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Female patients have fewer limb amputations compared to male patients in the BEST-CLI trial
No full textOBJECTIVE: Female patients are less likely to be diagnosed with and treated for peripheral artery disease. When treated, there are also reported sex disparities in short- and long-term outcomes. We designed this study to compare outcomes after open and endovascular revascularization in the Best Endovascular vs best Surgical Therapy in patients with Critical Limb Ischemia (BEST-CLI) trial between females and males, and to examine outcomes of each revascularization type in an all-female cohort. METHODS: In a secondary analysis of cohorts 1 and 2 of the BEST-CLI Trial, patients with chronic limb-threatening ischemia (CLTI) undergoing open surgical bypass (with or without adequate conduit) and endovascular therapy were stratified by sex. In addition, in a female-only cohort, we evaluated differences in outcomes between treatment arm (combined all bypasses from cohorts 1 and 2 and compared with all endovascular treatment in cohorts 1 and 2). Outcomes included major amputation, reintervention, major adverse limb event (MALE, a composite of major amputation and reintervention), all-cause death, and composite outcome of MALE or all-cause death. Univariable and adjusted Cox regressions were used to assess outcome between males and females. Similar methods were used to assess differences in outcomes between treatment arm in females. RESULTS: Among 1830 patients, females were significantly underrepresented, comprising only 28% (n = 519) of the BEST-CLI cohort. Overall, the characteristics of females enrolled in the trial had some differences compared with males: females were more likely to have rest pain alone (72% vs 60%; P \u3c .0001) and when presenting with an ischemic wound, were less likely to have a wound infection (38% vs 47%; P = .01). Females were less likely to have an adequate single-segment greater saphenous vein (SSGSV) available (82% vs 89%; P = .01). Controlled for baseline clinical factors, at 1 year, females had significantly lower rates of major limb amputation compared with males (hazard ratio [HR], 0.70; P = .023), which drove better amputation- and MALE-free survival rates. All-cause death at 1 year was not statistically different between sexes (11.8% vs 11.2%; P = .286). In the all-female cohort, results paralleled the overall trial; open surgical bypass (with any conduit) had significantly better outcomes compared with endovascular therapy. Specifically, among females undergoing endovascular therapy, the rate of major reintervention was particularly high compared with females undergoing open surgical bypass (24.8% vs 10.5%; P \u3c .001). CONCLUSIONS: Despite being underrepresented in BEST-CLI, the primary results of the trial, namely, improved MALE-free survival with open surgical bypass with SSGSV, were mirrored in the all-female subset. Female patients enrolled in BEST-CLI had better amputation-free survival at 1 year compared with male patients. These findings suggest that in treating female patients with CLTI considered appropriate for both open and endovascular revascularization, surgical bypass with optimal conduit is the preferred treatment option and can potentially ameliorate poor limb preservation outcomes associated with sex
Symptom management in isocitrate dehydrogenase mutant glioma
No full textAccording to the 2021 World Health Organization classification of CNS tumors, gliomas harboring a mutation in isocitrate dehydrogenase (mIDH) are considered a distinct disease entity, typically presenting in adult patients before the age of 50 years. Given their multiyear survival, patients with mIDH glioma are affected by tumor and treatment-related symptoms that can have a large impact on the daily life of both patients and their caregivers for an extended period of time. Selective oral inhibitors of mIDH enzymes have recently joined existing anticancer treatments, including resection, radiotherapy, and chemotherapy, as an additional targeted treatment modality. With new treatments that improve progression-free and possibly overall survival, preventing and addressing daily symptoms becomes even more clinically relevant. In this review we discuss the management of the most prevalent symptoms, including tumor-related epilepsy, cognitive dysfunction, mood disorders, and fatigue, in patients with mIDH glioma, and issues regarding patient\u27s health-related quality of life and caregiver needs in the era of mIDH inhibitors. We provide recommendations for practicing healthcare professionals caring for patients who are eligible for treatment with mIDH inhibitors
Noise audit of device selection for peripheral vascular interventions in the Vascular Quality Initiative
No full textOBJECTIVE: To conduct a noise audit of the Vascular Quality Initiative (VQI) Peripheral Vascular Intervention (PVI) Registry to analyze variation in device selection for similar patients and anatomies. METHODS: We conducted a retrospective cohort study analysis of the VQI PVI Registry. Eight clinical-based and seven lesion-based scenarios were developed, and the VQI was queried for all procedures matching these descriptions from December 2010 to December 2021. All patients undergoing PVI for either claudication or chronic limb-threatening ischemia were included. Device selection was then identified for each procedure, with a treatment hierarchy to designate the primary device class along with a separate accounting of specialty balloons, including drug-coated and lithoplasty devices. Variability was then quantified in each mock patient scenario using the most commonly used device as the reference standard. RESULTS: The number of patients matching the criteria for each mock scenario ranged from 223 to 1379 across 8 clinical and from 6166 to 26,241 in 7 lesion-based scenarios. The most commonly used device in a given patient scenario was used between 32% and 72% of procedures in the clinical based scenarios, and between 34% and 67% of procedures in the lesion-based scenarios. Variation in device selection and use of specialty balloons were found to be significant across all patient scenarios (P \u3c .0001). CONCLUSIONS: Noise in PVI device selection and use of drug-coated balloons in the VQI was significant across 15 mock scenarios. This finding indicates that similar patients with similar vascular pathologies are receiving vastly different devices and confirms that future comparative effectiveness studies are required to combat this systemic source of noise in device selection more effectively
Efficacy and safety of LAU-7b in a Phase 2 trial in adults with cystic fibrosis
No full textBACKGROUND: Lung inflammation is associated with tissue damage in cystic fibrosis (CF). LAU-7b, a novel oral drug candidate, was shown to control inflammation and stabilize CFTR protein in the epithelial membrane during inflammatory stress in preclinical models of CF. METHODS: A double-blind, randomized, placebo-controlled Phase 2 study was conducted to evaluate efficacy and safety of LAU-7b in adults with CF. LAU-7b or placebo was administered over 24 weeks as six 21-day treatment cycles each separated by 7 days. The primary efficacy endpoint was the absolute change from baseline in percent predicted forced expiratory volume in 1 second (ppFEV) at 24 weeks. RESULTS: A total of 166 subjects received at least one dose of study drug (Intent-To-Treat population, ITT), of which 122 received ≥5 treatment cycles (Per-Protocol population, PP). Both treatment arms showed a mean lung function loss at 24 weeks of 1.18 ppFEV points with LAU-7b and 1.95 ppFEV with placebo, a 0.77 ppFEV (40 s) difference, p=0.345, and a 0.95 ppFEV (49 %) difference in the same direction in PP population, p=0.263. Primary analysis of mean ppFEV through 24 weeks showed differences of 1.01 and 1.23 ppFEV, in the ITT (65 % less loss, p=0.067) and PP populations (78 % less loss, reaching statistical significance p=0.049), respectively. LAU-7b had an acceptable safety profile. CONCLUSION: Although the study did not meet its primary efficacy endpoint in the ITT population, LAU-7b was generally well tolerated and showed evidence of preservation of lung function to support further development
Canagliflozin-induced adaptive metabolism in bone
No full textSodium-glucose transporter-2 inhibitor (SGLT2i) drugs are widely used for lowering blood glucose levels independent of insulin. Beyond this, these drugs induce various metabolic changes, including weight loss and impaired bone integrity. There is a significant gap in understanding SGLT2i-induced skeletal changes, as SGLT2 is not expressed in osteoblasts or osteocytes, which use glucose to remodel the bone matrix. We studied the impact of 1, 3, or 6 months of canagliflozin (CANA), an SGLT2i treatment, on the skeleton of 6-month-old genetically heterogeneous UM-HET3 mice. Significant metabolic adaptations to CANA were evident as early as 1.5 months post-treatment, specifically in male mice. CANA-treated male mice exhibited notable reductions in body weight and decreased proinflammatory and bone remodeling markers associated with reduced cortical bone remodeling indices. Bone tissue metabolome indicated enrichment in metabolites related to amino acid transport and tryptophan catabolism in CANA-treated male mice. In contrast, CANA-treated female mice showed increases in nucleic acid metabolism. An integrOmics approach of source-matched bone tissue metabolome and bone marrow RNAseq indicated a positive correlation between the two omics data sets in male mice. Three clusters of transcripts and metabolites involved in energy metabolism, oxidative stress response, and cellular proliferation and differentiation were reduced in CANA-treated male mice. In conclusion, CANA affects bone metabolism mainly via the \u27glucose restriction state\u27 it induces and impacts bone cell proliferation and differentiation. These findings underline the effects of SGLT2i on bone health and highlight the need to consider sex-specific responses when developing clinical treatments that alter substrate availability
Conversion from Minimally Invasive Surgical Approaches to Open Surgery Among Patients with Endometrial Cancer in the SGO Clinical Outcomes Registry
No full textBACKGROUND: Endometrial cancer (EC) ranks as the most common gynecologic malignancy in the USA. While minimally invasive surgical (MIS) techniques have revolutionized EC management, conversion to laparotomy remains a concern due to the loss of laparoscopic benefits such as fewer surgical site infections and shorter hospital stays with reported rates varying widely. Factors influencing this conversion, including patient characteristics and tumor attributes, have not been fully understood. Our study aims to provide a framework for identifying patients at higher risk of conversion, thereby helping to inform surgical decision-making and patient counseling Addressing this gap, our study employs a national registry to analyze patient- and tumor-related factors associated with the transition from MIS to open surgery in EC. PATIENTS AND METHODS: We queried the SGO Clinical Outcomes Registry (COR) to identify all patients with EC who underwent surgical management. The COR indeed validated clinical data from 29 sites collected between 2014 and 2018. The primary outcome was to assess the conversion rate from MIS to open surgery. Descriptive statistics using means with standard deviations or frequency with percentages were used. Chi-squared analysis was used to examine the bivariate relationship between group status and the subjects\u27 demographic and clinical variables. RESULTS: A total of 3.4% (135/4028) of patients underwent conversion from MIS to open surgery. Demographic characteristics were balanced between the groups. Conversion was more prevalent in patients with obesity (29%) and morbid obesity (37%) than in patients who are underweight (2%), normal weight (16%), and overweight (16%). Similarly, conversion was more prevalent in patients with prior abdominal surgery (63% versus 52%; P = 0.001). Endometrioid (EC) predominated (59%) in the converted group, with higher-than-expected non-endometrioid rates (serous carcinoma 16%, clear cell carcinoma 4%, carcinosarcoma 5%, mixed histology 12%; all P \u3c 0.01). Advanced International Federation of Gynecology and Obstetrics (FIGO) stages were more common in patients who converted to open surgery (stage II: 5%, stage III: 25%, stage IV: 9%; all P \u3c 0.001). Type II (24%) and type III (5%) hysterectomies were more frequent in patients who converted to open (P \u3c 0.001). Logistic regression indicated body mass index (BMI), prior surgery, FIGO stage, histology, and hysterectomy type affected conversion (P \u3c 0.001), explaining 12.3% of the variance in the conversion outcome. Indications for conversion included uterine size, adhesions, and disease extent. CONCLUSIONS: The adoption of MIS has become increasingly common standard of care for managing EC, attributed to enhanced perioperative outcomes. Factors associated with conversion such as uterine size, prior abdominal surgeries, surgical complexity, disease extent, and histologic types can affect the surgeon\u27s choice. Ultimately, a personalized surgical approach, tailored to individual patient attributes, remains pivotal for optimizing outcomes in EC management
Telemedicine consultations in community hospitals improve neonatal encephalopathy assessment
No full textOBJECTIVE: We aimed to determine if the implementation of teleconsults in the community hospital would decrease time to initiation of therapeutic hypothermia (TH). METHODS: We compared neonates treated with TH prior to implementation of the teleconsult program (pre-tele) to those treated after (post-tele) for the outcomes of time to initiation of TH, seizures and death/severe injury on brain MRI. We controlled for confounders using multivariable linear and logistic regression models. RESULTS: There were 52 pre-tele neonates and 49 post-tele who were all born in community hospitals and treated with TH. Mothers in the post-tele group were older and had higher rates of gestational diabetes. Fewer neonates with mild encephalopathy were cooled in the post-tele period (13 (25.0%) pre-tele versus 2 (4.1%) post-tele). After controlling for gestational diabetes, maternal age, and severity of encephalopathy, there was no difference in time to TH initiation (p = 0.445), brain injury or death (p = 0.136), or seizure (p = 0.433) between the pre- and post-tele groups. In sub-analysis of the post-tele group, time to initiation was 4.50 hours (3.75, 5.00) for those with teleconsults versus 3.25 (2.12, 4.00) hours (p=0.007) for those without. CONCLUSION: When comparing pre- to post-tele groups, teleconsults in the community hospital did not significantly change the time to initiate TH or result in more adverse short-term outcomes of seizures or death/brain injury. In sub-analysis of the post-tele group, teleconsults did result in delayed initiation of TH but also possible improved patient selection with fewer mildly encephalopathic neonates treated
Testing ChatGPT\u27s Ability to Provide Patient and Physician Information on Aortic Aneurysm
No full textINTRODUCTION: Our objective was to test the ability of ChatGPT 4.0 to provide accurate information for patients and physicians about abdominal aortic aneurysms (AAA) and to assess its alignment with Society for Vascular Surgery (SVS) clinical practice guidelines (CPG) for AAA care. MATERIAL AND METHODS: Fifteen patient-level questions, 37 questions selected to reflect 28 SVS CPGs and 4 questions regarding AAA rupture risk were posed to ChatGPT 4.0. Single responses were recorded and graded for accuracy and quality by ten board-certified vascular surgeons as well as two fellow trainees using a 5-point Likert scale; 1 = very poor, 2 = poor, 3 = fair, 4 = good, and 5 = excellent. RESULTS: The mean of the means (MoM) accuracy rating across all 15 patient-level questions was 4.4 (SD 0.4, quartile range (QR) 4.2-4.7). ChatGPT 4.0 demonstrated good alignment with SVS practice guidelines (MoM: 4.2, SD: 0.4, QR: 3.9-4.5). The accuracy of responses was consistent across guideline categories; screening or surveillance (4.2), indications for surgery (4.5), preoperative risk assessment (4.5), perioperative coronary revascularization (4.1), and perioperative management (4.2). The generative artificial intelligence bot demonstrated only fair performance in answering the annual AAA rupture risk (MoM: 3.4, SD: 1.2, QR: 2.3-4.3). CONCLUSIONS: ChatGPT 4.0 provided accurate responses to a variety of patient-level questions regarding AAA. Responses were well-aligned with current SVS CPGs except for inaccuracies in the risk of AAA rupture at varying diameters. The emergence of generative artificial intelligence bots presents an opportunity for study of applications in patient education and to determine their ability to augment the vascular specialist\u27s knowledge base
AAPM Medical Physics Practice Guideline MPPG 17.a: Quality management for mammography review workstation displays
No full textThe Mammography Quality Standards Act (MQSA) sets quality standards for displays used to interpret mammography images. With the shift to digital mammography and the widespread use of remote reading workstations (RWS), updated quality management (QM) programs are needed to ensure consistent image presentation and accurate interpretation. This document recommends a QM framework for mammography RWS displays, addressing challenges such as remote environments, regulatory compliance, and evolving technology. The QM model highlights the central role of medical physicists in program design, oversight, and data review. It emphasizes periodic quality assurance (QA) and quality control (QC) procedures and training for interpreting physicians and staff. A structure for QM for remote RWS, including guidance on environmental conditions, hands-on testing, and remote monitoring solutions, is included. The proposed program balances scientific rigor, cost-effectiveness, and practical implementation, maintaining image quality and safety. By providing a structured approach to RWS display management, this framework supports regulators, accreditation bodies, and healthcare facilities in adapting to advancements in mammography technology while addressing logistical and operational challenges
April 2nd, 2025: When Thoughts Become Traps: Helping Your Patients Find Relief from Obsessive-Compulsive Disorder
No full texthttps://knowledgeconnection.mainehealth.org/medicine_gr/1038/thumbnail.jp