RESUMEN
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.
Asunto(s)
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
AIMS: To evaluate the effectiveness of intensive lifestyle intervention (ILI) on the risk of type 2 diabetes (T2D) in prediabetes (PD). METHODS: We searched the Cochrane Central, Embase, MEDLINE, and Web of Science (until February 2024) to include RCTs of adults with PD, comparing ILI vs. general advice on the incidence of T2D. Two authors extracted the data, applied the Cochrane Risk of Bias (RoB) 2.0 tool and the GRADE framework. Meta-analysis was performed using random effects models, estimating relative risk (RR) and the 95%CI. RESULTS: Fifteen studies (n = 8,563, 46.7 % female, 53.3 ± 8.7 years, BMI 26.7 ± 5.4 Kg/m2) were included. ILI reduced T2D risk by 22 % when compared with general advice (RR 0.78; 95 %CI 0.72-0.85; I2 = 40 %; low certainty of evidence). Most studies had high risk of bias or raised some concerns. Sensitivity analysis showed that studies with mostly female populations and those using the WHO 1985 criteria for T2D had lower risk of the disease and that the longer the follow-up, the lower the protection. CONCLUSION: ILI can prevent T2D in subjects with PD. Healthcare teams should aim for structured ILI to maintain long-term lifestyle improvements.
Asunto(s)
Diabetes Mellitus Tipo 2 , Estilo de Vida , Estado Prediabético , Humanos , Diabetes Mellitus Tipo 2/prevención & control , Diabetes Mellitus Tipo 2/epidemiología , Estado Prediabético/terapia , Estado Prediabético/epidemiología , Femenino , Conducta de Reducción del Riesgo , Persona de Mediana EdadRESUMEN
AIM: To evaluate the effect of metformin on cancer incidence in subjects with overweight/obesity and/or prediabetes/diabetes. MATERIALS AND METHODS: We searched MEDLINE, Embase and CENTRAL for randomized controlled trials (RCTs) in adults with overweight/obesity and/or prediabetes/diabetes that compared metformin to other interventions for ≥24 weeks. Independent reviewers selected and extracted data including population and intervention characteristics and new diagnoses of cancer. We used the RoB 2.0 risk-of-bias tool and the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) framework to assess risk of bias and certainty of evidence. RESULTS: From 14 895 records after removal of duplicates, 27 trials were included, providing a total of 10 717 subjects in the metformin group and 10 003 in the control group, with 170 and 208 new cases of cancer, respectively. Using a random-effects model, the relative risk was 1.07 (95% confidence interval 0.87-1.31), with similar results in subgroup analyses by study duration or effect of control intervention on weight. Risk of bias in most studies was low, and no evidence of publication bias was found. Trial sequential analysis provided evidence that the cumulative sample size was large enough to exclude a significant effect of metformin on cancer incidence. CONCLUSIONS: Metformin did not reduce cancer incidence in RCTs involving subjects with overweight/obesity and/or prediabetes/diabetes.
Asunto(s)
Diabetes Mellitus Tipo 2 , Hipoglucemiantes , Metformina , Neoplasias , Obesidad , Estado Prediabético , Metformina/uso terapéutico , Humanos , Neoplasias/prevención & control , Neoplasias/epidemiología , Obesidad/complicaciones , Hipoglucemiantes/uso terapéutico , Estado Prediabético/complicaciones , Estado Prediabético/tratamiento farmacológico , Estado Prediabético/epidemiología , Diabetes Mellitus Tipo 2/complicaciones , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Diabetes Mellitus Tipo 2/epidemiología , Diabetes Mellitus Tipo 2/prevención & control , Ensayos Clínicos Controlados Aleatorios como Asunto , IncidenciaRESUMEN
OBJECTIVE: To update the recommendations to support decisions regarding the pharmacological treatment of patients hospitalized with COVID-19 in Brazil. METHODS: Experts, including representatives of the Ministry of Health and methodologists, created this guideline. The method used for the rapid development of guidelines was based on the adoption and/or adaptation of existing international guidelines (GRADE ADOLOPMENT) and supported by the e-COVID-19 RecMap platform. The quality of the evidence and the preparation of the recommendations followed the GRADE method. RESULTS: Twenty-one recommendations were generated, including strong recommendations for the use of corticosteroids in patients using supplemental oxygen and conditional recommendations for the use of tocilizumab and baricitinib for patients on supplemental oxygen or on noninvasive ventilation and anticoagulants to prevent thromboembolism. Due to suspension of use authorization, it was not possible to make recommendations regarding the use of casirivimab + imdevimab. Strong recommendations against the use of azithromycin in patients without suspected bacterial infection, hydroxychloroquine, convalescent plasma, colchicine, and lopinavir + ritonavir and conditional recommendations against the use of ivermectin and remdesivir were made. CONCLUSION: New recommendations for the treatment of hospitalized patients with COVID-19 were generated, such as those for tocilizumab and baricitinib. Corticosteroids and prophylaxis for thromboembolism are still recommended, the latter with conditional recommendation. Several drugs were considered ineffective and should not be used to provide the best treatment according to the principles of evidence-based medicine and to promote resource economy.
Asunto(s)
COVID-19 , Tromboembolia , Humanos , Brasil/epidemiología , Sueroterapia para COVID-19 , Corticoesteroides , OxígenoRESUMEN
ABSTRACT Objective: To update the recommendations to support decisions regarding the pharmacological treatment of patients hospitalized with COVID-19 in Brazil. Methods: Experts, including representatives of the Ministry of Health and methodologists, created this guideline. The method used for the rapid development of guidelines was based on the adoption and/or adaptation of existing international guidelines (GRADE ADOLOPMENT) and supported by the e-COVID-19 RecMap platform. The quality of the evidence and the preparation of the recommendations followed the GRADE method. Results: Twenty-one recommendations were generated, including strong recommendations for the use of corticosteroids in patients using supplemental oxygen and conditional recommendations for the use of tocilizumab and baricitinib for patients on supplemental oxygen or on noninvasive ventilation and anticoagulants to prevent thromboembolism. Due to suspension of use authorization, it was not possible to make recommendations regarding the use of casirivimab + imdevimab. Strong recommendations against the use of azithromycin in patients without suspected bacterial infection, hydroxychloroquine, convalescent plasma, colchicine, and lopinavir + ritonavir and conditional recommendations against the use of ivermectin and remdesivir were made. Conclusion: New recommendations for the treatment of hospitalized patients with COVID-19 were generated, such as those for tocilizumab and baricitinib. Corticosteroids and prophylaxis for thromboembolism are still recommended, the latter with conditional recommendation. Several drugs were considered ineffective and should not be used to provide the best treatment according to the principles of evidence-based medicine and to promote resource economy.
RESUMO Objetivo: Atualizar as recomendações para embasar as decisões para o tratamento farmacológico de pacientes hospitalizados com COVID-19 no Brasil. Métodos: A elaboração desta diretriz foi feita por especialistas, incluindo representantes do Ministério da Saúde e metodologistas. O método utilizado para o desenvolvimento rápido de diretrizes baseou-se na adoção e/ou adaptação de diretrizes internacionais existentes (GRADE ADOLOPMENT) e contou com o apoio da plataforma e-COVID-19 RecMap. A qualidade das evidências e a elaboração das recomendações seguiram o método GRADE. Resultados: Chegaram-se a 21 recomendações, incluindo recomendações fortes quanto ao uso de corticosteroides em pacientes em uso de oxigênio suplementar e recomendações condicionais para o uso de tocilizumabe e baricitinibe, em pacientes com oxigênio suplementar ou ventilação não invasiva, e de anticoagulantes, para prevenção de tromboembolismo. Devido à suspensão da autorização de uso, não foi possível fazer recomendações para o tratamento com casirivimabe + imdevimabe. Foram feitas recomendações fortes contra o uso de azitromicina em pacientes sem suspeita de infecção bacteriana, hidroxicloroquina, plasma convalescente, colchicina e lopinavir + ritonavir, além de recomendações condicionais contra o uso de ivermectina e rendesivir. Conclusão: Foram criadas novas recomendações para o tratamento de pacientes hospitalizados com COVID-19, como as recomendações de tocilizumabe e baricitinibe. Ainda são recomendados corticosteroides e profilaxia contra tromboembolismo, esta em caráter condicional. Vários medicamentos foram considerados ineficazes e não devem ser usados, no intuito de proporcionar o melhor tratamento segundo os princípios da medicina baseada em evidências e promover a economia de recursos.
RESUMEN
BACKGROUND: Type 2 diabetes mellitus (T2DM) is a severe metabolic condition which is commonly comorbid with depression. Lifestyle factors are involved in the pathophysiology of both conditions; however, the role of lifestyle interventions remains unclear. OBJECTIVE: The objective of this study is to systematically review the literature on randomized controlled trials evaluating the effect of lifestyle interventions on depressive scores in patients with T2DM. METHODS: A systematic search was conducted in computerized databases before October 2022. A random-effects model was used to investigate the effect of lifestyle interventions on depression scores and meta-regression was conducted to assess the influence of age and disease onset. RESULTS: Six trials met the eligibility criteria for inclusion. A statistically significant reduction in depression scores was found for groups receiving lifestyle interventions compared to controls (SMD = -0.49 [95%CI -0.89 to -0.08]; p = 0.0269]). Interventions increased in efficacy with the age of the participants but no significant correlation was found with years since disease onset. Participants in a control group receiving a less intense lifestyle intervention demonstrated improved depression scores when compared to those who received standard care or no intervention at all. Trial design and outcome measurement tools were heterogeneous between studies and limited data on antidepressant use was available which may introduce bias into the results. CONCLUSION: Lifestyle interventions were effective at improving depressive symptom severity in patients with T2DM.
Asunto(s)
Diabetes Mellitus Tipo 2 , Humanos , Antidepresivos , Depresión/terapia , Diabetes Mellitus Tipo 2/complicaciones , Diabetes Mellitus Tipo 2/terapia , Estilo de Vida , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
Recent data from meta-analyses of randomized clinical trials (RCTs) suggest that dietary intake of coconut oil, rich in saturated fatty acids, does not result in cardiometabolic benefits, nor in improvements in anthropometric, lipid, glycemic, and subclinical inflammation parameters. Nevertheless, its consumption has surged in recent years all over the world, a phenomenon which can possibly be explained by an increasing belief among health professionals that this oil is as healthy as, or perhaps even healthier than, other oils, in addition to social network misinformation spread. The objective of this review is to present nutritional and epidemiological aspects related to coconut oil, its relationship with metabolic and cardiovascular health, as well as possible hypotheses to explain its high rate of consumption, in spite of the most recent data regarding its actual effects.
Asunto(s)
Enfermedades Cardiovasculares , Salud Pública , Humanos , Aceite de Coco , Ácidos Grasos , Factores de Riesgo , Enfermedades Cardiovasculares/etiología , Aceites de Plantas/uso terapéutico , Grasas de la DietaRESUMEN
AIMS: Concerns regarding breast and bladder cancer risk with Sodium-glucose cotransporter-2 (SGLT2) inhibitors remain controversial and its effect on cancer mortality is unknown. We aim to evaluate the association between SGLT2 inhibitors and the risk of cancer outcomes. METHODS: We searched PubMed, Embase and CENTRAL up to June 20th, 2022, for randomized controlled trials of SGLT2 inhibitors in adults, with a minimum follow-up of 48 weeks. Researchers extracted study-level data and assessed within-study risk of bias with the RoB 2.0 tool and quality of evidence with GRADE. We performed meta-analyses summarizing the relative risks (RRs) of cancer outcomes. RESULTS: Seventy-six trials encompassing 116,375 participants were selected. Overall risk of bias was low. SGLT2 inhibitors did not reduce/increase the overall risk of cancer (RR, 1.03; 95% confidence interval [CI], 0.96-1.10) and cancer mortality (RR, 0.99; 95% CI, 0.85-1.16). SGLT2 inhibitors likely result in little to no difference in the risk of breast (RR, 1.01; 95% CI 0.77-1.32) and bladder cancers (RR, 0.93; 95% CI 0.71-1.21). Trial sequential analysis provided evidence that the sample size was sufficient to avoid missing alternative results. CONCLUSIONS: SGLT2 inhibitors are not associated with an increased risk of cancer outcomes, providing reassuring data regarding previous safety concerns.
Asunto(s)
Diabetes Mellitus Tipo 2 , Neoplasias , Inhibidores del Cotransportador de Sodio-Glucosa 2 , Humanos , Hipoglucemiantes/efectos adversos , Inhibidores del Cotransportador de Sodio-Glucosa 2/efectos adversos , Diabetes Mellitus Tipo 2/complicaciones , Ensayos Clínicos Controlados Aleatorios como Asunto , Neoplasias/tratamiento farmacológico , Neoplasias/complicaciones , Glucosa , SodioRESUMEN
CONTEXT: People with type 2 diabetes (T2D) have higher risks of cancer incidence and death. OBJECTIVE: We aimed to evaluate the relationship between dietary and physical activity-based lifestyle intervention and cancer outcomes among prediabetes and T2D populations. METHODS: We searched for randomized controlled trials with at least 24 months of lifestyle interventions in prediabetes or T2D populations. Data were extracted by pairs of reviewers and discrepancies were resolved by consensus. Descriptive syntheses were performed, and the risk of bias was assessed. Relative risks (RRs) and 95% CIs were estimated using a pairwise meta-analysis with both a random-effects model and a general linear mixed model (GLMM). Certainty of evidence was evaluated using the Grading of Recommendations Assessment, Development, and Evaluation framework, and trial sequential analysis (TSA) was conducted to assess if current information is enough for definitive conclusions. Subgroup analysis was performed by glycemic status. RESULTS: Six clinical trials were included. Among 12 841 participants, the combined RR for cancer mortality comparing lifestyle interventions with usual care was 0.94 (95% CI, 0.81-1.10 using GLMM and 0.82-1.09 using random-effects model). Most studies had a low risk of bias, and the certainty of evidence was moderate. TSA showed that the cumulative Z curve reached futility boundary while total number did not reach detection boundary. CONCLUSION: Based on the limited data available, dietary and physical activity-based lifestyle interventions had no superiority to usual care on reducing cancer risk in populations with prediabetes and T2D. Lifestyle interventions focused on cancer outcomes should be tested to better explore their effects.
Asunto(s)
Diabetes Mellitus Tipo 2 , Neoplasias , Estado Prediabético , Humanos , Diabetes Mellitus Tipo 2/complicaciones , Diabetes Mellitus Tipo 2/epidemiología , Diabetes Mellitus Tipo 2/terapia , Estado Prediabético/complicaciones , Estado Prediabético/epidemiología , Estado Prediabético/terapia , Estilo de Vida , Ejercicio Físico , Neoplasias/epidemiología , Neoplasias/terapiaRESUMEN
ABSTRACT Recent data from meta-analyses of randomized clinical trials (RCTs) suggest that dietary intake of coconut oil, rich in saturated fatty acids, does not result in cardiometabolic benefits, nor in improvements in anthropometric, lipid, glycemic, and subclinical inflammation parameters. Nevertheless, its consumption has surged in recent years all over the world, a phenomenon which can possibly be explained by an increasing belief among health professionals that this oil is as healthy as, or perhaps even healthier than, other oils, in addition to social network misinformation spread. The objective of this review is to present nutritional and epidemiological aspects related to coconut oil, its relationship with metabolic and cardiovascular health, as well as possible hypotheses to explain its high rate of consumption, in spite of the most recent data regarding its actual effects.
RESUMEN
BACKGROUND: Lifestyle interventions improve the metabolic control of individuals with hyperglycemia. PURPOSE: We aimed to determine the effect of lifestyle interventions on cardiovascular and all-cause mortality in this population. DATA SOURCES: Searches were made through MEDLINE, Cochrane CENTRAL, Embase, and Web of Science (no date/language restriction, until 15 May 2022). STUDY SELECTION: We included randomized clinical trials (RCTs) of subjects with prediabetes and type 2 diabetes, comparing intensive lifestyle interventions with usual care, with a minimum of 2 years of active intervention. DATA EXTRACTION: Data from the 11 RCTs selected were extracted in duplicate. A frequentist and arm-based meta-analysis was performed with random-effects models to estimate relative risk (RR) for mortality, and heterogeneity was assessed through I2 metrics. A generalized linear mixed model (GLMM) was used to confirm the findings. DATA SYNTHESIS: Lifestyle interventions were not superior to usual care in reducing cardiovascular (RR 0.99; 95% CI 0.79-1.23) or all-cause (RR 0.93; 95% CI 0.85-1.03) mortality. Subgroup, sensitivity, and meta-regression analyses showed no influence of type of intervention, mean follow-up, age, glycemic status, geographical location, risk of bias, or weight change. All of these results were confirmed with the GLMM. Most studies had a low risk of bias according to the RoB 2.0 tool and the certainty of evidence was moderate for both outcomes. LIMITATIONS: Most studies had a low risk of bias according to the RoB 2.0 tool, and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach resulted in moderate certainty of evidence for both outcomes. Differences in lifestyle programs and in usual care between the studies should be considered in the interpretation of our results. CONCLUSIONS: Intensive lifestyle interventions implemented so far did not show superiority to usual care in reducing cardiovascular or all-cause mortality for subjects with prediabetes and type 2 diabetes.
Asunto(s)
Sistema Cardiovascular , Diabetes Mellitus Tipo 2 , Hiperglucemia , Estado Prediabético , Humanos , Estilo de VidaRESUMEN
BACKGROUND: Despite having a 92% concentration of saturated fatty acid composition, leading to an apparently unfavorable lipid profile, body weight and glycemic effect, coconut oil is consumed worldwide. Thus, we conducted an updated systematic review and meta-analysis of randomized clinical trials (RCTs) to analyze the effect of coconut oil intake on different cardiometabolic outcomes. METHODS: We searched Medline, Embase, and LILACS for RCTs conducted prior to April 2022. We included RCTs that compared effects of coconut oil intake with other substances on anthropometric and metabolic profiles in adults published in all languages, and excluded non-randomized trials and short follow-up studies. Risk of bias was assessed with the RoB 2 tool and certainty of evidence with GRADE. Where possible, we performed meta-analyses using a random-effects model. RESULTS: We included seven studies in the meta-analysis (n = 515; 50% females, follow up from 4 weeks to 2 years). The amount of coconut oil consumed varied and is expressed differently among studies: 12 to 30 ml of coconut oil/day (n = 5), as part of the amount of SFAs or total daily consumed fat (n = 1), a variation of 6 to 54.4 g/day (n = 5), or as part of the total caloric energy intake (15 to 21%) (n = 6). Coconut oil intake did not significantly decrease body weight (MD -0.24 kg, 95% CI -0.83 kg to 0.34 kg), waist circumference (MD -0.64 cm, 95% CI -1.69 cm to 0.41 cm), and % body fat (-0.10%, 95% CI -0.56% to 0.36%), low-density lipoprotein cholesterol (LDL-C) (MD -1.67 mg/dL, 95% CI -6.93 to 3.59 mg/dL), and triglyceride (TG) levels (MD -0.24 mg/dL, 95% CI -5.52 to 5.04 mg/dL). However, coconut oil intake was associated with a small increase in high-density lipoprotein cholesterol (HDL-C) (MD 3.28 mg/dL, 95% CI 0.66 to 5.90 mg/dL). Overall risk of bias was high, and certainty of evidence was very-low. Study limitations include the heterogeneity of intervention methods, in addition to small samples and short follow-ups, which undermine the effects of dietary intervention in metabolic parameters. CONCLUSIONS: Coconut oil intake revealed no clinically relevant improvement in lipid profile and body composition compared to other oils/fats. Strategies to advise the public on the consumption of other oils, not coconut oil, due to proven cardiometabolic benefits should be implemented. REGISTRATION: PROSPERO CRD42018081461.
Asunto(s)
Enfermedades Cardiovasculares , Grasas de la Dieta , Adulto , Peso Corporal , Enfermedades Cardiovasculares/tratamiento farmacológico , Enfermedades Cardiovasculares/prevención & control , HDL-Colesterol , Aceite de Coco/farmacología , Aceite de Coco/uso terapéutico , Grasas de la Dieta/farmacología , Femenino , Humanos , Masculino , Aceites de Plantas/farmacología , Aceites de Plantas/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
OBJECTIVE: Several therapies are being used or proposed for COVID-19, and many lack appropriate evaluations of their effectiveness and safety. The purpose of this document is to develop recommendations to support decisions regarding the pharmacological treatment of patients hospitalized with COVID-19 in Brazil. METHODS: A group of 27 experts, including representatives of the Ministry of Health and methodologists, created this guideline. The method used for the rapid development of guidelines was based on the adoption and/or adaptation of existing international guidelines (GRADE ADOLOPMENT) and supported by the e-COVID-19 RecMap platform. The quality of the evidence and the preparation of the recommendations followed the GRADE method. RESULTS: Sixteen recommendations were generated. They include strong recommendations for the use of corticosteroids in patients using supplemental oxygen, the use of anticoagulants at prophylactic doses to prevent thromboembolism and the nonuse of antibiotics in patients without suspected bacterial infection. It was not possible to make a recommendation regarding the use of tocilizumab in patients hospitalized with COVID-19 using oxygen due to uncertainties regarding the availability of and access to the drug. Strong recommendations against the use of hydroxychloroquine, convalescent plasma, colchicine, lopinavir + ritonavir and antibiotics in patients without suspected bacterial infection and also conditional recommendations against the use of casirivimab + imdevimab, ivermectin and rendesivir were made. CONCLUSION: To date, few therapies have proven effective in the treatment of hospitalized patients with COVID-19, and only corticosteroids and prophylaxis for thromboembolism are recommended. Several drugs were considered ineffective and should not be used to provide the best treatment according to the principles of evidence-based medicine and promote economical resource use.
OBJETIVOS: Há diversas terapias sendo utilizadas ou propostas para a COVID-19, muitas carecendo de apropriada avaliação de efetividade e segurança. O propósito deste documento é elaborar recomendações para subsidiar decisões sobre o tratamento farmacológico de pacientes hospitalizados com COVID-19 no Brasil. MÉTODOS: Um grupo de 27 membros, formado por especialistas, representantes do Ministério da Saúde e metodologistas, integra essa diretriz. Foi utilizado o método de elaboração de diretrizes rápidas, tomando por base a adoção e/ou a adaptação de recomendações a partir de diretrizes internacionais existentes (GRADE ADOLOPMENT), apoiadas pela plataforma e-COVID-19 RecMap. A qualidade das evidências e a elaboração das recomendações seguiram o método GRADE. RESULTADOS: Foram geradas 16 recomendações. Entre elas, estão recomendações fortes para o uso de corticosteroides em pacientes em uso de oxigênio suplementar, para o uso de anticoagulantes em doses de profilaxia para tromboembolismo e para não uso de antibacterianos nos pacientes sem suspeita de infecção bacteriana. Não foi possível fazer uma recomendação quanto à utilização do tocilizumabe em pacientes hospitalizados com COVID-19 em uso de oxigênio, pelas incertezas na disponibilidade e de acesso ao medicamento. Foi feita recomendação para não usar azitromicina, casirivimabe + imdevimabe, cloroquina, colchicina, hidroxicloroquina, ivermectina, lopinavir/ ritonavir, plasma convalescente e rendesivir. CONCLUSÃO: Até o momento, poucas terapias se provaram efetivas no tratamento do paciente hospitalizado com COVID-19, sendo recomendados apenas corticosteroides e profilaxia para tromboembolismo. Diversos medicamentos foram considerados ineficazes, devendo ser descartados, de forma a oferecer o melhor tratamento pelos princípios da medicina baseada em evidências e promover economia de recursos não eficazes.
Asunto(s)
Tratamiento Farmacológico de COVID-19 , COVID-19 , Tromboembolia , Corticoesteroides/uso terapéutico , Antibacterianos , Anticuerpos Monoclonales Humanizados , Brasil , COVID-19/terapia , Humanos , Inmunización Pasiva , Oxígeno , Sueroterapia para COVID-19RESUMEN
BACKGROUND: Heart failure (HF) is a growing problem for healthcare systems worldwide. Sodium and fluid restriction are non-pharmacological treatments recommended for patients with HF by several guidelines over the years, even without consensus. OBJECTIVE: To evaluate the effects of sodium and fluid restriction in patients with HF. METHODS: We searched MEDLINE, Embase, and Cochrane CENTRAL databases up to June 2020 and screened the reference lists of relevant articles. We included randomized controlled trials evaluating sodium and/or fluid restriction in patients with HF. We assessed three independent comparisons: (a) sodium restriction versus control; (b) fluid restriction versus control; and (c) sodium and fluid restriction versus control. Main outcomes of interest were all-cause mortality and hospitalization. Two independent reviewers selected studies and extracted data. We pooled the results using random-effects meta-analysis. We used the RoB 2.0 and the GRADE framework to assess risk of bias and quality of evidence. RESULTS: We included 16 studies totaling 3545 patients in our meta-analysis. Daily sodium intake was 1.5-2.4 g for the intervention group and >2.7 g for the control group, and daily fluid intake was 0.8-1.5 L for the intervention group and free oral fluid intake for the control group. Sodium restriction increased mortality (relative risk 1.92, 95% confidence interval 1.51 to 2.45, moderate quality of evidence) and hospitalization (relative risk 1.63, 1.11 to 2.40, low quality of evidence). Fluid restriction reduced mortality (relative risk 0.32, 0.13 to 0.82, low quality of evidence) and hospitalization (relative risk 0.46, 0.27 to 0.77, n = 331, low quality of evidence). The combination of sodium and fluid restriction did not significantly affect the risk of mortality (relative risk 0.92, 0.49 to 1.73, low quality of evidence) or the risk of hospitalization (relative risk 0.94, 0.75 to 1.19, low quality of evidence). CONCLUSION: The combination of sodium and fluid restriction in clinical trials resulted in a null effect although results in the opposite direction were observed for each intervention independently. Combined sodium and fluid restriction are usually recommended for patients with HF. Our findings of sodium restriction harm, risk of mortality and hospitalization are consistent with publications from several clinical trial and physiologic explanations. A well-designed clinical trial nested by an implementation study is urgent for definitive sodium range recommendation, specially considering the change of currently guidelines, pushing up the cut-off of sodium restriction range.
Asunto(s)
Insuficiencia Cardíaca , Sodio , Ingestión de Líquidos , Fluidoterapia/métodos , Insuficiencia Cardíaca/terapia , Hospitalización , HumanosRESUMEN
BACKGROUND: Several therapies have been used or proposed for the treatment of COVID-19, although their effectiveness and safety have not been properly evaluated. The purpose of this document is to provide recommendations to support decisions about the drug treatment of outpatients with COVID-19 in Brazil. METHODS: A panel consisting of experts from different clinical fields, representatives of the Brazilian Ministry of Health, and methodologists (37 members in total) was responsible for preparing these guidelines. A rapid guideline development method was used, based on the adoption and/or adaptation of recommendations from existing international guidelines combined with additional structured searches for primary studies and new recommendations whenever necessary (GRADE-ADOLOPMENT). The rating of quality of evidence and the drafting of recommendations followed the GRADE method. RESULTS: Ten technologies were evaluated, and 10 recommendations were prepared. Recommendations were made against the use of anticoagulants, azithromycin, budesonide, colchicine, corticosteroids, hydroxychloroquine/chloroquine alone or combined with azithromycin, ivermectin, nitazoxanide, and convalescent plasma. It was not possible to make a recommendation regarding the use of monoclonal antibodies in outpatients, as their benefit is uncertain and their cost is high, with limitations of availability and implementation. CONCLUSION: To date, few therapies have demonstrated effectiveness in the treatment of outpatients with COVID-19. Recommendations are restricted to what should not be used, in order to provide the best treatment according to the principles of evidence-based medicine and to promote resource savings by aboiding ineffective treatments.
Asunto(s)
Tratamiento Farmacológico de COVID-19 , COVID-19 , Cardiología , Enfermedades Transmisibles , Medicina de Emergencia , Geriatría , Azitromicina , Brasil , COVID-19/terapia , Medicina Comunitaria , Humanos , Inmunización Pasiva , Pacientes Ambulatorios , Procedimientos Quirúrgicos Vasculares , Sueroterapia para COVID-19RESUMEN
BACKGROUND AND AIMS: Despite recent scientific evidence indicating absence of cardiometabolic benefit resulting from coconut oil intake, its consumption has increased in recent years, which can be attributed to a promotion of its use on social networks. We evaluated the patterns, reasons and beliefs related to coconut oil consumption and its perceived benefits in an online survey of a population in southern Brazil. METHODS AND RESULTS: We conducted a before-and-after study using an 11-item online questionnaire that evaluated coconut oil consumption. In the same survey, participants who consumed coconut oil received an intervention to increase literacy about the health effects of coconut oil intake. We obtained 3160 valid responses. Among participants who consumed coconut oil (59.1%), 82.5% considered it healthy and 65.4% used it at least once a month. 81.2% coconut oil consumers did not observe any health improvements. After being exposed to the conclusions of a meta-analysis showing that coconut oil does not show superior health benefits when compared to other oils and fats, 73.5% of those who considered coconut oil healthy did not change their opinion. Among individuals who did not consume coconut oil, 47.6% considered it expensive and 11.6% deemed it unhealthy. CONCLUSIONS: Coconut oil consumption is motivated by the responders' own beliefs in its supposed health benefits, despite what scientific research demonstrates. This highlights the difficulty in deconstructing inappropriate concepts of healthy diets that are disseminated in society.
Asunto(s)
Estado Nutricional , Aceites de Plantas , Aceite de Coco/efectos adversos , Comunicación , Dieta Saludable , Grasas de la Dieta , Humanos , Aceites de Plantas/efectos adversosRESUMEN
Há diversas terapias sendo utilizadas ou propostas para a COVID-19, muitas carecendo de apropriada avaliação de efetividade e segurança. O propósito deste documento é elaborar recomendações para subsidiar decisões sobre o tratamento farmacológico de pacientes hospitalizados com COVID-19 no Brasil. Métodos: Um grupo de 27 membros, formado por especialistas, representantes do Ministério da Saúde e metodologistas, integra essa diretriz. Foi utilizado o método de elaboração de diretrizes rápidas, tomando por base a adoção e/ou a adaptação de recomendações a partir de diretrizes internacionais existentes (GRADE ADOLOPMENT), apoiadas pela plataforma e-COVID-19 RecMap. A qualidade das evidências e a elaboração das recomendações seguiram o método GRADE. Resultados: Foram geradas 16 recomendações. Entre elas, estão recomendações fortes para o uso de corticosteroides em pacientes em uso de oxigênio suplementar, para o uso de anticoagulantes em doses de profilaxia para tromboembolismo e para não uso de antibacterianos nos pacientes sem suspeita de infecção bacteriana. Não foi possível fazer uma recomendação quanto à utilização do tocilizumabe em pacientes hospitalizados com COVID-19 em uso de oxigênio, pelas incertezas na disponibilidade e de acesso ao medicamento. Foi feita recomendação para não usar azitromicina, casirivimabe + imdevimabe, cloroquina, colchicina, hidroxicloroquina, ivermectina, lopinavir/ ritonavir, plasma convalescente e rendesivir. Conclusão: Até o momento, poucas terapias se provaram efetivas no tratamento do paciente hospitalizado com COVID-19, sendo recomendados apenas corticosteroides e profilaxia para tromboembolismo. Diversos medicamentos foram considerados ineficazes, devendo ser descartados, de forma a oferecer o melhor tratamento pelos princípios da medicina baseada em evidências e promover economia de recursos não eficazes.
Several therapies are being used or proposed for COVID-19, and many lack appropriate evaluations of their effectiveness and safety. The purpose of this document is to develop recommendations to support decisions regarding the pharmacological treatment of patients hospitalized with COVID-19 in Brazil. Methods: A group of 27 experts, including representatives of the Ministry of Health and methodologists, created this guideline. The method used for the rapid development of guidelines was based on the adoption and/or adaptation of existing international guidelines (GRADE ADOLOPMENT) and supported by the e-COVID-19 RecMap platform. The quality of the evidence and the preparation of the recommendations followed the GRADE method. Results: Sixteen recommendations were generated. They include strong recommendations for the use of corticosteroids in patients using supplemental oxygen, the use of anticoagulants at prophylactic doses to prevent thromboembolism and the nonuse of antibiotics in patients without suspected bacterial infection. It was not possible to make a recommendation regarding the use of tocilizumab in patients hospitalized with COVID-19 using oxygen due to uncertainties regarding the availability of and access to the drug. Strong recommendations against the use of hydroxychloroquine, convalescent plasma, colchicine, lopinavir + ritonavir and antibiotics in patients without suspected bacterial infection and also conditional recommendations against the use of casirivimab + imdevimab, ivermectin and rendesivir were made. Conclusion: To date, few therapies have proven effective in the treatment of hospitalized patients with COVID-19, and only corticosteroids and prophylaxis for thromboembolism are recommended. Several drugs were considered ineffective and should not be used to provide the best treatment according to the principles of evidence-based medicine and promote economical resource use.
Asunto(s)
Humanos , SARS-CoV-2/efectos de los fármacos , COVID-19/tratamiento farmacológico , Terapia por Inhalación de Oxígeno , Tromboembolia/prevención & control , Inmunización Pasiva , Corticoesteroides/uso terapéutico , Lopinavir/uso terapéutico , Directrices para la Planificación en Salud , Hidroxicloroquina , Antibacterianos/uso terapéuticoRESUMEN
Over the last decade, there has been a 10-fold increase in the number of published systematic reviews of prevalence. In meta-analyses of prevalence, the summary estimate represents an average prevalence from included studies. This estimate is truly informative only if there is no substantial heterogeneity among the different contexts being pooled. In systematic reviews, heterogeneity is usually explored with I-squared statistic (I2 ), but this statistic does not directly inform us about the distribution of effects and frequently systematic reviewers and readers misinterpret this result. In a sample of 134 meta-analyses of prevalence, the median I2 was 96.9% (IQR 90.5-98.7). We observed larger I2 in meta-analysis with higher number of studies and extreme pooled estimates (defined as <10% or >90%). Studies with high I2 values were more likely to have conducted a sensitivity analysis, including subgroup analysis but only three (2%) systematic reviews reported prediction intervals. We observed that meta-analyses of prevalence often present high I2 values. However, the number of studies included in the meta-analysis and the point estimate can be associated with the I2 value, and a high I2 value is not always synonymous with high heterogeneity. In meta-analyses of prevalence, I2 statistics may not be discriminative and should be interpreted with caution, avoiding arbitrary thresholds. To discuss heterogeneity, reviewers should focus on the description of the expected range of estimates, which can be done using prediction intervals and planned sensitivity analysis.
Asunto(s)
Revisiones Sistemáticas como Asunto , PrevalenciaRESUMEN
ABSTRACT Background Several therapies have been used or proposed for the treatment of COVID-19, although their effectiveness and safety have not been properly evaluated. The purpose of this document is to provide recommendations to support decisions about the drug treatment of outpatients with COVID-19 in Brazil. Methods A panel consisting of experts from different clinical fields, representatives of the Brazilian Ministry of Health, and methodologists (37 members in total) was responsible for preparing these guidelines. A rapid guideline development method was used, based on the adoption and/or adaptation of recommendations from existing international guidelines combined with additional structured searches for primary studies and new recommendations whenever necessary (GRADE-ADOLOPMENT). The rating of quality of evidence and the drafting of recommendations followed the GRADE method. Results Ten technologies were evaluated, and 10 recommendations were prepared. Recommendations were made against the use of anticoagulants, azithromycin, budesonide, colchicine, corticosteroids, hydroxychloroquine/chloroquine alone or combined with azithromycin, ivermectin, nitazoxanide, and convalescent plasma. It was not possible to make a recommendation regarding the use of monoclonal antibodies in outpatients, as their benefit is uncertain and their cost is high, with limitations of availability and implementation. Conclusion To date, few therapies have demonstrated effectiveness in the treatment of outpatients with COVID-19. Recommendations are restricted to what should not be used, in order to provide the best treatment according to the principles of evidence-based medicine and to promote resource savings by aboiding ineffective treatments.