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BACKGROUND: Neonates may undergo surgery because of malformations such as diaphragmatic hernia, gastroschisis, congenital heart disease, and hypertrophic pyloric stenosis, or complications of prematurity, such as necrotizing enterocolitis, spontaneous intestinal perforation, and retinopathy of prematurity that require surgical treatment. Options for treatment of postoperative pain include opioids, non-pharmacological interventions, and other drugs. Morphine, fentanyl, and remifentanil are the opioids most often used in neonates. However, negative impact of opioids on the structure and function of the developing brain has been reported. The assessment of the effects of opioids is of utmost importance, especially for neonates in substantial pain during the postoperative period. OBJECTIVES: To evaluate the benefits and harms of systemic opioid analgesics in neonates who underwent surgery on all-cause mortality, pain, and significant neurodevelopmental disability compared to no intervention, placebo, non-pharmacological interventions, different types of opioids, or other drugs. SEARCH METHODS: We searched Cochrane CENTRAL, MEDLINE via PubMed and CINAHL in May 2021. We searched the WHO ICTRP, clinicaltrials.gov, and ICTRP trial registries. We searched conference proceedings, and the reference lists of retrieved articles for RCTs and quasi-RCTs. SELECTION CRITERIA: We included randomized controlled trials (RCTs) conducted in preterm and term infants of a postmenstrual age up to 46 weeks and 0 days with postoperative pain where systemic opioids were compared to 1) placebo or no intervention; 2) non-pharmacological interventions; 3) different types of opioids; or 4) other drugs. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were pain assessed with validated methods, all-cause mortality during initial hospitalization, major neurodevelopmental disability, and cognitive and educational outcomes in children more than five years old. We used the fixed-effect model with risk ratio (RR) and risk difference (RD) for dichotomous data and mean difference (MD) for continuous data. We used GRADE to assess the certainty of evidence for each outcome. MAIN RESULTS: We included four RCTs enrolling 331 infants in four countries across different continents. Most studies considered patients undergoing large or medium surgical procedures (including major thoracic or abdominal surgery), who potentially required pain control through opioid administration after surgery. The randomized trials did not consider patients undergoing minor surgery (including inguinal hernia repair) and those individuals exposed to opioids before the beginning of the trial. Two RCTs compared opioids with placebo; one fentanyl with tramadol; and one morphine with paracetamol. No meta-analyses could be performed because the included RCTs reported no more than three outcomes within the prespecified comparisons. Certainty of the evidence was very low for all outcomes due to imprecision of the estimates (downgrade by two levels) and study limitations (downgrade by one level). Comparison 1: opioids versus no treatment or placebo Two trials were included in this comparison, comparing either tramadol or tapentadol with placebo. No data were reported on the following critical outcomes: pain; major neurodevelopmental disability; or cognitive and educational outcomes in children more than five years old. The evidence is very uncertain about the effect of tramadol compared with placebo on all-cause mortality during initial hospitalization (RR 0.32, 95% Confidence Interval (CI) 0.01 to 7.70; RD -0.03, 95% CI -0.10 to 0.05, 71 participants, 1 study; I² = not applicable). No data were reported on: retinopathy of prematurity; or intraventricular hemorrhage. Comparison 2: opioids versus non-pharmacological interventions No trials were included in this comparison. Comparison 3: head-to-head comparisons of different opioids One trial comparing fentanyl with tramadol was included in this comparison. No data were reported on the following critical outcomes: pain; major neurodevelopmental disability; or cognitive and educational outcomes in children more than five years old. The evidence is very uncertain about the effect of fentanyl compared with tramadol on all-cause mortality during initial hospitalization (RR 0.99, 95% CI 0.59 to 1.64; RD 0.00, 95% CI -0.13 to 0.13, 171 participants, 1 study; I² = not applicable). No data were reported on: retinopathy of prematurity; or intraventricular hemorrhage. Comparison 4: opioids versus other analgesics and sedatives One trial comparing morphine with paracetamol was included in this comparison. The evidence is very uncertain about the effect of morphine compared with paracetamol on COMFORT pain scores (MD 0.10, 95% CI -0.85 to 1.05; 71 participants, 1 study; I² = not applicable). No data were reported on the other critical outcomes, i.e. major neurodevelopmental disability; cognitive and educational outcomes in children more than five years old, all-cause mortality during initial hospitalization; retinopathy of prematurity; or intraventricular hemorrhage. AUTHORS' CONCLUSIONS: Limited evidence is available on opioid administration for postoperative pain in newborn infants compared to either placebo, other opioids, or paracetamol. We are uncertain whether tramadol reduces mortality compared to placebo; none of the studies reported pain scores, major neurodevelopmental disability, cognitive and educational outcomes in children older than five years old, retinopathy of prematurity, or intraventricular hemorrhage. We are uncertain whether fentanyl reduces mortality compared to tramadol; none of the studies reported pain scores, major neurodevelopmental disability, cognitive and educational outcomes in children older than five years old, retinopathy of prematurity, or intraventricular hemorrhage. We are uncertain whether morphine reduces pain compared to paracetamol; none of the studies reported major neurodevelopmental disability, cognitive and educational outcomes in children more than five years old, all-cause mortality during initial hospitalization, retinopathy of prematurity, or intraventricular hemorrhage. We identified no studies comparing opioids versus non-pharmacological interventions.
Assuntos
Retinopatia da Prematuridade , Tramadol , Criança , Lactente , Humanos , Recém-Nascido , Pré-Escolar , Analgésicos Opioides , Acetaminofen , Analgésicos , Fentanila , Morfina , Dor Pós-Operatória , Hemorragia CerebralRESUMO
BACKGROUND: Postoperative pain clinical management in neonates has always been a challenging medical issue. Worldwide, several systemic opioid regimens are available for pediatricians, neonatologists, and general practitioners to control pain in neonates undergoing surgical procedures. However, the most effective and safe regimen is still unknown in the current body of literature. OBJECTIVES: To determine the effects of different regimens of systemic opioid analgesics in neonates submitted to surgery on all-cause mortality, pain, and significant neurodevelopmental disability. Potentially assessed regimens might include: different doses of the same opioid, different routes of administration of the same opioid, continuous infusion versus bolus administration, or 'as needed' administration versus 'as scheduled' administration. SEARCH METHODS: Searches were conducted in June 2022 using the following databases: Cochrane Central Register of Controlled Trials [CENTRAL], PubMed, and CINAHL. Trial registration records were identified via CENTRAL and an independent search of the ISRCTN registry. SELECTION CRITERIA: We included randomized controlled trials (RCTs), quasi-randomized, cluster-randomized, and cross-over controlled trials evaluating systemic opioid regimens' effects on postoperative pain in neonates (pre-term or full-term). We considered suitable for inclusion: I) studies evaluating different doses of the same opioid; 2) studies evaluating different routes of administration of the same opioid; 3) studies evaluating the effectiveness of continuous infusion versus bolus infusion; and 4) studies establishing an assessment of an 'as needed' administration versus 'as scheduled' administration. DATA COLLECTION AND ANALYSIS: According to Cochrane methods, two investigators independently screened retrieved records, extracted data, and appraised the risk of bias. We stratified meta-analysis by the type of intervention: studies evaluating the use of opioids for postoperative pain in neonates through continuous infusion versus bolus infusion and studies assessing the 'as needed' administration versus 'as scheduled' administration. We used the fixed-effect model with risk ratio (RR) for dichotomous data and mean difference (MD), standardized mean difference (SMD), median, and interquartile range (IQR) for continuous data. Finally, we used the GRADEpro approach for primary outcomes to evaluate the quality of the evidence across included studies. MAIN RESULTS: In this review, we included seven randomized controlled clinical trials (504 infants) from 1996 to 2020. We identified no studies comparing different doses of the same opioid, or different routes. The administration of continuous opioid infusion versus bolus administration of opioids was evaluated in six studies, while one study compared 'as needed' versus 'as scheduled' administration of morphine given by parents or nurses. Overall, the effectiveness of continuous infusion of opioids over bolus infusion as measured by the visual analog scale (MD 0.00, 95% confidence interval (CI) -0.23 to 0.23; 133 participants, 2 studies; I² = 0); or using the COMFORT scale (MD -0.07, 95% CI -0.89 to 0.75; 133 participants, 2 studies; I² = 0), remains unclear due to study designs' limitations, such as the unclear risk of attrition, reporting bias, and imprecision among reported results (very low certainty of the evidence). None of the included studies reported data on other clinically important outcomes such as all-cause mortality rate during hospitalization, major neurodevelopmental disability, the incidence of severe retinopathy of prematurity or intraventricular hemorrhage, and cognitive- and educational-related outcomes. AUTHORS' CONCLUSIONS: Limited evidence is available on continuous infusion compared to intermittent boluses of systemic opioids. We are uncertain whether continuous opioid infusion reduces pain compared with intermittent opioid boluses; none of the studies reported the other primary outcomes of this review, i.e. all-cause mortality during initial hospitalization, significant neurodevelopmental disability, or cognitive and educational outcomes among children older than five years old. Only one small study reported on morphine infusion with parent- or nurse-controlled analgesia.
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Analgésicos Opioides , Morfina , Dor Pós-Operatória , Humanos , Recém-Nascido , Analgesia/métodos , Analgésicos Opioides/administração & dosagem , Analgésicos Opioides/uso terapêutico , Protocolos Clínicos , Morfina/administração & dosagem , Morfina/uso terapêutico , Dor Pós-Operatória/tratamento farmacológicoRESUMO
BACKGROUND: Postoperative pain clinical management in neonates has always been a challenging medical issue. Worldwide, several systemic opioid regimens are available for pediatricians, neonatologists, and general practitioners to control pain in neonates undergoing surgical procedures. However, the most effective and safe regimen is still unknown in the current body of literature. OBJECTIVES: To determine the effects of different regimens of systemic opioid analgesics in neonates submitted to surgery on all-cause mortality, pain, and significant neurodevelopmental disability. Potentially assessed regimens might include: different doses of the same opioid, different routes of administration of the same opioid, continuous infusion versus bolus administration, or 'as needed' administration versus 'as scheduled' administration. SEARCH METHODS: Searches were conducted in June 2022 using the following databases: Cochrane Central Register of Controlled Trials [CENTRAL], PubMed, and CINAHL. Trial registration records were identified via CENTRAL and an independent search of the ISRCTN registry. SELECTION CRITERIA: We included randomized controlled trials (RCTs), quasi-randomized, cluster-randomized, and cross-over controlled trials evaluating systemic opioid regimens' effects on postoperative pain in neonates (pre-term or full-term). We considered suitable for inclusion: I) studies evaluating different doses of the same opioid; 2) studies evaluating different routes of administration of the same opioid; 3) studies evaluating the effectiveness of continuous infusion versus bolus infusion; and 4) studies establishing an assessment of an 'as needed' administration versus 'as scheduled' administration. DATA COLLECTION AND ANALYSIS: According to Cochrane methods, two investigators independently screened retrieved records, extracted data, and appraised the risk of bias. We stratified meta-analysis by the type of intervention: studies evaluating the use of opioids for postoperative pain in neonates through continuous infusion versus bolus infusion and studies assessing the 'as needed' administration versus 'as scheduled' administration. We used the fixed-effect model with risk ratio (RR) for dichotomous data and mean difference (MD), standardized mean difference (SMD), median, and interquartile range (IQR) for continuous data. Finally, we used the GRADEpro approach for primary outcomes to evaluate the quality of the evidence across included studies. MAIN RESULTS: In this review, we included seven randomized controlled clinical trials (504 infants) from 1996 to 2020. We identified no studies comparing different doses of the same opioid, or different routes. The administration of continuous opioid infusion versus bolus administration of opioids was evaluated in six studies, while one study compared 'as needed' versus 'as scheduled' administration of morphine given by parents or nurses. Overall, the effectiveness of continuous infusion of opioids over bolus infusion as measured by the visual analog scale (MD 0.00, 95% confidence interval (CI) -0.23 to 0.23; 133 participants, 2 studies; I² = 0); or using the COMFORT scale (MD -0.07, 95% CI -0.89 to 0.75; 133 participants, 2 studies; I² = 0), remains unclear due to study designs' limitations, such as the unclear risk of attrition, reporting bias, and imprecision among reported results (very low certainty of the evidence). None of the included studies reported data on other clinically important outcomes such as all-cause mortality rate during hospitalization, major neurodevelopmental disability, the incidence of severe retinopathy of prematurity or intraventricular hemorrhage, and cognitive- and educational-related outcomes. AUTHORS' CONCLUSIONS: Limited evidence is available on continuous infusion compared to intermittent boluses of systemic opioids. We are uncertain whether continuous opioid infusion reduces pain compared with intermittent opioid boluses; none of the studies reported the other primary outcomes of this review, i.e. all-cause mortality during initial hospitalization, significant neurodevelopmental disability, or cognitive and educational outcomes among children older than five years old. Only one small study reported on morphine infusion with parent- or nurse-controlled analgesia.
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Analgesia , Analgésicos Opioides , Criança , Pré-Escolar , Humanos , Lactente , Recém-Nascido , Analgesia/métodos , Analgésicos Opioides/uso terapêutico , Protocolos Clínicos , Morfina/uso terapêutico , Dor Pós-Operatória/tratamento farmacológicoRESUMO
Objective: To compare and summarize the literature regarding infodemics and health misinformation, and to identify challenges and opportunities for addressing the issues of infodemics. Methods: We searched MEDLINE®, Embase®, Cochrane Library of Systematic Reviews, Scopus and Epistemonikos on 6 May 2022 for systematic reviews analysing infodemics, misinformation, disinformation and fake news related to health. We grouped studies based on similarity and retrieved evidence on challenges and opportunities. We used the AMSTAR 2 approach to assess the reviews' methodological quality. To evaluate the quality of the evidence, we used the Grading of Recommendations Assessment, Development and Evaluation guidelines. Findings: Our search identified 31 systematic reviews, of which 17 were published. The proportion of health-related misinformation on social media ranged from 0.2% to 28.8%. Twitter, Facebook, YouTube and Instagram are critical in disseminating the rapid and far-reaching information. The most negative consequences of health misinformation are the increase of misleading or incorrect interpretations of available evidence, impact on mental health, misallocation of health resources and an increase in vaccination hesitancy. The increase of unreliable health information delays care provision and increases the occurrence of hateful and divisive rhetoric. Social media could also be a useful tool to combat misinformation during crises. Included reviews highlight the poor quality of published studies during health crises. Conclusion: Available evidence suggests that infodemics during health emergencies have an adverse effect on society. Multisectoral actions to counteract infodemics and health misinformation are needed, including developing legal policies, creating and promoting awareness campaigns, improving health-related content in mass media and increasing people's digital and health literacy.
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Letramento em Saúde , Mídias Sociais , Humanos , Comunicação , Infodemia , Revisões Sistemáticas como AssuntoRESUMO
BACKGROUND: Several systematic reviews evaluating the use of telemedicine by clinicians, patients, and health authorities to improve the delivery of care in the 53 member states of the World Health Organization (WHO) European Region have been conducted in recent years. However, a study summarizing the findings of these reviews has not been conducted. OBJECTIVE: This overview of systematic reviews aimed to summarize findings regarding the use of telemedicine across the 53 member states and identify the medical fields and levels of care in and at which the effectiveness, feasibility, and applicability of telemedicine have been demonstrated. The barriers to and facilitators of telemedicine use were also evaluated and collated to help with the design and implementation of telemedicine interventions. METHODS: Through a comprehensive systematic evaluation of the published and unpublished literature, we extracted clinical, epidemiological, and technology-related data from each review included in the study. We focused on evaluating the barriers to and facilitators of the use of telemedicine apps across the 53 member states considered. We rated the methodological quality of each of the included reviews based on A Measurement Tool to Assess Systematic Review 2 approach and judged the overall certainty of evidence by using the Grading of Recommendations, Assessment, Development, and Evaluations methodology. The entire process was performed by 2 independent authors. RESULTS: This overview drew on data from >2239 primary studies, with >20,000 enrolled patients in total, within the WHO European Region. On the basis of data from randomized trials, observational studies, and economic evaluations from several countries, the results show a clear benefit of telemedicine technologies in the screening, diagnosis, management, treatment, and long-term follow-up of a series of chronic diseases. However, we were unable to pool the results into a reliable numeric parameter because of the high heterogeneity of intervention methodologies, scheduling, primary study design discrepancies, settings, and geographical locations. In addition to the clinical outcomes of the interventions, the social and economic outcomes are highlighted. CONCLUSIONS: The application of telemedicine is well established across countries in the WHO European Region; however, some countries could still benefit from the many uses of these digital solutions. Barriers related to users, technology, and infrastructure were the largest. Conversely, the provision of health services using technological devices was found to significantly enhance patients' clinical outcomes, improve the long-term follow-up of patients by medical professionals, and offer logistical benefits for both patients and health workers. TRIAL REGISTRATION: PROSPERO (International Prospective Register of Systematic Reviews) CRD42022309375; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=309375.
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Telemedicina , Humanos , Revisões Sistemáticas como Assunto , Telemedicina/métodos , Atenção à Saúde , Organização Mundial da Saúde , TecnologiaRESUMO
BACKGROUND: Navigating the rapidly growing body of scientific literature on the SARS-CoV-2 pandemic is challenging, and ongoing critical appraisal of this output is essential. We aimed to summarize and critically appraise systematic reviews of coronavirus disease (COVID-19) in humans that were available at the beginning of the pandemic. METHODS: Nine databases (Medline, EMBASE, Cochrane Library, CINAHL, Web of Sciences, PDQ-Evidence, WHO's Global Research, LILACS, and Epistemonikos) were searched from December 1, 2019, to March 24, 2020. Systematic reviews analyzing primary studies of COVID-19 were included. Two authors independently undertook screening, selection, extraction (data on clinical symptoms, prevalence, pharmacological and non-pharmacological interventions, diagnostic test assessment, laboratory, and radiological findings), and quality assessment (AMSTAR 2). A meta-analysis was performed of the prevalence of clinical outcomes. RESULTS: Eighteen systematic reviews were included; one was empty (did not identify any relevant study). Using AMSTAR 2, confidence in the results of all 18 reviews was rated as "critically low". Identified symptoms of COVID-19 were (range values of point estimates): fever (82-95%), cough with or without sputum (58-72%), dyspnea (26-59%), myalgia or muscle fatigue (29-51%), sore throat (10-13%), headache (8-12%) and gastrointestinal complaints (5-9%). Severe symptoms were more common in men. Elevated C-reactive protein and lactate dehydrogenase, and slightly elevated aspartate and alanine aminotransferase, were commonly described. Thrombocytopenia and elevated levels of procalcitonin and cardiac troponin I were associated with severe disease. A frequent finding on chest imaging was uni- or bilateral multilobar ground-glass opacity. A single review investigated the impact of medication (chloroquine) but found no verifiable clinical data. All-cause mortality ranged from 0.3 to 13.9%. CONCLUSIONS: In this overview of systematic reviews, we analyzed evidence from the first 18 systematic reviews that were published after the emergence of COVID-19. However, confidence in the results of all reviews was "critically low". Thus, systematic reviews that were published early on in the pandemic were of questionable usefulness. Even during public health emergencies, studies and systematic reviews should adhere to established methodological standards.
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COVID-19/diagnóstico , COVID-19/terapia , Pandemias , Revisões Sistemáticas como Assunto , Medicina Baseada em Evidências , HumanosRESUMO
BACKGROUND: Medical emergencies during short- or long-haul commercial airline flights have become more commonplace due to the aviation industry's contemporary growth, the popularization of commercial flights, and an increased aging of air travelers with significant comorbidities. However, the precise incidence of onboard medical events on commercial airlines and the most common medical conditions is unclear. METHODS: In this systematic review and meta-analysis, we explored the incidence of in-flight medical emergencies among airline passengers and estimated the incidence rate by physiological body system, or organ class/syndrome for emergencies that may be associated with different body systems. We limited our search to cohort studies published between 1945 to October 31, 2020 in MEDLINE, Embase, Cochrane Library and official reports from the Federal Aviation Administration/International Air Transport Association, regardless of the language of publication. Only studies that evaluated the overall frequency of onboard medical events on commercial air carriers (in which they also presented the total number of annual revenue passengers) and the frequency of events by physiological body systems or organ class/syndrome were included. We excluded case reports and case series, systematic or narrative reviews, and studies addressing specific health-related conditions. Two independent investigators performed first- and second-phase study screening, abstracted data, and appraised risk of bias. We rated the certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Using a quality effect model, we meta-analyzed data associated with the incidence of in-flight medical emergencies, all-cause fatality, incidence of medical events by medical condition category, frequency of en-route diversion, presence of medical personnel on board, and the use of an automatic external defibrillator. We also extracted data regarding the cost of flight diversion. RESULTS: Of 18 individual studies with approximately 1.5 billion passengers, 11 reported the overall incidence of in-flight medical emergencies. Low certainty of evidence suggested that the global incidence of in-flight medical emergencies was 18.2 events per million passengers (95% CI 0.5 to 53.4 per million; I2 = 100%, P < 0.001, very low certainty), and an all-cause mortality rate was 0.21 per million passengers (95% CI 0 to 0.76 per million; I2 = 99%, P < 0.001, low certainty). The four most common categories of medical conditions or syndromes during flight were syncope, gastrointestinal events, respiratory and neurological diagnostic groups. The diversion rate was 11.1 per 100,000 flights (95% CI 5.9 to17.6 per 100,000 flights; I2 = 97%, P < 0.001), with an average cost ranging from $15,000 to $893,000 per unplanned emergency landing across studies which examined this outcome. CONCLUSIONS: In-flight medical events on commercial travels are extremely low with a corresponding very low in-flight mortality rate. Associated costs derived from en-route diversion might significantly influence airlines' budgetary equilibrium. Novel and modern standardized reporting systems or platforms should be internationally provided and enforced by health and aviation authorities to obtain higher quality patient-passengers datasets. Onboard volunteer medical providers must be aware of everyday life-threatening events during commercial flights and should consider the establishment of a connection between the aircraft and ground-based medical advisory services while assisting in-flight medical events.
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Medicina Aeroespacial , Emergências/epidemiologia , Asma/epidemiologia , Queimaduras/epidemiologia , Doenças Cardiovasculares/epidemiologia , Desfibriladores/estatística & dados numéricos , Progressão da Doença , Dispneia/epidemiologia , Gastroenteropatias/epidemiologia , Pessoal de Saúde/estatística & dados numéricos , Humanos , Transtornos Mentais/epidemiologia , Doenças do Sistema Nervoso/epidemiologia , Doença Pulmonar Obstrutiva Crônica/epidemiologia , Voluntários/estatística & dados numéricos , Ferimentos e Lesões/epidemiologiaRESUMO
BACKGROUND: Although the potential of big data analytics for health care is well recognized, evidence is lacking on its effects on public health. OBJECTIVE: The aim of this study was to assess the impact of the use of big data analytics on people's health based on the health indicators and core priorities in the World Health Organization (WHO) General Programme of Work 2019/2023 and the European Programme of Work (EPW), approved and adopted by its Member States, in addition to SARS-CoV-2-related studies. Furthermore, we sought to identify the most relevant challenges and opportunities of these tools with respect to people's health. METHODS: Six databases (MEDLINE, Embase, Cochrane Database of Systematic Reviews via Cochrane Library, Web of Science, Scopus, and Epistemonikos) were searched from the inception date to September 21, 2020. Systematic reviews assessing the effects of big data analytics on health indicators were included. Two authors independently performed screening, selection, data extraction, and quality assessment using the AMSTAR-2 (A Measurement Tool to Assess Systematic Reviews 2) checklist. RESULTS: The literature search initially yielded 185 records, 35 of which met the inclusion criteria, involving more than 5,000,000 patients. Most of the included studies used patient data collected from electronic health records, hospital information systems, private patient databases, and imaging datasets, and involved the use of big data analytics for noncommunicable diseases. "Probability of dying from any of cardiovascular, cancer, diabetes or chronic renal disease" and "suicide mortality rate" were the most commonly assessed health indicators and core priorities within the WHO General Programme of Work 2019/2023 and the EPW 2020/2025. Big data analytics have shown moderate to high accuracy for the diagnosis and prediction of complications of diabetes mellitus as well as for the diagnosis and classification of mental disorders; prediction of suicide attempts and behaviors; and the diagnosis, treatment, and prediction of important clinical outcomes of several chronic diseases. Confidence in the results was rated as "critically low" for 25 reviews, as "low" for 7 reviews, and as "moderate" for 3 reviews. The most frequently identified challenges were establishment of a well-designed and structured data source, and a secure, transparent, and standardized database for patient data. CONCLUSIONS: Although the overall quality of included studies was limited, big data analytics has shown moderate to high accuracy for the diagnosis of certain diseases, improvement in managing chronic diseases, and support for prompt and real-time analyses of large sets of varied input data to diagnose and predict disease outcomes. TRIAL REGISTRATION: International Prospective Register of Systematic Reviews (PROSPERO) CRD42020214048; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=214048.
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Big Data , Doenças Cardiovasculares , Ciência de Dados , Atenção à Saúde/estatística & dados numéricos , Diabetes Mellitus , Transtornos Mentais , Neoplasias , Adolescente , Adulto , Idoso , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/terapia , Diabetes Mellitus/diagnóstico , Diabetes Mellitus/terapia , Feminino , Humanos , Masculino , Transtornos Mentais/diagnóstico , Transtornos Mentais/terapia , Pessoa de Meia-Idade , Neoplasias/diagnóstico , Neoplasias/terapia , Prognóstico , Revisões Sistemáticas como Assunto , Adulto JovemRESUMO
BACKGROUND: Oxidative stress plays an important role in the occurrence of chronic diseases. Zinc supplementation is also known to be an antioxidant agent. While, there is no review on the effects of zinc supplementation on oxidative stress, this study aimed to systematically summarize randomized clinical trials (RCTs) which have evaluated the impacts of zinc supplementation on oxidative stress biomarkers. METHODS: Systematic searches were performed using the PubMed/Medline, Scopus, and Google Scholar databases, up to April 2020. All RCTs assessed the effect of oral zinc supplementation on serum malondialdehyde (MDA), total antioxidant capacity (TAC), glutathione (GSH), and nitric oxide (NO) levels, were included. For each variable, mean differences (MD) and standard deviations (SDs) were combined using the random-effects model, and the fractional polynomial model was used to implement the dose-response analysis. RESULTS: Ten RCTs were included. The pooled analysis of data showed that zinc supplementation significantly reduced MDA levels (MD: -0.42 µmol/L; 95 % CI: -0.71 to -0.13), increased serum TAC (MD: 225.96 mmol/L; 95 % CI: 68.42-383.5) and GSH levels (MD: 49.99 µmol/L; 95 % CI: 2.25 t 97.73), compared with the placebo group. In contrast, no significant changes were seen in NO levels following zinc supplementation (MD: -1.66 µmol/L; 95 % CI: -5.89 to 2.57). Dose-response analysis showed a significant non-linear relationship between zinc supplementation dosage and serum levels of MDA (p < 0.01), but not other biomarkers. CONCLUSIONS: The current study showed that zinc supplementation would significantly decrease MDA and increase TAC and GSH, but not NO levels. Thus, it encourages the use of zinc supplementation in oxidative stress-related diseases.
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Antioxidantes/uso terapêutico , Suplementos Nutricionais , Estresse Oxidativo/efeitos dos fármacos , Compostos de Zinco/uso terapêutico , Adulto , Idoso , Antioxidantes/efeitos adversos , Biomarcadores/sangue , Suplementos Nutricionais/efeitos adversos , Feminino , Glutationa/sangue , Humanos , Masculino , Malondialdeído/sangue , Pessoa de Meia-Idade , Óxido Nítrico/sangue , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem , Compostos de Zinco/efeitos adversosRESUMO
The original version of this article unfortunately contained a mistake. The family name of "Israel Júnior Borges do Nascimento" was incorrect.
RESUMO
The effects of green tea (GT) in obese subjects have been evaluated in different studies, but no consensus has been obtained due to the heterogeneity of the results. The dosage, the type of extract, and the duration of the intervention are the main contributors to the heterogeneity of the results. Therefore, the present systematic review and meta-analysis aimed to evaluate the efficacy and dose-response relationship of GT. Several databases were searched from inception to September 2019 to identify clinical trials that examined the influence of GT supplements on obesity indices in humans. Combined results using the random-effects model indicated that body weight (WMD: -1.78 kg, 95% CI: -2.80, -0.75, p = .001) and body mass index (BMI) (WMD: -0.65 kg/m2 , 95% CI: -1.04, -0.25, p = .001) did change significantly following GT administration. The reduction in waist circumference (WC) after GT consumption was significant in subjects in trials employing GT ≥800 mg/day (WMD: -2.06 cm) and with a treatment duration <12 weeks (WMD: -2.39 cm). Following the dose-response evaluation, GT intake did alter body weight, with a more important reduction when the GT dosage was <500 mg/day and the treatment duration was of 12 weeks. The results of present meta-analysis study support the use of GT for the improvement of obesity indices. Thus, we suggest that the use of GT can be combined with a balanced and healthy diet and regular physical exercise in the management of obese patients.
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Obesidade/tratamento farmacológico , Extratos Vegetais/administração & dosagem , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Chá/fisiologia , Adiposidade/efeitos dos fármacos , Adiposidade/fisiologia , Índice de Massa Corporal , Peso Corporal/efeitos dos fármacos , Suplementos Nutricionais , Relação Dose-Resposta a Droga , Feminino , Humanos , Masculino , Extratos Vegetais/farmacologia , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Chá/química , Circunferência da Cintura/efeitos dos fármacosRESUMO
Systematic reviews have quantified the effectiveness, feasibility, acceptability, and cost-effectiveness of digital health technologies (DHTs) used by health-care workers. We aimed to collate available evidence on technologies' effect on health-care workers' competencies and performance. We searched the Cochrane Database of Systematic Reviews, Embase, MEDLINE, Epistemonikos, and Scopus for reviews published from database inception to March 1, 2023. Studies assessing the effects of DHTs on the organisational, socioeconomic, clinical, and epidemiological levels within the workplace, and on health-care workers' performance parameters, were included. Data were extracted and clustered into 25 domains using vote counting based on the direction of effect. The relative frequency of occurrence (RFO) of each domain was estimated using R software. AMSTAR-2 tool was used to appraise the quality of reporting, and the Confidence in the Evidence from Reviews of Qualitative research approach developed by Grading of Recommendations Assessment, Development and Evaluation was used to analyse the certainty of evidence among included studies. The 12â794 screened reviews generated 132 eligible records for assessment. Top-ranked RFO identifiers showed associations of DHT with the enhancement of health-care workers' performance (10·9% [95% CI 5·3-22·5]), improvement of clinical practice and management (9·8% [3·9-24·2]), and improvement of care delivery and access to care (9·2% [4·1-20·9]). Our overview found that DHTs positively influence the daily practice of health-care workers in various medical specialties. However, poor reporting in crucial domains is widely prevalent in reviews of DHT, hindering our findings' generalisability and interpretation. Likewise, most of the included reviews reported substantially more data from high-income countries. Improving the reporting of future studies and focusing on low-income and middle-income countries might elucidate and answer current knowledge gaps.
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Atenção à Saúde , Pessoal de Saúde , Humanos , Revisões Sistemáticas como Assunto , Metanálise como AssuntoRESUMO
Digital technologies change the healthcare environment, with several studies suggesting barriers and facilitators to using digital interventions by healthcare professionals (HPs). We consolidated the evidence from existing systematic reviews mentioning barriers and facilitators for the use of digital health technologies by HP. Electronic searches were performed in five databases (Cochrane Database of Systematic Reviews, Embase®, Epistemonikos, MEDLINE®, and Scopus) from inception to March 2023. We included reviews that reported barriers or facilitators factors to use technology solutions among HP. We performed data abstraction, methodological assessment, and certainty of the evidence appraisal by at least two authors. Overall, we included 108 reviews involving physicians, pharmacists, and nurses were included. High-quality evidence suggested that infrastructure and technical barriers (Relative Frequency Occurrence [RFO] 6.4% [95% CI 2.9-14.1]), psychological and personal issues (RFO 5.3% [95% CI 2.2-12.7]), and concerns of increasing working hours or workload (RFO 3.9% [95% CI 1.5-10.1]) were common concerns reported by HPs. Likewise, high-quality evidence supports that training/educational programs, multisector incentives, and the perception of technology effectiveness facilitate the adoption of digital technologies by HPs (RFO 3.8% [95% CI 1.8-7.9]). Our findings showed that infrastructure and technical issues, psychological barriers, and workload-related concerns are relevant barriers to comprehensively and holistically adopting digital health technologies by HPs. Conversely, deploying training, evaluating HP's perception of usefulness and willingness to use, and multi-stakeholders incentives are vital enablers to enhance the HP adoption of digital interventions.
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Liver test abnormalities are frequently observed in patients with coronavirus disease 2019 (COVID-19) and are associated with worse prognosis. However, information is limited about pathological changes in the liver in this infection, so the mechanism of liver injury is unclear. Here we describe liver histopathology and clinical correlates of 27 patients who died of COVID-19 in Manaus, Brazil. There was a high prevalence of liver injury (elevated alanine aminotransferase and aspartate aminotransferase in 44% and 48% of patients, respectively) in these patients. Histological analysis showed sinusoidal congestion and ischemic necrosis in more than 85% of the cases, but these appeared to be secondary to systemic rather than intrahepatic thrombotic events, as only 14% and 22% of samples were positive for CD61 (marker of platelet activation) and C4d (activated complement factor), respectively. Furthermore, the extent of these vascular findings did not correlate with the extent of transaminase elevations. Steatosis was present in 63% of patients, and portal inflammation was present in 52%. In most cases, hepatocytes expressed angiotensin-converting enzyme 2 (ACE2), which is responsible for binding and entry of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), even though this ectoenzyme was minimally expressed on hepatocytes in normal controls. However, SARS-CoV-2 staining was not observed. Most hepatocytes also expressed inositol 1,4,5-triphosphate receptor 3 (ITPR3), a calcium channel that becomes expressed in acute liver injury. Conclusion: The hepatocellular injury that commonly occurs in patients with severe COVID-19 is not due to the vascular events that contribute to pulmonary or cardiac damage. However, new expression of ACE2 and ITPR3 with concomitant inflammation and steatosis suggests that liver injury may result from inflammation, metabolic abnormalities, and perhaps direct viral injury.
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COVID-19/complicações , Hepatopatias/patologia , Hepatopatias/virologia , Fígado/patologia , Fígado/virologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Brasil , COVID-19/mortalidade , COVID-19/patologia , COVID-19/fisiopatologia , Feminino , Humanos , Fígado/fisiopatologia , Hepatopatias/diagnóstico , Hepatopatias/fisiopatologia , Testes de Função Hepática , Masculino , Pessoa de Meia-IdadeRESUMO
Blood loss in the first days of life has been associated with increased morbidity and mortality in very preterm infants. In this systematic review we included randomized controlled trials comparing the effects of interventions to preserve blood volume in the infant from birth, reduce the need for sampling, or limit the blood sampled. Mortality and major neurodevelopmental disabilities were the primary outcomes. Included studies underwent risk of bias-assessment and data extraction by two review authors independently. We used risk ratio or mean difference to evaluate the treatment effect and meta-analysis for pooled results. The certainty of evidence was assessed using GRADE. We included 31 trials enrolling 3,759 infants. Twenty-five trials were pooled in the comparison delayed cord clamping or cord milking vs. immediate cord clamping or no milking. Increasing placental transfusion resulted in lower mortality during the neonatal period (RR 0.51, 95% CI 0.26 to 1.00; participants = 595; trials = 5; I2 = 0%, moderate certainty of evidence) and during first hospitalization (RR 0.70, 95% CI 0.51, 0.96; 10 RCTs, participants = 2,476, low certainty of evidence). The certainty of evidence was very low for the other primary outcomes of this review. The six remaining trials compared devices to monitor glucose levels (three trials), blood sampling from the umbilical cord or from the placenta vs. blood sampling from the infant (2 trials), and devices to reintroduce the blood after analysis vs. conventional blood sampling (1 trial); the certainty of evidence was rated as very low for all outcomes in these comparisons. Increasing placental transfusion at birth may reduce mortality in very preterm infants; However, extremely limited evidence is available to assess the effects of other interventions to reduce blood loss after birth. In future trials, infants could be randomized following placental transfusion to different blood saving approaches. Trial registration: PROSPERO CRD42020159882.
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Parto Obstétrico/métodos , Hemorragia/prevenção & controle , Lactente Extremamente Prematuro , Glicemia/análise , Dióxido de Carbono/sangue , Constrição , Parto Obstétrico/efeitos adversos , Humanos , Recém-Nascido , Oxigênio/sangueRESUMO
BACKGROUND: To date, there is no comprehensive systematic review and meta-analysis to assess the suitability of COVID-19 vaccines for mass immunization. The current systematic review and meta-analysis was conducted to evaluate the safety and immunogenicity of novel COVID-19 vaccine candidates under clinical trial evaluation and present a contemporary update on the development and implementation of a potential vaccines. METHODS: For this study PubMed, MEDLINE, and Embase electronic databases were used to search for eligible studies on the interface between novel coronavirus and vaccine design until December 31, 2020. RESULTS: We have included fourteen non-randomized and randomized controlled phase I-III trials. Implementation of a universal vaccination program with proven safety and efficacy through robust clinical evaluation is the long-term goal for preventing COVID-19. The immunization program must be cost-effective for mass production and accessibility. Despite pioneering techniques for the fast-track development of the vaccine in the current global emergency, mass production and availability of an effective COVID-19 vaccine could take some more time. CONCLUSION: Our findings suggest a revisiting of the reported solicited and unsolicited systemic adverse events for COVID-19 candidate vaccines. Hence, it is alarming to judiciously expose thousands of participants to COVID-19 candidate vaccines at Phase-3 trials that have adverse events and insufficient evidence on safety and effectiveness that necessitates further justification.
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BACKGROUND & OBJECTIVE: Effects of walnut intake on anthropometric measurements have been inconsistent among clinical studies. Thus, we conducted a meta-analysis of randomized clinical trials (RCTs) to evaluate and quantify the effects of walnut intake on anthropometric characteristics. METHODS: We carried out a systematic search of all available RCTs up to June 2019 in the following electronic databases: PubMed, Scopus, Web of Science and Google Scholar. Pooled weight mean difference (WMD) of the included studies was estimated using random-effects model. RESULTS: A total of 27 articles were included in this meta-analysis, with walnuts dosage ranging from 15 to 108 g/d for 2 wk to 2 y. Overall, interventions with walnut intake did not alter waist circumference (WC) (WMD: -0.193 cm, 95 % CI: -1.03, 0.64, p = 0.651), body weight (BW) (0.083 kg, 95 % CI: -0.032, 0.198, p = 0.159), body mass index (BMI) (WMD: -0.40 kg/m,295 % CI: -0.244, 0.164, p = 0.703), and fat mass (FM) (WMD: 0.28 %, 95 % CI: -0.49, 1.06, p = 0.476). Following dose-response evaluation, reduced BW (Coef.= -1.62, p = 0.001), BMI (Coef.= -1.24, p = 0.041) and WC (Coef.= -5.39, p = 0.038) were significantly observed through walnut intake up to 35 g/day. However, the number of studies can be limited as to the individual analysis of the measures through the dose-response fashion. CONCLUSIONS: Overall, results from this meta-analysis suggest that interventions with walnut intake does not alter BW, BMI, FM, and WC. To date, there is no discernible evidence to support walnut intake for improving anthropometric indicators of weight loss.
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Antropometria , Suplementos Nutricionais , Juglans , Nozes , Peso Corporal , Relação Dose-Resposta a Droga , Humanos , Obesidade/dietoterapia , Ensaios Clínicos Controlados Aleatórios como Assunto , Circunferência da CinturaRESUMO
New evidence on the COVID-19 pandemic is being published daily. Ongoing high-quality assessment of this literature is therefore needed to enable clinical practice to be evidence-based. This review builds on a previous scoping review and aimed to identify associations between disease severity and various clinical, laboratory and radiological characteristics. We searched MEDLINE, CENTRAL, EMBASE, Scopus and LILACS for studies published between January 1, 2019 and March 22, 2020. Clinical studies including ≥10 patients with confirmed COVID-19 of any study design were eligible. Two investigators independently extracted data and assessed risk of bias. A quality effects model was used for the meta-analyses. Subgroup analysis and meta-regression identified sources of heterogeneity. For hospitalized patients, studies were ordered by overall disease severity of each population and this order was used as the modifier variable in meta-regression. Overall, 86 studies (n = 91,621) contributed data to the meta-analyses. Severe disease was strongly associated with fever, cough, dyspnea, pneumonia, any computed tomography findings, any ground glass opacity, lymphocytopenia, elevated C-reactive protein, elevated alanine aminotransferase, elevated aspartate aminotransferase, older age and male sex. These variables typically increased in prevalence by 30-73% from mild/early disease through to moderate/severe disease. Among hospitalized patients, 30-78% of heterogeneity was explained by severity of disease. Elevated white blood cell count was strongly associated with more severe disease among moderate/severe hospitalized patients. Elevated lymphocytes, low platelets, interleukin-6, erythrocyte sedimentation rate and D-dimers showed potential associations, while fatigue, gastrointestinal symptoms, consolidation and septal thickening showed non-linear association patterns. Headache and sore throat were associated with the presence of disease, but not with more severe disease. In COVID-19, more severe disease is strongly associated with several clinical, laboratory and radiological characteristics. Symptoms and other variables in early/mild disease appear non-specific and highly heterogeneous. Clinical Trial Registration: PROSPERO CRD42020170623.
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Betacoronavirus , Infecções por Coronavirus/epidemiologia , Pandemias , Pneumonia Viral/epidemiologia , Adulto , Idoso , Biomarcadores , Contagem de Células Sanguíneas , Proteínas Sanguíneas/análise , Sedimentação Sanguínea , COVID-19 , Terapia Combinada , Infecções por Coronavirus/sangue , Infecções por Coronavirus/diagnóstico por imagem , Infecções por Coronavirus/terapia , Feminino , Hospitalização , Humanos , Pulmão/diagnóstico por imagem , Masculino , Pessoa de Meia-Idade , Pneumonia Viral/sangue , Pneumonia Viral/diagnóstico por imagem , Pneumonia Viral/terapia , Gravidez , Complicações Infecciosas na Gravidez/epidemiologia , Prevalência , Ensaios Clínicos Controlados Aleatórios como Assunto , SARS-CoV-2 , Avaliação de SintomasRESUMO
A growing body of literature on the 2019 novel coronavirus (SARS-CoV-2) is becoming available, but a synthesis of available data has not been conducted. We performed a scoping review of currently available clinical, epidemiological, laboratory, and chest imaging data related to the SARS-CoV-2 infection. We searched MEDLINE, Cochrane CENTRAL, EMBASE, Scopus and LILACS from 01 January 2019 to 24 February 2020. Study selection, data extraction and risk of bias assessment were performed by two independent reviewers. Qualitative synthesis and meta-analysis were conducted using the clinical and laboratory data, and random-effects models were applied to estimate pooled results. A total of 61 studies were included (59,254 patients). The most common disease-related symptoms were fever (82%, 95% confidence interval (CI) 56%-99%; n = 4410), cough (61%, 95% CI 39%-81%; n = 3985), muscle aches and/or fatigue (36%, 95% CI 18%-55%; n = 3778), dyspnea (26%, 95% CI 12%-41%; n = 3700), headache in 12% (95% CI 4%-23%, n = 3598 patients), sore throat in 10% (95% CI 5%-17%, n = 1387) and gastrointestinal symptoms in 9% (95% CI 3%-17%, n = 1744). Laboratory findings were described in a lower number of patients and revealed lymphopenia (0.93 × 109/L, 95% CI 0.83-1.03 × 109/L, n = 464) and abnormal C-reactive protein (33.72 mg/dL, 95% CI 21.54-45.91 mg/dL; n = 1637). Radiological findings varied, but mostly described ground-glass opacities and consolidation. Data on treatment options were limited. All-cause mortality was 0.3% (95% CI 0.0%-1.0%; n = 53,631). Epidemiological studies showed that mortality was higher in males and elderly patients. The majority of reported clinical symptoms and laboratory findings related to SARS-CoV-2 infection are non-specific. Clinical suspicion, accompanied by a relevant epidemiological history, should be followed by early imaging and virological assay.