Showing papers on "Subgroup analysis published in 2021"
TL;DR: In this paper, a systematic review of current evidence for the use of the ABC pathway on clinical outcomes was performed, with a pooled prevalence of ABC-adherent management of 21% (95% confidence interval, CI: 13-34%).
Abstract: Objective The ‘Atrial fibrillation Better Care’ (ABC) pathway has been recently proposed as a holistic approach for the comprehensive management of patients with atrial fibrillation (AF). We performed a systematic review of current evidence for the use of the ABC pathway on clinical outcomes. Methods and Results We performed a systematic review and meta-analysis according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. PubMed and EMBASE were searched for studies reporting the prevalence of ABC-pathway-adherent management in AF patients, and its impact on clinical outcomes (all-cause death, cardiovascular death, stroke, and major bleeding). Meta-analysis of odds ratio (OR) was performed with random-effects models; subgroup analysis and meta-regression were performed to account for heterogeneity. Among the eight studies included, we found a pooled prevalence of ABC-adherent management of 21% (95% confidence interval, CI: 13–34%), with a high grade of heterogeneity, explained by the increasing adherence to each ABC criterion. Patients treated according to the ABC pathway showed a lower risk of all-cause death (OR: 0.42; 95% CI: 0.31–0.56), cardiovascular death (OR: 0.37; 95% CI: 0.23–0.58), stroke (OR: 0.55; 95% CI: 0.37–0.82) and major bleeding (OR: 0.69; 95% CI: 0.51–0.94), with moderate heterogeneity. Prevalence of comorbidities was moderators of heterogeneity for all-cause and cardiovascular death, while longer follow-up was associated with increased effectiveness for all outcomes. Conclusion Adherence to the ABC pathway was suboptimal, being adopted in one in every five patients. Adherence to the ABC pathway was associated with a reduction in the risk of major adverse outcomes.
147 citations
TL;DR: A higher degree of obesity indicated a higher risk of almost all of the above events and could promote the occurrence of the whole course of COVID‐19.
Abstract: This review aimed to evaluate the impact of obesity on the onset, exacerbation, and mortality of coronavirus disease 2019 (COVID-19); and compare the effects of different degrees of obesity. PubMed, EMBASE, and Web of Science were searched to find articles published between December 1, 2019, and July 27, 2020. Only observational studies with specific obesity definition were included. Literature screening and data extraction were conducted simultaneously by two researchers. A random-effects model was used to merge the effect quantity. Sensitivity analysis, subgroup analysis, and meta-regression analysis were used to deal with the heterogeneity among studies. Forty-one studies with 219,543 subjects and 115,635 COVID-19 patients were included. Subjects with obesity were more likely to have positive SARS-CoV-2 test results (OR = 1.50; 95% CI: 1.37-1.63, I2 = 69.2%); COVID-19 patients with obesity had a higher incidence of hospitalization (OR = 1.54, 95% CI: 1.33-1.78, I2 = 60.9%); hospitalized COVID-19 patients with obesity had a higher incidence of intensive care unit admission (OR = 1.48, 95% CI: 1.24-1.77, I2 = 67.5%), invasive mechanical ventilation (OR = 1.47, 95% CI: 1.31-1.65, I2 = 18.8%), and in-hospital mortality (OR = 1.14, 95% CI: 1.04-1.26, I2 = 74.4%). A higher degree of obesity also indicated a higher risk of almost all of the above events. The region may be one of the causes of heterogeneity. Obesity could promote the occurrence of the whole course of COVID-19. A higher degree of obesity may predict a higher risk. Further basic and clinical therapeutic research needs to be strengthened.
98 citations
TL;DR: Whether hypertension is an independent risk factor for critical COVID-19 and mortality and the effect of covariates was analyzed using subgroup analysis and meta-regression analysis.
Abstract: AIMS: As reported, hypertension may play an important role in adverse outcomes of coronavirus disease-2019 (COVID-19), but it still had many confounding factors. The aim of this study was to explore whether hypertension is an independent risk factor for critical COVID-19 and mortality. DATA SYNTHESIS: The Medline, PubMed, Embase, and Web of Science databases were systematically searched until November 2020. Combined odds ratios (ORs) with their 95% confidence interval (CIs) were calculated by using random-effect models, and the effect of covariates was analyzed using the subgroup analysis and meta-regression analysis. A total of 24 observational studies with 99,918 COVID-19 patients were included in the meta-analysis. The proportions of hypertension in critical COVID-19 were 37% (95% CI: 0.27 -0.47) when compared with 18% (95% CI: 0.14 -0.23) of noncritical COVID-19 patients, in those who died were 46% (95%CI: 0.37 -0.55) when compared with 22% (95% CI: 0.16 -0.28) of survivors. Pooled results based on the adjusted OR showed that patients with hypertension had a 1.82-fold higher risk for critical COVID-19 (aOR: 1.82; 95% CI: 1.19 - 2.77; P = 0.005) and a 2.17-fold higher risk for COVID-19 mortality (aOR: 2.17; 95% CI: 1.67 - 2.82; P 60 years was associated with a significantly increased risk of COVID-19 mortality (OR: 3.12; 95% CI: 1.93 - 5.05; P < 0.001). Meta-regression analysis results also showed that age (Coef. = 2.3×10-2, P = 0.048) had a significant influence on the association between hypertension and COVID-19 mortality. CONCLUSIONS: Evidence from this meta-analysis suggested that hypertension was independently associated with a significantly increased risk of critical COVID-19 and inhospital mortality of COVID-19.
79 citations
TL;DR: In this article, the effect of resistance training (RT) performed until volitional failure with low, moderate, and high loads on muscle hypertrophy and muscle strength in healthy adults was analyzed.
Abstract: PURPOSE This study aimed to analyze the effect of resistance training (RT) performed until volitional failure with low, moderate, and high loads on muscle hypertrophy and muscle strength in healthy adults and to assess the possible participant-, design-, and training-related covariates that may affect the adaptations. METHODS Using Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, MEDLINE, CINAHL, EMBASE, SPORTDiscus, and Web of Science databases were searched. Including only studies that performed sets to volitional failure, the effects of low- (>15 repetitions maximum (RM)), moderate- (9-15 RM), and high-load (≤8 RM) RTs were examined in healthy adults. Network meta-analysis was undertaken to calculate the standardized mean difference (SMD) between RT loads in overall and subgroup analyses involving studies deemed of high quality. Associations between participant-, design-, and training-related covariates with SMD were assessed by univariate and multivariate network meta-regression analyses. RESULTS Twenty-eight studies involving 747 healthy adults were included. Although no differences in muscle hypertrophy between RT loads were found in overall (P = 0.113-0.469) or subgroup analysis (P = 0.871-0.995), greater effects were observed in untrained participants (P = 0.033) and participants with some training background who undertook more RT sessions (P = 0.031-0.045). Muscle strength improvement was superior for both high-load and moderate-load compared with low-load RT in overall and subgroup analysis (SMD, 0.60-0.63 and 0.34-0.35, respectively; P < 0.001-0.003), with a nonsignificant but superior effect for high compared with moderate load (SMD, 0.26-0.28, P = 0.068). CONCLUSIONS Although muscle hypertrophy improvements seem to be load independent, increases in muscle strength are superior in high-load RT programs. Untrained participants exhibit greater muscle hypertrophy, whereas undertaking more RT sessions provides superior gains in those with previous training experience.
66 citations
TL;DR: In this article, a large number of studies have explored the association between frailty and mortality among COVID-19 patients, with inconsistent results, and the aim of this meta-analysis was to synthesize the evidence on this issue.
Abstract: A large number of studies have explored the association between frailty and mortality among COVID-19 patients, with inconsistent results. The aim of this meta-analysis was to synthesize the evidence on this issue. Three databases, PubMed, Embase, and Cochrane Library, from inception to 20th January 2021 were searched for relevant literature. The Newcastle–Ottawa Scale (NOS) was used to assess quality bias, and STATA was employed to pool the effect size by a random effects model. Additionally, potential publication bias and sensitivity analyses were performed. Fifteen studies were included, with a total of 23,944 COVID-19 patients, for quantitative analysis. Overall, the pooled prevalence of frailty was 51% (95% CI: 44–59%). Patients with frailty who were infected with COVID-19 had an increased risk of mortality compared to those without frailty, and the pooled hazard ratio (HR) and odds ratio (OR) were 1.99 (95% CI: 1.66–2.38) and 2.48 (95% CI: 1.78–3.46), respectively. In addition, subgroup analysis based on population showed that the pooled ORs for hospitalized patients in eight studies and nursing home residents in two studies were 2.62 (95% CI: 1.68–4.07) and 2.09 (95% CI: 1.40–3.11), respectively. Subgroup analysis using the frailty assessment tool indicated that this association still existed when using the clinical frailty scale (CFS) (assessed in 6 studies, pooled OR = 2.88, 95% CI: 1.52–5.45; assessed in 5 studies, pooled HR = 1.99, 95% CI: 1.66–2.38) and other frailty tools (assessed in 4 studies, pooled OR = 1.98, 95% CI: 1.81–2.16). In addition, these significant positive associations still existed in the subgroup analysis based on study design and geographic region. Our study indicates that frailty is an independent predictor of mortality among patients with COVID-19. Thus, frailty could be a prognostic factor for clinicians to stratify high-risk groups and remind doctors and nurses to perform early screening and corresponding interventions urgently needed to reduce mortality rates in patients infected by SARS-CoV-2.
58 citations
TL;DR: A systematic review and meta‐analysis basing on the prospective cohort studies were conducted to explore the risk of all‐cause mortality and dementia in cognitively frail older adults compared to robust older adults and to determine whether it was a predictor of adverse outcomes.
Abstract: OBJECTIVE A systematic review and meta-analysis basing on the prospective cohort studies were conducted to explore the risk of all-cause mortality and dementia in cognitively frail older adults compared to robust older adults and to determine whether it was a predictor of adverse outcomes. METHODS Pubmed, Web of Science, The Cochrane Library, EMBASE, and CINAHL databases were searched to retrieve studies on adverse outcomes of cognitive frailty. Two reviewers independently screened the literature, extracted data, and assessed the risk of bias of the included studies. Stata 15.0 Software was used to perform the meta-analysis. The all-cause mortality and dementia were observed to be the primary outcomes, while the other data were considered as the secondary outcome. RESULTS A total of 14 studies were included in qualitative analysis and 12 studies were included in the meta-analysis, with low risk of bias and moderate to good methodological quality. The results showed that cognitive frailty in older people had a higher risk of all-cause mortality [HR = 1.93, 95%CI (1.67, 2.23), p < .001] and dementia [HR = 3.66, 95%CI (2.86, 4.70) as compared with robust. The subgroup analysis showed that the assessment tools were the main source of heterogeneity. CONCLUSION In older adults living in communities, the cognitive frailty was found to be a significant predictor of all-cause mortality and dementia. Nonetheless, cognitive frailty was found to be a better predictor of all-cause mortality and dementia than just frailty.
56 citations
TL;DR: In this article, the authors investigated if overweight, obesity, and diabetes were independently associated with severe coronavirus disease 2019 severity and whether the BMI-associated risk was increased among those with diabetes.
Abstract: OBJECTIVE Obesity is an established risk factor for severe coronavirus disease 2019 (COVID-19), but the contribution of overweight and/or diabetes remains unclear. In a multicenter, international study, we investigated if overweight, obesity, and diabetes were independently associated with COVID-19 severity and whether the BMI-associated risk was increased among those with diabetes. RESEARCH DESIGN AND METHODS We retrospectively extracted data from health care records and regional databases of hospitalized adult patients with COVID-19 from 18 sites in 11 countries. We used standardized definitions and analyses to generate site-specific estimates, modeling the odds of each outcome (supplemental oxygen/noninvasive ventilatory support, invasive mechanical ventilatory support, and in-hospital mortality) by BMI category (reference, overweight, obese), adjusting for age, sex, and prespecified comorbidities. Subgroup analysis was performed on patients with preexisting diabetes. Site-specific estimates were combined in a meta-analysis. RESULTS Among 7,244 patients (65.6% overweight/obese), those with overweight were more likely to require oxygen/noninvasive ventilatory support (random effects adjusted odds ratio [aOR], 1.44; 95% CI 1.15–1.80) and invasive mechanical ventilatory support (aOR, 1.22; 95% CI 1.03–1.46). There was no association between overweight and in-hospital mortality (aOR, 0.88; 95% CI 0.74–1.04). Similar effects were observed in patients with obesity or diabetes. In the subgroup analysis, the aOR for any outcome was not additionally increased in those with diabetes and overweight or obesity. CONCLUSIONS In adults hospitalized with COVID-19, overweight, obesity, and diabetes were associated with increased odds of requiring respiratory support but were not associated with death. In patients with diabetes, the odds of severe COVID-19 were not increased above the BMI-associated risk.
54 citations
TL;DR: Both galcanezumab doses demonstrated significant improvement compared with placebo for overall least squares mean change in monthly migraine headache days in patients with baseline medication overuse in both the episodic and chronic migraine studies.
Abstract: IntroductionAcute medication overuse is prevalent in patients with migraine.MethodsIn three phase 3, double-blind, randomized, placebo-controlled studies, patients with episodic migraine (EVOLVE-1 ...
52 citations
TL;DR: In this paper, the authors systematically searched for randomised trials comparing neoadjuvant therapy with upfront surgery for resectable and borderline resectably pancreatic cancer published since database inception until December 2020.
48 citations
TL;DR: In this article, a systematic review and meta-analysis was performed to estimate the pooled relative risk of mortality among birth asphyxiated neonates with hypoxic-ischemic encephalopathy in a global context.
Abstract: Background Hypoxic perinatal brain injury is caused by lack of oxygen to baby’s brain and can lead to death or permanent brain damage. However, the effectiveness of therapeutic hypothermia in birth asphyxiated infants with encephalopathy is uncertain. This systematic review and meta-analysis was aimed to estimate the pooled relative risk of mortality among birth asphyxiated neonates with hypoxic-ischemic encephalopathy in a global context. Methods We used the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guidelines to search randomized control trials from electronic databases (PubMed, Cochrane library, Google Scholar, MEDLINE, Embase, Scopus, Web of Science, Cochrane Central Register of Controlled Trials (CENTRAL), and meta register of Current Controlled Trials (mCRT)). The authors extracted the author’s name, year of publication, country, method of cooling, the severity of encephalopathy, the sample size in the hypothermic, and non-hypothermic groups, and the number of deaths in the intervention and control groups. A weighted inverse variance fixed-effects model was used to estimate the pooled relative risk of mortality. The subgroup analysis was done by economic classification of countries, methods of cooling, and cooling devices. Publication bias was assessed with a funnel plot and Eggers test. A sensitivity analysis was also done. Results A total of 28 randomized control trials with a total sample of 35, 92 (1832 hypothermic 1760 non-hypothermic) patients with hypoxic-ischemic encephalopathy were used for the analysis. The pooled relative risk of mortality after implementation of therapeutic hypothermia was found to be 0.74 (95%CI; 0.67, 0.80; I2 = 0.0%; p<0.996). The subgroup analysis revealed that the pooled relative risk of mortality in low, low middle, upper-middle and high income countries was 0.32 (95%CI; -0.95, 1.60; I2 = 0.0%; p<0.813), 0.5 (95%CI; 0.14, 0.86; I2 = 0.0%; p<0.998), 0.62 (95%CI; 0.41–0.83; I2 = 0.0%; p<0.634) and 0.76 (95%CI; 0.69–0.83; I2 = 0.0%; p<0.975) respectively. The relative risk of mortality was the same in selective head cooling and whole-body cooling method which was 0.74. Regarding the cooling device, the pooled relative risk of mortality is the same between the cooling cap and cooling blanket (0.74). However, it is slightly lower (0.73) in a cold gel pack. Conclusions Therapeutic hypothermia reduces the risk of death in neonates with moderate to severe hypoxic-ischemic encephalopathy. Both selective head cooling and whole-body cooling method are effective in reducing the mortality of infants with this condition. Moreover, low income countries benefit the most from the therapy. Therefore, health professionals should consider offering therapeutic hypothermia as part of routine clinical care to newborns with hypoxic-ischemic encephalopathy especially in low-income countries.
43 citations
TL;DR: In this paper, a systematic review and meta-analysis of the effects of training to failure or non-failure on muscular strength and hypertrophy was performed, showing no significant difference between the training conditions for muscular strength (ES = 0.09; 95% confidence interval (95%CI): 0.03-0.26).
TL;DR: Nearly a quarter of the type 1 diabetes mellitus patients were affected by metabolic syndrome, and more attention should be paid to the prevention and control of the epidemic and for the reduction of the morbidity and mortality associated with metabolic syndrome among type 1 diabetic mellitus Patients.
Abstract: The presence of metabolic syndrome among diabetes patients is frequent and is associated with an increased incidence of chronic complications and mortality. Despite several studies have been conducted, there is no overall estimation on the prevalence of metabolic syndrome among type 1 diabetic patients. Therefore, this study aimed to estimate the pooled prevalence of metabolic syndrome among patients with type 1 diabetes mellitus. Medline via PubMed, CINAHL, ScienceDirect, Ovid, Google Scholar, ResearchGate and African Journals Online were searched by limiting publication period from January 2005 to October 2020. Data were extracted with a standardized format prepared in Microsoft Excel and exported to Stata 16.0 for analyses. The I2 statistic was used to check heterogeneity across the included studies. DerSimonian and Laird random-effects model was applied to estimate pooled prevalence and 95% confidence interval across studies. Funnel plot symmetry, Begg’s test and Egger’s regression test were used to determine the presence of publication bias. Subgroup and sensitivity analysis as well as meta-regression were conducted to explore the potential sources of heterogeneity. The study protocol is registered on PROSPERO with reference number: CRD42020213435. In this meta-analysis, a total of 27 studies with 45,811 study participants were included. The pooled prevalence of metabolic syndrome was 23.7% with substantial heterogeneity (I2 = 98.2%; P < 0.001). Geographical-based subgroup analysis revealed that the highest prevalence was observed in Australia (27.3%). As per meta-analysis of 17 studies, the pooled prevalence of metabolic syndrome in female type 1 diabetes patients (25.9%) was slightly higher than male T1DM patients (22.5%). Nearly a quarter of the type 1 diabetes mellitus patients were affected by metabolic syndrome. Therefore, more attention should be paid to the prevention and control of the epidemic and for the reduction of the morbidity and mortality associated with metabolic syndrome among type 1 diabetes mellitus patients.
TL;DR: In this paper, the effect of melatonin on sleep quality in adults with various diseases was investigated using randomized clinical trials (RCTs) with a random effects model (DerSimonian-Laird method).
Abstract: The Present study was conducted to systematically review the effect of the melatonin on sleep quality. We summarized evidence from randomized clinical trials (RCTs) that investigated the effects of melatonin on sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) in adults with various diseases. The literature searches of English publications in MEDLINE and EMBASE databases were performed up June 2020. Results were summarized as mean differences (MD) with 95% confidence intervals (CI) using random effects model (DerSimonian–Laird method). Heterogeneity among studies was evaluated by the Cochrane Q test and I-squared (I2). To determine the predefined sources of heterogeneity, subgroup analysis was performed. Of 2642 papers, 23 RCTs met inclusion criteria. Our results indicated that melatonin had significant effect on sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) (WMD: − 1.24; 95% CI − 1.77, − 0.71, p = 0.000). There was significant heterogeneity between studies (I2 = 80.7%, p = 0.000). Subgroup analysis based on health status and kind of intervention were potential between-study heterogeneity. Subgroup analysis based on health status revealed melatonin intervention in subjects with Respiratory diseases (WMD: − 2.20; 95% CI − 2.97, − 1.44, p = 0.000), Metabolic disorders (WMD: − 2.74; 95% CI − 3.48, − 2.00, p = 0.000) and sleep disorders (WMD: − 0.67; 95% CI − 0.98, − 0.37, p = 0.000) has significant effect on sleep quality. We found that the treatment with exogenous melatonin has positive effects on sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) in adult. In adults with respiratory diseases, metabolic disorders, primary sleep disorders, not with mental disorders, neurodegenerative diseases and other diseases.
TL;DR: It is confirmed that close to 4% of patients diagnosed with OSF may develop oral cancer, and the demographic and clinicopathological factors contributing to the progression of OSF to cancer are evaluated.
Abstract: OBJECTIVES This systematic review and meta-analysis aimed to determine the proportion of patients who develop oral carcinomas following a diagnosis of oral submucous fibrosis (OSF) in reported longitudinal studies. We also aimed to evaluate the demographic and clinicopathological factors contributing to the progression of OSF to cancer. METHODS Individual search strategies were applied for the following bibliographic databases: MEDLINE by PubMed, Scopus, Embase, Web of Science, and Grey literature databases until August 30, 2020. Methodological assessment of the risk of bias of the included studies was undertaken using the modified Newcastle-Ottawa scale. Meta-analyses were conducted using a random-effects (DerSimonian and Liard) method to calculate the pooled proportion of the malignant transformation (MT) in OSF patients. RESULTS Out of 585 records screened, a total of 9 observational studies were included with a total number of 6,337 patients; of these, 292 OSF cases developed carcinomas. The pooled proportion of the MT was 4.2% (95% CI: 2.7%-5.6%) with an annual transformation rate of 0.73%. Subgroup analysis revealed that the pooled MT proportion was significantly higher among population-based studies in comparison with hospital-based ones (p < .005). Most of the studies showed a high risk of bias. In several studies, there was a lack of information about the demographic and clinicopathological characteristics of OSF patients and associated risk indicators; this insufficiency in details hindered the ability to conduct further subgroup analyses. CONCLUSIONS Despite the poorly reported and the limited number of studies, our analysis confirms that close to 4% of patients diagnosed with OSF may develop oral cancer. Cases with oral epithelial dysplasia had a higher potential for malignant transformation.
TL;DR: In this article, a systematic review and meta-analysis aimed to estimate the global prevalence of sarcopenic obesity in older adults was conducted, which indicated that sarcopenia affects more than one in ten adults globally.
TL;DR: In this paper, a systematic review and meta-analysis was conducted to quantitatively determine the relationship between baseline grip strength and the risk of cognitive impairment and provide evidence for clinical work.
Abstract: Purpose: Loss of grip strength and cognitive impairment are prevalent in the elderly, and they may share the pathogenesis in common Several original studies have investigated the association between them, but the results remained controversial In this systematic review and meta-analysis, we aimed to quantitatively determine the relationship between baseline grip strength and the risk of cognitive impairment and provide evidence for clinical work Methods: We performed a systematic review using PubMed, EMBASE, Cochrane, and Web of Science up to March 23, 2020, and focused on the association between baseline grip strength and onset of cognitive impairment Next, we conducted a meta-analysis using a hazard ratio (HR) and 95% confidence interval (CI) as effect measures Heterogeneity between the studies was examined using I 2 and p-value Sensitivity analyses and subgroup analyses were also performed, and publication bias was assessed by Begg's and Egger's tests Results: Fifteen studies were included in this systematic review After sensitivity analyses, poorer grip strength was associated with more risk of cognitive decline and dementia (HR = 199, 95%CI: 171-232; HR = 154, 95%CI: 132-179, respectively) Furthermore, subgroup analysis indicated that people with poorer strength had more risk of Alzheimer's disease (AD) and non-AD dementia (HR = 141, 95%CI: 109-181; HR = 145, 95%CI: 110-191, respectively) Conclusions: Lower grip strength is associated with more risk of onset of cognitive decline and dementia despite of subtype of dementia We should be alert for the individuals with poor grip strength and identify cognitive dysfunction early
TL;DR: A small number of patients with HER2+ metastatic breast cancer are at high risk of developing brain metastases (BMs), and treatment options are limited once BMs occur, and T-DXd is an antibody that binds to HER2 and acts as a “spatially aggregating force” towards BMs.
Abstract: 526Background: Patients (pts) with HER2+ metastatic breast cancer (mBC) are at high risk of developing brain metastases (BMs), and treatment options are limited once BMs occur. T-DXd is an antibody...
TL;DR: In this paper, a systematic review and meta-analysis of randomised controlled trials (RCTs) was performed to examine the long term risk of major amputation using paclitaxel coated balloons in peripheral arterial disease (PAD).
TL;DR: The analysis supports the use of an improved-bioavailability formulation of curcumin to improve HRQOL, however, given the heterogeneity among the studies included in this review, additional evidence from well-designed, large, and long-term trials is still required.
TL;DR: In this paper, a systematic review and network meta-analysis of randomized controlled trials (RCTs) on the role of probiotics in preventing necrotizing enterocolitis (NEC) in preterm infants, focusing on the differential effect of type of feeding, was performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.
Abstract: Background: Recent evidence supports a role of probiotics in preventing necrotizing enterocolitis (NEC) in preterm infants. Methods: A systematic review and network meta-analysis of randomized controlled trials (RCTs) on the role of probiotics in preventing NEC in preterm infants, focusing on the differential effect of type of feeding, was performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A random-effects model was used; a subgroup analysis on exclusively human milk (HM)-fed infants vs. infants receiving formula (alone or with HM) was performed. Results: Fifty-one trials were included (10,664 infants, 29 probiotic interventions); 31 studies (19 different probiotic regimens) were suitable for subgroup analysis according to feeding. In the overall analysis, Lactobacillus acidophilus LB revealed the most promising effect for reducing NEC risk (odds ratio (OR), 0.03; 95% credible intervals (CrIs), 0.00–0.21). The subgroup analysis showed that Bifidobacterium lactis Bb-12/B94 was associated with a reduced risk of NEC stage ≥2 in both feeding type populations, with a discrepancy in the relative effect size in favour of exclusively HM-fed infants (OR 0.04; 95% CrIs <0.01–0.49 vs. OR 0.32; 95% CrIs 0.10–0.36). Conclusions: B. lactis Bb-12/B94 could reduce NEC risk with a different size effect according to feeding type. Of note, most probiotic strains are evaluated in few trials and relatively small populations, and outcome data according to feeding type are not available for all RCTs. Further trials are needed to confirm the present findings.
TL;DR: The use of statins was associated with a reduced need for invasive mechanical ventilation and decreased all-cause mortality among individuals with coronavirus disease 2019 (COVID-19) as discussed by the authors.
Abstract: Background Statins are widely used to treat people with metabolic and cardiovascular disorders. The effect of statins on coronavirus disease 2019 (COVID-19) is unclear. To investigate the association between statins and COVID-19 outcomes and, if possible, identify the subgroup population that benefits most from statin use. Materials and methods A systematic review and meta-analysis of published studies that included statin users and described COVID-19 outcomes through 10 November 2020. This study used the generic inverse variance method to perform meta-analyses with random-effects modelling. The main outcomes were evaluation of the need for invasive mechanical ventilator (IMV) support, the need for intensive care unit (ICU) care and death. All outcomes were measured as dichotomous variables. Results A total of 28 observational studies, covering data from 63,537 individuals with COVID-19, were included. The use of statins was significantly associated with decreased mortality (odds ratio [OR] = 0.71, 95% confidence interval [CI]: 0.55-0.92, I2=72%) and the need for IMV (OR = 0.81, 95% CI: 0.69-0.95, I2=0%) but was not linked to the need for ICU care (OR = 0.91, 95% CI: 0.55-1.51, I2=66%). Subgroup analysis further identified five types of studies in which statin users had even lower odds of death. Conclusions The use of statins was significantly associated with a reduced need for IMV and decreased mortality among individuals with COVID-19. Statins may not need to be discontinued because of concern for COVID-19 on admission. Further randomized controlled trial (RCTs) are needed to clarify the causal effect between statin use and severe COVID-19 outcomes.Key messagesParticipants in five types of studies were shown to have even lower odds of death when taking statins.The use of statins was significantly associated with a reduced need for invasive mechanical ventilation and decreased all-cause mortality among individuals with COVID-19. However, statin use did not prevent participants from needing care in the intensive care unit.The results justify performing randomized controlled trials (RCTs) to validate the benefits of statins on COVID-19 outcomes.
TL;DR: In this article, the association between statin use and composite poor outcomes of COVID-19 was analyzed using review manager 5.4 and Comprehensive Meta-Analysis 3 software, which showed that the association was weaker in studies with median age ≥ 60 years-old (OR 0.94).
Abstract: Aims One of the comorbidities associated with severe outcome and mortality of COVID-19 is dyslipidemia. Statin is one of the drugs which is most commonly used for the treatment of dyslipidemic patients. This study aims to analyze the association between statin use and composite poor outcomes of COVID-19. Data synthesis We systematically searched the PubMed and Europe PMC database using specific keywords related to our aims until November 25th, 2020. All articles published on COVID-19 and statin were retrieved. Statistical analysis was done using Review Manager 5.4 and Comprehensive Meta-Analysis 3 software. Results A total of 35 studies with a total of 11, 930, 583 patients were included in our analysis. Our meta-analysis showed that statin use did not improve the composite poor outcomes of COVID-19 [OR 1.08 (95% CI 0.86–1.35), p = 0.50, I2 = 98%, random-effect modelling]. Meta-regression showed that the association with composite poor outcomes of COVID-19 was influenced by age (p = 0.010), gender (p = 0.045), and cardiovascular disease (p = 0.012). Subgroup analysis showed that the association was weaker in studies with median age ≥60 years-old (OR 0.94) compared to Conclusion Statin use did not improve the composite poor outcomes of COVID-19. Patients with dyslipidemia should continue taking statin drugs despite COVID-19 infection status, given its beneficial effects on cardiovascular outcomes.
TL;DR: In this article, the potential association between DPP-4 inhibitor and composite poor outcome of COVID-19 was analyzed using PubMed and Europe PMC database using specific keywords related to our aims until November 29th, 2020.
Abstract: One of the drugs which is commonly used in diabetic patients is Dipeptidyl Peptidase-4 (DPP-4) inhibitor Currently, the association between DPP-4 inhibitor and coronavirus disease 2019 (COVID-19) outcome is not yet established This study aims to analyze the potential association between DPP-4 inhibitor and the composite poor outcome of COVID-19 We systematically searched the PubMed and Europe PMC database using specific keywords related to our aims until November 29th, 2020 All articles published on COVID-19 and DPP-4 inhibitor were retrieved Statistical analysis was done using Review Manager 54 and Comprehensive Meta-Analysis version 3 software Our pooled analysis showed that DPP-4 inhibitor use was not associated with composite poor outcomes of COVID-19 [OR 109 (95% CI 093–128), p = 029, I2 = 0%, random-effect modelling], and its subgroup which comprised of severe COVID-19 [OR 107 (95% CI 087–131), p = 054, I2 = 0%, random-effect modelling], and mortality [OR 114 (95% CI 087–151), p = 035, I2 = 8%, random-effect modelling] Meta-regression showed that the association was not influenced by age (p = 0663), hypertension (p = 0454), and admission blood glucose (p = 0310) Subgroup analysis showed that the association was weaker in East Asian populations (OR 102) compared to European populations (OR 111) DPP-4 inhibitor in diabetic patients did not alter the outcomes from COVID-19 Our study suggest that the use of DPP-4 inhibitor in COVID-19 patients with diabetes may still be continued according to the patients’ need
TL;DR: When existing clinical trial data suggest a promising subgroup, it is necessary to address the question of how good the selected subgroup really is to determine whether the subgroup actually is good.
Abstract: When existing clinical trial data suggest a promising subgroup, we must address the question of how good the selected subgroup really is. The usual statistical inference applied to the selected sub...
University of Chicago1, MedStar Health2, University of Salerno3, University of Tokyo4, University of Washington5, University of Cambridge6, University of Milano-Bicocca7, Samsung Medical Center8, Iran University of Medical Sciences9, University of Occupational and Environmental Health Japan10, University Health Network11, University of São Paulo12, Shandong University13
TL;DR: In this paper, the authors focused on two-dimensional and three-dimensional (3D) measures of left atrial (LA) structure and function, with subgroup analysis by age, sex, and race.
Abstract: Background Left atrial (LA) evaluation includes volumetric and functional parameters with an abundance of diagnostic and prognostic implications. Solid normal reference ranges are compulsory for accurate interpretation in individual patients, but previous studies have yielded mixed conclusions regarding the effects of age, sex, and/or race. The present report from the World Alliance Societies of Echocardiography study focuses on two-dimensional (2D) and three-dimensional (3D) measures of LA structure and function, with subgroup analysis by age, sex, and race. Methods Transthoracic 2D and 3D echocardiographic images were obtained in 1,765 healthy individuals (901 men, 864 women) evenly distributed among age subgroups: 18 to 40 years (n = 745), 41 to 65 years (n = 618), and >65 years (n = 402); the racial distribution was 38.4% white, 39.9% Asian, and 9.7% black. Images were analyzed using dedicated LA analysis software to measure LA volumes and phasic function from 3D volume and 2D strain curves. Results Three-dimensional maximum and minimum LA volumes adjusted for body surface area were nearly identical for men and women, but women demonstrated higher 3D total and passive emptying fractions (EFs). Two-dimensional reservoir strain was similar for both sexes. Age was associated with an incremental rise in LA volumes alongside characteristic shifts in functional indices. Total 2D EF and reservoir and conduit strain varied inversely with age, counteracted by higher booster strain, with a greater magnitude of effect in women. Active 3D EF was significantly higher, while total and passive EFs decreased with age. Interracial differences were noted in LA volumes, without substantial differences in functional indices. Conclusion Although similar normal values for LA volumes and strain can be applied to both sexes, meaningful differences in LA size occur with aging. Indices of function also shift with age, with a compensatory rise in booster function, which may serve to counteract observed lower total and passive EFs. Defining age-associated normal values may help differentiate age-associated “healthy” LA aging from pathologic processes.
TL;DR: In this article, the authors explore the power problems of subgroup analyses in more detail, using "metapower", a recently developed statistical package in R to examine power in meta-analyses, including sub-group analyses.
Abstract: One of the most used methods to examine sources of heterogeneity in meta-analyses is the so-called ‘subgroup analysis’. In a subgroup analysis, the included studies are divided into two or more subgroups, and it is tested whether the pooled effect sizes found in these subgroups differ significantly from each other. Subgroup analyses can be considered as a core component of most published meta-analyses. One important problem of subgroup analyses is the lack of statistical power to find significant differences between subgroups. In this paper, we explore the power problems of subgroup analyses in more detail, using ‘metapower’, a recently developed statistical package in R to examine power in meta-analyses, including subgroup analyses. We show that subgroup analyses require many more included studies in a meta-analysis than are needed for the main analyses. We work out an example of an ‘average’ meta-analysis, in which a subgroup analysis requires 3–4 times the number of studies that are needed for the main analysis to have sufficient power. This number of studies increases exponentially with decreasing effect sizes and when the studies are not evenly divided over the subgroups. Higher heterogeneity also requires increasing numbers of studies. We conclude that subgroup analyses remain an important method to examine potential sources of heterogeneity in meta-analyses, but that meta-analysts should keep in mind that power is very low for most subgroup analyses. As in any statistical evaluation, researchers should not rely on a test and p-value to interpret results, but should compare the confidence intervals and interpret results carefully.
TL;DR: The authors investigated the efficacy and safety of pembrolizumab plus best supportive care (BSC) in patients with advanced hepatocellular carcinoma (HCC) treated with sorafenib.
Abstract: Introduction KEYNOTE-240 investigated the efficacy and safety of pembrolizumab plus best supportive care (BSC) in sorafenib-treated patients with advanced hepatocellular carcinoma (HCC). Results for the subgroup of patients from Asia are described. Methods Adults with advanced HCC previously treated with sorafenib were randomized 2:1 to pembrolizumab or placebo plus BSC. Here, the Asian subgroup comprised patients enrolled in Hong Kong, Japan, Korea, the Philippines, Taiwan, and Thailand. Primary endpoints were progression-free survival (PFS) per blinded central imaging review and overall survival (OS). Secondary endpoints included objective response rate (ORR) per blinded central imaging review, duration of response (DOR), and safety. Results The Asian subgroup included 157 patients. As of January 2, 2019, the median follow-up in this subgroup was 13.8 months for pembrolizumab and 8.3 months for placebo. The median PFS was 2.8 months for pembrolizumab (95% confidence interval [CI] 2.6-4.1) versus 1.4 months (95% CI 1.4-2.4) for placebo (hazard ratio [HR] 0.48; 95% CI 0.32-0.70). The median OS was 13.8 months (95% CI 10.1-16.9) for pembrolizumab versus 8.3 months (95% CI 6.3-11.8) for placebo (HR 0.55; 95% CI 0.37-0.80). ORR was 20.6% (95% CI 13.4-29.5) for pembrolizumab versus 2.0% (95% CI 0.1-10.6) for placebo (difference: 18.5%; 95% CI 8.3-27.6). The median DOR was 8.6 and 2.8 months for pembrolizumab and placebo, respectively. Any grade treatment-related adverse events (TRAEs) occurred in 63 patients (58.9%) receiving pembrolizumab and 24 patients (48.0%) receiving placebo; 14 (13.1%) and 2 (4.0%) patients experienced grade 3-5 TRAEs, respectively. No treatment-related deaths occurred. Conclusion Pembrolizumab demonstrated antitumor activity and was well tolerated in the Asian subgroup of KEYNOTE-240. A trend toward greater benefit with pembrolizumab in the Asian subgroup was observed compared with the overall cohort, supporting further evaluation of pembrolizumab treatment in this population.
TL;DR: Wang et al. as mentioned in this paper performed a meta-analysis to estimate the association of human immunodeficiency virus (HIV) infection and risk of coronavirus disease 2019 (COVID-19) mortality.
TL;DR: A systematic review and meta-analysis of burning mouth syndrome was conducted in this paper, where the authors evaluated the worldwide prevalence and epidemiology profile of burn mouth syndrome and found that the prevalence was relatively high in both general population and clinical patients, varies in different regions with the highest prevalence in Europe and females over 50 years were the most susceptible group.
Abstract: Objectives To evaluate the worldwide prevalence and epidemiology profile of burning mouth syndrome. Material and methods A systematic review and meta-analysis was conducted. Search strategies were performed in PubMed, EMBASE, Web of Science, the Cochrane Library, China National Knowledge Infrastructure, and Wanfang database for studies published before January 31, 2021, for the prevalence of burning mouth syndrome. Results Eighteen articles were included. The overall pooled prevalence of burning mouth syndrome was 1.73% (95% CI = 0.176-0.351, n = 26,632) in general population, and 7.72% (95% CI = 0.434-0.691, n = 86,591) in clinical patients. The subgroup analysis by continent showed that among the population-based studies the prevalence in Asia (1.05%) lower than in Europe (5.58%) and North America (1.10%). The subgroup analysis by gender showed the prevalence of female (1.15%) was higher than male (0.38%) in general population. The subgroup analysis by age showed the prevalence was higher for people over 50 (3.31%) than under 50 (1.92%). Conclusions The pooled prevalence of burning mouth syndrome was relatively high in both general population and clinical patients, varies in different regions with the highest prevalence in Europe, and females over 50 years were the most susceptible group. More epidemiological surveys on the prevalence of burning mouth syndrome are needed.
TL;DR: In this paper, the effects of thrombolytic clot removal and anticoagulation compared to antico-agulation alone for the management of people with acute deep vein thrombosis (DVT) of the lower limb were assessed.
Abstract: Background Standard treatment for deep vein thrombosis (DVT) aims to reduce immediate complications. Use of thrombolytic clot removal strategies (i.e. thrombolysis (clot dissolving drugs), with or without additional endovascular techniques), could reduce the long-term complications of post-thrombotic syndrome (PTS) including pain, swelling, skin discolouration, or venous ulceration in the affected leg. This is the fourth update of a Cochrane Review first published in 2004. Objectives To assess the effects of thrombolytic clot removal strategies and anticoagulation compared to anticoagulation alone for the management of people with acute deep vein thrombosis (DVT) of the lower limb. Search methods The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL and AMED and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registries to 21 April 2020. We also checked the references of relevant articles to identify additional studies. Selection criteria We considered randomised controlled trials (RCTs) examining thrombolysis (with or without adjunctive clot removal strategies) and anticoagulation versus anticoagulation alone for acute DVT. Data collection and analysis We used standard methodological procedures as recommended by Cochrane. We assessed the risk of bias in included trials with the Cochrane 'Risk of bias' tool. Certainty of the evidence was evaluated using GRADE. For dichotomous outcomes, we calculated the risk ratio (RR) with the corresponding 95% confidence interval (CI). We pooled data using a fixed-effect model, unless we identified heterogeneity, in which case we used a random-effects model. The primary outcomes of interest were clot lysis, bleeding and post thrombotic syndrome. Main results Two new studies were added for this update. Therefore, the review now includes a total of 19 RCTs, with 1943 participants. These studies differed with respect to the thrombolytic agent, the doses of the agent and the techniques used to deliver the agent. Systemic, loco-regional and catheter-directed thrombolysis (CDT) strategies were all included. For this update, CDT interventions also included those involving pharmacomechanical thrombolysis. Three of the 19 included studies reported one or more domain at high risk of bias. We combined the results as any (all) thrombolysis interventions compared to standard anticoagulation. Complete clot lysis occurred more frequently in the thrombolysis group at early follow-up (RR 4.75; 95% CI 1.83 to 12.33; 592 participants; eight studies) and at intermediate follow-up (RR 2.42; 95% CI 1.42 to 4.12; 654 participants; seven studies; moderate-certainty evidence). Two studies reported on clot lysis at late follow-up with no clear benefit from thrombolysis seen at this time point (RR 3.25, 95% CI 0.17 to 62.63; two studies). No differences between strategies (e.g. systemic, loco-regional and CDT) were detected by subgroup analysis at any of these time points (tests for subgroup differences: P = 0.41, P = 0.37 and P = 0.06 respectively). Those receiving thrombolysis had increased bleeding complications (6.7% versus 2.2%) (RR 2.45, 95% CI 1.58 to 3.78; 1943 participants, 19 studies; moderate-certainty evidence). No differences between strategies were detected by subgroup analysis (P = 0.25). Up to five years after treatment, slightly fewer cases of PTS occurred in those receiving thrombolysis; 50% compared with 53% in the standard anticoagulation (RR 0.78, 95% CI 0.66 to 0.93; 1393 participants, six studies; moderate-certainty evidence). This was still observed at late follow-up (beyond five years) in two studies (RR 0.56, 95% CI 0.43 to 0.73; 211 participants; moderate-certainty evidence). We used subgroup analysis to investigate if the level of DVT (iliofemoral, femoropopliteal or non-specified) had an effect on the incidence of PTS. No benefit of thrombolysis was seen for either iliofemoral or femoropopliteal DVT (six studies; test for subgroup differences: P = 0.29). Systemic thrombolysis and CDT had similar levels of effectiveness. Studies of CDT included four trials in femoral and iliofemoral DVT, and results from these are consistent with those from trials of systemic thrombolysis in DVT at other levels of occlusion. Authors' conclusions Complete clot lysis occurred more frequently after thrombolysis (with or without additional clot removal strategies) and PTS incidence was slightly reduced. Bleeding complications also increased with thrombolysis, but this risk has decreased over time with the use of stricter exclusion criteria of studies. Evidence suggests that systemic administration of thrombolytics and CDT have similar effectiveness. Using GRADE, we judged the evidence to be of moderate-certainty, due to many trials having small numbers of participants or events, or both. Future studies are needed to investigate treatment regimes in terms of agent, dose and adjunctive clot removal methods; prioritising patient-important outcomes, including PTS and quality of life, to aid clinical decision making.