Clinical utility of the Prostate Health Index (phi) for biopsy decision management in a large group urology practice setting.

BACKGROUND: Deciding when to biopsy a man with non-suspicious DRE findings and tPSA in the 4-10 ng/ml range can be challenging, because two-thirds of such biopsies are typically found to be benign. The Prostate Health Index (phi) exhibits significantly improved diagnostic accuracy for prostate cancer detection when compared to tPSA and %fPSA, however only one published study to date has investigated its impact on biopsy decisions in clinical practice. METHODS: An IRB approved observational study was conducted at four large urology group practices using a physician reported two-part questionnaire. Physician recommendations were recorded before and after receiving the phi test result. A historical control group was queried from each site's electronic medical records for eligible men who were seen by the same participating urologists prior to the implementation of the phi test in their practice. 506 men receiving a phi test were prospectively enrolled and 683 men were identified for the historical control group (without phi). Biopsy and pathological findings were also recorded for both groups. RESULTS: Men receiving a phi test showed a significant reduction in biopsy procedures performed when compared to the historical control group (36.4% vs. 60.3%, respectively, P < 0.0001). Based on questionnaire responses, the phi score impacted the physician's patient management plan in 73% of cases, including biopsy deferrals when the phi score was low, and decisions to perform biopsies when the phi score indicated an intermediate or high probability of prostate cancer (phi ≥36). CONCLUSIONS: phi testing significantly impacted the physician's biopsy decision for men with tPSA in the 4-10 ng/ml range and non-suspicious DRE findings. Appropriate utilization of phi resulted in a significant reduction in biopsy procedures performed compared to historical patients seen by the same participating urologists who would have met enrollment eligibility but did not receive a phi test.

Longitudinal treatment patterns among US patients with atherosclerotic cardiovascular disease or familial hypercholesterolemia initiating lipid-lowering pharmacotherapy.

BACKGROUND: The most recent American College of Cardiology-American Heart Association guidelines recommend high-dose statin therapy for most patients with confirmed atherosclerotic cardiovascular disease (ASCVD) and patients with high cardiovascular risk. There is limited information regarding long-term treatment patterns among these patients. OBJECTIVE: To examine longitudinal treatment modifications in patients with ASCVD or familial hypercholesterolemia (FH). METHODS: This retrospective analysis of administrative claims data identified patients initiating statin or ezetimibe therapy between January 1, 2007, and December 31, 2012, who had evidence of ASCVD or FH. Patients were followed for up to 3 years and up to 4 treatment episodes. After initial treatment, subsequent treatment episodes began on the date of a treatment modification, which included discontinuation, statin dose change, switching, and augmentation. RESULTS: A total of 92,621 patients (mean age 64.7 years, 57.3% male) were identified; 91,740 had ASCVD, 937 had FH (56 had both). Most ASCVD (89.6%) and FH (85.8%) patients initiated on statin monotherapy. The most common treatment modification in the first treatment episode was discontinuation (ASCVD: 42.0%; FH: 58.4%); among patients who discontinued, most reinitiated therapy (70.5% of ASCVD, 76.8% of FH). Most ASCVD (68.2%) and FH (71.1%) patients initiated on moderate-dose statins; statin dose increase occurred in 10.3% of ASCVD and 18.5% of FH patients in the first episode. CONCLUSION: Among patients with high cardiovascular risk, most initiated on moderate-dose statins with infrequent uptitration. In light of the recent American College of Cardiology-American Heart Association guidelines, statin initiation practices will need to change to ensure appropriate therapy for high-risk patients.

Productivity losses associated with cardiovascular disease: a systematic review.

INTRODUCTION: People with cardiovascular disease (CVD) often require time off work to recover from illness or surgery; for example, following a myocardial infarction (MI) or stroke. These individuals incur income losses, work-related productivity is reduced for employers, and output is reduced for the wider economy. Productivity impacts to the economy also arise due to CVD-related mortality. Areas covered: A systematic literature review was conducted to identify and collate studies that report the magnitude of work-related productivity losses associated with CVD generally or specific cardiovascular (CV) events or conditions (coronary heart disease, MI, stroke, transient ischemic attack, angina, heart failure, peripheral artery disease, coronary revascularization). The search was conducted using Medline, Embase, the Cochrane Library, and Google to find studies published from January 2004 to January 2015. In total, 60 studies were identified, including 20 studies conducted in the USA, 25 studies conducted in Europe, and 18 studies conducted in other countries (three studies were conducted in multiple regions). The studies differed by the scope of losses assessed (absenteeism, presenteeism, early retirement, premature mortality) and CVD conditions/events included. Studies reported either average patient or population losses, and generally used a human capital rather than friction cost method. Outcomes were standardized and adjusted to 2015 US dollars where possible. Expert commentary: The review demonstrates that CVD imposes substantial morbidity- and mortality-related productivity costs. The studies identified in the review may be used to inform and populate societal economic evaluations in CVD, with the most appropriate source study being that most closely matching the context of the evaluation.

Hemoglobin stability and patient compliance with darbepoetin alfa in peritoneal dialysis patients after the implementation of the prospective payment system.

PURPOSE: Since the Centers for Medicare & Medicaid Services implemented the End-Stage Renal Disease Prospective Payment System, dialysis providers have increasingly focused on balancing resource utilization and quality outcomes for the treatment of anemia in patients undergoing peritoneal dialysis. Limited data exist regarding anemia management outcomes for these patients in US-based dialysis centers after the implementation of the new payment system. METHODS: This was a retrospective, observational, cohort study of stable PD patients with end-stage renal disease who received darbepoetin alfa for anemia management over a 15-month period (April 1, 2011-June 29, 2012). The medication was administered by staff in the home-training unit instead of being self-administered at home. The primary end point was mean quarterly hemoglobin (Hb) levels. Variability in Hb levels was assessed over the 5 quarters by using repeated measures ANOVA to test for differences in the observed mean SDs. FINDINGS: In the 139 adult patients on stable peritoneal dialysis and meeting the eligibility criteria, mean (SD) Hb level by quarter was 10.8 (1.2) g/dL in quarters 2 and 3 of 2011, 10.5 (1.1) g/dL in quarter 4 of 2011, and 10.4 (1.1) g/dL in quarters 1 and 2 of 2012. Hb levels were stable (mean SDs, 0.58-0.72) over the 5 quarters of the study. Patient compliance with attendance for all scheduled home training unit visits was 84%. IMPLICATIONS: PD patients who underwent darbepoetin alfa administration and twice-monthly laboratory testing in the home-training unit had stable Hb levels. Despite more frequent center visits compared with a home-administered approach, patient compliance was high.

Red blood cell (RBC) transfusion rates among US chronic dialysis patients during changes to Medicare end-stage renal disease (ESRD) reimbursement systems and erythropoiesis stimulating agent (ESA) labels.

BACKGROUND: Several major ESRD-related regulatory and reimbursement changes were introduced in the United States in 2011. In several large, national datasets, these changes have been associated with decreases in erythropoiesis stimulating agent (ESA) utilization and hemoglobin concentrations in the ESRD population, as well as an increase in the use of red blood cell (RBC) transfusions in this population. Our objective was to examine the use of RBC transfusion before and after the regulatory and reimbursement changes implemented in 2011 in a prevalent population of chronic dialysis patients in a large national claims database. METHODS: Patients in the Truven Health MarketScan Commercial and Medicare Databases with evidence of chronic dialysis were selected for the study. The proportion of chronic dialysis patients who received any RBC transfusion and RBC transfusion event rates per 100 patient-months were calculated in each month from January 1, 2007 to March 31, 2012. The results were analyzed overall and stratified by primary health insurance payer (commercial payer or Medicare). RESULTS: Overall, the percent of chronic dialysis patients with RBC transfusion and RBC transfusion event rates per 100 patient-months increased between January 2007 and March 2012. When stratified by primary health insurance payer, it appears that the increase was driven by the primary Medicare insurance population. While the percent of patients with RBC transfusion and RBC transfusion event rates did not increase in the commercially insured population between 2007 and 2012 they did increase in the primary Medicare insurance population; the majority of the increase occurred in 2011 during the same time frame as the ESRD-related regulatory and reimbursement changes. CONCLUSIONS: The regulatory and reimbursement changes implemented in 2011 may have contributed to an increase in the use of RBC transfusions in chronic dialysis patients in the MarketScan dataset who were covered by Medicare plus Medicare supplemental insurance.

Health care costs for patients with cancer at the end of life.

PURPOSE: With rising health care costs in the United States, clearly defined end-of-life (EOL) cancer costs are needed to help health administrators proactively manage this important care. Our objective was to examine EOL health care resource costs among oncology patients in a US commercial insurance population. METHODS: A retrospective claims database affiliated with OptumInsight was analyzed. Included patients had: a medical claim with cancer diagnosis between July 1, 2002, and December 31, 2009; death on or before December 31, 2009; continuous enrollment with medical/pharmacy benefits from diagnosis until death; ≥ 180 follow-up days; and active cancer in the last 6 months before death (MBD). Death was captured from facility discharge codes or Social Security Administration death files. Costs were determined by summing paid amounts on all services utilized within the last 6 MBD: cancer-related inpatient (IP) stays, cancer- related hospice care, and cancer-related outpatient (OP) services (ie, chemotherapy, erythropoiesis-stimulating agents, granulocyte colony-stimulating factors, radiation, cancer-related office or emergency room visits, cancer-related hospital OP procedures, and other services with cancer diagnosis). RESULTS: A total of 28,530 patients met inclusion criteria. Mean total cancer-related costs in the last 6 MBD were $74,212 (standard deviation, $112,740), comprising IP costs of $40,702 (55%), OP costs of $30,254 (41%), and hospice costs of $3,256 (4%). OP costs decreased from $6,021 in the sixth MBD to $2,238 in the last MBD, whereas IP care costs increased from $1,785 to $20,559. Hospice utilization increased from 0.7% in the sixth MBD to 35.6% in the last MBD. CONCLUSION: Oncology costs increase in the last 6 MBD largely because of increased IP costs, whereas OP costs decrease.