Patient and care partner perspectives and preferences related to myasthenia gravis treatment: A qualitative study.

Background and Aims: Due to the high symptom and treatment burden in myasthenia gravis (MG), understanding patient and care partner perspectives and preferences is crucial. Methods: This study used voice analysis and virtual focus groups to understand patient and care partner experiences with MG-related symptoms, treatments, and preferences. The voice analysis via social media listening used artificial intelligence-powered tools to gather and structure public digital conversations on MG. Focus groups included people living with MG and care partners who completed a questionnaire and participated in a 1-h virtual session facilitated using a semi-structured interview guide. Qualitative data were aggregated, transcribed, and thematically analyzed. Results: The voice analysis examined 11,554 posts from 8321 individuals, discussing MG symptoms, treatments, and burden. Of 7563 symptom-related posts, 5902 (78%) conveyed negative, 1427 (19%) neutral, and 234 (3%) positive sentiment. The most frequently mentioned symptoms were categorized as dysarthria, muscle weakness, and dysphagia. MG treatment sentiment analysis identified 6667 posts (67%) as neutral, 2887 (29%) as negative, and 350 (4%) as positive. For the focus groups, 15 individuals (12 patients and 3 care partners) completed the questionnaire and 14 participated in the virtual focus group sessions. The 15 participants who completed the questionnaire prioritized treatment convenience, symptom control for improved quality of life, and preventing potential MG crises in their current treatment. New treatment expectations included increased effectiveness, less frequent dosing, faster onset, and fewer side effects. Participants were also receptive to wearable medication delivery systems placed on the body and valued direct involvement in treatment decisions. Conclusion: Patients and care partners are often negatively impacted by MG symptoms and value convenient and fast-acting treatments that control symptoms with minimal side effects. Considering patient preferences may help optimize treatment decisions and improve patients' overall well-being and satisfaction in their care.

Characterizing Myasthenia Gravis Symptoms, Exacerbations, and Crises From Neurologist's Clinical Notes Using Natural Language Processing.

Background Myasthenia gravis (MG) is a rare, autoantibody neuromuscular disorder characterized by fatigable weakness. Real-world evidence based on administrative and structured datasets regarding MG may miss important details related to the clinical encounter. Examination of free-text clinical progress notes has the potential to illuminate aspects of MG care. Objective The primary objective was to examine and characterize neurologist progress notes in the care of individuals with MG regarding the prevalence of documentation of clinical subtypes, antibody status, symptomatology, and MG deteriorations, including exacerbations and crises. The secondary objectives were to categorize MG deteriorations into practical, objective states as well as examine potential sources of clinical inertia in MG care. Methods We performed a retrospective, cross-sectional analysis of de-identified neurologist clinical notes from 2017 to 2022. A qualitative analysis of physician descriptions of MG deteriorations and a discussion of risks in MG care (risk for adverse effects, risk for clinical decompensation, etc.) was performed. Results Of the 3,085 individuals with MG, clinical subtypes and antibody status identified included gMG (n = 400; 13.0%), ocular MG (n = 253; 8.2%), MG unspecified (2,432; 78.8%), seropositivity for acetylcholine receptor antibody (n = 441; 14.3%), and MuSK antibody (n = 29; 0.9%). The most common gMG manifestations were dysphagia (n = 712; 23.0%), dyspnea (n = 626; 20.3%), and dysarthria (n = 514; 16.7%). In MG crisis patients, documentation of difficulties with MG standard therapies was common (n = 62; 45.2%). The qualitative analysis of MG deterioration types includes symptom fluctuation, symptom worsening with treatment intensification, MG deterioration with rescue therapy, and MG crisis. Qualitative analysis of MG-related risks included the toxicity of new therapies and concern for worsening MG because of changing therapies. Conclusions This study of neurologist progress notes demonstrates the potential for real-world evidence generation in the care of individuals with MG. MG patients suffer fluctuating symptomatology and a spectrum of clinical deteriorations. Adverse effects of MG therapies are common, highlighting the need for effective, less toxic treatments.

Understanding profiles of patients with treatment-resistant depression by stringency of health plan prior authorization criteria for approval of esketamine nasal spray.

OBJECTIVES: In the United States (US), prescription drug coverage is subject to prior authorization (PA) criteria, which may vary between health plans and may exceed drug label requirements. This study aimed to characterize profiles and treatment history of patients with treatment-resistant depression (TRD) who initiated esketamine nasal spray, by stringency of their health plans' PA criteria relative to the esketamine label. METHODS: Adults with evidence of TRD (≥2 antidepressant courses of adequate dose and duration) prior to initiating esketamine were identified using US insurance claims data (03/2016-02/2022). Based on health plan PA criteria for esketamine obtained from Managed Markets Insight & Technology data (05/2020-02/2022), patients were grouped into stringent (PA criteria exceeds label) and non-stringent (PA criteria less stringent or equal to label) cohorts. Patient treatment history before esketamine initiation was compared using Wilcoxon rank sum and Fisher's exact tests. RESULTS: The stringent cohort included 168 patients (mean age: 45 years, 63% female) and the non-stringent cohort included 400 patients (mean age: 45 years, 70% female). During the ongoing major depressive episode before esketamine initiation, the stringent versus non-stringent cohort completed 3.9 versus 3.8 antidepressant treatment courses, on average (p = 0.217); 94.6% versus 96.8% used augmentation therapy (p = 0.240), including 59.3% versus 58.1% with an antipsychotic (p = 0.844), respectively. CONCLUSIONS: Regardless of health plan stringency, on average, patients exceeded US label-mandated number of antidepressant trials before esketamine initiation, which questions the need for health insurance plans PA criteria above label.

Predictors of High Healthcare Cost Among Patients with Generalized Myasthenia Gravis: A Combined Machine Learning and Regression Approach from a US Payer Perspective.

BACKGROUND: High healthcare costs could arise from unmet needs. This study used random forest (RF) and regression methods to identify predictors of high costs from a US payer perspective in patients newly diagnosed with generalized myasthenia gravis (gMG). METHODS: Adults with gMG (first diagnosis = index) were selected from the IQVIA PharMetrics® Plus database (2017-2021). Predictors of high healthcare costs were measured 12 months pre-index (main cohort) and during both the 12 months pre- and post-index (subgroup). Top 50 predictors of high costs [≥ $9404 (main cohort) and ≥ $9159 (subgroup) per-patient-per-month] were identified with RF models; the magnitude and direction of association were estimated with multivariable modified Poisson regression models. RESULTS: The main cohort and subgroup included 2739 and 1638 patients, respectively. In RF analysis, the most important predictors of high costs before/on the index date were index MG exacerbation, all-cause inpatient admission, and number of days with corticosteroids. After the index date, these were immunoglobulin and monoclonal antibody use and number of all-cause outpatient visits and MG-related encounters. Adjusting for the top 50 predictors, post-index immunoglobulin use increased the risk of high costs by 261%, monoclonal antibody use by 135%, index MG exacerbation by 78%, and pre-index all-cause inpatient admission by 27% (all p < 0.05). CONCLUSIONS: This analysis links patient characteristics both before the formal MG diagnosis and in the first year to high future healthcare costs. Findings may help inform payers on cost-saving strategies, and providers can potentially shift to targeted treatment approaches to reduce the clinical and economic burden of gMG.

Analysis of Hospitals Switching From a "Danger to Self" Question to Universal Columbia-Suicide Severity Rating Scale Screening: Impact on Screenings, Identification of Suicide Risk, and Documented Psychiatric Care.

Objective: Sutter Health launched system-wide general population standardized suicide screening with the Columbia-Suicide Severity Rating Scale (C-SSRS) screen (triage) version in 23 hospitals in 2019, replacing a one-question "danger to self" (DTS) assessment. This study analyzed the impact of C-SSRS implementation on screening rates, positive screenings, and documented psychiatric care within 90 days for all patients and a subgroup diagnosed with Major Depressive Disorder (MDD). Methods: Adults seen at hospitals in the pre-period (July 1, 2017-June 30, 2019) and post-period (July 1, 2019-December 31, 2020) were identified using electronic health records. Outcomes were compared using chi-square statistics and interrupted time series (ITS) models. Results: Pre-period, 92.8% (740,984/798,653) of patients were screened by DTS versus 84.6% (504,015/595,915) by C-SSRS in the post-period. Positive screening rates were 1.5% pre-period and 2.2% post-period, and 9.2% pre-period versus 10.8% post-period for those with MDD. Among individuals with positive screenings, 64.0% (pre-period) had documented follow-up psychiatric care versus 52.5% post-period and 66.4% of those with moderate or high-risk. Among all patients seen there was an overall increase in documentation of psychiatric care within 90 days (0.87% pre- to 0.96% post-period). ITS models revealed a 9.6% decline in screening, 1.3% increase in positive screenings, and 12.9% decline in documented psychiatric care following C-SSRS implementation (all p < 0.01). Conclusions: Following implementation, there was meaningful increase in suicide risk identification, and an increase in the proportion of patients with documented psychiatric care. Observed relative declines in screening warrant future research examining opportunities and barriers to general population C-SSRS use.

Economic burden of generalized myasthenia gravis (MG) in the United States and the impact of common comorbidities and acute MG-events.

BACKGROUND: This study assessed the incremental healthcare costs and resource utilization (HRU) associated with generalized myasthenia gravis (gMG), as well as variability in these outcomes among patients with gMG and common comorbidities and acute MG-related events. METHODS: Adults with gMG and without MG were identified from a large US database (2017-2021). The index date was the first MG diagnosis (gMG cohort) or random date (non-MG cohort). Cohorts were propensity score matched 1:1. The gMG cohort included subgroups of patients with a 12-month pre-index (baseline) cardiometabolic or psychiatric comorbidity, or a post-index MG exacerbation/crisis. Monthly healthcare costs (2021 USD) and HRU were compared post-index between gMG and non-MG cohorts. RESULTS: The gMG and matched non-MG cohorts each contained 2,739 patients. Mean incremental healthcare costs associated with MG were $4,155 (gMG: $5,567; non-MG: $1,411), with differences driven by incremental inpatient costs of $2,166 (gMG: $2,617; non-MG: $452); all p < 0.001. The gMG versus non-MG cohort had 4.36 times more inpatient admissions and 2.26 times more outpatient visits; all p < 0.001. Among patients with gMG in cardiometabolic (n = 1,859), psychiatric (n = 1,308), and exacerbation/crisis (n = 419) subgroups, mean monthly healthcare costs were $6,660, $7,443, and $17,330, respectively. CONCLUSIONS: gMG is associated with substantial incremental costs and HRU, with inpatient costs driving the total incremental costs. Costs increased by 20% and 34% among patients with cardiometabolic and psychiatric conditions, respectively, and over three times among those with acute MG-related events. gMG is a complex disease requiring management of comorbidities and treatment options that can prevent acute symptomatic events.

Generalized myasthenia gravis (gMG) is a rare long-standing condition that affects the junctions between nerves and muscles, causing them to be weak. In a serious case, the diaphragm ­ a muscle that helps with breathing ­ becomes so weak that a patient will need a machine to breathe for them. This is called MG exacerbation or crisis. In this study, we used a large insurance database in the United States to look at how much money healthcare payers paid for gMG patients on average and what healthcare resources patients with gMG used. We compared these findings with patients without gMG. Also, among patients with gMG, we reported these findings specifically for patients who also had heart, blood, or blood vessel disease; patients who had a mental illness; and patients who had MG exacerbation or crisis later on. We found that patients with gMG used $5,567 per month on average ($4,155 more than patients without gMG), mostly from overnight hospital stays. Patients with gMG also had four times more overnight hospital stays and two times more hospital day visits when we compared them to patients without gMG. Patients with gMG and other health conditions used even more money and resources per month. Patients with MG exacerbation or crisis used $17,330 per month on average. Our results showed that gMG led to higher healthcare cost and resource use. In order to reduce cost and resources, doctors also need to control for other health conditions as they treat patients with gMG, and to prevent patients from having MG exacerbation or crisis later on.

Patient perceptions of disease burden and treatment of myasthenia gravis based on sentiment analysis of digital conversations.

Myasthenia gravis (MG) is a rare, autoimmune, antibody-mediated, neuromuscular disease. This study analyzed digital conversations about MG to explore unprovoked perspectives. Advanced search, data extraction, and artificial intelligence-powered algorithms were used to harvest, mine, and structure public domain digital conversations about MG from US Internet Protocol addresses (August 2021 to August 2022). Thematic analyses examined topics, mindsets, and sentiments/key drivers via natural language processing and text analytics. Findings were described by sex/gender and treatment experience with steroids or intravenous immunoglobulin (IVIg). The 13,234 conversations were extracted from message boards (51%), social media networks (22%), topical sites (21%), and blogs (6%). Sex/gender was confirmed as female in 5703 and male in 2781 conversations, and treatment experience was with steroids in 3255 and IVIg in 2106 conversations. Topics focused on diagnosis (29%), living with MG (28%), symptoms (24%), and treatment (19%). Within 3176 conversations about symptoms, eye problems (21%), facial muscle problems (18%), and fatigue (18%) were most commonly described. Negative sentiments about MG were expressed in 59% of conversations, with only 2% considered positive. Negative conversations were dominated by themes of impact on life (29%), misdiagnosis problems (27%), treatment issues (24%), and symptom severity (20%). Impact on life was a key driver of negativity in conversations by both men (27%) and women (34%), and treatment issues was a dominant theme in conversations by steroid-treated (29%) and IVIg-treated (31%) patients. Of 1382 conversations discussing treatment barriers, 36% focused on side effects, 33% on lack of efficacy, 21% on misdiagnosis, and 10% on cost/insurance. Side effects formed the main barrier in conversations by both steroid-treated and IVIg-treated patients. Capturing the patient voice via digital conversations reveals a high degree of concern related to burden of disease, misdiagnosis, and common MG treatments among those with MG, pointing to a need for treatment options that can improve quality of life.

The impact of myasthenia gravis severity on work and daily activities.

INTRODUCTION/AIMS: People with myasthenia gravis (MG) experience impaired quality of life. However, the impact of MG symptoms on work productivity has not been well-studied. We aimed to evaluate this impact and to examine associations between disease severity and the degree of impairment. METHODS: Data were drawn from the Adelphi MG Disease-Specific Programme™, a multinational (USA, France, Germany, Italy, Spain, UK) survey completed by physicians and their patients with MG in 2020. Patient-reported measures included the Work Productivity and Activity Impairment (WPAI): Specific Health Problem questionnaire. RESULTS: The WPAI questionnaire was completed by 330 patients. Among those currently employed, the mean percentage of work time missed (absenteeism) was 13.3% (N = 116), percentage impairment of productivity at work (presenteeism) was 26.7% (N = 121), and overall work impairment was 30.0% (N = 110). Across all patients, impairment of non-work-related activities due to health problems (ADL impairment) was 39.2% (N = 330). Regression analysis indicated that impairment differed according to MG Foundation of America (MGFA) class (p = .0147, p < .0001, p < .0001 and p < .0001 for absenteeism, presenteeism, overall work impairment and ADL impairment, respectively). Being MGFA class III/IV was a predictor of presenteeism, overall work impairment and ADL impairment in a predictor model. DISCUSSION: Patients with MG experience substantial work impairment particularly those with more severe symptoms, highlighting an important way in which patient quality of life is negatively affected. More effective treatment strategies would enable patients to lead more productive lives and could impact decisions relating to work and career.

Homelessness Among Acute Care Patients Within a Large Health Care System in Northern California.

The impacts of homelessness on health and health care access are detrimental. Intervention and efforts to improve outcomes and increase availability of affordable housing have mainly originated from the public health sector and government. The role that large community-based health systems may play has yet to be established. This study characterizes patients self-identified as homeless in acute care facilities in a large integrated health care system in Northern California to inform the development of collaborative interventions addressing unmet needs of this vulnerable population. The authors compared sociodemographic characteristics, clinical conditions, and health care utilization of individuals who did and did not self-identify as homeless and characterized their geographical distribution in relation to Sutter hospitals and homeless resources. Between July 1, 2019 and June 30, 2020, 5% (N = 20,259) of the acute care settings patients had evidence of homelessness, among which 51.1% age <45 years, 66.4% males, and 24% non-Hispanic Black. Patients experiencing homelessness had higher emergency department utilization and lower utilization of outpatient and urgent care services. Mental health conditions were more common among patients experiencing homelessness. More than half of the hospitals had >5% of patients who identified as homeless. Some hospitals with higher proportions of patients experiencing homelessness are not located near many shelter resources. By understanding patients who self-identify as homeless, it is possible to assess the role of the health system in addressing their unmet needs. Accurate identification is the first step for the health systems to develop and deliver better solutions through collaborations with nonprofit organizations, community partners, and government agencies.

Real-world assessment of treatment inertia in the management of patients treated for major depressive disorder in the USA.

Aim: Major depressive disorder (MDD) is a debilitating illness in which depressive symptoms may persist after treatment. Treatment inertia is the continued use of the same pharmacotherapy regimen when treatment goals are not met. This study assessed the frequency of treatment inertia among adult patients with MDD treated in a real-world setting. Patients & methods: This was a retrospective, observational study of patients with MDD identified in the Decision Resources Group Real World Evidence US Data Repository from January 2014 to June 2018. Patients (≥18 years) had an elevated Patient Health Questionnaire-9 (PHQ-9) score (≥5) following 8 weeks of stable baseline antidepressant use with/without mental-health outpatient therapy. Treatment inertia, modification and discontinuation were evaluated over a 16-week follow-up period (timeline based on the APA Practice Guidelines). The primary outcome was the proportion of MDD patients experiencing treatment inertia. Results: 2850 patients (median age, 55 years; 74% female) met the study criteria. Of these patients, 834 (29%) had study-defined treatment inertia, 1534 (54%) received treatment modification and 482 (17%) discontinued treatment. Use of mirtazapine (Odd ratio [OR]: 0.63; 95% confidence interval [CI]: 0.50-0.79), selective serotonin reuptake inhibitors (OR: 0.64; 95% CI: 0.54-0.75) or bupropion (OR: 0.71; 95% CI: 0.60-0.84) in the baseline period was associated with an increased likelihood of treatment modification versus not receiving treatment with these medications. Frequency of treatment inertia may differ among those who do not have a documented PHQ-9 score. Conclusion: Effective symptom management is critical for optimal outcomes in MDD. Results demonstrate that treatment inertia is common in MDD despite guidelines recommending treatment modification in patients not reaching remission.

Racial disparities in utilization of first-generation versus second-generation long-acting injectable antipsychotics in Medicaid beneficiaries with schizophrenia.

BACKGROUND: Multiple studies report racial disparities in antipsychotic prescription patterns. This study assessed demographic and clinical factors associated with the utilization of first-generation (FG) versus second-generation (SG) long-acting injectable (LAI) antipsychotics. METHODS: This retrospective, observational cohort analysis used claims data from the IBM MarketScan® Multi-State Medicaid database. The study included adults with an LAI claim between 01-January-2009 and 31-December-2018, an ICD-9-CM or ICD-10-CM diagnosis of schizophrenia, race recorded as Black or White, and ≥12 months of continuous enrollment before the index LAI. Descriptive analysis detailed the relationship between race and FG or SG LAI initiation. Multivariate logistic regression was used to assess potential associations with FG vs. SG LAI initiation, including clinical and demographic factors, comorbidities, and index year. RESULTS: A total of 10,773 patients were included: 6659 (62 %) Black and 4114 (38 %) White. Black patients had a higher utilization of FG LAIs than White patients (46.8 % vs. 38.9 %) over the 10 years analyzed. Black patients were more likely to utilize FG LAIs than White patients (odds ratio: 1.47; 95 % CI: 1.34, 1.62) after controlling for index year and covariates (race, age, gender, insurance plan type, Quan-Charlson Comorbidity index score, comorbidities, prior medications). Significant predictors of FG LAI utilization were older age, type of baseline oral antipsychotic (FG vs SG), type of coverage (managed care vs fee for service), and greater comorbidity burden. CONCLUSION: The utilization of FG LAIs was greater in Black compared to White Medicaid beneficiaries with schizophrenia over a 10-year period. These findings suggest that racial disparities exist in LAI initiation, with implications for differential quality of schizophrenia treatment.

Factors associated with patient activation among individuals with depression within racial/ethnic groups in the United States.

Increasing patient activation may be vital for improving quality of care for individuals with depression. Among adults with depression who reside in the United States, we sought to examine the association of depression severity, race/ethnicity, and household income with patient activation and within identify factors associated with patient activation within race/ethnicity groups. Data from the 2020 US National Health and Wellness Survey, a cross-sectional, general population survey, were used to identify White, Black/African American, Asian, and Hispanic respondents with self-reported physician-diagnosed depression. Generalized linear models were used to identify factors associated with patient activation. Analyses included 8,216 respondents (mean age = 44 years, 68.0% female). Depression severity was negatively associated with patient activation (ß = -0.29, p < 0.001). Patient activation was significantly higher in Black vs. White respondents (ß = 1.50, p = 0.001) and in respondents with a household income of $25,000-$49,999 (ß = 0.96, p = 0.015), $50,000-$99,000 (ß = 0.88, p = 0.031), and ≥$100,000 (ß = 1.78, p < 0.001) vs. <$25,000. Adjusted mean patient activation scores were highest among Black respondents (61.1), followed by Hispanic (60.2), White (59.6), and Asian (59.0) respondents. Neither race/ethnicity nor household income moderated the relationship between depression severity and patient activation; however, the factors most strongly associated with patient activation differed by race/ethnicity. These results indicate that the pathway to improving patient activation in individuals with depression may vary by race/ethnicity. Understanding factors associated with patient activation can help inform the design of interventions to increase patient activation in individuals with depression.

Social determinants and distance from certified treatment centers are associated with initiation of esketamine nasal spray among patients with challenging-to-treat major depressive disorder.

Indicated for treatment-resistant depression or major depression with suicidal ideation, esketamine (ESK) is self-administered under supervision at certified treatment centers. Our study was to determine if social determinants of health and distance were associated with ESK utilization. We conducted a retrospective cohort study among 308 US adults initiating ESK between October 11, 2019 and December 31, 2020 and 1540 propensity-score matched controls with treatment-resistant depression or major depression with suicidal ideation. Adjusting for demographics, prior health care utilization and comorbidities, social determinant variables and distance were regressed separately on each outcome: ESK initiation, failure to complete induction (8 treatments in 45 days), and discontinuation within 6 months. ESK initiation was associated with higher population density (odds ratio [OR]: 2.12), American Indian, Alaska Native, Native Hawaiian, Other Pacific Islander (OR: 3.19), and mental health (OR: 1.55) and primary care providers (OR: 1.55) per capita. Lower likelihood of ESK initiation was associated with living > 7.2 miles from a treatment center (OR: 0.75), living in rural areas (OR: 0.64), and percent non-Hispanic African American (OR: 0.58) and Hispanic (OR: 0.40). Health care providers should tailor patient engagement strategies to mitigate potential barriers to initiating and continuing appropriate treatment. Failing to complete induction was associated with substance use disorder and longer distance to treatment center was associated with discontinuation (hazard ratio: 1.48), as was percent Asian population (hazard ratio: 1.37). Prior psychiatric care and residence in counties with high rates of primary care providers per capita, unemployment, and high school graduation were associated with both higher likelihood of completing induction and lower likelihood of discontinuation.

Implementing universal suicide screening in a large healthcare system's hospitals: rates of screening, suicide risk, and documentation of subsequent psychiatric care.

Implementation of suicide risk screening may improve prevention and facilitate mental health treatment. This study analyzed implementation of universal general population screening using the Columbia-Suicide Severity Rating Scale (C-SSRS) within hospitals. The study included adults seen at 23 hospitals from 7/1/2019-12/31/2020. We describe rates of screening, suicide risk, and documented subsequent psychiatric care (i.e., transfer/discharge to psychiatric acute care, or referral/consultation with system-affiliated behavioral health providers). Patients with suicide risk (including those with Major Depressive Disorder [MDD]) were compared to those without using Wilcoxon rank-sum -tests for continuous variables and χ2 tests for categorical variables. Results reported are statistically significant at p < 0.05 level. Among 595,915 patients, 84.5% were screened by C-SSRS with 2.2% of them screening positive (37.6% low risk [i.e., ideation only], and 62.4% moderate or high risk [i.e., with a plan, intent, or suicidal behaviors]). Of individuals with suicide risk, 52.5% had documentation of psychiatric care within 90 days. Individuals with suicide risk (vs. without) were male (48.1% vs 43.0%), Non-Hispanic White (55.0% vs 47.8%), younger (mean age 41.0 [SD: 17.7] vs. 49.8 [SD: 20.4]), housing insecure (12.5% vs 2.6%), with mental health diagnoses (80.3% vs 25.1%), including MDD (41.3% vs 6.7%). Universal screening identified 2.2% of screened adults with suicide risk; 62.4% expressed a plan, intent or suicidal behaviors, and 80.3% had mental health diagnoses. Documented subsequent psychiatric care likely underestimates true rates due to care fragmentation. These findings reinforce the need for screening, and research on whether screening leads to improved care and fewer suicides.

This study reported outcomes of standardized suicide screening using the Columbia-Suicide Severity Rating Scale among adults in 23 hospitals in a large health system in northern California between 7/1/2019 and 12/31/2020. Out of 595,915 patients seen in hospital inpatient or emergency departments, 84.5% were screened and among them 2.2% had suicide risk, 41.3% of whom had a diagnosis of Major Depressive Disorder. Compared to patients without suicide risk, a higher proportion of patients who screened positive for suicide risk were male, Non-Hispanic White, younger, recently homeless, and had co-occurring mental health diagnoses. Overall, 52.5% of those screening positive for suicide risk had documentation of subsequent psychiatric care within the health system within 90 days and this rate was even higher (73%) for individuals whose screenings indicated the highest risk. These findings reinforce the need for increased screening, and research to determine whether screening leads to improved care and fewer suicides.

Predicting Poor Outcomes Among Individuals Seeking Care for Major Depressive Disorder.

Objective: To develop and validate algorithms to identify individuals with major depressive disorder (MDD) at elevated risk for suicidality or for an acute care event. Methods: We conducted a retrospective cohort analysis among adults with MDD diagnosed between January 1, 2018 and February 28, 2019. Generalized estimating equation models were developed to predict emergency department (ED) visit, inpatient hospitalization, acute care visit (ED or inpatient), partial-day hospitalization, and suicidality in the year following diagnosis. Outcomes (per 1000 patients per month, PkPPM) were categorized as all-cause, psychiatric, or MDD-specific and combined into composite measures. Predictors included demographics, medical and pharmacy utilization, social determinants of health, and comorbid diagnoses as well as features indicative of clinically relevant changes in psychiatric health. Models were trained on data from 1.7M individuals, with sensitivity, positive predictive value, and area-under-the-curve (AUC) derived from a validation dataset of 0.7M. Results: Event rates were 124.0 PkPPM (any outcome), 21.2 PkPPM (psychiatric utilization), and 7.6 PkPPM (suicidality). Among the composite models, the model predicting suicidality had the highest AUC (0.916) followed by any psychiatric acute care visit (0.891) and all-cause ED visit (0.790). Event-specific models all achieved an AUC >0.87, with the highest AUC noted for partial-day hospitalization (AUC = 0.938). Select predictors of all three outcomes included younger age, Medicaid insurance, past psychiatric ED visits, past suicidal ideation, and alcohol use disorder diagnoses, among others. Conclusions: Analytical models derived from clinically-relevant features identify individuals with MDD at risk for poor outcomes and can be a practical tool for health care organizations to divert high-risk populations into comprehensive care models.

Factors associated with COVID-19 Infection among a national population of individuals with schizophrenia or schizoaffective disorder in the United States.

BACKGROUND: Individuals with schizophrenia are a vulnerable and under-served population who are also at risk for severe morbidity and mortality following COVID-19 infection. Our research was designed to identify factors that put individuals with schizophrenia at increased risk of COVID-19 infection. METHODS: This study was a retrospective cohort analysis of medical and pharmacy claims among 493,796 individuals residing in the United States with schizophrenia or schizoaffective disorder, between January 1, 2019 and June 30, 2020. A confirmed diagnosis of COVID-19 infection by September 30, 2020 was regressed on demographics, social determinants, comorbidity, and pre-pandemic (December 2019 - February 2020) healthcare utilization characteristics. RESULTS: A total of 35,249 (7.1%) individuals were diagnosed with COVID-19. Elevated odds of COVID-19 infection were associated with age, increasing consistently from 40-49 years (OR: 1.16) to 80+ years (OR:5.92), male sex (OR: 1.08), Medicaid (OR: 2.17) or Medicare (OR: 1.23) insurance, African American race (OR: 1.42), Hispanic ethnicity (OR: 1.23), and higher Charlson Comorbidity Index. Select psychiatric comorbidities (depressive disorder, adjustment disorder, bipolar disorder, anxiety, and sleep-wake disorder) were associated with elevated odds of infection, while alcohol use disorder and PTSD were associated with lower odds. A pre-pandemic psychiatry (OR:0.56) or community mental health center (OR:0.55) visit were associated with lower odds as was antipsychotic treatment with long-acting injectable antipsychotic (OR: 0.72) and oral antipsychotic (OR: 0.62). CONCLUSIONS: Among individuals with schizophrenia, risk of COVID-19 infection was substantially higher among those with fewer economic resources, with greater medical and psychiatric comorbidity burden, and those who resided in African American or Hispanic communities. In contrast, individuals actively engaged in psychiatric treatment had substantially lower likelihood of infection. These results provide insights for healthcare providers that can translate into improved identification of at-risk individuals and interventions to reduce the risk and consequences of COVID-19 infection.

Improving diversity in study participation: Patient perspectives on barriers, racial differences and the role of communities.

INTRODUCTION: The lack of racial/ethnic diversity in research potentially limits the generalizability of findings to a broader population, highlighting the need for greater diversity and inclusion in clinical research. Qualitative research (i.e., focus groups) was conducted to identify (i) the potential motivators and barriers to study participation across different races and ethnicities; (ii) preferred delivery of education and information to support healthcare decision-making and the role of the community. METHODS: Patient focus groups were conducted with 26 participants from the sponsor's Patient Engagement Research Councils selected through subjective sampling. Recruitment prioritized adequate representation across different race/ethnic groups. Participation was voluntary and participants underwent a confidential interview process before selection. Narrative analysis was used to identify themes and draw insights from interactions. Experienced research specialists identified emerging concepts, and these were tested against new observations. The frequency of each concept was examined to understand its importance. RESULTS: Based on self-selected race/ethnicity, participants were divided into five focus groups (Groups: African American/Black: 2; Hispanic/Latino, Asian American, and white: 1 each) and were asked to share their experiences/opinions regarding the stated objectives. Barriers to study participation included: limited awareness of opportunities to participate in research, fears about changes in standard therapy, breaking cultural norms/stigma, religion-related concerns and mistrust of clinical research. Participants identified the importance of transparency by pharmaceutical companies and other entities to build trust and partnership and cited key roles that communities can play. The perceptions of the African American group regarding diversity/inclusion in research studies appeared to be different from other groups; a lack of trust in healthcare providers, concerns about historical instances of research abuse and the importance of prayer were cited. CONCLUSION: This study provided insights into barriers to study participation, and also highlighted the need for pharmaceutical companies and other entities to authentically engage in strategies that build trust within communities to enhance recruitment among diverse populations. PATIENT OR PUBLIC CONTRIBUTION: The data collected in the present study was provided by the participants in the focus groups.

Healthcare resource utilization and costs before and after long-acting injectable antipsychotic initiation in commercially insured young adults with schizophrenia.

BACKGROUND: Long-acting injectable (LAI) antipsychotics use is associated with improved adherence which can reduce the rate of relapse, hospitalization, and associated costs in patients with schizophrenia. Young adults could be at higher risk of poor adherence, hence use of LAI in this population may offer a benefit but the evidence is limited. This study aimed to compare clinical and economic outcomes before and after the initiation of LAI antipsychotics in commercially insured young adults (18-35 years of age) with schizophrenia. METHODS: A retrospective claims data study was conducted using the data from the IBM MarketScan® Commercial Claims and Encounters (CCAE) Database. Patients with a continuous enrollment of at least 1-year before and 1-year after the first observed schizophrenia diagnosis (index date) and with the use of ≥1 typical or atypical LAI antipsychotic during the post-index follow-up period were included. A pre-post analysis was conducted to compare relapse rates, healthcare resource utilization, and costs before (from index date to LAI initiation) and after LAI initiation (to end of follow up). RESULTS: A total of 2222 patients who initiated LAIs after an index schizophrenia diagnosis were identified. The per patient per month (PPPM) composite relapse event rate (0.109 pre-LAI to 0.073 post-LAI) and hospitalization rate (0.091 to 0.058), all-cause inpatient visits (0.231 to 0.119), and length of stay (2.694 to 1.092 days) significantly decreased from before LAI initiation to after LAI initiation with similar trends seen for mental health and schizophrenia-related measures (all significant; P < 0.0001). All-cause total costs ($4898 to $3078 PPPM) were also decreased after LAI initiation, with similar trends seen for mental health and schizophrenia-related costs (all significant; P < 0.0001). Although medication costs were higher post-LAI period ($311 to $542 PPPM), the cost increase was substantially offset by the decreased costs associated with total healthcare costs. CONCLUSIONS: Treatment with LAI antipsychotics was associated with a decrease in relapse event rate, healthcare resource utilization, and costs after LAI initiation compared to before LAI initiation in commercially insured young adults with schizophrenia. Treatment with LAIs in young adults with schizophrenia is potentially associated with significant cost savings to commercial payers.

Applying the Health Belief Model to Characterize Racial/Ethnic Differences in Digital Conversations Related to Depression Pre- and Mid-COVID-19: Descriptive Analysis.

BACKGROUND: The prevalence of depression in the United States is >3 times higher mid-COVID-19 versus prepandemic. Racial/ethnic differences in mindsets around depression and the potential impact of the COVID-19 pandemic are not well characterized. OBJECTIVE: This study aims to describe attitudes, mindsets, key drivers, and barriers related to depression pre- and mid-COVID-19 by race/ethnicity using digital conversations about depression mapped to health belief model (HBM) concepts. METHODS: Advanced search, data extraction, and artificial intelligence-powered tools were used to harvest, mine, and structure open-source digital conversations of US adults who engaged in conversations about depression pre- (February 1, 2019-February 29, 2020) and mid-COVID-19 pandemic (March 1, 2020-November 1, 2020) across the internet. Natural language processing, text analytics, and social data mining were used to categorize conversations that included a self-identifier into racial/ethnic groups. Conversations were mapped to HBM concepts (ie, perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues to action, and self-efficacy). Results are descriptive in nature. RESULTS: Of 2.9 and 1.3 million relevant digital conversations pre- and mid-COVID-19, race/ethnicity was determined among 1.8 million (62.2%) and 979,000 (75.3%) conversations, respectively. Pre-COVID-19, 1.3 million (72.1%) conversations about depression were analyzed among non-Hispanic Whites (NHW), 227,200 (12.6%) among Black Americans (BA), 189,200 (10.5%) among Hispanics, and 86,800 (4.8%) among Asian Americans (AS). Mid-COVID-19, a total of 736,100 (75.2%) conversations about depression were analyzed among NHW, 131,800 (13.5%) among BA, 78,300 (8.0%) among Hispanics, and 32,800 (3.3%) among AS. Conversations among all racial/ethnic groups had a negative tone, which increased pre- to mid-COVID-19; finding support from others was seen as a benefit among most groups. Hispanics had the highest rate of any racial/ethnic group of conversations showing an avoiding mindset toward their depression. Conversations related to external barriers to seeking treatment (eg, stigma, lack of support, and lack of resources) were generally more prevalent among Hispanics, BA, and AS than among NHW. Being able to benefit others and building a support system were key drivers to seeking help or treatment for all racial/ethnic groups. CONCLUSIONS: There were considerable racial/ethnic differences in drivers and barriers to seeking help and treatment for depression pre- and mid-COVID-19. As expected, COVID-19 has made conversations about depression more negative and with frequent discussions of barriers to seeking care. Applying concepts of the HBM to data on digital conversation about depression allowed organization of the most frequent themes by race/ethnicity. Individuals of all groups came online to discuss their depression. These data highlight opportunities for culturally competent and targeted approaches to addressing areas amenable to change that might impact the ability of people to ask for or receive mental health help, such as the constructs that comprise the HBM.

Depression and food insecurity among patients with rheumatoid arthritis in NHANES.

BACKGROUND: Social determinants of health (SDH), including food insecurity, are associated with depression in the general population. This study estimated the prevalence of depression and food insecurity and evaluated the impact of food insecurity and other SDH on depression in adults with rheumatoid arthritis (RA). METHODS: Adults (≥ 18 years) with RA were identified from the 2013-2014 and 2015-2016 National Health and Nutrition Examination Survey (NHANES). Depression was defined as a score of ≥ 5 (mild depression: 5-9; moderate-to-severe depression: 10-27) using the Patient Health Questionnaire-9 (PHQ-9). Food insecurity was assessed with the 18-item US Household Food Security Survey Module. Adults with household-level marginal-to-very-low food security were classified as experiencing food insecurity. The prevalence of depression and food insecurity among participants with RA were estimated. Weighted logistic regression was used to evaluate the association between depression and participants' characteristics including SDH. Penalized regression was performed to select variables included in the final multivariable logistic regression. RESULTS: A total of 251 and 276 participants from the 2013-2014 and the 2015-2016 NHANES, respectively, had self-reported RA. The prevalence of depression among these participants was 37.1% in 2013-2014 and 44.1% in 2015-2016. The prevalence of food insecurity was 33.1% in 2013-2014 and 43.0% in 2015-2016. Food insecurity was associated with higher odds of having depression (OR 2.17, 95% CI 1.27, 3.72), and the association varied by depression severity. Compared with participants with full food security, the odds of having depression was particularly pronounced for those with very low food security (OR 2.96, 95% CI 1.48, 5.90) but was not significantly different for those with marginal or low food security. In the multivariable regression, being female, having fair/poor health condition, any physical disability, and ≥ 4 physical limitations were significantly associated with depression. CONCLUSIONS: In adults with self-reported RA, the prevalence of depression and food insecurity remained high from 2013 to 2016. We found that depression was associated with SDH such as food insecurity, although the association was not statistically significant once adjusted for behavioral/lifestyle characteristics. These results warrant further investigation into the relationship between depression and SDH among patients with RA.