The burden of selected cancers in the US: health behaviors and health care resource utilization.

OBJECTIVE: To characterize the disease burden among survivors of those cancers having the highest incidence in the US. METHODS: Adult (≥18 years) survivors of the 11 most frequently diagnosed cancers were identified from publically available data sources, including the Surveillance Epidemiology and End Results 9 1973-2012, National Health Interview Survey 2013, and the Medical Expenditure Panel Survey 2011. Chi-square tests and one-way analyses of variance were utilized to assess differences between cancer survivors and non-cancer controls in behavioral characteristics, symptoms and functions, preventative screenings, and health care costs. RESULTS: Hematologic malignancies, melanoma, and breast, prostate, lung, colon/rectal, bladder, kidney/renal, uterine, thyroid, and pancreatic cancers had the highest incidence rates. Breast cancer had the highest incidence among women (156.4 per 100,000) and prostate cancer among men (167.2 per 100,000). The presence of pain (P=0.0003), fatigue (P=0.0005), and sadness (P=0.0012) was consistently higher in cancer survivors 40-64 years old vs. non-cancer controls. Cancer survivors ≥65 years old had higher rates of any functional limitations (P=0.0039) and reported a lack of exercise (P<0.0001) compared with the non-cancer controls. However, obesity rates were similar between cancer survivors and non-cancer controls. Among cancer survivors, an estimated 13.5 million spent $169.4 billion a year on treatment, with the highest direct expenditures for breast cancer ($39 billion), prostate cancer ($37 billion), and hematologic malignancies ($25 billion). Prescription medications and office-based visits contributed equally as the cost drivers of direct medical spending for breast cancer, while inpatient hospitalization was the driver for prostate (52.8%) and lung (38.6%) cancers. CONCLUSION: Understanding the resource utilization implications, health, and well-being of cancer survivors can inform approaches to interventions for improving long-term care.

The burden of family caregiving in the United States: work productivity, health care resource utilization, and mental health among employed adults.

BACKGROUND: Family caregiving is an increasingly important component of care for patients and the elderly. OBJECTIVE: The aim of this study is to characterize the burden of family caregiving among employed adults. METHODS: Employed adults (≥18 years) from the 2013 US National Health and Wellness Survey (NHWS) were classified as family caregivers if they reported currently caring for at least one adult relative. Chi-square tests and one-way analyses of variance assessed whether employed caregivers, weighted to the US population, differed from employed non-caregivers on behavioral characteristics, workplace productivity, and health care resource utilization. RESULTS: Eight million workers were family caregivers in the United States, more often female than male (51% vs. 49%, P < 0.05), and 53% were between 40 and 64 years of age. Eighteen percent of caregivers were Hispanic compared with 15% of non-caregivers (P < 0.05). Similar behavioral characteristics between caregivers and non-caregivers included daily alcohol consumption (6% vs. 5%) and lack of vigorous exercise (25% vs. 29%), but caregivers had a higher prevalence of smoking (26% vs. 19%, P < 0.05). Caregivers reported a higher mean percentage of work time missed (8% vs. 4%, P < 0.05) and greater productivity impairment (24% vs. 14%, P < 0.05). Some form of depression was reported by 53% of caregivers compared with 32% of non-caregivers (P < 0.05), and more caregivers had self-reported insomnia than non-caregivers (46% vs. 37%, P < 0.05). The number of self-reported diagnosed comorbidities was higher among caregivers compared with that of non-caregivers (5.0 vs. 3.1, P < 0.05), as was the mean number of outpatient visits in the previous 6 months (4.1 vs. 2.7, P < 0.05). CONCLUSION: Family caregiving is associated with a multidimensional burden that impacts caregivers and has implications for employers and the health care system. Clinicians and employers need to recognize and understand this burden. Characterization of caregivers as reported in this study can inform development of targeted programs to help mitigate the burden.

Evaluation of the Relationship Between Serum Uric Acid Levels and Cardiovascular Events in Patients With Gout: A Retrospective Analysis Using Electronic Medical Record Data.

OBJECTIVES: The aim of this study was to evaluate relationships between serum uric acid (SUA) and newly emergent acute myocardial infarction (AMI), congestive heart failure (CHF), coronary artery disease (CAD), composite cardiovascular (CV) events (AMI, CHF, CAD), hypertension, hyperlipidemia, and renal disease in gout patients. METHODS: Retrospective analysis of electronic medical records from Humedica identified adults (≥18 years) with 2 or more International Classification of Diseases, Ninth Revision, Clinical Modification codes for gout 30 days or more apart (first diagnosis = index event) having 1 or more SUA assessment on or after the index date, and at least 6 months preindex and at least 12 months postindex enrollment. Outcomes were measured during 12 months postindex; patients with preindex events were excluded from analysis of those events. The SUA level (0.01-4.00 mg/dL, 4.01-6.00 mg/dL, 6.01-8.00 mg/dL, and ≥8.01 mg/dL) was determined using the closest laboratory assessment before or on the date of the CV event. Tukey-Kramer comparisons were performed for pairs of SUA strata and Cox proportional model estimated hazard ratios. RESULTS: A significantly higher incidence of AMI, CHF, and renal disease was observed for patients with 8.01 mg/dL or greater relative to other SUA levels (P < 0.0001), and a significantly higher incidence of composite CV events (AMI, CHF, and CAD) was observed for hypouricemia (SUA, 0.01-4.00 mg/dL) compared with other SUA levels (P < 0.0001). Cox models confirmed the increased risk associated with SUA 8.01 mg/dL or greater; hazard ratios ranged from 1.16 for hypertension to 2.04 for renal disease. Hyperlipidemia and hypertension were diagnosed concurrently with gout in 24% and 28% of patients, respectively. CONCLUSIONS: Hyperuricemia and hypouricemia were associated with an increased risk of CV events.

The burden of atopic dermatitis in US adults: results from the 2013 National Health and Wellness Survey.

OBJECTIVES: To characterize comorbidities, health-related quality-of-life (HRQoL), productivity, and healthcare resource use in adults with atopic dermatitis (AD) relative to those without AD, and to evaluate the impact of patient-reported AD severity on these outcomes. METHODS: Data were from the 2013 National Health and Wellness Survey (NHWS), which collected self-reported information on demographics, comorbidities, HRQoL (SF-36v2 Health Survey), productivity (Work Productivity and Impairment questionnaire [WPAI]), and healthcare utilization, which were weighted to the US general population. The AD cohort consisted of subjects who reported that they experienced AD within the past 12 months (n = 428), and the non-AD cohort included all subjects who did not report experiencing AD (n = 74,572); 366 AD subjects self-reported mild (n = 182) or moderate/severe (n = 184) disease. Univariable and multivariable analyses compared characteristics and outcomes between cohorts and between AD severity levels. RESULTS: The AD cohort was younger than non-AD cohort (44.3 vs. 46.6 years; P = 0.0033), and had a higher proportion of females (64.4% vs. 51.8%; P < 0.0001). Relative to the non-AD cohort, the AD cohort had a significantly higher prevalence of atopic conditions including nasal allergies (46.4% vs. 19.8%) and asthma (22.4% vs. 7.9%), and neuropsychiatric conditions such as anxiety (42.5% vs. 21.3%) and depression (37.2% vs. 20.9%) (all P < 0.0001). Units of resource use (healthcare practitioner visits, emergency room, hospitalizations) were higher (all P < 0.05) and HRQoL was poorer (P < 0.0001) with AD. On the WPAI, AD employees reported almost twice as much lost work productivity as non-AD employees (30.0% vs. 16.3%; P < 0.0001). No clear differences in outcomes were observed among patient-reported AD severity categories, except greater impairment of work productivity and daily activities in those with moderate/severe AD relative to mild. CONCLUSIONS: The significant burden associated with AD relative to those without AD suggests an unmet need for more effective management strategies. There also appears to be a need for further characterization of disease severity and its impact on HRQoL.

Impact of Out-of-pocket Costs on Varenicline Utilization and Persistence.

Background: Varenicline is a smoking cessation medication. Objectives: We analyzed patients' out-of-pocket costs and utilization of and persistence with varenicline. Methods: De-identified claims data in the MarketScan® Commercial Claims and Encounters Database were analyzed retrospectively. Participants were all patients at least 18 years of age continuously enrolled in plans during 2009. Plans were categorized according to restriction (no coverage; prior authorization; smoking cessation program requirement; no restrictions) and out-of-pocket cost for a 30-day supply (low:

Burden of smoking on quality of life in patients with chronic obstructive pulmonary disease.

The objective of this study was to assess the impact of smoking on health-related quality of life, Work Productivity and Activity Impairment (WPAI) in chronic obstructive pulmonary disease (COPD) patients. Respondents of the 2009/2010 US National Health and Wellness Survey (NHWS), aged ≥ 40 years, with COPD, chronic bronchitis or emphysema, were included in the study. Current and former (had not smoked for ≥ 11 years) smokers were compared. Physical component summary (PCS) and mental component summary (MCS) scores from the Short Form-12 version 2 (SF-12v2), health utilities (SF-6D) and WPAI were evaluated. Differences between current (n = 1685) and former (n = 1932) smokers were revealed: MCS (44.80, 46.73; p < 0.01); PCS (35.12, 35.79; p < 0.1); SF-6D (0.63, 0.65; p < 0.05). WPAI: presenteeism (23%, 18%; p < 0.05); work impairment (25%, 21%; p < 0.05); activity impairment (52%, 49%; p < 0.01). In conclusion, COPD patients who smoke have poorer health-related quality of life, impaired productivity and higher healthcare costs than former smokers.

Impact of access restrictions on varenicline utilization.

AIM: To assess the impact of access restrictions on varenicline utilization. METHODS: Employer-sponsored health plans contributing to the MarketScan Commercial Claims and Encounters Database were categorized according to 2009 varenicline access restrictions: no coverage; prior authorization; smoking cessation program requirement; no restrictions. The cohort comprised all adults continuously enrolled in plans during 2009. Each restriction cohort was compared with the no restrictions cohort using descriptive analyses. Data were assessed using logistic regression; demographic and clinical characteristics were covariates. RESULTS: In this study (no coverage, n = 454,419; prior authorization, n = 171,530; smoking cessation program, n = 108,181; no restrictions, n = 607,389), compared with the no restrictions cohort, the odds of treatment were 71% lower (odds ratio: 0.29; 95% CI: 0.26, 0.31) in the smoking cessation program cohort (p < 0.001) and 80% lower (odds ratio: 0.20; 95% CI: 0.19, 0.22) in the prior authorization cohort (p < 0.001). CONCLUSIONS: Access restrictions were associated with significantly lower odds for varenicline utilization.

Nurse practitioners, wake up and smell the smoke.

PURPOSE: With the focus of modern health care on preventive care, and the well-known benefits of smoking cessation on improving health and reducing healthcare costs, smoking cessation is a key focus of healthcare reform. To change the smoking habits of the U.S. population, two strategies are of particular importance to healthcare professionals: promoting tobacco-free environments in healthcare systems and expanding affordable and effective treatments. DATA SOURCES: Recent policy literature. CONCLUSIONS: Barriers to providing smoking cessation counseling most frequently cited by healthcare professionals are lack of training and poor reimbursement; however, recent legislation, for example, the Patient Protection and Affordable Care Act (PPACA), should make preventive services more available and affordable. Nurse practitioners (NPs) have vast experience in addressing health promotion and disease prevention, and are therefore well placed to lead this reform. However, despite consistently higher referrals of tobacco-dependent patients for smoking cessation interventions than any other group of healthcare provider, evidence suggests that NPs are not adequately trained to treat this addiction. IMPLICATIONS FOR PRACTICE: This article is a call to action for NPs to become familiar with the tobacco cessation policy changes affecting clinical practice, to become experts in tobacco treatment, and to take the lead in this healthcare reform initiative.

Patient-level pooled analysis of adjudicated gastrointestinal outcomes in celecoxib clinical trials: meta-analysis of 51,000 patients enrolled in 52 randomized trials.

INTRODUCTION: Although the safety of celecoxib has been investigated, limited data are available on complications affecting the entire (upper and lower) gastrointestinal (GI) tract, with no patient-level pooled analyses of upper and lower GI outcomes available. We therefore evaluated the upper and lower GI safety of celecoxib by using patient-level data from randomized controlled trials (RCTs). METHODS: This patient-level pooled analysis included 52 prospective, randomized, double-blind parallel-group studies from the Celecoxib Clinical Database. Each study had a planned duration of continuous treatment with celecoxib or a nonselective nonsteroidal antiinflammatory drug (nsNSAID), rofecoxib, or the placebo comparator arm for at least 4 weeks. All studies with final reports completed by 1 October 2007 were included. The primary end point was the combined incidence of clinically significant upper and lower GI events (CSULGIEs). An independent blinded committee reviewed and adjudicated all end points by using predefined criteria and all available reported adverse events, laboratory data, and case narratives. All doses of celecoxib and all doses of all nsNSAIDs were pooled for analysis. RESULTS: The pooled analysis involved 51,048 patients; 28,614 were randomized to celecoxib; 15,278 to nsNSAIDs (including 3,248 patients taking naproxen, 2,640 taking ibuprofen, 8,066 taking diclofenac, 1,234 taking loxoprofen, and 90 taking ketoprofen); 5,827 to placebo and 1,329 to rofecoxib. The mean age was 60 years, and 65% were women. Data on 1,042 patients with potential GI events were reviewed for end-points adjudication; the adjudication committee confirmed 89 patients with CSULGIEs. The majority were in the celecoxib and nsNSAID groups (with raw incidence proportions of 37 (0.1%) and 40 (0.3%), respectively). The incidence rates were 0.3, 0.9 and 0.3 per 100 patient-years in the celecoxib, nsNSAID, and placebo groups, respectively. The time to incidence of CSULGIEs was significantly longer with celecoxib than with nsNSAIDs (P=0.0004). CONCLUSIONS: When compared with nsNSAIDs, celecoxib is associated with a significantly lower risk of all clinically significant GI events throughout the entire GI tract. This pooled analysis of 52 RCTs significantly advances the understanding of the upper and lower GI safety profile of celecoxib and its potential benefits to patients.

Tolerability and adverse events in clinical trials of celecoxib in osteoarthritis and rheumatoid arthritis: systematic review and meta-analysis of information from company clinical trial reports.

The objective was to improve understanding of adverse events occurring with celecoxib in the treatment of osteoarthritis and rheumatoid arthritis. Data were extracted from company clinical trial reports of randomised trials of celecoxib in osteoarthritis or rheumatoid arthritis lasting 2 weeks or more. Outcomes were discontinuations (all cause, lack of efficacy, adverse event, gastrointestinal adverse event), endoscopically detected ulcers, gastrointestinal or cardio-renal events, and major changes in haematological parameters. The main comparisons were celecoxib (all doses) versus placebo, paracetamol (acetaminophen) 4,000 mg daily, rofecoxib 25 mg daily, or nonsteroidal anti-inflammatory drugs (NSAIDs) (naproxen, diclofenac, ibuprofen, and loxoprofen). For NSAIDs, celecoxib was compared both at all doses and at licensed doses (200 to 400 mg daily). Thirty-one trials included 39,605 randomised patients. Most patients had osteoarthritis and were women of average age 60 years or above. Most trials lasted 12 weeks or more. Doses of celecoxib were 50 to 800 mg/day. Compared with placebo, celecoxib had fewer discontinuations for any cause or for lack of efficacy, fewer serious adverse events, and less nausea. It had more patients with dyspepsia, diarrhoea, oedema, more adverse events that were gastrointestinal or treatment related, and more patients experiencing an adverse event. There were no differences for hypertension, gastrointestinal tolerability, or discontinuations for adverse events. Compared with paracetamol, celecoxib had fewer discontinuations for any cause, for lack of efficacy, or diarrhoea, but no other differences. Compared with rofecoxib, celecoxib had fewer patients with abdominal pain and oedema, but no other differences. Compared with NSAIDs, celecoxib had fewer symptomatic ulcers and bleeds, endoscopically detected ulcers, and discontinuations for adverse events or gastrointestinal adverse events. Fewer patients had any, or a gastrointestinal, or a treatment-related adverse event, or vomiting, abdominal pain, dyspepsia, or reduced haemoglobin or haematocrit. Discontinuations for lack of efficacy were higher. No differences were found for all-cause discontinuations, serious adverse events, hypertension, diarrhoea, nausea, oedema, myocardial infarction, cardiac failure, or raised creatinine. Company clinical trial reports present much more information than published papers. Adverse event information is clearly presented in company clinical trial reports, which are an ideal source of information for systematic review and meta-analysis.