Tag: pubmed

JAMA Netw Open. 2024 May 1;7(5):e2411140. doi: 10.1001/jamanetworkopen.2024.11140.

ABSTRACT

IMPORTANCE: Providing assisted ventilation during delayed umbilical cord clamping may improve outcomes for extremely preterm infants.

OBJECTIVE: To determine whether assisted ventilation in extremely preterm infants (23 0/7 to 28 6/7 weeks’ gestational age [GA]) followed by cord clamping reduces intraventricular hemorrhage (IVH) or early death.

DESIGN, SETTING, AND PARTICIPANTS: This phase 3, 1:1, parallel-stratified randomized clinical trial conducted at 12 perinatal centers across the US and Canada from September 2, 2016, through February 21, 2023, assessed IVH and early death outcomes of extremely preterm infants randomized to receive 120 seconds of assisted ventilation followed by cord clamping vs delayed cord clamping for 30 to 60 seconds with ventilatory assistance afterward. Two analysis cohorts, not breathing well and breathing well, were specified a priori based on assessment of breathing 30 seconds after birth.

INTERVENTION: After birth, all infants received stimulation and suctioning if needed. From 30 to 120 seconds, infants randomized to the intervention received continuous positive airway pressure if breathing well or positive-pressure ventilation if not, with cord clamping at 120 seconds. Control infants received 30 to 60 seconds of delayed cord clamping followed by standard resuscitation.

MAIN OUTCOMES AND MEASURES: The primary outcome was any grade IVH on head ultrasonography or death before day 7. Interpretation by site radiologists was confirmed by independent radiologists, all masked to study group. To estimate the association between study group and outcome, data were analyzed using the stratified Cochran-Mantel-Haenszel test for relative risk (RR), with associations summarized by point estimates and 95% CIs.

RESULTS: Of 1110 women who consented to participate, 548 were randomized and delivered infants at GA less than 29 weeks. A total of 570 eligible infants were enrolled (median [IQR] GA, 26.6 [24.9-27.7] weeks; 297 male [52.1%]). Intraventricular hemorrhage or death occurred in 34.9% (97 of 278) of infants in the intervention group and 32.5% (95 of 292) in the control group (adjusted RR, 1.02; 95% CI, 0.81-1.27). In the prespecified not-breathing-well cohort (47.5% [271 of 570]; median [IQR] GA, 26.0 [24.7-27.4] weeks; 152 male [56.1%]), IVH or death occurred in 38.7% (58 of 150) of infants in the intervention group and 43.0% (52 of 121) in the control group (RR, 0.91; 95% CI, 0.68-1.21). There was no evidence of differences in death, severe brain injury, or major morbidities between the intervention and control groups in either breathing cohort.

CONCLUSIONS AND RELEVANCE: This study did not show that providing assisted ventilation before cord clamping in extremely preterm infants reduces IVH or early death. Additional study around the feasibility, safety, and efficacy of assisted ventilation before cord clamping may provide additional insight.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02742454.

PMID:38758557 | DOI:10.1001/jamanetworkopen.2024.11140

JAMA Netw Open. 2024 May 1;7(5):e2411742. doi: 10.1001/jamanetworkopen.2024.11742.

ABSTRACT

IMPORTANCE: The National Health Service Corps (NHSC) Loan Repayment Program (LRP) expansion in fiscal year (FY) 2019 intended to improve access to medication for opioid use disorder (MOUD) by adding more clinicians who could prescribe buprenorphine. However, some clinicians still face barriers to prescribing, which may vary between rural and nonrural areas.

OBJECTIVE: To examine the growth in buprenorphine prescribing by NHSC clinicians for Medicaid beneficiaries during the NHSC LRP expansion and describe the challenges to prescribing that persist in rural and nonrural areas.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study analyzed preexpansion and postexpansion Medicaid claims data to evaluate the percentage of prescriptions of buprenorphine filled during FY 2017 through 2021. This study also analyzed challenges and barriers to prescribing MOUD between rural and urban areas, using results from annual surveys conducted with NHSC clinicians and sites from FY 2019 through FY 2021.

EXPOSURE: Prescribing of buprenorphine by NHSC clinicians.

MAIN OUTCOMES AND MEASURES: The main outcomes were the percentage and number of Medicaid beneficiaries with opioid use disorder (OUD) who filled a prescription for buprenorphine before and after the LRP expansion and the challenges NHSC clinicians and sites faced in providing substance use disorder and OUD services. Survey results were analyzed using descriptive statistics.

RESULTS: During FYs 2017 through 2021, 7828 NHSC clinicians prescribed buprenorphine (standard LRP: mean [SD] age, 38.1 [8.4] years and 4807 females [78.9%]; expansion LRPs: mean [SD] age, 39.4 [8.1] years and 1307 females [75.0%]). A total of 3297 NHSC clinicians and 4732 NHSC sites responded to at least 1 survey question to the 3 surveys. The overall percentage of Medicaid beneficiaries with OUD who filled a prescription for buprenorphine during the first 2.5 years post expansion increased significantly from 18.9% before to 43.7% after expansion (an increase of 123 422 beneficiaries; P < .001). The percentage more than doubled among beneficiaries living in areas with a high Social Vulnerability Index score (from 17.0% to 36.7%; an increase of 31 964) and among beneficiaries living in rural areas (from 20.8% to 55.7%; an increase of 45 523). However, 773 of 2140 clinicians (36.1%; 95% CI, 33.6%-38.6%) reported a lack of mental health services to complement medication for OUD treatment, and 290 of 1032 clinicians (28.1%; 95% CI, 24.7%-31.7%) reported that they did not prescribe buprenorphine due to a lack of supervision, mentorship, or peer consultation.

CONCLUSIONS AND RELEVANCE: These findings suggest that although the X-waiver requirement has been removed and Substance Abuse and Mental Health Services Administration guidelines encourage all eligible clinicians to screen and offer patients with OUD buprenorphine, as permissible by state law, more trained health care workers and improved care coordination for counseling and referral services are needed to support comprehensive OUD treatment.

PMID:38758556 | DOI:10.1001/jamanetworkopen.2024.11742

JAMA Netw Open. 2024 May 1;7(5):e2411852. doi: 10.1001/jamanetworkopen.2024.11852.

ABSTRACT

IMPORTANCE: High intake of ultraprocessed foods (UPFs) has been associated with higher cardiometabolic risk in adults; however, the evidence in children is limited.

OBJECTIVE: To investigate the association between UPF consumption and cardiometabolic risk factors in the Childhood Obesity Risk Assessment Longitudinal Study (CORALS).

DESIGN, SETTING, AND PARTICIPANTS: This baseline cross-sectional analysis was conducted using the data of CORALS participants recruited between March 22, 2019, and June 30, 2022. Preschool children (aged 3-6 years) were recruited from schools and centers in 7 cities in Spain. Inclusion criteria included informed consent signed by parents or caregivers and having a completed a set of questionnaires about the child’s prenatal history at home. Exclusion criteria included low command of Spanish or unstable residence.

EXPOSURE: Energy-adjusted UPF consumption (in grams per day) from food frequency questionnaires and based on the NOVA food classification system.

MAIN OUTCOMES AND MEASURES: Age- and sex-specific z scores of adiposity parameters (body mass index [BMI], fat mass index, waist-to-height ratio, and waist circumference) and cardiometabolic parameters (diastolic and systolic blood pressure, fasting plasma glucose, homeostasis model assessment for insulin resistance, high-density and low-density lipoprotein cholesterol, and triglycerides) were estimated using linear regression models.

RESULTS: Of 1509 enrolled CORALS participants, 1426 (mean [SD] age, 5.8 [1.1] years; 698 boys [49.0%]) were included in this study. Mothers of children with high UPF consumption were younger, had a higher BMI, were more likely to have overweight or obesity, and had lower education levels and employment rates. Compared with participants in the lowest tertile of energy-adjusted UPF consumption, those in the highest tertile showed higher z scores of BMI (β coefficient, 0.20; 95% CI, 0.05-0.35), waist circumference (β coefficient, 0.20; 95% CI, 0.05-0.35), fat mass index (β coefficient, 0.17; 95% CI, 0.00-0.32), and fasting plasma glucose (β coefficient, 0.22; 95% CI, 0.06-0.37) and lower z scores for HDL cholesterol (β coefficient, -0.19; 95% CI, -0.36 to -0.02). One-SD increments in energy-adjusted UPF consumption were associated with higher z scores for BMI (β coefficient, 0.11; 95% CI, 0.05-0.17), waist circumference (β coefficient, 0.09; 95% CI, 0.02-0.15), fat mass index (β coefficient, 0.11; 95% CI, 0.04-1.18), and fasting plasma glucose (β coefficient, 0.10; 95% CI, 0.03-0.17) and lower HDL cholesterol (β coefficient, -0.07; 95% CI, -0.15 to -0.00). Substituting 100 g of UPFs with 100 g of unprocessed or minimally processed foods was associated with lower z scores of BMI (β coefficient, -0.03; 95% CI, -0.06 to -0.01), fat mass index (β coefficient, -0.03; 95% CI, -0.06 to 0.00), and fasting plasma glucose (β coefficient, -0.04; 95% CI, -0.07 to -0.01).

CONCLUSIONS AND RELEVANCE: These findings suggest that high UPF consumption in young children is associated with adiposity and other cardiometabolic risk factors, highlighting the need for public health initiatives to promote the replacement of UPFs with unprocessed or minimally processed foods.

PMID:38758555 | DOI:10.1001/jamanetworkopen.2024.11852

JAMA Netw Open. 2024 May 1;7(5):e2411909. doi: 10.1001/jamanetworkopen.2024.11909.

ABSTRACT

IMPORTANCE: Oral endocrine treatments have been shown to be effective when carefully adhered to. However, in patients with early breast cancer, adherence challenges are notable, with 17% experiencing nonpersistence and 41% nonadherence at least once.

OBJECTIVE: To model the persistence of and adherence to oral anticancer treatment of a patient with localized breast cancer.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study was conducted using anonymous reimbursement data belonging to French female patients with breast cancer, extracted from the French Health Insurance database from January 2013 to December 2018. Data analysis was conducted from January 2021 to May 2022.

MAIN OUTCOMES AND MEASURES: The main outcome was the detection of episodes of nonpersistence and nonadherence 6 months before they happened. Adherence was defined as the ratio between the time covered by a drug purchase and the time between 2 purchases; patients were considered nonadherent if the ratio of their next 3 purchases was less than 80%. Disparities in persistence and adherence based on criteria such as age, treatment type, and income were identified.

RESULTS: A total of 229 695 female patients (median [IQR] age, 63 [52-72] years) with localized breast cancer were included. A deep learning model based on a gated-recurrent unit architecture was used to detect episodes of nonpersistence or nonadherence. This model demonstrated an area under the receiving operating curve of 0.71 for persistence and 0.73 for adherence. Analyzing the Shapley Additive Explanations values also gave insights into the contribution of the different features over the model’s decision. Patients older than 70 years, with past nonadherence, taking more than 1 treatment in the previous 3 months, and with low income had greater risk of episodes of nonpersistence. Age and past nonadherence, including regularity of past adherence, were also important features in the nonadherence model.

CONCLUSIONS AND RELEVANCE: This cohort study found associations of patient age and past adherence with nonpersistence or nonadherence. It also suggested that regular intervals in treatment purchases enhanced adherence, in contrast to irregular purchasing patterns. This research offers valuable tools for improving persistence of and adherence to oral anticancer treatment among patients with early breast cancer.

PMID:38758553 | DOI:10.1001/jamanetworkopen.2024.11909

JAMA Netw Open. 2024 May 1;7(5):e2412313. doi: 10.1001/jamanetworkopen.2024.12313.

ABSTRACT

IMPORTANCE: β-lactam (BL) allergies are the most common drug allergy worldwide, but most are reported in error. BL allergies are also well-established risk factors for adverse drug events and antibiotic-resistant infections during inpatient health care encounters, but the understanding of the long-term outcomes of patients with BL allergies remains limited.

OBJECTIVE: To evaluate the long-term clinical outcomes of patients with BL allergies.

DESIGN, SETTING, AND PARTICIPANTS: This longitudinal retrospective cohort study was conducted at a single regional health care system in western Pennsylvania. Electronic health records were analyzed for patients who had an index encounter with a diagnosis of sepsis, pneumonia, or urinary tract infection between 2007 and 2008. Patients were followed-up until death or the end of 2018. Data analysis was performed from January 2022 to January 2024.

EXPOSURE: The presence of any BL class antibiotic in the allergy section of a patient’s electronic health record, evaluated at the earliest occurring observed health care encounter.

MAIN OUTCOMES AND MEASURES: The primary outcome was all-cause mortality, derived from the Social Security Death Index. Secondary outcomes were defined using laboratory and microbiology results and included infection with methicillin-resistant Staphylococcus aureus (MRSA), Clostridium difficile, or vancomycin-resistant Enterococcus (VRE) and severity and occurrence of acute kidney injury (AKI). Generalized estimating equations with a patient-level panel variable and time exposure offset were used to evaluate the odds of occurrence of each outcome between allergy groups.

RESULTS: A total of 20 092 patients (mean [SD] age, 62.9 [19.7] years; 12 231 female [60.9%]), of whom 4211 (21.0%) had BL documented allergy and 15 881 (79.0%) did not, met the inclusion criteria. A total of 3513 patients (17.5%) were Black, 15 358 (76.4%) were White, and 1221 (6.0%) were another race. Using generalized estimating equations, documented BL allergies were not significantly associated with the odds of mortality (odds ratio [OR], 1.02; 95% CI, 0.96-1.09). BL allergies were associated with increased odds of MRSA infection (OR, 1.44; 95% CI, 1.36-1.53), VRE infection (OR, 1.18; 95% CI, 1.05-1.32), and the pooled rate of the 3 evaluated antibiotic-resistant infections (OR, 1.33; 95% CI, 1.30-1.36) but were not associated with C difficile infection (OR, 1.04; 95% CI, 0.94-1.16), stage 2 and 3 AKI (OR, 1.02; 95% CI, 0.96-1.10), or stage 3 AKI (OR, 1.06; 95% CI, 0.98-1.14).

CONCLUSIONS AND RELEVANCE: Documented BL allergies were not associated with the long-term odds of mortality but were associated with antibiotic-resistant infections. Health systems should emphasize accurate allergy documentation and reduce unnecessary BL avoidance.

PMID:38758551 | DOI:10.1001/jamanetworkopen.2024.12313

J Burn Care Res. 2024 May 17:irae085. doi: 10.1093/jbcr/irae085. Online ahead of print.

ABSTRACT

A National Trauma Research Action Plan identified the involvement of burn survivors as critical informants to determine the direction of research. This study employed a web-based survey to identify care gaps in a sample of burn survivors. We surveyed burn survivors from around the United States through social media and email contact with the Phoenix Society for Burn Survivors. We elicited demographic info, burn history, and unmet needs. Statistical analysis was performed to test our hypothesis that lack of access to mental health support/professionals would be identified as an unmet need in long-term burn survivors. Of 178 survey respondents, most were at least ten years removed from the date of their burn injury (n=94, 53%). Compared to those less than 3 years from their burn injury, individuals greater than 10 years were at least 5 times more likely to note lack of access to mental health support [11-20 years OR 8.7, p< 0.001; >20 years OR5.7, p=0.001]. 60% of Spanish speakers reported lack of support group access was among their greatest unmet needs, compared to 37% of English speakers (p=0.184). This study highlights the need for ongoing access to mental health resources in burn survivors. Our findings emphasize that burn injury is not just an acute ailment, but a complex condition that evolves into a chronic disease. Additional studies should focus on the experiences of Spanish-speaking burn survivors, given small sample size leading to a likely clinically significant but not statistically different lack of access to support groups.

PMID:38758544 | DOI:10.1093/jbcr/irae085

Anat Sci Int. 2024 May 17. doi: 10.1007/s12565-024-00777-3. Online ahead of print.

ABSTRACT

Variations in the arch of the aorta and aortic valves among fetal, cadaveric, and post-mortem specimens present a spectrum of anatomical configurations, posing challenges in establishing a standard norm. While some variations hold surgical significance, many bear little functional consequence but provide insights into embryological origins. The aortic arch exhibits diverse branching patterns, including common trunks and different orders, relevant for endovascular surgeries. Meanwhile, malformations in the aortic valve, affecting the aorta, may lead to ischemia and cerebral infarction, warranting understanding of coexisting arch and valve anomalies to predict complications like aortic dissection. Studies in the Indian population mirror global variations, underscoring the need to explore embryological, clinical, and surgical implications for safer vascular surgeries involving the aortic arch and valves. The study’s objectives included examining branching patterns, diameters, and distances between arch branches and exploring aortic valve variations. Employing a cross-sectional design, the study was conducted across Anatomy, Forensic Medicine, and Obstetrics and Gynecology departments. A sample of 100, comprising cadavers, fetuses, and postmortem specimens, were gathered. Specimens ranged from 14 weeks of intrauterine life to 85 years, with intact thoracic cages as inclusion criteria. Methodology involved dissection, specimen fixation, and macroscopic examination for variations and morphological parameters. Results showed aortic diameter increase with age, with significant gender differences. A statistically significant association between arch variations and anomalous valves was observed, suggesting mutual predictability. Individuals with valve anomalies should undergo comprehensive cardiology evaluation to avert complications like aortic dissection during endovascular surgeries. While atheromatous plaques were prevalent in younger groups, their frequency rose with age, necessitating vigilant vascular monitoring. Careful handling during surgeries is paramount, given potential adverse outcomes resulting from variations. Overall, the study underscores the importance of comprehensive anatomical understanding in clinical contexts, guiding effective management strategies and ensuring patient safety in vascular surgeries.

PMID:38758496 | DOI:10.1007/s12565-024-00777-3

Infection. 2024 May 17. doi: 10.1007/s15010-024-02281-2. Online ahead of print.

NO ABSTRACT

PMID:38758488 | DOI:10.1007/s15010-024-02281-2

Invest New Drugs. 2024 May 17. doi: 10.1007/s10637-024-01440-4. Online ahead of print.

ABSTRACT

Cancer is a disease caused by uncontrolled cell growth that is responsible for several deaths worldwide. Breast cancer is the most common type of cancer among women and is the leading cause of death. Chemotherapy is the most commonly used treatment for cancer; however, it often causes various side effects in patients. In this study, we evaluate the antineoplastic activity of a parent compound based on a combretastatin A4 analogue. We test the compound at 0.01 mg mL^{– 1}, 0.1 mg mL^{– 1}, 1.0 mg mL^{– 1}, 10.0 mg mL^{– 1}, 100.0 mg mL^{– 1}, and 1,000.0 mg mL^{– 1}. To assess molecular antineoplastic activity, we conduct in vitro tests to determine the viability of Ehrlich cells and the blood mononuclear fraction. We also analyze the cytotoxic behavior of the compound in the blood and blood smear. The results show that the molecule has a promising antineoplastic effect and crucial anticarcinogenic action. The toxicity of blood cells does not show statistically significant changes.

PMID:38758478 | DOI:10.1007/s10637-024-01440-4

Updates Surg. 2024 May 17. doi: 10.1007/s13304-024-01876-6. Online ahead of print.

ABSTRACT

To compare the short-term outcomes and explore the potential economic benefits of laparoscopic-assisted colectomy with extracorporeal anastomosis (LAC/EA) vs. laparoscopic complete colectomy with intracorporeal anastomosis (LCC/IA) for patients with non-metastatic resectable colon cancer. Data of patients who underwent laparoscopic hemicolectomy from January 2017 to March 2023 were collected and analyzed. Propensity score matching (PSM) analyses was carried out to minimize the selection bias. Before PSM, a total of 113 patients met the inclusion criteria (39 in the LCC/IA vs. 74 in the LAC/EA). Clinicopathologic characteristics were comparable except for the median number of removed lymph nodes (P = 0.023). LCC/IA was associated with longer operative time, less intraoperative blood loss, and shorter incision length. The rate of 30-day postoperative complications was similar, but the time to first flatus and soft diet was shorter in the LCC/IA. No deaths were reported in either group within 30 days after surgery. Costs of surgical instruments (25,945.8 ± 1,918.0 vs. 23,551.9 ± 2,665.5 RMB; P < 0.01) were higher for the LCC/IA but overall costs were similar (LCC/IA, 43,220.0 ± 4,954.0 vs. LAC/EA, 41,269.2 ± 6,685.9 RMB; P = 0.112). After PSM, 38 patients in the LCC/IA and 63 patients in the LAC/EA were compared. LCC/IA was superior in terms of intraoperative blood loss, incision length, and postoperative functional recovery. There was an extra charge of 2385.0 RMB regarding surgical instruments in the LCC/IA but the overall cost did not reach statistical significance. LCC/IA is a feasible, safe, and cost-effective surgical treatment for patients with non-metastatic resectable colon cancer.

PMID:38758468 | DOI:10.1007/s13304-024-01876-6