Projecting the Potential Clinical and Economic Impact of Human Immunodeficiency Virus Prevention Resource Reallocation in Tennessee.

BACKGROUND: In 2023, Tennessee replaced $6.2 M in US Centers for Disease Control and Prevention (CDC) human immunodeficiency virus (HIV) prevention funding with state funds to redirect support away from men who have sex with men (MSM), transgender women (TGW), and heterosexual Black women (HSBW) and to prioritize instead first responders (FR), pregnant people (PP), and survivors of sex trafficking (SST). METHODS: We used a simulation model of HIV disease to compare the clinical impact of Current, the present allocation of condoms, preexposure prophylaxis (PrEP), and HIV testing to CDC priority risk groups (MSM/TGW/HSBW); with Reallocation, funding instead increased HIV testing and linkage of Tennessee-determined priority populations (FR/PP/SST). Key model inputs included baseline condom use (45%-49%), PrEP provision (0.1%-8%), HIV testing frequency (every 2.5-4.8 years), and 30-day HIV care linkage (57%-65%). We assumed Reallocation would reduce condom use (-4%), PrEP provision (-26%), and HIV testing (-47%) in MSM/TGW/HSBW, whereas it would increase HIV testing among FR (+47%) and HIV care linkage (to 100%/90%) among PP/SST. RESULTS: Reallocation would lead to 166 additional HIV transmissions, 190 additional deaths, and 843 life-years lost over 10 years. HIV testing reductions were most influential in sensitivity analysis; even a 24% reduction would result in 287 more deaths compared to Current. With pessimistic assumptions, we projected 1359 additional HIV transmissions, 712 additional deaths, and 2778 life-years lost over 10 years. CONCLUSIONS: Redirecting HIV prevention funding in Tennessee would greatly harm CDC priority populations while conferring minimal benefits to new priority populations.

Model-Projected Cost-Effectiveness of Adult Hearing Screening in the USA.

BACKGROUND: While 60% of older adults have hearing loss (HL), the majority have never had their hearing tested. OBJECTIVE: We sought to estimate long-term clinical and economic effects of alternative adult hearing screening schedules in the USA. DESIGN: Model-based cost-effectiveness analysis simulating Current Detection (CD) and linkage of persons with HL to hearing healthcare, compared to alternative screening schedules varying by age at first screen (45 to 75 years) and screening frequency (every 1 or 5 years). Simulated persons experience yearly age- and sex-specific probabilities of acquiring HL, and subsequent hearing aid uptake (0.5-8%/year) and discontinuation (13-4%). Quality-adjusted life-years (QALYs) were estimated according to hearing level and treatment status. Costs from a health system perspective include screening ($30-120; 2020 USD), HL diagnosis ($300), and hearing aid devices ($3690 year 1, $910/subsequent year). Data sources were published estimates from NHANES and clinical trials of adult hearing screening. PARTICIPANTS: Forty-year-old persons in US primary care across their lifetime. INTERVENTION: Alternative screening schedules that increase baseline probabilities of hearing aid uptake (base-case 1.62-fold; range 1.05-2.25-fold). MAIN MEASURES: Lifetime undiscounted and discounted (3%/year) costs and QALYs and incremental cost-effectiveness ratios (ICERs). KEY RESULTS: CD resulted in 1.20 average person-years of hearing aid use compared to 1.27-1.68 with the screening schedules. Lifetime total per-person undiscounted costs were $3300 for CD and ranged from $3630 for 5-yearly screening beginning at age 75 to $6490 for yearly screening beginning at age 45. In cost-effectiveness analysis, yearly screening beginning at ages 75, 65, and 55 years had ICERs of $39,100/QALY, $48,900/QALY, and $96,900/QALY, respectively. Results were most sensitive to variations in hearing aid utility benefit and screening effectiveness. LIMITATION: Input uncertainty around screening effectiveness. CONCLUSIONS: We project that yearly hearing screening beginning at age 55+ is cost-effective by US standards.

The Impact of Hearing Loss and Its Treatment on Health-Related Quality of Life Utility: a Systematic Review with Meta-analysis.

BACKGROUND: Hearing loss significantly impacts health-related quality of life (QoL), yet the effects of current treatments on QoL utility remain uncertain. Our objective was to describe the impact of untreated and treated hearing loss on QoL utility to inform hearing healthcare policy. METHODS: We searched databases for articles published through 02/01/2021. Two independent reviewers screened for articles that reported elicitation of general QoL utility values for untreated and treated hearing loss health states. We extracted data and quality indicators from 62 studies that met the inclusion criteria. RESULTS: Included studies predominately used observational pre/post designs (61%), evaluated unilateral cochlear implantation (65%), administered the Health Utilities Index 3 (HUI3; 71%), and were conducted in Europe and North America (84%). In general, treatment of hearing loss improved post-treatment QoL utility when measured by most methods except the Euro-QoL 5 dimension (EQ-5D). In meta-analysis, hearing aids for adult mild-to-moderate hearing loss compared to no treatment significantly improved HUI3-estimated QoL utility (3 studies; mean change=0.11; 95% confidence interval (CI): 0.07 to 0.14) but did not impact EQ-5D-estimated QoL (3 studies; mean change=0.0; 95% CI: -0.03 to 0.04). Cochlear implants improved adult QoL utility 1-year post-implantation when measured by the HUI3 (7 studies; mean change=0.17; 95% CI: 0.11 to 0.23); however, pediatric VAS-estimated QoL utility was non-significant (4 studies; mean change=0.12; 95% CI: -0.02 to 0.25). The quality of included studies was limited by failure to report missingness of data and low survey response rates. Our study was limited by heterogeneous study populations and designs. FINDINGS: Treatment of hearing loss significantly improves QoL utility, and the HUI3 and VAS were most sensitive to improvements in hearing. Improved access to hearing healthcare should be prioritized. SYSTEMATIC REVIEW REGISTRATION: PROSPERO: CRD42021253314.

Interventions for Preventing Thromboembolic Events in Patients With Atrial Fibrillation: A Systematic Review.

Background: The comparative safety and effectiveness of treatments to prevent thromboembolic complications in atrial fibrillation (AF) remain uncertain. Purpose: To compare the effectiveness of medical and procedural therapies in preventing thromboembolic events and bleeding complications in adults with nonvalvular AF. Data Sources: English-language studies in several databases from 1 January 2000 to 14 February 2018. Study Selection: Two reviewers independently screened citations to identify comparative studies of treatments to prevent stroke in adults with nonvalvular AF who reported thromboembolic or bleeding complications. Data Extraction: Two reviewers independently abstracted data, assessed study quality and applicability, and rated strength of evidence. Data Synthesis: Data from 220 articles were included. Dabigatran and apixaban were superior and rivaroxaban and edoxaban were similar to warfarin in preventing stroke or systemic embolism. Apixaban and edoxaban were superior and rivaroxaban and dabigatran were similar to warfarin in reducing the risk for major bleeding. Treatment effects with dabigatran were similar in patients with renal dysfunction (interaction P > 0.05), and patients younger than 75 years had lower bleeding rates with dabigatran (interaction P < 0.001). The benefit of treatment with apixaban was consistent in many subgroups, including those with renal impairment, diabetes, and prior stroke (interaction P > 0.05 for all). The greatest bleeding risk reduction was observed in patients with a glomerular filtration rate less than 50 mL/min/1.73 m2 (P = 0.003). Similar treatment effects were observed for rivaroxaban and edoxaban in patients with prior stroke, diabetes, or heart failure (interaction P > 0.05 for all). Limitation: Heterogeneous study populations, interventions, and outcomes. Conclusion: The available direct-acting oral anticoagulants (DOACs) are at least as effective and safe as warfarin for patients with nonvalvular AF. The DOACs had similar benefits across several patient subgroups and seemed safe and efficacious for a wide range of patients with nonvalvular AF. Primary Funding Source: Patient-Centered Outcomes Research Institute. (PROSPERO: CRD42017069999).

Do Less Harm: Evaluating HIV Programmatic Alternatives in Response to Cutbacks in Foreign Aid.

BACKGROUND: Resource-limited nations must consider their response to potential contractions in international support for HIV programs. OBJECTIVE: To evaluate the clinical, epidemiologic, and budgetary consequences of alternative HIV program scale-back strategies in 2 recipient nations, the Republic of South Africa (RSA) and Côte d'Ivoire (CI). DESIGN: Model-based comparison between current standard (CD4 count at presentation of 0.260 × 109 cells/L, universal antiretroviral therapy [ART] eligibility, and 5-year retention rate of 84%) and scale-back alternatives, including reduced HIV detection, no ART or delayed initiation (when CD4 count is <0.350 × 109 cells/L), reduced investment in retention, and no viral load monitoring or second-line ART. DATA SOURCES: Published RSA- and CI-specific estimates of the HIV care continuum, ART efficacy, and HIV-related costs. TARGET POPULATION: HIV-infected persons, including future incident cases. TIME HORIZON: 5 and 10 years. PERSPECTIVE: Modified societal perspective, excluding time and productivity costs. OUTCOME MEASURES: HIV transmissions and deaths, years of life, and budgetary outlays (2015 U.S. dollars). RESULTS OF BASE-CASE ANALYSIS: At 10 years, scale-back strategies increase projected HIV transmissions by 0.5% to 19.4% and deaths by 0.6% to 39.1%. Strategies can produce budgetary savings of up to 30% but no more. Compared with the current standard, nearly every scale-back strategy produces proportionally more HIV deaths (and transmissions, in RSA) than savings. When the least harmful and most efficient alternatives for achieving budget cuts of 10% to 20% are applied, every year of life lost will save roughly $900 in HIV-related outlays in RSA and $600 to $900 in CI. RESULTS OF SENSITIVITY ANALYSIS: Scale-back programs, when combined, may result in clinical and budgetary synergies and offsets. LIMITATION: The magnitude and details of budget cuts are not yet known, nor is the degree to which other international partners might step in to restore budget shortfalls. CONCLUSION: Scaling back international aid to HIV programs will have severe adverse clinical consequences; for similar economic savings, certain programmatic scale-back choices result in less harm than others. PRIMARY FUNDING SOURCE: National Institutes of Health and Steve and Deborah Gorlin MGH Research Scholars Award.

The Clinical and Economic Impact of Attaining National HIV/AIDS Strategy Treatment Targets in the United States.

Background: The US National HIV/AIDS Strategy (NHAS) aims for 72% (90% diagnosed times 80% of those virally suppressed) viral suppression among persons with human immunodeficiency virus (HIV) by 2020. We examined the clinical and economic impact of reaching this target, in the general US population and among black men who have sex with men (MSM), the group with the highest HIV prevalence. Methods: Using a mathematical simulation, we project the 5- and 20-year clinical outcomes, costs, and incremental cost-effectiveness ratios for (1) Current Pace of detection, linkage, retention, and virologic suppression and (2) NHAS investments in expanded testing ($24-$74 per test) and adherence ($400 per person-year), calibrated to achieve 72% suppression by 2020. We examined alternative rates of testing, retention, and suppression and the efficacy and cost of adherence interventions. Results: Compared with Current Pace over 20 years, NHAS averted 280000 HIV transmissions (80000 in black MSM) and 199000 (45000) deaths and saved 2138000 (453000) years of life, while increasing costs by 23%. The incremental cost-effectiveness ratio for NHAS compared with Current Pace was $68900 per quality-adjusted life-year ($38300 for black MSM) and was most sensitive to antiretroviral therapy costs. Conclusions: Reaching NHAS targets would yield substantial clinical benefits and be cost-effective in both the general US and black MSM populations.

Projecting 10-year, 20-year, and Lifetime Risks of Cardiovascular Disease in Persons Living With Human Immunodeficiency Virus in the United States.

Background: Cardiovascular disease (CVD) is an increasing cause of morbidity among persons living with human immunodeficiency virus (HIV; PLWH). We projected cumulative CVD risk in PLWH in care compared to the US general population and persons HIV-uninfected, but at high risk for HIV. Methods: We used a mathematical model to project cumulative CVD incidence. We simulated a male and female cohort for each of 3 populations: US general population; HIV-uninfected, at high risk for HIV; and PLWH. We incorporated the higher smoking prevalence and increased CVD risk due to smoking into the HIV-infected and HIV-uninfected, at high risk for HIV populations. We incorporated HIV-attributable CVD risk, independent of smoking. Results: For men, life expectancy ranged from 70.2 to 77.5 years and for women from 67.0 to 81.1 years (PLWH, US general population). Without antiretroviral therapy, lifetime CVD risk for HIV-infected males and females was 12.9% and 9.0%. For males, by age 60, cumulative CVD incidence was estimated at 20.5% in PLWH in care, 14.6% in HIV-uninfected high-risk persons, and 12.8% in the US general population. For females, cumulative CVD incidence was projected to be 13.8% in PLWH in care, 9.7% for high-risk HIV-uninfected persons, and 9.4% in the US general population. Lifetime CVD risk was 64.8% for HIV-infected males compared to 54.8% for males in the US general population, but similar among females. Conclusions: CVD risks should be a part of treatment evaluation among PLWH. CVD prevention strategies could offer important health benefits for PLWH and should be evaluated.

The Anticipated Clinical and Economic Effects of 90-90-90 in South Africa.

BACKGROUND: The Joint United Nations Programme on HIV/AIDS (UNAIDS) 90-90-90 global treatment target aims to achieve 73% virologic suppression among HIV-infected persons worldwide by 2020. OBJECTIVE: To estimate the clinical and economic value of reaching this ambitious goal in South Africa, by using a microsimulation model of HIV detection, disease, and treatment. DESIGN: Modeling of the "current pace" strategy, which simulates existing scale-up efforts and gradual increases in overall virologic suppression from 24% to 36% in 5 years, and the UNAIDS target strategy, which simulates 73% virologic suppression in 5 years. DATA SOURCES: Published estimates and South African survey data on HIV transmission rates (0.16 to 9.03 per 100 person-years), HIV-specific age-stratified fertility rates (1.0 to 9.1 per 100 person-years), and costs of care ($11 to $31 per month for antiretroviral therapy and $20 to $157 per month for routine care). TARGET POPULATION: South African HIV-infected population, including incident infections over the next 10 years. PERSPECTIVE: Modified societal perspective, excluding time and productivity costs. TIME HORIZON: 5 and 10 years. INTERVENTION: Aggressive HIV case detection, efficient linkage to care, rapid treatment scale-up, and adherence and retention interventions toward the UNAIDS target strategy. OUTCOME MEASURES: HIV transmissions, deaths, years of life saved, maternal orphans, costs (2014 U.S. dollars), and cost-effectiveness. RESULTS OF BASE-CASE ANALYSIS: Compared with the current pace strategy, over 5 years the UNAIDS target strategy would avert 873 000 HIV transmissions, 1 174 000 deaths, and 726 000 maternal orphans while saving 3 002 000 life-years; over 10 years, it would avert 2 051 000 HIV transmissions, 2 478 000 deaths, and 1 689 000 maternal orphans while saving 13 340 000 life-years. The additional budget required for the UNAIDS target strategy would be $7.965 billion over 5 years and $15.979 billion over 10 years, yielding an incremental cost-effectiveness ratio of $2720 and $1260 per year of life saved, respectively. RESULTS OF SENSITIVITY ANALYSIS: Outcomes generally varied less than 20% from base-case outcomes when key input parameters were varied within plausible ranges. LIMITATION: Several pathways may lead to 73% overall virologic suppression; these were examined in sensitivity analyses. CONCLUSION: Reaching the 90-90-90 HIV suppression target would be costly but very effective and cost-effective in South Africa. Global health policymakers should mobilize the political and economic support to realize this target. PRIMARY FUNDING SOURCE: National Institutes of Health and the Steve and Deborah Gorlin MGH Research Scholars Award.

Priorities for hearing loss prevention and estimates of global cause-specific burdens of hearing loss: a systematic rapid review.

BACKGROUND: Hearing loss affects approximately 1·6 billion individuals worldwide. Many cases are preventable. We aimed to estimate the annual number of new hearing loss cases that could be attributed to meningitis, otitis media, congenital rubella syndrome, cytomegalovirus, and ototoxic medications, specifically aminoglycosides, platinum-based chemotherapeutics, and antimalarials. METHODS: We used a targeted and a rapid systematic literature review to calculate yearly global incidences of each cause of hearing loss. We estimated the prevalence of hearing loss for each presumed cause. For each cause, we calculated the global number of yearly hearing loss cases associated with the exposure by multiplying the estimated exposed population by the prevalence of hearing loss associated with the exposure, accounting for mortality when warranted. FINDINGS: An estimated 257·3 million people per year are exposed to these preventable causes of hearing loss, leading to an estimated 33·8 million new cases of hearing loss worldwide per year. Most hearing loss cases were among those with exposure to ototoxic medications (19·6 million [range 12·6 million-27·9 million] from short-course aminoglycoside therapy and 12·3 million from antimalarials). We estimated that 818 000 cases of hearing loss were caused by otitis media, 346 000 by meningitis, 114 000 by cytomegalovirus, and 59 000 by congenital rubella syndrome. INTERPRETATION: The global burden of preventable hearing loss is large. Hearing loss that is attributable to disease sequelae or ototoxic medications contributes substantially to the global burden of hearing loss. Prevention of these conditions should be a global health priority. FUNDING: The US National Institute on Deafness and Other Communication Disorders and the US National Institute on Aging.

Patient education and extracorporeal membrane oxygenation preferences of patients and providers in COVID care.

BACKGROUND: Extracorporeal membrane oxygenation (ECMO) represents an important but limited treatment for patients with severe COVID-19. We assessed the effects of an educational intervention on a person's ECMO care preference and examined whether patients and providers had similar ECMO preferences. METHODS: In the Video+Survey group, patients watched an educational video about ECMO's purpose, benefits, and risks followed by an assessment of ECMO knowledge and care preferences in seven scenarios varying by hypothetical patient age, function, and comorbidities. Patients in the Survey Only group and providers didn't watch the video. Logistic regression was used to estimate the probability of agreement for each ECMO scenario between the two patient groups and then between all patients and providers. RESULTS: Video+Survey patients were more likely (64% vs. 17%; p = 0.02) to correctly answer all ECMO knowledge questions than Survey Only patients. Patients in both groups agreed that ECMO should be considered across all hypothetical scenarios, with predicted agreement above 65%. In adjusted analyses, patients and providers had similar predicted agreement for ECMO consideration across six of the seven scenarios, but patients showed greater preference (84% vs. 41%, p = 0.003) for the scenario of a functionally dependent 65-year-old with comorbidities than providers. DISCUSSION AND CONCLUSIONS: An educational video increased a person's ECMO knowledge but did not change their ECMO preferences. Clinicians were less likely than patients to recommend ECMO for older adults, so advanced care planning discussion between patients and providers about treatment options in critically ill patients with COVID-19 is critical.

The Cost Utility of Nonpregnancy Laboratory Monitoring for Persons on Isotretinoin Acne Therapy.

We sought to project the 1-year cost utility of nonpregnancy laboratory monitoring cessation among patients initiating isotretinoin. We conducted a model-based cost utility analysis comparing (i) current practice (CP) and (ii) cessation of nonpregnancy laboratory monitoring. Simulated 20-year-old persons initiating isotretinoin were maintained on therapy for 6 months, unless taken off because of laboratory abnormalities in CP. Model inputs included probabilities of cell-line abnormalities (0.12%/wk), early cessation of isotretinoin therapy after detection of an abnormal laboratory result (2.2%/wk, CP only), quality-adjusted life-years (0.84-0.93), and laboratory monitory costs ($5/wk). We collected adverse events, deaths, and quality-adjusted life-years and costs (2020 USD) from a health care payer perspective. Over 1 year, and for 200,000 people on isotretinoin in the United States, the CP strategy resulted in 184,730 quality-adjusted life-years (0.9236 per person), and nonpregnancy laboratory monitoring resulted in 184,770 quality-adjusted life-years (0.9238 per person). The CP and nonpregnancy laboratory monitoring strategies resulted in 0.08 and 0.09 isotretinoin-related deaths, respectively. Nonpregnancy laboratory monitoring was the dominating strategy, realizing $24 million savings per year. No variation of a single parameter across its plausible range changed our cost utility findings. Cessation of laboratory monitoring could realize savings of $24 million per year for the US health care system and improve patient outcomes, with negligible effects on adverse events.

The potential cost-effectiveness of novel cord blood therapies in children with autism spectrum disorder.

OBJECTIVE: To model the long-term clinical and economic outcomes of potential cord blood therapy in autism spectrum disorder (ASD). STUDY DESIGN: Markov microsimulation of ASD over the lifespan was used to compare two strategies: 1) standard of care (SOC), including behavioral and educational interventions, and 2) novel cord blood (CB) intervention in addition to SOC. Input data reflecting behavioral outcomes included baseline Vineland Adaptive Behavior Scale (VABS-3), monthly VABS-3 changes, and CB intervention efficacy on adaptive behavior based on a randomized, placebo-controlled trial (DukeACT). Quality-adjusted life-years (QALYs) were correlated to VABS-3. Costs for children with ASD ($15,791, ages 2-17 years) and adults with ASD ($56,559, ages 18+ years), and the CB intervention (range $15,000-45,000) were incorporated. Alternative CB efficacy and costs were explored. RESULTS: We compared model-projected results to published data on life-expectancy, mean VABS-3 changes, and lifetime costs. Undiscounted lifetime QALYs in the SOC and CB strategies were 40.75 and 40.91. Discounted lifetime costs in the SOC strategy were $1,014,000, and for CB ranged from $1,021,000-$1,058,000 with CB intervention cost ($8,000-$45,000). At $15,000 cost, CB was borderline cost-effective (ICER = $105,000/QALY). In one-way sensitivity analysis, CB cost and efficacy were the most influential parameters on CB ICER. CB intervention was cost-effective at costs<$15,000 and efficacies ≥2.0. Five-year healthcare payer projected budgetary outlays at a $15,000 CB cost were $3.847B. CONCLUSIONS: A modestly effective intervention designed to improve adaptive behavior in autism can be cost-effective under certain circumstances. Intervention cost and efficacy most affected the cost-effectiveness results and should be targeted to increase economic efficiency.

Implementation Evaluation of a Teledermatology Virtual Clinic at an Academic Medical Center.

Background: Teledermatology (TD) is an evidence-based practice that may increase access to dermatologic care. We sought to evaluate implementation of TD at four Duke primary care practices. Methods: We implemented a hybrid TD program where trained primary care providers (PCPs) sent referrals with clinical and dermatoscopic images to dermatology. Patients were seen by dermatologists over video visit within days, and dermatologists managed the patient plan. We evaluated implementation using the Reach, Efficacy, Adoption, Implementation, and Maintenance (RE-AIM) framework using electronic health record data. Implementation barriers and facilitators were collected through surveys (n = 24 PCPs, n = 10 dermatologists, n = 10 dermatology residents). Results: At four PCP clinics throughout 9/1/2021-4/30/2022 there were 218 TD referrals. Video visits occurred on average 7.5 days after referral and 18/18 patients completing the post-visit survey were satisfied. Adoption varied between clinics, with one placing 22% of all dermatology referrals as TD and another placing 2%. The primary PCP barriers to TD were time burdens, lack of fit in clinic flow, and discomfort with image taking. Top-endorsed potential facilitating interventions included allowing for rash referrals without dermoscopy and assurance for clinical evaluation within 3 days. Conclusions: Addressing TD process fit into PCP clinic flow and reducing time burdens may increase PCP uptake of TD.

Implementation evaluation of a teledermatology virtual clinic at an academic medical center.

BACKGROUND: Teledermatology (TD) is an evidence-based practice that may increase access to dermatologic care. We sought to use the Exploration, Preparation, Implementation, and Sustainment (EPIS) and the Reach, Efficacy, Adoption, Implementation, and Maintenance (RE-AIM) frameworks to evaluate implementation of TD at Duke. METHODS: The EPIS and RE-AIM frameworks were deployed to design and implement a TD program that leveraged the strengths of the Duke University Health System and addressed previously reported barriers to implementation of store-and-forward and synchronous TD models. In the resultant hybrid TD model, trained primary care providers (PCPs) sent e-comm referrals with clinical and dermatoscopic images to dermatology. These e-consults were reviewed asynchronously and patients were scheduled for a synchronous video visit with dermatology within days. Dermatologists managed the patient plan. This hybrid TD model was piloted at four primary care clinics. Pertinent outcomes from a TD-adapted RE-AIM framework were tracked using electronic health record data. Patient satisfaction was assessed using a post-video visit survey (n = 18). Implementation barriers and facilitators were also collected through provider surveys (n = 24 PCPs, n = 10 dermatologists, n = 10 dermatology residents). RESULTS: At four PCP clinics throughout 9/1/2021-4/30/2022, there were 218 TD referrals. Video visits occurred on average 7.5 ± 0.5 days after referral and 18/18 patients completing the post-visit survey were satisfied. Adoption varied between clinics, with one placing 22% of all dermatology referrals as TD and another placing 2%. The primary PCP barriers to TD were time burdens, lack of fit in clinic flow, and discomfort with image taking. Top-endorsed potential facilitating interventions included allowing for rash referrals without dermoscopy and assurance for clinical evaluation within 3 days. CONCLUSIONS: The use of implementation science frameworks allowed for identification of system and contextual strengths which informed the hybrid TD pilot. Barriers and facilitating interventions will provide guidance for expansion and ongoing maintenance of TD.

Potential Clinical and Economic Outcomes of Over-the-Counter Hearing Aids in the US.

Importance: Over-the-counter (OTC) hearing aids are now available in the US; however, their clinical and economic outcomes are unknown. Objective: To project the clinical and economic outcomes of traditional hearing aid provision compared with OTC hearing aid provision. Design, Setting, and Participants: This cost-effectiveness analysis used a previously validated decision model of hearing loss (HL) to simulate US adults aged 40 years and older across their lifetime in US primary care offices who experienced yearly probabilities of acquiring HL (0.1%-10.4%), worsening of their HL, and traditional hearing aid uptake (0.5%-8.1%/y at a fixed uptake cost of $3690) and utility benefits (0.11 additional utils/y). For OTC hearing aid provision, persons with perceived mild to moderate HL experienced increased OTC hearing aid uptake (1%-16%/y) based on estimates of time to first HL diagnosis. In the base case, OTC hearing aid utility benefits ranged from 0.05 to 0.11 additional utils/y (45%-100% of traditional hearing aids), and costs were $200 to $1400 (5%-38% of traditional hearing aids). Distributions were assigned to parameters to conduct probabilistic uncertainty analysis. Intervention: Provision of OTC hearing aids, at increased uptake rates, across a range of effectiveness and costs. Main Outcomes and Measures: Lifetime undiscounted and discounted (3%/y) costs and quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICERs). Results: Traditional hearing aid provision resulted in 18.162 QALYs, compared with 18.162 to 18.186 for OTC hearing aids varying with OTC hearing aid utility benefit (45%-100% that of traditional hearing aids). Provision of OTC hearing aids was associated with greater lifetime discounted costs by $70 to $200 along with OTC device cost ($200-$1000/pair; 5%-38% traditional hearing aid cost) due to increased hearing aid uptake. Provision of OTC hearing aids was considered cost-effective (ICER<$100 000/QALY) if the OTC utility benefit was 0.06 or greater (55% of the traditional hearing aid effectiveness). In probabilistic uncertainty analysis, OTC hearing aid provision was cost-effective in 53% of simulations. Conclusions and Relevance: In this cost-effectiveness analysis, provision of OTC hearing aids was associated with greater uptake of hearing intervention and was cost-effective over a range of prices so long as OTC hearing aids were greater than 55% as beneficial to patient quality of life as traditional hearing aids.

Estimated Monetary Value of Future Research Clarifying Uncertainties Around the Optimal Adult Hearing Screening Schedule.

Importance: Adult hearing screening is not routinely performed, and most individuals with hearing loss (HL) have never had their hearing tested as adults. Objective: To project the monetary value of future research clarifying uncertainties around the optimal adult hearing screening schedule. Design, Setting, and Participants: In this economic evaluation, a validated decision model of HL (DeciBHAL-US: Decision model of the Burden of Hearing loss Across the Lifespan) was used to simulate current detection and treatment of HL vs hearing screening schedules. Key model inputs included HL incidence (0.06%-10.42%/y), hearing aid uptake (0.54%-8.14%/y), screening effectiveness (1.62 × hearing aid uptake), utility benefits of hearing aids (+0.11), and hearing aid device costs ($3690). Distributions to model parameters for probabilistic uncertainty analysis were assigned. The expected value of perfect information (EVPI) and expected value of partial perfect information (EVPPI) using a willingness to pay of $100 000 per quality-adjusted life-year (QALY) was estimated. The EVPI and EVPPI estimate the upper bound of the dollar value of future research. This study was based on 40-year-old persons over their remaining lifetimes in a US primary care setting. Exposures: Screening schedules beginning at ages 45, 55, 65, and 75 years, and frequencies of every 1 or 5 years. Main Outcomes and Measures: The main outcomes were QALYs and costs (2020 US dollars) from a health system perspective. Results: The average incremental cost-effectiveness ratio for yearly screening beginning at ages 55 to 75 years ranged from $39 200 to $80 200/QALY. Yearly screening beginning at age 55 years was the optimal screening schedule in 38% of probabilistic uncertainty analysis simulations. The population EVPI, or value of reducing all uncertainty, was $8.2 to $12.6 billion varying with willingness to pay and the EVPPI, or value of reducing all screening effectiveness uncertainty, was $2.4 billion. Conclusions and Relevance: In this economic evaluation of US adult hearing screening, large uncertainty around the optimal adult hearing screening schedule was identified. Future research on hearing screening has a high potential value so is likely justified.

Development and validation of DeciBHAL-US: A novel microsimulation model of hearing loss across the lifespan in the United States.

BACKGROUND: Hearing loss affects over 50% of people in the US across their lifespan and there is a lack of decision modeling frameworks to inform optimal hearing healthcare delivery. Our objective was to develop and validate a microsimulation model of hearing loss across the lifespan in the US. METHODS: We collaborated with the Lancet Commission on Hearing Loss to outline model structure, identify input data sources, and calibrate/validate DeciBHAL-US (Decision model of the Burden of Hearing loss Across the Lifespan). We populated the model with literature-based estimates and validated the conceptual model with key informants. We validated key model endpoints to the published literature, including: 1) natural history of sensorineural hearing loss (SNHL), 2) natural history of conductive hearing loss (CHL), and 3) the hearing loss cascade of care. We reported the coefficient of variance root mean square error (CV-RMSE), considering values ≤15% to indicate adequate fit. FINDINGS: For SNHL prevalence, the CV-RMSE for model projected male and female age-specific prevalence compared to sex-adjusted National Health and Nutrition Examination Survey (NHANES) data was 4.9 and 5.7%, respectively. Incorporating literature-based age-related decline in SNHL, we validated mean four-frequency average hearing loss in the better ear (dB) among all persons to longitudinal data (CV-RMSE=11.3%). We validated the age-stratified prevalence of CHL to adjusted NHANES data (CV-RMSE=10.9%). We incorporated age- and severity-stratified time to first hearing aid (HA) use data and HA discontinuation data (adjusted for time-period of use) and validated to NHANES estimates on the prevalence of adult HA use (CV-RMSE=10.3%). INTERPRETATION: Our results indicate adequate model fit to internal and external validation data. Future incorporation of cost and severity-stratified utility data will allow for cost-effectiveness analysis of US hearing healthcare interventions across the lifespan. Further research might expand the modeling framework to international settings. FUNDING: This study was funded by the National Institute on Deafness and Other Communication Disorders and the National Institute on Aging (3UL1-TR002553-03S3 and F30 DC019846).

Validation of the Decision model of the Burden of Hearing loss Across the Lifespan (DeciBHAL) in Chile, India, and Nigeria.

Background: There is no published decision model for informing hearing health care resource allocation across the lifespan in low- and middle-income countries. We sought to validate the Decision model of the Burden of Hearing loss Across the Lifespan International (DeciBHAL-I) in Chile, India, and Nigeria. Methods: DeciBHAL-I simulates bilateral sensorineural hearing loss (SNHL) and conductive hearing loss (CHL) acquisition, SNHL progression, and hearing loss treatment. To inform model inputs, we identified setting-specific estimates including SNHL prevalence from the Global Burden of Disease (GBD) studies, acute otitis media (AOM) incidence and prevalence of otitis-media related CHL from a systematic review, and setting-specific pediatric and adult hearing aid use prevalence. We considered a coefficient of variance root mean square error (CV-RMSE) of ≤15% to indicate good model fit. Findings: The model-estimated prevalence of bilateral SNHL closely matched GBD estimates, (CV-RMSEs: 3.2-7.4%). Age-specific AOM incidences from DeciBHAL-I also achieved good fit (CV-RMSEs=5.0-7.5%). Model-projected chronic suppurative otitis media prevalence (1.5% in Chile, 4.9% in India, and 3.4% in Nigeria) was consistent with setting-specific estimates, and the incidence of otitis media-related CHL was calibrated to attain adequate model fit. DeciBHAL-projected adult hearing aid use in Chile (3.2-19.7% ages 65-85 years) was within the 95% confidence intervals of published estimates. Adult hearing aid prevalence from the model in India was 1.4-2.3%, and 1.1-1.3% in Nigeria, consistent with literature-based and expert estimates. Interpretation: DeciBHAL-I reasonably simulates hearing loss natural history, detection, and treatment in Chile, India, and Nigeria. Future cost-effectiveness analyses might use DeciBHAL-I to inform global hearing health policy. Funding: National Institutes of Health (3UL1-TR002553-03S3 and F30 DC019846).