Health state utilities for non small cell lung cancer.

BACKGROUND: Existing reports of utility values for metastatic non-small cell lung cancer (NSCLC) vary quite widely and are not all suitable for use in submissions in the UK. The aim of this study was to elicit UK societal based utility values for different stages of NSCLC and different grade III-IV toxicities commonly associated with chemotherapy treatments. Toxicities included neutropenia, febrile neutropenia, fatigue, diarrhoea, nausea and vomiting, rash and hair loss. METHODS: Existing health state descriptions of metastatic breast cancer were revised to make them suitable as descriptions of metastatic NSCLC patients on second-line treatment. The existing health states were used in cognitive debrief interviews with oncologists (n = 5) and oncology specialist nurses (n = 5). Changes were made as suggested by the clinical experts. The resulting health states (n = 17) were piloted and used in a societal based valuation study (n = 100). Participants rated half of the total health states in a standard gamble interview to derive health state utility scores. Data were analysed using a mixed model analysis. RESULTS: Each health state described the symptom burden of disease and impact on different levels of functioning (physical, emotional, sexual, and social). The disutility related to each disease state and toxicity was estimated and were combined to give health state values. All disease states and toxicities were independent significant predictors of utility (p < 0.001). Stable disease with no toxicity (our base state) had a utility value of 0.653. Utility scores ranged from 0.673 (responding disease with no toxicity) to 0.473 for progressive disease. CONCLUSION: This study reflects the value that society place on the avoidance of disease progression and severe toxicities in NSCLC.

Clinical interpretation of quality-of-life outcomes: an investigation of data from the randomized trial of gemcitabine plus paclitaxel compared with paclitaxel alone for advanced breast cancer.

Quality-of-Life (QL) data are increasingly relevant to trial results, but are often difficult to interpret and apply clinically; methods to address this problem are needed. Exploratory analyses were conducted using QL data from a recent phase III trial comparing front line gemcitabine plus paclitaxel (GT) versus paclitaxel (T) alone in patients with advanced breast cancer. The most troublesome symptom and toxicity items were identified. For each QL domain, associations and change over time were analyzed using clinically relevant data. The impact of tumor response and duration of therapy on QL outcomes was assessed using pooled data from both treatment arms. Baseline QL data were available from 336 patients, out of 266 patients enrolled on the GT arm and 263 patients enrolled on the T arm. The prevalence of disease-related symptoms was low; 7 of the 10 most troublesome items were psychological. Clinical levels of psychological distress were significantly associated with global QL and reduced significantly over time in both arms. Improved QL was significantly associated with reduced functional impairment, tumor response and completing more cycles of therapy. In this patient population, QL may be closely associated with the clinical efficacy of chemotherapy, functional status and psychological well-being, rather than outcomes such as symptom palliation and toxicity.

Cost-effectiveness of pemetrexed plus cisplatin: malignant pleural mesothelioma treatment in UK clinical practice.

OBJECTIVES: Findings from the largest randomized phase III trial in patients with unresectable malignant pleural mesothelioma (EMPHACIS study; n = 448) were used to examine the cost-effectiveness of pemetrexed plus cisplatin therapy versus cisplatin monotherapy in patients with the disease. The cost-effectiveness of pemetrexed/cisplatin versus alternative treatments was also examined. METHODS: Two cost-effectiveness analyses were designed to model best survival outcome over time for a number of patient cohorts. First, trial-based patient-level data were utilized and resource use was costed for the study arm and comparator. A second cost-effectiveness analysis then compared the mean costs and outcomes associated with pemetrexed/cisplatin with the most commonly used (unlicensed) regimens in the United Kingdom-mitomycin-C, vinblastine, and cisplatin (MVP); vinorelbine; and active symptom control-using trial-based data and data extrapolated from a review of the literature. RESULTS: The total pemetrexed/cisplatin cost per patient varied between pound8779 and pound9020 for all cohorts studied in model 1. Average life-years gained per patient were between 0.20 and 0.28. Quality-adjusted life-years, based on mean and median survival, ranged from 0.13 to 0.31. Incremental cost per life-year gained and quality-adjusted life-year ratios, using both mean and median survival, ranged from pound20,475 to pound68,598. The second cost-effectiveness analysis resulted in ratios ranging from pound14,595 to pound32,066. CONCLUSIONS: Pemetrexed/cisplatin demonstrated acceptable cost-effectiveness when compared with cisplatin monotherapy and alternative treatments commonly used in UK clinical practice.

The economic burden of diabetic retinopathy in Germany in 2002.

BACKGROUND: The aims of our study were to describe the costs associated with diabetic retinopathy (DR), and to evaluate its economic impact in Germany. METHODS: Forty-one German ophthalmologists, randomly selected from a physicians' database in Germany, provided information on adult Type 1 and Type 2 diabetic patients with DR (n = 207). This information included socio-demographics, clinical characteristics and resource use during the year 2002. National-level cost estimates were calculated, based on these results and the prevalence data on DR in Germany. RESULTS: This study found that costs associated with DR tend to increase as DR progresses, being highest in patients with proliferative DR and lowest in patients with mild, non-proliferative DR. The German statutory health insurance (Gesetzliche Krankenversicherung, GKV) covered two-thirds of the total costs paid by all the payers. The total cost of DR from a societal perspective was calculated at 3.51 euros bn for the year 2002, and from the GKV perspective amounted to 2.23 euros bn. CONCLUSIONS: This study is the first comprehensive study to provide estimates of costs associated with DR in Germany. These costs were estimated to account for approximately 1.5% of the total health-care expenditure in 2002.

Perspectives on epilepsy in people with intellectual disabilities: comparison of family carer, staff carer and clinician score profiles on the Glasgow Epilepsy Outcome Scale (GEOS).

PURPOSE: Clinical practice with people with intellectual disability relies heavily upon caregiver report. Crucially, the carer's perspective may depend upon his or her relationship to the patient. We investigated similarities and differences within and between family and paid carers in their reports on the Glasgow Epilepsy Outcome Scale (GEOS), an instrument that quantifies concerns about epilepsy in this population [Epilepsia 42 (2001) 1043]. METHODS: GEOS forms were available on 186 patients (108 males; mean age 39 years) across 384 primary respondents (141 staff, 83 family, 160 clinicians) and independently completed secondary respondents (67 staff, 36 family). Data were analysed to consider levels of concern as rated bv staff carers, family members and clinicians, and also to consider inter-rater agreement on the concerns raised. RESULTS: There were significant differences in the magnitude of concern on each sub-scale [concerns about seizures, treatment, caring and social impact; range of F(2,171)=9.5-64.7; all P<0.0001]. Post hoc testing revealed that family members scored all sub-scales more highly than staff carers or clinicians, and that staff carers scored more highly than clinicians on all but one sub-scale. Inter-rater agreement between family members was considerably higher (range of r=0.69-0.91) than between staff carers (r=0.30-0.47) across the GEOS sub-scales. Association between staff and family ratings was also modest (r< or = 0.39). CONCLUSIONS: It is preferable for the same staff member to complete each administration of the GEOS because of inter-staff variability in reporting of concerns. Families provide a consistent, but more extreme, picture and clinicians generally underestimate the concerns of direct caregivers. However, content of concerns varies relatively little across respondents.