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Biomedical subjects

Henry A Glick

Publications and source records attributed to Henry A Glick.

At least 19 recordsLinked to original sources

The role of risk stratification in the decision to provide upstream versus selective glycoprotein IIb/IIIa inhibitors for acute coronary syndromes: a cost-effectiveness analysis.

OBJECTIVES: We endeavored to determine under what conditions a strategy of upstream use of small molecule platelet glycoprotein (GP) IIb/IIIa inhibitors for all acute coronary syndromes (ACS) patients is cost effective compared to that of selective use of abciximab in only those patients requiring percutaneous coronary intervention (PCI). BACKGROUND: Small molecule GP IIb/IIIa inhibitors have shown benefit in ACS, but abciximab, the more expensive GP IIb/IIIa inhibitor, may be more effective during PCI. However, abciximab does not have proven efficacy in medical management. No prior study has attempted to balance these competing benefits. METHODS: A decision analysis was performed to examine two strategies: 1) treat all ACS patients upstream with a small molecule GP IIb/IIIa inhibitor and continue through medical management and PCI, if performed; or 2) wait, and selectively use abciximab only in patients who ultimately undergo PCI. Applicable randomized controlled trial data were used for the principal analysis. RESULTS: The strategy of upstream use of a small molecule GP IIb/IIIa inhibitor was superior to selective use, and economically acceptable, with a cost-effectiveness ratio of 18,000 dollars per year of life gained. The superiority of the upstream use strategy persisted over the majority of sensitivity analyses. When stratified by risk according to Thrombolysis in Myocardial Infarction risk score, a strategy of upstream use was only cost effective in those patients with moderate or high risk. CONCLUSIONS: Upstream use of small molecule GP IIb/IIIa inhibition in ACS patients with moderate or high risk for cardiovascular events is a cost-effective approach that should be considered in this subset of patients.

Abciximab↗

Medicare coverage of tumor necrosis factor alpha inhibitors as an influence on physicians' prescribing behavior.

BACKGROUND: Rheumatoid arthritis is a chronic debilitating disease that affects 1% of the population. Tumor necrosis factor alpha inhibitors, such as etanercept and infliximab, have revolutionized the treatment of rheumatoid arthritis by averting disability but at great financial expense, generally borne by third-party payors. Prior to implementation of the Medicare Modernization Act, Medicare reimbursed for the infusion drug infliximab but not for the self-injectable drug etanercept. To determine the impact of this differential Medicare drug coverage on physicians' prescribing behavior in clinical practice, we analyzed patterns of prescribing etanercept and infliximab for patients with rheumatoid arthritis who had public insurance compared with those who had private insurance. METHODS: We conducted an observational cohort study of 1663 patients with rheumatoid arthritis newly prescribed etanercept or infliximab after enrollment in the National Databank for Rheumatic Diseases. Univariate and multivariable analyses of patient demographic and disease characteristics were conducted to characterize predictors of the biologic drug prescribed. RESULTS: Treatment groups who received etanercept and infliximab differed in 6 of 8 demographic variables and in 8 of 10 disease variables. However, stratification by type of insurance reduced many of these differences. In multivariable analyses, type of insurance plan and demographic factors were strong predictors of differential prescribing of etanercept compared with prescribing of infliximab, whereas disease characteristics generally were not. Patients with public insurance were 30% more likely to receive infliximab than those who were privately insured (P<.001). CONCLUSIONS: Public insurance predicted prescription of infliximab, reflecting preferential Medicare reimbursement for infusion drugs. Financial considerations are influential in physicians' prescription decisions. Differential drug coverage has an impact on patient care and health care costs because it influences physicians' prescribing behavior.

Age Distribution↗

Indications for CT scanning in mild traumatic brain injury: A cost-effectiveness study.

BACKGROUND: There is considerable uncertainty about the indications for cranial computed tomography (CT) scanning in patient with minor traumatic brain injury (TBI). This analysis involves an evidence-based comparison of several strategies for selecting patients for CT with regard to effectiveness and cost. METHODS: We performed a structured literature review of mild traumatic brain injury and constructed a cost-effectiveness model. The model estimated the impact of missed intracranial lesions on longevity, quality of life and costs. Using a 20-year-old patient for primary analysis, we compared the following strategies to screen for the need to perform a CT scan: observation in the emergency department or hospital floor, skull radiography, Selective CT based on the presence of additional risk factors and scanning all. RESULTS: Outcome measures for each strategy included average years of life, quality of life and costs. Selective CT and the CT All policy performed significantly better than the alternatives with respect to outcome. They were also less expensive in terms of total direct health care costs, although the differences did not reach statistical significance. The model yielded similar, but smaller, differences between the selective imaging and other strategies when run for older patients. CONCLUSIONS: Although the incidence of intracranial lesions, especially those that require surgery, is low in mild TBI, the consequences of delayed diagnosis are forbidding. Adverse outcome of an intracranial hematoma is so costly that it more than balances the expense of CT scans. In our cost-effectiveness model, the liberal use of CT scanning in mild TBI appears justified.

Brain Injuries↗

Clinical trial-based cost-effectiveness analyses of antipsychotic use.

OBJECTIVE: Second-generation antipsychotics make up one of the fastest growing segments of the rapidly growing pharmaceutical sector. Given limited health care resources, assessment of the value for the cost of second-generation antipsychotics relative to first-generation antipsychotics is critical for resource-allocation decisions. METHOD: With a MEDLINE search, the authors identified eight studies (based on six randomized clinical trials) that analyzed the cost-effectiveness of second-generation antipsychotics relative to first-generation antipsychotics in individuals with schizophrenia disorders. The authors reviewed appropriate methods of measurement, analysis, and design of cost-effectiveness studies in randomized clinical trials and evaluated the validity of economic results derived from the studies in light of appropriate methods. RESULTS: The eight randomized clinical trial-based cost-effectiveness studies of antipsychotic medications faced a variety of threats to validity related to 1) measurement of costs, 2) measurement of effectiveness, 3) analysis of costs, 4) measurement of sampling uncertainty, 5) analysis of incomplete cost data, 6) minimizing loss to follow-up, and 7) threats to external validity. CONCLUSIONS: Economic claims made by the authors of a number of trial-based economic evaluations have generally been favorable to second-generation antipsychotics. However, the methodological issues the authors of the current study identified suggest that there is no clear evidence that atypical antipsychotics generate cost savings or are cost-effective in general use among all schizophrenia patients. Psychiatrists, researchers, and administrators should consider the methodological issues highlighted in interpreting study results. These issues should be addressed in future trial designs.

Antipsychotic Agents↗

Conducting economic evaluations alongside multinational clinical trials: toward a research consensus.

Demand for economic evaluations in multinational clinical trials is increasing, but there is little consensus about how such studies should be conducted and reported. At a workshop in Durham, North Carolina, we sought to identify areas of agreement about how the primary findings of economic evaluations in multinational clinical trials should be generated and presented. In this paper, we propose a framework for classifying multinational economic evaluations according to (a) the sources of an analyst's estimates of resource use and clinical effectiveness and (b) the analyst's method of estimating costs. We review existing studies in the cardiology literature in the context of the proposed framework. We then describe important methodological and practical considerations in conducting multinational economic evaluations and summarize the advantages and disadvantages of each approach. Finally, we describe opportunities for future research. Delineation of the various approaches to multinational economic evaluation may assist researchers, peer reviewers, journal editors, and decision makers in evaluating the strengths and limitations of particular studies.

Clinical Trials as Topic↗

Cost-effectiveness of a low-carbohydrate diet and a standard diet in severe obesity.

OBJECTIVE: Low-carbohydrate diets have become a popular alternative to standard diets for weight loss. Our aim was to compare the cost-effectiveness of these two diets. RESEARCH METHODS AND PROCEDURES: The patient population included 129 severely obese subjects (BMI = 42.9) from a randomized trial; participants had a high prevalence of diabetes or metabolic syndrome. We compared within-trial costs, quality-adjusted life years (QALYs), and the incremental cost-effectiveness ratio (CER) for the two study groups. We imputed missing values for QALYs. The CER was bootstrapped to derive 95% confidence intervals and to define acceptability cut-offs. We took a societal perspective for our analysis. RESULTS: Total costs during the one year of the trial were 6742 dollars +/- 6675 and 6249 dollars +/- 5100 for the low-carbohydrate and standard groups, respectively (p = 0.78). Participants experienced 0.64 +/- 0.02 and 0.61 +/- 0.02 QALYs during the one year of the study, respectively (p = 0.17 for difference). The point estimate of the incremental CER was -1225 dollars/QALY (i.e., the low-carbohydrate diet dominated the standard diet). However, in the bootstrap analysis, the wide spread of CERs caused the 95% confidence interval to be undefined. The probabilities that the low-carbohydrate diet was acceptable, using cut-offs of 50,000 dollars/QALY, 100,000 dollars/QALY, and 150,000 dollars/QALY, were 72.4% 78.6%, and 79.8%, respectively. DISCUSSION: The low-carbohydrate diet was not more cost-effective for weight loss than the standard diet in the patient population studied. Larger studies are needed to better assess the cost-effectiveness of dietary therapies for weight loss.

Adult↗

Clinical nurse specialist care managers' time commitments in a disease-management program for bipolar disorder.

OBJECTIVES: As part of a cost-effectiveness analysis for Department of Veterans Affairs Cooperative Studies Program #430, 'Reducing the Efficacy-Effectiveness Gap in Bipolar Disorder,' we conducted a time and motion study to quantify the time psychiatric clinical nurse specialist (CNS) care managers spent providing care for patients. METHODS: Clinical nurse specialist care managers completed activity logs in which they recorded time spent implementing the Bipolar Disorders Program (BDP) during a 1-week period in spring, summer, fall and winter over a 1-year period when caseloads were at steady state. Mean service time was estimated by use of univariate analysis of means and by multivariable regression analysis. RESULTS: On average CNS care managers spent 40% of their clinical time in activities that typically are reimbursed (e.g. clinic visits) and spent the remaining 60% of their time in activities that are typically unreimbursed. Total clinic time increased as the number of visits per day increased; however, this increase got smaller with each additional visit per day. CONCLUSIONS: As with other chronic illness management programs, CNS care managers expend a substantial portion of their clinical effort for the BDP in activities that are typically unreimbursed. Their activities have a fixed component per day as well as a component that systematically varies with the number of visits per day. These findings should be considered when costing out and disseminating psychiatric and other medical chronic illness management programs.

Bipolar Disorder↗

Economic evaluation of breast cancer treatment: considering the value of patient choice.

PURPOSE: To use 5 years of primary data to compare the incremental cost-effectiveness of breast conservation and radiation versus mastectomy with the restriction of choice to a single therapy versus providing a choice of either therapy. PATIENTS AND METHODS: We evaluated a random retrospective cohort of 2,517 Medicare beneficiaries treated for newly diagnosed stage I or II breast cancer from 1992 through 1994. The outcome measures were quality-adjusted life-years (QALYs) and 5-year medical costs. Risk and propensity score adjustments were used in the analysis. RESULTS: A breast conservation and radiation regimen has significantly higher costs than mastectomy in the first year after surgery; the adjusted 5-year costs are $14,054 (95% confidence interval, $9,791 to $18,312) greater than those of mastectomy. The adjusted incremental cost-effectiveness ratio comparing breast conservation and radiation to mastectomy was $219,594 per QALY for the comparison of the two strategies. If the possibility of patient choice from maintaining the availability of multiple treatments versus restricting choice to mastectomy alone provides a quality-of-life gain of 0.031 QALYs, then the cost-effectiveness ratio of this choice option is $80,440 per QALY. CONCLUSION: The current system of providing a choice between mastectomy and breast conservation surgery is economically attractive when the economic analysis includes the benefit of patient choice of treatment.

Adult↗

Design and analysis of unit cost estimation studies: How many hospital diagnoses? How many countries?

We evaluated three questions that commonly arise when unit costing exercises for multinational trials are conducted: (1). In countries where investigators plan to collect hospital unit cost estimates for a selected set of diagnoses, how should one estimate unit costs for the remaining diagnoses observed in the trial for which cost data were not collected? (2). For how many hospital diagnoses should estimates be obtained? (3). For how many countries should they be obtained? We addressed these questions using unit cost data collected in four western European countries and three relative value measures from the US Medicare diagnosis-related group (DRG) payment system. We found that the arithmetic mean length of stay from the US DRG payment system was a good predictor of unit costs in four countries in Europe. We also found that the imputation error decreased as the number of hospital diagnoses and countries sampled increased, but that the rate of reduction in error shrank. Finally, we found that - given the existence of a reliable method for cost imputation - from a pure information standpoint, it is better to obtain estimates for fewer hospital diagnoses from more countries than the reverse.

Costs and Cost Analysis↗

Factors affecting decisions to seek treatment for sick children in Kerala, India.

The purpose of this study was to measure the effects of social and economic variables, disease-related variables, and child gender on the decisions of parents in Kerala, India, to seek care for their children and on their choice of providers in the allopathic vs. the alternative system. A case-control analysis was done using data from the Kerala section of the 1996 Indian National Family Health Survey, a cross-sectional survey of a probability sample of households conducted by trained interviewers with a close-ended questionnaire. Of the 469 children who were eligible for this study because they had at least one common symptom suggestive of acute respiratory illness or diarrhea during the 2 weeks before the interview, 78 (17%) did not receive medical care, while the remaining 391 (83%) received medical care. Of the 391 children who received medical care, 342 (88%) received allopathic medical care, and 48 (12%) received alternative medical care. In multivariable analyses, parents chose not to seek medical care for their children significantly more often when the illness was mild, the child had a specific diagnosis, the mother had previously made fewer antenatal visits, and the family had a higher economic status. When parents sought medical care for their children, care was sought significantly more often in the alternative provider system when the child was a boy, the family lived in a rural area, and the family had a lower social class. We conclude that, in Kerala, disease severity and economic status predict whether children with acute respiratory infection or diarrhea are taken to medical providers. In contrast, most studies of this issue carried out in other populations have identified economic status as the primary predictor of medical system utilization. Also in Kerala, the gender of the child did not influence whether or not the child was taken for treatment but did influence whether care was sought in the alternative or the allopathic system.

Acute Disease↗

A manic-depressive symptom self-report in optical scanable format.

INTRODUCTION: The Internal State Scale (ISS) is a self-report instrument that allows the simultaneous assessment of both manic and depressive symptoms in individuals with manic-depressive disorder. Prior work indicates that subscales are highly correlated with clinician ratings of mania and depression and provide a discriminant function that identifies individuals in manic/hypomanic, mixed, depressed, and euthymic mood states. A drawback to the ISS is that its items were developed in the visual analogue scale (VAS) format which is labor-intensive to score, particularly with repeat (e.g. daily) administration. A Likert-based format would allow quick and easy optical scanning for which scoring could be automated. METHODS: To compare discriminating properties in Likert versus VAS format we re-analyzed previously collected data and collected new data: (a) VAS-based ISS scores from 86 subjects from a prior four-site study were re-analyzed by collapsing scores into 20 and then 10 Likert-based bins to assess loss of precision from collapsing scores, and (b) 24 additional subjects were administered the ISS in VAS and Likert formats to assess loss of precision due to instrument completion factors. RESULTS: Discriminant ability, including kappas and receiver operator characteristic curves, were unchanged across the two formats. Within-subjects reliability was uniformally high across formats. CONCLUSIONS: Likert-based scoring of the ISS can be used without loss of precision, thus making automated scoring of the ISS feasible. This format will be particularly useful for studies that require processing of large numbers of ISSs, such as those that collect frequent ratings over long periods of time and/or those that utilize large samples.

Bipolar Disorder↗

Preference-based quality-of-life in patients with Parkinson's disease.

BACKGROUND: Preference-based instruments are a specific type of health-related quality-of-life scale designed to measure the relative value of health. Because of this property, they are the appropriate measures of quality of life for cost-effectiveness analysis. Although preference-based scales are widely used, their validity has rarely been tested in specific patient groups. OBJECTIVES: To assess quality of life using preference-based scales in a group of patients with PD and to compare these scores with measures of clinical severity and traditional quality of life. METHODS: Each patient was rated using the Disability and Distress Index (DDI), the Euroqol System (EQ-5D), and the Health Utilities Index Mark II (HUI). Clinical severity was measured using the Unified PD Rating Scale (UPDRS) and PD Questionnaire-39 (PDQ-39) quality-of-life instrument. Results from preference-based instruments were compared with each other and with clinical measures of disease severity. RESULTS: One hundred subjects participated in the study, and 97 completed all preference-based instruments. Scores from all three instruments correlated well with the UPDRS and most domains of the PDQ-39. The mean scores for the DDI, HUI, and EQ-5D were 0.92 (range 0 to 1), 0.74 (range 0.19 to 1), and 0.58 (range -0.429 to 1). Differences between mean scores for the instruments were significant. CONCLUSIONS: In the sample of patients with PD, the Disability and Distress Index, Euroqol System, and the Health Utilities Index Mark II correlate well with measures of disease severity and quality of life. However, they give strikingly different values. When applied in cost-effectiveness analysis, these discrepancies could result in substantially different cost-effectiveness ratios for PD-related interventions.

Aged↗

Decision-analytic model and cost-effectiveness evaluation of postmastectomy radiation therapy in high-risk premenopausal breast cancer patients.

PURPOSE: To present a decision model that describes the clinical and economic outcomes of node-positive breast cancer with and without postmastectomy radiation therapy (PMRT). METHODS: A Markov process was constructed to project the natural history of breast cancer following mastectomy in premenopausal node-positive women. Biannual hazards of local and distant recurrence without PMRT were derived from a large meta-analysis of adjuvant systemic therapy trials for breast cancer. The addition of PMRT reduced the risk of disease relapse by an odds ratio of 0.69. Costs of PMRT ($11,600) and recurrent breast cancer ($4,250 to 16,200/year) were estimated from available literature. The model projected number of recurrences, relapse-free and overall survival, and costs to 15 years, using a discount rate of 3%. Cost-effectiveness ratios were calculated per incremental year of life and quality-adjusted year of life gained. One- and two-way sensitivity analyses were performed to determine the sensitivity of results to clinical and economic assumptions. RESULTS: The model projected 15-year relapse-free survival of 52% and 43% with and without PMRT, respectively. Overall survival was increased from 48% to 55% with PMRT, resulting in an incremental 0.29 years of life gained per subject. PMRT increased 15-year costs from $40,800 to $48,100. Cost per year of life gained was $24,900, or $22,600 when survival was adjusted for quality of life. Results of the model were relatively sensitive to radiation therapy cost and breast cancer relapse risk. CONCLUSION: This analysis suggests that PMRT offers substantial clinical benefits achieved in a cost-effective manner, with an average cost per year of life gained of $24,900. Results of the model were robust under a wide range of clinical and economic parameters.

Aftercare↗

Economic evaluation of the randomized aldactone evaluation study (RALES): treatment of patients with severe heart failure.

PURPOSE: To use data from the Randomized Aldactone Evaluation Study (RALES) to compare clinical outcomes and costs as part of the assessment of the economic implications of spironolactone treatment of advanced heart failure. METHODS: RALES was a randomized, double-blinded, placebo-controlled trial that enrolled participants who had severe heart failure and a left ventricular ejection fraction of no more than 35% and who were receiving standard therapy, including an angiotensin-converting enzyme inhibitor, a loop diuretic, and, in some cases, digoxin. We used a decision analytic model that incorporated data from participants in RALES as well as cost data from five countries that participated in the study. Costs were calculated for nonfatal hospitalizations, ambulatory care, spironolactone therapy, and death. The primary health outcome was quality-adjusted life-years saved (QALYS). Outcomes were evaluated for the first 35 months of observation in RALES. RESULTS: Spironolactone therapy during the first 35 months of follow-up in RALES increased quality-adjusted survival time (0.13 QALYS, 95% CI, 0.07 to 0.18) without increasing costs ($713 savings, 95% CI, $2,123 savings to $783 in costs). Spironolactone therapy either dominated placebo or had a ratio of cost per QALYS that was unlikely to exceed $20,300. These results were robust in both one-way and multiway sensitivity analyses. CONCLUSIONS: Even after implementation of current clinical guidelines, addition of spironolactone therapy provides an opportunity to further reduce the large clinical and economic burden of patients with heart failure.

Ambulatory Care↗

Approaches to analysis of length of hospital stay related to antibiotic therapy in a randomized clinical trial: linezolid versus vancomycin for treatment of known or suspected methicillin-resistant Staphylococcus species infections.

As length of hospital stay (LOS) represents about 70-90% of the total cost of treating serious infections, it represents a key variable in analyzing the health economic differences between treatments for hospitalized patients. In a retrospective analysis using LOS data from a multinational, randomized, phase III clinical trial, we examined two methods (the log-logistic model and Kaplan-Meier survival function) and three approaches (unadjusted total LOS, total LOS adjusted for nontreatment factors, and adjusted LOS based on antibiotic treatment [the antibiotic treatment LOS]) for estimating antibiotic treatment effect on LOS and determined if these approaches could reduce the variation in LOS and control for the imbalance between treatment groups. The trial enrolled patients who were hospitalized with known or suspected Staphylococcus species infections who received at least one dose of linezolid or vancomycin (intent-to-treat sample) and who continued taking the study drug for at least 7 days (clinically evaluable sample). In the intent-to-treat sample, the linezolid group had a 2- (unadjusted) or 4-day (adjusted for nontreatment factors) shorter LOS at the 25th percentile; a 1- or 2-day advantage, respectively, at the 50th percentile (median); and a 0.6- or 1.6-day mean LOS advantage, compared with the vancomycin group. With the antibiotic treatment LOS approach, the linezolid group had mean and median LOS reductions comparable to or greater than those seen in the nontreatment-factor-adjusted results. Results for the clinically evaluable sample were similar to those of the intent-to-treat sample, but the differences between the treatment groups were greater. Linezolid-treated patients had significant LOS reductions that otherwise would be masked without the use of more appropriate, but less commonly used, methods.

Acetamides↗

Economic evaluation of vaccination programmes: a consensus statement focusing on viral hepatitis.

The methods that have been used to estimate the clinical and economic impact of vaccination programmes are not always uniform, which makes it difficult to compare results between economic analyses. Furthermore, the relative efficiency of vaccination programmes can be sensitive to some of the more controversial aspects covered by general guidelines for the economic evaluation of healthcare programmes, such as discounting of health gains and the treatment of future unrelated costs. In view of this, we interpret some aspects of these guidelines with respect to vaccination and offer recommendations for future analyses. These recommendations include more transparency and validation, more careful choice of models (tailored to the infection and the target groups), more extensive sensitivity analyses, and for all economic evaluations (also nonvaccine related) to be in better accordance with general guidelines. We use these recommendations to interpret the evidence provided by economic evaluation applied to viral hepatitis vaccination. We conclude that universal hepatitis B vaccination (of neonates, infants or adolescents) seems to be the most optimal strategy worldwide, except in the few areas of very low endemicity, where the evidence to enable a choice between selective and universal vaccination remains inconclusive. While targeted hepatitis A vaccination seems economically unattractive, universal hepatitis A vaccination strategies have not yet been sufficiently investigated to draw general conclusions.

Adolescent↗

Duration of therapy and health care costs of fluoxetine, paroxetine, and sertraline in 6 health plans.

BACKGROUND: Previous studies comparing fluoxetine, paroxetine, and sertraline, the 3 most common selective serotonin reuptake inhibitors (SSRIs), in naturalistic settings have produced conflicting results. With this study, we provide new evidence as to the similarities and differences among these SSRI therapies with respect to the duration of use and health care costs. METHOD: Data from 6 health maintenance organizations were used to identify patients with new-onset major depression. number of days with filled prescriptions, and total health care and depression-related costs. The sample consisted of 1771 patients given initial prescriptions for sertraline (N = 386), fluoxetine (N = 840), or paroxetine (N = 545) in the period from July 1, 1994, to March 31, 1997. Analyses included Cox proportional hazards models (for duration of initial therapy) and ordinary least squares regression (for cost). RESULTS: Patients who initiated therapy with fluoxetine were more likely to have a later interruption of therapy than patients who initiated therapy with sertraline (p = .03) and paroxetine (p = .001). Total 1-year costs did not differ statistically between the treatment groups, but 1-year depression-related costs were significantly lower for patients who initiated therapy with sertraline or paroxetine than for those who initiated therapy with fluoxetine ($332 less for sertraline, 95% confidence interval [CI] = $125 to $562; $339 less for paroxetine, 95% CI = $144 to $416). LIMITATIONS: A limitation of this observational study, as well as of observational studies in general, is that unobserved characteristics of the patients may lead to biased estimates of the impact of treatment on adherence or cost, even with controls for observed characteristics. CONCLUSION: We found no significant differences in total health care costs among the 3 SSRIs, but noted significant differences in depression-related costs (the costs of fluoxetine are greater than those of sertraline and paroxetine). Importantly, there was no relationship between treatment interruption and increased health care or depression-related costs, in contrast to the findings of some, but not all, prior studies.

Adolescent↗

Effects of linezolid on hospital length of stay compared with vancomycin in treatment of methicillin-resistant Staphylococcus infections. An application of multivariate survival analysis.

OBJECTIVES: This study was designed to estimate the effects of treatment with linezolid as compared with vancomycin, on the distribution of length of stay (LOS) for hospitalized patients with methicillin-resistant staphylococcal infections. Treatment with intravenous-oral linezolid may allow some patients to be discharged earlier than would treatment with intravenous vancomycin. METHODS: The analysis is based on the intention-to-treat sample from a randomized multinational phase 3 clinical trial of 460 patients showing that the treatments had equal efficacy. Given the nature of the LOS data, some censoring, and some imbalances between treatment groups, multivariate survival analysis was indicated. Cox proportional hazards assumptions were tested and failed, and accelerated failure time models were tested for best fit. The log-logistic model was selected and used as the basis for estimating the overall treatment effect on LOS. Two methods for multivariate corrections to the survivorship functions allowed more thorough description of the treatment effect on the distribution of LOS, including multivariate-adjusted Kaplan-Meier curves. RESULTS: The average reduction in LOS associated with linezolid treatment, based on the log-logistic model after correction for covariate effects, was 18.1% (p = .041) or 2.53 days at the median. This was consistent with differences at the medians of the adjusted survivorship functions, which were 2 or 3 days depending on the method used. Treatment-based differences exist at each decile of LOS and consistently favor linezolid. Estimated mean reduction in LOS due to linezolid was 1.62 days in both methods. CONCLUSIONS: In this study sample, linezolid treatment resulted in statistically significantly shorter hospital LOS as compared with vancomycin treatment. Appropriate use of multivariate survival analysis allows better examination of the nature of the treatment effect on LOS, which may be important for economic analysis.

Acetamides↗