Estimating an EQ-5D-Y-3L Value Set for Brazil.

INTRODUCTION: The EQ-5D-Y-3L is a generic measure of health-related quality of life in children and adolescents. Although the Brazilian-Portuguese EQ-5D-Y-3L version is available, there is no value set for it, hampering its use in economic evaluations. This study aimed to elicit a Brazilian EQ-5D-Y-3L value set based on preferences of the general adult population. METHODS: Two independent samples of adults participated in an online discrete choice experiment (DCE) survey and a composite time trade-off (cTTO) face-to-face interview. The framing was "considering your views for a 10-year-old child". DCE data were analyzed using a mixed-logit model. The 243 DCE predicted values were mapped into the observed 28 cTTO values using linear and non-linear mapping approaches with and without intercept. Mapping approaches' performance was assessed to estimate the most valid method to rescale DCE predicted values using the model fit (R2), Akaike Information Criteria (AIC), root mean squared error (RMSE), and mean absolute error (MAE). RESULTS: A representative sample of 1376 Brazilian adults participated (DCE, 1152; cTTO, 211). The linear mapping without intercept (R2 = 96%; AIC, - 44; RMSE, 0.0803; MAE, - 0.0479) outperformed the non-linear without intercept (R2 = 98%; AIC, - 63; RMSE, 0.1385; MAE, - 0.1320). Utilities ranged from 1 (full health) to - 0.0059 (the worst health state). Highest weights were assigned to having pain or discomfort (pain/discomfort), followed by walking about (mobility), looking after myself (self-care), doing usual activities (usual activities), and feeling worried, sad, or unhappy (anxiety/depression). CONCLUSION: This study elicited the Brazilian EQ-5D-Y-3L value set using a mixed-logit DCE model with a power parameter based on a linear mapping without intercept, which can be used to estimate the quality-adjusted life-years for economic evaluations of health technologies targeting the Brazilian youth population.

Systems approach in planetary health education for medical students: a mixed methods study.

BACKGROUND: Introducing students to the "planetary health lenses" perspective is crucial. Comprehensive strategies for teaching this perspective are lacking, especially in the domains of "interconnection within nature (IWN)" and "systems thinking/complexity." There is also a scarcity of studies assessing medical students' opinions on planetary health and evaluating teaching strategies. OBJECTIVE: To understand Brazilian medical students' perceptions and knowledge of planetary health (PH) and evaluate the application of the educational material "Patient and Clinic through the Lens of Planetary Health," which addresses "IWN" and "complexity" through the sociological lens of Actor-Network Theory, in an integrative course at a medical school in Brazil. METHODS: A mixed-methods, quasi-experimental design involving two medical student classes during 2022/2023. Participants completed a questionnaire on sociodemographic data; pre- and post-intervention closed-ended questions about perceptions related to PH, and an open-ended questionnaire on experience and learning. Each student group presented a portfolio under the planetary health lenses regarding a real patient, developing a network diagram that described the social network involving both human and non-human actors with which this person is interconnected. The cohorts participated in "IWN" activities: a contemplative trail or reflection on belonging to the planet. RESULTS: Ninety-six students and 9 professors participated. The majority of students (66.7%) reported significant or extremely significant learning from the sessions. There was an increase in perception of the need for physicians to incorporate PH into their clinical practice (p = 0.002; r = 0.46) and an intensification of the sense of interconnection with the environment (p = 0.003; r = 0.46). There was a gain in knowledge about how many diseases were related to PH (p < 0.02 for all 13 listed diseases). The majority (83%) found the sessions relevant or highly relevant and commented on their impact, both professionally and personally. CONCLUSIONS: Teaching PH in a medical school allowed students to learn from the patient's perspective, considering psychosocial and environmental determinants, about the intrinsic interdependence between population's health and PH. This strategy made a significant contribution by proposing pioneering didactics and offering valuable insights into the challenges and nuances of teaching PH.

Factors associated with higher quality of clinical practice guidelines and their recommendations for the pharmacological treatment of depression: a systematic review.

OBJECTIVE: The objective of this study was to assess the quality of clinical practice guidelines (CPGs) for the pharmacological treatment of depression along with their recommendations and factors associated with higher quality. DESIGN: We conducted a systematic review that included CPGs for the pharmacological treatment of depression in adults. DATA SOURCES: We searched for publications from 1 January 2011 to 31 December 2021, in MEDLINE, Cochrane Library, Embase, PsycINFO, BVS and 12 other databases and guideline repositories. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: We included CPGs containing recommendations for the pharmacological treatment of depression in adults at outpatient care setting, regardless of whether it met the U.S. National Academy of Medicine criteria, or not. If a CPG included recommendations for both children and adults, they were considered. No language restriction was applied. DATA EXTRACTION AND SYNTHESIS: Data extraction was also conducted independently and in duplicate, a process that was validated in a previous project. The quality of the CPGs and their recommendations were assessed by three independent reviewers using Appraisal of Guidelines for Research and Evaluation (AGREE II) and Appraisal of Guidelines for Research and Evaluation-Recommendations Excellence (AGREE-REX). A CPG was considered to be of high quality if AGREE II Domain 3 was ≥60%; while their recommendations were considered high if AGREE-REX Domain 1 was ≥60%. RESULTS: Seventeen out of 63 (27%) CPGs were classified as high quality, while 7 (11.1%) had high-quality recommendations. The factors associated with higher-scoring CPGs and recommendations in the multiple linear regression analyses were 'Handling of conflicts of interest', 'Multiprofessional team' and 'Type of institution'. 'Inclusion of patient representative in the team' was also associated with higher-quality recommendations. CONCLUSIONS: The involvement of professionals from diverse backgrounds, the handling of conflicts of interest, and the inclusion of patients' perspectives should be prioritised by developers aiming for high-quality CPGs for the treatment of depression.

Guidelines' recommendations for the treatment-resistant depression: A systematic review of their quality.

INTRODUCTION: Depression is a serious and widespread mental health disorder. A significant proportion of patients with depression fail to remit after two antidepressant treatment trials, a condition named treatment-resistant depression (TRD). Clinical practice guidelines (CPGs) are instruments aimed to improve diagnosis and treatment. This study objective is to systematically appraise the quality and elaborate a comparison of high-quality CPGs with high-quality recommendations aimed at TRD. METHODS AND ANALYSIS: We searched several specialized databases and organizations that develop CPGs. Independent researchers assessed the quality of the CPGs and their recommendations using AGREE II and AGREE-REX instruments, respectively. We selected only high-quality CPGs that included definition and recommendations for TRD. We investigated their divergencies and convergencies as well as weak and strong points. RESULTS: Among seven high-quality CPGs with high-quality recommendations only two (Germany's Nationale Versorgungs Leitlinie-NVL and US Department of Veterans Affairs and Department of Defense-VA/DoD) included specific TRD definition and were selected. We found no convergent therapeutic strategy among these two CPGs. Electroconvulsive therapy is recommended by the NVL but not by the VA/DoD, while repetitive transcranial magnetic stimulation is recommended by the VA/DoD but not by the NVL. While the NVL recommends the use of lithium, and a non-routine use of thyroid or other hormones, psychostimulants, and dopaminergic agents the VA/DoD does not even include these drugs among augmentation strategies. Instead, the VA/DoD recommends ketamine or esketamine as augmentation strategies, while the NVL does not mention these drugs. Other differences between these CPGs include antidepressant combination, psychotherapy as a therapeutic augmentation, and evaluation of the need for hospitalization all of which are only recommended by the NVL. CONCLUSIONS: High-quality CPGs for the treatment of depression diverge regarding the definition and use of the term TRD. There is also no convergent approach to TRD from currently high-quality CPGs.

Low-Risk Antenatal Care Enhanced by Telemedicine: A Practical Guideline Model / Atenção ao pré-natal de baixo risco potencializada por telemedicina: Diretriz clínica prática

Abstract Objective To develop a protocol for hybrid low-risk prenatal care adapted to Brazilian guidelines, merging reduced face-to-face consultations and remote monitoring. Methods The PubMed, Embase, and Cochrane Library databases were systematically searched on telemedicine and antenatal care perspectives and adaptation of the low-risk prenatal care protocols recommended by the Ministry of Health and by the Brazilian Federation of Gynecology and Obstetrics Associations. Results Five relevant articles and three manuals were included in the review, for presented criteria to develop this clinical guideline. We identified, in these studies, that the schedule of consultations is unevenly distributed among the gestational trimesters, and ranges from 7 to 14 appointments. In general, the authors propose one to two appointments in the first trimester, two to three appointments in the second trimester, and two to six appointments in the third trimester. Only three studies included puerperal evaluations. The routine exams recommended show minimal variations among authors. To date, there are no validated Brazilian protocols for prenatal care by telemedicine. The included studies showed that pregnant women were satisfied with this form of care, and the outcomes of interest, except for hypertensive diseases, were similar between the groups exposed to traditional and hybrid prenatal care. Conclusion The presented guideline comprises the Ministry of Health recommendations for low-risk prenatal care and reduces exposure to the hospital environment and care costs. A randomized clinical trial, to be developed by this group, will provide real-world data on safety, effectiveness, satisfaction, and costs.

Resumo Objetivo Desenvolver uma diretriz clínica híbrida para atendimento pré-natal de baixo risco, mesclando consultas presenciais e remotas por telemedicina, adapta às recomendações brasileiras. Métodos Revisão sistemática da literatura nas bases de dados PubMed, Embase e Cochrane e adaptação dos protocolos de atenção ao pré-natal de baixo risco preconizados pelo Ministério da Saúde e pela Federação Brasileira das Associações de Ginecologia e Obstetrícia. Resultados Cinco artigos relevantes e três manuais foram incluídos na revisão por preencherem critérios para o desenvolvimento desta diretriz clínica. Nos estudos incluídos, identificou-se que o cronograma de consultas se distribui de forma desigual entre os trimestres gestacionais, variando entre 07 e 14 encontros. De forma geral, os autores propõem uma a duas consultas no primeiro trimestre, duas a três consultas no segundo trimestre e duas a seis consultas no terceiro trimestre. Somente três estudos incluíram avaliações puerperais. A rotina de exames preconizada apresenta mínimas variações entre os autores. Até o momento, não existem protocolos brasileiros validados para atendimento pré-natal por telemedicina. Os estudos incluídos evidenciaram a satisfação das gestantes em relação a esta forma de atendimento, e os desfechos de interesse, excetuando doenças hipertensivas, foi semelhante entre os grupos expostos ao pré-natal tradicional e ao pré-natal híbrido. Conclusão A diretriz apresentada contempla as recomendações do Ministério da Saúde para atendimento pré-natal de gestantes de baixo risco, reduz a exposição ao ambiente hospitalar e os custos de atendimento. Seu emprego em um ensaio clínico randomizado, a ser desenvolvido por este grupo, proporcionará dados de mundo real, relativos à segurança, efetividade, satisfação e custos.

Low-Risk Antenatal Care Enhanced by Telemedicine: A Practical Guideline Model.

OBJECTIVE: To develop a protocol for hybrid low-risk prenatal care adapted to Brazilian guidelines, merging reduced face-to-face consultations and remote monitoring. METHODS: The PubMed, Embase, and Cochrane Library databases were systematically searched on telemedicine and antenatal care perspectives and adaptation of the low-risk prenatal care protocols recommended by the Ministry of Health and by the Brazilian Federation of Gynecology and Obstetrics Associations. RESULTS: Five relevant articles and three manuals were included in the review, for presented criteria to develop this clinical guideline. We identified, in these studies, that the schedule of consultations is unevenly distributed among the gestational trimesters, and ranges from 7 to 14 appointments. In general, the authors propose one to two appointments in the first trimester, two to three appointments in the second trimester, and two to six appointments in the third trimester. Only three studies included puerperal evaluations. The routine exams recommended show minimal variations among authors. To date, there are no validated Brazilian protocols for prenatal care by telemedicine. The included studies showed that pregnant women were satisfied with this form of care, and the outcomes of interest, except for hypertensive diseases, were similar between the groups exposed to traditional and hybrid prenatal care. CONCLUSION: The presented guideline comprises the Ministry of Health recommendations for low-risk prenatal care and reduces exposure to the hospital environment and care costs. A randomized clinical trial, to be developed by this group, will provide real-world data on safety, effectiveness, satisfaction, and costs.

OBJETIVO: Desenvolver uma diretriz clínica híbrida para atendimento pré-natal de baixo risco, mesclando consultas presenciais e remotas por telemedicina, adapta às recomendações brasileiras. MéTODOS: Revisão sistemática da literatura nas bases de dados PubMed, Embase e Cochrane e adaptação dos protocolos de atenção ao pré-natal de baixo risco preconizados pelo Ministério da Saúde e pela Federação Brasileira das Associações de Ginecologia e Obstetrícia. RESULTADOS: Cinco artigos relevantes e três manuais foram incluídos na revisão por preencherem critérios para o desenvolvimento desta diretriz clínica. Nos estudos incluídos, identificou-se que o cronograma de consultas se distribui de forma desigual entre os trimestres gestacionais, variando entre 07 e 14 encontros. De forma geral, os autores propõem uma a duas consultas no primeiro trimestre, duas a três consultas no segundo trimestre e duas a seis consultas no terceiro trimestre. Somente três estudos incluíram avaliações puerperais. A rotina de exames preconizada apresenta mínimas variações entre os autores. Até o momento, não existem protocolos brasileiros validados para atendimento pré-natal por telemedicina. Os estudos incluídos evidenciaram a satisfação das gestantes em relação a esta forma de atendimento, e os desfechos de interesse, excetuando doenças hipertensivas, foi semelhante entre os grupos expostos ao pré-natal tradicional e ao pré-natal híbrido. CONCLUSãO: A diretriz apresentada contempla as recomendações do Ministério da Saúde para atendimento pré-natal de gestantes de baixo risco, reduz a exposição ao ambiente hospitalar e os custos de atendimento. Seu emprego em um ensaio clínico randomizado, a ser desenvolvido por este grupo, proporcionará dados de mundo real, relativos à segurança, efetividade, satisfação e custos.

Recommendations for the pharmacological treatment of treatment-resistant depression: A systematic review protocol.

INTRODUCTION: Depression is a serious and widespread mental health disorder. Although effective treatment does exist, a significant proportion of patients with depression fail to respond to antidepressant treatment trials, a condition named treatment-resistant depression. Efficient approach should be given this condition in order to revert the burden caused by depression. Clinical practice guidelines (CPGs) are evidence-based health promotion instruments to improve diagnosis and treatment. CPGs recommendations for treatment-resistant depression must be trustworthy. The objective of the proposed study is to systematically identify, appraise the quality of CPGs for the treatment of depression and elaborate a synthesis of recommendations for treatment-resistant depression of CPGs considered to be of high quality and with high quality recommendations. METHODS AND ANALYSIS: We will search the databases of organizations, such as PubMed, Embase, Cochrane Library, PsycInfo, and the Virtual Health Library, and organizations that develop CPGs. Three independent researchers will assess the quality of the CPGs and their recommendations using the AGREE II and AGREE-REX instruments, respectively. Given the identification of divergences and convergences as well as weak and strong points among high quality CPGs, our work may help developers, clinicians and eventually patients. ETHICS AND DISSEMINATION: No ethical approval is required for a systematic review, as no patient data will be used. The research results will be disseminated in conferences and submitted to a peer reviewed journal.

Quality of clinical practice guidelines for inadequate response to first-line treatment for depression according to AGREE II checklist and comparison of recommendations: a systematic review.

OBJECTIVE: To assess similarities and differences in the recommended sequence of strategies among the most relevant clinical practice guidelines (CPGs) for the treatment of depression in adults with inadequate response to first-line treatment. DATA SOURCES: We performed a systematic review of the literature spanning January 2011 to August 2020 in Medline, Embase, Cochrane Library and 12 databases recognised as CPGs repositories. CPGs quality was assessed using the Appraisal of Guidelines for Research and Evaluation II (AGREE II). STUDY SELECTION: The eligibility criteria were CPGs that described pharmacological recommendations for treating depression for individuals aged 18 years or older in outpatient care setting. We included CPGs considered of high-quality (≥80% in domain 3 of AGREE II) or recognised as clinically relevant. DATA EXTRACTION: Two independent researchers extracted recommendations for patients who did not respond to first-line pharmacological treatment from the selected CPGs. RESULTS: We included 46 CPGs and selected 8, of which 5 were considered high quality (≥80% in domain 3 of AGREE II) and 3 were recognised as clinically relevant. Three CPGs did not define inadequate response to treatment and 3 did not establish a clear sequence of strategies. The duration of treatment needed to determine that a patient had not responded was not explicit in 3 CPGs and was discordant in 5 CPGs. Most CPGs agree in reassessing the diagnosis, assessing the presence of comorbidities, adherence to treatment, and increase dosage as first steps. All CPGs recommend psychotherapy, switching antidepressants, and considering augmentation/combining antidepressants. CONCLUSION: Relevant CPGs present shortcomings in recommendations for non-responders to first-line antidepressant treatment including absence and divergencies in definition of inadequate response and sequence of recommended strategies. Overall, most relevant CPGs recommend reassessing the diagnosis, evaluate comorbidities, adherence to treatment, increase dosage of antidepressants, and psychotherapy as first steps. PROSPERO REGISTRATION NUMBER: CRD42016043364.

Adult patients admitted to a tertiary hospital for COVID-19 and risk factors associated with severity: a retrospective cohort study.

COVID-19 is a disease whose knowledge is still under construction, high transmissibility, with no consensual treatment available to everyone. Therefore, the identification of patients at higher risk of evolving to the critical form of the disease is fundamental. The study aimed to determine risk factors associated with the severity of COVID-19 in adults patients. This is an observational, retrospective study from a cohort of adult patients with COVID-19 admitted to a public hospital from March to August 2020, whose medical records were evaluated. For the association of possible severity predictors, a Poisson regression was used. The primary outcome was the critical form of the disease (need for admission to the Intensive Care Unit and/or invasive mechanical ventilation). We included 565 patients: mostly men; 55.5% of those who progressed to the critical form of the disease were over sixty years old. Hypertension, diabetes mellitus and obesity were the most frequent comorbidities. There were 39.8% of patients who progressed to the critical form of the disease. The hospital mortality rate was 22.1%, and that of critical patients was 46.7%. The independent factors associated with the severity of the disease were obesity [RR = 1.33 (95% CI 1.07 to 1.66; p = 0.011)], SpO2/FiO2 ratio ≤ 315 [RR = 2.20 (95% CI 1.79 to 2.71; p = 0.000)], C-reactive protein > 100 mg/L [RR = 1.65 (95% CI 1.33 to 2.06; p = 0.000)], and lymphocytes < 1,000/µL [RR = 1.44 (95% CI 1.18 to 1.75; p = 0.000)]. Advanced age and comorbidities were dependent factors strongly associated with the critical form of the disease.

Effect of oral exercises and photobiomodulation therapy in the rehabilitation of patients with mandible fractures: randomized double-blind clinical trial.

Mandible fractures compromise stomatognathic functions, requiring rehabilitation. Evaluate the effectiveness of photobiomodulation (PBM) associated with oral exercises for rehabilitation of patients with mandible fractures. In this randomized clinical trial, we compared PBM with PBM sham in 14 adults with mandibular fractures who underwent surgical intervention. The sessions were performed 24 h and 48 h after surgical procedure, and weekly for 4 weeks after hospital discharge. Both groups performed oral exercises after each PBM session. Restriction of food consistencies, mandibular mobility, pain, and facial sensitivity measured before and after the surgical procedure were the outcomes evaluated, one and 3 months after surgery. Maximum interincisal distances (MID), exercise pain, and restriction of food consistencies were also evaluated during each week of intervention. Both groups showed normal MID (> 35 mm) and food consistencies consumed 1 month after the surgical procedure, with no significant differences between them. Individuals in the PBM group had less pain response to exercise during all the weeks of intervention than the sham group (p < 0.05). The patients presented a reduction in the painful response in MID and mandibular laterality movements 1 month after surgery compared to the preoperative period. In contrast, there was an improvement in laterality in the sham group only 3 months postoperatively and persistent pain in MID. There was no significant difference in facial sensitivity within and between groups during follow-up. The performance of oral exercises associated with PBM effectively facilitated the early rehabilitation of oral functions, with significant gains in pain management.

Elaboração de instrumento de avaliação da assistência ao paciente com tuberculose na atenção primária em saúde / Elaboration of instrument for assessing assistance to patients with tuberculosis in primary health care / Elaboración de instrumento de evaluación de asistencia a pacientes con tuberculosis en atención primaria de salud

Objetivo: elaborar e validar um instrumento de avaliação da assistência ao paciente com tuberculose na Atenção Primária em Saúde. Método: as etapas de construção do instrumento avaliativo foram: construção do modelo lógico, revisão bibliográfica, identificação das dimensões e subdimensões avaliativas e elaboração de indicadores. A Técnica Delfos com especialistas foi utilizada a fim de obter consenso sobre a relevância das dimensões e subdimensões e atribuir pesos aos indicadores. O teste piloto foi realizado em duas unidades de saúde. Resultados: o instrumento de avaliação resulta em uma nota máxima de dez pontos distribuída em recursos físicos, recursos humanos e capacidade técnica, subdividida em sete subdimensões e 44 indicadores. A avaliação possibilitou o conhecimento da realidade individual das unidades avaliadas. Conclusão: o instrumento proposto pode ser utilizado como instrumento de gestão, podendo ser útil na identificação de estratégias para qualificação da assistência do paciente com tuberculose na Atenção Primária em Saúde

Objective: validate an instrument for assessing the care of patients with tuberculosis in Primary Health Care. Method: the construction stages of the evaluation instrument were: construction of logical model, bibliographic review, identification of the evaluative dimensions and subdimensions and indicators development. The Delphi Technique with specialists was used in order to obtain consensus on the relevance of dimensions and subdimensions and to assign weights to the indicators. The pilot test was carried out in two units. Results: the evaluation instrument results in a maximum score of ten points distributed in physical resources, human resources and technical capacity, subdivided into seven subdimensions and 44 indicators. The evaluation enabled the knowledge of the individual reality of the units evaluated. Conclusion: the proposed instrument can be used as a management tool and can be useful in identifying strategies for qualifying the care of patients with tuberculosis in Primary Health Care

Objetivo: validar un instrumento de evaluación de la atención de pacientes con tuberculosis en Atención Primaria de Salud. Método:las etapas de construcción del instrumento de evaluación fueron: construcción del modelo lógico, revisión bibliográfica, identificación de las dimensiones y subdimensiones evaluativas y desarrollo de indicadores. Se utilizó la Técnica Delphi con especialistas para lograr consenso sobre la relevancia de dimensiones y subdimensiones y asignar ponderaciones a los indicadores. La prueba piloto se realizó en dos unidades. Resultados: el instrumento de evaluación arroja un puntaje máximo de diez puntos distribuidos en recursos físicos, recursos humanos y capacidad técnica, subdivididos en siete subdimensiones y 44 indicadores. La evaluación permitió conocer la realidad individual de las unidades evaluadas. Conclusión: el instrumento propuesto puede ser utilizado como herramienta de manejo y puede ser útil en la identificación de estrategias para calificar la atención de pacientes con tuberculosis en Atención Primaria de Salud

Adult patients admitted to a tertiary hospital for COVID-19 and risk factors associated with severity: a retrospective cohort study

ABSTRACT COVID-19 is a disease whose knowledge is still under construction, high transmissibility, with no consensual treatment available to everyone. Therefore, the identification of patients at higher risk of evolving to the critical form of the disease is fundamental. The study aimed to determine risk factors associated with the severity of COVID-19 in adults patients. This is an observational, retrospective study from a cohort of adult patients with COVID-19 admitted to a public hospital from March to August 2020, whose medical records were evaluated. For the association of possible severity predictors, a Poisson regression was used. The primary outcome was the critical form of the disease (need for admission to the Intensive Care Unit and/or invasive mechanical ventilation). We included 565 patients: mostly men; 55.5% of those who progressed to the critical form of the disease were over sixty years old. Hypertension, diabetes mellitus and obesity were the most frequent comorbidities. There were 39.8% of patients who progressed to the critical form of the disease. The hospital mortality rate was 22.1%, and that of critical patients was 46.7%. The independent factors associated with the severity of the disease were obesity [RR = 1.33 (95% CI 1.07 to 1.66; p = 0.011)], SpO2/FiO2 ratio ≤ 315 [RR = 2.20 (95% CI 1.79 to 2.71; p = 0.000)], C-reactive protein > 100 mg/L [RR = 1.65 (95% CI 1.33 to 2.06; p = 0.000)], and lymphocytes < 1,000/µL [RR = 1.44 (95% CI 1.18 to 1.75; p = 0.000)]. Advanced age and comorbidities were dependent factors strongly associated with the critical form of the disease.

Recommendations for the development of Clinical Practice Guidelines / Recomendações para o desenvolvimento de Diretrizes de Prática Clínica

Clinical practice guidelines are statements that include recommendations intended to optimize patient care, are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options, and ensure that the best available clinical knowledge is used to provide effective and quality care. They can reduce inappropriate care and variability in clinical practice and can support the translation of new research knowledge into clinical practice. Recommendations from clinical practice guidelines can support health professionals by facilitating the decision-making process, empowering them to make more informed health care choices, clarifying which interventions should be priorities based on a favorable tradeoff, and discouraging the use of those that have proven ineffective, dangerous, or wasteful. This review aims to summarize the key components of high-quality and trustworthy guidelines. Articles were retrieved from various libraries, databases, and search engines using free-text term searches adapted for different databases, and selected according to author discretion. Clinical practice guidelines in geriatrics can have a major impact on prevention, diagnosis, treatment, rehabilitation, health care, and the management of diseases and conditions, but they should only be implemented when they have high-quality, rigorous, and unbiased methodologies that consider older adult priorities and provide valid recommendations.

As diretrizes de prática clínica são declarações que incluem recomendações destinadas a otimizar o atendimento ao paciente, informadas por uma revisão sistemática de evidências e uma avaliação dos benefícios e malefícios de opções alternativas de atendimento, garantindo que o melhor conhecimento clínico disponível seja usado para fornecer atendimento eficaz e de qualidade. Elas contribuem reduzindo os cuidados inadequados e a variabilidade na prática clínica e podem apoiar a tradução de novos conhecimentos de pesquisa. As recomendações dessas diretrizes podem apoiar os profissionais de saúde, facilitando o processo de tomada de decisão, capacitando-os a fazer escolhas de cuidados de saúde mais informadas, esclarecendo quais intervenções devem ser prioritárias com base em um trade-off favorável e desencorajando o uso daquelas comprovadamente ineficazes, perigosas ou que consistam em desperdício. Esta revisão visa resumir os principais componentes de diretrizes confiáveis e de alta qualidade. Os artigos foram recuperados de várias bibliotecas, bancos de dados e mecanismos de busca por meio de buscas de termos de texto livre adaptados para diferentes bancos de dados e selecionados de acordo com o critério do autor. As diretrizes de prática clínica em geriatria podem ter grande impacto na prevenção, diagnóstico, tratamento, reabilitação, assistência à saúde e manejo de doenças e condições, mas só devem ser implementadas quando tiverem metodologias de alta qualidade, rigorosas e imparciais, que considerem as prioridades da pessoa idosa e forneçam recomendações válidas.

Saúde Baseada em Evidências e pandemias: dilemas sobre a Saúde Planetária e a decisão individual de impacto populacional / Evidence-Based Health and pandemics: Planetary Health dilemmas and the individual decision of population impact / Salud Basada en Evidencias y pandemias: dilemas de Salud Planetaria y la decisión individual de impacto poblacional

Durante a trajetória na prática clínica e na pesquisa, o médico, professor e pesquisador Airton Tetelbom Stein compreendeu que para ser um bom médico é necessário um embasamento científico aprofundado. Em entrevista à Reciis, Stein discute sobre o conceito de Saúde Baseada em Evidências (SBE) na sua relevância de integrar as melhores evidências com a experiência clínica e os valores e as preferências do paciente. A partir da sua experiência na Medicina de Família e Comunidade (MFC), Stein enfatiza que epidemias e pandemias, como a da covid-19, revelam o impacto das mudanças climáticas na saúde da população. Ressalta que um dos pilares da Atenção Primária à Saúde (APS) é o entendimento sobre as causas do surgimento das doenças no âmbito populacional. Nesse sentido, nas dinâmicas sociais, sobretudo as midiáticas acerca da covid-19, o pesquisador esclarece que as decisões sobre o tratamento precoce, sobre tomar ou não a vacina, dizem respeito à valorização de pressupostos baseados em informações não sistematizadas em detrimento de metodologias robustas, referem-se às decisões individuais que impactam na saúde da população. "As pessoas que têm se negado a realizar a vacinação precisam entender que isso não é apenas uma liberdade individual". Airton Tetelbom Stein é professor titular da Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA) e médico da família e comunidade do Grupo Hospitalar Conceição.

During his trajectory in clinical practice and in research, the physician, professor and researcher Airton Tetelbom Stein understood that, in order to be a good doctor, a deep scientific foundation is necessary. In an interview with Reciis, Stein discusses the concept of Evidence-Based Health in its relevance to integrate the best evidence with clinical experience and patients' values and preferences. Based on his experience in Family Practice, Stein emphasizes that epidemics and pandemics, such as covid-19, reveal the impact of climate change on the population's health. He also emphasizes that one of the pillars of Primary Health Care is the understanding of the causes of the emergence of diseases within the population. In this sense, in social dynamics, especially the mediatic dynamics about covid-19, Stein clarifies that decisions about early treatment, whether to vaccinate or not, concern the valuation of assumptions based on non-systematized information to the detriment of robust methodologies, refer to individual decisions that impact the health of the population. "People who have refused to vaccinate need to understand that this is not just a matter of individual freedom." Airton Tetelbom Stein is full professor of Public Health at the Federal University of Health Sciences of Porto Alegre (UFCSPA) and a family practice physician at Conceição Hospital Group.

Durante su trayectoria en la práctica clínica y la investigación, el médico, profesor e investigador Airton Tetelbom Stein comprendió que, para ser un buen médico, es necesaria una base científica profunda. En entrevista a Reciis, Stein analiza el concepto de Salud Basada en Evidencias (SBE) en su relevancia para integrar la mejor evidencia con la experiencia clínica y los valores y preferencias del paciente. Basado en su experiencia en Medicina Familiar y Comunitaria (MFC), Stein enfatiza que las epidemias y pandemias, como covid-19, revelan el impacto del cambio climático en la salud de la población. Destaca que uno de los pilares de la Atención Primaria de Salud (APS) es la comprensión de las causas de la aparición de enfermedades en el ámbito poblacional. En este sentido, en dinámica social, especialmente en los medios de comunicación sobre covid-19, Stein aclara que las decisiones sobre el tratamiento temprano, la decisión de vacunarse o no, tienen que ver con la valoración de supuestos basados en información no sistematizada en detrimento de metodologías robustas, se refieren a decisiones individuales que impactan en la salud de la población. "Las personas que se han negado a vacinarse deben comprender que esto no es solo una cuestión de libertad individual". Airton Tetelbom Stein es profesor de salud colectiva en la Universidad Federal de Ciencias de la Salud de Porto Alegre (UFCSPA) y médico de familia y comunidad en Grupo Hospitalar Conceição.

Pay for performance in primary care: the contribution of the Programme for Improving Access and Quality of Primary Care (PMAQ) on avoidable hospitalisations in Brazil, 2009-2018.

BACKGROUND: Evidence on the effect of pay-for-performance (P4P) schemes on provider performance is mixed in low-income and middle-income countries. Brazil introduced its first national-level P4P scheme in 2011 (PMAQ-Brazilian National Programme for Improving Primary Care Access and Quality). PMAQ is likely one of the largest P4P schemes in the world. We estimate the association between PMAQ and hospitalisations for ambulatory care sensitive conditions (ACSCs) based on a panel of 5564 municipalities. METHODS: We conducted a fixed effect panel data analysis over the period of 2009-2018, controlling for coverage of primary healthcare, hospital beds per 10 000 population, education, real gross domestic product per capita and population density. The outcome is the hospitalisation rate for ACSCs among people aged 64 years and under per 10 000 population. Our exposure variable is defined as the percentage of family health teams participating in PMAQ, which captures the roll-out of PMAQ over time. We also provided several sensitivity analyses, by using alternative measures of the exposure and outcome variables, and a placebo test using transport accident hospitalisations instead of ACSCs. RESULTS: The results show a negative and statistically significant association between the rollout of PMAQ and ACSC rates for all age groups. An increase in PMAQ participating of one percentage point decreased the hospitalisation rate for ACSC by 0.0356 (SE 0.0123, p=0.004) per 10 000 population (aged 0-64 years). This corresponds to a reduction of approximately 60 829 hospitalisations in 2018. The impact is stronger for children under 5 years (-0.0940, SE 0.0375, p=0.012), representing a reduction of around 11 936 hospitalisations. Our placebo test shows that the association of PMAQ on the hospitalisation rate for transport accidents is not statistically significant, as expected. CONCLUSION: We find that PMAQ was associated with a modest reduction in hospitalisation for ACSCs.

Prediction of all-cause and cardiovascular mortality using central hemodynamic indices among elderly people: systematic review and meta-analysis

ABSTRACT BACKGROUND: Despite widespread usage of central blood pressure assessment its predictive value among elderly people remains unclear. OBJECTIVE: To ascertain the capacity of central hemodynamic indices for predicting future all-cause and cardiovascular hard outcomes among elderly people. DESIGN AND SETTING: Systematic review and meta-analysis developed at the Del Cuore cardiology clinic, in Antonio Prado, Rio Grande do Sul, Brazil. METHODS: 312 full-text articles were analyzed, from which 35 studies were included for systematic review. The studies included needed to report at least one central hemodynamic index among patients aged 60 years or over. RESULTS: For all-cause mortality, aortic pulse wave velocity (aPWV) and central systolic blood pressure (SBP) were significant, respectively with standardized mean difference (SMD) 0.85 (95% confidence interval, CI 0.69-1.01; I2 96%; P < 0.001); and SMD 0.27 (95% CI 0.15-0.39; I2 77%; P 0.012). For cardiovascular mortality brachial-ankle PWV (baPWV), central SBP and carotid-femoral PWV (cfPWV) were significant, respectively SMD 0.67 (95% CI 0.40-0.93; I2 0%; P 0.610); SMD 0.65 (95% CI 0.48- 0.82; I2 80%; P 0.023); and SMD 0.51 (95% CI 0.32-0.69; I2 85%; P 0.010). CONCLUSIONS: The meta-analysis results showed that aPWV was promising for predicting all-cause mortality, while baPWV and central SBP demonstrated consistent results in evaluating cardiovascular mortality outcomes. Thus, the findings support usage of central blood pressure as a risk predictor for hard outcomes among elderly people. REGISTRATION NUMBER IN PROSPERO: RD42018085264

Prediction of all-cause and cardiovascular mortality using central hemodynamic indices among elderly people: systematic review and meta-analysis.

BACKGROUND: Despite widespread usage of central blood pressure assessment its predictive value among elderly people remains unclear. OBJECTIVE: To ascertain the capacity of central hemodynamic indices for predicting future all-cause and cardiovascular hard outcomes among elderly people. DESIGN AND SETTING: Systematic review and meta-analysis developed at the Del Cuore cardiology clinic, in Antonio Prado, Rio Grande do Sul, Brazil. METHODS: 312 full-text articles were analyzed, from which 35 studies were included for systematic review. The studies included needed to report at least one central hemodynamic index among patients aged 60 years or over. RESULTS: For all-cause mortality, aortic pulse wave velocity (aPWV) and central systolic blood pressure (SBP) were significant, respectively with standardized mean difference (SMD) 0.85 (95% confidence interval, CI 0.69-1.01; I2 96%; P < 0.001); and SMD 0.27 (95% CI 0.15-0.39; I2 77%; P 0.012). For cardiovascular mortality brachial-ankle PWV (baPWV), central SBP and carotid-femoral PWV (cfPWV) were significant, respectively SMD 0.67 (95% CI 0.40-0.93; I2 0%; P 0.610); SMD 0.65 (95% CI 0.48- 0.82; I2 80%; P 0.023); and SMD 0.51 (95% CI 0.32-0.69; I2 85%; P 0.010). CONCLUSIONS: The meta-analysis results showed that aPWV was promising for predicting all-cause mortality, while baPWV and central SBP demonstrated consistent results in evaluating cardiovascular mortality outcomes. Thus, the findings support usage of central blood pressure as a risk predictor for hard outcomes among elderly people. REGISTRATION NUMBER IN PROSPERO: RD42018085264.

Evaluation of the initial response in clinical trial efforts for COVID-19 in Brazil. / Avaliação da resposta inicial de desenvolvimento de ensaios clínicos para COVID-19 no Brasil.

OBJECTIVE: To describe the methodological characteristics and good research practices of COVID-19 interventional studies developed in Brazil in the first months of the pandemic. METHODS: We reviewed the bulletin of the National Research Ethics Committee - Coronavirus Special Edition (Comissão Nacional de Ética em Pesquisa - CONEP-COVID) (May 28, 2020) and the databases of the International Clinical Trials Registry Platform (ICTRP), ClinicalTrials.gov, and Brazilian Clinical Trials Registry (Registro Brasileiro de Ensaios Clínicos - ReBEC) to identify interventional studies registered in Brazil that assessed drug type, biological therapy, or vaccines. We described their methodological characteristics and calculated their power for different effect magnitudes. RESULTS: A total of 62 studies were included, 55 retrieved from the CONEP website, and 7 from registry databases. The most tested pharmacological interventions in these studies were: chloroquine/hydroxychloroquine, azithromycin, convalescent plasma, tocilizumab, sarilumab, eculizumab, vaccine, corticosteroids, anticoagulants, n-acetylcysteine, nitazoxanide, ivermectin, and lopinavir/ritonavir. Out of 22 protocols published on registry databases until May 2020, 18 (82%) were randomized clinical trials, and 13 (59%) had an appropriate control group. However, 9 (41%) of them were masked, and only 5 (24%) included patients diagnosed with a specific laboratory test (for example, reverse transcription polymerase chain reaction - RT-PCR). Most of these studies had power > 80% only to identify large effect sizes. In the prospective follow-up, 60% of the studies available at CONEP until May 2020 had not been published on any registry platform (ICTRP/ReBEC/ClinicalTrials) by July 21, 2020. CONCLUSION: The interventions evaluated during the Brazilian research response reflect those of international initiatives, but with a different distribution and a large number of studies assessing hydroxychloroquine/chloroquine. Limitations in methodological design and sample planning represent challenges that could affect the research outreach.

OBJETIVO: Descrever as características metodológicas e de boas práticas em pesquisa dos estudos de intervenção para COVID-19 desenvolvidos no Brasil nos primeiros meses da pandemia. MÉTODOS: Revisamos o boletim da Comissão Nacional de Ética em Pesquisa - edição especial Coronavírus (CONEP-COVID) (28 de maio de 2020) e as bases International Clinical Trials Registry Platform (ICTRP), ClinicalTrials.gov e Registro Brasileiro de Ensaios Clínicos (ReBEC) para identificar estudos registrados no Brasil que avaliassem intervenções de tipo de medicamento, terapia biológica ou vacinas. Descrevemos as características metodológicas e calculamos o poder para diferentes magnitudes de efeito. RESULTADOS: Foram incluídos 62 estudos, 55 identificados no site da CONEP e mais sete nas bases de registro. As intervenções medicamentosas mais frequentemente testadas nesses estudos foram: cloroquina/hidroxicloroquina, azitromicina, plasma convalescente, tocilizumabe, sarilumabe, eculizumabe, vacina, corticoides, anticoagulantes, n-acetilcisteína, nitazoxanida, ivermectina e lopinavir/ritonavir. De 22 protocolos publicados até maio de 2020 nas bases de registro, 18 (82%) eram ensaios clínicos randomizados e 13 (59%) tinham grupo controle adequado. Entretanto, nove (41%) eram mascarados e somente cinco (24%) incluíam pacientes diagnosticados com teste de laboratório específico (por exemplo, transcrição reversa seguida de reação em cadeia da polimerase - RT-PCR). A maioria desses trabalhos teria poder > 80% apenas para identificar grandes tamanhos de efeito. Em seguimento prospectivo, observamos que 60% dos estudos disponíveis na CONEP até maio de 2020 não estavam em nenhuma das plataformas de registro (ICTRP/ReBEC/ClinicalTrials) até o dia 21 de julho de 2020. CONCLUSÃO: As intervenções avaliadas durante a resposta brasileira em pesquisa refletem iniciativas internacionais, porém com distribuição diferente, tendo número elevado de estudos que avaliam hidroxicloroquina/cloroquina. Limitações no delineamento metodológico e planejamento amostral representam desafios que podem afetar o alcance dos trabalhos.

Evaluation of the initial response in clinical trials efforts for COVID-19 in Brazil / Avaliação da resposta inicial de desenvolvimento de ensaios clínicos para COVID-19 no Brasil

Objective: To describe the methodological characteristics and good research practices of the intervention studies for COVID-19 developed in Brazil in the first months of the pandemic. Method: A review in the CONEP-COVID bulletin (05/28/2020) and the International Clinical Trials Registry Platform, ClinicalTrials.gov, ReBEC was conducted to identify drug-type, biological therapy or vaccine intervention studies registered in Brazil. The studies were evaluated for methodological characteristics and power for different magnitudes of effect. Results: 62 studies were included, 55 identified on the CONEP website and seven on a registration database. Several interventions are being tested: chloroquine/hydroxychloroquine, azithromycin, plasma convalescent, tocilizumab, sarilumab, eculizumab, vaccine, corticoids, anticoagulants, n-acetylcysteine, nitazoxanide, ivermectin, lopinavir/ritonavir, etc. By May 2020, 22 research protocols were published in a protocol registry database, 82% were randomized clinical trials and 59% had adequate control group. However, 59% were not masked and only 24% included patients with positive test with diagnostic accuracy. Most of the studies would have power >80% just to identify large effect sizes. In a prospective follow-up, until July 21st/2020, 60% of the studies available at CONEP were not registered in the ICTRP/ReBEC/ClinicalTrials platforms. Conclusion: The interventions evaluated during the Brazilian research response reflect international initiatives, but with a different distribution, a larger proportion of studies asseessed hydroxychloroquine/chloroquine. Limitations in methodological design and sample planning represent challenges that could affect the research outreach.

Objetivo: Descrever as características metodológicas e de boas práticas em pesquisa dos estudos de intervenção para COVID-19 desenvolvidos no Brasil nos primeiros meses da pandemia. Método: Revisamos o boletim da CONEP-COVID (28/05/2020) e as bases International Clinical Trials Registry Platform, ClinicalTrials.gov e ReBEC para identificar estudos registrados no Brasil, avaliando intervenções de tipo medicamento, terapia biológica ou vacinas. Descrevemos as características metodológicas e calculamos o poder para diferentes magnitudes de efeito. Resultados: Foram incluídos 62 estudos, 55 identificados no site da CONEP e mais sete nas bases de registro. As intervenções medicamentosas mais frequentemente testadas nesses estudos foram: cloroquina/hidroxicloroquina, azitromicina, plasma convalescente, tocilizumabe, sarilumabe, eculizumabe, vacina, corticoides, anticoagulantes, n-acetilcisteína, nitazoxanida, ivermectina e lopinavir/ritonavir. De 22 protocolos, publicados até maio de 2020 nas bases de registro, 18 (82%) eram ensaios clínicos randomizados e 13 (59%) tinham grupo controle adequado. Entretanto, nove (41%) eram mascarados e somente cinco (24%) incluía pacientes diagnosticados com teste de laboratório específico (e.g. RT-PCR). A maioria desses trabalhos teria poder >80% apenas para identificar grandes tamanhos de efeito. Em seguimento prospectivo, observamos que 60% dos estudos, disponíveis na CONEP até maio de 2020, não estava em nenhuma das plataformas de registro (ICTRP/ReBEC/ClinicalTrials) até o dia 21/07/2020.Conclusão: As intervenções avaliadas durante a resposta brasileira em pesquisa refletem iniciativas internacionais, porém com uma distribuição diferente, tendo um número elevado de estudos avaliando hidroxicloroquina/ cloroquina. Limitações no delineamento metodológico e planejamento amostral representam desafios que poderiam afetar o alcance dos trabalhos.