Faculty Bibliography

BACKGROUND:Black communities, compared to White communities, are disproportionately targeted with more unhealthy food advertisements on television and social media. Exposure to unhealthy food and beverage marketing is associated with appetitive sensations, purchase intention, and intake behaviors, which may contribute to poor overall diet quality and worsening nutritional disparities in Black communities. Despite the negative effects, food and beverage companies are expanding their reach and harnessing advanced technology to create immersive experiences using virtual reality (VR). Black young adults may be uniquely vulnerable. OBJECTIVE:We aim to explore the effect of a VR-based fast-food marketing experience (compared with a VR-based nonfood control) on purchase intention, arousal, and hunger in a sample of Black and White young adults. METHODS:We will recruit 200 Black and White young adults (aged 18-24 years) from the New York City metropolitan area for a 1-time, 2-hour laboratory-based study. After screening and obtaining informed consent, eligible participants will be randomized to 1 of 2 VR conditions: a VR-based fast-food marketing experience (Wendyverse; experimental) or a VR-based nonfood control (Nikeland). In the Wendyverse, users can order from the restaurant operated by Wendy's, play games, meet others who may be visiting the Wendyverse, and access codes that can be used to obtain free food at physical restaurants. The control condition will be the Nikeland app, where participants can play sports, try on apparel, and engage with celebrity athletes. Study personnel will provide a 5-minute training session to participants before beginning the experiment to ensure that they feel comfortable in the VR environment. Participants will otherwise engage with the VR app independently. The primary outcomes will be fast-food purchase intention, assessed via a self-report questionnaire; arousal, assessed via electrodermal activity or skin conductance; and hunger, assessed via salivary reactivity. We will also conduct secondary analyses to examine interactions by race, ethnicity, and food or nutrition insecurity as a proxy for socioeconomic status. Analyses of covariance and multiple linear regressions will be conducted to examine the effects of VR-based fast-food marketing exposure on the relevant outcomes (compared to the control). RESULTS:This study was funded by the National Institute on Minority Health and Health Disparities in September 2024. Recruitment is expected to begin in September 2025. We expect to complete data collection by October 2026 and begin data cleaning and analysis in November 2026. CONCLUSIONS:On the basis of previous research and data, we anticipate that young adults randomized to view VR-based food and beverage marketing will self-report higher purchase intention and demonstrate stronger arousal and hunger. The data will be used to support future research and improve the understanding of the effects of digital forms of unhealthy food and beverage marketing on young people. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov NCT06917391; https://clinicaltrials.gov/study/NCT06917391. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)/UNASSIGNED:PRR1-10.2196/69096.

Poor diet quality is a leading risk factor for cardiometabolic disease (ie, diabetes and diseases associated with metabolism and inflammation), which is present in about half of American adults. Support has grown for incorporating the provision of healthy food as a complement to or a component of clinical care. Such "Food Is Medicine" programs provide free or subsidized healthy food directly to patients in close coordination with the health care system. In this review, we systematically examined published randomized controlled trials examining Food Is Medicine programs in the United States, categorizing them into different stages of development using the National Institutes of Health Model for Behavioral Intervention Development. This review identified a total of 14 randomized controlled trials of Food Is Medicine interventions in the United States with noncommunicable disease outcomes, more than one-third of which were early-stage smaller-scale trials (stage 1 randomized controlled trials). Broad variations in populations enrolled; intervention design, duration, and intensity; and outcomes precluded many direct comparisons between studies. Randomized controlled trial data were generally consistent with findings in the observational literature, indicating that common Food Is Medicine approaches often positively influence diet quality and food security, which are theorized to be key mediators for clinical outcomes. However, the impact on clinical outcomes was inconsistent and often failed to reach statistical significance. These observations highlight the need for larger, higher-quality Food Is Medicine studies focusing on the measurement of clinical outcomes within well-designed programs and the need for additional randomized controlled trials that more systematically map out the relationship between participation in different types of Food Is Medicine programs and health outcomes.

Millions of Americans affected by Long COVID (LC) report difficulty accessing care and support. One barrier is obtaining a diagnosis. In response, US federal agencies commissioned a National Academies of Sciences, Engineering, and Medicine (NASEM) committee to re-examine the existing federal definitions for LC. The Committee concluded that LC is "an infection-associated chronic condition (IACC) occurring after SARS-CoV-2 infection that is present for at least 3 months as a continuous, relapsing and remitting, or progressive disease state that can present as singular or multiple symptoms and/or diagnosable conditions." The full report was released in June 2024. We briefly highlight features and aspects of the definition that may help clinicians identify those who remain undiagnosed and improve care for all LC patients.

BACKGROUND:While fatal food-induced anaphylaxis is rare, adolescence is the period of highest risk. However, we lack strong estimates of the incidence of food allergic reactions among adolescents. OBJECTIVE:To estimate the incidence of food allergic reactions and anaphylactic reactions among adolescents with food allergy who have a prescription for epinephrine. METHODS:As part of a cohort study that was embedded in a randomized trial to promote safe food allergy management, we followed adolescents ages 15-19 years with food allergy and a current prescription for epinephrine for a period of 15 months in 2019-2020. At monthly intervals, participants were asked, via text message check-in, whether they had experienced a food allergic reaction due to accidental exposure to food allergens in the past month. RESULTS:Among the cohort of 131 adolescents, 112 answered at least one of the 15 monthly check-ins. Together, these respondents contributed 742 person-months of follow-up data out of a total possible 1,680 person-months. Over the 15-month study period, the incidence of food allergic reactions among adolescents with food allergy was 34.0 events per 100 person-years (95% CI: 21.0, 51.9). The incidence of food allergic reactions meeting the criteria for anaphylaxis was 16.2 events per 100 person-years (95% CI: 7.8, 29.7). CONCLUSION/CONCLUSIONS:Data on the incidence of food allergic reactions can help set expectations for safe food allergy management for adolescents and their families and can help inform discussions between patients, families, and physicians regarding different treatment options available and their associated risks and benefits.

BACKGROUND:Dickkopf-related protein 1 (DKK1) is a Wingless-related integrate site (Wnt) signaling modulator that is upregulated in prostate cancers (PCa) with low androgen receptor expression. DKN-01, an IgG4 that neutralizes DKK1, delays PCa growth in pre-clinical DKK1-expressing models. These data provided the rationale for a clinical trial testing DKN-01 in patients with metastatic castration-resistant PCa (mCRPC). METHODS:(combination) for men with mCRPC who progressed on ≥1 AR signaling inhibitors. DKK1 status was determined by RNA in-situ expression. The primary endpoint of the phase 1 dose escalation cohorts was the determination of the recommended phase 2 dose (RP2D). The primary endpoint of the phase 2 expansion cohorts was objective response rate by iRECIST criteria in patients treated with the combination. RESULTS:18 pts were enrolled into the study-10 patients in the monotherapy cohorts and 8 patients in the combination cohorts. No DLTs were observed and DKN-01 600 mg was determined as the RP2D. A best overall response of stable disease occurred in two out of seven (29%) evaluable patients in the monotherapy cohort. In the combination cohort, five out of seven (71%) evaluable patients had a partial response (PR). A median rPFS of 5.7 months was observed in the combination cohort. In the combination cohort, the median tumoral DKK1 expression H-score was 0.75 and the rPFS observed was similar between patients with DKK1 H-score ≥1 versus H-score = 0. CONCLUSION/CONCLUSIONS:DKN-01 600 mg was well tolerated. DKK1 blockade has modest anti-tumor activity as a monotherapy for mCRPC. Anti-tumor activity was observed in the combination cohorts, but the response duration was limited. DKK1 expression in the majority of mCRPC is low and did not clearly correlate with anti-tumor activity of DKN-01 plus docetaxel.

OBJECTIVE:To compare the pre-post intervention findings of dentists remotely trained to use shared decision-making (SDM) and motivational interviewing (MI) techniques. METHODS:In partnership with the New York Simulation Center for the Health Sciences and a Motivational Interviewing Network of Trainers consultant, three scenarios regarding interprofessional care were developed toward fostering the essential skills to build nonjudgmental dentist-patient partnerships: (1) screening and referral for the social determinants of health with an older adult dental patient; (2) parental consideration of the human papillomavirus vaccine for a 9-year-old dental patient; and (3) engagement with an obese adolescent dental patient to decrease their sugary drink intake. A Welch t-test was used to compare the importance and confidence ruler poll ratings pre-post intervention. RESULTS:In Fall 2024, four remote objective structured clinical exercise training sessions were conducted where standardized participants previously trained as patients rotated between three different breakout rooms so that dentist learners were able to participate in all three scenarios. The subset of dentist learners who responded to both the pre- and post-intervention surveys (37%) reported both greater use and usefulness of MI when discussing oral health recommendations with their patients/parents after the training. Poll results with 16 dentist learners were that they were more likely to feel confident in using SDM and MI techniques with parents/patients post- versus pre-intervention: mean difference [95% confidence interval] = 1.12 [-0.16, 2.41]. CONCLUSIONS:Respectful, participatory training strategies can shift the focus from healthcare providers as the authorities to patients as the agents of their behavior change.

IMPORTANCE/UNASSIGNED:Evidence regarding suppressive valacyclovir treatment on postherpetic neuralgia is necessary to guide care. OBJECTIVE/UNASSIGNED:To test the hypothesis that suppressive treatment with 1000 mg/d of oral valacyclovir for 12 months reduces the prevalence, severity, and duration of postherpetic neuralgia compared with placebo at 12 and 18 months in participants with herpes zoster ophthalmicus (HZO). DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:Multicenter, placebo-controlled randomized clinical trial including 527 immunocompetent, nonpregnant adults with history of HZO rash, documented keratitis, or iritis within 1 year and an estimated glomerular filtration rate of 45 mL/min/1.73 m2 or greater. The study was conducted at 95 participating sites (in Canada, New Zealand, and the US) from November 2017 to June 2024 and participant visits occurred every 3 months. INTERVENTION/UNASSIGNED:Treatment with 1000 mg/d of valacyclovir or placebo for 12 months. MAIN OUTCOMES AND MEASURES/UNASSIGNED:Prevalence of postherpetic neuralgia, severity as determined by pain score (a score of ≥3 on a scale of 1-10), pain duration (≥3 months after HZO onset), and total daily dose of pain medication. RESULTS/UNASSIGNED:Of the 527 participants (490 completed 12 months of treatment and 460 completed 18 months), 73 (14%) had postherpetic neuralgia and were analyzed by age at HZO onset (<60 years or ≥60 years) and disease duration (recent [<6 months] or chronic [≥6 months]). Of the 73 participants with postherpetic neuralgia (34 in the valacyclovir group and 39 in the placebo group), the mean age was 62.4 years (SD, 13.6 years), 59% were female, 5% were Black or African American, and 10% were Hispanic. The prevalence of postherpetic neuralgia at 12 months was not reduced by valacyclovir (12/32 [38%]) compared with placebo (14/35 [40%]) (between-group difference, 2.5% [95% CI, -20.8% to 25.8%]; P>.99). The participants who were younger than 60 years at HZO onset and had a chronic disease duration had lower pain scores in the valacyclovir group (mean score, 0.3 [SD, 0.9]) vs the placebo group (mean score, 0.8 [SD, 1.9]) at 12 months (P = .045) and at 18 months (mean score, 0.2 [SD, 0.9] vs 1.0 [SD, 2.3], respectively; P = .02). There was a decrease in pain duration in the valacyclovir group at 18 months (mean, 13.6 [SD, 11.4] months) vs the placebo group (mean, 18.7 [SD, 29.5] months) (linear mixed-effects model between-group difference, -3.39 months [95% CI, -6.73 to -0.04 months]; P = .046). The total daily dose of neuropathic pain medication was lower in the valacyclovir group (mean, 271.4 [SD, 593.8] mg/d) vs the placebo group (mean, 363.4 [SD, 592.2] mg/d) at 12 months (linear mixed-effects model P = .006) and at 18 months (mean, 209.0 [SD, 412.8] mg/d vs 286.2 [SD, 577.9] mg/d, respectively; linear mixed-effects model P = .01). CONCLUSIONS AND RELEVANCE/UNASSIGNED:One year of suppressive treatment with valacyclovir was associated with a lower dosage of neuropathic pain medication. Participants in the valacyclovir group, who were younger at HZO onset and had a chronic disease duration, had lower pain scores. These secondary outcomes support consideration of 1 year of suppressive treatment with valacyclovir to reduce dosage of pain medications and pain due to HZO. TRIAL REGISTRATION/UNASSIGNED:ClinicalTrials.gov Identifier: NCT03134196.

IMPORTANCE/UNASSIGNED:High-quality evidence regarding suppressive valacyclovir treatment in herpes zoster ophthalmicus (HZO) is necessary to guide care. OBJECTIVE/UNASSIGNED:To determine whether suppressive valacyclovir compared with placebo delays the occurrence of new or worsening stromal keratitis (SK), endothelial keratitis (EK), iritis, or dendriform epithelial keratitis (DEK) during 12 months of treatment and if treatment benefit persisted at 18 months (secondary end point). DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:The Zoster Eye Disease Study (ZEDS) was a randomized clinical trial conducted in 95 sites from November 2017 to June 2024. Immunocompetent, nonpregnant adults with a history of an HZO rash, documented active keratitis or iritis within 1 year, and an estimated glomerular filtration rate of 45 mL/min/1.73 m2 or greater were eligible. After determined to be eligible, participants were randomized in 4 strata: age at onset (<60 years vs ≥60 years) and disease duration (<6 months vs ≥6 months). INTERVENTIONS/UNASSIGNED:A total of 12 months of double-masked daily valacyclovir, 1000 mg, or placebo. MAIN OUTCOMES AND MEASURES/UNASSIGNED:The primary outcome was time to first occurrence within 12 months of new or worsening SK, EK, iritis, or DEK. RESULTS/UNASSIGNED:A total of 527 participants (median [IQR] age, 60 [50-68] years; 266 female [50.5%]; 266 in the valacyclovir group; 261 in the placebo group) were randomized in 4 strata; 481 completed 12 months, and 460 completed 18 months. Data were analyzed by intention to treat. At 12 months, primary end points occurred in 86 participants (33%) assigned to placebo and 74 (28%) assigned to valacyclovir, and at 18 months in 104 participants (40%) assigned to placebo and 86 (32%) assigned to valacyclovir. The hazard ratio (HR) of the primary end point at 12 months was 0.77 for participants taking valacyclovir vs placebo (HR, 0.77; adjusted 95% CI, 0.56-1.05; P = .09) and 0.73 at the secondary end point at 18 months (HR, 0.73; adjusted 95% CI, 0.55-0.97; P = .03). There was a reduction of multiple other secondary end points at 12 months (HR, 0.70; 95% CI, 0.52-0.95; P = .02) and 18 months (HR, 0.72; 95% CI, 0.55-0.95; P = .02). CONCLUSIONS AND RELEVANCE/UNASSIGNED:Although the primary outcome did not show a benefit of suppressive valacyclovir treatment, secondary study outcomes showed treatment superiority at the 18-month end point and reduced number of multiple episodes of keratitis or iritis at both 12 and 18 months. These results support consideration of 1 year of suppressive valacyclovir treatment for HZO. TRIAL REGISTRATION/UNASSIGNED:ClinicalTrials.gov Identifier: NCT03134196.

Acne is a common skin condition, but little data exist on the comparative efficacy of topical acne therapies. We conducted a systematic review and network meta-analysis to evaluate the efficacy of topical therapies for mild-to-moderate acne. Searches in PubMed/MEDLINE, Cochrane CENTRAL via Ovid, Embase via Ovid and Web of Science were conducted on 29 November 2021. Randomized controlled trials examining ≥12 weeks of topical treatments for acne vulgaris in subjects aged 12 and older were included. Main outcomes were absolute or percent change in acne lesion count and treatment success on the Investigator's Global Assessment scale. Thirty-five randomized clinical trials with 33,472 participants comparing nine different topical agents were included. Adapalene-benzoyl peroxide (BPO), clindamycin-BPO and clindamycin-tretinoin demonstrated the greatest reduction in non-inflammatory (ratio of means [RoM] 1.76; 95% CI [1.46; 2.12], RoM 1.70; 95% CI [1.44; 2.02] and RoM 1.87; 95% CI [1.53; 2.30], respectively), inflammatory (RoM 1.56; 95% CI [1.44; 1.70], RoM 1.49; 95% CI [1.39; 1.60] and RoM 1.48; 95% CI [1.36; 1.61], respectively) and total lesion count (ROM 1.67; 95% CI [1.47; 1.90], RoM 1.59; 95% CI [1.42; 1.79] and RoM 1.64; 95% CI [1.42; 1.89], respectively) compared to placebo. All single agents outperformed placebo except tazarotene, which did not significantly outperform placebo for inflammatory and non-inflammatory lesion count reduction. Most combination agents significantly outperformed their individual components in lesion count reduction and global assessment scores, except for clindamycin-tretinoin and clindamycin-BPO, which did not significantly outperform tretinoin (RoM 1.13; 95% CI [0.94; 1.36]) and BPO (RoM = 1.15, 95% CI [0.98; 1.36]), respectively, for non-inflammatory lesion reduction. There was no significant difference amongst most single agents when evaluating lesion count reduction. Combination agents are generally most effective for mild-to-moderate acne; however for non-inflammatory acne, the addition of clindamycin in topical regimens is unnecessary and should be avoided.

BACKGROUND:Acute post-subarachnoid hemorrhage (SAH) headaches are common and severe. Management strategies for post-SAH headaches are limited, with heavy reliance on opioids, and pain control is overall poor. Pterygopalatine fossa (PPF) nerve blocks have shown promising results in treatment of acute headache, including our preliminary and published experience with PPF-blocks for refractory post-SAH headache during hospitalization. The BLOCK-SAH trial was designed to assess the efficacy and safety of bilateral PPF-blocks in awake patients with severe headaches from aneurysmal SAH who require opioids for pain control and are able to verbalize pain scores. METHODS:BLOCK-SAH is a phase II, multicenter, randomized, double-blinded, placebo-controlled clinical trial using the sequential parallel comparison design (SPCD), followed by an open-label phase. RESULTS:Across 12 sites in the United States, 195 eligible study participants will be randomized into three groups to receive bilateral active or placebo PPF-injections for 2 consecutive days with periprocedural monitoring of intracranial arterial mean flow velocities with transcranial Doppler, according to SPCD (group 1: active block followed by placebo; group 2: placebo followed by active block; group 3: placebo followed by placebo). PPF-injections will be delivered under ultrasound guidance and will comprise 5-mL injectates of 20 mg of ropivacaine plus 4 mg of dexamethasone (active PPF-block) or saline solution (placebo PPF-injection). CONCLUSIONS:The trial has a primary efficacy end point (oral morphine equivalent/day use within 24 h after each PPF-injection), a primary safety end point (incidence of radiographic vasospasm at 48 h from first PPF-injection), and a primary tolerability end point (rate of acceptance of second PPF-injection following the first PPF-injection). BLOCK-SAH will inform the design of a phase III trial to establish the efficacy of PPF-block, accounting for different headache phenotypes.