Completed Baseline Research Articles

Etiology remains king: health-related quality of life outcome at 5years following growth friendly instrumentation for EOS.

The etiology of early-onset scoliosis (EOS) has been shown to significantly influence baseline parent-reported health-related quality of life (HRQoL) measures as assessed by the Early Onset Scoliosis Questionnaire (EOSQ). However, it remains unclear how etiology influences mid-term outcomes following growth friendly instrumentation (GFI) for EOS. A retrospective review of a multi-center prospective spinal database was performed. Children undergoing primary distraction-based, GFI for EOS with complete baseline, 2-year, and 5-year post-surgical EOSQ were included. The identified children were subdivided by etiology as classified by the C-EOS system. EOSQ scores were compared over time according to etiology cohorts and between instrumentation types. Minimal clinically important difference (MCID) was defined as ≥ 20% change in domain score and compared across etiologies. Dominance analysis was used to assess for drivers of treatment satisfaction. A total of 178 children (mean 7.3 ± 2.1years, 51.1% female) were included. The most common etiology was neuromuscular (NM: 36.5%), with the majority of children treated with MCGR (N = 125). Significant differences between etiology groups were present with congenital and idiopathic cohorts demonstrating similar EOSQ domain scores that were significantly higher than neuromuscular and syndromic cohorts. In assessing clinically important changes in EOSQ scores over the 5-year follow-up period, neuromuscular and syndromic patients demonstrated the greatest capacity for improved outcomes. Instrumentation type had no influence on HRQoL scores at 5-year follow-up. Etiology was a driver of satisfaction with syndromic etiology and transfer domain score at 2years follow-up associated with dissatisfaction. Curve etiology remains a significant driver of HRQoL domains following growth-friendly instrumentation for EOS. Neuromuscular and syndromic patient have significantly lower domain scores. Despite this, or perhaps because of it, they also demonstrate the greatest capacity for clinically important improvement in HRQoL measures 5years following intervention.

Colorectal cancer legal and administrative burden support (COLLABS): A pilot clinical trial.

TPS307 Background: Patients with colorectal cancer often have health-related social needs (e.g. food insecurity, housing instability, employment loss). Failure to adequately address these is associated with financial hardship, worse quality-of-life, psychosocial distress, lower rates of treatment receipt, and worse survival. Cancer clinical care teams often lack the resources, knowledge, and processes to resolve these issues, many of which are actually legal in nature. Engagement with legal teams—medical-legal partnerships—can screen for, prevent, and resolve health-related social needs, as well as address related legal issues such as insurance denials, employment rights and protections, disability benefits, debt management, and estate planning. Cancer Legal Care (CLC) is a nonprofit providing free legal services to persons affected by cancer in MN. Past CLC clients have indicated a preference for proactive connection to CLC to prevent crises and overcome barriers to access such as concerns regarding perceived costs of legal services. Methods: This is a single-arm, pilot study to evaluate the feasibility, acceptability, and preliminary efficacy of proactive and free legal care support for patients with colorectal cancer at the University of Minnesota. The enrollment goal is 20 patients and the trial duration is 6 months. Inclusion criteria include English-speaking adults with advanced stage colorectal cancer and estimated life expectancy of >6 months. There is no requirement for baseline health-related social need(s) or time from diagnosis. After participants complete baseline surveys, we will connect them to a CLC attorney for an initial “legal care checkup”— the timing and method of connection (in-person, video visit, or phone call) is based on patient preference. Patients can bring up self-identified or active issues themselves, while CLC will also screen for needs. CLC will provide any required legal services and engage with the cancer care team as needed. CLC will follow-up with participants at 3 and 6 months, though services may continue after the study period off trial. Participants will complete surveys at baseline, 3 months, and 6 months. Surveys will assess patient-reported outcomes on financial toxicity, quality-of-life, comfort levels with accessing cancer care, status of health-related social and legal needs, perceived stress, life mastery and engagement, relationship with CLC contact, and acceptability of the intervention. The primary outcomes are feasibility (rates of initial engagement, continued engagement, and intervention completion; feasible if >50% on each metric) and acceptability. We will conduct exit qualitative interviews. We will collect sociodemographics, rates of treatment adherence/ completion, legal services provided, outcome of legal issues, and monetary savings or recovery for patients. Enrollment opened August 2024 and we have enrolled 15/20 participants. Clinical trial information: NCT06475664 .

P-1424. Patient Experiences at Month 6 after Initiation of Cabotegravir Long-Acting (CAB LA) for PrEP in the First Male Gender Concordant Implementation Science Trial (PILLAR) in the US

Abstract Background Little is known outside of registrational clinical trials about patient experiences on CAB LA, the first long-acting injectable regimen for HIV prevention. We report real-world experiences and outcomes of men at month 6 (M6) after initiating CAB LA in the US. Methods PILLAR is a Phase 4 gender-concordant implementation science trial assessing integrating CAB LA at 17 clinics for men who have sex with men (MSM) and transgender men (TGM). MSM and TGM completed surveys at baseline (BL) and M6 on experiences and implementation outcomes. A purposeful sample of men completed interviews about their experiences. Results 201 men enrolled and initiated CAB LA from May 2022-August 2023, 186 (93%) and 159 (79%) completed BL and M6 surveys, respectively; of these, 45 men completed interviews at M6. Table 1 presents BL demographics. At BL,15-29% of men reported experiencing stigma and anxiety on oral PrEP (Table 2). At M6, 0-1% of CAB LA users reported stigma and anxiety concerns. At BL, 53-54% oral PrEP users reported concerns about forgetting to take and running out of PrEP. At M6, 2-7% of CAB LA users concerns were forgetting or missing injection visits. Interviewees noted CAB LA reduced stress and fear of missing PrEP, while offering confidence of protection. High acceptability of CAB LA increased from BL to M6 [mean acceptability: 4.4 (SD:0.69) vs. 4.6 (SD:0.61)] and feasibility remained high [mean feasibility: 4.4 (SD:0.74) vs 4.4 (SD:0.75)]. Interviewees noted CAB LA was convenient for their life. Though 45% reported injection site reactions, majority (86%) returned to daily activities the same day. Few were bothered by injection pain (8%) and reported that pain decreased over subsequent injections. At M6, 80-92% of survey respondents reported flexible scheduling by clinics as useful to supporting CAB LA use, which was also expressed by most interviewees. Among men who received transportation to visits, had injection reminders and had virtual appointments, over 80% rated them useful. Conclusion M6 results show that MSM and TGM report no to little PrEP stigma and anxiety concerns while on CAB LA and that it is feasible and acceptable in their lives. Flexible and virtual appointments and transportation support are helpful while on injectable PrEP. Disclosures Nanlesta Pilgrim, PhD, GSK: Stocks/Bonds (Public Company)|ViiV Healthcare: Employee William M. Valenti, MD, FIDSA, Gilead Sciences: Grant/Research Support|Gilead Sciences: Stocks/Bonds (Public Company)|ViiV Healthcare: Grant/Research Support Bo Li, PhD, GSK: Employee Alison Gaudion, PhD, GSK: Stocks/Bonds (Public Company)|ViiV Healthcare: Employee Deanna Merrill, PharmD, MBA, AAHIVP, GSK: Stocks/Bonds (Public Company)|ViiV Healthcare: Employee Patrick Daniele, MS, GSK: Advisor/Consultant|ViiV Healthcare: Advisor/Consultant Larissa Stassek, MPH, ViiV Healthcare: Advisor/Consultant|ViiV Healthcare: Travel support Riya Moodley, FCP, GSK: Stocks/Bonds (Public Company)|ViiV Healthcare: Employee Toyin Nwafor, MD, GSK: Stocks/Bonds (Public Company)|ViiV Healthcare: Employee Katherine L. Nelson, PhD, MPH, GSK: Stocks/Bonds (Public Company)|ViiV Healthcare: Employee Kimberley Brown, PharmD, GSK: Stocks/Bonds (Public Company)|ViiV Healthcare: Employee Maggie Czarnogorski, MD MPH, GSK: Stocks/Bonds (Public Company)|ViiV Healthcare: Employee

Rethinking gender differences: An investigation of comorbid psychopathology and alcohol use disorder in veterans.

While men have been found to drink more alcohol and have higher rates of alcohol-related mortality, women tend to experience higher rates of alcohol-related consequences, including psychological comorbidities and worse alcohol use disorder (AUD) outcomes. However, gender differences in comorbid psychopathology and associations with AUD outcomes among veterans are less well understood. Veterans (N = 126; 32 women) receiving inpatient treatment for AUD completed baseline clinical measures including the Beck Depression Inventory-II, Beck Anxiety Inventory, Early Life Stress Questionnaire, and PTSD Checklist for DSM-5. Alcohol use was assessed with the Timeline Followback for the 90 days prior to the baseline assessment and again at 1-, 3-, and 6-month follow-ups. Gender differences in baseline alcohol and psychopathology measures were examined using Fisher's exact test and Mann-Whitney U test. Linear/logistic regression was used to examine associations between comorbid psychopathology and alcohol relapse/use severity post-study. Consistent with prior literature, statistically significant gender differences in psychopathology were observed, with women reporting higher anxiety (p < 0.001), depression (p = 0.001), early life stress (p < 0.001), and PTSD (p < 0.001) at baseline. Higher early life stress was also associated with higher anxiety, depression, and PTSD. Statistically significant gender differences were not observed for alcohol use in the 90 days prior to the study. Similarly, gender was not associated with relapse or severity of use at 1-, 3-, or 6-month follow ups (ps > 0.05). Psychopathology measures were not associated with relapse or severity of use at any time point (ps > 0.05). Our study highlights that women veterans are drinking similar quantities of alcohol to men, supporting emerging evidence of a narrowing gender gap in alcohol use. Women also have a higher psychiatric burden than men; thus, identifying ways to mitigate comorbidity among women veterans should be a health priority.

Construction of feature selection and efficacy prediction model for transformation therapy of locally advanced pancreatic cancer based on CT, 18F-FDG PET/CT, DNA mutation, and CA199

BackgroundImmunotherapy and radiotherapy play crucial roles in the transformation therapy of locally advanced pancreatic cancer; however, the exploration of effective predictive biomarkers has been unsatisfactory. With the rapid development of radiomics, next-generation sequencing, and machine learning, there is hope to identify biomarkers that can predict the efficacy of transformative treatment for locally advanced pancreatic cancer through simple and non-invasive clinical methods. Our study focuses on using computed tomography (CT), positron emission tomography/computed tomography (PET/CT), gene mutations, and baseline carbohydrate antigen 199 (CA199) to identify biomarkers for predicting the efficacy of transformative treatment.MethodsWe retrospectively collected data from 70 patients with locally advanced pancreatic cancer who had undergone a biopsy for pathological diagnosis. These patients had complete baseline enhanced CT images and baseline CA199 results. Among them, 65 patients had efficacy evaluation results after 4 treatment cycles, 54 patients had complete baseline PET/CT images, 51 patients had complete DNA mutation detection results, and 34 patients had both complete PET/CT images and DNA mutation detection results. Additionally, 47 patients had complete available CT images at baseline, after 2 treatment cycles, and after 4 treatment cycles. We extracted radiomic features from the original lesion-enhanced CT images (including baseline and subsequent follow-up CT scans), radiomic features from baseline 18F-fluoro-2-deoxy-2-D-glucose (18F-FDG) PET, and patient-specific features related to abdominal and visceral fat. We used short-term and long-term treatment efficacy as the prediction outcomes and performed statistical and machine learning-based feature selection and COX regression analysis to identify potentially predictive features. Subsequently, we separately or in combination modeled the CT features, PET features, baseline CA199, and gene mutation data to construct efficacy prediction models. Finally, we investigated the mixed effects model of the dynamic changes in CT features at baseline, after 2 treatment cycles, and after 4 treatment cycles on the prediction of short-term treatment efficacy.ResultsWe found that a combination of CT radiomic features, including F1_ gray level co-occurrence matrix (GLCM), F2_gray level run length matrix (GLRLM), F5_neighboring gray tone difference matrix (NGTDM), and F6_Shape, PET radiomic features such as visceral adipose tissue (VAT), tumor-to-liver ratio (T/L), standardized uptake value mean (SUVmean), and GLCM, as well as baseline CA199, can be used to predict short-term treatment efficacy. Baseline CA199, GLCM, IntensityDirect, Shape, and PET/CT features are independent factors for long-term treatment efficacy. In constructing the short-term treatment efficacy prediction model, ensemble learning methods such as adaptive boosting (AdaBoost), extreme gradient boosting (XGBoost), and RandomForest performed the best. However, in terms of model interpretability, decision tree methods provide the most intuitive display of the predictive details of the model. For the time series data of patients’ baseline CT, CT after 2 treatment cycles, and CT after 4 treatment cycles, long short-term memory (LSTM) modeling yielded better predictive models.ConclusionA multimodal combination of radiomics, DNA mutations, and baseline CA199 can predict the efficacy of transformative treatment in locally advanced pancreatic cancer. Various feature selection methods and multimodal fusion approaches contribute to guiding personalized and precise treatment for pancreatic cancer.

Identity Pathology and Emptiness as Novel Predictors of Suicidal Ideation.

We examined whether identity pathology was indirectly associated with future SI via emptiness, and tested impulsivity and emotion dysregulation as moderators. Participants (N = 251) completed baseline questionnaires assessing SI, borderline personality disorder symptoms, emotion dysregulation, and impulsivity, and SI 2 months later. Identity pathology was indirectly associated with future SI via emptiness, controlling for baseline SI (β = 0.15, Bootstrap 95% CI = [0.06, 0.24]). There was a two-way interaction between emptiness and both poor use of emotion regulation strategies (β = 0.06, p < 0.001) and impulsive lack of premeditation (β = 0.09, p = 0.03) predicting SI. Those with greater identity pathology were more likely to experience emptiness, which was in turn associated with future SI. Participants who felt empty were also more likely to experience SI when they also reported an inability to use emotion regulation strategies and a tendency to act without considering the consequences. We provide preliminary support for an untested risk pathway for SI, highlighting the need to further study these important experiences.

One is not like the other: health quality of life scores vary in neuromuscular EOS by diagnosis.

The etiology of early-onset scoliosis (EOS) has been shown to significantly influence baseline parent-reported health-related quality of life (HrQOL). In combining these etiology groups, we obligatorily lump together many disparate diagnoses, particularly true in the neuromuscular (NM) cohort. We sought to evaluate the influence of underlying neuromuscular diagnosis on the HrQOL at 5years following surgery for EOS. A retrospective review of a multi-center EOS database was performed. Children treated with primary distraction-based, growth-friendly instrumentation (GFI) for EOS with complete baseline, 2-year, and 5-year post-surgical EOSQs were included. Neuromuscular scoliosis patients, as classified by the C-EOS system, were isolated and subdivided by underlying diagnosis into 5 groups. EOSQ domains and composite HrQOL score at presentation, 2-year, and 5-year follow-up were compared across underlying diagnosis. A total of 65 neuromuscular EOS patients were identified (mean 7.6 ± 1.99years of age, 50% female). Cerebral palsy was the most common underlying diagnosis (30%, N = 18), followed by spinal muscular atrophy (SMA, N = 16). There were differences in EOSQ domains with CP, SMA, and MD having significantly lower scores than Chiari/Syrinx patients at 2-year follow-up. Chiari/Syrinx patients demonstrated EOSQ scores statistically similar to idiopathic EOS patients at all time points (P > 0.05). CP patients were most likely to experience improvement in HrQOL at 5-year follow-up. Underlying NM diagnosis has direct implications on treatment response following GFI for EOS. Cerebral palsy patients demonstrate the best improvement in HrQOL at 5years following surgery while others actually deteriorate over time. Children with EOS related to Chiari and Syringomyelia had similar HrQOL scores to idiopathic EOS and may not be best suited for inclusion in NM cohorts when assessing HrQOL scores following treatment. Increasing population-based HrQOL data may allow further refinement and prognostication of neuromuscular diagnoses over time.

Examining Discrimination as a Distal Moderator of the Proximal Association Between LGBQ+ College Students’ Alcohol Use and Cyber Dating Abuse

Comprehensive and inclusive dating abuse prevention is hindered by a lack of research on proximal antecedents of cyber dating abuse (CDA) among lesbian, gay, bi-/pansexual, queer, and other nonheterosexual (LGBQ+) young adults. Guided by sexual minority stress and alcohol-related violence theories, we addressed this gap by examining whether (a) alcohol use preceded and was positively related to CDA perpetration and (b) more frequent LGBQ+-based discrimination strengthened this association. LGBQ+ college students (N= 41; 75.6% women, 22% men, and 2.4% transgender/nonbinary) completed baseline assessments of past-year LGBQ+-specific discrimination (hostility, heterosexist harassment, and incivility) followed by daily assessments of alcohol use and CDA for 60 days. Multilevel modeling revealed that participants were less likely to perpetrate CDA on days when they consumed more alcohol than usual (adjusted odds ratio [aOR] = .49,p&lt; .001). Individuals who experienced more frequent hostility (aOR = .63,p&lt; .001) and incivility (aOR = .88,p= .003) were less likely to perpetrate CDA. No other main effects or alcohol × discrimination interactions emerged. Alcohol may not be a proximal antecedent of LGBQ+ college students’ CDA. Daily assessments of discrimination and couple-level coping may help clarify the role of LGBQ+-specific discrimination in CDA.

Descriptive norms for simultaneous cannabis and alcohol use predict simultaneous use patterns assessed via daily surveys.

Simultaneous cannabis and alcohol use is common, but few studies have examined normative perceptions of simultaneous use. This study examined unique associations of baseline descriptive norms for simultaneous use (i.e., perceptions about others' simultaneous use) with simultaneous use behaviors assessed via daily surveys. Young adults reporting frequent simultaneous use (N = 150) completed baseline measures of descriptive norms for the frequency of simultaneous use and the amounts of cannabis and alcohol consumed during typical simultaneous use occasions. Further, participants completed measures of descriptive norms for the frequency and quantity of cannabis and alcohol use in general (not limited to simultaneous use). Norms were assessed referencing both peer and friend groups. Following this assessment, participants completed 21 daily smartphone surveys assessing cannabis and alcohol use each day. Simultaneous use was operationalized as same-day use of cannabis and alcohol. Multilevel models revealed that, controlling for descriptive norms for cannabis and alcohol use in general, perceiving more frequent simultaneous use among friends (but not peers) was significantly associated with a greater tendency to engage in simultaneous use relative to cannabis-only use across days. Further, perceiving heavier cannabis and alcohol consumption during simultaneous use occasions among friends (but not peers) was significantly associated with greater quantities of cannabis and alcohol consumed, respectively, across simultaneous use days. Descriptive norms for simultaneous use contribute uniquely to simultaneous use behavior, over and above norms for cannabis use and alcohol use in general. Findings may inform norms-based interventions for young adults who engage in simultaneous use. (PsycInfo Database Record (c) 2025 APA, all rights reserved).

The Impacts of Substance Use and Depression on HIV Pre-Exposure Prophylaxis Use and Adherence Among Sexual and Gender Minority Adolescents and Young Adults in the Keeping it LITE Cohort.

Substance use and depression are prevalent in sexual and gender minorities (SGM), but evidence about their impacts on HIV pre-exposure prophylaxis (PrEP) use is mixed. We assessed these impacts in a US-based cohort of 3,330 young SGM who tested negative for HIV and completed baseline and semiannual assessments on substance use (cocaine, methamphetamine, or heroin), depression, and PrEP use and adherence. We estimated prevalence differences (PDs) to compare baseline and 12-month PrEP use and adherence between participants with and without substance use and depression, separately and jointly. At baseline, 8% of participants reported substance use and depression, 7% reported substance use only, 38% reported depression only, and 47% reported neither. PrEP use was reported by 22%, with 78% reporting prior-day adherence. Compared to participants without depression or substance use, participants with substance use alone were more likely to report PrEP use at baseline (PD = 18.9; 95% CI: 7.6, 30.2) and 12 months (PD = 15.9, 95% CI: 5.1, 26.7), without adherence differences. Depression alone was associated with lower baseline PrEP use (PD=-3.6, 95% CI: -6.7, -0.4) and adherence (PD=-10.0, 95% CI: -18.4, -1.6), but associations attenuated over 12 months. Those with both substance use and depression (vs. neither) reported higher baseline PrEP use (PD = 6.5, 95% CI: -0.6, 13.5) and lower adherence (PD=-12.9, 95% CI: -26.2, 0.5), with associations weakening over 12 months. Substance use and depression had opposing relationships with PrEP use and adherence. In addition to its mental health benefits, depression treatment may improve PrEP uptake and adherence in young SGM.

Access to results of patient reported outcome surveys did not improve longitudinal patient reported outcomes in breast cancer patients in a randomized controlled trial.

We assessed the impact of breast cancer (BC) patients receiving their own patient-reported outcome (PRO) results on future PROs. Newly diagnosed female BC patients completed validated measures of satisfaction with breasts (SB), and psychosocial (PsyW), physical (PhW), and sexual wellbeing (SW) longitudinally during treatment. Patients were randomized to receive their PRO scores (Intervention) or not (Control). The primary outcome was difference in PRO scores from baseline to 1-year post-surgery. T- and chi2-tests compared baseline characteristics between groups. Linear mixed models assessed differences in PRO changes over time. 131 patients (70 intervention, 61 control) completed baseline and 1-year modules; groups were well-balanced. At 1-year, the intervention group had less improvement in PsyW compared to controls with a t-test (mean difference: 1.2 vs 8.3, p​=​0.04); this difference did not remain in mixed models (intervention group effect estimate (SE) 1.7 (2.1) vs control group 7.0 (2.2), p​=​0.08). Changes in SB, PhW, and SW did not differ. Access to individual PRO scores throughout treatment did not improve BC patients' future PROs.

Cognitive and Alzheimer's disease biomarker effects of oral nicotinamide riboside (NR) supplementation in older adults with subjective cognitive decline and mild cognitive impairment.

Age-associated depletion in nicotinamide adenine dinucleotide (NAD+) concentrations has been implicated in metabolic, cardiovascular, and neurodegenerative disorders. Supplementation with NAD+ precursors, such as nicotinamide riboside (NR), offers a potential therapeutic avenue against neurodegenerative pathologies in aging, Alzheimer's disease, and related dementias. A crossover, double-blind, randomized placebo (PBO) controlled trial was conducted to test the safety and efficacy of 8 weeks' active treatment with NR (1 g/day) on cognition and plasma AD biomarkers in older adults with subjective cognitive decline and mild cognitive impairment. The primary efficacy outcome was the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). Secondary outcomes included plasma phosphorylated tau 217 (pTau217), glial fibrillary acidic protein (GFAP), and neurofilament light chain (NfL). Exploratory outcomes included Lumosity gameplay (z-scores) for cognition and step counts from wearables. Mixed model for repeated measures was used for between-group comparisons; paired t-tests were used for within-individual comparisons. Forty-six participants aged over 55 were randomized to NR-PBO or PBO-NR groups; 41 completed baseline visits, and 37 completed the trial. NR supplementation was safe and well tolerated with no differences in adverse events reported between NR and PBO treatment phases. For the between-group comparison, there was a 7% reduction in pTau217 concentrations after taking NR, while an 18% increase with PBO (p = 0.02). No significant between-group differences were observed for RBANS, other plasma biomarkers(GFAP and NfL), Lumosity gameplay scores or step counts. For the within-individual comparison, pTau217 concentrations significantly decreased during the NR phase compared to the PBO (p = 0.02), while step counts significantly increased during the NR phase than PBO (p = 0.04). Eight weeks NR supplementation is safe and lowered pTau217 concentrations but did not alter cognition as measured by conventional or novel digital assessments. Further research is warranted to validate NR's efficacy in altering pathological brain aging processes. The integrated study design combines a two-arm parallel trial with a crossover phase, offering the opportunity to enhance sample size for within-individual analysis and assess carryover effects.NR is safe but did not alter cognition as measured by multi-modal assessments in SCD/MCI.For between-group comparison, pTau217 levels decreased with NR and increased with PBO at 8-week follow-up.For within-individual comparison, step counts increased after NR and decreased after PBO.A larger, longer study with pharmacodynamic and pathophysiological biomarkers is needed to assess NR's disease-modifying effects.

Evaluating translational science knowledge gains following an online short course for a general scientific audience

Abstract Purpose: The translational science workforce requires preparation in both core skills for biomedical research and competencies for advancing progress along the translational pipeline. Delivering this content in a highly accessible manner will help expand and diversify the workforce. Methods: The NCATS Education Branch offers online case study-based courses in translational science for a general scientific audience. The branch updated its course in preclinical translational science with additional content aligned with the NCATS Translational Science Principles, which characterize effective approaches to advance translation. The updated course was offered in 2021 and 2022. The branch also revised the course evaluation to capture knowledge change aligned with the NCATS Translational Science Principles. Results: Of 106 students, 88 completed baseline or endpoint surveys, with 48 completing both. Most found the online format (n = 48; 91%) and case study approach (n = 48; 91%) effective. There was a statistically significant increase in knowledge related to the Translational Science Principles (p &lt; 0.001). Survey items with the highest endpoint scores reflected the principles on creativity and innovation, efficiency, cross-disciplinary team science, and boundary-crossing collaborations. Findings highlighted the effectiveness of pairing a case study with lectures that offer generalizable strategies aligned with the translational science principles. Students reported the course helped them learn about the trajectory of a drug discovery and development initiative, where their own work fit in, and scientific and operational approaches to apply in their own work. Conclusions: This online case study-based course was effective in teaching generalizable principles for translational science to students with varied scientific backgrounds.

Tensor Coupled Learning of Incomplete Longitudinal Features and Labels for Clinical Score Regression.

Longitudinal data with incomplete entries pose a significant challenge for clinical score regression over multiple time points. Although many methods primarily estimate longitudinal scores with complete baseline features (i.e., features collected at the initial time point), such snapshot features may overlook beneficial latent longitudinal traits for generalization. Alternatively, certain completion approaches (e.g., tensor decomposition technology) have been proposed to impute incomplete longitudinal data before score estimation, most of which, however, are transductive and cannot utilize label semantics. This work presents a tensor coupled learning (TCL) paradigm of incomplete longitudinal features and labels for clinical score regression. The TCL enjoys three advantages: 1) It drives semantic-aware factor matrices and collaboratively deals with incomplete longitudinal entries (of features and labels), during which a dynamic regularizer is designed for adaptive attribute selection. 2) It establishes a closed loop connecting baseline features and the coupled factor matrices, which enables inductive inference of longitudinal scores relying on only baseline features. 3) It reinforces the information encoding of baseline data by preserving the local manifold of longitudinal feature space and detecting the temporal alteration across multiple time points. Extensive experiments demonstrate the remarkable performance improvement of our method on clinical score regression with incomplete longitudinal data.

Pediatric SARS-CoV-2 long term outcomes study (PECOS): cross sectional analysis at baseline.

PECOS is an ongoing study aimed to characterize long-term outcomes following pediatric SARS-CoV-2 infection. This is a cross-sectional analysis of infected and uninfected cohorts at baseline. Participants (0-21 years) with laboratory-confirmed SARS-CoV-2 infection were enrolled as infected. Uninfected were defined as individuals without history or laboratory evidence of SARS-CoV-2 infection. Outcome measures included demographics, medical history, review of symptoms, physical exam, cardiopulmonary evaluation and validated psychological and developmental surveys. Primary outcomes were cohort comparisons for abnormalities on all measures. 654 participants (541 infected, 113 uninfected) completed baseline visits by June 30, 2023. Infected participants were more likely to report constitutional (OR: 2.24), HEENT (OR: 3.74); respiratory (OR: 2.41), or gastrointestinal (OR: 2.58) symptoms. Infected had worse scores in domains of Pain, Fatigue, Global Health, Physical and Cognitive functioning, Mobility and Sleep disturbances when compared to uninfected controls using Patient Reported Outcomes. Cardiopulmonary findings were similar among cohorts. The first report of this ongoing longitudinal study demonstrates that infected participants were more likely to report symptoms compared to uninfected controls, which may affect performance and quality of life of these individuals. Longitudinal data will increase understanding of long-term effects of SARS-CoV-2 infection in children. gov Identifier: NCT04830852 IMPACT: This study establishes a large, diverse, prospective, longitudinal, multi-center cohort of children with history of SARS-CoV-2 infection compared to an uninfected cohort to be followed for 3 years. Cross-sectional cohort analysis at study entry showed infected participants were more likely to report constitutional, respiratory, and GI symptoms compared to uninfected controls. Infected participants were more likely to have significantly worse parent-reported performance in 6 of 10 Patient Reported Outcome Measures domains. Continued study of this cohort will help identify clinical sequelae of COVID-19, characterize the immune response to SARS-CoV-2 infection, and identify potential genetic/immunologic factors associated with long-term outcomes.

Examination of Energy Needs and Low Energy Availability Among Historically Black College and University Female Student-Athletes.

This study examined the energy needs and LEA prevalence, with or without eating disorder (ED) risk, among HBCU female student-athletes. Twenty-seven female student-athletes (age = 19 ± 1 year; height = 166.9 ± 7.6 cm; weight = 68.8 ± 11.3 kg) completed baseline measures, including the Eating Disorder Inventory-3 (EDI-3), EDI-3 symptom checklist (EDI-SC), anthropometric measures, and resting metabolic rate (RMR). Participants maintained a dietary log to measure energy intake and wore a heart rate monitor to estimate exercise energy expenditures for 7 days. LEA was defined as <30 kcal/kg of fat-free mass (FFM)/day. The mean energy availability (15.9 ± 10.1 kcal/kg FFM/day) indicated 92.6% of participants (n = 25) displayed LEA; of those, 60% (n = 15) had LEA with ED risk. ED risk was identified in 59.3% of student-athletes (n = 13; EDI-3: n = 2; SC: n = 3; Both: n = 11). Interestingly, of the two student-athletes without LEA, one was identified at risk for EDs using both the EDI-3 and SC. HBCU female student-athletes face high risks of LEA and EDs, with most showing signs of both. This underscores the need for culturally sensitive interventions to improve EA and support mental health in this underserved group. Clinicians should focus on nutrition education and early ED identification to enhance long-term health and athletic performance.

Cross-sectional and longitudinal associations between glycaemic measures and grip strength in people without diabetes in the UK Biobank cohort study.

To investigate associations between glycaemic measures (HbA1c, random glucose), and grip strength (GS) in adults without prevalent diabetes. We included 381,715 UK Biobank participants aged 38-73years without diabetes (any type) with complete baseline measures for GS and HbA1c (main analyses), and glucose (supplementary analyses). Cross-sectional sex- and age-stratified associations between each glycaemic measure, GS, and probable sarcopenia (low GS) were examined with regression analyses. Changes in GS over 8.9years were classified into four groups (decline, stable low, stable high, or reference (increase or maintained within the normal range)) in 36,228 participants and associations with baseline glycaemic measures explored using multinomial regression. Higher HbA1c (mmol/mol) was associated with weaker mean GS (kg) (regression coefficient and 95% confidence intervals (CI): -0.08 (-0.09, -0.07)), and increased odds of probable sarcopenia (odds ratio (OR) and 95% CIs: 1.02 (95% CI: 1.01, 1.02)) in males and across the age groups. In females, higher HbA1c was associated with weaker mean GS only in mid-life (e.g., 50-59years: -0.06 (-0.07, -0.05)). In males, but not in females with repeated GS, higher HbA1c was associated with decreased odds of stable high (0.97 (0.96, 0.99) and increased odds of stable low (1.03 (1.01, 1.04)) GS pattern (0.98 (0.97, 0.980)) over the follow-up. The results for glucose in supplementary analyses were mixed, especially in females. The associations between HbA1c and GS in people without diabetes warrant replication and consideration of the effect on muscle strength when interventions to promote normoglycaemia are trialled.

Evaluating an approach for communicating integrated risk scores for melanoma.

Integrated risk scores (polygenic and non-genetic risk factors) can facilitate risk-stratification, to inform targeted melanoma screening. This mixed-methods pilot study assessed satisfaction, attitudes, and psychosocial impact of a protocol for communicating integrated risk for melanoma using questionnaires (baseline and 1-month post-results) and semi-structured interviews. Affected and unaffected adults enroled in ongoing melanoma studies were recruited to receive their integrated risk booklets and attend a genetic counselling appointment. 35/73 consented to participate; 31 and 33 completed baseline and follow-up questionnaires, respectively. Participants rated the information as useful, felt it motivated favourable health behaviours and were satisfied with the quality and content of the booklet. All participants felt highly empowered managing melanoma risk at baseline and follow-up. Most participants were unsure or felt little to no control over preventing future melanomas, which did not change at follow-up (Chi-square p = 0.73). Genetic-specific distress, and uncertainty was low for all participants post-results. Qualitative interviews supported quantitative findings and highlighted importance of access to a clinician for results interpretation and risk-management. In this high-risk cohort, the communication model was acceptable, and did not result in negative psychosocial sequelae. Findings from this study highlight key considerations for effective communication and delivery of integrated risk which can be used to inform future research in more diverse cohorts for melanoma and other common conditions.

Anhedonia in flux: Understanding the associations of emotion regulation and anxiety with anhedonia dynamics in a sample with major depressive disorder

Negative rumination and emotion regulation difficulties have been consistently linked with depression. Despite anhedonia—the lack of interest in pleasurable experiences—being a cardinal symptom of depression, emotion regulation of positive emotions, including dampening, are considered far less in the literature. Given that anhedonia may manifest through blunted responses to previously positive or enjoyable experiences, it is vital to understand how different positive emotion regulation strategies impact anhedonia symptom severity and how it can vary or change over time. Moreover, understanding the detrimental or protective nature of positive emotion regulation on anhedonia can aid with future anhedonia-focused treatments. Therefore, the current study examined the temporal association between anhedonia dynamics and two different emotion rumination strategies in response to positive emotions: dampening and positive rumination. Depressed persons (N = 137) completed baseline measures of positive emotion regulation, difficulties regulating negative emotions, and anxiety, and completed ecological momentary assessments three times per day for 90 days regarding their depressive symptoms, including anhedonia. We assessed baseline dampening and amplifying scores to predict anhedonia dynamics through four linear models with interactions. Providing partial support for our hypotheses, results indicate that amplifying positivity is positively associated with fluctuations, instability, and acute changes in anhedonia over the course of 90 days; however, neither dampening, difficulties regulating negative emotions, nor anxiety were related to anhedonia dynamics. The current findings suggest that amplifying positivity may be able to predict changes in anhedonia over time and should further be examined as a potential protective factor of anhedonia.

OCT analysis and MPOD assessment in patients affected by retinitis pigmentosa

This study aimed to analyze Optical Coherence Tomography (OCT) parameters and Macular Pigment Optical Density (MPOD) changes in patients affected by Retinitis pigmentosa (RP). Eighteen eyes of 18 patients suffering from early-stage RP were enrolled in our observational study. 18 eyes of 18 patients age and gender matched were enrolled as controls. Patients were analyzed at baseline by undergoing complete baseline ophthalmologic examination, Spectral-domain Optical Coherence Tomography (OCT), Electroretinogram (ERG) and Heterochromatic Flicker Photometry (HFP). Main outcome measures were Macular Pigment Optical Density (MPOD), Central macular thickness (CMT), Central Choroidal Thickness (CCT) and Choroidal Vascularity Index (CVI). Lower CCT (p = 0.006), CVI (p < 0.001) and MPOD levels (p = 0.038) were found in affected patients, whereas higher CMT was detected in cases compared to healthy controls. Correlation analysis revealed the presence of a negative correlation between BCVA and Age and CMT and BCVA and a positive correlation between CCT and MPOD and CVI and CCT. Retinal and choroidal variations occur in patients affected by early-stage RP regarding functional and anatomical changes.