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Background: In the context of the COVID-19 pandemic, people with multiple sclerosis (pwMS) have been particularly vulnerable to adverse outcomes due to increased risk of severe infection and/or widespread disruptions in care. The CopeMS study led by The University of Texas at Austin and the MS Association of America investigates the long-term impact of the COVID-19 pandemic on healthcare access, disease modifying therapy (DMT) utilization and outcomes of pwMS., Methods: This retrospective cohort analysis used Optum's de-identified Clinformatics® Data Mart Database (CDM), a large de-identified administrative healthcare claims database to identify pwMS who were continuously enrolled from 01/01/2019 to 12/31/2020 and assessed changes in the utilization of DMTs and healthcare services during the COVID-19 pandemic compared to the year prior. Additionally, a national survey of pwMS and healthcare providers (HCPs) was conducted to further understand the indirect impact of the pandemic on healthcare resource utilization (HCRU), outcomes and prescription patterns., Results: Out of 529 pwMS in our national survey, over 47 % reported that their overall health and neurologic symptoms had deteriorated during the COVID-19 pandemic, with increased anxiety, and inability to maintain exercise habits as leading perceived causes for worsening. Survey respondents reported widespread disruption of MS-related services during the pandemic. In the Optum database, we identified 39,209 pwMS validating inclusion criteria. We observed a decrease in the utilization of MS-related services in 2020 compared to 2019. Significantly fewer pwMS had visits with their neurologist, primary care provider, physical or occupational therapist despite an increased utilization of telemedicine services. Fewer pwMS had magnetic resonance imaging (MRI) studies of the brain or spinal cord during the pandemic. Only 22.2 % of HCPs surveyed agreed that the perceived risk of more severe COVID-19 infection on a specific DMT influenced their therapeutic decisions. In the Optum database, individuals with an established diagnosis of MS prior to 2019 saw decreases in utilization of platform and moderate efficacy DMTs. In this group, those over the age of 55 saw a decrease in utilization of B-cell therapies (rate ratio 0.79, CI 0.75-0.83), whereas individuals under the age of 55 saw an increase in utilization of B-cell therapies (rate ratio 1.10, CI 1.03-1.17). We did not see any difference in rates of starting DMTs in persons diagnosed in 2019 prior to the pandemic and those diagnosed in 2020. Compared to 2019, B-cell therapies were prescribed more frequently in pwMS diagnosed in 2020 who were younger than 55 or commercially insured (rate ratio 1.35, CI 1.11-1.63)., Conclusion: The COVID-19 pandemic was associated with perceived worsening of neurological symptoms in pwMS. Despite the expansion of telemedicine, we observed decreased access to healthcare services important to the comprehensive care of pwMS. Additionally, we observed changes in DMT utilization in pwMS during the pandemic, particularly in older adults with an established diagnosis of MS., Competing Interests: Declaration of Competing Interest E.M. has received consulting fees from Horizon Therapeutics and TG Therapeutics, and grant support from Genentech through institution. O.C and J.W. report grant support from Genentech through institution. A.M. participates as a member of the MUSE Advisory Board with Johnson & Johnson; The International MS Committee Advisory Board with Novartis; Gilead Global Advisory Board: Patient Engagement Horizon Scanning, hosted by Gilead; EMD Serono Advisory Board: Effective Support and Information Sharing Post-COVID Era Advisory Board; MS in the 21st Century Global Advisory Board hosted by Merck; and MS Health Equities Advisory Board Co-Chair with Bristol Meyers Squibb; on behalf of MSAA has received grant support from Biogen, Genentech, Greenwich Bioscience, Novartis, Bristol Meyers Squibb, Johnson & Johnson, EMD Serono, Sanofi Genzyme, and Johnson & Johnson. A.C.K. participates as a Merit Reviewer and has received compensation from the Patient Center Outcomes Research Institute (PCORI); she has received speaker honorarium for presentations at the Multiple Sclerosis Update: Clinical, Economic, and Patient-Centric Strategies for Managed Care Professionals Asembia Specialty Pharmacy Summit; and has received grant support on behalf of MSAA from Biogen, Genentech, Greenwich Bioscience, Novartis, Bristol Meyers Squibb, Johnson & Johnson, EMD Serono, Sanofi Genzyme; and Johnson & Johnson. T.M.K. reports minimal shares in Abbvie and Abbot and grant support from Genentech through institution. L.F. has received fees for consultancy and/or advisory board participation from Genentech, Novartis, Bristol Myers Squibb, EMD Serono, Sanofi, Horizon Therapeutics and TG Therapeutics; has received honorarium for participation in educational programs from Medscape, Inc, the MS Association of America and Impact Education; has received program sponsorship from EMD Serono and grant support from NIH/NINDS, PCORI, Genentech, and EMD Serono through her institution; currently serves on the Healthcare Advisory Committee of the MS Association of America. H.O. and A.L. have nothing to disclose., (Copyright © 2023. Published by Elsevier B.V.)

Importance: The detection of seasonal patterns in suicidality should be of interest to clinicians and US public health officials, as intervention efforts can benefit by targeting periods of heightened risk., Objectives: To examine recent trends in suicidality rates, quantify the seasonality in suicidality, and demonstrate the disrupted seasonality patterns during the spring 2020 COVID-19-related school closures among US children and adolescents., Design, Setting, and Participants: This population-based, descriptive cross-sectional study used administrative claims data from Optum's deidentifed Clinformatics Data Mart Database. Participants included children aged 10 to 12 years and adolescents aged 13 to 18 years who were commercially insured from January 1, 2016, to December 31, 2021. Statistical analysis was conducted between April and November 2022., Exposures: Month of the year and COVID-19 pandemic., Main Outcomes and Measures: Rates and seasonal patterns of emergency department (ED) visits and hospitalizations for suicidality., Results: The analysis included 73 123 ED visits and hospitalizations for suicidality reported between 2016 and 2021. Among these events, 66.1% were reported for females, and the mean (SD) age at the time of the event was 15.4 (2.0) years. The mean annual incidence of ED visits and hospitalizations for suicidality was 964 per 100 000 children and adolescents (95% CI, 956-972 per 100 000), which increased from 760 per 100 000 (95% CI, 745-775 per 100 000) in 2016 to 1006 per 100 000 (95% CI, 988-10 024 per 100 000) in 2019, with a temporary decrease to 942 per 100 000 (95% CI, 924-960 per 100 000) in 2020 and a subsequent increase to 1160 per 100 000 (95% CI, 1140-1181 per 100 000) in 2021. Compared with January, seasonal patterns showed peaks in April (incidence rate ratio [IRR], 1.15 [95% CI, 1.11-1.19]) and October (IRR, 1.24 [95% CI, 1.19-1.29]) and a nadir in July (IRR, 0.63 [95% CI, 0.61-0.66]) during pre-COVID-19 years and 2021. However, during the spring of 2020, which coincided with school closures, seasonal patterns were disrupted and April and May exhibited the lowest rates., Conclusions and Relevance: The findings of this study indicated the presence of seasonal patterns and an observed unexpected decrease in suicidality among children and adolescents after COVID-19-related school closures in March 2020, which suggest a potential association between suicidality and the school calendar.

Objective: To create and validate a methodology to assign a severity level to an episode of COVID-19 for retrospective analysis in claims data., Data Source: Secondary data obtained by license agreement from Optum provided claims records nationally for 19,761,754 persons, of which, 692,094 persons had COVID-19 in 2020., Study Design: The World Health Organization (WHO) COVID-19 Progression Scale was used as a model to identify endpoints as measures of episode severity within claims data. Endpoints used included symptoms, respiratory status, progression to levels of treatment and mortality., Data Collection/extraction Methods: The strategy for identification of cases relied upon the February 2020 guidance from the Centers for Disease Control and Prevention (CDC)., Principal Findings: A total of 709,846 persons (3.6%) met the criteria for one of the nine severity levels based on diagnosis codes with 692,094 having confirmatory diagnoses. The rates for each level varied considerably by age groups, with the older age groups reaching higher severity levels at a higher rate. Mean and median costs increased as severity level increased. Statistical validation of the severity scales revealed that the rates for each level varied considerably by age group, with the older ages reaching higher severity levels (p < 0.001). Other demographic factors such as race and ethnicity, geographic region, and comorbidity count had statistically significant associations with severity level of COVID-19., Conclusion: A standardized severity scale for use with claims data will allow researchers to evaluate episodes so that analyses can be conducted on the processes of intervention, effectiveness, efficiencies, costs and outcomes related to COVID-19., (© 2023. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)

Background: Since the initial COVID-19 cases were identified in the United States in February 2020, the United States has experienced a high incidence of the disease. Understanding the risk factors for severe outcomes identifies the most vulnerable populations and helps in decision-making., Objective: This study aims to assess the factors associated with COVID-19-related deaths from a large, national, individual-level data set., Methods: A cohort study was conducted using data from the Optum de-identified COVID-19 electronic health record (EHR) data set; 1,271,033 adult participants were observed from February 1, 2020, to August 31, 2020, until their deaths due to COVID-19, deaths due to other reasons, or the end of the study. Cox proportional hazards models were constructed to evaluate the risks for each patient characteristic., Results: A total of 1,271,033 participants (age: mean 52.6, SD 17.9 years; male: 507,574/1,271,033, 39.93%) were included in the study, and 3315 (0.26%) deaths were attributed to COVID-19. Factors associated with COVID-19-related death included older age (80 vs 50-59 years old: hazard ratio [HR] 13.28, 95% CI 11.46-15.39), male sex (HR 1.68, 95% CI 1.57-1.80), obesity (BMI 40 vs <30 kg/m 2 : HR 1.71, 95% CI 1.50-1.96), race (Hispanic White, African American, Asian vs non-Hispanic White: HR 2.46, 95% CI 2.01-3.02; HR 2.27, 95% CI 2.06-2.50; HR 2.06, 95% CI 1.65-2.57), region (South, Northeast, Midwest vs West: HR 1.62, 95% CI 1.33-1.98; HR 2.50, 95% CI 2.06-3.03; HR 1.35, 95% CI 1.11-1.64), chronic respiratory disease (HR 1.21, 95% CI 1.12-1.32), cardiac disease (HR 1.10, 95% CI 1.01-1.19), diabetes (HR 1.92, 95% CI 1.75-2.10), recent diagnosis of lung cancer (HR 1.70, 95% CI 1.14-2.55), severely reduced kidney function (HR 1.92, 95% CI 1.69-2.19), stroke or dementia (HR 1.25, 95% CI 1.15-1.36), other neurological diseases (HR 1.77, 95% CI 1.59-1.98), organ transplant (HR 1.35, 95% CI 1.09-1.67), and other immunosuppressive conditions (HR 1.21, 95% CI 1.01-1.46)., Conclusions: This is one of the largest national cohort studies in the United States; we identified several patient characteristics associated with COVID-19-related deaths, and the results can serve as the basis for policy making. The study also offered directions for future studies, including the effect of other socioeconomic factors on the increased risk for minority groups., (©Uan-I Chen, Hua Xu, Trudy Millard Krause, Raymond Greenberg, Xiao Dong, Xiaoqian Jiang. Originally published in JMIR Public Health and Surveillance (https://publichealth.jmir.org), 12.05.2022.)

Importance: People with major psychiatric disorders are more likely to have comorbidities associated with worse outcomes of COVID-19. This fact alone could determine greater vulnerability of people with major psychiatric disorders to COVID-19., Objective: To assess the odds of testing positive for and mortality from COVID-19 among and between patients with schizophrenia, mood disorders, anxiety disorders and a reference group in a large national database., Design, Setting, and Participants: This cross-sectional study used an electronic health record data set aggregated from many national sources in the United States and licensed from Optum with current and historical data on patients tested for COVID-19 in 2020. Three psychiatric cohorts (patients with schizophrenia, mood disorders, or anxiety disorders) were compared with a reference group with no major psychiatric conditions. Statistical analysis was performed from March to April 2021., Exposure: The exposures observed include lab-confirmed positivity for COVID-19 and mortality., Main Outcomes and Measures: The odds of testing positive for COVID-19 in 2020 and the odds of death from COVID-19 were measured., Results: The population studied included 2 535 098 unique persons, 3350 with schizophrenia, 26 610 with mood disorders, and 18 550 with anxiety disorders. The mean (SD) age was 44 (23) years; 233 519 were non-Hispanic African American, 1 583 440 were non-Hispanic Caucasian; and 1 580 703 (62%) were female. The schizophrenia cohort (positivity rate: 9.86%; adjusted OR, 0.90 [95% CI, 0.84-0.97]) and the mood disorder cohort (positivity rate: 9.86%; adjusted OR, 0.93 [95% CI, 0.87-0.99]) had a significantly lower rate of positivity than the anxiety disorder cohort (positivity rate: 11.17%; adjusted OR, 1.05 [95% CI, 0.98-1.12) which was closer to the reference group (11.91%). After fully adjusting for demographic factors and comorbid conditions, patients with schizophrenia were nearly 4 times more likely to die from the disease than the reference group (OR, 3.74; 95% CI, 2.66-5.24). The mood disorders COVID-19 cohort had a 2.76 times greater odds of mortality than the reference group (OR, 2.76; 95% CI, 2.00-3.81), and the anxiety disorders cohort had a 2.39 times greater odds of mortality than the reference group (OR, 2.39; 95% CI, 1.68-3.27)., Conclusions and Relevance: By examining a large database while controlling for multiple confounding factors such as age, race and ethnicity, and comorbid medical conditions, the present study found that patients with schizophrenia had much increased odds of mortality by COVID-19.