27740 research outputs found
Sort by
P-15 Peptide Enhanced Bone Graft in Transforaminal Lumbar Interbody Fusion: A Randomized, Controlled, Investigational Device Exemption Study Demonstrating Improved Composite Clinical Success
No full textSTUDY DESIGN: Prospective, multicenter, single-blind, randomized, controlled pivotal study.
OBJECTIVE: To evaluate whether P-15L (PearlMatrix P-15 Peptide Enhanced Bone Graft) is noninferior in effectiveness to local autograft when applied in single-level instrumented transforaminal lumbar interbody fusion (TLIF).
SUMMARY OF BACKGROUND DATA: P-15L, an FDA-designated Breakthrough Drug-Device, is a composite drug-device combination bone graft containing P-15, a 15-amino acid polypeptide, which enhances cell binding, proliferation, and differentiation, resulting in bone formation.
MATERIALS AND METHODS: Skeletally mature patients, aged 22 to 80 years, with degenerative disc disease (DDD) were randomized 1:1 to P-15L (investigational) or to the local autograft (control) during single-level TLIF with a polyetheretherketone (PEEK) cage and supplemental pedicle screw fixation. The primary outcome was composite clinical success (CCS) at 24 months, defined as: no index level secondary surgical procedures; achievement of fusion; ≥15-point improvement in Oswestry low back pain disability questionnaire (ODI) from baseline; no new or worsening persistent neurological deficit relative to baseline; and no device-related serious adverse events (SAEs).
RESULTS: A total of 290 patients were enrolled at 33 sites: 141 (48.6%) received P-15L, and 149 (51.3%) received local autograft. P-15L was noninferior ( P \u3c 0.0001) and superior ( P =0.002) to autograft with respect to CCS, with 55.5% of the investigational group achieving composite clinical success compared with 37.5% of the control group. P-15L had a 25.8% higher fusion rate as compared with autograft for the CCS at 24 months (84.3% vs. 58.5%, respectively). Device-related SAE rates were similar in both groups.
CONCLUSION: P-15L was superior to local autograft in achieving clinical success at 24 months. Furthermore, P-15L produced a significantly higher fusion rate as compared with autograft. No meaningful clinical differences were found in the incidence of device-related SAEs. P-15L appears to be a safe and effective option for TLIF.
LEVEL OF EVIDENCE: Level I
Career Plans Among Graduating US Emergency Medicine Residents
No full textIMPORTANCE: The emergency medicine (EM) workforce is undergoing complex change, including a potential projected physician surplus, the volatile and evolving interests of medical students, and the continued high rates of burnout. Understanding the career intentions of graduating residents is critical to inform workforce planning.
OBJECTIVE: To examine the career plans, anticipated career durations, and key factors associated with the career decisions of graduating US EM residents.
DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional survey study, which sampled graduating residents from all Accreditation Council for Graduate Medical Education-accredited categorical EM programs, was conducted after the 2023 American Board of Emergency Medicine In-Training Examination. Resident-level characteristics, including gender, race and ethnicity, educational debt, and burnout status, were examined. Data were obtained from June 20 to August 18, 2024, and analysis occurred from December 16, 2024, to August 12, 2025.
MAIN OUTCOMES AND MEASURES: Primary outcomes included immediate postresidency career plans, intended practice setting, anticipated years of clinical practice, and importance of 10 career decision factors.
RESULTS: Of 2782 eligible residents, 2711 (97.4%; 1394 men [51.4%]) responded to at least 1 survey item. Most respondents (1654 [61.0%]) reported educational debt exceeding 200 000 or more in debt (1376 [50.7%]) were significantly more likely to cite salary as a major factor (299 000: odds ratio [OR], 2.01 [95% CI, 1.39-2.89]; 399 000: OR, 2.31 [95% CI, 1.58-3.39]; ≥$400 000: OR, 1.58 [95% CI, 1.05-2.42]).
CONCLUSIONS AND RELEVANCE: In this survey study of graduating EM residents in 2023, most respondents planned to practice clinical EM for 2 decades primarily in community or hybrid settings, with a minority of residents interested in rural practice. Career decisions are overarching and encompass career factors; lifestyle, location, professional fulfillment, and salary were the strongest career factors. Burnout, educational debt, and demographic characteristics were associated with career decisions. These findings have implications for workforce modeling, retention strategies, and policies to support the EM workforce
AI in Healthcare Quality - Advancing Excellence through Innovation
No full textLearning Objectives Understand AI\u27s Transformation: Discover how artificial intelligence is revolutionizing healthcare quality, from predictive analysis to real-time decision support systems that augment clinical judgment. Recognize Real Applications: Explore proven case studies and emerging trends that are delivering measurable improvements in patients outcomes across diverse care settings. Understand Predictive Insights: Evaluate how AI-driven predictive analytics shift the care model from reactive find-and fix medicine to proactive predict-and-prevent strategies. Evaluation Ethics and Governance: Identify the critical frameworks required to manage algorithmic bias, data privacy, and the ethical integration of AI into the clinical workflow
The Double Threat: Balancing Ischemic and Bleeding Risk in Antithrombotic Therapy for PAD
No full textExercise Performance in Ordinary Children and Adolescents: Baseline, Pandemic, and Post-Pandemic
No full textBackground: The COVID-19 pandemic might have created considerable negative impacts on the physical fitness of ordinary adolescents, which may pose a major threat to long-term cardiovascular health.
Methods: Healthy adolescents (ages 11 to 18) who underwent cardiopulmonary exercise testing (CPET) were grouped into baseline (~ 3/2020), pandemic (4/2020 ~12/2022), and post-pandemic (1/2023~ 5/2024) periods. Data are shown as mean ± standard deviation.
Results: Peak oxygen consumption (VO2/kg) and peak work rate (WR/kg) were significantly reduced during pandemic in both sexes and did not improve during post-pandemic in males (Table 1). The decline of peak oxygen pulse (OP/kg) during pandemic persisted through post-pandemic in both sexes. Submaximal slope parameters including oxygen uptake efficiency slope/kg, Δ[VO2/kg]/Δheart rate, and work efficiency (ΔVO2/ΔWR) were significantly diminished from baseline with no difference between pandemic and post-pandemic periods in both sexes. Ventilatory anaerobic threshold (VAT)/kg remained unaltered over all periods in both sexes. Peak respiratory exchange ratio and ventilatory efficiency (ΔVE/ΔVCO2) revealed some sex differences.
Conclusions: Exercise performance was significantly reduced during pandemic and did not improve during post-pandemic when the pandemic restriction was released. These CPET trends, including some sex differences, may characterizehttps://jdc.jefferson.edu/aoa_research_symposium_posters/1023/thumbnail.jp
Teriparatide Use in Osteopenic Patients Undergoing Single-Level Lumbar Fusion Associated with Decreased 2-Year Revision Rates
No full textContext: Low bone density is common among lumbar fusion patients and increases the risks of pseudarthrosis, hardware failure, and revision. Teriparatide improves bone mass and fusion in osteoporosis, but its benefit in osteopenia or normal bone remains uncertain.
Aims: To evaluate the association between teriparatide exposure and (1) postoperative complications, (2) 90-day readmission, and (3) 2-year reoperation, stratified by bone health status (osteoporotic, osteopenic, and normal) in patients undergoing single-level lumbar fusion.
Setting and Design: A retrospective cohort study using the PearlDiver database from 2010 to 2021 identified patients undergoing single-level lumbar fusion.
Subjects and Methods: Patients on teriparatide were matched 1:5 to controls based on age, gender, obesity status, bisphosphonate use, and Elixhauser Comorbidity Index. Patients were categorized by bone health status: Normal, osteopenic, or osteoporotic. Outcomes included postoperative complications, 90-day readmissions, and 2-year revision rates.
Statistical Analysis Used: Chi-square tests and multivariate logistic regressions were used for analysis, with statistical significance set at P \u3c 0.05.
Results: The analysis included 3527 teriparatide users and 17,576 controls. Teriparatide use was associated with significantly lower 90-day readmission and 2-year revision rates in osteopenic and normal bone health patients compared to osteoporotic patients. However, osteopenic patients on teriparatide experienced higher rates of deep vein thrombosis (1.8% vs. 0.4%, P = 0.030) and pulmonary embolism (1.2% vs. 0.1%, P = 0.021) than nonteriparatide counterparts.
Conclusions: Among osteopenic patients, teriparatide was linked to fewer 2-year revisions but higher 90-day thromboembolic events. These findings support nuanced risk–benefit discussions and highlight the need for trials clarifying indications across bone-health categories
Phase 1b/2 study of BMS-813160, a CCR2/5 Dual Antagonist, in Combination With Chemotherapy or Nivolumab in Patients With Advanced Pancreatic or Colorectal Cancer
No full textBACKGROUND: Cysteine-cysteine chemokine receptors 2 (CCR2) and 5 (CCR5) contribute to immune suppression in tumor microenvironments. CCR2 and CCR5 antagonists have demonstrated antitumor activity in pancreatic ductal adenocarcinoma (PDAC) and colorectal cancer (CRC), respectively. This phase 1b/2, open-label study evaluated BMS-813160, a CCR2/5 dual antagonist, in combination with chemotherapy±nivolumab in advanced PDAC or metastatic CRC.
METHODS: Part 1 included patients with metastatic untreated (first-line (1L)) PDAC, 1L CRC, or previously treated (second or third line (2/3L)) microsatellite stable (MSS) CRC. Patients received 2 weeks of BMS-813160 monotherapy (300 mg two times a day, 600 mg once daily, 300 mg once daily, or 150 mg once daily) and then BMS-813160+chemotherapy (gemcitabine+nab-paclitaxel (gem/nabP; 1L PDAC), 5-fluorouracil+leucovorin+irinotecan (FOLFIRI; 1L CRC)), or nivolumab (2/3L MSS CRC).Part 2 included patients with metastatic 1L PDAC or 2L CRC. Patients received BMS-813160 300 mg two times a day+gem/nabP±nivolumab (1L PDAC), BMS-813160 300 mg two times a day or 150 mg once daily+FOLFIRI (2L CRC), or chemotherapy alone. Primary endpoints were safety and pharmacodynamics (Part 1) and efficacy (Part 2).
RESULTS: In Part 1, 22 of 75 (29%) and 54 of 72 (72%) patients experienced a treatment-related adverse event during monotherapy lead-in and overall, respectively. Two dose-limiting toxicities (rash and pericardial effusion with pericarditis, both grade 3) occurred. In Part 2, patients with 1L PDAC who received BMS-813160 300 mg two times a day+gem/nabP+nivolumab achieved an overall response rate (ORR) of 37% (13/35); the median duration of response (DOR) was 45 weeks (95% CI 26.1 to not evaluable). ORRs with BMS-813160 300 mg two times a day+gem/nabP and gem/nabP alone were 26% (9/35) and 28% (9/32), respectively; median DORs were 121 and 31 weeks, respectively. Progression-free survival rates at 24 weeks were 56% (BMS-813160 300 mg two times a day+gem/nabP+nivolumab), 56% (BMS-813160 300 mg two times a day+gem/nabP), and 50% (gem/nabP). ORRs in 2L CRC were 19% (6/32; BMS-813160 300 mg two times a day+FOLFIRI), 13% (4/32; BMS-813160 150 mg once daily+FOLFIRI), and 27% (7/26; FOLFIRI).
CONCLUSIONS: In 1L PDAC, BMS-813160 300 two times a day+gem/nabP±nivolumab demonstrated durable antitumor response and was well tolerated. BMS-813160 combination regimens were tolerable in other cohorts, but clinical efficacy was not demonstrated.
TRIAL REGISTRATION NUMBER: NCT03184870
Exploring Physician Views on Birth Method and Route of Delivery
No full textPurpose: In the United States, rates of cesarean deliveries (CD) have been increasing. Despite recommendations from the American College of Obstetrics and Gynecology to prevent increasing rates of CDs, planned CD has been associated with lower rates of perinatal deaths and better maternal outcomes when compared to planned vaginal delivery (VD). However, the data is limited, so it is important that we conduct randomized controlled trials (RCTs) comparing maternal and perinatal outcomes in planned CD vs planned vaginal delivery (VD) for nulliparous, term, single, vertex pregnancies. The purpose of study is to survey obstetricians and gynecologists (ob/gyns) on their views of birth methodology, route of delivery, and willingness to enroll patients in such a trial.
Methods: A web-based survey was sent to attending ob/gyns. The survey was open for eight weeks and hosted on the institution’s REDCap.
Results: Eighteen physicians participated, predominantly women (15, 83.3%) with 10-19 years of experience (8, 44.4%). Nearly all respondents (16, 88.9%) reported that patients often request planned VD, while requests for planned CD occur \u3c 4 times per month (11, 61.1%) or between 4-8 times per month (3, 16.7%). Eleven (61.1%) agreed a trial evaluating planned CD is reasonable. Six (33.3%) expressed willingness to enroll all eligible patients; 3 (16.7%) would enroll some patients.
Conclusion: More than half of physicians agreed to conducting an RCT on planned VD versus planned CD. However, few expressed willingness to enroll patients in such a trial, suggesting that physician hesitancy may be a barrier to trial feasibility and recruitment.https://jdc.jefferson.edu/aoa_research_symposium_posters/1021/thumbnail.jp
Italian Medical Students\u27 Knowledge, Attitudes and Beliefs about Medical Marijuana and their Implications on the Italian Medical Curriculum
No full textPurpose: Medical marijuana is gaining clinical and legislative relevance in Italy, yet little is known about Italian medical students’ knowledge, attitudes, and preparedness regarding its therapeutic use. As future physicians, medical students will play a key role in integrating cannabis-based therapies safely into patient care. This study assessed Italian medical students’ perceived knowledge, clinical exposure, and attitudes toward medical marijuana, and evaluated implications for the medical curriculum.
Methods: A cross-sectional, anonymous online survey was distributed to students across Italian medical universities from May 2023 to March 2024. The survey used Likert-scale items to assess attitudes, perceived knowledge, educational exposure, and acceptability across various medical conditions. Descriptive statistics were generated, and chi-square tests examined differences by demographics, year of study, and university type (public vs private).
Results: Among 382 participants, attitudes were overwhelmingly positive: 95.0% supported inclusion in medical curricula, and 86.6% would prescribe it under current laws. However, a significant gap exists between support and preparedness. Among clinical-year students (n=155), only 12.9% felt adequately knowledgeable to counsel patients, and only 5.8% had participated in the care of a patient using medical marijuana. While 43.2% reported classroom instruction, only 12.9% received adequate clinical instruction.
Conclusion: Medical students in Italy strongly support the use and study of medical cannabis but lack the formal knowledge and clinical exposure necessary for safe practice. These findings highlight the need for improved clinical training, and inclusion of evidence-based instruction in the medical curriculum to prepare future physicians for safe prescribing in an environment of evolving legislation.https://jdc.jefferson.edu/aoa_research_symposium_posters/1022/thumbnail.jp
Medicine During the Holocaust: A Comparative Study of Righteous Dutch, German, and Italian Physicians
No full textPurpose: Authoritarianism can hinder altruism, even among physicians, the most altruistic members of society. Hence, we postulated that the proportion of doctors who saved Jews during the Holocaust (i.e. “Righteous Among the Nations”) was higher in a democratic country like the Netherlands as compared to authoritarian ones like Germany and Italy.
Methods: We analyzed the Yad Vashem database and other census data to determine the total populations, numbers of physicians, numbers of “Righteous”, and numbers of “Righteous” physicians in Germany, Italy, and the Netherlands during WWII. A chi-squared analysis for independence evaluated the association between proportion of “Righteous” physicians to total physicians in Germany, Italy, and the Netherlands.
Results: We found 8/651 physicians among the “Righteous” in Germany (out of 68.6 million people); 13/766 in Italy (out of 45 million); and 46/5,982 in the Netherlands (out of 9.3 million). There was a statistically significant difference (α = 0.05) in the proportion of “Righteous” physicians in Germany vs. Italy (p = 0.0328), Germany vs. the Netherlands (p \u3c 0.00001), and Italy vs. the Netherlands (p \u3c 0.00001).
Conclusions: These results support our hypothesis, despite small but significant differences between Germany and Italy. Among the “Righteous”, selfless humanitarian values seemed to be defining traits. Authoritarian influences from Fascist and antisemitic ideology appeared to curb altruism, resulting in lower numbers of “Righteous”, including physicians. This study found only association, not causation. Further research should evaluate causation, but also the effects of authoritarianism in modern medicine.https://jdc.jefferson.edu/aoa_research_symposium_posters/1025/thumbnail.jp