Intensive care unit-related fluconazole use in Spain and Germany: patient characteristics and outcomes of a prospective multicenter longitudinal observational study.

BACKGROUND: Candida spp. are a frequent cause of nosocomial bloodstream infections worldwide. OBJECTIVE: To evaluate the use patterns and outcomes associated with intravenous (IV) fluconazole therapy in intensive care units in Spain and Germany. PATIENTS AND METHODS: The research reported here was a prospective multicenter longitudinal observational study in adult intensive care unit patients receiving IV fluconazole. Demographic, microbiologic, therapy success, length of hospital stay, adverse event, and all-cause mortality data were collected at 14 sites in Spain and five in Germany, from February 2004 to November 2005. RESULTS: Patients (n = 303) received prophylaxis (n = 29), empiric therapy (n = 140), preemptive therapy (n = 85), or definitive therapy (n = 49). A total of 298 patients (98.4%) were treated with IV fluconazole as first-line therapy. The treating physicians judged therapy successful in 66% of prophylactic, 55% of empiric, 45% of preemptive, and 43% of definitive group patients. In the subgroup of 152 patients with proven and specified Candida infection only, 32% suffered from Candida specified as potentially resistant to IV fluconazole. The overall mortality rate was 42%. CONCLUSION: Our study informs treatment decision makers that approximately 32% of the patients with microbiological results available suffered from Candida specified as potentially resistant to IV fluconazole, highlighting the importance of appropriate therapy.

Cost-effectiveness of raltegravir in HIV/AIDS.

Raltegravir is a first-in-class HIV-1 integrase inhibitor with established antiviral efficacy in treatment-naive and treatment-experienced patients with multidrug-resistant HIV-1 infection. In this article, we summarize pharmacoeconomic evaluations of raltegravir-based treatment regimens, compared with alternative therapies, in the treatment of patients with HIV infection and/or AIDS. Cost-effectiveness evaluations of raltegravir in treatment-experienced patients conducted using a continuous-time, state-transition Markov cohort model suggest that raltegravir, combined with optimized background therapy, falls within the range that would generally be considered cost effective compared with optimized therapy alone in Spanish, Swiss and UK health systems. In treatment-naive populations, raltegravir was evaluated using a three-stage continuous-time state-transition cohort model. Raltegravir-based initiation treatment strategies (first-line raltegravir) were compared with protease inhibitor and non-nucleoside reverse-transcriptase inhibitor initiation strategies, in which raltegravir was retained for salvage therapy. First-line raltegravir was cost-effective versus retaining raltegravir for salvage therapy in several European populations. A separate economic model was used to evaluate first-line raltegravir against two alternative initiation regimens representing standard clinical practice in Australia; raltegravir proved to be cost effective in both scenarios. In all studies examined, results were sensitive to factors including treatment duration, mortality rate, analytic time horizon, health utility weights, cost of raltegravir and optimized therapy, incidence of opportunistic infection and discount rates. Nonetheless, raltegravir remained cost effective under most scenarios.

Comparative effectiveness of efavirenz, protease inhibitors, and raltegravir-based regimens as first-line treatment for HIV-infected adults: a mixed treatment comparison.

OBJECTIVE: Compare the efficacy of 2 NRTIs combined with raltegravir (RAL), efavirenz (EFV), or protease inhibitors (PI) in the management of antiretroviral-naïve HIV adult patients. METHODS: By means of a systematic literature view, 7 randomized controlled trials were identified: 2 RAL vs EFV trials; 1 ritonavir-boosted lopinavir (LPV/RTV) vs EFV trial; 1 ritonavir-boosted atazanavir (ATV/RTV) vs LPV/RTV trial; 1 ritonavir-boosted darunavir (DRV/RTV) vs LPV/RTV trial; 1 ritonavir-boosted fosamprenavir (FPV/RTV) vs LPV/RTV trial; and 1 FPV/RTV vs ATV/RTV trial. Endpoints concerned virological suppression and immunologic efficacy. Trials were analyzed with Bayesian mixed treatment comparison meta-analysis. RESULTS: For up to 24 weeks of treatment, a PI-based regimen resulted in a lower proportion of patients with virological response than an EFV-based regimen, whereas RAL seems more efficacious than EFV up to at least 12 weeks. After 48 weeks, the odds ratio (OR) of virological suppression with RAL relative to EFV was 1.34 (95% credible interval [CrI], 0.87-2.07). ORs for PIs relative to EFV varied from 0.68 (0.41-1.07) with LPV/RTV to 0.99 (0.52-1.84) with DRV/RTV. RAL demonstrated a greater improvement in CD4+ T cell counts than EFV at 48 weeks. The PI regimens showed all similar improvements relative to EFV. CONCLUSION: Based on available RCTs, the fastest virological suppression is expected with RAL followed by EFV and PIs. Over time, RAL appears to be at least as good as PI and EFV regimens. CD4+ cell recovery seems the greatest with LPV/RTV, DRV/RTV, and RAL. Given the limited number of RCTs, additional studies are recommended.

Retrospective evaluation of caspofungin therapy in invasive aspergillosis (RECAM-IA).

To evaluate caspofungin in high-risk invasive aspergillosis (IA) patient, a retrospective review of patient characteristics, antifungal therapies and clinical outcomes on hospitalised patients at sites in Russia, Canada, Germany, and Thailand was performed. Fifty-five patients were included, six with proven and 49 with probable aspergillosis; 76.4% had haematological diseases, 80% were on immunosuppressive drugs, 32.7% were neutropenic at caspofungin initiation. Median duration of prior antifungal therapy was 9 days (range 1-232). Reasons for initiating caspofungin included: disease refractory to first-line antifungal (49.1%) and toxicities with prior antifungals (18.2%). Median caspofungin therapy duration was 14 days (range 2-62), with a median of 13 days (range 1-62) as monotherapy. Favourable responses were observed in 45.5% of the patients, complete responses in 40% and partial responses in 5.5%; 74.5% survived 7 days after completion of caspofungin therapy with 69.1% having been successfully discharged from the hospital. Few patients (14.6%) on caspofungin switched because of suspected resistance, lack of response or adverse events. There were no increases in hospital stay as a result of adverse events or drug-drug interactions related to caspofungin; 7.3% of patients had a mean value of 13 (± 14.11) days of increased stay attributable to treatment failure. Caspofungin was well-tolerated. It exhibited effectiveness and high survival in treating severe IA patients.

Cost-effectiveness of raltegravir in antiretroviral treatment-experienced HIV-1-infected patients in Switzerland.

OBJECTIVES: Raltegravir, a novel integrase inhibitor, has shown great efficacy in reducing HIV viral load among treatment-experienced patients. A cohort state-transition model was used to assess the long-term effect of raltegravir treatment on costs and quality-adjusted life expectancy from a Swiss perspective. METHODS: Patients were stratified into health states according to opportunistic infection status, HIV RNA level, and CD4 count, with each group assigned a treatment cost and utility (quality of life) score. Model inputs came from published studies, clinical trials, and database analyses. Results were used to calculate incremental cost-effectiveness ratio (ICER) of raltegravir use, expressed in Swiss francs (CHF) as incremental cost/quality-adjusted life-year (QALY) gained. Future costs and QALYs were discounted at 3% per year. RESULTS: Five years of raltegravir treatment increased discounted quality-adjusted life expectancy by 3.73 years over placebo, with additional discounted cost of CHF 170,347, resulting in an ICER of CHF 45,687/QALY. ICERs ranged from CHF 42,751 to 53,478/QALY for treatment duration of 3 and 10 years, respectively. Results were most sensitive to changes in raltegravir treatment duration, source of estimated quality of life weights, and raltegravir price. CONCLUSIONS: Adding raltegravir to optimized background therapy was a cost-effective strategy for treatment-experienced patients in Switzerland.

Cost-effectiveness analysis of raltegravir in treatment-experienced HIV type 1-infected patients in Spain.

Raltegravir, a novel HIV-1 integrase inhibitor, has superior efficacy with optimized background treatment (OBT) vs. placebo + OBT in treatment-experienced HIV-1 patients. This study assessed the long-term cost effectiveness of raltegravir from a Spanish National Healthcare System perspective. A cohort-state-transition model was used to estimate clinical and economic outcomes associated with raltegravir + OBT vs. OBT alone. Subjects were stratified into health states according to HIV RNA level, CD4 count, and opportunistic infection (OI) history, and could transition into different health states over time based on projected long-term efficacy. Each health state was associated with a distinct treatment cost and utility (QoL) score. Model inputs for mortality, resource utilization, unit costs, OI risk, and long-term durability of viral suppression were obtained from clinical trials, published studies, and database analyses. Model outcomes were reported as incremental cost-effectiveness ratios (ICERs) in 2007 Euros per quality-adjusted life-year (euro/QALY) gained. Costs and QALYs were discounted at 6% per year based on Spanish cost-effectiveness guidelines. Extensive sensitivity analyses were conducted. Five years of treatment with raltegravir + OBT resulted in an additional 4.5 years of undiscounted life expectancy vs. OBT alone. The ICER of raltegravir + OBT vs. OBT alone was euro22,908/QALY and euro31,431/QALY for 3- and 5-year use, respectively. Lower ICERs were observed with lower discount rates (3%) for costs and benefits, lower raltegravir price (20%), and shorter treatment duration (3 years). ICER was also sensitive to analytical time horizon and alternative sources of QoL scores. In treatment-experienced Spanish patients, raltegravir was projected to provide survival benefits and be cost effective.

Patient Characteristics and Treatment Outcome Associated with Protease Inhibitor (PI) use in the Asia-Pacific Region.

OBJECTIVES: Regimens containing protease inhibitors (PI) are less commonly used in developing countries due to high cost and less availability. We evaluated characteristics of patients initiating PI-based therapy according to previous antiretroviral (ARV) exposure; factors associated with initiating a PI-containing regimen using newer versus older PIs, and proportion of patients with detectable viral loads (VL) after initiating a PI-based regimen. METHODS: This analysis includes all patients who have initiated a PI-based regimen. ARV exposure was categorised: naïve (no previous ARV), 1st, 2nd, >/= 3rd switches; a switch was defined as starting or stopping any drug in a regimen. Newer PIs were defined as those approved by the US FDA after 1 January 2000. Detectable VL at 12 months was defined as VL >/= 400 copies/mL. Characteristics at PI initiation were evaluated. Logistic regression was used to determine factors associated with initiating a newer PI and detectable VL at 12 months after PI initiation. RESULTS: 1106 patients initiated PI-based therapy; of these, 618 (56%) were naïve patients. Overall, 22% (176) of patients had detectable VL at 12 months following the PI initiation. Being from a high income country (vs. mid/low income, OR = 1.80, p = 0.034) were more likely to be associated with detectable VL. CONCLUSION: The use of PIs in this cohort is dictated by accessibility and affordability issues particularly for the newer PIs. Short-term virological outcomes following PI-therapy in our cohort were good, and were associated with CD4 count at time of initiation.

Comparative costs of ertapenem and cefotetan as prophylaxis for elective colorectal surgery.

BACKGROUND AND PURPOSE: The costs of treating surgical site infections can be considerable. There is a cost associated with the prophylactic use of antibiotics; however, the use of prophylactic agents may reduce infection rates and lengths of stay, thus offsetting the overall treatment cost and potentially generating cost savings to hospitals. This project was intended to determine the potential cost impact of using ertapenem 1 g vs. cefotetan 2 g as prophylaxis for elective colorectal surgery. METHODS: Cost analysis using efficacy data from the PREVENT clinical trial and drug acquisition and total hospital costs in 2005 dollars from Premier's Perspective Comparative Database in patients > or = 18 year of age, evaluable at four weeks after elective surgery of the colon or rectum and prophylactic treatment with ertapenem (n = 338) or cefotetan (n = 334). The primary outcome measures were the rate of prophylactic drug failure and the difference between the ertapenem and cefotetan groups in costs related to and total hospital stay. Prophylactic failure was defined as a surgical site infection, unexplained antibiotic use, or anastomotic leak. RESULTS: Prophylactic failure occurred in 28.1% of the patients receiving ertapenem and 42.8% of those receiving cefotetan (p < 0.05). The most common prophylactic failure was surgical site infection: 18.3% for ertapenem, 31.1% for cefotetan, difference (95% confidence interval) -13.0% (-19.5, -6.5%) (p < 0.05). The mean +/- standard deviation length of stay for all patients, including prophylactic successes and failures, was 7.6 +/- 6.6 days for ertapenem and 8.7 +/- 9.5 days for cefotetan. The mean per-patient cost of prophylactic drugs and hospital room and board was $15,245 with ertapenem and $17,428 cefotetan, a net difference of -$2,181. CONCLUSIONS: Ertapenem used in prophylaxis for elective colorectal operations results in a lower rate of surgical site infection and a shorter average length of stay than cefotetan. The calculated net difference in prophylactic antibiotic drug and hospital costs represents a saving of $2,181 per patient with ertapenem relative to cefotetan.

Economic evaluation of caspofungin versus liposomal amphotericin B for empiric antifungal treatment in patients with neutropenic fever in Italy.

OBJECTIVE: To evaluate the cost-effectiveness of caspofungin versus liposomal amphotericin B as empiric antifungal treatment in patients with neutropenic fever in Italy. METHODS: The cost-effectiveness of caspofungin versus liposomal amphotericin B was evaluated using a decision-tree model. Patients were stratified by presence or absence of baseline infection. Model outcomes included success in terms of resolution of fever, resolution of baseline infection, absence of breakthrough infection, survival, and quality-adjusted life years (QALYs) saved. Discontinuation because of nephrotoxicity or other adverse events were included in the model. Efficacy and safety data were based on a randomized, double-blind, multinational trial of caspofungin compared to liposomal amphotericin B (Walsh 2004). Information on life expectancy, quality of life, medical resource consumption, and costs was obtained from the literature. RESULTS: The caspofungin estimated total treatment cost amounted to 8351 euros (95% uncertainty interval 7801 euros-8903 euros), which is 3470 euros (2575 euros-4382 euros) less than with liposomal amphotericin B. Treatment with caspofungin resulted in 0.25 (-0.11; 0.59) QALYs saved in comparison to treatment with liposomal amphotericin B. Probabilistic sensitivity analysis demonstrated a 93% probability that caspofungin was economically dominant, i.e., cost and QALY saving, and a probability of more than 99% that the costs per QALY saved were below 20,000 euros, a commonly accepted threshold for cost-effectiveness. Additional analyses with alternative doses of liposomal amphotericin B confirmed these findings. CONCLUSION: Given the underlying assumptions, our economic evaluation demonstrated that caspofungin is cost-effective compared to liposomal amphotericin B in empiric antifungal treatment of patients with neutropenic fever in Italy.

Consequences of inappropriate initial empiric parenteral antibiotic therapy among patients with community-acquired intra-abdominal infections in Spain.

To assess the association between inappropriate antibiotic therapy and clinical outcomes for complicated community-acquired intra-abdominal infections in Spain, patient records from October 1998 to August 2002 in 24 hospitals were reviewed. Initial empiric therapy was classified appropriate if all isolates were sensitive to at least 1 of the antibiotics administered. Multivariate analyses were performed to assess associations between appropriateness of therapy and patient outcomes. Healthcare resource use was measured as hospital length of stay (LOS) and d on intravenous antibiotic therapy. A total of 425 patients were included. Of these, 387 (91%) received appropriate initial empiric therapy. Patients on inappropriate therapy were less likely to have clinical success (79% vs 26%, p<0.001), more likely to require additional antibiotic therapy (40% vs 7%, p<0.01) and more likely to be re-hospitalized within 30 d of discharge (18% vs 3%, p<0.01). Multivariate analyses also showed that inappropriate therapy was associated with an almost 16% increase in LOS (p<0.05) and 26% in d of intravenous antibiotic therapy compared with appropriate therapy (p<0.05). Inappropriate initial antibiotic therapy was associated with a significantly higher proportion of unsuccessful patient outcomes (including death, re-operation, re-hospitalization or additional parental antibiotic therapies), increased length of stay and length on therapy.

The association of consumer expectations, experiences and satisfaction with newly prescribed medications.

OBJECTIVE: To examine the association between medication expectations and subsequent experience on treatment satisfaction and intention to continue using the medication. METHODS: A longitudinal study with two surveys administered to each patient. Patients prescribed a new medication were recruited in pharmacies within Michigan. Medication-related expectations were evaluated at baseline. Experiences, satisfaction and intent to continue were evaluated a month later. Analyses used included factorial ANOVA models, multiple linear regressions and structural equation modeling (SEM). Impact of satisfaction on intention to continue was evaluated using correlation analysis and SEM. RESULTS: A total of 344 usable responses were obtained. SEM showed that expectation scores were not associated with both experience (path coefficient = 0.10) and satisfaction (path coefficient = 0.02, NS). On the other hand, experience was strongly associated with satisfaction (path coefficient = 0.89) and satisfaction was strongly associated with intent to continue using the new medication (path coefficient = 0.81). CONCLUSIONS: This study empirically supports the value of the patient's experience and its contribution to satisfaction, which in turn is associated with intended continued use mainly due to greater effectiveness of the newly prescribed medication. Satisfied consumers should be more adherent, thus enhancing the probability of positive therapeutic outcomes.

A cost-effectiveness analysis of caspofungin vs. liposomal amphotericin B for treatment of suspected fungal infections in the UK.

OBJECTIVE: To evaluate the cost-effectiveness of caspofungin vs. liposomal amphotericin B in the treatment of suspected fungal infections in the UK. METHODS: The cost-effectiveness of caspofungin vs. liposomal amphotericin B was evaluated using a decision-tree model. The decision tree was populated using both data and clinical definitions from published clinical studies. Model outcomes included success in terms of resolution of fever, baseline infection, absence of breakthrough infection, survival and quality adjusted life years (QALYs) saved. Discontinuation due to nephrotoxicity or other adverse events were included in the model. Efficacy and safety data were based on additional analyses of a randomised, double blind, multinational trial of caspofungin compared with liposomal amphotericin B. Information on life expectancy, quality of life, medical resource consumption and costs were obtained from peer-reviewed published data. RESULTS: The caspofungin mean total treatment cost was 9762 pounds (95% uncertainty interval 6955-12,577), which was 2033 pounds (-2489; 6779) less than liposomal amphotericin B. Treatment with caspofungin resulted in 0.40 (-0.12; 0.94) additional QALYs saved in comparison with liposomal amphotericin B. Probabilistic sensitivity analysis found a 95% probability of the incremental cost per QALY saved being within the generally accepted threshold for cost-effectiveness (30,000 pounds). Additional analyses with varying dose of caspofungin and liposomal amphotericin B confirmed these findings. CONCLUSION: Given the underlying assumptions, caspofungin is cost-effective compared with liposomal amphotericin B in the treatment of suspected fungal infections in the UK.

Fluconazole for empiric antifungal therapy in cancer patients with fever and neutropenia.

BACKGROUND: Several clinical trials have demonstrated the efficacy of fluconazole as empiric antifungal therapy in cancer patients with fever and neutropenia. Our objective was to assess the frequency and resource utilization associated with treatment failure in cancer patients given empiric fluconazole antifungal therapy in routine inpatient care. METHODS: We performed a retrospective cohort study of cancer patients treated with oral or intravenous fluconazole between 7/97 and 6/01 in a tertiary care hospital. The final study cohort included cancer patients with neutropenia (an absolute neutrophil count below 500 cells/mm3) and fever (a temperature above 38 degrees C or 100.4 degrees F), who were receiving at least 96 hours of parenteral antibacterial therapy prior to initiating fluconazole. Patients' responses to empiric therapy were assessed by reviewing patient charts. RESULTS: Among 103 cancer admissions with fever and neutropenia, treatment failure after initiating empiric fluconazole antifungal therapy occurred in 41% (95% confidence interval (CI) 31%-50%) of admissions. Patients with a diagnosis of hematological malignancy had increased risk of treatment failure (OR = 4.6, 95% CI 1.5-14.8). When treatment failure occurred the mean adjusted increases in length of stay and total costs were 7.4 days (95% CI 3.3-11.5) and $18,925 (95% CI 3,289-34,563), respectively. CONCLUSION: Treatment failure occurred in more than one-third of neutropenic cancer patients on fluconazole as empiric antifungal treatment for fever in routine clinical treatment. The increase in costs when treatment failure occurs is substantial.

Treatment outcomes in patients receiving conventional amphotericin B therapy: a prospective multicentre study in Taiwan.

OBJECTIVES: To evaluate treatment outcomes and healthcare resource use with conventional amphotericin B therapy for invasive fungal infections (IFIs). PATIENTS AND METHODS: A prospective observational study in hospitalized adult patients receiving amphotericin B treatment was undertaken at four hospitals in Taiwan. Patients were observed from the start of therapy to hospital discharge. RESULTS: A total of 108 patients (October 2000 to April 2002) were included in the study. Proven or probable IFIs as defined by the EORTC/MSG criteria were the reasons for the initiation of amphotericin B in 35.2% of the sample. A total of 24.1% patients developed nephrotoxicity (NT) (defined as a 50% increase in the baseline serum creatinine and achieving a peak of at least 2.0 mg/dL). Treatment of proven/probable IFIs [odds ratio (OR) = 4.16, 95% confidence interval (CI) = 1.61-10.75] was a significant predictor of the development of NT. The in-hospital mortality rate was 38.0%. Proven/probable IFIs (OR = 6.93, 95% CI = 2.62-18.29) and the development of NT (OR = 3.68, 95% CI = 1.22-11.04) were independent predictors of in-hospital mortality. For patients alive at discharge, those with NT had a trend of longer hospital stay compared with patients who had not developed NT (mean, 49.3 +/- 18.2 versus 29.3 +/- 22.3 days, P = 0.069). For patients who died, those who had developed NT died sooner (15.5 +/- 16.7 versus 33. 8 +/- 26.9 days, P = 0.0004). CONCLUSIONS: NT was associated with accelerated mortality and increased hospital stay for patients who survived. Using amphotericin B carefully or the use of antifungal agents with less potential for NT might improve patient outcomes.

Direct health care costs of 4 common skin ulcers in New Mexico Medicaid fee-for-service patients.

OBJECTIVE: To determine health care costs associated with pressure ulcers, ulcers of the lower limbs, other chronic ulcers, and venous leg ulcers from the New Mexico Medicaid fee-for-service program perspective. DESIGN: Retrospective analysis of claims database MAIN OUTCOME MEASURES: Physician visit, hospital, and prescription costs were determined for New Mexico Medicaid patients with a primary and/or secondary diagnosis of 1 of 4 identified categories of skin ulcers from January 1, 1994, through December 31, 1998. Costs were determined in terms of mean and median annual cost per patient and total costs per year. Zero dollar claims were included within the cost calculations. All costs are expressed in 2000-dollar values. MAIN RESULTS: Mean annual physician visit costs per patient ranged from $71 (standard deviation [SD] = $60) for venous leg ulcers in 1998 to $520 (SD = $1228) for pressure ulcers in 1996. Mean annual hospital costs per patient ranged from $266 (SD = $348) for other chronic ulcers in 1998 to $15,760 (SD = $30,706) for pressure ulcers in 1998. Mean annual prescription costs per patient ranged from $145 (SD = $282) for other chronic ulcers in 1998 to $654 (SD = $1488) for pressure ulcers in 1994. CONCLUSION: The New Mexico Medicaid fee-for-service system incurred a total cost of approximately $11.6 million (in 2000 dollars) from 1994 through 1998 for the treatment of the 4 categories of skin ulcers studied. The data showed that the majority of wounds were coded as pressure ulcers, which had the highest associated costs.

Validation of a general measure of treatment satisfaction, the Treatment Satisfaction Questionnaire for Medication (TSQM), using a national panel study of chronic disease.

BACKGROUND: The objective of this study was to develop and psychometrically evaluate a general measure of patients' satisfaction with medication, the Treatment Satisfaction Questionnaire for Medication (TSQM). METHODS: The content and format of 55 initial questions were based on a formal conceptual framework, an extensive literature review, and the input from three patient focus groups. Patient interviews were used to select the most relevant questions for further evaluation (n = 31). The psychometric performance of items and resulting TSQM scales were examined using eight diverse patient groups (arthritis, asthma, major depression, type I diabetes, high cholesterol, hypertension, migraine, and psoriasis) recruited from a national longitudinal panel study of chronic illness (n = 567). Participants were then randomized to complete the test items using one of two alternate scaling methods (Visual Analogue vs. Likert-type). RESULTS: A factor analysis (principal component extraction with varimax rotation) of specific items revealed three factors (Eigenvalues > 1.7) explaining 75.6% of the total variance; namely Side effects (4 items, 28.4%, Cronbach's Alpha =.87), Effectiveness (3 items, 24.1%, Cronbach's Alpha =.85), and Convenience (3 items, 23.1%, Cronbach's Alpha =.87). A second factor analysis of more generally worded items yielded a Global Satisfaction scale (3 items, Eigenvalue = 2.3, 79.1%, Cronbach's Alpha =.85). The final four scales possessed good psychometric properties, with the Likert-type scaling method performing better than the VAS approach. Significant differences were found on the TSQM by the route of medication administration (oral, injectable, topical, inhalable), level of illness severity, and length of time on medication. Regression analyses using the TSQM scales accounted for 40-60% of variation in patients' ratings of their likelihood to persist with their current medication. CONCLUSION: The TSQM is a psychometrically sound and valid measure of the major dimensions of patients' satisfaction with medication. Preliminary evidence suggests that the TSQM may also be a good predictor of patients' medication adherence across different types of medication and patient populations.

Prescription drug use among elderly and nonelderly families.

OBJECTIVE: This study augments existing literature by examining characteristics associated with prescription drug utilization and makes an in-depth assessment of family prescription drug economic burden within the United States. The objective of this study was to examine differences in prescription drug use and prescription drug characteristics among elderly and nonelderly families. METHODS: A measure of out-of-pocket prescription drug burden associated with family prescription drug utilization was constructed using data from the 1996 Medical Expenditure Panel Survey (MEPS). Families were designated as the unit of analysis and further divided by age (<65 and e 65 years) of the reference person. The 1996 MEPS database provides medical expenditure data on a national sample of 8,917 families (22,601 individuals) and 147,308 drug episodes, i.e., prescription procurement. The ratio of family prescription out-of-pocket expenditures to family income was used to assign families to economic burden rank-ordered quintiles, each representing 20% of U.S. families in 1996. RESULTS: Prescription size, price, and drug use were higher among elderly families. Their proportion of generic use was higher compared to nonelderly families. Additionally, out-of-pocket prescription expenditures represented 23.7% and 45.6% of the total out-of-pocket medical care burden for nonelderly and elderly families, respectively. The average prescription drug burden (total prescription out-of-pocket costs/family income) was 0.4% for nonelderly and 1.9% for elderly households. CONCLUSION: The study results demonstrate an ability to identify populations with high economic burden for prescription medications. The presumption is that persons age 65 or older, lacking purchasing leverage, are more likely to pay full retail price and, consequently, higher prices. Our findings suggest that high prescription drug burden was a function of prescription size and cost per prescription, with prescription size showing more drastic differences between the high and low prescription drug burden subgroups. Future studies should continue to assess factors influencing families. prescription drug economic burden, and the information derived from these studies should be used by benefit planners in designing drug benefits within health insurance plans.

Validation of the Health-Related Productivity Questionnaire Diary (HRPQ-D) on a sample of patients with infectious mononucleosis: results from a phase 1 multicenter clinical trial.

The objective of this work was to assess the performance of the newly developed Health-Related Productivity Questionniare-Diary (HRPQ-D). Patients completed the HRPQ-D daily for 1-week periods during weeks 1, 2, 4, and 8 of a clinical trial for infectious mononucleosis. Productivity data were collected on a daily basis in terms of absenteeism, presenteeism, and combined lost productivity for three work venues (work outside home, housework, and classes/homework). These were then correlated with patient symptom scores. Symptom scores were positively correlated with lost work hours because of absenteeism and combined lost productivity scores. However, negative correlations were observed between symptom scores and the lost work hours due to presenteeism. The HRPQ-D demonstrated good construct validity, making it a useful tool for determining productivity levels across different work venues within clinical trial or survey research applications.

Quality assessment of economic analyses of pharmacological and nutritional therapy for hyperlipidemia.

Our objective was to evaluate the quality of published pharmacoeconomic studies of lipid-lowering therapies. A 13-item evaluation checklist was used to assess the quality of articles. Two reviewers assessed each article. Discrepancies in ratings were resolved using a third reviewer. Potential scores on each item ranged from 0 to 4 and 50 articles met our inclusion criteria. Mean quality scores ranged from 1.73 to 3.89. Treatment and policy implications are: secondary prevention is more cost-effective than primary prevention, the cost-effectiveness of lipid-lowering treatments correlates with risk-factors and statin drugs are more cost-effective than cholesterol-sequestering agents. This review provides a summarization of the literature regarding the cost-effectiveness of lipid-lowering therapies. Results from lower-quality studies may be less accurate because the most common criteria assessed as questionable or incorrect were perspective, measurement and analysis.