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.

Acute medical costs of fluoxetine versus tricyclic antidepressants. A prospective multicentre study of antidepressant drug overdoses.

Despite demonstrated differences in toxicity profiles between tricyclic antidepressants (TCAs) and selective serotonin (5-hydroxytryptamine; 5-HT) reuptake inhibitors (SSRIs), no studies have examined hospital costs associated with acute antidepressant overdoses. Given the high incidence of such overdoses, it is important to examine treatment patterns and associated costs. This prospective, multicentre cohort study compared the hospital and physician costs associated with TCA and fluoxetine drug overdoses. Over a 30-month period, 622 consecutive patients with a fluoxetine or TCA overdose presented to the emergency departments, or were admitted to intensive care or medical units, of 9 participating medical centres across the US. Inclusion criteria were: ingestion of a single antidepressant (fluoxetine or a TCA), without clinically significant co-ingestants; laboratory confirmation of the overdose; and retrievable hospital bills. Patients were followed until discharge from the emergency department or hospital. Hospital and physician charges were collected from billing data. Hospital charges were adjusted using Health Care Financing Administration cost: charge ratios to estimate costs; physician charges were adjusted to estimate costs. Patient demographic and clinical data were prospectively gathered during the course of medical treatment. Clinical data recorded included level of consciousness, cardiopulmonary complications, vital sign or ECG abnormalities, agitation, seizures, CNS depression and death. 136 patients (121 with TCA overdose and 15 with fluoxetine overdose), representing 21.8% of the 622 patients entered, met the inclusion criteria. Mean length of stay varied from 0.73 [+/-standard error of the mean (SEM) 0.33] days for fluoxetine overdose patients to 3.59 (+/-SEM 0.48) days for TCA overdose patients (p = 0.038). Mean hospital costs were $US668 for patients with a fluoxetine overdose compared with $US4691 for those with a TCA overdose (p < 0.0001). No significant differences were observed between the TCA and fluoxetine overdose groups with regard to physician costs. Median hospital and physician costs increased from $US3029 to $US4396 from the first 15-month period of the study to the second 15-month period of the study for the TCA overdose group, but decreased from $US881 to $US396 for the fluoxetine overdose group. Patients with fluoxetine overdoses had lower hospital and total medical costs compared with patients with TCA overdoses. There was some evidence supporting a reduction in the medical costs of treating fluoxetine overdoses over the 30-month study period.

Cost analysis of imipenem-cilastatin versus clindamycin with tobramycin in the treatment of acute intra-abdominal infection.

Clinical effectiveness of imipenem/cilastatin (I/C) versus tobramycin with clindamycin (T + C) in treatment of patients presenting with suspected acute intra-abdominal infection was assessed in a multicentre randomised clinical trial conducted during 1985 to 1986. The principal finding was a lower incidence of treatment failure among patients in the I/C arm (p = 0.043). We now report results of retrospective analysis of hospital treatment costs during an episode of infection incurred by patients enrolled in the trial. Treatment costs (in 1989 US dollars) were calculated from a hospital perspective, using an intention-to-treat analysis. Among 161 patients with low illness severity (APACHE II less than or equal to 14) the mean cost for the episode of care was $US7038 in the I/C arm versus $US8404 for the T + C regimen; the difference was not statistically significant (p = 0.40). For 93 more severely ill patients (APACHE II score greater than 14) the mean cost for the I/C arm was $US19 985 versus $US16 582 for the T + C regimen; the difference was not statistically significant (p = 0.36). Multiple regression analysis, controlling for patient demographics and study site, showed that the cost of the episode was positively associated with the severity of illness (p less than 0.01) and presence of malnutrition (p < 0.01), but that the total cost of the episode of infection was not statistically different for the 2 drug regimens (p = 0.45).

Health care CBA/CEA: an update on the growth and composition of the literature.

Cost-benefit (CBA) and cost-effectiveness analyses (CEA) are methods that enumerate the costs and consequences associated with health-related technologies, services, and programs. This article examines the trends in published CBA and CEA of personal health services from 1979 through 1990. It is based on a bibliography that was compiled to help address the immense need for information on the variation and effectiveness of medical practices, particularly as researchers expand their analysis to a study of the cost effectiveness of medical and surgical interventions, health care technologies, preventive practices, and other health programs. A systematic search was conducted for all articles under the heading "cost-benefit analysis" (which includes cost-effectiveness analysis) and "costs and cost analysis." Data sources included the MEDLARS (National Library of Medicine) database, other bibliographies in specialized areas, reference lists in key articles, and contacts with researchers in the field. All titles and abstracts were scanned to determine if the articles pertained to personal health services and if both costs and consequences were assessed. If both criteria were met, the article was included in the bibliography. This search resulted in 3,206 eligible CBA/CEA publications from 1979 through 1990. The publications were subdivided into two major categories: reports of studies and "other" publications, including reviews, descriptions of methodology, letters, and editorials. Reports of studies and "other" publications were classified into approximately 250 different topic areas. The studies were further classified by parameters, such as study type, publication vehicle, and medical function. This article describes the results of this classification and describes trends during 1979 to 1990 compared with 1966 to 1978. The classification of study reports and "other" publications into 250 topic areas is presented in Appendix A. The entire bibliography is reproduced in Appendix B. Detailed tables of findings are presented in Appendix C, and the results are illustrated graphically in Appendix D. Appendix E provides the coding scheme used in the bibliography's data base.