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1.
Cochrane Database Syst Rev ; 9: CD013708, 2020 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-32870512

RESUMO

BACKGROUND: Supplemental oxygen is frequently administered to patients with acute respiratory distress syndrome (ARDS), including ARDS secondary to viral illness such as coronavirus disease 19 (COVID-19). An up-to-date understanding of how best to target this therapy (e.g. arterial partial pressure of oxygen (PaO2) or peripheral oxygen saturation (SpO2) aim) in these patients is urgently required. OBJECTIVES: To address how oxygen therapy should be targeted in adults with ARDS (particularly ARDS secondary to COVID-19 or other respiratory viruses) and requiring mechanical ventilation in an intensive care unit, and the impact oxygen therapy has on mortality, days ventilated, days of catecholamine use, requirement for renal replacement therapy, and quality of life. SEARCH METHODS: We searched the Cochrane COVID-19 Study Register, CENTRAL, MEDLINE, and Embase from inception to 15 May 2020 for ongoing or completed randomized controlled trials (RCTs). SELECTION CRITERIA: Two review authors independently assessed all records in accordance with standard Cochrane methodology for study selection. We included RCTs comparing supplemental oxygen administration (i.e. different target PaO2 or SpO2 ranges) in adults with ARDS and receiving mechanical ventilation in an intensive care setting. We excluded studies exploring oxygen administration in patients with different underlying diagnoses or those receiving non-invasive ventilation, high-flow nasal oxygen, or oxygen via facemask. DATA COLLECTION AND ANALYSIS: One review author performed data extraction, which a second review author checked. We assessed risk of bias in included studies using the Cochrane 'Risk of bias' tool. We used the GRADE approach to judge the certainty of the evidence for the following outcomes; mortality at longest follow-up, days ventilated, days of catecholamine use, and requirement for renal replacement therapy. MAIN RESULTS: We identified one completed RCT evaluating oxygen targets in patients with ARDS receiving mechanical ventilation in an intensive care setting. The study randomized 205 mechanically ventilated patients with ARDS to either conservative (PaO2 55 to 70 mmHg, or SpO2 88% to 92%) or liberal (PaO2 90 to 105 mmHg, or SpO2 ≥ 96%) oxygen therapy for seven days. Overall risk of bias was high (due to lack of blinding, small numbers of participants, and the trial stopping prematurely), and we assessed the certainty of the evidence as very low. The available data suggested that mortality at 90 days may be higher in those participants receiving a lower oxygen target (odds ratio (OR) 1.83, 95% confidence interval (CI) 1.03 to 3.27). There was no evidence of a difference between the lower and higher target groups in mean number of days ventilated (14.0, 95% CI 10.0 to 18.0 versus 14.5, 95% CI 11.8 to 17.1); number of days of catecholamine use (8.0, 95% CI 5.5 to 10.5 versus 7.2, 95% CI 5.9 to 8.4); or participants receiving renal replacement therapy (13.7%, 95% CI 5.8% to 21.6% versus 12.0%, 95% CI 5.0% to 19.1%). Quality of life was not reported. AUTHORS' CONCLUSIONS: We are very uncertain as to whether a higher or lower oxygen target is more beneficial in patients with ARDS and receiving mechanical ventilation in an intensive care setting. We identified only one RCT with a total of 205 participants exploring this question, and rated the risk of bias as high and the certainty of the findings as very low. Further well-conducted studies are urgently needed to increase the certainty of the findings reported here. This review should be updated when more evidence is available.


Assuntos
Betacoronavirus , Infecções por Coronavirus/complicações , Unidades de Terapia Intensiva , Oxigênio/administração & dosagem , Pneumonia Viral/complicações , Respiração Artificial , Síndrome do Desconforto Respiratório do Adulto/terapia , Viés , Catecolaminas/uso terapêutico , Tratamento Conservador , Humanos , Razão de Chances , Pandemias , Terapia de Substituição Renal/estatística & dados numéricos , Respiração Artificial/estatística & dados numéricos , Síndrome do Desconforto Respiratório do Adulto/mortalidade , Síndrome do Desconforto Respiratório do Adulto/virologia , Autoimagem , Fatores de Tempo
2.
PLoS One ; 15(9): e0238339, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32946453

RESUMO

BACKGROUND: Faced with the global pandemic of COVID-19, declared by World Health Organization (WHO) on March 11th 2020, and the need to better understand the seasonal behavior of the virus, our team conducted this systematic review to describe current knowledge about the emergence and replicability of the virus and its connection with different weather factors such as temperature and relative humidity. METHODS: The review was registered with the PROSPERO database. The electronic databases PubMed, Scopus, Web of Science, Cochrane Library, LILACS, OpenGrey and Google Scholar were examined with the searches restricted to the years 2019 and 2020. Risk of bias assessment was performed using the Joanna Briggs Institute (JBI) Critical Appraisal Checklist tool. The GRADE tool was used to assess the certainty of the evidence. RESULTS: The initial screening identified 517 articles. After examination of the full texts, seventeen studies met the review's eligibility criteria. Great homogeneity was observed in the findings regarding the effect of temperature and humidity on the seasonal viability and transmissibility of COVID-19. Cold and dry conditions were potentiating factors on the spread of the virus. After quality assessment, two studies had a high risk of bias, eleven studies were scored as moderate risk of bias, and four studies were classified as low risk of bias. The certainty of evidence was graded as low for both outcomes evaluated. CONCLUSION: Considering the existing scientific evidence, warm and wet climates seem to reduce the spread of COVID-19. However, these variables alone could not explain most of the variability in disease transmission. Therefore, the countries most affected by the disease should focus on health policies, even with climates less favorable to the virus. Although the certainty of the evidence generated was classified as low, there was homogeneity between the results reported by the included studies.


Assuntos
Betacoronavirus/fisiologia , Infecções por Coronavirus/transmissão , Umidade , Pneumonia Viral/transmissão , Temperatura , Viés , Infecções por Coronavirus/epidemiologia , Humanos , Pandemias/estatística & dados numéricos , Pneumonia Viral/epidemiologia
3.
Epidemiol Infect ; 148: e207, 2020 09 11.
Artigo em Inglês | MEDLINE | ID: mdl-32912354

RESUMO

COVID-19 has spread across the globe with higher burden placed in Europe and North America. However, the rate of transmission has recently picked up in low- and middle-income countries, particularly in the Indian subcontinent. There is a severe underreporting bias in the existing data available from these countries mostly due to the limitation of resources and accessibility. Most studies comparing cross-country cases or fatalities could fail to account for this systematic bias and reach erroneous conclusions. This paper provides several recommendations on how to effectively tackle these issues regarding data quality, test coverage and case counts.


Assuntos
Betacoronavirus , Infecções por Coronavirus/epidemiologia , Pneumonia Viral/epidemiologia , Viés , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/mortalidade , Humanos , Pandemias , Pneumonia Viral/diagnóstico , Pneumonia Viral/mortalidade , Relatório de Pesquisa
5.
Environ Health Perspect ; 128(9): 95001, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32902328

RESUMO

BACKGROUND: Studies have reported that ambient air pollution is associated with an increased risk of developing or dying from coronavirus-2 (COVID-19). Methodological approaches to investigate the health impacts of air pollution on epidemics should differ from those used for chronic diseases, but the methods used in these studies have not been appraised critically. OBJECTIVES: Our study aimed to identify and critique the methodological approaches of studies of air pollution on infections and mortality due to COVID-19 and to identify and critique the methodological approaches of similar studies concerning severe acute respiratory syndrome (SARS). METHODS: Published and unpublished papers of associations between air pollution and developing or dying from COVID-19 or SARS that were reported as of 10 May 2020 were identified through electronic databases, internet searches, and other sources. RESULTS: All six COVID-19 studies and two of three SARS studies reported positive associations. Two were time series studies that estimated associations between daily changes in air pollution, one was a cohort that assessed associations between air pollution and the secondary spread of SARS, and six were ecological studies that used area-wide exposures and outcomes. Common shortcomings included possible cross-level bias in ecological studies, underreporting of health outcomes, using grouped data, the lack of highly spatially resolved air pollution measures, inadequate control for confounding and evaluation of effect modification, not accounting for regional variations in the timing of outbreaks' temporal changes in at-risk populations, and not accounting for nonindependence of outcomes. DISCUSSION: Studies of air pollution and novel coronaviruses have relied mainly on ecological measures of exposures and outcomes and are susceptible to important sources of bias. Although longitudinal studies with individual-level data may be imperfect, they are needed to adequately address this topic. The complexities involved in these types of studies underscore the need for careful design and for peer review. https://doi.org/10.1289/EHP7411.


Assuntos
Poluição do Ar/efeitos adversos , Infecções por Coronavirus/epidemiologia , Pneumonia Viral/epidemiologia , Síndrome Respiratória Aguda Grave/epidemiologia , Poluição do Ar/análise , Viés , Surtos de Doenças , Estudos Epidemiológicos , Humanos , Pandemias , Projetos de Pesquisa , Fatores de Risco
8.
S D Med ; 73(8): 372-374, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32809297

RESUMO

Within an unrelenting COVID-19 pandemic, the burden of helping without harming has grown under the weight of destructive political bias which is harming without helping. This pandemic has created three flashpoints surrounding patient, population and policy. As science is further politicized, the coronafication of medicine is now a subset of the politicization of everything and is challenging these obligations. It is not the presence of personal political bias which degrades science, it is the absence of institutional acknowledgment as conflict of interest. Physicians must interrogate in Socratic fashion, seven deadly sins of destructive bias - character assassination, raw animus, cynical omniscience, historical amnesia, false choice, divisive labelling and selective truthing, which undermine our coming together. At a time when public trust is at risk, we must defend the best interest of the patient against politicized science - for this bias has reached the bedside.


Assuntos
Infecções por Coronavirus/epidemiologia , Pneumonia Viral/epidemiologia , Política , Betacoronavirus , Viés , Humanos , Pandemias
9.
BMJ ; 370: m2898, 2020 08 26.
Artigo em Inglês | MEDLINE | ID: mdl-32847800

RESUMO

OBJECTIVE: To assess the risk of bias associated with missing outcome data in systematic reviews. DESIGN: Imputation study. SETTING: Systematic reviews. POPULATION: 100 systematic reviews that included a group level meta-analysis with a statistically significant effect on a patient important dichotomous efficacy outcome. MAIN OUTCOME MEASURES: Median percentage change in the relative effect estimate when applying each of the following assumption (four commonly discussed but implausible assumptions (best case scenario, none had the event, all had the event, and worst case scenario) and four plausible assumptions for missing data based on the informative missingness odds ratio (IMOR) approach (IMOR 1.5 (least stringent), IMOR 2, IMOR 3, IMOR 5 (most stringent)); percentage of meta-analyses that crossed the threshold of the null effect for each method; and percentage of meta-analyses that qualitatively changed direction of effect for each method. Sensitivity analyses based on the eight different methods of handling missing data were conducted. RESULTS: 100 systematic reviews with 653 randomised controlled trials were included. When applying the implausible but commonly discussed assumptions, the median change in the relative effect estimate varied from 0% to 30.4%. The percentage of meta-analyses crossing the threshold of the null effect varied from 1% (best case scenario) to 60% (worst case scenario), and 26% changed direction with the worst case scenario. When applying the plausible assumptions, the median percentage change in relative effect estimate varied from 1.4% to 7.0%. The percentage of meta-analyses crossing the threshold of the null effect varied from 6% (IMOR 1.5) to 22% (IMOR 5) of meta-analyses, and 2% changed direction with the most stringent (IMOR 5). CONCLUSION: Even when applying plausible assumptions to the outcomes of participants with definite missing data, the average change in pooled relative effect estimate is substantive, and almost a quarter (22%) of meta-analyses crossed the threshold of the null effect. Systematic review authors should present the potential impact of missing outcome data on their effect estimates and use this to inform their overall GRADE (grading of recommendations assessment, development, and evaluation) ratings of risk of bias and their interpretation of the results.


Assuntos
Metanálise como Assunto , Projetos de Pesquisa/normas , Revisões Sistemáticas como Assunto , Viés , Interpretação Estatística de Dados , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto
10.
Pediatrics ; 146(3)2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32788267

RESUMO

CONTEXT: The International Liaison Committee on Resuscitation Neonatal Life Support Task Force reviewed evidence for the duration of cardiopulmonary resuscitation (CPR) for newborns immediately after birth. OBJECTIVE: To summarize evidence for ongoing CPR on the outcomes of survival, neurodevelopment, and the composite of survival without moderate or severe neurodevelopmental impairment (NDI). DATA SOURCES: Medline, Embase, Evidence-Based Medicine Reviews, Cumulative Index to Nursing and Allied Health Literature, and Scientific Electronic Library Online were searched between inception and February 29, 2020. STUDY SELECTION: Two independent reviewers selected studies of newborns with at least 10 minutes of asystole, bradycardia, or pulseless electrical activity for which CPR is indicated. DATA EXTRACTION: Two independent reviewers extracted data and appraised the risk of bias. RESULTS: In 16 eligible studies, researchers reported outcomes of 579 newborns born between 1982 and 2017. Within individual studies, 2% to 100% of infants survived to last follow-up (hospital discharge through 12 years). Summarized across studies, 237 of 579 (40.9%) newborns survived to last follow-up. In 13 studies, researchers reported neurodevelopmental outcomes of 277 newborns. Of these, 30 of 277 (10.8%) survived without moderate or severe impairment, and 240 of 277 (87%) met the composite outcome of death or NDI (191 died and 49 survived with moderate or severe impairment). LIMITATIONS: There was very low certainty of evidence because of risk of bias and inconsistency. CONCLUSIONS: Infants with ongoing CPR at 10 minutes after birth are at high risk for mortality and neurodisability, but survival without moderate or severe NDI is possible. One specified duration of CPR is unlikely to uniformly predict survival or survival without neuroimpairment.


Assuntos
Bradicardia/terapia , Reanimação Cardiopulmonar/estatística & dados numéricos , Desenvolvimento Infantil , Parada Cardíaca/terapia , Transtornos do Neurodesenvolvimento/epidemiologia , Comitês Consultivos , Viés , Frequência Cardíaca , Humanos , Recém-Nascido , Transtornos do Neurodesenvolvimento/mortalidade , Sobreviventes/estatística & dados numéricos , Fatores de Tempo
12.
Anesthesiology ; 133(3): 500-509, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32788557

RESUMO

There are an increasing number of "big data" studies in anesthesia that seek to answer clinical questions by observing the care and outcomes of many patients across a variety of care settings. This Readers' Toolbox will explain how to estimate the influence of patient factors on clinical outcome, addressing bias and confounding. One approach to limit the influence of confounding is to perform a clinical trial. When such a trial is infeasible, observational studies using robust regression techniques may be able to advance knowledge. Logistic regression is used when the outcome is binary (e.g., intracranial hemorrhage: yes or no), by modeling the natural log for the odds of an outcome. Because outcomes are influenced by many factors, we commonly use multivariable logistic regression to estimate the unique influence of each factor. From this tutorial, one should acquire a clearer understanding of how to perform and assess multivariable logistic regression.


Assuntos
Anestesiologia/métodos , Anestesiologia/estatística & dados numéricos , Adulto , Viés , Feminino , Humanos , Modelos Logísticos , Gravidez
13.
PLoS One ; 15(8): e0232385, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32790729

RESUMO

Classical value-based decision theories state that economic choices are solely based on the value of available options. Experimental evidence suggests, however, that individuals' choices are biased towards default options, prompted by the framing of decisions. Although the effects of default options created by exogenous framing-such as how choice options are displayed-are well-documented, little is known about the potential effects and properties of endogenous framing, that is, originating from an individual's internal state. In this study, we investigated the existence and properties of endogenous default options in a task involving choices between risky lotteries. By manipulating and examining the effects of three experimental features-time pressure, time spent on task and relative choice proportion towards a specific option-, we reveal and dissociate two features of endogenous default options which bias individuals' choices: a natural tendency to prefer certain types of options (natural default), and the tendency to implicitly learn a default option from past choices (learned default). Additional analyses suggest that while the natural default may bias the standard choice process towards an option category, the learned default effects may be attributable to a second independent choice process. Overall, these investigations provide a first experimental evidence of how individuals build and apply diverse endogenous default options in economic decision-making and how this biases their choices.


Assuntos
Comportamento de Escolha , Teoria da Decisão , Modelos Econômicos , Adolescente , Adulto , Viés , Tomada de Decisões , Feminino , Humanos , Masculino , Modelos Psicológicos , Assunção de Riscos , Adulto Jovem
14.
PLoS One ; 15(8): e0235502, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32790666

RESUMO

Traditionally, machine learning algorithms relied on reliable labels from experts to build predictions. More recently however, algorithms have been receiving data from the general population in the form of labeling, annotations, etc. The result is that algorithms are subject to bias that is born from ingesting unchecked information, such as biased samples and biased labels. Furthermore, people and algorithms are increasingly engaged in interactive processes wherein neither the human nor the algorithms receive unbiased data. Algorithms can also make biased predictions, leading to what is now known as algorithmic bias. On the other hand, human's reaction to the output of machine learning methods with algorithmic bias worsen the situations by making decision based on biased information, which will probably be consumed by algorithms later. Some recent research has focused on the ethical and moral implication of machine learning algorithmic bias on society. However, most research has so far treated algorithmic bias as a static factor, which fails to capture the dynamic and iterative properties of bias. We argue that algorithmic bias interacts with humans in an iterative manner, which has a long-term effect on algorithms' performance. For this purpose, we present an iterated-learning framework that is inspired from human language evolution to study the interaction between machine learning algorithms and humans. Our goal is to study two sources of bias that interact: the process by which people select information to label (human action); and the process by which an algorithm selects the subset of information to present to people (iterated algorithmic bias mode). We investigate three forms of iterated algorithmic bias (personalization filter, active learning, and random) and how they affect the performance of machine learning algorithms by formulating research questions about the impact of each type of bias. Based on statistical analyses of the results of several controlled experiments, we found that the three different iterated bias modes, as well as initial training data class imbalance and human action, do affect the models learned by machine learning algorithms. We also found that iterated filter bias, which is prominent in personalized user interfaces, can lead to more inequality in estimated relevance and to a limited human ability to discover relevant data. Our findings indicate that the relevance blind spot (items from the testing set whose predicted relevance probability is less than 0.5 and who thus risk being hidden from humans) amounted to 4% of all relevant items when using a content-based filter that predicts relevant items. A similar simulation using a real-life rating data set found that the same filter resulted in a blind spot size of 75% of the relevant testing set.


Assuntos
Aprendizagem , Aprendizado de Máquina/normas , Viés , Humanos
15.
Korean J Anesthesiol ; 73(4): 269-270, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32746540
16.
Cochrane Database Syst Rev ; 8: CD012328, 2020 08 03.
Artigo em Inglês | MEDLINE | ID: mdl-32746500

RESUMO

BACKGROUND: About half of patients with Crohn's disease (CD) require surgery within 10 years of diagnosis. Resection of the affected segment is highly effective, however the majority of patients experience clinical recurrence after surgery. Most of these patients have asymptomatic endoscopic recurrence weeks or months before starting with symptoms. This inflammation can be detected by colonoscopy and is a good predictor of poor prognosis.Therapy guided by colonoscopy could tailor the management and improve the prognosis of postoperative CD. OBJECTIVES: To assess the effects of prophylactic therapy guided by colonoscopy in reducing the postoperative recurrence of CD in adults. SEARCH METHODS: The following electronic databases were searched up to 17 December 2019: MEDLINE, Embase, CENTRAL, Clinical Trials.gov, WHO Trial Registry and Cochrane IBD specialized register. Reference lists of included articles, as well as conference proceedings were handsearched. SELECTION CRITERIA: Randomised controlled trials (RCTs), quasi-RCTs and cohort studies comparing colonoscopy-guided management versus management non-guided by colonoscopy. DATA COLLECTION AND ANALYSIS: Two review authors independently considered studies for eligibility, extracted the data and assessed study quality. Methodological quality was assessed using both the Cochrane 'Risk of bias' tool for RCTs and Newcastle-Ottawa scale (NOS) for cohort studies. The primary outcome was clinical recurrence. Secondary outcomes included: endoscopic, surgical recurrence and adverse events. We calculated the risk ratio (RR) for each dichotomous outcome and extracted the hazard ratio (HR) for time-to-event outcomes. All estimates were reported with their corresponding 95% confidence interval (CI). Data were analysed on an intention-to-treat (ITT) basis. The overall quality of the evidence was evaluated using GRADE criteria. MAIN RESULTS: Two RCTs (237 participants) and five cohort studies (794 participants) met the inclusion criteria. Meta-analysis was not conducted as the studies were highly heterogeneous. We included two comparisons. Intensification of prophylactic-therapy guided by colonoscopy versus intensification guided by clinical recurrence One unblinded RCT and four retrospective cohort studies addressed this comparison. All participants received the same prophylactic therapy immediately after surgery. In the colonoscopy-based management group the therapy was intensified in case of endoscopic recurrence; in the control group the therapy was intensified only in case of symptoms. In the RCT, clinical recurrence (defined as Crohn's Disease Activity Index (CDAI) > 150 points) in the colonoscopy-based management group was 37.7% (46/122) compared to 46.1% (21/52) in the control group at 18 months' follow up (RR 0.82, 95% CI: 0.56 to 1.18, 174 participants, low-certainty evidence). There may be a reduction in endoscopic recurrence at 18 months with colonoscopy-based management (RR 0.73, 95% CI 0.56 to 0.95, 1 RCT, 174 participants, low-certainty evidence). The certainty of the evidence for surgical recurrence was very low, due to only four cohort studies with inconsistent results reporting this outcome. Adverse events at 18 months were similar in both groups, with 82% in the intervention group (100/122) and 86.5% in the control group (45/52) (RR 0.95, 95% CI:0.83 to 1.08, 1 RCT, 174 participants, low-certainty of evidence).The most common adverse events reported were alopecia, wound infection, sensory symptoms, systemic lupus, vasculitis and severe injection site reaction. Perforations or haemorrhages secondary to colonoscopy were not reported. Initiation of prophylactic-therapy guided by colonoscopy versus initiation immediately after surgery An unblinded RCT and two retrospective cohort studies addressed this comparison. The control group received prophylactic therapy immediately after surgery, and in the colonoscopy-based management group the therapy was delayed up to detection of endoscopic recurrence. The effects on clinical and endoscopic recurrence are uncertain (clinical recurrence until week 102: RR 1.16, 95% CI 0.73 to 1.84; endoscopic recurrence at week 102: RR 1.16, 95% CI 0.73 to 1.84; 1 RCT, 63 participants, very low-certainty evidence). Results from one cohort study were similarly uncertain (median follow-up 32 months, 199 participants). The effects on surgical recurrence at a median follow-up of 50 to 55 months were also uncertain in one cohort study (RR 0.79, 95% CI 0.38 to 1.62, 133 participants, very low-certainty evidence). There were fewer adverse events with colonoscopy-based management (54.8% (17/31)) compared with the control group (93.8% (30/32)) but the evidence is very uncertain (RR 0.58, 95% CI 0.42 to 0.82; 1 RCT, 63 participants). Common adverse events were infections, gastrointestinal intolerance, leukopenia, pancreatitis and skin lesions. Perforations or haemorrhages secondary to colonoscopy were not reported. AUTHORS' CONCLUSIONS: Intensification of prophylactic-therapy guided by colonoscopy may reduce clinical and endoscopic postoperative recurrence of CD compared to intensification guided by symptoms, and there may be little or no difference in adverse effects. We are uncertain whether initiation of therapy guided by colonoscopy impacts postoperative recurrence and adverse events when compared to initiation immediately after surgery, as the certainty of the evidence is very low. Further studies are necessary to improve the certainty of the evidence of this review.


Assuntos
Colonoscopia , Doença de Crohn/prevenção & controle , Doença de Crohn/cirurgia , Prevenção Secundária/métodos , Adalimumab/efeitos adversos , Adalimumab/uso terapêutico , Adulto , Antibacterianos/uso terapêutico , Anti-Inflamatórios não Esteroides/efeitos adversos , Anti-Inflamatórios não Esteroides/uso terapêutico , Doenças Assintomáticas , Azatioprina/efeitos adversos , Azatioprina/uso terapêutico , Viés , Estudos de Coortes , Doença de Crohn/diagnóstico por imagem , Humanos , Imunossupressores/efeitos adversos , Imunossupressores/uso terapêutico , Mesalamina/efeitos adversos , Mesalamina/uso terapêutico , Metronidazol/efeitos adversos , Metronidazol/uso terapêutico , Purinas/efeitos adversos , Purinas/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Recidiva , Estudos Retrospectivos , Fator de Necrose Tumoral alfa/antagonistas & inibidores
17.
Cochrane Database Syst Rev ; 8: CD012977, 2020 08 05.
Artigo em Inglês | MEDLINE | ID: mdl-32767571

RESUMO

BACKGROUND: Asthma is an illness that commonly affects adults and children, and it serves as a common reason for children to attend emergency departments. An asthma exacerbation is characterised by acute or subacute worsening of shortness of breath, cough, wheezing, and chest tightness and may be triggered by viral respiratory infection, poor compliance with usual medication, a change in the weather, or exposure to allergens or irritants. Most children with asthma have mild or moderate exacerbations and respond well to first-line therapy (inhaled short-acting beta-agonists and systemic corticosteroids). However, the best treatment for the small proportion of seriously ill children who do not respond to first-line therapy is not well understood. Currently, a large number of treatment options are available and there is wide variation in management. OBJECTIVES: Main objective - To summarise Cochrane Reviews with or without meta-analyses of randomised controlled trials on the efficacy and safety of second-line treatment for children with acute exacerbations of asthma (i.e. after first-line treatments, titrated oxygen delivery, and administration of intermittent inhaled short-acting beta2-agonists and oral corticosteroids have been tried and have failed) Secondary objectives - To identify gaps in the current evidence base that will inform recommendations for future research and subsequent Cochrane Reviews - To categorise information on reported outcome measures used in trials of escalation of treatment for acute exacerbations of asthma in children, and to make recommendations for development and reporting of standard outcomes in future trials and reviews - To identify relevant randomised controlled trials that have been published since the date of publication of each included review METHODS: We included Cochrane Reviews assessing interventions for children with acute exacerbations of asthma. We searched the Cochrane Database of Systematic Reviews. The search is current to 28 December 2019. We also identified trials that were potentially eligible for, but were not currently included in, published reviews. We assessed the quality of included reviews using the ROBIS criteria (tool used to assess risk of bias in systematic reviews). We presented an evidence synthesis of data from reviews alongside an evidence map of clinical trials. Primary outcomes were length of stay, hospital admission, intensive care unit admission, and adverse effects. We summarised all findings in the text and reported data for each outcome in 'Additional tables'. MAIN RESULTS: We identified 17 potentially eligible Cochrane Reviews but extracted data from, and rated the quality of, 13 reviews that reported results for children alone. We excluded four reviews as one did not include any randomised controlled trials (RCTs), one did not provide subgroup data for children, and the last two had been updated and replaced by subsequent reviews. The 13 reviews included 67 trials; the number of trials in each review ranged from a single trial up to 27 trials. The vast majority of comparisons included between one and three trials, involving fewer than 100 participants. The total number of participants included in reviews ranged from 40 to 2630. All studies included children; 16 (24%) included children younger than two years of age. Most of the reviews reported search dates older than four years. We have summarised the published evidence as outlined in Cochrane Reviews. Key findings, in terms of our primary outcomes, are that (1) intravenous magnesium sulfate was the only intervention shown to reduce hospital length of stay (high-certainty evidence); (2) no evidence suggested that any intervention reduced the risk of intensive care admission (low- to very low-certainty evidence); (3) the risk of hospital admission was reduced by the addition of inhaled anticholinergic agents to inhaled beta2-agonists (moderate-certainty evidence), the use of intravenous magnesium sulfate (high-certainty evidence), and the use of inhaled heliox (low-certainty evidence); (4) the addition of inhaled magnesium sulfate to usual bronchodilator therapy appears to reduce serious adverse events during hospital admission (moderate-certainty evidence); (5) aminophylline increased vomiting compared to placebo (moderate-certainty evidence) and increased nausea and nausea/vomiting compared to intravenous beta2-agonists (low-certainty evidence); and (6) the addition of anticholinergic therapy to short-acting beta2-agonists appeared to reduce the risk of nausea (high-certainty evidence) and tremor (moderate-certainty evidence) but not vomiting (low-certainty evidence). We considered 4 of the 13 reviews to be at high risk of bias based on the ROBIS framework. In all cases, this was due to concerns regarding identification and selection of studies. The certainty of evidence varied widely (by review and also by outcome) and ranged from very low to high. AUTHORS' CONCLUSIONS: This overview provides the most up-to-date evidence on interventions for escalation of therapy for acute exacerbations of asthma in children from Cochrane Reviews of randomised controlled trials. A vast majority of comparisons involved between one and three trials and fewer than 100 participants, making it difficult to assess the balance between benefits and potential harms. Due to the lack of comparative studies between various treatment options, we are unable to make firm practice recommendations. Intravenous magnesium sulfate appears to reduce both hospital length of stay and the risk of hospital admission. Hospital admission is also reduced with the addition of inhaled anticholinergic agents to inhaled beta2-agonists. However, further research is required to determine which patients are most likely to benefit from these therapies. Due to the relatively rare incidence of acute severe paediatric asthma, multi-centre research will be required to generate high-quality evidence. A number of existing Cochrane Reviews should be updated, and we recommend that a new review be conducted on the use of high-flow nasal oxygen therapy. Important priorities include development of an internationally agreed core outcome set for future trials in acute severe asthma exacerbations and determination of clinically important differences in these outcomes, which can then inform adequately powered future trials.


Assuntos
Antiasmáticos/uso terapêutico , Asma/terapia , Broncodilatadores/uso terapêutico , Progressão da Doença , Revisões Sistemáticas como Assunto , Doença Aguda , Administração por Inalação , Agonistas de Receptores Adrenérgicos beta 2/uso terapêutico , Aminofilina/administração & dosagem , Aminofilina/efeitos adversos , Antiasmáticos/administração & dosagem , Antibacterianos/uso terapêutico , Asma/tratamento farmacológico , Viés , Broncodilatadores/administração & dosagem , Criança , Pré-Escolar , Antagonistas Colinérgicos/uso terapêutico , Hélio , Humanos , Lactente , Tempo de Internação , Antagonistas de Leucotrienos/uso terapêutico , Sulfato de Magnésio/administração & dosagem , Sulfato de Magnésio/efeitos adversos , Sulfato de Magnésio/uso terapêutico , Náusea/induzido quimicamente , Náusea/prevenção & controle , Oxigênio/administração & dosagem , Respiração com Pressão Positiva , Ensaios Clínicos Controlados Aleatórios como Assunto , Vômito/induzido quimicamente , Trabalho Respiratório/efeitos dos fármacos
18.
Cochrane Database Syst Rev ; 8: CD013267, 2020 Aug 11.
Artigo em Inglês | MEDLINE | ID: mdl-32789891

RESUMO

BACKGROUND: Intracranial atherosclerotic stenosis (ICAS) is an arterial narrowing in the brain that can cause stroke. Endovascular therapy and medical management may be used to prevent recurrent ischaemic stroke caused by ICAS. However, there is no consensus on the best treatment for people with ICAS. OBJECTIVES: To compare the safety and efficacy of endovascular therapy (ET) plus conventional medical treatment (CMT) with CMT alone for the management of symptomatic ICAS. SEARCH METHODS: We searched the Cochrane Stroke Group Trials Register (30 August 2019), Cochrane Central Register of Controlled Trials (CENTRAL: to 30 August 2019), MEDLINE Ovid (1946 to 30 August 2019), Embase Ovid (1974 to 30 August 2019), Scopus (1960 to 30 August 2019), Science Citation Index Web of Science (1900 to 30 July 2019), Academic Source Complete EBSCO (ASC: 1982 to 30 July 2019), and China Biological Medicine Database (CBM: 1978 to 30 July 2019). We also searched the following trial registers: ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, and Stroke Trials Registry. We also contacted trialists and researchers where additional information was required. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing ET plus CMT with CMT alone for the treatment of symptomatic ICAS. ET modalities included angioplasty alone, balloon-mounted stent, and angioplasty followed by placement of a self-expanding stent. CMT included antiplatelet therapy in addition to control of risk factors such as hypertension, hyperlipidaemia, and diabetes. DATA COLLECTION AND ANALYSIS: Two review authors independently screened trials to select potentially eligible RCTs and extracted data. Any disagreements were resolved by discussing and reaching consensus decisions with the full team. We assessed risk of bias and applied the GRADE approach to assess the quality of the evidence. The primary outcome was death of any cause or non-fatal stroke of any type within three months of randomisation. Secondary outcomes included any-cause death or non-fatal stroke of any type more than three months of randomisation, ipsilateral stroke, type of recurrent event, death, restenosis, dependency, and health-related quality of life. MAIN RESULTS: We included three RCTs with 632 participants who had symptomatic ICAS with an age range of 18 to 85 years. The included trials had high risks of performance bias and other potential sources of bias due to the impossibility of blinding of the endovascular intervention and early termination of the trials. Moreover, one trial had a high risk of attrition bias because of the high rate of loss of one-year follow-up and the high proportion of participants transferred from endovascular therapy to medical management. The quality of evidence ranged from low to moderate, downgraded for imprecision. Compared to CMT, ET probably results in a higher rate of 30-day death or stroke (risk ratio (RR) 3.07, 95% confidence interval (CI) 1.80 to 5.24; 3 RCTs, 632 participants, moderate-quality evidence), 30-day ipsilateral stroke (RR 3.54, 95% CI 1.98 to 6.33; 3 RCTs, 632 participants, moderate-quality evidence), 30-day ischaemic stroke (RR 2.52, 95% CI 1.37 to 4.62; 3 RCTs, 632 participants, moderate-quality evidence), and 30-day haemorrhagic stroke (RR 15.53, 95% CI 2.10 to 115.16; 3 RCTs, 632 participants, low-quality evidence). ET was also likely associated with a worse outcome in one-year death or stroke (RR 1.69, 95% CI 1.21 to 2.36; 3 RCTs, 632 participants, moderate-quality evidence), one-year ipsilateral stroke (RR 2.28, 95% CI 1.52 to 3.42; 3 RCTs, 632 participants, moderate-quality evidence), one-year ischaemic stroke (RR 2.07, 95% CI 1.37 to 3.13; 3 RCTs, 632 participants, moderate-quality evidence), and one-year haemorrhagic stroke (RR 10.13, 95% CI 1.31 to 78.51; 2 RCTs, 521 participants, low-quality evidence). There were no significant differences between ET and CMT in 30-day transient ischaemic attacks (TIA) (RR 0.52, 95% CI 0.11 to 2.35, P = 0.39; 2 RCTs, 181 participants, moderate-quality evidence), 30-day death (RR 5.53, 95% CI 0.98 to 31.17, P = 0.05; 3 RCTs, 632 participants, low-quality evidence), one-year TIA (RR 0.82, 95% CI 0.32 to 2.12; 2 RCTs, 181 participants, moderate-quality evidence), one-year death (RR 1.20, 95% CI 0.50 to 2.86, P = 0.68; 3 RCTs, 632 participants, moderate-quality evidence), and one-year dependency (RR 1.90, 95% CI 0.91 to 3.97, P = 0.09; 3 RCTs, 613 participants, moderate-quality evidence). No data on restenosis and health-related quality of life for meta-analysis were available from the included trials. Two RCTs are ongoing. AUTHORS' CONCLUSIONS: This systematic review provides moderate-quality evidence showing that ET, compared with CMT, in people with recent symptomatic severe intracranial atherosclerotic stenosis probably does not prevent recurrent stroke and appears to carry an increased hazard. The impact of delayed ET intervention (more than three weeks after a qualifying event) is unclear and may warrant further study.


Assuntos
Isquemia Encefálica/terapia , Procedimentos Endovasculares/métodos , Arteriosclerose Intracraniana/complicações , Inibidores da Agregação de Plaquetas/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Angioplastia/efeitos adversos , Angioplastia/métodos , Viés , Isquemia Encefálica/etiologia , Isquemia Encefálica/mortalidade , Humanos , Ataque Isquêmico Transitório/epidemiologia , Ataque Isquêmico Transitório/etiologia , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Risco , Stents Metálicos Autoexpansíveis , Stents , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia
19.
Cochrane Database Syst Rev ; 8: CD013063, 2020 Aug 14.
Artigo em Inglês | MEDLINE | ID: mdl-32797689

RESUMO

BACKGROUND: Despite substantial improvements in the success of assisted reproduction techniques (ART), live birth rates may remain consistently low, and practitioners may look for innovative treatments to improve the outcomes. The injection of embryo culture supernatant in the endometrial cavity can be undertaken at various time intervals before embryo transfer. It provides an altered endometrial environment through the secretion of factors considered to facilitate implantation. It is proposed that injection of the supernatant into the endometrial cavity prior to embryo transfer will stimulate the endometrium and provide better conditions for implantation to take place. An increased implantation rate would subsequently increase rates of clinical pregnancy and live birth, but current robust evidence on the efficacy of injected embryo culture supernatant is lacking. OBJECTIVES: To evaluate the effectiveness and safety of endometrial injection of embryo culture supernatant before embryo transfer in women undergoing ART. SEARCH METHODS: Our search strategies were designed with the help of the Cochrane Gynaecology and Fertility Group Information Specialist. We sought to identify all published and unpublished randomised controlled trials (RCTs) meeting inclusion criteria. Searches were performed on 2 December 2019. We searched the Cochrane Gynaecology and Fertility Group Specialised Register of controlled trials, CENTRAL, MEDLINE, Embase, CINAHL, trials registries and grey literature. We made further searches in the UK National Institute for Health and Care Excellence (NICE) fertility assessment and treatment guidelines. We handsearched reference lists of relevant systematic reviews and RCTs, together with searches of PubMed and Google for any recent trials that have not yet been indexed in the major databases. We had no language or location restrictions. SELECTION CRITERIA: We included RCTs testing the use of endometrial injection of embryo culture supernatant before embryo transfer during an ART cycle, compared with the non-use of this intervention, the use of placebo or the use of any other similar drug. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, assessed risk of bias, extracted data from studies and attempted to contact the authors where data were missing. We pooled studies using a fixed-effect model. Our primary outcomes were live birth/ongoing pregnancy and miscarriage. We performed statistical analysis using Review Manager 5. We assessed evidence quality using GRADE methods. MAIN RESULTS: We found five RCTs suitable for inclusion in the review (526 women analysed). We made two comparisons: embryo culture supernatant use versus standard care or no intervention; and embryo culture supernatant use versus culture medium. All studies were published as full-text articles. Data derived from the reports or through direct communication with investigators were available for the final meta-analysis performed. The GRADE evidence quality of studies ranged from very low-quality to moderate-quality. Factors reducing evidence quality included high risk of bias due to lack of blinding, unclear risk of publication bias and selective outcome reporting, serious inconsistency among study outcomes, and serious imprecision due to wide confidence intervals (CIs) and low numbers of events. Comparison 1. Endometrial injection of embryo culture supernatant before embryo transfer versus standard care or no intervention: One study reported live birth only and two reported the composite outcome live birth and ongoing pregnancy. We are uncertain whether endometrial injection of embryo culture supernatant before embryo transfer during an ART cycle improves live birth/ongoing pregnancy rates compared to no intervention (odds ratio (OR) 1.11, 95% CI 0.73 to 1.70; 3 RCTs; n = 340, I2 = 84%; very low-quality evidence). Results suggest that if the chance of live birth/ongoing pregnancy following placebo or no treatment is assumed to be 42%, the chance following the endometrial injection of embryo culture supernatant before embryo transfer would vary between 22% and 81%. We are also uncertain whether the endometrial injection of embryo culture supernatant could decrease miscarriage rates, compared to no intervention (OR 0.89, 95% CI 0.44 to 1.78, 4 RCTs, n = 430, I2 = 58%, very low-quality evidence). Results suggest that if the chance of miscarriage following placebo or no treatment is assumed to be 9%, the chance following injection of embryo culture supernatant would vary between 3% and 30%. Concerning the secondary outcomes, we are uncertain whether the injection of embryo culture supernatant prior to embryo transfer could increase clinical pregnancy rates (OR 1.13, 95% CI 0.80 to 1.61; 5 RCTs; n = 526, I2 = 0%; very low-quality evidence), decrease ectopic pregnancy rates (OR 0.32, 95% CI 0.01 to 8.24; n = 250; 2 RCTs; I2 = 41%; very low-quality evidence), decrease multiple pregnancy rates (OR 0.70, 95% CI 0.26 to 1.83; 2 RCTs; n = 150; I2 = 63%; very low-quality evidence), or decrease preterm delivery rates (OR 0.63, 95% CI 0.17 to 2.42; 1 RCT; n = 90; I2 = 0%; very low-quality evidence), compared to no intervention. Finally, there may have been little or no difference in foetal abnormality rates between the two groups (OR 3.10, 95% CI 0.12 to 79.23; 1 RCT; n = 60; I2 = 0%; low-quality evidence). Comparison 2. Endometrial injection of embryo culture supernatant versus endometrial injection of culture medium before embryo transfer We are uncertain whether the use of embryo culture supernatant improves clinical pregnancy rates, compared to the use of culture medium (OR 1.09, 95% CI 0.48 to 2.46; n = 96; 1 RCT; very low-quality evidence). No study reported live birth/ongoing pregnancy, miscarriage, ectopic or multiple pregnancy, preterm delivery or foetal abnormalities. AUTHORS' CONCLUSIONS: We are uncertain whether the addition of endometrial injection of embryo culture supernatant before embryo transfer as a routine method for the treatment of women undergoing ART can improve pregnancy outcomes. This conclusion is based on current available data from five RCTs, with evidence quality ranging from very low to moderate across studies. Further large well-designed RCTs reporting on live births and adverse clinical outcomes are still required to clarify the exact role of endometrial injection of embryo culture supernatant before embryo transfer.


Assuntos
Meios de Cultura , Técnicas de Cultura Embrionária , Endométrio , Infertilidade Feminina/terapia , Técnicas de Reprodução Assistida , Aborto Espontâneo/epidemiologia , Viés , Transferência Embrionária , Feminino , Humanos , Injeções/métodos , Nascimento Vivo , Gravidez , Taxa de Gravidez , Gravidez Ectópica/epidemiologia , Gravidez Múltipla/estatística & dados numéricos , Nascimento Prematuro/epidemiologia , Ensaios Clínicos Controlados Aleatórios como Assunto
20.
Cochrane Database Syst Rev ; 8: CD009438, 2020 08 16.
Artigo em Inglês | MEDLINE | ID: mdl-32799320

RESUMO

BACKGROUND: Rates of injury and death caused by car crashes with teenage drivers remain high in most high-income countries. In addition to injury and death, car use includes other non-traffic risks; these may be health-related, such as physical inactivity or respiratory disease caused by air pollution, or have global significance, such as the environmental impact of car use. Research demonstrates that reducing the amount of time driving reduces the risk of injury, and it is expected that it would also reduce other risks that are unrelated to traffic. Mobility management interventions aim to increase mobility awareness and encourage a shift from private car use to active (walking, cycling, skateboarding), and public (bus, tram, train), transportation. 'Soft' mobility management interventions include the application of strategies and policies to reduce travel demand and may be instigated locally or more widely, to target a specific or a non-specific population group; 'hard' mobility management interventions include changes to the built environment or transport infrastructure and are not the focus of this review. Between the ages of 15 to 19 years, young people enter a development stage known as the 'transition teens' in which they are likely to make long-lasting lifestyle changes. It is possible that using this specific time point to introduce mobility management interventions may influence a person's long-term mobility behaviour. OBJECTIVES: To assess whether 'soft' mobility management interventions prevent, reduce, or delay car driving in teenagers aged 15 to 19 years, and to assess whether these mobility management interventions also reduce crashes caused by teenage drivers. SEARCH METHODS: We searched the Cochrane Injuries Group Specialised Register, CENTRAL, MEDLINE, Embase, Web of Science, and Social Policy and Practice on 16 August 2019. We searched clinical trials registers, relevant conference proceedings, and online media sources of transport organisations, and conducted backward- and forward-citation searching of relevant articles. SELECTION CRITERIA: We included randomised controlled trials (RCTs) or controlled before-after studies (CBAs) evaluating mobility management interventions in teenagers aged 15 to 19 years. We included informational, educational, or behavioural interventions that aimed to prevent, reduce, or delay car driving in this age group, and we compared these interventions with no intervention or with standard practice. We excluded studies that evaluated graduated drivers licensing (GDL) programmes, separate components of GDL, or interventions that act in conjunction with, or as an extension of, GDL. Such programmes aim to increase driving experience and skills through stages of supervised and unsupervised exposure, but assume that all participants will drive; they do not attempt to encourage people to drive less in the long term or promote alternatives to driving. We also excluded studies which evaluated school-based safe-driving initiatives. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for inclusion, extracted data, and assessed risks of bias. We assessed the certainty of evidence with GRADE. MAIN RESULTS: We included one RCT with 178 participants and one CBA with 860 participants. The RCT allocated university students, with a mean age of 18 years, who had not yet acquired a driving licence, to one of four interventions that provided educational information about negative aspects of car use, or to a fifth group in which no information was given. Types of educational information about car use related to cost, risk, or stress, or all three types of educational information combined. In the CBA, 860 school students, aged 17 to 18 years taking a driving theory course, had an additional interactive lesson about active transport (walking or cycling), and some were invited to join a relevant Facebook group with posts targeting awareness and habit. We did not conduct meta-analyses because we had insufficient studies. We could not be certain whether educational interventions versus no information affected people's decision to obtain a driving licence 18 months after receiving the intervention (risk ratio 0.62, 95% confidence interval 0.45 to 0.85; very low-certainty evidence). We noted that fewer participants who were given information obtained a driving licence (42.6%) compared to those who did not receive information (69%), but we had very little confidence in the effect estimate; the study had high or unclear risks of bias and the evidence was from one small study and was therefore imprecise. We could not be certain whether interventions about active transport, given during a driving theory course, could influence behavioural predictors of car use. Study authors noted: - an increased intention to use active transport after obtaining a driving licence between postintervention and an eight-week follow-up in students who were given an active transport lesson and a Facebook invitation compared to those given only the active transport lesson; and - a decrease in intention between pre- and postintervention in those given an active transport lesson and Facebook invitation compared to those given the active transport lesson only. There were high risks of bias in this CBA study design, a large amount of missing data (very few participants accepted the Facebook invitation), and data came from a single study only, so we judged the evidence to be of very low certainty. These studies did not measure our primary outcome (driving frequency), or other secondary outcomes (driving distance, driving hours, use of alternative modes of transport, or car crashes). AUTHORS' CONCLUSIONS: We found only two small studies, and could not determine whether mobility management interventions were effective to prevent, reduce, or delay car driving in teenagers. The lack of evidence in this review raises two points. First, more foundational research is needed to discover how and why young people make decisions surrounding their personal transport, in order to find out what might encourage them to delay licensing and driving. Second, we need longitudinal studies with a robust study design - such as RCTs - and with large sample sizes that incorporate different socioeconomic groups in order to evaluate the feasibility and effectiveness of relevant interventions. Ideally, evaluations will include an assessment of how attitudes and beliefs evolve in teenagers during these transition years, and the potential effect of these on the design of a mobility management intervention for this age group.


Assuntos
Condução de Veículo/educação , Transportes , Adolescente , Viés , Estudos Controlados Antes e Depois , Humanos , Intenção , Licenciamento/estatística & dados numéricos , Ensaios Clínicos Controlados Aleatórios como Assunto , Adulto Jovem
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