Two-arm Studies Research Articles

Does Long-term Surveillance Imaging Improve Survival in Patients Treated for Head and Neck Squamous Cell Carcinoma? A Systematic Review of the Current Evidence.

Long-term post-treatment surveillance imaging algorithms for head and neck squamous cell carcinoma are not standardized due to debates over optimal surveillance strategy and efficacy. Consequently, current guidelines do not provide long-term surveillance imaging recommendations beyond 6 months. We performed a systematic review to evaluate the impact of long-term imaging surveillance (i.e., imaging beyond 6 months following treatment completion) on survival in patients treated definitively for head and neck squamous cell carcinoma. A search was conducted on PubMed, Embase, Scopus, the Cochrane Central Register of Controlled Trials, and Web of Science for English literature published between 2003 and 2024 evaluating the impact of long-term surveillance imaging on survival in patients with head and neck squamous cell carcinoma. 718 abstracts were screened and 95 underwent full-text review, with 2 articles meeting inclusion criteria. The Risk of Bias in Non-randomized Studies of Interventions assessment tool was used. A qualitative assessment without a pooled analysis was performed for the two studies meeting inclusion criteria. No randomized prospective controlled trials were identified. Two retrospective two-arm studies were included comparing long-term surveillance imaging with clinical surveillance and were each rated as having moderate risk of bias. Each study included heterogeneous populations with variable risk profiles and imaging surveillance protocols. Both studies investigated the impact of long-term surveillance imaging on overall survival and came to a different conclusion with one study reporting a survival benefit for long-term surveillance imaging with FDG PET/CT in patients with stage III or IV disease or an oropharyngeal primary tumor and the other study demonstrating no survival benefit. Limited heterogeneous retrospective data available precludes definitive conclusions on the impact of long-term surveillance imaging in head and neck squamous cell carcinoma. There is insufficient quality evidence regarding the impact of long-term surveillance imaging on survival in patients treated definitively for head and neck squamous cell carcinoma. There is a lack of standardized definition of long-term surveillance, variable surveillance protocols, and inconsistencies in results reporting, underscoring the need for a prospective multi-center registry assessing outcomes. HNSCC = Head and Neck Squamous Cell Carcinoma; RT= radiotherapy; NCCN = National Comprehensive Cancer Network; MPC = metachronous primary cancer; CR = complete response; OS = overall survival; CRT = chemoradiotherapy; HPV = human papillomavirus; PFS = progression-free survival; CFU = clinical follow up; NI-RADS = Neck Imaging Reporting and Data System.

Does the use of acellular dermal matrices (ADM) in women undergoing pre-pectoral implant-based breast reconstruction increase operative success versus non-use of ADM in the same setting? A systematic review protocol

BackgroundBreast cancer is the most common malignancy among women in the UK. Following mastectomy, reconstruction is now integral to the surgical management of breast cancer, of which implant-based reconstruction (IBBR) is the most common type. IBBR initially evolved from pre-pectoral to post-pectoral due to complications, but with developments in oncoplastic techniques and new implant technology, interest in pre-pectoral IBBR has increased.Many surgeons use acellular dermal matrices (ADM); however, there is little evidence in literature as to whether this improves surgical outcomes in terms of complications, failure and patient satisfaction. This review aims to assess the available evidence as to whether there is a difference in surgical outcomes for breast reconstructions using ADM versus non-use of ADM.MethodsA database search will be performed using Ovid MEDLINE, Embase, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews and Clinicaltrials.org. The search timeframe will be 10 years.Studies will be screened using inclusion and exclusion criteria and data extracted into a standardised spreadsheet. Risk of bias will be assessed. Screening, extraction and risk-of-bias assessments will be performed independently by two reviewers and discrepancies discussed and rectified. Data analysis and meta-analysis will be performed using Microsoft Excel and R software. Forest plots will be used for two-arm studies to calculate heterogeneity and p-value for overall effect.DiscussionWith the renaissance of pre-pectoral IBBR, it is important that surgeons have adequate evidence available to assist operative decision-making. Assessing evidence in literature is important to help surgeons determine whether using ADM for IBBR is beneficial compared to non-use of ADM. This has potential impacts for patient complications, satisfaction and cost to healthcare trusts.Systematic review registrationPROSPERO 2023 CRD42023389072.

Peer specialist-led interventions in primary care at the Veterans Health Administration: An integrative review.

The Veterans Health Administration (VHA) currently employs over 1,300 peer specialists-veterans with lived experience of mental illness who are in recovery and have been trained to provide support to other veterans experiencing these issues. VHA peer specialists have largely been employed in behavioral health settings. In 2014, VHA began to employ peer specialists in primary care settings via the peers in Patient Aligned Care Team (PACT) program, and congressional legislation was passed to expand this program in 2022. In light of this expansion, it is important to evaluate the effectiveness of interventions provided in the Peers in PACT program. This integrative review of studies of peer specialist-led interventions in VHA primary care includes 13 articles with 11 unique studies represented in these articles. These studies targeted mental health symptoms, substance use, health/well-being, and health/treatment engagement. Seven described single-arm studies, three described two-arm studies with a treatment as usual control group, and three described two-arm studies with an active control group. The majority of these studies demonstrated statistically significant improvements on at least one main outcome. Seven studies also included qualitative interviews with veterans; several common themes emerged, including the importance of working with a veteran peer with shared lived experiences, and finding peers helpful in providing accountability, motivation, encouragement, emotional support, resources, and assistance navigating VA health care. Recommendations for future research on the peers in PACT program are discussed, including a need for more RCTs with active controls. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Cardiovascular risk factors and complications in patients with systemic lupus erythematosus with and without nephritis: a systematic review and meta-analysis

IntroductionIt remains unclear how the presence of renal involvement will affect the cardiovascular (CV) risk factors and complications in patients with SLE.MethodsWe conducted a systematic review and meta-analysis using PubMed,...

The effectiveness of telemedicine in the management of type 2 diabetes: A systematic review.

Type 2 diabetes, a lifestyle-related disease demanding daily self-management, is a significant health concern. In this context, the use of telemedicine as a management tool is a relatively new and promising approach. This study aims to contribute to the growing body of knowledge by identifying the effectiveness of telemedicine in managing type 2 diabetes through a systematic review approach. Four databases were searched including PubMed, Virtual Health Library, Global Health Library, and Google Scholar on 27 July 2022. Additionally, a manual search was performed to identify any relevant articles that may have been missed. The quality of the included articles was rigorously assessed using the Study Quality Assessment Tools of the National Institute of Health. We analyzed data from 134 articles. All 134 studies were published between 2002 and 2022, including 103 controlled intervention trials, 13 cohort studies, 7 before-after (pre-post) studies with no control group, 1 initial trial, 1 case study, 1 pilot study, and 8 two-arm studies that did not report the study design. Accordingly, most studies show positive changes in glycemic index in every group using telemedicine. Overall, although the BMI and weight indices in the studies improved at the end of the course, the improvement values were considered insignificant. Telemedicine may be a valuable solution for blood sugar management in patients with type 2 diabetes. However, the effectiveness of telemedicine in improving BMI and quality of life is unclear.

Cerebrospinal fluid shunting for the management of cryptococcal meningitis: a scoping review

Objective: This scoping review aimed to describe studies that evaluate the management of cryptococcal meningitis (CM) using cerebrospinal fluid (CSF) shunts, types of shunts used, and clinically relevant patient outcomes. Methods: We searched in the following databases: PubMed, Web of Science/Core collection, Embase, the Cochrane Library, and clinicaltrials.gov on 1 April 2022. We included two-arm and one-arm cohort studies that evaluated clinically relevant patient outcomes. Case reports were used to describe the type of CSF shunts used and the rationale behind its selection. The selection and extraction processes were independently performed by two authors. Results: This study included 20 cohort studies and 26 case reports. Only seven cohort studies compared two groups. Ventriculoperitoneal shunt was the most commonly used type of shunt (82.1%). The main indications for placing a shunt were persistently high opening pressure (57.1%) and persisting neurological symptoms or deterioration (54.3%). Cohort studies suggest that patients with shunt showed improvement in some outcomes such as neurological symptoms and hospital stay length. The most common shunt complications were post-operative fever (1–35.6%) and shunt obstruction (7–16%). Conclusion: CSF shunts may improve some clinically relevant outcomes in patients with CM, but the evidence is very uncertain.

Endoscopic Versus Microscopic Type I Tympanoplasty: An Updated Systematic Review and Meta-analysis.

Our objective was to perform a systematic review and meta-analysis comparing the clinical outcomes after endoscopic and microscopic type I tympanoplasty. Randomized controlled trials, two-arm prospective studies, and retrospective studies were included. Medline, Cochrane, EMBASE, and Google Scholar databases were searched until March 1, 2022 using the combinations of search terms: "endoscopic," "microscopic," and "tympanoplasty." Two independent reviewers utilized the abovementioned search strategy to identify eligible studies. If any uncertainty existed regarding eligibility, a third reviewer was consulted. Primary outcome measures were graft success rate, air-bone gap (ABG) improvement, and operative time. Secondary outcomes were the rate of need for canalplasty, the proportion of self-rated excellent cosmetic results, and pain visual analog scale (VAS). Forty-three studies enrolled a total of 3712 patients who were undergoing type I tympanoplasty and were finally included. The pooled result showed endoscopic approach was significantly associated with shorter operative time (difference in means: -20.021, 95% confidence interval [CI]: -31.431 to -8.611), less need for canalplasty (odds ratio [OR]: 0.065, 95% CI: 0.026-0.164), more self-rated excellent cosmetic results (OR: 87.323, 95% CI: 26.750-285.063), and lower pain VAS (difference in means: -2.513, 95% CI: -4.737 to -0.228). No significant differences in graft success rate or ABG were observed between the two procedures. Endoscopic type I tympanoplasty provides a similar graft success rate, improvement in ABG, and reperforation rate to microscopic tympanoplasty with a shorter operative time, better self-rated cosmetic results, and less pain. Unless contraindicated, the endoscopic approach should be the procedure of choice in type I tympanoplasty.

Review of Techniques for Protecting Side Branch from Occlusion during Provisional Stenting in Coronary Bifurcation Lesions.

Coronary bifurcation lesions remain one of the most challenging lesions for cardiology interventionists. The provisional stenting strategy has been regarded as the first option for most of these lesions. However, the main complication of this technique is side branch (SB) occlusion, which could lead to a peri-procedural myocardial infarction or even death. Various studies have focused on addressing this issue, but there are no definitive guidelines in the literature to treat these lesions. There isn't enough clinical evidence from randomized controlled trial or two-arm cohort studies to illustrate which techniques provide the best outcomes. In this review, we summarize the mechanisms, independent predictors and predictive models of SB occlusion, and review seventeen techniques involving SB protection and occlusion rescue. Every technique was evaluated according to related bench tests, clinical studies and our own clinical experiences. The aim of this review is to provide interventionists with new insights for the treatment of coronary bifurcation lesions.

The effect of mindfulness interventions on stress in medical students: A systematic review and meta-analysis.

Medical students have high levels of stress, which is associated with higher incidents of burnout, depression, and suicide compared to age-matched peers. Mindfulness practices have been shown to reduce stress among medical students. The purpose of this systematic review and meta-analysis was to examine if mindfulness interventions have an overall effect on stress outcomes in the high-stress population of medical students globally, particularly given the wide variety of interventions. Any intervention designed to promote mindfulness was included. A comprehensive literature search was completed to include multiple databases, ancestry, and hand-searching and 35 studies were included. Standardized mean difference effect sizes (ES) were synthesized across studies using a random-effects model for changes in stress levels in medical students ≥ 18. Moderator analyses were performed to explore variations in effects by participant and intervention characteristics. Mindfulness interventions significantly improved stress among medical students in both the two-arm studies (d = 0.370, k = 19, n = 2,199, 95% CI 0.239-0.501, p < .001) and one-arm pre-post studies (d = 0.291, k = 30, n = 18 (two cohorts from Dyrbye et al), 95% CI 0.127-0.455, p = 0.001). Moderator analyses found trends in less hours and less required practice resulted in better improvement in stress. This study further confirms that despite a wide variety of mindfulness interventions for medical students around the world, they produce an overall small-to-moderate effect on stress reduction. Future research looking at the most effective protocols for high-stress medical students would be beneficial.

Efficacy and safety of therapeutic HPV vaccines to treat CIN 2/CIN 3 lesions: a systematic review and meta-analysis of phase II/III clinical trials

ObjectivesWe aim to assess the efficacy and safety of therapeutic human papillomavirus (HPV) vaccines to treat cervical intraepithelial neoplasia of grade 2 or 3 (CIN 2/3).DesignSystematic review and meta-analysis, following...

Comparison of trans-gastric vs trans-enteric (trans-duodenal or trans-jejunal) endoscopic ultrasound guided gallbladder drainage using lumen apposing metal stents.

Endoscopic ultrasound guided gallbladder drainage (EUS-GBD) is being increasingly used in practice (either as a bridge to cholecystectomy in high-risk patients or as destination therapy in non-surgical patients). Stents are used to create a conduit between the lumen of the gallbladder (GB) and the intestinal lumen through the gastric or enteric routes. Among the various types of stents used, cautery-enhanced lumen apposing metallic stents (LAMS) may be associated with fewer adverse events (AEs). To compare the clinical success, technical success, and rate of AEs between transgastric (TG) and trans-enteric [transduodenal (TD)/transjejunal (TJ)] approach to GB drainage. Further, we analyzed whether using cautery enhanced stents during EUS-GBD impacts the above parameters. Study was registered in PROSPERO (CRD42022319019) and comprehensive literature review was conducted. Manuscripts were reviewed for the data collection: Rate of AEs, clinical success, and technical success. Random effects model was utilized for the analysis. No statistically significant difference in clinical and technical success between the TD/TJ and TG approaches (P > 0.05) were noted. There was no statistically significant difference in the rate of AEs when comparing two-arm studies only. However, when all studies were included in the analysis difference was almost significant favoring the TD/TJ approach. When comparing cautery-enhanced LAMS with non-cautery enhanced LAMS, a statistically significant difference in the rate of AEs was observed when all the studies were included, with the rate being higher in non-cautery enhanced stents (14.0% vs 37.8%; P < 0.01). As per our study results, TD/TJ approach appears to be associated with lower rate of adverse events and comparable efficacy when compared to the TG approach for the EUS-GBD. Additionally, use of cautery-enhanced LAMS for EUS-GBD is associated with a more favorable adverse event profile compared to cold LAMS. Though the approach chosen depends on several patient and physician factors, the above findings could help in deciding the ideal drainage route when both TG and TD/TJ approaches are feasible.

Compare the safety and efficacy of endoscopic third ventriculostomy and ventriculoperitoneal shunt placement in infants and children with hydrocephalus: a systematic review and meta-analysis

Purpose Endoscopic third ventriculostomy (ETV) and ventriculoperitoneal shunt placement are two surgical options used for treatment of non-communicating hydrocephalus. The purpose of this study was to compare the efficiency and safety of these techniques in pediatric patients. Materials and methods An extensive literature review regarding the clinical outcome, safety and efficiency of ETV and shunting in treatment of hydrocephalus was conducted in Medline, PubMed, Cochrane and Google Scholar databases up to 27 November 2015. Patient demographics, ETV and shunting success and failure rates were extracted. Results A total of seven two-arm studies were included for quantitative analysis and 25 single-arm studies were included for systematic review. The two-arm studies recruited a total of 6995 patients: 1046 in the ETV group and 5949 in the shunt group. The pooled results showed that the 1 year success rate of ETV and shunt-placement procedure were similar (pooled RR = 0.870, 95% CI = 0.680–1.112, P = 0.266). The failure rate in the ETV treatment group was 0.9 times higher than in the shunt group; however, the results did not reach statistical significance (pooled RR = 0.893, 95% CI = 0.576–1.383, P = 0.611). Conclusions Both ETV and shunts are associated with similar 1 year success and failure rates. Therefore, there are no current indications to recommend one mode of treatment over the other. Future studies designed to assess the effectiveness of ETV and shunt procedures depending on patient’s age and etiology are warranted.

Fragility index of positive phase II and III randomised clinical trials of treatments for hepatocellular carcinoma (2002–2022)

Background & AimsThe fragility index (FI), i.e., theminimum number of best survivors reassigned to the control group required to revert the statistically significant result of a clinical trial to non-significant, is a metric to evaluate the robustness of randomized controlled trials (RCTs). We aimed to assess the FI in the field of HCC. MethodsThis is a retrospective analysis of phase 2 and 3 RCTs for the treatment of HCC published between 2002 and 2022. We included two-arm studies with 1:1 randomization and significant positive results for a primary time-to-event endpoint for the FI calculation, which involves the iterative addition of a best survivor from the experimental group to the control group, until positive significance (p <0,05, Log-rank test) is lost. ResultsWe identified 51 phase 2 and 3 positive RCTs, of which 29 (57%) were eligible for fragility index calculation. After reconstruction of the Kaplan-Meier curves, 25/29 studies remained significant, among which the analysis was performed. The median (interquartile range (IQR)) FI was 5 (2-10) and Fragility Quotient (FQ) was 3% (1%-6%). Ten trials (40%) had a FI of 2 or less. FI was positively correlated to the blind assessment of the primary endpoint (median FI 9 with blind assessment versus 2 without, p = 0.01), the number of reported events in the control arm (RS = 0.45, p = 0.02) and to impact factor (RS = 0.58, p = 0.003). ConclusionsSeveral phases 2 and 3 RCTs in HCC have a low fragility index, underlying the limited robustness on the conclusion of their superiority over control treatments. The fragility index might provide an additional tool to assess the robustness of clinical trial data in HCC. Impact and implicationsThe fragility index is a method to assess robustness of a clinical trial and is defined the minimum number of best survivors reassigned to the control group required to revert the statistically significant result of a clinical trial to non-significant. Among 25 randomised controlled trials in HCC, the median fragility index was 5, and 10 trials among 25 (40%) had a fragility index of 2 or less, indicating an important fragility.

S1117 Is Transduodenal Approach Better Than the Transgastric for EUS-GBD? - A Meta-Analysis

Introduction: Endoscopic ultrasound-guided gallbladder drainage is achieved by creating cholecysto-enteric stoma, via either transduodenal (TD)/transjuojenal (TJ) or transgastric (TG) approach. In TD/TJ approach, retroperitoneal duodenum is immobile thus, provides a stable access point for the gallbladder (GB) neck. The inflamed GB can adhere to wall of duodenum/jejunum lending further stability. Other advantages are decreased risk of stent migration (due to reduced peristalsis) and stent occlusion (due to lower chances of food reflux) compared to TG approach. Hence, TD/TJ approach can be expected to have lesser adverse events (AE) compared to TG approach. We aimed to compare the AE, technical success, and clinical success of two approaches. Methods: Study was registered in PROSPERO and comprehensive literature search was done on PubMed, Embase, Scopus, CENTRAL, CINAHL, and Web of Science. In total, 3707 studies were screened and 24 met the inclusion criteria (Figure). Summary statistics from each study (both 1 arm and 2 arm studies) were extracted for clinical outcomes of AE, clinical success, and technical success. Random effects model was used for analysis using the software Comprehensive Meta-Analysis. Results: Analysis was done by 2 methods (Table). Method 1: Including studies with patients in both arms. TG vs. TD/TJ: Pooled OR (95% CI), p-value: AE (6 studies): 1.58 (0.46-5.45), p=0.47; Clinical success (3 studies): 0.30 (0.06-1.48), p=0.14; and Technical success (3 studies): 0.30 (0.05-1.89), p=0.20. Method 2: Including all studies (15 TD/TJ & 9 TG). TG vs. TD/TJ: AE (Studies: 9 vs 15): 27.5% (17.1%-41.1%) vs. 15.2% (9.5%-23.6%), p=0.07; Clinical success (Studies: 6 vs 13): 83.3% (71.0%-91.0%) vs. 91.7% (82.4%-96.3%), p=0.16; and Technical success (Studies: 9 vs. 15): 91.3% (83.6%-95.6%) vs. 95.3% (90.7%-97.7%), p=0.22. Conclusion: Our meta-analysis showed no significant difference in clinical and technical success between the TD/TJ and TG approach. The rate of AE was similar when comparing two-arm studies only; however, the difference was almost statistically significant when all studies were included, the rate being higher in TG approach. Limitations include data sparsity and heterogeneity of studies analyzed. Sufficiently powered RCTs are needed to verify the above results. While approach to transluminal GB drainage depends on endoscopist preference and patient’s anatomy (proximity of GB to lumen), it would be useful to know which approach has a favorable AE profile when both are feasible.Figure 1.: PRSIMA flow diagram Table 1. - Results of comparison of technical success, clinical success, and rate of adverse events between the transgastric and transduodenal/transjejunal approach METHOD 1- Including studies with patients in both arms N of studies Pooled odds ratio (TG vs. TD/TJ) 95% CI p-value Adverse events 6 1.58 0.46-5.45 0.47 Clinical success 3 0.30 0.06-1.48 0.14 Technical success 3 0.30 0.05-1.89 0.20 METHOD 2- : Including all the studies N of Studies (TG vs TD/TJ) AE(%) 95% CI p-value Adverse events 9 vs 15 27.5% vs 15.2% 17.1%-41.1%) vs (9.5%-23.6%) 0.07 Clinical success 6 vs 13 83.3% vs 91.7% (71.0%-91.0%) vs (82.4%-96.3%) 0.16 Technical success 9 vs 15 91.3% vs 95.6% 83.6%-95.6%) vs 90.7%-97.7%) 0.22

A Randomized Phase 2 Study of 5-Aminolevulinic Acid Hydrochloride and Sodium Ferrous Citrate for the Prevention of Nephrotoxicity Induced by Cisplatin-Based Chemotherapy of Lung Cancer

Introduction: Cisplatin-based chemotherapy was established in the 1980s, and it has been improved by the development of a short hydration protocol in lung cancer therapy. However, cisplatin-based chemotherapy is still associated with renal toxicity. Because 5-aminolevulinic acid (5-ALA) with sodium ferrous citrate (SFC) is known to be a mitochondrial activator and a heme oxygenase-1 (HO-1) inducer, 5-ALA with SFC is speculated to mitigate cisplatin-induced renal inflammation. Methods: We investigated the effects of oral administration of 5-ALA with SFC for preventing cisplatin-based nephrotoxicity in patients with lung cancer and evaluated its benefits for patients who received cisplatin-based chemotherapy. The primary endpoint was the significance of the difference between the serum creatinine (sCr) levels of the patients administered 5-ALA with SFC and those given placebo after course 1 of chemotherapy. The difference in the estimated glomerular filtration rate (eGFR) between the two groups was also evaluated as the secondary endpoint. Results: The double-blind, randomized two-arm studies were conducted at 15 medical facilities in Japan; 54 male and 20 female patients with lung cancer who received cisplatin-based chemotherapy between the ages of 42 and 75 years were included in the study. The compliance rate was greater than 94% in the primary assessment and subsequent drug administration periods. All enrolled patients completed the four cycles of cisplatin-based chemotherapy with short hydration. The average level of sCr on day 22 of course 1 was 0.707 mg/dL in the group treated with 5-ALA and SFC and 0.735 mg/dL in the placebo group, respectively, and the sCr in the test group was significantly lower than that in the placebo group (p = 0.038). In addition, the eGFR was significantly higher in the SPP-003 group than in the placebo group up to day 1 of course 3 (84.66 and 75.68 mL/min/1.73 m², respectively, p = 0.02) and kept better even after the last administration of the study drug (82.37 and 73.49 mL/min/1.73 m², respectively, p = 0.013). Conclusions: The oral administration of 5-ALA with SFC is beneficial to patients undergoing cisplatin-based chemotherapy for lung cancer with short hydration.

Splenectomy versus Imaging-Guided Percutaneous Drainage for Splenic Abscess: A Systematic Review and Meta-Analysis.

Background: Splenic abscess (SA) is a rare, life-threatening illness that is generally treated with splenectomy. However, this is associated with high mortality and morbidity. Recently, percutaneous drainage (PD) has emerged as an alternative therapy in select patients. In this study, we compare mortality and complications in patients with SA treated with splenectomy versus PD. Patients and Methods: A systematic literature search of 13 databases and online search engines was conducted from 2019 to 2020. A bivariate generalized linear mixed model (BGLMM) was used to conduct a separate meta-analysis for both mortality and complications. We used the risk of bias in non-randomized studies of interventions (ROBINS-I) tool to evaluate risk of bias in non-randomized studies, and the Grading of Recommendation, Assessment, Development, and Evaluation (GRADE) approach for assessing quality of evidence and strength of recommendations. Results were presented according to Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines. Results: The review included 46 retrospective studies from 21 countries. For mortality rate, 27 studies compared splenectomy and PD whereas 10 used PD only and nine used splenectomy only. Data for major complications were available in 18 two-arm studies, seven single-arm studies with PD, and seven single-arm studies with splenectomy. Of a total of 589 patients, 288 were treated with splenectomy and 301 underwent PD. Mortality rate was 12% (95% confidence interval [CI], 8%-17%) in patients undergoing splenectomy compared with 8% (95% CI, 4%-13%) with PD. Complication rates were 26% (95% CI, 16%-37%) in the splenectomy group compared with 10% (95% CI, 4%-17%) in the PD group. Conclusions: Percutaneous drainage s associated with a trend toward lower complications and mortality rates compared with splenectomy in the treatment of SA, however, these findings were not statistically significant. Because of the heterogeneity of the data, further prospective studies are needed to draw definitive conclusions.

Sutureless Closure Versus Conventional Technique in the Primary Surgery of Total Anomalous Pulmonary Venous Connection: A Systematic Review and Meta-analysis.

Sutureless closure has been used for primary repair of total anomalous pulmonary venous connection (TAPVC) for over 20years but its superiority over conventional technique is still uncertain. This systematic review was conducted to compare the effectiveness of sutureless closure and conventional surgery as the primary repair for TAPVC. Systematic search was performed in June 2021 on 12 databases. All studies comparing sutureless and conventional surgery for TAPVC were included. The primary endpoints were early mortality, overall mortality, postoperative pulmonary venous stenosis (PVS), and reoperation. Meta-analysis of two-arm studies was performed with several sensitivity and subgroup analyses. Six retrospective studies with 767 patients were included in meta-analyses. Sutureless closure significantly reduced the risk of early mortality, overall mortality, postoperative PVS, and reoperation by 53%, 45%, 77%, and 67% compared to conventional technique, respectively. No heterogeneity was found and presence of publication bias was non-significant. The results were consistent in all sensitivity analyses. Subgroup analyses revealed that sutureless closure was superior to conventional technique in patients with and without preoperative pulmonary venous obstruction, and neonates and non-neonates. Sutureless closure is better than conventional closure as the primary surgery for TAPVC patients. We advocate using sutureless closure for patients with TAPVC. Future large-scale observational studies or clinical trials are required to confirm our findings.

CONGENITAL MYOPATHIES – CENTRONUCLEAR MYOPATHIES: EP.26 Leveraging natural history data in one- and two-arm hierarchical Bayesian studies of rare disease progression

Clinical trial designs in rare and ultra-rare diseases yield multiple challenges due to restricted sample sizes. In the context of an ongoing investigation of centronuclear myopathies (CNMs), a group of congenital neuromuscular diseases whose most severe and most common incident form is X-linked, affecting approximately 1 in 50,000 newborn boys, this feature holds especially true. In such settings, innovative Bayesian methods can often pay dividends, allowing the sensible incorporation of auxiliary data and other relevant information to bolster that collected by the trial itself.

Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder.

Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder.

Effectiveness and safety of bevacizumab in extensive-disease small cell lung cancer: a systemic review and meta-analysis

BackgroundSmall cell lung cancer (SCLC) is highly invasive and poorly prognostic. The effects of chemotherapy with bevacizumab are promising on other tumors but unclear in extensive-disease SCLC (ED-SCLC). A systemic review and meta-analysis were performed to investigate the efficacy and toxicity in ED-SCLC patients.MethodsA review of current studies was performed on electronic databases and other sources to identify publications of ED-SCLC patients who received bevacizumab. Endpoints included overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and complications.ResultsNine relevant articles with six single-arm and three two-arm studies were identified. Four hundred seventy-six patients were included, of which 368 and 108 were untreated and relapse patients. Most patients were performance status 0–1 (71.6%) and male (58.1%). The comparisons showed CT/bevacizumab slightly prolonged OS (HR =0.84) but significantly improved PFS (HR =0.74). The ORRs of untreated and relapse patients were 71% and 19%, though no significant difference was observed than CT/placebo. The most grade 3–4 complication and bevacizumab-associated complications were neutropenia and hypertension, whose rates were 33% and 6%. Patients who received CT/bevacizumab had a higher hypertension rate than CT/placebo (6% vs. 2%). No different complication rate was observed between high and lose dose groups.DiscussionThe present study suggests that bevacizumab in the combination of standard chemotherapy provides better PFS than chemotherapy alone. Although the combined regimen is well-tolerated, no superiority in OS or response rate is observed.