Risk of Cardiovascular Conditions in Patients with Chronic Hypoparathyroidism: A Retrospective Cohort Study.

INTRODUCTION: In patients with chronic hypoparathyroidism disordered calcium homeostasis has been associated with risk of cardiovascular diseases, including cardiomyopathy, congestive heart failure, and arrhythmia; however, larger-scale studies are needed to examine these risks. This study evaluated the risk of cardiovascular conditions among patients with chronic hypoparathyroidism. METHODS: Adults with and without chronic hypoparathyroidism were selected from a medical insurance claims database in the USA from January 2007 to June 2017, and were followed for up to 5 years. Associations between chronic hypoparathyroidism and incident atrial fibrillation (AF), tachyarrhythmia, myocardial infarction (MI), coronary artery disease (CAD), heart failure (HF), stroke, cerebrovascular disease, peripheral vascular disease (PVD), and a combined cardiovascular endpoint of cerebrovascular disease, CAD, HF, and PVD were compared between cohorts using Kaplan-Meier analyses and unadjusted and adjusted Cox proportional hazards models. RESULTS: In 8097 patients with chronic hypoparathyroidism compared with 40,485 patients without, respectively, mean ± SD ages were 58.6 ± 16.3 and 47.3 ± 18.0 years, 76.2% and 54.4% were female, and 19.4% and 9.5% had the combination of cardiovascular findings at baseline. In adjusted analyses, patients with chronic hypoparathyroidism had significantly higher risk (adjusted hazard ratio and 95% confidence interval) of incident AF (1.72; 1.51-1.97), tachyarrhythmia (1.68; 1.32-2.14), MI (1.18; 1.01-1.38), CAD (1.39; 1.26-1.54), HF (1.64; 1.46-1.84), stroke (1.45; 1.31-1.62), cerebrovascular disease (1.48; 1.34-1.62), PVD (1.66; 1.51-1.81), and combined cardiovascular endpoint (1.63; 1.52-1.75), all P < 0.001 except P = 0.036 for MI, compared with patients without chronic hypoparathyroidism. CONCLUSIONS: This large retrospective cohort study showed that chronic hypoparathyroidism was associated with increased risk of incident cardiovascular conditions and arrhythmias. Results should be evaluated in light of limitations inherent to claims database analyses. Further studies are warranted to investigate reasons for these risks and to develop strategies for reducing cardiovascular conditions in patients with chronic hypoparathyroidism.

Risk of Chronic Kidney Disease and Estimated Glomerular Filtration Rate Decline in Patients with Chronic Hypoparathyroidism: A Retrospective Cohort Study.

INTRODUCTION: Chronic hypoparathyroidism, treated with conventional therapy of oral calcium supplements and active vitamin D, may increase the risk of kidney complications. This study examined risks of development and progression of chronic kidney disease (CKD) and estimated glomerular filtration rate (eGFR) decline in patients with chronic hypoparathyroidism. METHODS: A retrospective cohort study using a managed care claims database in the United States from January 2007 to June 2017 included patients with chronic hypoparathyroidism (excluding those receiving parathyroid hormone) and randomly selected patients without hypoparathyroidism followed for up to 5 years. Main outcome measures were (1) development of CKD, defined as new diagnosis of CKD stage 3 and higher or ≥ 2 eGFR measurements < 60 ml/min/1.73 m2 ≥ 3 months apart, (2) progression of CKD, defined as increase in baseline CKD stage, (3) progression to end-stage kidney disease (ESKD), and (4) eGFR decline ≥ 30% from baseline. Time-to-event analyses included Kaplan-Meier analyses with log-rank tests, and both unadjusted and adjusted Cox proportional hazards models were used to compare outcomes between cohorts. RESULTS: The study included 8097 adults with and 40,485 without chronic hypoparathyroidism. In Kaplan-Meier analyses, patients with chronic hypoparathyroidism had higher risk of developing CKD and CKD progression and higher rates of eGFR decline (all P < 0.001). In multivariable Cox models adjusted for baseline characteristics, hazard ratios (95% confidence intervals [CIs]) were 2.91 (2.61-3.25) for developing CKD, 1.58 (1.23-2.01) for CKD stage progression, 2.14 (1.51-3.04) for progression to ESKD, and 2.56 (1.62-4.03) for eGFR decline (all P < 0.001) among patients with chronic hypoparathyroidism compared with those without hypoparathyroidism. CONCLUSION: Patients with chronic hypoparathyroidism have increased risk of development and progression of CKD and eGFR decline compared with those without hypoparathyroidism. Further studies are warranted to understand underlying mechanisms for the associations between chronic hypoparathyroidism and kidney disease.

Cost-effectiveness of pembrolizumab with axitinib as first-line treatment for advanced renal cell carcinoma.

OBJECTIVE: Pembrolizumab/axitinib significantly prolonged overall survival (OS) and progression-free survival (PFS), and increased objective response rate versus sunitinib in the phase III trial KEYNOTE-426 among previously untreated patients with advanced renal cell carcinoma (RCC). This study assessed the cost-effectiveness of pembrolizumab/axitinib versus other first-line treatments of advanced RCC from a US public healthcare payer perspective. METHODS: A partitioned survival model with three states (progression-free, progressed, death) evaluated lifetime costs and quality-adjusted life-years (QALYs) for pembrolizumab/axitinib and other first-line regimens: sunitinib, pazopanib and avelumab/axitinib in the overall population; and sunitinib, cabozantinib and nivolumab/ipilimumab in the subgroup with intermediate/poor prognostic risk. Costs of treatments, adverse events and medical resources were estimated. OS, PFS and treatment duration were extrapolated using parametric models fitted to KEYNOTE-426 data and hazard ratios from network meta-analyses. Utilities were derived through mixed-effects regressions of KEYNOTE-426 EuroQol-5 Dimensions-3 Levels data. RESULTS: In the overall population, pembrolizumab/axitinib was associated with incremental cost-effectiveness ratios (ICERs) of $95,725/QALY versus sunitinib and $128,210/QALY versus pazopanib, and was dominant (lower cost, higher effectiveness) versus avelumab/axitinib, with incremental QALY gains of 2.73, 2.40 and 1.80 versus these therapies, respectively. In the intermediate/poor-risk subgroup, base-case ICERs for pembrolizumab/axitinib were $101,030/QALY versus sunitinib, $6989/QALY versus cabozantinib, and $130,934/QALY versus nivolumab/ipilimumab, with incremental QALY gains of 2.62, 1.78 and 1.06 versus these therapies. CONCLUSIONS: In this economic evaluation, pembrolizumab/axitinib was associated with higher life expectancy and QALYs and, based on typical willingness-to-pay thresholds of $150,000-$180,000/QALY, was found cost-effective versus other first-line treatments for advanced RCC in the US.

Hospital purchasing alliances: Ten years after.

BACKGROUND: Most hospitals outsource supply procurement to purchasing alliances, or group purchasing organizations (GPOs). Despite their early 20th century origin, we lack both national and trend data on alliance utilization, services, and performance. The topic is important as alliances help hospitals control costs, enjoy tailwinds from affiliated regional/local alliances, and face headwinds from hospital self-contracting and criticism of certain business practices. PURPOSE: We compare the utilization, services, and performance of alliances in 2004 and 2014. APPROACH: We analyze alliances using two comparable surveys of hospitals. We use significance tests to assess changes in alliance utilization, services, and performance (e.g., cost savings). We also assess the use of regional/local alliances affiliated with national GPOs. RESULTS: Purchasing through national alliances has somewhat diminished. Over 10 years, hospitals have diversified GPO memberships to include regional/local alliances (many affiliated with their national GPO) and engaged in self-contracting. At the same time, hospitals have increased purchases of many categories of supplies/services through national GPOs and endorsed their value-added functions and increasingly important role. Hospitals report greater satisfaction with several GPO functions; performance on most dimensions has not changed. CONCLUSIONS: National alliances still play important roles that hospitals find valuable. PRACTICE IMPLICATIONS: Purchasing alliances continue to play an important role in helping hospitals with both cost savings and new services. Their growing complexity, along with growing use of self-contracting, poses managerial challenges for hospital purchasing staff that may require greater hospital investment.

Association between the food and physical activity environment, obesity, and cardiovascular health across Maine counties.

BACKGROUND: Accounting for nearly one-third of all deaths, cardiovascular disease is the leading cause of mortality and morbidity in the United States. Adverse health behaviors are major determinants of this high incidence of disease. Examining local food and physical activity environments and population characteristics in a poor, rural state may highlight underlying drivers of these behaviors. We aimed to identify demographic and environmental factors associated with both obesity and overall poor cardiovascular health (CVH) behaviors in Maine counties. METHODS: Our cross-sectional study analyzed 40,398 Behavioral Risk Factor Surveillance System (BRFSS) 2011-2014 respondents alongside county-level United States Department of Agriculture (USDA) Food Environment Atlas 2010-2012 measures of the built environment (i.e., density of restaurants, convenience stores, grocery stores, and fitness facilities; food store access; and county income). Poor CVH score was defined as exhibiting greater than 5 out of the 7 risk factors defined by the American Heart Association (current smoking, physical inactivity, obesity, poor diet, hypertension, diabetes, and high cholesterol). Multivariable logistic regression models described the contributions of built environment variables to obesity and overall poor CVH score after adjustment for demographic controls. RESULTS: Both demographic and environmental factors were associated with obesity and overall poor CVH. After adjustment for demographics (age, sex, personal income, and education), environmental characteristics most strongly associated with obesity included low full-service restaurant density (OR 1.34; 95% CI 1.24-1.45), low county median household income (OR 1.31; 95% CI 1.21-1.42) and high convenience store density (OR 1.21; 95% CI 1.12-1.32). The strongest predictors of overall poor CVH behaviors were low county median household income (OR 1.30; 95% CI 1.13-1.51), low full-service restaurant density (OR 1.38; 95% CI 1.19-1.59), and low fitness facility density (OR 1.27; 95% CI 1.11-1.46). CONCLUSIONS: In a rural state, both demographic and environmental factors predict overall poor CVH. These findings may help inform communities and policymakers of the impact of both social determinants of health and local environments on health outcomes.

Expanded genetic carrier screening in clinical practice: a current survey of patient impressions and attitudes.

PURPOSE: Expanded genetic carrier screening (ECS) is an important part of gynecological practice and preconception planning. We evaluated the awareness and attitudes among women regarding ECS and factors that may influence decision-making in a family planning context. METHODS: A 32-question survey in an academic university practice was given to 521 women who were either currently pregnant (n = 108), undergoing gynecologic care who were considering future fertility (n = 308), and considering or receiving fertility treatment (n = 105). Data are reported descriptively. RESULTS: Forty-seven percent (n = 246) of patients were aware of ECS. Though most reported feeling positive or neutral towards ECS, 51% (n = 263) reported no desire for testing. Fifty-eight percent (n = 303) felt it beneficial to know their carrier status, and 55% (n = 257) said it was their responsibility to undergo testing. Those considering future fertility were found to have a more positive attitude towards ECS (51.4%) than those considering or receiving fertility treatment (34%). For positive carriers of a genetic disorder, 228 (49%) of patients would proceed with having their partner screened, 58 (13%) would undergo prenatal screening only and 12 (2.6%) would continue with vitro fertilization (IVF). Related to cost for ECS, 53.5% (n = 191) would be willing to pay at least $50-100 for testing, while 29% (n = 146) would not pay anything out of pocket. CONCLUSIONS: Despite patients' beliefs that it would be beneficial and their responsibility to undergo carrier status testing, the majority reported no desire for ECS and many were unwilling to pay out of pocket. Further education is necessary to reconcile the gap between technology and patient decision-making.

Expanded carrier screening: a current survey of physician utilization and attitudes.

PURPOSE: Expanded carrier screening (ECS) is an available component of preconception and prenatal care. There is complexity around offering, administering, and following-up test results. The goal of this study is to evaluate current physicians' utilization and attitudes towards ECS in current practice. METHODS: This was a prospective qualitative survey study. A 32-question electronic survey was distributed during a 1-year period to obstetricians-gynecologists who were identified using a Qualtrics listserv database. RESULTS: While more than 90% of physicians offered ethnic-based carrier screening (CS), ECS was offered significantly less (2010, 20.6%, and 2016, 27.1%). Physicians who were not fellowship-trained in reproductive endocrinology and infertility (REI) preferred ethnic-based carrier screening (95.9 vs 16.8%; P < 0.001). REI subspecialists were more likely to offer ECS (80%) compared to 70% of maternal fetal medicine physicians (MFM). Physicians were comfortable discussing negative results (53.6%) compared to positive results (48.4%). Most physicians (56%) believed that ECS should not be offered until the significance of each disease is understood; 52% believed that testing should be restricted to those conditions important to couples; while 26% felt that testing should be done regardless of the clinical significance. CONCLUSIONS: Discussion and application of ECS has increased in clinical practice. However, lack of comfort with counseling and varying beliefs surrounding ECS continue to hinder its utilization. Further education and training programs, and subsequent evaluation are warranted.

Behavioral Risk Factors and Regional Variation in Cardiovascular Health Care and Death.

INTRODUCTION: Reducing the burden of death from cardiovascular disease includes risk factor reduction and medical interventions. METHODS: This was an observational analysis at the hospital service area (HSA) level, to examine regional variation and relationships between behavioral risks, health services utilization, and cardiovascular disease mortality (the outcome of interest). HSA-level prevalence of cardiovascular disease behavioral risks (smoking, poor diet, physical inactivity) were calculated from the Behavioral Risk Factor Surveillance System; HSA-level rates of stress tests, diagnostic cardiac catheterization, and revascularization from a statewide multi-payer claims data set from Maine in 2013 (with 606,260 patients aged ≥35 years), and deaths from state death certificate data. Analyses were done in 2016. RESULTS: There were marked differences across 32 Maine HSAs in behavioral risks: smoking (12.4%-28.6%); poor diet (43.6%-73.0%); and physical inactivity (16.4%-37.9%). After adjustment for behavioral risks, rates of utilization varied by HSA: stress tests (28.2-62.4 per 1,000 person-years, coefficient of variation=17.5); diagnostic cardiac catheterization (10.0-19.8 per 1,000 person-years, coefficient of variation=17.3); and revascularization (4.6-6.2 per 1,000 person-years; coefficient of variation=9.1). Strong HSA-level associations between behavioral risk factors and cardiovascular disease mortality were observed: smoking (R2=0.52); poor diet (R2=0.38); and physical inactivity (R2=0.35), and no association between revascularization and cardiovascular disease mortality after adjustment for behavioral risk factors (R2=0.02). HSA-level behavioral risk factors were also strongly associated with all-cause mortality: smoking (R2=0.57); poor diet (R2=0.49); and physical inactivity (R2=0.46). CONCLUSIONS: There is substantial regional variation in behavioral risks and cardiac utilization. Behavioral risk factors are associated with cardiovascular disease mortality regionally, whereas revascularization is not. Efforts to reduce cardiovascular disease mortality in populations should focus on prevention efforts targeting modifiable risk factors.