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Sjogren's disease (SjD) is an autoimmune disease that is characterized not only by the sicca symptoms it causes but also by its systemic nature, which is capable of several and not yet fully understood extraglandular manifestations. To gain a clearer understanding of these manifestations as well as a better practical approach, a panel of experts from the Brazilian Society of Rheumatology conducted a systematic review and meta-analysis on the identification of epidemiologic and clinical features of the extraglandular manifestations present in ESSDAI (EULAR Sjogren´s syndrome disease activity index), followed by a voting panel with recommendations for clinical practice. This publication is complementary to others already published and covers cutaneous and hematological manifestations, with prevalence data generated by a meta-analysis of 13 clinical or laboratory manifestations and 6 clinical management recommendations.
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Síndrome de Sjögren , Enfermedades de la Piel , Humanos , Brasil/epidemiología , Enfermedades Hematológicas/etiología , Reumatología/normas , Síndrome de Sjögren/complicaciones , Enfermedades de la Piel/etiología , Sociedades MédicasRESUMEN
BACKGROUND: The impact of closed-loop control systems to titrate oxygen flow in critically ill patients, including their effectiveness, efficacy, workload and safety, remains unclear. This systematic review investigated the utilization of closed-loop oxygen systems for critically ill patients in comparison to manual oxygen titration systems focusing on these topics. METHODS AND FINDINGS: A search was conducted across several databases including MEDLINE, CENTRAL, EMBASE, LILACS, CINAHL, LOVE, ClinicalTrials.gov, and the World Health Organization on March 3, 2022, with subsequent updates made on June 27, 2023. Evidence databases were searched for randomized clinical parallel or crossover studies investigating closed-loop oxygen control systems for critically ill patients. This systematic review and meta-analysis was performed following the Preferred Reporting Items for Systematic Review and Meta-analysis guidelines. The analysis was conducted using Review Manager software, adopting the mean difference or standardized mean difference with a 95% confidence interval (95% CI) for continuous variables or risk ratio with 95% CI for dichotomous outcomes. The main outcome of interest was the percentage of time spent in the peripheral arterial oxygen saturation target. Secondary outcomes included time for supplemental oxygen weaning, length of stay, mortality, costs, adverse events, and workload of healthcare professional. A total of 37 records from 21 studies were included in this review with a total of 1,577 participants. Compared with manual oxygen titration, closed-loop oxygen control systems increased the percentage of time in the prescribed SpO2 target, mean difference (MD) 25.47; 95% CI 19.7, 30.0], with moderate certainty of evidence. Current evidence also shows that closed-loop oxygen control systems have the potential to reduce the percentage of time with hypoxemia (MD -0.98; 95% CI -1.68, -0.27) and healthcare workload (MD -4.94; 95% CI -7.28, -2.61) with low certainty of evidence. CONCLUSION: Closed-loop oxygen control systems increase the percentage of time in the preferred SpO2 targets and may reduce healthcare workload. TRIAL REGISTRATION: PROSPERO: CRD42022306033.
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Enfermedad Crítica , Terapia por Inhalación de Oxígeno , Oxígeno , Humanos , Enfermedad Crítica/terapia , Oxígeno/administración & dosificación , Terapia por Inhalación de Oxígeno/métodos , Saturación de OxígenoRESUMEN
INTRODUCTION: Cardiac surgery is a frequent surgical procedure and may present a high risk of complications. Among the prophylactic strategies studied to decrease the rates of negative outcomes, respiratory care seems to reduce pulmonary complications. Incentive spirometry (IS) is a low-cost, respiratory exercise technique, used for the prevention and treatment of postoperative pulmonary complications (PPC). The aim of this review was to evaluate whether IS is superior to respiratory care, mobilization exercises, and noninvasive ventilation on PPC, and clinical outcomes. METHODS: Systematic review. Medical Literature Analysis and Retrieval System Online (or MEDLINE®), Embase®, Cochrane Central Register of Controlled Trials (or CENTRAL), Physiotherapy Evidence Database (or PEDro), Cumulative Index of Nursing and Allied Health (or CINAHL®), Latin American and Caribbean Health Sciences Literature (or LILACS), Scientific Electronic Library Online (or SciELO), Allied, Scopus®, and OpenGrey databases, clinical trial registration sites, conferences, congresses, and symposiums were searched. RESULTS: Twenty-one randomized trials and one quasi-randomized trial (1,677 participants) were included. For partial pressure of oxygen (PaO2), IS was inferior to respiratory care (mean difference [MD] -4.48; 95% confidence interval [CI] -8.32 to -0.63). Flow-oriented IS was inferior to respiratory care on PaO2 (MD -4.53; 95% CI -8.88 to -0.18). However, compared to respiratory care, flow-oriented IS was superior on recovery vital capacity. CONCLUSIONS: This meta-analysis revealed that IS was not superior to standard respiratory care for PPCs and clinical outcomes, therefore its use should not be widely recommended until further studies with high quality be performed to ensure this clinical guidance.
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Procedimientos Quirúrgicos Cardíacos , Espirometría , Humanos , Hospitales , Unidades de Cuidados Intensivos , Motivación , Oxígeno , Modalidades de FisioterapiaRESUMEN
ABSTRACT Introduction: Cardiac surgery is a frequent surgical procedure and may present a high risk of complications. Among the prophylactic strategies studied to decrease the rates of negative outcomes, respiratory care seems to reduce pulmonary complications. Incentive spirometry (IS) is a low-cost, respiratory exercise technique, used for the prevention and treatment of postoperative pulmonary complications (PPC). The aim of this review was to evaluate whether IS is superior to respiratory care, mobilization exercises, and noninvasive ventilation on PPC, and clinical outcomes. Methods: Systematic review. Medical Literature Analysis and Retrieval System Online (or MEDLINE®), Embase®, Cochrane Central Register of Controlled Trials (or CENTRAL), Physiotherapy Evidence Database (or PEDro), Cumulative Index of Nursing and Allied Health (or CINAHL®), Latin American and Caribbean Health Sciences Literature (or LILACS), Scientific Electronic Library Online (or SciELO), Allied, Scopus®, and OpenGrey databases, clinical trial registration sites, conferences, congresses, and symposiums were searched. Results: Twenty-one randomized trials and one quasi-randomized trial (1,677 participants) were included. For partial pressure of oxygen (PaO2), IS was inferior to respiratory care (mean difference [MD] -4.48; 95% confidence interval [CI] -8.32 to -0.63). Flow-oriented IS was inferior to respiratory care on PaO2 (MD -4.53; 95% CI -8.88 to -0.18). However, compared to respiratory care, flow-oriented IS was superior on recovery vital capacity. Conclusions: This meta-analysis revealed that IS was not superior to standard respiratory care for PPCs and clinical outcomes, therefore its use should not be widely recommended until further studies with high quality be performed to ensure this clinical guidance.
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Purpose: Impaired respiratory muscle strength has been associated with some geriatric syndromes. However, no studies have previously evaluated the relationship between respiratory muscle strength and dynapenic abdominal obesity. This study aimed to analyze whether there is an association between respiratory muscle strength and abdominal obesity, dynapenia and dynapenic abdominal obesity (DAO) in community-dwelling older adults. Patients and Methods: Cross-sectional study conducted with community-dwelling older adults (n=382 / 70.03 ± 7.3 years) from Macapá, Amapá, Brazil. Respiratory muscle strength was assessed by measuring maximal inspiratory and expiratory pressures (MIP and MEP, respectively), using an analog manovacuometry. DAO was defined as the combination of dynapenia (grip strength < 26 kgf for men and < 16 kgf for women) and abdominal obesity (abdominal circumference > 102 cm for men and > 88 cm for women). We performed descriptive and inferential statistical analyses using the student's t-test for independent and related samples and linear regression model. Results: Older adults with abdominal obesity, dynapenia, and DAO presented lower mean values (obtained and obtained versus predicted; except abdominal obesity versus MIP) for maximal respiratory pressures compared to individuals without these conditions. However, the adjusted analysis only indicated an association between MIP and the following conditions: dynapenia (MIP - ß =-0.171; p<0.001), abdominal obesity (MIP - ß=0.102; p=0.042), and DAO (MIP - ß=-0.101; p=0.028). Conclusion: Older adults with abdominal obesity, dynapenia, and DAO showed impaired maximal respiratory pressures. The results of the adjusted analysis indicate that inspiratory muscle strength may require greater attention by health professionals aiming at preventing respiratory complications and improving respiratory health care in older people with these conditions.
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Vida Independiente , Obesidad Abdominal , Masculino , Femenino , Humanos , Anciano , Obesidad Abdominal/epidemiología , Estudios Transversales , Obesidad/epidemiología , Fuerza Muscular , Músculos RespiratoriosRESUMEN
BACKGROUND: Although exercise is recommended as part of the cystic fibrosis (CF) therapeutic routine, adherence to exercise is still limited. Digital health technologies can provide easy-to-access health information and may help improve healthcare and outcomes in individuals with long-term conditions. However, its effects for delivering and monitoring exercise programs in CF have not yet been synthesized. OBJECTIVES: To evaluate the benefits and harms of digital health technologies for delivering and monitoring exercise programs, increasing adherence to exercise regimens, and improving key clinical outcomes in people with CF. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was 21 November 2022. SELECTION CRITERIA: We included randomized controlled trials (RCTs) or quasi-RCTs of digital health technologies for delivering or monitoring exercise programs in CF. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were 1. physical activity, 2. self-management behavior, and 3. pulmonary exacerbations. Our secondary outcomes were 4. usability of technologies, 5. quality of life, 6. lung function, 7. muscle strength, 8. exercise capacity, 9. physiologic parameters, and 10. ADVERSE EVENTS: We used GRADE to assess certainty of evidence. MAIN RESULTS: We identified four parallel RCTs (three single-center and one multicenter with 231 participants aged six years or older). The RCTs evaluated different modes of digital health technologies with distinct purposes, combined with diverse interventions. We identified important methodologic concerns in the RCTs, including insufficient information on the randomization process, blinding of outcome assessors, balance of non-protocol interventions across groups, and whether the analyses performed corrected for bias due to missing outcome data. Non-reporting of results may also be a concern, especially because some planned outcome results were reported incompletely. Furthermore, each trial had a small number of participants, resulting in imprecise effects. These limitations on the risk of bias, and on the precision of effect estimates resulted in overall low- to very low-certainty evidence. We undertook four comparisons and present the findings for our primary outcomes below. There is no information on the effectiveness of other modes of digital health technologies for monitoring physical activity or delivering exercise programs in people with CF, on adverse events related to the use of digital health technologies either for delivering or monitoring exercise programs in CF, and on their long-term effects (more than one year). Digital health technologies for monitoring physical activity Wearable fitness tracker plus personalized exercise prescription compared to personalized exercise prescription alone One trial (40 adults with CF) evaluated this outcome, but did not report data for any of our primary outcomes. Wearable fitness tracker plus text message for personalized feedback and goal setting compared to wearable fitness tracker alone The evidence is very uncertain about the effects of a wearable fitness tracker plus text message for personalized feedback and goal setting, compared to wearable technology alone on physical activity measured by step count at six-month follow-up (mean difference [MD] 675.00 steps, 95% confidence interval [CI] -2406.37 to 3756.37; 1 trial, 32 participants). The same study measured pulmonary exacerbation rates and reported finding no difference between groups. Web-based application to record, monitor, and set goals on physical activity plus usual care compared to usual care alone Using a web-based application to record, monitor, and set goals on physical activity plus usual care may result in little to no difference on time spent in moderate-to-vigorous physical activity measured via accelerometry compared to usual care alone at six-month follow-up (MD -4 minutes/day, 95% CI -37 to 29; 1 trial, 63 participants). Low certainty-evidence from the same trial suggests that the intervention may result in little to no difference on pulmonary exacerbations during 12 months of follow-up (median 1 respiratory hospitalization, interquartile range [IQR] 0 to 3) versus control (median 1 respiratory hospitalization, IQR 0 to 2; P = 0.6). Digital health technologies for delivering exercise programs Web-based versus face-to-face exercise delivery The evidence is very uncertain about the effects of web-based compared to face-to-face exercise delivery on adherence to physical activity as assessed by the number of participants who completed all exercise sessions after three months of intervention (risk ratio 0.92, 95% CI 0.69 to 1.23; 1 trial, 51 participants). AUTHORS' CONCLUSIONS: The evidence is very uncertain about the effects of an exercise program plus the use of a wearable fitness tracker integrated with a social media platform compared with exercise prescription alone and on the effects of receiving a wearable fitness tracker plus text message for personalized feedback and goal setting, compared to a wearable fitness tracker alone. Low-certainty evidence suggests that using a web-based application to record, monitor, and set goals on physical activity plus usual care may result in little to no difference in time spent in moderate-to-vigorous physical activity, total time spent in activity, pulmonary exacerbations, quality of life, lung function, and exercise capacity compared to usual care alone. Regarding the use of digital health technologies for delivering exercise programs in CF, the evidence is very uncertain about the effects of using a wearable fitness tracker plus personalized exercise prescription compared to personalized exercise prescription alone. Further high-quality RCTs, with blinded outcome assessors, reporting the effects of digital health technologies on clinically important outcome measures, such as physical activity participation and intensity, self-management behavior, and the occurrence of pulmonary exacerbations in the long term are needed. The results of six ongoing RCTs identified through our searches may help clarify the effects of different modes of digital health technologies for delivering and monitoring exercise programs in people with CF.
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Fibrosis Quística , Adulto , Humanos , Fibrosis Quística/terapia , Tecnología Digital , Ejercicio Físico , Terapia por Ejercicio , Estudios Multicéntricos como Asunto , Fuerza Muscular , Calidad de VidaRESUMEN
OBJECTIVE: To identify and assess the current evidence available about the costs of managing hospitalized pediatric patients diagnosed with Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3) in upper-middle-income countries. METHODS: The authors conducted a systematic review across seven key databases from database inception to July 2022. Costs extracted were converted into 2022 International Dollars using the Purchasing Power Parity-adjusted. PROSPERO identifier: CRD42020225757. RESULTS: No eligible study for PIV3 was recovered. For RSV, cost analysis and COI studies were performed for populations in Colombia, China, Malaysia, and Mexico. Comparing the total economic impact, the lowest cost per patient at the pediatric ward was observed in Malaysia ($ 347.60), while the highest was in Colombia ($ 709.66). On the other hand, at pediatric ICU, the lowest cost was observed in China ($ 1068.26), while the highest was in Mexico ($ 3815.56). Although there is no consensus on the major cost driver, all included studies described that the medications (treatment) consumed over 30% of the total cost. A high rate of inappropriate prescription drugs was observed. CONCLUSION: The present study highlighted how RSV infection represents a substantial economic burden to health care systems and to society. The findings of the included studies suggest a possible association between baseline risk status and expenditures. Moreover, it was observed that an important amount of the cost is destinated to treatments that have no evidence or support in most clinical practice guidelines.
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Infecciones por Virus Sincitial Respiratorio , Virus Sincitial Respiratorio Humano , Humanos , Niño , Lactante , Países en Desarrollo , Estrés Financiero , Virus de la Parainfluenza 3 Humana , HospitalizaciónRESUMEN
ABSTRACT BACKGROUND: Tocilizumab is an anti-human interleukin 6 receptor monoclonal antibody that has been used to treat coronavirus disease 2019 (COVID-19). However, there is no consensus on its efficacy for the treatment of COVID-19. OBJECTIVE: To evaluate the effectiveness and safety of tocilizumab for treating COVID-19. DESIGN AND SETTING: Systematic Review of randomized controlled trials (RCTs), Universidade Federal de São Paulo (UNIFESP), São Paulo (SP), Brazil. METHODS: We searched MEDLINE via PubMed, EMBASE, CENTRAL, and IBECS for RCTs published up to March 2021. Two authors selected studies and assessed the risk of bias and the certainty of the evidence following Cochrane Recommendations. RESULTS: Eight RCTs with 6,139 participants were included. We were not able to find differences between using tocilizumab compared to standard care on mortality in hospitalized patients with COVID-19 (risk ratio (RR) 0.97, 95% confidence interval (CI) 0.84 to 1.13; 8 trials; 5,950 participants; low-certainty evidence). However, hospitalized patients under tocilizumab plus standard care treatment seemed to present a significantly lower risk of needing mechanical ventilation (risk ratio = 0.78; 95% CI 0.64−0.94 moderate-certainty of evidence). CONCLUSIONS: To date, the best evidence available shows no difference between using tocilizumab plus standard care compared to standard care alone for reducing mortality in patients with COVID-19. However, as a finding with a practical implication, the use of tocilizumab in association to standard care probably reduces the risk of progressing to mechanical ventilation in those patients. REGISTRATION: osf.io/qe4fs.
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BACKGROUND: The term central sleep apnoea (CSA) encompasses diverse clinical situations where a dysfunctional drive to breathe leads to recurrent respiratory events, namely apnoea (complete absence of ventilation) and hypopnoea sleep (insufficient ventilation) during sleep. Studies have demonstrated that CSA responds to some extent to pharmacological agents with distinct mechanisms, such as sleep stabilisation and respiratory stimulation. Some therapies for CSA are associated with improved quality of life, although the evidence on this association is uncertain. Moreover, treatment of CSA with non-invasive positive pressure ventilation is not always effective or safe and may result in a residual apnoea-hypopnoea index. OBJECTIVES: To evaluate the benefits and harms of pharmacological treatment compared with active or inactive controls for central sleep apnoea in adults. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was 30 August 2022. SELECTION CRITERIA: We included parallel and cross-over randomised controlled trials (RCTs) that evaluated any type of pharmacological agent compared with active controls (e.g. other medications) or passive controls (e.g. placebo, no treatment or usual care) in adults with CSA as defined by the International Classification of Sleep Disorders 3rd Edition. We did not exclude studies based on the duration of intervention or follow-up. We excluded studies focusing on CSA due to periodic breathing at high altitudes. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were central apnoea-hypopnoea index (cAHI), cardiovascular mortality and serious adverse events. Our secondary outcomes were quality of sleep, quality of life, daytime sleepiness, AHI, all-cause mortality, time to life-saving cardiovascular intervention, and non-serious adverse events. We used GRADE to assess certainty of evidence for each outcome. MAIN RESULTS: We included four cross-over RCTs and one parallel RCT, involving a total of 68 participants. Mean age ranged from 66 to 71.3 years and most participants were men. Four trials recruited people with CSA associated with heart failure, and one study included people with primary CSA. Types of pharmacological agents were acetazolamide (carbonic anhydrase inhibitor), buspirone (anxiolytic), theophylline (methylxanthine derivative) and triazolam (hypnotic), which were given for between three days and one week. Only the study on buspirone reported a formal evaluation of adverse events. These events were rare and mild. No studies reported serious adverse events, quality of sleep, quality of life, all-cause mortality, or time to life-saving cardiovascular intervention. Carbonic anhydrase inhibitors versus inactive control Results were from two studies of acetazolamide versus placebo (n = 12) and acetazolamide versus no acetazolamide (n = 18) for CSA associated with heart failure. One study reported short-term outcomes and the other reported intermediate-term outcomes. We are uncertain whether carbonic anhydrase inhibitors compared to inactive control reduce cAHI in the short term (mean difference (MD) -26.00 events per hour, 95% CI -43.84 to -8.16; 1 study, 12 participants; very low certainty). Similarly, we are uncertain whether carbonic anhydrase inhibitors compared to inactive control reduce AHI in the short term (MD -23.00 events per hour, 95% CI -37.70 to 8.30; 1 study, 12 participants; very low certainty) or in the intermediate term (MD -6.98 events per hour, 95% CI -10.66 to -3.30; 1 study, 18 participants; very low certainty). The effect of carbonic anhydrase inhibitors on cardiovascular mortality in the intermediate term was also uncertain (odds ratio (OR) 0.21, 95% CI 0.02 to 2.48; 1 study, 18 participants; very low certainty). Anxiolytics versus inactive control Results were based on one study of buspirone versus placebo for CSA associated with heart failure (n = 16). The median difference between groups for cAHI was -5.00 events per hour (IQR -8.00 to -0.50), the median difference for AHI was -6.00 events per hour (IQR -8.80 to -1.80), and the median difference on the Epworth Sleepiness Scale for daytime sleepiness was 0 points (IQR -1.0 to 0.00). Methylxanthine derivatives versus inactive control Results were based on one study of theophylline versus placebo for CSA associated with heart failure (n = 15). We are uncertain whether methylxanthine derivatives compared to inactive control reduce cAHI (MD -20.00 events per hour, 95% CI -32.15 to -7.85; 15 participants; very low certainty) or AHI (MD -19.00 events per hour, 95% CI -30.27 to -7.73; 15 participants; very low certainty). Hypnotics versus inactive control Results were based on one trial of triazolam versus placebo for primary CSA (n = 5). Due to very serious methodological limitations and insufficient reporting of outcome measures, we were unable to draw any conclusions regarding the effects of this intervention. AUTHORS' CONCLUSIONS: There is insufficient evidence to support the use of pharmacological therapy in the treatment of CSA. Although small studies have reported positive effects of certain agents for CSA associated with heart failure in reducing the number of respiratory events during sleep, we were unable to assess whether this reduction may impact the quality of life of people with CSA, owing to scarce reporting of important clinical outcomes such as sleep quality or subjective impression of daytime sleepiness. Furthermore, the trials mostly had short-term follow-up. There is a need for high-quality trials that evaluate longer-term effects of pharmacological interventions.
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Trastornos de Somnolencia Excesiva , Insuficiencia Cardíaca , Apnea Central del Sueño , Triazolam , Masculino , Adulto , Humanos , Anciano , Femenino , Apnea Central del Sueño/tratamiento farmacológico , Inhibidores de Anhidrasa Carbónica , Buspirona , Apnea , Teofilina , Acetazolamida , Hipnóticos y SedantesRESUMEN
The scientific literature mentions the existence of factors associated with fear of falling in older adults. However, the direct and indirect paths of its predictors have not yet been fully explored. This study aimed to analyze the socioeconomic, clinical, and health factors directly and indirectly associated with fear of falling in community-dwelling older adults. This is a cross-sectional study conducted in older adults (n = 410 - 70.11 ± 7.22 years). Clinical and health-condition data were collected, as were data on fear of falling using the Falls Efficacy Scale International-Brazil (FES-I Brazil). It was found that being female and having a higher number of self-reported morbidities, worse physical performance, and a higher number of depressive symptoms were directly associated with greater fear of falling. Regarding indirect associations, physical inactivity, mediated by a greater number of morbidities, worse physical performance, and a greater number of depressive symptoms, was associated with greater fear of falling. In addition, worse self-rated health, mediated by a greater number of depressive symptoms, as well as older age, mediated by worse physical performance, were associated with the outcome. This study provides information on the predictors directly and indirectly associated with fear of falling, expanding current understanding of this relationship.
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Abstract Objective: To identify and assess the current evidence available about the costs of managing hospitalized pediatric patients diagnosed with Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3) in upper-middle-income countries. Methods: The authors conducted a systematic review across seven key databases from database inception to July 2022. Costs extracted were converted into 2022 International Dollars using the Purchasing Power Parity-adjusted. PROSPERO identifier: CRD42020225757. Results: No eligible study for PIV3 was recovered. For RSV, cost analysis and COI studies were performed for populations in Colombia, China, Malaysia, and Mexico. Comparing the total economic impact, the lowest cost per patient at the pediatric ward was observed in Malaysia ($ 347.60), while the highest was in Colombia ($ 709.66). On the other hand, at pediatric ICU, the lowest cost was observed in China ($ 1068.26), while the highest was in Mexico ($ 3815.56). Although there is no consensus on the major cost driver, all included studies described that the medications (treatment) consumed over 30% of the total cost. A high rate of inappropriate prescription drugs was observed. Conclusion: The present study highlighted how RSV infection represents a substantial economic burden to health care systems and to society. The findings of the included studies suggest a possible association between baseline risk status and expenditures. Moreover, it was observed that an important amount of the cost is destinated to treatments that have no evidence or support in most clinical practice guidelines.
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INTRODUCTION: Oxygen is the most common drug used in critical care patients to correct episodes of hypoxaemia. The adoption of new technologies in clinical practice, such as closed-loop systems for an automatic oxygen titration, may improve outcomes and reduce the healthcare professionals' workload at the bedside; however, certainty of the evidence regarding the safety and benefits still remains low. We aim to evaluate the effectiveness, efficacy and safety of the closed-loop oxygen control for patients with hypoxaemia during the hospitalisation period by conducting a systematic review and meta-analysis. METHODS AND ANALYSIS: MEDLINE, CENTRAL, EMBASE, LILACS, CINAHL and LOVE evidence databases will be searched. Randomised controlled trials and cross-over studies investigating the PICO (Population, Intervention, Comparator and Outcome) framework will be included. The primary outcomes will be the time in the peripheral oxygen saturation target. Secondary outcomes will include time for oxygen weaning time; length of stay; costs; adverse events; mortality; healthcare professionals' workload, and percentage of time with hypoxia and hyperoxia. Two reviewers will independently screen and extract data and perform quality assessment of included studies. The Cochrane risk of bias tool will be used to assess risk of bias. The RevMan V.5.4 software will be used for statistical analysis. Heterogeneity will be analysed using I2 statistics. Mean difference or standardised mean difference with 95% CI and p value will be used to calculate treatment effect for outcome variables. ETHICS AND DISSEMINATION: Ethical approval is not required because this systematic review and meta-analysis is based on previously published data. Final results will be published in peer-reviewed journals and presented at relevant conferences and events. PROSPERO REGISTRATION NUMBER: CRD42022306033.
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Hiperoxia , Oxígeno , Humanos , Oxígeno/uso terapéutico , Hipoxia/terapia , Cuidados Críticos , Hospitalización , Metaanálisis como Asunto , Revisiones Sistemáticas como AsuntoRESUMEN
Introdução: A apneia obstrutiva do sono (AOS) é o distúrbio respiratório do sono mais comum. O treino muscular respiratório tem surgido como uma intervenção promissora para a melhora dos sintomas e com boa adesão, porém muito ainda se tem discutido sobre sua efetividade e segurança. Objetivo: Avaliar a efetividade e segurança do TMR no tratamento de pacientes com AOS. Métodos: Para tanto, realizaremos uma revisão sistemática de ensaios clínicos randomizados (ECR). O protocolo do estudo foi registrado na Plataforma Prospero (CRD42018096980). Incluiremos indivíduos de idade superior ou igual a 18 anos, com diagnóstico de AOS, em uso ou não de pressão positiva nas vias aéreas. Excluiremos estudos com pacientes diagnosticados com lesão da medula espinhal ou doenças neuromusculares. As buscas serão realizadas nas bases de dados: Medical Literature Analysis and Retrieval System Online (Medline) via Pubmed, Excerpta Medica dataBASE (Embase) via Elsevier, Cochrane Central Register of Controlled Trials (Central) via Cochrane Library, Literatura Latino-Americana e do Caribe em Ciências da Saúde (Lilacs) via Portal da Biblioteca Virtual em Saúde e Physiotherapy Evidence Database (PEDro), sem restrições de idioma ou ano de publicação. Avaliaremos o rigor metodológico dos estudos incluídos e a certeza da evidência dos principais desfechos da revisão sistemática utilizando a ferramenta Risco de Viés 2.0 da Cochrane e a abordagem Grading of Recommendations Assessment, Development and Evaluation (GRADE), respectivamente. A seleção dos estudos, extração de dados, avaliação do viés dos estudos incluídos e avaliação da certeza da evidência serão realizados por dois pesquisadores independentes. Resultados esperados: Espera-se que os resultados desta revisão forneçam informações úteis para a tomada de decisão clínica, exponham lacunas de conhecimento, assim como forneçam um bom embasamento para futuros ECR de alta qualidade sobre o assunto.
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BACKGROUND: Central sleep apnoea (CSA) is characterised by abnormal patterns of ventilation during sleep due to a dysfunctional drive to breathe. Consequently, people with CSA may present poor sleep quality, sleep fragmentation, inattention, fatigue, daytime sleepiness, and reduced quality of life. OBJECTIVES: To assess the effectiveness and safety of non-invasive positive pressure ventilation (NIPV) for the treatment of adults with CSA. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and Scopus on 6 September 2021. We applied no restrictions on language of publication. We also searched clinical trials registries for ongoing and unpublished studies, and scanned the reference lists of included studies to identify additional studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) reported in full text, those published as abstract only, and unpublished data. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies for inclusion, extracted data, and assessed risk of bias of the included studies using the Cochrane risk of bias tool version 1.0, and the certainty of the evidence using the GRADE approach. In the case of disagreement, a third review author was consulted. MAIN RESULTS: We included 15 RCTs with a total of 1936 participants, ranging from 10 to 1325 participants. All studies had important methodological limitations. We assessed most studies (11 studies) as at high risk of bias for at least one domain, and all studies as at unclear risk of bias for at least two domains. The trials included participants aged > 18 years old, of which 70% to 100% were men, who were followed from one week to 60 months. The included studies assessed the effects of different modes of NIPV and CSA. Most participants had CSA associated with chronic heart failure. Because CSA encompasses a variety of causes and underlying clinical conditions, data were carefully analysed, and different conditions and populations were not pooled. The findings for the primary outcomes for the seven evaluated comparisons are presented below. Continuous positive airway pressure (CPAP) plus best supportive care versus best supportive care in CSA associated with chronic heart failure In the short term, CPAP plus best supportive care may reduce central apnoea hypopnoea index (AHI) (mean difference (MD) -14.60, 95% confidence interval (CI) -20.11 to -9.09; 1 study; 205 participants). However, CPAP plus best supportive care may result in little to no difference in cardiovascular mortality compared to best supportive care alone. The evidence for the effect of CPAP plus best supportive care on all-cause mortality is very uncertain. No adverse effects were observed with CPAP, and the results for adverse events in the best supportive care group were not reported. Adaptive servo ventilation (ASV) versus CPAP in CSA associated with chronic heart failure The evidence is very uncertain about the effect of ASV versus CPAP on quality of life evaluated in both the short and medium term. Data on adverse events were not reported, and it is not clear whether data were sought but not found. ASV versus bilevel ventilation in CSA associated with chronic heart failure In the short term, ASV may result in little to no difference in central AHI. No adverse events were detected with ASV, and the results for adverse events in the bilevel ventilation group were not reported. ASV plus best supportive care versus best supportive care in CSA associated with chronic heart failure In the medium term, ASV plus best supportive care may reduce AHI compared to best supportive care alone (MD -20.30, 95% CI -28.75 to -11.85; 1 study; 30 participants). In the long term, ASV plus best supportive care likely increases cardiovascular mortality compared to best supportive care (risk ratio (RR) 1.25, 95% CI 1.04, 1.49; 1 study; 1325 participants). The evidence suggests that ASV plus best supportive care may result in little to no difference in quality of life in the short, medium, and long term, and in all-cause mortality in the medium and long term. Data on adverse events were evaluated but not reported. ASV plus best supportive care versus best supportive care in CSA with acute heart failure with preserved ejection fraction Only adverse events were reported for this comparison, and no adverse events were recorded in either group. ASV versus CPAP maintenance in CPAP-induced CSA In the short term, ASV may slightly reduce central AHI (MD -4.10, 95% CI -6.67 to -1.53; 1 study; 60 participants), but may result in little to no difference in quality of life. Data on adverse events were not reported, and it is not clear whether data were sought but not found. ASV versus bilevel ventilation in CPAP-induced CSA In the short term, ASV may slightly reduce central AHI (MD -8.70, 95% CI -11.42 to -5.98; 1 study; 30 participants) compared to bilevel ventilation. Data on adverse events were not reported, and it is not clear whether data were sought but not found. AUTHORS' CONCLUSIONS: CPAP plus best supportive care may reduce central AHI in people with CSA associated with chronic heart failure compared to best supportive care alone. Although ASV plus best supportive care may reduce AHI in people with CSA associated with chronic heart failure, it likely increases cardiovascular mortality in these individuals. In people with CPAP-induced CSA, ASV may slightly reduce central AHI compared to bilevel ventilation and to CPAP. In the absence of data showing a favourable impact on meaningful patient-centred outcomes and defining clinically important differences in outcomes in CSA patients, these findings need to be interpreted with caution. Considering the level of certainty of the available evidence and the heterogeneity of participants with CSA, we could draw no definitive conclusions, and further high-quality trials focusing on patient-centred outcomes, such as quality of life, quality of sleep, and longer-term survival, are needed to determine whether one mode of NIPV is better than another or than best supportive care for any particular CSA patient group.
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Trastornos de Somnolencia Excesiva , Insuficiencia Cardíaca , Apnea Central del Sueño , Apnea Obstructiva del Sueño , Adulto , Masculino , Humanos , Adolescente , Femenino , Apnea Central del Sueño/terapia , Apnea Obstructiva del Sueño/terapia , Presión de las Vías Aéreas Positiva ContínuaRESUMEN
Sjogren's syndrome (SS) is an autoimmune disease characterized by lymphocytic infiltration of the exocrine glands and other organs, associated with sicca syndrome but also with systemic involvement with varying degrees of severity. Despite their importance, some systemic manifestations, mainly liver, gastrointestinal, and pancreatic are not routinely evaluated. To address these manifestations, the Sjögren's Syndrome Committee of the Brazilian Society of Rheumatology conducted a broad systematic review of the literature on studies investigating prevalence and diagnosis of these symptoms in Sjogren´s patients and made recommendations based on the findings. Agreement between the experts was achieved using the Delphi method. This is the second part of this guideline, providing 6 recommendations for liver, gastrointestinal, and pancreatic care of SS patients.
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Reumatología , Síndrome de Sjögren , Humanos , Brasil/epidemiología , Consenso , Hígado , Síndrome de Sjögren/complicaciones , Síndrome de Sjögren/diagnóstico , Síndrome de Sjögren/epidemiologíaRESUMEN
BACKGROUND: Tocilizumab is an anti-human interleukin 6 receptor monoclonal antibody that has been used to treat coronavirus disease 2019 (COVID-19). However, there is no consensus on its efficacy for the treatment of COVID-19. OBJECTIVE: To evaluate the effectiveness and safety of tocilizumab for treating COVID-19. DESIGN AND SETTING: Systematic Review of randomized controlled trials (RCTs), Universidade Federal de São Paulo (UNIFESP), São Paulo (SP), Brazil. METHODS: We searched MEDLINE via PubMed, EMBASE, CENTRAL, and IBECS for RCTs published up to March 2021. Two authors selected studies and assessed the risk of bias and the certainty of the evidence following Cochrane Recommendations. RESULTS: Eight RCTs with 6,139 participants were included. We were not able to find differences between using tocilizumab compared to standard care on mortality in hospitalized patients with COVID-19 (risk ratio (RR) 0.97, 95% confidence interval (CI) 0.84 to 1.13; 8 trials; 5,950 participants; low-certainty evidence). However, hospitalized patients under tocilizumab plus standard care treatment seemed to present a significantly lower risk of needing mechanical ventilation (risk ratio = 0.78; 95% CI 0.64-0.94 moderate-certainty of evidence). CONCLUSIONS: To date, the best evidence available shows no difference between using tocilizumab plus standard care compared to standard care alone for reducing mortality in patients with COVID-19. However, as a finding with a practical implication, the use of tocilizumab in association to standard care probably reduces the risk of progressing to mechanical ventilation in those patients. REGISTRATION: osf.io/qe4fs.
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Antivirales , Tratamiento Farmacológico de COVID-19 , COVID-19 , Humanos , Brasil , COVID-19/terapia , Ensayos Clínicos Controlados Aleatorios como Asunto , Antivirales/uso terapéutico , Resultado del TratamientoRESUMEN
BACKGROUND: Hypertrophic and keloid scars are common skin conditions resulting from abnormal wound healing. They can cause itching, pain and have a negative physical and psychological impact on patients' lives. Different approaches are used aiming to improve these scars, including intralesional corticosteroids, surgery and more recently, laser therapy. Since laser therapy is expensive and may have adverse effects, it is critical to evaluate the potential benefits and harms of this therapy for treating hypertrophic and keloid scars. OBJECTIVES: To assess the effects of laser therapy for treating hypertrophic and keloid scars. SEARCH METHODS: In March 2021 we searched the Cochrane Wounds Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL EBSCO Plus and LILACS. To identify additional studies, we also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses, and health technology reports. There were no restrictions with respect to language, date of publication, or study setting. SELECTION CRITERIA: We included randomised controlled trials (RCTs) for treating hypertrophic or keloid scars (or both), comparing laser therapy with placebo, no intervention or another intervention. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, extracted the data, assessed the risk of bias of included studies and carried out GRADE assessments to assess the certainty of evidence. A third review author arbitrated if there were disagreements. MAIN RESULTS: We included 15 RCTs, involving 604 participants (children and adults) with study sample sizes ranging from 10 to 120 participants (mean 40.27). Where studies randomised different parts of the same scar, each scar segment was the unit of analysis (906 scar segments). The length of participant follow-up varied from 12 weeks to 12 months. All included trials had a high risk of bias for at least one domain: all studies were deemed at high risk of bias due to lack of blinding of participants and personnel. The variability of intervention types, controls, follow-up periods and limitations with report data meant we pooled data for one comparison (and only two outcomes within this). Several review secondary outcomes - cosmesis, tolerance, preference for different modes of treatment, adherence, and change in quality of life - were not reported in any of the included studies. Laser versus no treatment: We found low-certainty evidence suggesting there may be more hypertrophic and keloid scar improvement (that is scars are less severe) in 585-nm pulsed-dye laser (PDL) -treated scars compared with no treatment (risk ratio (RR) 1.96; 95% confidence interval (CI): 1.11 to 3.45; two studies, 60 scar segments). It is unclear whether non-ablative fractional laser (NAFL) impacts on hypertrophic scar severity when compared with no treatment (very low-certainty evidence). It is unclear whether fractional carbon dioxide (CO2) laser impacts on hypertrophic and keloid scar severity compared with no treatment (very low-certainty evidence). Eight studies reported treatment-related adverse effects but did not provide enough data for further analyses. Laser versus other treatments: We are uncertain whether treatment with 585-nm PDL impacts on hypertrophic and keloid scar severity compared with intralesional corticosteroid triamcinolone acetonide (TAC), intralesional Fluorouracil (5-FU) or combined use of TAC plus 5-FU (very low-certainty evidence). It is also uncertain whether erbium laser impacts on hypertrophic scar severity when compared with TAC (very low-certainty evidence). Other comparisons included 585-nm PDL versus silicone gel sheeting, fractional CO2 laser versus TAC and fractional CO2 laser versus verapamil. However, the authors did not report enough data regarding the severity of scars to compare the interventions. As only very low-certainty evidence is available on treatment-related adverse effects, including pain, charring (skin burning so that the surface becomes blackened), telangiectasia (a condition in which tiny blood vessels cause thread-like red lines on the skin), skin atrophy (skin thinning), purpuric discolorations, hypopigmentation (skin colour becomes lighter), and erosion (loss of part of the top layer of skin, leaving a denuded surface) secondary to blistering, we are not able to draw conclusions as to how these treatments compare. Laser plus other treatment versus other treatment: It is unclear whether 585-nm PDL plus TAC plus 5-FU leads to a higher percentage of good to excellent improvement in hypertrophic and keloid scar severity compared with TAC plus 5-FU, as the certainty of evidence has been assessed as very low. Due to very low-certainty evidence, it is also uncertain whether CO2 laser plus TAC impacts on keloid scar severity compared with cryosurgery plus TAC. The evidence is also very uncertain about the effect of neodymium-doped yttrium aluminium garnet (Nd:YAG) laser plus intralesional corticosteroid diprospan plus 5-FU on scar severity compared with diprospan plus 5-FU and about the effect of helium-neon (He-Ne) laser plus decamethyltetrasiloxane, polydimethylsiloxane and cyclopentasiloxane cream on scar severity compared with decamethyltetrasiloxane, polydimethylsiloxane and cyclopentasiloxane cream. Only very low-certainty evidence is available on treatment-related adverse effects, including pain, atrophy, erythema, telangiectasia, hypopigmentation, regrowth, hyperpigmentation (skin colour becomes darker), and depigmentation (loss of colour from the skin). Therefore, we are not able to draw conclusions as to how these treatments compare. AUTHORS' CONCLUSIONS: There is insufficient evidence to support or refute the effectiveness of laser therapy for treating hypertrophic and keloid scars. The available information is also insufficient to perform a more accurate analysis on treatment-related adverse effects related to laser therapy. Due to the heterogeneity of the studies, conflicting results, study design issues and small sample sizes, further high-quality trials, with validated scales and core outcome sets should be developed. These trials should take into consideration the consumers' opinion and values, the need for long-term follow-up and the necessity of reporting the rate of recurrence of scars to determine whether lasers may achieve superior results when compared with other therapies for treating hypertrophic and keloid scars.
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Cicatriz Hipertrófica , Hipopigmentación , Queloide , Terapia por Láser , Telangiectasia , Corticoesteroides/uso terapéutico , Adulto , Aluminio , Atrofia , Dióxido de Carbono , Niño , Cicatriz Hipertrófica/etiología , Cicatriz Hipertrófica/radioterapia , Dimetilpolisiloxanos , Erbio , Fluorouracilo , Helio , Humanos , Hipertrofia , Hipopigmentación/etiología , Queloide/etiología , Queloide/radioterapia , Terapia por Láser/efectos adversos , Neodimio , Neón , Dolor/etiología , Geles de Silicona , Telangiectasia/etiología , Triamcinolona Acetonida , Verapamilo , Cicatrización de Heridas , ItrioRESUMEN
Sjogren's Syndrome (SS) is an autoimmune disease characterized by lymphocytic infiltration of the exocrine glands and other organs, associated with sicca syndrome but also with systemic involvement with varying degrees of severity. Despite their importance, these systemic manifestations are not routinely evaluated and there is no homogenous approach to their diagnosis or evaluation. To close this gap, a panel of experts from the Brazilian Society of Rheumatology conducted a systematic review and meta-analysis on the identification of epidemiologic and clinical features of these manifestations and made recommendations based on the findings. Agreement between the experts was achieved using the Delphi method. The first part of this guideline summarizes the most important topics, and 11 recommendations are provided for the articular, pulmonary, and renal care of SS patients.
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Guías de Práctica Clínica como Asunto , Reumatología , Síndrome de Sjögren , Brasil/epidemiología , Consenso , Humanos , Metaanálisis como Asunto , Síndrome de Sjögren/complicaciones , Síndrome de Sjögren/diagnóstico , Síndrome de Sjögren/epidemiología , Revisiones Sistemáticas como AsuntoRESUMEN
QUESTION: How effective and safe is telerehabilitation for people with COVID-19 and post-COVID-19 conditions? DESIGN: Systematic review of randomised trials. PARTICIPANTS: People with COVID-19 and post-COVID-19 conditions. INTERVENTION: Any type of telerehabilitation. OUTCOME MEASURES: Satisfaction, quality of life, adverse events, adherence to telerehabilitation, dyspnoea, functional performance, readmissions, mortality, pulmonary function and level of independence. RESULTS: Database searches retrieved 2,962 records, of which six trials with 323 participants were included in the review. Breathing exercises delivered via telerehabilitation improved 6-minute walk distance (MD 101 m, 95% CI 61 to 141; two studies), 30-second sit-to-stand test performance (MD 2.2 repetitions, 95% CI 1.5 to 2.8; two studies), Multidimensional Dyspnoea-12 questionnaire scores (MD -6, 95% CI -7 to -5; two studies) and perceived effort on the 0-to-10 Borg scale (MD -2.8, 95% CI -3.3 to -2.3; two studies), with low certainty of evidence. Exercise delivered via telerehabilitation improved 6-minute walk distance (MD 62 m, 95% CI 42 to 82, four studies), 30-second sit-to-stand test performance (MD 2.0 repetitions, 95% CI 1.3 to 2.7; two studies) and Multidimensional Dyspnoea-12 scores (MD -1.8, 95% CI -2.5 to -1.1; one study), with low certainty of evidence. Adverse events were almost all mild or moderate and occurred with similar frequency in the telerehabilitation group (median 0 per participant, IQR 0 to 2.75) as in the control group (median 0 per participant, IQR 0 to 2); Hodges-Lehmann median difference 0 (95% CI 0 to 0), with low certainty of evidence. CONCLUSION: Telerehabilitation may improve functional capacity, dyspnoea, performance and physical components of quality of life and does not substantially increase adverse events. REGISTRATION: PROSPERO CRD42021271049.