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Are National Comprehensive Cancer Network Evidence Block Affordability Ratings Representative of Real-World Costs? An Evaluation of Advanced Non-Small-Cell Lung Cancer

J Oncol Pract

2019 Ramsey, Scott D, MD, PhD Scott Ramsey

PURPOSE: The National Comprehensive Cancer Network (NCCN) developed the Evidence Blocks framework to assess the value of oncology regimens. This study characterizes the relationship between real-world costs and NCCN affordability ratings (ARs) for advanced non-small-cell lung cancer (aNSCLC) treatments. METHODS: Using the MarketScan and PharMetrics Plus databases, we identified patients treated between 2012 and 2017 with an aNSCLC regimen evaluated by the NCCN Evidence Blocks. We estimated adjusted mean total per-patient-per-month (PPPM) costs and drug costs for each regimen using a log-linked gamma generalized linear model. Weighted regression was used to examine the correlation between adjusted mean PPPM costs per regimen and NCCN AR. RESULTS: A total of 25,162 patients with aNSCLC (mean age, 63 years [standard deviation, 10 years]; 52% male) had identifiable regimens. Mean total PPPM cost by therapeutic class ranged from $16,824 for epidermal growth factor receptors to $41,815 for immunotherapy-based treatment. Epidermal growth factor receptor and anaplastic lymphoma kinase inhibitor treatment had lower ARs compared with generic chemotherapy. No therapy was listed as AR group 5 (least expensive). In pairwise comparisons, AR group 1 had significantly higher PPPM total costs compared with AR groups 2 and 4. There were no significant differences in PPPM total cost among AR groups 2, 3, and 4. CONCLUSION: Real-world aNSCLC treatment costs are often inconsistent with the NCCN ARs. Given that NCCN Evidence Blocks are intended to inform provider-patient discussions and other decision support resources, such as the NCCN Categories of Preference, our results suggest that the NCCN ARs require further refinement and validation.

Interaction of nutritional status and diabetes on active and latent tuberculosis: a cross-sectional analysis

BMC Infectious Diseases

2019 Kratz, Mario, PhD Mario Kratz

BACKGROUND: Malnutrition and diabetes are risk factors for active tuberculosis (TB), possible risk factors for latent TB infection (LTBI), and may interact to alter their effect on these outcomes. Studies to date have not investigated this interaction. METHODS: We enrolled 919 newly diagnosed active TB patients and 1113 household contacts at Primary Health Centres in Puducherry and Tamil Nadu, India from 2014 to 2018. In cross-sectional analyses, we used generalized estimating equations to measure additive and multiplicative interaction of body mass index (BMI) and diabetes on two outcomes, active TB and LTBI. RESULTS: Among overweight or obese adults, active TB prevalence was 12-times higher in diabetic compared to non-diabetic participants, 2.5-times higher among normal weight adults, and no different among underweight adults (P for interaction < 0.0001). Diabetes was associated with 50 additional active TB cases per 100 overweight or obese participants, 56 per 100 normal weight participants, and 17 per 100 underweight participants (P for interaction < 0.0001). Across BMI categories, screening 2.3-3.8 active TB patients yielded one hyperglycemic patient. LTBI prevalence did not differ by diabetes and BMI*diabetes interaction was not significant. CONCLUSIONS: BMI and diabetes are associated with newly diagnosed active TB, but not LTBI. Diabetes conferred the greatest risk of active TB in overweight and obese adults whereas the burden of active TB associated with diabetes was similar for normal and overweight or obese adults. Hyperglycemia was common among all active TB patients. These findings highlight the importance of bi-directional diabetes-active TB screening in India.

Antidepressant continuation in pregnancy and risk of gestational diabetes

Pharmacoepidemiol Drug Saf

2019 Weiss, Noel S, MD, PhD Noel Weiss

PURPOSE: Previous studies observed modestly higher risk of gestational diabetes (GDM) associated with antidepressant use in pregnancy, potentially due to confounding by indication. We assessed the association of antidepressant continuation in pregnancy with GDM, as well as blood glucose levels, after accounting for confounding. METHODS: We conducted a retrospective cohort study of singleton live births from 2001 to 2014 to women enrolled in Kaiser Permanente Washington, an integrated health care delivery system, utilizing electronic health data and linked Washington State birth records. We required that women have >/=1 antidepressant prescription fills </=6 months before pregnancy. Women with an antidepressant fill during pregnancy were categorized as "continuers" (n = 1634); those without a fill were "discontinuers" (n = 1211). We calculated relative risks (RRs) for GDM and mean differences in screening blood glucose levels using generalized estimating equations with inverse probability of treatment weighting to account for baseline characteristics, including mental health conditions and indicators of mental health severity. RESULTS: Compared with discontinuers, antidepressant continuers had comparable risk of GDM (RR: 1.10; 95% confidence interval [CI], 0.84-1.44) and blood glucose levels (mean difference: 2.3 mg/dL; 95% CI, -1.5 to 6.1 mg/dL). We observed generally similar results for specific antidepressants, with the potential exceptions of risk of GDM associated with sertraline (RR: 1.30; 95% CI, 0.90-1.88) and venlafaxine (RR: 1.52; 95% CI, 0.87-2.68), but neither association was statistically significant. CONCLUSIONS: Our study suggests that overall, women who continue antidepressants in pregnancy are not at increased risk for GDM or higher blood glucose, although further study may be warranted for sertraline and venlafaxine.

Evaluating screening participation, follow-up and outcomes for breast, cervical and colorectal cancer in the PROSPR consortium

J Natl Cancer Inst

2019 Zheng, Yingye, PhD Yingye Zheng

BACKGROUND: Cancer screening is a complex process encompassing risk assessment, the initial screening examination, diagnostic evaluation, and treatment of cancer precursors or early cancers. Metrics that enable comparisons across different screening targets are needed. We present population-based screening metrics for breast, cervical, and colorectal cancers for nine sites participating in the PROSPR consortium. METHODS: We describe how selected metrics map to a trans-organ conceptual model of the screening process. For each cancer type, we calculated calendar year 2013 metrics for the screen-eligible target population (breast: ages 40-74; cervical: ages 21-64; colorectal: ages 50-75). Metrics for screening participation, timely diagnostic evaluation, and diagnosed cancers in the screened and total populations are presented for the total eligible population and stratified by age group and cancer type. RESULTS: The overall screening eligible populations in 2013 were 305,568 participants for breast, 3,160,128 for cervical, and 2,363,922 for colorectal cancer screening. Being up-to-date for testing was common for all three cancer types: breast (63.5%); cervical (84.6%); and colorectal (77.5%). Percentage of abnormal screens ranged from 10.7% for breast, 4.4% for cervical, and 4.5% for colorectal cancer screening. Abnormal breast screens were followed up diagnostically in almost all (96.8%) cases while cervical and colorectal were similar (76.2% and 76.3%, respectively). Cancer rates per 1,000 screens were 5.66, 0.17, and 1.46, respectively for breast, cervical, and colorectal cancer. CONCLUSIONS: Comprehensive assessment of metrics by the PROSPR consortium enabled systematic identification of screening process steps in need of improvement. We encourage widespread use of common metrics to allow interventions to be tested across cancer types and healthcare settings.

Heritable variation at the chromosome 21 gene ERG is associated with acute lymphoblastic leukemia risk in children with and without Down syndrome


2019 Mueller, Beth A, Dr, PH Beth A Mueller


Gaussian process regression for survival time prediction with genome-wide gene expression


2019 Sun, Wei, PhD Wei Sun

Predicting the survival time of a cancer patient based on his/her genome-wide gene expression remains a challenging problem. For certain types of cancer, the effects of gene expression on survival are both weak and abundant, so identifying non-zero effects with reasonable accuracy is difficult. As an alternative to methods that use variable selection, we propose a Gaussian process accelerated failure time model to predict survival time using genome-wide or pathway-wide gene expression data. Using a Monte Carlo expectation-maximization algorithm, we jointly impute censored log-survival time and estimate model parameters. We demonstrate the performance of our method and its advantage over existing methods in both simulations and real data analysis. The real data that we analyze were collected from 513 patients with kidney renal clear cell carcinoma and include survival time, demographic/clinical variables, and expression of more than 20 000 genes. In addition to the right-censored survival time, our method can also accommodate left-censored or interval-censored outcomes; and it provides a natural way to combine multiple types of high-dimensional -omics data. An R package implementing our method is available in the Supplementary material available at Biostatistics online.

Anti-inflammatory diet and risk of abdominal aortic aneurysm in two Swedish cohorts


2019 Harris, Holly R, MPH, ScD Holly Harris

OBJECTIVE: The relationship between dietary patterns and development of abdominal aortic aneurysm (AAA) is not well understood. Thus, we prospectively evaluated the association between the anti-inflammatory potential of diet and risk of AAA. METHODS: The study population included the Cohort of Swedish Men (45 072 men) and the Swedish Mammography Cohort (36 633 women), aged 45-83 years at baseline. The anti-inflammatory potential of diet was estimated using Anti-inflammatory Diet Index (AIDI) based on 11 foods with anti-inflammatory potential and 5 with proinflammatory potential (maximum 16 points) that was validated againsthigh sensitivity C reactive protein (hsCRP). Cox proportional hazard regression models were used to estimate HRs and 95% CIs. During the 14.9 years of follow-up (1 217 263 person-years), 1528 AAA cases (277 (18%) ruptured, 1251 non-ruptured) were ascertained via the Swedish Inpatient Register, the National Cause of Death Register and the Register for Vascular Surgery (Swedvasc). RESULTS: We observed an inverse association between the AIDI and AAA risk in women and men; HRs between extreme quartiles of the AIDI (>/=8 vs </=5 points) were 0.55 (95% CI 0.36 to 0.83) in women and 0.81 (95% CI 0.68 to 0.98) in men. The AIDI was inversely associated with both ruptured and non-ruptured AAA incidence; the HR of participants in the highest quartile of AIDI compared with those in the lowest quartile was 0.61 (95% CI 0.41 to 0.90) for ruptured AAA and 0.79 (95% CI 0.65 to 0.95) for non-ruptured AAA. CONCLUSION: Adherence to diet with a high anti-inflammatory potential was associated with a reduced AAA risk, an association that was even more pronounced for AAA rupture.

BMI and related risk factors among US Marshallese with diabetes and their families

Ethnicity & health

2019 Ko, Linda K, PhD Linda Ko

Objective: Examine cross-sectional associations between body mass index (BMI) and related health behaviors, barriers and facilitators to health care, and perceived health status among a sample of U.S. Marshallese adults with Type 2 diabetes and evaluate associations of interest between participants and their family members. Design: Cross-sectional baseline data were analyzed from participants in a diabetes self-management education intervention trial. Setting: Data collection took place in home or community settings through a community-academic partnership in Arkansas. Participants: Study participants consisted of U.S. Marshallese adults with Type 2 diabetes (N = 221) and their family members (N = 211) recruited through community settings. Intervention(s): N/A. Main Outcome Measure(s): Participants' height and weight were measured using standard protocols to calculate BMI (kg/m(2)). Diet, physical activity, health care access, financial strain related to health care, perceived health status, and health care satisfaction were measured using self-report surveys. Results: Participants' mean BMI was 31.0 (95% CI: 30.2-31.7), with over half of study participants and their family members' BMI falling in the obese category. Participants' BMI was positively associated with spreading health care bill payments over time (beta = 1.75 (SE = 0.87); p = 0.045). Positive associations between participants and their family members were observed for self-reported health status conditions, health care coverage, health care utilization, and health care satisfaction. Conclusion: Study findings highlight the high prevalence of obesity and related risk factors among U.S. Marshallese adults with Type 2 diabetes and emphasize the need for intervention strategies that build upon cultural strengths and target community, policy, systems, and environmental changes to address obesity and chronic disease in this marginalized community.

Racial and ethnic disparities in neurocognitive, emotional, and quality-of-life outcomes in survivors of childhood cancer: A report from the Childhood Cancer Survivor Study


2019 Leisenring, Wendy M, ScD Wendy m Leisenring

BACKGROUND: Survivors of childhood cancer are at risk of neurocognitive impairment, emotional distress, and poor health-related quality of life (HRQOL); however, the effect of race/ethnicity is understudied. The objective of this study was to identify race/ethnicity-based disparities in neurocognitive, emotional, and HRQOL outcomes among survivors of childhood cancer. METHODS: Self-reported measures of neurocognitive function, emotional distress (the Brief Symptom Inventory-18), and HRQOL (the Medical Outcomes Study Short Form-36 health survey) were compared between minority (Hispanic, n = 821; non-Hispanic black [NHB], n = 600) and non-Hispanic white (NHW) (n = 12,287) survivors from the Childhood Cancer Survivor Study (median age, 30.9 years; range, 16.0-54.1 years). By using a sample of 3055 siblings, the magnitude of same-race/same-ethnicity survivor-sibling differences was compared between racial/ethnic groups, adjusting for demographic and treatment characteristics and current socioeconomic status (SES). RESULTS: No clear pattern of disparity in neurocognitive outcomes by race/ethnicity was observed. The magnitude of the survivor-sibling difference in the mean score for depression was greater in Hispanics than in NHWs (3.59 vs 1.09; P = .004). NHBs and Hispanics had greater survivor-sibling differences in HRQOL than NHWs for mental health (NHBs: -5.78 vs -0.69; P = .001; Hispanics: -3.87 vs -0.69; P = .03), and social function (NHBs: -7.11 vs -1.47; P < .001; Hispanics: -5.33 vs -1.47; P = .001). NHBs had greater survivor-sibling differences in physical subscale scores for HRQOL than NHWs. In general, the findings were not attenuated by current SES. CONCLUSIONS: Although no pattern of disparity in neurocognitive outcomes was observed, differences across many HRQOL outcomes among minorities compared with NHWs, not attenuated by current SES, were identified. This suggests that further research into environmental and sociocultural factors during and immediately after treatment is needed.

Late Health Outcomes After Contemporary Lymphome Malin de Burkitt Therapy for Mature B-Cell Non-Hodgkin Lymphoma: A Report From the Childhood Cancer Survivor Study

J Clin Oncol

2019 Leisenring, Wendy M, ScD Wendy m Leisenring

PURPOSE: The widely used, risk-based Lymphome Malin de Burkitt (LMB) chemotherapy regimen has improved survival rates for children with mature B-cell non-Hodgkin lymphoma (NHL); however, associated late effects remain understudied. We assessed late health outcomes after LMB treatment in the Childhood Cancer Survivor Study. PATIENTS AND METHODS: Multivariable regression models compared chronic health conditions, health status, and socioeconomic and neurocognitive outcomes between survivors of NHL treated with the LMB regimen (n = 126), survivors of NHL treated with non-LMB regimens (n = 444), and siblings (n = 1,029). RESULTS: LMB survivors were a median age of 10.2 years (range, 2.5 to 20.5 years) at diagnosis and 24.0 years (range, 10.3 to 35.3 years) at evaluation. Compared with siblings, LMB survivors were at increased risk for adverse health outcomes. However, survivors of NHL treated with LMB and non-LMB regimens did not differ with regard to risk of having any chronic health conditions, impaired health status, neurocognitive deficits, or poorer socioeconomic outcomes. Increased risk for the following specific neurologic conditions was observed in LMB survivors compared with non-LMB survivors: epilepsy (relative risk [RR], 15.2; 95% CI, 3.1 to 73.4); balance problems (RR, 8.9; 95% CI, 2.3 to 34.8); tremors (RR, 7.5; 95% CI, 1.9 to 29.9); weakness in legs (RR, 8.1; 95% CI, 2.5 to 26.4); severe headaches (RR, 3.2; 95% CI, 1.6 to 6.3); and prolonged arm, leg, or back pain (RR, 4.0; 95% CI, 2.2 to 7.1). The survivors from the group C LMB risk group (n = 50) were at the highest risk for these conditions; however, except for worse functional status (odds ratio, 2.7; 95% CI, 1.2 to 5.8), they were not at increased risk for other adverse health status or socioeconomic outcomes compared with non-LMB survivors. CONCLUSION: Survivors treated with LMB and non-LMB regimens are largely comparable in late health outcomes except for excess neurotoxicity among LMB survivors. These data inform treatment efforts seeking to optimize disease control while minimizing toxicity.