Treatment patterns and real world clinical outcomes in ER+/HER2- post-menopausal metastatic breast cancer patients in the United States.

BACKGROUND: With several new therapies becoming available, treatment of metastatic breast cancer (mBC) is evolving. The objective of this study is to describe patient characteristics, treatment patterns and real-world clinical outcomes in post-menopausal women with ER+, HER2- mBC and to obtain insight into patient outcomes and potential unmet needs with current therapies. METHODS: The current study is a physician survey followed by a retrospective chart review of patient medical records by physicians in the US between March and April 2015. One hundred three physicians were asked to complete an online survey aiming to understand their satisfaction and expectations with current available treatments and potential areas of unmet need for mBC patients. Medical records from 178 females were extracted for the chart review. Using these data from medical records, patient characteristics and treatment patterns were analyzed descriptively. Time to progression (TTP) on first line, and progression-free survival (PFS) on second and third line of therapy were analyzed using the Kaplan-Meier method. RESULTS: Sixty-seven percent (n = 119) of patients had metastatic disease at initial diagnosis of breast cancer. Mean age at chart data extraction was 65.8 (SD: 9.4) years. Aromatase inhibitors (AIs) were prescribed for 58% and around 13% of patients in first line and second line, respectively. Chemotherapy was prescribed to 14% in first line and 31% in second line. Median TTP on first line therapy was 12 months for patients receiving AIs as compared to 7.9 months for patients receiving chemotherapy. Across all treatment lines, bone pain and fatigue were reported as the main symptoms associated with disease progression which had an impact on patient quality of life. Physicians expressed that prolonging life was deemed the most important treatment goal, followed by preservation or improvement of quality of life. CONCLUSION: In this study the majority of patients received endocrine therapy as first line treatment and current therapies still resulted in a short time to progression in first line. Results from the chart review and the physician survey highlight a quantitative unmet need for more effective treatments which delay disease progression and improve survival outcomes while maintaining quality of life.

Diagnostic imaging and biopsy pathways following abnormal screen-film and digital screening mammography.

The transition from screen-film to digital mammography may have altered diagnostic evaluation of women following a positive screening examination. This study compared the use and timeliness of diagnostic imaging and biopsy for women screened with screen-film or digital mammography. Data were obtained from 35,321 positive screening mammograms on 32,087 women aged 40-89 years, from 22 breast cancer surveillance consortium facilities in 2005-2008. Diagnostic pathways were classified by their inclusion of diagnostic mammography, ultrasound, magnetic resonance imaging, and biopsy. We compared time to resolution and frequency of diagnostic pathways by patient characteristics, screening exam modality, and radiology facility. Between-facility differences were evaluated by computing the proportion of mammograms receiving follow-up with a particular pathway for each facility and examining variation in these proportions across facilities. Multinomial logistic regression adjusting for age, calendar year, and facility compared odds of follow-up with each pathway. The median time to resolution of a positive screening mammogram was 10 days. Compared to screen-film mammograms, digital mammograms were more frequently followed by only a single diagnostic mammogram (46 vs. 36 %). Pathways following digital screening mammography were also less likely to include biopsy (16 vs. 20 %). However, in adjusted analyses, most differences were not statistically significant (p = 0.857 for mammography only; p = 0.03 for biopsy). Substantial variability in diagnostic pathway frequency was seen across facilities. For instance, the frequency of evaluation with diagnostic mammography alone ranged from 23 to 55 % across facilities. Differences in evaluation of positive digital and screen-film screening mammograms were minor, and appeared to be largely attributable to substantial variation between radiology facilities. To guide health systems in their efforts to eliminate practices that do not contribute to effective care, we need further research to identify the causes of this variation and the best evidence-based approach for follow-up.

Economic measurement of medical errors using a hospital claims database.

OBJECTIVE: The primary objective of this study was to estimate the occurrence and costs of medical errors from the hospital perspective. METHODS: Methods from a recent actuarial study of medical errors were used to identify medical injuries. A visit qualified as an injury visit if at least 1 of 97 injury groupings occurred at that visit, and the percentage of injuries caused by medical error was estimated. Visits with more than four injuries were removed from the population to avoid overestimation of cost. Population estimates were extrapolated from the Premier hospital database to all US acute care hospitals. RESULTS: There were an estimated 161,655 medical errors in 2008 and 170,201 medical errors in 2009. Extrapolated to the entire US population, there were more than 4 million unique injury visits containing more than 1 million unique medical errors each year. This analysis estimated that the total annual cost of measurable medical errors in the United States was $985 million in 2008 and just over $1 billion in 2009. The median cost per error to hospitals was $892 for 2008 and rose to $939 in 2009. Nearly one third of all medical injuries were due to error in each year. CONCLUSIONS: Medical errors directly impact patient outcomes and hospitals' profitability, especially since 2008 when Medicare stopped reimbursing hospitals for care related to certain preventable medical errors. Hospitals must rigorously analyze causes of medical errors and implement comprehensive preventative programs to reduce their occurrence as the financial burden of medical errors shifts to hospitals.

Patient-reported treatment burden of chronic immune thrombocytopenia therapies.

BACKGROUND: Chronic immune thrombocytopenia (ITP) is a debilitating autoimmune disorder that causes a reduction in blood platelets and increased risk of bleeding. ITP is currently managed with various pharmacologic therapies and splenectomy.This study was conducted to assess patient perceived and reported treatment side effects, as well as the perceived burden or bother, and need to reduce or stop treatment, associated with these side effects among adult patients with chronic ITP. METHODS: A Web-enabled survey was administered to members of a US-based ITP patient support group. Patients reported demographic and clinical characteristics, ITP treatments' side effects for treatments received since diagnosed, level of bother (or distress), and need to reduce or stop treatment, associated with side effects. Current and past exposure was assessed for five specific treatment types: corticosteroids (CS), intravenous immunoglobulin (IVIg), anti-D immunoglobulin (anti-D), rituximab (RT), and splenectomy (SPL), as well as for other patient-referenced therapies (captured as "other"). RESULTS: The survey was completed by 589 patients; 78% female, 89% white, mean age 48 years (SD = 14.71), and 68% reported a typical low platelet count of < 50,000/µL. Current or past treatment with CS was reported by 92% (n = 542) of patients, 56% (n = 322) for IVIg, 36% (n = 209) for anti-D, 36% (n = 213) for RT, and 39% (n = 227) for SPL. A substantial proportion of CS-treated patients reported side effects (98%, P < 0.05), were highly bothered by their side effects (53.1%, P < 0.05), and reported the need to stop or reduce treatment due to side effects (37.8%, P < 0.05). Among patients reporting side effects of treatment, significant associations were noted for the number of side effects, aggregate bother of reported side effects, and the need to stop or reduce treatment (all P < 0.05). CONCLUSIONS: Current ITP treatments, particularly corticosteroids, are associated with multiple bothersome side effects that may lead to patients stopping or reducing therapy. Open, informed and complete communication between clinician and patient regarding both the benefits and the side effects of ITP treatment may better prepare patients for their prescribed regimens.

The development and initial assessment of the strategy and leadership systems capability evaluation survey.

Hospital management and leadership systems are associated with organizational success and quality care. The Strategy and Leadership Systems Capability Evaluation (CE) survey was developed by GE Healthcare to assess management and leadership systems at health care institutions, serve as a benchmark for improvement, and measure progress. To assess the psychometric properties of the 29-item CE survey, including the factor structure, scoring algorithm, reliability, and discriminant validity, an online survey was completed by 3450 employees at 15 US hospitals. Of these employees, 609 worked at a hospital where a leadership and management intervention occurred after the initial survey administration. Data were also collected on job level, number of hospital beds, hospital ownership, location, community type, and the implementation of hospital interventions. Item response frequencies showed no floor or ceiling effects and limited missing data. Interitem correlations were strong without obvious redundancies, and factor analysis suggested a unidimensional scale. The resulting scale had strong internal consistency and was able to discriminate among known groups. The CE survey was developed to evaluate management and leadership systems at health care institutions. This study provides psychometric evidence in support of the reliability, validity, and scoring structure of this survey.

Out of control little-used clinical assets are draining healthcare budgets.

To improve utilization and reduce the cost of maintaining mobile clinical equipment, healthcare organization leaders should do the following: Select an initial asset group to target. Conduct a physical inventory. Evaluate the organization's asset "ecosystem." Optimize workflow processes. Phase in new processes, and phase out inventory. Devote time to change management. Develop a replacement strategy.

Burden of deep vein thrombosis in the outpatient setting following major orthopedic surgery.

BACKGROUND: Venous thromboembolism (VTE) is a known complication of major orthopedic surgery (MOS) with important clinical and economic consequences. Recently published orthopedic guidelines have focused on prevention of pulmonary embolism as a primary outcome, but deep vein thrombosis (DVT) occurrence should not be readily dismissed. OBJECTIVE: To describe the burden of DVT following hospital discharge for MOS by assessing the impact of DVT on costs and resource utilization from the third-party payer perspective. METHODS: Retrospective analysis used outpatient medical and pharmacy data from the PharMetrics Patient-Centric Database (January 1, 2002-March 31, 2006). Patients 18 years of age or older with a record of MOS were eligible for inclusion. Included patients were stratified based on the presence of a DVT during the first month after hospital discharge. Characteristics of the samples were described. The impact of DVT on total 6-month costs and resource utilization (readmissions, outpatient, emergency department visits) was assessed through statistical models. RESULTS: Of the 32,899 patients in the analysis, 1221 (3.71%) had a record of DVT during the first month following discharge for MOS. Compared with patients who did not develop DVT, patients who developed DVT postdischarge were slightly older (56.5 vs 55.8 y; p = 0.0127), had a higher occurrence of prior VTE (26.2% vs 3.4%; p < 0.0001), and had undergone recent surgical procedures other than MOS (73.0% vs 69.6%; p = 0.0116). After controlling for potential confounders, DVT was associated with a 22% and 74% increase in the average number of expected outpatient and emergency department visits, respectively, during the 6-month postdischarge period but did not significantly impact the number of readmissions. Furthermore, total 6-month costs were significantly higher for patients who developed DVT, with an incremental increase of over $2000. CONCLUSIONS: The burden of DVT following hospital discharge for MOS is substantial. Specifically, DVT increases total costs and outpatient and emergency department visits.

Postdischarge oral versus injectable anticoagulation following major orthopedic surgery.

BACKGROUND: Multiple clinical studies have shown postdischarge anticoagulation to be beneficial following major orthopedic surgery (MOS); however, outpatient prophylaxis is not widely practiced. OBJECTIVE: To quantify, from a third-party payer perspective, real-world clinical and economic outcomes for patients receiving injectable or oral anticoagulation as prophylaxis for venous thromboembolism (VTE) following discharge after MOS. METHODS: A retrospective database analysis was conducted using outpatient medical and pharmacy data from the PharMetrics Patient-Centric Database (January 1, 2002, to March 31, 2006). Patients greater than 18 years of age with 9 months of continuous eligibility who received an anticoagulant in the outpatient setting following MOS were eligible. Patients were stratified into 2 cohorts: injectable (dalteparin, enoxaparin, fondaparinux) and oral (warfarin), and were matched 1:1 on demographic and clinical characteristics. RESULTS: A total of 12,724 patients were included (injectable, 6362; oral, 6362). At 90 days, patients receiving oral anticoagulation were 20% more likely to experience a VTE than were those receiving an injectable agent (7.4% vs 6.3%; p = 0.02, OR 1.18; 95% CI 1.03 to 1.36). No significant differences in bleeding were observed (<0.4%). The average adjusted total 6-month costs were significantly (p < 0.001) higher for the oral versus injectable cohort ($18,039 vs $16,429). Medical costs in the oral cohort offset the higher pharmacy costs in the injectable cohort. CONCLUSIONS: This study demonstrates that the risk of VTE extends to the outpatient setting following MOS, even with postdischarge anticoagulation. Injectable agents used in the outpatient setting may result in fewer clinical VTEs without increasing the risk for major bleeding. These findings support the data from controlled clinical studies and expand the evidence to the real-world setting. Despite higher pharmacy acquisition costs for injectable anticoagulants, injectable agents may offer significant per patient savings to third party payers.

Decreased venous thromboembolism with injectable vs oral anticoagulation after discharge for major orthopedic surgery.

The use of outpatient anticoagulation after major orthopedic surgery with oral or injectable anticoagulants is recommended by national guidelines. A retrospective analysis of medical and pharmacy claims data using the PharMetrics Patient-Centric Database Inc, Watertown, Mass, was conducted. After adjusting for covariates, patients receiving warfarin were approximately 30% more likely to experience a venous thromboembolism than those receiving an injectable anticoagulant (6.3% vs 4.8%; adjusted odds ratio, 1.3; 95% confidence interval, 1.1-1.5) by 30 days. The data at 90 days showed similar results. No significant differences in the incidence of major bleeding events between the cohorts were observed (incidence of major bleed <0.4%). These findings support the randomized controlled studies and expand the data to the real-world perspective. Clinicians should evaluate these data alongside the clinical trial data when selecting the safest and most effective prophylactic therapy for postdischarge anticoagulation.

Outcomes associated with warfarin time in therapeutic range among US veterans with nonvalvular atrial fibrillation.

BACKGROUND: Poor quality of warfarin control (time in therapeutic range [TTR] < 65%) can lead to increased risk of adverse events. The objective of this study was to examine the overall quality of international normalized ratio (INR) control and the association of TTR with clinical outcomes including stroke, major bleeding, and all-cause mortality among US warfarin users. METHODS AND RESULTS: This retrospective observational cohort study utilized the US Veterans Affairs electronic medical records database (VA EMR). Patients with NVAF who newly initiated warfarin from 1 January 2005 to 31 December 2015 were grouped into two cohorts based on TTR <65% or ≥65%. TTR was computed from INR test results. Clinical outcomes assessed were stroke/systemic embolism (SE), hemorrhagic stroke, ischemic stroke, and major bleeding, defined based on hospitalization with those conditions as primary diagnosis, as well as all-cause mortality. Patients were followed from warfarin initiation to the first occurrence of an outcome or censoring. Propensity score weighted time-varying Cox regression was used to evaluate the risk of the clinical events. A total of 127,385 NVAF patients with mean TTR of 51% were included. TTR <65% was observed in 65% of patients. Mean CHA2DS2-VASC score (SD) was 2.9 (1.5) in the low TTR cohort and 2.7 (1.4) in the high TTR cohort. Patients with TTR <65% had a higher risk for any stroke/SE (HR: 1.57; 95% CI: 1.41-1.75), major bleeding (HR: 2.78; 95% CI: 2.55-3.03) and all-cause mortality (HR: 1.73; 95% CI: 1.67-1.79). CONCLUSIONS: The observed quality of warfarin control in VA EMR suggests room for improvement given the association with elevated risk of adverse clinical outcomes.

Apixaban 5 and 2.5 mg twice-daily versus warfarin for stroke prevention in nonvalvular atrial fibrillation patients: Comparative effectiveness and safety evaluated using a propensity-score-matched approach.

Prior real-world studies have shown that apixaban is associated with a reduced risk of stroke/systemic embolism (stroke/SE) and major bleeding versus warfarin. However, few studies evaluated the effectiveness and safety of apixaban according to its dosage, and most studies contained limited numbers of patients prescribed 2.5 mg twice-daily (BID) apixaban. Using pooled data from 4 American claims database sources, baseline characteristics and outcomes for patients prescribed 5 mg BID and 2.5 mg BID apixaban versus warfarin were compared. After 1:1 propensity-score matching, 31,827 5 mg BID apixaban-matched warfarin patients and 6600 2.5 mg BID apixaban-matched warfarin patients were identified. Patients prescribed 2.5 mg BID apixaban were older, had clinically more severe comorbidities, and were more likely to have a history of stroke and bleeding compared with 5 mg BID apixaban patients. Compared with warfarin, 5 mg BID apixaban was associated with a lower risk of stroke/SE (hazard ratio [HR]: 0.70, 95% confidence interval [CI]: 0.60-0.81) and major bleeding (HR: 0.59, 95% CI: 0.53-0.66). Compared with warfarin, 2.5 mg BID apixaban was also associated with a lower risk of stroke/SE (HR: 0.63, 95% CI: 0.49-0.81) and major bleeding (HR: 0.59, 95% CI: 0.49-0.71). In this real-world study, both apixaban doses were assessed in 2 patient groups differing in age and clinical characteristics. Each apixaban dose was associated with a lower risk of stroke/SE and major bleeding compared with warfarin in the distinct population for which it is being prescribed in United States clinical practice. TRIAL REGISTRATION: Clinicaltrials.Gov Identifier: NCT03087487.

Comparisons of rosiglitazone versus pioglitazone monotherapy introduction and associated health care utilization in medicaid-enrolled patients with type 2 diabetes mellitus.

BACKGROUND: Outcomes in patients with type 2 diabetes mellitus (DM) can differ based on the antidiabetic medication that is used. Thiazolidinediones (TZDs) are a newer class of agents used for the treatment of type 2 DM. No previous study has compared health care utilization associated with the 2 TZDs on the market. OBJECTIVE: The objective of this study was to compare health care utilization and costs associated with initiation of treatment with either rosiglitazone or pioglitazone by Medicaid-enrolled patients with type 2 DM. METHODS: This was a retrospective data analysis comparing cohorts of patients with type 2 DM starting a new antidiabetic medication in terms of hospitalizations, emergency department visits, outpatient physician visits, and health care costs reimbursed by the North Carolina Medicaid program. The perspective adopted in this analysis was that of the third-party payer (ie, the North Carolina Medicaid program). Patients starting rosiglitazone between July 1, 2001, and June 30, 2002, were compared with patients starting pioglitazone during the same period. The patients were followed up for 30 months to examine the difference in health care utilization over time. Multivariate regression techniques were employed for comparisons between the 2 different antidiabetic therapies. RESULTS: A total of 1705 patients with type 2 DM were identified and included in the final cohort. There were 660 patients (mean [SD] age, 49.0 [10.2] years) in the rosiglitazone arm and 1045 patients (mean [SD] age, 49.1 [10.5] years) in the pioglitazone arm. Multivariate analysis showed that the rosiglitazone monotherapy group was associated with a 12.2% decrease in the mean number of hospitalizations, a 10.4% decrease in the mean number of emergency department visits, and a 7.3% decrease in total health care costs compared with the pioglitazone monotherapy group (all, P < 0.05). This study only looked at patients who used the same drug for the entire follow-up period. It did not account for drug switching or addition of a new drug to an existing therapy. CONCLUSIONS: Introduction of rosiglitazone was associated with a decreased number of hospitalizations, emergency department visits, and total health care costs compared with pioglitazone. The utilization of oral antidiabetic agents, with documented clinical and economic benefits, should continue to be advocated to reduce avoidable medical care utilization and to improve patient outcomes in this population.

Association Between Breast Cancer Disease Progression and Workplace Productivity in the United States.

OBJECTIVE: Determine workplace productivity losses attributable to breast cancer progression. METHODS: Longitudinal analysis linking 2005 to 2012 medical and pharmacy claims and workplace absence data in the US patients were commercially insured women aged 18 to 64 diagnosed with breast cancer. Productivity was measured as employment status and total quarterly workplace hours missed, and valued using average US wages. RESULTS: Six thousand four hundred and nine women were included. Breast cancer progression was associated with a lower probability of employment (hazard ratio [HR] = 0.65, P < 0.01) and increased workplace hours missed. The annual value of missed work was $24,166 for non-metastatic and $30,666 for metastatic patients. Thus, progression to metastatic disease is associated with an additional $6500 in lost work time (P < 0.05), or 14% of average US wages. CONCLUSIONS: Breast cancer progression leads to diminished likelihood of employment, increased workplace hours missed, and increased cost burden.

Effectiveness and safety of apixaban versus warfarin in non-valvular atrial fibrillation patients in "real-world" clinical practice. A propensity-matched analysis of 76,940 patients.

The ARISTOTLE trial showed a risk reduction of stroke/systemic embolism (SE) and major bleeding in non-valvular atrial fibrillation (NVAF) patients treated with apixaban compared to warfarin. This retrospective study used four large US claims databases (MarketScan, PharMetrics, Optum, and Humana) of NVAF patients newly initiating apixaban or warfarin from January 1, 2013 to September 30, 2015. After 1:1 warfarin-apixaban propensity score matching (PSM) within each database, the resulting patient records were pooled. Kaplan-Meier curves and Cox proportional hazards models were used to estimate the cumulative incidence and hazard ratios (HRs) of stroke/SE and major bleeding (identified using the first listed diagnosis of inpatient claims) within one year of therapy initiation. The study included a total of 76,940 (38,470 warfarin and 38,470 apixaban) patients. Among the 38,470 matched pairs, 14,563 were from MarketScan, 7,683 were from PharMetrics, 7,894 were from Optum, and 8,330 were from Humana. Baseline characteristics were balanced between the two cohorts with a mean (standard deviation [SD]) age of 71 (12) years and a mean (SD) CHA2DS2-VASc score of 3.2 (1.7). Apixaban initiators had a significantly lower risk of stroke/SE (HR: 0.67, 95 % CI: 0.59-0.76) and major bleeding (HR: 0.60, 95 % CI: 0.54-0.65) than warfarin initiators. Different types of stroke/SE and major bleeding - including ischaemic stroke, haemorrhagic stroke, SE, intracranial haemorrhage, gastrointestinal bleeding, and other major bleeding - were all significantly lower for apixaban compared to warfarin treatment. Subgroup analyses (apixaban dosage, age strata, CHA2DS2-VASc or HAS-BLED score strata, or dataset source) all show consistently lower risks of stroke/SE and major bleeding associated with apixaban as compared to warfarin treatment. This is the largest "real-world" study on apixaban effectiveness and safety to date, showing that apixaban initiation was associated with significant risk reductions in stroke/SE and major bleeding compared to warfarin initiation after PSM. These benefits were consistent across various high-risk subgroups and both the standard- and low-dose apixaban dose regimens.

Real-world comparison of major bleeding risk among non-valvular atrial fibrillation patients initiated on apixaban, dabigatran, rivaroxaban, or warfarin. A propensity score matched analysis.

In addition to warfarin, there are four non-vitamin K antagonist oral anticoagulants (NOACs) available for stroke prevention in non valvular atrial fibrillation (NVAF). There are limited data on the comparative risks of major bleeding among newly anticoagulated NVAF patients who initiate warfarin, apixaban, dabigatran, or rivaroxaban, when used in 'real world' clinical practice. The study used the Truven MarketScan® Commercial & Medicare supplemental US claims database. NVAF patients aged ≥18 years newly prescribed an oral anticoagulant 01JAN2013-31DEC2014, with a ≥1-year baseline period, were included (study period: 01JAN2012-31DEC2014). Major bleeding was defined as bleeding requiring hospitalisation. Propensity score matching (PSM) was used to balance age, sex, region, baseline comorbidities, and comedications. Cox proportional hazards models were used to estimate the PSM hazard ratio (HR) of major bleeding. Among 45,361 newly anticoagulated NVAF patients, 15,461 (34.1 %) initiated warfarin, 7,438 (16.4 %) initiated apixaban, 17,801 (39.2 %) initiated rivaroxaban, and 4,661 (10.3 %) initiated dabigatran. Compared to matched warfarin initiators, apixaban (HR: 0.53; 95 % CI: 0.39-0.71) and dabigatran (HR: 0.69; 95 % CI: 0.50-0.96) initiators had a significantly lower risk of major bleeding. Patients initiating rivaroxaban (HR: 0.98; 95 % CI: 0.83-1.17) had a non-significant difference in major bleeding risk compared to matched warfarin patients. When comparisons were made between NOACs, matched rivaroxaban patients had a significantly higher risk of major bleeding (HR: 1.82; 95 % CI: 1.36-2.43) compared to apixaban patients. The differences for apixaban-dabigatran and dabigatran-rivaroxaban matched cohorts were not statistically significant. Among newly anticoagulated NVAF patients in the real-world setting, apixaban and dabigatran initiation was associated with significantly lower risk of major bleeding compared to warfarin initiation. When compared to apixaban, rivaroxaban initiation was associated with significantly higher risk of major bleeding.

Clinical and economic outcomes by first-line treatment among women with HR+/HER2- metastatic breast cancer in a large US health plan database.

BACKGROUND: Guidelines recommend that women with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC) initiate hormonal therapy before chemotherapy. This study compared outcomes of women with mBC who received chemotherapy first vs hormonal therapy. METHODS: A retrospective cohort study of women with mBC was conducted using a large US commercial health plan database between January 1, 2008-April 30, 2013. Subjects had evidence of a HR+/HER2- tumor sub-type in a cancer registry and use of chemotherapy or hormonal therapy in claims. Subjects were continuously enrolled for ≥6 months after metastasis and assigned to cohorts for receiving chemotherapy only or hormonal therapy only during first-line (CT-1L vs HT-1L). Adjusted incidence rates of clinically significant events were compared using a negative binomial model, and adjusted healthcare costs were compared using a generalized linear model. RESULTS: Three hundred and twenty-four women with HR+/HER2- mBC met the selection criteria; 179 (55%) received CT-1L and 145 (45%) received HT-1L. Mortality rates did not differ between cohorts (unadjusted incidence rate ratio (IRR) = 1.67, 95% CI = 0.82-3.46; adjusted IRR = 0.64, 95% CI = 0.32-1.27). Adjusted average total all-cause healthcare costs were $11 090 for women with CT-1L and $6743 for women with HT-1L (cost ratio =1.64, 95% CI =1.36-1.99). CONCLUSIONS: Observed use of first-line chemotherapy (>50%) was higher than expected given the HR + molecular profile of the tumors. Chemotherapy use during first-line did not appear to be associated with a survival benefit, but was associated with significantly higher costs compared with the use of hormonal therapy during first-line; however, this comparison is limited by demographic and baseline characteristic differences between the two cohorts. This study contributes to understanding real-world treatment patterns and the associated clinical and economic outcomes of using chemotherapy vs hormonal therapy as a first-line treatment option for the HR+/HER2- mBC population.

Reduction in use of healthcare services with combination sulfonylurea and rosiglitazone: findings from the Rosiglitazone Early vs SULfonylurea Titration (RESULT) study.

OBJECTIVE: To assess and compare healthcare utilization and costs over a 2-year period in older patients (> or = 60 years) with type 2 diabetes receiving combination therapy with rosiglitazone plus a sulfonylurea (glipizide) or progressive up-titration of glipizide monotherapy. STUDY DESIGN: Two-year, randomized, double-blind, parallel-group clinical trial. PATIENTS AND METHODS: Older type 2 diabetic patients initially receiving submaximal doses of a sulfonylurea were randomized to receive rosiglitazone plus glipizide (n = 115) or up-titrated glipizide monotherapy (n = 110). Information on patient self-reported healthcare utilization (hospitalizations, emergency department [ED] visits, physician office visits) was collected prospectively for the duration of the trial. National average healthcare costs per unit were applied to calculate direct medical costs. RESULTS: Demographic characteristics of the 2 groups were similar. At the study's end, glycemic values were better in the rosiglitazone-plus-glipizide group. Compared with the glipizide group, patients receiving rosiglitazone plus glipizide had significantly fewer ED visits (P = .0006) and hospitalizations (P = .0263). Although the glipizide group had more unscheduled physician office visits, the difference was not statistically significant. Estimated treatment costs per patient per month were significantly lower for the rosiglitazone-plus-glipizide group than for the glipizide group (480 dollars vs 645 dollars; P < .05). CONCLUSION: Addition of rosiglitazone to sulfonylurea therapy was associated with decreased use of medical resources, in particular hospitalizations and ED visits, compared with progressive sulfonylurea up-titration. Although causality could not be established, this therapeutic approach could improve clinical outcomes in patients with type 2 diabetes and reduce healthcare utilization and costs.

Prevalence and cost of hospital medical errors in the general and elderly United States populations.

OBJECTIVE: The primary objective of this study was to quantify the differences in the prevalence rate and costs of hospital medical errors between the general population and an elderly population aged ≥65 years. METHODS: Methods from an actuarial study of medical errors were modified to identify medical errors in the Premier Hospital Database using data from 2009. Visits with more than four medical errors were removed from the population to avoid over-estimation of cost. Prevalence rates were calculated based on the total number of inpatient visits. RESULTS: There were 3,466,596 total inpatient visits in 2009. Of these, 1,230,836 (36%) occurred in people aged ≥ 65. The prevalence rate was 49 medical errors per 1000 inpatient visits in the general cohort and 79 medical errors per 1000 inpatient visits for the elderly cohort. The top 10 medical errors accounted for more than 80% of the total in the general cohort and the 65+ cohort. The most costly medical error for the general population was postoperative infection ($569,287,000). Pressure ulcers were most costly ($347,166,257) in the elderly population. LIMITATIONS: This study was conducted with a hospital administrative database, and assumptions were necessary to identify medical errors in the database. Further, there was no method to identify errors of omission or misdiagnoses within the database. CONCLUSIONS: This study indicates that prevalence of hospital medical errors for the elderly is greater than the general population and the associated cost of medical errors in the elderly population is quite substantial. Hospitals which further focus their attention on medical errors in the elderly population may see a significant reduction in costs due to medical errors as a disproportionate percentage of medical errors occur in this age group.

Consequences of major bleeding in hospitalized patients with non-ST segment elevation acute coronary syndromes receiving injectable anticoagulants.

OBJECTIVE: To evaluate the burden of major bleed in patients with non-ST segment elevation acute coronary syndromes (NSTE ACS) receiving injectable anticoagulation from the hospital perspective. METHODS: Retrospective analysis of inpatient medical and pharmacy data from the Premier Perspective Comparative Database between 1/1/2003 and 3/31/2006. Hospitalized patients aged >or=18 years with a diagnosis of UA or NSTEMI who received an injectable anticoagulant agent during the same hospital stay were stratified into two cohorts: those who experienced a major bleed during hospitalization and those who did not, defined by the presence of >or=1 pre-specified ICD-9 codes. Length of hospital stay (LOS), inpatient mortality, 30-day readmissions, and hospitalization costs over 30 days were assessed between the cohorts using statistical models to control for covariates which may have impacted the outcomes. RESULTS: Patients with a major bleed had significantly longer length of stay (13.8 days vs 5.6 days), higher readmission rates (31.3% vs 14.7%), and increased all-cause mortality (15.0% vs 4.5%) compared with patients who did not bleed. After controlling for covariates, major bleeding was significantly associated with increased length of stay, readmission rate, and mortality. Adjusted costs were $13,856 higher on average for patients with a major bleed (95% CI: $13,828-$18,884; p < 0.0001). Subanalyses conducted on patients aged >or=65 years and those undergoing invasive procedures demonstrated higher occurrence of bleed than the general population and a similar impact on outcomes assessed. CONCLUSION: In conclusion, the study showed that patients with UA or NSTEMI who experience a major bleed have significantly longer hospital stays, higher readmission rates, increased costs, and increased mortality than those without a major bleed. These data emphasize the importance of considering the safety profile in context of the efficacy of the recommended agents. The findings from this study are limited by the retrospective study design and certain endpoints, such as readmissions, may have been underreported.

Economic and clinical evaluation of fondaparinux vs. enoxaparin for thromboprophylaxis following general surgery.

PURPOSE: Patients undergoing general surgical procedures are at increased risk for venous thromboembolism (VTE). Compliance rates with established guidelines for VTE thromboprophylaxis in patients at moderate-to-high risk are notably low. Recent literature has demonstrated that fondaparinux is associated with lower costs and fewer VTEs than enoxaparin in patients undergoing major orthopedic surgery (MOS), but data are limited in patients undergoing general surgery. This study was conducted to evaluate the cost implications and relative real-world effectiveness of fondaparinux vs. enoxaparin in general surgery patients. METHODS: Data were obtained from inpatient billing records from over 500 hospitals using Premier's Perspective Comparative Database. Patients hospitalized for general surgery between July 1, 2003 and January 31, 2006 were eligible for inclusion. Eligible patients were included if they received fondaparinux or enoxaparin after their general surgery date. Patients were excluded if they received both anticoagulants on their first day of therapy, were <18 years of age on the surgery date, or did not have data 6 months prior and 1 month post hospitalization. Included patients were stratified into two cohorts based on their first anticoagulant, fondaparinux or enoxaparin. Patients were matched in each group on 1:1 case-control matching based on propensity scores. RESULTS: A total of 5364 patients were included (n = 2682 for each cohort) from 326 unique hospitals. Average total costs per patient for the fondaparinux group were significantly lower than the enoxaparin group ($15 156 vs. 17 741, p < 0.0001). Patients receiving fondaparinux were significantly less likely to experience a VTE (2.80 vs. 3.77%, p = 0.046, a 35% relative risk reduction). No significant differences in bleeding events between the cohorts were observed (p = 0.6047), and no significant differences in all-cause inpatient death were noted (p = 0.3673). CONCLUSION: Fondaparinux was associated with significantly lower costs and fewer VTEs compared to enoxaparin without an increase in bleed rates or all-cause inpatient mortality. The findings from this study are limited by the retrospective study design and should only be generalized to a similar patient population.