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Long COVID trajectories in the prospectively followed RECOVER-Adult US cohort
Thaweethai, Tanayott; Donohue, Sarah E; Martin, Jeffrey N; Hornig, Mady; Mosier, Jarrod M; Shinnick, Daniel J; Ashktorab, Hassan; Atieh, Ornina; Blomkalns, Andra; Brim, Hassan; Chen, Yu; Cortez, Melissa M; Erdmann, Nathan B; Flaherman, Valerie; Goepfert, Paul; Goldman, Jason D; Hamburg, Naomi M; Han, Jenny E; Heath, James R; Jacoby, Vanessa; Jolley, Sarah E; Kelly, J Daniel; Kelly, Sara W; Kim, C; Krishnan, Jerry A; Letts, Rebecca; Levitan, Emily B; Modes, Matthew E; McComsey, Grace A; Metz, Torri D; Mullington, Janet M; Ofotokun, Igho; Okumura, Megumi J; Paredes, Claudia Castillo; Patterson, Thomas F; Peluso, Michael J; Reece, Rebecca; Sherif, Zaki A; Simhan, Hyagriv N; Simmons, Christopher; Singh, Upinder; Taylor, Barbara S; Taylor, Brittany D; Trinity, Joel D; Troxel, Andrea B; Utz, Paul J; Vasey, Andrew J; Weinberger, Elisheva; Wiley, Zanthia; Wisnivesky, Juan; Yee, Lynn M; Horwitz, Leora; Foulkes, Andrea S; Levy, Bruce D; ,
Longitudinal trajectories of Long COVID remain ill-defined, yet are critically needed to advance clinical trials, patient care, and public health initiatives for millions of individuals with this condition. Long COVID trajectories were determined prospectively among 3,659 participants (69% female; 99.6% Omicron era) in the National Institutes of Health Researching COVID to Enhance Recovery (RECOVER) Adult Cohort. Finite mixture modeling was used to identify distinct longitudinal profiles based on a Long COVID research index measured 3 to 15 months after infection. Eight longitudinal profiles were identified. Overall, 195 (5%) had persistently high Long COVID symptom burden, 443 (12%) had non-resolving, intermittently high symptom burden, and 526 (14%) did not meet criteria for Long COVID at 3 months but had increasing symptoms by 15 months, suggestive of distinct pathophysiologic features. At 3 months, 377 (10%) met the research index threshold for Long COVID. Of these, 175 (46%) had persistent Long COVID, 132 (35%) had moderate symptoms, and 70 (19%) appeared to recover. Identification of these Long COVID symptom trajectories is critically important for targeting enrollment for future studies of pathophysiologic mechanisms, preventive strategies, clinical trials and treatments.
PMCID:12623977
PMID: 41249167
ISSN: 2041-1723
CID: 5969242
Analysis of the Zoster Eye Disease Study using original endpoint criteria
Jeng, Bennie H; Jacobs, Deborah S; Lee, Ting-Fang; Troxel, Andrea B; Liu, Mengling; Colby, Kathryn A; Kim, Jiyu; Hochman, Judith S; Cohen, Elisabeth J; ,
PMID: 41167530
ISSN: 1549-4713
CID: 5961592
The 2024 NASEM Long COVID Definition as a Starting Point for Research [Editorial]
Troxel, Andrea B; Krishnan, Jerry A; Verduzco-Gutierrez, Monica
PMID: 41083891
ISSN: 1525-1497
CID: 5954582
Examining the Effect of Virtual Reality-Based Fast-Food Marketing on Eating-Related Outcomes in Young Adults: Protocol for a Randomized Controlled Trial
Cassidy, Omni; Boyland, Emma; Persky, Susan; Troxel, Andrea B; Elbel, Brian
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.
PMID: 40982800
ISSN: 1929-0748
CID: 5937622
Understanding sleep behaviors and barriers to OSA evaluation and treatment among highway maintenance vehicle operators
Robbins, Rebecca; Troxel, Andrea B; Quan, Stuart F; Barger, Laura K; DiClemente, Ralph; Fray-Witzer, Maya; Jean-Louis, Girardin; Rapoport, David M; Czeisler, Charles A
OBJECTIVE:Poor sleep and obstructive sleep apnea (OSA) are prevalent among transportation workers. METHODS:45 transportation workers from worksites in the Northeast US completed surveys assessing 1) sleepiness, 2) OSA, and 3) OSA stage of change, then participated in focus groups or interviews. RESULTS:Participants were 93.2% male, 90.1% white non-Hispanic. 77.8% scored high risk for OSA, while 11.1% of those at risk reported an OSA diagnosis. Only 31.4% of high risk participants reported having contemplated OSA evaluation or treatment. Qualitative themes pertained to difficulty unwinding, uncertain work hours, fears about and barriers to OSA treatment, and misinformation about OSA. CONCLUSIONS:Results reveal a high prevalence of OSA risk and a low rate of diagnosis and OSA readiness to change. We identify themes for future interventions to improve awareness about OSA among transportation workers.
PMID: 40952978
ISSN: 1536-5948
CID: 5934992
A Systematic Review of "Food Is Medicine" Randomized Controlled Trials for Noncommunicable Disease in the United States: A Scientific Statement From the American Heart Association
Seligman, Hilary K; Angell, Sonia Y; Berkowitz, Seth A; Elkind, Mitchell S V; Hager, Kurt; Moise, Nathalie; Posner, Hannah; Muse, Jen; Odoms-Young, Angela; Ridberg, Ronit; Troxel, Andrea B; Yaroch, Amy L; Volpp, Kevin G
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.
PMID: 40528749
ISSN: 1524-4539
CID: 5906212
The 2024 National Academies of Sciences, Engineering, and Medicine Long COVID Definition: What Clinicians Need to Know [Editorial]
Chu, Lily; Bishof, Karyn; Dumes, Abigail A; Wesley Ely, E; Joseph, Paule V; Troxel, Andrea B; ,
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.
PMID: 40063321
ISSN: 1525-1497
CID: 5808202
Incidence of food allergic reactions among adolescents engaged in food allergy management
Dupuis, Roxanne; Spergel, Jonathan M; Brown-Whitehorn, Terri F; Troxel, Andrea B; Kenney, Erica L; Block, Jason P; Feuerstein-Simon, Rachel; Marti, Xochitl Luna; Mollen, Cynthia J; Meisel, Zachary F; Volpp, Kevin G; Gortmaker, Steven L; Cannuscio, Carolyn C
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.
PMID: 40068800
ISSN: 1534-4436
CID: 5808392
A Phase 1/2 multicenter trial of DKN-01 as monotherapy or in combination with docetaxel for the treatment of metastatic castration-resistant prostate cancer (mCRPC)
Wise, David R; Pachynski, Russell K; Denmeade, Samuel R; Aggarwal, Rahul R; Deng, Jiehui; Febles, Victor Adorno; Balar, Arjun V; Economides, Minas P; Loomis, Cynthia; Selvaraj, Shanmugapriya; Haas, Michael; Kagey, Michael H; Newman, Walter; Baum, Jason; Troxel, Andrea B; Griglun, Sarah; Leis, Dayna; Yang, Nina; Aranchiy, Viktoriya; Machado, Sabrina; Waalkes, Erika; Gargano, Gabrielle; Soamchand, Nadia; Puranik, Amrutesh; Chattopadhyay, Pratip; Fedal, Ezeddin; Deng, Fang-Ming; Ren, Qinghu; Chiriboga, Luis; Melamed, Jonathan; Sirard, Cynthia A; Wong, Kwok-Kin
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.
PMID: 38341461
ISSN: 1476-5608
CID: 5635542
Shifting the Focus Using Remote Training on Shared Decision-Making and Motivational Interviewing: A Quantitative Evaluation
Northridge, Mary E; Allen, Matthew; Franck, Etienne; Pipaliya, Chandni; Vazquez-Sanchez, Manuel R; Troxel, Andrea B; Lieberman, Martin
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.
PMID: 40189787
ISSN: 1930-7837
CID: 5823542