed by the authors, and the results obtained were critically analyzed and validated. RESULTS: The prevalence of OA was 33% in Brazil, corresponding to one-third of the individuals in the reference population, which included individuals over 25 years of age. Another significant finding was that most patients did not receive any form of treatment in the early stages of OA. CONCLUSION: The committee pointed to the need for early intervention and that the available medicinal resources can fulfil this important role, as is the case with SYSADOA treatments. Glucosamine-based medicinal products with or without chondroitin could also fulfill this need for early treatment. The other generated evidence and included investigations were then grouped together and are the subject of this publication.
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Competencia Clínica/normas , Técnica Delphi , Medicina Basada en la Evidencia/normas , Osteoartritis/terapia , Adulto , Antiinflamatorios no Esteroideos/administración & dosificación , Brasil , Sulfatos de Condroitina/uso terapéutico , Consenso , Quimioterapia Combinada , Femenino , Glucosamina/uso terapéutico , Humanos , Masculino , Persona de Mediana Edad , Ortopedia/normas , Osteoartritis/tratamiento farmacológico , Osteoartritis de la Rodilla/terapia , Medicina Física y Rehabilitación/normas , Guías de Práctica Clínica como Asunto , Reumatología/normas , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
OBJECTIVE: To assist clinicians to make adequate interpretation of scientific evidence from studies that evaluate diagnostic tests in order to allow their rational use in clinical practice. METHODS: This is a narrative review focused on the main concepts, study designs, the adequate interpretation of the diagnostic accuracy data, and making inferences about the impact of diagnostic testing in clinical practice. RESULTS: Most of the literature that evaluates the performance of diagnostic tests uses cross-sectional design. Randomized clinical trials, in which diagnostic strategies are compared, are scarce. Cross-sectional studies measure diagnostic accuracy outcomes that are considered indirect and insufficient to define the real benefit for patients. Among the accuracy outcomes, the positive and negative likelihood ratios are the most useful for clinical management. Variations in the study's cross-sectional design, which may add bias to the results, as well as other domains that contribute to decreasing the reliability of the findings, are discussed, as well as how to extrapolate such accuracy findings on impact and consequences considered important for the patient. Aspects of costs, time to obtain results, patients' preferences and values should preferably be considered in decision making. CONCLUSION: Knowing the methodology of diagnostic accuracy studies is fundamental, but not sufficient, for the rational use of diagnostic tests. There is a need to balance the desirable and undesirable consequences of tests results for the patients in order to favor a rational decision-making approach about which tests should be recommended in clinical practice.