Faculty Bibliography

BackgroundThe decision to undergo deep brain stimulation (DBS) surgery for patients with Parkinson's disease (PD) is often challenging and complex. Decisional outcomes may be improved by using decisional support tools that foster shared decision making.ObjectiveThe objective of this study was to develop a decision aid for PD patients considering DBS surgery and evaluate its acceptability.MethodsThe decision aid was developed using an evidence-based and systematic approach. The steps in development included a needs assessment, literature review, development of a decision aid prototype, and testing of the prototype with surveys for acceptability in a clinic setting.ResultsA total of 136 participants with PD participated in this study. The needs assessment included 57 participants who completed the decisional conflict scale with a mean score of 35.3, indicating high decisional conflict. After development, initial testing of the decision aid was completed by 22 participants (16 on paper version and 6 on interactive website version). Subsequently, 46 PD participants evaluated the decision aid for acceptability. Eighty seven percent of participants agreed or strongly agreed that they were satisfied with the quality of the decision aid. Most participants found the language, amount of information, length, balance, and risk and benefits section acceptable.ConclusionWe determined that PD patients undergoing DBS evaluation experience high decisional conflict. We subsequently created a DBS decision aid to increase knowledge, manage expectations, clarify values, and facilitate shared decision making. The decision aid was acceptable to PD patients with and without DBS.

Despite advances in endoscopic techniques, many colorectal surgeries in the United States are still performed for non-malignant colorectal polyps (NMCRPs). This study evaluated trends, demographic variations, and outcomes of surgeries for NMCRPs among all colorectal surgeries over the past decade. Using the TriNetX nationwide database, we identified adults (≥ 18 years of age) who underwent colectomy or proctectomy for NMCRPs or colorectal cancer between 2013 and 2023. We evaluated the proportion of surgeries performed for NMCRPs, stratified by demographic factors, and compared postoperative adverse events (AEs) between NMCRP and colorectal cancer surgeries. Among 136,721 surgeries, 52,480 (38.4%) were for NMCRPs. The proportion of NMCRP surgeries decreased from 59% in 2013 to 33% in 2023, with the most significant decline between 2013 and 2016. Black individuals showed the highest decrease. Compared with colorectal cancer surgeries, NMCRP surgeries were associated with significantly lower risks of wound, infectious, urinary, pulmonary, gastrointestinal, and cardiac AEs. Although the proportion of NMCRP surgeries has declined, ongoing efforts in education and training are needed to further reduce unnecessary surgeries and improve patient outcomes.

OBJECTIVE:The latest European Medicines Agency (EMA) guideline on the clinical investigation of medicines to treat epileptic disorders was adopted by the EMA Committee for Medicinal Products for Human Use in 2025. We compared this guideline with the previous version (2010), highlighting areas where significant revisions were introduced. METHODS:The 2025 and 2010 versions of the guideline were systematically analyzed to identify significant modifications. RESULTS:The latest EMA guideline incorporated terminology from the 2017 International League Against Epilepsy (ILAE) classification of seizures and epilepsy and the 2022 classification of syndromes and replaced the older term "antiepileptic drug (AED)" with "antiseizure medication (ASM)." Recommendations for add-on studies in common epilepsies have remained substantially unchanged, the main revision being the acceptability of the time-to-event design also for confirmatory trials, provided it is not the only design in the clinical development plan. A major novelty is the feasibility of extrapolating data from add-on trials to the monotherapy indication, provided specific conditions are met. Guidance on pediatric ASM development has been expanded, addressing extrapolation of efficacy from data in adults and older children and options for studies in developmental and epileptic encephalopathies and other rare epilepsies. Compared with the previous guideline, greater emphasis is placed on nonseizure outcomes, including functional, quality of life, and patient-reported outcomes. Two new sections have been introduced, addressing studies in neonates and clinical trials in status epilepticus and other seizure emergencies. Options for innovative designs, including registry-based studies, are also discussed in situations where randomized controlled trials are unfeasible. SIGNIFICANCE/CONCLUSIONS:The updated guideline reflects the changing scenario in epilepsy treatment development, with a greater focus on pediatric epilepsies, rare epilepsies, and other indications with high unmet needs. The updates also reflect the contribution during the consultation process by a wide range of stakeholders, including the ILAE Task Force on Regulatory Affairs.

IMPORTANCE/UNASSIGNED:Lung cancer screening (LCS) with low-dose computed tomography (CT) remains underused in the US, partly because of incomplete smoking history documentation in electronic health records (EHRs) and limited time for shared decision-making in primary care. OBJECTIVE/UNASSIGNED:To determine whether a patient-facing, EHR-integrated tool combined with clinician-facing clinical decision support improves the identification of LCS-eligible patients and the ordering of low-dose CT compared with clinician-facing tools alone. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:This pragmatic, unstratified, randomized clinical trial with parallel groups was conducted from March 29, 2024, to March 28, 2025, at primary care clinics at University of Utah Health and New York University Langone Health. Adults aged 50 to 79 years with a documented smoking history, an active patient portal account, and a primary care visit in the preceding year were included. Study 1 enrolled patients with uncertain LCS eligibility (10 to 19 pack-years, unknown pack-years, or missing quit date); study 2 enrolled patients with documented eligibility (20 or more pack-years and currently smoking or quit smoking within 15 years). INTERVENTIONS/UNASSIGNED:The control included the clinician-facing Decision Precision+ tool (preventive care reminders and a shared decision-making tool). The intervention included the Decision Precision+ tool as well as the MyLungHealth tool, which collected detailed smoking history (study 1) and delivered personalized education and risk/benefit information (studies 1 and 2) via the patient portal in English and Spanish. MAIN OUTCOMES AND MEASURES/UNASSIGNED:The primary outcomes were the proportion of patients newly identified as eligible for LCS (study 1) and low-dose CT ordering rates (study 2) over 12 months. Analyses used intention-to-treat mixed-effects logistic regression. RESULTS/UNASSIGNED:There were 31 303 randomized participants, including 26 729 in study 1 (13 144 [49.2%] female; 13 580 [50.8%] male; median [IQR] age, 62 [55-69] years) and 4574 in study 2 (2230 [48.8%] female; 2344 [51.2%] male; median [IQR] age, 63 [56-69] years). In study 1, the MyLungHealth tool increased new LCS eligibility identification (635 of 13 412 [4.7%] vs 308 of 13 317 [2.3%]; adjusted odds ratio, 2.19; 95% CI, 1.99-2.42; P < .001). In study 2, low-dose CT ordering was higher in the intervention arm (474 of 2312 [20.5%] vs 434 of 2262 [19.2%]; adjusted odds ratio, 1.16; 95% CI, 1.04-1.30; P = .008). CONCLUSIONS AND RELEVANCE/UNASSIGNED:In this randomized clinical trial, integrating a patient-centered tool into primary care EHR workflows increased the identification of patients eligible for LCS and the ordering of low-dose CTs. The relative increases in these primary outcomes were substantial, but absolute increases were more modest. Research on more intensive interventions is warranted to evaluate their ability to further improve LCS screening. TRIAL REGISTRATION/UNASSIGNED:ClinicalTrials.gov Identifier: NCT06338592.

OBJECTIVES/OBJECTIVE:New York has seen increasing utilization of consumer-directed care, whereby recipients of Medicaid-funded personal care hire, train, and supervise their own caregivers. This study evaluates how switching from agency-based to consumer-directed care impacts health, functional, and social outcomes among care recipients. DESIGN/METHODS:Retrospective cohort study. SETTING AND PARTICIPANTS/METHODS:Enrollees in a large health plan in the New York Metropolitan area who received Medicaid-funded personal care. METHODS:Linked 2017-2022 administrative and clinical assessment data were examined for 10,479 health plan enrollees initially receiving agency-based care, of whom 844 (8%) switched to consumer direction during the observation period. Propensity score matching and doubly robust multivariable regression models were used to examine the impact of switching on 5 outcomes: all-cause hospitalization, falls, any decline in social activities, emergency department visits, and functional decline (impairment in activities of daily living). RESULTS:After matching, groups were well-balanced on baseline covariates. Switching to consumer direction was associated with significantly lower odds of hospitalization (OR, 0.45; P < .001), a lower odds of falls (OR, 0.69; P =.032), and a lower odds of decline in social activities (OR, 0.61; P =.006). Switching was also associated with less functional decline (β, -0.09; P < .001). CONCLUSIONS AND IMPLICATIONS/CONCLUSIONS:For those who chose to do so, switching to consumer-directed care was associated with a range of positive outcomes. Reconfiguring older adults' care convoys to include trusted, consistent caregivers may enhance health monitoring and social well-being. Policies that create administrative barriers to choosing consumer-directed care models should be evaluated for their potential to produce unintended health consequences.

BACKGROUND:Access to liver transplantation (LT) for pediatric registrants is complex and impacted by many factors. Assessing the state of pediatric LT requires understanding the balance between policy, the availability of livers, and the quantity of pediatric patients requiring LT. METHODS:Using Scientific Registry of Transplant Recipients data with Cox regression (to compare rates) and competing risk regression (to compare cumulative incidence), we evaluated pediatric patient characteristics, number of registrants transplanted, and waitlist mortality from (January 1, 2017-February 4, 2020) to (May 1, 2020-June 4, 2023) using the implementation of acuity circles to divide the eras. RESULTS:In 4314 pediatric LT registrants, transplantation rate increased in the post-policy era, compared with the pre-policy era (adjusted hazard ratio [HR], 1.05 1.12 1.20 ; P  < 0.001). When accounting for competing risks, the increase was attenuated and not statistically significant (adjusted subdistribution HR, 0.99 1.06 1.14 ; P  = 0.08); recipients were no more likely to die on the waitlist (adjusted subdistribution HR, 0.78 1.01 1.30 ; P  = 0.99). Importantly, the prevalent pediatric waitlist dropped from 396 (2017) to 225 (2023), the rate of deceased donor LT from pediatric donors increased (weighted HR, 1.20 1.31 1.42 ; P  < 0.001), and access to living donor LT increased, compared with the pre-policy era (weighted HR, 1.11 1.33 1.59 ; P  = 0.002). The transplant rate for pediatric patients did not decrease during the study period despite the introduction of acuity circles. During the study period, the prevalent waitlist shrank, access to LT from pediatric donors increased, and access to living donor LT increased. CONCLUSIONS:Comprehensive assessment following the policy change is necessary to ensure that pediatric candidates maintain priority. Changes in pediatric transplantation are modest and likely related to changes in the pool, rather than to the policy of acuity circles.

BACKGROUND/UNASSIGNED:Although infective endocarditis during pregnancy is rare, it carries significant morbidity and mortality for both mother and foetus. While professional societies provide recommendations for the treatment of infective endocarditis, there are no specific guidelines for the management of pregnancy-associated infective endocarditis. In this report, we present two cases of infective endocarditis presenting during the second trimester of pregnancy that required surgical intervention, focusing on the unique considerations when caring for pregnant individuals. CASE SUMMARIES/UNASSIGNED:Two patients in the second trimester of pregnancy presented with fevers and malaise. Both were found to have positive blood cultures and mitral valve vegetations, leading to diagnoses of mitral valve endocarditis. Their hospital courses were complicated by embolic strokes, and one patient required transcatheter embolization of a mycotic aneurysm. Both patients underwent surgical valve replacements with bioprosthetic valves. Ultimately, both patients delivered at term without complication. DISCUSSION/UNASSIGNED:In addition to the standard management of infective endocarditis, pregnancy-associated infective endocarditis requires multidisciplinary collaboration regarding the relative timing of cardiac surgery and delivery, the use of intraoperative foetal monitoring, and the choice of valve replacement and anticoagulation. Each of these decisions requires balancing the risk of morbidity and mortality to the patient, the risk of neonatal prematurity and associated complications and disability, and the risk of foetal death during cardiopulmonary bypass. We discuss our teams' decision-making processes with a focus on the relevant considerations for each of these challenging decisions.

BACKGROUND/UNASSIGNED:Few studies have directly compared limitations in activities of daily living (ADLs) between reverse shoulder arthroplasty (RSA) and anatomic total shoulder arthroplasty (aTSA). This study evaluates ADL function at mid-term follow-up in patients with revision-free RSA and aTSA. METHODS/UNASSIGNED:This retrospective cohort study included 250 patients who underwent primary aTSA (n = 177) or RSA (n = 73) with a minimum follow-up of 7 years (mean 10 ± 2 years). Patients who had revision surgery were excluded. Multivariable ordinal logistic regression analysis was used to assess the odds of RSA patients reporting better ADL function compared to aTSA patients. RESULTS/UNASSIGNED:Postoperatively, a greater proportion of aTSA patients reported normal ADLs compared to RSA patients. On multivariable analysis, controlling for baseline differences, RSA patients reported lower ADL function for personal hygiene/toilet needs (Odds ratio [OR] 0.21 [95% CI: 0.07-0.65]; p = 0.006), washing/combing hair (OR 0.36 [0.13-1.02]; p = 0.049), putting on a button-up shirt (OR 0.08 [0.02-0.25]; p < 0.001), and putting on pants (OR 0.12 [0.03-0.39]; p < 0.001). DISCUSSION/UNASSIGNED:After adjusting for differences in baseline factors, RSA patients reported greater difficulty with specific ADL tasks-including toileting, personal hygiene, grooming, and dressing-compared to aTSA patients. LEVEL OF EVIDENCE/UNASSIGNED:Level III; Retrospective cohort study.

Few prospective benchmark studies exist to characterize the evolving contemporary real-world practice for PTCL. We report the patterns of first-line care and outcomes for 720 patients with systemic PTCL enrolled in two related prospective cohort studies, LEO from 2015-2020 (ClinicalTrials.gov NCT02736357) and MER from 2002-2015, both followed through 2024. The primary endpoints were EFS and OS using Kaplan-Meier estimator and Cox regression model. Secondary endpoints included correlations of clinical and treatment factors with survival. The most common induction regimens were CHOP-based (70%), given as CHOP (36%), CHOP plus etoposide (23%), or CHOP-like plus novel agents (11.5%, including 5% BV-CHP). Consolidative autologous stem cell transplant was performed in 102 patients (14%). Within nodal PTCL, EFS and OS were adversely associated with IPI 2-5 (HR=2.00, 95%CI: 1.59-2.52 for EFS; HR=2.44, 95%CI: 1.86-3.19 for OS), PIT 1-4 (HR=3.02, 95%CI 2.07-4.39 for EFS; HR=5.10, 95%CI 3.01-8.63 for OS), and non-ALCL subtypes (HR=2.97, 95%CI: 2.26-3.91 for EFS; HR=3.71, 95%CI: 2.65-5.20 for OS). Within LEO, which captured increasing first-line etoposide and BV, adding etoposide to CHOP was associated with better OS in ALK-negative ALCL (HR=0.14, 95%CI: 0.03-0.69, p=0.015). BV-CHP showed a trend toward OS improvement in ALCL (HR=0.15, 95%CI 0.02-1.19, p=0.073). Patients failing EFS6 and EFS24 had 5-year subsequent OS of 12% (95% CI: 7.8%, 19%) and 17% (95% CI: 13%, 22%), respectively. The inferior outcomes in non-ALCL subtypes and patients failing EFS6 and EFS24 highlight unmet needs with CHOP-based induction, where clinical trials with targeted therapy should be prioritized.