A comparison of clinical, utilization, and cost outcomes between oral treatments for multiple sclerosis.

BACKGROUND: Multiple sclerosis (MS) affects nearly 1 million people in the United States and causes significant disability and economic loss. Among the first available oral MS treatment options, clinical outcome comparisons and associated health care resource utilization are not clearly defined. OBJECTIVE: To compare MS outcomes, health care resource utilization, and relative costs across treatment with dimethyl fumarate (DMF), fingolimod (FG), or teriflunomide (TERI) among Medicare Advantage Prescription Drug (MAPD) plan and commercially insured beneficiaries. METHODS: This retrospective cohort study used the Humana Research Database. Eligible study patients had their first MS medication claim for oral DMG, FG, or TERI between January 1, 2013, and December 31, 2018. Patients were followed for a minimum of 12 months (mean follow-up = 3.8 years), until the earliest of the following occurred: health plan disenrollment, the end of the study period, or death. Study cohorts were balanced with inverse probability of treatment weighting. All-cause and MS-related health care resource utilization, time on therapy, and time after therapy were compared using inverse probability of treatment-adjusted multivariate generalized linear models across treatment groups. Relative costs were compared using a generalized linear model with a gamma distribution and log link. RESULTS: We identified 1,442 patients in 3 medication groups: DMF (n = 843), FG (n = 213), and TERI (n = 386). After weighting, there were no significant differences between the medication groups on demographic and clinical characteristics. Time on therapy (days) was significantly different across medication groups (P < 0.001). Time on therapy was longest for FG compared with the DM and TERI groups (644 vs 462 vs 521). The number discontinuing the index medication was significantly different for FG vs DMF vs TERI (74.7% vs 85.3% vs 80.7%; P < 0.001). FG had the lowest discontinuation rate. The mean (SD) annualized relapse rates (ARRs) were 0.47 (0.80), 0.42 (1.3), and 0.53 (1.3) (P = 0.037) for DMF, FG, and TERI, respectively. The percentage of those experiencing inpatient stays and the number of stays (mean [SD]) were significantly different among the FG group vs DMF vs TERI (29.9% vs 34.1% vs 40.9%; P < 0.001) and (0.57 [2.9] vs 0.74 [1.9] vs 0.91 [3.5]; P = 0.007), respectively. All-cause emergency department visits and the number of visits (mean [SD]) were significantly different for the FG cohort vs DMF vs TERI (46% vs 54.3% vs 61%; P < 0.001) and (1.84 [7.7] vs 2.38 [5.9] vs 2.87 [8.8]; P = 0.002), respectively. FG had the lowest impatient stays and emergency department visits of the 3 groups. CONCLUSIONS: Patients with MS initiated on FG used fewer health care resources and experienced lower ARR compared with patients on DMF and TERI.

HIV preexposure prophylaxis treatment patterns in a national health plan population.

BACKGROUND: Medication nonadherence diminishes the benefits of preexposure prophylaxis (PrEP) for the 1.2 million Americans at risk for HIV exposure. OBJECTIVE: To describe HIV PrEP treatment patterns among Medicare Advantage Prescription Drug (MAPD) plan and commercially insured beneficiaries. METHODS: This retrospective cohort study identified patients aged 16 to 89 years with at least 1 dispensing of emtricitabine-tenofovir disoproxil fumarate from July 2012, through December 2020, or emtricitabine-tenofovir alafenamide from October 2019 through December 2020, and who were continuously enrolled at least 12 months prior to and following the earliest PrEP claim. Outcomes were HIV PrEP adherence measured by proportion of days covered (PDC) using 2 binary thresholds of 0.60 (4 doses/week) and 0.80 (5-6 doses/week) and duration of index treatment episode, total time on treatment, and total number of prescription fills. RESULTS: The study cohort of 707 (292 MAPD plan, 415 commercial) was predominantly made up of male patients (90.0%) and resided in the South (78.9%) with a mean age of 46.2 years (MAPD plan: 54.5, commercial: 40.4). Both populations engaged in high-risk sexual behavior (All: 18.7%, MAPD plan: 16.8%, commercial: 20.0%) and experienced sexually transmitted infections (All: 3.3%, MAPD plan: 2.1%, commercial: 4.1%). The mean index treatment episode length was 297.0 days (MAPD plan: 283.6, commercial: 306.5). Total time on treatment was 477.3 days (MAPD plan: 450.7, commercial 496.0). At 3 months, 84.9% (MAPD plan: 83.6%, commercial: 85.8%) and at 12 months, 58.7% (MAPD plan: 57.2, commercial: 59.8) of patients achieved a PDC of at least 0.80. At 3 months, 100.0% (MAPD plan: 100.0%, commercial: 100.0%), and at 12 months, 74.3% (MAPD plan: 70.2%, commercial: 76.9%) of patients achieved a PDC of at least 0.60. The cohort had a mean of 16.4 fills of 30 days (MAPD plan: 16.4, commercial: 16.3) supply. CONCLUSIONS: There is an opportunity for clinical programs to focus on improving longer-term PrEP adherence among individuals at risk for HIV exposure.

Home versus outpatient hospital intravenous immunoglobulin infusion and health care resource utilization.

BACKGROUND: Home health care delivery is projected to increase. Intravenous immunoglobulin (IVIG) therapy has high potential to move from the outpatient hospital (OPH) setting to home delivery. OBJECTIVE: This study examined the relationship between home and OPH IVIG infusions and health care utilization. METHODS: We used a retrospective cohort study design and the Humana Research Database to identify patients with 1 or more medical or pharmacy claims for an IVIG infusion agent from January 1, 2017, to December 31, 2018. Eligible patients were enrolled in a Medicare Advantage Prescription Drug (MAPD) or commercial health plan, with at least 12 months of continuous enrollment before and after their first infusion (i.e., index date) received in the home or OPH setting. We measured the odds of experiencing an inpatient (IP) stay or emergency department (ED) visit, adjusted for baseline differences in age, sex, race, region, population density, low-income, and dual eligibility status, MAPD or commercial health plan, plan type, treatment-naïve status, home health use, RxRisk-V comorbidity burden score, and indications for IVIG use. RESULTS: A total of 208 and 1079 patients received IVIG infusions in the home and OPH setting, respectively. The odds for an IP stay (odds ratio [OR] 0.56 [95% CI 0.38-0.82]) and ED visit (OR 0.62 [95% CI 0.41-0.93]) were significantly lower in patients who received IVIG infusion in the home than patients receiving infusion in the OPH setting. CONCLUSIONS: Our findings suggest there may be value to increasing referrals for IVIG home infusion. Decreased health care utilization provides value to the system in cost savings and to patients and families owing to less disruption and improved clinical outcomes. Further study can help inform health policy designed to maximize the benefits of IVIG home infusion while minimizing potential risks.

Early vs late filling of new heart failure prescription and its association with avoidable hospital admissions.

BACKGROUND: Individuals with heart failure (HF) are at increased risk for hospitalization and readmission after discharge. The impact of timing to new prescription filling on avoidable HF hospitalization is understudied in HF management. The Agency of Healthcare Research and Quality identifies HF-related inpatient admissions as potentially avoidable if they could be managed successfully in outpatient settings. OBJECTIVE: To compare avoidable HF hospitalization rate and all-cause and HF-related costs in patients who were early fillers (≤30 days) vs late fillers (>30 days) of newly prescribed HF medications following an HF-related inpatient stay or emergency department visit. METHODS: This retrospective cohort study used the Humana Research Database to identify patients with at least 1 claim for a new HF medication from January 1, 2018, to June 30, 2019. Eligible patients were enrolled in a Medicare Advantage Prescription Drug plan for at least 12 months pre-index and 6-months post-index (ie, first new HF prescription). Individuals who were early (n = 794) vs late fillers (n = 397) were propensity-score matched in a 2:1 ratio to balance baseline characteristics. A logistic regression model was fitted to compare avoidable HF hospitalization in those who were late fillers vs early fillers. Mean cost differences were compared using paired t-test. Outcomes were measured 6-months post-index. RESULTS: Late fillers had greater odds of experiencing an avoidable HF hospitalization compared with early fillers (odds ratio = 1.65; P = 0.001). Late filling was associated with a 49.5% increase in average all-cause medical costs (P < 0.0001), a 13.6% decrease in average all-cause pharmacy costs (P = 0.0929), and a 39.4% increase in average all-cause total costs (P < 0.0001). HF-related costs showed similar trends. CONCLUSION: Compared with patients who filled their prescription within 30 days of discharge following an HF admission, those who delayed the filling of a new HF prescription experienced increased likelihood of an avoidable readmission, and late filling was associated with increased 6-month total and medical costs. DISCLOSURES: Humana Healthcare Research, Inc., funded the research and article development. No external funds were used in the creation of this work. All authors are/were employees of Humana Inc. and/or Humana Healthcare Research, Inc., at the time of the work.

The impact of real-world cardiovascular-related pharmacogenetic testing in an insured population.

BACKGROUND: Pharmacogenomics is intended to help clinicians provide the right drug to the right patient at an appropriate dose. However, limited evidence of clinical utility has slowed uptake of pharmacogenomic testing (PGT). OBJECTIVE: To evaluate the impact of real-world cardiovascular (CV)-related PGT on clinical outcomes, healthcare resource utilisation (HCRU) and cost in a large, heterogeneous population. METHODS: Individuals with Medicare Advantage Prescription Drug, Medicaid, or commercial coverage between 1/1/2011 and 9/30/2015 and ≥1 atherosclerotic CV-related diagnosis were identified. Those with ≥1 claim for CV-related PGT were included in the test group (index date = 1st PGT claim) and matched 1:2 to controls without PGT. Individuals aged <22 or ≥90 years old on the index date, with <12 months continuous enrollment before and after the index date, or without an ASCVD-related diagnosis in the 12-month pre-index period were excluded. The primary outcome was occurrence of a major CV event during the 12-month post-index period. RESULTS: After adjustment, the PGT group was significantly more likely to experience ischaemic stroke, pulmonary embolism, deep vein thrombosis or a composite event compared with controls. Adjusting for baseline characteristics, HCRU was significantly higher for the test group across all measured outcomes except all-cause and ASCVD-related inpatient admissions. Median all-cause and ASCVD-related healthcare costs were significantly higher for the test group. CONCLUSIONS: Real world PGT in a large population did not improve outcomes. Tailoring medication therapy to each patient holds great promise for providing quality care but a deeper understanding of how widespread utilisation of PGT might impact objective health outcomes is needed.

Comparative Effectiveness of Rapid-Acting Insulins in Adults with Diabetes.

BACKGROUND: Although there are a variety of insulin products and new delivery modalities available, the absence of direct clinical and economic comparisons can make treatment planning and formulary decision making difficult. Direct comparisons between insulin aspart and insulin lispro from a large heterogeneous population are not available. OBJECTIVE: To assess differences in clinical outcomes, medication adherence, utilization, and total health care costs between aspart and lispro and vial versus pen modalities for administering these short-acting insulin analogs. METHODS: This retrospective cohort study used administrative claims data from the Humana Research Database to identify people with type 1 or type 2 diabetes and Medicare or commercial insurance (with medical and pharmacy benefits) who newly initiated rapid-acting insulin between January 1, 2008, and December 31, 2013, and were continuously enrolled during the 12-month baseline and 12-month follow-up periods. Generalized linear models were used to assess differences in costs and utilization. Logistic regression models measured the likelihood of having a hypoglycemic event, worsening diabetes complications, or a change in glycated hemoglobin (A1c). RESULTS: 8,189 patients included in the study were grouped by rapid-acting insulin product (aspart, n = 5,364, and lispro, n = 2,566) and modality (vial, n = 6,135, and pen, n = 2,054). There were no significant differences in the percentage of patients with a hypoglycemic event, new or worsening diabetes complications, or change in A1c, and there were no significant differences in adjusted total health care, medical and pharmacy costs, or emergency department visits between any of the product or modality comparisons. There was a significant difference in mean annual inpatient stays between lispro and aspart (adjusted mean = 2.24, 95% CI = 0.73-6.69, and adjusted mean = 2.65, 95% CI = 0.86-7.86, respectively; P < 0.001) and pen and vial cohorts (adjusted mean = 1.74, 95% CI = 0.56-4.99, and adjusted mean = 3.05, 95% CI = 1.01-9.08, respectively; P < 0.001). Adherence was similar for the lispro and aspart cohorts. Adherence was higher in the pen cohort (as measured by medication possession ratio ≥80%) compared with the vial cohort (adjusted odds ratio = 1.29, 95% CI = 1.12-1.50). CONCLUSIONS: This study provides a comprehensive assessment of outcomes and costs between 2 commonly used rapid-acting insulin products. Overall, there was little differentiation between products, although adherence improved significantly with pen devices. These findings may simplify decisions related to formulary options and choice of therapy. DISCLOSURES: No outside funding supported this study. Racsa and Ellis are employees of Comprehensive Health Insights, a subsidiary of Humana, and Saverno was employed with Comprehensive Health Insights at the time of this study. Meah is an employee of, and owns stock in, Humana. The authors have no financial disclosures or potential conflicts of interest to report. All authors contributed equally to study concept and design, data interpretation, and manuscript preparation. Racsa collected the data.

Development and Validation of a Predictive Model to Identify Individuals Likely to Have Undiagnosed Chronic Obstructive Pulmonary Disease Using an Administrative Claims Database.

BACKGROUND: Despite the importance of early detection, delayed diagnosis of chronic obstructive pulmonary disease (COPD) is relatively common. Approximately 12 million people in the United States have undiagnosed COPD. Diagnosis of COPD is essential for the timely implementation of interventions, such as smoking cessation programs, drug therapies, and pulmonary rehabilitation, which are aimed at improving outcomes and slowing disease progression. OBJECTIVE: To develop and validate a predictive model to identify patients likely to have undiagnosed COPD using administrative claims data. METHODS: A predictive model was developed and validated utilizing a retro-spective cohort of patients with and without a COPD diagnosis (cases and controls), aged 40-89, with a minimum of 24 months of continuous health plan enrollment (Medicare Advantage Prescription Drug [MAPD] and commercial plans), and identified between January 1, 2009, and December 31, 2012, using Humana's claims database. Stratified random sampling based on plan type (commercial or MAPD) and index year was performed to ensure that cases and controls had a similar distribution of these variables. Cases and controls were compared to identify demographic, clinical, and health care resource utilization (HCRU) characteristics associated with a COPD diagnosis. Stepwise logistic regression (SLR), neural networking, and decision trees were used to develop a series of models. The models were trained, validated, and tested on randomly partitioned subsets of the sample (Training, Validation, and Test data subsets). Measures used to evaluate and compare the models included area under the curve (AUC); index of the receiver operating characteristics (ROC) curve; sensitivity, specificity, positive predictive value (PPV); and negative predictive value (NPV). The optimal model was selected based on AUC index on the Test data subset. RESULTS: A total of 50,880 cases and 50,880 controls were included, with MAPD patients comprising 92% of the study population. Compared with controls, cases had a statistically significantly higher comorbidity burden and HCRU (including hospitalizations, emergency room visits, and medical procedures). The optimal predictive model was generated using SLR, which included 34 variables that were statistically significantly associated with a COPD diagnosis. After adjusting for covariates, anticholinergic bronchodilators (OR = 3.336) and tobacco cessation counseling (OR = 2.871) were found to have a large influence on the model. The final predictive model had an AUC of 0.754, sensitivity of 60%, specificity of 78%, PPV of 73%, and an NPV of 66%. CONCLUSIONS: This claims-based predictive model provides an acceptable level of accuracy in identifying patients likely to have undiagnosed COPD in a large national health plan. Identification of patients with undiagnosed COPD may enable timely management and lead to improved health outcomes and reduced COPD-related health care expenditures.

A retrospective, matched cohort study of potential drug-drug interaction prevalence and opioid utilization in a diabetic peripheral neuropathy population initiated on pregabalin or duloxetine.

BACKGROUND: Anticipating and controlling drug-drug interactions (DDIs) in older patients with painful diabetic peripheral neuropaty (pDPN) presents a significant challenge to providers. The purpose of this study was to examine the impact of newly initiated pregabalin or duloxetine treatment on Medicare Advantage Prescription Drug (MAPD) plan pDPN patients' encounters with potential drug-drug interactions, the healthcare cost and utilization consequences of those interactions, and opioid utilization. METHODS: Study subjects required a pregabalin or duloxetine pharmacy claim between 07/01/2008-06/30/2012 (index event), ≥1 inpatient or ≥2 outpatient medical claims with pDPN diagnosis between 01/01/2008-12/31/2012, and ≥12 months pre- and ≥6 post-index enrollment. Propensity score matching was used to balance the pregabalin and duloxetine cohorts on pre-index demographics and comorbidities. Potential DDIs were defined by Micromedex 2.0 and identified by prescription claims. Six-month post-index healthcare utilization (HCU) and costs were calculated using pharmacy and medical claims. RESULTS: No significant differences in pre-index demographics or comorbidities were found between pregabalin subjects (n = 446) and duloxetine subjects (n = 446). Potential DDI prevalence was significantly greater (p < 0.0001) among duoxetine subjects (56.7%) than among pregabalin subjects (2.9%). There were no significant differences in HCU or costs between pregablin subjects with and without a potential DDI. By contrast, duloxetine subjects with a potential DDI had higher mean all-cause costs ($13,908 vs. $9,830; p = 0.001), more subjects with ≥1 inpatient visits (35.6% vs 25.4%; p = 0.02), and more subjects with ≥1 emergency room visits (32.8% vs. 20.7%; p = 0.005) in comparison to duloxetine subjects without a potential DDI. There was a trend toward a difference between pregabalin and duloxetine subjects in their respective pre-versus-post differences in milligrams (mg) of morphine equivalents/30 days used (60.2 mg and 176.9 mg, respectively; p = 0.058). CONCLUSION: The significantly higher prevalence of potential DDIs and potential cost impact found in pDPN duloxetine users, relative to pregabalin users, underscore the importance of considering DDIs when selecting a treatment.

Impact of roflumilast on exacerbations of COPD, health care utilization, and costs in a predominantly elderly Medicare Advantage population.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) exacerbations are associated with declining lung function and health-related quality of life, and increased hospitalization and mortality. Clinical trials often poorly represent the elderly and thus have only partial applicability to their clinical care. OBJECTIVE: To compare exacerbations, COPD-related health care utilization (HCU), and costs in a predominantly elderly Medicare COPD population initiated on roflumilast versus those not initiated on roflumilast. METHODS: Deidentified administrative claims data from a large, national payer were utilized. Medicare patients aged 40-89 years with at least one COPD diagnosis from May 1, 2010 to December 31, 2012 were included. Members with at least one roflumilast pharmacy claim (index) were assigned to the roflumilast group and those without were assigned to the non-roflumilast group. Proxy index dates for the non-roflumilast group were randomly assigned for similar distribution of all patients' time at risk. Subjects with at least one pre-index COPD exacerbation had to be continuously enrolled for ≥365 days pre-index and post-index. Unadjusted and adjusted difference-in-difference (DID) analyses contrasted pre-index with post-index changes in exacerbations, HCU, and costs of roflumilast treatment compared with non-roflumilast treatment. RESULTS: A total of 500 roflumilast and 60,145 non-roflumilast patients were included (mean age 69.7 and 72.3 years, respectively; P<0.0001). Unadjusted DID favored roflumilast for all exacerbations, with greater pre-index to post-index reductions in mean per 30-day COPD-related hospitalizations (-0.0182 versus -0.0013, P=0.009), outpatient visits (-0.2500 versus -0.0606, P<0.0001), and COPD-related inpatient costs (-US$141 versus -US$11, P=0.0346) and outpatient costs (-US$31 versus -US$4, P<0.0001). Multivariate analyses identified significantly improved pre-index to post-index COPD-related total costs (P=0.0005) and total exacerbations (P<0.0001) for the roflumilast group versus non-roflumilast group. CONCLUSION: In a predominantly elderly Medicare COPD population, newly initiated roflumilast patients displayed similar or significantly better unadjusted reductions in all exacerbation-related, COPD-related HCU-related, and COPD-related costs outcomes compared with non-roflumilast patients. These analyses also suggest better adjusted COPD-related costs and total exacerbations for roflumilast-initiated patients.

Impact of potential pregabalin or duloxetine drug-drug interactions on health care costs and utilization among Medicare members with fibromyalgia.

PURPOSE: To examine the impact of newly initiated pregabalin or duloxetine treatment on fibromyalgia (FM) patients' encounters with potential drug-drug interactions (DDIs), the health care cost and utilization consequences of those interactions, and the impact of treatment on opioid utilization. PATIENTS AND METHODS: Subjects included those with an FM diagnosis, a pregabalin or duloxetine prescription claim (index event), ≥1 inpatient or ≥2 outpatient medical claims, and ≥12 months preindex and ≥6 postindex enrollment. Propensity score matching was used to help balance the pregabalin and duloxetine cohorts on baseline demographics and comorbidities. Potential DDIs were defined based on Micromedex 2.0 software and were identified by prescription claims. RESULTS: No significant differences in baseline characteristics were found between matched pregabalin (n=794) and duloxetine cohorts (n=794). Potential DDI prevalence was significantly greater (P<0.0001) among duloxetine subjects (71.9%) than among pregabalin subjects (4.0%). There were no significant differences in all-cause health care utilization or costs between pregabalin subjects with and without a potential DDI. By contrast, duloxetine subjects with a potential DDI had higher mean all-cause costs ($9,373 versus $7,228; P<0.0001) and higher mean number of outpatient visits/member (16.0 versus 13.0; P=0.0009) in comparison to duloxetine subjects without a potential DDI. There was a trend toward a statistically significant difference between pregabalin and duloxetine subjects in their respective pre- versus post-differences in use of ≥1 long-acting opioids (1.6% and 3.4%, respectively; P=0.077). CONCLUSION: The significantly higher prevalence of potential DDIs and potential cost impact found in FM duloxetine subjects, relative to pregabalin subjects, underscore the importance of considering DDIs when selecting a treatment.

Effects of an adverse-drug-event alert system on cost and quality outcomes in community hospitals.

PURPOSE: The effects of an adverse-drug-event (ADE) alert system on cost and quality outcomes in community hospitals were evaluated. METHODS: This retrospective observational study evaluated the effects of an ADE alert system in seven hospitals in the Trinity Health network. Outcomes for all inpatients admitted to these hospitals after and one year before the deployment of an ADE alert system were evaluated. Inpatients in two network hospitals that lacked any computerized ADE alert system constituted the external control group. Administrative data were gathered for patients from these facilities for the same time frames as for the preimplementation and postimplementation groups. Primary outcomes evaluated included pharmacy department costs, variable drug costs, and mortality rates. Secondary outcomes included total hospitalization costs, length of hospital stay (LOS), rate of readmission, and case-mix index. Mean differences in primary and secondary outcome measures across all four groups were examined using analysis of variance. RESULTS: Significant decreases in mean pharmacy department costs per patient were observed from preimplementation to postimplementation (p < 0.001), while pharmacy department costs increased significantly in the external control group (p = 0.029). Drug costs decreased significantly from baseline (p < 0.001) in the postimplementation group. Drug costs increased significantly in the external control group (p = 0.029). Severity-adjusted mortality rates and LOS decreased significantly in the postimplementation group. Total patient hospitalization costs, both crude and severity adjusted, significantly increased in both groups. CONCLUSION: Implementation of an ADE alert system in seven community hospitals demonstrated significant decreases in pharmacy department costs, variable drug costs, and severity-adjusted mortality rates.

Satisfaction with current health status in patients with a history of acute coronary syndrome.

OBJECTIVE: To describe satisfaction with current health status in patients with a recent history of an acute coronary syndrome (ACS) event and to determine the association between satisfaction and patient-specific variables. RESEARCH DESIGN AND METHODS: Patients from an ACS registry who were discharged from a university affiliated hospital over a 3-year period were mailed the study questionnaire. MAIN OUTCOMES MEASURES: Data included demographics, cardiac-specific measures, and general health status (SF-8 PCS, MCS and the EQ-5D VAS) and health status preference weight (EQ-5D Health Index). Satisfaction with current health status was assessed by a single question derived for this study with a 5-point Likert scale from 'not satisfied at all' to 'highly satisfied.' ANOVA determined the association between levels of satisfaction and health status scores. A multivariate linear regression model determined the association of patient, disease, and treatment variables with satisfaction. Independent variables were determined to be significant if the p-value in the model was <0.05. RESULTS: Respondents (490, 40.3% response rate) averaged 65.2 +/- 11.3 years of age; 71% male; 92% Caucasian; 64% with MI history; and 17% had their most recent cardiac event within 6 months. 63% of respondents were either mostly satisfied or highly satisfied with there current health status. Based on level of satisfaction, the mean PCS ranged from 36.9 +/- 8.9 to 63.0 +/- 6.2; mean MCS from 38.3 +/- 13.1 to 55.7 +/- 5.7; mean EQ-5D VAS from 37.0 +/- 21.7 to 90.8 +/- 20.7, and mean EQ-5D Health Index from 0.38 +/- 0.3 to 0.93 +/- 0.14, all ANOVA models p < 0.001. Statistically significant independent variables in the multivariate linear regression model included the number of symptoms, DASI cardiac function score, perceived severity of disease, and age. Satisfaction with current health state was associated with older age, fewer symptoms, better DASI cardiac function scores, and lower perceived severity of illness. CONCLUSION: Health-related quality of life, or health status, and satisfaction with health status have a direct, positive association. Greater burden of illness and younger age were significantly associated with dissatisfaction with health status. Extrapolation of results is limited to determining association but not causation due to the cross sectional study design.

Comparative cost-effectiveness of posaconazole versus fluconazole or itraconazole prophylaxis in patients with prolonged neutropenia.

PURPOSE: A cost-effectiveness analysis was performed to investigate the financial impact of using posaconazole versus fluconazole or itraconazole prophylaxis in patients with prolonged neutropenia. METHODS: A decision-analytic model was developed from a hospital perspective based on the use of posaconazole versus fluconazole or itraconazole prophylaxis in patients with prolonged neutropenia (i.e., longer than 7-10 days). Data reported in a multicenter study, medication-cost information, and reports of costs to treat invasive fungal infections were used to accurately populate the model. Sensitivity analyses enhanced the robustness of the model through variation of all probabilities and costs. RESULTS: In the base case, patients initiated on posaconazole displayed a 45% reduction in overall cost as compared with patients initiated on fluconazole or itraconazole ($3051 versus $5529, respectively). Sensitivity analyses determined that univariate changes in all model variables, including medication cost, duration of therapy, and cost of treating invasive fungal infections, did not impact overall results. A Monte Carlo simulation analysis found that use of posaconazole remains the best overall prophylactic strategy when taking into consideration the potential variance in all model assumptions. Posaconazole dominated the use of fluconazole or itraconazole because of previously demonstrated lower incidence of breakthrough fungal infections and lower overall treatment cost. CONCLUSION: The decision model indicated that use of posaconazole as prophylaxis in patients with prolonged neutropenia should result in lower overall treatment costs relative to the cost of fluconazole or itraconazole.

Cost-effectiveness of quantitative fecal lactoferrin assay for diagnosis of symptomatic patients with ileal pouch-anal anastomosis.

BACKGROUND AND AIMS: To assess cost-effectiveness of fecal lactoferrin (FL) as the initial diagnostic approach to symptomatic patients with ileal pouch-anal anastomosis (IPAA). METHODS: Four competing strategies [empiric metronidazole therapy (txMTZ), initial pouch endoscopy with biopsy (testBiop), initial FL assay followed by metronidazole therapy (testFL+MTZ), and initial FL assay followed by pouch endoscopy and biopsy (testFL+Biop)] were modeled in a decision tree. RESULTS: In the base-case, the average cost per patient was $241 for testFL+MTZ, $251 for txMTZ, $405 for testFL+Biop, and $431 for testBiop. The testBiop strategy had greater effectiveness compared with txMTZ but at an incremental cost of $158 per day. The txMTZ strategy was slightly more costly and minimally more effective than testFL+MTZ with an incremental cost effectiveness of just over $12 per day. However, the testFL+MTZ strategy was associated with a 31% absolute reduction in antibiotic exposure compared with the txMTZ strategy. CONCLUSIONS: Compared with empiric metronidazole therapy, FL before treatment with metronidazole is less costly with less exposure to antibiotics and less need for endoscopy, with only marginal decrease in effectiveness.

Effect of pharmacy practice residency training on residents' knowledge of and interest in clinical research.

PURPOSE: The effect of pharmacy practice residency training on subjectively and objectively assessed research knowledge, skills, and interests of residents was studied. METHODS: A preintervention versus post-intervention design was used. Residency year 2004- 05 residents were administered a validated Web-based survey at the beginning of residency and again at the end of residency. The survey collected resident responses to questions regarding resident and residency characteristics, subjective assessments of specific professional skills and research skills and knowledge, and objective assessments of basic research knowledge. For residents who completed beginning and end of residency surveys, results were linked when possible to allow for paired and unpaired statistical analyses. RESULTS: Totals of 346 (33.2% response rate) and 222 (21.3% response rate) surveys were completed at the beginning and the end of the residency, respectively, with 129 respondents completing both. Statistically significant improvements were observed for the total and paired population in subjectively assessed research-related skills and abilities and general professional skills. Subjectively assessed understanding of specific statistical tests revealed a significant improvement. Total population analysis and paired population analysis revealed no changes in objectively assessed research-related knowledge from the beginning of the residency to the end of the residency. CONCLUSION: Although there was improvement from the beginning to the end of residency in subjectively assessed research-related skills and abilities and in self-assessed understanding of most statistical tests, the end of residency objectively assessed research-related knowledge scores were unchanged. Residents' expectations that the residency would increase research knowledge, skills, and desire for research involvement were unmet. These results suggest that training based on residency program standards may not increase residents' interest or provide them with the skills necessary to participate in clinical research.

Evaluation of clinical research knowledge and interest among pharmacy residents: survey design and validation.

PURPOSE: The development and validation of a survey to describe the research knowledge, attitudes, and skills of pharmacy practice residents are described. SUMMARY: A survey was drafted to determine if pharmacy practice residency experience and the American Society of Health-System Pharmacists (ASHP)-required project improve the residents' objectively and subjectively assessed research knowledge, to determine if the residency experience and the ASHP-required project affect the residents' attitudes regarding research as a component of their future professional practice, and to subjectively assess the effect of the residency experience and the ASHP-required project on other essential skills, such as problem solving, critical thinking, and time management. An initial questionnaire was developed and underwent content validation testing by clinical pharmacists and faculty, residents, and research fellows. Following content validation, the questionnaire underwent construct validity testing (for discriminative validity and responsiveness) in students, residents, and clinical pharmacists and faculty. Reliability was tested in a subgroup of subjects who completed the questionnaire twice within two to four weeks. From the content validation phase, average scores for individual questions ranged from 1.00 to 2.00. Discriminative validity testing of the revised questionnaire demonstrated the instrument's ability to discriminate between groups expected to differ. Effect-size and mean-knowledge score differences indicated high levels of responsiveness, signifying the instrument's ability to detect change over time or after an intervention. CONCLUSION: A survey questionnaire developed to measure research knowledge and interest among pharmacy practice residents demonstrated its validity and reliability with significant sensitivity and responsiveness.

Patient-reported underuse of prescription medications: a comparison of nine surveys.

Nine national surveys documenting patient underuse of prescription medications were examined to describe the variation and trends in that underuse and identify possible reasons for the substantially different rates that were reported. Underuse includes unfilled prescriptions, delayed therapy, reduced frequency, and lowered dosage. Rates of cost-related patient underuse in the studies ranged from 1.6 to 22 percent. Insurance coverage, level of wealth, age, and health status were the sociodemographic variables most strongly related to underuse. Seven additional factors in the design and administration of the surveys were identified as providing plausible explanations for the variance across surveys. The most conspicuous variation was between three government-sponsored periodic surveys and six generally one-time assessments, with the latter yielding higher rates and greater variance in underuse. Understanding the factors contributing to the variation in reported rates of underuse of medications is an important prerequisite for the design of effective prescription-drug benefit programs.

Gender and perceived severity of cardiac disease: evidence that women are "tougher".

PURPOSE: Patients' beliefs about their disease may affect their willingness to engage in preventive health behaviors. We sought to determine whether men and women with acute coronary syndrome differ in their perceptions of the severity of cardiac-related illness while controlling for the clinical severity of their condition. METHODS: All patients with acute coronary syndrome discharged from a university hospital during a 3-year period were mailed a questionnaire, and medical records were abstracted. The questionnaire assessed perceived severity of cardiac-related illness (5-point scale from "very mild" to "very severe"), symptom frequency, type of acute coronary syndrome event, number of medications, Duke Activity Status Index (DASI), time since most recent cardiac event, Charlson Comorbidity Index, and demographic information. A logistic regression model was constructed with perceived severity of heart disease as the dependent variable. Gender was the key independent variable while controlling for the other patient and disease variables. RESULTS: The 490 respondents (1217 surveys sent, 40.3% response rate) included 348 men and 142 women who were similar with regard to race and type of acute coronary syndrome event experienced. Women were older, less educated, had a lower DASI score, had more symptoms, and were taking more medications. However, they perceived their cardiac disease as being no more severe than the men. The significant predictors in the regression model of perceived severity included gender, DASI, number of symptoms, type of acute coronary syndrome event, and comorbidity. Female gender was associated with lower perceived severity (odds ratio 0.30-0.80). CONCLUSIONS: Women rate their cardiac disease as less severe than do men when controlling for other measures of cardiac disease severity.

Perceived work performance of patients who experienced an acute coronary syndrome event.

The objectives of this study were to describe the perceived work performance of patients previously diagnosed with acute coronary syndrome (ACS) and to determine the relationship between patient-specific variables and perceived work performance. This cross-sectional study utilized a mailed survey to all patients discharged from a university affiliated hospital with the diagnosis of ACS during a 3-year period. Perceived work performance was measured using the Work Performance Scale (WPS). Independent variables included health status (SF-8, PCS-8, MCS-8 and EQ-5D visual analog scale), cardiac functional status (Duke activity status index), symptom count, comorbidity index, patient-perceived cardiac disease severity, medication count and compliance, job satisfaction, current employment duration, patient demographics and ACS type. Step-wise multivariate linear regression models determined the independent variables with significant association (p < 0.05) to WPS. Of 1,217 patients surveyed, 490 (40%) responded, including 158 currently working (study sample). The regression model with the highest explanatory ability (r(2) = 0.29) included number of symptoms, age, perceived cardiac severity and PCS-8, with more symptoms, higher perceived severity, higher age and lower PCS-8 scores associated with lower WPS. Currently employed ACS patients report a high level of work performance. Symptom burden, perceived disease severity, age and physical function appear to be associated with perceived work performance.

Validation of the EQ-5D in patients with a history of acute coronary syndrome.

OBJECTIVE: To analyze the construct validity of the EQ-5D in patients with acute coronary syndromes (ACS). METHODS: All ACS-diagnosed patients discharged from a university-affiliated hospital during a 3-year period were mailed a questionnaire that included the EQ-5D and the SF-8. The EQ-5D includes a visual analogue scale (EQ VAS) to measure self-reported current health-status (0-100) and a five-item descriptive system measuring mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Also included were disease severity measures [Duke Activity Status Index (DASI), cardiac symptom count (SC), patient-perceived cardiac disease severity], comorbidity measures (Charlson comorbidity index, total medication count), and other demographic and disease-related items. RESULTS: Of 1217 patients, 490 (40.3%) responded. Patients averaged 65.2 (SD 11.3) years of age; 71.0% male; 91.9% Caucasian; 64.3% history of MI. Only 0.2%-0.4% of EQ-5D items and 8% of the EQ VAS were left unanswered by respondents. The nine most common health states were identified based on the five EQ-5D item scores. Levels of responses to EQ-5D items and the EQ VAS score were significantly better for patients with very mild/mild perceived disease severity compared to severe/very severe, for patients with lower comorbidity, for patients with lower symptom responses, and for patients with a higher cardiac-related functioning. EQ VAS score and SF-8 subscale score correlation coefficients ranged from 0.527 to 0.798 (all p < 0.0001). Significant differences were observed between the response level of individual EQ-5D items and scores of comparable SF-8 subscales. CONCLUSIONS: This study demonstrated the construct validity of the EQ-5D in a population-based sample of patients with a history of ACS.