Estimating the Impact of COVID-19 on Changes in Volume Sales of Cigars, Smokeless Tobacco Products, Pipe, and Roll-your-own Tobacco in the United States.

INTRODUCTION: We examined the potential impact of COVID-19 on trends in volume sales of non-cigarette combustible and smokeless tobacco products in the United States. AIMS AND METHODS: We analyzed monthly national sales for cigars, smokeless tobacco, pipe, and roll-your-own tobacco during June 2019-June 2021. Data were from the U.S Department of the Treasury. Interrupted time-series were used to measure associations of the COVID-19 "shock" (taken as June 2020 or 6 months after the first diagnosis of COVID-19 in the United States) and volume sales. Negative binomial regression was used to evaluate associations between volume sales and changes in community mobility. RESULTS: Within interrupted time-series analysis, the shock of the COVID-19 pandemic was associated with an initial increase in the number of little cigars sold by 11.43 million sticks (p < .01), with no significant sustained change in trend. The COVID-19 shock was also associated with an initial increase in large cigar volume sales by 59.02 million sticks, followed by a subsequent decrease by 32.57 million sticks per month (p = .005). Every 10% reduction in mobility to retail stores was significantly associated with reduced volume sales of little cigars (IRR = 0.84, 95% CI, 0.71 to 0.98) and large cigars (IRR = 0.92, 95% CI, 0.88 to 0.96). Other findings were statistically nonsignificant. CONCLUSIONS: COVID-19 was associated with increased volume sales for cigars and there was a significant association between reduced mobility to points of sale and reduced cigar volume sales. Intensified efforts are needed to prioritize evidence-based tobacco prevention and control efforts amidst the pandemic.

Cost-Effectiveness of Providing the Depression Care for People With Cancer Program to Patients With Prostate Cancer in the United States.

OBJECTIVES: The Depression Care for People with Cancer program (DCPC) is a cost-effective depression care model for UK patients with cancer. However, DCPC's cost-effectiveness in the United States is unknown, particularly for patients with prostate cancer in the United States. This study evaluates the health and economic impact of providing DCPC to patients with prostate cancer. METHODS: DCPC was compared with usual care in a mathematical model that simulates depression and its outcomes in a hypothetical cohort of US patients with prostate cancer. DCPC was modeled as a sequential combination of universal depression screening, post-screening evaluations, and first-line combination therapy. Primary outcomes were lifetime direct costs of depression care, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios. Secondary outcomes included life expectancy, number of depression-free months and lifetime depressive episodes, duration of depressive episodes, cumulative incidence of depression, lifetime depression diagnoses/misdiagnoses, and the cumulative incidence of maintenance therapy for depression. Sensitivity analyses were used to examine uncertainty. RESULTS: In the base case, DCPC dominated usual care by offering 0.11 more QALYs for $2500 less per patient (from averted misdiagnoses). DCPC also offered 5 extra depression-free months, shorter depressive episodes, and a lower chance of maintenance therapy. DCPC's trade-offs were a higher cumulative incidence of depression and more lifetime depressive episodes. Life expectancy was identical under usual care and DCPC. Sensitivity analyses indicate that DCPC was almost always preferable to usual care. CONCLUSION: Compared with usual care, DCPC may offer more value to US patients with prostate cancer. DCPC should be considered for inclusion in prostate cancer survivorship care guidelines.

Mapping the Memorial Anxiety Scale for Prostate Cancer to the SF-6D.

PURPOSE: To create a crosswalk that predicts Short Form 6D (SF-6D) utilities from Memorial Anxiety Scale for Prostate Cancer (MAX-PC) scores. METHODS: The data come from prostate cancer patients enrolled in the North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study (NC ProCESS, N = 1016). Cross-sectional data from 12- to 24-month follow-up were used as estimation and validation datasets, respectively. Participants' SF-12 scores were used to generate SF-6D utilities in both datasets. Beta regression mixture models were used to evaluate SF-6D utilities as a function of MAX-PC scores, race, education, marital status, income, employment status, having health insurance, year of cancer diagnosis and clinically significant prostate cancer-related anxiety (PCRA) status in the estimation dataset. Models' predictive accuracies (using mean absolute error [MAE], root mean squared error [RMSE], Akaike information criterion [AIC] and Bayesian information criterion [BIC]) were examined in both datasets. The model with the highest prediction accuracy and the lowest prediction errors was selected as the crosswalk. RESULTS: The crosswalk had modest prediction accuracy (MAE = 0.092, RMSE = 0.114, AIC = - 2708 and BIC = - 2595.6), which are comparable to prediction accuracies of other SF-6D crosswalks in the literature. About 24% and 52% of predictions fell within ± 5% and ± 10% of observed SF-6D, respectively. The observed mean disutility associated with acquiring clinically significant PCRA is 0.168 (standard deviation = 0.179). CONCLUSION: This study provides a crosswalk that converts MAX-PC scores to SF-6D utilities for economic evaluation of clinically significant PCRA treatment options for prostate cancer survivors.

Prevalence and predictors of probable depression in prostate cancer survivors.

BACKGROUND: The early diagnosis and treatment of depression are cancer care priorities. These priorities are critical for prostate cancer survivors because men rarely seek mental health care. However, little is known about the epidemiology of depression in this patient population. The goal of this study was to describe the prevalence and predictors of probable depression in prostate cancer survivors. METHODS: The data were from a population-based cohort of North Carolinian prostate cancer survivors who were enrolled from 2004 to 2007 in the North Carolina-Louisiana Prostate Cancer Project (n = 1031) and were prospectively followed annually from 2008 to 2011 in the Health Care Access and Prostate Cancer Treatment in North Carolina study (n = 805). Generalized estimating equations were used to evaluate an indicator of probable depression (Short Form 12 mental composite score ≤48.9; measured at enrollment and during the annual follow-up) as a function of individual-level characteristics within the longitudinal data set. RESULTS: The prevalence of probable depression fell from 38% in the year of the cancer diagnosis to 20% 6 to 7 years later. Risk factors for probable depression throughout the study were African American race, unemployment, low annual income, younger age, recency of cancer diagnosis, past depression, comorbidities, treatment decisional regret, and nonadherence to exercise recommendations. CONCLUSIONS: Depression is a major challenge for prostate cancer survivors, particularly in the first 5 years after the cancer diagnosis. To the authors' knowledge, this is the first study to demonstrate an association between treatment decisional regret and probable depression.

Cost effectiveness of neoadjuvant chemotherapy followed by interval cytoreductive surgery versus primary cytoreductive surgery for patients with advanced stage ovarian cancer during the initial treatment phase.

OBJECTIVE: Advanced stage epithelial ovarian cancer (AEOC) can be treated with either neoadjuvant chemotherapy (NACT) or primary cytoreductive surgery (PCS). Although randomized controlled trials show that NACT is non-inferior in overall survival compared to PCS, there may be improvement in short-term morbidity. We sought to investigate the cost-effectiveness of NACT relative to PCS for AEOC from the US Medicare perspective. METHODS: A cost-effectiveness analysis using a Markov model with a 7-month time horizon comparing (1) 3cycles of NACT with carboplatin and paclitaxel (CT), followed by interval cytoreductive surgery, then 3 additional cycles of CT, or (2) PCS followed by 6cycles of CT. Input parameters included probability of chemotherapy complications, surgical complications, treatment completion, treatment costs, and utilities. Model outcomes included costs, life-years gained, quality-adjusted life-years (QALYs) gained, and incremental cost-effectiveness ratios (ICER), in terms of cost per life-year gained and cost per QALY gained. We accounted for differences in surgical complexity by incorporating the cost of additional procedures and the probability of undergoing those procedures. Probabilistic sensitivity analysis (PSA) was performed via Monte Carlo simulations. RESULTS: NACT resulted in a savings of $7034 per patient with a 0.035 QALY increase compared to PCS; therefore, NACT dominated PCS in the base case analysis. With PSA, NACT was the dominant strategy more than 99% of the time. CONCLUSIONS: In the short-term, NACT is a cost-effective alternative compared to PCS in women with AEOC. These results may translate to longer term cost-effectiveness; however, data from randomized control trials continues to mature.

The spillover effect of midwife attrition from the Nigerian midwives service scheme.

BACKGROUND: The Nigerian Midwives Service Scheme (MSS) increased use of antenatal services at rural public sector clinics. However, it is unclear if women who would not have otherwise sought care, or those who would have sought care in rural private sector clinics caused this change. Additionally, it is also unclear if the reported midwife attrition was associated with a spillover of the scheme's effect on urban areas. We sought to answer these two questions using data from two nationally representative surveys. METHODS: We used an interrupted time series model to assess trends in the use of obstetric (i.e. antenatal and delivery) services among rural and urban respondents in the 2008 and 2013 Nigerian demographic and health surveys. RESULTS: We found that the MSS led to a 5-percentage point increase in the use of antenatal services at rural public sector clinics, corroborating findings from a previous study. This change was driven by women who would not have sought care otherwise. We also found that there was a 4-percentage point increase in the use of delivery services at urban public sector clinics, and a concurrent 4-percentage point decrease in urban home deliveries. These changes are most likely explained by midwives' attrition and exemplify a spillover of the scheme's effect. CONCLUSION: Midwife attrition from the Nigerian MSS was associated with a spillover of the scheme's effect on the use of delivery services, on urban areas.

Cost Utility Analysis of Topical Steroids Compared With Dietary Elimination for Treatment of Eosinophilic Esophagitis.

BACKGROUND & AIMS: Topical corticosteroids or dietary elimination are recommended as first-line therapies for eosinophilic esophagitis, but data to directly compare these therapies are scant. We performed a cost utility comparison of topical corticosteroids and the 6-food elimination diet (SFED) in treatment of eosinophilic esophagitis, from the payer perspective. METHODS: We used a modified Markov model based on current clinical guidelines, in which transition between states depended on histologic response simulated at the individual cohort-member level. Simulation parameters were defined by systematic review and meta-analysis to determine the base-case estimates and bounds of uncertainty for sensitivity analysis. Meta-regression models included adjustment for differences in study and cohort characteristics. RESULTS: In the base-case scenario, topical fluticasone was about as effective as SFED but more expensive at a 5-year time horizon ($9261.58 vs $5719.72 per person). SFED was more effective and less expensive than topical fluticasone and topical budesonide in the base-case scenario. Probabilistic sensitivity analysis revealed little uncertainty in relative treatment effectiveness. There was somewhat greater uncertainty in the relative cost of treatments; most simulations found SFED to be less expensive. CONCLUSIONS: In a cost utility analysis comparing topical corticosteroids and SFED for first-line treatment of eosinophilic esophagitis, the therapies were similar in effectiveness. SFED was on average less expensive, and more cost effective in most simulations, than topical budesonide and topical fluticasone, from a payer perspective and not accounting for patient-level costs or quality of life.

Cost-effectiveness of Prophylaxis Against Pneumocystis jiroveci Pneumonia in Patients with Crohn's Disease.

BACKGROUND: Emerging evidence suggests that Pneumocystis jiroveci pneumonia is occurring more frequently in Crohn's disease patients on immunosuppressive medications, especially corticosteroids. Considering its excess mortality and the efficacy of chemoprophylaxis in reducing P. jiroveci pneumonia in acquired immunodeficiency syndrome, there is debate without consensus on the need for chemoprophylaxis in Crohn's disease patients on corticosteroids. AIMS: We sought to address this debate using insights from simulation modeling. METHODS: We used a Markov microsimulation model to simulate the natural history of Crohn's disease in 1 million virtual patients receiving appropriate care and who faced P. jiroveci pneumonia risks that varied with corticosteroid use. We examined several chemoprophylaxis strategies and compared their population-level economic and clinical impact using various indices including costs, quality-adjusted life expectancy, and incremental cost-effectiveness ratios. We also performed several nested probabilistic sensitivity analyses to estimate the health and economic impact of chemoprophylaxis in patients on triple immunosuppressive therapy. RESULTS: At the current PJP incidence, no PJP chemoprophylaxis was the preferred strategy from a population perspective. Considered chemoprophylactic strategies led to higher average costs and fewer P. jiroveci pneumonia cases. However, they also led to lower average quality-adjusted life expectancy and were thus dominated. Nevertheless, these alternative strategies became preferred with progressively higher risks of P. jiroveci pneumonia. Our results also suggest that PJP chemoprophylaxis may be cost-effective in patients on triple immunosuppressive therapy. CONCLUSION: Our findings support a case-by-case consideration of P. jiroveci pneumonia chemoprophylaxis in Crohn's disease patients receiving corticosteroids.

Assessing health and economic outcomes of interventions to reduce pregnancy-related mortality in Nigeria.

BACKGROUND: Women in Nigeria face some of the highest maternal mortality risks in the world. We explore the benefits and cost-effectiveness of individual and integrated packages of interventions to prevent pregnancy-related deaths. METHODS: We adapt a previously validated maternal mortality model to Nigeria. Model outcomes included clinical events, population measures, costs, and cost-effectiveness ratios. Separate models were adapted to Southwest and Northeast zones using survey-based data. Strategies consisted of improving coverage of effective interventions, and could include improved logistics. RESULTS: Increasing family planning was the most effective individual intervention to reduce pregnancy-related mortality, was cost saving in the Southwest zone and cost-effective elsewhere, and prevented nearly 1 in 5 abortion-related deaths. However, with a singular focus on family planning and safe abortion, mortality reduction would plateau below MDG 5. Strategies that could prevent 4 out of 5 maternal deaths included an integrated and stepwise approach that includes increased skilled deliveries, facility births, access to antenatal/postpartum care, improved recognition of referral need, transport, and availability quality of EmOC in addition to family planning and safe abortion. The economic benefits of these strategies ranged from being cost-saving to having incremental cost-effectiveness ratios less than $500 per YLS, well below Nigeria's per capita GDP. CONCLUSIONS: Early intensive efforts to improve family planning and control of fertility choices, accompanied by a stepwise effort to scale-up capacity for integrated maternal health services over several years, will save lives and provide equal or greater value than many public health interventions we consider among the most cost-effective (e.g., childhood immunization).

Estimating the Impact of Delayed Access to Oncology Drugs on Patient Outcomes in Canada.

INTRODUCTION: New requirements in Canada's pricing processes for patented drugs may exacerbate delays in regulatory and reimbursement reviews. This study seeks to better understand the impact of any additional delays on non-small cell lung cancer (NSCLC) patients by measuring the following: (a) durations and outcomes of regulatory and reimbursement reviews of NSCLC drugs in Canada and reference countries; (b) delays in Canada's reviews of three NSCLC drugs (nivolumab, afatinib, and pemetrexed [NAP]); and (c) estimating clinical, patient, and economic impacts of delays in Canada's reviews on access to NAP. METHODS: Information from the Context Matters database and the literature (2005-2020) was used to evaluate the durations and outcomes of reimbursement reviews of NSCLC drugs in Canada and comparator countries. Public information was used to assess delays in Canada's reviews of NAP. Empirical modeling with data from the literature and the Southern Alberta Lung Cancer database was used to estimate the impact of delays in Canada's NAP reviews on patients (i.e., as losses in person-years of life and quality-adjusted life-years [QALYs]). RESULTS: Regulatory and reimbursement reviews in countries of interest take 12-18 months. In Canada, reviews of NSCLC drugs took 216 days (median), with a 24% rejection rate (mean = 19%). Delays in NAP reviews ranged from 5 to 94 days at Health Canada, 0-80 days at CADTH/pCODR, and 12-797 days in Canadian provinces. These delays may have affected 6400 patients, who lost up to 1740 person-years of life and 1122 QALYs (valued at CA$112 million). CONCLUSION: Changes to Canada's prescription drug pricing processes may prolong reviews.

Patient-provider discussion about emotional and social needs, mental health outcomes, and benefit finding among U.S. Adults living with cancer.

BACKGROUND: A discussion about patient's nonmedical needs during treatment is considered a crucial component of high-quality patient-provider communication. We examined whether having a patient-provider discussion about cancer patients' emotional and social needs is associated with their psychological well-being. METHODS: Using the 2016-2017 Medical Expenditure Panel Survey-Experiences with Cancer Survivorship Supplement (MEPS-ECSS) data, we identified the cancer survivors in the United States (US) who reported having a detailed discussion about emotional and social needs during cancer care. We used multivariable logistic regression to assess the association between having a patient-provider discussion and the patients' psychological well-being outcomes (depressive symptoms, severe psychological distress, and worrying about cancer recurrence/worsening condition) and benefit finding experience after a cancer diagnosis. RESULTS: Among 1433 respondents (equivalent to 13.8 million cancer survivors in the US), only 33.6% reported having a detailed patient-provider discussion about their emotional and social needs. Having a discussion was associated with 55% lower odds (odds ratio [OR], 0.45; 95% confidence interval [CI], 0.26-0.77) of having depressive symptoms and 97% higher odds (OR, 1.97; 95% CI, 1.46-2.66) of having benefit finding experience. There was no statistically significant association between patient-provider discussion and psychological distress or worrying about cancer recurrence/worsening. CONCLUSION: Detailed patient-provider discussion about the cancer patients' emotional and social needs was associated with a lower likelihood of depressive symptoms and a higher likelihood of experiencing benefit finding. These findings stress the importance of improving the patient-provider discussion about psychosocial needs in cancer survivorship.

Associations of Government-Mandated Closures and Restrictions With Aggregate Mobility Trends and SARS-CoV-2 Infections in Nigeria.

Importance: To prepare for future coronavirus disease 2019 (COVID-19) waves, Nigerian policy makers need insights into community spread of COVID-19 and changes in rates of infection associated with government-mandated closures and restrictions. Objectives: To measure the association of closures and restrictions with aggregate mobility and the association of mobility with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections and to characterize community spread of COVID-19. Design, Setting, and Participants: This cross-sectional study used aggregated anonymized mobility data from smartphone users in Nigeria who opted to provide location history (from a pool of up to 40 million individuals) collected between February 27 and July 21, 2020. The analyzed data included daily counts of confirmed SARS-CoV-2 infections and daily changes in aggregate mobility across 6 categories: retail and recreation, grocery and pharmacy, parks, transit stations, workplaces, and residential. Closures and restrictions were initiated on March 30, 2020, and partially eased on May 4, 2020. Main Outcomes and Measures: Interrupted time series were used to measure associations of closures and restrictions with aggregate mobility. Negative binomial regression was used to evaluate associations between confirmed SARS-CoV-2 infections and mobility categories. Averted infections were estimated by subtracting cumulative confirmed infections from estimated infections assuming no closures and restrictions. Results: Closures and restrictions had negative associations with mean change in daily aggregate mobility in retail and recreation (-46.87 [95% CI, -55.98 to -37.76] percentage points; P < .001), grocery and pharmacy (-28.95 [95% CI, -40.12 to -17.77] percentage points; P < .001), parks (-43.59 [95% CI, -49.89 to -37.30] percentage points; P < .001), transit stations (-47.44 [95% CI, -56.70 to -38.19] percentage points; P < .001), and workplaces (-53.07 [95% CI, -67.75 to -38.39] percentage points; P < .001) and a positive association with mobility in residential areas (24.10 [95% CI, 19.14 to 29.05] percentage points; P < .001). Most of these changes reversed after closures and restrictions were partially eased (retail and recreation: 14.63 [95% CI, 10.95 to 18.30] percentage points; P < .001; grocery and pharmacy: 15.29 [95% CI, 10.90 to 19.67] percentage points; P < .001; parks: 6.48 [95% CI, 3.98 to 8.99] percentage points; P < .001; transit stations: 17.93 [95% CI, 14.03 to 21.83] percentage points; P < .001; residential: -5.59 [95% CI, -9.08 to -2.09] percentage points; P = .002). Additionally, every percentage point increase in aggregate mobility was associated with higher incidences of SARS-CoV-2 infection in residential areas (incidence rate ratio [IRR], 1.03 [95% CI, 1.00 to 1.07]; P = .04), transit stations (IRR, 1.02 [95% CI, 1.00 to 1.03]; P = .008), and workplaces (IRR, 1.01 [95% CI, 1.00 to 1.02]; P = .04). Lastly, closures and restrictions may have been associated with averting up to 5.8 million SARS-CoV-2 infections over the study period. Conclusions and Relevance: In this cross-sectional study, closures and restrictions had significant associations with aggregate mobility and were associated with decreased SARS-CoV-2 infections. These findings suggest that future anticontagion measures need better infection control and contact tracing in residential areas, transit stations, and workplaces.

Combination of Interventions Needed to Improve Maternal Healthcare Utilization: A Multinomial Analysis of the Inequity in Place of Childbirth in Afghanistan.

Giving birth with a skilled birth attendant at a facility that provides emergency obstetric care services has better outcomes, but many women do not have access to these services in low- and middle-income countries. Individual, household, and societal factors influence women's decisions about place of birth. Factors influencing birthplace preference by type of provider and level of public facility are not well understood. Applying the Andersen Behavioral Model of healthcare services use, we explored the association between characteristics of women and their choice of childbirth location using a multinomial logistic regression, and conducted a scenario analysis to predict changes in the childbirth location by imposing various interventions. Most women gave birth at home (68.1%), while 15.1% gave birth at a public clinic, 12.1% at a public hospital, and 4.7% at a private facility. Women with higher levels of education, from households in the upper two wealth quintiles, and who had any antenatal care were more likely to give birth in public or private facilities than at home. A combination of multisector interventions had the strongest signals from the model for increasing the predicted probability of in-facility childbirths. This study enhances our understanding of factors associated with the use of public facilities and the private sector for childbirth in Afghanistan. Policymakers and healthcare providers should seek to improve equity in the delivery of health services. This study highlights the need for decisionmakers to consider a combination of multisector efforts (e.g., health, education, and social protection), to increase equitable use of maternal healthcare services.

Associations between prostate cancer-related anxiety and health-related quality of life.

BACKGROUND: There are uncertainties about prostate cancer-related anxiety's (PCRA) associations with health-related quality of life (HRQOL) and major depression, and these could affect the quality of mental healthcare provided to prostate cancer patients. Addressing these uncertainties will provide more insight into PCRA and inform further research on the value of PCRA prevention. The goals of this study were to measure associations between PCRA and HRQOL at domain and subdomain levels, and to evaluate the association between PCRA and probable (ie, predicted major) depression. METHOD: We analyzed secondary cross-sectional data from the North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study (NC ProCESS-a population-based cohort of prostate cancer patients enrolled shortly after diagnosis [between January 2011 and June 2013] and followed prospectively). Patient-reported measures of PCRA and HRQOL from 1,016 enrollees who participated in NC ProCESS's 1-year follow-up survey were assessed. Outcomes of interests were a) linear correlations between contemporaneous memorial anxiety scale for prostate cancer (MAX-PC) and Short Form 12 (SF-12) scores, and b) measures of association between indicators of clinically significant PCRA (ie, MAX-PC > 27) and probable depression during survey contact (ie, SF-12 mental component score ≤43). RESULTS: PCRA measures had notable associations with SF-12's mental health subscale (assesses low mood/nervousness [rho = -0.42]) and emotional role functioning subscale (assesses subjective productivity loss [rho = -0.46]). Additionally, the risk of probable depression was significantly higher in participants with clinically significant PCRA compared with those without it (weighed risk ratio = 5.3, 95% confidence interval 3.6-7.8; P < .001). CONCLUSION: Prostate cancer patients with clinically significant PCRA should be assessed for major depression and productivity loss.

The economic impact of substandard and falsified antimalarial medications in Nigeria.

INTRODUCTION: Substandard and falsified medications pose significant risks to global health. Nearly one in five antimalarials circulating in low- and middle-income countries are substandard or falsified. We assessed the health and economic impact of substandard and falsified antimalarials on children under five in Nigeria, where malaria is endemic and poor-quality medications are commonplace. METHODS: We developed a dynamic agent-based SAFARI (Substandard and Falsified Antimalarial Research Impact) model to capture the impact of antimalarial use in Nigeria. The model simulated children with background characteristics, malaria infections, patient care-seeking, disease progression, treatment outcomes, and incurred costs. Using scenario analyses, we simulated the impact of substandard and falsified medicines, antimalarial resistance, as well as possible interventions to improve the quality of treatment, reduce stock-outs, and educate caregivers about antimalarial quality. RESULTS: We estimated that poor quality antimalarials are responsible for 12,300 deaths and $892 million ($890-$893 million) in costs annually in Nigeria. If antimalarial resistance develops, we simulated that current costs of malaria could increase by $839 million (11% increase, $837-$841 million). The northern regions of Nigeria have a greater burden as compared to the southern regions, with 9,700 deaths and $698 million ($697-$700 million) in total economic losses annually due to substandard and falsified antimalarials. Furthermore, our scenario analyses demonstrated that possible interventions-such as removing stock-outs in all facilities ($1.11 billion), having only ACTs available for treatment ($594 million), and 20% more patients seeking care ($469 million)-can save hundreds of millions in costs annually in Nigeria. CONCLUSIONS: The results highlight the significant health and economic burden of poor quality antimalarials in Nigeria, and the impact of potential interventions to counter them. In order to reduce the burden of malaria and prevent antimalarials from developing resistance, policymakers and donors must understand the problem and implement interventions to reduce the impact of ineffective and harmful antimalarials.

Comparison of the Harms, Advantages, and Costs Associated With Alternative Guidelines for the Evaluation of Hematuria.

IMPORTANCE: Existing recommendations for the diagnostic testing of hematuria range from uniform evaluation of varying intensity to patient-level risk stratification. Concerns have been raised about not only the costs and advantages of computed tomography (CT) scans but also the potential harms of CT radiation exposure. OBJECTIVE: To compare the advantages, harms, and costs associated with 5 guidelines for hematuria evaluation. DESIGN, SETTING, AND PARTICIPANTS: A microsimulation model was developed to assess each of the following guidelines (listed in order of increasing intensity) for initial evaluation of hematuria: Dutch, Canadian Urological Association (CUA), Kaiser Permanente (KP), Hematuria Risk Index (HRI), and American Urological Association (AUA). Participants comprised a hypothetical cohort of patients (n = 100 000) with hematuria aged 35 years or older. This study was conducted from August 2017 through November 2018. EXPOSURES: Under the Dutch and CUA guidelines, patients received cystoscopy and ultrasonography if they were 50 years or older (Dutch) or 40 years or older (CUA). Under the KP and HRI guidelines, patients received different combinations of cystoscopy, ultrasonography, and CT urography or no evaluation on the basis of risk factors. Under the AUA guidelines, all patients 35 years or older received cystoscopy and CT urography. MAIN OUTCOMES AND MEASURES: Urinary tract cancer detection rates, radiation-induced secondary cancers (from CT radiation exposure), procedural complications, false-positive rates per 100 000 patients, and incremental cost per additional urinary tract cancer detected. RESULTS: The simulated cohort included 100 000 patients with hematuria, aged 35 years or older. A total of 3514 patients had urinary tract cancers (estimated prevalence, 3.5%; 95% CI, 3.0%-4.0%). The AUA guidelines missed detection for the fewest number of cancers (82 [2.3%]) compared with the detection rate of the HRI (116 [3.3%]) and KP (130 [3.7%]) guidelines. However, the simulation model projected 108 (95% CI, 34-201) radiation-induced cancers under the KP guidelines, 136 (95% CI, 62-229) under the HRI guidelines, and 575 (95% CI, 184-1069) under the AUA guidelines per 100 000 patients. The CUA and Dutch guidelines missed detection for a larger number of cancers (172 [4.9%] and 251 [7.1%]) but had 0 radiation-induced secondary cancers. The AUA guidelines cost approximately double the other 4 guidelines ($939/person vs $443/person for Dutch guidelines), with an incremental cost of $1 034 374 per urinary tract cancer detected compared with that of the HRI guidelines. CONCLUSIONS AND RELEVANCE: In this simulation study, uniform CT imaging for patients with hematuria was associated with increased costs and harms of secondary cancers, procedural complications, and false positives, with only a marginal increase in cancer detection. Risk stratification may optimize the balance of advantages, harms, and costs of CT.

Patterns and predictors of self-reported clinical diagnosis and treatment for depression in prostate cancer survivors.

BACKGROUND: Appropriate depression care is a cancer-care priority. However, many cancer survivors live with undiagnosed and untreated depression. Prostate cancer survivors may be particularly vulnerable, but little is known about their access to depression care. The goal of this study was to describe patterns and predictors of clinical diagnosis and treatment of depression in prostate cancer survivors. METHODS: Generalized estimating equations were used to evaluate indicators of self-reported clinical diagnosis and treatment depression as a function of individual-level characteristics within a longitudinal dataset. The data were from a population-based cohort of North Carolinian prostate cancer survivors who were enrolled from 2004 to 2007 on the North Carolina-Louisiana Prostate Cancer Project (N = 1,031), and prospectively followed annually from 2008 to 2011 on the Health Care Access and Prostate Cancer Treatment in North Carolina (N = 805). RESULTS: The average rate of self-reported clinical diagnosis of depression was 44% (95% CI: 39%-49%), which declined from 60% to 40% between prostate cancer diagnosis and 5-7 years later. Factors associated with lower odds of self-reported clinical diagnosis of depression include African-American race, employment, age at enrollment, low education, infrequent primary care visits, and living with a prostate cancer diagnosis for more than 2 years. The average rate of self-reported depression treatment was 62% (95% CI: 55%-69%). Factors associated with lower odds of self-reported depression treatment included employment and living with a prostate cancer diagnosis for 2 or more years. CONCLUSION: Prostate cancer survivors experience barriers when in need of depression care.

The Value of Vedolizumab as Rescue Therapy in Moderate-Severe Crohn's Disease Patients with Adalimumab Non-response in the USA.

BACKGROUND AND AIMS: In May 2014, vedolizumab was approved by the Food and Drug Administration for the treatment of moderate-to-severe Crohn's disease. In clinical practice it is typically used in patients who are primary or secondary non-responders to adalimumab [Humira]. We aim to estimate the incremental benefits and costs of using vedolizumab as rescue therapy for adalimumab non-responders. METHODS: A Markov model was used to simulate the clinical course of Crohn's disease in a hypothetical cohort of 10,000 patients over a 12-month period. The treatment strategies evaluated were adalimumab only [with and without dose intensification] and adalimumab and vedolizumab [with and without adalimumab dose intensification]. The base case strategy was adalimumab only with 25% of non-responders undergoing dose intensification. Our primary outcomes were changes in costs and quality of life measures over the analytical horizon. RESULTS: In a 1-year period, initiating vedolizumab as rescue therapy in adalimumab non-responders reduces the average total cost per patient by 10%, and increases the average amount of time spent in remission or mild disease by up to 2 months. CONCLUSIONS: Treating on-label adalimumab non-responders with vedolizumab can, in the short term, significantly improves the quality of life of Crohn's disease patients that do not respond to adalimumab.

Cost-effectiveness of nonmelanoma skin cancer screening in Crohn's disease patients.

BACKGROUND: Several studies have demonstrated an increased risk of nonmelanoma skin cancer (NMSC) in patients with inflammatory bowel disease, with the greatest risk in patients with Crohn's disease (CD). We investigated the cost-effectiveness of NMSC screening in patients with CD. METHODS: A mathematical model was used to compare lifetime costs, life expectancies, and benefits of NMSC screening in a hypothetical cohort of 100,000 patients with CD. Strategies studied include: (1) Treat NMSC cases as they present and follow affected patients annually; (2) Screen patients with CD annually once they turn 50 years old, treat NMSC cases as they present and follow affected patients annually; (3) Screen patients with CD annually once they start receiving thiopurines, treat NMSC cases as they present and follow affected patients annually; (4) Screen patients with CD annually when they turn 50 years old or start receiving thiopurines, treat NMSC cases as they present, and follow affected patients annually; (5) Screen all patients with CD annually. These strategies were then studied on a biennial basis, accounting for 10 competing strategies. RESULTS: Screening all patients with CD annually proved the most cost-effective strategy with an average lifetime cost of more than $333,000, a quality-adjusted life expectancy of about 26 QALYs (95% confidence interval: 22-29), ICER of $3263/QALY, and led to early detection of about 94% of incident NMSC cases. The next best strategy was screening all CD patients biennially with an average lifetime cost of more than $328,000 with 24.5 QALYs (95% confidence interval: 21-25). Only 47% of new NMSC cases were detected early with this strategy. CONCLUSION: At a willingness-to-pay threshold of $50,000, screening all patients with CD annually for NMSC proved the most cost-effective strategy.