Patterns of Care in Patients with Metastatic Renal Cell Carcinoma Among a U.S. Payer Population with Commercial or Medicare Advantage Membership.

BACKGROUND: Several systemic therapies are now approved for first- and second-line treatment of metastatic renal cell carcinoma (mRCC). Although the National Comprehensive Cancer Network (NCCN) guidelines offer physicians evidence-based recommendations for therapy, there are few real-world studies to help inform the utilization of these agents in clinical practice. OBJECTIVES: To (a) describe the patterns of use associated with systemic therapies for mRCC among Humana members in the United States diagnosed with mRCC, (b) assess consistency with the NCCN guidelines for treatment, and (c) to describe the initial first-line therapy regimen by prescriber specialty and site of care. METHODS: This was a retrospective study using Humana's claims database of commercially insured patients and patients insured by the Medicare Advantage Prescription Drug plan. The study period was from January 1, 2007, to December 31, 2013. Patients with mRCC were identified by ICD-9-CM codes 189.0/189.1 and 196.xx to 199.xx; all patients were between 18 and 89 years of age, had received systemic therapy for their disease, and were followed up for 180 days. Outcome measures included choice of initial systemic therapy, starting and ending doses, first-line treatment persistence and compliance, and choice of second-line therapy. Persistence was measured using time to discontinuation of first-line therapy and proportion of days covered (PDC; the ratio of [total days of drug available minus days of supply of last prescription] to [last prescription date minus first prescription date]). Compliance was measured using the medication possession ratio (MPR; the ratio of [total days supply minus days supply of last prescription] to [last prescription date minus first prescription date]). RESULTS: A total of 649 patients met all inclusion criteria; 109 were insured by commercial plans and 540 were insured by Medicare. The mean ± SD age of patients was 68.6 ± 9.4 years, and 68.6% were male; Medicare patients were older than commercial patients (71.7 ± 7.4 vs. 56.6 ± 9.1 years, respectively; P < 0.001). The most common comorbidities among the patient population were hypertension, hyperlipidemia, diabetes, and heart disease. The majority of patients (68.6%) received an oral tyrosine kinase inhibitor (TKI) as their first line of therapy: 43.9% received sunitinib, 14.0% received sorafenib, 10.0% received pazopanib, and 0.6% received axitinib. Mean ± SD time to discontinuation of first-line TKI treatment was 169.1 ± 29.5 days with sunitinib, 160.3 ± 41.1 days with pazopanib, and 160.1 ± 41.4 days with sorafenib. Other first-line therapies included inhibitors of mammalian target of rapamycin (mTOR) (19.7%) and the antivascular endothelial growth factor agent bevacizumab (9.4%). Among patients receiving mTOR inhibitors, 14.8% were started on temsirolimus and 4.9% were started on everolimus. The median starting and ending doses were the same for each drug except for sunitinib. Mean ± SD times to discontinuation of temsirolimus, everolimus, and bevacizumab were 171.8 ± 26.2, 137.0 ± 62.2, and 150.8 ± 56.0 days, respectively. Persistence on first-line regimen as measured by PDC was high (PDC ≥ 80%) for 89% of oral therapies and 77% of injectable therapies; first-line compliance was high (MPR ≥ 80%) for 77% of oral therapies and 68% of injectables. Among patients who received second-line therapy, the most common regimen was everolimus (29.2%), followed by bevacizumab (19.8%), temsirolimus (15.6%), and sunitinib (13.6%). Specialty codes obtained from the database provider identified internal medicine specialists and oncologists as the most common prescribers of TKIs and mTOR inhibitors. CONCLUSIONS: Patterns of use were similar for each of the prescribed systemic treatments for mRCC, and the majority of patients were highly persistent and compliant with first-line therapies. Time to treatment discontinuation was slightly longer with oral agents compared with injectable drugs.

Persistence and compliance with pazopanib in patients with advanced renal cell carcinoma within a U.S. administrative claims database.

BACKGROUND: Pazopanib is an oral tyrosine kinase inhibitor with demonstrated efficacy and tolerability in patients with advanced renal cell carcinoma (RCC). OBJECTIVE: To examine pazopanib persistence and compliance (adherence) and other drug utilization patterns in both treatment-naïve (first-line) patients and those previously treated with RCC therapy in the real-world setting. Key factors affecting persistence and compliance were also explored. METHODS: This was a retrospective claims analysis using the Truven Health MarketScan Databases to cover claims activity from October 2007 through March 2012. Patients with advanced RCC aged ≥ 18 years who had received pazopanib with 180 days of follow-up were included. Bivariate comparisons of results from first-line and previously treated patients with RCC were conducted. Pazopanib persistence was measured using (a) estimated level of persistence with therapy (ELPT; i.e., the percentage of patients remaining on therapy at 30, 60, and 90 days [patients were censored at 180 days]); (b) time to discontinuation (i.e., duration of therapy); and (c) proportion of days covered (PDC; i.e., the ratio of [total days drug available minus days' supply of last prescription] to [last prescription date minus first prescription date]). Compliance was measured by medication possession ratio (MPR; i.e., the ratio of [total days' supply minus days' supply of last prescription] to [last prescription date minus first prescription date]). Other drug utilization measures included days' supply, time to initiation, time to switching, and dose-related measures. Random forest models were used to explore key factors of pazopanib persistence and compliance. RESULTS: A total of 143 patients met all inclusion criteria; 43.3% were treated with pazopanib first line (first-line cohort), and 56.6% had ≥ 1 prior lines of therapy (previously treated cohort). The mean (± standard deviation [SD]) age of patients was 62.9 (± 10.3) years, and 71.3% of them were males. Continuous pazopanib therapy for up to 90 days was observed in greater than 50% of patients in both cohorts. In the first-line cohort, ELPT at 30, 60, and 90 days was 98.39%, 70.97%, and 56.45%, respectively; the mean (± SD) number of days to discontinuation was 112.2 (± 62.8); the mean (± SD) PDC was 84.7% (± 16.7%); and the mean (± SD) MPR was 85.2% (± 16.9%). Similar results were observed in the previously treated population: ELPT at 30, 60, and 90 days was 98.77%, 75.31%, and 58.02%, respectively; the mean (± SD) number of days to discontinuation was 118.7 (± 61.4); the mean (± SD) PDC was 87.8% (± 13.5%); and the mean (± SD) MPR was 90.1% (± 13.9%). Differences between the 2 cohorts were not statistically significant. More than 90% of patients in both cohorts had at least a 30-day supply of therapy (91.9% of first-line versus 90.2% of previously treated; P = 0.153). The mean (± SD) time from metastatic diagnosis to start of pazopanib therapy was 104.7 (± 199.3) days in the first-line cohort and 360.9 (± 187.0) days in previously treated patients (P = 0.001). Forty-six patients switched to another therapy: 17 patients in the first-line cohort and 29 patients in the previously treated cohort; the mean (± SD) time to switching therapy from each cohort was 94.7 (± 41.4) days and 87.8 (± 49.6) days (P = 0.146), respectively. Statistically significant differences were observed for the starting and ending doses between the 2 cohorts. The average daily dosage of pazopanib was greater than 700 mg in both cohorts (P = 0.055), with a maximum dose of 800 mg. Random forest models demonstrated that younger age and higher comorbidity predicted both higher persistence and compliance. CONCLUSIONS: In this observational study, greater than 50% of patients with advanced RCC were on pazopanib for almost 4 months, with the majority of both cohorts achieving high persistence and high compliance. Additionally, younger age and higher comorbidity index were the strongest predictors of both greater persistence and compliance. Further studies with larger cohorts and longer follow-up are needed to validate these findings.

Costs Associated with Intravenous Cancer Therapy Administration in Patients with Metastatic Soft Tissue Sarcoma in a US Population.

Background. The most common chemotherapies in metastatic soft tissue sarcoma (mSTS) require intravenous (IV) administration. This often requires patients to make multiple outpatient visits per chemotherapy cycle, possibly impeding patients' daily activities and increasing caregiver burden and medical costs. This study investigated costs associated with IV cancer therapy administration in mSTS from the payer perspective of the health care system. Patients and Methods. From the Experian Healthcare database, 1,228 mSTS patients were selected. Data were analyzed on outpatient visits during 2005-2012 involving IV cancer therapy administration. Costs were estimated on a per patient per visit (PPPV) and per patient per month (PPPM) basis. Results. The mean (median) cost of IV therapy was $2,427 ($1,532) PPPV and $5,468 ($4,310) PPPM, of which approximately 60% was IV drug costs. IV administration costs averaged $399 PPPV and $900 PPPM, representing 16.5% of total visit costs. Anthracycline and alkylating-agents-based therapies had the highest PPPV and PPPM IV administration costs, respectively (mean $479 and $1,336, resp.). Patients with managed care insurance had the highest IV administration costs (mean $504 PPPV; $1,120 PPPM). Conclusions. IV administration costs constitute a considerable proportion of the total costs of receiving an IV cancer therapy to treat mSTS.

Pediatricians' self-reported role in treating children and adolescents with major depressive disorder: a national random survey.

OBJECTIVE: Major depressive disorder (MDD) is a serious US public health problem for children and adolescents. This study explored pediatricians' self-reported role in treating children and adolescents with DSM-IV-TR MDD after the 2004 US Food and Drug Administration black-box warning. METHOD: A national random sample of pediatricians (N = 2,000) was surveyed from the beginning of November 2007 through the end of January 2008, with a usable response rate of 22.7% (408 of 1,800 deliverable surveys). Descriptive statistics and χ(2) tests were used to analyze the data on treatment versus referral of children and adolescents with MDD and on the proportion of pediatricians in 4 geographic regions who treat children and adolescents with MDD. RESULTS: The majority of the pediatricians (60.0%, 245 of 408) do not treat either children or adolescents with MDD. Fewer than one-third of the pediatricians (28.2%, 115) reported treating both children and adolescents. The majority of the pediatricians (83.6%, 341) reported referring both children and adolescents to psychiatrists for treatment. The χ(2) tests indicate that the proportion of pediatricians who treat children (P = .088) and adolescents (P = .259) does not vary significantly according to the 4 geographic regions analyzed (Northeast, South, Midwest, and West). CONCLUSIONS: On the basis of self-report, the majority of US pediatricians do not treat children and adolescents with MDD but instead refer these patients to psychiatrists. In light of the current shortage of child and adolescent psychiatrists in the United States, referral to these specialists may be problematic.

Patterns of cervical cancer screening, diagnosis, and follow-up treatment in a state Medicaid fee-for-service population.

Despite being a screening-amenable cancer, cervical cancer is the third most common genital cancer among white women and the most common among African American women. The study objective was to use administrative claims data for CC disease surveillance among recipients enrolled in a state Medicaid fee-for-service (FFS) program. West Virginia (WV) Medicaid FFS administrative claims data for female recipients aged 21-64 years from 2003 to 2008 were used for this study. All medical and prescription claims were aggregated to reflect each recipient's medical care and prescription drug utilization. The yearly prevalence of Pap smear testing declined from 23.9% in 2003 to 15.8% in 2008 in the Medicaid FFS population. During the 6-year study period, persistence with Pap smear testing was low; 41.8% of recipients received no Pap smear testing. Only 73.1% of recipients received Pap smear testing during the year prior to their CC or precancerous cervical lesions (PCL) diagnosis. The likelihood of a CC diagnosis increased with a decrease in Pap smear testing persistence. Only 10.1% of recipients received appropriate follow-up care following a diagnosis of high-grade PCL; only 31.5% of the recipients received appropriate follow-up care for low-grade PCL diagnosis. Although CC preventive services such as screening and PCL follow-up care are covered under Medicaid programs, underutilization of these services by recipients in the Medicaid FFS population is a concern. Results of this study emphasize the need to address disparities in screening and appropriate PCL follow-up care among recipients in the Medicaid FFS population.

Child psychiatrists' self-reported treatment and monitoring of children and adolescents with major depressive disorder.

OBJECTIVE: Major depressive disorder (MDD) is a serious U.S. public health problem for children and adolescents. This study examined the type and course of treatment and monitoring habits of child psychiatrists treating newly diagnosed children and adolescents with MDD. Length of treatment and monitoring frequency were compared to current recommendations. METHODS: A national random sample of child psychiatrists (N = 2,250) was surveyed via a modified Dillman approach to mailed surveys. Descriptive statistics and t-tests were used to report and analyze the data. RESULTS: Of 1,982 surveys that were delivered to child psychiatrists, 316 (15.9%) were returned, with 299 surveys (15.1%) providing usable data. The child psychiatrists who responded to the survey reported that they use a combination of antidepressant and psychotherapy treatment, although many (40.1%) treat children with psychotherapy alone as a first-line treatment. With regard to pharmacotherapy for MDD, the child psychiatrists self-reported using fluoxetine or sertraline. Many child psychiatrists also use bupropion or other drug classes as a third-line treatment strategy. The child psychiatrists reported that they treat children and adolescents with antidepressant medication for an average of 10 months. This is significantly (p < 0.05) longer than the 6 month minimum recommended by the American Academy of Child and Adolescent Psychiatry (AACAP). During the first and second months of treatment, the monitoring reported was significantly (p < 0.05) less than that recommended by the U.S. Food and Drug Administration (FDA), while the reported monitoring did not differ (p = 0.10) from FDA recommendations in the third month. CONCLUSIONS: Child psychiatrists reported using combination treatment when treating children and adolescents with MDD. When they reported using antidepressant medications, the most commonly prescribed agents were fluoxetine or sertraline. Reported length of antidepressant treatment was adequate for relapse prevention. The monitoring behavior reported by respondents was not consistent with the FDA's recommendations for the first 2 months of treatment, but it was consistent for month 3.

Exenatide BID and liraglutide QD treatment patterns among type 2 diabetes patients in Germany.

OBJECTIVES: This study evaluated patient and prescriber characteristics, treatment patterns, average daily dose (ADD), and glycemic control of patients initiating glucagon-like peptide 1 (GLP-1) receptor agonists in Germany. METHODS: The LifeLink™ EMR-EU database was searched to identify patients initiating exenatide twice daily (BID) or liraglutide once daily (QD) during the index period (January 1, 2009-April 4, 2010). Eligible patients had ≥ 180 days pre-index history, ≥ 90 days post-index follow-up, and a pre-index type 2 diabetes diagnosis. Univariate tests were conducted at α=0.05. RESULTS: Six hundred and ninety-two patients were included (exenatide BID 292, liraglutide QD 400): mean (SD) age 59 (10) years, 59% male. Diabetologists prescribed liraglutide QD to a larger share of patients (65% vs 35% exenatide BID) than non-diabetologists (51% vs 49%). GLP-1 receptor agonist choice was not associated with age (p=0.282), gender (p=0.960), number of pre-index glucose-lowering medications (2.0 [0.9], p=0.159), pre-index HbA1c (8.2 [1.5%], p=0.231) or Charlson Comorbidity Index score (0.45 [0.78], p=0.547). Mean (SD) ADD was 16.7 mcg (9.2, label range 10-20 mcg) for exenatide BID and 1.4 mg (0.7, label range 0.6-1.8 mg) for liraglutide QD. Among patients with post-index HbA1c tests, mean unadjusted values did not differ between cohorts. Exenatide BID patients were more likely than liraglutide QD patients to continue pre-index glucose-lowering medications (67.1% vs 60.3%, p=0.027) or to start concomitant glucose-lowering medications at index (32.2% vs 25.0%, p=0.013); exenatide BID patients were less likely to augment treatment with another drug post-index (15.8% vs 22.5%, p=0.027). LIMITATIONS: Results may not be generalizable. Lab measures for clinical outcomes were available only for a sub-set of patients. CONCLUSIONS: Results suggested that some differences exist between patients initiating exenatide BID or liraglutide QD, with respect to prescribing physician specialty and pre- and post-index treatment patterns. Both GLP-1 receptor agonists showed comparable post-index HbA1c values in a sub-set of patients.

Cost-effectiveness analysis of a randomized study comparing radiosurgery with radiosurgery and whole brain radiation therapy in patients with 1 to 3 brain metastases.

BACKGROUND: In this study, we compare 2 treatment options and determine cost-effectiveness and cost-utility. METHODS: We carried out a decision analysis populated with data from patients with brain metastasis in a concurrent trial randomized to either stereotactic radiosurgery (SRS) and observation or SRS and whole brain radiation therapy. Outcomes included actual life years saved (LYS), quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER). Costs used were from the healthcare perspective and utilities were captured through a time-trade-off method, using 10-year, 5-year, and 1-year time horizons. One-way sensitivity analyses were carried out to determine robustness of the decision analysis model. RESULTS: Compared with SRS and whole brain radiation therapy, SRS and observation not only had a higher average cost ($74,000 vs $119,000, respectively) but also a higher average effectiveness (0.60 LYS vs 1.64 LYS, respectively) with an ICER of $44,231/LYS or $41,783/QALY (with utilities captured using a 10-year horizon). Slightly higher ICER estimates were achieved with utilities captured using the other time horizons ($43,280/QALY and $44,064/QALY, respectively). Sensitivity analysis showed that the following variables had the highest impact on the ICER: probability of no recurrence in recursive-partitioning analysis class 2 after SRS and observation; probability of being alive after SRS and observation in recursive-partitioning analysis class 2 and being treated for recurrence. CONCLUSIONS: Compared with other interventions in the $50,000 to $100,000/QALY cost-effectiveness range, the application of SRS and observation, with subsequent neurosurgical management of recurrences, is shown to be a reasonable treatment modality for brain metastases.

Exenatide BID Observational Study (ExOS): results for primary and secondary endpoints of a prospective research study to evaluate the clinical effectiveness of exenatide BID use in patients with type 2 diabetes in a real-world setting.

OBJECTIVE: The Exenatide BID Observational Study (ExOS) was designed to evaluate the clinical effectiveness of exenatide BID use in patients with type 2 diabetes (T2D) in a real-world clinical practice setting in the United States. METHODS: Patients were enrolled from 74 practice sites from 9/2007 through 1/2009 and followed for 12 months. The primary effectiveness endpoint was achieving or maintaining hemoglobin A1C of ≤7.0%, or an absolute drop of 0.5% from baseline. Secondary measures included absolute and percentage change from baseline for a variety of clinical measures (lipid markers, weight, BMI, etc.), and quality of life (QOL) was assessed using the Impact of Weight on Quality of Life (IWQOL)-Lite. RESULTS: A total of 452 patients were included in the primary study population. At baseline, patients (60% female) had mean (SD) age of 55 (11), T2D duration of 9 (8) years, HbA1c of 8.0 (1.7) %, and body mass index (BMI) of 38.2 (7.4) kg/m(2). Family history of T2D was reported in 73.9% of patients. Hypertension was reported in 61.5% of patients, and 47.1% had hyperlipidemia. The HbA1c goal was achieved in 76.3% of the 118 patients with A1C measurements available at 12 months (P < 0.0001). Patients with available clinical measurements achieved significant improvements in HbA1c, weight, BMI, and QOL measurements at 12 months. A mean improvement of 4.56 was seen in the total IWQOL-Lite score at 12 months (P = 0.001). The single-arm design of this study is a limitation; however, the overall objective of the study was to observe patients on exenatide BID therapy over time, comparing their status at endpoint to baseline, rather than to make comparisons among different drug therapies. CONCLUSIONS: The Exenatide BID Observational Study supports the clinical effectiveness of exenatide BID observed in previous clinical trials and retrospective database studies.

Treatment of metastatic renal carcinoma patients with the combination of gemcitabine, capecitabine and bevacizumab at a tertiary cancer centre.

OBJECTIVE: • To investigate the effect of combining gemcitabine plus capecitabine (GX) with bevacizumab (A) in patients with metastatic RCC previously treated with cytokines and targeted agents. METHODS: • The combination of GX + A was evaluated in patients with metastatic RCC using institutional databases. • Data included demographics, previous therapies, number of metastatic sites, Memorial Sloan-Kettering Cancer Center risk stratification variables, and previous nephrectomy status. • Descriptive statistics and survival analysis were employed for data analysis. RESULTS: • Between January 2005 and October 2008, 28 patients were identified. Mean age was 55.7 years. Fifteen (53.57%) patients had been given tyrosine kinase inhibitor (TKI) previously. Nine (32.14%) patients had clear cell histology, 10 (35.71%) patients had sarcomatoid features on histopathology, and 19 patients (67.86%) had a prior nephrectomy. • Initial treatment consisted of G (mean dose 786.07 mg/m²) every 2 weeks, X (mean dose 2.73 g/day), and A (mean dose 10 mg/kg) every 2 weeks. Median progression-free survival (PFS) was 5.9 months and the median overall survival (OS) was 10.4 months. • In patients with previous TKI therapy, median PFS was 6.2 months and median OS was 11.7 months. • In patients with sarcomatoid features, median PFS was 3.9 months and OS was 9.0 months. • Three patients discontinued one or more of the drugs because of adverse reactions. CONCLUSIONS: • The combination of GX + A shows potential efficacy and acceptable tolerability in patients with intermediate and poor prognosis metastatic RCC. • Based on these observations, a phase II trial is now underway assessing this combination in patients with sarcomatoid RCC.

Exenatide bid observational study (ExOS): baseline population characteristics of a prospective research study to evaluate the clinical effectiveness of exenatide bid use in patients with type 2 diabetes in a real-world setting.

OBJECTIVES: To describe the Exenatide Observational Study (ExOS) and patients initiating exenatide therapy in a real-world clinical practice setting. METHODS: ExOS is a prospective, single-arm, multicenter, observational study to assess the effectiveness of up to 24 months of exenatide therapy in patients with type 2 diabetes (T2D). Patients with T2D ≥18 years of age, who initiated exenatide therapy, were eligible. The primary effectiveness endpoint is achieving or maintaining hemoglobin A1C of ≤7.0%, or an absolute drop of 0.5% from baseline. Secondary objective measures evaluate the absolute and percentage changes from baseline for a variety of clinical measures (lipid markers, weight, BMI, etc.) and quality of life (QOL) is assessed using the Impact of Weight on Quality of Life (IWQOL)-Lite. RESULTS: On average, the baseline population (n = 531) was aged 55 years, predominantly female (62%), white (79%), educated, obese (mean BMI 39 kg/m(2)), with mean HbA(1c), blood pressure, total cholesterol, and triglyceride values of 8.0%, 129/76 mmHg, 174 mg/dL, and 197 mg/dL, respectively. A total of 28% entered the study with HbA(1c) ≤7.0% and 67% were being treated with oral antihyperglycemic drug(s) (OAD) only [1 (28.4%), 2 (28.4%), >2 (10.2%)], or some form of insulin ±OADs (19%), and ≥50% were on a cholesterol-lowering drug(s) ± antihypertensive medication(s). The single-arm design of this study is a limitation; however, the overall objective of the ongoing study is to observe patients on exenatide therapy over time, comparing their status at endpoint to baseline, rather than to make comparisons among different drug therapies. CONCLUSIONS: Patients treated with exenatide tended to be obese, middle-aged women on various combinations of OADs and/or insulin who often had hypertension and/or dyslipidemia. Further planned analyses will provide the largest sample of prospective data on outcomes of exenatide therapy for up to 24 months in this usual-care population.

Evaluation of medication compliance in patients on antidepressants at an outpatient tertiary cancer center setting.

OBJECTIVE: The purpose is to evaluate antidepressant compliance in a cancer population at a tertiary cancer center and to determine if there are covariates of importance in predicting the level of compliance in the study population. METHODS: Patients who received at least three prescriptions covering parts of each month for a continuous 6-month period with at least one of the months being in 2006 from a tertiary cancer center were identified as the prevalent population of interest for this retrospective study. Data collected included demographics, cancer and co-morbid diagnoses, and compliance to antidepressant medication using medication possession ratio (MPR) by patient, medication class, and individual agents. Analysis was conducted using descriptive statistics, analysis of variance, and logistic regression (using MPR ≥ 80 as cutoff). RESULTS: The study population included 297 patients with demographics showing 69% female, 71% Caucasian, a mean age of 52.94 (SD: 12.42), and an average 403 days of follow-up. The MPR for the total study population was 0.87 with 78% of the population having an MPR of ≥ 80% and 22% having an MPR of less than 80%. While there was no significant difference in MPR by different pharmaceutical classes, there were significant differences in the MPR by specific agents (p = 0.02), with nortriptyline having the lowest MPR of 0.79 and doxepin, fluoxetine, mirtazapine, and venlafaxine all having MPR over 0.90. There was also a trend toward a difference in MPR between Caucasians versus non-Caucasians, p = 0.055. CONCLUSION: There appears to be relatively good compliance to antidepressant medications in the study population.

Economic evaluation of four angiotensin II receptor blockers in the treatment of hypertension.

OBJECTIVE: To evaluate the cost effectiveness of achieving JNC 7 blood pressure goals with angiotensin II receptor blockers (ARBs). RESEARCH DESIGN AND METHODS: Cost effectiveness of olmesartan, losartan, valsartan, and irbesartan was compared with real world patient chart and claims data from a large US health plan. Patients 18 and older with >or=2 claims for an ARB between May 1, 2002 and December 31, 2005 were identified from the claims database. Patients with a diagnosis of hypertension in the 6-month baseline period before the first (index) ARB claim and ARB-free during baseline were included. Medical charts were randomly sampled from the cohort of identified patients; effectiveness data were obtained from charts and linked to healthcare claims and costs. These data were used to populate the decision analytic model. MAIN OUTCOME MEASURES: All-cause and hypertension-attributable costs to achieve JNC 7 goals were measured. Comparisons were made within low and high-dose strata and pooled across ARB doses. RESULTS: 121 472 patients were identified, and charts were randomly abstracted for 1600. Of these, 1293 patients were hypertensive at index. Baseline patient characteristics for the chart group were modestly different from the larger cohort. More patients treated with olmesartan (77.8%) than with losartan (66.5%), valasartan (68.8%), or irbesartan (68.8%) achieved JNC 7 BP goals. In pooled-dose comparisons, cost per patient reaching BP goal was $8964 (all-cause) and $2704 (hypertension-attributable) for olmesartan; compared with $10 848 and $3291 for losartan; $10 557 and $3577 for valsartan; and $13395 and $4325 for irbesartan, respectively. The trend was similar for the dose stratification analysis, except in the comparison between high-dose losartan and olmesartan, where losartan had a lower cost-effectiveness ratio. CONCLUSION: Overall olmesartan was the most effective and cost-saving treatment option compared to losartan, valsartan, and irbesartan for the achievement of JNC 7 BP goals in this managed-care population.

Estimation of a valuation function for a diabetes mellitus-specific preference-based measure of health: the Diabetes Utility Index.

Preference-based measures of health (PBMH) provide 'preference' or 'utility' weights that enable the calculation of QALYs for the economic evaluations of interventions. The Diabetes Utility Index (DUI) was developed as a brief, self-administered, diabetes mellitus-specific PBMH that can efficiently estimate patient-derived health state utilities. To describe the development of the valuation function for the DUI, and to report the validation results of the valuation function. Multi-Attribute Utility Theory (MAUT) was used as the framework to develop a valuation function for the DUI. Twenty of 768 possible health states of the DUI classified as anchor states, single-attribute level states including corner states, and marker states were selected and described for preference elicitation interviews. Visual analogue scale and standard gamble (SG) exercises were used to measure preferences from individuals with diabetes recruited from primary care and community settings in and around Morgantown, WV, USA for the 20 health states defined by combinations of DUI attributes and severity levels. Data collected in the interviews were used to develop a valuation function that calculates utilities for the DUI health states and calculates attribute-level utilities. A validation survey of the valuation function was conducted in collaboration with the West Virginia University (WVU) Diabetes Institute. A total of 100 individuals with diabetes were interviewed and their preferences for various DUI health states measured. From data generated in the interviews, a DUI valuation function was developed on a scale where 1.00 = perfect health (PH) and 0.00 = the all worse 'pits' state, and adjusted to yield utilities on the conventional scale 1.00 = PH and 0.00 = dead. A total of 396 patients with diabetes who received care at WVU clinics completed a DUI mail validation survey (response rate = 33%). Clinical data consisting of International Classification of Diseases, 9th edition, diagnosis codes and glycosylated haemoglobin (HbA(1c)) values for the respondents were merged with their responses to the DUI. The utilities calculated by the scoring function of the DUI compared favourably to cardinal SG utilities for three DUI health states for which both assessments were available. The DUI utility function slightly underestimated actual SG utilities for mild and moderate health states (mean absolute difference = 0.05). There was a small but significant correlation between DUI utility scores and average past year HbA(1c) values (r = -0.30; p < 0.001). Respondents with two or more complications had significantly lower DUI utilities than those with no complications (p < 0.001) or one complication (p = 0.015). Insulin users had significantly lower DUI utilities than non-users (p < 0.001), and those with HbA(1c) values <7% had significantly higher DUI utilities than those with HbA(1c) values of >or=7% (p < 0.001). No significant association was found between DUI scores and age or sex. These results show evidence of the feasibility and validity of the DUI. Further research is suggested to demonstrate the generalizability of these findings, to study the responsiveness of the DUI, and to examine the clinical meaningfulness of DUI change scores.

Impact of changes in reimbursement policies and institutional practice algorithm for utilization of erythropoietic-stimulating agents on treatment patterns and costs in anemic lymphoma patients.

PURPOSE: The objective of this study was to assess the impact of a new evidence-based institutional practice algorithm on the patterns and costs of treatment of chemotherapy-induced anemia (CIA) in lymphoma patients prescribed erythropoietic-stimulating agents (ESAs). METHODS: The study design was retrospective, with a historical control group. Patient demographic data, clinical data (including chemotherapy and hemoglobin values), and cost data were extracted from patient medical charts and institutional databases. Descriptive statistics, t tests, and chi-square analyses were conducted to evaluate the study objectives. RESULTS: The study population consisted of 154 patients, 90 patients in the pre-implementation group and 64 in the post-implementation group. Both groups had similar demographic and baseline clinical characteristics. After implementation, there was a significant decrease in the mean hemoglobin level at the time of subsequent ESA dosing from 9.59 to 8.98 g/dL (P < 0.0001). The proportion of patients who received an ESA at a hemoglobin level >10 g/dL decreased significantly from 66% to 17% (P < 0.0001). There was no significant difference in the mean hemoglobin level at week 4 of ESA therapy, which may indicate that patients were not clinically affected by the change in practice. There were also no significant differences in the number of transfusions administered associated with the treatment of CIA in the study population. CONCLUSIONS: The results of the study show an association between implementation of the new institutional practice algorithm for ESA usage in CIA and a change in ESA utilization patterns.

Rasch analysis informed the development of a classification system for a diabetes-specific preference-based measure of health.

OBJECTIVE: To develop a classification system (CS) for a diabetes-specific preference-based measure of health titled the Diabetes Utility Index (DUI). STUDY DESIGN AND SETTING: Factor analysis of the Audit of Diabetes-Dependent Quality-of-Life (ADDQoL) items (n=385) identified plausible attributes. An expert panel provided qualitative input, including additional items. Data from three pilot rounds on patients with type 1 or type 2 diabetes were analyzed using Rasch analysis (RA). In a validation survey, the final version of the CS was mailed along with the SF-12v2, Well-Being Questionnaire, and Diabetes Empowerment Scale Short Form to a convenience sample (type 1 or type 2 diabetes). RESULTS: Factor analysis identified two plausible attributes. Experts rated the importance of ADDQoL and additional items, described attributes from item sets and suggested severity levels. Three pilot rounds (n1=52, n2=65, n3=111) tested versions of a CS, containing five attributes with severity levels that were modified using RA and expert input. The final attributes were Physical Ability and Energy, Relationships, Mood and Feelings, Enjoyment of Diet, and Satisfaction with Management of Diabetes. The validation survey (n=396) results indicated satisfactory Rasch fit statistics, reliability, and severity scaling, whereas correspondence of responses to the CS with included measures suggested validity. CONCLUSION: Results provide initial report of the validity and reliability of the CS of the DUI.

Using the theory of reasoned action to determine physicians' intention to measure body mass index in children and adolescents.

BACKGROUND: Over the past few decades, childhood obesity has become a major public health issue in the United States. Numerous public and professional organizations recommend that physicians periodically screen for obesity in children and adolescents using the body mass index (BMI). However, studies have shown that physicians infrequently measure BMI in children and adolescents. OBJECTIVES: The purpose of this study was to use the theory of reasoned action (TRA) to explain physicians' intentions to measure BMI in children and adolescents. The study objectives were to (1) determine if attitude and subjective norm predict physicians' intention to measure BMI in children and adolescents; (2) determine if family physicians and pediatricians differ in terms of theoretical factors; and (3) assess differences in behavioral beliefs, outcome evaluations, normative beliefs, and motivation to comply among physicians based on their level of intention to measure BMI. METHODS: A cross-sectional mailed survey of 2590 physicians (family physicians and pediatricians) practicing in 4 states was conducted. A self-administered questionnaire was designed that included items related to the TRA constructs. The association between the theoretical constructs was examined using correlation and regression analyses. Student's t test was used to determine differences between family physicians and pediatricians on theoretical constructs and to compare the underlying beliefs of nonintenders with intenders. RESULTS: The usable response rate was 22.8%. Less than half (44%) of the physicians strongly intended to measure BMI in children and adolescents. Together, the TRA constructs attitude and subjective norm explained up to 49.9% of the variance in intention. Pediatricians had a significantly (P<.01) higher intention to measure BMI as compared to family physicians. There were significant (P<.01) behavioral and normative belief differences between physicians who intend and those who do not intend to measure BMI. CONCLUSION: The TRA is a useful model in identifying the factors that are associated with physicians' intentions to measure BMI.

Smoking behaviors among cancer survivors: an observational clinical study.

PURPOSE: Smoking is a well-recognized risk factor for several cancers including cancers of the lung, bladder, and head and neck. Studies have shown that smoking can adversely affect the outcomes of different modalities of cancer treatment. This study examines smoking behaviors among cancer survivors to collect information necessary to create successful smoking cessation interventions. METHODS: For this observational clinical study, questionnaires were sent to 1,000 randomly selected patients diagnosed with cancer between 2003 and 2007 in one cancer center. Data were statistically analyzed to determine the likelihood of a patient quitting smoking after being diagnosed with cancer. RESULTS: We received 187 responses from the 1,000 surveys sent (18.7%). Of these, 166 were usable for analysis. The mean age of respondents was 64 (± 13) years. Men were more likely than women to be past smokers (55% of men and 32% of women respectively, P = .003). Fifty-two percent of respondents reported having a history of smoking. However, only 20% of patients reported having been active smokers at the time they were diagnosed with cancer. Furthermore, only 44% of these reported having quit smoking after their diagnosis with cancer. Only 62% of all respondents reported that they had been informed of the dangers of smoking by their health care provider during cancer treatment. CONCLUSION: In our study sample, less than one half (44%) of smoking cancer patients quit smoking after their cancer diagnosis, and only 62% of smoking cancer patients received smoking cessation counseling from their physicians. Intervention programs are needed to help cancer survivors to quit smoking. Prospective clinical trials may help identify the ideal intervention for smoking cessation.

Disparities in outpatient antidepressant prescribing patterns and determinants of resource utilization at a tertiary care cancer center.

Our objective was to assess the prevalence of use of different classes of antidepressants, prescribing patterns, and determinants of exposure to specific types of antidepressants and resource utilization at a comprehensive cancer center from 2001 to 2006. Data were collected from the institution's outpatient pharmacy database and cross-referenced with the institution's electronic medical record system. Data collected included demographic characteristics, cancer diagnosis, comorbidities, prescribing physician and service, type and number of antidepressant prescriptions, and resource utilization. Significant differences in the usage and prescribing patterns of the type of antidepressants were found in the analysis by gender and ethnicity, with women seeing a psychiatrist more often than men (P = 0.001) and Caucasians receiving more selective serotonin reuptake inhibitors (SSRIs) than other ethnic groups (P = 0.002). In terms of resource utilization, men had significantly more hospital admissions (P < 0.0001) and emergency room visits (P = 0.004) than women, whereas non-Caucasian ethnic groups had more emergency room visits (P < 0.0001) and clinic visits (P = 0.001) than Caucasians. Further investigation of men and non-Caucasians in the screening, evaluation, and treatment of depression is necessary to confirm disparities and evaluate their possible causes.

Persistence, adherence, and switch rates among extended-release and immediate-release overactive bladder medications in a regional managed care plan.

BACKGROUND: Pharmacotherapy constitutes an important adjunct to behavioral therapy for the treatment of overactive bladder (OAB). Tolterodine and oxybutynin are commonly prescribed drugs for OAB treatment that exert their beneficial effect by suppressing bladder muscle contractions. However, high discontinuation rates have been observed for these drugs in clinical trials, as well as in real-world settings, in part due to adverse effects. Extended-release (ER) formulations were introduced with an improved tolerability profile over immediate-release (IR) versions of the 2 drugs. No study has compared persistence and adherence to therapy for both the ER and IR versions of tolterodine and oxybutynin. OBJECTIVE: To compare persistence, adherence, and switch rates for the IR and ER formulations of oxybutynin and tolterodine for patients enrolled in a regional managed care plan. METHODS: Study patients were adults (aged e 18 years), with at least 1 pharmacy claim for either tolterodine extended-release (tol-ER), oxybutynin extended-release (oxy-ER), tolterodine immediate-release (tol-IR), or oxybutynin immediate-release (oxy-IR) during the period from July 1, 1999, to December 31, 2003, and were continuously eligible for benefits from 6 months before through 12 months after the initial OAB pharmacy claim (index) date. A retrospective cohort study design was used following patients from the index date to the occurrence of non-persistence with the index medication (i.e., a gap of > 45 days between successive prescription fills or a switch to any other OAB medication), or the end of a 1-year follow-up period, through December 31, 2004. Switching was defined as any change from the index medication, including a change in dose form (e.g., tol-IR to tol-ER), to one of the other 3 study drugs, or to a different OAB treatment (e.g., trospium chloride, oxybutynin patch, flavoxate, hyoscyamine sulfate, or propantheline bromide) during the follow-up period. Adherence was measured as the proportion of patients with a medication possession ratio (MPR) of at least 80%. MPR was calculated as (1) the sum of days supply for all pharmacy claims except the last pharmacy claim, divided by (2) the total number of days from the first fill date to the fill date of the last pharmacy claim. The association of drug therapy with study outcomes was assessed with bivariate and adjusted (multivariate) analyses. Multivariate analyses controlled for demographic and clinical characteristics, plan type, patient out-of-pocket cost for the index medication, and year of therapy initiation. RESULTS: 1,117 patients had at least 1 pharmacy claim for an OAB study drug (n = 454 for tol-ER [40.6%], n = 249 for oxy-ER [22.3%], n = 306 for tol-IR [27.4%], n = 108 for oxy-IR [9.7%]), of whom 81.6% were women. The mean (standard deviation [SD]) age of the study population was 55.7 (14.5) years. Only 53.7% had at least 1 OAB diagnosis recorded during the 18-month eligibility period. 44.5% of patients did not have a refill after the initial (index) pharmacy claim (39.4% for oxy-ER, 42.7% for tol-ER, 46.1% for tol-IR, and 59.3% for oxy-IR; P = 0.004). Only 13.2% persisted with treatment for at least 1 year (tol-ER = 15.0%, oxy-ER = 15.3%, tol-IR = 11.4%, oxy-IR = 6.5%; P = 0.050). The median days to discontinuation (non-persistency) were 31.0 overall, 33.0 for tol-ER, 34.0 for oxy-ER, 32.0 for tol-IR, and 0 for oxy-IR; P = 0.010. The overall switch rate as a percentage of all study patients was 13.3%, ranging from 9.9% for tol-ER, 13.7% for tol-IR, 16.5% for oxy-ER, and 19.4% for oxy-IR; P = 0.020. Of patients who refilled their initial prescription at least once, 24.0% made a medication switch. Adherence rates as measured by percentage of patients with MPR >or= 80% were 30.3% overall and higher for the ER formulations: 35.2% for tol-ER, 36.1% for oxy-ER, 23.5% for tol-IR, and 14.8% for oxy-IR; P < 0.001. CONCLUSIONS: Adherence was significantly better for ER than IR agents. The high rate of non-persistence (44.5%) following the first (index) prescription highlights the need for medication counseling by health care professionals.