Societal preference values for advanced melanoma health states in the United Kingdom and Australia.

BACKGROUND: No studies measure preference-based utilities in advanced melanoma that capture both intended clinical response and unintended toxicities associated with treatment. METHODS: Using standard gamble, utilities were elicited from 140 respondents in the United Kingdom and Australia for 13 health states. RESULTS: Preferences decreased with reduced treatment responsiveness and with increasing toxicity. CONCLUSIONS: These general population utilities can be incorporated into treatment-specific cost-effectiveness evaluations.

HIV patient insight on adhering to medication: a qualitative analysis.

Research on HIV medication adherence has relied mainly on quantitative methods. The objective of this study was to explore factors associated with adherence from the HIV-infected patient's perspective. Six focus groups were convened with treatment-experienced HIV-positive individuals. The discussions focused on issues that make it easy or difficult to adhere to HIV regimens. Thirty-five patients participated in the focus groups, which were conducted in Washington, D.C., and Los Angeles. The mean age was 48; 66% were male; 63% were black; and 40% contracted HIV through heterosexual contact. Six major themes emerged from the data that influenced adherence to medication: regimen complexity/medication features (including number of pills), lifestyle fit, emotional impacts (including worry, anger, stress and anxiety), side effects, medication effectiveness, and communication (including information from friends, physicians, and published sources). The data informed a conceptual framework, illustrating the possible interactions among these themes that can potentially be used by clinicians when discussing HIV treatment options with patients. This is potentially one of the first focus group studies concentrating on HIV medication adherence. The findings highlight specific factors that should be considered when trying to improve adherence and may be helpful in clinical decision-making.

Patient preferences among third agent HIV medications: a US and German perspective.

The objective is to assess patient preferences for attributes associated with third agent HIV medications, including fosamprenavir/ritonavir (FPVr), fosamprenavir (FPV), lopinavir/ritonavir (LPVr), atazanavir (ATZ), and efavirenz (EFV). Subjects with HIV were recruited in the US and Germany to complete a computerized adaptive conjoint survey that assessed 13 attributes, including moderate to severe side effects, regimen convenience, drug resistance and efficacy. Literature on the target third-agent HIV drugs was used to identify percentage risk and severity level descriptions for each attribute. The derived preference (utility) weights for each attribute level informed the calculation of relative importance estimates for each attribute and the desirability of combinations of attributes matching the respective target third agents. The analysis included 288 HIV-positive participants (US: 132; Germany: 156), 205 of whom were treatment-experienced and 83 of whom were treatment-naïve. Of the 13 medication attributes evaluated, developing drug resistance, the risk of lipodystrophy, the risk of gastronitestinal side effects (diarrhoea, nausea and vomiting) and regimen convenience had the greatest impact on preferences. The profile based on FPVr was most preferred. Differences in the risk of developing drug resistance, risk of lipodystrophy, risk of gastrointestinal side effects and regimen convenience would likely be most influential in the perceived relative value of a third-agent medication. Physicians may wish to consider these features, especially when discussing HIV treatment options with their patients.

Persistency and clinical outcomes associated with latanoprost and beta-blocker monotherapy: evidence from a European retrospective cohort study.

PURPOSE: To evaluate persistency (time on initial therapy) and the clinical impact of latanoprost versus beta-blocker monotherapy in treating glaucoma. METHODS: This observational, multicenter, retrospective medical chart review study conducted in four European countries included patients with primary open-angle glaucoma or ocular hypertension who began their first glaucoma treatment with latanoprost or a beta-blocker between November 1996 and November 1998. Persistency and glaucoma-related clinical outcomes data were abstracted for the 2 years following treatment initiation. RESULTS: In all, 260 patient charts were analyzed (94 latanoprost, 166 beta-blocker). Patients in the latanoprost group stayed on therapy twice as long as those who received a beta-blocker (p < 0.0001). After adjusting for baseline characteristics, patients receiving a beta-blocker as initial therapy were 3.8 times more likely to change therapy than those initially treated with latanoprost (p < 0.0001). Patients in the latanoprost group also experienced greater mean decreases in intraocular pressure (IOP) than those receiving a beta-blocker (7.4 mmHg versus 4.6 mmHg, respectively; p < 0.0001), and fewer had worsened optic nerve head excavation (1.7% versus 14.2%, respectively; p < 0.05) by the time of their first therapy change or last study visit, whichever came first. CONCLUSIONS: Over a 2-year period, latanoprost was associated with significantly greater persistency and better clinical IOP outcomes compared with beta-blocker therapy.

The impact of pamidronate on inpatient and outpatient services among metastatic breast cancer patients.

Our goal was to evaluate the impact of pamidronate therapy on medical resource utilization for treatment of bone metastases among patients with breast cancer. In this 12-center retrospective study, inpatient and outpatient resource utilization was abstracted from the medical charts of 295 patients with breast cancer who were diagnosed with bone metastases between July 1996 and April 1999. Data were abstracted from the time of bone metastasis diagnosis (baseline) to the present. The analysis compared non-pamidronate patients against pamidronate patients, who were stratified on the basis of whether their pamidronate therapy had been initiated within 3 months (early pamidronate group) or more than 3 months (late pamidronate group) after diagnosis. Resource utilization was compared among groups using multivariate regression analyses. A total of 101 early pamidronate, 72 late pamidronate, and 122 non-pamidronate patients were included in the analysis. The results showed that the early pamidronate group was roughly one-half as likely to have unplanned office visits attributable to bone metastases as the late pamidronate and non-pamidronate groups. The groups had a similar likelihood of ever being hospitalized for bone-related conditions; however, among those hospitalized, there were roughly one-half as many bone-related hospitalizations in the late pamidronate group as in the non-pamidronate group. Also, the mean length of stay was approximately 50% shorter in both pamidronate groups than in the non-pamidronate group. We conclude that pamidronate therapy may be associated with less medical resource utilization, particularly among patients hospitalized for bone-related conditions.

The impact of tacrolimus ointment on health-related quality of life of adult and pediatric patients with atopic dermatitis.

BACKGROUND: Atopic dermatitis can have detrimental effects on health-related quality of life (QOL). OBJECTIVE: Our purpose was to examine the QOL impact of tacrolimus ointment in patients with atopic dermatitis. METHODS: The Dermatology Life Quality Index (DLQI), Children's DLQI (CDLQI), and Toddler QOL Survey were used to assess QOL in adults (16 years or older), children (5-15 years), and toddlers (2-4 years) enrolled in 12-week, randomized, double-blind studies comparing two concentrations of tacrolimus ointment (0.03% and 0.1%) versus vehicle ointment for treatment of atopic dermatitis. QOL was assessed at baseline, week 3, and week 12/early discontinuation. RESULTS: Of the 985 patients enrolled, 91.5% had evaluable QOL data. Among adults, both tacrolimus ointment groups experienced improved QOL relative to the vehicle control group for all QOL scales (P<.001). Among children and toddlers, both tacrolimus ointment groups demonstrated significant QOL improvements relative to the vehicle control group (P<.05) for all but the Personal Relationships scale in the 0.03% tacrolimus ointment group among children. CONCLUSION: Tacrolimus ointment is associated with significant QOL benefits in adults, children, and toddlers with atopic dermatitis.

Cost-effectiveness of catheter ablation in patients with ventricular tachycardia.

BACKGROUND: This study evaluated the cost-effectiveness of catheter ablation therapy versus amiodarone for treating ventricular tachycardia (VT) in patients with structural heart disease. The analysis used a societal perspective for a hypothetical cohort of VT patients with implantable cardioverter-defibrillators, who were experiencing frequent shocks. METHODS AND RESULTS: We calculated incremental cost-effectiveness of ablation relative to amiodarone over 5 years after treatment initiation. Event probabilities were from the Chilli randomized clinical trial (Chilli Cooled Ablation System, Cardiac Pathways Corporation, Sunnyvale, Calif), the literature, and a consensus panel. Costs were from 1998 national Medicare reimbursement schedules. Quality-of-life weights (utilities) were estimated using an established preference measurement technique. In a hypothetical cohort of 10 000 patients, 5-year costs were higher for patients undergoing ablation compared with amiodarone therapy ($21 795 versus $19 075). Ablation also produced a greater increase in quality of life (2.78 versus 2.65 quality-adjusted life-years [QALYs]). This yielded a cost-effectiveness ratio of $20 923 per QALY gained for ablation compared with amiodarone. Results were relatively insensitive to assumptions about ablation success and durability. In less severe patients with good ejection fractions who suffer their first VT episode, the incremental cost-effectiveness ratio was $6028 per QALY gained. These cost-effectiveness ratios are within the range generally thought to warrant technology adoption. CONCLUSIONS: This study demonstrates that, from a societal perspective, catheter ablation appears to be a cost-effective alternative to amiodarone for treating VT patients.

Health-related quality of life effects of modafinil for treatment of narcolepsy.

OBJECTIVE: To evaluate the burden of illness of narcolepsy and assess the health-related quality-of-life (HQL) effects of oral modafinil, a wake-promoting therapy for excessive daytime sleepiness associated with narcolepsy. METHODS: Subjects with narcolepsy enrolled in a nine-week, placebo-controlled, double-blind study and were randomized to placebo, modafinil 200 mg, or modafinil 400 mg. After the study, consenting subjects received modafinil in a 40-week open-label extension. A self-administered HQL questionnaire consisting of the 36-Item Short Form Health Survey (SF-36) and supplemental narcolepsy-specific scales was given to subjects at baseline, study endpoint, and several open-label timepoints. RESULTS: 481 subjects completed a baseline and double-blind endpoint HQL assessment. Compared to population norms, baseline HQL scores reflected substantial burden in vitality, social functioning, and performing usual activities. At study endpoint, subjects in the 400 mg modafinil group had significantly higher scores than placebo for 10 of the 17 HQL scales. The 400 mg modafinil group had more energy, fewer difficulties performing usual activities, fewer interferences with social activities, improved psychological well-being and higher productivity, attention and self-esteem compared to placebo subjects (p<.05). The positive treatment effects were sustained over the open-label extension. CONCLUSION: Modafinil significantly improves health-related quality of life in narcolepsy.

Cost effectiveness of recombinant human insulin-like growth factor I therapy in patients with ALS.

OBJECTIVE: Amyotrophic lateral sclerosis (ALS) is a fatal, degenerative neuromuscular disease characterised by a progressive loss of voluntary motor activity. Recombinant human insulin-like growth factor I (rhIGF-I) has been shown to be useful in treating ALS. The purpose of this study was to examine the cost effectiveness of rhIGF-I therapy in patients who have ALS. DESIGN: We performed a cost-effectiveness analysis from the societal perspective on 177 patients who received treatment with rhIGF-I or placebo in a North American randomised clinical trial. We estimated the incremental cost-effectiveness ratio of rhIGF-I using resource utilisation and functional status measurements from the clinical trial. Costs were estimated from 1996 US Medicare reimbursement schedules. Utility weights were elicited from ALS healthcare providers using the standard gamble technique. MAIN OUTCOME MEASURES AND RESULTS: The overall cost per quality-adjusted life-year (QALY) gained for rhIGF-I therapy compared with placebo was $US67,440. For the subgroups of patients who were progressing rapidly or were in earlier stages of disease at enrolment, rhIGF-I cost $US52,823 and $US43,197 per QALY gained, respectively. CONCLUSIONS: Treatment with rhIGF-I is most cost effective in ALS patients who are either in earlier stages of the disease or progressing rapidly. The cost effectiveness of rhIGF-I therapy compares favourably with treatments for other chronic progressive diseases.

Medical costs of treating venous stasis ulcers: evidence from a retrospective cohort study.

Venous stasis ulcers (VSU) account for approximately 80-90% of lower extremity ulcerations. Given their prevalence and chronic nature, VSU are thought to impose a significant economic burden on Medicare (the USA's largest health insurance program) and other third party payers. However, comprehensive studies on the costs of VSU treatment are lacking. The objective of this study therefore was to examine comprehensively the direct medical costs of treating patients with a VSU in routine clinical practice. A cohort of 78 patients who presented with a VSU to the Cleveland Clinic Foundation (CCF), a large primary and tertiary referral center, was studied retrospectively. All inpatient and outpatient costs related to VSU treatment that were incurred during the year following VSU presentation or until the ulcer healed, whichever occurred first, were quantified. A total of 71 (91%) patients healed during the study. The average duration of follow-up was 119 days (median: 84 days). The average number of visits per patient was seven (range: 2 to 57). A total of 14 (18%) patients underwent 18 hospitalizations for VSU care. The average total medical cost per patient was $9685 (median: $3036). Home health care, hospitalizations and home dressing changes accounted for 48%, 25% and 21% of total costs, respectively. Total costs were related to duration of active therapy, ulcer size and the presence of at least one comorbidity (p<0.05). VSU are costly to manage, especially when time to healing is prolonged. The present findings reflect an underestimate of VSU costs since indirect costs were not examined. Time absent from work, forced early retirement, loss of functional independence and unquantifiable suffering may be additional factors that contribute to the overall burden of VSU.

The effects of recombinant human erythropoietin on functional health and well-being in chronic dialysis patients.

As a component of the open-label, multicenter National Cooperative Recombinant Human Erythropoietin (Epo) Study, the health-related quality-of-life effects of Epo therapy were assessed in 484 dialysis patients who had not previously been treated with Epo therapy (New-to-Epo) and 520 dialysis patients who were already receiving Epo therapy at the time of study enrollment (Old-to-Epo). Using scales from the Medical Outcomes Study 36-item Short Form Health Survey (SF-36), health-related quality of life was assessed on study enrollment (baseline) and at an average of 99 days follow-up. At baseline, SF-36 scores for Old- and New-to-Epo patients were well below those observed in the general population, reflecting substantial impairments in functional status and well-being among patients with chronic renal failure. Significant improvements from baseline to follow-up were observed among New-to-Epo patients in vitality, physical functioning, social functioning, mental health, looking after the home, social life, hobbies, and satisfaction with sexual activity (P < 0.05 for each). The mean improvements in hematocrit values among New-to-Epo and Old-to Epo patients were 4.6 and 0.3, respectively. At the time of follow-up, SF-36 scores for New-to-Epo patients were comparable with those observed among Old-to-Epo patients, whose scores did not change significantly from baseline to follow-up. Analysis of the relationship between Epo therapy, hematocrit values, and health-related quality of life suggest that some of the beneficial quality-of-life effects of Epo are mediated through a change in hematocrit level.

Usefulness of the SF-36 Health Survey in measuring health outcomes in the depressed elderly.

Longitudinal data from a clinical trial were analyzed to evaluate the usefulness of the SF-36 Health Survey in estimating the impact of depression and changes in severity over time on the functional health and well-being of 532 patients, 60 to 86 years of age, who met DSM-III-R criteria for major depressive disorder. The Hamilton Depression Rating Scale, the Clinician's Global Impression of Severity and Improvement, and the Geriatric Depression Scale were used to define clinical severity and changes in severity over a 6-week period. Answers to SF-36 questions tended to be complete and to satisfy assumptions underlying methods of scale construction and scoring. As hypothesized, the SF-36 Mental Health Scale and Mental Component Summary measure, shown in previous studies to be most valid in measuring differences in mental health, exhibited the strongest associations with severity of depression in cross-sectional analyses and were most responsive to changes in severity in longitudinal comparisons. We conclude that the SF-36 Health Survey is useful for estimating the burden of depression and in monitoring changes in functional health and well-being over time among the depressed elderly.

Acute effects of fluoxetine versus placebo on functional health and well-being in late-life depression.

In a randomized 6-week trial comparing fluoxetine with placebo, the Medical Outcomes Study 36-Item Short-Form Health Status Survey (SF-36) scales were used to measure the effects of treatment on functional health and well-being among elderly (age > or = 60 years) outpatients with major depression. In the fluoxetine and placebo groups, 261 and 271 patients, respectively, completed the SF-36 before treatment and at Weeks 3 and 6. Compared with national norms for individuals over age 60, study patients before treatment exhibited baseline decrements on the following SF-36 scales: mental health, role limitations due to emotional problems, social functioning, vitality, role limitations due to physical problems, and bodily pain. Analyses of SF-36 changed scores from baseline to Week 6 revealed that the fluoxetine group improved more than the placebo group across all scales. Differences in changes of scores between groups were significant (p < .05), favoring the fluoxetine group for the scales of mental health, role limitations due to emotional problems, physical functioning, and bodily pain. Improvements observed in the fluoxetine group were both clinically and socially significant.

Indoor air mercury concentrations following application of interior latex paint.

Mercury vapors are released from paint containing mercury compounds used to prolong the shelf-life of interior latex paint. To determine whether homes recently painted with paint containing mercury had elevated indoor-air mercury concentrations, we studied 37 Ohio homes. Twenty-one homes painted with mercury-containing paint a median of 86 days earlier were compared with 16 homes not recently painted with mercury-containing paint. Paint samples from the exposed homes contained a median of 210 mg Hg/L (range 120-610 mg/L). The median air mercury concentration was higher in the exposed homes (0.3 microgram/m3; range nondetectable--1.5 microgram/m3) than in the unexposed homes (nondetectable; range nondetectable--0.3 microgram/m3, P less than 0.0001). Among the exposed homes there were seven in which paint containing less than 200 mg/L had been applied. In these homes, the median air mercury concentration was 0.2 microgram/m3 (range nondetectable--1 microgram/m3). Six (33%) exposed homes had air mercury concentrations greater than 0.5 microgram/m3, the acceptable indoor concentration recommended by the Agency for Toxic Substances and Disease Registry. Elemental mercury was the form of mercury released into the air. These data demonstrate that potentially hazardous mercury exposure may occur in homes recently painted with paint that contains mercury concentrations less than 200 mg/L.