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Elevated Cancer Prevalence Identified at Specific Anatomical Sites Among People With Myotonic Dystrophy Using a Population-Based Sample
No full textINTRODUCTION/AIM: To optimize patient care and cancer screening in myotonic dystrophy (DM), it is crucial to clarify cancer risks by DM type to guide targeted screening and prevention efforts. This study describes the prevalence of cancer among individuals diagnosed with DM from the Muscular Dystrophy Surveillance, Tracking, and Research Network (MD STARnet), and compares it to cancer prevalence in the US Surveillance, Epidemiology, and End Result (SEER) data. METHODS: This retrospective cohort study used 2008-2019 medical records data on 1229 individuals diagnosed with DM (DM1: 81.4%, DM2: 9.4%, DM-not otherwise specified [NOS]: 9.2%) from MD STARnet. Age- and sex-specific cancer prevalence rates from SEER were applied to the MD STARnet data to calculate 12-year limited duration (LD) and complete standardized prevalence ratios (SPR) for total cancer and by primary cancer site. RESULTS: Over a 12-year span, individuals with DM1 had a 4.01-fold higher LD prevalence of thyroid cancer and a 17.97-fold higher LD prevalence of nonmelanoma skin cancer compared to the SEER prevalence, respectively. Complete prevalence assessments identified that individuals with DM1 had a 4.18-fold higher prevalence of thyroid cancer, a 2.36-fold higher prevalence of melanoma, and a 4.68-fold higher prevalence of ovarian cancer. For DM2, the study observed a 34.02-fold higher LD prevalence for nonmelanoma skin cancer. Additionally, a significantly elevated complete prevalence of breast cancer (2.65-fold) was noted for DM2 compared to SEER data. DISCUSSION: Future research with larger cohorts is needed to define cancer risks by DM subtype and investigate underlying biological mechanisms
Profiles of quality of life among US young adult cancer survivors and their associations with potential psychosocial intervention targets of hope and psychological flexibility
No full textPURPOSE: Given the growing population of young adult (YA) cancer survivors, understanding their different quality of life (QOL) profiles is important for informing interventions to promote QOL, which may target constructs like hope or psychological flexibility. This study assessed YA survivors\u27 QOL profiles and their associations with these 2 constructs. METHODS: Latent class analysis (LCA) was conducted on PROMIS QOL measures (physical functioning, social functioning, fatigue, sleep disturbance, pain interference, anxiety, depression) among 155 YA survivors (ages 18-39; M = 32.89, 87.7% female, 8.4% Hispanic, 22.6% racial minority) within 3 years post-treatment. Multivariable regressions assessed sociodemographic and cancer-related factors in relation to class (multinomial logistic), and class in relation to scores on Snyder\u27s Hope Scale and the Acceptance and Action Questionnaire-II assessing psychological inflexibility (linear). RESULTS: LCA identified 4 classes: (1) low physical/social functioning with high symptoms (i.e., fatigue, sleep disturbance, pain interference, anxiety, depression; 43.2%); (2) high physical/social functioning with high symptoms (23.9%); (3) high physical/social functioning with low symptoms (17.4%); and (4) low physical functioning, moderate social functioning and physical symptoms, and low mental health symptoms (15.5%). Compared to class 3 (referent), classes 1 and 4 more likely had chemotherapy (aOR = 6.54, CI 1.22-34.48; aOR = 12.82, CI 1.05-28.67), and class 2 had higher monthly income (≥ vs. \u3c $4,200: aOR = 1.16, CI 1.02-1.54). Additionally, classes 1 and 2 had lower hope (B = -10.95, CI -14.42, -7.48; B = -5.50, CI -9.28, -1.71) and higher psychological inflexibility (B = 12.41, CI 9.06, 15.76; B = 8.21, CI 4.57, 11.86). CONCLUSIONS: YA survivors demonstrated varied QOL profiles, often with considerable symptoms. Interventions targeting hope and/or psychological flexibility may promote QOL. TRIAL REGISTRATION: NCT05905250
Navigating women with congenital heart disease during pregnancy: Management strategies and future directions
No full textWomen with adult congenital heart disease (CHD) face unique challenges during pregnancy, as gestational cardiovascular (CV) and hemodynamic changes can exacerbate underlying cardiac conditions. While these adaptations are well tolerated in women with structurally and functionally normal hearts, they pose significant risks for those with adult CHD (ACHD), whether repaired, palliated, or with residual defects. Maternal CHD is associated with an increased risk of adverse CV events, including stroke, heart failure, arrhythmias, and thromboembolic complications during pregnancy and the peripartum period. Effective management requires a multidisciplinary team, including cardiologists, perinatologists, anesthesiologists, and other skilled care providers. Risk stratification tools such as the modified World Health Organization classification, CARPREG II, and ZAHARA scores are useful for predicting maternal and fetal outcomes and guiding clinical decision-making. Preconception counseling plays a critical role in assessing individual risks, optimizing cardiac function, and educating patients about potential complications. Future research should prioritize innovative therapies, including targeted pharmacological agents and minimally invasive interventions, alongside improved screening methods to identify high-risk patients before symptomatic disease manifests. This review synthesizes current literature on managing pregnant women with ACHD, highlights gaps in clinical practice, and explores future directions to enhance care. Addressing these challenges is essential to improving maternal and fetal outcomes and ensuring comprehensive, patient-centered care throughout the reproductive journey
A Customized Neural Transcranial Magnetic Stimulation Target for Functional Disability Among Veterans With Co-Occurring Alcohol Use Disorder and Mild Traumatic Brain Injury: Protocol for a Pilot Randomized Controlled Trial
No full textBACKGROUND: Alcohol use disorder (AUD) and mild traumatic brain injury (mTBI) commonly co-occur, exacerbating symptoms and negatively impacting function. Co-occurring AUD and mTBI (AUD+mTBI) represents a unique and heterogeneous brain state impacting symptoms and function. Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive neuromodulatory treatment with burgeoning evidence for improving brain function and symptoms for AUD and mTBI each alone. However, there is no consensus on the optimal neural target or treatment site of stimulation for either condition alone or when they co-occur. OBJECTIVE: This study aims to (1) test the preliminary efficacy of high-frequency rTMS provided to a customized neural target to treat functional disability among veterans with AUD+mTBI and (2) assess the sustainability of rTMS effects on functional disability among veterans with AUD+mTBI. METHODS: This single-blind randomized controlled trial (RCT) involved treatment-seeking veterans with AUD+mTBI recruited from a Department of Veterans Affairs hospital. Veterans will be randomly assigned to (1) a novel TMS target site using neuronavigation or (2) standard clinical left dorsolateral prefrontal cortex using the Beam F3 method. All participants first receive 10 daily sessions of sham rTMS, followed by 10 daily sessions of active rTMS (10 Hz) provided by a trained TMS administrator. Veterans will complete self-report study questionnaires before and after sham and active rTMS session blocks as well as at 2-week, 1-month, 3-month, and 6-month posttreatment follow-up time points. The primary outcome is the WHO Disability Assessment Schedule 2.0. The secondary outcomes include alcohol use on the Timeline Follow-Back calendar, the Penn Alcohol Craving Scale, the Obsessive-Compulsive Drinking Scale, the Alcohol Craving Questionnaire, the Neurobehavioral Symptom Inventory, the PTSD Checklist for DSM-5, the Beck Depression Inventory-II, the Beck Anxiety Inventory, and the Mood and Anxiety Symptom Questionnaire. RESULTS: This study protocol was approved by the institutional review board of the Edward Hines Jr Department of Veterans Affairs Hospital (19-021). This study includes a Food and Drug Administration investigational device exemption (G180292). A 6-year research plan timeline was developed, including cost and no-cost extensions due to the COVID-19 pandemic. As of June 2025, overall, 27 veterans with AUD+mTBI who had been enrolled in the study had completed the neural target identification phase and were awaiting enrollment in the RCT phase. Data collection for the RCT phase will be initiated soon and is expected to be completed by April 2026. We expect the results of this study to be available by May 2027. CONCLUSIONS: We will be able to provide preliminary evidence of the efficacy, safety, and feasibility of a novel TMS target for veterans with AUD+mTBI. TRIAL REGISTRATION: ClinicalTrials.gov NCT04043442; https://www.clinicaltrials.gov/study/NCT04043442
Symptomatic Neonates With Tetralogy of Fallot: Shunt or Primary Repair?
No full textBACKGROUND: The optimal management strategy for symptomatic neonates with tetralogy of Fallot is unclear. We compared the outcomes of staged repair (SR) (shunt palliation followed by complete repair) and primary repair (PR) in two institutions that have each exclusively adopted one of these strategies. METHOD: We retrospectively compared 65 symptomatic neonates who underwent shunt palliation between 1993 and 2021 at the Royal Children\u27s Hospital, Melbourne, Australia with 38 symptomatic neonates who underwent PR between 2005 and 2018 at the Children\u27s National Hospital, Washington, USA. Median follow-up duration was 8.0 (interquartile range 2.9-13.5) years. RESULTS: After the initial procedure, hospital mortality (shunt 4.6% vs PR 7.9%; p=0.50) and 5-year survival (shunt 94%; 95% confidence interval [CI] 84%-98% vs PR 89%; 95% CI 72%-96%; p=0.21) were not significantly different. The SR group had shorter durations of cardiopulmonary bypass and intensive care admission during the neonatal period, but a higher burden of unplanned re-interventions before discharge. Five-year freedom from re-interventions was not significantly different (shunt 63%; 95% CI 49%-74% vs PR 49%; 95% CI 29%-66%; p=0.13). Postoperative morbidity, mortality, and re-interventions were not significantly different among 13 propensity score-matched pairs balanced for operative weight. For neonates weighing \u3c3 kg, PR was associated with significantly more early re-interventions. CONCLUSIONS: In symptomatic neonates with tetralogy of Fallot operated at two institutions with distinct treatment protocols, no statistically significant difference in medium-term survival and re-intervention was observed between the two strategies. SR was associated with lower neonatal morbidity but more unplanned re-interventions before discharge. PR in neonates weighing \u3c3 kg may result in more early re-interventions
A pediatric emergency medicine workshop for trainees and junior faculty in a low-and-middle-income country
No full textIndia\u27s pediatric health care faces challenges, underscoring the need for specialized pediatric emergency medicine (PEM) training tailored to the country\u27s clinical and cultural context. Simulation-based PEM training has gained momentum in India, leveraging hands-on workshops and collaborative learning to enhance emergency medical competencies. This project aimed to develop and implement a 2-day PEM workshop for pediatric and EM trainees and junior faculty in Bangalore, India. The workshop, a collaborative effort between the Ronald Reagan Institute of Emergency Medicine at George Washington University, Aster CMI Emergency Department, and PediStars, was designed to improve participants\u27 competencies and self-efficacy in managing pediatric emergencies. The workshop featured procedural skill stations and collaborative learning experiences, including immersive simulations and an escape room challenge, culminating in a SimOlympics competition. The implementation included 34 participants from Karnataka, Kerala, and West Bengal, with significant improvements noted in confidence and skill levels. Posttraining, participants rated their confidence in handling pediatric emergencies at 8.1 out of 10, up from 2.8 pretraining. Notable skills such as intraosseous access, intravenous access, bag-valve-mask ventilation, and intubation proficiency showed marked improvement. Follow-up data indicated sustained confidence in managing pediatric emergencies. Feedback highlighted systematic approaches to managing pediatric emergencies gained from the workshop. This initiative relied on international partnerships and local resources and has the potential for replication. Follow-up training is needed for sustained competencies. This workshop serves as a promising model for future simulation-based medical education for PEM training in low- and middle-income countries
Fixed dosing versus weight-based dosing of HIV-1 prophylactic monoclonal antibodies in adults: a post-hoc, cross-protocol pharmacokinetics modelling study
No full textBACKGROUND: Pharmacokinetic (PK) modelling and simulations have been used to support label changes of dosing levels or strategies for multiple marketed therapeutic monoclonal antibodies (mAbs). Using data from early-phase clinical trials in adults without HIV-1, we compared fixed and weight-based dosing strategies for three HIV-1 broadly neutralising mAbs planned for prevention efficacy evaluation: PGDM1400LS, PGT121.414.LS, and VRC07-523LS. METHODS: We used a two-compartment population PK model to describe overall trends and inter-individual variability in post-administration serum concentrations over time from individuals administered PGDM1400LS (n = 95), PGT121.414.LS (n = 113), or VRC07-523LS (n = 251) subcutaneously or intravenously. We evaluated the effect of body weight on various PK parameters, including clearance rate, and simulated mAb concentrations after fixed and weight-based dosing administrations using sex-specific weights observed in participants from two recent HIV-1 mAb efficacy trials. We compared magnitudes and inter-individual variabilities of concentrations at specific post-administration timepoints, areas under the time-concentration curves (AUC), and predicted neutralisation titres against representative HIV-1 virus strains. FINDINGS: For all three mAbs, we observed a modest effect of body weight on clearance rate and volumes of the central and peripheral compartments. The population-level magnitude and variability in time-specific concentrations, AUC, and predicted neutralisation titres were comparable between the two dosing strategies for both sexes. The relationship between body weight and concentrations differed between the two dosing strategies with a positive correlation for weight-based dosing and a negative correlation for fixed dosing. For individuals with body weight below the 15th or above the 85th percentiles, fixed dosing resulted in \u3c3% difference in median AUC compared to the overall population. For lower weight individuals, fixed dosing improved AUC, potentially correcting the underdosing seen in the previous weight-based mAb efficacy trials. For higher weight individuals (e.g., \u3e100 kg), body weight-based dosing or a higher fixed dose may be preferred. INTERPRETATION: For HIV-1 prophylactic mAbs, a fixed-dose approach, possibly banded by weight categories may be advantageous over weight-based dosing, as it offers increased operational efficiency while maintaining comparable pharmacokinetics and inter-individual consistency. FUNDING: NIAID
In-Hospital Outcomes of Patients with Hepatorenal Syndrome Who Underwent Transjugular Intrahepatic Portosystemic Shunt Procedure
No full textBACKGROUND: Hepatorenal syndrome (HRS) is a severe complication of cirrhosis associated with poor survival. The use of transjugular intrahepatic portosystemic shunt (TIPS) as a therapeutic or bridging therapy for HRS patients remains debated due to its potential severe early complications. This study aimed to retrospectively compare the in-hospital outcomes of HRS patients who received TIPS with those who did not, using a large-scale, population-based national database. METHODS: This study identified patients with HRS in National/Nationwide Inpatient Sample (NIS) database from Q4 2015-2021. A 1:3 propensity-score matching was used to match demographics, socioeconomic status, primary payer status, hospital characteristics, clinical presentations, APR-DRG mortality class, etiology of cirrhosis, and comorbidities between TIPS and non-TIPS cohorts. In-hospital outcomes were compared. RESULTS: The NIS database identified 55,545 HRS patients, where 479 patients underwent TIPS. African American patients and those in rural or smaller hospitals were significantly less likely to receive TIPS. Following propensity-score matching, 1,441 HRS patients who did not undergo TIPS were matched to all patients who underwent the procedure. In-hospital mortality (22.59% vs 24.36%, p = 0.46), hepatic encephalopathy (37.87% vs 35.95%, p = 0.48), and liver transplantation rates (7.11% vs 8.26%, p = 0.50) were comparable between patients who underwent TIPS and those who did not. However, patients who underwent TIPS had a longer length of stay (p \u3c 0.01) and higher total hospital charges (p \u3c 0.01) but had a lower transfer-out rate (p \u3c 0.01). CONCLUSION: TIPS does not appear to negatively impact immediate outcomes and could be considered as a potentially therapeutic treatment option for suitable candidates, considering its long-term benefits. Future studies should focus on the long-term prognosis of patients who received TIPS and the potential role of TIPS as a bridging therapy to liver transplantation. Moreover, there could be potential racial and institutional disparities in accessing/offering TIPS that may warrant further investigation
Early Cleft Lip Repair: Who\u27s Getting it and Why Sociodemographics Matter
No full textObjectiveTo analyze the sociodemographic factors influencing access to early cleft lip repair (ECLR) at our institution, with the goal of identifying and addressing disparities in care.DesignRetrospective cohort study.SettingSingle-center, tertiary hospital.Patients/ParticipantsPatients who underwent ECLR at a pediatric hospital in Los Angeles between 2014 and 2024 were included. Sociodemographics included median household income, parental unemployment rates, insurance, race/ethnicity, and area deprivation index (ADI).InterventionECLR, performed before 3 months of age.Main Outcome MeasuresAge at surgery, perioperative complications, and readmission/revision rates.ResultsA total of 271 patients met inclusion criteria. The mean age at ECLR was 35 ± 19 days, with 94.8% residing in-state. Racial and ethnic disparities were observed in the timing of surgery, with White patients undergoing ECLR at a younger age than non-White patients (P = 0.01). Publicly insured patients had later surgeries and higher complication rates compared to privately insured patients (P = 0.005 for both). A higher ADI was associated with older age at surgery (r = 0.15, P = 0.02), while patients from lower ADI areas had significantly lower readmission rates (P = 0.04). Income and parental unemployment did not significantly affect outcomes.ConclusionsAccess to ECLR was influenced by sociodemographic factors, with public insurance linked to delayed surgery and higher complication rates. While ADI did not significantly impact outcomes, it highlighted geographic disparities. To promote more equitable care, cleft surgeons should consider refining eligibility criteria and providing additional support, particularly for non-White and publicly insured patients
Unlocking the Power of Data Harmonization in Environmental Health Sciences: A Comprehensive Exploration of Significance, Use Cases, and Recommendations for Standardization Efforts
No full textBACKGROUND: The field of environmental health sciences increasingly demands comprehensive and diverse datasets, particularly in response to emerging research areas such as climate change, mixtures, and exposomics. The data needed to address the complexity of environmental health research questions often extend beyond the boundaries of a single study or data resource. Traditional data management approaches struggle to harmonize the ever-expanding and heterogeneous data sources needed for research in the environmental health sciences. Harmonization may help address this issue as it involves aligning and standardizing various elements of data to allow comprehensive analysis, data pooling and interpretation across studies. OBJECTIVES: The primary objective is to inform researchers about the transformative potential of embracing harmonization methodologies and to motivate contributions to ongoing efforts, thereby fostering advancements. METHODS: Using the Environmental Health Language Collaborative\u27s Data Harmonization Use Case, we provide a practical illustration of existing data harmonization approaches, identify gaps, and emphasize future research and application directions. We selected two publicly available environmental epidemiology studies on the topic of childhood asthma and three studies on the topic of biomarkers of metals exposure during pregnancy and birth outcomes and applied several existing harmonization approaches to assess interoperability. DISCUSSION: Our process revealed the potential limitations of many existing harmonization approaches, with notable failures to identify common variables across independent datasets and lack of agreement between human and computer-based approaches. This use case identified various challenges with existing approaches, including reliance on often incomplete data documentation and large amounts of manual effort. To address these challenges, we recommend the continued advancement and dissemination of community data standards, the development of software and tools to facilitate harmonization through automation, and strategic efforts to promote engagement in data harmonization within the environmental health sciences community. Collaborative science is needed to advance our understanding of environmental contributors to health, and realizing the harmonization potential of our scientific data is a step toward improved collaboration. https://doi.org/10.1289/EHP15410