Vascular access-specific health-related quality of life impacts among hemodialysis patients: qualitative development of the hemodialysis access-related quality of life (HARQ) instrument.

BACKGROUND: End stage kidney disease and hemodialysis dependence are associated with impairments in health-related quality of life (HRQOL), which may be related to vascular access (VA). Few HRQOL measures are VA-specific and none differentiate HRQOL impact by VA type. We developed a VA-targeted HRQOL measure to distinguish the impact of fistulas, grafts and catheters. METHODS: We created an initial item pool based on literature review and then conducted focus groups at 4 US sites with 37 adults and interviews with nine dialysis clinicians about VA's impact on HRQOL. We then drafted the Hemodialysis Access-Related Quality of Life (HARQ) measure and cognitively tested it with 17 hemodialysis patients. Focus group and cognitive interview participants were diverse in age, gender, years on dialysis, and VA. RESULTS: We identified six domains for the HARQ: symptoms, physical functioning, emotional impacts, social and role functioning, sleep, and care-related burdens. Cognitive interviews indicated that items were easily understood and supported content validity. Attributing HRQOL impact to VA as opposed to other hemodialysis burden was challenging for some items. Some items were dropped that were considered redundant by patients, limitations while dressing was added, and reference to VA-specific impact was included for each item. The average Flesch-Kincaid reading grade level for the revised 47-item HARQ was 5.3. CONCLUSIONS: The HARQ features VA-specific content not addressed in other HRQOL measures, making it ideal for comparisons of different VA types and new VA technologies. The psychometric properties of the HARQ will be evaluated in future research.

Angiotensin II for the treatment of distributive shock in the intensive care unit: A US cost-effectiveness analysis.

BACKGROUND: Patients with distributive shock who are unresponsive to traditional vasopressors are commonly considered to have severe distributive shock and are at high mortality risk. Here, we assess the cost-effectiveness of adding angiotensin II to the standard of care (SOC) for severe distributive shock in the US critical care setting from a US payer perspective. METHODS: Short-term mortality outcomes were based on 28-day survival rates from the ATHOS-3 study. Long-term outcomes were extrapolated to lifetime survival using individually estimated life expectancies for survivors. Resource use and adverse event costs were drawn from the published literature. Health outcomes evaluated were lives saved, life-years gained, and quality-adjusted life-years (QALYs) gained using utility estimates for the US adult population weighted for sepsis mortality. Deterministic and probabilistic sensitivity analyses assessed uncertainty around results. We analyzed patients with severe distributive shock from the ATHOS-3 clinical trial. RESULTS: The addition of angiotensin II to the SOC saved .08 lives at Day 28 compared to SOC alone. The cost per life saved was estimated to be $108,884. The addition of angiotensin II to the SOC was projected to result in a gain of .96 life-years and .66 QALYs. This resulted in an incremental cost-effectiveness ratio of $12,843 per QALY. The probability of angiotensin II being cost-effective at a threshold of $50,000 per QALY was 86 percent. CONCLUSIONS: For treatment of severe distributive shock, angiotensin II is cost-effective at acceptable thresholds.

Treatment Patterns of Bone-targeting Agents Among Solid Tumor Patients With Bone Metastases: An Analysis of Electronic Health Record Data in the United States From 2014 to 2018.

OBJECTIVES: This study evaluated real-world treatment patterns of approved bone-targeting agents (BTAs) with various mechanisms of action-pamidronate, zoledronic acid, and denosumab-for the prevention of skeletal-related events in patients with bone metastases (BM) from solid tumors. METHODS: Adult patients with BM secondary to solid tumors between January 1, 2014, and December 31, 2018, were identified from the Flatiron Health Oncology Services Comprehensive Electronic Records database and categorized by BTA use and therapy type. Time from diagnosis to initiation, persistence (mean time on treatment), and compliance (≥12 administrations/year) with BTA with up to 4 years of follow-up were examined. RESULTS: This study included 27,268 patients with BM (breast cancer, 32.7%; lung cancer, 16.5%; prostate cancer, 17.2%; and other solid tumors, 33.6%); of these, 41.4% initiated denosumab after BM diagnosis; 21.3%, zoledronic acid; 0.6%, pamidronate; and 36.7% had no treatment record. Mean (SD) time to initiation for denosumab or zoledronic acid was 68.6 (157.0) days (denosumab, 70.3 (160.4) days; zoledronic acid, 65.2 [150.2] days). Mean persistence and compliance (first year of treatment) were significantly higher for denosumab than for zoledronic acid (22.0 vs. 14.9 mo [ P <0.0001] and 42.3% vs. 34.8% [ P <0.0001], respectively). Treatment compliance was the highest in patients with breast cancer (denosumab, 48.2%; zoledronic acid, 39.1%). CONCLUSION: Real-world BTA treatment patterns in the United States suggest that over one-third of patients with BM secondary to solid tumors remain untreated and less than 50% of the patients received ≥12 administrations/year of BTA therapy.

Access to dental care and the capacity of the California dental care system.

The authors estimated the following levels of technical efficiency for three types of dental practices in California where technical efficiency is defined as the maximum output that can be produced from a given set of inputs: generalists (including pediatric dentists), 96.5 percent; specialists, 77.1 percent; community dental clinics, 83.6 percent. Combining this with information on access, it is estimated that the California dental care system in 2009-10 could serve approximately 74 percent of the population.

Medically-attended anxiety and depression is increased among newly diagnosed patients with cold agglutinin disease: Analysis of an integrated claim-clinical cohort in the United States.

BACKGROUND: Cold agglutinin disease (CAD) is a rare, chronic form of autoimmune hemolytic anemia. Clinical manifestations can include classical complement pathway-mediated chronic hemolysis, anemia, and profound fatigue. Research has shown that patients with other anemias may develop anxiety and depression, but this has not been studied previously in patients with CAD. METHODS: CAD patients were identified in the Optum Claims-Clinical dataset (between January 1, 2006-June 30, 2016) and matched to comparison patients without CAD by patient factors. Adjusted Cox regression models estimated time to anxiety and depression, defined by three different outcomes: medication use, hospitalization, and therapy related to anxiety and depression. Subset analyses were performed for primary CAD. Patients were followed until they had anxiety and depression, they left the Optum system, death, or the study period ended (June 30, 2016). RESULTS: Patients with CAD (n = 384) were more likely to have medically attended anxiety and depression (adjusted hazard ratio [aHR]: 1.6; 95% confidence interval [CI]: 1.3-2.1), to be prescribed antidepressants or psychotherapy after their CAD diagnosis (aHR: 1.8; 95% CI: 1.2-2.9), or to be hospitalized for an anxiety and depression-related event along with medication or psychotherapy (aHR: 2.0; 95% CI: 1.4-2.9) relative to matched comparisons (n = 2789), during the follow-up period. Patients with primary CAD were at increased risk for medically attended anxiety and depression (aHR: 1.8; 95% CI: 1.4-2.4), with the highest risk for prescription medication or therapy (aHR: 2.7; 95% CI: 1.6-4.6). CONCLUSIONS: Our study indicates that medically attended anxiety and depression manifest at a higher rate in CAD patients than in a matched non-CAD cohort. Study findings suggest that CAD patients may experience a greater burden on mental health that may negatively contribute to their overall quality of life. Further investigation on this topic is warranted.

The epidemiology of desmoid tumors in Denmark.

INTRODUCTION/AIM: The epidemiology, demographic, clinical, treatment, and healthcare resource utilization (HRU) characteristics of desmoid tumor (DT) patients treated at two sarcoma centers in Denmark is described. METHODS: Using Danish health registers, we studied DT patients treated at two sarcoma centers between 2009 and 2018. For each patient, ten persons from the general population were randomly matched on birth year, sex, and region of residence. RESULTS: Of the 179 DT patients identified, 76% were female and the median patient age was 38 years at diagnosis (interquartile range: 31-50). An average annual incidence of DTs over the study period was 3.2 per 1000,000 individuals with the observed annual incidence of DTs ranging from 2.2 (2011) to 4.3 (2017) per 1000,000 individuals. No notable linear time trend in incidence was observed. Anatomical DT sites included extra-abdominal (49%), abdominal wall (40%), and intra-abdominal or retroperitoneal areas (8%). In total, 56% of patients were initially treated surgically. However, while 75% of patients diagnosed with DT between 2009 and 2014 were initially treated surgically, this was true for only 32% of patients diagnosed with DT between 2015 and 2018. A total of 56% of DT patients used chemotherapeutic agents, tyrosine kinase inhibitors, NSAIDs, opioids, antidepressants, or steroids at some point during the three years before their DT diagnoses. In contrast, 70% of surgically treated and 63% of non-surgically treated patients used one of these drugs in the subsequent three years, including NSAIDs (45% surgical vs. 33% non-surgical), opioids (39% surgical vs. 27% non-surgical), and steroids (22% surgical vs. 18% non-surgical). The average number of inpatient and outpatient visits, days of hospitalization, and additional surgical procedures were higher among DT patients than the comparison cohort. CONCLUSION: DTs are rare but have a large impact on patients' health, HRU, and medication utilization.

Healthcare resource utilization among patients with cold agglutinin disease in Denmark.

OBJECTIVES: Cold agglutinin disease (CAD) is a rare form of autoimmune hemolytic anemia that may manifest in complement-mediated chronic hemolytic anemia, profound fatigue, and transient agglutination-mediated circulatory symptoms. This study compared the healthcare resource utilization (HRU) of patients with CAD with a matched non-CAD comparison cohort using national Danish health registry data. METHODS: All cases of CAD were identified from 1 January 1999 to 30 June 2016, in the Danish National Patient Registry using the International Classification of Diseases, Tenth Revision, discharge diagnosis codes. A subcohort of patients with primary CAD was identified based on the absence of secondary predisposing concomitant diseases. CAD cases were matched to individuals without CAD from the general population based on birth year, sex, and 19 disease categories of the Charlson Comorbidity Index. Comparative analyses assessed inpatient hospitalizations, outpatient clinic visits, emergency room visits, transfusion use, and expensive drug use between cohorts 6 months before and 12 months after the admission date of the first hospital visit with CAD diagnosis (index date). RESULTS: A total of 104 patients with CAD were matched to 1003 comparison cohort members. Throughout the 12 months after the index date, patients with CAD were more likely to have at least one inpatient hospitalization (odds ratio [OR], 3.9; 95% confidence interval [CI], 2.5-6.0), outpatient clinic visit (OR, 17.2; 95% CI, 6.8-43.1), and blood transfusion (OR, 93.0; 95% CI, 33.3-259.8) than matched comparisons. HRU was similarly higher among patients with CAD than matched comparisons during the 6 months before the index date. Findings were similar among patients with primary CAD. CONCLUSIONS: Characterization of HRU among European patients with CAD has not previously been conducted. This study shows that patients with CAD utilize significant resources in Denmark. Increased HRU uses among patients with CAD before diagnosis presents opportunities for earlier diagnosis and management.

Patency of ePTFE Arteriovenous Graft Placements in Hemodialysis Patients: Systematic Literature Review and Meta-Analysis.

Arteriovenous grafts (AVGs) are an appropriate option for vascular access in certain hemodialysis patients. Expanded polytetrafluoroethylene (ePTFE) has become the dominant material for such grafts, due in part to innovations in graft design and surgical interventions to reduce complications and improve patency rates. Comprehensive evidence syntheses have not been conducted to update AVG performance in an era in which both access choice and ePTFE graft functioning may have changed. We conducted a systematic review and meta-analysis summarizing outcomes from recent studies of ePTFE AVGs in hemodialysis, following PRISMA standards. Literature searches were conducted in multiple databases to identify observational and interventional studies of AVG patency and infection risk. Primary, primary-assisted, and secondary patency rates were analyzed at 6, 12, 18, and 24 months postplacement. Kaplan-Meier graft survival plots were digitized to recreate individual patient-level data. Patency rates were pooled using a random effects model. We identified 32 studies meeting our selection criteria that were published from 2004 through 2019. A total of 38 study arms of ePTFE grafts were included, representing 3381 AVG accesses placed. The mean primary, primary-assisted, and secondary patency rates at 1 year were 41% (95% CI, 35% to 47%), 46% (95% CI, 41% to 51%), and 70% (95% CI, 64% to 75%), respectively. Mean 24-month patency rates were 28% (95% CI, 22% to 33%), 34% (95% CI, 27% to 41%), and 54% (95% CI, 47% to 61%), respectively. A high degree of heterogeneity across studies was observed. Overall risk of infection was not consistently reported, but among available studies the pooled estimate was 9% per patient-year (95% CI, 6% to 12%). This meta-analysis provides an up-to-date estimate of the performance of ePTFE AVGs, within the context of improved graft designs and improved interventional techniques.

Patient-level costs of major cardiovascular conditions: a review of the international literature.

OBJECTIVE: Robust cost estimates of cardiovascular (CV) events are required for assessing health care interventions aimed at reducing the economic burden of major adverse CV events. This review synthesizes international cost estimates of CV events. METHODS: MEDLINE database was searched electronically for English language studies published during 2007-2012, with cost estimates for CV events of interest - unstable angina, myocardial infarction, heart failure, stroke, and CV revascularization. Included studies provided at least one estimate of patient-level direct costs in adults for any identified country. Information on study characteristics and cost estimates were collected. All costs were adjusted for inflation to 2013 values. RESULTS: Across the 114 studies included, the average cost was US $6,466 for unstable angina, $11,664 for acute myocardial infarction, $11,686 for acute heart failure, $11,635 for acute ischemic stroke, $37,611 for coronary artery bypass graft, and $13,501 for percutaneous coronary intervention. The ranges for cost estimates varied widely across countries with US cost estimate being at least twice as high as European Union costs for some conditions. Few studies were found on populations outside the US and European Union. CONCLUSION: This review showed wide variation in the cost of CV events within and across countries, while showcasing the continuing economic burden of CV disease. The variability in costs was primarily attributable to differences in study population, costing methodologies, and reporting differences. Reliable cost estimates for assessing economic value of interventions in CV disease are needed.

Review of treatment recommendations for persons with a co-occurring affective or anxiety and substance use disorder.

OBJECTIVE: The authors review and evaluate the literature and guidelines on care for individuals with a co-occurring affective or anxiety disorder and substance use disorder. METHODS: MEDLINE and PsycINFO computerized searches of the English language literature were conducted for the period 1990-2002. These articles were supplemented with searches of the Cochrane Database of Systematic Reviews (1990 to 2002) and with articles that were sent to the authors by experts in the field to review. Bibliographies of selected papers were hand searched for additional articles. From these searches a total of 219 articles were found, of which 127 were selected for review. RESULTS AND DISCUSSION: The literature shows that, over the past several decades, treatment for co-occurring disorders has undergone a broad shift in approach, from treating substance abuse before providing mental health care to providing simultaneous treatment for each disorder, regardless of the status of the comorbid condition. Many treatment recommendations are supported by a broad consensus. However, despite this broad agreement, recommendations are often not specific enough to guide clinical care. Most recommendations with specificity are for acute pharmacotherapy, but even specific recommendations lag behind current clinical practice. Although the use of psychotropic medication for mental illness is encouraged, experts disagree as to whether it is necessary to wait for abstinence before beginning pharmacotherapy. In addition, most diagnosis-specific guidelines are silent as to whether the specific treatment recommendation applies to co-occurring disorders. Finally, empirical evidence is lacking for most recommendations. The authors conclude that the mental health and substance abuse treatment fields need to consider its research priorities and how to address the multitude of potential combinations of disorders.

African Americans in commercial HMOs more likely to delay prescription drugs and use the emergency room.

Health Maintenance Organizations (HMOs) are designed to provide comprehensive health care, including primary care to their enrollees. However, HMOs deliver care through a wide variety of physician networks, settings and methods throughout the nation and in California. Minorities and individuals of lower socioeconomic status continue to disproportionately rely on the health care safety net, even when insured. Individuals enrolled in HMOs should be less likely to rely on emergency rooms and experience ambulatory care sensitive hospitalizations given the focus of HMOs on centralized care through the use of a primary care provider. This policy brief uses data from the 2007 California Health Interview Survey (CHIS 2007) to examine delays in fulfilling prescribed medications, delays in obtaining needed medical care, visits to emergency rooms, and the presence of a usual source of care among insured African Americans in public and commercial HMOs. We find that African-American HMO enrollees in California are more likely to delay obtaining needed medications and use the emergency room than other racial/ethnic groups in comparable HMO plans.