Significant Differences In Outcomes Research Articles

Dual Antiplatelet Therapy vs Alteplase in Adult Patients with Acute Minor Ischemic Stroke: A Systematic Review and Meta-Analysis.

The efficacy and safety of dual antiplatelet therapy (DAPT) relative to intravenous (IV) alteplase in patients with acute minor ischemic stroke are insufficiently established. Therefore, we aimed to perform a meta-analysis to compare DAPT with IV alteplase in patients with acute minor stroke. MEDLINE, Embase, and Cochrane were searched for studies comparing DAPT with IV alteplase in patients with minor stroke. Functional and safety outcomes in 90days were analyzed. Statistical analysis was performed using Rstudio 4.3.1. Subanalyses were performed restricted to non-disabling minor strokes and NIHSS score ≤ 3. PROSPERO (CRD42023440986). We included five studies with a total of 6,340 patients, of whom 4,050 (63.9%) received DAPT. The follow-up period for all included studies was 90days. There was no significant difference for individual outcomes of mRS 0-1 (OR 1.26; 95% CI 0.85-1.89; p = 0.25), mRS 0-2 (OR 0.99; 95% CI 0.69-1.43; p = 0.97), or all-cause mortality (OR 0.80; 95% CI 0.20-3.13; p = 0.75) between groups. Symptomatic intracranial hemorrhage (sICH) was significantly lower (OR 0.11; 95% CI 0.003-0.36; p < 0.001) in patients treated with DAPT compared with IV alteplase. In terms of mRS 0-1 and mRS 0-2, we found no significant difference in both subgroup analyses. We found no statistically significant difference between DAPT and IV alteplase regarding functional outcome (mRS scores of 0-1 and 0-2) or all-cause mortality at 90days in patients with minor ischemic stroke. Additionally, DAPT was associated with a significantly lower rate of sICH.

A 12-month randomised controlled trial using intensive dietary interventions for adolescents with obesity associated complications

Adolescent obesity requires effective and accessible intervention options and there is potential for intensive dietary interventions to be used as adjunctive therapy to behavioural weight management for some individuals(1). The aim of this study was to determine the effect of two novel diet therapies, delivered in the as part of an intensive behavioural weight management intervention, in adolescents with metabolic complications associated with obesity. The Fast Track to Health study (HREC/17/SCHN/164; ACTRN12617001630303) was a multi-site 52-week RCT, conducted 2018 – 2023, comparing a very-low-energy diet (800kcal/day) followed by i) an intermittent energy restricted (IER) diet; and ii) a continuous energy restricted diet (CER), for adolescents (13-17years) with ≥1 obesity associated complication. Interventions were delivered as part of an intensive behavioural weight management intervention by a multidisciplinary team2. Anthropometry, body composition and cardiometabolic health were assessed at baseline and week-52. The primary outcome was change in BMI z-score at week-52. Dyslipidaemia was defined as HDL &lt;1.03mmol/L and/or triglycerides ≥1.7mmol/l, and elevated liver function tests (LFTs) as ALT and/or GGT ≥1.5 upper limit of 30U/L3. The difference in BMI z-score between groups at week-52 (±4) was assessed using a t-test. Mixed models was used to investigate changes over time. Descriptive statistics were used to describe participants above and below clinical cut-points at baseline and week-52. In total, 141 adolescents (70 female) were enrolled and 97 (48 female) completed the intervention. At week-52, BMI z-score reduced by −0.23 [95%CI −0.37 to −0.22], BMI expressed as a percentage of 95th percentile reduced by −8.86 [95%CI −12.46 to −7.47] and Fat Mass Index reduced by −1.49 [95%CI −2.36 to −1.08]. There was no significant difference for weight or cardiometabolic outcomes between diet groups. The occurrence of dyslipidaemia was unchanged between baseline and week-52 (n = 60 [43%] and n = 37 [43%] respectively) and a small improvement in the occurrence of impaired LFTs (n = 37 [27%] to n = 15 [17.2%] respectively). There were no differences in change of occurrence of dyslipidaemia or impaired LFTs between intervention groups. These findings suggest that both IER and CER, delivered as part of an intensive behavioural weight management program, are equally effective for improving weight and cardiometabolic outcomes for adolescents with obesity.

192 Feasibility of Magnetic Resonance-Guided Focused Ultrasound Thalamotomy for Essential Tremor Patients With Low Skull Density Ratio

INTRODUCTION: Magnetic resonance-guided focused ultrasound (MRgFUS) is a safe, effective treatment for essential tremor (ET). Skull density ratio (SDR), the ratio between the densities of cancellous bone and cortical bone, affects energy penetration of the skull. Major clinical trials and guidelines have excluded patients with low skull density ratio due to concerns of disrupted treatment, though these patients represent nearly 40% of ET patients. METHODS: In this single-surgeon cohort study of prospectively collected and retrospectively analyzed data, we report the characteristics and clinical outcomes of all ET patients with low SDR (&lt;0.40) vs. high SDR (=0.40) treated at Brigham and Women’s Hospital between June 2019 and February 2023. Clinical outcomes were determined by Fahn-Tolosa-Marin (FTM) scores in the affected limb and percentage of patients with clinical improvements. RESULTS: Thirty-one patients had low SDR. 239 patients had high SDR. Mean (±SD) SDRs in the low SDR and high SDR groups were 0.36 (±0.02) and 0.51 (±0.08), respectively. There were no significant differences between the two groups in the following characteristics: sex, handedness, duration of tremor, total preoperative Fahn-Tolosa-Marin (FTM) score, intention + posture preoperative FTM score, age at treatment, treatment laterality, and rate of intraoperative complications. While there were significant differences in the clinical outcomes of low SDR vs. high SDR patients on postoperative day 1 (POD1), the clinical outcomes between the two groups were not significantly different at every follow-up time point, including up to three years post-treatment. CONCLUSIONS: While clinical outcomes were significantly different on POD1, low SDR and high SDR patients had similar long-term clinical outcomes, suggesting that MRgFUS of ET patients with SDR &lt; 0.40 is feasible and effective.

Germline Genetic Testing and Survival Outcomes Among Children With Rhabdomyosarcoma

Determining the impact of germline cancer-predisposition variants (CPVs) on outcomes could inform novel approaches to testing and treating children with rhabdomyosarcoma. To assess whether CPVs are associated with outcome among children with rhabdomyosarcoma. In this cohort study, data were obtained for individuals, aged 0.01-23.23 years, newly diagnosed with rhabdomyosarcoma who were treated across 171 Children's Oncology Group sites from March 15, 1999, to December 8, 2017. Data analysis was performed from June 16, 2021, to May 15, 2023. The presence of a CPV in 24 rhabdomyosarcoma-associated cancer-predisposition genes (CPGs) or an expanded set of 63 autosomal-dominant CPGs. Overall survival (OS) and event-free survival (EFS) were the main outcomes, using the Kaplan-Meier estimator to assess survival probabilities and the Cox proportional hazards regression model to adjust for clinical covariates. Analyses were stratified by tumor histology and the fusion status of PAX3 or PAX7 to the FOXO1 gene. In this study of 580 individuals with rhabdomyosarcoma, the median patient age was 5.9 years (range, 0.01-23.23 years), and the male-to-female ratio was 1.5 to 1 (351 [60.5%] male). For patients with CPVs in rhabdomyosarcoma-associated CPGs, EFS was 48.4% compared with 57.8% for patients without a CPV (P = .10), and OS was 53.7% compared with 65.3% for patients without a CPV (P = .06). After adjustment, patients with CPVs had significantly worse OS (adjusted hazard ratio [AHR], 2.49 [95% CI, 1.39-4.45]; P = .002), and the outcomes were not better among patients with embryonal histology (EFS: AHR, 2.25 [95% CI, 1.25-4.06]; P = .007]; OS: AHR, 2.83 [95% CI, 1.47-5.43]; P = .002]). These associations were not due to the development of a second malignant neoplasm, and importantly, patients with fusion-negative rhabdomyosarcoma who harbored a CPV had similarly inferior outcomes as patients with fusion-positive rhabdomyosarcoma without CPVs (EFS: AHR, 1.35 [95% CI, 0.71-2.59]; P = .37; OS: AHR, 1.71 [95% CI, 0.84-3.47]; P = .14). There were no significant differences in outcome by CPV status of the 63 CPG set. This cohort study identified a group of patients with embryonal rhabdomyosarcoma who had a particularly poor outcome. Other important clinical findings included that individuals with TP53 had poor outcomes independent of second malignant neoplasms and that patients with fusion-negative rhabdomyosarcoma who harbored a CPV had outcomes comparable to patients with fusion-positive rhabdomyosarcoma. These findings suggest that germline CPV testing may aid in clinical prognosis and should be considered in prospective risk-based clinical trials.

Elevated white blood cell count and long-term clinical outcomes of patients with vasospastic angina.

Inflammation is known as one of key pathophysiologic mechanisms of coronary artery disease. We aimed to investigate the relationship between white blood cell (WBC) count and long-term clinical outcomes of patients with vasospastic angina (VA). A total of 823 patients who were diagnosed as VA without significant coronary lesion by coronary angiography with ergonovine provocation test were enrolled for analysis. Patients were divided according to WBC count tertile at the time of diagnosis: group I, tertile 1 and 2 (n = 546, <7490/ml); group II, tertile 3 (n = 277, ≥7490/ml). Primary outcome was defined as major adverse cardiovascular events (MACE), a composite outcome of all-cause death, cardiac death, myocardial infarction (MI), readmission due to cardiac symptoms, and revascularization. Median follow-up duration was 4.3 years. No significant difference of primary outcome was observed between group I and group II (14.7% vs. 20.2%, hazard ratio (HR) 1.29, confidence interval (CI) 0.90-1.83, P = 0.162), while incidence of cardiac death and MI was significantly higher in group II (1.5% vs. 4.3%, HR 2.86, CI 1.14-7.17), P = 0.025). In multivariate Cox regression model, elevated WBC count at the time of diagnosis of VA was an independent predictor of MI (HR 3.43, CI 1.02-11.59, P = 0.047). Elevated WBC count at the time of diagnosis was associated with a significantly increased risk of cardiac death and MI during long-term follow-up in VA patients.

Clinical Effectiveness of Continuous Glucose Monitoring in Pregnancies Affected by Type 1 Diabetes.

Background: Continuous glucose monitoring (CGM) improves neonatal outcomes in type 1 diabetes pregnancies; however, its effectiveness has not been assessed in a real-world setting in the United States. Objective: The Triple C Study aimed to examine the clinical effectiveness, assessed through maternal glucose control and gestational health outcomes, of CGM use compared with self-monitoring of blood glucose (SMBG) in pregnancies associated with type 1 diabetes in a real-world setting. Research Design and Methods: We retrospectively identified 160 type 1 diabetes pregnancies at the Barbara Davis Center for Diabetes managed with CGM therapy (n = 109) or SMBG (n = 51) over a 6.5-year period (2014-2020). Obstetric care was provided at multiple practices. CGM use was defined as ≥60% wear in the second and third trimesters of pregnancy. Data were obtained from the electronic medical record system, hospital records, and vital statistics departments (Colorado and Wyoming). We used Student's t-test for continuous variables and chi-square test for categorical variables to compare outcomes between groups. Results: The CGM group had more participants meeting trimester-specific hemoglobin A1C (HbA1c) goals throughout pregnancy and postpartum (P < 0.01 in each time period). The CGM group had fewer participants never meeting HbA1c goals in any trimester than the SMBG group (P < 0.001). There were no significant differences in neonatal outcomes between groups, other than for macrosomia (12.8% CGM vs. 29.4% SMBG, P = 0.01). Infants of CGM users required a neonatal intensive care unit admission less often (52.9% CGM vs. 68.3% SMBG, P = 0.0989). Conclusions: CGM use was associated with improved maternal glucose levels in a diverse real-world cohort.

Ambulatory facial feminization surgery: a comparative analysis of outcomes and complications

BackgroundTo date, there are no studies investigating the safety and outcomes of facial feminization surgery (FFS) as an outpatient procedure. This is the first study of its kind analyzing the outcomes of ambulatory FFS based on a comparison of complications, post-operative emergency department or urgent care (ED/UC) visits, and readmissions between patients who underwent FFS with admission versus same-day surgery. MethodsA retrospective analysis was conducted on all patients who underwent FFS in a single integrated healthcare system. Patient charts were reviewed for operative details, complications, post-operative ED/UC visits, readmission, and demographic factors. Major outcomes including complications, readmissions, and ED/UC visits were compared between groups with same-day discharge and post-operative hospital admission. ResultsOf 242 patients included in the study, ED/UC visits were comparable between patients discharged same-day (18.2%) and patients admitted post-operatively (21.6%, p = 0.52). Logistic regression showed no significant difference in the composite outcomes of minor complications, major complications, and readmissions (15.6% for ambulatory versus 19.3% for admission, p = 0.46). Temporary nerve palsy, infection, and hematoma were the most common post-operative complications. However, covariates of a lower face procedure and operative time were shown to have significant differences in the composite complication outcome (p = 0.04 and p = 0.045, respectively). ConclusionAmbulatory FFS is a safe practice with no associated increase in adverse outcomes including complications, ED/UC visits, and readmission when compared to post-operative admission. Adoption of same-day FFS should be considered by high-volume gender health centers to potentially benefit from increased scheduling flexibility and efficiency, increased access to care, and lower healthcare costs.

Is mechanical bowel preparation mandatory for elective colon surgery? A systematic review and meta-analysis.

Growing evidence demonstrates minimal impact of mechanical bowel preparation (MBP) on reducing postoperative complications following elective colectomy. This study investigated the necessity of MBP prior to elective colonic resection. A systematic literature review was conducted across PubMed, Ovid, and the Cochrane Library to identify studies comparing the effects of MBP with no preparation before elective colectomy, up until May 26, 2023. Surgical-related outcomes were compiled and subsequently analyzed. The primary outcomes included the incidence of anastomosis leakage (AL) and surgical site infection (SSI), analyzed using Review Manager Software (v 5.3). The analysis included 14 studies, comprising seven RCTs with 5146 participants. Demographic information was consistent across groups. No significant differences were found between the groups in terms of AL ((P = 0.43, OR = 1.16, 95% CI (0.80, 1.68), I2 = 0%) or SSI (P = 0.47, OR = 1.20, 95% CI (0.73, 1.96), I2 = 0%), nor were there significant differences in other outcomes. Subgroup analysis on oral antibiotic use showed no significant changes in results. However, in cases of right colectomy, the group without preparation showed a significantly lower incidence of SSI (P = 0.01, OR = 0.52, 95% CI (0.31, 0.86), I2 = 1%). No significant differences were found in other subgroup analyses. The current evidence robustly indicates that MBP before elective colectomy does not confer significant benefits in reducing postoperative complications. Therefore, it is justified to forego MBP prior to elective colectomy, irrespective of tumor location.

O142: Current clinical applications and limitations of graft augmentation in rotator cuff repair: a systematic review

Abstract Background Rotator cuff tears (RCTs) are a leading source of chronic and acute shoulder pain globally, with causes spanning from tendon degeneration to traumatic injury. Especially prevalent in the aging population, RCTs have a significant retear rate despite surgical intervention, and recent years have seen an increase in the use of grafts in surgery to address many of the clinical issues previously encountered in tendon-healing. Objectives To compare the effectiveness of various grafts in graft-augmentation surgery for full-thickness rotator cuff tears, assessed with functional and clinical outcomes. Selection criteria Adult patients with MRI-diagnosed full-thickness RCT and subsequently underwent graft-augmentation surgery; followed-up &amp;gt;1year, with assessment for retear and quantitative clinical outcomes. Results 32 primary studies, mean follow-up of 2 years and total of 1052 patients were included. The effectiveness of graft-augmentation was assessed using retear rate, ASES, Constant, UCLA and VAS. Graft-augmentation significantly improves all functional and clinical scores (p&amp;lt;0.05), and decreases retear rate to an average of 18.5% &amp;gt;1year post-surgery (p&amp;lt;0.0001), with no significant difference in effectiveness between the 4 different types of grafts. (p&amp;gt;0.05). No significant difference in outcomes was found in graft-augmentation between different tear sizes. Conclusions Graft augmentation for RCTs shows significant improvements in clinical and functional outcomes, and significantly lowers retear rate compared to conservative treatment or surgery without graft augmentation. The choice of graft has been shown to be of less importance than the clinical decision to use surgical-intervention with graft-augmentation, which applies to full-thickness tears of all sizes; both primary and revision tears.

Simple aspiration for spontaneous pneumothorax in adults: A systematic review and meta-analysis of randomized controlled trials

BackgroundSpontaneous pneumothorax (SP) is a widespread clinical entity, and methods of managing adult SP remain controversial. The aim of this meta-analysis was to further determine the clinical efficacy and safety of simple aspiration (SA) in comparison to intercostal tube drainage (ITD) during the management of adult SP. MethodsEMBASE, Medline and the Cochrane Central Register of Controlled Trials via Ovid SP were searched (to June 2023) to identify randomized controlled trials (RCT) that reported outcomes of interest after comparing SA with ITD for the management of adult SP. ResultsThe search strategy yielded 1447 citations, of which 10 RCTs enrolling 1044 subjects were included. Compared with the ITD group, the SA group had a significantly lower the initial success rate of the procedure for the management of SP (OR 0.63, 95% CI [0.47–0.86]; P = 0.004). Moreover, SA was associated with a decreased duration of hospitalization (mean difference-2.05 days, 95% CI [−2.66 – −1.44]; P < 0.001) and a decreased need for operation (P = 0.03). For frequently reported adverse events such as subcutaneous emphysema (P = 0.32), bleeding (P = 0.0.26) and wound infection (P = 0.07), no significant difference between the SA and ITD groups was found. There was no significant difference for other outcomes. Subgroup analysis found that there was no significant difference between SA and ITD in terms of the initial success rate, 1-week success rate or any type of adverse event for PSP patients. ConclusionsIn the management of adult SP, the use of SA decreased the initial success rate but also decreased the duration of hospitalization and the need for operation compared with ITD. The incidence of adverse events did not differ between the two approaches.The research plan was registered at PROSPERO, and the registration number was CRD42023436770.

Clinical Profile and Outcome of Covid-19 Intensive Care Patients with Nosocomial Infections: A Single-Centred Experience from India

Background: Incidences of nosocomial infections in COVID-19 patients admitted to the intensive care unit (ICU) have become a common occurrence. Hospital-acquired infections (HAI) present increased mortality, cost-of-care, especially relevant in multidrug resistant (MDR) infections. Our study aimed to assess the clinical implications associated with HAI-infected COVID-19 patients. Patients and Methods: We conducted retrospective single-centred study on ICU-admitted adult COVID-19 patients for a year i.e., 2021-22 at a tertiary Indian institute and collated data of HAI epidemiological, clinical and microbiological reports. Results: Rate of HIA at our centre was estimated to be 10.29% and the mortality rate was 40.4%. 10 different organisms(Bacteria: 8, Fungi: 2) were detected in HAI, of which the incidence of Gram-negative infections (GNI) was highest i.e., 60% and that of Gram-positive infections (GPI)/Fungi (Fungi infected) were 20% each. Mortality was highest among GPI (36.67%), FI (13.46%), followed by and GPI (7.69%). Tocilizumab treatment decreased the risk of survivability with no significant difference in the treatment outcomes. Conclusion: This study provides a comprehensive picture of nosocomial infections characteristics among COVID-19patients and provides insights regarding the impact of treatment on the outcome of these patients with suggestions for strategies. We found that critically ill patients with COVID- 19 are at a high risk of developing HAI, especially MDR mediated CLABSI and CAUTI. Clinicians must therefore be cautious and mindful during implementing protocols for management of infectious complications with COVID-19 patients.

Early vs Late Fixation of Extremity Fractures Among Adults With Traumatic Brain Injury

The optimal timing for fixation of extremity fractures after traumatic brain injury (TBI) remains controversial. To investigate whether patients who underwent extremity fixation within 24 hours of TBI experienced worse outcomes than those who had the procedure 24 hours or more after TBI. This cohort study used data from the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI) study. Patients 16 years or older with TBI who underwent internal extremity fixation met inclusion criteria. To compare outcomes, patients who underwent the procedure within 24 hours were propensity score matched with those who underwent it 24 hours or later. Patients were treated from December 9, 2014, to December 17, 2017. Data analysis was conducted between August 1, 2022, and December 25, 2023. The primary outcome was an unfavorable functional status at 6 months (Glasgow Outcome Scale-Extended [GOSE] score ≤4). A total of 253 patients were included in this study. The median age was 41 (IQR, 27-57) years, and 184 patients (72.7%) were male. The median Injury Severity Score (ISS) was 41 (IQR, 27-49). Approximately half of the patients (122 [48.2%]) had a mild TBI while 120 (47.4%) had moderate to severe TBI. Seventy-four patients (29.2%) underwent an internal extremity fixation within 24 hours, while 179 (70.8%) had the procedure 24 hours or later. At 6 months, 86 patients (34.0%) had an unfavorable functional outcome. After propensity score matching, there were no statistically significant differences in unfavorable functional outcomes at 6 months (odds ratio [OR], 1.12 [95% CI, 0.51-1.99]; P = .77) in patients with TBI of any severity. Similar results were observed in patients with mild TBI (OR, 0.71 [95% CI, 0.22-2.29]; P = .56) and moderate to severe TBI (OR, 1.08 [95% CI, 0.32-3.70]; P = .90). The outcomes of extremity fracture fixation performed within 24 hours after TBI appear not to be worse than those of procedures performed 24 hours or later. This finding suggests that early fixation after TBI could be considered in patients with mild head injuries.

Reverse-sequence endoscopic nipple-sparing mastectomy with immediate implant-based breast reconstruction: an improvement of conventional minimal access breast surgery.

Our center proposes a new technique that effectively provides space to broaden the surgical field of view and overcomes the limitations of endoscopy-assisted nipple-sparing mastectomy (E-NSM) by changing the dissection sequence and combining it with air inflation. The purpose of this study was to compare the clinical outcomes of the new technique designated "reverse-sequence endoscopic nipple-sparing mastectomy (R-E-NSM) with subpectoral breast reconstruction (SBR)" and the conventional E-NSM (C-E-NSM) with SBR. All patients undergoing E-NSM with SBR at our breast center between April 2017 and December 2022 were included in this study. The cohort was divided into the C-E-NSM group and the R-E-NSM group. The operation time, anesthesia time, medical cost, complications, cosmetic outcomes, and oncological safety were compared. Twenty-six and seventy-nine consecutive patients were included in the C-E-NSM and R-E-NSM groups, with average ages of 36.9 ± 7.0 years and 39.7 ± 8.4 years (P=0.128). Patients in the R-E-NSM group had significantly shorter operation time (204.6 ± 59.2 vs. 318.9 ± 75.5 minutes, p<0.001) and anesthesia time (279.4 ± 83.9 vs. 408.9 ± 87.4 minutes, p<0.001) and decreased medical costs [5063.4 (4439.6-6532.3) vs. 6404.2 (5152.5-7981.5), USD, p=0.001] and increase SCAR-Q scores (77.2 ± 17.1 vs. 68.8 ± 8.7, P=0.002) compared to the C-E-NSM group. Although trends increased in both the excellent rate of Ueda scores (53.8% vs. 42.3%, P = 0.144), excellent rate of Harris scores (44.0% vs. 63.1%, P=0.102), and decreased surgical complications (7.6% vs. 19.2%, P = 0.135) were observed in the R-E-NSM group, the differences were not significant. There were no significant differences in oncological outcomes between the two groups. R-E-NSM improves cosmetic outcomes and efficiency of C-E-NSM, reduces medical costs, and has a trend of lower surgical complications while maintaining the safety of oncology. It is a safe and feasible option for oncological procedures that deserves to be promoted and widely adopted in practice.

Feasibility of a wearable self-management application for patients with COPD at home: a pilot study

BackgroundAmong people with COPD, smartphone and wearable technology may provide an effective method to improve care at home by supporting, encouraging, and sustaining self-management. The current study was conducted to determine if patients with COPD will use a dedicated smartphone and smartwatch app to help manage their COPD and to determine the effects on their self-management.MethodsWe developed a COPD self-management application for smartphones and smartwatches. Participants were provided with the app on a smartphone and a smartwatch, as well as a cellular data plan and followed for 6 months. We measured usage of the different smartphone app functions. For the primary outcome, we examined the change in self-management from baseline to the end of follow up. Secondary outcomes include changes in self-efficacy, quality of life, and COPD disease control.ResultsThirty-four patients were enrolled and followed. Mean age was 69.8 years, and half of the participants were women. The most used functions were recording steps through the smartwatch, entering a daily symptom questionnaire, checking oxygen saturation, and performing breathing exercises. There was no significant difference in the primary outcome of change in self-management after use of the app or in overall total scores of health-related quality of life, disease control or self-efficacy.ConclusionWe found older patients with COPD would engage with a COPD smartphone and smartwatch application, but this did not result in improved self-management. More research is needed to determine if a smartphone and smartwatch application can improve self-management in people with COPD.Trial registrationClinicalTrials.Gov NCT03857061, First Posted February 27, 2019.

Effects of combined dietary intervention and physical-cognitive exercise on cognitive function and cardiometabolic health of postmenopausal women with obesity: a randomized controlled trial

BackgroundPostmenopausal women with obesity are markedly at risk of cognitive impairment and several health issues. Emerging evidence demonstrated that both diet and exercise, particularly physical-cognitive exercise are involved in cognitive and health benefits. However, the comparative effect of diet, exercise, and combined interventions in postmenopausal women with obesity on cognition and cardiometabolic health is still lacking. Identifying the effective health promotion program and understanding changes in cardiometabolic health linking these interventions to cognition would have important medical implications. This RCT aimed to examine the effect of single and combined interventions of diet and exercise on cognitive function and cardiometabolic health in postmenopausal women with obesity.MethodsNinety-two postmenopausal women with obesity were randomly assigned to diet group (intermittent fasting 2 days/week, 3 months), exercise group (physical-cognitive exercise 3 days/week, 3 months), combined group, or control group (n = 23/group). All cognitive outcomes and cardiometabolic outcomes were measured at baseline and post-3 months. Primary outcomes were executive functions, memory, and plasma BDNF levels. Secondary outcomes were global cognition, attention, language domain, plasma adiponectin levels, IL-6 levels, metabolic parameters, and physical function.ResultsAt the end of the 3-month intervention, the exercise and combined group demonstrated significant memory improvement which was accompanied by significant improvements in plasma BDNF level, insulin levels, HOMA-IR, %body fat, and muscle strength when compared to controls (p < 0.05). Only the combined intervention group demonstrated a significant improvement in executive function and increased plasma adiponectin levels when compared to control (p < 0.05). Surprisingly, no cognitive improvement was observed in the diet group (p > 0.05). Significant reduction in cholesterol levels was shown in the diet and combined groups when compared to controls (p < 0.05). Among the three intervention groups, there were no significant differences in all cognitive outcomes and cardiometabolic outcomes (p > 0.05). However, all three intervention groups showed significant improvements in plasma BDNF levels, weight, BMI, WHR, fat mass, and predicted VO2 max, when compared to control (p < 0.05).ConclusionThese findings suggest that combined physical-cognitive exercise and dietary intervention are promising interventions to improve cognition and obesity-related complications of postmenopausal women with obesity.Trial registrationNCT04768725 (https://clinicaltrials.gov) 24th February 2021.

Business Models of Chinese Firms Impacted by the Crisis Based on Case Studies

The Covid-19 pandemic has hit businesses extremely hard. Because of reduced social contact, many business models (BMs) have been limited, and some have become unviable. In the current external crisis, timely BM changes are crucial for more effective responses to challenges of critical importance. Based on the resource-based view theory, this study adopts a multi-case study approach to investigate the core competencies demonstrated by firms in different industries in adjusting to the external environment. Integrating and adapting existing BMs to form new BMs presents significant differences in operational outcomes between firms. This study focuses on the response and development of firm crisis management during the Covid-19 pandemic. Successful BM can enable firms to survive the crisis and even achieve improvement in the crisis. In addition, this paper distinguishes between business model innovation (BMI) and business model adaptation (BMA) at the theoretical and substantive levels, mainly from the perspective of firm value, including value proposition, value creation, value capture and value transfer, to differentiate between BMI and BMA. This study explains the impact of various BM changes on sustainable firm profitability and value through a detailed collection of media and company official reports. The emphasis on strategic flexibility has positively impacted firm BMs and value, which has implications for providing insights into companies’ long-term development.&#x0D; &#x0D; Received: 15 November 2023 / Accepted: 9 February 2024 / Published: 5 March 2024

Immediate application of frozen-thawed embryo transfer cycle in month following COVID-19 infection does not impair subsequent pregnancy outcomes.

To investigate whether immediate frozen embryo transfer (FET) in the next month following COVID-19 recovery affects the subsequent pregnancy outcomes. A retrospective cohort study was carried out at a university-affiliated reproductive medicine center. The study group (post-COVID-19 group) consisted of women who were afflicted with COVID-19 in December 2022 and immediately invested in FET in January 2023 after recovery, with embryos transferred and not exposed to the infection. The control group was composed of women treated during the pre-COVID-19 period (January 2019). Multivariable logistic regression analyses as well as a propensity score matching (PSM) approach were introduced to control for the potential confounders and selection bias. A total of 200 patients were included in the post-COVID-19 group while a total of 641 women were enrolled in the control group. The rate of ongoing pregnancy was comparable between the study cohorts in both the unadjusted and confounder-adjusted logistic regression models. The other reproductive outcomes, including the odds of the positive pregnancy test, implantation, clinical pregnancy, and early pregnancy loss were all similar between the comparison groups. Results from PSM models further confirmed the lack of significant differences in pregnancy outcomes between the post-COVID-19 group versus the control group. Our findings suggested that for patients who get infected with COVID-19, the immediate investment in a FET cycle in the next month after recovery did not seem to compromise the ongoing pregnancy outcomes in cases of transferred embryos resulting from the pre-infection stage. Thus, women who had frozen embryos from the pre-infection cycles should be counseled and encouraged to invest in IVF as soon as possible after recovering from COVID-19 infection. This article is protected by copyright. All rights reserved.

Safety and effectiveness of stent-assisted coiling with adjunctive techniques in ruptured acute aneurysms: a propensity score-matched cohort study.

The use of stent-assisted coiling (SAC) in acute subarachnoid hemorrhage cases is associated with higher incidence rates of bleeding and ischemic complications. The aim of this study was to evaluate the safety and efficacy of the SAC technique in the treatment of ruptured intracranial aneurysms (RIAs). A retrospective analysis was conducted on patients with RIAs treated with SAC or coiling alone (CA). Univariate analysis compared clinical information between the two groups. Propensity score matching was used to select patients for comparison and analyze surgical complications, prognosis, and imaging outcomes in both groups. A total of 394 aneurysms were included, and 272 aneurysms remained after application of propensity score matching, with an equal distribution of 136 cases in both the SAC and CA groups. There was no statistically significant difference in the immediate postoperative outcomes between the two groups (63.2% of SAC patients achieved class 1 on the Raymond-Roy occlusion classification scale vs 58.8% of CA patients, difference [95% CI] 4.4% [-0.076 to 0.163]; 33.1% achieved class 2 vs 38.2%, 5.1% [-0.065 to 0.170]; 3.7% achieved class 3 vs 2.9%, 0.8% [-0.047 to 0.062], p = 0.506). At the 1-year follow-up, the SAC group exhibited higher rates of complete occlusion (59.5% vs 42.4%, 17.1% [0.040-0.294]) and stability (24.0% vs 19.2%, 4.8% [-0.061 to 0.156]), while experiencing lower rates of improvement (12.4% vs 22.4%, 10.0% [0.001-0.201]) and recanalization (4.1% vs 16.0%, 11.9% [0.036-0.120]), with statistically significant differences in these outcomes (p < 0.001). No significant disparities were observed in clinical outcomes in terms of modified Rankin Scale (mRS) scores at discharge (76.5% vs 77.2% had mRS score 0-2, 0.7% [-0.098 to 0.113]; 23.5% vs 22.8% had mRS score 3-6, 0.7% [-0.098 to 0.113], p = 0.886) and 1-year follow-up (90.8% vs 92.2% had mRS score 0-2, 1.4% [-0.063 to 0.091]; 9.2% vs 7.8% had mRS score 3-6, 1.4% [-0.063 to 0.091], p = 0.683). Intraoperative rupture occurred more frequently in the SAC group compared with the CA group, although the difference was not statistically significant (5.1% vs 2.9%, 2.2% [-0.035 to 0.081], p = 0.356). The SAC group demonstrated a higher incidence of intraoperative thrombosis, but the difference was not statistically significant (8.1% vs 2.9%, 5.2% [-0.010 to 0.117], p = 0.063). Postoperative thrombosis in the SAC group was 3 times higher, but this difference was not statistically significant (6.6% vs 2.2%, 4.4% [-0.013, 0.106], p = 0.076). The surgery-related mortality rates did not differ significantly between the two groups (4.4% vs 5.9%, 1.5% [-0.048 to 0.077], p = 0.583). Although stent treatment for RIA results in some incidents of complications, it is safe and effective. Besides, the SAC group showed better vascular imaging results compared with the CA group.

Abstract B012: Application of shallow whole genome sequencing to identify therapeutic opportunities in p53abn endometrial cancers

Abstract Background: Shallow whole genome sequencing (sWGS) can be used to detect copy number (CN) aberrations. In high-grade serous ovarian (HGSOC) it has been used to identify CN signatures to direct therapy, recognizing two signatures associated with homologous recombination deficiency (HRD). p53abn endometrial carcinomas (EC) represent the most lethal subtype of EC with molecular similarities to HGSOC. Recent data have shown improved outcomes in patients with p53abn EC when adjuvant chemotherapy is used in addition to radiation, however, overall prognosis is still poor and therapeutic advances are urgently needed. Our aim was to apply sWGS with targeted sequencing to assess CN signatures in a cohort of p53abn ECs to identify additional prognostic or predictive stratification. Methods: sWGS was performed on formalin fixed paraffin embedded (FFPE) tissue from 215 p53abn ECs and 188 samples had targeted panel sequencing for 275 cancer related genes. CN variations, common mutations and CN signatures were derived, and associations to clinicopathologic and outcomes data were assessed. Results: 187 p53abn ECs had sufficient quality DNA to generate CN signatures (including 96 serous, 39 endometrioid, 33 carcinosarcoma, 12 clear cell and 7 other), with 5 distinct CN signatures identified. Signature 5 was associated with HRD due to CN loss of BRCA1 and 2 and was found in 35 (19%) of patients. Signatures 3 and 4 were associated with whole genome duplications, with mutations in PIK3CA defining Signature 3. 28% of cases had CCNE1 amplification, and this was enriched with carcinosarcoma histotype (p= 0.0019). 34% of patients had either HER2 gene amplification or HER2 overexpression by immunohistochemistry (IHC), which was seen across all histotypes, and was associated with worse outcomes (p=0.017). The most common mutations beyond TP53 were PIK3CA (32%), PPP2R1A (29%), PIK3R1 (18%), FBXW7 (16%) and PTEN (16%). There was no significant difference in outcomes observed between the CN signatures (35% of patients had recurred and 22% had died from disease at 3 years in total cohort), nor in the distribution of histotypes across signatures. After adjusting for stage, there was no difference in outcomes between histotypes. sWGS in combination with selective sequencing and IHC identified targetable pathways in 84% of patients with p53abn EC (HRD-PARP inhibitors, HER2-anti HER2 therapy, CCNE1-Wee1 inhibitor, PPP2R1A/FBXW7-PKMYT1 inhibitor). Conclusions: sWGS is a relatively inexpensive tool that can be performed on standard FFPE material and identified therapeutic opportunities in 84% of p53abn EC patients. Outcomes were uniformly poor in this cohort of p53abn ECs highlighting the need for improved treatment options beyond surgery and conventional chemoradiation. Further research is needed to determine the efficacy of treatments targeting these identified pathways within p53abn ECs. Citation Format: Amy Jamieson, Juliana Sobral de Barros, Dawn R. Cochrane, Maxwell Douglas, Sameer Shankar, Samuel Leung, Branden Lynch, Janine Senz, Blake Gilks, David G. Huntsman, Jessica N. McAlpine. Application of shallow whole genome sequencing to identify therapeutic opportunities in p53abn endometrial cancers [abstract]. In: Proceedings of the AACR Special Conference on Endometrial Cancer: Transforming Care through Science; 2023 Nov 16-18; Boston, Massachusetts. Philadelphia (PA): AACR; Clin Cancer Res 2024;30(5_Suppl):Abstract nr B012.

Outcomes of paediatric fundoplication stratified by subtype of neurological impairment

AimsJejunal feeding is increasingly seen as an alternative to fundoplication in neurologically impaired children. However, fundoplication may offer important advantages. This study aimed to determine: (i) contemporary outcomes of fundoplication from a sub-specialised service; and (ii) whether outcomes were influenced by neurological characteristics. MethodsSingle-centre retrospective review of consecutive children undergoing fundoplication by three surgeons over five years (2017–2022) using a standardised technique. Children were stratified as neurologically unimpaired, static brain injury, neuromuscular condition or neurodegenerative impairment. Failure was defined as a requirement for subsequent jejunal feeding or further surgery. Data are presented as median (IQR) unless stated. Comparisons used Fisher's test. Results144 children underwent fundoplication at 1.9 years (1–5 years): 97/144 (67 %) had neurological impairment. Surgery was completed laparoscopically 128/144 (89 %) and converted in 9/137 (7 %). 84/144 (60 %) underwent concomitant gastrostomy formation. At 35 months (22–47), absolute failure was 16 % (23/144). Failure was higher in those with neurodegenerative conditions (not significant). Persistence of symptoms was noted in 23/144 (16 %). Two (1.4 %) required reoperation (<30 days). Nine (6.4 %) required admission to critical care. One death within 30 days was unrelated. ConclusionsGiven fundoplication may provide significant benefits (avoiding pump feeds, frequent tube failure/changes and risk of jejunal perforation), success rates are high and morbidity low, fundoplication should be offered to families as an alternative to jejunal feeding as part of comprehensive counselling. There was no significant difference in outcome between neurological impairment subtypes in this sample size.