Using mHealth to Improve Communication in Adult Day Services Around the Needs of People With Dementia: Mixed Methods Assessment of Acceptability and Feasibility.

BACKGROUND: Adult day services (ADS) provide community-based health care for older adults with complex chronic conditions but rely on outdated methods for communicating users' health information with providers. CareMOBI, a novel mobile health (mHealth) app, was developed to address the need for a technological platform to improve bidirectional information exchange and communication between the ADS setting and providers. OBJECTIVE: This study aims to examine the feasibility and acceptability of CareMOBI in the ADS setting. METHODS: A concurrent-triangulation mixed methods design was used, and participants were client-facing ADS staff members, including direct care workers (paid caregivers), nurses, and social workers. Interviews were conducted to describe barriers and facilitators to the adoption of the CareMOBI app. The acceptability of the app was measured using an adapted version of the Technology Acceptance Model questionnaire. Data were integrated into 4 themes as anchors of an informational matrix: ease of use, clinical value, fit within workflow, and likelihood of adoption. RESULTS: A mix of ADS staff (N=22) participated in the study. Participants reported high levels of acceptability across the 4 domains. Qualitative findings corroborated the questionnaire results; participants viewed the app as useful and were likely to implement CareMOBI in their practice. However, participants expressed a need for proper training and technical support throughout the implementation process. CONCLUSIONS: The CareMOBI app has the potential to improve care management in the ADS setting by promoting effective communication through an easy-to-use and portable method. While the integration of CareMOBI is acceptable and feasible, developing role-specific training modules and technical assistance programs is imperative for successful implementation within the ADS setting.

Impact of the Affordable Care Act on Prescription Contraceptive Use and Costs Among Privately Insured Women, 2006-2020.

BACKGROUND: In the years immediately following the Affordable Care Act (ACA)'s contraceptive coverage requirement, out-of-pocket costs fell for all Food and Drug Administration-approved contraceptive methods and use of long-acting reversible contraception (LARC) increased. This analysis examines whether these trends have continued through 2020 for privately insured women. METHODS: Using 2006-2020 MarketScan data, we examined trends in prescription contraceptive use and out-of-pocket costs among women 13 to 49 years old. Multivariable analyses model the likelihood of contraceptive use and paying $0 post-ACA requirement (vs. pre-ACA requirement) for contraception, controlling for age group, U.S. region, urban versus rural, and cohort year. RESULTS: The likelihood of LARC insertion increased post-ACA requirement (adjusted odds ratio [aOR] 1.127, 95% confidence interval [CI] 1.121-1.133), with insertion rates peaking at 3.73% for intrauterine devices (IUDs) and 1.08% for implants in 2019, before declining with the onset of the COVID-19 pandemic in 2020. Although the likelihood of paying $0 for LARC increased after the ACA requirement (IUD: aOR 5.495, 95% CI 5.278-5.716; implant: aOR 7.199, 95% CI 6.992-7.412), the proportion of individuals paying $0 declined to 69% for IUDs and 73% for implants in 2020, after having peaked at 88% in 2014 and 90% in 2016, respectively. For oral contraceptives, both use (aOR 1.028, 95% CI 1.026-1.030) and paying $0 (aOR 20.399, 95% CI 20.301-20.499) increased significantly after the ACA requirement. CONCLUSION: With the exception of oral contraceptives, the proportion of individuals paying $0 for all contraceptive methods declined after peaking in 2014 for IUDs, 2016 for the implant, and 2019 for non-LARC methods. Future monitoring is needed to understand the continuing impact of the ACA requirement on prescription contraceptive use and costs.

Clinical and Economic Effects of Widespread Rapid Testing to Decrease SARS-CoV-2 Transmission.

BACKGROUND: The value of frequent, rapid testing to reduce community transmission of SARS-CoV-2 is poorly understood. OBJECTIVE: To define performance standards and predict the clinical, epidemiologic, and economic outcomes of nationwide, home-based antigen testing. DESIGN: A simple compartmental epidemic model that estimated viral transmission, portrayed disease progression, and forecast resource use, with and without testing. DATA SOURCES: Parameter values and ranges as informed by Centers for Disease Control and Prevention guidance and published literature. TARGET POPULATION: U.S. population. TIME HORIZON: 60 days. PERSPECTIVE: Societal; costs included testing, inpatient care, and lost workdays. INTERVENTION: Home-based SARS-CoV-2 antigen testing. OUTCOME MEASURES: Cumulative infections and deaths, number of persons isolated and hospitalized, and total costs. RESULTS OF BASE-CASE ANALYSIS: Without a testing intervention, the model anticipates 11.6 million infections, 119 000 deaths, and $10.1 billion in costs ($6.5 billion in inpatient care and $3.5 billion in lost productivity) over a 60-day horizon. Weekly availability of testing would avert 2.8 million infections and 15 700 deaths, increasing costs by $22.3 billion. Lower inpatient outlays ($5.9 billion) would partially offset additional testing expenditures ($12.5 billion) and workdays lost ($14.0 billion), yielding incremental cost-effectiveness ratios of $7890 per infection averted and $1 430 000 per death averted. RESULTS OF SENSITIVITY ANALYSIS: Outcome estimates vary widely under different behavioral assumptions and testing frequencies. However, key findings persist across all scenarios, with large reductions in infections, mortality, and hospitalizations. Costs per death averted are roughly an order of magnitude lower than commonly accepted willingness-to-pay values per statistical life saved ($5 to $17 million). LIMITATIONS: Analysis was restricted to at-home testing. There are uncertainties concerning test performance. CONCLUSION: High-frequency home testing for SARS-CoV-2 with an inexpensive, imperfect test could contribute to pandemic control at justifiable cost and warrants consideration as part of a national containment strategy. PRIMARY FUNDING SOURCE: National Institutes of Health.

Clinical and Economic Impact of Widespread Rapid Testing to Decrease SARS-CoV-2 Transmission.

BACKGROUND: The value of frequent, rapid testing to reduce community transmission of SARS-CoV-2 is poorly understood. OBJECTIVE: To define performance standards and predict the clinical, epidemiological, and economic outcomes of nationwide, home-based, antigen testing. DESIGN: A simple compartmental epidemic model estimated viral transmission, clinical history, and resource use, with and without testing. DATA SOURCES: Parameter values and ranges informed by Centers for Disease Control guidance and published literature. TARGET POPULATION: United States population. TIME HORIZON: 60 days. PERSPECTIVE: Societal. Costs include: testing, inpatient care, and lost workdays. INTERVENTION: Home-based SARS-CoV-2 antigen testing. OUTCOME MEASURES: Cumulative infections and deaths, numbers isolated and/or hospitalized, and total costs. RESULTS OF BASE-CASE ANALYSIS: Without a testing intervention, the model anticipates 15 million infections, 125,000 deaths, and $10.4 billion in costs ($6.5 billion inpatient; $3.9 billion lost productivity) over a 60-day horizon. Weekly availability of testing may avert 4 million infections and 19,000 deaths, raising costs by $21.5 billion. Lower inpatient outlays ($5.9 billion) would partially offset additional testing expenditures ($12.0 billion) and workdays lost ($13.9 billion), yielding incremental costs per infection (death) averted of $5,400 ($1,100,000). RESULTS OF SENSITIVITY ANALYSIS: Outcome estimates vary widely under different behavioral assumptions and testing frequencies. However, key findings persist across all scenarios: large reductions in infections, mortality, and hospitalizations; and costs per death averted roughly an order of magnitude lower than commonly accepted willingness-to-pay values per statistical life saved ($5-17 million). LIMITATIONS: Analysis restricted to at-home testing and limited by uncertainties about test performance. CONCLUSION: High-frequency home testing for SARS-CoV-2 using an inexpensive, imperfect test could contribute to pandemic control at justifiable cost and warrants consideration as part of a national containment strategy.

Asians and Asian Subgroups are Underrepresented in Medical Research Studies Published in High-Impact Generalist Journals.

Including diverse participants in biomedical research is essential to reduce health disparities. We assessed the inclusion of Asians in original research studies conducted in North America and published from 2015-2016 in six high-impact generalist journals: New England Journal of Medicine, Journal of the American Medical Association (JAMA), JAMA Internal Medicine, JAMA Pediatrics, Annals of Internal Medicine, and Pediatrics. We determined race reporting method, participant percentage, and reporting of outcomes or implications of findings for Asians and Asian subgroups. Of 1077 studies, 263 articles (24.4%) identified Asians as a distinct race/ethnicity; the median percentage of Asians per study was 3.8%. Of the 263 articles, 28 (10.6%) studies reported outcomes for Asians; nine (3.4%) articles included information about Asian subgroups. Asians are underrepresented in high-impact medical research studies in North America. Efforts to improve study enrollment, data collection, and reporting of findings of Asians in studies remain essential to improve health outcomes for this population.

Assessment of SARS-CoV-2 Screening Strategies to Permit the Safe Reopening of College Campuses in the United States.

Importance: The coronavirus disease 2019 (COVID-19) pandemic poses an existential threat to many US residential colleges; either they open their doors to students in September or they risk serious financial consequences. Objective: To define severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) screening performance standards that would permit the safe return of students to US residential college campuses for the fall 2020 semester. Design, Setting, and Participants: This analytic modeling study included a hypothetical cohort of 4990 students without SARS-CoV-2 infection and 10 with undetected, asymptomatic SARS-CoV-2 infection at the start of the semester. The decision and cost-effectiveness analyses were linked to a compartmental epidemic model to evaluate symptom-based screening and tests of varying frequency (ie, every 1, 2, 3, and 7 days), sensitivity (ie, 70%-99%), specificity (ie, 98%-99.7%), and cost (ie, $10/test-$50/test). Reproductive numbers (Rt) were 1.5, 2.5, and 3.5, defining 3 epidemic scenarios, with additional infections imported via exogenous shocks. The model assumed a symptomatic case fatality risk of 0.05% and a 30% probability that infection would eventually lead to observable COVID-19-defining symptoms in the cohort. Model projections were for an 80-day, abbreviated fall 2020 semester. This study adhered to US government guidance for parameterization data. Main Outcomes and Measures: Cumulative tests, infections, and costs; daily isolation dormitory census; incremental cost-effectiveness; and budget impact. Results: At the start of the semester, the hypothetical cohort of 5000 students included 4990 (99.8%) with no SARS-CoV-2 infection and 10 (0.2%) with SARS-CoV-2 infection. Assuming an Rt of 2.5 and daily screening with 70% sensitivity, a test with 98% specificity yielded 162 cumulative student infections and a mean isolation dormitory daily census of 116, with 21 students (18%) with true-positive results. Screening every 2 days resulted in 243 cumulative infections and a mean daily isolation census of 76, with 28 students (37%) with true-positive results. Screening every 7 days resulted in 1840 cumulative infections and a mean daily isolation census of 121 students, with 108 students (90%) with true-positive results. Across all scenarios, test frequency was more strongly associated with cumulative infection than test sensitivity. This model did not identify symptom-based screening alone as sufficient to contain an outbreak under any of the scenarios we considered. Cost-effectiveness analysis selected screening with a test with 70% sensitivity every 2, 1, or 7 days as the preferred strategy for an Rt of 2.5, 3.5, or 1.5, respectively, implying screening costs of $470, $910, or $120, respectively, per student per semester. Conclusions and Relevance: In this analytic modeling study, screening every 2 days using a rapid, inexpensive, and even poorly sensitive (>70%) test, coupled with strict behavioral interventions to keep Rt less than 2.5, is estimated to maintain a controllable number of COVID-19 infections and permit the safe return of students to campus.

Cost-effectiveness of urine-based tuberculosis screening in hospitalised patients with HIV in Africa: a microsimulation modelling study.

BACKGROUND: Testing urine improves the number of tuberculosis diagnoses made among patients in hospital with HIV. In conjunction with the two-country randomised Rapid Urine-based Screening for Tuberculosis to Reduce AIDS-related Mortality in Hospitalised Patients in Africa (STAMP) trial, we used a microsimulation model to estimate the effects on clinical outcomes and the cost-effectiveness of adding urine-based tuberculosis screening to sputum screening for hospitalised patients with HIV. METHODS: We compared two tuberculosis screening strategies used irrespective of symptoms among hospitalised patients with HIV in Malawi and South Africa: a GeneXpert assay (Cepheid, Sunnyvale, CA, USA) for Mycobacterium tuberculosis and rifampicin resistance (Xpert) in sputum samples (standard of care) versus sputum Xpert combined with a lateral flow assay for M tuberculosis lipoarabinomannan in urine (Determine TB-LAM Ag test, Abbott, Waltham, MA, USA [formerly Alere]; TB-LAM) and concentrated urine Xpert (intervention). A cohort of simulated patients was modelled using selected characteristics of participants, tuberculosis diagnostic yields, and use of hospital resources in the STAMP trial. We calibrated 2-month model outputs to the STAMP trial results and projected clinical and economic outcomes at 2 years, 5 years, and over a lifetime. We judged the intervention to be cost-effective if the incremental cost-effectiveness ratio (ICER) was less than US$750/year of life saved (YLS) in Malawi and $940/YLS in South Africa. A modified intervention of adding only TB-LAM to the standard of care was also evaluated. We did a budget impact analysis of countrywide implementation of the intervention. FINDINGS: The intervention increased life expectancy by 0·5-1·2 years and was cost-effective, with an ICER of $450/YLS in Malawi and $840/YLS in South Africa. The ICERs decreased over time. At lifetime horizon, the intervention remained cost-effective under nearly all modelled assumptions. The modified intervention was at least as cost-effective as the intervention (ICERs $420/YLS in Malawi and $810/YLS in South Africa). Over 5 years, the intervention would save around 51 000 years of life in Malawi and around 171 000 years of life in South Africa. Health-care expenditure for screened individuals was estimated to increase by $37 million (10·8%) and $261 million (2·8%), respectively. INTERPRETATION: Urine-based tuberculosis screening of all hospitalised patients with HIV could increase life expectancy and be cost-effective in resource-limited settings. Urine TB-LAM is especially attractive because of high incremental diagnostic yield and low additional cost compared with sputum Xpert, making a compelling case for expanding its use to all hospitalised patients with HIV in areas with high HIV burden and endemic tuberculosis. FUNDING: UK Medical Research Council, UK Department for International Development, Wellcome Trust, US National Institutes of Health, Royal College of Physicians, Massachusetts General Hospital.

The cost-effectiveness and budgetary impact of a dolutegravir-based regimen as first-line treatment of HIV infection in India.

INTRODUCTION: Dolutegravir (DTG)-based antiretroviral therapy (ART) is recommended for first-line HIV treatment in the US and Europe. Efavirenz (EFV)-based regimens remain the standard of care (SOC) in India. We examined the clinical and economic impact of DTG-based first-line ART in the setting of India's recent guidelines change to treating all patients with HIV infection regardless of CD4 count. METHODS: We used a microsimulation of HIV disease, the Cost-Effectiveness of Preventing AIDS Complications (CEPAC)-International model, to project outcomes in ART-naive patients under two strategies: (1) SOC: EFV/tenofovir disoproxil fumarate (TDF)/lamivudine (3TC); and (2) DTG: DTG + TDF/3TC. Regimen-specific inputs, including virologic suppression at 48 weeks (SOC: 82% vs. DTG: 90%) and annual costs ($98 vs. $102), were informed by clinical trial data and other sources and varied widely in sensitivity analysis. We compared incremental cost-effectiveness ratios (ICERs), measured in $/year of life saved (YLS), to India's per capita gross domestic product ($1600 in 2015). We compared the budget impact and HIV transmission effects of the two strategies for the estimated 444,000 and 916,000 patients likely to initiate ART in India over the next 2 and 5 years. RESULTS: Compared to SOC, DTG improved 5-year survival from 76.7% to 83.0%, increased life expectancy from 22.0 to 24.8 years (14.0 to 15.5 years, discounted), averted 13,000 transmitted HIV infections over 5 years, increased discounted lifetime care costs from $3040 to $3240, and resulted in a lifetime ICER of $130/YLS, less than 10% of India's per capita GDP in 2015. DTG maintained an ICER below 50% of India's per capita GDP as long as the annual three-drug regimen cost was ≤$180/year. Over a 2- or 5-year horizon, total undiscounted outlays for HIV-related care were virtually the same for both strategies. CONCLUSIONS: A generic DTG-based regimen is likely to be cost-effective and should be recommended for initial therapy of HIV infection in India.

Implementing Generalized Additive Models to Estimate the Expected Value of Sample Information in a Microsimulation Model: Results of Three Case Studies.

BACKGROUND: The expected value of sample information (EVSI) can help prioritize research but its application is hampered by computational infeasibility, especially for complex models. We investigated an approach by Strong and colleagues to estimate EVSI by applying generalized additive models (GAM) to results generated from a probabilistic sensitivity analysis (PSA). METHODS: For 3 potential HIV prevention and treatment strategies, we estimated life expectancy and lifetime costs using the Cost-effectiveness of Preventing AIDS Complications (CEPAC) model, a complex patient-level microsimulation model of HIV progression. We fitted a GAM-a flexible regression model that estimates the functional form as part of the model fitting process-to the incremental net monetary benefits obtained from the CEPAC PSA. For each case study, we calculated the expected value of partial perfect information (EVPPI) using both the conventional nested Monte Carlo approach and the GAM approach. EVSI was calculated using the GAM approach. RESULTS: For all 3 case studies, the GAM approach consistently gave similar estimates of EVPPI compared with the conventional approach. The EVSI behaved as expected: it increased and converged to EVPPI for larger sample sizes. For each case study, generating the PSA results for the GAM approach required 3 to 4 days on a shared cluster, after which EVPPI and EVSI across a range of sample sizes were evaluated in minutes. The conventional approach required approximately 5 weeks for the EVPPI calculation alone. CONCLUSION: Estimating EVSI using the GAM approach with results from a PSA dramatically reduced the time required to conduct a computationally intense project, which would otherwise have been impractical. Using the GAM approach, we can efficiently provide policy makers with EVSI estimates, even for complex patient-level microsimulation models.

Setting Performance Standards for a Cost-Effective Human Immunodeficiency Virus Cure Strategy in South Africa.

BACKGROUND: Reports of a single case of human immunodeficiency virus (HIV) eradication suggest that elimination of HIV from individuals is possible. Anticipating both increased research funding and the development of effective, durable cure technologies, we describe the circumstances under which a cure might improve survival and be cost-effective in South Africa. METHODS: We adapted a simulation model comparing a hypothetical cure strategy ("Cure") to the standard of care, lifetime antiretroviral therapy ("LifetimeART") among adherent South Africans (58% female; mean age 33.8 years; mean CD4 257/µL; virologic suppression ≥1 year). We portrayed cure as a single intervention, producing sustained viral eradication without ART. We considered both a plausible, more imminently achievable "Baseline Scenario" and a more aspirational "Optimistic Scenario". Inputs (Baseline/Optimistic) included the following: 50%/75% efficacy; 0.6%/0.0% fatal toxicity; 0.37%/0.085% monthly relapse over 5 years (0.185%/0.0425% per month thereafter); and $2000/$500 cost. These inputs were varied extensively in sensitivity analysis. RESULTS: At baseline, Cure was "dominated," yielding lower discounted life expectancy (19.31 life-years [LY] vs 19.37 LY) and greater discounted lifetime costs ($13 800 vs $13 700) than LifetimeART. Under optimistic assumptions, Cure was "cost-saving," producing greater survival (19.91 LY) and lower lifetime costs ($11 000) than LifetimeART. Findings were highly sensitive to data assumptions, leaving little middle ground where a tradeoff existed between improved survival and higher costs. CONCLUSIONS: Only under the most favorable performance assumptions will an HIV cure strategy prove clinically and economically justifiable in South Africa. The scientific pursuit of a cure should not undermine continued expansions of access to proven, effective, and cost-effective ART.