Empirical Development of a Behavioral Intervention for African American/Black and Latino Persons with Unsuppressed HIV Viral Load Levels: An Application of the Multiphase Optimization Strategy (MOST) Using Cost-Effectiveness as an Optimization Objective.

We used results from an optimization randomized controlled trial which tested five behavioral intervention components to support HIV antiretroviral adherence/HIV viral suppression, grounded in the multiphase optimization strategy and using a fractional factorial design to identify intervention components with cost-effectiveness sufficiently favorable for scalability. Results were incorporated into a validated HIV computer simulation to simulate longer-term effects of combinations of components on health and costs. We simulated the 32 corresponding long-term trajectories for viral load suppression, health related quality of life (HRQoL), and costs. The components were designed to be culturally and structurally salient. They were: motivational interviewing counseling sessions (MI), pre-adherence skill building (SB), peer mentorship (PM), focused support groups (SG), and patient navigation (short version [NS], long version [NL]. All participants also received health education on HIV treatment. We examined four scenarios: one-time intervention with and without discounting and continuous interventions with and without discounting. In all four scenarios, interventions that comprise or include SB and NL (and including health education) were cost effective (< $100,000/quality-adjusted life year). Further, with consideration of HRQoL impact, maximal intervention became cost-effective enough to be scalable. Thus, a fractional factorial experiment coupled with cost-effectiveness analysis is a promising approach to optimize multi-component interventions for scalability. The present study can guide service planning efforts for HIV care settings and health departments.

Reducing overdose deaths among persons with opioid use disorder in connecticut.

BACKGROUND: People in Connecticut are now more likely to die of a drug-related overdose than a traffic accident. While Connecticut has had some success in slowing the rise in overdose death rates, substantial additional progress is necessary. METHODS: We developed, verified, and calibrated a mechanistic simulation of alternative overdose prevention policy options, including scaling up naloxone (NLX) distribution in the community and medications for opioid use disorder (OUD) among people who are incarcerated (MOUD-INC) and in the community (MOUD-COM) in a simulated cohort of people with OUD in Connecticut. We estimated how maximally scaling up each option individually and in combinations would impact 5-year overdose deaths, life-years, and quality-adjusted life-years. All costs were assessed in 2021 USD, employing a health sector perspective in base-case analyses and a societal perspective in sensitivity analyses, using a 3% discount rate and 5-year and lifetime time horizons. RESULTS: Maximally scaling NLX alone reduces overdose deaths 20% in the next 5 years at a favorable incremental cost-effectiveness ratio (ICER); if injectable rather than intranasal NLX was distributed, 240 additional overdose deaths could be prevented. Maximally scaling MOUD-COM and MOUD-INC alone reduce overdose deaths by 14% and 6% respectively at favorable ICERS. Considering all permutations of scaling up policies, scaling NLX and MOUD-COM together is the cost-effective choice, reducing overdose deaths 32% at ICER $19,000/QALY. In sensitivity analyses using a societal perspective, all policy options were cost saving and overdose deaths reduced 33% over 5 years while saving society $338,000 per capita over the simulated cohort lifetime. CONCLUSIONS: Maximally scaling access to naloxone and MOUD in the community can reduce 5-year overdose deaths by 32% among people with OUD in Connecticut under realistic budget scenarios. If societal cost savings due to increased productivity and reduced crime costs are considered, one-third of overdose deaths can be reduced by maximally scaling all three policy options, while saving money.

The Influence of Patient Preference on Surgeons' Treatment Recommendations in the Management of Intraductal Papillary Mucinous Neoplasms.

OBJECTIVE: We aimed to determine whether surgeon variation in management of intraductal papillary mucinous neoplasms (IPMN) is driven by differences in risk perception and quantify surgeons' risk threshold for changing their recommendations. BACKGROUND: Surgeons vary widely in management of IPMN. METHODS: We conducted a survey of members of the Americas HepatoPancreatoBiliary Association, presented participants with 2 detailed clinical vignettes and asked them to choose between surgical resection and surveillance. We also asked them to judge the likelihood that the IPMN harbors cancer and that the patient would have a serious complication if surgery was performed. Finally, we asked surgeons to rate the level of cancer risk at which they would change their treatment recommendation. We examined the association between surgeons' treatment recommendations and their risk perception and risk threshold. RESULTS: One hundred and fifty surgeons participated in the study. Surgeons varied in their recommendations for surgery [19% for vignette 1 (V1) and 12% for V2] and in their perception of the cancer risk (interquartile range: 2%-10% for V1 and V2) and risk of surgical complications (V1 interquartile range: 10%-20%, V2 20%-30%). After adjusting for surgeon characteristics, surgeons who were above the median in cancer risk perception were 22 percentage points (27% vs. 5%) more likely to recommend resection than those who were below the median (95% CI: 11.34%; P <0.001). The median risk threshold at which surgeons would change their recommendation was 15% (V1 and V2). Surgeons who recommended surgery had a lower risk threshold for changing their recommendation than those who recommended surveillance (V1: 10.0 vs. 15.0, P =0.06; V2: 7.0 vs. 15.0, P =0.05). CONCLUSIONS: The treatment that patients receive for IPMNs depends greatly on how their surgeons perceive the risk of cancer in the lesion. Efforts to improve cancer risk prediction for IPMNs may lead to decreased variations in care.

Risk Perceptions and Risk Thresholds Among Surgeons in the Management of Intraductal Papillary Mucinous Neoplasms.

OBJECTIVES: We aimed to determine whether surgeon variation in management of intraductal papillary mucinous neoplasm (IPMN) is driven by differences in risk perception and quantify surgeons' risk threshold for changing their recommendations. BACKGROUND: Surgeons vary widely in management of IPMN. METHODS: We conducted a survey of members of the Americas HepatoPancreatoBiliary Association, presented participants with 2 detailed clinical vignettes and asked them to choose between surgical resection and surveillance. We also asked them to judge the likelihood that the IPMN harbors cancer and that the patient would have a serious complication if surgery was performed. Finally, we asked surgeons to rate the level of cancer risk at which they would change their treatment recommendation. We examined the association between surgeons' treatment recommendations and their risk perception and risk threshold. RESULTS: One hundred fifty surgeons participated in the study. Surgeons varied in their recommendations for surgery [19% for vignette 1 (V1) and 12% for V2] and in their perception of the cancer risk (interquartile range: 2%-10% for V1 and V2) and risk of surgical complications (V1 interquartile range: 10%-20%, V2 20-30%). After adjusting for surgeon characteristics, surgeons who were above the median in cancer risk perception were 22 percentage points (27% vs 5%) more likely to recommend resection than those who were below the median (95% CI: 11%-4%; P <0.001). The median risk threshold at which surgeons would change their recommendation was 15% (V1 and V2). Surgeons who recommended surgery had a lower risk threshold for changing their recommendation than those who recommended surveillance (V1: 10.0 vs 15.0, P =0.06; V2: 7.0 vs 15.0, P =0.05). CONCLUSIONS: The treatment that patients receive for IPMNs depends greatly on how their surgeons perceive the risk of cancer in the lesion. Efforts to improve cancer risk prediction for IPMNs may lead to decreased variations in care.

Sustaining PrEP Prescriptions at a Safety-Net Hospital in New York City During COVID-19: Lessons Learned.

To understand the impact of COVID-19-related disruptions on PrEP services, we reviewed PrEP prescriptions at NYC Health + Hospitals/Bellevue from July 2019 through July 2021. PrEP prescriptions were examined as PrEP person-equivalents (PrEP PE) in order to account for the variable time of refill duration (i.e., 1-3 months). To assess "PrEP coverage", we calculated PrEP medication possession ratios (MPR) while patients were under study observation. Pre-clinic closure, mean PrEP PE = 244.2 (IQR 189.2, 287.5; median = 252.5) were observed. Across levels of clinic closures, mean PrEP PE = 247.3, (IQR 215.5, 265.4; median = 219.9) during 100% clinic closure, 255.4 (IQR 224, 284.3; median = 249.0) during 80% closure, and 274.6 (IQR 273.0, 281.0; median = 277.2) during 50% closure were observed. Among patients continuously prescribed PrEP pre-COVID-19, the mean MPR mean declined from 83% (IQR 72-100%; median = 100%) to 63% (IQR 35-97%; median = 66%) after the onset of COVID-19. For patients newly initiated on PrEP after the onset of COVID-19, the mean MPR was 73% (IQR 41-100%; median = 100%). Our ability to sustain PrEP provisions, as measured by both PrEP PE and MPR, can likely be attributed to our pre-COVID-19 system for PrEP delivery, which emphasizes navigation, same-day initiation, and primary care integration. In the era of COVID-19 as well as future unforeseen healthcare disruptions, PrEP programs must be robust and flexible in order to sustain PrEP delivery.

How severe would prioritization-induced bottlenecks need to be offset the benefits from prioritizing COVID-19 vaccination to those most at risk in New York City?

BACKGROUND: Prioritization of higher-risk people for COVID-19 vaccination could prevent more deaths, but could slow vaccination speed. We used mathematical modeling to examine the trade-off between vaccination speed and prioritization for individuals age 65+ and essential workers. METHODS: We used a stochastic, discrete-time susceptible-exposed-infected-recovered (SEIR) model with age- and comorbidity-adjusted COVID-19 outcomes (infections, hospitalizations, and deaths). The model was calibrated to COVID-19 hospitalizations, ICU census, and deaths in NYC. We assumed 10,000 vaccinations per day, initially restricted to healthcare workers and nursing home populations, and subsequently expanded to other populations at alternative times (4, 5, or 6 weeks after vaccine launch) and speeds (20,000, 50,000, 100,000, or 150,000 vaccinations per day), as well as prioritization options (+/- prioritization of people age 65+ and essential workers). In sensitivity analyses, we examined the effect of a SARS-COV-2 variant with greater transmissibility. RESULTS: To be beneficial, prioritization must not create a bottleneck that decreases vaccination speed by > 50% without a more transmissible variant, or by > 33% with the emergence of the more transmissible variant. More specifically, prioritizing people age 65+ and essential workers increased the number of lives saved per vaccine dose delivered: 3000 deaths could be averted by delivering 83,000 vaccinations per day without prioritization or 50,000 vaccinations per day with prioritization. Other tradeoffs involve vaccination speed and timing. Compared to the slowest-examined vaccination speed of 20,000 vaccinations per day, achieving the fastest-examined vaccination speed of 150,000 vaccinations per day would avert additional 313,700 (28.6%) infections and 1693 (24.1%) deaths. Emergence of a more transmissible variant would double COVID-19 infections, hospitalizations, and deaths over the first 6 months of vaccination. The fastest-examined vaccination speed could only offset the harm of the more transmissible variant if achieved within 5 weeks of vaccine launch. CONCLUSIONS: Faster vaccination speed with sooner vaccination expansion would save more lives. Prioritization of COVID-19 vaccines to higher-risk populations would be more beneficial only if it does not create an excessive vaccine delivery bottleneck.

Real-Time Infectious Disease Modeling to Inform Emergency Public Health Decision Making.

Infectious disease transmission is a nonlinear process with complex, sometimes unintuitive dynamics. Modeling can transform information about a disease process and its parameters into quantitative projections that help decision makers compare public health response options. However, modelers face methodologic challenges, data challenges, and communication challenges, which are exacerbated under the time constraints of a public health emergency. We review methods, applications, challenges and opportunities for real-time infectious disease modeling during public health emergencies, with examples drawn from the two deadliest pandemics in recent history: HIV/AIDS and coronavirus disease 2019 (COVID-19).

Project ACTIVE: a Randomized Controlled Trial of Personalized and Patient-Centered Preventive Care in an Urban Safety-Net Setting.

BACKGROUND: Evidence-based preventive care in the USA is underutilized, diminishing population health and worsening health disparities. We developed Project ACTIVE, a program to improve adherence with preventive care goals through personalized and patient-centered care. OBJECTIVE: To determine whether Project ACTIVE improved utilization of preventive care and/or estimated life expectancy compared to usual care. DESIGN: Single-site randomized controlled trial. PARTICIPANTS: Cluster-randomized 140 English or Spanish speaking adult patients in primary care with at least one of twelve unfulfilled preventive care goals based on USPSTF grade A and B recommendations. INTERVENTION: Project ACTIVE employs a validated mathematical model to predict and rank individualized estimates of health benefit that would arise from improved adherence to different preventive care guidelines. Clinical staff engaged the participant in a shared medical decision-making (SMD) process to identify highest priority unfulfilled clinical goals, and health coaching staff engaged the participant to develop and monitor action steps to reach those goals. MAIN MEASURES: Change in number of unfulfilled preventive care goals from USPSTF grade A and B recommendations and change in overall gain in estimated life expectancy. KEY RESULTS: In an intent-to-treat analysis, Project ACTIVE increased the average number of fulfilled preventive care goals out of 12 by 0.68 in the intervention arm compared with 0.15 in the control arm (mean difference [95% CI] 0.53 [0.19-0.86]), yielding a gain in estimated life expectancy of 8.8 months (3.8, 14.2). In a per-protocol analysis, Project ACTIVE increased fulfilled preventive care goals by 0.80 in the intervention arm compared with 0.16 in the control arm (mean difference [95% CI], 0.65 [0.25-1.04]), yielding a gain in estimated life expectancy of 13.7 months (6.2, 21.2). Among the 12 preventive care goals, more improvement occurred for alcohol use, hypertension, hyperlipidemia, depression, and smoking. CONCLUSIONS: Project ACTIVE improved unfulfilled preventive care goals and improved estimated life expectancy. CLINICAL TRIAL REGISTRATION NUMBER: NCT04211883.

Integrating Screening and Treatment of Unhealthy Alcohol Use and Depression with Screening and Treatment of Anxiety, Pain, and Other Substance Use Among People with HIV and Other High-Risk Persons.

We review and synthesize results from a series of analyses estimating the benefit of screening for unhealthy alcohol use, depression, and tobacco to detect individuals at heightened risk for co-occurring anxiety, pain, depression, unhealthy alcohol use, and other substance use among people with HIV and HIV-uninfected individuals in the Veterans Aging Cohort Study. We also examine the potential impact of reducing unhealthy alcohol use and depressive symptoms on the incidence of co-occurring conditions. We found that screening for alcohol and depression may help identify co-occurring symptoms of anxiety, depression, and pain interference, treating unhealthy alcohol use may improve co-occurring pain interference and substance use, and improving depressive symptoms may improve co-occurring anxiety, pain interference, and smoking. We propose that an integrated approach to screening and treatment for unhealthy alcohol use, depression, anxiety, pain, and other substance use may facilitate diagnostic assessment and treatment of these conditions, improving morbidity and mortality.

Association of Syndemic Unhealthy Alcohol Use, Smoking, and Depressive Symptoms on Incident Cardiovascular Disease among Veterans With and Without HIV-Infection.

Unhealthy alcohol use, smoking, and depressive symptoms are risk factors for cardiovascular disease (CVD). Little is known about their co-occurrence - termed a syndemic, defined as the synergistic effect of two or more conditions-on CVD risk in people with HIV (PWH). We used data from 5621 CVD-free participants (51% PWH) in the Veteran's Aging Cohort Study-8, a prospective, observational study of veterans followed from 2002 to 2014 to assess the association between this syndemic and incident CVD by HIV status. Diagnostic codes identified cases of CVD (acute myocardial infarction, stroke, heart failure, peripheral artery disease, and coronary revascularization). Validated measures of alcohol use, smoking, and depressive symptoms were used. Baseline number of syndemic conditions was categorized (0, 1, ≥ 2 conditions). Multivariable Cox Proportional Hazards regressions estimated risk of the syndemic (≥ 2 conditions) on incident CVD by HIV-status. There were 1149 cases of incident CVD (52% PWH) during the follow-up (median 10.1 years). Of the total sample, 64% met our syndemic definition. The syndemic was associated with greater risk for incident CVD among PWH (Hazard Ratio [HR] 1.87 [1.47-2.38], p < 0.001) and HIV-negative veterans (HR 1.70 [1.35-2.13], p < 0.001), compared to HIV-negative with zero conditions. Among those with the syndemic, CVD risk was not statistically significantly higher among PWH vs. HIV-negative (HR 1.10 [0.89, 1.37], p = .38). Given the high prevalence of this syndemic combined with excess risk of CVD, these findings support linked-screening and treatment efforts.

Sustainable HIV treatment in Africa through viral-load-informed differentiated care.

There are inefficiencies in current approaches to monitoring patients on antiretroviral therapy in sub-Saharan Africa. Patients typically attend clinics every 1 to 3 months for clinical assessment. The clinic costs are comparable with the costs of the drugs themselves and CD4 counts are measured every 6 months, but patients are rarely switched to second-line therapies. To ensure sustainability of treatment programmes, a transition to more cost-effective delivery of antiretroviral therapy is needed. In contrast to the CD4 count, measurement of the level of HIV RNA in plasma (the viral load) provides a direct measure of the current treatment effect. Viral-load-informed differentiated care is a means of tailoring care so that those with suppressed viral load visit the clinic less frequently and attention is focussed on those with unsuppressed viral load to promote adherence and timely switching to a second-line regimen. The most feasible approach to measuring viral load in many countries is to collect dried blood spot samples for testing in regional laboratories; however, there have been concerns over the sensitivity and specificity of this approach to define treatment failure and the delay in returning results to the clinic. We use modelling to synthesize evidence and evaluate the cost-effectiveness of viral-load-informed differentiated care, accounting for limitations of dried blood sample testing. We find that viral-load-informed differentiated care using dried blood sample testing is cost-effective and is a recommended strategy for patient monitoring, although further empirical evidence as the approach is rolled out would be of value. We also explore the potential benefits of point-of-care viral load tests that may become available in the future.

Cost-effectiveness of Direct Antiviral Agents for Hepatitis C Virus Infection and a Combined Intervention of Syringe Access and Medication-assisted Therapy for Opioid Use Disorders in an Injection Drug Use Population.

BACKGROUND: There are too many plausible permutations and scale-up scenarios of combination hepatitis C virus (HCV) interventions for exhaustive testing in experimental trials. Therefore, we used a computer simulation to project the health and economic impacts of alternative combination intervention scenarios for people who inject drugs (PWID), focusing on direct antiviral agents (DAA) and medication-assisted treatment combined with syringe access programs (MAT+). METHODS: We performed an allocative efficiency study, using a mathematical model to simulate the progression of HCV in PWID and its related consequences. We combined 2 previously validated simulations to estimate the cost-effectiveness of intervention strategies that included a range of coverage levels. Analyses were performed from a health-sector and societal perspective, with a 15-year time horizon and a discount rate of 3%. RESULTS: From a health-sector perspective (excluding criminal justice system-related costs), 4 potential strategies fell on the cost-efficiency frontier. At 20% coverage, DAAs had an incremental cost-effectiveness ratio (ICER) of $27 251/quality-adjusted life-year (QALY). Combinations of DAA at 20% with MAT+ at 20%, 40%, and 80% coverage had ICERs of $165 985/QALY, $325 860/QALY, and $399 189/QALY, respectively. When analyzed from a societal perspective (including criminal justice system-related costs), DAA at 20% with MAT+ at 80% was the most effective intervention and was cost saving. While DAA at 20% with MAT+ at 80% was more expensive (eg, less cost saving) than MAT+ at 80% alone without DAA, it offered a favorable value compared to MAT+ at 80% alone ($23 932/QALY). CONCLUSIONS: When considering health-sector costs alone, DAA alone was the most cost-effective intervention. However, with criminal justice system-related costs, DAA and MAT+ implemented together became the most cost-effective intervention.

Personalized Treatment for Small Renal Tumors: Decision Analysis of Competing Causes of Mortality.

Purpose To compare the effectiveness of personalized treatment for small (≤4 cm) renal tumors versus routine partial nephrectomy (PN), accounting for various competing causes of mortality. Materials and Methods A state-transition microsimulation model was constructed to compare life expectancy of management strategies for small renal tumors by using 1 000 000 simulations in the following ways: routine PN or personalized treatment involving percutaneous ablation for risk factors for worsening chronic kidney disease (CKD), and otherwise PN; biopsy, with triage of renal cell carcinoma (RCC) to PN or ablation depending on risk factors for worsening CKD; active surveillance for growth; and active surveillance when MRI findings are indicative of papillary RCC. Transition probabilities were incorporated from the literature. Effects of parameter variability were assessed in sensitivity analysis. Results In patients of all ages with normal renal function, routine PN yielded the longest life expectancy (eg, 0.67 years in 65-year-old men with nephrometry score [NS] of 4). Otherwise, personalized strategies extended life expectancy versus routine PN: in CKD stages 2 or 3a, moderate or high NS, and no comorbidities, MRI guidance for active surveillance extended life expectancy (eg, 2.60 years for MRI vs PN in CKD 3a, NS 10); and with Charlson comorbidity index of 1 or more, biopsy or active surveillance for growth extended life expectancy (eg, 2.70 years for surveillance for growth in CKD 3a, NS 10). CKD 3b was most effectively managed by using MRI to help predict papillary RCC for surveillance. Conclusion For patients with chronic kidney disease and small renal tumors, personalized treatment selection likely extends life expectancy. © RSNA, 2019 Online supplemental material is available for this article.

Past year and prior incarceration and HIV transmission risk among HIV-positive men who have sex with men in the US.

Three quarters of new HIV infections in the US are among men who have sex with men (MSM). In other populations, incarceration is a social determinant of elevations in viral load and HIV-related substance use and sex risk behavior. There has been limited research on incarceration and these HIV transmission risk determinants in HIV-positive MSM. We used the Veterans Aging Cohort Study (VACS) 2011-2012 follow-up survey to measure associations between past year and prior (more than one year ago) incarceration and HIV viral load and substance use and sex risk behavior among HIV-positive MSM (N = 532). Approximately 40% had ever been incarcerated, including 9% in the past year. In analyses adjusting for sociodemographic factors, past year and prior incarceration were strongly associated with detectable viral load (HIV-1 RNA >500 copies/mL) (past year adjusted odds ratio (AOR): 3.50 95% confidence interval (CI): 1.59, 7.71; prior AOR: 2.48 95% CI: 1.44, 4.29) and past 12 month injection drug use (AORs > 6), multiple sex partnerships (AORs > 1.8), and condomless sex in the context of substance use (AORs > 3). Past year incarceration also was strongly associated with alcohol and non-injection drug use (AOR > 2.5). Less than one in five HIV-positive MSM recently released from incarceration took advantage of a jail/prison re-entry health care program available to veterans. We need to reach HIV-positive MSM leaving jails and prisons to improve linkage to care and clinical outcomes and reduce transmission risk upon release.

A Randomized Study of Patient Risk Perception for Incidental Renal Findings on Diagnostic Imaging Tests.

OBJECTIVE: The purpose of this study is to assess differences in patient distress, risk perception, and treatment preferences for incidental renal findings with descriptive versus combined descriptive and numeric graphical risk information. MATERIALS AND METHODS: A randomized survey study was conducted for adult patients about to undergo outpatient imaging studies at a large urban academic institution. Two survey arms contained either descriptive or a combination of descriptive and numeric graphical risk information about three hypothetical incidental renal findings at CT: 2-cm (low risk) and 5-cm (high risk) renal tumors and a 2-cm (low risk) renal artery aneurysm. The main outcomes were patient distress, perceived risk (qualitative and quantitative), treatment preference, and valuation of lesion discovery. RESULTS: Of 374 patients, 299 participated (79.9% response rate). With inclusion of numeric and graphical, rather than only descriptive, risk information about disease progression for a 2-cm renal tumor, patients reported less worry (3.56 vs 4.12 on a 5-point scale; p < 0.001) and favored surgical consultation less often (29.3% vs 46.9%; p = 0.003). The proportion choosing surgical consultation for the 2-cm renal tumor decreased to a similar level as for the renal artery aneurysm with numeric risk information (29.3% [95% CI, 21.7-36.8%] and 27.9% [95% CI, 20.5-35.3%], respectively). Patients overestimated the absolute risk of adverse events regardless of risk information type, but significantly more so when given descriptive information only, and valued the discovery of lesions regardless of risk information type (range, 4.41-4.81 on a 5-point scale). CONCLUSION: Numeric graphical risk communication for patients about incidental renal lesions may facilitate accurate risk comprehension and support patients in informed decision making.

Using value of information methods to determine the optimal sample size for effectiveness trials of alcohol interventions for HIV-infected patients in East Africa.

BACKGROUND: Unhealthy alcohol consumption exacerbates the HIV epidemic in East Africa. Potential benefits of new trials that test the effectiveness of alcohol interventions could not be evaluated by traditional sampling methods. Given the competition for health care resources in East Africa, this study aims to determine the optimal sample size given the opportunity cost of potentially re-allocating trial funds towards cost-effective alcohol treatments. METHODS: We used value of information methods to determine the optimal sample size by maximizing the expected net benefit of sampling for a hypothetical 2-arm intervention vs. control randomized trial, across ranges of policymaker's willingness-to-pay for the health benefit of an intervention. Probability distributions describing the relative likelihood of alternative trial results were imputed based on prior studies. In the base case, policymaker's willingness-to-pay was based on a simultaneously resource-constrained priority (routine HIV virological testing). Sensitivity analysis was performed for various willingness-to-pay thresholds and intervention durations. RESULTS: A new effectiveness trial accounting for the benefit of more precise decision-making on alcohol intervention implementation would benefit East Africa $67,000 with the optimal sample size of 100 persons per arm under the base case willingness-to-pay threshold and intervention duration of 20 years. At both a conservative willingness-to-pay of 1 x GDP/capita and a high willingness-to-pay of 3 x GDP/capita for an additional health gain added by an alcohol intervention, a new trial was not recommended due to limited decision uncertainty. When intervention duration was 10 or 5 years, there was no return on investment across suggested willingness-to-pay thresholds. CONCLUSIONS: Value of information methods could be used as an alternative approach to assist the efficient design of alcohol trials. If reducing unhealthy alcohol use is a long-term goal for HIV programs in East Africa, additional new trials with optimal sample sizes ranging from 100 to 250 persons per arm could save the opportunity cost of implementing less cost-effective alcohol strategies in HIV prevention. Otherwise, conducting a new trial is not recommended.

Risk-stratified versus Non-Risk-stratified Diagnostic Testing for Management of Suspected Acute Biliary Obstruction: Comparative Effectiveness, Costs, and the Role of MR Cholangiopancreatography.

Purpose To analyze the cost-effectiveness of the American Society for Gastrointestinal Endoscopy (ASGE) risk stratification guidelines versus magnetic resonance (MR) cholangiopancreatography-based treatment of patients with possible choledocholithiasis. Materials and Methods A decision-analytic model was constructed to compare cost and effectiveness of three diagnostic strategies for gallstone disease with possible choledocholithiasis: noncontrast MR cholangiopancreatography, contrast material-enhanced MR imaging/MR cholangiopancreatography, and ASGE risk stratification guidelines for diagnostic evaluation recommending endoscopy (high risk), MR cholangiopancreatography (intermediate risk), or no test (low risk). Analysis was performed from a U.S. health system perspective over 1-year and lifetime horizons. The model accounted for benign and malignant causes of biliary obstruction and procedural complications. Cost information was based on Medicare reimbursements. Sensitivity analysis assessed the impact of parameter variability on model results. Results Noncontrast MR cholangiopancreatography was most cost-effective in 45-55-year-old patients (less than $100 000 per quality-adjusted life-year [QALY] gained), while contrast-enhanced MR imaging was favored in younger adults. Risk-stratified testing was less costly than MR cholangiopancreatography, with long-term savings of $1870 and $2068 versus noncontrast and contrast-enhanced MR cholangiopancreatography, respectively, but was also less effective (-0.1814, -0.1831 QALY, respectively). The lifetime incremental cost per QALY for noncontrast MR cholangiopancreatography was $10 311. Contrast-enhanced MR imaging was favored with pretest probabilities of biliary stricture or malignancy 0%-73% for patients aged 20-44 years. For patients older than 55 years, ASGE guidelines maximized QALYs at the lowest cost. Conclusion Although adults older than 55 years of age are optimally evaluated by using ASGE guidelines, younger patients suspected of having acute biliary obstruction likely benefit from MR cholangiopancreatography rather than risk-stratified diagnostic imaging because of improved detection of choledocholithiasis and alternative causes of biliary obstruction. © RSNA, 2017 Online supplemental material is available for this article.

What are the Patterns Between Depression, Smoking, Unhealthy Alcohol Use, and Other Substance Use Among Individuals Receiving Medical Care? A Longitudinal Study of 5479 Participants.

To evaluate and characterize the structure of temporal patterns of depression, smoking, unhealthy alcohol use, and other substance use among individuals receiving medical care, and to inform discussion about whether integrated screening and treatment strategies for these conditions are warranted. Using the Veterans Aging Cohort Study (VACS) we measured depression, smoking, unhealthy alcohol use and other substance use (stimulants, marijuana, heroin, opioids) and evaluated which conditions tended to co-occur within individuals, and how this co-occurrence was temporally structured (i.e. concurrently, sequentially, or discordantly). Current depression was associated with current use of every substance examined with the exception of unhealthy alcohol use. Current unhealthy alcohol use and marijuana use were also consistently associated. Current status was strongly predicted by prior status (p < 0.0001; OR = 2.99-22.34) however, there were few other sequential relationships. Associations in the HIV infected and uninfected subgroups were largely the same with the following exceptions. Smoking preceded unhealthy alcohol use and current smoking was associated with current depression in the HIV infected subgroup only (p < 0.001; OR = 1.33-1.41 and p < 0.001; OR = 1.25-1.43). Opioid use and current unhealthy alcohol use were negatively associated only in the HIV negative subgroup (p = 0.01; OR = 0.75). Patterns of depression, smoking, unhealthy alcohol use, and other substance use were temporally concordant, particularly with regard to depression and substance use. These patterns may inform future development of more integrated screening and treatment strategies.

Potential return on investment of a family-centered early childhood intervention: a cost-effectiveness analysis.

BACKGROUND: ParentCorps is a family-centered enhancement to pre-kindergarten programming in elementary schools and early education centers. When implemented in high-poverty, urban elementary schools serving primarily Black and Latino children, it has been found to yield benefits in childhood across domains of academic achievement, behavior problems, and obesity. However, its long-term cost-effectiveness is unknown. METHODS: We determined the cost-effectiveness of ParentCorps in high-poverty, urban schools using a Markov Model projecting the long-term impact of ParentCorps compared to standard pre-kindergarten programming. We measured costs and quality adjusted life years (QALYs) resulting from the development of three disease states (i.e., drug abuse, obesity, and diabetes); from the health sequelae of these disease states; from graduation from high school; from interaction with the judiciary system; and opportunity costs of unemployment with a lifetime time horizon. The model was built, and analyses were performed in 2015-2016. RESULTS: ParentCorps was estimated to save $4387 per individual and increase each individual's quality adjusted life expectancy by 0.27 QALYs. These benefits were primarily due to the impact of ParentCorps on childhood obesity and the subsequent predicted prevention of diabetes, and ParentCorps' impact on childhood behavior problems and the subsequent predicted prevention of interaction with the judiciary system and unemployment. Results were robust on sensitivity analyses, with ParentCorps remaining cost saving and health generating under nearly all assumptions, except when schools had very small pre-kindergarten programs. CONCLUSIONS: Effective family-centered interventions early in life such as ParentCorps that impact academic, behavioral and health outcomes among children attending high-poverty, urban schools have the potential to result in longer-term health benefits and substantial cost savings.

A Framework for Incorporating Patient Preferences Regarding Benefits and Risks into Regulatory Assessment of Medical Technologies.

BACKGROUND: In response to 2012 guidance in which the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) stated the importance of patient-centric measures in regulatory benefit-risk assessments, the Medical Device Innovation Consortium (MDIC) initiated a project. The project was used to develop a framework to help the Food and Drug Administration (FDA) and industry sponsors understand how patient preferences regarding benefit and risk might be integrated into the review of innovative medical devices. METHODS: A public-private partnership of experts from medical device industry, government, academia and non-profits collaborated on development of the MDIC patient centered benefit-risk framework. RESULTS: The MDIC Framework examines what patient preference information is and the potential use and value of patient preference information in the regulatory process and across the product development life cycle. The MDIC Framework also includes a catalog of patient preference assessment methods and an agenda for future research to advance the field. CONCLUSIONS: This article discusses key concepts in patient preference assessment of particular importance for regulators and researchers that are addressed in the MDIC Framework for patient centered benefit-risk assessment as well as the unique public-private collaboration that led its development.