Objective: To evaluate whether ankle-foot orthosis (AFO) has a beneficial effect on dorsiflexion angle increase during the swing phase among individuals with stroke and patient-important outcomes in individuals with stroke. Literature Survey: Randomized controlled trials (RCTs), randomized crossover trials, and cluster RCTs until May 2020 were researched through CEN-TRAL, MEDLINE, EMBASE, PEDro, CINAHL, and REHABDATA databases. Studies reporting on AFO use to improve walking, functional mobility, quality of life, and activity limitations and reports of adverse events in individuals with stroke were included. Methodology: Two independent reviewers extracted the data and assessed the risk of bias. The certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluations approach. Synthesis: Fourteen trials that enrolled 282 individuals with stroke and compared AFO with no AFO were included. Compared with no AFO, AFO could increase the dorsiflexion angle of ankle joints during walking (mean difference [MD, 3.7 ]; 95% confidence interval [CI], 2.0-5.3; low certainty of evidence). Furthermore, AFO could improve walking ability (walking speed) (MD, 0.09 [m/s]; 95% CI, 0.06-0.12; low certainty of evidence). No study had reported the effects of AFO on quality of life, adverse events, fall frequency, and activities of daily life. Conclusions: Our findings suggest that AFO improved ankle kinematics and walking ability in the short term; nonetheless, the evidence was characterized by a low degree of certainty.
IntroductionThere is no established clinical prediction model for in-hospital death among patients with pneumonic chronic obstructive pulmonary disease (COPD) exacerbation. We aimed to externally validate BAP-65 and CURB-65 and to develop a new model based on the eXtreme Gradient Boosting (XGBoost) algorithm.MethodsThis multicentre cohort study included patients aged ≥40 years with pneumonic COPD exacerbation. The input data were age, sex, activities of daily living, mental status, systolic and diastolic blood pressure, respiratory rate, heart rate, peripheral blood eosinophil count, and blood urea nitrogen. The primary outcome was in-hospital death. BAP-65 and CURB-65 underwent external validation using the area under the receiver operating characteristic curve (AUROC) in the whole dataset. We used XGBoost to develop a new prediction model. We compared the AUROCs of XGBoost with that of BAP-65 and CURB-65 in the test dataset using bootstrap sampling.ResultsWe included 1190 patients with pneumonic COPD exacerbation. The in-hospital mortality was 7% (88/1190). In the external validation of BAP-65 and CURB-65, the AUROCs (95% confidence interval [CI]) of BAP-65 and CURB-65 were 0.69 (0.66–0.72, and 0.69 (0.66–0.72), respectively. XGBoost showed an AUROC of 0.71 (0.62–0.81) in the test dataset. There was no significant difference in the AUROCs of XGBoost versus BAP-65 (absolute difference, 0.054; 95% CI, −0.057–0.16) or versus CURB-65 (absolute difference, 0.0021; 95% CI, −0.091–0.088).ConclusionBAP-65, CURB-65, and XGBoost showed low predictive performance for in-hospital death in pneumonic COPD exacerbation. Further large-scale studies including more variables are warranted.
To date, no consensus exists on the effects of systemic steroid use on pneumonic chronic obstructive pulmonary disease (COPD) exacerbation owing to trial design issues in previous trials involving these conditions. This multicenter study aimed to evaluate more precisely the effectiveness of the use of systemic steroids in treating pneumonic COPD exacerbation in a larger sample by adjusting for confounding factors. Patients and Methods: This multicenter, retrospective, observational study was conducted across five acute general hospitals in Japan. We analyzed the association between parenteral/ oral steroid therapy and time to clinical stability in pneumonic COPD exacerbation. We used a validated algorithm derived from the 10th revision of the International Classification of Diseases and Related Health Problems (ICD-10) to include patients with pneumonic COPD exacerbation. We excluded patients with other hypoxia causes (asthma exacerbation, pneumothorax, heart failure) and complicated pneumonia (obstructive pneumonia, empyema), those who required tracheal intubation/vasopressors, and those who were clinically stable on day of admission. The primary outcome was the time to clinical stability. Multiple imputation was used for missing data. Propensity scores within each imputed dataset were calculated using potential confounding factors. The Fine and Gray model was used within each dataset to account for the competing risk of death and hospital discharge without clinical stability, and we combined the results. Results: Altogether, 1237 patients were included. Systemic steroid therapy was administered to 658 patients (53%). The pooled estimated subdistribution hazard ratio of time to clinical stability in steroid vs non-steroid users was 0.89 (95% confidence interval, 0.78 to 1.0). Conclusion: This study revealed that systemic steroid therapy may not improve the time to clinical stability in patients with pneumonic COPD exacerbation of mild to moderate severity. Further randomized controlled trials including more severe patients will be needed to evaluate the effectiveness of systemic steroid therapy accurately.
This systematic review aimed to evaluate the diagnostic accuracy of thoracic ultrasound in malignant pleural effusion.Articles published until December 2019 in MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, and the International Clinical Trials Registry Platform were screened by two authors independently to extract data and evaluate the risks of bias and applicability using the modified Quality Assessment of Diagnostic Accuracy Studies-2 tool. We described the forest plots of each thoracic ultrasound finding. We estimated the pooled sensitivity and specificity of pleural nodularity using the bivariate random-effects model.We included seven articles and found that each thoracic ultrasound finding had low sensitivity. The pooled specificity of pleural nodularity was 96.9% (95% confidence interval, 93.2%–98.6%).In conclusion, thoracic ultrasound is not useful in ruling out malignant pleural effusion. Physicians can proceed rigorously to repeat thoracentesis or other invasive procedures when pleural nodularity is detected.
Background Previous studies have suggested that metformin might improve survival outcomes in patients with breast cancer. However, findings on the efficacy of metformin with chemotherapy or endocrine therapy are inconsistent. Objective To clarify the efficacy of metformin with chemotherapy or endocrine therapy in breast cancer patients according to the treatment setting, including neoadjuvant, adjuvant, and metastasis/recurrence. Methods We systematically searched for randomized controlled trials (RCTs) in MEDLINE, CENTRAL, and EMBASE from inception through July 2020. Overall survival (OS), progression-free survival (PFS), and hypoglycemia rate were the primary outcomes. Secondary outcomes included severe adverse events (SAEs) and relapse-free survival. We used the Grading of Recommendations Assessment, Development, and Evaluation approach and performed a meta-analysis to evaluate the efficacy and safety of metformin with chemotherapy and endocrine therapy in patients with breast cancer. Results Our systematic review included 412 participants from 5 trials. Metformin showed little to no difference in OS (hazard ratio [HR] = 1.13; 95% CI = 0.71-1.81; certainty of evidence [COE], moderate) and PFS (HR = 1.14; 95% CI = 0.86-1.50; COE, moderate) in patients with metastasis/recurrence. The evidence was very uncertain about the effect of metformin on survival outcomes in patients who received metformin with neoadjuvant or adjuvant treatment. Metformin showed little to no difference in hypoglycemia and SAEs. Conclusion and Relevance Metformin should be discouraged routinely in nondiabetic patients with metastatic/recurrent breast cancer. Further RCTs are needed to verify whether metformin with chemotherapy or endocrine therapy results in significant clinical benefits in the neoadjuvant or adjuvant setting.
Background: Serologic assays for specific immunoglobulin G (IgG) antibodies are available for diagnosing the condition of bird fancier's lung, however, their usefulness is controversial. This systematic review was aimed at investigating the diagnostic accuracy of specific IgG antibodies used for avian antigens.Methods: Medline, Embase, the Cochrane Library, the International Clinical Trials Registry Platform, and the Web of Science were searched for studies performed to evaluate the diagnostic accuracy of the Ouchterlony method, enzyme-linked immunosorbent assays (ELISAs), electrosyneresis, and ImmunoCAP assays for diagnosing bird fancier's lung. Nine articles were included in the meta-analysis. The pooled sensitivity and specificity were summarized using a bivariate mixed-effects model, and a hierarchical summary receiver operating characteristic curve was rendered to determine the diagnostic accuracy of the antibodies. Results:The pooled sensitivities and specificities of each specific IgG antibody were 82.9% (95% confidence interval, 71.1-90.5%) and 93.0% (95% confidence interval, 74.4-98.4%) for the Ouchterlony method, 92.5% (95% confidence interval, 71.3-98.4%) and 90.8% (95% confidence interval, 72.1-97.4%) for ELISAs, 90.0% (95% confidence interval, 55.5-99.7%) and 84.6% (95% confidence interval, 73.5-92.4%) for the electrosyneresis method, and 43.5% (95% confidence interval, 35.3-52.1%) and 100% (95% confidence interval, 0-100%) for ImmunoCAP assays. The overall quality of the collective evidence was low, primarily due to the high risk of bias, indirectness, and imprecision of the included studies. Conclusions:The Ouchterlony method demonstrated high specificity, the ELISA method showed high sensitivity, and the diagnostic utilities of electrosyneresis and ImmunoCAP assay testing remain unclear.
<b><i>Background:</i></b> The sensitivity and specificity of anti-glomerular basement membrane (GBM) antibodies have not been systematically analyzed. In this systematic review, we aimed to evaluate the diagnostic accuracy of anti-GBM antibodies for anti-GBM disease. <b><i>Summary:</i></b> Potential studies were searched using MEDLINE, Embase, the Cochrane Library, and the International Clinical Trials Registry Platform based on the index test and target condition. The inclusion criteria were prospective or retrospective cohort studies or case-control studies assessing the sensitivity and specificity of anti-GBM antibodies, and the reference standard was clinical diagnosis including biopsy results. The exclusion criteria were review articles, case reports, animal studies, and in vitro studies. Quality assessment was conducted based on the Quality Assessment of Diagnostic Accuracy Studies-2. The pooled estimates of sensitivity and specificity were calculated using a bivariate random-effects model. The overall quality was evaluated using the Grades of Recommendation, Assessment, Development, and Evaluation. Six studies (1,691 patients) and 11 index tests were included in our systematic review. A high risk of bias and concerns regarding the applicability of patient selection were noted because of the case-control design in 67% of the included studies. The pooled sensitivity and specificity were 93% (95% CI: 84–97%) and 97% (95% CI: 94–99%), respectively. The certainty of evidence was low because of the high risk of bias and indirectness. <b><i>Key Messages:</i></b> Anti-GBM antibodies may exhibit high sensitivity and specificity in the diagnosis of anti-GBM disease. Further cohort studies are needed to confirm their precise diagnostic accuracy and compare diagnostic accuracies among different immunoassays.
Simulation training is key to developing skills for vascular access. However, the efficacy of simulation-based education remains unclear. We conducted a well-designed and updated systematic review to investigate the efficacy of these programs. Randomized controlled trials (RCTs) were researched using the following databases from inception until July 26, 2020: MEDLINE, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), Education Resources Information Center (ERIC), Cumulative Index to Nursing and Allied Health Literature (CINAHL), ClinicalTrials.gov , and International Clinical Trials Registry Platform (ICTRP). RCTs included patients undergoing insertion of central venous catheters (CVCs), peripherally inserted central catheters (PICCs), and radial arterial catheters. We compared the group that received simulation training with the group that received traditional training. We also assessed the success rate, adverse events, and first-attempt success using a random-effects meta-analysis. The protocol was registered at Protocols.io ( dx.doi.org/10.17504/protocols.io.biu6keze ). Seven RCTs (n=866) were evaluated. The meta-analysis showed that simulation-based education increased the overall success rate compared with traditional education (risk ratio: 1.08, 95% CI: 1.03 to 1.13; six RCTs; 840 participants; I 2 =0%; moderate certainty of evidence). However, it was unclear whether or not simulation-based education had an effect on reducing adverse events when compared with traditional education (risk ratio: 1.00, 95% CI: 0.63 to 1.58; five studies; 750 participants; I 2 =37%; very low certainty of evidence) or on raising first-attempt success rates (risk ratio: 1.34, 95% CI: 0.93 to 1.94; three studies; 244 participants; I 2 =59%; very low certainty of evidence). Simulation-based education may help develop skills for successful vascular access. However, it is unclear whether simulation-based education actually reduces the incidence of adverse events. Fine control of the needle tip is probably necessary to prevent adverse events. Simulation-based education might be required in the future for outcome-based task training.
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