Faculty Bibliography

PURPOSE/OBJECTIVE:Cancer and its treatments accelerate biological aging. This analysis tested the hypothesis that exercise and diet reduce oxidative stress and prevent telomere shortening in breast cancer survivors. METHODS:) and lymphocyte telomere length. RESULTS:did not correlate with change in telomere length (r = 0.07; 95% CI - 0.07, 0.20). CONCLUSION/CONCLUSIONS:In breast cancer survivors, diet alone or exercise plus diet were associated with reduced oxidative stress but did not change telomere length. This analysis may inform future trials that aim to optimize healthy aging in cancer survivors.

BACKGROUND:The social determinants of health (SDOH) are the conditions in which people are born, grow, work, live, and age. Lack of SDOH training of dental providers on SDOH may result in suboptimal care provided to pediatric dental patients and their families. The purpose of this pilot study is to report the feasibility and acceptability of SDOH screening and referral by pediatric dentistry residents and faculty in the dental clinics of Family Health Centers at NYU Langone (FHC), a Federally Qualified Health Center (FQHC) network in Brooklyn, NY, USA. METHODS:Guided by the Implementation Outcomes Framework, 15 pediatric dentists and 40 pediatric dental patient-parent/guardian dyads who visited FHC in 2020-2021 for recall or treatment appointments participated in this study. The a priori feasibility and acceptability criteria for these outcomes were that after completing the Parent Adversity Scale (a validated SDOH screening tool), ≥ 80% of the participating parents/guardians would feel comfortable completing SDOH screening and referral at the dental clinic (acceptable), and ≥ 80% of the participating parents/guardians who endorsed SDOH needs would be successfully referred to an assigned counselor at the Family Support Center (feasible). RESULTS:The most prevalent SDOH needs endorsed were worried within the past year that food would run out before had money to buy more (45.0%) and would like classes to learn English, read better, or obtain a high school degree (45.0%). Post-intervention, 83.9% of the participating parents/guardians who expressed an SDOH need were successfully referred to an assigned counselor at the Family Support Center for follow-up, and 95.0% of the participating parents/guardians felt comfortable completing the questionnaire at the dental clinic, surpassing the a priori feasibility and acceptability criteria, respectively. Furthermore, while most (80.0%) of the participating dental providers reported being trained in SDOH, only one-third (33.3%) usually or always assess SDOH for their pediatric dental patients, and most (53.8%) felt minimally comfortable discussing challenges faced by pediatric dental patient families and referring patients to resources in the community. CONCLUSIONS:This study provides novel evidence of the feasibility and acceptability of SDOH screening and referral by dentists in the pediatric dental clinics of an FQHC network.

IMPORTANCE:Despite recent growth in online redemption of Supplemental Nutrition Assistance Program (SNAP) benefits, no previous work has tested the impact of economic and behavioral economic strategies on food purchasing behaviors in an online grocery retail setting among adults with low income. OBJECTIVE:To examine the extent to which financial incentives and default shopping cart options influence fruit and vegetable purchases. DESIGN, SETTING, AND PARTICIPANTS:This randomized clinical trial used an experimental online grocery store for adults who currently or have ever received SNAP benefits. From October 7 to December 2, 2021, participants were instructed to shop for a week's worth of groceries for their household, with a budget tailored to household size; no payment was taken. INTERVENTIONS:Random assignment to 1 of 4 conditions: no intervention, 50% discount on eligible fruits and vegetables, prefilled shopping carts with tailored fruit and vegetable items (ie, default options), or a combination of the discount and default options. MAIN OUTCOMES AND MEASURES:The primary outcome was the percentage of nondiscounted dollars spent on eligible fruit and vegetables per basket. RESULTS:Of 2744 participants, mean (SD) age was 46.7 (16.0) years, and 1447 (52.7%) identified as women. A total of 1842 participants (67.1%) reported currently receiving SNAP benefits and 1492 (54.4%) reported shopping online for groceries in the previous 12 months. Participants spent a mean (SD) 20.5% (23.5%) of total dollars on eligible fruits and vegetables. Compared with no intervention, those in the discount condition spent 4.7% (98.3% CI, 1.7%-7.7%) of more total dollars on eligible fruits and vegetables; those in the default condition, 7.8% (98.3% CI, 4.8%-10.7%) more; and those in the combination condition, 13.0% (98.3% CI, 10.0%-16.0%) more (P < .001 for all). There was no difference between the discount and the default conditions (P = .06), but the effect in the combination condition was significantly larger than both discount and default conditions (P < .001). Default shopping cart items were purchased by 679 participants (93.4%) in the default condition and 655 (95.5%) in the combination condition, whereas 297 (45.8%) in the control and 361 (52.9%) in the discount conditions purchased those items (P < .001). No variation was observed by age, sex, or race and ethnicity, and results were similar when those who reported never shopping online for groceries were excluded. CONCLUSIONS AND RELEVANCE:In this randomized clinical trial, financial incentives for fruits and vegetables and default options, especially in combination, led to meaningful increases in online fruit and vegetable purchases among adults with low income. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT04766034.

OBJECTIVE:We sought to evaluate the use of behavioral economics approaches to promote the carrying of epinephrine auto-injectors (EAIs) among adolescents with food allergies. We hypothesized that adolescents who receive frequent text message nudges (Intervention 1) or frequent text message nudges plus modest financial incentives (Intervention 2) would be more likely to carry their epinephrine than members of the usual care control group. METHODS:We recruited 131 adolescents ages 15 to 19 with a food allergy and a current prescription for epinephrine to participate in a cohort multiple randomized controlled trial. Participants were randomly assigned to participate in Intervention 1, Intervention 2, or to receive usual care. The primary outcome was consistency of epinephrine-carrying, measured as the proportion of checkpoints at which a participant could successfully demonstrate they were carrying their EAI, with photo-documentation of the device. RESULTS:During Intervention 1, participants who received the intervention carried their EAI 28% of the time versus 38% for control group participants (P = .06). During Intervention 2, participations who received the intervention carried their EAI 45% of the time versus 23% for control group participants (P = .002). CONCLUSIONS:Text message nudges alone were unsuccessful at promoting EAI-carrying but text message nudges combined with modest financial incentives almost doubled EAI-carriage rates among those who received the intervention compared with the control group. However, even with the intervention, adolescents with food allergies carried their EAI <50% of the time. Alternative strategies for making EAIs accessible to adolescents at all times should be implemented.

Backgroud: Psoriatic arthritis (PsA) is a chronic, inflammatory arthritis that, when left untreated, can lead to erosions, deformities and decrease in quality of life. PsA is known to be associated with multiple comorbidities, including cardiovascular, metabolic and mental health syndromes, all of which can increase its overall morbidity and mortality. Objective: To characterize a cohort of patients with PsA and understand the impact of depression on PsA outcome measures. Methods: 527 consecutive patients with PsA were enrolled in an observational, longitudinal registry that followed them prospectively at standard of care visits. Demographics, medical history, medication use, and clinical exam were all recorded. Results: Depression was reported in 22.8% of the population, anxiety in 18%, and attention deficit hyperactivity disorder in 4%. Depression was more common in female participants (P <.001). At baseline, individuals with PsA and concomitant depression had similar tender and swollen joint counts and RAPID3 compared to those without depression, and had lower body surface area affected by psoriasis (P =.04). At year one, all patients had improvement in clinical outcomes. However, patients with depression had a significantly higher tender joint count compared to those without depression (P =.001), despite similar swollen joint count and body surface area. Conclusion: In patients with depression, there is a discrepancy between improvement in physician assessed measures and patient reported outcomes. These observations underscore the importance of addressing depression and psychological distress as part of PsA treatment outcomes and points towards the need to address residual pain through co-adjuvant approaches.

AIM/OBJECTIVE:Pragmatic clinical trials (PCTs) are randomized trials implemented through routine clinical practice, where design parameters of traditional randomized controlled trials are modified to increase generalizability. However, this may introduce statistical challenges. We aimed to identify these challenges and discuss possible solutions leading to best practice recommendations for the design and analysis of PCTs. METHODS:A modified Delphi method was used to reach consensus among a panel of 11 experts in clinical trials and statistics. Statistical issues were identified in a focused literature review and aggregated with insights and possible solutions from experts collected through a series of survey iterations. Issues were ranked according to their importance. RESULTS:Twenty-seven articles were included and combined with experts' insight to generate a list of issues categorized into participants, recruiting sites, randomization, blinding and intervention, outcome (selection and measurement) and data analysis. Consensus was reached about the most important issues: risk of participants' attrition, heterogeneity of "usual care" across sites, absence of blinding, use of a subjective endpoint and data analysis aligned with the trial estimand. Potential issues should be anticipated and preferably be addressed in the trial protocol. The experts provided solutions regarding data collection and data analysis, which were considered of equal importance. DISCUSSION/CONCLUSIONS:A set of important statistical issues in PCTs was identified and approaches were suggested to anticipate and/or minimize these through data analysis. Any impact of choosing a pragmatic design feature should be gauged in the light of the trial estimand.

BACKGROUND: While most meningiomas are considered benign tumors, a subset of these tumors are characterized by a more aggressive clinical course and require multimodal treatment. Beyond surgical and radiotherapeutic options, there are no effective medical treatments available. Somatostatin receptor 2 (SSTR2) is expressed by the majority of meningiomas. 177Lu-DOTATATE is a SSTR2-targeting radionuclide that has been successful in neuroendocrine tumors. Here we report the results of the interim analysis of an ongoing clinical trial (NCT03971461) that is evaluating the effect of 177Lu-DOTATATE in treating progressive intracranial meningiomas.
METHOD(S): In this Simon two-stage design phase II study, adults with advanced intracranial meningiomas received 177Lu-DOTATATE 7.4 GBq (200 mCi) every eight weeks for four doses. 68Ga-DOTATATE PET-MRI was performed before and at the end of treatment. The primary endpoint was progression-free survival at 6 months (PFS-6). Correlative studies evaluated the association of PFS-6, objective response rate, progression-free survival, overall survival with radiographic tumor measurements, 68Ga-DOTATATE uptake on PET-MRI, SSTR2 expression in tumor, and meningioma methylation subclass.
RESULT(S): Fourteen patients (F = 11, M = 3) with progressive meningiomas (WHO I = 3, II = 10, III = 1) have been enrolled. Median age was 63.1 (range 49-78) years. All patients previously underwent tumor resection and at least one course of radiation. Treatment with 177Lu-DOTATATE was well tolerated, no treatment-limiting toxicities were observed. Six of 14 patients (42%) achieved PFS-6. Radiographically, all six patients had achieved Stable Disease. A functional alteration of tumoral SSTR2 expression by 68Ga-DOTATATE PET-MR imaging was observed in three patients.
CONCLUSION(S): Treatment with SSTR2- targeting 177Lu-DOTATATE is well tolerated. In this interim analysis, six of 14 patients achieved PFS-6. This exceeds the predefined threshold to continue to stage two of this study. This clinical trial is now open to patient enrollment at two study sites in the US