Development, psychometric evaluation, and initial feasibility assessment of a symptom tracker for use by patients with heart failure (HFaST).

BACKGROUND: This study aimed to develop and provide a psychometric and feasibility pilot evaluation of the Heart Failure (HF) Symptom Tracker (HFaST), a new patient-reported tool designed to facilitate communication between patients and health care providers (HCPs) in routine clinical care. The HFaST enables patients to identify worsening HF symptoms, with a long-term goal of preventing hospitalizations or emergency room visits. METHODS: The HFaST was developed drawing on evidence from the literature, qualitatively with cognitive interviews (12 patient/caregiver and 8 HCPs), and evaluated quantitatively (psychometric, feasibility assessment). The HFaST was administered for 7 consecutive days to 100 individuals diagnosed with HF during a multisite, non-interventional US pilot study. Health care providers then completed a survey assessing the feasibility and importance of the HFaST in clinical practice. Qualitative development included a literature review and cognitive interviews with patients, caregivers, and HCPs. The psychometric properties of the HFaST were evaluated using classical test theory methods. Descriptive statistics provided insight into HCPs' perceptions of the feasibility of using the HFaST in clinical practice. RESULTS: A preliminary set of 40 items was developed for the symptom tracker and iteratively reduced to 10 items based on the qualitative phase. Test-retest reliability (weighted kappa 0.71-0.97), discriminating validity, and construct validity of the HFaST were acceptable. HCPs rated the HFaST as a good (70%) or excellent (30%) means of tracking HF symptoms. Six HFaST items were ultimately retained, covering concepts of fatigue, shortness of breath (3 items), swelling, and rapid weight gain. CONCLUSIONS: The 6-item HFaST is an easy-to-use tool designed to raise patients' awareness of HF symptoms and facilitate communication with HCPs. Future research should evaluate HFaST implementation in clinical practice and effectiveness as an intervention to potentially prevent hospitalizations and emergency room visits.

Characteristics of early sacubitril/valsartan patients and considerations for studies in electronic health record data.

AIM: We examined characteristics of early sacubitril/valsartan users in a large US electronic health records database. PATIENTS & METHODS: We identified three cohorts of patients with heart failure (HF): sacubitril/valsartan patients with a prior HF diagnosis; patients with HF with reduced ejection fraction; and patients with HF treated with an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker and a ß-blocker. RESULTS: Sacubitril/valsartan patients were younger than patients in the other cohorts; the mean age of sacubitril/valsartan patients increased by 2 years in the first 15 months of marketing. Most sacubitril/valsartan patients had prior use of HF treatment. CONCLUSION: Overall, sacubitril/valsartan patients resembled those in the HF with reduced ejection fraction cohort, and commonly used other drugs for HF.

Economic evaluation of micafungin versus liposomal amphotericin B (LAmB) for treating patients with candidaemia and invasive candidiasis (IC) in Turkey.

Micafungin was reported to be non-inferior to liposomal amphotericin B (LAmB) in treating patients with candidaemia and invasive candidiasis (IC). The current study aimed to evaluate the economic impact of using micafungin versus LAmB for treatment of candidaemia and IC in Turkey. A decision analytic model, which depicted economic consequences upon administration of micafungin or LAmB for treating patients with candidaemia and IC in the Turkish hospitals, was constructed. Patients were switched to an alternative antifungal agent if initial treatment failed due to mycological persistence. All patients were followed up until treatment success or death. Outcome probabilities were obtained from published literature and cost inputs were derived from the latest Turkish resources. Expert panels were used to estimate data that were not available in the literature. Cost per patient treated for each intervention was then calculated. Sensitivity analyses including Monte Carlo simulation were performed. For treatment of candidaemia and IC, micafungin (€4809) was associated with higher total cost than LAmB (€4467), with an additional cost of €341 per treated patient. Cost of initial antifungal treatment was the major cost driver for both comparators. The model outcome was robust over a wide variation in input variables except for drug acquisition cost and duration of initial antifungal treatment with micafungin or LAmB. LAmB is cost-saving relative to micafungin for the treatment of candidaemia and IC from the Turkish hospital perspective, with variation in drug acquisition cost of the critical factor affecting the model outcome.

Home-Time After Discharge Among Patients Hospitalized With Heart Failure.

BACKGROUND: Surveys of patients with cardiovascular disease have suggested that "home-time"-being alive and out of any health care institution-is a prioritized outcome. This novel measure has not been studied among patients with heart failure (HF). OBJECTIVES: This study sought to characterize home-time following hospitalization for HF and assess its relationship with patient characteristics and traditionally reported clinical outcomes. METHODS: Using GWTG-HF (Get With The Guidelines-Heart Failure) registry data, patients discharged alive from an HF hospitalization between 2011 and 2014 and ≥65 years of age were identified. Using Medicare claims, post-discharge home-time over 30-day and 1-year follow-up was calculated for each patient as the number of days alive and spent outside of a hospital, skilled nursing facility (SNF), or rehabilitation facility. RESULTS: Among 59,736 patients, 57,992 (97.1%) and 42,153 (70.6%) had complete follow-up for home-time calculation through 30 days and 1 year, respectively. The mean home-time was 21.6 ± 11.7 days at 30 days and 243.9 ± 137.6 days at 1 year. Contributions to reduced home-time varied by follow-up period, with days spent in SNF being the largest contributor though 30 days and death being the largest contributor through 1 year. Over 1 year, 2,044 (4.8%) patients had no home-time following index hospitalization discharge, whereas 8,194 (19.4%) had 365 days of home-time. In regression models, several conditions were associated with substantially reduced home-time, including chronic obstructive pulmonary disease, renal insufficiency, and dementia. Through 1 year, home-time was highly correlated with time-to-event endpoints of death (tau = 0.72) and the composite of death or HF readmission (tau = 0.59). CONCLUSIONS: Home-time, which can be readily calculated from administrative claims data, is substantially reduced for many patients following hospitalization for HF and is highly correlated with traditional time-to-event mortality and hospitalization outcomes. Home-time represents a novel, easily measured, patient-centered endpoint that may reflect effectiveness of interventions in future HF studies.

Signs, symptoms, and treatment patterns across serial ambulatory cardiology visits in patients with heart failure: insights from the NCDR PINNACLE® registry.

BACKGROUND: Due to a relative lack of outpatient heart failure (HF) clinical registries, we aimed to describe symptoms, signs, and medication treatment among ambulatory patients with heart failure (HF) over time. METHODS: Using health records from 234 PINNACLE (Practice Innovation and Clinical Excellence) U.S. cardiology practices (2008-2014), serial visits for patients with HF were characterized. Symptoms, signs, and HF medications (angiotensin-converting enzyme inhibitors [ACEI], angiotensin receptor blockers [ARB], beta blockers [BB], and diuretics) were compared between visits. RESULTS: Among 763,331 patients with HF, 550,581 had ≥2 clinic visits < 1 year apart, with 2,998,444 visit pairs. In the 12 months following an index visit, patients had a mean of 2.5 ± 2.3 additional visits. Recorded index visit symptoms ranged from dyspnea (53.6%) to orthopnea (23.1%); signs ranged from peripheral edema (52.2%) to hepatomegaly (0.6%). Of those with ejection fraction < 40%, ACEI was prescribed in 58.6%, ARB in 18.5%, BB in 85.2%, and diuretics in 70.0%. Between-visit recorded changes were infrequent: dyspnea appeared in 3.8%, resolved in 2.7%; NYHA class increased in 2.9%, decreased in 2.9%; number of signs increased in 6.0%, decreased in 5.1%; ACEI/ARB or BB added in 6.4%, removed in 6.2%; diuretic added in 3.7%, removed in 3.8%. Changes in recorded symptoms were rarely associated with initiation or discontinuation in HF medication classes. CONCLUSIONS: Ambulatory HF care in U.S. cardiology practices seldom recorded changes in symptoms, signs, and medication class. Although templated medical records and absence of medication dosing likely underestimated the degree to which clinical changes occur over serial visits for HF, these PINNACLE data suggest opportunities for greater symptom-based and therapy-focused visits.

Cost-effectiveness analysis of anidulafungin vs fluconazole for the treatment of invasive candidiasis (IC) in Turkey.

Anidulafungin has been shown to be non-inferior to, and possibly more efficacious, than fluconazole in treating patients with invasive candidiasis (IC). This study aimed to determine the cost-effectiveness of anidulafungin vs fluconazole for treatment of IC in the Turkish setting. A decision analytic model was constructed to depict downstream economic consequences of using anidulafungin or fluconazole for treatment of IC in the Turkish hospitals. Transition probabilities (ie treatment success, observed or indeterminate treatment failures) were obtained from a published randomised clinical trial. Cost inputs were from the latest Turkish resources. Data not available in the literature were estimated by expert panels. Sensitivity analyses were performed to assess the robustness of the model outcome. While anidulafungin [TL 17 171 (USD 4589)] incurred a higher total cost than fluconazole [TL 8233 (USD 2200) per treated patient, treatment with anidulafungin was estimated to save an additional 0.58 life-years, with an incremental cost-effectiveness ratio of TL 15 410 (USD 4118) per life-years saved. Drug acquisition cost and hospitalisation were the main cost drivers for anidulafungin and fluconazole arms respectively. The model findings were robust over a wide range of input variables except for anidulafungin drug cost. Anidulafungin appears to be a cost-effective therapy in treating IC from the Turkish hospital perspective.

Change the management of patients with heart failure: Rationale and design of the CHAMP-HF registry.

Heart failure (HF) with reduced ejection fraction (HFrEF) is a common and costly condition that diminishes patients' health status and confers a poor prognosis. Despite the availability of multiple guideline-recommended pharmacologic and cardiac device therapies for patients with chronic HFrEF, outcomes remain suboptimal. Currently, there is limited insight into the rationale underlying clinical decisions by health care providers and patient factors that guide the use and intensity of outpatient HF treatments. A better understanding of current practice patterns has the potential to improve patients' outcomes. The CHAnge the Management of Patients with Heart Failure (CHAMP-HF) registry will evaluate the care and outcomes of patients with chronic HFrEF by assessing real-world treatment patterns, as well as the reasons for and barriers to medication treatment changes. CHAMP-HF will enroll approximately 5,000 patients with chronic HFrEF (left ventricular ejection fraction ≤40%) at approximately 150 US sites, and patients will be followed for a maximum duration of 24 months. Participating sites will collect data from both providers (HF history, examination findings, results of diagnostic studies, pharmacotherapy treatment patterns, decision-making factors, and clinical outcomes) and patients (medication adherence and patient-reported outcomes). The CHAMP-HF registry will provide a unique opportunity to study practice patterns and the adoption of new HF therapies across a diverse mix of health care providers and outpatient practices in the United States that care for HFrEF patients.

Early Adoption of Sacubitril/Valsartan for Patients With Heart Failure With Reduced Ejection Fraction: Insights From Get With the Guidelines-Heart Failure (GWTG-HF).

OBJECTIVES: The aim of this study was to assess the prevalence and variation in angiotensin receptor/neprilysin inhibitor (ARNI) prescription among a real-world population with heart failure with reduced ejection fraction (HFrEF). BACKGROUND: The U.S. Food and Drug Administration approved sacubitril/valsartan for patients with HFrEF in July 2015. Little is known about the early patterns of use of this novel therapy. METHODS: The study included patients discharged alive from hospitals in Get With the Guidelines-Heart Failure (GWTG-HF), a registry of hospitalized patients with heart failure, between July 2015 and June 2016 who had documentation of whether ARNIs were prescribed at discharge. Patient and hospital characteristics were compared among patients with HFrEF (ejection fraction ≤40%) with and without ARNI prescription at discharge, excluding those with documented contraindications to ARNIs. To evaluate hospital variation, hospitals with at least 10 eligible hospitalizations during the study period were assessed. RESULTS: Of 21,078 patients hospitalized with HFrEF during the study period, 495 (2.3%) were prescribed ARNIs at discharge. Patients prescribed ARNIs were younger (median age 65 years vs. 70 years; p < 0.001), had lower ejection fractions (median 23% vs. 25%; p < 0.001), and had higher use of aldosterone antagonists (45% vs. 31%; p < 0.001) at discharge. At the 241 participating hospitals with 10 or more eligible admissions, 125 (52%) reported no discharge prescriptions of ARNIs. CONCLUSIONS: Approximately 2.3% of patients hospitalized for HFrEF in a national registry were prescribed ARNI therapy in the first 12 months following Food and Drug Administration approval. Further study is needed to identify and overcome barriers to implementing new evidence into practice, such as ARNI use among eligible patients with HFrEF.

Healthcare Costs Among Patients with Heart Failure: A Comparison of Costs between Matched Decedent and Survivor Cohorts.

INTRODUCTION: Prior research suggests increased costs during the final months of life, yet little is known about healthcare cost differences between patients with heart failure (HF) who die or survive. METHODS: A retrospective claims study from a large US health plan [commercial and Medicare Advantage with Part D (MAPD)] was conducted. Patients were ≥18 years old with two non-inpatient or one inpatient claim(s) with HF diagnosis code(s). The earliest HF claim date during 1 January 2010-31 December 2011 was the index date. Cohort assignment was based on evidence of death within 1 year (decedents) or survival for >1 year (survivors) post-index. Per-patient-per-month (PPPM) and 1-year (variable decedent follow-up) costs (all-cause and HF-related) were calculated up to 1 year post-index. Cohorts were matched on demographic and clinical characteristics. Independent samples t tests and Pearson's chi-square tests were used to examine cohort differences. RESULTS: Among patients with HF, 8344 survivors were 1:1 matched to decedents [mean age 75 years, 50% female, 88% MAPD; mean time to decedents' death: 150 (SD 105) days]. Compared to survivors, more decedents had no pharmacy claims for HF-related outpatient pharmacotherapy within 60 days post-index (42.1% vs. 27.1%; p < 0.001). Decedents also incurred higher all-cause medical costs (PPPM: $21,400 vs. $2663; 1 year: $60,048 vs. $32,394; both p < 0.001) and higher HF-related medical costs (PPPM: $16,477 vs. $1358; 1 year: $39,052 vs. $16,519; both p < 0.001). Hospitalizations accounted for more than half of all-cause PPPM medical costs (54.6% for survivors, 84.3% for decedents). CONCLUSION: Patients with HF who died within 1 year after an index HF encounter incurred markedly higher costs within 1 year (despite the much shorter post-index period) and PPPM costs than those who survived, with the majority of costs attributable to hospitalizations for both patient cohorts. There may be opportunities for improving outcomes in HF, considering higher use of pharmacotherapy and lower costs were seen among survivors.

Health Care Costs for Patients with Heart Failure Escalate Nearly 3-Fold in Final Months of Life.

BACKGROUND: Heart failure (HF) is a severe chronic disease with growing prevalence and health care burden as well as high mortality. End-of-life cost data for patients with HF may inform disease and medication therapy management. OBJECTIVES: To (a) characterize a real-world sample of patients with HF who died; (b) estimate health care costs for 6 months and semiannually for 24 months, before death; and (c) examine associations between patient characteristics and predeath health care costs. METHODS: This was a retrospective study of commercial and Medicare Advantage with Part D (MAPD) enrollees (aged ≥ 18 years), using data from a large national health plan. Included patients had evidence of HF during January 1, 2009-December 31, 2013, based on ≥ 1 inpatient hospitalization or ≥ 2 noninpatient encounters with diagnosis code for HF and evidence of mortality during July 1, 2009-December 31, 2013. Demographic data, comorbidities, guideline-directed HF-related outpatient pharmacotherapy (HFRx), and predeath health care costs (all-cause and HF-related) were described. A generalized linear model examined associations between all-cause health care costs (months 6 and 1 previous to death) and specific patient characteristics. RESULTS: Of 48,026 identified patients, mean age was 77.9 years; 52.8% were female; 93.0% were MAPD enrolled; 92.5% had Quan-Charlson comor-bidity score ≥ 3; and about one quarter (26.0%) had no evidence of HFRx. Over the last 6 months of life, monthly all-cause total cost increased 3.2-fold for MAPD enrollees and 2.8-fold for commercial enrollees, although pharmacy cost decreased slightly (0.8-fold for both plan types). Cumulative 6-month all-cause medical cost was $37,186 for MAPD enrollees and $143,363 for commercial enrollees (68.8% and 73.2% due to hospitalization, respectively), and cumulative HF-related medical cost was $20,794 for MAPD enrollees and $78,440 for commercial enrollees (88.8% and 95.3% due to hospitaliza-tion, respectively). Over the last 24 months, semiannual all-cause total cost increased 3.2-fold for MAPD enrollees and 4.5-fold for commercial enroll-ees, although pharmacy cost increased only slightly (1.1-fold and 1.3-fold, respectively). Based on multivariable analysis, factors associated with higher risk of incurring a cost increase between month 6 and month 1 before death included older age (75-84 years: cost ratio [CR] = 1.33, P < 0.001; 226585 years: CR = 1.43, P < 0.001), comorbid coronary heart disease (CR = 1.12, P = 0.003), and no evidence of HFRx (CR = 1.48, P < 0.001). CONCLUSIONS: Patients with HF experienced ≥ 2.8-fold increase in monthly all-cause total cost over the last 6 months of life, which was driven by hospitalization. Although MAPD enrollees incurred greater cost increases, cumulative costs were higher for commercial enrollees. After multivariable adjustment, older age, comorbid coronary heart disease, and no evidence of HFRx were among factors associated with higher risk of cost increase over the last 6 months of life. Study findings provide predeath cost information that should be useful in value assessments of innovative HF interventions and highlight impact of HFRx on predeath health care costs.

Cost-effectiveness Analysis of Sacubitril/Valsartan vs Enalapril in Patients With Heart Failure and Reduced Ejection Fraction.

IMPORTANCE: The angiotensin receptor neprilysin inhibitor sacubitril/valsartan was associated with a reduction in cardiovascular mortality, all-cause mortality, and hospitalizations compared with enalapril. Sacubitril/valsartan has been approved for use in heart failure (HF) with reduced ejection fraction in the United States and cost has been suggested as 1 factor that will influence the use of this agent. OBJECTIVE: To estimate the cost-effectiveness of sacubitril/valsartan vs enalapril in the United States. DESIGN, SETTING, AND PARTICIPANTS: Data from US adults (mean [SD] age, 63.8 [11.5] years) with HF with reduced ejection fraction and characteristics similar to those in the PARADIGM-HF trial were used as inputs for a 2-state Markov model simulated HF. Risks of all-cause mortality and hospitalization from HF or other reasons were estimated with a 30-year time horizon. Quality of life was based on trial EQ-5D scores. Hospital costs combined Medicare and private insurance reimbursement rates; medication costs included the wholesale acquisition cost for sacubitril/valsartan and enalapril. A discount rate of 3% was used. Sensitivity analyses were performed on key inputs including: hospital costs, mortality benefit, hazard ratio for hospitalization reduction, drug costs, and quality-of-life estimates. MAIN OUTCOMES AND MEASURES: Hospitalizations, quality-adjusted life-years (QALYs), costs, and incremental costs per QALY gained. RESULTS: The 2-state Markov model of US adult patients (mean age, 63.8 years) calculated that there would be 220 fewer hospital admissions per 1000 patients with HF treated with sacubitril/valsartan vs enalapril over 30 years. The incremental costs and QALYs gained with sacubitril/valsartan treatment were estimated at $35 512 and 0.78, respectively, compared with enalapril, equating to an incremental cost-effectiveness ratio (ICER) of $45 017 per QALY for the base-case. Sensitivity analyses demonstrated ICERs ranging from $35 357 to $75 301 per QALY. CONCLUSIONS AND RELEVANCE: For eligible patients with HF with reduced ejection fraction, the Markov model calculated that sacubitril/valsartan would increase life expectancy at an ICER consistent with other high-value accepted cardiovascular interventions. Sensitivity analyses demonstrated sacubitril/valsartan would remain cost-effective vs enalapril.

Treatment Initiation Patterns, Modifications, and Medication Adherence Among Newly Diagnosed Heart Failure Patients: A Retrospective Claims Database Analysis.

BACKGROUND: Heart failure (HF) is a debilitating disease associated with high mortality and frequent hospitalizations. American College of Cardiology Foundation and American Heart Association (ACCF/AHA) guidelines recommend the following drug classes for HF treatment: angiotensin-converting enzyme inhibitor (ACEI), angiotensin receptor II blocker (ARB) for patients intolerant to ACEI, beta blocker (BB), and aldosterone antagonist (AA). OBJECTIVE: To examine, in a real-word setting, the treatment initiation pattern among newly diagnosed HF patients in the United States, subsequent treatment modifications, hospitalizations and the impact of hospitalizations on therapy changes, and treatment adherence and persistence. METHODS: Using medical and pharmacy claims data from the Truven Health MarketScan database, this retrospective cohort study included adult patients with ≥ 2 medical claims corresponding to an HF diagnosis (ICD-9-CM codes 428.x, 402.11, 402.91, 404.01, 404.11, 404.91, 404.03, 404.13, and 404.93) between April 2009 and March 2012. The date of the first claim was defined as the index date. Patients with continuous medical and pharmacy eligibility for a minimum of 12 months pre- and post-index were included in the analysis. Patients with an HF diagnosis in the 12 months before the index date were excluded. Index treatment (within 30 days post-index), subsequent treatment modification (class addition/removal) during the study period, hospitalization, and change in treatment after hospitalization (within 15 days after hospital discharge) were determined. Adherence was evaluated using the proportion of days covered (PDC) method, and persistence was defined as the proportion of patients remaining on index treatment after a defined period of time (12 months). RESULTS: A total of 235,758 patients meeting the sample selection criteria were included in the analysis and were followed for a median of 28 months after the index date. Approximately 42% of patients were not prescribed any HF-specific treatment within 30 days post-index. Among those treated, prescriptions for ACEIs were filled by 46.42% of patients, ARBs by 17.07%, BBs by 75.62%, and AAs by 9.83%. Based on HF therapy class, monotherapy was prescribed to 51% of patients, bi-therapy to 40%, and triple therapy to 9%. More than 80% of patients experienced treatment modification during the median 28 months of follow-up. A total of 174,563 (74.0%) patients had at least 1 all-cause hospitalization (mean 1.11 [SD = 0.98]) per year, with a mean length of stay (LOS) of 7.19 [SD = 8.69] days. Within 12 months post-index, 85.7% of these patients experienced an all-cause hospitalization, with 29.6% having HF-related hospitalization (mean 0.18 [0.36]) and mean LOS of 5.85 [5.45] days. More than 60% of patients continued on the same therapy after all-cause or HF hospitalization. More patients on multiple therapies remained on the same treatment (73%-89%) compared with those treated with monotherapy (60%-73%) after the first HF hospitalization. Among patients untreated before hospitalization, 9.8% and 17% received treatment after all-cause and HF hospitalization, respectively. During the entire study period (median 28 months), 29% of patients did not have a prescription fill for HF-specific treatments. The median PDC was > 0.65, and considering a gap of 30 days between ends of supply from 1 medication fill to the subsequent fill, persistence ranged from 41% (AA) to 52% (BB). CONCLUSIONS: Findings of this claims database analysis among 235,758 HF patients suggest that more than one third of newly diagnosed HF patients do not receive HF-specific medication within 30 days following initial diagnosis. Despite ACCF/AHA recommendations of initiating treatment with a combination of 2 HF drug classes, only 40% of patients had a prescription fill for bi-therapy. Hospitalization did not have a major impact on HF therapy prescribing patterns. To our knowledge, this is the first study to establish the impact of hospitalization on HF-specific treatment among newly diagnosed patients. Adherence and persistence were moderate across all HF therapies of interest. This analysis reveals the need for further research to better understand the reasons for the demonstrated delay in HF treatment initiation and limited use of guideline-directed medical therapy after initial diagnosis. DISCLOSURES: This study was funded by Novartis Pharma AG, Basel, Switzerland. Deschaseaux, McSharry, Hudson, Agrawal, and Turner are permanent employees of Novartis. Concept and study design were contributed by Deschaseaux, Hudson, and Turner, along with McSharry. McSharry took the lead in data collection, along with Deschaseaux, Hudson, and Turner. Data interpretation was performed by Hudson, along with the other authors. The manuscript was written by Agrawal, along with Deschaseaux and Turner, and revised by Deschaseaux and Turner, along with the other authors.

Physician-Patient Concordance in Pharmacological Management of Patients with COPD.

A retrospective analysis of a cross-sectional, multicenter survey was conducted in United States (US) medical practices to evaluate the concordance between patients with COPD and their physicians on disease-specific characteristics. Associations between patient and disease-related characteristics with monotherapy, dual therapy, or triple therapy prescribed as COPD maintenance regimens were also examined. Eligible physicians completed patient record forms (PRFs) for up to 6 consecutive patients with COPD. Patients for whom a PRF was completed were invited to complete a patient self-completion (PSC) survey consisting of questions similar to those on the PRF, as well as several validated measures to assess the impact of COPD on patients' lives. A total of 469 patients completed a PSC that was matched with the PRF completed by their physician, forming the sample for the concordance analysis. Moderate agreement (kappa (κ) = 0.41-0.60) was observed for 79% of measures, with the lowest concordance rating corresponding to hemoptysis (κ = 0.22). There were few differences in demographic or clinical characteristics between patients prescribed monotherapy and dual therapy. Triple therapy rather than monotherapy or dual therapy was more often prescribed for patients with greater frequency of symptoms, negative impact of COPD on daily life and interpersonal relationships, and respiratory impairment based on the most recent FEV1. Diverse factors influence US physicians' perceptions of disease and treatment choices, including patient symptoms, quality of life, and disease impact. Our results highlight that concordance between physicians and patients regarding symptoms and physical function may contribute to optimal management of COPD.

Effect of chronic urticaria on US patients: analysis of the National Health and Wellness Survey.

BACKGROUND: Chronic idiopathic (also called spontaneous) urticaria (CIU/CSU) is the most common form of chronic urticaria and has been associated with impairment to health outcomes, although the effect has never been assessed using a nationally representative sample in the United States. OBJECTIVES: To assess the burden of CIU/CSU from the patients' perspective in terms of health related quality of life, impairment to work and nonwork activities, and health care resource use. METHODS: Data were obtained from the US National Health and Wellness Survey. Current use of a prescription for the treatment of chronic hives was used as a proxy for CIU/CSU. Patients with CIU/CSU in the proxy group were matched 1:4 to respondents without chronic hives using survey year, sex, age, and race. Generalized linear models were adjusted for comorbidities, smoking, body mass index, and health insurance status. Outcome measures included the Medical Outcomes Study 12-Item and 36-Item Short Form Health Surveys; self-reported depression, anxiety, and sleep difficulties; the Work Productivity and Activity Impairment questionnaire, and health care resource use. RESULTS: After matching and adjustment for covariates, those currently using a prescription for chronic hives had mental component summary scores 5.7 points lower, physical component summary scores 6.5 points lower, and health utility scores 0.11 points lower than controls, as well as higher adjusted odds of reporting depression, anxiety, and sleep difficulties. Mean adjusted work impairment was approximately double in prescription-treated chronic hives relative to controls, as was frequency of health care visits. CONCLUSION: Chronic hives substantially affects quality of life, nonwork activities, capacity to work, and health care use, providing further evidence of a high burden of CIU/CSU across multiple health outcomes and unmet need for effective treatment.

Comparison of US emergency department acute asthma care quality: 1997-2001 and 2011-2012.

BACKGROUND: It remains unclear whether the quality of acute asthma care in US emergency departments (EDs) has improved over time. OBJECTIVES: We investigated changes in concordance of ED asthma care with 2007 National Institutes of Health guidelines, identified ED characteristics predictive of concordance, and tested whether higher concordance was associated with lower risk of hospitalization. METHODS: We performed chart reviews in ED patients aged 18 to 54 years with asthma exacerbations in 48 EDs during 2 time periods: 1997-2001 (2 prior studies) and 2011-2012 (new study). Concordance with guideline recommendations was evaluated by using item-by-item quality measures and composite concordance scores at the patient and ED levels; these scores ranged from 0 to 100. RESULTS: The analytic cohort comprised 4039 patients (2119 from 1997-2001 vs 1920 from 2011-2012). Over these 16 years, emergency asthma care became more concordant with level A recommendations at both the patient and ED levels (both P < .001). By contrast, concordance with non-level A recommendations (peak expiratory flow measurement and timeliness) decreased at both the patient (median score, 75 [interquartile range, 50-100] to 50 [interquartile range, 33-75], P < .001) and ED (mean score, 67 [SD, 7] to 50 [SD, 16], P < .001) levels. Multivariable analysis demonstrated ED concordance was lower in Southern and Western EDs compared with Midwestern EDs. After adjusting for severity, guideline-concordant care was associated with lower risk of hospitalization (odds ratio, 0.37; 95% CI, 0.26-0.53). CONCLUSIONS: Between 1997 and 2012, we observed changes in the quality of emergency asthma care that differed by level of guideline recommendation and substantial interhospital and geographic variations. Greater concordance with guideline-recommended management might reduce unnecessary hospitalizations.

A multicenter observational study of US adults with acute asthma: who are the frequent users of the emergency department?

BACKGROUND: Despite the substantial burden of asthma-related emergency department (ED) visits, there have been no recent multicenter efforts to characterize this high-risk population. OBJECTIVE: We aimed to characterize patients with asthma according to their frequency of ED visits and to identify factors associated with frequent ED visits. METHODS: A multicenter chart review study of 48 EDs across 23 US states. We identified ED patients ages 18 to 54 years with acute asthma during 2011 and 2012. Primary outcome was frequency of ED visits for acute asthma in the past year, excluding the index ED visit. RESULTS: Of the 1890 enrolled patients, 863 patients (46%) had 1 or more (frequent) ED visits in the past year. Specifically, 28% had 1 to 2 visits, 11% had 3 to 5 visits, and 7% had 6 or more visits. Among frequent ED users, guideline-recommended management was suboptimal. For example, of patients with 6 or more ED visits, 85% lacked evidence of prior evaluation by an asthma specialist, and 43% were not treated with inhaled corticosteroids. In a multivariable model, significant predictors of frequent ED visits were public insurance, no insurance, and markers for chronic asthma severity (all P < .05). Stronger associations were found among those with a higher frequency of asthma-related ED visits (eg, 6 or more ED visits). CONCLUSION: This multicenter study of US adults with acute asthma demonstrated many frequent ED users and suboptimal preventive management in this high-risk population. Future reductions in asthma morbidity and associated health care utilization will require continued efforts to bridge these major gaps in asthma care.

Costs and health care resource utilization among chronic obstructive pulmonary disease patients with newly acquired pneumonia.

BACKGROUND: Patients with chronic obstructive pulmonary disease (COPD) are at increased risk for lung infections and other pathologies (eg, pneumonia); however, few studies have evaluated the impact of pneumonia on health care resource utilization and costs in this population. The purpose of this study was to estimate health care resource utilization and costs among COPD patients with newly acquired pneumonia compared to those without pneumonia. METHODS: A retrospective claims analysis using Truven MarketScan(®) Commercial and Medicare databases was conducted. COPD patients with and without newly acquired pneumonia diagnosed between January 1, 2004 and September 30, 2011 were identified. Propensity score matching was used to create a 1:1 matched cohort. Patient demographics, comorbidities (measured by Charlson Comorbidity Index), and medication use were evaluated before and after matching. Health care resource utilization (ie, hospitalizations, emergency room [ER] and outpatient visits), and associated health care costs were assessed during the 12-month follow-up. Logistic regression was conducted to evaluate the risk of hospitalization and ER visits, and gamma regression models and two-part models compared health care costs between groups after matching. RESULTS: In the baseline cohort (N=467,578), patients with newly acquired pneumonia were older (mean age: 70 versus [vs] 63 years) and had higher Charlson Comorbidity Index scores (3.3 vs 2.6) than patients without pneumonia. After propensity score matching, the pneumonia cohort was nine times more likely to have a hospitalization (odds ratio; 95% confidence intervals [CI] =9.2; 8.9, 9.4) and four times more likely to have an ER visit (odds ratio; 95% CI =4.4; 4.3, 4.5) over the 12-month follow-up period compared to the control cohort. The estimated 12-month mean hospitalization costs ($14,353 [95% CI: $14,037-$14,690]), outpatient costs ($6,891 [95% CI: $6,706-$7,070]), and prescription drug costs ($1,104 [95% CI: $1,054-$1,142]) were higher in the pneumonia cohort than in the control cohort. CONCLUSION: This study demonstrated elevated health care resource use and costs in patients with COPD after acquiring pneumonia compared to those without pneumonia.

Pharmacoeconomic evaluation of voriconazole vs. liposomal amphotericin B in empiric treatment of invasive fungal infections in Turkey.

BACKGROUND: Invasive fungal infections (IFI) are associated with considerable expense and mortality on healthcare systems. There is a need to provide evidence of both clinical efficacy and value for money with any health technology. The current pharmacoeconomic evaluation investigated the use of liposomal amphotericin B (LAmB) and voriconazole for the empiric treatment of IFI in the Turkish setting. METHODS: Decision analytic modelling was used to create a pathway for patient treatment with a 5-point composite outcome measure. The data was obtained from a major non-inferiority multicentre randomised controlled study, with an expert panel of clinicians in Turkey providing transition probabilities and cost not available in the literature. Sensitivity analyses were performed on the inputs from the clinical trial and the expert panel. RESULTS: As per the base case analysis, voriconazole was preferred by Turkish Lira (TL) 2,523 per patient treated and TL2,520 per surviving patient. LAmB was the preferred alternative by TL5,362 per successfully treated patient. Removing fever resolution as part of the composite outcome measure resulted in voriconazole being the preferred alternative per successfully treated patient. Univariate sensitivity analysis highlighted that increasing the duration of voriconazole by >1.2 days or decreasing LAmB by >1.0 days changes the result. Monte Carlo Simulation resulted in 69.4% of simulations favouring voriconazole per patient treated. CONCLUSION: There is a strong likelihood that voriconazole is economically more favourable than LAmB in the empiric treatment of IFI in Turkey.

Protease inhibitors for hepatitis C: economic implications.

Chronic hepatitis C virus (HCV) infection, a blood-borne virus, is the leading cause of chronic liver disease and liver transplantation worldwide. Chronic HCV infection is usually asymptomatic in the early stages of the disease, making an estimation of the total population affected difficult to elicit. The gold standard treatment option to date has been a combination of pegylated interferon and ribavirin. Recent developments have led to the introduction of two protease inhibitors for use in chronic HCV-boceprevir and telaprevir. Phase III studies have shown both agents have the potential to significantly increase the probability of attaining a sustained virologic response (the primary outcome of interest in chronic HCV) in genotype 1 infections. However, the added cost of these agents also presents the need for decision makers to determine their place on drug formularies. The protease inhibitors are to be administered as triple therapy with the existing gold standard. However, significant variation exists as to the proposed duration of triple therapy, use of lead-in pegylated interferon and ribavirin and subsequent pegylated interferon therapy after finishing the course of triple therapy. Treatment algorithms also exist for the use of stopping rules in the case of early non-responders.The aim of this review is to highlight the current understanding of the economic impact protease inhibitors may have on health care systems and considerations required in the treatment of HCV. Economic and health-related quality of life issues are addressed from multiple viewpoints. The major aspects of the economic evaluations, to date, that included triple therapy as an alternative in the treatment of chronic HCV are brought to light. Future economic evaluations in alternative settings would be useful. The review also emphasizes the challenges for future research. This includes the potential for new therapies to no longer require inclusion of pegylated interferon and/or ribavirin, as well as the use of protease inhibitors in non-genotype 1 patients or those with significant co-morbidities such as HIV/AIDS.