Faculty Bibliography

Restaurants are important institutions in the communities' economy with the potential to promote healthier foods but have been under-engaged in public health nutrition efforts. In particular, independently owned, minority-serving and minority-owned restaurants, remain under-represented in nutrition promotion efforts despite disproportionate burdens of diet-related health outcomes among minority populations. Addressing this gap in engagement, we undertook a process of co-designing and implementing healthy eating-focused interventions in two Latin American restaurants in New York City, combining the Behavior Change Wheel intervention development framework with a Human-Centered Design approach. Restaurant owners and chefs were involved in the research synthesis and solution development processes, resulting in two tailored interventions. This paper describes this co-development process and offers reflections and lessons regarding: (1) implementation research in community settings, (2) the application of Human-Centered Design to promote the uptake of community-based interventions on food and health equity, and (3) the combined use of Human-Centered Design and Implementation science in these complex community settings.

BACKGROUND/UNASSIGNED:In Part 1 of the phase III RUBY trial (NCT03981796) in patients with primary advanced or recurrent endometrial cancer (EC), dostarlimab plus carboplatin-paclitaxel (CP) significantly improved progression-free survival and overall survival compared with CP alone. Limited safety data have been reported for the combination of immunotherapies plus chemotherapy in this setting. OBJECTIVES/UNASSIGNED:The objective of this analysis was to identify the occurrence of treatment-related adverse events (TRAEs) and immune-related adverse events (irAEs) and to describe irAE management in Part 1 of the RUBY trial. DESIGN/UNASSIGNED:RUBY is a phase III, randomized, double-blind, multicenter study of dostarlimab plus CP compared with CP alone in patients with primary advanced or recurrent EC. METHODS/UNASSIGNED:Patients were randomized 1:1 to dostarlimab 500 mg, or placebo, plus CP every 3 weeks for 6 cycles, followed by dostarlimab 1000 mg, or placebo, every 6 weeks for up to 3 years. Adverse events (AEs) were assessed according to Common Terminology Criteria for Adverse Events, version 4.03. RESULTS/UNASSIGNED:The safety population included 487 patients who received ⩾1 dose of treatment (241 dostarlimab plus CP; 246 placebo plus CP). Treatment-emergent AEs were experienced by 100% of patients in both arms. TRAEs occurred in 97.9% of the dostarlimab arm and 98.8% of the placebo arm.The most common TRAEs occurred at similar rates between arms and were mostly low grade. IrAEs occurred in 58.5% of patients in the dostarlimab arm and 37.0% of patients in the placebo arm. Dostarlimab- or placebo-related irAEs were reported in 40.7% of patients in the dostarlimab arm and 16.3% of the placebo arm. CONCLUSION/UNASSIGNED:The safety profile of dostarlimab plus CP was generally consistent with that of the individual components. Dostarlimab plus CP has a favorable benefit-risk profile and is a new standard of care for patients with primary advanced or recurrent EC. TRIAL REGISTRATION/UNASSIGNED:NCT03981796.

Sexual and gender minority (SGM) individuals smoke at higher rates than their heterosexual and cisgender peers. SGM persons, especially transgender and gender diverse (TGD) individuals, face unique, adverse health effects associated with smoking. As such, SGM individuals may benefit from smoking cessation interventions that are tailored to meet their needs. This systematic review aims to describe the ways in which these interventions have been tailored for SGM individuals and summarize available acceptability and efficacy data. Four databases were searched to identify smoking cessation interventions adapted for SGM populations. Thirteen articles were identified, with tailored aspects focusing on culturally tailored references, SGM-specific psychoeducation, and intra-community support strategies. No clear patterns of efficacy were identified, and only one study included bioverified abstinence. Preliminary evidence suggests that smoking cessation interventions can be acceptably tailored to SGM individuals, however, additional research is needed to determine if SGM-tailored interventions are more efficacious than non-tailored approaches.

PURPOSE/UNASSIGNED:The etiopathogenesis of coronal nonsyndromic craniosynostosis (cNCS), a congenital condition defined by premature fusion of 1 or both coronal sutures, remains largely unknown. METHODS/UNASSIGNED:We conducted the largest genome-wide association study of cNCS followed by replication, fine mapping, and functional validation of the most significant region using zebrafish animal model. RESULTS/UNASSIGNED:intron and enriched in 4 rare risk variants. In zebrafish, the activity of the transfected human eDlx36 enhancer was observed in the frontonasal prominence and calvaria during skull development and was reduced when the 4 rare risk variants were introduced into the sequence. CONCLUSION/UNASSIGNED:Our findings support a polygenic nature of cNCS risk and functional role of craniofacial enhancers in cNCS susceptibility with potential broader implications for bone health.

BACKGROUND:Biportal endoscopic transforaminal lumbar interbody fusion (BE-TLIF) is a minimally invasive surgical technique for treating degenerative lumbar spine conditions. It offers advantages such as reduced soft tissue trauma and lower infection rates, but certain technical aspects may be challenging. The current study aims to identify strategies to enhance the fusion rate in BE-TLIF by addressing these specific challenges. METHODS:A literature review was conducted on techniques to improve fusion rates in BE-TLIF. RESULTS:The review suggests that lateral-based portals supplemented with medial portals allowed for safe insertion of interbody cages with large footprint. Direct visualization of the disc space with a 30° endoscope assisted with better disc space preparation. Facetectomies performed with osteotomes, rather than burrs, ensured maximum retrieval of autologous bone graft. Utilizing bone morphogenetic proteins with sustained release carriers such as hydroxyapatite can be useful to increase fusion rates of BE-TLIF. CONCLUSIONS:To our knowledge, the current literature is the first comprehensive review of strategies to enhance fusion rates in BE-TLIF. The proposed techniques and biological adjuncts are effective means to address key challenges associated with the procedure, and such strategies would potentially shorten the learning curve and improve clinical outcomes. Further clinical studies are required to validate these findings and establish standardized protocols. CLINICAL RELEVANCE/CONCLUSIONS:These findings provide practical solutions to overcome common challenges in BE-TLIF. The suggested techniques would reduce the incidence of pseudarthrosis, improve patient outcomes, and ultimately offer a safer and more reliable option for lumbar interbody fusion patients.

OBJECTIVE:To evaluate implementation of a patient decision aid for symptomatic uterine fibroid management to improve shared decision-making at five clinical settings across the United States. METHODS:We used a type 3 hybrid effectiveness-implementation stepped-wedge design and the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) planning and evaluation framework. We conducted clinician training, monthly reach tracking with feedback to site clinical leads, patient and clinician surveys, and visit audio-recordings. Implementation strategies included assessment of organizational readiness for shared decision-making, synchronous clinician training, audit and feedback of decision aid reach, and access to multiple decision aid formats. Outcomes and analyses included patient-level reach, clinician-level adoption, and associations of patient-reported decision aid exposure (as treated) and setting-level implementation (intention-to-treat) with patient-reported (collaboRATE measure) and observed (OPTION-5 measure) shared decision-making. We also designed and assessed setting-level plans for sustainability and other factors impacting sustained decision aid use. RESULTS:The decision aid was adopted by 72 of the 74 eligible gynecologists (97%) and reached 2553 patients across five settings. CollaboRATE scores improved among patients who reported receiving the decision aid (as-treated analysis, 69% vs. 59%; OR 1.6, 95% CI 1.16-2.27). CollaboRATE scores remained consistent before and after setting-level decision aid implementation (intention-to-treat analysis, 64% vs. 63%; OR 0.86, 95% CI 0.61-1.22). Participants would prefer to receive a decision aid at multiple time points (91.9% before the visit, 90.7% during the visit, 86.5% after the visit). Shared decision-making experiences did not improve when comparing pre vs. post-implementation collaboRATE scores across included settings (intention-to-treat, 64% vs. 63%; OR 0.86, 95% CI 0.61-1.22). CONCLUSION:When patients with symptomatic uterine fibroids are given decision aids, they report higher shared decision-making scores. However, the differences we observed between the as-treated and intention-to-treat results suggest that unaddressed implementation challenges continue to limit the extent to which patients receive decision aids and likely hinder their overall impact. Future efforts to implement decision aids should explore enhancing their integration into clinical workflows and standard operating procedures, supported by organizational incentives that prioritize shared decision-making. TRIAL REGISTRATION:ClinicalTrials.gov NCT03985449; registered 6 June 2019.

OBJECTIVE:This study aimed to identify predictors of brain CT abnormalities in patients who sustained a mild traumatic brain injury (mTBI). METHODS:Retrospective observational cohort of adult patients with mTBI (Glasgow Coma Score 13-15) that occurred within the preceding 24 h. RESULTS:2548 (91%) of the cohort had a brain CT and 698 (27%) demonstrated abnormal findings. The most frequently observed CT abnormalities were bleeding (638, 25%) and fractures (190, 7.4%). Multivariate logistic regression analysis revealed several significant predictors associated with the presence of brain CT abnormalities including older age [P < 0.0001], male sex [P < 0.0001], loss of consciousness [P = 0.0041], associated vomiting [P = 0.0011], alteration of consciousness (AOC) [P = 0102], and GCS score [P < 0.0001]. This was a robust model with an R² of 14.2%. CONCLUSION/CONCLUSIONS:In this retrospective analysis, older age, male sex, the presence of loss of consciousness or alteration in consciousness, lower GCS score, and associated vomiting were found to be significant predictors of having an abnormal brain CT. These findings highlight the importance of considering these factors when determining the necessity of brain CT scans in patients with mTBI and suggest that existing clinical decision rules may be limited. These findings may also help to inform clinical decision rules. Early identification of individuals at a higher risk of CT abnormalities may assist in appropriate management and allocation of healthcare resources.

In the past decade, there have been substantial changes in diagnostic nomenclature. This study investigated sex differences in attention-deficit/hyperactivity disorder (ADHD) symptom severity based on Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV, DSM-IV(TR), and DSM-5 criteria, separating rating scale and clinical interview data in children and adults with ADHD. PubMed, PsycINFO, and Scopus were searched for published studies (1996-2021) reporting severity of attention, and hyperactivity/impulsivity in males and females. We compared data: (1) across the entire lifespan aggregating rating scale and clinical interview data (51 studies), (2) drawing solely on rating scale data (18 studies), and (3) drawing solely on clinical interview data (33 studies). Fifty-two studies met inclusion criteria comparing data for females (n = 8423) and males (n = 9985) with ADHD across childhood and/or adulthood. In total, 15 meta-analyses were conducted. Pooled data across the lifespan aggregating both rating scale and clinical diagnostic interview data, showed males had significantly more severe hyperactivity/impulsivity symptoms than females. Rating scale data were similar; boys had significantly more severe hyperactivity/impulsivity than girls. In adulthood, men were rated to have significantly more severe inattention than women with no difference in the hyperactivity/impulsivity dimension. All significant differences were of small effect size. No significant sex differences in the severity of symptoms emerged for clinical interview data for children or adults, in contrast. Possible reasons for the discrepancy in findings between rating scales and clinical diagnostic interviews are discussed.

OBJECTIVE/UNASSIGNED:To evaluate for equivalence in postoperative changes of speech recognition scores in a veteran patient population undergoing cochlear implantation (CI) compared to matched nonveteran patients. STUDY DESIGN/UNASSIGNED:Retrospective chart review. SETTING/UNASSIGNED:Tertiary referral center. PATIENTS/UNASSIGNED:A total of 83 veteran patients who underwent CI at a single Veterans Affairs Medical Center (VA cohort) were matched to 83 nonveteran patients from the Health Insurance Portability and Accountability Act-secure, Encrypted, Research, Management and Evaluation Solution database (HERMES cohort) based on age, sex, and baseline Consonant-Nucleus-Consonant (CNC) scores. INTERVENTION/UNASSIGNED:Patients underwent CI. MAIN OUTCOME MEASURES/UNASSIGNED:Comparison of postoperative CNC and Arizona Biomedical Institute recognition scores. RESULTS/UNASSIGNED:The mean difference and lower confidence interval of CNC scores between matched Veterans Affairs and HERMES cohorts were within a -ΔNI boundary of -15% at the 3-month (mean = 6.15, lower confidence interval = -2.38), 6-month (mean = 7.36, lower confidence interval = -2.21), and 12-month (mean = 4.03, lower confidence interval = -4.88) postoperative time points. The mean difference and lower confidence interval of Arizona Biomedical Institute scores between cohorts were within the -ΔNI boundary of -30% at 3 months (mean = 1, lower confidence interval = -8.71), 6 months (mean = 0.31, lower confidence interval = -12.30), and 12 months (mean = 0.72, lower confidence interval = -10.48). CONCLUSION/UNASSIGNED:Our veteran population demonstrated improvements in speech recognition scores after CI comparable to a matched nonveteran population. Although veterans face unique factors that affect their hearing, access to medical care, and baseline general health, these findings affirm appropriate veteran candidates should be offered CI.