scholarly journals Representation of Women in Randomized Trials in Cardiac Surgery: A Meta‐Analysis

2021 ◽  
Author(s):  
Mario Gaudino ◽  
Michele Di Mauro ◽  
Stephen E. Fremes ◽  
Antonino Di Franco
Keyword(s):  
Cardiac Surgery ◽  
Sample Size ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Geographic Location ◽  
Coronary Bypass ◽  
Cardiac Surgical Procedures ◽  
Systematic Evaluation ◽  
Cochrane Library ◽  
Representation Of Women

Background Women have traditionally been underrepresented in randomized clinical trials (RCTs). We performed a systematic evaluation of the inclusion of women in cardiac surgery RCTs published in the past 2 decades. Methods and Results MEDLINE, EMBASE, and the Cochrane Library were searched (2000 to July 2020) for RCTs written in English, comparing ≥2 adult cardiac surgical procedures. The percentage of women enrolled and its association with year of publication, sample size, mean age, funding source, geographic location, number of sites involved, and interventions tested were analyzed using a meta‐analytic approach. Fifty‐one trials were included. Of 25 425 total patients, 5029 were women (20.8%; 95% CI, 17.6–24.4; range, 0.5%–57.9%). The proportion of women dropped significantly during the study period (29.6% in 2000 versus 13.1% in 2019, P <0.001). Women were significantly more represented in European trials (26.2%; 95% CI, 21.2–31.9), and less represented in trials of coronary bypass surgery versus other interventions (16.8%; 95% CI, 12.3–22.7 versus 33.6%; 95% CI, 27.4–40.5; P =0.0002) and in trials enrolling younger patients ( P =0.009); the percentage of women was higher in industry‐sponsored versus non‐industry sponsored trials (31.7%; 95% CI, 27.2–36.6 versus 15.5%; 95% CI, 10.0–23.2; P =0.0004) and was not associated with trial sample size ( P =0.52) or study design (multicenter versus monocenter: P =0.22). After exclusion of trials conducted at Veteran Affairs centers, women representation was 24.4% (95% CI, 21.1–28.0; range, 10.4%–57.9%), with no significant changes during the study period. Conclusions The proportion of women in cardiac surgery trials is low and likely inadequate to provide meaningful estimates of the treatment effect.

scholarly journals Effectiveness of Physical Activity Intervention on ADHD Symptoms: A Systematic Review and Meta-Analysis

2021 ◽  
Vol 12 ◽  
Author(s):  
Yongtao Xie ◽  
Xuping Gao ◽  
Yiling Song ◽  
Xiaotong Zhu ◽  
Mengge Chen ◽  
...  
Keyword(s):  
Physical Activity ◽  
Sample Size ◽  
Motor Skills ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Attention Problems ◽  
Cochrane Library ◽  
Large Sample Size ◽  
Group Control ◽  
Meta Analyses

Objective: To assess the effectiveness of physical activity (PA) intervention on attention-deficit/hyperactivity disorder (ADHD)-related symptoms.Method: Studies that investigated PA intervention for ADHD-related symptoms were identified through searching PubMed, Web of Science, Cochrane Library, and Embase databases from inception through June 2021. Standardized mean difference (SMD) with 95% confidence interval (CI) was used to assess the effectiveness of PA intervention on improving ADHD-related symptoms. The meta-analyses were conducted using fixed-effect or random-effect models according to the heterogeneity of the studies.Results: Nine before–after studies (232 participants) and 14 two-group control studies (162 participants/141 controls) were included in this meta-analysis. Combined results for before–after studies indicated significant improvements on all studied ADHD-related symptoms (inattention: SMD = 0.604, 95% CI: 0.374–0.834, p &lt; 0.001; hyperactivity/impulsivity: SMD = 0.676, 95% CI: 0.401–0.950, p &lt; 0.001; emotional problems: SMD = 0.416, 95% CI: 0.283–0.549, p &lt; 0.001; behavioral problems: SMD = 0.347, 95% CI: 0.202–0.492, p &lt; 0.001). Meta-analyses for two-group control studies further confirmed that PA intervention significantly improved the inattentive symptom (SMD = 0.715, 95% CI: 0.105, 1.325, p = 0.022). Subgroup analyses suggested significant beneficial effect on inattention symptoms in children. Moreover, closed motor skills were beneficial for hyperactive/impulsive problems (SMD = 0.671, p &lt; 0.001), while open motor skills were beneficial for attention problems (SMD = 0.455, p = 0.049). When excluding studies with combined medication, the studies in unmedicated participants in before–after studies still showed significant results in all studied ADHD-related symptoms as in the overall analysis. Given the limited sample size, the best frequency and intensity of PA intervention need further investigation.Conclusion: Our results suggested that PA intervention could possibly improve ADHD-related symptoms, especially inattention symptoms. Closed-skill and open-skill activities could be beneficial for hyperactivity/impulsivity and inattention symptoms, respectively. Further high-quality randomized clinical trials with large sample size are needed.

scholarly journals The Use of Angiotensin II for the Treatment of Post-cardiopulmonary Bypass Vasoplegia

2020 ◽  
Author(s):  
Olga Papazisi ◽  
Meindert Palmen ◽  
A. H. Jan Danser
Keyword(s):  
Cardiac Surgery ◽  
Cardiopulmonary Bypass ◽  
Angiotensin Ii ◽  
Randomized Clinical Trials ◽  
Case Reports ◽  
Cardiac Surgical Procedures ◽  
Cochrane Library ◽  
Pharmacologic Agent ◽  
Mesh Terms ◽  
Post Cardiopulmonary Bypass

Abstract Purpose Vasoplegia is a common complication after cardiac surgery and is related to the use of cardiopulmonary bypass (CPB). Despite its association with increased morbidity and mortality, no consensus exists in terms of its treatment. In December 2017, angiotensin II (AII) was approved by the Food and Drug Administration (FDA) for use in vasodilatory shock; however, except for the ATHOS-3 trial, its use in vasoplegic patients that underwent cardiac surgery on CPB has mainly been reported in case reports. Thus, the aim of this review is to collect all the clinically relevant data and describe the pharmacologic mechanism, efficacy, and safety of this novel pharmacologic agent for the treatment of refractory vasoplegia in this population. Methods Two independent reviewers performed a systematic search in PubMed, Embase, Web of Science, and Cochrane Library using relevant MeSH terms (Angiotensin II, Vasoplegia, Cardiopulmonary Bypass, Cardiac Surgical Procedures). Results The literature search yielded 820 unique articles. In total, 9 studies were included. Of those, 2 were randomized clinical trials (RCTs) and 6 were case reports and 1 was a retrospective cohort study. Conclusions AII appears to be a promising means of treatment for patients with post-operative vasoplegia. It is demonstrated to be effective in raising blood pressure, while no major adverse events have been reported. It remains uncertain whether this agent will be broadly available and whether it will be more advantageous in the clinical management of vasoplegia compared to other available vasopressors. For that reason, we should contain our eagerness and enthusiasm regarding its use until supplementary knowledge becomes available.

Laser Influence on Dental Sensitivity Compared to Other Light Sources Used During In-office Dental Bleaching: Systematic Review and Meta-analysis

2020 ◽  
Vol 45 (6) ◽  
pp. 589-597
Author(s):  
BGS Casado ◽  
EP Pellizzer ◽  
JR Souto Maior ◽  
CAA Lemos ◽  
BCE Vasconcelos ◽  
...  
Keyword(s):  
Randomized Clinical Trials ◽  
Color Change ◽  
Meta Analysis ◽  
Present Review ◽  
Cochrane Library ◽  
Light Sources ◽  
Eligibility Criteria ◽  
Tooth Color ◽  
Significant Difference ◽  
Meta Analyses

Clinical Relevance The use of laser light during bleaching will not reduce the incidence or severity of sensitivity and will not increase the degree of color change compared with nonlaser light sources. SUMMARY Objective: To evaluate whether the use of laser during in-office bleaching promotes a reduction in dental sensitivity after bleaching compared with other light sources. Methods: The present review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) and is registered with PROSPERO (CDR42018096591). Searches were conducted in the PubMed/Medline, Web of Science, and Cochrane Library databases for relevant articles published up to August 2018. Only randomized clinical trials among adults that compared the use of laser during in-office whitening and other light sources were considered eligible. Results: After analysis of the texts retrieved during the database search, six articles met the eligibility criteria and were selected for the present review. For the outcome dental sensitivity, no significant difference was found favoring any type of light either for intensity (mean difference [MD]: −1.60; confidence interval [CI]: −3.42 to 0.22; p=0.09) or incidence (MD: 1.00; CI: 0.755 to 1.33; p=1.00). Regarding change in tooth color, no significant differences were found between the use of the laser and other light sources (MD: −2.22; CI: −6.36 to 1.93; p=0.29). Conclusions: Within the limitations of the present study, laser exerts no influence on tooth sensitivity compared with other light sources when used during in-office bleaching. The included studies demonstrated that laser use during in-office bleaching may have no influence on tooth color change.

Effect of antihypertensive drugs on cognition and behavioral symptoms of patients with Alzheimer’s disease: A meta-analysis

2020 ◽  
Vol 21 ◽  
Author(s):  
Roja Rahimi ◽  
Shekoufeh Nikfar ◽  
Masoud Sadeghi ◽  
Mohammad Abdollahi ◽  
Reza Heidary Moghaddam ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Randomized Clinical Trials ◽  
Antihypertensive Drugs ◽  
Meta Analysis ◽  
Behavioral Symptoms ◽  
Cochrane Library ◽  
Mean Differences ◽  
Global Impression Of Change ◽  
State Examination

Background: It has been found that there is a link between hypertension and elevated risk of Alzheimer’s disease (AD). Herein, a meta-analysis based on randomized clinical trials (RCTs) was used to assess the effect of antihypertensive drugs on cognition and behavioral symptoms of AD patients. Method: The three databases – PubMed/Medline, Scopus, and Cochrane Library- were searched up to March 2020. The quality of the studies included in the meta-analysis was evaluated by the Jadad score. Clinical Global Impression of Change (CGIC) included in two studies, Mini-Mental State Examination (MMSE) included in three studies, and Neuropsychiatric Inventory (NPI) in three studies were the main outcomes in this systematic review. Results: Out of 1506 studies retrieved in the databases, 5 RCTs included and analyzed in the meta-analysis. The pooled mean differences of CGIC, MMSE, and NPI in patients with AD receiving antihypertensive drugs compared to placebo was -1.76 with (95% CI = -2.66 to -0.86; P=0.0001), 0.74 (95% CI = 0.20 to 1.28; P= 0.007), and -9.49 (95% CI = -19.76 to 0.79; P = 0.07), respectively. Conclusion: The findings of the present meta-analysis show that antihypertensive drugs may improve cognition and behavioral symptoms of patients with AD. However, more well-designed RCTs with similar drugs are needed to achieve more conclusive results.

scholarly journals Comparison of the cerebroprotective effect of inhalation anaesthesia and total intravenous anaesthesia in patients undergoing cardiac surgery with cardiopulmonary bypass: a systematic review and meta-analysis

BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e014629 ◽  
Author(s):  
Feng Chen ◽  
Guangyou Duan ◽  
Zhuoxi Wu ◽  
Zhiyi Zuo ◽  
Hong Li
Keyword(s):  
Cardiac Surgery ◽  
Cardiopulmonary Bypass ◽  
Meta Analysis ◽  
Cerebral Protection ◽  
Neurological Dysfunction ◽  
Cochrane Library ◽  
Secondary Outcome ◽  
Total Intravenous Anaesthesia ◽  
Intravenous Anaesthesia ◽  
Inhalation Anaesthesia

ObjectiveNeurological dysfunction remains a devastating postoperative complication in patients undergoing cardiac surgery with cardiopulmonary bypass (CPB), and previous studies have shown that inhalation anaesthesia and total intravenous anaesthesia (TIVA) may produce different degrees of cerebral protection in these patients. Therefore, we conducted a systematic literature review and meta-analysis to compare the neuroprotective effects of inhalation anaesthesia and TIVA.DesignSearching in PubMed, EMBASE, Science Direct/Elsevier, China National Knowledge Infrastructure and Cochrane Library up to August 2016, we selected related randomised controlled trials for this meta-analysis.ResultsA total of 1485 studies were identified. After eliminating duplicate articles and screening titles and abstracts, 445 studies were potentially eligible. After applying exclusion criteria (full texts reported as abstracts, review article, no control case, lack of outcome data and so on), 13 studies were selected for review. Our results demonstrated that the primary outcome related to S100B level in the inhalation anaesthesia group was significantly lower than in the TIVA group after CPB and 24 hours postoperatively (weighted mean difference (WMD); 95% CI (CI): −0.41(–0.81 to –0.01), −0.32 (−0.59 to −0.05), respectively). Among secondary outcome variables, mini-mental state examination scores of the inhalation anaesthesia group were significantly higher than those of the TIVA group 24 hours after operation (WMD (95% CI): 1.87 (0.82 to 2.92)), but no significant difference was found in arteriovenous oxygen content difference, cerebral oxygen extraction ratio and jugular bulb venous oxygen saturation, which were assessed at cooling and rewarming during CPB.ConclusionThis study demonstrates that anaesthesia with volatile agents appears to provide better cerebral protection than TIVA for patients undergoing cardiac surgery with CPB, suggesting that inhalation anaesthesia may be more suitable for patients undergoing cardiac surgery.

Abstract 1122‐000223: Direct to Angiography Suite versus Conventional Imaging in Suspected Large Vessel Occlusion Strokes: A Meta‐Analysis

2021 ◽  
Vol 1 (S1) ◽  
Author(s):  
Mahmoud H Mohammaden ◽  
Mohamed Elfil ◽  
Mohamed Fahmy Doheim ◽  
Agostinho Camara Pinheiro ◽  
Alhamza R Al‐Bayati ◽  
...  
Keyword(s):  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Functional Independence ◽  
Large Vessel ◽  
Cochrane Library ◽  
Conventional Imaging ◽  
Large Vessel Occlusion ◽  
Vessel Occlusion ◽  
Angiography Suite ◽  
Significant Difference

Introduction : Direct transfer to angiography suite (DTAS) for patients with suspected large vessel occlusion strokes potentially requiring mechanical thrombectomy has been shown to shorten treatment times and improve outcomes compared to conventional imaging (CI) selection. This meta‐analysis compares both approaches to build more concrete evidence. Methods : The potentially relevant studies that were published in four electronic databases/search engines (PubMed, Web of Science, Cochrane Library, and Scopus) till August 2021 were reviewed. Eligible studies were included if they enrolled >10 patients in both groups, were published in English and reported baseline and procedural characteristics and 90‐day outcomes. Relevant data were then extracted and analyzed. Results : Among 4514 searched studies, six qualified for the analysis. Time from door to puncture (MD = ‐26.76minutes, 95 % CI [‐39.48, ‐14.03], P< 0.0001) as well as door to reperfusion (MD = ‐27.21 minutes,95% CI [‐47.42, ‐7.01], P = 0.008) were significantly shorter and the rates of functional independence(mRS0‐2: RR = 1.28, 95% CI [1.03, 1.60], P = 0.03) at 90‐days were significantly higher in the DTAS versus the CI approach. There was no statistically significant difference between DTAS and CI groups in terms of successful reperfusion (modified Thrombolysis In Cerebral Infraction [mTICI] score2B‐3: RR = 0.99, 95% CI [0.93, 1.06], P = 0.86), near complete/ full reperfusion (mTICI 2C‐3: RR = 0.84,95% CI [0.68, 1.04], P = 0.11), or fair outcomes at 90‐days (mRS 0–3: RR = 1.05, 95% CI [0.67, 1.64],P = 0.84). Moreover, there was no difference between groups regarding symptomatic intracranial hemorrhage (RR = 0.81, 95% CI [0.55, 1.17], P = 0.26) or 90 day‐mortality (RR = 0.85, 95% CI [0.59, 1.24],P = 0.41). Conclusions : Our meta‐analysis showed that DTAS significantly improves time metrics and functional outcome with comparable safety to the CI approach. Multicenter randomized clinical trials are ongoing to confirm these results.

Novel oral anticoagulats for the treatment of left ventricle thrombosis: a systematic review and meta-analysis

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
M Serenelli ◽  
F Vitali ◽  
R Pavasini ◽  
E Tonet ◽  
G Pompei ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Random Effect ◽  
Random Effect Model ◽  
Left Ventricular ◽  
Left Ventricular Thrombus ◽  
Cochrane Library ◽  
Secondary Outcome ◽  
Ventricular Thrombus

Abstract Funding Acknowledgements Type of funding sources: None. Background novel oral anticoagulants (NOACs) are not guideline-recommanded treatment for left ventricular thrombus.  Purpose: the aim of this meta-analysis is to compare NOACs versus vitamin-K atagonsits (VKAs) efficacy in treating left ventricular thrombus (LVT). Methods: we systematically searched MEDLINE, Cochrane Library, Biomed Central, and Web of Science for trials comparing NOACs versus VKAs in the setting of LVT. Five studies, out of the 74 initially selected after first screening, were included in the meta-analysis. For the development of this meta-analysis, the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines were followed. The shortlisted studies were retrieved as full articles and appraised independently by two unblinded reviewers. The Mantel-Haensel method with a random effect model was used for the pooled analysis. The primary outcome was the occurrence of stroke and systemic embolism. Secondary outcome was occurrence of left ventricular thrombosis resolution during treatment.  Results: 707 patients were included in the analysis for the primary outcome. Of these, 230 were treated with NOACs and 477 with VKAs. The pooled OR for the primary outcome was 0.71 (95% CI 0.18-2.86, I2 67%), thus showing similar effect in term of ischaemic protection. A total of 698 patients, 228 on NOACs and 470 on VKAs were included in the analysis of the secondary outcome. The pooled OR for the secondary outcome pooled OR 0.97, 95% CI 0.56-1.68, I2 46%. Conclusions and Relevance: NOACs seem to have a similar efficacy profile compare to VKAs and so they should be considered as an alternative treatment for left ventricular thrombosis. Large prospective randomized clinical trials are needed to confirm this exploratory finding. Abstract Figure 1

Abstract P391: Marine N-3 Fatty Acids Reduce Atherosclerosis Cardiovascular Disease: A Systemic Review and Meta-analysis of Clinical Trials

Circulation ◽  
2013 ◽  
Vol 127 (suppl_12) ◽  
Author(s):  
Akira Sekikawa ◽  
Nobutake Hirooka ◽  
Abhishek Vishnu ◽  
Vashudha Ahuja ◽  
Emmanuel Sampene ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Fatty Acids ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Imaging Techniques ◽  
Meta Analysis ◽  
Quantitative Information ◽  
Systemic Review ◽  
Cochrane Library ◽  
Cardiac Imaging Techniques

Introduction: Although marine n-3 fatty acids are believed to be cardioprotective through their anti-arrhythmic, anti-thrombotic, anti-atherogenic and other effects, results from recent meta-analyses of marine n-3 fatty acids on cardiovascular disease (CVD) are controversial. We performed a meta-analysis of marine n-3 fatty acids on CVD outcomes in randomized clinical trials (RCTs) to test the hypothesis that marine n-3 fatty acids are anti-atherogenic. We also tested the hypothesis that such benefit is dose-dependent. Methods: A systematic review of English language articles using PubMed, EMBASE and Cochrane Library through Aug 2012 was performed selecting RCTs evaluating the effect of marine n-3 fatty acids intake for 2 years or more on cardiovascular diseases, coronary disease, arteriosclerosis, cardiac imaging techniques, and carotid artery ultrasound. Descriptive and quantitative information was extracted. Odds ratios were calculated for cardiac event outcome. Correlation coefficients were obtained from studies of which outcome is intima-media thickness (IMT) and coronary lumen diameter (CD). We converted the estimates into a single effect size; the log odds ratio and its corresponding standard error. Results: Of 14,236 citations retrieved, 13 studies were selected, including studies reporting IMT (n=3) and CD (n=2) and major CVD events (n=8). Overall, marine n-3 fatty acids significantly reduced atherosclerotic CVD (RR 0.94: 95%CI 0.90 to 0.99, p<0.05). There was no evidence of heterogeneity (p=0.65) or publication bias (p=0.37, Begg’s test). A sub-analysis among 8 studies of major CVD events showed the similar results (RR 0.94: 95% CI 0.89 to 0.99, p<0.05). Another sub-analysis among 4 studies excluding sudden cardiac death as an outcome showed RR of 0.91 (95% CI 0.82 to 1.02, p=0.097). A meta-regression analysis shows that dose of marine n-3 fatty acids was inversely associated with CVD outcome, although the association was not statistically significant (p=0.06). Conclusions: The result of our meta-analysis supports a modest anti-atherogenic effect of marine n-3 fatty acids. This benefit may be proportional to the amount of marine n-3 fatty acids consumed.

scholarly journals Clinical and Molecular Characteristics Associated with Survival in Advanced Melanoma Treated with Checkpoint Inhibitors

2018 ◽  
Vol 2018 ◽  
pp. 1-13 ◽  
Author(s):  
Sunil Badami ◽  
Sunil Upadhaya ◽  
Ravi Kanth Velagapudi ◽  
Pushyami Mikkilineni ◽  
Ranju Kunwor ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Checkpoint Inhibitors ◽  
Meta Analysis ◽  
Random Effect ◽  
Eastern Cooperative Oncology Group ◽  
Advanced Melanoma ◽  
Cochrane Library ◽  
Molecular Characteristics ◽  
Significant Heterogeneity

Background. We performed meta-analysis to gather more evidence regarding clinical-molecular subgroups associated with better overall survival (OS) in advanced melanoma treated with checkpoint inhibitors. Materials and Methods. We performed a systematic search of PubMed, Scopus, Cochrane Library, and clinical trial.gov. Randomized clinical trials that compared a checkpoint inhibitor (nivolumab or pembrolizumab) with investigator choice chemotherapy or ipilimumab were included in our study. Hazard ratios (HR) and confidence interval (CI) were calculated for progression-free survival (PFS) and OS for each subgroup using generic inverse model along with the random effect method. Results. A total of 6 clinical trials were eligible for the meta-analysis. OS was prolonged in wild BRAF subgroup (HR 0.65, 95% CI 0.49-0.85, p 0.002), Programmed cell death subgroup (PD-1+) (HR 0.57, 95% CI 0.41-0.80, p 0.001), and high lactate dehydrogenase (LDH) level subgroup (HR 0.60, 95% CI 0.38-0.95, p 0.03). Similarly, we found increased OS in eastern cooperative oncology group (ECOG) 1, males and age >65 years subgroups. Conclusions. Checkpoint inhibitors significantly increased OS in patients with wild BRAF, positive PD-1, and high LDH. However, results should be interpreted keeping in mind associated significant heterogeneity. The results of this study should help in designing future clinical trials.

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