Faculty Bibliography

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.

INTRODUCTION/UNASSIGNED:Awareness, assessment and treatment of sleep apnea are disproportionately lower among Blacks, compared to other racial/ethnic groups. To address this health disparity gap, communication strategies that connect Blacks to OSA education, detection and treatment adherence interventions are needed. Strategies that engage individuals through communication technologies, community-level social network support, and medical providers in clinical settings are also needed. We present lessons learned from three studies that offer these solutions using a community-engaged research model: The Metabolic Syndrome Outcome Study (MetSO), Peer-enhanced Education to Reduce Sleep Ethnic Disparities (PEERS-ED), and Tailored Approach to Sleep Health Education (TASHE), to capture program effectiveness and lessons learned from project successes and failures. METHODS/UNASSIGNED:The methods of OSA community-based programs included the application of an OSA community-engaged research model. This model served as a strategic guideline for effective interventions to engage communities in research and ensure cultural appropriateness in OSA interventions. Focus groups, in-depth interviews and community steering committee meetings were conducted with various stakeholders. Delphi surveys were used to identify high priority diseases and conditions. Community barriers and needs were identified through iterative combinations of surveys and focus group meetings. Stakeholder groups participated in all aspects of our studies, including the development, dissemination and implementation phases, reflecting a bi-directional decision-making process that ensures the interests of both parties were considered. The MetSO, PEERS-ED and TASHE studies were reviewed to understand the effectiveness of the programs and to evaluate lessons learned. RESULTS/UNASSIGNED:MetSO, PEERS-ED and TASHE interventions revealed that community-engaged strategies are successful in enrolling Black populations into clinical trials. The study teams reached nearly 3,000 Blacks at risk of OSA and screened about 2,000 people in sleep apnea studies in New York City. Sleep brochures were distributed to over 10,000 people. Lessons learned from MetSO, PEERS-ED and TASHE interventions revealed that building relationships, establishing trust, identifying a study champion, learning to adjust and providing participant incentives are key strategic elements for successful recruitment and retention of Blacks participations in clinical trials. CONCLUSION/UNASSIGNED:Strategic application of community-oriented frameworks ensures active community engagement throughout the research process, allowing for greater enrollment of Blacks in clinical studies as well as increased OSA awareness, diagnosis, and treatment.

Reaching population-level impact for families in poverty requires moving beyond a sole focus on individuals, to a wider focus on interactions between individuals and their broader environmental contexts. Place-based initiatives have emerged as a policy response to promote community-level change around these broader interactions between individuals and their local communities through addressing long-standing disparities in housing, employment, education, and health. Together Growing Strong (TGS) is one such place-based initiative focused on transforming the health, wellbeing, and development of young children and their families in Sunset Park, Brooklyn. The Children, Caregivers, and Community (C3) Study is an outcomes-based study designed to assess the trajectories of children and families in Sunset Park along indicators such as family health and wellbeing and child development in relation to TGS program participation. The aims, scope, and protocol of the C3 Study are the subjects of this paper.

STUDY OBJECTIVES/OBJECTIVE:To assess parental experience of their child's OSA detection process and inform the development of interventions and health communication strategies to improve OSA detection. METHODS:Semi-structured interviews were conducted with 30 parents of children (ages 3-14) who snored and were referred for an overnight polysomnogram (PSG). Parents (60.0% Black race; 93.3% mothers) described how their child was referred for PSG and their perceptions and feelings throughout the detection process. Parents also completed an OSA knowledge measure. Interview data were analyzed using a descriptive approach and thematic analysis was conducted using the NVivo 12 software system. RESULTS:Twenty-one themes were identified across five categories (first steps; PSG facilitators and barriers; health information; health care experiences; parent experiences). Respondents experienced multiple pathways to OSA detection, with more than half of referrals initiated by parental concerns (vs. screening efforts). Parents reported a willingness to take any necessary steps to help their child. Both barriers and facilitators to completing a PSG were described. Parents observed both nighttime and daytime symptoms related to OSA in their child but often did not connect the symptoms to each other until later in the process. Participants had varying degrees of OSA knowledge, with a mean knowledge score of 56% correct (range 10%-90% correct). CONCLUSIONS:Parental experiences highlight aspects of the health care system that are both effective and ineffective in detecting children with OSA. Implications include a need for strategies to promote timely detection and to provide parents with accurate information about pediatric OSA.

Our study examines the acceptability and feasibility of Moshi, an audio-based mobile application, among children 3-8 years old using a parent-child dyadic approach. Our 10-day within-subject pre-post study design consisted of five nights of a normal bedtime routine and a subsequent five nights exposed to one story on the Moshi application during the intervention. Each five-night period spanned three weeknights and two weekend nights. The Short-Form Children's Sleep Habits Questionnaire (SF-CSHQ) was used to measure children's sleep at baseline and post-intervention. The PROMIS, Epworth Sleepiness Scale and Pittsburgh Sleep Quality Index were used to assess parents' sleep. Among the 25 child-parent dyads, the mean child age was 4 (SD = 1.23) and 63% were male (n = 15). Mean parent age was 35 (SD = 5.83), 84% were female (n = 21), and 48.0% were Black (n = 12). For child-only comparisons, mean post-SF-CSHQ measures were lower compared to baseline. A trend in parent sleep is reported. This study shows the potential of an audio-based mobile sleep aid to improve sleep health in a racially diverse parent and child dyad sample.

Patient health literacy is vital to clinical trial engagement. Knowledge and beliefs about clinical trials may contribute to patient literacy of clinical trials, influencing engagement, enrollment and retention. We developed and assessed a survey that measures clinical trial health knowledge and beliefs, known as the Clinical trial HEalth Knowledge and belief Scale (CHEKS). The 31 survey items in CHEKS represent knowledge and beliefs about clinical trial research (n = 409) in 2017. We examined item-scale correlations for the 31 items, eliminated items with item-scale correlations less than 0.30, and then estimated internal consistency reliability for the remaining 25 items. We used the comparative fit index (CFI) and the root mean squared error of approximation (RMSEA) to evaluate model fit. The average age of the sample was 34 (SD = 15.7) and 48% female. We identified 6 of the 31 items that had item-scale correlations (corrected for overlap) lower than 0.30. Coefficient alpha for the remaining 25 items was 0.93 A one-factor categorical confirmatory factor analytic model with 16 correlated errors was not statistically significant (chi-square = 10011.994, df = 300, p < 0.001) but fit the data well (CFI = 0.95 and RMSEA = 0.07). CHEKS can assess clinical trial knowledge and beliefs.