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Active Compared With Passive Voiding Trials After Midurethral Sling Surgery: A Systematic Review
No full textOBJECTIVE: To compare active with passive voiding trials on the rate of passing a trial of void and discharge rates with catheter in women who have undergone midurethral sling for treatment of stress urinary incontinence (SUI). DATA SOURCES: MEDLINE, EMBASE, and ClinicalTrials.gov were searched through February 24, 2023. METHODS OF STUDY SELECTION: Our population included women undergoing midurethral sling, with or without anterior or posterior repair, for treatment of SUI. Our two primary outcomes were rate of passing voiding trial and rate of discharge with a catheter. Our secondary outcome was the rate of delayed postoperative urinary retention, when a patient initially passes a trial of void but then subsequently presents in retention. TABULATION, INTEGRATION, AND RESULTS: Abstracts were doubly screened; full-text articles were doubly screened; and accepted articles were doubly extracted. In single-arm studies evaluating either passive or active voiding trial, random-effects meta-analyses of pooled proportions were used to assess outcomes. Of 3,033 abstracts screened, 238 full-text articles were assessed, and 26 met inclusion criteria. Ten studies including 1,370 patients reported active trial of void. Sixteen studies including 3,643 patients reported passive trial of void. We included five randomized controlled trials, five comparative retrospective studies, five prospective single group studies, and 11 retrospective single group studies. Five of the studies included patients with a concomitant anterior or posterior colporrhaphy. On proportional meta-analysis, the active trial of void group was less likely to pass the voiding trial (81.0%, 95% CI, 0.76-0.87% vs 89.0%, 95% CI, 0.84-0.9%3, P =.029) with high heterogeneity ( I2 =93.0%). Furthermore, there were more discharges with catheter in active trial of void compared with passive trial of void (19.0%, 95% CI, 0.14-0.24% vs 7.0%, 95% CI, 0.05-0.10%, P \u3c.01). The rates of delayed postoperative urinary retention were low and not different between groups (0.6%, 95% CI, 0.00-0.02% vs 0.2%, 95% CI, 0.00-0.01%, P =.366) with low heterogeneity ( I2 =0%). Sling revisions were statistically lower in the active trial of void group (0.5%, 95% CI, 0.00-0.01% vs 1.5%, 95% CI, 0.01-0.02%, P =.035) with low heterogeneity ( I2 =10.4%). CONCLUSION: Passive trial of void had higher passing rates and lower discharge with catheter than active trial of void. Rates of most complications were low and similar between both groups, although passive trial of void had higher sling revisions. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42022341318
Obesity as a Risk Factor for Adverse Outcomes After Pedestrian Trauma Accidents in the Pediatric Population
No full textOBJECTIVE: The aim of the study is to determine whether overweight or obese children are at an increased risk for injury and adverse outcomes following pedestrian motor vehicle accidents. METHODS: We performed a retrospective study of patients between the ages of 2 and 17 who were pedestrians injured in a collision with a motorized vehicle, presenting to a level 1 trauma center, between January 1, 2010, to December 31, 2021. Patients with admission weights falling above the 90th percentile of the Centers for Disease Control and Prevention\u27s sex-specific growth charts were identified as overweight/obese, those below the cutoff were categorized as nonobese. Groups were compared regarding demographics, mechanism of injury, Injury Severity Score, and Abbreviated Injury Scale by body region of injury. Outcome measures included hospital admission, length of hospital stay, intensive care unit (ICU) admission, ICU length of stay, and mortality. RESULTS: Of the 306 patients included, 72 (23.5%) were overweight/obese and 234 (76.5%) were nonobese. The mean Injury Severity Score scores were higher among overweight/obese patients (5.37 vs 8.74, P = 0.008). Overweight/obese children were more likely to sustain severe abdominal injuries (Abbreviated Injury Scale ≥ 3) (12.2% vs 5.1%; odds ratio [OR], 2.64; 95% CI, 1.07-6.56; P = 0.030), be admitted to the hospital (94.5% vs 74.3%; OR, 12.07; 95% CI, 2.87-50.72; P \u3c 0.001), require ICU admission (31.0% vs 20.0%, OR, 1.87; 95% CI, 1.03-3.36; P = 0.036), and require a longer ICU stay (0.9 vs 0.4 days, P = 0.014) compared with nonobese patients. CONCLUSIONS: Obese and overweight children are at increased risk for higher injury severity scores, severe abdominal injuries, and ICU admission after pedestrian motor vehicle accidents
Trainee Perspectives Regarding the Effect of the Dobbs V. Jackson Women\u27s Health Organization Supreme Court Decision on Obstetrics and Gynecology Training
No full textWe aimed to describe obstetrics and gynecology (OBGYN) trainees\u27 anticipation of how the Dobbs v. Jackson Women\u27s Health Organization (Dobbs) U.S. Supreme Court decision may affect their training. A REDCap survey of OBGYN residents and fellows in the United States from September 19, 2022, to December 1, 2022, queried trainees\u27 anticipated achievement of relevant Accreditation Council for Graduate Medical Education (ACGME) training milestones, their concerns about the ability to provide care and concern about legal repercussions during training, and the importance of OBGYN competence in managing certain clinical situations for residency graduates. The primary outcome was an ACGME program trainee feeling uncertain or unable to obtain the highest level queried for a relevant ACGME milestone, including experiencing 20 abortion procedures in residency. We received 469 eligible responses; the primary outcome was endorsed by 157 respondents (33.5%). After correction for confounders, significant predictors of the primary outcome were state environment (aOR = 3.94 for pending abortion restrictions; aOR = 2.71 for current abortion restrictions), trainee type (aOR = 0.21 for fellow vs. resident), and a present or past Ryan Training Program in residency (aOR = 0.55). Although the vast majority of trainees believed managing relevant clinical situations are key to OBGYN competence, 10%-30% of trainees believed they would have to stop providing the standard of care in clinical situations during training. This survey of OBGYN trainees indicates higher uncertainty about achieving ACGME milestones and procedural competency in clinical situations potentially affected by the Dobbs decision in states with legal restrictions on abortion
In-Hospital Outcomes of Combined Coronary Revascularization and Transcatheter Aortic Valve Implantation in Inpatient Nationwide Analysis
No full textTranscatheter aortic valve implantation (TAVI) is accepted as an alternative to surgery, but data on combined percutaneous coronary interventions (PCI) and TAVI during the same in-hospital stay are still lacking. Using the national inpatient sample (NIS) database, we identified all TAVI encounters and compared in-hospital outcomes of patients who had TAVI only to patients who had TAVI and PCI. We used multivariable logistic regression analysis to calculate the adjusted odds ratio (aOR). Of 291,810 patient encounters with TAVI, 13,114 (4.5%) had combined PCI during the same index admission. The average age was 79.61 ± 8.61 years in the TAVI-only vs 80.25 ± 8.73 years in the combined TAVI-PCI group. Combined TAVI and PCI was associated with higher in-hospital mortality (4.5% vs 1.8%, aOR: 2.3), stroke (4.7% vs 2.9%, aOR: 1.4), net adverse events (NAE) (20.2% vs 5.7%, aOR: 3.6), major bleeding (40.1% vs 24.3%, aOR: 1.8), vascular complications (10.6% vs 2.5%, aOR: 3.9), acute kidney injury (AKI) (23.3% vs 11.7%, aOR: 2.1), hemodialysis (HD) (4.2% vs 2.4%, aOR: 1.4), postoperative cardiogenic shock (1.2% vs 0.4%, aOR: 2.8), need for mechanical circulatory support (6.9% vs 1%, aOR: 7); p-value \u3c 0.001 for all. The utilization of permanent pacemakers was similar between the groups (9.8% vs 9.2%, aOR: 1; p = 0.6). Combining TAVI and PCI during the same index admission is associated with worse outcomes. The decision to do PCI for patients undergoing TAVI should be individualized and tailored based on the patient\u27s clinical conditions
Design of the Hpv-Automated Visual Evaluation (Pave) Study: Validating a Novel Cervical Screening Strategy
No full textBACKGROUND: The HPV-automated visual evaluation (PAVE) Study is an extensive, multinational initiative designed to advance cervical cancer prevention in resource-constrained regions. Cervical cancer disproportionally affects regions with limited access to preventive measures. PAVE aims to assess a novel screening-triage-treatment strategy integrating self-sampled HPV testing, deep-learning-based automated visual evaluation (AVE), and targeted therapies. METHODS: Phase 1 efficacy involves screening up to 100,000 women aged 25-49 across nine countries, using self-collected vaginal samples for hierarchical HPV evaluation: HPV16, else HPV18/45, else HPV31/33/35/52/58, else HPV39/51/56/59/68 else negative. HPV-positive individuals undergo further evaluation, including pelvic exams, cervical imaging, and biopsies. AVE algorithms analyze images, assigning risk scores for precancer, validated against histologic high-grade precancer. Phase 1, however, does not integrate AVE results into patient management, contrasting them with local standard care.Phase 2 effectiveness focuses on deploying AVE software and HPV genotype data in real-time clinical decision-making, evaluating feasibility, acceptability, cost-effectiveness, and health communication of the PAVE strategy in practice. RESULTS: Currently, sites have commenced fieldwork, and conclusive results are pending. CONCLUSIONS: The study aspires to validate a screen-triage-treat protocol utilizing innovative biomarkers to deliver an accurate, feasible, and cost-effective strategy for cervical cancer prevention in resource-limited areas. Should the study validate PAVE, its broader implementation could be recommended, potentially expanding cervical cancer prevention worldwide. FUNDING: The consortial sites are responsible for their own study costs. Research equipment and supplies, and the NCI-affiliated staff are funded by the National Cancer Institute Intramural Research Program including supplemental funding from the Cancer Cures Moonshot Initiative. No commercial support was obtained. Brian Befano was supported by NCI/ NIH under Grant T32CA09168
Landiolol: An Ultra-Short-Acting Β-Blocker
No full textLandiolol is an ultra-short-acting, highly cardio-selective, β-blocker, that is currently approved for clinical use in Japan and the European Union, for the treatment of tachyarrhythmias. Landiolol is highly cardio-selective with high β1 selectivity and receptor affinity, resulting in a more potent chronotropic effect and less potent hypotensive effect compared with other β-blockers such as esmolol and propranolol. Based on the recent randomized controlled trials, low-dose landiolol may have a beneficial role in the prevention and management of postoperative atrial fibrillation following noncardiac and cardiac surgeries, including on-pump and off-pump coronary artery bypass grafting and valve surgery. Additionally, landiolol may have potential utility for myocardial salvage and prevention of postpercutaneous coronary intervention myocardial infarction. Furthermore, the use of landiolol may also have a therapeutic effect for rate control of sepsis-related tachyarrhythmias. Positive results of recent randomized controlled trials should continue to inspire clinicians to conduct further, larger studies, to find new potential clinical applications for this novel drug
Multicenter Evaluation of Mechanical Thrombectomy for Distal Medium Vessel Occlusions With National Institute of Health Stroke Scale Scores ≥ 6 And ≤ 6
No full textBACKGROUND: While mechanical thrombectomy is considered standard of care for large vessel occlusions, scientific evidence to support treatment for distal and medium vessel occlusions remains scarce. PURPOSE: To evaluate feasibility, safety, and outcomes in patients with low National Institute of Health Stroke Scale scores undergoing mechanical thrombectomy for treatment of distal medium vessel occlusions. MATERIALS AND METHODS: Retrospective data review and analysis of prospectively maintained databases at 41 academic centers in North America, Asia, and Europe between January 2017 and January 2022. Characteristics and outcomes were compared between groups with low stroke scale score (≤ 6) versus and higher stroke scale scores (\u3e 6). Propensity score matching using the optimal pair matching method and 1:1 ratio was performed. RESULTS: Data were collected on a total of 1068 patients. After propensity score matching, there were a total of 676 patients included in the final analysis, with 338 patients in each group. High successful reperfusion rates were seen in both groups, 90.2% in ≤ 6 and 88.7% in the \u3e 6 stroke scale groups. The frequency of excellent and good functional outcome was seen more common in low versus higher stroke scale score patients (64.5% and 81.1% versus 39.3% and 58.6%, respectively). The 90-day mortality rate observed in the ≤ 6 stroke scale group was 5.3% versus 13.3% in the \u3e 6 stroke scale group. CONCLUSION: Mechanical thrombectomy in distal and medium vessel occlusions, specifically in patients with low stroke scale scores is feasible, though it may not necessarily improve outcomes over IVT
Preferences for Attributes of Oral Antipsychotic Treatments: Results From a Discrete-Choice Experiment in Respondents With Schizophrenia or Bipolar I Disorder
No full textBACKGROUND: Antipsychotic medications are effective treatments for schizophrenia (SZ) and bipolar I disorder (BD-I), but when presented with different treatment options, there are tradeoffs that individuals make between clinical improvement and adverse effects. As new options become available, understanding the attributes of antipsychotic medications that are valued and the tradeoffs that individuals consider when choosing among them is important. METHODS: A discrete-choice experiment (DCE) was administered online to elicit preferences across 5 attributes of oral antipsychotics: treatment efficacy (i.e., improvement in symptom severity), weight gain over 6 months, sexual dysfunction, sedation, and akathisia. Eligible respondents were aged 18-64 years with a self-reported clinician diagnosis of SZ or BD-I. RESULTS: In total, 144 respondents with SZ and 152 with BD-I completed the DCE. Of those with SZ, 50% identified themselves as female and 69.4% as White, with a mean (SD) age of 41.0 (10.1) years. Of those with BD-I, most identified themselves as female (69.7%) and as White (77.6%), with a mean (SD) age of 40.0 (10.7) years. In both cohorts, respondents preferred oral antipsychotics with better efficacy, less weight gain, no sexual dysfunction or akathisia, and lower risk of sedation. Treatment efficacy was the most important attribute, with a conditional relative importance (CRI) of 31.4% for respondents with SZ and 31.0% for those with BD-I. Weight gain (CRI = 21.3% and 23.1%, respectively) and sexual dysfunction (CRI = 23.4% and 19.2%, respectively) were adverse effects in this study that respondents most wanted to avoid. Respondents with SZ were willing to accept 9.8 lb of weight gain or \u3e 25% risk of sedation for symptom improvement; those with BD-I were willing to accept 8.5 lb of weight gain or a \u3e 25% risk of sedation. CONCLUSIONS: In this DCE, treatment efficacy was the most important attribute of oral antipsychotic medications among respondents with SZ and BD-I. Weight gain and sexual dysfunction were the adverse effects respondents most wanted to avoid; however, both cohorts were willing to accept some weight gain or sedation to obtain better efficacy. These results highlight features that patients value in antipsychotic medications and how they balance benefits and risks when choosing among treatments
The IL-6 Hypothesis in COVID-19: A Phase 2, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Free IL-6 Sequestration by the Monoclonal Antibody Sirukumab in Severe and Critical COVID-19
No full textBACKGROUND: Upregulation of IL-6 has been associated with worse prognosis in COVID-19 patients. Impact on IL-6 signalling has mostly been limited to clinical outcomes in IL-6 receptor antagonist trials. METHODS: We performed a phase 2, randomised, double-blind, placebo-controlled trial (NCT04380961) of US-based hospitalised adults (\u3c85 years) with laboratory-confirmed SARS-CoV-2 infection and severe (low levels of supplemental oxygen) or critical disease (high levels of oxygen supplementation). Patients received sirukumab 5 mg/kg or placebo single dose IV on Day 1 plus standard of care. The primary endpoint was time to sustained clinical improvement up to Day 28 based on an ordinal scale. Secondary endpoints included clinical improvement, all-cause mortality, and safety. Following an interim analysis, the protocol was amended to only recruit patients with critical COVID-19. FINDINGS: From May 2020 to March 2021, 209 patients were randomised; 112 had critical disease (72 sirukumab, 40 placebo) at baseline. Median time to sustained clinical improvement in critical patients was 17 and 23 days in the sirukumab and placebo groups (HR, 1∙1; 95% CI, 0∙66-1∙88; p \u3e 0∙05). At Day 28, 59∙4% versus 55∙0% of patients achieved clinical improvement with sirukumab versus placebo and rates of all-cause mortality were 24∙6% versus 30∙0%, respectively. Rates of grade ≥3 adverse events were comparable between the sirukumab and placebo groups (25∙9% vs 32∙9%; all patients). INTERPRETATION: In critical COVID-19 patients who received sirukumab, there was no statistically significant difference in time to sustained clinical improvement versus placebo despite objective sequestration of circulating IL-6, questioning IL-6 as a key therapeutic target in COVID-19