Experiences of Health Departments on Community Engagement and Implementation of a COVID-19 Self-testing Program.

CONTEXT: Health departments (HDs) work on the front lines to ensure the health of their communities, providing a unique perspective to public health response activities. Say Yes! COVID Test (SYCT) is a US federally funded program providing free COVID-19 self-tests to communities with high COVID-19 transmission, low vaccination rates, and high social vulnerability. The collaboration with 9 HDs was key for the program distribution of 5.8 million COVID-19 self-tests between March 31 and November 30, 2021. OBJECTIVE: The objective of this study was to gather qualitative in-depth information on the experiences of HDs with the SYCT program to better understand the successes and barriers to implementing community-focused self-testing programs. DESIGN: Key informant (KI) interviews. SETTING: Online interviews conducted between November and December 2021. PARTICIPANTS: Sixteen program leads representing 9 HDs were purposefully sampled as KIs. KIs completed 60-minute structured interviews conducted by one trained facilitator and recorded. MAIN OUTCOME MEASURES: Key themes and lessons learned were identified using grounded theory. RESULTS: Based on perceptions of KIs, HDs that maximized community partnerships for test distribution were more certain that populations at a higher risk for COVID-19 were reached. Where the HD relied predominantly on direct-to-consumer distribution, KIs were less certain that communities at higher risk were served. Privacy and anonymity in testing were themes linked to higher perceived community acceptance. KIs reported that self-test demand and distribution levels increased during higher COVID-19 transmission levels. CONCLUSION: HDs that build bridges and engage with community partners and trusted leaders are better prepared to identify and link high-risk populations with health services and resources. When collaborating with trusted community organizations, KIs perceived that the SYCT program overcame barriers such as mistrust of government intervention and desire for privacy and motivated community members to utilize this resource to protect themselves against COVID-19.

Symptoms of Mental Health Conditions and Suicidal Ideation Among State, Tribal, Local, and Territorial Public Health Workers - United States, March 14-25, 2022.

An increase in adverse mental health symptoms occurred in the general population at the onset of the COVID-19 pandemic, which peaked in 2020 and subsequently decreased (1-3). The pandemic exacerbated existing stress and fatigue among public health workers responding to the public health crisis.* During March-April 2021, a survey of state, tribal, local, and territorial (STLT) public health workers found that 52.8% of respondents experienced symptoms of at least one of the following mental health conditions: depression, anxiety, or posttraumatic stress disorder (PTSD) (4); however, more recent estimates of mental health symptoms among this population are limited. To evaluate trends in these conditions from the previous year, the prevalence of symptoms of mental health conditions and suicidal ideation, a convenience sample of STLT public health workers was surveyed during March 14-25, 2022. In total, 26,069 STLT public health workers responded to the survey. Among respondents,† 6,090 (27.7%) reported symptoms of depression, 6,467 (27.9%) anxiety, 6,324 (28.4%) PTSD, and 1,853 (8.1%) suicidal ideation. Although the prevalences of depression, anxiety, and PTSD among public health workers were lower (p<0.001)§ among 2022 survey respondents compared with those of 2021 survey respondents (4), the prevalences of symptoms of suicidal ideation, anxiety, depression, and PTSD remained high among those who worked >60 hours per week (range = 11.3%-45.9%) and those who spent ≥76% of their work time on COVID-19 response activities (range = 9.0%-37.6%). Respondents were less likely to report mental health symptoms if they could take time off (prevalence ratio [PR] range = 0.48-0.55), or if they perceived an increase in mental health resources from their employer (PR range = 0.58-0.84). To support the mental health of public health workers, public health agencies can modify work-related factors, including making organizational changes for emergency responses and facilitating access to mental health resources and services.¶.

Investigation of SARS-CoV-2 Transmission Associated With a Large Indoor Convention - New York City, November-December 2021.

During November 19-21, 2021, an indoor convention (event) in New York City (NYC), was attended by approximately 53,000 persons from 52 U.S. jurisdictions and 30 foreign countries. In-person registration for the event began on November 18, 2021. The venue was equipped with high efficiency particulate air (HEPA) filtration, and attendees were required to wear a mask indoors and have documented receipt of at least 1 dose of a COVID-19 vaccine.* On December 2, 2021, the Minnesota Department of Health reported the first case of community-acquired COVID-19 in the United States caused by the SARS-CoV-2 B.1.1.529 (Omicron) variant in a person who had attended the event (1). CDC collaborated with state and local health departments to assess event-associated COVID-19 cases and potential exposures among U.S.-based attendees using data from COVID-19 surveillance systems and an anonymous online attendee survey. Among 34,541 attendees with available contact information, surveillance data identified test results for 4,560, including 119 (2.6%) persons from 16 jurisdictions with positive SARS-CoV-2 test results. Most (4,041 [95.2%]), survey respondents reported always wearing a mask while indoors at the event. Compared with test-negative respondents, test-positive respondents were more likely to report attending bars, karaoke, or nightclubs, and eating or drinking indoors near others for at least 15 minutes. Among 4,560 attendees who received testing, evidence of widespread transmission during the event was not identified. Genomic sequencing of 20 specimens identified the SARS-CoV-2 B.1.617.2 (Delta) variant (AY.25 and AY.103 sublineages) in 15 (75%) cases, and the Omicron variant (BA.1 sublineage) in five (25%) cases. These findings reinforce the importance of implementing multiple, simultaneous prevention measures, such as ensuring up-to-date vaccination, mask use, physical distancing, and improved ventilation in limiting SARS-CoV-2 transmission, during large, indoor events.†.

Evaluation of Mpox Exposures and Outcomes in Workplaces, 6 Jurisdictions, June 1-August 31, 2022.

OBJECTIVES: The risk for mpox virus (MPXV) transmission in most workplaces has not been thoroughly assessed in the context of the 2022 global mpox outbreak. Our objectives were to describe mpox case patients who worked while infectious and the subsequent workplace contact tracing efforts, risk assessments, and outcomes. METHODS: The Centers for Disease Control and Prevention requested information from health departments in the United States in September 2022 to identify people with confirmed or probable mpox who worked outside the home while infectious, either before or after diagnosis, from June 1 through August 31, 2022. We collected and summarized data on demographic, clinical, and workplace characteristics of case patients and workplace contact investigations. We stratified data by industry and occupation categories. RESULTS: In total, 102 case patients were reported by 6 jurisdictions. The most common industries were accommodation and food services (19.8%) and professional business, management, and technical services (17.0%). Contact investigations identified 178 total contacts; 54 cases (52.9%) had no contacts identified. Of 178 contacts, 54 (30.3%) were recommended to receive postexposure prophylaxis (PEP) and 18 (10.1%) received PEP. None of the contacts developed a rash or were tested for orthopox or mpox, and none were reported to have confirmed or probable mpox. CONCLUSION: Data from 6 jurisdictions suggest that the risk of MPXV transmission from workers to others in workplace settings in many industries is low. These findings might support future updates to exposure risk classifications and work activity recommendations for patients. These findings also demonstrate the importance of collecting and analyzing occupation and industry data in case reports to better understand risks in workplaces.

Workplace Violence and the Mental Health of Public Health Workers During COVID-19.

INTRODUCTION: During the COVID-19 pandemic, public health workers were at an increased risk for violence and harassment due to their public health work and experienced adverse mental health conditions. This article quantifies the prevalence of job-related threats, harassment, and discrimination against public health workers and measures the association of these incidents with mental health symptoms during the COVID-19 pandemic. METHODS: A nonprobability convenience sample of state, local, and tribal public health workers completed a self-administered, online survey in April 2021. The survey link was emailed to members of national public health associations and included questions on workplace violence, demographics, workplace factors, and mental health symptoms. Mental health symptoms were measured using standardized, validated tools to assess depression, anxiety, post-traumatic stress disorder, and suicidal ideation. Multivariable Poisson models calculated adjusted prevalence ratios of mental health symptoms, with workplace violence as the primary risk factor. Analyses were conducted in 2021-2022. RESULTS: Experiencing any type or combination of workplace violence was significantly associated with an increased likelihood of reporting depression symptoms (prevalence ratio=1.21, 95% CI=1.15, 1.27), anxiety (prevalence ratio=1.21, 95% CI=1.15, 1.27), post-traumatic stress disorder (prevalence ratio=1.31, 95% CI=1.25, 1.37), and suicidal ideation (prevalence ratio=1.26, 95% CI=1.14, 1.38), after adjusting for confounders. A dose‒response relationship was found between the number of workplace violence events experienced by a public health worker and the likelihood of reporting mental health symptoms. CONCLUSIONS: Violence targeted at the public health workforce is detrimental to workers and their communities. Ongoing training, workplace support, and increased communication after a workplace violence incident may be helpful. Efforts to strengthen public health capacities and support the public health workforce are also needed.

Understanding Low Utilization of Employee Assistance Programs and Time Off by US Public Health Workers During the COVID-19 Pandemic.

OBJECTIVE: Despite high rates of reported mental health symptoms among public health workers (PHWs) during the COVID-19 pandemic, utilization of employer-offered resources was low. Our objective was to understand what barriers and deterrents exist for PHWs accessing employer-offered resources. METHODS: Four national public health organizations disseminated a national online survey of public health department employees during March-April 2021; 26 174 PHWs completed the survey. We examined 5164 write-in survey responses using thematic analysis to identify key reasons why PHWs were not accessing time off and employee assistance programs (EAPs) and to understand what resources PHWs would like to see their employers offer. RESULTS: The top reasons that PHWs reported for not taking time off during the COVID-19 pandemic were financial concerns (24.4%), fear of judgment or retaliation (20.8%), and limitations in the amount of time off offered or available (11.0%). The top reasons that PHWs reported for not using EAPs during the COVID-19 pandemic were difficulty accessing EAPs (53.1%), use of external services (21.5%), and a lack of awareness about EAPs or motivation to initiate their use (11.3%). While desired employer-offered resources varied widely, PHWs most frequently listed financial incentives, paid time off, flexible scheduling, and organizational change. CONCLUSION: Organizations can best help their employees by organizing the workforce in a way that allows PHWs to take time off, creating a positive and supportive organizational climate, regularly assessing the needs of PHWs, clearly communicating the availability of employer-offered benefits, and emphasizing the acceptability of using those benefits.

Evaluation of the impact of guideline communication from the Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services among US healthcare providers: COVID-19 prevention counselling guidance.

AIM: To evaluate healthcare provider awareness and uptake of the Centers for Medicare & Medicaid Services (CMS) billing for coronavirus disease 2019 (COVID-19) prevention counselling and the delivery of prevention counselling to patients awaiting severe acute respiratory syndrome coronavirus 2 test results. DESIGN: Cross sectional survey of US-based healthcare providers in February 2021. METHODS: Analysis of associations with healthcare provider-reported awareness of CMS prevention counselling guidance and billing with provider type, specialty, and work setting. RESULTS: A total of 1919 healthcare providers responded to the survey. Overall, 38% (726/1919) of providers reported awareness of available CMS reimbursement for COVID-19 patient counselling and 29% (465/1614) of CMS billing-eligible providers reported billing for this counselling. Among physicians, those aware of CMS guidance were significantly more likely to bill (58%) versus those unaware (10%). Among RNSights respondents eligible for CMS billing (n = 114), 31% of those aware of the guidance reported billing as compared to 0% of those not aware.

New York State, New York City, New Jersey, Puerto Rico, and the US Virgin Islands' Health Department Experiences Promoting Health Equity During the Initial COVID-19 Omicron Variant Period, 2021-2022.

In this case study, we aim to understand how health departments in 5 US jurisdictions addressed health inequities and implemented strategies to reach populations disproportionately affected by COVID-19 during the initial Omicron variant period. We used qualitative methods to examine health department experiences during the initial Omicron surge, from November 2021 to April 2022, assessing successful interventions, barriers, and lessons learned from efforts to promote health equity. Our findings indicate that government leadership supported prioritizing health equity from the beginning of the pandemic, seeing it as a need and vital part of the response framework. All jurisdictions acknowledged the historical trauma and distrust of the government. Health departments found that collaborating and communicating with trusted community leaders helped mitigate public distrust. Having partnerships, resources, and infrastructure in place before the pandemic facilitated the establishment of equity-focused COVID-19 response activities. Finally, misinformation about COVID-19 was a challenge for all jurisdictions. Addressing the needs of diverse populations involves community-informed decisionmaking, diversity of thought, and delivery measures that are tailored to the community. It is imperative to expand efforts to reduce and eliminate health inequities to ensure that individuals and communities recover equitably from the effects of COVID-19.

COVID-19 Outbreaks Linked to Workplaces, 23 US Jurisdictions, August-October 2021.

OBJECTIVES: Early in the COVID-19 pandemic, several outbreaks were linked with facilities employing essential workers, such as long-term care facilities and meat and poultry processing facilities. However, timely national data on which workplace settings were experiencing COVID-19 outbreaks were unavailable through routine surveillance systems. We estimated the number of US workplace outbreaks of COVID-19 and identified the types of workplace settings in which they occurred during August-October 2021. METHODS: The Centers for Disease Control and Prevention collected data from health departments on workplace COVID-19 outbreaks from August through October 2021: the number of workplace outbreaks, by workplace setting, and the total number of cases among workers linked to these outbreaks. Health departments also reported the number of workplaces they assisted for outbreak response, COVID-19 testing, vaccine distribution, or consultation on mitigation strategies. RESULTS: Twenty-three health departments reported a total of 12 660 workplace COVID-19 outbreaks. Among the 12 470 workplace types that were documented, 35.9% (n = 4474) of outbreaks occurred in health care settings, 33.4% (n = 4170) in educational settings, and 30.7% (n = 3826) in other work settings, including non-food manufacturing, correctional facilities, social services, retail trade, and food and beverage stores. Eleven health departments that reported 3859 workplace outbreaks provided information about workplace assistance: 3090 (80.1%) instances of assistance involved consultation on COVID-19 mitigation strategies, 1912 (49.5%) involved outbreak response, 436 (11.3%) involved COVID-19 testing, and 185 (4.8%) involved COVID-19 vaccine distribution. CONCLUSIONS: These findings underscore the continued impact of COVID-19 among workers, the potential for work-related transmission, and the need to apply layered prevention strategies recommended by public health officials.

Diagnostic accuracy of the repeatable battery of the assessment of neuropsychological status update, Spanish version, in predicting Alzheimer's disease among Hispanic older adults in the United States reporting memory problems.

OBJECTIVES: There are few standardized, Spanish-language diagnostic tools to help identify Hispanic persons at early stages of Alzheimer's disease (AD). This study evaluated the accuracy of the Spanish version of the Repeatable Battery for the Assessment of Neuropsychological Status-Update (RBANS) in predicting AD in older Hispanic adults in the United States reporting memory problems. METHODS: We analyzed data from age, sex, and education level propensity score-matched Hispanic memory clinic patients with (n = 38) and without (n = 38) a clinical diagnosis of AD. Estimates of diagnostic accuracy included sensitivity, specificity, predictive value, and receiver operating characteristic analysis. RESULTS: After controlling for sex and matched pairs, the Total Scale score [area under curve (AUC) = 0.7417] and the Immediate (AUC = 0.7258) and Delayed (AUC = 0.7735) Memory index scores provided better estimates of diagnostic accuracy than Language, Attention, and Visuospatial/Constructional index scores. A minus 2-standard deviation (SD) cut point enhanced the predictive probability of the Delayed Memory index score. A cut point of -1.5 SD optimized the predictive probability of the Total Scale score. CONCLUSIONS: These results suggest that optimal cutoff values for the RBANS Delayed Memory index and Total Scale scores that may help identify Hispanic patients with AD as part of a comprehensive diagnostic AD assessment.

Incidence of COVID-19 Among Persons Experiencing Homelessness in the US From January 2020 to November 2021.

Importance: A lack of timely and high-quality data is an ongoing challenge for public health responses to COVID-19 among people experiencing homelessness (PEH). Little is known about the total number of cases of COVID-19 among PEH. Objective: To estimate the number of COVID-19 cases among PEH and compare the incidence rate among PEH with that in the general population. Design, Setting, and Participants: This cross-sectional study used data from a survey distributed by the Centers for Disease Control and Prevention to all US state, district, and territorial health departments that requested aggregated COVID-19 data among PEH from January 1, 2020, to September 30, 2021. Jurisdictions were encouraged to share the survey with local health departments. Main Outcomes and Measures: The primary study outcome was the number of cases of COVID-19 identified among PEH. COVID-19 cases and incidence rates among PEH were compared with those in the general population in the same geographic areas. Results: Participants included a population-based sample of all 64 US jurisdictional health departments. Overall, 25 states, districts, and territories completed the survey, among which 18 states (72.0%) and 27 localities reported COVID-19 data among PEH. A total of 26 349 cases of COVID-19 among PEH were reported at the state level and 20 487 at the local level. The annual incidence rate of COVID-19 among PEH at the state level was 567.9 per 10 000 person-years (95% CI, 560.5-575.4 per 10 000 person-years) compared with 715.0 per 10 000 person-years (95% CI, 714.5-715.5 per 10 000 person-years) in the general population. At the local level, the incidence rate of COVID-19 among PEH was 799.2 per 10 000 person-years (95% CI, 765.5-834.0 per 10 000 person-years) vs 812.5 per 10 000 person-years (95% CI, 810.7-814.3 per 10 000 person-years) in the general population. Conclusions and Relevance: These results provide an estimate of COVID-19 incidence rates among PEH in multiple US jurisdictions; however, a national estimate and the extent of under- or overestimation remain unknown. The findings suggest that opportunities exist for incorporating housing and homelessness status in infectious disease reporting to inform public health decision-making.

The impact of traumatic experiences, coping mechanisms, and workplace benefits on the mental health of U.S. public health workers during the COVID-19 pandemic.

PURPOSE: To evaluate the association between risk factors, mitigating factors, and adverse mental health outcomes among United States public health workers. METHODS: Cross-sectional online survey data were collected March to April 2021. The survey was distributed to public health workers who worked in a state, tribal, local, or territorial public health department since March 2020. RESULTS: In total, 26,174 United States state and local public health workers completed the survey. Feeling isolated was a risk factor for anxiety (PR, 1.84; 95% CI, 1.74-1.95), depression (PR, 1.84; 95% CI, 1.75-1.94), post-traumatic stress disorder (PR, 1.50; 95% CI, 1.43-1.57), and suicidal ideation (PR, 3.23; 95% CI, 2.82-3.69). The ability to take time off was linked to fewer reported symptoms of anxiety (PR, 0.87; 95% CI, 0.83-0.90), depression (PR, 0.86; 95% CI, 0.83-0.89), post-traumatic stress disorder (PR, 0.84; 95% CI, 0.81-0.88), and suicidal ideation (PR, 0.84; 95% CI, 0.77-0.92). CONCLUSIONS: Since COVID-19 was declared a pandemic, respondents who felt isolated and alone were at an increased risk for adverse mental health outcomes. Findings from this study call for public health organizations to provide their workforce with services and resources to mitigate adverse mental health outcomes.

Change in unemployment by social vulnerability among United States counties with rapid increases in COVID-19 incidence-July 1-October 31, 2020.

OBJECTIVE: During the COVID-19 pandemic, the unemployment rate in the United States peaked at 14.8% in April 2020. We examined patterns in unemployment following this peak in counties with rapid increases in COVID-19 incidence. METHOD: We used CDC aggregate county data to identify counties with rapid increases in COVID-19 incidence (rapid riser counties) during July 1-October 31, 2020. We used a linear regression model with fixed effect to calculate the change of unemployment rate difference in these counties, stratified by the county's social vulnerability (an indicator compiled by CDC) in the two months before the rapid riser index month compared to the index month plus one month after the index month. RESULTS: Among the 585 (19% of U.S. counties) rapid riser counties identified, the unemployment rate gap between the most and least socially vulnerable counties widened by 0.40 percentage point (p<0.01) after experiencing a rapid rise in COVID-19 incidence. Driving the gap were counties with lower socioeconomic status, with a higher percentage of people in racial and ethnic minority groups, and with limited English proficiency. CONCLUSION: The widened unemployment gap after COVID-19 incidence rapid rise between the most and least socially vulnerable counties suggests that it may take longer for socially and economically disadvantaged communities to recover. Loss of income and benefits due to unemployment could hinder behaviors that prevent spread of COVID-19 (e.g., seeking healthcare) and could impede response efforts including testing and vaccination. Addressing the social needs within these vulnerable communities could help support public health response measures.

Phenotypic clustering of heart failure with preserved ejection fraction reveals different rates of hospitalization.

AIMS: Approximately 50% of patients with heart failure have preserved (≥50%) ejection fraction (HFpEF). Improved understanding of the phenotypic heterogeneity of HFpEF might facilitate development of targeted therapies and interventions. METHODS: This retrospective study characterized a cohort of patients with HFpEF based on similar clinical profiles and evaluated 1-year heart failure related hospitalization. Enrolment, medical and pharmacy data were used to identify patients newly diagnosed with heart failure enrolled in a Medicare Advantage Prescription Drug or commercial healthcare plan. To identify only those patients with HFpEF, we used natural language processing techniques of ejection fraction values abstracted from a linked free-text clinical notes data source. The study population comprised 1515 patients newly identified with HFpEF between 1 January 2011 and 31 December 2015. RESULTS: Using unsupervised machine learning, we identified three distinguishable patient clusters representing different phenotypes: cluster-1 patients had the lowest prevalence of heart failure comorbidities and highest mean age; cluster-2 patients had higher prevalence of metabolic syndrome and pulmonary disease, despite younger mean age; and cluster-3 patients had higher prevalence of cardiac arrhythmia and renal disease. Cluster-3 had the highest 1-year heart failure related hospitalization rates. Within-cluster analysis, prior use of diuretics (cluster-1 and cluster-2) and age (cluster-2 and cluster-3) was associated with 1-year heart failure related hospitalization. Combination therapy was associated with decreased 1-year heart failure related hospitalization in cluster-1. CONCLUSION: This study demonstrated that clustering can be used to characterize subgroups of patients with newly identified HFpEF, assess differences in heart failure related hospitalization rates at 1 year and suggest patient subtypes may respond differently to treatments or interventions.

Cardiovascular Risk in Users of Mirabegron Compared with Users of Antimuscarinic Treatments for Overactive Bladder: Findings from a Non-Interventional, Multinational, Cohort Study.

INTRODUCTION: During clinical trials, mirabegron, a ß3-adrenoreceptor agonist, was associated with increased vital signs vs placebo in patients with overactive bladder. OBJECTIVE: The purpose of this study was to compare incidence rates of adverse cardiovascular (CV) outcomes following mirabegron or antimuscarinic use. METHODS: We conducted an observational post-marketing safety study utilising real-world data. The study population was identified within five sources: Danish and Swedish National Registers, Clinical Practice Research Datalink (UK), Optum (USA) and Humana (USA). Episodes of time when patients were new users of mirabegron or antimuscarinics (October 2012-December 2018) were sourced from prescriptions and matched on propensity scores. Occurrences of major adverse cardiovascular events (MACE), acute myocardial infarction (AMI), stroke, CV mortality and all-cause mortality were identified. Outcome incidence rates and hazard ratios from Cox models were estimated. RESULTS: Overall, 152,026 mirabegron and 152,026 antimuscarinic episodes were matched. The population consisted of 63.1% women and 72.6% were ≥ 65 years old. There were no appreciable differences in the incidence rates of MACE, AMI or stroke between users of mirabegron and antimuscarinics. Incidence rates of CV mortality (hazard ratio 0.83, 95% confidence interval 0.73-0.95) and all-cause mortality (hazard ratio 0.80, 95% confidence interval 0.76-0.84) were no higher with mirabegron vs antimuscarinics. Results restricted to episodes at high risk for CV events or stratified by age (< 65 years, ≥ 65 years) or prior overactive bladder medication use were consistent with overall findings. CONCLUSIONS: This large, multinational study found no higher risk of MACE, AMI, stroke, CV mortality or all-cause mortality among users of mirabegron relative to users of antimuscarinics.

During clinical trials, mirabegron, which is a treatment for overactive bladder, was associated with small increases in heart rate and blood pressure. This study was conducted to compare the frequency of cardiac events following the use of mirabegron or antimuscarinics, a group of treatments also used to treat overactive bladder. We obtained the data for this study from four countries: Denmark, Sweden, the UK and the USA. We identified people who were new users of mirabegron or antimuscarinics from 2012 to 2018 using prescription or dispensing records. Occurrences of major cardiac events, heart attack, stroke, death due to cardiac events and death from any cause were evaluated. Overall, we identified 152,026 times when mirabegron or antimuscarinics were each used as new treatments. Most of the people in the study were women (63.1%) and at least 65 years old (72.6%). There were no notable differences between the treatment groups with regard to how often major cardiac events, heart attack or stroke occurred. Further, death due to cardiac events and death from any cause were no higher with mirabegron compared with antimuscarinics. We obtained similar results when the data were assessed for patients who were at high risk for cardiac events or split by age (less than 65 years or at least 65 years) or a history of overactive bladder medication use. In conclusion, this large study involving data from several countries found no higher risk of major cardiac events, heart attack, stroke or death among people prescribed mirabegron compared with antimuscarinics.

A study of cancer occurrence in users of mirabegron and antimuscarinic treatments for overactive bladder.

OBJECTIVE: This post-authorization safety study (EU PAS Register Number: EUPAS16088) was designed to compare the incidence of cancer outcomes in patients treated with mirabegron versus antimuscarinic medications. METHODS: Cohorts of mirabegron initiators during 2012-2018 were propensity-score matched to antimuscarinic medication initiators within real-world data sources (Danish National Registers, Swedish National Registers, Clinical Practice Research Datalink [UK], Optum [US], and Humana [US]). Incident cancer cases were identified during follow-up from direct linkage to cancer registers or validated through medical record review or through physician questionnaires. Comparisons of sex-specific composite cancer outcomes (cancer of the lung/bronchus, colon/rectum, melanoma of skin, urinary bladder, non-Hodgkin lymphoma, kidney/renal pelvis, pancreas, prostate in men and breast and uterus in women) were made overall and for person-time in the first year and after the first year following start of treatment, for all ages and for the subgroup ≥65 years. RESULTS: Among the 80,637 mirabegron initiators matched to 169,885 antimuscarinic medication initiators, 68% were at least 65 years of age and 66% were women. Over 5000 incident cancer cases were observed overall. Incidence rates were higher for men than women for composite and individual cancer outcomes. The pooled fixed effects hazard ratios for composite cancer outcomes (all ages) were 1.05 (95% confidence interval [CI]: 0.98-1.14) for women and 1.06 (95% CI: 0.98-1.14) for men. Results were similar in persons ≥65 years. CONCLUSIONS: The results suggest no association between mirabegron use and risk of cancer, compared with antimuscarinic medications, in either men or women. Registration: EU PAS Register Number: EUPAS16088.

Shortening treatment in adults with noncavitary tuberculosis and 2-month culture conversion.

RATIONALE: Cavitary disease and delayed culture conversion have been associated with relapse. Combining patient characteristics and measures of bacteriologic response might allow treatment shortening with current drugs in some patients. OBJECTIVES: To assess whether treatment could be shortened from 6 to 4 months in patients with noncavitary tuberculosis whose sputum cultures converted to negative after 2 months. METHODS: This study was a randomized, open-label equivalence trial. HIV-uninfected adults with noncavitary tuberculosis were treated daily with isoniazid, rifampin, pyrazinamide, and ethambutol for 2 months, followed by 2 months of isoniazid and rifampin. After 4 months, patients with drug-susceptible TB whose sputum cultures on solid media were negative after 8 weeks of treatment were randomly assigned to continue treatment for 2 more months or to stop treatment. Patients were followed for relapse for 30 months after beginning treatment. MEASUREMENTS AND MAIN RESULTS: Enrollment was stopped by the safety monitoring committee after 394 patients were enrolled due to apparent increased risk for relapse in the 4-month arm. A total of 370 patients were eligible for per protocol analysis. Thirteen patients in the 4-month arm relapsed, compared with three subjects in the 6-month arm (7.0 vs. 1.6%; risk difference, 0.054; 95% confidence interval with Hauck-Anderson correction, 0.01-0.10). CONCLUSION: Shortening treatment from 6 to 4 months in adults with noncavitary disease and culture conversion after 2 months using current drugs resulted in a greater relapse rate. The combination of noncavitary disease and 2-month culture conversion was insufficient to identify patients with decreased risk for relapse.

Real-world Effectiveness of Liraglutide vs. Sitagliptin Among Older Patients with Type 2 Diabetes Enrolled in a Medicare Advantage Prescription Drug Plan: A Retrospective Observational Study.

INTRODUCTION: Liraglutide and sitagliptin were compared on glycemic control and all-cause healthcare costs over a 1-year period among older adults with type 2 diabetes (65-89 years) enrolled in a national Medicare Advantage Prescription Drug health plan. METHODS: This was a retrospective study in which the index date was the first prescription fill for liraglutide or sitagliptin between 25 January 2010 and 31 December 2014. Post-index treatment persistence and glycosylated hemoglobin (HbA1c) at baseline and 1 year (± 90 days) post-index date were required. Patients were excluded if their record included use of insulin during the baseline period. Inverse probability of treatment weighting using stabilized weights was employed with final covariate adjusted regression modeling to estimate the primary outcome (mean change in HbA1c) and secondary outcomes (achieving glycemic goal and costs), each at 1-year post-index date. RESULTS: Overall, 3056 patients met the selection criteria, of whom 218 filled prescriptions for liraglutide and 2838 for sitagliptin. Adjusted mean change in HbA1c at 1 year post-index was - 0.42 with liraglutide versus - 0.12 with sitagliptin (P = 0.0012). Adjusted odds of achieving the treatment goals of HbA1c < 7% and achieving an HbA1c reduction of ≥ 1% were higher for  those on liraglutide than for those on sitagliptin (1.68, 95% confidence interval [CI] 1.25-2.24 and 1.76, 95% CI 1.31-2.36), respectively. Total healthcare costs in those achieving an HbA1c of < 7% were not significantly different between treatment groups but were higher within the liraglutide group for those achieving an HbA1c < 8%. CONCLUSIONS: When compared to sitagliptin, liraglutide was associated with greater achievement of an HbA1c < 7% over a 1-year period in an older population. This finding was not associated with a statistically significant increase in all-cause total healthcare costs, although costs were slightly higher in the liraglutide group than in the sitagliptin group.

Metabolic Monitoring Rates of Youth Treated with Second-Generation Antipsychotics in Usual Care: Results of a Large US National Commercial Health Plan.

Objectives: To examine metabolic monitoring rates in commercially insured children and adolescents treated with a second-generation antipsychotic (SGA) during calendar years (CYs) 2016 and 2017. Methods: In this retrospective study, data were collected from a large national commercial health plan for the period covering January 1, 2016 to December 31, 2017. Commercially insured children and adolescents, aged 8-19 years with ≥2 SGA prescription claims during the CY, were identified for the CY2016 and CY2017 cohorts. The primary outcome of interest was the percentage of subjects with any glucose or lipid metabolism parameter monitoring. Other calculated metabolic testing rates included glucose, hemoglobin A1c (HbA1c), low-density lipoprotein cholesterol (LDL-C), other cholesterol (including triglycerides), and combined glucose and lipid metabolism testing (≥1 test for blood glucose or HbA1c and ≥1 test for LDL-C or other cholesterol). Results: In CY2016 and CY2017, 1502 and 1239 subjects, respectively, were identified for this study. The most common psychiatric diagnoses in CY2016 and CY2017 were major depressive disorder (57.1%, 56.5%, respectively), anxiety disorders (42.9%, 47.5%), attention-deficit/hyperactivity disorder (41.6%, 45.8%), and bipolar disorder (24.1%, 25.9%). The rate of any metabolic testing was 53.5% in CY2016 and 51.3% in CY2017. Glucose testing (50.3%, 46.9%, respectively) was most common in both CYs, followed by LDL-C testing (31.2%, 28.5%). Rates of combined glucose and lipid metabolism testing were 30.7% in CY2016 and 26.9% in CY2017. Conclusions: Given the known potential for adverse cardiometabolic effects, rates of metabolic monitoring associated with SGA use in children and adolescents urgently need to be improved. There is a critical need for understanding barriers to routine monitoring, particularly of lipids, and developing interventions to enhance metabolic monitoring.