Current practice patterns and gaps in guideline-concordant breast cancer survivorship care.

PURPOSE: Breast cancer-specific survivorship care guidelines for the more than 3.8 million survivors in the U.S. are available, but implementation in clinical practice remains challenging. We examined current practice patterns and factors associated with guideline-concordant survivorship care among oncologists. METHODS: A national sample of medical oncologists, recruited using two databases, participated in a survey focused on practice patterns for breast cancer survivorship care. A "survivorship care composite score" was calculated for each respondent based on provision of services recommended in the survivorship guidelines. Descriptive statistics and multivariable linear regression analyses examined associations between physician and practice characteristics and composite scores. RESULTS: The survey was completed by 217 medical oncologists, with an overall response rate of 17.9% and eligibility rate of 56.9% for those who responded. Oncologists reported high engagement in evaluation of disease recurrence (78%). Performed less frequently were the provision of survivorship care plans (46%), assessment of psychosocial long-term and late effects (34%), and screening for subsequent cancers (34%). Lack of survivorship care training (p = 0.038) and not routinely informing patients about potential late effects (p = 0.003) were significantly associated with poorer survivorship care composite scores. CONCLUSIONS: Despite the availability of disease-specific survivorship care guidelines, adherence to their recommendations in clinical practice is suboptimal. Survey results identified key gaps in survivorship care for breast cancer survivors, particularly related to subsequent primary cancers and psychosocial long-term and late effects. IMPLICATIONS FOR CANCER SURVIVORS: Improving the delivery of comprehensive survivorship care for the growing population of breast cancer survivors is a high priority. Disease-specific clinical guidelines for cancer survivorship provide valuable recommendations, but innovative strategies are needed to integrate them into the care of long-term breast cancer survivors.

Nursing home staff networks and COVID-19.

Nursing homes and other long-term care facilities account for a disproportionate share of COVID-19 cases and fatalities worldwide. Outbreaks in US nursing homes have persisted despite nationwide visitor restrictions beginning in mid-March. An early report issued by the Centers for Disease Control and Prevention identified staff members working in multiple nursing homes as a likely source of spread from the Life Care Center in Kirkland, WA, to other skilled nursing facilities. The full extent of staff connections between nursing homes-and the role these connections serve in spreading a highly contagious respiratory infection-is currently unknown given the lack of centralized data on cross-facility employment. We perform a large-scale analysis of nursing home connections via shared staff and contractors using device-level geolocation data from 50 million smartphones, and find that 5.1% of smartphone users who visited a nursing home for at least 1 h also visited another facility during our 11-wk study period-even after visitor restrictions were imposed. We construct network measures of connectedness and estimate that nursing homes, on average, share connections with 7.1 other facilities. Traditional federal regulatory metrics of nursing home quality are unimportant in predicting outbreaks, consistent with recent research. Controlling for demographic and other factors, a home's staff network connections and its centrality within the greater network strongly predict COVID-19 cases.

Political storms: Emergent partisan skepticism of hurricane risks.

Mistrust of scientific evidence and government-issued guidelines is increasingly correlated with political affiliation. Survey evidence has documented skepticism in a diverse set of issues including climate change, vaccine hesitancy, and, most recently, COVID-19 risks. Less well understood is whether these beliefs alter high-stakes behavior. Combining GPS data for 2.7 million smartphone users in Florida and Texas with 2016 U.S. presidential election precinct-level results, we examine how conservative-media dismissals of hurricane advisories in 2017 influenced evacuation decisions. Likely Trump-voting Florida residents were 10 to 11 percentage points less likely to evacuate Hurricane Irma than Clinton voters (34% versus 45%), a gap not present in prior hurricanes. Results are robust to fine-grain geographic controls, which compare likely Clinton and Trump voters living within 150 m of each other. The rapid surge in media-led suspicion of hurricane forecasts-and the resulting divide in self-protective measures-illustrates a large behavioral consequence of science denialism.

Cost-effectiveness analysis of palbociclib or ribociclib in the treatment of advanced hormone receptor-positive, HER2-negative breast cancer.

PURPOSE: Three CDK4/6 inhibitors, palbociclib (PAL), ribociclib (RIB), and abemaciclib, when combined with letrozole (LET), have been approved as first-line therapy for postmenopausal women with metastatic HR+, HER2- breast cancer. However, an economic evaluation of these newer therapies is currently lacking. The purpose of this article is to evaluate the cost-effectiveness of PAL or RIB for the treatment of advanced HR+, HER2- breast cancer in the United States. METHODS: A Markov simulation model was constructed using data from published clinical trials evaluating PAL and RIB. Three simulated treatment strategies included PAL + LET, RIB + LET, or LET alone. The main outcome measures were simulated progression-free survival (PFS), overall survival (OS), costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). RESULTS: Simulated median OS was 38.9 months for PAL + LET and 33.0 months for LET alone. Simulated median OS for RIB + LET was 43.3 months. Compared to LET alone, PAL + LET provided an additional 0.48 QALYs, on average, with an ICER of $634,000 per QALY gained; RIB + LET provided an additional 0.86 QALYs, on average, with an ICER of $440,000 per QALY gained. At current prices, neither PAL nor RIB was cost-effective, assuming a willingness-to-pay threshold of $100,000 per QALY gained. To reach such a cost-effectiveness threshold, PAL and RIB prices must decrease by approximately 70%. CONCLUSION: Despite significant gains in progression-free survival over letrozole alone, the addition of palbociclib or ribociclib in the treatment of advanced HR+, HER2- breast cancer is not cost-effective in the United States given current drug prices.

Communicating Risks of Adjuvant Chemotherapy for Breast Cancer: Getting Beyond the Laundry List.

PURPOSE: According to the Institute of Medicine, high-quality cancer care should include effective communication between clinicians and patients about the risks and benefits, expected response, and impact on quality of life of a recommended therapy. In the delivery of oncology care, the barriers to and facilitators of communication about potential long-term and late effects, post-treatment expectations, and transition to survivorship care have not been fully defined. PATIENTS AND METHODS: We collected qualitative data through semistructured interviews with medical oncologists and focus groups with breast cancer survivors and applied the Theoretical Domains Framework to systematically analyze and identify the factors that may influence oncologists' communication with patients with breast cancer about the long-term and late effects of adjuvant therapy. RESULTS: Eight key informant interviews with medical oncologists and two focus groups with breast cancer survivors provided data. Both oncologists and patients perceived information on long-term effects as valuable in terms of improved clinical communication but had concerns about the feasibility of inclusion before treatment. They described the current approaches to communication of therapy risks as a brief laundry list that emphasized acute adverse effects and minimized more long-term issues. We describe the barriers to communication about potential long-term effects from the perspectives of both groups. CONCLUSION: This study provides insight into oncologists' communication with patients with breast cancer regarding the potential long-term and late effects of adjuvant chemotherapy and about setting realistic expectations for life after treatment. Opportunities to improve oncologists' communication about the potential toxicities of therapy, particularly regarding long-term and late effects, should be examined further.

The Boarding Patient: Effects of ICU and Hospital Occupancy Surges on Patient Flow.

Patients admitted to a hospital's intensive care unit (ICU) often endure prolonged boarding within the ICU following receipt of care, unnecessarily occupying a critical care bed, and thereby delaying admission for other incoming patients due to bed shortage. Using patient-level data over two years at two major academic medical centers, we estimate the impact of ICU and ward occupancy levels on ICU length of stay (LOS), and test whether simultaneous "surge occupancy" in both areas impacts overall ICU length of stay. In contrast to prior studies that only measure total LOS, we split LOS into two individual periods based on physician requests for bed transfers. We find that "service time" (when critically ill patients are stabilized and treated) is unaffected by occupancy levels. However, the less essential "boarding time" (when patients wait to exit the ICU) is accelerated during periods of high ICU occupancy and, conversely, prolonged when hospital ward occupancy levels are high. When the ICU and wards simultaneously encounter bed occupancies in the top quartile of historical levels-which occurs 5% of the time-ICU boarding increases by 22% compared to when both areas experience their lowest utilization, suggesting that ward bed availability dominates efforts to accelerate ICU discharges to free up ICU beds. We find no adverse effects of high occupancy levels on ICU bouncebacks, in-hospital deaths, or 30-day hospital readmissions, which supports our finding that the largely discretionary boarding period fluctuates with changing bed occupancy levels.

Integrating Community-Based Interventions to Reverse the Convergent TB/HIV Epidemics in Rural South Africa.

The WHO recommends integrating interventions to address the devastating TB/HIV co-epidemics in South Africa, yet integration has been poorly implemented and TB/HIV control efforts need strengthening. Identifying infected individuals is particularly difficult in rural settings. We used mathematical modeling to predict the impact of community-based, integrated TB/HIV case finding and additional control strategies on South Africa's TB/HIV epidemics. We developed a model incorporating TB and HIV transmission to evaluate the effectiveness of integrating TB and HIV interventions in rural South Africa over 10 years. We modeled the impact of a novel screening program that integrates case finding for TB and HIV in the community, comparing it to status quo and recommended TB/HIV control strategies, including GeneXpert, MDR-TB treatment decentralization, improved first-line TB treatment cure rate, isoniazid preventive therapy, and expanded ART. Combining recommended interventions averted 27% of expected TB cases (95% CI 18-40%) 18% HIV (95% CI 13-24%), 60% MDR-TB (95% CI 34-83%), 69% XDR-TB (95% CI 34-90%), and 16% TB/HIV deaths (95% CI 12-29). Supplementing these interventions with annual community-based TB/HIV case finding averted a further 17% of TB cases (44% total; 95% CI 31-56%), 5% HIV (23% total; 95% CI 17-29%), 8% MDR-TB (68% total; 95% CI 40-88%), 4% XDR-TB (73% total; 95% CI 38-91%), and 8% TB/HIV deaths (24% total; 95% CI 16-39%). In addition to increasing screening frequency, we found that improving TB symptom questionnaire sensitivity, second-line TB treatment delays, default before initiating TB treatment or ART, and second-line TB drug efficacy were significantly associated with even greater reductions in TB and HIV cases. TB/HIV epidemics in South Africa were most effectively curtailed by simultaneously implementing interventions that integrated community-based TB/HIV control strategies and targeted drug-resistant TB. Strengthening existing TB and HIV treatment programs is needed to further reduce disease incidence.

Cost effectiveness of option B plus for prevention of mother-to-child transmission of HIV in resource-limited countries: evidence from Kumasi, Ghana.

BACKGROUND: Achieving the goal of eliminating mother-to-child HIV transmission (MTCT) necessitates increased access to antiretroviral therapy (ART) for HIV-infected pregnant women. Option B provides ART through pregnancy and breastfeeding, whereas Option B+ recommends continuous ART regardless of CD4 count, thus potentially reducing MTCT during future pregnancies. Our objective was to compare maternal and pediatric health outcomes and cost-effectiveness of Option B+ versus Option B in Ghana. METHODS: A decision-analytic model was developed to simulate HIV progression in mothers and transmission (in utero, during birth, or through breastfeeding) to current and all future children. Clinical parameters, including antenatal care access and fertility rates, were estimated from a retrospective review of 817 medical records at two hospitals in Ghana. Additional parameters were obtained from published literature. Modeled outcomes include HIV infections averted among newborn children, quality-adjusted life-years (QALYs), and cost-effectiveness ratios. RESULTS: HIV-infected women in Ghana have a lifetime average of 2.3 children (SD 1.3). Projected maternal life expectancy under Option B+ is 16.1 years, versus 16.0 years with Option B, yielding a gain of 0.1 maternal QALYs and 3.2 additional QALYs per child. Despite higher initial ART costs, Option B+ costs $785/QALY gained, a value considered very cost-effective by World Health Organization benchmarks. Widespread implementation of Option B+ in Ghana could theoretically prevent up to 668 HIV infections among children annually. Cost-effectiveness estimates remained favorable over robust sensitivity analyses. CONCLUSIONS: Although more expensive than Option B, Option B+ substantially reduces MTCT in future pregnancies, increases both maternal and pediatric QALYs, and is a cost-effective use of limited resources in Ghana.

A Conceptual Framework for Improving Critical Care Patient Flow and Bed Use.

RATIONALE: High demand for intensive care unit (ICU) services and limited bed availability have prompted hospitals to address capacity planning challenges. Simulation modeling can examine ICU bed assignment policies, accounting for patient acuity, to reduce ICU admission delays. OBJECTIVES: To provide a framework for data-driven modeling of ICU patient flow, identify key measurable outcomes, and present illustrative analysis demonstrating the impact of various bed allocation scenarios on outcomes. METHODS: A description of key inputs for constructing a queuing model was outlined, and an illustrative simulation model was developed to reflect current triage protocol within the medical ICU and step-down unit (SDU) at a single tertiary-care hospital. Patient acuity, arrival rate, and unit length of stay, consisting of a "service time" and "time to transfer," were estimated from 12 months of retrospective data (n = 2,710 adult patients) for 36 ICU and 15 SDU staffed beds. Patient priority was based on acuity and whether the patient originated in the emergency department. The model simulated the following hypothetical scenarios: (1) varied ICU/SDU sizes, (2) reserved ICU beds as a triage strategy, (3) lower targets for time to transfer out of the ICU, and (4) ICU expansion by up to four beds. Outcomes included ICU admission wait times and unit occupancy. MEASUREMENTS AND MAIN RESULTS: With current bed allocation, simulated wait time averaged 1.13 (SD, 1.39) hours. Reallocating all SDU beds as ICU decreased overall wait times by 7.2% to 1.06 (SD, 1.39) hours and increased bed occupancy from 80 to 84%. Reserving the last available bed for acute patients reduced wait times for acute patients from 0.84 (SD, 1.12) to 0.31 (SD, 0.30) hours, but tripled subacute patients' wait times from 1.39 (SD, 1.81) to 4.27 (SD, 5.44) hours. Setting transfer times to wards for all ICU/SDU patients to 1 hour decreased wait times for incoming ICU patients, comparable to building one to two additional ICU beds. CONCLUSIONS: Hospital queuing and simulation modeling with empiric data inputs can evaluate how changes in ICU bed assignment could impact unit occupancy levels and patient wait times. Trade-offs associated with dedicating resources for acute patients versus expanding capacity for all patients can be examined.

Cost-effectiveness analysis of brief and expanded evidence-based risk reduction interventions for HIV-infected people who inject drugs in the United States.

AIMS: Two behavioral HIV prevention interventions for people who inject drugs (PWID) infected with HIV include the Holistic Health Recovery Program for HIV+ (HHRP+), a comprehensive evidence-based CDC-supported program, and an abbreviated Holistic Health for HIV (3H+) Program, an adapted HHRP+ version in treatment settings. We compared the projected health benefits and cost-effectiveness of both programs, in addition to opioid substitution therapy (OST), to the status quo in the U.S. METHODS: A dynamic HIV transmission model calibrated to epidemic data of current US populations was created. Projected outcomes include future HIV incidence, HIV prevalence, and quality-adjusted life years (QALYs) gained under alternative strategies. Total medical costs were estimated to compare the cost-effectiveness of each strategy. RESULTS: Over 10 years, expanding HHRP+ access to 80% of PWID could avert up to 29,000 HIV infections, or 6% of the projected total, at a cost of $7,777/QALY gained. Alternatively, 3H+ could avert 19,000 infections, but is slightly more cost-effective ($7,707/QALY), and remains so under widely varying effectiveness and cost assumptions. Nearly two-thirds of infections averted with either program are among non-PWIDs, due to reduced sexual transmission from PWID to their partners. Expanding these programs with broader OST coverage could avert up to 74,000 HIV infections over 10 years and reduce HIV prevalence from 16.5% to 14.1%, but is substantially more expensive than HHRP+ or 3H+ alone. CONCLUSIONS: Both behavioral interventions were effective and cost-effective at reducing HIV incidence among both PWID and the general adult population; however, 3H+, the economical HHRP+ version, was slightly more cost-effective than HHRP+.

Expanded HIV testing in low-prevalence, high-income countries: a cost-effectiveness analysis for the United Kingdom.

OBJECTIVE: In many high-income countries with low HIV prevalence, significant numbers of persons living with HIV (PLHIV) remain undiagnosed. Identification of PLHIV via HIV testing offers timely access to lifesaving antiretroviral therapy (ART) and decreases HIV transmission. We estimated the effectiveness and cost-effectiveness of HIV testing in the United Kingdom (UK), where 25% of PLHIV are estimated to be undiagnosed. DESIGN: We developed a dynamic compartmental model to analyze strategies to expand HIV testing and treatment in the UK, with particular focus on men who have sex with men (MSM), people who inject drugs (PWID), and individuals from HIV-endemic countries. METHODS: We estimated HIV prevalence, incidence, quality-adjusted life years (QALYs), and health care costs over 10 years, and cost-effectiveness. RESULTS: Annual HIV testing of all adults could avert 5% of new infections, even with no behavior change following HIV diagnosis because of earlier ART initiation, or up to 18% if risky behavior is halved. This strategy costs £67,000-£106,000/QALY gained. Providing annual testing only to MSM, PWID, and people from HIV-endemic countries, and one-time testing for all other adults, prevents 4-15% of infections, requires one-fourth as many tests to diagnose each PLHIV, and costs £17,500/QALY gained. Augmenting this program with increased ART access could add 145,000 QALYs to the population over 10 years, at £26,800/QALY gained. CONCLUSIONS: Annual HIV testing of key populations in the UK is very cost-effective. Additional one-time testing of all other adults could identify the majority of undiagnosed PLHIV. These findings are potentially relevant to other low-prevalence, high-income countries.

Comparative survival and cost-effectiveness of advanced therapies for end-stage heart failure.

BACKGROUND: Treatment options for end-stage heart failure include inotrope-dependent medical therapy, orthotopic heart transplantation (OHT), left ventricular assist device (LVAD) as destination therapy or bridge to transplant. METHODS AND RESULTS: We developed a state-transition model to simulate 4 treatment options and associated morbidity and mortality. Transition probabilities, costs, and utilities were estimated from published sources. Calculated outcomes included survival, quality-adjusted life-years, and incremental cost-effectiveness. Sensitivity analyses were performed on model parameters to test robustness. Average life expectancy for OHT-eligible patients is estimated at 1.1 years, with 39% surviving to 1 year. OHT with a median wait time of 5.6 months is estimated to increase life expectancy to 8.5 years, and costs <$100,000/quality-adjusted life-year gained, relative to inotrope-dependent medical therapy. Bridge to transplant-LVAD followed by OHT further is estimated to increase life expectancy to 12.3 years, for $226,000/quality-adjusted life-year gained versus OHT. Among OHT-ineligible patients, mean life expectancy with inotrope-dependent medical therapy is estimated at 9.4 months, with 26% surviving to 1 year. Patients who instead received destination therapy-LVAD are estimated to live 4.4 years on average from extrapolation of recent constant hazard rates beyond the first year. This strategy costs $202,000/quality-adjusted life-year gained, relative to inotrope-dependent medical therapy. Patient's age, time on wait list, and costs associated with care influence outcomes. CONCLUSIONS: Under most scenarios, OHT prolongs life and is cost effective in eligible patients. Bridge to transplant-LVAD is estimated to offer >3.8 additional life-years for patients waiting ≥6 months, but does not meet conventional cost-effectiveness thresholds. Destination therapy-LVAD significantly improves life expectancy in OHT-ineligible patients. However, further reductions in adverse events or improved quality of life are needed for destination therapy-LVAD to be cost effective.

HIV epidemic control-a model for optimal allocation of prevention and treatment resources.

With 33 million people living with human immunodeficiency virus (HIV) worldwide and 2.7 million new infections occurring annually, additional HIV prevention and treatment efforts are urgently needed. However, available resources for HIV control are limited and must be used efficiently to minimize the future spread of the epidemic. We develop a model to determine the appropriate resource allocation between expanded HIV prevention and treatment services. We create an epidemic model that incorporates multiple key populations with different transmission modes, as well as production functions that relate investment in prevention and treatment programs to changes in transmission and treatment rates. The goal is to allocate resources to minimize R 0, the reproductive rate of infection. We first develop a single-population model and determine the optimal resource allocation between HIV prevention and treatment. We extend the analysis to multiple independent populations, with resource allocation among interventions and populations. We then include the effects of HIV transmission between key populations. We apply our model to examine HIV epidemic control in two different settings, Uganda and Russia. As part of these applications, we develop a novel approach for estimating empirical HIV program production functions. Our study provides insights into the important question of resource allocation for a country's optimal response to its HIV epidemic and provides a practical approach for decision makers. Better decisions about allocating limited HIV resources can improve response to the epidemic and increase access to HIV prevention and treatment services for millions of people worldwide.

Portfolios of biomedical HIV interventions in South Africa: a cost-effectiveness analysis.

BACKGROUND: Recent clinical trials of male circumcision, oral pre-exposure prophylaxis (PrEP), and a vaginal microbicide gel have shown partial effectiveness at reducing HIV transmission, stimulating interest in implementing portfolios of biomedical prevention programs. OBJECTIVE: To evaluate the effectiveness and cost-effectiveness of combination biomedical HIV prevention and treatment scale-up in South Africa, given uncertainty in program effectiveness. DESIGN: Dynamic HIV transmission and disease progression model with Monte Carlo simulation and cost-effectiveness analysis. PARTICIPANTS: Men and women aged 15 to 49 years in South Africa. INTERVENTIONS: HIV screening and counseling, antiretroviral therapy (ART), male circumcision, PrEP, microbicide, and select combinations. MAIN MEASURES: HIV incidence, prevalence, discounted costs, discounted quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios. KEY RESULTS: Providing half of all uninfected persons with PrEP averts 28 % of future HIV infections for $9,000/QALY gained, but the affordability of such a program is questionable. Given limited resources, annual HIV screening and ART utilization by 75 % of eligible infected persons could avert one-third of new HIV infections, for approximately $1,000/QALY gained. Male circumcision is more cost-effective, but disproportionately benefits men. A comprehensive portfolio of expanded screening, ART, male circumcision, microbicides, and PrEP could avert 62 % of new HIV infections, reducing HIV prevalence from a projected 14 % to 10 % after 10 years. This strategy doubles treatment initiation and adds 31 million QALYs to the population. Despite uncertainty in program effectiveness, a comprehensive portfolio costs less than $10,000/QALY gained in 33 % of simulation iterations and less than $30,000/QALY gained in 90 % of iterations, assuming an annual microbicide cost of $100. CONCLUSIONS: A portfolio of modestly-effective biomedical HIV prevention programs, including male circumcision, vaginal microbicides, and oral PrEP, could substantially reduce HIV incidence and prevalence in South Africa and be likely cost-effective. Given limited resources, PrEP is the least cost-effective intervention of those considered.

HIV treatment as prevention: systematic comparison of mathematical models of the potential impact of antiretroviral therapy on HIV incidence in South Africa.

BACKGROUND: Many mathematical models have investigated the impact of expanding access to antiretroviral therapy (ART) on new HIV infections. Comparing results and conclusions across models is challenging because models have addressed slightly different questions and have reported different outcome metrics. This study compares the predictions of several mathematical models simulating the same ART intervention programmes to determine the extent to which models agree about the epidemiological impact of expanded ART. METHODS AND FINDINGS: Twelve independent mathematical models evaluated a set of standardised ART intervention scenarios in South Africa and reported a common set of outputs. Intervention scenarios systematically varied the CD4 count threshold for treatment eligibility, access to treatment, and programme retention. For a scenario in which 80% of HIV-infected individuals start treatment on average 1 y after their CD4 count drops below 350 cells/µl and 85% remain on treatment after 3 y, the models projected that HIV incidence would be 35% to 54% lower 8 y after the introduction of ART, compared to a counterfactual scenario in which there is no ART. More variation existed in the estimated long-term (38 y) reductions in incidence. The impact of optimistic interventions including immediate ART initiation varied widely across models, maintaining substantial uncertainty about the theoretical prospect for elimination of HIV from the population using ART alone over the next four decades. The number of person-years of ART per infection averted over 8 y ranged between 5.8 and 18.7. Considering the actual scale-up of ART in South Africa, seven models estimated that current HIV incidence is 17% to 32% lower than it would have been in the absence of ART. Differences between model assumptions about CD4 decline and HIV transmissibility over the course of infection explained only a modest amount of the variation in model results. CONCLUSIONS: Mathematical models evaluating the impact of ART vary substantially in structure, complexity, and parameter choices, but all suggest that ART, at high levels of access and with high adherence, has the potential to substantially reduce new HIV infections. There was broad agreement regarding the short-term epidemiologic impact of ambitious treatment scale-up, but more variation in longer term projections and in the efficiency with which treatment can reduce new infections. Differences between model predictions could not be explained by differences in model structure or parameterization that were hypothesized to affect intervention impact.

HIV screening via fourth-generation immunoassay or nucleic acid amplification test in the United States: a cost-effectiveness analysis.

BACKGROUND: At least 10% of the 56,000 annual new HIV infections in the United States are caused by individuals with acute HIV infection (AHI). It unknown whether the health benefits and costs of routine nucleic acid amplification testing (NAAT) are justified, given the availability of newer fourth-generation immunoassay tests. METHODS: Using a dynamic HIV transmission model instantiated with U.S. epidemiologic, demographic, and behavioral data, I estimated the number of acute infections identified, HIV infections prevented, quality-adjusted life years (QALYs) gained, and the cost-effectiveness of alternative screening strategies. I varied the target population (everyone aged 15-64, injection drug users [IDUs] and men who have sex with men [MSM], or MSM only), screening frequency (annually, or every six months), and test(s) utilized (fourth-generation immunoassay only, or immunoassay followed by pooled NAAT). RESULTS: Annual immunoassay testing of MSM reduces incidence by 9.5% and costs <$10,000 per QALY gained. Adding pooled NAAT identifies 410 AHI per year, prevents 9.6% of new cases, costs $92,000 per QALY gained, and remains <$100,000 per QALY gained in settings where undiagnosed HIV prevalence exceeds 4%. Screening IDUs and MSM annually with fourth-generation immunoassay reduces incidence by 13% with cost-effectiveness <$10,000 per QALY gained. Increasing the screening frequency to every six months reduces incidence by 11% (MSM only) or 16% (MSM and IDUs) and costs <$20,000 per QALY gained. CONCLUSIONS: Pooled NAAT testing every 12 months of MSM and IDUs in the United States prevents a modest number of infections, but may be cost-effective given sufficiently high HIV prevalence levels. However, testing via fourth-generation immunoassay every six months prevents a greater number of infections, is more economically efficient, and may obviate the benefits of acute HIV screening via NAAT.

The cost-effectiveness of symptom-based testing and routine screening for acute HIV infection in men who have sex with men in the USA.

OBJECTIVE: Acute HIV infection often causes influenza-like illness (ILI) and is associated with high infectivity. We estimated the effectiveness and cost-effectiveness of strategies to identify and treat acute HIV infection in men who have sex with men (MSM) in the USA. DESIGN: Dynamic model of HIV transmission and progression. INTERVENTIONS: We evaluated three testing approaches: viral load testing for individuals with ILI, expanded screening with antibody testing, and expanded screening with antibody and viral load testing. We included treatment with antiretroviral therapy for individuals identified as acutely infected. MAIN OUTCOME MEASURES: New HIV infections, discounted quality-adjusted life years (QALYs) and costs, and incremental cost-effectiveness ratios. RESULTS: At the present rate of HIV-antibody testing, we estimated that 538,000 new infections will occur among MSM over the next 20 years. Expanding antibody screening coverage to 90% of MSM annually reduces new infections by 2.8% and costs US$ 12,582 per QALY gained. Symptom-based viral load testing with ILI is more expensive than expanded antibody screening, but is more effective and costs US$ 22,786 per QALY gained. Combining expanded antibody screening with symptom-based viral load testing prevents twice as many infections compared to expanded antibody screening alone, and costs US$ 29,923 per QALY gained. Adding viral load testing to all annual HIV tests costs more than US$ 100,000 per QALY gained. CONCLUSION: Use of HIV viral load testing in MSM with ILI prevents more infections than does expanded annual antibody screening alone and is inexpensive relative to other screening interventions. Clinicians should consider symptom-based viral load testing in MSM, in addition to encouraging annual antibody screening.

The cost-effectiveness of a modestly effective HIV vaccine in the United States.

BACKGROUND: The recent RV144 clinical trial showed that an ALVAC/AIDSVAX prime-boost HIV vaccine regimen may confer partial immunity in recipients and reduce transmission by 31%. Trial data suggest that efficacy may initially exceed 70% but decline over the following 3.5 years. Estimating the potential health benefits associated with a one-time vaccination campaign, as well as the projected benefits of repeat booster vaccination, may inform future HIV vaccine research and licensing decisions. METHODS: We developed a mathematical model to project the future course of the HIV epidemic in the United States under varying HIV vaccine scenarios. The model accounts for disease progression, infection transmission, antiretroviral therapy, and HIV-related morbidity and mortality. We projected HIV prevalence and incidence over time in multiple risk groups, and we estimated quality-adjusted life years (QALYs) and costs over a 10-year time horizon. We assumed an exponentially declining efficacy curve fit to trial data, and that subsequent vaccine boosters confer similar immunity. Variations in vaccine parameters were examined in sensitivity analysis. RESULTS: Under existing HIV prevention and treatment efforts, an estimated 590,000 HIV infections occur over 10 years. One-time vaccination achieving 60% coverage of adults could prevent 9.8% of projected new infections over 10 years (and prevent 34% of new infections in the first year) and cost approximately $91,000/QALY gained relative to the status quo, assuming $500 per vaccination series. Targeted vaccination strategies result in net cost savings for vaccines costing less than $750. One-time vaccination of 60% of all adults coupled with three-year boosters only for men who have sex with men and people who inject drugs could prevent 21% of infections for $81,000/QALY gained relative to vaccination of higher risk sub-populations only. A program attaining 90% vaccination coverage prevents 15% of new HIV cases over 10 years (and approximately 50% of infections in the first year). CONCLUSIONS: A partially effective HIV vaccine with effectiveness similar to that observed in the RV144 trial would provide large health benefits in the United States and could meet conventionally accepted cost-effectiveness thresholds. Strategies that prioritize key populations are most efficient, but broader strategies provide greater total population health benefit.

Cost-effectiveness of elective induction of labor at 41 weeks in nulliparous women.

OBJECTIVE: To investigate the cost-effectiveness of elective induction of labor at 41 weeks in nulliparous women. STUDY DESIGN: A decision analytic model comparing induction of labor at 41 weeks vs expectant management with antenatal testing until 42 weeks in nulliparas was designed. Baseline assumptions were derived from the literature as well as from analysis of the National Birth Cohort dataset and included an intrauterine fetal demise rate of 0.12% in the 41st week and a cesarean rate of 27% in women induced at 41 weeks. One-way and multiway sensitivity analyses were conducted to examine the robustness of the findings. RESULTS: Compared with expectant management, induction of labor is cost-effective with an incremental cost of $10,945 per quality-adjusted life year gained. Induction of labor at 41 weeks also resulted in a lower rate of adverse obstetric outcomes, including neonatal demise, shoulder dystocia, meconium aspiration syndrome, and severe perineal lacerations. CONCLUSION: Elective induction of labor at 41 weeks is cost-effective and improves outcomes.