Development and Validation of the US Diabetes, Obesity, Cardiovascular Disease Microsimulation (DOC-M) Model: Health Disparity and Economic Impact Model.

BACKGROUND: Few simulation models have incorporated the interplay of diabetes, obesity, and cardiovascular disease (CVD); their upstream lifestyle and biological risk factors; and their downstream effects on health disparities and economic consequences. METHODS: We developed and validated a US Diabetes, Obesity, Cardiovascular Disease Microsimulation (DOC-M) model that incorporates demographic, clinical, and lifestyle risk factors to jointly predict overall and racial-ethnic groups-specific obesity, diabetes, CVD, and cause-specific mortality for the US adult population aged 40 to 79 y at baseline. An individualized health care cost prediction model was further developed and integrated. This model incorporates nationally representative data on baseline demographics, lifestyle, health, and cause-specific mortality; dynamic changes in modifiable risk factors over time; and parameter uncertainty using probabilistic distributions. Validation analyses included assessment of 1) population-level risk calibration and 2) individual-level risk discrimination. To illustrate the application of the DOC-M model, we evaluated the long-term cost-effectiveness of a national produce prescription program. RESULTS: Comparing the 15-y model-predicted population risk of primary outcomes among the 2001-2002 National Health and Nutrition Examination Survey (NHANES) cohort with the observed prevalence from age-matched cross-sectional 2003-2016 NHANES cohorts, calibration performance was strong based on observed-to-expected ratio and calibration plot analysis. In most cases, Brier scores fell below 0.0004, indicating a low overall prediction error. Using the Multi-Ethnic Study of Atherosclerosis cohorts, the c-statistics for assessing individual-level risk discrimination were 0.85 to 0.88 for diabetes, 0.93 to 0.95 for obesity, 0.74 to 0.76 for CVD history, and 0.78 to 0.81 for all-cause mortality, both overall and in three racial-ethnic groups. Open-source code for the model was posted at https://github.com/food-price/DOC-M-Model-Development-and-Validation. CONCLUSIONS: The validated DOC-M model can be used to examine health, equity, and the economic impact of health policies and interventions on behavioral and clinical risk factors for obesity, diabetes, and CVD. HIGHLIGHTS: We developed a novel microsimula'tion model for obesity, diabetes, and CVD, which intersect together and - critically for prevention and treatment interventions - share common lifestyle, biologic, and demographic risk factors.Validation analyses, including assessment of (1) population-level risk calibration and (2) individual-level risk discrimination, showed strong performance across the overall population and three major racial-ethnic groups for 6 outcomes (obesity, diabetes, CVD, and all-cause mortality, CVD- and DM-cause mortality)This paper provides a thorough explanation and documentation of the development and validation process of a novel microsimulation model, along with the open-source code (https://github.com/food-price/ DOCM_validation) for public use, to serve as a guide for future simulation model assessments, validation, and implementation.

Health and Economic Impacts of Implementing Produce Prescription Programs for Diabetes in the United States: A Microsimulation Study.

Background Produce prescription programs, providing free or discounted produce and nutrition education to patients with diet-related conditions within health care systems, have been shown to improve dietary quality and cardiometabolic risk factors. The potential impact of implementing produce prescription programs for patients with diabetes on long-term health gains, costs, and cost-effectiveness in the United States has not been established. Methods and Results We used a validated state-transition microsimulation model (Diabetes, Obesity, Cardiovascular Disease Microsimulation model), populated with national data of eligible individuals from the National Health and Nutrition Examination Survey 2013 to 2018, further incorporating estimated intervention effects and diet-disease effects from meta-analyses, and policy- and health-related costs from published literature. The model estimated that over a lifetime (mean=25 years), implementing produce prescriptions in 6.5 million US adults with both diabetes and food insecurity (lifetime treatment) would prevent 292 000 (95% uncertainty interval, 143 000-440 000) cardiovascular disease events, generate 260 000 (110000-411 000) quality-adjusted life-years, cost $44.3 billion in implementation costs, and save $39.6 billion ($20.5-58.6 billion) in health care costs and $4.8 billion ($1.84-$7.70 billion) in productivity costs. The program was highly cost effective from a health care perspective (incremental cost-effectiveness ratio: $18 100/quality-adjusted life-years) and cost saving from a societal perspective (net savings: $-0.05 billion). The intervention remained cost effective at shorter time horizons of 5 and 10 years. Results were similar in population subgroups by age, race or ethnicity, education, and baseline insurance status. Conclusions Our model suggests that implementing produce prescriptions among US adults with diabetes and food insecurity would generate substantial health gains and be highly cost effective.

What is the cost-effectiveness of menu calorie labelling on reducing obesity-associated cancer burdens? An economic evaluation of a federal policy intervention among 235 million adults in the USA.

OBJECTIVE: To assess the impact of menu calorie labelling on reducing obesity-associated cancer burdens in the USA. DESIGN: Cost-effectiveness analysis using a Markov cohort state-transition model. SETTING: Policy intervention. PARTICIPANTS: A modelled population of 235 million adults aged ≥20 years in 2015-2016. INTERVENTIONS: The impact of menu calorie labelling on reducing 13 obesity-associated cancers among US adults over a lifetime was evaluated for: (1) effects on consumer behaviours; and (2) additional effects on industry reformulation. The model integrated nationally representative demographics, calorie intake from restaurants, cancer statistics and estimates on associations of policy with calorie intake, dietary change with body mass index (BMI) change, BMI with cancer rates, and policy and healthcare costs from published literature. MAIN OUTCOME MEASURES: Averted new cancer cases and cancer deaths and net costs (in 2015 US$) among the total population and demographic subgroups were determined. Incremental cost-effectiveness ratios from societal and healthcare perspectives were assessed and compared with the threshold of US$150 000 per quality-adjusted life year (QALY) gained. Probabilistic sensitivity analyses incorporated uncertainty in input parameters and generated 95% uncertainty intervals (UIs). RESULTS: Considering consumer behaviour alone, this policy was associated with 28 000 (95% UI 16 300 to 39 100) new cancer cases and 16 700 (9610 to 23 600) cancer deaths averted, 111 000 (64 800 to 158 000) QALYs gained, and US$1480 (884 to 2080) million saved in cancer-related medical costs among US adults. The policy was associated with net cost savings of US$1460 (864 to 2060) million and US$1350 (486 to 2260) million from healthcare and societal perspectives, respectively. Additional industry reformulation would substantially increase policy impact. Greater health gains and cost savings were predicted among young adults, Hispanic and non-Hispanic Black individuals. CONCLUSIONS: Study findings suggest that menu calorie labelling is associated with lower obesity-related cancer burdens and reduced healthcare costs. Policymakers may prioritise nutrition policies for cancer prevention in the USA.

Developing Criteria for Health Economic Quality Evaluation Tool.

OBJECTIVES: Because existing publication guidelines and checklists have limitations when used to assess the quality of cost-effectiveness analysis, we developed a novel quality assessment tool for cost-effectiveness analyses, differentiating methods and reporting quality and incorporating the relative importance of different quality attributes. METHODS: We defined 15 quality domains from a scoping review and identified 72 methods and reporting quality attributes (36 each). After designing a best-worst scaling survey, we fielded an online survey to researchers and practitioners to estimate the relative importance of the attributes in February 2021. We analyzed the survey data using a sequential conditional logit model. The final tool included 48 quality attributes deemed most important for assessing methods and reporting quality (24 each), accompanied by a free and web-based scoring system. RESULTS: A total of 524 participants completed the methodology section, and 372 completed both methodology and reporting sections. Quality attributes pertaining to the "modeling" and "data inputs and evidence synthesis" domains were deemed most important for methods quality, including "structure of the model reflects the underlying condition and intervention's impact" and "model validation is conducted." Quality attributes pertaining to "modeling" and "Intervention/comparator(s)" domains were considered most important for reporting quality, including "model descriptions are detailed enough for replication." Despite its growing prominence, "equity considerations" were not deemed as important as other quality attributes. CONCLUSIONS: The Criteria for Health Economic Quality Evaluation tool allows users to differentiate methods and reporting as well as quantifies the relative importance of quality attributes. Alongside other considerations, it could help assess and improve the quality of cost-effectiveness evidence to inform value-based decisions.

Association of Preexisting Heart Failure With Outcomes in Older Patients With Diffuse Large B-Cell Lymphoma.

Importance: Anthracycline-containing regimens are highly effective for diffuse large B-cell lymphoma (DLBCL); however, patients with preexisting heart failure (HF) may be less likely to receive anthracyclines and may be at higher risk of lymphoma mortality. Objective: To assess the prevalence of preexisting HF in older patients with DLBCL and its association with treatment patterns and outcomes. Design, Setting, and Participants: This longitudinal cohort study used data from the Surveillance, Epidemiology, and End Results (SEER)-Medicare registry from 1999 to 2016. The SEER registry is a system of population-based cancer registries, capturing more than 25% of the US population. Linkage to Medicare offers additional information from billing claims. This study included individuals 65 years and older with newly diagnosed DLBCL from 2000 to 2015 with Medicare Part A or B continuously in the year prior to lymphoma diagnosis. Data were analyzed from September 2020 to December 2022. Exposures: Preexisting HF in the year prior to DLBCL diagnosis ascertained from billing codes required one of the following: (1) 1 primary inpatient discharge diagnosis, (2) 2 outpatient diagnoses, (3) 3 secondary inpatient discharge diagnoses, (4) 3 emergency department diagnoses, or (5) 2 secondary inpatient discharge diagnoses plus 1 outpatient diagnosis. Main Outcomes and Measures: The primary outcome was anthracycline-based treatment. The secondary outcomes were (1) cardioprotective medications and (2) cause-specific mortality. The associations between preexisting HF and cancer treatment were estimated using multivariable logistic regression. The associations between preexisting HF and cause-specific mortality were evaluated using cause-specific Cox proportional hazards models with adjustment for comorbidities and cancer treatment. Results: Of 30 728 included patients with DLBCL, 15 474 (50.4%) were female, and the mean (SD) age was 77.8 (7.2) years. Preexisting HF at lymphoma diagnosis was present in 4266 patients (13.9%). Patients with preexisting HF were less likely to be treated with an anthracycline (odds ratio, 0.55; 95% CI, 0.49-0.61). Among patients with preexisting HF who received an anthracycline, dexrazoxane or liposomal doxorubicin were used in 78 of 1119 patients (7.0%). One-year lymphoma mortality was 41.8% (95% CI, 40.5-43.2) with preexisting HF and 29.6% (95% CI, 29.0%-30.1%) without preexisting HF. Preexisting HF was associated with higher lymphoma mortality in models adjusting for baseline and time-varying treatment factors (hazard ratio, 1.24; 95% CI, 1.18-1.31). Conclusions and Relevance: In this study, preexisting HF in patients with newly diagnosed DLBCL was common and was associated with lower use of anthracyclines and lower use of any chemotherapy. Trials are needed for this high-risk population.

Low-Value Prostate-Specific Antigen Test for Prostate Cancer Screening and Subsequent Health Care Utilization and Spending.

Importance: Delivering low-value care can lead to unnecessary follow-up services and associated costs, and such care cascades have not been well examined in common clinical scenarios. Objective: To evaluate the utilization and costs of care cascades of prostate-specific antigen (PSA) tests for prostate cancer screening, as the routine use of which among asymptomatic men aged 70 years and older is discouraged by multiple guidelines. Design, Setting, and Participants: This cross-sectional study included men aged 70 years and older without preexisting prostate conditions enrolled in a Medicare Advantage plan during January 2016 to December 2018 with at least 1 outpatient visit. Medical billing claims data from the deidentified OptumLabs Data Warehouse were used. Data analysis was conducted from September 2020 to August 2021. Exposures: At least 1 claim for low-value PSA tests for prostate cancer screening during the observation period. Main Outcomes and Measures: Utilization of and spending on low-value PSA cancer screening and associated care cascades and the difference in overall health care utilization and spending among individuals receiving low-value PSA cancer screening vs those who did not, adjusting for observed characteristics using inverse probability of treatment weighting. Results: Of 995 442 men (mean [SD] age, 78.0 [5.6] years) aged 70 years or older in a Medicare Advantage plan included in this study, 384 058 (38.6%) received a low-value PSA cancer screening. Utilization increased for each subsequent cohort from 2016 to 2018 (49 802 of 168 951 [29.4%] to 134 404 of 349 228 [38.5%] to 199 852 of 477 203 [41.9%]). Among those receiving initial low-value PSA cancer screening, 241 188 of 384 058 (62.8%) received at least 1 follow-up service. Repeated PSA testing was the most common, and 27 268 (7.1%) incurred high-cost follow-up services, such as imaging, radiation therapy, and prostatectomy. Utilization and spending associated with care cascades also increased from 2016 to 2018. For every $1 spent on a low-value PSA cancer screening, an additional $6 was spent on care cascades. Despite avoidable care cascades, individuals who received low-value PSA cancer screening were not associated with increased overall health care utilization and spending during the 1-year follow-up period compared with an unscreened population. Conclusions and Relevance: In this cross-sectional study, low-value PSA tests for prostate cancer screening remained prevalent among Medicare Advantage plan enrollees and were associated with unnecessary expenditures due to avoidable care cascades. Innovative efforts from clinicians and policy makers, such as payment reforms, to reduce initial low-value care and avoidable care cascades are warranted to decrease harm, enhance equity, and improve health care efficiency.

Association of National Expansion of Insurance Coverage of Medically Tailored Meals With Estimated Hospitalizations and Health Care Expenditures in the US.

Importance: Medically tailored meals (MTMs) are associated with lower health care utilization among patients with complex diet-related diseases but are not a covered benefit in Medicare or Medicaid. The potential impact of extending insurance coverage for MTMs nationally remains unknown. Objective: To estimate 1- and 10-year potential changes in annual hospitalizations, potential changes in annual health care expenditures, and overall policy cost-effectiveness associated with national MTM coverage for US patients with diet-related disease and limited instrumental activities of daily living who have Medicaid, Medicare, or private insurance. Design, Setting, and Participants: In this economic evaluation, conducted from January 2021 to February 2022, a nationally representative sample from the 2019 Medical Expenditure Panel Survey was used to create a population-level cohort policy simulation model that estimated changes in annual hospitalizations and health care expenditures associated with coverage of MTMs. Participants were 6 309 998 US adults aged 18 years or older who had Medicare, Medicaid, or private payer insurance and at least 1 diet-sensitive condition and 1 limitation in instrumental activities of daily living. Interventions: Ten nutritionally tailored MTMs per week for a mean of 8 months in each year of intervention. Main Outcomes and Measures: The main outcomes were total hospitalizations, program costs, health care expenditures, and net policy costs. One thousand Monte Carlo simulations for each of 10 years (2019-2028) jointly incorporated uncertainty in model inputs for effect sizes, hospitalizations, health care expenditures, and program costs. Results: At the 2019 baseline, an estimated 6 309 998 US adults were eligible to receive MTMs. Mean (SD) age was 68.1 (16.6) years; most were female (63.4%), were non-Hispanic White (66.7%), and had Medicare and/or Medicaid (76.5%). The most common eligibility diagnoses were cardiovascular diseases (70.6%), diabetes (44.9%), and cancer (37.2%). If all eligible individuals received MTMs, an estimated 1 594 000 hospitalizations (95% uncertainty interval [UI], 1 297 000-1 912 000) and $38.7 billion (95% UI, $24.9 billion to $53.9 billion) in health care expenditures could potentially be averted in 1 year. Program costs were $24.8 billion (95% UI, $23.1 billion to $26.8 billion), for an associated net savings of $13.6 billion (95% UI, $0.2 billion to $28.5 billion) from a health care perspective. In 2019 dollars, 10 years of the MTM intervention was anticipated to cost $298.7 billion (95% UI, $279.7 billion to $317.4 billion) and to potentially be associated with 18 257 000 averted hospitalizations (95% UI, 14 690 000-22 109 000) and reductions in health care expenditures of $484.5 billion (95% UI, $310.2 billion to $678.4 billion), for net savings of $185.1 billion (95% UI, $12.9 billion to $377.8 billion). Findings were robust in multiple sensitivity analyses. Conclusions and Relevance: The findings suggest that national implementation of MTMs for patients with diet-sensitive conditions and activity limitations could potentially be associated with approximately 1.6 million averted hospitalizations and net cost savings of $13.6 billion annually. The results may inform US state, federal, and private-payer interest in expanding insurance coverage for MTMs among patients with diet-related chronic illness.

State-Level Variation In Low-Value Care For Commercially Insured And Medicare Advantage Populations.

Low-value care is a major source of health care inefficiency in the US. Our analysis of 2009-19 administrative claims data from OptumLabs Data Warehouse found that low-value care and associated spending remain prevalent among commercially insured and Medicare Advantage enrollees. The aggregated prevalence of twenty-three low-value services was 1,920 per 100,000 eligible enrollees, which amounted to $3.7 billion in wasteful expenditures during the study period. State-level variation in spending was greater than variation in utilization, and much of the variation in spending was driven by differences in average procedure prices. If the average price for twenty-three low-value services among the top ten states in spending were set to the national average, their spending would decrease by 19.8 percent (from $735,000 to $590,000 per 100,000 eligible enrollees). State-level actions to improve the routine measurement and reporting of low-value care could identify sources of variation and help design state-specific policies that lead to better patient-centered outcomes, enhanced equity, and more efficient spending.

Effect of the 2012 US Preventive Services Task Force Recommendations on Prostate-Specific Antigen Screening in a Medicare Advantage Population.

BACKGROUND: In 2012, the US Preventive Service Task Force revised its recommendations for prostate-specific antigen (PSA) screening from "insufficient evidence" to "do not recommend" for men aged 70-74 while maintaining "do not recommend" for men aged 75+. METHODS: Using the difference-in-difference approach, we evaluated whether the rate of change in the use of low-value PSA screening differed between the control group (men aged 75+, N=7,856,204 person-years) and the intervention group (men aged 70-74, N=5,329,192 person-years) enrolling in the Medicare Advantage plan without a history of prostate cancer within the OptumLabs Data Warehouse claims data (2009-2019). A generalized estimating equation logistic model was specified with independent variables: an intervention group indicator, a pre- and post-period (after 2012 Q2) indicator, index time, and interaction terms. We assumed a 12-month dissemination period. RESULTS: Before the revised recommendation in 2012, the trends did not significantly differ between the 2 age groups with the odds of receiving PSA screening decreasing by 1.2% (95% confidence interval [1.0, 1.4%]) per quarter. However, the odds of receiving PSA screening increased by 3.0% [2.8, 3.2%] per quarter across both groups since the revision. There was no significant additional change in the trend for those aged 70-74 (0.1% [-0.2, 0.5%]). CONCLUSIONS: Although the 2012 US Preventive Service Task Force's recommendations were expected to only change behaviors among men aged 70-74, our analysis found that men aged 70-74 and aged 75+ exhibited similar trends from 2009 to 2019, including the increased use of low-value PSA screening since 2016. Multifaceted efforts to discourage low-value PSA screening would be important for a sustained impact.

Emerging Therapies for COVID-19: The Value of Information From More Clinical Trials.

OBJECTIVES: The COVID-19 pandemic necessitates time-sensitive policy and implementation decisions regarding new therapies in the face of uncertainty. This study aimed to quantify consequences of approving therapies or pursuing further research: immediate approval, use only in research, approval with research (eg, emergency use authorization), or reject. METHODS: Using a cohort state-transition model for hospitalized patients with COVID-19, we estimated quality-adjusted life-years (QALYs) and costs associated with the following interventions: hydroxychloroquine, remdesivir, casirivimab-imdevimab, dexamethasone, baricitinib-remdesivir, tocilizumab, lopinavir-ritonavir, interferon beta-1a, and usual care. We used the model outcomes to conduct cost-effectiveness and value of information analyses from a US healthcare perspective and a lifetime horizon. RESULTS: Assuming a $100 000-per-QALY willingness-to-pay threshold, only remdesivir, casirivimab-imdevimab, dexamethasone, baricitinib-remdesivir, and tocilizumab were (cost-) effective (incremental net health benefit 0.252, 0.164, 0.545, 0.668, and 0.524 QALYs and incremental net monetary benefit $25 249, $16 375, $54 526, $66 826, and $52 378). Our value of information analyses suggest that most value can be obtained if these 5 therapies are approved for immediate use rather than requiring additional randomized controlled trials (RCTs) (net value $20.6 billion, $13.4 billion, $7.4 billion, $54.6 billion, and $7.1 billion), hydroxychloroquine (net value $198 million) is only used in further RCTs if seeking to demonstrate decremental cost-effectiveness and otherwise rejected, and interferon beta-1a and lopinavir-ritonavir are rejected (ie, neither approved nor additional RCTs). CONCLUSIONS: Estimating the real-time value of collecting additional evidence during the pandemic can inform policy makers and clinicians about the optimal moment to implement therapies and whether to perform further research.

Actions to Transform US Preventive Services Task Force Methods to Mitigate Systemic Racism in Clinical Preventive Services.

Importance: US life expectancy and health outcomes for preventable causes of disease have continued to lag in many populations that experience racism. Objective: To propose iterative changes to US Preventive Services Task Force (USPSTF) processes, methods, and recommendations and enact a commitment to eliminate health inequities for people affected by systemic racism. Design and Evidence: In February 2021, the USPSTF began operational steps in its work to create preventive care recommendations to address the harmful effects of racism. A commissioned methods report was conducted to inform this process. Key findings of the report informed proposed updates to the USPSTF methods to address populations adversely affected by systemic racism and proposed pilots on implementation of the proposed changes. Findings: The USPSTF proposes to consider the opportunity to reduce health inequities when selecting new preventive care topics and prioritizing current topics; seek evidence about the effects of systemic racism and health inequities in all research plans and public comments requested, and integrate available evidence into evidence reviews; and summarize the likely effects of systemic racism and health inequities on clinical preventive services in USPSTF recommendations. The USPSTF will elicit feedback from its partners and experts and proposed changes will be piloted on selected USPSTF topics. Conclusions and Relevance: The USPSTF has developed strategies intended to mitigate the influence of systemic racism in its recommendations. The USPSTF seeks to reduce health inequities and other effects of systemic racism through iterative changes in methods of developing evidence-based recommendations, with partner and public input in the activities to implement the advancements.

Cost-effectiveness Analysis of Nutrition Facts Added-Sugar Labeling and Obesity-Associated Cancer Rates in the US.

Importance: Obesity-associated cancer burdens are increasing in the US. Nutrition policies, such as the Nutrition Facts added-sugar labeling, may reduce obesity-associated cancer rates. Objective: To evaluate the cost-effectiveness of Nutrition Facts added-sugar labeling and obesity-associated cancer rates in the US. Design, Setting, and Participants: A probabilistic cohort state-transition model was used to conduct an economic evaluation of added-sugar labeling and 13 obesity-associated cancers among 235 million adults aged 20 years or older by age, sex, and race/ethnicity over a median follow-up of 34.4 years. Policy associations were considered in 2 scenarios: with consumer behaviors and with additional industry reformulation. The model integrated nationally representative population demographics, diet, and cancer statistics; associations of policy intervention with diet, diet change and body mass index, and body mass index with cancer risk; and policy and health-related costs from established sources. Data were analyzed from January 8, 2019, to May 6, 2020. Main Outcomes and Measures: Net costs and incremental cost-effectiveness ratio were estimated from societal and health care perspectives. Probabilistic sensitivity analyses incorporated uncertainty in input parameters and generated 95% uncertainty intervals (UIs). Results: Based on consumer behaviors, the policy was associated with a reduction of 30 000 (95% UI, 21 600-39 300) new cancer cases and 17 100 (95% UI, 12 400-22 700) cancer deaths, a gain of 116 000 (95% UI, 83 800-153 000) quality-adjusted life-years, and a saving of $1600 million (95% UI, $1190 million-$2030 million) in medical costs associated with cancer care among US adults over a lifetime. The policy was associated with a savings of $704 million (95% UI, $44.5 million-$1450 million) from the societal perspective and $1590 million (95% UI, $1180 million-$2020 million) from the health care perspective. Additional industry reformulation to reduce added-sugar amounts in packaged foods and beverages would double the impact. Greater health gains and cost savings were expected among young adults, women, and non-Hispanic Black individuals than other population subgroups. Conclusions and Relevance: These findings suggest that the added-sugar labeling is associated with reduced costs and lower rates of obesity-associated cancers. Policymakers may consider and prioritize nutrition policies for cancer prevention in the US.

Advance Care Planning in Older Adults with CKD: Patient, Care Partner, and Clinician Perspectives.

BACKGROUND: Older patients with advanced CKD are at high risk for serious complications and death, yet few discuss advance care planning (ACP) with their kidney clinicians. Examining barriers and facilitators to ACP among such patients might help identify patient-centered opportunities for improvement. METHODS: In semistructured interviews in March through August 2019 with purposively sampled patients (aged ≥70 years, CKD stages 4-5, nondialysis), care partners, and clinicians at clinics in across the United States, participants described discussions, factors contributing to ACP completion or avoidance, and perceived value of ACP. We used thematic analysis to analyze data. RESULTS: We conducted 68 semistructured interviews with 23 patients, 19 care partners, and 26 clinicians. Only seven of 26 (27%) clinicians routinely discussed ACP. About half of the patients had documented ACP, mostly outside the health care system. We found divergent ACP definitions and perspectives; kidney clinicians largely defined ACP as completion of formal documentation, whereas patients viewed it more holistically, wanting discussions about goals, prognosis, and disease trajectory. Clinicians avoided ACP with patients from minority groups, perceiving cultural or religious barriers. Four themes and subthemes informing variation in decisions to discuss ACP and approaches emerged: (1) role ambiguity and responsibility for ACP, (2) questioning the value of ACP, (3) confronting institutional barriers (time, training, reimbursement, and the electronic medical record, EMR), and (4) consequences of avoiding ACP (disparities in ACP access and overconfidence that patients' wishes are known). CONCLUSIONS: Patients, care partners, and clinicians hold discordant views about the responsibility for discussing ACP and the scope for it. This presents critical barriers to the process, leaving ACP insufficiently discussed with older adults with advanced CKD.

An Evidence Review of Low-Value Care Recommendations: Inconsistency and Lack of Economic Evidence Considered.

BACKGROUND: Low-value care, typically defined as health services that provide little or no benefit, has potential to cause harm, incur unnecessary costs, and waste limited resources. Although evidence-based guidelines identifying low-value care have increased, the guidelines differ in the type of evidence they cite to support recommendations against its routine use. OBJECTIVE: We examined the evidentiary rationale underlying recommendations against low-value interventions. DESIGN: We identified 1167 "low-value care" recommendations across five US organizations: the US Preventive Services Task Force (USPSTF), the "Choosing Wisely" Initiative, American College of Physicians (ACP), American College of Cardiology/American Heart Association (ACC/AHA), and American Society of Clinical Oncology (ASCO). For each recommendation, we classified the reported evidentiary rationale into five groups: (1) low economic value; (2) no net clinical benefit; (3) little or no absolute clinical benefit; (4) insufficient evidence; (5) no reason mentioned. We further investigated whether any cited or otherwise available cost-effectiveness evidence was consistent with conventional low economic value benchmarks (e.g., exceeding $100,000 per quality-adjusted life-year). RESULTS: Of the identified low-value care recommendations, Choosing Wisely contributed the most (N=582, 50%), followed by ACC/AHA (N=250, 21%). The services deemed "low value" differed substantially across organizations. "No net clinical benefit" (N=428, 37%) and "little or no clinical benefit" (N=296, 25%) were the most commonly reported reasons for classifying an intervention as low value. Consideration of economic value was less frequently reported (N=171, 15%). When relevant cost-effectiveness studies were available, their results were mostly consistent with low-value care recommendations. CONCLUSIONS: Our study found that evidentiary rationales for low-value care vary substantially, with most recommendations relying on clinical evidence. Broadening the evidence base to incorporate cost-effectiveness evidence can help refine the definition of "low-value" care to reflect whether an intervention's costs are worth the benefits. Developing a consensus grading structure on the strength and evidentiary rationale may help improve de-implementation efforts for low-value care.

Targeting of the diabetes prevention program leads to substantial benefits when capacity is constrained.

OBJECTIVE: Approximately 84 million people in the USA have pre-diabetes, but only a fraction of them receive proven effective therapies to prevent type 2 diabetes. We estimated the value of prioritizing individuals at highest risk of progression to diabetes for treatment, compared to non-targeted treatment of individuals meeting inclusion criteria for the Diabetes Prevention Program (DPP). METHODS: Using microsimulation to project outcomes in the DPP trial population, we compared two interventions to usual care: (1) lifestyle modification and (2) metformin administration. For each intervention, we compared targeted and non-targeted strategies, assuming either limited or unlimited program capacity. We modeled the individualized risk of developing diabetes and projected diabetic outcomes to yield lifetime costs and quality-adjusted life expectancy, from which we estimated net monetary benefits (NMB) for both lifestyle and metformin versus usual care. RESULTS: Compared to usual care, lifestyle modification conferred positive benefits and reduced lifetime costs for all eligible individuals. Metformin's NMB was negative for the lowest population risk quintile. By avoiding use when costs outweighed benefits, targeted administration of metformin conferred a benefit of $500 per person. If only 20% of the population could receive treatment, when prioritizing individuals based on diabetes risk, rather than treating a 20% random sample, the difference in NMB ranged from $14,000 to $20,000 per person. CONCLUSIONS: Targeting active diabetes prevention to patients at highest risk could improve health outcomes and reduce costs compared to providing the same intervention to a similar number of patients with pre-diabetes without targeted selection.

Screening for Intracranial Aneurysms in Coarctation of the Aorta: A Decision and Cost-Effectiveness Analysis.

BACKGROUND: Patients with coarctation of the aorta have a high prevalence of intracranial aneurysms (IA) and suffer subarachnoid hemorrhage (SAH) at younger ages than the general population. American Heart Association/American College of Cardiology guidelines recommend IA screening, but appropriate age and interval of screening and its effectiveness remain a critical knowledge gap. METHODS AND RESULTS: To evaluate the benefits and cost-effectiveness of magnetic resonance angiography screening for IA in patients with coarctation of the aorta, we developed and calibrated a Markov model to match published IA prevalence estimates. The primary outcome was the incremental cost-effectiveness ratio. Secondary outcomes included lifetime cumulative incidence of prophylactic IA treatment and mortality and SAH deaths prevented. Using a payer perspective, a lifetime horizon, and a willingness-to-pay of $150 000 per quality-adjusted life-year gained, we applied a 3% annual discounting rate to costs and effects and performed 1-way, 2-way, and probabilistic sensitivity analyses. In a simulated cohort of 10 000 patients, no screening resulted in a 10.1% lifetime incidence of SAH and 183 SAH-related deaths. Screening at ages 10, 20, and 30 years led to 978 prophylactic treatments for unruptured aneurysms, 19 procedure-related deaths, and 65 SAH-related deaths. Screening at ages 10, 20, and 30 years was cost-effective compared with screening at ages 10 and 20 years (incremental cost-effectiveness ratio $106 841/quality-adjusted life-year). Uncertainty in the outcome after aneurysm treatment and quality of life after SAH influenced the preferred screening strategy. In probabilistic sensitivity analysis, screening at ages 10, 20, and 30 years was cost-effective in 41% of simulations and at ages 10 and 20 in 59% of simulations. CONCLUSIONS: Our model supports the American Heart Association/American College of Cardiology recommendation to screen patients with coarctation of the aorta for IA and suggests screening at ages 10 and 20 or at 10, 20, and 30 years would extend life and be cost-effective.

Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left Heart Syndrome: A Decision Analysis.

BACKGROUND: Fetal aortic valvuloplasty (FAV) may prevent progression of midgestation aortic stenosis to hypoplastic left heart syndrome. However, FAV has well-established risks, and its survival benefit remains unknown. Our primary aim was to determine whether FAV for midgestation aortic stenosis increases survival from fetal diagnosis to age 6 years. METHODS AND RESULTS: We performed a retrospective analysis of 143 fetuses who underwent FAV from 2000 to 2017 and a secondary analysis of the Pediatric Heart Network Single Ventricle Reconstruction trial. Using these results, we developed a decision model to estimate probability of transplant-free survival from fetal diagnosis to age 6 years and postnatal restricted mean transplant-free survival time. FAV was technically successful in 84% of 143 fetuses with fetal demise in 8%. Biventricular circulation was achieved in 50% of 111 live-born infants with successful FAV but in only 16% of the 19 patients with unsuccessful FAV. The model projected overlapping probabilities of transplant-free survival to age 6 years at 75% (95% CI, 67%-82%) with FAV versus 72% (95% CI, 61%-82%) with expectant fetal management, resulting in a restricted mean transplant-free survival time benefit of 1.2 months. When limiting analyses to the improved FAV experience since 2009 to reflect current practice, (probability of technical success [94%], fetal demise [4%], and biventricular circulation [66%]), the model projected that FAV increased the probability of survival to age 6 years to 82% (95% CI, 73%-89%). Expectant management is favored if risk of fetal demise exceeded 12% or probability of biventricular circulation fell below 26%, but FAV remained favored over plausible recent range of technical success. CONCLUSIONS: Our model suggests that FAV provides a modest, medium-term survival benefit over expectant fetal management. Appropriate patient selection and low risk of fetal demise with FAV are critical factors for obtaining a survival benefit.

Cost-Effectiveness of a National Sugar-Sweetened Beverage Tax to Reduce Cancer Burdens and Disparities in the United States.

BACKGROUND: Sugar-sweetened beverage (SSB) consumption contributes to obesity, a risk factor for 13 cancers. Although SSB taxes can reduce intake, the health and economic impact on reducing cancer burdens in the United States are unknown, especially among low-income Americans with higher SSB intake and obesity-related cancer burdens. METHODS: We used the Diet and Cancer Outcome Model, a probabilistic cohort state-transition model, to project health gains and economic benefits of a penny-per-ounce national SSB tax on reducing obesity-associated cancers among US adults aged 20 years and older by income. RESULTS: A national SSB tax was estimated to prevent 22 075 (95% uncertainty interval [UI] = 16 040-28 577) new cancer cases and 13 524 (95% UI = 9841-17 681) cancer deaths among US adults over a lifetime. The policy was estimated to cost $1.70 (95% UI = $1.50-$1.95) billion for government implementation and $1.70 (95% UI = $1.48-$1.96) billion for industry compliance, while saving $2.28 (95% UI = $1.67-$2.98) billion cancer-related healthcare costs. The SSB tax was highly cost-effective from both a government affordability perspective (incremental cost-effectiveness ratio [ICER] = $1486, 95% UI = -$3516-$9265 per quality-adjusted life year [QALY]) and a societal perspective (ICER = $13 220, 95% UI = $3453-$28 120 per QALY). Approximately 4800 more cancer cases and 3100 more cancer deaths would be prevented, and $0.34 billion more healthcare cost savings would be generated among low-income (federal poverty-to-income ratio [FPIR] ≤ 1.85) than higher-income individuals (FPIR > 1.85). CONCLUSIONS: A penny-per-ounce national SSB tax is cost-effective for cancer prevention in the United States, with the largest health gains and economic benefits among low-income Americans.

Cost Effectiveness of Nutrition Policies on Processed Meat: Implications for Cancer Burden in the U.S.

INTRODUCTION: Processed meats are associated with increased risk of colorectal and stomach cancers, but health and economic impacts of policies to discourage processed meats are not well established. This paper aims to evaluate the cost effectiveness of implementing tax and warning labels on processed meats. METHODS: A probabilistic cohort-state transition model was developed in 2018, including lifetime and short-term horizons, healthcare, and societal perspectives, and 3% discount rates for costs and health outcomes. The model simulated 32 subgroups by age, gender, and race/ethnicity from the U.S. adult population and integrated nationally representative 2011-2014 data on processed meat consumption, with etiologic effects of processed meat consumption on cancer incidence, medical and indirect societal costs, and policy costs. RESULTS: Over a lifetime, the 10% excise tax would prevent 77,000 cases of colorectal cancer (95% uncertainty interval=56,800, 107,000) and 12,500 cases of stomach cancer (95% uncertainty interval=6,880, 23,900), add 593,000 quality-adjusted life years (95% uncertainty interval=419,000, 827,000), and generate net savings of $2.7 billion from a societal perspective, including $1.1 billion healthcare costs saved. The warning label policy would avert 85,400 cases of colorectal cancer (95% uncertainty interval=56,600, 141,000) and 15,000 cases of stomach cancer (95% uncertainty interval=6,860, 34,500), and add 660,000 quality-adjusted life years (95% uncertainty interval=418,000, 1,070,000), with net savings of $4.5 billion from a societal perspective, including $1.3 billion healthcare costs saved. In subgroup analyses, greater health and economic benefits accrued to (1) younger subpopulations, (2) subpopulations with greater cancer risk, and (3) those with higher baseline processed meat consumption. CONCLUSIONS: The model shows that implementing tax or warning labels on processed meats would be a cost-saving strategy with substantial health and economic benefits. The findings should encourage policy makers to consider nutrition-related policies to reduce cancer burden.

Screening for Pancreatic Cancer: US Preventive Services Task Force Reaffirmation Recommendation Statement.

Importance: Pancreatic cancer is an uncommon cancer with an age-adjusted annual incidence of 12.9 cases per 100 000 person-years. However, the death rate is 11.0 deaths per 100 000 person-years because the prognosis of pancreatic cancer is poor. Although its incidence is low, pancreatic cancer is the third most common cause of cancer death in the United States. Because of the increasing incidence of pancreatic cancer, along with improvements in early detection and treatment of other types of cancer, it is estimated that pancreatic cancer may soon become the second-leading cause of cancer death in the United States. Objective: To update the 2004 US Preventive Services Task Force (USPSTF) recommendation on screening for pancreatic cancer. Evidence Review: The USPSTF reviewed the evidence on the benefits and harms of screening for pancreatic cancer, the diagnostic accuracy of screening tests for pancreatic cancer, and the benefits and harms of treatment of screen-detected or asymptomatic pancreatic cancer. Findings: The USPSTF found no evidence that screening for pancreatic cancer or treatment of screen-detected pancreatic cancer improves disease-specific morbidity or mortality, or all-cause mortality. The USPSTF found adequate evidence that the magnitude of the benefits of screening for pancreatic cancer in asymptomatic adults can be bounded as no greater than small. The USPSTF found adequate evidence that the magnitude of the harms of screening for pancreatic cancer and treatment of screen-detected pancreatic cancer can be bounded as at least moderate. The USPSTF reaffirms its previous conclusion that the potential benefits of screening for pancreatic cancer in asymptomatic adults do not outweigh the potential harms. Conclusions and Recommendation: The USPSTF recommends against screening for pancreatic cancer in asymptomatic adults. (D recommendation).