Equivalent Safety Research Articles

Magnitude and associated factors of prescribing drugs by their brand names among prescribers working at selected hospitals in Addis Ababa, Ethiopia

Background One possible mechanism for lowering expenditure on drugs and increasing their accessibility is by prescribing generic drugs, which are less costly and have equivalent safety and effectiveness profile as brand drugs. However, in Addis Ababa brand-prescribing practice is so common to the extent of making the health department administration of the city to write letters to subcities and hospitals discouraging brand prescribing. This study tried to identify the magnitude and factors affecting brand prescribing in the city. Objective: General objective of this study was to assess magnitude and associated factors of prescribing drugs by brand names at Addis Ababa. Methods An institution based analytical cross-sectional study design was employed from May to August, 2022, using a sample of 485 prescribers. The hospitals were selected by using simple random sampling method and prescribers from different departments were selected by using systematic random sampling method. Data was collected using semistructured, self-administered questionnaire and entered into Statistical Package for Social Sciences version 25 for analysis. The data was described using percentages, graphs and tables. Mean and standard deviations were calculated to identify measures of central tendency and dispersion. Association between dependent and independent variables was checked using bivariate and multivariable logistic regression models. Statistical significance was declared at 95% confidence interval and p < .05. Results The magnitude of prescribing drugs by their brand names was 54.0%. Being trained on good prescribing practice (AOR: 6.81; 95%CI: 2.08-22.28), confidence on Ethiopian Food and Drug Administration Authority (AOR: 18.18; 95%CI: 6.78-48.80), and knowledge about generic drugs (AOR: 11.86; 95%CI: 4.76-29.55) were found to be independent predictors of prescribing drugs by their brand names. Conclusion and recommendation Brand medicine prescribing is positively associated with training on good prescribing practice and knowledge about generic drugs. Hence, training prescribers on good prescribing practice and educating them about generic drugs can minimize brand prescribing.

Promoting Equitable and Affordable Patient Access to Safe and Effective Innovations in Donation and Transplantation of Substances of Human Origin and Derived Therapies.

Innovation is a hallmark of organ, tissue, and cell transplantation. The development of new treatments derived from these substances of human origin (SoHO) has rapidly evolved in recent years. Despite the great benefits that these innovative therapies could bring to patients, significant difficulties have arisen in making them equitably and widely accessible. Herein, we identify and address 4 challenges to promote innovation in this field in a collaborative, sustainable, and transparent manner and propose some concrete solutions applicable to SoHO-derived treatments, ranging from cell therapies to solid organ transplantation. Regulators, health policymakers, and government officials are recommended to incorporate specific elements into the regulatory frameworks of their respective jurisdictions, although regulatory convergence and equivalent quality and safety standards applicable to SoHO at a global level would be needed. An innovation-driven regulatory environment, respectful with the human origin and in accordance with the altruistic donation of SoHO, should be encouraged to improve the safety, effectiveness, accessibility, and affordability of SoHO and to promote collaboration between countries and between public and private sectors. This overview is the outcome of a working group focused on "Innovation in the donation and clinical application of SoHO" as part of the international Summit "Towards Global Convergence in Transplantation: Sufficiency, Transparency and Oversight" convened by the Organización Nacional de Trasplantes under the Spanish Presidency of the Council of the European Union in November 2023 and cosponsored by the Council of Europe, the World Health Organization, the Transplantation Society, and the European Society for Organ Transplantation.

Comparative Efficacy and Safety of the β3-Adrenoceptor Agonist Vibegron for Urgency and Mixed Urinary Incontinence: A Post Hoc Analysis of a Randomized, Double-Blind, Placebo-Controlled Phase 3 Study.

Objective To compare the efficacy of vibegron for urgency urinary incontinence (UUI) and mixed urinary incontinence (MUI) in patients with overactive bladder(OAB). Methods We performed a post hoc analysis of a phase 3 study of vibegron in Japanese patients with OAB. Based on the patterns recorded in the three-day bladder diary, only female patients were categorized into UUI and MUI populations. The primary endpoint was the change in the mean micturition number per 24 hours from baseline to week 12. Other endpoints included the mean changes in urgency episodes per 24 hours, incontinence episodes per 24 hours, voided volume per micturition, and the number of nocturia episodes per night. The proportion of urinary incontinence (UI) normalization, quality of life (QOL) as measured by the King's Health Questionnaire (KHQ), and patient satisfaction level as assessed by the Patient Global Impression (PGI) were investigated. Result Data from a UUI population (vibegron 50 mg, n = 237; vibegron 100 mg, n = 231; placebo, n = 237) and an MUI population (vibegron 50 mg, n = 70; vibegron 100 mg, n = 77; placebo, n = 78) were analyzed. Vibegron 50 mg and 100 mg significantly improved the change in micturition number per 24 hours from baseline to week 12. Compared to those of patients receiving a placebo, all other endpoints of urinary parameters were significantly improved in patients receiving vibegron, except for nocturia in the vibegron 50 mg group in both populations. In the vibegron 50 mg, vibegron 100 mg, and placebo groups, the proportions of those who attained normalization of UI were stratified by the UUI (51.5%, 57.6%, and 44.7%, respectively) and MUI (40.0%, 41.6%, and 20.5%, respectively) populations. Furthermore, both vibegron doses improved KHQ scores in both populations, and PGI improvement was significantly higher than that in the placebo group in both populations. Conclusion This post hoc analysis demonstrated that vibegron has equivalent efficacy and safety in the MUI and UUI populations. The results of this study provide important information for the treatment of MUI.

Comparative Study on the Effectiveness, Safety, and Economic Costs of Endoscopic Submucosal Dissection for Colorectal Tumors Under Conscious Sedation and General Anesthesia.

Endoscopic submucosal dissection (ESD) is a minimally invasive surgical procedure used for en bloc removal of colorectal tumors. Although colorectal ESD is ideally conducted under conscious sedation, it is often performed under general anesthesia because of its complexity and lengthy duration. Currently, there is limited research on colorectal ESD performed under conscious sedation. The purpose of this study was to evaluate the effectiveness, safety, and economic cost of colorectal ESD under conscious sedation compared to general anesthesia. Retrospective analysis of 301 patients who underwent ESD treatment for colorectal tumors at the Endoscopy Center of Peking University Cancer Hospital from January 2018 to November 2020. Patients were divided into the sedation group (group S, n=88) and the general anesthesia group (group A, n=213) based on the anesthetic method. To balance the confounding factors between the 2 groups, 75 matched pairs were obtained after using propensity score matching (PSM). Intraoperative and postoperative parameters were then compared between the matched groups. After PSM, there was no statistically significant difference between group S and group A in terms of the surgical time, en bloc resection rate, and complete resection rate. There was also no statistically significant difference in the occurrence rates of bleeding, perforation, and post-ESD electrocoagulation syndrome (PEECS) between the 2 groups. However, the length of hospital stay was significantly shorter in group S (1.23±0.89d) than in group A (5.92±3.05d) ( P <0.05). The hospitalization costs were also significantly lower in group S (16482.34±13154.32 yuan) compared with group A (34743.74±13779.40 yuan) (P < 0.05 ). Compared to general anesthesia, performing ESD for colorectal tumors under conscious sedation has equivalent effectiveness and safety while shortening the hospital stay and reducing the economic costs.

Dispersion and explosion characteristics of multi-phase fuel with different charge structure

The fuel dispersion and explosion laws are important for safety design of fuel charge, concentration prediction of accidental release vapor cloud and prevention of fire and explosion accidents. The charge structure is an important factor in determining the fuel dispersion and explosion performance. Experiments and numerical simulations are carried out for cylindrical, square and fan-shaped charge structures. The dispersion process, concentration distribution, explosion overpressure, component reaction and safety radius of 11 kg solid-liquid-gas propylene oxide (PO) are obtained. The results show that square and fan-shaped structure have local enhancement effect. Compared with cylindrical structure, the dispersion distance of square at 0° and fan-shape at 45° increase by 10.13 % and 14.39 % respectively. The peak overpressure increased by 8.85 % and 4.73 %. At 4 m, the remaining fuel of the three structures is 39.13 %, 22.34 % and 17.20 %, respectively. The equivalent safety radius is 14.20 m, 14.80 m and 14.27 m respectively.

Safety and efficacy of the Tao facemask for positive pressure ventilation in morbidly obese patients

Purpose: Positive-pressure mask ventilation is an essential skill for individuals providing basic and advanced airway interventions in a variety of clinical settings. The C-E grip technique is most commonly used with standard facemasks to provide an effective seal that allows for positive pressure ventilation. The Tao mask is a novel facemask that utilises an ergonomic grip by using downwards pressure of the palm of the hand accompanied by midline jaw lift. Specifically, the technique to create a seal involves downwards pressure of the palm centred on the mask accompanied by a jaw lift with four fingers centred under the mandible. A previous comparison between the Tao and standard masks revealed superior performance across a cross-section of average patients. The purpose of this study was to evaluate the safety and effectiveness of the Tao mask compared to the standard mask in a subset of patients with morbid obesity as defined by a body mass index (BMI) greater than or equal to 40 kg/m2. Methods: This prospective crossover trial included 156 patients aged ⩾18 years at the Medical University of South Carolina who were scheduled for elective surgery under general endotracheal anaesthesia with a BMI of ⩾40 kg/m2 at the time of surgery. After the induction of general anaesthesia, but prior to the administration of a neuromuscular blocking drug (NMBD), each patient was ventilated with both the standard and Tao masks, and effectiveness was measured using both the Han and Warters scales. The process was repeated after the administration of an NMBD. Results: Data were collected and analysed from 153 individuals. The mean BMI was 50.7 ± 9.3 kg/m2. The Tao mask ventilation scores were significantly lower (more effective) than the standard mask scores on both the Han and Warters Scales before pre-NMBD ( p = 0.0002 and p &lt; 0.001, respectively) and after post-NMBD ( p = 0.002 and p &lt; 0.001, respectively). On the Warters Scale, it was significantly easier to ventilate with the Tao Mask pre-NMBD ( p = 0.0001). On the Han Scale, the Tao mask was significantly easier than the standard mask post-NMBD ( p = 0.03). With regard to mask sequence, the mean Warters scores were lower for the Tao mask pre-NMBD only when the standard mask was used first ( p = 0.002). Similarly, the difference in the mean Warters scores post-NBMD was significant only when the standard mask was used first ( p = 0.02). Conclusion: The Tao mask demonstrated equivalent safety and superior effectiveness in ventilating morbidly obese surgical patients despite a trial design that favoured the standard mask owing to anaesthetist experience. The use of the Tao mask may be particularly beneficial in clinical situations involving inexperienced operators or in patients for whom mask ventilation is likely to be difficult. ClinicalTrials.gov registration number: NCT03473366

The comparison of erector spinae plane block and caudal block for postoperative analgesia in paediatric surgery - meta-analysis.

To assess the efficacy of Erector Spinae Plane Block (ESPB) compared to caudal block in reducing postoperative pain in paediatric surgery. An electronic literature search was conducted using the Cochrane Library, PubMed, and Google Scholar databases, with data collected from January 2018 until September 2023. This meta-analysis includes English-language randomized controlled trials (RCTs) studies contrasting ESPB with caudal block in paediatric patients. The primary outcome was the 24-hour post-operative pain scores. The secondary outcome included the time to rescue analgesia, the number of patients requiring rescue analgesia, and the occurrence of post-operative nausea and vomiting (PONV) and urinary retention. Five RCTs with 295 samples were included. The results showed no significant difference between ESPB and caudal block in postoperative pain scores at 1st hour SMD (standardized mean difference) of -0.17 (95% CI -0.70, 0.36; I2=76%; p= 0.53), 2nd hour of SMD: -0.50 (95% CI -1.21, 0.21; I2=88%; p=0.17), 6th hour SMD -1.09 (95% CI -2.21, 0.03; I2=95%; p = 0.06), 12th hour SMD -0.77 (95% CI -1.75, 0.21; I2=93%; p=0.12), and the 24th hour SMD -0.13 (95% CI -0.39, 0.12;, I2=2%; p=0.30) were found. Furthermore, there was no significant difference in the time first to rescue analgesia, the number of patients requiring analgesia rescue, PONV occurrence, and urinary retention. ESPB and caudal block showed equivalent analgesia efficacy and safety in paediatric surgery.

630. ENDOSCOPIC MANAGEMENT OF DELAYED-GASTRIC-EMPTYING AFTER ESOPHAGECTOMY IN A TERTIARY REFERRAL CENTER: COMPARISON BETWEEN DIFFERENT ENDOSCOPIC PROCEDURES

Abstract Background Delayed Gastric Emptying (DGE) after Esophagectomy with a gastric conduit is a complication that occurs in 15-39% of patients. It is associated with short and long-term complications and with a poor quality of life. Intra-Pyloric Injection of Botulinum Toxin (BT), Pyloric Pneumatic Dilation (PD), and combination of these two techniques (BTPD) in the same session, represent the main endoscopic procedures, but comparative data are currently unavailable. Methods We retrospectively analyzed prospectively collected data on all consecutive patients with DGE after esophagectomy endoscopically treated from December 2018 to November 2023. DGE was classified based on the onset time (early/late), and the Gastric Outlet Obstruction Score (GOOS) was used for clinical staging. All BT patients received 200UI of toxin, while those PD patients have been dilated up to 20mm. Technical success (TS) was defined as the completion of the procedure, clinical success (CS) as achieving a GOOS of ≥2, and recurrence as the need for endoscopic/surgical treatment in patients who achieved CS. Adverse events (AEs) were classified using the AGREE classification. Results 34 patients (82.4% male, 94.1% Ivor-Lewis, divided as follow: 13 (38.2%)BTPD-group, 12 (35.3%)BT-group and 9(26.5%)PD-group. Median follow-up was of 170 days (IQR 67-604), with no differences between the three groups. No statistically significant differences were found in the baseline characteristics among the three groups (e.g.surgical pyloromyotomy, neoadjuvant treatments). Despite identical TS (100%), BT-group exhibited a higher rate of clinical failure (25%) compared to the other groups (p=0.03). No difference in the recurrence rate was observed between the three groups (p=0.47). Dysfunction analysis showed that BTPD-group was characterized by a significatively shorter median time to refeeding of 1 day (IQR 1) compared to the other two groups (log-rank test p=0.0051). No AEs procedures related were recorded. Conclusions Our study reveals that BT is associated with a considerable rate of clinical failure, and that the combined BTPD treatment may offer a more rapid clinical success, maintaining an equivalent safety profile. Further prospective studies are needed to validate these findings.

Simultaneous Bilateral Total Hip Arthroplasty With Either the Direct Anterior or Posterior Approaches: A Propensity Score Match Study

BackgroundBilateral hip osteoarthritis is evident in approximately 20% of patients who present to the clinic for evaluation of hip pain, and for those undergoing total hip arthroplasty (THA), 22% will end up needing a contralateral THA. The risk and benefits of simultaneous bilateral total hip arthroplasty (SBTHA) versus staged bilateral THA procedures have been well studied, demonstrating equivalent safety profiles comparable to unilateral and SBTHA. However, the influence of the surgical approach on SBTHA on postoperative outcomes remains unclear. We sought to compare perioperative outcomes and complication rates between the direct anterior approach (DAA) and posterior approach (PA) in patients undergoing SBTHA. MethodsWe performed a 1:1 propensity score match based on age, sex, and body mass index. A total of 252 patients were available after matching, 126 patients in the DAA group and 126 in the PA group. Perioperative outcomes as well as surgical complications at the latest follow-up were retrospectively collected for each group. The mean follow-up was 36.7 months (range, 12.5 to 74.4). ResultsA SBTHA with DAA had significantly shorter surgical time (P < 0.001), anesthesia time (P < 0.001), and length of stay (P < 0.001), compared to the PA. A greater percentage of patients in the DAA group (91%) were discharged home compared to the PA group (57%) (P < 0.001). There were no differences in in-hospital complications (P = 0.617), 90-day complications (P = 0.605), or reoperation rates (P = 0.309) between surgical approaches. ConclusionsA SBTHA, either through the DAA or PA, can be safely performed with low complication rates. The DAA in the setting of SBTHA provides shorter surgical times, a shorter length of stay, and a greater percentage of patients discharged home.

Graft choice in pancreatectomy with vascular resection: equivalent safety in selected patients

BackgroundPancreatic cancer is the third leading cause of cancer-related death in the United States, with surgical resection being the only option for long-term survival. The ability to manage vascular involvement has expanded the pool of patients who are able to undergo resection with curative intent. However, not all vascular involvements can be detected preoperatively. This study aimed to investigate the patterns of vascular resection and methods of repair or reconstruction MethodsThis was a single-center retrospective review of adult patients undergoing pancreatectomy with vascular involvement at a tertiary care referral hospital between 2010 and 2022. The primary endpoint was graft thrombosis within 90 days. ResultsA total of 147 patients were included in the study. Of note, 21.8% of patients were not suspected of having vascular involvement preoperatively. Moreover, 68.0% of patients required vascular reconstruction, whereas the remaining 32.0% of patients underwent repair (either primary repair or patch angioplasty). Most patients who underwent reconstruction underwent primary end-to-end anastomosis (63.0%), with 19 patients requiring autologous interposition grafts and 16 patients requiring CryoVein interposition grafts. Univariate analysis found no clinical or technical predictors of early or 90-day thrombosis, including graft choice. In addition, 30- and 90-day mortalities occurred in 1 and 7 patients, respectively. ConclusionPancreatectomy with vascular resection can be performed with low mortality in carefully selected patients. Unsuspected vascular involvement is relatively common (1 in 5). If autologous graft is not readily available, CryoVein is a safe alternative with similar perioperative outcomes.

Is Next-day Discharge Safe After Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis?

While the implementation of enhanced recovery after surgery protocols and improvements in pain control have decreased the length of stay (LOS) after scoliosis surgery, adolescents are typically hospitalized for several days after posterior spinal instrumented fusion (PSF). The purpose of this study was to determine whether next-day discharge after PSF for adolescent idiopathic scoliosis (AIS) had an equivalent safety profile compared with longer LOS. The secondary purpose was to examine perioperative factors associated with next-day discharge. We performed a retrospective study of all patients who underwent PSF for AIS at a single institution from 2017 to 2022. We compared patients based on postoperative LOS with an early discharge group consisting of those who were discharged on the first postoperative day 1 (POD1; n = 40) and a standard discharge group consisting of those who were discharged after POD1 (n = 71). We documented preoperative variables, including patient demographics and curve characteristics, intraoperative variables, including levels fused, implant density, operative time, and blood loss, and postoperative variables, including emergency department (ED) visits within 30 days and hospital readmissions within 90 days. One hundred eleven patients were included with a mean curve magnitude of 67 degrees. Forty patients (36%) were discharged on POD1. There were one (3%) ED visit and 2 (5%) readmissions in the early discharge group and 3 (4%) ED visits and 2 (3%) readmissions in the standard discharge group (P = 0.64 and 0.55, respectively). Patients in whom intravenous methadone was used intraoperatively were more likely to discharge POD1 (P = 0.02). There were no other significant differences in perioperative variables between the two groups including: BMI, distance from home to hospital, magnitude of main curve, curve flexibility, number of levels fused, estimated blood loss, implant density, operative time, or postoperative pain scores. Next-day discharge after PSF for AIS has an equivalent safety profile compared with longer LOS. Over one-third of patients were discharged on POD1, and there was no statistically significant difference in ED visits or hospital readmissions between the groups. Patients in whom intravenous methadone was used intraoperatively were more likely to discharge POD1. In a retrospective study of posterior spinal fusions for AIS, we found no increase in ED visits or hospital readmissions for those discharged the next day. Level III.

Revisiting the Posterior Approach for Cervical Radiculopathy Utilizing Endoscopic Techniques: A Favorable Short-Term Outcome and Cost Comparison With Anterior Cervical Discectomy and Fusion.

Cervical radiculopathy is a spine ailment frequently requiring surgical decompression via anterior cervical discectomy and fusion (ACDF) or posterior foraminotomy/discectomy. While endoscopic posterior foraminotomy/discectomy is gaining popularity, its financial impact remains understudied despite equivalent randomized long-term outcomes to ACDF. In a cohort of patients undergoing ACDF vs endoscopic posterior cervical foraminotomy/discectomy, we sought to compare the total cost of the surgical episode while confirming an equivalent safety profile and perioperative outcomes. A single-center retrospective cohort study of patients with unilateral cervical radiculopathy undergoing ACDF or endoscopic cervical foraminotomy between 2018 and 2023 was undertaken. Primary outcomes included the total cost of care for the initial surgical episode (not charges or reimbursement). Perioperative variables and neurological recovery were recorded. Multivariable analysis tested age, body mass index, race, gender, insurance type, operative time, and length of stay. A total of 38 ACDF and 17 endoscopic foraminotomy/discectomy operations were performed. All patients underwent single-level surgery except for 2 two-level endoscopic decompressions. No differences were found in baseline characteristics and symptom length except for younger age (46.8 ± 9.4 vs 57.6 ± 10.3, P = 0.002) and more smokers (18.4% vs 11.8%, P = 0.043) in the ACDF group. Actual hospital costs for the episode of surgical care were markedly higher in the ACDF cohort (mean ±95% CI; $27,782 ± $2011 vs $10,103 ± $720, P < 0.001) driven by the ACDF approach (β = $17,723, P < 0.001) on multivariable analysis. On sensitivity analysis, ACDF was never cost-efficient compared with endoscopic foraminotomy, and endoscopic failure rates of 64% were required for break-even cost. ACDF was associated with significantly longer operative time (167.7 ± 22.0 vs 142.7 ± 27.4 minutes, P < 0.001) and length of stay (1.1 ± 0.5 vs 0.1 ± 0.2 days, P < 0.001). No significant difference was found regarding 90-day neurological improvement, readmission, reoperation, or complications. Compared with patients treated with a single-level ACDF for unilateral cervical radiculopathy, endoscopic posterior cervical foraminotomy/discectomy can achieve a similar safety profile, pain relief, and neurological recovery at considerably less cost. These findings may help patients and surgeons revisit offering the posterior cervical foraminotomy/discectomy utilizing endoscopic techniques. Endoscopic posterior cervical foraminotomy/discectomy offers comparable safety, pain relief, and neurological recovery to traditional methods but at a significantly lower cost.

A stochastic constitutive model and its application to HTPB propellant

AbstractTo address the issue of randomness in the mechanical properties of the hydroxyl‐terminated polybutadiene (HTPB) propellant, a stochastic constitutive model (SCM) with a lognormally distributed random parameter Λ was proposed to describe their mechanical behaviors, and the structural integrity of a HTPB propellant grain was analyzed based on it. The results indicate that the stress‐strain curves predicted by the SCM have a good agreement with the experimental curves, and the experimental curves fall within a 95 % probability interval predicted by the SCM. The mechanical response of HTPB propellant grain under ignition pressurization is associated with the random parameters Λ. The maximum equivalent stress and safety factor increase approximately linearly with the increase of random parameters Λ, while the maximum equivalent strain and maximum damage coefficient decrease approximately linearly with the increase of random parameters Λ. The error in the mechanical response of the grain obtained based on the SCM and the experimental constitutive model is basically not more than 2 %, the SCM can effectively characterize the randomness in the mechanical response of propellant grain caused by the dispersion of HTPB propellant mechanical properties.

Safety Profile Comparison of 2 Smooth Tissue Expander Types: Artoura and CPX4.

With the recent transition to smooth tissue expanders (TEs), functional differences between TE subtypes have not been fully elucidated. This study evaluated the differences in TE characteristics and complications between 2 commonly used Mentor smooth TE models, Artoura and CPX4. A retrospective review of patients who received either smooth Mentor Artoura or CPX4 TE from 2012 to 2022 was conducted. Demographic data, perioperative information, pain scores, TE variables, cancer characteristics, and complications were collected. A multivariate analysis was used to evaluate the relationship between TE subtype and complications while controlling for demographic, TE characteristics, radiation, and chemotherapy exposure. During the study period, 62 smooth Artoura TEs and 79 smooth CPX4 TEs were used. Patients who received CPX4 smooth implants tended to be older (51.09 vs 46.18 years old, P = 0.02) and have a higher body mass index (28.66 vs 23.50 kg/m 2 , P < 0.001). There were no differences among patient comorbidities. CPX4 required on average a greater total fill volume (422.23 vs 348.07 mL, P = 0.01) and had a greater drain duration (16.91 vs 14.33 days, P = 0.05). There were no differences in TE plane placement between Artoura and CPX4. Additionally, there were no differences in complication rates, including infection, hematomas, seromas, wound breakdown, TE replacement, and capsular contracture. When controlling for body mass index, diabetes, TE plane placement, acellular dermal matrix use, radiation exposure, and chemotherapy, there was no association between TE subtype and any individual complication. Differences in total fill volume and drain duration were significantly different between Mentor Artoura and CPX4 implants, which may influence TE subtype selection. However, Artoura and CPX4 have excellent and equivalent safety profiles with similar complication rates, even when controlling for demographic and TE characteristics.

A Prospective, Randomized, Controlled Clinical Investigation Comparing the Efficacy and Safety of Sodium Hyaluronate-Based Ophthalmical Viscosurgical Devices FIDIAL PLUS and IAL®-F in Cataract Surgery.

Purpose: To protect the corneal endothelium, various ophthalmical viscoelastic devices (OVDs) are used during cataract surgery. In this study, we compared two sodium hyaluronate-based OVD, the bacteria-derived FIDIAL PLUS OVD (test) with the animal-derived IAL®-F OVD (reference) during the surgical procedure. Methods: Fifty patients with bilateral cataract participated in the study: 50 eyes randomly received FIDIAL PLUS and 50 eyes received IAL®-F (ratio 1:1). Noninferior efficacy of FIDIAL PLUS compared with reference OVD (first objective) was evaluated using a paired t-test comparing the mean percent loss of corneal endothelial cells (CECs) with FIDIAL PLUS against the mean percent loss with IAL®-F. Corneal endothelial protection during cataract surgery with FIDIAL PLUS without significant (≥30 mmHg) postoperative intraocular pressure (IOP) increase (main secondary objective) was assessed using a repeated measures logistic model comparing the incidence of significant postoperative IOP elevation between the two groups. Safety, tolerability, and efficacy were also evaluated by assessing secondary endpoints before and after surgery. Results: FIDIAL PLUS showed a statistically noninferior efficacy compared with IAL®-F; there was no significant increase in IOP in either group or different trends of the secondary endpoints were observed between the OVD groups. The safety profile was similar in both OVD groups and no adverse device effects were reported. Conclusions: This study demonstrates the equivalent efficacy, tolerability, and safety of the bacteria-derived FIDIAL PLUS compared with the animal-derived IAL®-F, confirming the clinical value of this product.

Which Is More Suitable for First-Line Treatment of Extensive-Stage Small Cell Lung Cancer, PD-L1 Inhibitors Versus PD-1 Inhibitors? A Systematic Review and Network Meta-Analysis.

In this network meta-analysis (NMA), the efficiency and safety of PD-1 inhibitors + chemotherapy and PD-L1 inhibitors + chemotherapy were compared in the first-line therapy of patients with extensive-stage small cell lung cancer (ES-SCLC). We searched research databases, conference abstracts, and trial registries and subsequently chose relevant studies and extracted dates. The NMA was conducted to estimate the efficiency and safety of the PD-1 inhibitors + chemotherapy and PD-L1 inhibitors + chemotherapy on overall survival (OS), progression-free survival (PFS), overall remission rate (ORR), and adverse events (AEs). Studies were assessed for quality. Subgroup analyses were used to evaluate study heterogeneity. We included six randomized trials with a total of 3163 patients. Direct comparisons showed that patients who received either PD-1 inhibitors + chemotherapy (HR: 0.71, 95% CI: 0.57-0.87) or PD-L1 inhibitors + chemotherapy (HR: 0.74, 0.61-0.89) demonstrated significantly longer OS than those who received placebo + chemotherapy. The results of the NMA showed that no significant differences in OS (HR 0.96 95% CI: 0.72-1.3), PFS (HR 0.83, 95% CI: 0.51-1.4), and ORR (OR 1.3 95% CI: 0.66-2.5) were observed for PD-1 inhibitors + chemotherapy compared with PD-L1 inhibitors + chemotherapy, but the Bayesian ranking revealed that patients receiving PD-1 inhibitors + chemotherapy tended to have longer OS, PFS benefit, and better treatment response than patients receiving PD-L1 inhibitors + chemotherapy. In terms of safety, no significant difference was observed in their safety profiles. In comparison to placebo + chemotherapy, PD-L1 inhibitors + chemotherapy and PD-1 inhibitors + chemotherapy significantly improved survival for ES-SCLC. According to the available data, PD-L1 inhibitors + chemotherapy and PD-1 inhibitors + chemotherapy had equivalent efficacy and safety; however, the level of evidence of this type of comparison is limited.

Effect of cetuximab plus FOLFOX4 regimen on clinical outcomes in advanced gastric carcinoma patients receiving evidence-based care

BACKGROUND Although chemotherapy is effective for treating advanced gastric carcinoma (aGC), it may lead to an adverse prognosis. Establishing a highly effective and low-toxicity chemotherapy regimen is necessary for improving efficacy and outcomes in aGC patients. AIM To determine the efficacy and safety of cetuximab (CET) combined with the FOLFOX4 regimen (infusional fluorouracil, folinic acid, and oxaliplatin) as first-line therapy for patients with aGC, who received evidence-based care (EBC). METHODS A total of 117 aGC patients who received EBC from March 2019 to March 2022 were enrolled. Of these, 60 in the research group (RG) received CET + FOLFOX4 as first-line therapy, whereas 57 in the control group (CG) received FOLFOX4. The efficacy [clinical response rate (RR) and disease control rate (DCR)], safety (liver and kidney dysfunction, leukopenia, thrombocytopenia, rash, and diarrhea), serum tumor marker expression [STMs; carbohydrate antigen (CA) 19-9, CA72-4, and carcinoembryonic antigen (CEA)], inflammatory indicators [interleukin (IL)-2 and IL-10], and quality of life (QOL) of the two groups were compared. RESULTS A markedly higher RR and DCR were observed in the RG compared with the CG, with an equivalent safety profile between the two groups. RG exhibited notably reduced CA19-9, CA72-4, CEA, and IL-2 levels following treatment, which were lower than the pre-treatment levels and those in the CG. Post-treatment IL-10 was statistically increased in RG, higher than the pre-treatment level and the CG. Moreover, a significantly improved QOL was evident in the RG. CONCLUSION The CET + FOLFOX4 regimen is highly effective as first-line treatment for aGC patients receiving EBC. It facilitates the suppression of STMs, ameliorates the serum inflammatory microenvironment, and enhances QOL, without increased adverse drug effects.

Magnetic sphincter augmentation: A promising alternative to fundoplication for preserving lung function and protecting against chronic lung transplant rejection

BackgroundEarly laparoscopic fundoplication (LF) has been shown to slow lung function decline in chronic lung disease (CLD) patients and lung transplant (LTx) recipients. Magnetic sphincter augmentation (MSA) has emerged as an effective minimally invasive alternative to LF for the treatment of GERD. We evaluate the safety and efficacy of MSA compared to LF for GERD in CLD and LTx. MethodsA retrospective review identified CLD and LTx patients undergoing LF or MSA for GERD. Primary outcome was change in percent predicted FEV1. Secondary outcomes were 30d morbidity, mortality, operative time, and length of stay (LOS). Results77 patients met inclusion criteria, 45 (58.5 %) were LTx recipients. 35 (45.5 %) underwent Nissen, 23 (29.9 %) underwent Toupet, and 19 (24.7 %) underwent MSA. Average age was 54.2 years, 54.5 % were female, and average BMI at ARS was 24.9 kg/m2. Median FEV1 % change between pre-ARS and post-ARS was 0 % with no significant differences between groups. MSA had faster operative times at 50.5 min than Nissen (83.5 min, p = 0.002) and Toupet (72.6 min, p = 0.003) and shorter LOS at 0.8 days than Nissen (3.7 days, p = 0.002) and Toupet (2.1 days, p = 0.0008). MSA and Nissen had higher reintervention rates than Toupet, though this was not statistically significant. There were no differences in 30-day morbidities or 30-day ED visits between groups. There were no mortalities. ConclusionMSA is an advantageous alternative to LF in the CLD and LTx population with stabilization of percent predicted FEV1, equivalent safety profile, shorter operative times, and shorter length of hospital stay.

Comparing the effectiveness of AR training and slide-based training: The case study of metro construction safety

Metro construction poses significant risks and is prone to severe safety accidents. Safety training is critical to mitigate risks and reduce the number of accidents, as it allows workers to enhance their skills in risk identification, risk assessment, and risk response and ultimately reduce accidents. However, traditional training methods used today, such as slide presentations, videos, or text-based materials, provide a passive learning environment, which can limit their effectiveness in knowledge transfer. Augmented Reality (AR) has emerged as a promising tool for training, allowing trainees to have an active learning environment. Nevertheless, research on assessing the effectiveness of AR safety training while comparing it with traditional methods is still limited. This study aims to compare the short-term and long-term effects on objective performance measures and subjective evaluations of both traditional and AR training. This is done by developing a new AR safety training for metro construction and comparing it with an equivalent slide-based safety training with 72 participants divided into two training groups. The selected safety case study covers the entire safety risk management process, including risk identification, risk assessment, and risk response. Results indicate that AR training is more effective than traditional training in terms of short-term knowledge acquisition of risk identification and long-term knowledge retention of risk identification, risk assessment, and risk response. These findings can have implications for the design of future safety training guidelines and recommendations.

Comparative analysis of pulsed-field and cryoballoon ablation in octogenarians with atrial fibrillation: a multicenter study

Abstract Background The prevalence of atrial fibrillation (AF) increases with advancing age, and AF contributes to higher rates of stroke, dementia, heart failure, and mortality. Catheter ablation is recognized as an effective treatment for AF; however, data regarding its efficacy in octogenarians are limited. Cryoballoon ablation (CBA) has been reported to be safe and effective in this age group. Recently, single-shot devices using pulsed-field energy have been developed, offering a tissue-specific effect. However, data on the safety and effectiveness of this novel pulsed-field ablation (PFA) in octogenarians are still insufficient. Purpose This study aims to evaluate the procedural outcomes and complications of PFA in octogenarians with AF, in comparison to CBA, from 3 high-volume European centers. Methods We retrospectively enrolled patients who underwent PFA via the FarapulseTM system from January 2022 to June 2023, and those who underwent second-generation CBA from January 2015 to June 2023. Results A total of 176 patients (PFA group: 63, CBA group: 113) were included. The PFA group had a higher proportion of patients with persistent AF (p=0.03) and undergoing a repeat procedure (p&amp;lt;0.01). (Table 1) Unlike CBA, PFA procedures involved additional extrapulmonary targets, such as posterior wall and mitral isthmus. Nonetheless, procedure time was similar between groups. There were no significant differences in complications but phrenic nerve palsy was not observed in the PFA group (Table 2). Conclusions PFA for octogenarians provides the possibility to target additional extrapulmonary sites with equivalent procedural times and safety compared to CBA, without the concern of phrenic nerve palsy.Table 1Table 2