Mantel-Haenszel Method Research Articles

36. Clinical Outcome of Intensive Blood Pressure Lowering in Diabetic Patients: A Systematic Review and Meta-analysis

Background: It remains controversial in defining the optimal blood pressure (BP) targets for diabetes mellitus (DM) patients. There were various data on intensive BP lowering management in DM population, particularly in reducing cardiovascular outcomes. Objective: This study was conducted to compare the clinical outcome of intensive and standard BP lowering management in DM patients. Methods: Randomized Controlled Trials (RCTs) from Pubmed, Proquest, Google Scholar and Cochrane Library databases which compare the clinical outcome between intensive and standard BP lowering therapy were analyzed. Meta-analysis was conducted with random effects and Mantel-Haenszel method. Results: 18723 patients with DM from 11 RCTs were included. Intensive BP lowering strategy gave less number of stroke events (RR: 0.55; 95%CI: 0.36 to 0.85; p: 0.007) compared with standard BP lowering management. Between the two groups, there was no significant difference in causing all-cause death (RR: 0.94; 95%CI: 0.83 to 1.08; p: 0.39), cardiovascular death (RR: 0.85; 95%CI: 0.52 to 1.39; p: 0.53), myocardial infarction (RR: 0.96; 95%CI: 0.85 to 1.09; p: 0.54), heart failure (RR: 0.96; 95%CI: 0.75 to 1.23; p: 0.73), microalbuminuria (RR: 0.96; 95%CI: 0.65 to 1.40; p: 0.82). In the subgroup analysis, SBP reduction to lower than 120 mmHg caused lower incidence of stroke events compared with BP target of lower than 130 mmHg (RR: 0.57; 95%CI: 0.35 to 0.93; p: 0.02). Conclusion: Intensive BP lowering strategy gave a better outcome in reducing stroke events in DM patients. Targeting SBP to below 120 mmHg showed more benefit compared with below 130 mmHg.

666 Comparison of Minimally Invasive and Open Surgical Approaches for Intradural-Extramedullary Spine Tumors: A Systematic Review and Meta-Analysis

INTRODUCTION: Traditionally spinal intradural-extramedullary (ID-EM) tumors have been accessed via open surgery. Removal of these tumors involves significant tissue damage, prolonged recovery, and risk of infection. More recent minimally invasive surgery (MIS) techniques aim to reduce these risks and complications while achieving similar goals of surgery as traditional approaches. METHODS: A systematic literature search was employed (PROSPERO#CRD42022302574) with searches through PubMed (MEDLINE), EBSCO, and Wiley Cochrane Library databases from conception till 9th January 2022. Cohort and case series studies with comparisons of minimally-invasive and open surgery for ID-EM spinal tumors were included; pooled sampled data were included in the random-effects (Mantel-Haenszel method) model for meta-analysis. RESULTS: Our search strategy yielded 403 total articles across these databases – after systematic review and exclusion, 13 studies were included for qualitative and quantitative analysis. On meta-analysis, minimally-invasive approaches were non-inferior to open surgery for achieving gross total resection (RR = 1.01, 95% CI 0.94 – 1.09, p = 0.78, I2 = 0%). Intraoperative blood loss (MD = -119.18, 95% CI -157.83 - -80.52, p < 0.0001, I2 = 89%), operative time (MD = -25.94, 95% CI -50.28 – -1.60, p = 0.04, I2 = 91%), and length of stay (MD=-2.50, 95% CI -3.89 – -1.10, p = 0.0004, I2 = 95%) were significantly lower within cohorts undergoing MIS surgery for ID-EM spinal tumor. CONCLUSIONS: Data within the reviewed studies suggest similar rates of gross total resection within MIS and open surgery cohorts for ID-EM spinal tumors. Moreover, MIS affords shorter hospital stays, decreased blood loss, and operative time for patients. For certain patient groups, MIS spinal tumor resection can be preferred over standard surgical approaches, with preservation of function and decreasing overall surgical complications.

Antibody-drug conjugate monotherapy refines the oncological efficacy as compared to therapy of physicians' choices in advanced breast cancers: a systematic review and meta-analysis.

Antibody-drug conjugate (ADC) is an emerging therapy that bestows advanced breast tumors with encouraging clinical activity and manageable toxicity; however, the outcomes of phase 2/3 randomized controlled trials (RCTs) are heterogeneous. Our study aims to assess the clinical utilities [i.e., objective response rate (ORR), clinical benefit rate (CBR), progression-free survival (PFS), overall survival (OS)], and treatment-related adverse events (AEs) of ADC monotherapy (defined as the study cohort) versus the therapy of physician's choice (TPC) (defined as the control cohort) in participants with advanced breast tumors. We conducted a computerized retrieval to identify RCTs from MEDLINE, Web of Science, Cochrane Library, Embase databases, and ClinicalTrials.gov until April 4th, 2023. Screening, data extraction, and quality assessment were performed in duplicate. A total of 10 RCTs were involved, with 5,089 unique patients. A binary random-effect model Mantel-Haenszel method was employed to pool data due to the considerable heterogeneity. The primary outcome measure was odds ratio (OR) with the corresponding 95% confidential interval (CI) of ORR and CBR. The secondary outcome measure represented hazard ratio (HR) of PFS and OS and OR of the frequency of any grade/grade ≥3 AEs. The pooled results showed an insignificant difference of ORR (OR =1.64; 95% CI: 0.86-3.13; P=0.136) and CBR (OR =1.43; 95% CI: 0.89-2.31; P=0.142) in the study cohort than the control cohort. The pooled effect on PFS (HR =0.62; 95% CI: 0.50-0.74; P<0.001) and on OS (HR =0.70; 95% CI: 0.57-0.83; P<0.001) both indicated a significant superiority of the study cohort. The frequency of any grade AEs (OR =1.03; 95% CI: 0.75-1.41; P=0.849) and that of grade ≥3 AEs (OR =0.83; 95% CI: 0.57-1.21; P=0.342) were both observed a nonsignificant difference between the cohorts. These domains, i.e., allocation concealment, blinding of participants and personnel, and blinding of outcome assessment, had the high risk of bias over 50%. Compared to physician's choice, ADC monotherapy overall confirms a considerable refinement in survival benefits plus a similar safety profile in advanced breast tumors.

Comparison of neoadjuvant immunotherapy versus routine neoadjuvant therapy for patients with locally advanced esophageal cancer: A systematic review and meta-analysis.

The neoadjuvant use of immune checkpoint inhibitor combined with chemotherapy (nICT) or chemoradiotherapy (nICRT) in locally advanced esophageal cancer (EC) is currently an area of active ongoing research. Therefore, we carried out a comprehensive meta-analysis to compare the efficacy and safety of the new strategy with routine neoadjuvant strategy, which included neoadjuvant chemotherapy (nCT) and neoadjuvant chemoradiotherapy (nCRT). MEDLINE (via PubMed), Embase (via OVID), ISI Web of Science database and Cochrane Library were included. And, all of them were searched for eligible studies between January, 2000 and February, 2023. The pathological complete response (pCR) and major pathological response (MPR) were primary outcome of our study. The second outcome of interest was R0 resection rate. Odds ratio (OR) and associated 95% CI were used as the effect indicators comparing the safety and efficiency of the neoadjuvant immunotherapy with the routine neoadjuvant therapy. Fixed-effect model (Inverse Variance) or random-effect model (Mantel-Haenszel method) was performed depending on the statistically heterogeneity. There were eight trials with 652 patients were included in our meta-analysis. The estimated pCR rate was higher in the neoadjuvant immunotherapy group (OR =1.86; 95% CI, 1.25-2.75; I2 = 32.8%, P=0.166). The different results were found in the esophageal squamous cell carcinoma (ESCC) and esophageal adenocarcinoma (EAC) subgroups, the estimated OR was 2.35 (95%CI, 1.00-2.72; I2 = 30.9%, P=0.215) in the EAC subgroup, and 2.35 (95% CI, 1.20-4.54; I2 = 45.3%, P=0.161) in the ESCC subgroup, respectively. The neoadjuvant immunotherapy also showed the advantage in the MPR rates (OR =2.66; 95% CI, 1.69-4.19; I2 = 24.3%, P=0.252). There was no obvious difference between the neoadjuvant immunotherapy and routine neoadjuvant therapy with respect to surgical resection rate, R0 resection rate, surgical delay rate; while more treatment-related adverse events were observed for the neoadjuvant immunotherapy for pneumonitis/pneumonia (OR=3.46, 95% CI, 1.31-9.16; I2 = 67.3%, P=0.005) and thyroid dysfunction (OR=4.69, 95% CI, 1.53-14.36; I2 = 56.5%, P=0.032). The pooled correlations indicated that the neoadjuvant immunotherapy (both nICT and nICRT) could significantly increase the rates of pCR and MPR, compared with routine neoadjuvant therapy (both nCT and nCRT) in the treatment of locally advanced EC. The neoadjuvant immunotherapy and routine neoadjuvant therapy were with acceptable toxicity. However, randomized studies with larger groups of patients need to performed to confirm these results. https://www.crd.york.ac.uk/prospero/, identifier CRD42020155802.

General Anesthesia Versus Local Anesthesia in Patients Undergoing Transcatheter Aortic Valve Replacement: An Updated Meta-Analysis and Systematic Review

For patients with aortic stenosis, transcatheter aortic valve replacement (TAVR) offers a less invasive treatment modality than conventional surgical valve replacement. Although the surgery is performed traditionally under general anesthesia (GA), recent studies have described success with TAVR using local anesthesia (LA) and/or conscious sedation. The study authors performed a pairwise meta-analysis to compare the clinical outcomes of TAVR based on operative anesthesia management. A random effects pairwise meta-analysis via the Mantel-Haenszel method. Not applicable, as this is a meta-analysis. No individual patient data were used. Not applicable, as this is a meta-analysis. The authors comprehensively searched the PubMed, Embase, and Cochrane databases to identify studies comparing TAVR performed using LA or GA. Outcomes were pooled as risk ratios (RR) or standard mean differences (SMD) and their 95% CIs. The authors' pooled analysis included 14,388 patients from 40 studies (7,754 LA; 6,634 GA). Compared to GA TAVR, LA TAVR was associated with significantly lower rates of 30-day mortality (RR 0.69; p < 0.01) and stroke (RR 0.78; p=0.02). Additionally, LA TAVR patients had lower rates of 30-day major and/or life-threatening bleeding (RR 0.64; p=0.01), 30-day major vascular complications (RR 0.76; p=0.02), and long-term mortality (RR 0.75; p=0.009). No significant difference was seen between the 2 groups for a 30-day paravalvular leak (RR 0.88, p=0.12). Transcatheter aortic valve replacement performed using LA is associated with lower rates of adverse clinical outcomes, including 30-day mortality and stroke. No difference was seen between the 2 groups for a 30-day paravalvular leak. These results support the use of minimally invasive forms of TAVR without GA.

Patatin-like phospholipase domain-containing 3 gene (PNPLA3) polymorphic (rs738409) single nucleotide polymorphisms and susceptibility to nonalcoholic fatty liver disease: A meta-analysis of twenty studies.

To investigate the correlation between rs738409 polymorphism of patatin-like phospholipase domain-containing protein 3 (PNPLA3) gene (encoding I148m) and genetic susceptibility to nonalcoholic fatty liver disease (NAFLD). Web of Science, Embase, PubMed, Cochrane Library, China National Knowledge Infrastructure, Wanfang Data Knowledge Service Platform databases were subjected to study retrieving, from the earliest records to November 2022. International databases were searched using the key words (PNPLA3 gene or PNPLA3 polymorphism or patatin-like phospholipase domain-containing pro-tein3) and (nonalcoholic fatty liver disease or NAFLD or nonalcoholic steatohepatitis) and their possible combination. There was no limitation to language. Ethnicity and country restrictions were not applied. Hardy-Weinberg equilibrium about the genotype frequencies of rs738,409 polymorphism in group of controls was assessed using a chi-square goodness-of-fit test (P > .05). A chi-square-based Q test was applied to assess heterogeneity among studies. The random-effect model (DerSimonian-Laird method) was used when a probability value of P < .10, I2 > 50%. If not, the fixed-effect model (Mantel-Haenszel method) was adopted. The current meta-analysis was done by using STATA 16.0. Twenty studies are selected for this meta-analysis, which includes totally 3240 patients in the treatment group and 5210 patients in the control group. These studies demonstrated a significant increased association between rs738,409 and NAFLD under 5 models: allelic contrast (odds ratio [OR] = 1.98, 95% confidence interval [CI] = 1.65-2.37, Pheterogeneity = 0.000, Z = 7.346, P = .000), homozygote comparison (OR = 3.59, 95% CI = 2.56-5.04, Pheterogeneity = 0.000, Z = 7.416, P = .000), heterozygote comparison (OR = 1.93, 95% CI = 1.63-2.30, Pheterogeneity = 0.002, Z = 7.507, P = .000), the dominant allele model (OR = 2.33, 95% CI = 1.89-2.88, Pheterogeneity = 0.000, Z = 7.856, P = .000), and the recessive allele model (OR = 2.56, 95% CI = 1.96-3.35, Pheterogeneity = 0.000, Z = 6.850, P = .000). Subgroup analysis shows that the rs738,409 polymorphism of PNPLA3 gene in Caucasians and those with a sample size of < 300 is significantly associated with the susceptibility to nonalcoholic fatty liver. Sensitivity analysis shows that the results of meta-analysis are stable. PNPLA3 rs738,409 may play a significant role in increasing risk of NAFLD.

Abstract P4-07-02: Toxicity profile of single agent trastuzumab deruxtecan in solid tumors: A meta-analysis

Abstract Background: Trastuzumab deruxtecan (T-DXd) has been evaluated in numerous solid tumors and has been approved for metastatic HER2-positive breast and gastric/gastroesophageal cancers. We aimed to provide a precise estimate of toxicity of T-DXd observed in clinical trials. Methods: A systematic literature search was performed in PubMed and supplemented by review of abstracts from ASCO and ESMO. Eligible studies were clinical trials (dose-expansion phase 1, phase 2, and phase 3) investigating single agent T-DXd. The search was performed in June 2022. For single-arm trials, meta-analysis comprised one-sample proportions to obtain the random effects estimates of toxicity and respective 95% confidence intervals (CI) for T-DXd, while for randomized trials, the Mantel-Haenszel odds ratio method was utilized. Results: Fifteen trials comprising 1566 participants were evaluable for toxicity. ECOG Performance Status (PS) was reported in 11 studies and was ≥ 2 in only a single patient. The median age at enrollment was reported for 13 studies and was 57.5 years. Seven trials comprising 1023 (65.3%) participants evaluated T-DXd for breast cancer. From available data, 1209/1440 (84%)of participants were female and 735/1551 (47%) were from East Asia. The median follow-up time was 11.1 months (13 studies) and median previous lines of treatment were 3 (12 studies). All-grade toxicity rate of ≥10% was reported for most toxicities; however, grade ≥3 toxicity rate of ≥10% was reported only for neutropenia and anemia; 17.4% (95%CI 12-22.8) and 14.8% (95%CI 8.6-21), respectively (Table 1). Interstitial lung disease/pneumonitis (ILD) was reported in 203 (12.4%) patients, including 160 (9.41%) grade 1-2, and 23 (1.1%) grade 3-4. Treatment-related death was reported in 20 (1%) patients, and all were due to grade 5 ILD. No significant difference in ILD was identified in subgroup analysis of trials conducted in east Asia vs. the rest of the world, breast vs. other solid tumors, 5.4mg/kg vs. other doses, median follow-up &amp;lt; 12 months vs. ≥12 months or median previous lines ≥3 vs. &amp;lt; 3. In the three randomized clinical trials, grade ≥3 toxicity was significantly higher for nausea (OR: 9.32, 95%CI: 2.53-34.32), ILD (OR: 5.35, 95%CI: 0.97, 29.48), fatigue (OR:2.5, 95%CI: 1.11-5.66), and anemia (OR:1.77 95%CI: 1.14-2.74). Conclusions: T-DXd was associated with infrequent grade ≥3 toxicities across clinical trials. Grade 1-2 ILD was more common; however, grade 3-4 ILD occurred in 1.1%. This may be related to active monitoring of this toxicity in clinical trials and discontinuation of treatment in participants with G2 ILD. There is lack of evidence for the safety of T-DXd in patients with ECOG PS ≥ 2. Citation Format: Faris Tamimi, Abhenil Mittal, Consolacion Molto Valiente, Massimo Di Iorio, Laith Al-Showbaki, Michelle Nadler, Eitan Amir. Toxicity profile of single agent trastuzumab deruxtecan in solid tumors: A meta-analysis [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P4-07-02.

Abstract PD6-10: PD6-10 The impact of post mastectomy radiation therapy on clinical outcomes of male breast cancer: A meta-analysis of comparative studies

Abstract Background/Rationale: Male breast cancer accounts for less than 1 percent of all cancer diagnoses in men. Because it is rare, it does not lend itself to large, randomized trials. In general, the approach to the treatment of early, non-metastatic male breast cancer has largely been extrapolated from female breast cancer trials. Specifically, the data on early-stage post mastectomy radiation therapy (PMRT) is limited, and its benefits remain unclear. Objectives: We conducted this meta-analysis to determine the impact of PMRT on clinical outcomes of men with breast cancer. Methods: A review of the medical literature was conducted using online databases. Inclusion criteria consisted of English language, diagnosis of invasive non-metastatic male breast cancer (MBC), comparative studies of PMRT versus none, and studies that reported the incidence of local and distant recurrences as well as survival data in the compared arms. A meta-analysis using the Mantel-Haenszel method for calculating the weighted pooled relative risk (RR) under the fixed effects model. Subsequently, the heterogeneity statistic gets incorporated to calculate the summary RR under the random effects model. Results: Ten retrospective comparative studies with 3912 patients were included and analyzed. Eight studies reported survival data. Six and three studies reported local and distant recurrence incidence, respectively. PMRT did not have an impact on overall survival or distant recurrences. However, PMRT significantly lowered the RR of locoregional recurrences (RR=0.53, 95%CI 0.31-0.92). In addition, when survival was analyzed by TNM stage and N status, PMRT was found to have a significant reduction in RR of death in stage III (RR=0.85, 95%CI 0.75-0.97), N1 (RR=0.77, 95%CI 0.61-0.98), and N2 (RR=0.61, 95%CI 0.49-0.78) disease. Conclusions: This is the first meta-analysis to show that PMRT is associated with a lower relative risk of death in stage III MBC as well as N1 and N2 disease. It also demonstrates a significant reduction in RR of locoregional recurrences. In the absence of randomized clinical trials, it represents the most compelling data supporting the use of PMRT in this MBC patient population. Citation Format: Philip A. Haddad, Usman Zaheer. PD6-10 The impact of post mastectomy radiation therapy on clinical outcomes of male breast cancer: A meta-analysis of comparative studies [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr PD6-10.

Risk of Motor Vehicle Collisions and Culpability among Older Drivers Using Cannabis: A Meta-Analysis.

Limited studies have investigated the effects of cannabis use on driving among older adults, who represent the fastest growing segment of drivers globally. We conducted a systematic review and meta-analysis to evaluate the effects of delta-9-tetrahydrocannabinol (THC) exposure on risks of (1) motor vehicle collisions (MVC) and (2) culpability for MVCs among adults 50 years and older. Three reviewers screened 7022 studies identified through MEDLINE, EMBASE, CENTRAL, and PsycINFO. Odds Ratios (OR) were calculated using the Mantel-Haenszel method in Review Manager 5.4.1. Heterogeneity was assessed using I2. The National Heart, Lung, and Blood Institute tool was used to assess the quality of each study. Seven cross-sectional studies were included. Three studies evaluated culpability while four evaluated MVC. The pooled risk of MVC was not significantly different between THC-positive and THC-negative older drivers (OR, 95% CI 1.15 [0.40, 3.31]; I2 = 72%). In culpability studies, THC exposure was not significantly associated with an increased risk of being culpable for MVC among adults over the age of 50 (OR, 95% CI 1.24 [0.95, 1.61]; I2 = 0%). Inspection of funnel plots did not indicate publication bias. Our review found that THC exposure was not associated with MVC involvement nor with culpability for MVCs.

Meta-Analysis on the Impact of Ventricular Arrhythmias on Mortality in Patients With Continuous Flow Left Ventricular Assist Devices

Patients with continuous flow left ventricular assist devices (CFLVADs) have an increased risk of ventricular arrhythmias (VA), but the impact of VA on survival is unclear. A systematic search of electronic databases was conducted to identify studies that reported the impact of VA on all-cause mortality and right ventricular failure (RVF) in patients with CFLVAD. The Mantel-Haenszel method was used to calculate the 95% confidence interval (CI) and pooled risk ratio (RR) with a random-effects model. A total of 19 observational studies with 4,544 patients and a median follow-up of 18.5months (interquartile range 11.5 to 26.4) were included. There was statistically significantly higher mortality in patients with any VA than in those with no VA after CFLVAD implantation (RR 1.33, 95% CI 1.01 to 1.75, p=0.04, I2=78%). On sensitivity analysis, after removing the largest study by Rehorn etal,10 the association between overall mortality and VA was lost, suggesting that these results should be interpreted with caution. Early VA developing within 30days after implantation was associated with a higher risk of mortality (RR 1.37, 95% CI 1.15 to 1.63, p <0.01, I2=52%), whereas late VA developing after 30days after CFLVAD implantation was not associated with any significant difference in mortality (RR: 1.00; 95% CI: 0.80 to 1.24; p=0.98, I2=35%). In addition, there was a statistically significant higher risk of RVF in patients with VA than in those with no VA (RR 1.58, 95% CI 1.20 to 2.08, p <0.01, I2=0%). In conclusion, in patients with CFLVAD, the development of any VA was associated with a 33% higher risk of all-cause mortality. Early VA developing within 30days after implantation was significantly associated with a higher risk of mortality, whereas late VA was not associated with mortality. VA after left ventricular assist device was significantly associated with a higher risk of developing RVF.

Preoperative combined mechanical and oral antibiotic bowel preparation for preventing complications in elective colorectal surgery.

Preoperative combined mechanical and oral antibiotic bowel preparation for preventing complications in elective colorectal surgery.

Subclinical Leaflet Thrombosis After Balloon versus Self-Expandable Transcatheter Aortic Valve Implantation

Hypoattenuated leaflet thickening (HALT) has been recognized as one of the complications after transcatheter aortic valve implantation and may promote structural valve degeneration and increase the risk of cerebrovascular events. The 2 main types of available transcatheter heart valves (THVs), the balloon-expandable (BE) and the self-expanding (SE), are interchangeably used in clinical practice despite substantial design differences. There is unclear evidence on whether these 2 different THV models are achieving similar or different rates of subclinical leaflet thrombosis/HALT. A systematic search of electronic databases was conducted to identify studies that reported the incidence of HALT between SE THVs and BE THVs. The Mantel-Haenszel method was used to calculate the 95% confidence interval and pooled risk ratio with a random-effects model. A total of 126 records were identified, of which 22 studies comprising 14,401 patients were included in our final analysis. Among 5,951 patients receiving SE THVs, 194 (3.2%) developed HALT, compared with 8,450 patients receiving BE THVs, of whom 484 (5.7%) developed HALT. There was a statistically significant decrease in the risk of developing HALT in patients receiving SE THVs compared with those receiving BE THVs (risk ratio 0.75, 95% confidence interval 0.59 to 0.95, I2 32%, p=0.02). In conclusion, could potentially reduce the risk of HALT/subclinical leaflet thrombosis.

Different meta-analysis methods can change judgements about imprecision of effect estimates: a meta-epidemiological study

ObjectivesTo empirically evaluate five commonly used meta-analysis methods and their impact on imprecision judgements about effect estimates. The two fixed-effect model methods were the inverse variance method based on normal...

Sacrifice or preserve the superior petrosal vein in microvascular decompression surgery: a systematic review and meta-analysis.

In microvascular decompression (MVD) surgery through the retrosigmoid approach, the surgeon may have to sacrifice the superior petrosal vein (SPV). However, this is a controversial maneuver. To date, high-level evidence comparing the operative outcomes of patients who underwent MVD with and without SPV sacrifice is lacking. Therefore, this study sought to bridge this gap. The authors searched the Medline and PubMed databases with appropriate Medical Subject Heading (MeSH) terms and keywords. The primary outcome was vascular-related complications; secondary outcomes were new neurological deficit, cerebrospinal fluid (CSF) leak, and neuralgia relief. The pooled proportions of outcomes and OR (95% CI) for categorical data were calculated by using the logit transformation and Mantel-Haenszel methods, respectively. Six studies yielding 1143 patients were included, of which 618 patients had their SPV sacrificed. The pooled proportion (95% CI) values were 3.82 (0.87-15.17) for vascular-related complications, 3.64 (1.0-12.42) for new neurological deficits, 2.85 (1.21-6.58) for CSF leaks, and 88.90 (84.90-91.94) for neuralgia relief. The meta-analysis concluded that, whether the surgeon sacrificed or preserved the SPV, the odds were similar for vascular-related complications (2.5% vs 1.5%, OR [95% CI] 1.01 [0.33-3.09], p = 0.99), new neurological deficits (1.2% vs 2.8%, OR [95% CI] 0.55 [0.18-1.66], p = 0.29), CSF leak (3.1% vs 2.1%, OR [95% CI] 1.16 [0.46-2.94], p = 0.75), and neuralgia relief (86.6% vs 87%, OR [95% CI] 0.96 [0.62-1.49], p = 0.84). SPV sacrifice is as safe as SPV preservation. The authors recommend intentional SPV sacrifice when gentle retraction fails to enhance surgical field visualization and if the surgeon encounters SPV-related neurovascular conflict and/or anticipates impeding SPV-related bleeding.

Surgical site infection prevention in abdominal surgery: is intraoperative wound irrigation with antiseptics effective? Protocol for a systematic review and meta-analysis

IntroductionSurgical site infection (SSI) after laparotomy still represents the most frequent postoperative complicationin abdominal surgery. The effectiveness of reducing SSI rates by intra-operative irrigation of the incisional wound with antiseptic...

The sFlt-1/PlGF Ratio in Pregnant Patients Affected by COVID-19.

COVID-19 in pregnant women increases the risk of adverse pregnancy outcomes, including preeclampsia. This meta-analysis aimed to examine the effect of SARS-CoV-2 infection on sFlt-1/PIGF ratio during pregnancy. The study was designed as a systematic review and meta-analysis. PubMed, Web of Science, Embase and Cochrane Library were searched for relevant studies reporting the sFlt-1/PlGF ratio in pregnant women with COVID-19. Results were compared using meta-analysis by the Mantel-Haenszel method. A total of 7 studies were included in the analysis. sFlt-1/PlGF ratios between COVID-19 positive vs. negative women were 45.8 ± 50.3 vs. 37.4 ± 22.5, respectively (SMD = 1.76; 95% CI: 0.43 to 3.09; p = 0.01). sFlt-1/PlGF ratios between asymptomatic vs. symptomatic patients were 49.3 ± 35.7 vs. 37.1 ± 25.6 (SMD = 0.30; 95% CI: -0.35 to 0.95; p = 0.36). sFlt-1/PlGF ratio in non-severe group was 30.7 ± 56.5, compared to 64.7 ± 53.5 for severe patients (SMD = -1.88; 95% CI: -3.77 to 0.01; p = 0.05). sFlt-1/PlGF ratios in COVID-19 patients, with and without hypertensive disease of pregnancy, were 187.0 ± 121.8 vs. 21.6 ± 8.6, respectively (SMD = 2.46; 95% CI: 0.99 to 3.93; p = 0.001). Conclusions: Patients with COVID-19, as compared to patients without COVID-19, were characterized by higher sFlt-1/PlGF ratio. Moreover, severe COVID-19 and SARS-CoV-2 infection in hypertensive pregnant women was related to significantly higher sFlt-1/PlGF ratio.

Effectiveness of mHealth on Adherence to Antiretroviral Therapy in Patients Living With HIV: Meta-analysis of Randomized Controlled Trials.

The World Health Organization recommends that all adults with HIV adhere to antiretroviral therapy (ART). Good adherence to ART is beneficial to patients and the public. Furthermore, mHealth has shown promise in improving HIV medication adherence globally. The aim of this meta-analysis is to analyze the effectiveness of mHealth on adherence to antiretroviral therapy in patients living with HIV. Randomized controlled trials (RCTs) of the association between mHealth and adherence to ART published until December 2021 were searched in electronic databases. Odds ratios (ORs), weighted mean differences, and 95% CIs were calculated. This meta-analysis was performed using the Mantel-Haenszel method or the inverse variance test. We evaluated heterogeneity with the I2 statistic. If I2 was ≤50%, heterogeneity was absent, and a fixed effect model was used. If I2 was >50%, heterogeneity was present, and a random effects model was used. A total of 2163 participants in 8 studies were included in this meta-analysis. All included studies were RCTs. The random effects model was used for a meta-analysis of the effects of various intervention measures compared to routine nursing; the outcome was not statistically significant (OR 1.54, 95% CI 0.99-2.38; P=.05). In the subgroups, only short messaging service (SMS)-based interventions significantly increased adherence to ART (OR 1.76, 95% CI 1.07-2.89; P=.03). Further analysis showed that only interactive or bidirectional SMS could significantly increase ART adherence (OR 1.69, 95% CI 1.22-2.34; P=.001). After combining the difference in CD4 cell count before and after the interventions, we concluded that there was no statistical heterogeneity among the studies (I2=0%; tau2=0.37; P=.95). Interactive or bidirectional SMS can enhance intervention effects. However, whether mHealth can improve adherence to ART in patients with HIV needs further study. Owing to a lack of the required significant staff time, training, and ongoing supervision, there is still much more to do to apply mHealth to the clinical use of ART for patients living with HIV. PROSPERO CRD42022358774; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=358774.

The effects of khat use during pregnancy on perinatal and maternal outcomes: a meta-analysis.

Chewing khat during pregnancy adversely affects maternal and fetal health, but available studies are scarce and inconsistent, and it is difficult to conclude the relationship between khat consumption and perinatal outcomes. We aimed to investigate the available studies on the effect of khat use during pregnancy on perinatal and maternal outcomes. For this meta-analysis, we conducted a thorough search of articles published in PubMed, Embase, Scopus, and Web of Science up to the date this search was undertaken (03.01.2022). We used random effect model with the Mantel-Haenszel method to calculate the pooled odds ratio and mean difference. We found that khat use during pregnancy was significantly associated with increased odds of low birth weight (OR:2.51; 95% CI: 1.60 to 3.94), congenital anomalies (OR:3.17; 95% CI: 1.30 to 7.73), premature rupture of membrane (OR: 1.99; 95% CI: 1.59 to 2.50), perinatal mortality (OR: 1.95; 95% CI: 1.26 to 3.03), and lower APGAR scores at the fifth minute (MD: -1.7; 95% CI: -2.32 to -1.07). Also, increased odds for developing maternal psychological stress and anemia were reported in women using khat during pregnancy. There were no statistically significant differences in stillbirth and preterm birth between women using khat during pregnancy and their counterparts. Since prenatal khat use is associated with adverse perinatal and maternal outcomes, we strongly recommend equitable and easily accessible health services through the implementation of integrated addiction treatment with maternity services to address khat use during pregnancy and encourage the practice of healthy behavior of women.

Efficacy and Toxicity of Combined Inhibition of EGFR and VEGF in Patients With Advanced Non-small Cell Lung Cancer Harboring Activating EGFR Mutations: A Systematic Review and Meta-analysis.

Dual inhibition of epidermal growth factor receptor (EGFR) and vascular endothelial growth factor (VEGF) pathways have demonstrated promising results for treatment of advanced non-small cell lung cancer. We conducted a systematic review and meta-analysis to assess the efficacy and toxicity of the combined treatment with EGFR tyrosine kinase inhibitors (TKIs) and VEGF blockade for patients with advanced non-small cell lung cancer harboring activating EGFR mutations, in comparison to EGFR TKIs alone. The electronic databases were searched for relevant randomized trials between 2000 and 2022. The primary endpoints were overall survival (OS) and progression-free survival. Secondary endpoints included objective response rate (ORR), disease control rate, and grade ≥3 adverse events (AEs). The pooled hazard ratios (HR) and odds ratios were meta-analyzed using the generic inverse variance and the Mantel-Haenszel methods. A total of 1528 patients from 8 trials were evaluated for analyses. The combination treatment decreased the risk of disease progression by 37% (HR=0.63; 95% CI, 0.56 to 0.72) but had no added benefit on OS compared with EGFR inhibition alone (HR=0.90; 95% CI, 0.76 to 1.05). There was no significant difference in objective response rate or disease control rate between treatments. There was a significantly increased number of AEs reported in the dual treatment arm (odds ratio=3.02; 95% CI, 1.71 to 5.31), with proteinuria and hypertension being the most significantly increased AEs. This meta-analysis suggests combined inhibition of EGFR and VEGF pathways significantly improves progression-free survival, with no OS benefit, and increases AEs. Mature OS data are needed along with results from more trials exploring this strategy with third-generation EGFR TKIs to strengthen these results.

The refusal of COVID-19 vaccination and its associated factors: a systematic review

Background: To date, more than 10% of the global population is unvaccinated against the coronavirus disease 2019 (COVID-19), and the reasons why this population is not vaccinated are not well identified. Objectives: We investigated the prevalence of COVID-19 vaccine refusal and to assess the factors associated with COVID-19 vaccine refusal. Methods: A meta-analysis was conducted during August to November 2022 (PROSPERO: CRD42022384562). We searched articles investigating the refusal of COVID-19 vaccination and its potential associated factors in PubMed, Scopus, and the Web of Sciences. The quality of the articles was assessed using the Newcastle–Ottawa scale, and the data were collected using a pilot form. The cumulative prevalence of the refusal to vaccinate against COVID-19 was identified using a single-arm meta-analysis. The factors associated with COVID-19 vaccine refusals were determined using the Mantel-Haenszel method. Results: A total of 24 articles were included in the analysis. Our findings showed that the global prevalence of COVID-19 vaccine refusal was 12%, and the highest prevalence was in the general population, and the lowest prevalence was in the healthcare worker subgroup. Furthermore, individuals with a high socioeconomic status, history of previous vaccination, and medical background had a lower rate of COVID-19 vaccination refusal. Subsequently, the following factors were associated with an increased risk of COVID-19 vaccine refusal: being female, educational attainment lower than an undergraduate degree, and living in a rural area. Conclusion: Our study identified the prevalence of and factors associated with COVID-19 vaccine refusal. This study may serve as an initial reference to achieve global coverage of COVID-19 vaccination by influencing the population of COVID-19 vaccine refusal.