Breakthrough SARS-CoV-2 Infections after Vaccination in the North Carolina COVID-19 Community Research Partnership (NC-CCRP)

Background. We characterize the incidence and risk factors of SARS-CoV-2 breakthrough infections in the NC-CCRP. Cumulative Incidence of Breakthrough infections after Self-reported Symptomatic SARS-CoV-2 Test Cumulative incidence curves (1 minus the unadjusted Kaplan-Meier risk), number at risk at each time point for the first self-reported symptomatic positive SARS-CoV-2 test, starting from full vaccination among participants who reported full vaccination. Methods. The NC-CCRP is an observational cohort study assessing COVID-19 symptoms, test results, vaccination status, and risk behavior via daily email or text surveys. Cox models were used to estimate hazard rates. Fixed covariates were age at enrollment, race/ethnicity, sex, county of residence classification, vaccine product, and healthcare worker status. Time varying covariates were vaccination rate in county of residence, mask usage in the week prior, the Delta time frame, the Omicron time frame, and receipt of a vaccine booster. Results. Among 15,808 eligible adult participants, 638 (4.0%) reported a positive SARS-CoV-2 test after vaccination from 01/15/2021 to 01/03/2022. The breakthrough rate increased with time from vaccination (Figure), with a cumulative incidence of 6.95% over 45 weeks of follow-up. Factors associated with a lower risk of breakthrough infection (p< 0.05) included older age (HR 0.7 for participants 45-64 years and 0.41 for those > 65 years compared to those 18-44 years), prior SARS-CoV-2 infection (HR 0.58), higher rates of mask use (HR 0.66), and receipt of a booster vaccination (HR 0.33). Higher rates of breakthrough infection were reported by participants vaccinated with BNT162b2 (HR 1.35) or Ad26.COV2.S (1.74) compared to mRNA-1273, those residing in suburban (HR 1.33) or rural (1.24) counties compared to urban counties, and during circulation of the Delta (3.54) and Omicron (16.68) variants compared to earlier time periods. There was no association of breakthrough infection with sex, race/ethnicity, healthcare worker status, or vaccination rate in the county of residence. Conclusion. In this real-world analysis, risk of breakthrough infections increased with time since vaccination, with some variability among the specific vaccine products. Risk increased dramatically during the Omicron surge. Higher rates among younger individuals may reflect more frequent, or higher risk exposures, including those related to childcare. Significantly lower rates of breakthrough associated with mask wearing and receipt of a booster highlight specific measures that individuals can take to minimize the risk for COVID-19.

Analysis of Residential Segregation and Racial and Ethnic Disparities in Severe Maternal Morbidity Before and During the COVID-19 Pandemic.

Importance: Persistent racial and ethnic disparities in severe maternal morbidity (SMM) in the US remain a public health concern. Structural racism leaves women of color in a disadvantaged situation especially during COVID-19, leading to disproportionate pandemic afflictions among racial and ethnic minority women. Objective: To examine racial and ethnic disparities in SMM rates before and during the COVID-19 pandemic and whether the disparities varied with level of Black residential segregation. Design, Setting, and Participants: A statewide population-based retrospective cohort study used birth certificates linked to all-payer childbirth claims data in South Carolina. Participants included women who gave birth between January 2018 and June 2021. Data were analyzed from December 2021 to February 2022. Exposures: Exposures were (1) period when women gave birth, either before the pandemic (January 2018 to February 2020) or during the pandemic (March 2020 to June 2021) and (2) Black-White residential segregation (isolation index), categorizing US Census tracts in a county as low (<40%), medium (40%-59%), and high (≥60%). Main Outcomes and Measures: SMM was identified using International Statistical Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes developed by the US Centers for Disease Control and Prevention. Multilevel logistic regressions with an interrupted approach were used, adjusting for maternal-level and facility-level factors, accounting for residential county-level random effects. Results: Of 166 791 women, 95 098 (57.0%) lived in low-segregated counties (mean [SD] age, 28.1 [5.7] years; 5126 [5.4%] Hispanic; 20 523 [21.6%] non-Hispanic Black; 62 690 [65.9%] White), and 23 521 (14.1%) women (mean [SD] age, 28.1 [5.8] years; 782 [3.3%] Hispanic; 12 880 [54.8%] non-Hispanic Black; 7988 [34.0%] White) lived in high-segregated areas. Prepandemic SMM rates were decreasing, followed by monthly increasing trends after March 2020. On average, living in high-segregated communities was associated with higher odds of SMM (adjusted odds ratio [aOR], 1.61; 95% CI, 1.06-2.34). Black women regardless of residential segregation had higher odds of SMM than White women (aOR, 1.47; 95% CI, 1.11-1.96 for low-segregation; 2.12; 95% CI, 1.38-3.26 for high-segregation). Hispanic women living in low-segregated communities had lower odds of SMM (aOR, 0.48; 95% CI, 0.25-0.90) but those living in high-segregated communities had nearly twice the odds of SMM (aOR, 1.91; 95% CI, 1.07-4.17) as their White counterparts. Conclusions and Relevance: Living in high-segregated Black communities in South Carolina was associated with racial and ethnic SMM disparities. During the COVID-19 pandemic, Black vs White disparities persisted with no signs of widening gaps, whereas Hispanic vs White disparities were exacerbated. Policy reforms on reducing residential segregation or combating the corresponding structural racism are warranted to help improve maternal health.

Consumer Support for Small Business during COVID-19: An Abstract

The coronavirus outbreak (i.e., COVID-19) has swept across a growing number of countries worldwide, including the United States. In response, the U.S Department of Health and Human Services/Centers for Disease Control and Prevention has aggressively responded to the world health crisis to protect individuals from the virus. Official guidelines not only included recommendations such as social distancing and use of personal protective equipment, but also included several mandated business closures, which severely impacted small businesses. This study sought to understand factors that may attract consumers to small businesses during the ongoing COVID-19 to assist with business continuity. Specifically, this study explored whether consumer support for small business (shopping frequency and number of services used) during a pandemic can be explained by consumers’ emotional and cognitive experiences and whether there are any differences in consumer support for small business during a pandemic, depending on their demographic characteristics such as gender, generation, education and/or employment status. Using a national survey sample (n = 313), this study found that consumers’ support for small business during a pandemic can be explained by emotional and cognitive (resilience and optimism) experiences and demographic characteristics. Specifically, active resilience and negative and positive emotions influences small business shopping frequency and active resilience influences the number of services used at small businesses. Differences were found by generation, education and employment status on shopping frequency and services used. Differences were also found by annual income on shopping frequency. No differences were found by gender on shopping frequency or services used. Theoretically, this study contributes to research on disaster response by incorporating findings from the unprecedented global pandemic. Based on findings, small businesses may seek to trigger active resilience and emotions (negative and positive) in their advertising avenues to attract consumers. Small businesses may consider pivoting to attract particular consumer segments that are more likely to patronize frequently and use services offered by small business. © 2022, The Author(s), under exclusive license to Springer Nature Switzerland AG.

Multilevel determinants of racial/ethnic disparities in severe maternal morbidity and mortality in the context of the COVID-19 pandemic in the USA: protocol for a concurrent triangulation, mixed-methods study.

INTRODUCTION: The COVID-19 pandemic has affected communities of colour the hardest. Non-Hispanic black and Hispanic pregnant women appear to have disproportionate SARS-CoV-2 infection and death rates. METHODS AND ANALYSIS: We will use the socioecological framework and employ a concurrent triangulation, mixed-methods study design to achieve three specific aims: (1) examine the impacts of the COVID-19 pandemic on racial/ethnic disparities in severe maternal morbidity and mortality (SMMM); (2) explore how social contexts (eg, racial/ethnic residential segregation) have contributed to the widening of racial/ethnic disparities in SMMM during the pandemic and identify distinct mediating pathways through maternity care and mental health; and (3) determine the role of social contextual factors on racial/ethnic disparities in pregnancy-related morbidities using machine learning algorithms. We will leverage an existing South Carolina COVID-19 Cohort by creating a pregnancy cohort that links COVID-19 testing data, electronic health records (EHRs), vital records data, healthcare utilisation data and billing data for all births in South Carolina (SC) between 2018 and 2021 (>200 000 births). We will also conduct similar analyses using EHR data from the National COVID-19 Cohort Collaborative including >270 000 women who had a childbirth between 2018 and 2021 in the USA. We will use a convergent parallel design which includes a quantitative analysis of data from the 2018-2021 SC Pregnancy Risk Assessment and Monitoring System (unweighted n>2000) and in-depth interviews of 40 postpartum women and 10 maternal care providers to identify distinct mediating pathways. ETHICS AND DISSEMINATION: The study was approved by institutional review boards at the University of SC (Pro00115169) and the SC Department of Health and Environmental Control (DHEC IRB.21-030). Informed consent will be provided by the participants in the in-depth interviews. Study findings will be disseminated with key stakeholders including patients, presented at academic conferences and published in peer-reviewed journals.

Germline BRCA1/2 mutation testing in human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (ABC): A real-world study in the Syapse Learning Health Network (LHN)

Background: Germline (g)BRCA1/2 mutations represent approximately 5% of metastatic breast cancer. Poly ADP-ribose polymerase inhibitors (PARPi) have shown improved clinical outcomes, a manageable toxicity profile, and favorable patient (pt)-reported outcomes versus chemotherapy in pts with gBRCA1/2 mutated HER2-locally advanced or metastatic breast cancer. With the advent of PARPi, clinical guidelines have broadened eligibility criteria for gBRCA1/2 testing. However, limited information is available on the impact of the COVID-19 pandemic on gBRCA1/2 testing rates. We assessed trends and factors associated with gBRCA1/2 testing in pts with HER2-ABC before and during the COVID-19 pandemic. Methods: This retrospective study included pts from the Syapse LHN, a longitudinal database of pts with cancer cared for in community-based, integrated care delivery networks in 25 states in the United States. Pts were eligible for gBRCA1/2 testing from initial ABC diagnosis until death or date of last contact with the participating health system. Information on gBRCA1/2 testing was obtained from scaled sources and further curated by Certified Tumor Registrars. Logistic regression evaluated the associations between age at diagnosis, family Shistory of relevant cancer, race/ethnicity, median household income, health system, and diagnosis year with gBRCA1/2 testing among HER2-ABCs;models included hormone receptor status. Results: The study population included 1769 pts with HER2-ABC, including 577 pts with triple negative ABC initially diagnosed from 2010: 96% were women, 69% were non-Hispanic White, and 94% had an estimated median household income >$30, 000 USD;median age at initial diagnosis was 61 years. The percentage of pts ever gBRCA1/2-tested among those eligible increased over time: 26%, 28%, and 31% by end of 2018, 2019, and 2020, respectively. Similarly, the percentages of new testing among eligible but not previously tested pts increased from 2018-March 2020, decreased from April-September 2020, and trended upwards thereafter (Table 1). In logistic regression models combining data from pre-and post-COVID-19 periods, family history of relevant cancer (odds ratio [OR]=1.9;95% CI, 1.5-2.4), younger age at diagnosis (>65 reference;<45: OR=12.8, 95% CI, 8.9-18.3;45-54: OR=6.7, 95% CI, 4.9-9.3;55-64: OR=2.0, 95% CI, 1.5-2.8), and diagnosis year of 2013 or later (OR=1.9, 95% CI, 1.4-2.6) were significantly associated with increased odds of gBRCA1/2 testing. Positive hormone receptor status (OR=0.5;95% CI, 0.4-0.6) and Hispanic ethnicity (OR=0.5;95% CI, 0.3-0.9) were significantly associated with reduced odds;associations with non-Hispanic Black ethnicity did not reach statistical significance (OR=0.8;95% CI, 0.6-1.1). Conclusion: Following the expanded eligibility criteria for gBRCA1/2 testing, testing rates increased from 2018 to 2019 and decreased only slightly during the national COVID-19 lockdown. Age at diagnosis, family history, diagnosis year, ethnicity, and hormone receptor status impacted the odds of testing. Given that gBRCA1/2 mutations are actionable, focused efforts should be developed to resume the pre-pandemic trajectory of gBRCA1/2 mutation testing.

Seroconversion among Adults after Receiving at Least One Dose of a COVID-19 Vaccine: COVID-19 Community Research Partnership, Mid-Atlantic, Southeast and Southern United States, December 2020-May 2021

Background. Well-regulated clinical trials have shown authorized COVID-19 vaccines to be immunogenic and highly efficacious. Information about antibody responses after vaccination in real-world settings is needed. Methods. We evaluated seroconversion rates in adults reporting ≥ 1 dose of an authorized COVID-19 vaccine in a U.S. multistate longitudinal cohort study, the COVID-19 Community Research Partnership. Participants were recruited through 12 participating healthcare systems and community outreach. Participants had periodic home-based serologic testing using either a SARSCoV-2 nucleocapsid and spike IgM/IgG lateral flow assay (63% of participants) or a SARS-CoV-2 spike IgG enzyme-linked immunosorbent assay (37% of participants). The timing and number of tests before and after vaccination varied based on participant time in study. Participants were included if they were seronegative on the last test before and had >1 test result after vaccination (some had previously been seropositive, but seroreverted). A weighted Cox regression model with right censoring was used to obtain adjusted hazard ratios for sex, age, race/ethnicity, and prior seropositivity. Time-to-event (seroconversion) was defined as time to first positive test > 4 days after vaccination;participants were censored at the date of their last available test result. Results. 13,459 participants were included and 11,722 seroconverted (Table). Median time in study was 272 days (range 31-395). Median follow-up time from vaccine to last available test was 56 days (range 1-147). Participants had a median of 3 tests (range 1-12) before and 2 tests (range 1-8) after vaccination. Based on the Kaplan-Meier method, median time to seroconversion after first COVID-19 vaccination was 35 days (interquartile range: 25-45). Likelihood of seroconversion decreased with older age (Table). Female participants, non-Hispanic Black participants, and participants who were previously seropositive were more likely to seroconvert (Table). Conclusion. All subgroups had high rates of seroconversion, with some small differences in likelihood of seroconversion between subgroups. These data demonstrate the excellent immunogenicity of COVID-19 vaccines in real-world settings in the US.

Using the NICE evidence standards for digital health technologies to evaluate a digital self-management tool for people with musculoskeletal conditions

Keywords: Musculoskeletal;Digital health technology;Self-management Purpose: getUBetter provides digital self-management for people with musculoskeletal (MSK) conditions across care pathways in England. Digital health technologies (DHT) are being embedded at pace, but we need to determine their effectiveness, value, and suitability. NICE DHT evidence standards were used to identify gaps in getUBetter's evidence base. An evaluation was then undertaken in Wandsworth, south London to address these gaps. Methods: Between October 2019 and March 2021 the evaluation took a phased approach: 1. Mapping existing evidence for getUBetter against the NICE evidence standards and identifying gaps. 2. A mixed methods evaluation based on evidence gaps was developed with stakeholders then rescoped due to disruption from COVID-19. The evaluation assessed outcomes related to condition, satisfaction, behaviour change, and resource use. An online survey was sent to getUBetter users capturing respondents’ demographic profile and app usage;experiences and satisfaction;condition-related outcomes;and changes in self-management and understanding of their condition. Resource use was determined by a pragmatic health utilisation analysis using EMIS data comparing patients with lower back pain (LBP) with non-users in a sample of 10 GP practices. Results: getUBetter was identified as a Tier 3a DHT supporting self-management and preventative behaviour change. The mapping exercise against the NICE standards framework identified a gap in demonstrating evidence of effectiveness. Fifty getUBetter users responded to the survey, a 13% response rate (50/389). Respondents were mainly female (29/47), white (34/47) and in full-time paid employment (18/47) or retired (14/47). 60% rated the app as either good or very good (21/35), reporting they found it easy to register and use the app, an acceptable way to get advice and support, and would recommend it to family and friends. Respondents most liked the app's ease of use, and its support for self-management, giving reassurance and information relevant to recovery stage. Most reported benefits from using getUBetter, the greatest being improved confidence to self-manage (28/36), ability to self-manage (26/36), and a better understanding of their condition and recovery journey (25/36). 19 of 35 reported COVID-19 made them more likely to use the app. Health utilisation analysis found 835 patients were prescribed getUBetter for LBP, 50% of whom activated their account. Compared to non-users, getUBetter users consumed 4 times fewer GP appointments, 20% less Physiotherapy referrals and over 50% fewer prescriptions and referrals. Conclusion(s): The NICE standards provided a structured approach to assessing a DHT evidence-base in a MSK pathway and identifying gaps. Despite the challenge of COVID-19, this pragmatic evaluation showed a reduction in health resources use by patients using getUBetter. Users reported overall high rating for the app, with good patient acceptability and friends and family test scores. The results indicate most respondents got some benefit from using the app in terms of symptoms, function, and confidence and ability to self-manage their recovery. A larger controlled effectiveness study with economic evaluation is required to further strengthen the evidence-base for getUBetter. Impact: The NICE standards provide a useful decision-making framework to support innovators, commissioners and providers. Better awareness and understanding of using the NICE standards is required. Funding acknowledgements: The evaluation was funded through the Small Business Research Initiative (SBRI).

MICU for PICU webinar series: Adult critical care for pediatric intensivists

Rationale to the study:The high volume of critically-ill adults created by the COVID-19 pandemic forced many pediatric hospitals to accept adult patients. Pediatric hospitalists and intensivists had to rapidly prepare to care for medically-complex adults. We report on the creation of an interactive webinar on the care of the critically-ill adult patient to meet the emerging educational need for the pediatric intensivist. Methods: A 5-part webinar series was created by the Pediatric Overflow Contingency Response Network (POPCoRN), an ad hoc network dedicated to providing resources and collaboration for pediatricians caring for adults during the pandemic. The webinar highlighted key differences between pediatric and adult critical care on a variety of topics including anticoagulation, safety checklists, and ventilator management. A dual-boarded adult and pediatric intensivist served as the primary moderator for 3 panelists composed of pediatric and adult critical care physicians. A postwebinar survey was distributed to all attendees of at least one event to assess provider comfort and the efficacy of the series. Nonparametric analyses were used to assess quantitative metrics and free text narratives used to gather qualitative data. Results: Of 254 attendees, 41 (16%) completed the post-webinar survey. The majority of respondents were attendings (30, 73%) followed by fellows (6, 15%), residents (3, 7%), allied health professionals (1, 2%), and students (1, 2%). Respondents were international, with 23 (56%) of respondents primarily practicing within the United States, 5 (12%) in Uruguay, and 3 (7%) in Colombia. The most common area of practice was pediatric critical care (29, 71%), followed by dual trained internal medicine-pediatrics providers (6, 15%). On average, attendees watched 2.6 webinars. Pediatric providers described an increased preparedness to care for the critically ill adult after attending (on a scale of 0-7 with 7 most prepared), with averages of 3.6 before to 4.9 after (P < 0.0001). Respondents found recordings to be the most helpful (4.0 out of 5 on a 1-5 likert scale), followed by the panel format (3.9) and white board function (3.8). The narrative comments reaffirmed that the collaborative presentation style was a helpful component of the webinars. Conclusions: Our project shows the successful use of a webinar series to disseminate information broadly and rapidly during the COVID-19 pandemic. Such cross-professional educational venues can serve as effective means for introductory preparedness for adult care.

Recent sars-cov-2 seroconversion in a national prospective cohort of us adults

Background: Epidemiologic risk factors for SARS-CoV-2 infection are best characterized via prospective cohort studies, complementing case-based surveillance and cross-sectional seroprevalence studies. Methods: We estimated the cumulative incidence of SARS-CoV-2 infection and incidence rates of seroconversion in a national prospective online cohort of 6745 US adults, enrolled during March-July 2020. A subset (n=4459) underwent serologic testing (Bio-Rad Platelia Total Ab, IgA/IgM/IgG), offered initially during May-Sept. 2020 and again in Nov. 2020-Jan. 2021. Results: A total of 303 of 4459 individuals showed serologic evidence of past SARS-CoV-2 infection (6.8%, 95%CI 6.1-7.6%). Among 3280 initially seronegative participants who had a subsequent serologic test, there were 145 seroconversions over 1562 person years of follow-up (incidence rate=9.3 per 100 person-years [95%CI 7.9-11.0]). Racial/ethnic disparities in crude incidence rates were apparent through Jan. 2021 (rate ratio [RRHispanic v White]=2.1, 95%CI 1.4-3.1;RRnon-Hispanic Black v White=1.8, 95%CI 0.96- 3.1). Incidence was higher in the southern (RRSouth v Northeast=1.7, 95%CI 1.1-2.8) and midwest (RRmidwest v Northeast=1.6, 95%CI 0.98-2.7) regions, in rural v urban areas (RR=1.5, 95%CI 1.0-2.2), and among essential workers (RR=1.7, 95%CI 1.1-2.5). Household crowding (RR=1.6, 95%CI 1.1-2.3), indoor restaurant dining (RR=2.0, 95%CI 1.4-2.8), visiting places of worship (RR=2.0, 95%CI 1.3-2.9), wearing masks sometimes (v always) while grocery shopping (RR=2.5, 95%CI 1.3-4.4), not wearing masks when visiting people outside the household (RRsometimes v always=1.3, 95%CI 0.88-2.1;RRnever v always=2.0, 95%CI 1.2-3.2), gathering in groups of >10 (RRindoors v never=1.74, 95%CI 1.2-2.5;RRoutdoors v never=1.8, 95%CI 1.3-4.3), and recent air travel (RR=1.7, 95%CI 1.1-2.6) were associated with higher incidence. Among 303 seropositive persons, 27.4% had asymptomatic infections and 32% reported a positive SARSCoV- 2 PCR test or provider diagnosis. There were major gaps in the uptake of public health interventions aimed at isolation (31%) and contact tracing (asked about contacts [18%];told about exposure to a case [7.6%]). Conclusion: Modifiable risk factors and low uptake of public health strategies drive SARS-CoV-2 transmission across the US. It is critical to address inequities in incidence, reduce risk factors, and improve the reach of public health strategies.