Propensity score matching in the evaluation of drug therapy management programs: an illustrative analysis of a program for patients with hepatitis C virus.

This retrospective cohort analysis demonstrates the application of propensity score methods in the Be In Charge (BIC) program, a drug therapy management program for patients with hepatitis C. Data were drawn from BIC participant records and program utilization and from a longitudinal database of administrative claims for pharmacy and medical services. Eligible patients must have received peginterferon alfa-2b (PEG-IFN alfa-2b) and ribavirin, but analyses evaluated only PEG-IFN alfa-2b use; BIC enrollees were matched with patients not enrolled in BIC (controls). Adherence was measured on the basis of the number of injections dispensed and the proportion of patients for whom an average of at least 1 injection per week was dispensed during follow-up. BIC subjects refilled 1.2 more injections than did controls (P < .001) within 12 weeks, 2.7 more (P < .001) within 24 weeks, and 6.7 more (P < .001) within 48 weeks. BIC enrollees were more likely than controls to refill the indicated dose (1 injection per week) within 12 weeks (72% vs 64%, P < .001), 24 weeks (52% vs 41%, P < .001), and 48 weeks (22% vs 13%, P = .002) of initiation. These data suggest that the BIC program may significantly improve adherence to PEG-IFN alfa-2b.

Patterns and predictors of discontinuation of rhythm-control drug therapy in patients with newly diagnosed atrial fibrillation.

STUDY OBJECTIVE: To assess patterns and predictors of discontinuation of rhythm-control drug therapy in managed care patients with newly diagnosed atrial fibrillation and the direct medical costs of atrial fibrillation in these patients. DESIGN: Retrospective cohort study. DATA SOURCE: PharMetrics Patient-Centric Database. PATIENTS: A total of 3549 adults with a new diagnosis of atrial fibrillation between April 1, 2002, and March 31, 2006, and who had at least one claim for rhythm-control drug therapy within 6 months of the initial diagnosis. MEASUREMENTS AND MAIN RESULTS: Discontinuation (defined as a gap in rhythm-control drug therapy coverage [days' supply] > or = 30 days) was assessed after the initiation of rhythm-control therapy. Among the 3549 patients included in the analysis, 2688 (75.7%) discontinued initial rhythm-control therapy in the first 12 months, with a median time to discontinuation of 89 days. Significant predictors of rhythm-control therapy discontinuation included cardiac arrest (odds ratio [OR] 2.24, 95% confidence interval [CI] 1.04-4.83), history of coronary artery bypass graft surgery (OR 2.03, 95% CI 1.02-4.05), valvular heart disease (OR 1.67, 95% CI 1.33-2.09), ischemic heart disease (OR 1.44, 95% CI 1.13-1.82), and severity of illness (Charlson Comorbidity Index score; OR 1.09, 95% CI 1.01-1.17). Over 12 months, 661 (18.6%) of the 3549 patients had a hospital stay and 285 (8.0%) had an emergency department visit that were related to atrial fibrillation. Total annual atrial fibrillation-related costs/patient were $6165: $3872 for inpatient costs, $1503 for outpatient costs, and $790 for pharmacy costs. CONCLUSION: Initial rhythm-control drug therapy is associated with a high rate of discontinuation, especially early in therapy. Such rates of discontinuation will likely have an impact on the effectiveness of disease management and the quality of care in patients with atrial fibrillation.

Cost of hospital admission for antiarrhythmic drug initiation in atrial fibrillation.

BACKGROUND: Initiation of some rhythm-control therapies for atrial fibrillation (AF) requires an inpatient hospital stay and telemetry monitoring, adding to the cost burden of AF. However, specific cost data for inpatient initiation of AF therapies are lacking. OBJECTIVE: To examine costs associated with initiating sotalol or dofetilide in the inpatient setting in the US. METHODS: This retrospective cohort study used data from billing/discharge records in the Premier Perspective Database for adults with a primary diagnosis of AF, hospitalized between January 2002 and September 2007. Patients had to have received 4 or more sotalol doses or 5 or more dofetilide doses starting within 2 days of admission (with >/=1 dose within 3 days of discharge). Patients admitted solely for AF drug initiation were identified by excluding patients who were admitted on an emergency basis, received care in the emergency department, or underwent major surgical procedures. The primary outcome was direct medical costs for in-hospital services during the stay. RESULTS: Among 7290 patients included in the analysis (4847 sotalol, 2443 dofetilide), mean total inpatient costs per patient were $3278 in the sotalol group and $3610 in the dofetilide group. The greatest costs were for room/board ($1874 sotalol, $1985 dofetilide) and cardiology/electrocardiograms ($394 sotalol, $443 dofetilide). Pharmacy costs were $230 and $201 per patient in the sotalol and dofetilide groups, respectively. CONCLUSIONS: The admission of patients for in-hospital initiation of AF rhythm-control therapy represents a high cost burden in the US.

Utility of bortezomib retreatment in relapsed or refractory multiple myeloma patients: a multicenter case series.

Bortezomib therapy has become an important part of the standard of care for patients with relapsed multiple myeloma, and preliminary clinical evidence suggests that bortezomib retreatment in patients previously treated with the drug may prolong disease control. This retrospective study was designed to clarify the utility of bortezomib as a repeat therapy. We reviewed records from 3 major cancer centers that had participated in the phase II (SUMMIT or CREST) or phase III (APEX) registration studies to identify patients who were subsequently retreated off protocol with bortezomib-based therapy. We found 22 patients who received bortezomib retreatment following a 60 or more day gap between bortezomib treatments. Twelve patients had intervening therapy between initial bortezomib treatment and bortezomib retreatment. During retreatment, 14 of 22 patients received bortezomib in combination with another antineoplastic agent. The overall response rate for bortezomib retreatment was 50% (9% complete responses). The median length of retreatment was 5.1 months in responding patients and 2.4 months in nonresponding patients. Therapy was terminated due to unmanageable toxicity in 2 patients during retreatment, compared with 6 patients during initial treatment. During retreatment, no patients required dose reduction due to peripheral neuropathy, compared to 4 patients during their initial treatment. Thus, bortezomib retreatment appears to be safe and effective. Favorable observed response rates with bortezomib retreatment suggest that it may be a viable option for relapsed or refractory multiple myeloma, even in patients previously exposed to bortezomib.

Therapeutic goal attainment in patients with hypertension and dyslipidemia.

BACKGROUND: Recent guidelines emphasize the need to assess and treat overall risk for cardiovascular disease through the concomitant management of multiple risk factors. We sought to ascertain treatment patterns and attainment of therapeutic goals in patients with isolated and concomitant hypertension and dyslipidemia, both with and without diabetes mellitus (DM) and symptomatic cardiovascular disease. METHODS: Inception cohorts of more than 41,000 newly diagnosed hypertension and dyslipidemia patients from 6 medical centers of the south-central Veterans Affairs health care system were evaluated. Treatment patterns and goal attainment for low-density lipoprotein cholesterol (LDL-C; Third Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults guidelines: <160, <130, or

Predictors of adherence with antihypertensive and lipid-lowering therapy.

BACKGROUND: Patients with comorbid hypertension and dyslipidemia are at high risk for cardiovascular disease, which can be considerably mitigated by treatment. Adherence with prescribed drug therapy is, therefore, especially important in these patients. This study was undertaken to describe the patterns and predictors of adherence with concomitant antihypertensive (AH) and lipid-lowering (LL) therapy. METHODS: This retrospective cohort study examined 8406 enrollees in a US managed care plan who initiated treatment with AH and LL therapy within a 90-day period. Adherence was measured as the proportion of days covered in each 3-month interval following initiation of concomitant therapy (mean follow-up, 12.9 months). Patients were considered adherent if they had filled prescriptions sufficient to cover at least 80% of days with both classes of medications. A multivariate regression model evaluated potential predictors of adherence. RESULTS: The percentage of patients adherent with both AH and LL therapy declined sharply following treatment initiation, with 44.7%, 35.9%, and 35.8% of patients adherent at 3, 6, and 12 months, respectively. After adjustment for age, sex, and other potential predictors, patients were more likely to be adherent if they initiated AH and LL therapy together, had a history of coronary heart disease or congestive heart failure, or took fewer other medications. CONCLUSIONS: Adherence with concomitant AH and LL therapy is poor, with only 1 in 3 patients adherent with both medications at 6 months. Physicians may be able to significantly improve adherence by initiating AH and LL therapy concomitantly and by reducing pill burden.

Prevalence of comorbid hypertension and dyslipidemia and associated cardiovascular disease.

OBJECTIVES: To estimate the prevalence of concurrent hypertension and dyslipidemia among a general veteran population and separately among patients with diabetes mellitus, and to compare the prevalence of cardiovascular disease among groups with isolated versus concurrent hypertension and dyslipidemia. STUDY DESIGN: Retrospective cohort study. PATIENTS AND METHODS: This study was conducted in 6 medical centers of the Department of Veterans Affairs and included 371221 patients seen for any reason from October 1, 1998, to September 30, 2001. The proportion of patients with isolated or concurrent hypertension and dyslipidemia was estimated based on diagnostic, pharmacy, laboratory, and vital sign information, and the age-adjusted proportions of individuals with cardiovascular disease were compared between groups. RESULTS: We found that 57.8% of all patients had hypertension or dyslipidemia; 30.7% had both. Sixteen percent of all patients had diabetes mellitus, and 66.3% of these patients had concomitant hypertension and dyslipidemia. The prevalence of coronary artery disease was often more than doubled among patients with concomitant conditions compared with patients with either condition alone. The prevalence of stroke and peripheral arterial disease similarly increased among patients with both conditions. The prevalence of these cardiovascular diseases was highest among patients with diabetes mellitus. CONCLUSION: The prevalence of cardiovascular disease was high among this population of older, predominately male US veterans.

Economic consequences of renal dysfunction among cardiopulmonary bypass surgery patients: a hospital-based perspective.

BACKGROUND: Renal dysfunction is common after cardiopulmonary bypass procedures and is associated with higher mortality rates and longer lengths of stay. However, less is known about the actual cost of care for these patients. We sought to quantify the hospital costs attributed to renal dysfunction in cardiopulmonary bypass patients at a large academic referral center. METHODS: All patients undergoing cardiopulmonary bypass procedures were identified through administrative databases for a 3-year study period. Renal failure was defined using laboratory values from the hospitalization. Total direct costs and costs by hospital department were determined using the hospital cost-accounting system. A multivariate linear model was developed to determine total direct hospital costs after cardiopulmonary bypass procedures after adjusting for relevant clinical and demographic variables. RESULTS: Nine percent of the study population developed new-onset renal dysfunction, and 18% of patients overall undergoing cardiopulmonary bypass experienced renal dysfunction during the hospitalization. Direct costs were 42% higher for patients with renal dysfunction, an average of 5807 US dollars per case. Higher costs were noted in intensive care unit use and pharmacy, laboratory, and radiology services. CONCLUSIONS: Renal dysfunction increases the direct hospital costs of care, even after adjustment for age, sex, race, and comorbidities. Nationwide, we estimate that renal dysfunction may add up to 643 million US dollars in hospital costs for caring for cardiopulmonary bypass patients. Interventions designed to reduce the incidence and severity of renal dysfunction may significantly reduce hospital costs for these patients.

Rapid antibiotic delivery and appropriate antibiotic selection reduce length of hospital stay of patients with community-acquired pneumonia: link between quality of care and resource utilization.

OBJECTIVES: To measure quality-of-care variables relevant to the treatment of community-acquired pneumonia and to determine their relative contribution to variation in length of hospital stay (LOS). METHODS: One hundred cases of pneumonia requiring hospitalization from each of 7 institutions (2 community and 5 university teaching hospitals) were randomly selected (total sample, 700 cases). Demographic and clinical variables were abstracted using a standardized data instrument. Three quality-of-care measures were analyzed: (1) site of initial antibiotic treatment (emergency department vs floor), (2) door-to-needle time, and (3) appropriateness of antibiotic selection. Appropriate antibiotic selection was defined by the 1998 Infectious Disease Society of America guidelines for the treatment of hospitalized pneumonia cases. Regression modeling was used to determine associations between LOS and our quality-of-care (process) variables. RESULTS: The mean +/- SD LOS for this sample was 7.0 +/- 4.1 days. Prolonged LOS, defined as greater than or equal to the 75th percentile of the LOS distribution, was the dependent variable in our regression analysis and was greater than or equal to 9.0 days. After clinical and demographic variables were adjusted for, logistic regression modeling revealed that all 3 quality-of-care measures were associated with prolonged LOS: (1) initial antibiotic treatment in the emergency department (odds ratio [OR], 0.31; 95% confidence interval [CI], 0.19-0.48); (2) appropriate antibiotic selection (OR, 0.55; 95% CI, 0.35-0.88); and (3) door-to-needle time (OR, 1.75 per 8 hours; 95% CI, 1.34-2.29). In a secondary analysis, we examined the clinical and demographic characteristics of the patients who were treated more rapidly in the emergency department compared with those who were treated on the inpatient floor. No clinically meaningful differences were observed between these groups. CONCLUSIONS: Unlike clinical and demographic variables, process-of-care variables are modifiable and amenable to quality improvement. We observed that rapid antibiotic initiation and appropriate antibiotic selection in the emergency department have a statistically significant association with shorter LOS. These findings suggest quality improvement targeted at these processes of care may improve resource utilization and reduce LOS for patients with community-acquired pneumonia.