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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.
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Ciência da Implementação , Guias de Prática Clínica como Assunto , Humanos , Guias de Prática Clínica como Assunto/normas , Fidelidade a DiretrizesRESUMO
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 Baseada em Evidências , Hemofilia A , Hemofilia B , Humanos , Coagulantes/uso terapêutico , Consenso , Medicina Baseada em Evidências/normas , Fator VIII/uso terapêutico , Fator VIII/genética , Hemofilia A/sangue , Hemofilia A/genética , Hemofilia A/terapia , Hemofilia A/diagnóstico , Hemofilia B/sangue , Hemofilia B/terapia , Hemofilia B/diagnóstico , Hemofilia B/genética , Hemorragia/sangue , Hemostasia , Sociedades Médicas , Resultado do Tratamento , Hematologia/métodos , Hematologia/normasRESUMO
PURPOSE: Pulmonary arterial hypertension (PAH) is a progressive disease with a poor prognosis, and its management should be grounded in well-developed clinical practice guidelines (CPG). Thus, we critically assess the methodological quality of the available CPG for pharmacological treatments for PAH. METHODS: A systematic review (CRD42023387168) was performed in PubMed, Cochrane, Embase, and Tripdatabase (Jan-2023). Eligible records were appraised by four reviewers using the Appraisal of Guidelines, Research, and Evaluation Collaboration tool (AGREE II) and the complementary tool for assessing recommendations' quality and certainty, AGREE REX. Descriptive statistics were used to summarize the data. RESULTS: Overall, 31 guidelines, mainly authored by professional societies (90%), targeting only physicians as primary users (84%), were identified. Guidelines presented a moderate overall quality (scores of 63% and 51% in AGREE II and AGREE REX, respectively), with a few domains showing slight improvements over the years. AGREE II "Scope and Purpose" (94%) and "Presentation Clarity" (99%) domains obtained the highest scores. The items related to "Stakeholder involvement," "Editorial independence," and "Clinical applicability" (AGREE REX) were fairly reported. Conversely, CPG lacks rigor in development (32% score, AGREE II), scarcely discusses the role of stakeholders, and provides deficient data on the implementation of recommendations (scores of 35% and 46% in AGREE II and AGREE REX, respectively). No differences in the quality of guidelines published by different developers or countries were observed (p > 0.05). CONCLUSION: Methodological weaknesses are common among guidelines addressing PAH treatment, especially regarding scientific rigor, stakeholders' values and preferences, and facilitators and barriers to implementability. Particular attention should be given to developing future guidelines.
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INTRODUCTION: These guidelines aim to provide evidence-based recommendations for the supplementation of Vitamin D in maintaining bone health. An unmet need persists in Latin American regarding the availability of clinical and real-world data for rationalizing the use of vitamin D supplementation. The objective of these guidelines is to establish clear and practical recommendations for healthcare practitioners from Latin American countries to address Vitamin D insufficiency in clinical practice. METHODS: The guidelines were developed according to the GRADE-ADOLOPMENT methodology for the adaptation or adoption of CPGs or evidence-based recommendations. A search for high quality CPGs was complemented through a comprehensive review of recent literature, including randomized controlled trials, observational studies, and systematic reviews evaluating the effects of Vitamin D supplementation on bone health. The evidence to decision framework proposed by the GRADE Working Group was implemented by a panel of experts in endocrinology, bone health, and clinical research. RESULTS: The guidelines recommend Vitamin D supplementation for individuals aged 18 and above, considering various populations, including healthy adults, individuals with osteopenia, osteoporosis patients, and institutionalized older adults. These recommendations offer dosing regimens depending on an individualized treatment plan, and monitoring intervals of serum 25-hydroxyvitamin D levels and adjustments based on individual results. DISCUSSION: The guidelines highlight the role of Vitamin D in bone health and propose a standardized approach for healthcare practitioners to address Vitamin D insufficiency across Latin America. The panel underscored the necessity for generating local data and stressed the importance of considering regional geography, social dynamics, and cultural specificities when implementing these guidelines.
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Suplementos Nutricionais , Osteoporose , Deficiência de Vitamina D , Vitamina D , Humanos , Vitamina D/uso terapêutico , Vitamina D/administração & dosagem , América Latina , Deficiência de Vitamina D/tratamento farmacológico , Deficiência de Vitamina D/prevenção & controle , Osteoporose/tratamento farmacológico , Osteoporose/prevenção & controle , Adulto , Idoso , Feminino , MasculinoRESUMO
Objetivo: Realizar una síntesis comparativa sobre las guías de control prenatal en países hispanohablantes de Latinoamérica. Métodos: Se seleccionaron las guías de atención prenatal más actualizadas de cada país latinoamericano y se expusieron sus criterios en un cuadro comparativo. Resultados: Se evidenció que la mayoría de las guías de control prenatal comparten criterios guiados por las recomendaciones dadas por la Organización Mundial de la Salud (OMS). Sin embargo, existen diferencias que dependen del riesgo epidemiológico o de exposición que se presente en cada país. Conclusión: A través de esta investigación, se ha reafirmado que el control prenatal desempeña un papel crucial en la promoción de la salud materno-fetal, permitiendo detectar y abordar de manera temprana factores de riesgo, así como proporcionar la atención y seguimiento adecuados durante el embarazo(AU)
Objective: To perform a comparative synthesis of prenatal care guidelines in Spanish-speaking countries of Latin America. Methods: The most up-to-date prenatal care guidelines from each Latin American country were selected, and their criteria were presented in a comparative table. Results: It was evident that the majority of prenatal care guidelines share criteria guided by recommendations from the World Health Organization (WHO). However, there are differences that depend on the epidemiological risk or exposure present in each country. Conclusion: Through this research, it has been reaffirmed that prenatal care plays a crucial role in promoting maternalfetal health by allowing the early detection and management of risk factors, as well as providing adequate care and monitoring during pregnancy(AU)
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Humanos , Feminino , Gravidez , Recém-Nascido , Lactente , Cuidado Pré-Natal , Estudo Comparativo , Pessoal de Saúde , Guias de Prática Clínica como Assunto , Promoção da Saúde , Complicações na Gravidez , Organização Mundial da Saúde , Mortalidade Infantil , Mortalidade Materna , América LatinaRESUMO
Objective: Conduct an analysis to determine the existence and updating of national essential medicines lists (EMLs) and clinical practice guidelines (CPGs) for the treatment of diabetes in Latin America and the Caribbean (LAC); and compare the medicines included in each country's list and guidelines both with each other and with those of the World Health Organization (WHO). Methods: Cross-sectional study. EMLs and CPGs for diabetes were found on the websites of the Pan American Health Organization and national health authorities. Medicines were noted and analyzed according to pharmacological group, based on the fourth level of nomenclature of the Anatomical Therapeutic Chemical (ATC) classification system. F1 scoring was used to assess the proximity of EMLs to the WHO Model List of Essential Medicines (MLEM). Results: Of the total number of countries, 87.2% have EMLs, and 91% have CPGs (78% and 45% updated in the last five years, respectively). Compared to the six hypoglycemic groups of the MLEM, the EMLs had a median (range) of 6 (4-13) and an F1 score of 0.80; This indicates proper alignment. CPGs had a median (range) of 12 (1-12) hypoglycemic drugs compared to eight in the WHO guidelines. CPGs had a median of 15 more drugs than their respective EMLs. Conclusions: While most LAC countries have EMLs and CPGs for diabetes, the lack of concordance among them limits their effectiveness. It is necessary to align the processes and criteria for the development of these two tools for policymaking on medicines.
Objetivos: Analisar a existência e a atualização das listas nacionais de medicamentos (LNMs) e guias de prática clínica (GPCs) para o tratamento do diabetes na América Latina e no Caribe (ALC). Comparar os medicamentos incluídos nas listas e nas diretrizes de cada país entre si e com as da Organização Mundial da Saúde (OMS). Métodos: Estudo transversal. Foram identificadas LMNs e GPCs para o diabetes nos sites da Organização Pan-Americana da Saúde e das autoridades sanitárias nacionais. Os medicamentos foram pesquisados e analisados por grupo farmacológico de acordo com o quarto nível da classificação ATC. A pontuação F1 foi utilizada para avaliar o grau de proximidade das LMNs com a lista-modelo de medicamentos essenciais (LMME) da OMS. Resultados: Do total de países, 87,2% dispõem de uma LNM e 91%, de GPCs (78% e 45%, respectivamente, atualizadas nos últimos 5 anos). Em comparação com os seis grupos de agentes hipoglicemiantes da LMME, as LMNs tinham uma mediana (intervalo) de 6 (4 a 13) e uma pontuação F1 de 0,80, o que indica uma conformidade adequada. As GPCs tinham uma mediana (intervalo) de 12 (1 a 12) agentes hipoglicemiantes, em comparação com 8 nos guias da OMS. As GPCs tinham uma mediana de 15 medicamentos a mais do que as respectivas LNMs. Conclusões: Embora a maioria dos países da América Latina e do Caribe disponha de LNMs e GPCs para o diabetes, a falta de concordância entre elas limita sua eficácia. É necessário alinhar os processos e os critérios de desenvolvimento dessas duas ferramentas da política de medicamentos.
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Background: The safety of direct-to-consumer telemedicine (TM) is closely related to red flag detection and correct referrals. The adherence to referral criteria from current guidelines is not well quantified. Objective: To analyze the emergency department (ED) referral rate and adherence to referral guidelines in TM encounters of acutely ill patients calling a center that adopts stewardship protocols. Methods: This is a retrospective observational unicentric study, between March 2020 and March 2022, with patients who spontaneously sought direct-to-consumer urgent virtual medical assistance. A video-based teleconsultation was provided immediately after connection. Physicians managed situations according to their clinical judgment. Current guidelines, containing specific guidance for referral if red flags were identified, were available for consultation. Physicians' semiannual performance feedback was carried out. We analyzed the patterns for referral to immediate face-to-face medical evaluation and the agreement degree with the institutional guidelines. Results: A total of 232,197 patients were available, and 14,051 (6.05%) patients were referred to ED. A total of 8,829 (68.4%) referrals were based in specific guidelines according to the International Classification of Diseases hypothesis, and 8,708 (98.6%) were justified according to guidelines. Diarrhea had the highest guidelines' adherence to referral (97.6%), followed by COVID-19 (90%), headache (84.2%), and conjunctivitis (78.8%). Policies did not support 5,222 (31.6%) referrals, though 5,100 (97.6%) of these were justified according to the doctor's clinical judgment. Conclusion: TM doctors' assessment of acutely ill patients has high rates of adherence to guidelines regarding referral. Stewardship protocol adoption provides high rates of red flag description, even in the referral of nonpolicy diseases.
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Serviço Hospitalar de Emergência , Fidelidade a Diretrizes , Encaminhamento e Consulta , Humanos , Encaminhamento e Consulta/organização & administração , Estudos Retrospectivos , Serviço Hospitalar de Emergência/organização & administração , Serviço Hospitalar de Emergência/normas , Feminino , Masculino , Fidelidade a Diretrizes/estatística & dados numéricos , Pessoa de Meia-Idade , Adulto , Telemedicina/organização & administração , Telemedicina/normas , Idoso , Consulta Remota/organização & administração , Consulta Remota/normas , COVID-19 , Adolescente , Adulto Jovem , CriançaRESUMO
Fundamento la maloclusión de clase II presenta la mayor prevalencia entre las alteraciones dentoesqueléticas. Objetivo: proponer una guía de atención para pacientes con maloclusión de clase II con dentición permanente en crecimiento activo. Métodos: se realizó una investigación de innovación tecnológica de enfoque mixto en el Departamento de Ciencias Clínicas de la Facultad de Estomatología de la Universidad de Ciencias Médicas de Villa Clara, en el periodo comprendido entre los años 2020 y 2023. El universo de estudio estuvo constituido por todos los especialistas de Ortodoncia de la provincia de Villa Clara, Sancti Spíritus y Cienfuegos, a partir del cual se realizó un muestreo no probabilístico intencional por criterios y quedó constituida la muestra por 20 especialistas y siete expertos (especialistas de categoría superior) con criterios de inclusión. Resultados: la documentación revisada aportó información valiosa para determinar el estado actual de la atención de la maloclusión de estudio. Los especialistas emitieron diferentes criterios sobre el diagnóstico y tratamiento de la maloclusión de clase II. Los expertos establecieron los elementos invariables para su clasificación. Finalmente se diseñó una guía de atención para los pacientes con maloclusión de clase II con dentición permanente en crecimiento activo, valorada por los especialistas con la categoría de excelente. Conclusiones: la guía propuesta contiene elementos invariables de diagnóstico y pautas de tratamiento con el fin de lograr una atención más integral y eficiente de la maloclusión.
Foundation: Class II malocclusion has the highest prevalence among dentoskeletal disorders. Objective: to propose a care guide for patients with class II malocclusion with actively growing permanent dentition. Method: a mixed approach technological innovation research was carried out in the Clinical Sciences Department from the Stomatology Faculty of the Villa Clara Medical Sciences University, from 2020 to 2023. The studied universe was all the Orthodontic specialists in the Villa Clara province, Sancti Spíritus and Cienfuegos, from which an intentional non-probabilistic sampling was carried out by criteria and the sample was made up of 20 specialists and seven experts (higher category specialists) with criteria of inclusion. Results: The reviewed documentation provided valuable information to determine the current state of care for malocclusion under study. Specialists issued different criteria on the diagnosis and treatment of class II malocclusion. The experts established the invariable elements for their classification. Finally, a care guide was designed for patients with class II malocclusion with actively growing permanent dentition, rated by specialists as excellent. Conclusions: the proposed guide contains invariable diagnostic elements and treatment guidelines in order to achieve more comprehensive and efficient malocclusion care.
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BACKGROUND AND AIMS: Single-operator cholangioscopy (SOC) offer a diagnostic and therapeutic alternative with an improved optical resolution over conventional techniques; however, there are no standardized clinical practice guidelines for this technology. This evidence-based guideline from the Colombian Association of Digestive Endoscopy (ACED) intends to support patients, clinicians, and others in decisions about using in adults the SOC compared to endoscopic retrograde cholangiopancreatography (ERCP), to diagnose indeterminate biliary stricture and to manage difficult biliary stones. METHODS: ACED created a multidisciplinary guideline panel balanced to minimize potential bias from conflicts of interest. Universidad de los Andes and the Colombia Grading of Recommendations Assessment, Development and Evaluation (GRADE) Network supported the guideline-development process, updating and performing systematic evidence reviews. The panel prioritized clinical questions and outcomes according to their importance for clinicians and patients. The GRADE approach was used, including GRADE Evidence-to-Decision frameworks. RESULTS: The panel agreed on one recommendation for adult patients with indeterminate biliary strictures and one for adult patients with difficult biliary stones when comparing SOC versus ERCP. CONCLUSION: For adult patients with indeterminate biliary strictures, the panel made a conditional recommendation for SOC with stricture pattern characterization over ERCP with brushing and/or biopsy for sensitivity, specificity, and procedure success rate outcomes. For the adult patients with difficult biliary stones the panel made conditional recommendation for SOC over ERCP with large-balloon dilation of papilla. Additional research is required on economic estimations of SOC and knowledge translation evaluations to implement SOC intervention in local contexts.