Development of a Definition of Postacute Sequelae of SARS-CoV-2 Infection.

Importance: SARS-CoV-2 infection is associated with persistent, relapsing, or new symptoms or other health effects occurring after acute infection, termed postacute sequelae of SARS-CoV-2 infection (PASC), also known as long COVID. Characterizing PASC requires analysis of prospectively and uniformly collected data from diverse uninfected and infected individuals. Objective: To develop a definition of PASC using self-reported symptoms and describe PASC frequencies across cohorts, vaccination status, and number of infections. Design, Setting, and Participants: Prospective observational cohort study of adults with and without SARS-CoV-2 infection at 85 enrolling sites (hospitals, health centers, community organizations) located in 33 states plus Washington, DC, and Puerto Rico. Participants who were enrolled in the RECOVER adult cohort before April 10, 2023, completed a symptom survey 6 months or more after acute symptom onset or test date. Selection included population-based, volunteer, and convenience sampling. Exposure: SARS-CoV-2 infection. Main Outcomes and Measures: PASC and 44 participant-reported symptoms (with severity thresholds). Results: A total of 9764 participants (89% SARS-CoV-2 infected; 71% female; 16% Hispanic/Latino; 15% non-Hispanic Black; median age, 47 years [IQR, 35-60]) met selection criteria. Adjusted odds ratios were 1.5 or greater (infected vs uninfected participants) for 37 symptoms. Symptoms contributing to PASC score included postexertional malaise, fatigue, brain fog, dizziness, gastrointestinal symptoms, palpitations, changes in sexual desire or capacity, loss of or change in smell or taste, thirst, chronic cough, chest pain, and abnormal movements. Among 2231 participants first infected on or after December 1, 2021, and enrolled within 30 days of infection, 224 (10% [95% CI, 8.8%-11%]) were PASC positive at 6 months. Conclusions and Relevance: A definition of PASC was developed based on symptoms in a prospective cohort study. As a first step to providing a framework for other investigations, iterative refinement that further incorporates other clinical features is needed to support actionable definitions of PASC.

Assessing the Impact of COVID-19 on Retention in HIV Primary Care: A Longitudinal Multisite Analysis.

We compared retention in care outcomes between a pre-COVID-19 (Apr19-Mar20) and an early-COVID-19 (Apr20-Mar21) period to determine whether the pandemic had a significant impact on these outcomes and assessed the role of patient sociodemographics in both periods in individuals enrolled in the Data for Care Alabama project (n = 6461). Using scheduled HIV primary care provider visits, we calculated a kept-visit measure and a missed-visit measure and compared them among the pre-COVID-19 and early-COVID-19 periods. We used logistic regression models to calculated odds ratios (OR) and accompanying 95% confidence intervals (CI). Overall, individuals had lowers odds of high visit constancy [OR (95% CI): 0.85 (0.79, 0.92)] and higher odds of no-shows [OR (95% CI): 1.27 (1.19, 1.35)] during the early-COVID-19 period. Compared to white patients, Black patients were more likely to miss an appointment and transgender people versus cisgender women had lower visit constancy in the early-COVID-19 period.

Collaborative Cohort of Cohorts for COVID-19 Research (C4R) Study: Study Design.

The Collaborative Cohort of Cohorts for COVID-19 Research (C4R) is a national prospective study of adults comprising 14 established US prospective cohort studies. Starting as early as 1971, investigators in the C4R cohort studies have collected data on clinical and subclinical diseases and their risk factors, including behavior, cognition, biomarkers, and social determinants of health. C4R links this pre-coronavirus disease 2019 (COVID-19) phenotyping to information on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and acute and postacute COVID-related illness. C4R is largely population-based, has an age range of 18-108 years, and reflects the racial, ethnic, socioeconomic, and geographic diversity of the United States. C4R ascertains SARS-CoV-2 infection and COVID-19 illness using standardized questionnaires, ascertainment of COVID-related hospitalizations and deaths, and a SARS-CoV-2 serosurvey conducted via dried blood spots. Master protocols leverage existing robust retention rates for telephone and in-person examinations and high-quality event surveillance. Extensive prepandemic data minimize referral, survival, and recall bias. Data are harmonized with research-quality phenotyping unmatched by clinical and survey-based studies; these data will be pooled and shared widely to expedite collaboration and scientific findings. This resource will allow evaluation of risk and resilience factors for COVID-19 severity and outcomes, including postacute sequelae, and assessment of the social and behavioral impact of the pandemic on long-term health trajectories.

Role of Visit Modality in the HIV-Related No-Shows During the COVID-19 Pandemic: A Multisite Retrospective Cohort Study.

The emergence of the COVID-19 pandemic necessitated rapid expansion of telehealth as part of healthcare delivery. This study compared HIV-related no-shows by visit type (in-person; video; telephone) during the COVID-19 pandemic (April 2020-September 2021) from the Data for Care Alabama project. Using all primary care provider visits, each visit's outcome was categorized as no-show or arrived. A logistic regression model using generalized estimating equations accounting for repeat measures in individuals and within sites calculated odds ratios (OR) and their accompanying 95% confidence interval (CI) for no-shows by visit modality. The multivariable models adjusted for sociodemographic factors. In-person versus telephone visits [OR (95% CI) 1.64 (1.48-1.82)] and in-person versus video visits [OR (95% CI) 1.53 (1.25-1.85)] had higher odds of being a no-show. In-person versus telephone and video no-shows were significantly higher. This may suggest success of telehealth visits as a method for HIV care delivery even beyond COVID-19.

Diabetes distress and self-reported health in a sample of Alabama Medicaid-covered adults before and during the COVID-19 pandemic

Temporary closures of outpatient health facilities and transitions to virtual care during the COVID-19 pandemic interrupted the care of millions of patients with diabetes contributing to worsening psychosocial factors and enhanced difficulty in managing type 2 diabetes mellitus. We explored associations between COVID time period and self-reported diabetes distress on self-reported health among a sample of Alabama Medicaid-covered adults with diabetes pre-COVID (2017–2019) and during-COVID (2020–2021). Method: In this cross-sectional study, we surveyed a population-based sample of adults with type 2 diabetes covered by the Alabama Medicaid Agency. Participants were dichotomized into pre-COVID (March 2017 to October 2019) vs during-COVID (October 2020 to May 2021) groups. Participants with missing data were removed from analyses. We assessed diabetes related stress by the Diabetes Distress Scale. We measured self-reported health using a single item with a 5-point Likert scale. We ran logistic regressions modeling COVID time period on self-reported poor health controlling for demographics, severity of diabetes, and diabetes distress. Results: In this sample of 1822 individuals, median age was 54, 74.5% were female and 59.4% were Black. Compared to pre-COVID participants, participants surveyed during COVID were younger, more likely to be Black (64.1% VS 58.2%, p=0.01) and female (81.8% VS 72.5%, p<0.001). This group also had fewer individuals from rural areas (29.2% VS 38.4%, p<0.001), and shorter diabetes duration (7 years VS 9 years, p<0.001). During COVID individuals reported modestly lower levels of diabetes distress (1.2 VS 1.4, p<0.001) when compared to the pre-COVID group. After adjusting for demographic differences, diabetes severity, and diabetes distress, participants responding during COVID had increased odds of reporting poor health (Odds ratio [OR] 1.41, 95% Confidence Interval [CI] 1.11–1.80). Discussion: We found respondents were more likely to report poorer health during COVID compared to pre-COVID. These results suggest that increased outreach may be needed to address diabetes management for vulnerable groups, many of whom were already at high risk for poor outcomes prior to the pandemic.

COVID Community-Engaged Testing in Alabama: Reaching Underserved Rural Populations Through Collaboration.

Rural communities are often underserved by public health testing initiatives in Alabama. As part of the National Institutes of Health's Rapid Acceleration of Diagnostics‒Underserved Populations initiative, the University of Alabama at Birmingham, along with community partners, sought to address this inequity in COVID-19 testing. We describe the participatory assessment, selection, and implementation phases of this project, which administered more than 23 000 COVID-19 tests throughout the state, including nearly 4000 tests among incarcerated populations. (Am J Public Health. 2022;112(10):1399-1403. https://doi.org/10.2105/AJPH.2022.306985).

COVID-19 Vaccination and Remdesivir are Associated With Protection From New or Increased Levels of Donor-Specific Antibodies Among Kidney Transplant Recipients Hospitalized With COVID-19.

Alloimmune responses in kidney transplant (KT) patients previously hospitalized with COVID-19 are understudied. We analyzed a cohort of 112 kidney transplant recipients who were hospitalized following a positive SARS-CoV-2 test result during the first 20 months of the COVID-19 pandemic. We found a cumulative incidence of 17% for the development of new donor-specific antibodies (DSA) or increased levels of pre-existing DSA in hospitalized SARS-CoV-2-infected KT patients. This risk extended 8 months post-infection. These changes in DSA status were associated with late allograft dysfunction. Risk factors for new or increased DSA responses in this KT patient cohort included the presence of circulating DSA pre-COVID-19 diagnosis and time post-transplantation. COVID-19 vaccination prior to infection and remdesivir administration during infection were each associated with decreased likelihood of developing a new or increased DSA response. These data show that new or enhanced DSA responses frequently occur among KT patients requiring admission with COVID-19 and suggest that surveillance, vaccination, and antiviral therapies may be important tools to prevent alloimmunity in these individuals.

Health care experiences during the COVID-19 pandemic by race and social determinants of health among adults age ≥ 58 years in the REGARDS study.

BACKGROUND: Understanding health care experiences during the COVID-19 pandemic may provide insights into patient needs and inform policy. The objective of this study was to describe health care experiences by race and social determinants of health. METHODS: We conducted a telephone survey (July 6, 2020-September 4, 2021) among 9492 Black and White participants in the longitudinal REasons for Geographic And Racial Differences in Stroke cohort study, age 58-105 years, from the continental United States. Among participants with symptoms of COVID-19, outcomes were: 1. Sought care or advice for the illness; 2. Received a SARS-CoV-2 test for the illness; and 3. Tested positive. Among participants without symptoms of COVID-19, outcomes were: 1. Wanted a test; 2. Wanted and received a test; 3. Did not want but received a test; and 4. Tested positive. We examined these outcomes overall and in subgroups defined by race, household income, marital status, education, area-level poverty, rural residence, Medicaid expansion, public health infrastructure ranking, and residential segregation. RESULTS: The average age of participants was 76.8 years, 36% were Black, and 57% were female. Among participants with COVID-19 symptoms (n = 697), 74% sought care or advice for the illness, 50% received a SARS-CoV-2 test, and 25% had a positive test (50% of those tested). Among participants without potential COVID-19 symptoms (n = 8795), 29% wanted a SARS-CoV-2 test, 22% wanted and received a test, 8% did not want but received a test, and 1% tested positive; a greater percentage of participants who were Black compared to White wanted (38% vs 23%, p < 0.001) and received tests (30% vs 18%, p < 0.001) and tested positive (1.4% vs 0.8%, p = 0.005). CONCLUSIONS: In this national study of older US adults, many participants with potential COVID-19 symptoms and asymptomatic participants who desired testing did not receive COVID-19 testing.

The University of Alabama at Birmingham COVID-19 Collaborative Outcomes Research Enterprise: Developing an institutional learning health system in response to the global pandemic.

Introduction: As a local response to the COVID-19 global pandemic, the University of Alabama at Birmingham (UAB) established the UAB COVID-19 Collaborative Outcomes Research Enterprise (CORE), an institutional learning health system (LHS) to achieve an integrated health services outcomes and research response. Methods: We developed a network of expertise and capabilities to rapidly develop and deploy an institutional-level interdisciplinary LHS. Based upon a scoping review of the literature and the Knowledge to Action Framework, we adopted a LHS framework identifying contributors and components necessary to developing a system within and between the university academic and medical centers. We used social network analysis to examine the emergence of informal work patterns and diversified network capabilities based on the LHS framework. Results: This experience report details three principal characteristics of the UAB COVID-19 CORE LHS development: (a) identifying network contributors and components; (b) building the institutional network; and (c) diversifying network capabilities. Contributors and committees were identified from seven components of LHS: (a) collaborative and executive leadership committee, (b) research coordinating committee, (c) oversight and ethics committee, (d) thematic scientific working groups, (e) programmatic working groups, (f) informatics capabilities, and (g) patient advisory groups. Evolving from the topical interests of the initial CORE participants, scientific working groups emerged to support the learning system network. Programmatic working groups were charged with developing a comprehensive and mutually accessible COVID-19 database. Discussion: Our LHS framework allowed for effective integration of multiple academic and medical centers into a cohesive institutional-level learning system. Network analysis indicated diversity of institutional disciplines, professional rank, and topical focus pertaining to COVID-19, with each center leveraging existing institutional responsibilities to minimize gaps in network capabilities. Conclusion: Incorporating an adapted LHS framework designed for academic medical centers served as a foundational resource supporting further institutional-level efforts to develop agile and responsive learning networks.