Developing Evidence to Support Policy: Protocol for the StrAtegic PoLicy EvIdence-Based Evaluation CeNTer (SALIENT).

BACKGROUND: All federal agencies are required to support appropriation requests with evidence and evaluation (US Public Law 115-435; the Evidence Act). The StrAtegic PoLicy EvIdence-Based Evaluation CeNTer (SALIENT) is 1 of 6 centers that help the Department of Veterans Affairs (VA) meet this requirement. OBJECTIVE: Working with the existing VA evaluation structure, SALIENT evaluations will contribute to (1) optimize policies and programs for veteran populations; (2) improve outcomes regarding health, equity, cost, and provider well-being; (3) advance the science of dissemination and knowledge translation; and (4) expand the implementation and dissemination science workforce. METHODS: We leverage the Lean Sprint methodology (iterative, incremental, rule-governed approach to clearly defined, and time-boxed work) and 3 cores to develop our evaluation plans collaboratively with operational partners and key stakeholders including veterans, policy experts, and clinicians. The Operations Core will work with evaluation teams to develop timelines, facilitate work, monitor progress, and guide quality improvement within SALIENT. The Methods Core will work with evaluation teams to identify the most appropriate qualitative, quantitative, and mixed methods approaches to address each evaluation, ensure that the analyses are conducted appropriately, and troubleshoot when problems with data acquisition and analysis arise. The Knowledge Translation (KT) Core will target key partners and decision makers using a needs-based market segmentation approach to ensure that needs are incorporated in the dissemination of knowledge. The KT Core will create communications briefs, playbooks, and other materials targeted at these market segments to facilitate implementation of evidence-based practices and maximize the impact of evaluation results. RESULTS: The SALIENT team has developed a center infrastructure to support high-priority evaluations, often to be responsive to shifting operational needs and priorities. Our team has engaged in our core missions and operations to rapidly evaluate a high-priority areas, develop a comprehensive Lean Sprint systems redesign approach to training, and accelerate rapid knowledge translation. CONCLUSIONS: With an array of interdisciplinary expertise, operational partnerships, and integrated resources, SALIENT has an established and evolving infrastructure to rapidly develop and implement high-impact evaluations. Projects are developed with sustained efficiency approaches that can pivot to new priorities as needed and effectively translate knowledge for key stakeholders and policy makers, while creating a learning health system infrastructure to foster the next generation of evaluation and implementation scientists. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/59830.

Glycated Hemoglobin A1c Time in Range and Dementia in Older Adults With Diabetes.

Importance: Individuals with diabetes commonly experience Alzheimer disease and related dementias (ADRD). Factors such as hypoglycemia, hyperglycemia, and glycemic variability have been associated with increased risk of ADRD. Traditional glycemic measures, such as mean glycated hemoglobin A1c (HbA1c), may not identify the dynamic and complex pathophysiologic factors in the association between diabetes and ADRD. The HbA1c time in range (TIR) is a previously developed measure of glycemic control that expresses HbA1c stability over time within specific ranges. This measure may inform the current understanding of the association between glucose levels over time and ADRD incidence. Objective: To examine the association between HbA1c TIR and incidence of ADRD in older veterans with diabetes. Design, Setting, and Participants: The study sample for this cohort study was obtained from administrative and health care utilization data from the Veterans Health Administration and Medicare from January 1, 2004, to December 31, 2018. Veterans 65 years or older with diabetes were assessed. Participants were required to have at least 4 HbA1c tests during the 3-year baseline period, which could start between January 1, 2005, and December 31, 2014. Data analysis was conducted between July and December 2023. Main Outcomes and Measures: Hemoglobin A1c TIR was calculated as the percentage of days during baseline in which HbA1c was in individualized target ranges based on clinical characteristics and life expectancy, with higher HbA1c TIR viewed as more favorable. The association between HbA1c TIR and ADRD incidence was estimated. Additional models considered ADRD incidence in participants who were above or below HbA1c target ranges most of the time. Results: The study included 374 021 veterans with diabetes (mean [SD] age, 73.2 [5.8] years; 369 059 [99%] male). During follow-up of up to 10 years, 41 424 (11%) developed ADRD. Adjusted Cox proportional hazards regression models showed that lower HbA1c TIR was associated with increased risk of incident ADRD (HbA1c TIR of 0 to <20% compared with ≥80%: hazard ratio, 1.19; 95% CI, 1.16-1.23). Furthermore, the direction of out-of-range HbA1c levels was associated with incident ADRD. Having greater time below range (≥60%, compared with ≥60% TIR) was associated with significantly increased risk (hazard ratio, 1.23; 95% CI, 1.19-1.27). Findings remained significant after excluding individuals with baseline use of medications associated with hypoglycemia risk (ie, insulin and sulfonylureas) or with hypoglycemia events. Conclusions and Relevance: In this study of older adults with diabetes, increased HbA1c stability within patient-specific target ranges was associated with a lower risk of ADRD. Lower HbA1c TIR may identify patients at increased risk of ADRD.

Incorporating social determinants of health into transmission modeling of COVID-19 vaccine in the US: a scoping review.

During COVID-19 in the US, social determinants of health (SDH) have driven health disparities. However, the use of SDH in COVID-19 vaccine modeling is unclear. This review aimed to summarize the current landscape of incorporating SDH into COVID-19 vaccine transmission modeling in the US. Medline and Embase were searched up to October 2022. We included studies that used transmission modeling to assess the effects of COVID-19 vaccine strategies in the US. Studies' characteristics, factors incorporated into models, and approaches to incorporate these factors were extracted. Ninety-two studies were included. Of these, 11 studies incorporated SDH factors (alone or combined with demographic factors). Various sets of SDH factors were integrated, with occupation being the most common (8 studies), followed by geographical location (5 studies). The results show that few studies incorporate SDHs into their models, highlighting the need for research on SDH impact and approaches to incorporating SDH into modeling. Funding: This research was funded by the Centers for Disease Control and Prevention (CDC).

Measuring the Direct Medical Costs of Hospital-Onset Infections Using an Analogy Costing Framework.

BACKGROUND: The majority of recent estimates on the direct medical cost attributable to hospital-onset infections (HOIs) has focused on device- or procedure-associated HOIs. The attributable costs of HOIs that are not associated with device use or procedures have not been extensively studied. OBJECTIVE: We developed simulation models of attributable cost for 16 HOIs and estimated the total direct medical cost, including nondevice-related HOIs in the USA for 2011 and 2015. DATA AND METHODS: We used total discharge costs associated with HOI-related hospitalization from the National Inpatient Sample and applied an analogy costing methodology to develop simulation models of the costs attributable to HOIs. The mean attributable cost estimate from the simulation analysis was then multiplied by previously published estimates of the number of HOIs for 2011 and 2015 to generate national estimates of direct medical costs. RESULTS: After adjusting all estimates to 2017 US dollars, attributable cost estimates for select nondevice-related infections attributable cost estimates ranged from $7661 for ear, eye, nose, throat, and mouth (EENTM) infections to $27,709 for cardiovascular system infections in 2011; and from $8394 for EENTM to $26,445 for central nervous system infections in 2016 (based on 2015 incidence data). The national direct medical costs for all HOIs were $14.6 billion in 2011 and $12.1 billion in 2016. Nondevice- and nonprocedure-associated HOIs comprise approximately 26-28% of total HOI costs. CONCLUSION: Results suggest that nondevice- and nonprocedure-related HOIs result in considerable costs to the healthcare system.

Shallow Subsidies for Veterans Facing Housing Barriers in the VA Supportive Services for Veteran Families Program.

The Department of Veterans Affairs provides a shallow subsidy (i.e., subsidizing 50% of an individual's rent for two years) to Veterans experiencing housing instability. We sought to describe the characteristics of Veterans who received these subsidies. Methods. We conducted a retrospective cohort study of Veterans between 10/2019-9/2021. We identified Veteran-level characteristics associated with receiving a shallow subsidy using a multivariable two-part regression model. We also conducted qualitative interviews to identify how shallow subsidies are allocated. Results Black race, higher income, more education, and older age were positively associated with receiving a shallow subsidy; previous homelessness, prior VA outpatient cost, and participating in permanent supportive housing were negatively associated with receiving a shallow subsidy. Interviews revealed that income was the most influential determinant of whether to give shallow subsidies. Discussion Our mixed methods findings were consistent, indicating that socioeconomic stability is an important driver of shallow subsidy allocation decisions.

Surgical-decision making in the setting of unsuspected N2 disease: a cost-effectiveness analysis.

Background: Identification of unsuspected nodal metastasis may occur at the time of operation for a stage I non-small cell lung cancer. Guidelines for this scenario are unclear. Our goal was to assess the cost-effectiveness of aborting the operation in an attempt to first provide neoadjuvant systemic therapy compared with upfront resection. Methods: A computer simulation Markov model with a lifetime horizon was constructed to compare the costs and clinical outcomes, as measured by quality-adjusted life-years (QALYs), of upfront resection at the time of identification of unsuspected N2 mediastinal disease vs. aborting initial resection and continuing with neoadjuvant therapy prior to resection. Input parameters for the model were derived from published literature with costs measured from the healthcare perspective. The incremental cost-effectiveness ratio (ICER) was evaluated with a willingness-to-pay (WTP) threshold of $150,000/QALY. Both deterministic (one-, two-, and three-way) and probabilistic sensitivity analysis (PSA) were performed to assess the impact of variation in input parameter values on model results. Results: Aborting initial resection in favor of neoadjuvant therapy resulted in both higher costs ($40,415 vs. $29,873) and more QALYs (3.95 vs. 2.84) relative to upfront resection, yielding an ICER of $9,526/QALY. While variation in overall survival had a significant impact on the ICER, perioperative variables did not. As the annual mortality of best-case therapy in the abort group increased from a base-case estimate of 11% to 15%, the ICER exceeded the WTP threshold of $150,000/QALY. Subsequent one- and two-way sensitivity analyses did not find substantially alter the overall results. PSA resulted in aborting resection to be cost-effective in 99.7% of samples, with 13% of samples dominating upfront resection. Conclusions: Treatment of stage IIIa lung cancer requires the input of a multidisciplinary team who must consider cost, quality of life, and overall survival. As new treatments are developed, further analyses should be performed to determine optimal therapy.

Temporary Financial Assistance Reduced The Probability Of Unstable Housing Among Veterans For More Than 1 Year.

The Department of Veterans Affairs (VA) aims to reduce homelessness among veterans through programs such as Supportive Services for Veteran Families (SSVF). An important component of SSVF is temporary financial assistance. Previous research has demonstrated the effectiveness of temporary financial assistance in reducing short-term housing instability, but studies have not examined its long-term effect on housing outcomes. Using data from the VA's electronic health record system, we analyzed the effect of temporary financial assistance on veterans' housing instability for three years after entry into SSVF. We extracted housing outcomes from clinical notes, using natural language processing, and compared the probability of unstable housing among veterans who did and did not receive temporary financial assistance. We found that temporary financial assistance rapidly reduced the probability of unstable housing, but the effect attenuated after forty-five days. Our findings suggest that to maintain long-term housing stability for veterans who have exited SSVF, additional interventions may be needed.

Temporary Financial Assistance for Housing Expenditures and Mortality and Suicide Outcomes Among US Veterans.

INTRODUCTION: It is unclear whether interventions designed to increase housing stability can also lead to improved health outcomes such as reduced risk of death and suicide morbidity. The objective of this study was to estimate the potential impact of temporary financial assistance (TFA) for housing-related expenses from the US Department of Veterans Affairs (VA) on health outcomes including all-cause mortality, suicide attempt, and suicidal ideation. METHODS: We conducted a retrospective national cohort study of Veterans who entered the VA Supportive Services for Veteran Families (SSVF) program between 10/2015 and 9/2018. We assessed the association between TFA and health outcomes using a multivariable Cox proportional hazards regression approach with inverse probability of treatment weighting. We conducted these analyses on our overall cohort as well as separately for those in the rapid re-housing (RRH) and homelessness prevention (HP) components of SSVF. Outcomes were all-cause mortality, suicide attempt, and suicidal ideation at 365 and 730 days following enrollment in SSVF. RESULTS: Our analysis cohort consisted of 41,969 unique Veterans with a mean (SD) duration of 87.6 (57.4) days in the SSVF program. At 365 days following SSVF enrollment, TFA was associated with a decrease in the risk of all-cause mortality (HR: 0.696, p < 0.001) and suicidal ideation (HR: 0.788, p < 0.001). We found similar results at 730 days (HR: 0.811, p = 0.007 for all-cause mortality and HR: 0.881, p = 0.037 for suicidal ideation). These results were driven primarily by individuals enrolled in the RRH component of SSVF. We found no association between TFA and suicide attempts. CONCLUSION: We find that providing housing-related financial assistance to individuals facing housing instability is associated with improvements in important health outcomes such as all-cause mortality and suicidal ideation. If causal, these results suggest that programs to provide housing assistance have positive spillover effects into other important aspects of individuals' lives.

Cost and Utilization Outcomes in Huntsman at Home, a Novel Oncology Hospital at Home Program.

OBJECTIVES: In a real-world trial, we previously demonstrated that Huntsman at Home, a novel oncology hospital at home program, was associated with reduced health care utilization and costs. In this study, we sought to understand the impact of Huntsman at Home in specific patient subgroups defined by sex, age, area-level median income, Charlson Comorbidity Index, and current use of systemic anticancer therapy. DESIGN: Retrospective case-control study of the Huntsman Cancer Institute. Electronic Data Warehouse of patients enrolled in Huntsman at Home between August 2018 through October 2019 vs usual-care patients. SETTING AND PARTICIPANTS: A total of 169 patients admitted to Huntsman at Home compared with 198 usual-care patients. METHODS: Five dichotomous subgroups evaluated including sex (female vs male), age (≥65 vs <65), income (≥$78,735 vs <$78,735), Charlson Comorbidity Index (≥2 vs <2), and current systemic anticancer therapy use vs no current systemic anticancer therapy. Groups were compared with patients receiving usual care. Primary outcomes included 30-day costs, hospital length of stay, unplanned hospitalizations, and emergency room visits. RESULTS: Admission to Huntsman at Home was associated with an overall reduction across all 4 health care cost and utilization outcomes. Outcomes favoring admission to Huntsman at Home achieved statistical significance (P < .05) in at least 2 of the 4 outcomes for each subgroup studied. Of the subgroups that did not achieve statistically significant benefit from Huntsman at Home admission in some outcome categories, none of these subgroups favored usual care. CONCLUSIONS AND IMPLICATIONS: Admission to Huntsman at Home decreased utilization of unplanned health care and reduced costs across a wide spectrum of patient subgroups, suggesting overall consistent benefit from the service. Hospital at home models should be considered as a means by which the quality and efficiency of care can be maximized for patients with cancer.

Preimplantation genetic testing for sickle cell disease: a cost-effectiveness analysis.

Objective: To evaluate the cost-effectiveness of in vitro fertilization with preimplantation genetic testing for monogenic disease (IVF + PGT-M) in the conception of a nonsickle cell disease (non-SCD) individual compared with standard of care treatment for a naturally conceived, sickle cell disease (SCD)-affected individual. Design: A Markov simulation model was constructed to evaluate a one-time IVF + PGT-M treatment compared with the lifetime standard of care costs of treatment for an individual potentially born with SCD. Using an annual discount rate of 3% for cost and outcome measures, quality-adjusted life years were constructed from utility weights and life expectancy values and then used as the effectiveness measurement. An incremental cost-effectiveness ratio was calculated for both treatment arms, and a willingness-to-pay threshold of $50,000 per quality-adjusted life year was assumed. Setting: Tertiary care or university medical center. Patients: A hypothetical cohort of 10,000 patients was analzyed over a lifetime horizon using yearly cycles. Interventions: In vitro fertilization with preimplantation genetic testing for monogenic disease use in conception of a non-SCD individual. Main Outcome Measures: The primary outcomes of interest were the incremental cost and effectiveness of an IVF+PGT-M conception compared with the SOC treatment of an SCD-affected individual. Results: In vitro fertilization with preimplantation genetic testing for monogenic disease was the optimal strategy in 93.17% of the iterations. An incremental savings of $137,594 was demonstrated with a gain of 1.96 QALYs and 3.69 life years over a lifetime. Sensitivity analysis demonstrated that SOC treatment never met equivalent cost-effectiveness. Conclusions: Our model demonstrates that IVF + PGT-M for selection against SCD, compared with lifetime SOC treatment for those affected, is the most cost-effective strategy within the United States healthcare sector.

Disparities in COVID-19 related outcomes in the United States by race and ethnicity pre-vaccination era: an umbrella review of meta-analyses.

Background: Meta-analyses have investigated associations between race and ethnicity and COVID-19 outcomes. However, there is uncertainty about these associations' existence, magnitude, and level of evidence. We, therefore, aimed to synthesize, quantify, and grade the strength of evidence of race and ethnicity and COVID-19 outcomes in the US. Methods: In this umbrella review, we searched four databases (Pubmed, Embase, the Cochrane Database of Systematic Reviews, and Epistemonikos) from database inception to April 2022. The methodological quality of each meta-analysis was assessed using the Assessment of Multiple Systematic Reviews, version 2 (AMSTAR-2). The strength of evidence of the associations between race and ethnicity with outcomes was ranked according to established criteria as convincing, highly suggestive, suggestive, weak, or non-significant. The study protocol was registered with PROSPERO, CRD42022336805. Results: Of 880 records screened, we selected seven meta-analyses for evidence synthesis, with 42 associations examined. Overall, 10 of 42 associations were statistically significant (p ≤ 0.05). Two associations were highly suggestive, two were suggestive, and two were weak, whereas the remaining 32 associations were non-significant. The risk of COVID-19 infection was higher in Black individuals compared to White individuals (risk ratio, 2.08, 95% Confidence Interval (CI), 1.60-2.71), which was supported by highly suggestive evidence; with the conservative estimates from the sensitivity analyses, this association remained suggestive. Among those infected with COVID-19, Hispanic individuals had a higher risk of COVID-19 hospitalization than non-Hispanic White individuals (odds ratio, 2.08, 95% CI, 1.60-2.70) with highly suggestive evidence which remained after sensitivity analyses. Conclusion: Individuals of Black and Hispanic groups had a higher risk of COVID-19 infection and hospitalization compared to their White counterparts. These associations of race and ethnicity and COVID-19 outcomes existed more obviously in the pre-hospitalization stage. More consideration should be given in this stage for addressing health inequity.

Cost-effectiveness of HLA-B*58:01 testing to prevent Stevens-Johnson syndrome/toxic epidermal necrolysis in Vietnam.

Background: HLA-B*58:01 is strongly associated with allopurinol-induced Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) in Vietnam. This study assessed the cost-effectiveness of this testing to prevent SJS/TEN. Methods: A model was developed to compare three strategies: no screening, use allopurinol; HLA-B*58:01 screening; and no screening, use probenecid. A willingness-to-pay of three-times gross domestic product per capita was used. Results: Compared with 'no screening, use allopurinol', 'screening' increased quality-adjusted life-years by 0.0069 with the incremental cost of Vietnam dong (VND) 14,283,633 (US$617), yielding an incremental cost-effectiveness ratio of VND 2,070,459,122 (US$89,398) per quality-adjusted life-year. Therefore, 'screening' was unlikely to be cost-effective under the current willingness-to-pay. Testing's cost-effectiveness may change with targeted high-risk patients, reimbursed febuxostat or lower probenecid prices. Conclusion: The implementation of nationwide HLAB*58:01 testing before the use of allopurinol is not cost-effective, according to this analysis. This may be due to the lack of quality data on the effectiveness of testing and costing data in the Vietnamese population.

Cost-effectiveness analysis of 7 treatments in metastatic hormone-sensitive prostate cancer: a public-payer perspective.

BACKGROUND: Recently, several new treatment regimens have been approved for treating metastatic hormone-sensitive prostate cancer, building on androgen deprivation therapy alone. These include docetaxel androgen deprivation therapy, abiraterone acetate-prednisone androgen deprivation therapy, apalutamide androgen deprivation therapy, enzalutamide androgen deprivation therapy, darolutamide-docetaxel androgen deprivation therapy, and abiraterone-prednisone androgen deprivation therapy with docetaxel. There are no validated predictive biomarkers for choosing a specific regimen. The goal of this study was to conduct a health economic outcome evaluation to determine the optimal treatment from the US public sector (Veterans Affairs). METHODS: We developed a partitioned survival model in which metastatic hormone-sensitive prostate cancer patients transitioned between 3 health states (progression free, progressive disease to castrate resistance state, and death) at monthly intervals based on Weibull survival model estimated from published Kaplan-Meier curves using a Bayesian network meta-analysis of 7 clinical trials (7208 patients). The effectiveness outcome in our model was quality-adjusted life-years (QALYs). Cost input parameters included initial and subsequent treatment costs and costs for terminal care and for managing grade 3 or higher drug-related adverse events and were obtained from the Federal Supply Schedule and published literature. RESULTS: Average 10-year costs ranged from $34 349 (androgen deprivation therapy) to $658 928 (darolutamide-docetaxel androgen deprivation therapy) and mean QALYs ranged from 3.25 (androgen deprivation therapy) to 4.57 (enzalutamide androgen deprivation therapy). Treatment strategies docetaxel androgen deprivation therapy, enzalutamide androgen deprivation therapy docetaxel, apalutamide androgen deprivation therapy, and darolutamide-docetaxel androgen deprivation therapy were eliminated because of dominance (ie, they were more costly and less effective than other strategies). Of the remaining strategies, abiraterone acetate-prednisone androgen deprivation therapy was the most cost-effective strategy at a willingness-to-pay threshold of $100 000/QALY (incremental cost-effectiveness ratios = $21 247/QALY). CONCLUSIONS: Our simulation model found abiraterone acetate-prednisone androgen deprivation therapy to be an optimal first-line treatment for metastatic hormone-sensitive prostate cancer from a public (Veterans Affairs) payer perspective.

Condition-Dependent and Dynamic Impacts of Indoor Masking Policies for Coronavirus Disease 2019 Mitigation: A Nationwide, Interrupted Time-Series Analysis.

BACKGROUND: The effectiveness and sustainability of masking policies as a pandemic control measure remain uncertain. Our aim was to evaluate different masking policy types on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) incidence and to identify factors and conditions impacting effectiveness. METHODS: Nationwide, retrospective cohort study of US counties from 4/4/2020-28/6/2021. Policy impacts were estimated using interrupted time-series models with the masking policy change date (eg, recommended-to-required, no-recommendation-to-recommended, no-recommendation-to-required) modeled as the interruption. The primary outcome was change in SARS-CoV-2 incidence rate during the 12 weeks after the policy change; results were stratified by coronavirus disease 2019 (COVID-19) risk level. A secondary analysis was completed using adult vaccine availability as the policy change. RESULTS: In total, N = 2954 counties were included (2304 recommended-to-required, 535 no-recommendation-to-recommended, 115 no-recommendation-to-required). Overall, indoor mask mandates were associated with 1.96 fewer cases/100 000/week (cumulative reduction of 23.52/100 000 residents during the 12 weeks after policy change). Reductions were driven by communities with critical and extreme COVID-19 risk, where masking mandated policies were associated with an absolute reduction of 5 to 13.2 cases/100 000 residents/week (cumulative reduction of 60 to 158 cases/100 000 residents over 12 weeks). Impacts in low- and moderate-risk counties were minimal (<1 case/100 000 residents/week). After vaccine availability, mask mandates were not associated with significant reductions at any risk level. CONCLUSIONS: Masking policy had the greatest impact when COVID-19 risk was high and vaccine availability was low. When transmission risk decreases or vaccine availability increases, the impact was not significant regardless of mask policy type. Although often modeled as having a static impact, masking policy effectiveness may be dynamic and condition dependent.

Association of hemoglobin A1c stability with mortality and diabetes complications in older adults with diabetes.

INTRODUCTION: Hemoglobin A1c (A1c) treatment goals in older adults should be individualized to balance risks and benefits. It is unclear if A1c stability over time within unique target ranges also affects adverse outcomes. RESEARCH DESIGN AND METHODS: We conducted a retrospective observational cohort study from 2004 to 2016 of veterans with diabetes and at least four A1c tests during a 3-year baseline. We generated four distinct categories based on the percentage of time that baseline A1c levels were within patient-specific target ranges: ≥60% time in range (TIR), ≥60% time below range (TBR), ≥60% time above range (TAR), and a mixed group with all times <60%. We assessed associations of these categories with mortality, macrovascular, and microvascular complications. RESULTS: We studied 397 634 patients (mean age 76.9 years, SD 5.7) with an average of 5.5 years of follow-up. In comparison to ≥60% A1c TIR, mortality was increased with ≥60% TBR, ≥60% TAR, and the mixed group, with HRs of 1.12 (95% CI 1.11 to 1.14), 1.10 (95% CI 1.08 to 1.12), and 1.06 (95% CI 1.04 to 1.07), respectively. Macrovascular complications were increased with ≥60% TBR and ≥60% TAR, with estimates of 1.04 (95% CI 1.01 to 1.06) and 1.06 (95% CI 1.03 to 1.09). Microvascular complications were lower with ≥60% TBR (HR 0.97, 95% CI 0.95 to 1.00) and higher with ≥60% TAR (HR 1.11, 95% CI 1.08 to 1.14). Results were similar with higher TIR thresholds, shorter follow-up, and competing risk of mortality. CONCLUSIONS: In older adults with diabetes, mortality and macrovascular complications are associated with increased time above and below individualized A1c target ranges. Higher A1c TIR may identify patients with lower risk of adverse outcomes.

Long-Term Health Care Costs for Service Members Injured in Iraq and Afghanistan.

INTRODUCTION: Over the last two decades, the conflicts in Iraq and Afghanistan have cost the United States significantly in terms of lives lost, disabling injuries, and budgetary expenditures. This manuscript calculates the differences in costs between veterans with combat injuries vs veterans without combat injuries. This work could be used to project future costs in subsequent studies. MATERIALS AND METHODS: In this retrospective cohort study, we randomly selected 7,984 combat-injured veterans between February 1, 2002, and June 14, 2016, from Veterans Affairs Health System administrative data. We matched injured veterans 1:1 to noninjured veterans on year of birth (± 1 year), sex, and first service branch. We observed patients for a maximum of 10 years. This research protocol was reviewed and approved by the David Grant USAF Medical Center institutional review board (IRB), the University of Utah IRB, and the Research Review Committee of the VA Salt Lake City Health Care System in accordance with all applicable Federal regulations. RESULTS: Patients were primarily male (98.1% in both groups) and White (76.4% for injured patients, 72.3% for noninjured patients), with a mean (SD) age of 26.8 (6.6) years for the injured group and 27.7 (7.0) years for noninjured subjects. Average total costs for combat-injured service members were higher for each year studied. The difference was highest in the first year ($16,050 compared to $4,135 for noninjured). These differences remained significant after adjustment. Although this difference was greatest in the first year (marginal effect $12,386, 95% confidence interval $9,736-$15,036; P < 0.001), total costs continued to be elevated in years 2-10, with marginal effects ranging from $1,766 to $2,597 (P < 0.001 for all years). More severe injuries tended to increase costs in all categories. CONCLUSIONS: Combat injured patients have significantly higher long-term health care costs compared to their noninjured counterparts. If this random sample is extrapolated to the 53,251 total of combat wounded service members, it implies a total excess cost of $1.6 billion to date after adjustment for covariates and a median follow-up time of 10 years. These costs are likely to increase as injured veterans age and develop additional chronic conditions.

Integrating Real-World Evidence in Economic Evaluation of Oral Anticoagulants for Stroke Prevention in Non-valvular Atrial Fibrillation in a Developing Country.

OBJECTIVE: This study aimed to estimate the cost effectiveness of non-vitamin K oral anticoagulants (NOACs) compared with warfarin for stroke prevention in patients with non-valvular atrial fibrillation (NVAF) in Thailand where suboptimal anticoagulation control is common. MATERIALS AND METHODS: A hypothetical cohort of 65-year-old patients with NVAF and their disease progression was simulated in the Markov model. The following anticoagulant agents were used: warfarin, dabigatran, rivaroxaban, and apixaban. Warfarin with high, intermediate, and low time in therapeutic ranges (TTR) was used as the three different reference treatments. Baseline clinical events were obtained from a recently published real-world study in Thailand. A lifetime horizon was utilized in this model, and all analyses were performed from societal and healthcare perspectives. The results were reported as incremental cost-effectiveness ratios (ICERs) in 2021 US dollars per quality-adjusted life-year (QALY) gained. The sensitivity analyses were performed to assess the influence of parameter uncertainty. RESULTS: Apixaban was a cost-effective intervention compared with warfarin with low and intermediate TTR groups. In the low TTR group, the ICERs were $779 and $816 per QALY gained from the societal and healthcare perspectives, respectively, and in the intermediate TTR group, the ICERs were $2038 and $3159 per QALY gained from the societal and healthcare perspectives, respectively. Both ICERs were below the accepted willingness-to-pay threshold ($4806) in the context of Thailand's healthcare. CONCLUSIONS: In a developing country where suboptimal anticoagulation control is common, apixaban was the cost-effective alternative to warfarin for patients with both low and intermediate TTR control.

Predictors of homeless service utilization and stable housing status among Veterans receiving services from a nationwide homelessness prevention and rapid rehousing program.

Homelessness prevention and rapid rehousing (RRH) programs are increasingly important components of the homeless assistance system in the United States. Yet, there are key gaps in knowledge about the dynamics of the utilization of these programs, with scant attention paid to examining the duration of homelessness prevention and RRH service episodes or to patterns of repeated use of these programs over time. To address these gaps, we use data from the U.S. Department of Veterans Affairs' (VA) Supportive Services for Veteran Families (SSVF) program-the largest program in the country providing homelessness prevention and RRH services-to assess the relationship between individual and program-level factors and exits to stable housing, length of service episodes, and patterns of repeated service use over time. We analyze data for a primary cohort of 570,798 of Veterans who received SSVF services during Fiscal Years (FY) 2012-2021, and for separate cohorts of Veterans who received SSVF prevention and RRH services, respectively, during FY 2016-2021. We find that participants' income, indicators of their health status, their use of other VA homeless programs, and rurality are consistent predictors of our outcomes. These findings have implications for how to allocate homelessness prevention and RRH resources in the most efficient manner to help households maintain or obtain stable housing.

Cost-Effectiveness Analysis of Six Immunotherapy-Based Regimens and Sunitinib in Metastatic Renal Cell Carcinoma: A Public Payer Perspective.

PURPOSE: Several new treatment combinations have been approved in metastatic renal cell carcinoma (mRCC). To determine the optimal therapy on the basis of cost and health outcomes, we performed a cost-effectiveness analysis of approved immunotherapy-tyrosine kinase inhibitor/immunotherapy drug combinations and sunitinib using public payer acquisition costs in the United States. METHODS: We constructed a decision model with a 10-year time horizon. The seven treatment drug strategies included atezolizumab + bevacizumab, avelumab + axitinib, pembrolizumab + axitinib, nivolumab + ipilimumab (NI), nivolumab + cabozantinib, lenvatinib + pembrolizumab, and sunitinib. The effectiveness outcome in our model was quality-adjusted life-years (QALYs) with utility values on the basis of the published literature. Costs included drug acquisition costs and costs for management of grade 3-4 drug-related adverse events. We used a partitioned survival model in which patients with mRCC transitioned between three health states (progression-free, progressive disease, and death) at monthly intervals on the basis of parametric survival function estimated from published survival curves. To determine cost-effectiveness, we constructed incremental cost-effectiveness ratios (ICERs) by dividing the difference in cost by the difference in effectiveness between nondominated treatments. RESULTS: The least expensive treatment was sunitinib ($357,948 US dollars [USD]-$656,100 USD), whereas the most expensive was either lenvatinib + pembrolizumab or pembrolizumab + axitinib ($959,302 USD-$1,403,671 USD). NI yielded the most QALYs (3.6), whereas avelumab + axitinib yielded the least (2.5). NI had an incremental ICER of $297,465 USD-$348,516 USD compared with sunitinib. In sensitivity analyses, this ICER fell below $150,000 USD/QALY if the initial 4-month cost of NI decreased by 22%-38%. CONCLUSION: NI was the most effective combination for mRCC, but at a willingness-to-pay threshold of $150,000 USD/QALY, sunitinib was the most cost-effective approach.