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Researching COVID to enhance recovery (RECOVER) tissue pathology study protocol: Rationale, objectives, and design
Troxel, Andrea B; Bind, Marie-Abele C; Flotte, Thomas J; Cordon-Cardo, Carlos; Decker, Lauren A; Finn, Aloke V; Padera, Robert F; Reichard, R Ross; Stone, James R; Adolphi, Natalie L; Casimero, Faye Victoria C; Crary, John F; Elifritz, Jamie; Faustin, Arline; Ghosh, Saikat Kumar B; Krausert, Amanda; Martinez-Lage, Maria; Melamed, Jonathan; Mitchell, Roger A; Sampson, Barbara A; Seifert, Alan C; Simsir, Aylin; Adams, Cheryle; Haasnoot, Stephanie; Hafner, Stephanie; Siciliano, Michelle A; Vallejos, Brittany B; Del Boccio, Phoebe; Lamendola-Essel, Michelle F; Young, Chloe E; Kewlani, Deepshikha; Akinbo, Precious A; Parent, Brendan; Chung, Alicia; Cato, Teresa C; Mudumbi, Praveen C; Esquenazi-Karonika, Shari; Wood, Marion J; Chan, James; Monteiro, Jonathan; Shinnick, Daniel J; Thaweethai, Tanayott; Nguyen, Amber N; Fitzgerald, Megan L; Perlowski, Alice A; Stiles, Lauren E; Paskett, Moira L; Katz, Stuart D; Foulkes, Andrea S; ,
IMPORTANCE/OBJECTIVE:SARS-CoV-2 infection can result in ongoing, relapsing, or new symptoms or organ dysfunction after the acute phase of infection, termed Post-Acute Sequelae of SARS-CoV-2 (PASC), or long COVID. The characteristics, prevalence, trajectory and mechanisms of PASC are poorly understood. The objectives of the Researching COVID to Enhance Recovery (RECOVER) tissue pathology study (RECOVER-Pathology) are to: (1) characterize prevalence and types of organ injury/disease and pathology occurring with PASC; (2) characterize the association of pathologic findings with clinical and other characteristics; (3) define the pathophysiology and mechanisms of PASC, and possible mediation via viral persistence; and (4) establish a post-mortem tissue biobank and post-mortem brain imaging biorepository. METHODS:RECOVER-Pathology is a cross-sectional study of decedents dying at least 15 days following initial SARS-CoV-2 infection. Eligible decedents must meet WHO criteria for suspected, probable, or confirmed infection and must be aged 18 years or more at the time of death. Enrollment occurs at 7 sites in four U.S. states and Washington, DC. Comprehensive autopsies are conducted according to a standardized protocol within 24 hours of death; tissue samples are sent to the PASC Biorepository for later analyses. Data on clinical history are collected from the medical records and/or next of kin. The primary study outcomes include an array of pathologic features organized by organ system. Causal inference methods will be employed to investigate associations between risk factors and pathologic outcomes. DISCUSSION/CONCLUSIONS:RECOVER-Pathology is the largest autopsy study addressing PASC among US adults. Results of this study are intended to elucidate mechanisms of organ injury and disease and enhance our understanding of the pathophysiology of PASC.
PMCID:10781091
PMID: 38198481
ISSN: 1932-6203
CID: 5628642
Paradoxical Effects of Depression on Psoriatic Arthritis Outcomes in a Combined Psoriasis-Psoriatic Arthritis Center
Haberman, Rebecca H; Um, Seungha; Catron, Sydney; Chen, Alan; Lydon, Eileen; Attur, Malavikalakshmi; Neimann, Andrea L; Reddy, Soumya; Troxel, Andrea; Adhikari, Samrachana; Scher, Jose U
BACKGROUD/UNASSIGNED: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/UNASSIGNED:To characterize a cohort of patients with PsA and understand the impact of depression on PsA outcome measures. METHODS/UNASSIGNED: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/UNASSIGNED: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/UNASSIGNED: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.
PMCID:10768813
PMID: 38188536
ISSN: 2475-5303
CID: 5755232
Qualitative analysis of a remote monitoring intervention for managing heart failure
Klaiman, Tamar; Iannotte, L G; Josephs, Michael; Russell, Louise B; Norton, Laurie; Mehta, Shivan; Troxel, Andrea; Zhu, Jingsan; Volpp, Kevin; Asch, David A
BACKGROUND:Heart failure (HF) is one of the most common reasons for hospital admission and is a major cause of morbidity, mortality, and increasing health care costs. The EMPOWER study was a randomized trial that used remote monitoring technology to track patients' weight and diuretic adherence and a state-of-the-art approach derived from behavioral economics to motivate adherence to the reverse monitoring technology. OBJECTIVE:The goal was to explore patient and clinician perceptions of the program and its impact on perceived health outcomes and better understand why some patients or clinicians did better or worse than others in response to the intervention. APPROACH:This was a retrospective qualitative study utilizing semi-structured interviews with 43 patients and 16 clinicians to understand the trial's processes, reflecting on successes and areas for improvement for future iterations of behavioral economic interventions. KEY RESULTS:Many patients felt supported, and they appreciated the intervention. Many also appreciated the lottery intervention, and while it was not an incentive for enrolling for many respondents, it may have increased adherence during the study. Clinicians felt that the intervention integrated well into their workflow, but the number of alerts was burdensome. Additionally, responses to alerts varied considerably by provider, perhaps because there are no professional guidelines for alerts unaccompanied by severe symptoms. CONCLUSION:Our qualitative analysis indicates potential areas for additional exploration and consideration to design better behavioral economic interventions to improve cardiovascular health outcomes for patients with HF. Patients appreciated lottery incentives for adhering to program requirements; however, many were too far along in their disease progression to benefit from the intervention. Clinicians found the amount and frequency of electronic alerts burdensome and felt they did not improve patient outcomes. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT02708654.
PMID: 37679712
ISSN: 1471-2261
CID: 5599012
The effects of exercise and diet on oxidative stress and telomere length in breast cancer survivors
Brown, Justin C; Sturgeon, Kathleen; Sarwer, David B; Troxel, Andrea B; DeMichele, Angela M; Denlinger, Crystal S; Schmitz, Kathryn H
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.
PMID: 36933050
ISSN: 1573-7217
CID: 5539752
A feasibility and acceptability study of screening the parents/guardians of pediatric dental patients for the social determinants of health
Kaur, Raghbir; Lieberman, Martin; Mason, Margaret K; Dapkins, Isaac P; Gallager, Rebecca; Hopkins, Kathleen; Wu, Yinxiang; Troxel, Andrea B; Rashwan, Ayah; Hope, Chelsea; Kane, Daniel J; Northridge, Mary E
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.
PMCID:9996555
PMID: 36895054
ISSN: 2055-5784
CID: 5495522
Effect of Financial Incentives and Default Options on Food Choices of Adults With Low Income in Online Retail Settings: A Randomized Clinical Trial
Rummo, Pasquale E; Roberto, Christina A; Thorpe, Lorna E; Troxel, Andrea B; Elbel, Brian
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.
PMID: 36897592
ISSN: 2574-3805
CID: 5448662
Mind-Body Intervention for Dysfunctional Breathing in Chronic Obstructive Pulmonary Disease: Feasibility Study and Lessons Learned
Norweg, Anna Migliore; Wu, Yinxiang; Troxel, Andrea; Whiteson, Jonathan H; Collins, Eileen; Haas, Francois; Skamai, Anne; Goldring, Roberta; Jean-Louis, Girardin; Reibman, Joan; Ehrlich-Jones, Linda; Simon, Naomi
PMCID:10024272
PMID: 36800224
ISSN: 2768-3613
CID: 5435382
Food Allergy Management for Adolescents Using Behavioral Incentives: A Randomized Trial
Dupuis, Roxanne; Feuerstein-Simon, Rachel; Brown-Whitehorn, Terri F; Spergel, Jonathan M; Volpp, Kevin G; Marti, Xochitl Luna; Troxel, Andrea B; Meisel, Zachary F; Mollen, Cynthia J; Kenney, Erica L; Block, Jason; Gortmaker, Steven L; Cannuscio, Carolyn C
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.
PMCID:9890392
PMID: 36683454
ISSN: 1098-4275
CID: 5419422
Survival After Invasive or Conservative Management of Stable Coronary Disease
Hochman, Judith S; Anthopolos, Rebecca; Reynolds, Harmony R; Bangalore, Sripal; Xu, Yifan; O'Brien, Sean M; Mavromichalis, Stavroula; Chang, Michelle; Contreras, Aira; Rosenberg, Yves; Kirby, Ruth; Bhargava, Balram; Senior, Roxy; Banfield, Ann; Goodman, Shaun G; Lopes, Renato D; Pracon, Radoslaw; López-Sendón, José; Maggioni, Aldo Pietro; Newman, Jonathan D; Berger, Jeffrey S; Sidhu, Mandeep S; White, Harvey D; Troxel, Andrea B; Harrington, Robert A; Boden, William E; Stone, Gregg W; Mark, Daniel B; Spertus, John A; Maron, David J
PMID: 36335918
ISSN: 1524-4539
CID: 5356892
Reasearching COVID to enhance recorvery (RECOVER) autopsy tissue pathology study protocol: Rationale, objectives, and design [PrePrint]
Troxel, Andrea B; Bind, Marie-Abele C; Flotte, Thomas J; Cordon-Cardo, Carlos; Decker, Lauren A; Finn, Aloke V; Padera, Robert F; Reichard, R. Ross; Stone, James R; Adolphi, Natalie L; Casimero, Faye; Crary, John F; Elifritz, Jamie; Faustin, Arline; Kumar B Ghosh, Saikat; Krausert, Amanda; Martinez-Lage, Maria; Melamed, Jonathan; Mitchell Jr, Roger A; Sampson, Barbara A; Seifert, Alan C; Simsir, Aylin; Adams, Cheryle; Haasnoot, Stephanie; Hafner, Stephanie; Siciliano, Michelle A; Vallejos, Britanny B; Del Boccio, Pheobe; Lamendola-Essel; Michelle F; Young, Chloe E; Kewlani, Deepshikha; Akinbo, Precious A; Parent, Brendan; Chung, Alicia; Cato, Teresa C; Mudumbi, Praveen; Esquenazi-Karonika, Shari; Wood, Marion J; Chan, James; Monteiro, Jonathan; Shinnick, Daniel J; Thaweethai, Tanayott; Nguyen, Amber N; Fitzgerald, Megan L; Perlowski, Alice A; Stiles, Lauren E; Paskett, Moira L, Katz, Stuart D; Foulkes, Andrea S
ORIGINAL:0017086
ISSN: n/a
CID: 5573572