COVID-19 Publications by UMass Chan Authors

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This collection showcases journal articles, preprints, and other publications and presentations about the SARS-CoV-2 coronavirus and COVID-19 by faculty, students and researchers at UMass Chan Medical School in Worcester, MA, USA.

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Social Determinants, Mental Well-Being, and Disrupted Life Transitions Among Young Adults with Disabling Mental Health Conditions
(2025-01-13) Cook, Judith A; Jonikas, Jessica A; Burke-Miller, Jane K; Aranda, Frances; Mullen, Michelle G; Davis, Maryann; Sabella, Kathryn; Psychiatry
This study sought to understand how young adults (age 18-25) with histories of mental health disorders are coping with disrupted transitions to adulthood during the COVID-19 pandemic. A cross-sectional web survey was conducted in March-June 2021 of 967 US young adults with pre-pandemic psychiatric disability to assess their current psychiatric status, interrupted transitions, and associations with social determinants including income, community participation, and social context. Mental health was assessed with the Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder Scale (GAD-7), and PTSD Checklist-Civilian Version. Social determinants were identified with the Epidemic-Pandemic Impacts Inventory. Interrupted transitions were measured with the Young Adult Disrupted Transitions Assessment. Multivariable logistic regression models predicted four types of transition disruptions and associations with current mental health, social determinants, and demographic factors. Disruptions were reported by 81.1% including interrupted education completion (38.3%), employment careers (37.6%), residential independence (27.7%), and intimate partner relationships (22.9%). Many screened positive for major depressive disorder (81.7%), PTSD (85.5%), or GAD (58.6%). Disruption in establishing intimate partner relationships was associated with depression, anxiety, and PTSD. Interrupted residential independence was associated with anxiety. Interrupted education completion was associated with PTSD. Interrupted employment was associated with anxiety. Social determinants significant in these models included social connections, community participation, income, and racial/ethnic identification. Results illuminate ways that current mental health and social determinants affect transition interruptions during the pandemic. Findings suggest the need for interdisciplinary approaches, integrated models of care, and assistance accessing treatment, rehabilitation, and community support services from adult service systems.
Association between menstrual cycle pattern regularity and changes in menstrual bleeding following COVID-19 vaccination: secondary analysis of an observational study
(2024-12-31) Boniface, Emily R; Darney, Blair G; van Lamsweerde, Agathe; Benhar, Eleonora; Han, Leo; Matteson, Kristen; Male, Victoria; Cameron, Sharon; Alvergne, Alexandra; Edelman, Alison; Obstetrics and Gynecology
Safety and Immunogenicity of an mRNA-1273 Booster in Children
(2024-12-17) Berthaud, Vladimir; Creech, C Buddy; Rostad, Christina A; Carr, Quito; de Leon, Liberation; Dietrich, Monika; Gupta, Anil; Javita, David; Nachman, Sharon; Pinninti, Swetha; Rathore, Mobeen; Rodriguez, Carina A; Luzuriaga, Katherine; Towner, William; Yeakey, Anne; Brown, Mollie; Zhao, Xiaoping; Deng, Weiping; Xu, Wenqin; Zhou, Honghong; Girard, Bethany; Kelly, Roxanne; Slobod, Karen; Anderson, Evan J; Das, Rituparna; Miller, Jacqueline; Schnyder Ghamloush, Sabine; Program in Molecular Medicine; Center for Clinical and Translational Science
Background: A 2-dose mRNA-1273 primary series in children aged 6 months-5 years (25 µg) and 6-11 years (50 µg) had an acceptable safety profile and was immunogenic in the phase 2/3 KidCOVE study. We present data from KidCOVE participants who received an mRNA-1273 booster dose. Methods: An mRNA-1273 booster dose (10 µg for children aged 6 months-5 years; 25 µg for children aged 6-11 years; age groups based on participant age at enrollment) was administered ≥6 months after primary series completion. The primary safety objective was the safety and reactogenicity of an mRNA-1273 booster dose. The primary immunogenicity objective was to infer efficacy of an mRNA-1273 booster dose by establishing noninferiority of neutralizing antibody (nAb) responses after a booster in children versus nAb responses observed after the mRNA-1273 primary series in young adults (18-25 years) from the pivotal efficacy study. Data were collected from March 2022 to June 2023. Results: Overall, 153 (6 months-5 years) and 2519 (6-11 years) participants received an mRNA-1273 booster dose (median age at receipt of booster: 2 and 10 years, respectively). The booster dose safety profile was generally consistent with that of the primary series in children; no new safety concerns were identified. An mRNA-1273 booster dose elicited robust nAb responses against ancestral SARS-CoV-2 among children and met prespecified noninferiority success criteria versus responses observed after the primary series in young adults. Conclusions: Safety and immunogenicity data support administration of an mRNA-1273 booster dose in children aged 6 months to 11 years. Clinical trials registration: NCT04796896 (Clinicaltrials.gov).
Relationship Between Acute Severe Acute Respiratory Syndrome Coronavirus 2 Viral Clearance and Long Coronavirus 2019 (Long COVID) Symptoms: A Cohort Study
(2024-12-18) Herbert, Carly; Antar, Annukka A R; Broach, John; Wright, Colton; Stamegna, Pamela; Luzuriaga, Katherine; Hafer, Nathaniel; McManus, David D; Manabe, Yukari C; Soni, Apurv; Medicine; Center for Clinical and Translational Science; Emergency Medicine; Program in Molecular Medicine; Population and Quantitative Health Sciences
Background: The relationship between severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral dynamics during acute infection and the development of long coronavirus disease 2019 (COVID-19), or "long COVID," is largely unknown. Methods: Between October 2021 and February 2022, 7361 people not known to have COVID-19 self-collected nasal swab samples for SARS-CoV-2 reverse-transcription polymerase chain reaction testing every 24-48 hours for 10-14 days. Participants whose first known SARS-CoV-2 infection was detected were surveyed for long COVID in August 2023. Their slopes of viral clearance were modeled using linear mixed effects models with random slopes and intercepts, and the relative risk (RR) of long COVID based on viral slopes was calculated using a log binomial model, adjusted for age, symptoms, and variant. Sex-based interaction terms were also evaluated for significance. Results: A total of 172 participants were eligible for analyses, and 59 (34.3%) reported long COVID. The risk of long COVID with 3-4 symptoms (adjusted RR, 2.44 [95% confidence interval, .88-6.82]) and ≥5 symptoms (4.97 [1.90-13.0]) increased with each unit increase in slope of viral clearance. While the probability of long COVID increased with slowed viral clearance among women, the same relationship was not observed among men (interaction term: P = .02). Acute SARS-CoV-2 symptoms of abdominal pain (adjusted RR, 5.41 [95% confidence interval, 2.44-12.0]), nausea (3.01 [1.31-6.89]), and body aches (2.58 [1.26-5.30]) were most strongly associated with long COVID. Conclusions: We observed that slower viral clearance rates during acute COVID-19 were associated with increased risk and more symptoms of long COVID . Early viral-host dynamics appear to be mechanistically linked to the development of long COVID.
Creating a plasma coordination center to support COVID-19 outpatient trials across a national network of hospital blood banks
(2024-11-14) Yarava, Anusha; Marshall, Christi; Reichert, David E; Ye, Aaron; Khanal, Preeti; Robbins, Sanford H; Sachais, Bruce S; Oh, David; Metcalf, Ryan A; Conry-Cantilena, Kathleen; King, Karen; Reyes, Meredith; Adamski, Jill; Marques, Marisa B; Tran, Minh-Ha; Allen, Elizabeth S; Pach, Daniel; Blumberg, Neil; Hobbs, Rhonda; Nash, Tammon; Shenoy, Aarthi G; Mosnaim, Giselle S; Fukuta, Yuriko; Patel, Bela; Heath, Sonya L; Levine, Adam C; Meisenberg, Barry R; Anjan, Shweta; Huaman, Moises A; Blair, Janis E; Currier, Judith S; Paxton, James H; Rausch, William; Oei, Kevin; Abinante, Matthew; Forthal, Donald N; Zand, Martin S; Kassaye, Seble G; Cachay, Edward R; Gebo, Kelly A; Shoham, Shmuel; Casadevall, Arturo; McBee, Nichol A; Amirault, Daniel; Wang, Ying; Hopkins, Erica; Shade, David M; Layendecker, Oliver; Klein, Sabra L; Park, Han-Sol; Lee, John S; Caturegli, Patrizio; Raval, Jay S; Cruser, Daniel; Ziman, Alyssa F; Gerber, Jonathan; Gniadek, Thomas J; Bloch, Evan M; Tobian, Aaron A R; Hanley, Daniel F; Sullivan, David J; Lane, Karen; Medicine
Introduction: In response to the COVID-19 pandemic, we rapidly implemented a plasma coordination center, within two months, to support transfusion for two outpatient randomized controlled trials. The center design was based on an investigational drug services model and a Food and Drug Administration-compliant database to manage blood product inventory and trial safety. Methods: A core investigational team adapted a cloud-based platform to randomize patient assignments and track inventory distribution of control plasma and high-titer COVID-19 convalescent plasma of different blood groups from 29 donor collection centers directly to blood banks serving 26 transfusion sites. Results: We performed 1,351 transfusions in 16 months. The transparency of the digital inventory at each site was critical to facilitate qualification, randomization, and overnight shipments of blood group-compatible plasma for transfusions into trial participants. While inventory challenges were heightened with COVID-19 convalescent plasma, the cloud-based system, and the flexible approach of the plasma coordination center staff across the blood bank network enabled decentralized procurement and distribution of investigational products to maintain inventory thresholds and overcome local supply chain restraints at the sites. Conclusion: The rapid creation of a plasma coordination center for outpatient transfusions is infrequent in the academic setting. Distributing more than 3,100 plasma units to blood banks charged with managing investigational inventory across the U.S. in a decentralized manner posed operational and regulatory challenges while providing opportunities for the plasma coordination center to contribute to research of global importance. This program can serve as a template in subsequent public health emergencies.
Conformational dynamics of SARS-CoV-2 Omicron spike trimers during fusion activation at single molecule resolution
(2024-10-03) Dey, Shuvankar; Pahari, Purba; Mukherjee, Srija; Munro, James B; Das, Dibyendu Kumar; Microbiology; Biochemistry and Molecular Biotechnology
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron entry involves spike (S) glycoprotein-mediated fusion of viral and late endosomal membranes. Here, using single-molecule Förster resonance energy transfer (sm-FRET) imaging and biochemical measurements, we directly visualized conformational changes of individual spike trimers on the surface of SARS-CoV-2 Omicron pseudovirions during fusion activation. We observed that the S2 domain of the Omicron spike is a dynamic fusion machine. S2 reversibly interchanges between the pre-fusion conformation and two previously undescribed intermediate conformations. Acidic pH shifts the conformational equilibrium of S2 toward an intermediate conformation and promotes the membrane hemi-fusion reaction. Moreover, we captured conformational reversibility in the S2 domain, which suggests that spike can protect itself from pre-triggering. Furthermore, we determined that Ca directly promotes the S2 conformational change from an intermediate conformation to post-fusion conformation. In the presence of a target membrane, low pH and Ca stimulate the irreversible transition to S2 post-fusion state and promote membrane fusion.
Factors Associated With Patient Portal Engagement in Otolaryngology
(2024-11-26) Siegel, Jesse K; Verducci, Chloe; Hurtuk, Agnes; Otolaryngology
Objective: Online patient portals are important tools for patient engagement, and their use has increased particularly since the COVID-19 pandemic and the 21st Century Cures Act. However, prior work across various specialties has demonstrated disparities in patient portal usage with respect to age, gender, race, and insurance status. However, this has not been studied in the field of otolaryngology, and not since the onset of the COVID-19 pandemic. Study design: Retrospective study. Setting: Single tertiary care outpatient otolaryngology practice over a 3-year period (December 2019-December 2022). Methods: We used univariate and multivariate analyses to measure how patient portal use for appointment scheduling varied before and after the COVID-19 pandemic and across demographic groups including gender, race, age, primary language, insurance type, and primary care physician (PCP) status (Loyola vs non-Loyola). Results: From December 2019 to December 2022, 49,462 unique patients scheduled 221,611 otolaryngology clinic visits. Significantly more online scheduling occurred after the onset of the COVID-19 pandemic (10.7% vs 1.9%, P < .01). In multivariate analysis, male gender, age <18 or >65 years, non-English primary language, and outside PCP were all associated with a lower likelihood of online appointment scheduling (P < .01 for each). Patients with Medicare had higher odds of portal use than commercially insured patients when controlling for other demographic variables (P = .034). Conclusion: Patient portal use in otolaryngology has markedly increased over the last 3 years, but utilization varies across demographic groups. This provides an opportunity to improve patient portal content and outreach, and ultimately make portals more accessible to diverse patient populations.
Effect of Screening for Undiagnosed Atrial Fibrillation on Stroke Prevention
(2024-09-01) Lopes, Renato D; Atlas, Steven J; Go, Alan S; Lubitz, Steven A; McManus, David D; Dolor, Rowena J; Chatterjee, Ranee; Rothberg, Michael B; Rushlow, David R; Crosson, Lori A; Aronson, Ronald S; Patlakh, Michael; Gallup, Dianne; Mills, Donna J; O'Brien, Emily C; Singer, Daniel E; Medicine
Background: Atrial fibrillation (AF) often remains undiagnosed, and it independently raises the risk of ischemic stroke, which is largely reversible by oral anticoagulation. Although randomized trials using longer term screening approaches increase identification of AF, no studies have established that AF screening lowers stroke rates. Objectives: To address this knowledge gap, the GUARD-AF (Reducing Stroke by Screening for Undiagnosed Atrial Fibrillation in Elderly Individuals) trial screened participants in primary care practices using a 14-day continuous electrocardiographic monitor to determine whether screening for AF coupled with physician/patient decision-making to use oral anticoagulation reduces stroke and provides a net clinical benefit compared with usual care. Methods: GUARD-AF was a prospective, parallel-group, randomized controlled trial designed to test whether screening for AF in people aged ≥70 years using a 14-day single-lead continuous electrocardiographic patch monitor could identify patients with undiagnosed AF and reduce stroke. Participants were randomized 1:1 to screening or usual care. The primary efficacy and safety outcomes were hospitalization due to all-cause stroke and bleeding, respectively. Analyses used the intention-to-treat population. Results: Enrollment began on December 17, 2019, and involved 149 primary care sites across the United States. The COVID-19 pandemic led to premature termination of enrollment, with 11,905 participants in the intention-to-treat population. Median follow-up was 15.3 months (Q1-Q3: 13.8-17.6 months). Median age was 75 years (Q1-Q3: 72-79 years), and 56.6% were female. The risk of stroke in the screening group was 0.7% vs 0.6% in the usual care group (HR: 1.10; 95% CI: 0.69-1.75). The risk of bleeding was 1.0% in the screening group vs 1.1% in the usual care group (HR: 0.87; 95% CI: 0.60-1.26). Diagnosis of AF was 5% in the screening group and 3.3% in the usual care group, and initiation of oral anticoagulation after randomization was 4.2% and 2.8%, respectively. Conclusions: In this trial, there was no evidence that screening for AF using a 14-day continuous electrocardiographic monitor in people ≥70 years of age seen in primary care practice reduces stroke hospitalizations. Event rates were low, however, and the trial did not enroll the planned sample size.(Reducing Stroke by Screening for Undiagnosed Atrial Fibrillation in Elderly Individuals [GUARD-AF]; NCT04126486).
Design, creation, and use of the Test Us Bank (TUB) COVID-19 sample biorepository
(2024-11-12) Broach, John; Achenbach, Chad; Behar, Stephanie; O'Connor, Laurel; Tarrant, Seanan; Ferranto, Julia; Wright, Colton; Hartin, Paul; Orwig, Taylor; Nanavati, Janvi; Kalibala, Benedict; Woods, Kelsey; Shaw, Bernadette; Flahive, Julie; Barton, Bruce; Hafer, Nathaniel; Herbert, Carly; Fahey, Nisha; Gibson, Laura; Simin, Karl; Kowalik, Timothy; Ward, Doyle V; Mirza, Agha W; Murphy, Robert L; Caputo, Matthew; Buchholz, Bryan; Fantasia, Heidi; Koren, Ainat; Marchand, Lisa; Oludare, Simisola; Sogade, Felix; Ritland, Dana; Davis, Cedrice; Grenier, Allen; Baron, Christi; Brent, Ellie; McKenney, Jennifer Bacani; Elder, Nancy; Michaels, LeAnn; Ferrara, Laura; Theron, Grant; Palmer, Zaida; Levy, Barcey; Daly, Jeanette; Parang, Kim; Schmidt, Megan; Buxton, Denis; Heetderks, William; Manabe, Yukari C; Soni, Apurv; McManus, David; Emergency Medicine; Medicine; Center for Clinical and Translational Science; Population and Quantitative Health Sciences; Pediatrics; Biostatistics and Health Services Research; Molecular, Cell, and Cancer Biology; Microbiology
Shortly after the first case of SARS-CoV-2 was diagnosed a public health emergency (PHE) was declared and a multi-agency response was initiated within the US federal government to create and propagate testing capacity. As part of this response, an unprecedented program designated Rapid Acceleration of Diagnostics (RADx) Tech was established by the National Institutes of Health (NIH) to facilitate the development of point-of-care tests for the COVID-19. The RADx Tech Clinical Studies Core (CSC), located at the University of Massachusetts Chan Medical School (UMass Chan), with partnering academic, private, and non-governmental organizations around the country, was tasked with developing clinical studies to support this work. This manuscript details development of a biorepository specifically focused on the collection and storage of samples designed for diagnostic platform development. It highlights the unified collection and annotation process that enabled gathering a diverse set of samples. This diversity encompasses the geography and backgrounds of the participants as well as sample characteristics such as variant type and RT-PCR cycle threshold (CT) value of the corresponding reference sample on a uniform clinical reference platform.
Impacts of testing and immunity acquired through vaccination and infection on covid-19 cases in Massachusetts elementary and secondary students
(2024-10-16) Branch-Elliman, Westyn; Ertem, Melissa Zeynep; Nelson, Richard E; Danesharasteh, Anseh; Berlin, David; Fisher, Lloyd; Schechter-Perkins, Elissa M; Pediatrics
Background: During the 2021-22 academic year, Massachusetts supported several in-school testing programs to facilitate in-person learning. Additionally, COVID-19 vaccines became available to all school-aged children and many were infected with SARS-CoV-2. There are limited studies evaluating the impacts of these testing programs on SARS-CoV-2 cases in elementary and secondary school settings. The aim of this state-wide, retrospective cohort study was to assess the impact of testing programs and immunity on SARS-CoV-2 case rates in elementary and secondary students. Methods: Community-level vaccination and cumulative incidence rates were combined with data about participation in and results of in-school testing programs (test-to-stay, pooled surveillance testing). School-level impacts of surveillance testing programs on SARS-CoV-2 cases in students were estimated using generalized estimating equations within a target trial emulation approach stratified by school type (elementary/middle/high). Impacts of immunity and vaccination were estimated using random effects linear regression. Results: Here we show that among N = 652,353 students at 2141 schools participating in in-school testing programs, surveillance testing is associated with a small but measurable decrease in in-school positivity rates. During delta, pooled testing positivity rates are higher in communities with higher cumulative incidence of infection. During omicron, when immunity from prior infection became more prevalent, the effect reversed, such that communities with lower burden of infection during the earlier phases of the pandemic had higher infection rates. Conclusions: Testing programs are an effective strategy for supporting in-person learning. Fluctuating levels of immunity acquired via natural infection or vaccination are a major determinant of SARS-CoV-2 cases in schools.
A mixed-methods study of VA video connect utilization among veterans with diabetes experiencing housing instability during the pandemic
(2024-10-07) Kinney, Rebecca L; Copeland, Laurel A; Tsai, Jack; Abbott, Alice A; Wallace, Kate; Walker, Lorrie A; Weber, Jillian; Katsos, Shara; McInnes, Donald K; Population and Quantitative Health Sciences
Introduction: Prior to the coronavirus disease-2019 (COVID-19) pandemic the U.S. Department of Veterans Affairs (VA) had the largest telehealth program in the United States. The pandemic motivated providers within the VA to expand telehealth in effort to reduce disrupted care while mitigating risks. The pandemic provides a rare opportunity to examine how to better engage veterans experiencing housing instability (HI) in telehealth diabetes care. Methods: Mixed methods design to examine VA video connect (VVC) diabetes care utilization among veterans experiencing HI from March 1, 2019, to March 1, 2022, combining multivariable regression analyses of VA administrative data with semi-structured interviews. Study aims included: (a) examine changes in diabetes care delivery mode over the peri-pandemic timeframe; (b) identify sociodemographic and clinical characteristics associated with VVC care among veterans with HI; and (c) understand the facilitators and barriers of VVC utilization. Results: Totally, 5904 veterans were eligible for study analysis. Veterans who are female (OR: 1.63; 95% CI: 1.3, 2.0; p < 0.0001), self-identify as Hispanic (OR: 1.44; 95% CI: 1.1, 1.9; p = 0.02), are married (OR: 1.39; 95% CI: 1.2, 1.6; p < 0.0001), and are in VA priority group 1 (OR: 1.21; 95% CI 1.1, 1.4; p = 0.004) were more likely to use VVC the pandemic. Veterans of older age (OR: 0.97; 95% CI: 0.97, 0.98; p < .0001) and rural dwelling (OR: 0.85; 95% CI: 0.7, 1.2; p = 0.04), were less likely to use VVC. Thirteen VA providers and 15 veterans were interviewed. Veterans reported that decisions about using VVC were driven by limitations in in-person care availability, safety, and convenience. Discussion: Telehealth played an important role in providing veterans with HI access to diabetes care during the pandemic. Future interventions should seek to increase education and technology in effort to increase VVC uptake into routine diabetes care to ensure veterans' optimal and equitable access.
What Program Directors Think About Resident Education: Results of the 2023 Spring Survey of the Association of Program Directors in Radiology (APDR) Part II
(2024-09-25) Garner, Hillary W; Slanetz, Priscilla J; Swanson, Jonathan O; Griffith, Brent D; DeBenedectis, Carolynn M; Gould, Jennifer E; Holm, Tara L; Retrouvey, Michele; Paladin, Angelisa M; Rozenshtein, Anna; Radiology
Rationale and objectives: The Association of Program Directors in Radiology (APDR) administers an annual survey to assess issues and experiences related to residency program management and education. Response data from the 2023 survey provides insights on the impact of COVID-19 on resident recruitment (Part I) and education (Part II), which can be used to facilitate planning and resource allocation for the evolving needs of programs and their leadership. Materials and methods: An observational, cross-sectional study of the APDR membership was performed using a web-based survey consisting of 45 questions, 12 of which pertain to resident education in the post-pandemic era and are discussed in Part II of a two-part survey analysis. All active APDR members (n = 393) were invited to participate in the survey. Results: The response rate was 32% (124 of 393). Results were tallied using Qualtrics software and qualitative responses were tabulated or summarized as comments. Conclusions: The primary challenges to resident education are faculty burnout, rising case volumes, and remote instruction. However, most program leaders report that in-person readouts are much more common than remote readouts. The ability to offer both in-person and remote AIRP sessions is viewed positively. Most program leaders require Authorized User certification, although many do not think all residents need it. Assessment of procedural competence varies by the type of procedure and is similar to graduates' self-assessment of competence.
What Program Directors Think About Resident Recruitment: Results of the 2023 Spring Survey of the Association of Program Directors in Radiology (APDR) Part I
(2024-09-25) Garner, Hillary W; Slanetz, Priscilla J; Swanson, Jonathan O; Griffith, Brent D; DeBenedectis, Carolynn M; Gould, Jennifer E; Holm, Tara L; Retrouvey, Michele; Paladin, Angelisa M; Rozenshtein, Anna; Radiology
Rationale and objectives: The Association of Program Directors in Radiology (APDR) administers an annual survey to assess issues and experiences related to residency program management and education. Our purpose is to provide the response data from the 2023 survey and discuss its insights on the impact of COVID-19 on resident recruitment (Part I) and education (Part II), which can be used to facilitate planning and resource allocation for the evolving needs of programs and their leadership. In Part I, we consider the effects of ERAS preference signaling, the virtual interview format, and the potential of a universal interview release date. Materials and methods: An observational, cross-sectional study of the APDR membership was performed using a web-based survey consisting of 45 questions, 23 of which pertain to virtual recruitment and are discussed in Part I of a two-part survey analysis. All active APDR members (n = 393) were invited to participate in the survey. Results: The response rate was 32% (124 of 393). 83% reported that signaling increased the likelihood of an interview offer. 96% reported only offering virtual interviews; however, 59% intended to offer virtual-only interviews in the future. 53% would adhere to a universal interview release date but an additional 44% would do so depending on the agreed date, Results were tallied using Qualtrics software and qualitative responses were tabulated or summarized as comments. Conclusions: Virtual recruitment is expected to continue for many programs and most respondents would accept a universal interview release date. Preference signaling and geographic signaling are considered positive additions to the application process.
Buprenorphine discontinuation in telehealth-only treatment for opioid use disorder: A longitudinal cohort analysis
(2024-09-05) Chan, Brian; Cook, Ryan; Levander, Ximena; Wiest, Katharina; Hoffman, Kim; Pertl, Kellie; Petluri, Ritwika; McCarty, Dennis; Korthuis, P Todd; Martin, Stephen A; Center for Integrated Primary Care; Family Medicine and Community Health
Introduction: At the beginning of the COVID-19 pandemic, federal agencies permitted telehealth initiation of buprenorphine treatment for opioid use disorder (OUD) without in-person assessment. It remains unclear how telehealth-only buprenorphine treatment impacts time to discontinuation and patient reported treatment outcomes. Methods: A longitudinal observational cohort study conducted September 2021 through March, 2023 enrolled participants with OUD initiating buprenorphine (≤ 45 days) with internet and phone access in Oregon and Washington. The intervention was a fully telehealth-only (THO) app versus treatment as usual (TAU) in office-based settings with some telehealth. We assessed self-reported buprenorphine discontinuation at 4-,12-, and 24-weeks. Generalized estimating equations (GEE) calculated unadjusted and adjusted relative risk ratios (RR) for discontinuation averaged over the study period. Secondary outcomes included change in the Brief Addiction Monitor (BAM) and the visual analogue craving scale. Generalized linear models estimated average within-group and between-group differences over time. Results: Participants (n = 103 THO; n = 56 TAU) had a mean age of 37 years (SD = 9.8 years) and included 52 % women, 83 % with Medicaid insurance, 80 % identified as White, 65 % unemployed/student, and 19 % unhoused. There were differences in gender (THO = 54 % women vs. TAU = 44 %, p = .04), unemployed status (60 % vs 75 %, p = .02), and stable housing (84 % vs 73 %, p = .02). Rates of buprenorphine discontinuation were low in the THO (4 %) and TAU (13 %) groups across 24 weeks. In the adjusted analysis, the risk of discontinuation was 61 % lower in the THO group (aRR = 0.39, 95 % CI [0.17, 0.89], p = .026). Decreases occurred over time on the harms subscale of the BAM (within-group difference - 0.85, p = .0004 [THO], and - 0.68, p = .04 [TAU]) and cravings (within-group difference - 13.47, p = .0001 [THO] vs -7.65, p = .01 [TAU]). Conclusions: A telehealth-only platform reduced the risk of buprenorphine discontinuation compared to office-based TAU. In-person evaluation to receive buprenorphine may not be necessary for treatment-seeking patients. Clinical trials identifier: NCT03224858.
From Alpha to Omicron and Beyond: Associations Between SARS-CoV-2 Variants and Surgical Outcomes
(2024-06-24) Verhagen, Nathaniel B; Geissler, Thomas; SenthilKumar, Gopika; Gehl, Carson; Shaik, Tahseen; Flitcroft, Madelyn A; Yang, Xin; Taylor, Bradley W; Ghaferi, Amir A; Gould, Jon C; Kothari, Anai N; Center for Clinical and Translational Science
Introduction: The COVID-19 pandemic has significantly influenced surgical practices, with SARS-CoV-2 variants presenting unique pathologic profiles and potential impacts on perioperative outcomes. This study explores associations between Alpha, Delta, and Omicron variants of SARS-CoV-2 and surgical outcomes. Methods: We conducted a retrospective analysis using the National COVID Cohort Collaborative database, which included patients who underwent selected major inpatient surgeries within eight weeks post-SARS-CoV-2 infection from January 2020 to April 2023. The viral variant was determined by the predominant strain at the time of the patient's infection. Multivariable logistic regression models explored the association between viral variants, COVID-19 severity, and 30-d major morbidity or mortality. Results: The study included 10,617 surgical patients with preoperative COVID-19, infected by the Alpha (4456), Delta (1539), and Omicron (4622) variants. Patients infected with Omicron had the highest vaccination rates, most mild disease, and lowest 30-d morbidity and mortality rates. Multivariable logistic regression demonstrated that Omicron was linked to a reduced likelihood of adverse outcomes compared to Alpha, while Delta showed odds comparable to Alpha. Inclusion of COVID-19 severity in the model rendered the odds of major morbidity or mortality equal across all three variants. Conclusions: Our study examines the associations between the clinical and pathological characteristics of SARS-CoV-2 variants and surgical outcomes. As novel SARS-CoV-2 variants emerge, this research supports COVID-19-related surgical policy that assesses the severity of disease to estimate surgical outcomes.
SSRI use during acute COVID-19 and risk of long COVID among patients with depression
(2024-10-08) Butzin-Dozier, Zachary; Ji, Yunwen; Deshpande, Sarang; Hurwitz, Eric; Anzalone, A Jerrod; Coyle, Jeremy; Shi, Junming; Mertens, Andrew; van der Laan, Mark J; Colford, John M; Patel, Rena C; Hubbard, Alan E; Center for Clinical and Translational Science
Background: Long COVID, also known as post-acute sequelae of COVID-19 (PASC), is a poorly understood condition with symptoms across a range of biological domains that often have debilitating consequences. Some have recently suggested that lingering SARS-CoV-2 virus particles in the gut may impede serotonin production and that low serotonin may drive many Long COVID symptoms across a range of biological systems. Therefore, selective serotonin reuptake inhibitors (SSRIs), which increase synaptic serotonin availability, may be used to prevent or treat Long COVID. SSRIs are commonly prescribed for depression, therefore restricting a study sample to only include patients with depression can reduce the concern of confounding by indication. Methods: In an observational sample of electronic health records from patients in the National COVID Cohort Collaborative (N3C) with a COVID-19 diagnosis between September 1, 2021, and December 1, 2022, and a comorbid depressive disorder, the leading indication for SSRI use, we evaluated the relationship between SSRI use during acute COVID-19 and subsequent 12-month risk of Long COVID (defined by ICD-10 code U09.9). We defined SSRI use as a prescription for SSRI medication beginning at least 30 days before acute COVID-19 and not ending before SARS-CoV-2 infection. To minimize bias, we estimated relationships using nonparametric targeted maximum likelihood estimation to aggressively adjust for high-dimensional covariates. Results: We analyzed a sample (n = 302,626) of patients with a diagnosis of a depressive condition before COVID-19 diagnosis, where 100,803 (33%) were using an SSRI. We found that SSRI users had a significantly lower risk of Long COVID compared to nonusers (adjusted causal relative risk 0.92, 95% CI (0.86, 0.99)) and we found a similar relationship comparing new SSRI users (first SSRI prescription 1 to 4 months before acute COVID-19 with no prior history of SSRI use) to nonusers (adjusted causal relative risk 0.89, 95% CI (0.80, 0.98)). Conclusions: These findings suggest that SSRI use during acute COVID-19 may be protective against Long COVID, supporting the hypothesis that serotonin may be a key mechanistic biomarker of Long COVID.
The prevalence of postacute sequelae of coronavirus disease 2019 in solid organ transplant recipients: Evaluation of risk in the National COVID Cohort Collaborative
(2024-06-08) Vinson, Amanda J; Schissel, Makayla; Anzalone, Alfred J; Dai, Ran; French, Evan T; Olex, Amy L; Lee, Stephen B; Ison, Michael; Mannon, Roslyn B; Center for Clinical and Translational Science
Postacute sequelae after the coronavirus disease (COVID) of 2019 (PASC) is increasingly recognized, although data on solid organ transplant (SOT) recipients (SOTRs) are limited. Using the National COVID Cohort Collaborative, we performed 1:1 propensity score matching (PSM) of all adult SOTR and nonimmunosuppressed/immunocompromised (ISC) patients with acute COVID infection (August 1, 2021 to January 13, 2023) for a subsequent PASC diagnosis using International Classification of Diseases, 10th Revision, Clinical Modification codes. Multivariable logistic regression was used to examine not only the association of SOT status with PASC, but also other patient factors after stratifying by SOT status. Prior to PSM, there were 8769 SOT and 1 576 769 non-ISC patients with acute COVID infection. After PSM, 8756 SOTR and 8756 non-ISC patients were included; 2.2% of SOTR (n = 192) and 1.4% (n = 122) of non-ISC patients developed PASC (P value < .001). In the overall matched cohort, SOT was independently associated with PASC (adjusted odds ratio [aOR], 1.48; 95% confidence interval [CI], 1.09-2.01). Among SOTR, COVID infection severity (aOR, 11.6; 95% CI, 3.93-30.0 for severe vs mild disease), older age (aOR, 1.02; 95% CI, 1.01-1.03 per year), and mycophenolate mofetil use (aOR, 2.04; 95% CI, 1.38-3.05) were each independently associated with PASC. In non-ISC patients, only depression (aOR, 1.96; 95% CI, 1.24-3.07) and COVID infection severity were. In conclusion, PASC occurs more commonly in SOTR than in non-ISC patients, with differences in risk profiles based on SOT status.
Effects of Antidepressants on COVID-19 Outcomes: Retrospective Study on Large-Scale Electronic Health Record Data
(2023-04-11) Rahman, Md Mahmudur; Mahi, Atqiya Munawara; Melamed, Rachel; Alam, Mohammad Arif Ul; Medicine
Background: Antidepressants exert an anticholinergic effect in varying degrees, and various classes of antidepressants can produce a different effect on immune function. While the early use of antidepressants has a notional effect on COVID-19 outcomes, the relationship between the risk of COVID-19 severity and the use of antidepressants has not been properly investigated previously owing to the high costs involved with clinical trials. Large-scale observational data and recent advancements in statistical analysis provide ample opportunity to virtualize a clinical trial to discover the detrimental effects of the early use of antidepressants. Objective: We primarily aimed to investigate electronic health records for causal effect estimation and use the data for discovering the causal effects of early antidepressant use on COVID-19 outcomes. As a secondary aim, we developed methods for validating our causal effect estimation pipeline. Methods: We used the National COVID Cohort Collaborative (N3C), a database aggregating health history for over 12 million people in the United States, including over 5 million with a positive COVID-19 test. We selected 241,952 COVID-19-positive patients (age >13 years) with at least 1 year of medical history. The study included a 18,584-dimensional covariate vector for each person and 16 different antidepressants. We used propensity score weighting based on the logistic regression method to estimate causal effects on the entire data. Then, we used the Node2Vec embedding method to encode SNOMED-CT (Systematized Nomenclature of Medicine-Clinical Terms) medical codes and applied random forest regression to estimate causal effects. We used both methods to estimate causal effects of antidepressants on COVID-19 outcomes. We also selected few negatively effective conditions for COVID-19 outcomes and estimated their effects using our proposed methods to validate their efficacy. Results: The average treatment effect (ATE) of using any one of the antidepressants was -0.076 (95% CI -0.082 to -0.069; P<.001) with the propensity score weighting method. For the method using SNOMED-CT medical embedding, the ATE of using any one of the antidepressants was -0.423 (95% CI -0.382 to -0.463; P<.001). Conclusions: We applied multiple causal inference methods with novel application of health embeddings to investigate the effects of antidepressants on COVID-19 outcomes. Additionally, we proposed a novel drug effect analysis-based evaluation technique to justify the efficacy of the proposed method. This study offers causal inference methods on large-scale electronic health record data to discover the effects of common antidepressants on COVID-19 hospitalization or a worse outcome. We found that common antidepressants may increase the risk of COVID-19 complications and uncovered a pattern where certain antidepressants were associated with a lower risk of hospitalization. While discovering the detrimental effects of these drugs on outcomes could guide preventive care, identification of beneficial effects would allow us to propose drug repurposing for COVID-19 treatment.
Biomarker Trajectory Prediction and Causal Analysis of the Impact of the Covid-19 Pandemic on CVD Patients using Machine Learning
(2024-08-05) Inekwe, Trusting; Mkandawire, Winnie; Wee, Brian; Agu, Emmanuel; Colubri, Andres; Center for Accelerating Practices to End Suicide (CAPES); Genomics and Computational Biology; Morningside Graduate School of Biomedical Sciences; Winnie Mkandawire
Background: The COVID-19 pandemic disrupted healthcare services, increasing the susceptibility of high-risk patients including those with cardiovascular Diseases (CVDs), to adverse outcomes. Biomarkers provide insights into patients' underlying health status. However, few studies have investigated the effects of the COVID-19 pandemic on CVD biomarker trajectories using predictive modeling and causal analyses frameworks. Prior research explored the impacts of the COVID-19 pandemic on CVD severity and prognosis but did not investigate biomarker trajectories using Machine Learning (ML), which can discover complex multivariate relationships in multi-modal data. Objective: This study aimed to compare six ML regression models to select the best performing models for predicting biomarker trajectories in CVD patients using retrospective data. Subsequently, these models were used to assess the COVID-19 pandemic's impact on CVD patients and for causal analyses Approach: Using ML regression and causal inference, this study investigated the pandemic's impact on biomarker values of 80,917 CVD patients and 77,332 non-CVD controls, treated at two hospitals in Central Massachusetts between May 2018 and December 2021. ML regression algorithms, including Neural Networks (NN), Decision Trees (DT), Random Forests (RF), XGBoost, CATBoost and ADABoost, were trained and compared. Important CVD biomarkers (HbA1c, LDL cholesterol, BMI, and BP) were predicted as outcome variables with patients' risk factors (age, race, gender, socioeconomic status) as input variables. Shapley feature importance analyses identified the most predictive features, which were then utilized in Causal Analysis. A Difference-in-Differences (DID) approach within a Double/Debiased Machine Learning (DML) method isolated the pandemic's impact on biomarkers, while minimizing the effects of confounding factors. Results: CATBoost and XGBoost were the most predictive ML models for LDL cholesterol and HbA1c, yielding R 2 values of 0.13 and 0.10, respectively. RF outperformed other models for BMI and BP, achieving R 2 values of 0.192 and 0.071. The small R 2 values were due to the prevalence of categorical features in the data with substantial variation in biomarker values. Feature importance analysis determined age, socioeconomic status, and race/ethnicity to be important drivers of biomarker changes, highlighting the role of social determinants of health. DML with DID analysis revealed a statistically significant increase (p-value <0.05) in BMI and systolic BP values for CVD patients during the COVID-19 pandemic compared to the control group, their HbA1c and LDL cholesterol values actually improved during the pandemic, suggesting differential effects of the pandemic on key CVD biomarkers. Conclusion: Our proposed ML biomarker prediction models can facilitate personalized interventions and advance risk assessment for CVD patients. The predictive importance of factors such as age, socioeconomic status, and race highlights the need to address health disparities.
Longitudinal Changes in Youth Mental Health From Before to During the COVID-19 Pandemic
(2024-08-01) Blackwell, Courtney K; Wu, Guojing; Chandran, Aruna; Arizaga, Jessica; Bosquet Enlow, Michelle; Brennan, Patricia A; Burton, Phoebe; Bush, Nicole R; Cella, David; Cummins, Caroline; D'Sa, Viren A; Frazier, Jean A; Ganiban, Jody M; Gershon, Richard; Koinis-Mitchell, Daphne; Leve, Leslie D; Loftus, Christine T; Lukankina, Natalia; Margolis, Amy; Nozadi, Sara S; Wright, Rosalind J; Wright, Robert O; Zhao, Qi; LeWinn, Kaja Z; Eunice Kennedy Shriver Center; Pediatrics; Psychiatry
Importance: Robust longitudinal studies of within-child changes in mental health associated with the COVID-19 pandemic are lacking, as are studies examining sources of heterogeneity in such changes. Objective: To investigate within-child changes, overall and between subgroups, in youth mental health from prepandemic to midpandemic. Design, setting, and participants: This cohort study used longitudinal prepandemic and midpandemic data from the Environmental influences on Child Health Outcomes (ECHO) Program, collected between January 1, 2015, and March 12, 2020 (prepandemic), and between March 13, 2020, and August 31, 2022 (midpandemic). Data were analyzed between December 1, 2022, and June 1, 2024. The sample included 9 US-based observational longitudinal pediatric ECHO cohorts. Cohorts were included if they collected the Child Behavior Checklist (CBCL) School Age version before and during the pandemic on more than 20 participants of normal birth weight aged 6 to 17 years. Exposure: The COVID-19 pandemic. Main outcomes and measures: Prepandemic to midpandemic changes in CBCL internalizing, externalizing, depression, anxiety, and attention-deficit/hyperactivity disorder (ADHD) scores were estimated, and differences in outcome trajectories by child sociodemographic characteristics (age, sex, race, ethnicity, and poverty level) and prepandemic mental health problems were examined using established CBCL clinical score thresholds. Results: A total of 1229 participants (mean [SD] age during the pandemic, 10.68 [2.29] years; 625 girls [50.9%]) were included. The sample was socioeconomically diverse (197 of 1056 children [18.7%] lived at ≤130% of the Federal Poverty Level; 635 (51.7%) identified as White, 388 (31.6%) as Black, 147 (12.0%) as multiracial, 40 (3.3%) as another race, and 118 (9.6%) as Hispanic). Generalized linear mixed-effects models revealed minor decreases in externalizing problems (β = -0.88; 95% CI, -1.16 to -0.60), anxiety (β = -0.18; 95% CI, -0.31 to -0.05), and ADHD (β = -0.36; 95% CI, -0.50 to -0.22), but a minor increase in depression (β = 0.22; 95% CI, 0.10 to 0.35). Youth with borderline or clinically meaningful prepandemic scores experienced decreases across all outcomes, particularly externalizing problems (borderline, β = -2.85; 95% CI, -3.92 to -1.78; clinical, β = -4.88; 95% CI, -5.84 to -3.92). Low-income (β = -0.76; 95% CI, -1.14 to -0.37) and Black (β = -0.52; 95% CI, -0.83 to -0.20) youth experienced small decreases in ADHD compared with higher income and White youth, respectively. Conclusions and relevance: In this longitudinal cohort study of economically and racially diverse US youth, there was evidence of differential susceptibility and resilience for mental health problems during the pandemic that was associated with prepandemic mental health and sociodemographic characteristics.

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