Economic implications of nesiritide versus dobutamine in the treatment of patients with acutely decompensated congestive heart failure.

Pooled data from trials comparing nesiritide with dobutamine for treatment of acute decompensated congestive heart failure were combined with national hospital cost data in an economic model. Results indicate that the acquisition cost of nesiritide is fully offset by decreased hospital costs.

Management of acute proximal deep vein thrombosis: pharmacoeconomic evaluation of outpatient treatment with enoxaparin vs inpatient treatment with unfractionated heparin.

OBJECTIVES: A landmark Canadian randomized controlled clinical trial compared treatment of acute proximal vein thrombosis via low-molecular-weight heparin (LMWH) [enoxaparin] administered primarily at home with IV unfractionated heparin (UH) in the hospital. Results demonstrated equivalent safety and efficacy for home care with enoxaparin with a reduction in cost. Our objective was to validate these findings in the routine practice setting of a US health maintenance organization. DESIGN: Retrospective analysis of medical and administrative records of health-plan members meeting inclusion-exclusion criteria of the Canadian trial during the period from 1995 to 1998. SETTING: Staff-model health maintenance organization serving New Mexico. PATIENTS: Persons presenting as outpatients from 1995 to 1996 or from 1997 to 1998 with acute, proximal deep vein thrombosis (DVT) diagnosed by duplex ultrasonography. INTERVENTIONS: Initial anticoagulant therapy of IV UH administered in the hospital (from 1995 to 1996 group, n = 64) or subcutaneous LMWH (enoxaparin) administered primarily at home (from 1997 to 1998 group, n = 65), followed by warfarin therapy. RESULTS: No statistically significant differences were observed in the number of recurrent venous thromboembolic events (p = 0.36) or bleeding events (p = 1.0). Mean +/- SD cost per patient was 9,347 dollars +/- 8,469 in the enoxaparin group compared with 11,930 dollars +/- 10,892 in the UH group, a difference of - 2,583 dollars (95% bootstrap-adjusted asymmetrical confidence interval, - 6,147 dollars, + 650 dollars). CONCLUSIONS: Retrospective replication of the Canadian study in a US routine (managed) care setting found similar clinical and economic outcomes. Treatment of acute proximal DVT with enoxaparin in a primarily outpatient setting can be accomplished safely and yields savings through avoidance or minimization of inpatient stays.

The effect of risperidone on nursing burden associated with caring for patients with dementia.

OBJECTIVES: To compare risperidone treatment with placebo for the burden to nursing staff of older nursing-home residents with dementia. DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: Long-term care institutions in Australia and New Zealand. PARTICIPANTS: Two hundred seventy-nine residents had evaluable data for comparison of oral risperidone with placebo treatment at 4 weeks, 8 weeks, and endpoint across the 12-week trial. MEASUREMENTS: The Modified Nursing Care Assessment Scale (M-NCAS) is a 28-item instrument that measures behavior occurrence in patients (patient outcome) and difficulty of those behaviors for nursing staff as rated by nurse carers (nurse outcome). Treatment groups were compared via analysis of covariance (ANCOVA). To aid score interpretation, M-NCAS effect sizes were examined by response category, with response defined as subjects with mean Cohen-Mansfield Agitation Inventory total aggression subscale score change of 4 points or greater, a clinical outcome for patients. RESULTS: Between-group ANCOVAs showed statistically significant reductions in nurse-rated M-NCAS scores from baseline to endpoint for the patients randomized to risperidone relative to placebo (P<.05). Effects were evident at 4 weeks and maintained over time. Effect sizes were moderate to large for responders and near zero for nonresponders. CONCLUSION: Risperidone treatment was associated with an early and sustained reduction in nursing staff burden as measured using the M-NCAS compared with placebo treatment for older nursing home residents with dementia.

Subcutaneous injection survey: psychometric evaluation of a treatment satisfaction instrument associated with a novel HIV medication.

PURPOSE: The 20-item Subcutaneous Injection Survey (SIS) was developed to assess patients' experience with subcutaneous self-injection of an innovative anti-HIV fusion inhibitor (T-20). It measures ease of use and impact of treatment on daily life. This study presents the results of a psychometric evaluation of the SIS. METHOD: The SIS and MOS-HIV data (N = 547) from two multinational, phase III clinical trials of optimized background therapy (OBT) vs. OBT + T-20 were utilized for this evaluation. Item performance and internal consistency reliability were assessed. Exploratory factor analysis was used to identify subscales. Pearson correlations were used to examine the relationship between the SIS and the MOS-HIV scores. RESULTS: Patients were predominately white males. SIS items had low rates of missing data (0.9%-5.5%) and with two exceptions were not redundant, as indicated by generally moderate item-to-item correlations. Three factors were identified: daily functioning, ease of injections, and activities of daily living. The SIS also includes three individually scored items on overall injection interference with daily activities, effect of injections on daily activities, and satisfaction with personal appearance. Cronbach's alphas ranged from 0.71 to 0.87. Correlations between SIS and MOS-HIV subscales were low to moderate. CONCLUSION: The SIS is a reliable instrument for measuring patients' assessment of self-injection in HIV clinical trials. Patients' experiences with self-injection are not strongly associated with health-related quality of life.

Health-related quality of life associated with irritable bowel syndrome: comparison with other chronic diseases.

BACKGROUND: Despite the rapidly growing body of literature on health-related quality of life (HRQoL). placing the results in a context that is meaningful to clinicians and patients is often overlooked. OBJECTIVE: This study sought to quantify the impact of irritable bowel syndrome (IBS) on HRQoL by comparing the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) scores of IBS patients with normative US data and with the scores of patients having other chronic gastrointestinal (GI) and non-GI disorders. METHODS: Two IBS reference groups were identified from the published literature: a largely untreated community sample of health maintenance organization (HMO) members (N = 92) and a sample of patients with IBS recruited through clinics and in the community (N = 140). SF-36 scores for these groups were compared with published US population norms (N = 2474) and with published scores for 3 other IBS samples (N = 464); a sample with other chronic GI disorders (dyspepsia [N = 126], gastroesophageal reflux disease [GERD] [N = 516]); and samples with other chronic episodic disorders (asthma [N = 375], migraine [N = 303], panic disorder [N = 73], rheumatoid arthritis [N = 693]). RESULTS: The scores of patients in both IBS reference groups were significantly lower on several SF-36 domains than those of the US normative population (P < 0.003). Scores on several SF-36 scales were also significantly lower in the IBS reference groups compared with the GERD, asthma, and migraine samples (P < 0.003). Depending on the IBS sample used, scores did not differ or were higher compared with those in the sample with dyspepsia. Relative to the samples with panic disorder and rheumatoid arthritis, the IBS groups had significantly higher scores on most SF-36 domains (P < 0.003). Scores for the HMO reference group were generally higher than those for the clinic/community reference group. CONCLUSIONS: Based on the results of this analysis, IBS is associated with impairment of HRQoL relative to US population norms and to populations with GERD, asthma, or migraine. HRQoL appears to be greater in patients with IBS than in those with panic disorder or rheumatoid arthritis, although the relative symptom severity in these samples was not known.

Antibiotic prescribing rates in the US ambulatory care setting for patients diagnosed with influenza, 1997-2001.

To document the rate and cost of antibiotic prescribing for patients diagnosed only with influenza during US ambulatory care visits. Federal survey data for 1997-2001 were used to estimate outpatient trends for all patients and healthy people age 5-49 years. Cost estimates were based on Medicare payments and Red Book average wholesale prices in 2003. Antibiotic prescribing for influenza is widespread; 38% of visits led to an antibiotic prescription of which one-third were for broad spectrum antibiotics. Inappropriate antibiotics cost dollar 18.5 million annually and may contribute to resistance. Increased vaccination rates and viral testing could reduce these trends.

Economic impact of respiratory syncytial virus-related illness in the US: an analysis of national databases.

OBJECTIVE: To determine the impact of respiratory syncytial virus (RSV) infection on healthcare resource use and costs in the US from the third-party payer perspective. DESIGN: The study retrospectively analysed cross-sectional medical encounter data from three federally funded databases that comprise nationally representative samples of hospital inpatient stays, physician office visits and visits to hospital outpatient departments and emergency rooms. METHODS: Identification of RSV infection-related medical encounters was based on the occurrence of RSV-specific International Classification of Diseases (9th Edition)-Clinical Modification diagnosis codes (079.6, 466.11, 480.1) as principal discharge diagnoses or the assumption that 10-15% of all otitis media visits were due to RSV infection. Outpatient drug costs were estimated based on average wholesale price, and physician fees and test/procedure costs were estimated based on prevailing national fees. Inpatient costs were estimated from total billed charges using a cost-to-charge ratio of 0.53. RESULTS: In 2000, nearly 98% of RSV infection-related hospitalisations occurred in children <5 years old. There were approximately 86,000 hospitalisations, 1.7 million office visits, 402 000 emergency room visits and 236,000 hospital outpatient visits for children <5 years old that were attributable to RSV infection. Total annual direct medical costs for all RSV infection-related hospitalisations ($US394 million) and other medical encounters ($US258 million) for children <5 years old were estimated at $US652 million in 2000. Otitis media was a major cost driver for physician visits. RSV infection-related hospitalisations increased from 1993 to 2000, but average costs per hospitalisation were relatively stable. CONCLUSION: Treatment of RSV infection-related illness represents a significant healthcare burden in the US. The economic impact of ambulatory care for RSV infection-related illness could be as important as that for RSV infection-related hospitalisation.

Psychometric performance of an assessment scale for strain in nursing care: the M-NCAS.

BACKGROUND: Multiple instruments exist to measure dementia behaviors, but the nursing staff perspective on those behaviors and their level of burden has not been well measured. The goal of this study was to examine the psychometric performance of the Modified Nursing Care Assessment Scale (M-NCAS), a 28-item nurse rating of burden associated with care for institutionalized individuals with dementia. Nurses rate items in terms of extent to which the behavior or characteristic is present ("attitude" domain), and extent to which it is a burden ("strain" domain). METHODS: Data from 282 patients enrolled in a 12-week, double-blind, randomized clinical trial comparing risperidone treatment to placebo was used to evaluate M-NCAS item performance, internal consistency reliability, and construct validity. Empirical subscales were identified via exploratory factor analysis (EFA). RESULTS: Four poorly-performing items were deleted from further analyses. EFA identified 3 "attitude" subscales and 5 "strain" subscales. Cronbach's alphas were 0.65 and above. Correlation with the Cohen-Mansfield Agitation Inventory and the BEHAVE-AD, clinical ratings of dementia behaviors, were low to moderate. CONCLUSION: The M-NCAS provides a valid and reliable means of obtaining care burden ratings from formal caregivers in long-term care, and provides a method for evaluating dementia interventions from the perspective of nursing staff.