Large Managed Care Population Research Articles

Examining recent trends in spontaneous and iatrogenic preterm birth across race and ethnicity in a large managed care population

For the past several decades, epidemiological studies originating from the United States have consistently reported increasing rates of preterm birth (PTB). Despite the implementation of several clinical and public health interventions to reduce PTB rates, it remains the leading cause of infant morbidity and mortality in the United States and around the world. This study aimed to examine recent trends in preterm birth and its clinical subtypes by maternal race and ethnicity among singleton births. Kaiser Permanente Southern California electronic health records for all singleton births between 2009 and 2020 (n=427,698) were used to examine preterm birth trends and their subtypes (spontaneous and iatrogenic preterm births). Data on preterm labor triage extracted from electronic health records using natural language processing were used to define preterm birth subtypes. Maternal race and ethnicity are categorized as non-Hispanic White, non-Hispanic Black, Hispanic, and non-Hispanic Asian or Pacific Islander. Multiple logistic regression was used to quantify the linear trend for preterm birth and its subtypes. Racial and ethnic trends were further examined by considering statistical interactions and stratifications. From 2009 to 2020, the overall preterm birth rate decreased by 9.12% (from 8.04% to 7.31%; P<.001). The rates decreased by 19.29% among non-Hispanic Whites (from 7.23% to 5.83%; P<.001), 6.15% among Hispanics (from 7.82% to 7.34%; P=.036), and 12.60% among non-Hispanic Asian or Pacific Islanders (from 8.90% to 7.78%; P<.001), whereas a nonsignificantly increased preterm birth rate (8.45%) was observed among non-Hispanic Blacks (from 9.91% to 10.75%; P=.103). Between 2009 and 2020, overall spontaneous preterm birth rates decreased by 28.85% (from 5.75% to 4.09%; P<.001). However, overall iatrogenic preterm birth rates increased by 40.45% (from 2.29% to 3.22%; p<.001). Spontaneous preterm birth rates decreased by 34.73% among non-Hispanic Whites (from 5.44% to 3.55%; P<.001), 19.75% among non-Hispanic Blacks (from 6.82% to 5.47%; P<.001), 22.96%among Hispanics (from 5.55% to 4.28%; P<.001), and 28.19% among non-Hispanic Asian or Pacific Islanders (from 6.50% to 4.67%; P<.001). Iatrogenic preterm birth rates increased by 52.42% among non-Hispanic Whites (from 1.88% to 2.61%; P<.001), 107.89% among non-Hispanic Blacks (from 3.18% to 6.13%; P<.001), 46.88% among Hispanics (from 2.29% to 3.26%; P<.001), and 42.21% among non-Hispanic Asian or Pacific Islanders (from 2.45% to 3.44%; P<.001). The overall preterm birth rate decreased over time and was driven by a decrease in the spontaneous preterm birth rate. There is racial and ethnic variability in the rates of spontaneous preterm birth and iatrogenic preterm birth. The observed increase in iatrogenic preterm birth among all racial and ethnic groups, especially non-Hispanic Blacks, is disconcerting and needs further investigation.

Increasing prevalence of metastatic castration-resistant prostate cancer in a managed care population in the United States.

Numerous treatment breakthroughs for patients with metastatic castration-resistant prostate cancer (mCRPC) have been demonstrated in clinical trials in the past 15years. However, real-world evidence on the changing epidemiology and longevity of this population has not been demonstrated. This study assessed prevalence trends for mCRPC over eightyears in a large managed care population. In a claims database, adult male patients were included with ≥ 1 claim for prostate cancer, pharmacologic/surgical castration, and metastatic disease during the identification period. The index mCRPC date was the first metastatic claim; sixmonths of continuous enrollment before and after was required. Patients with metastatic disease at baseline were excluded. Patients were followed until death, end of study, or disenrollment, whichever was earliest. Total, mCRPC per-prostate cancer, and age-specific prevalence rates were calculated cross-sectionally for each year under study (2010-2017). Of 343,089 patients identified with a claim for prostate cancer, 3690 mCRPC cases (1.1%) were identified. Incidence (new cases per year) remained relatively constant over the study period while prevalence of mCRPC (total cases per year) increased. mCRPC prevalence increased with increasing age. Total and mCRPC per-prostate cancer prevalence rates increased in monotonic, year-over-year trends from 2010 to 2017, while incidence (new cases per year) of mCRPC remained relatively stable. This study found increasing prevalence of mCRPC in an insured patient population during the 8-year period, coupled with stable incidence, validating that patients with the disease are living longer. With the addition of androgen receptor-directed therapies and poly(ADP-ribose) polymerase inhibitors in recent years, this trend will likely continue.

Healthcare resource utilization and costs associated with hyperkalemia in a large managed care population

Abstract Background Hyperkalemia is a serious metabolic condition and can lead to life-threatening cardiac arrhythmias and sudden death. Guideline-directed medications that affect the renin-angiotensin-aldosterone axis can increase serum potassium and may limit their use. Hyperkalemia has been shown to drive healthcare resource utilization (HRU) and costs for patients with cardiorenal conditions. Objectives To describe hyperkalemic patient characteristics and quantify patient HRU and costs relative to normokalemic patients from a large US health plan. Methods A retrospective cohort study that identified and evaluated a hyperkalemic patient population from a large administrative claims database. The observation period was 1 January 2015 to 31 May 2018, with a 1-year follow-up period after the index date (the earliest service/claim with evidence of hyperkalemia). Primary patient outcomes included inpatient admissions, emergency department (ED) visits, primary care physician (PCP)/specialist visits, length of stay (LOS) and associated medical and pharmacy costs. This hyperkalemic cohort was stratified by renin-angiotensin-aldosterone system inhibitor (RAASi) utilization and chronic kidney disease (CKD) stage for the economic analysis. Key findings 86,129 adult patients with hyperkalemia were evaluated in the study cohort (median age: 69 years). There were more males [45,155 (52%)], with the majority of patients located in the Southern United States [45,541 (51%)] and a 70/30 split of Medicare to a commercial health plan. Most patients had CKD, hypertension and hyperlipidemia; ≥80% of the patients had ≥4 comorbidities. Over 40% of patients were not receiving RAASi therapy, and potassium binder use was low (&amp;lt;5%). Patients using optimal-dose RAASi with proportion of days covered ≥80% were observed to have the lowest HRU for inpatient admissions, ED and PCP visits and LOS days. Conclusions Hyperkalemia is associated with substantial HRU and costs. The development of a quality improvement program structured around the management of hyperkalemia in individuals with heart failure, diabetes and/or CKD may be necessary.

Healthcare Utilization, Costs of Care, and Mortality Among Patients With Spinal Muscular Atrophy

Objectives: To understand treatment patterns, healthcare resource utilization, and costs of care among patients with spinal muscular atrophy (SMA). Methods: SMA patients were identified from a large managed care population using administrative claims data from January 2006 to March 2016. Patients were classified into infantile, childhood-onset, and late-onset groups based on age of first SMA diagnosis. They were matched 1:1 to non-SMA patients based on age, gender, geography, and health plan type. Results: In the infantile group, 17.4% and 26.1% were treated with invasive and non-invasive ventilation, respectively. Uses of orthotics/orthoses and orthopedic surgery were frequent: 54.5% and 22.7% childhood group; 27.0% and 38.5% late-onset group. Mean per member per month costs in SMA vs. matched non-SMA patients was $25,517 vs. $406 (infantile); $6,357 vs. $188 (childhood-onset); $2,499 vs. $742 (late-onset). Conclusions: SMA patients, particularly with infantile onset, incurred significantly higher healthcare utilization and costs than the general population.

Healthcare Utilization, Costs of Care, and Mortality Among Patients With Spinal Muscular Atrophy

Objectives: To understand treatment patterns, healthcare resource utilization, and costs of care among patients with spinal muscular atrophy (SMA). Methods: SMA patients were identified from a large managed care population using administrative claims data from January 2006 to March 2016. Patients were classified into infantile, childhood-onset, and late-onset groups based on age of first SMA diagnosis. They were matched 1:1 to non-SMA patients based on age, gender, geography, and health plan type. Results: In the infantile group, 17.4% and 26.1% were treated with invasive and non-invasive ventilation, respectively. Uses of orthotics/orthoses and orthopedic surgery were frequent: 54.5% and 22.7% childhood group; 27.0% and 38.5% late-onset group. Mean per member per month costs in SMA vs. matched non-SMA patients was $25,517 vs. $406 (infantile); $6,357 vs. $188 (childhood-onset); $2,499 vs. $742 (late-onset). Conclusions: SMA patients, particularly with infantile onset, incurred significantly higher healthcare utilization and costs than the general population.

Healthcare Utilization, Costs of Care, and Mortality Among Psatients With Spinal Muscular Atrophy.

ObjectivesTo understand treatment patterns, healthcare resource utilization, and costs of care among patients with spinal muscular atrophy (SMA). Methods: SMA patients were identified from a large managed care population using administrative claims data from January 2006 to March 2016. Patients were classified into infantile, childhood-onset, and late-onset groups based on age of first SMA diagnosis. They were matched 1:1 to non-SMA patients based on age, gender, geography, and health plan type.ResultsIn the infantile group, 17.4% and 26.1% were treated with invasive and non-invasive ventilation, respectively. Uses of orthotics/orthoses and orthopedic surgery were frequent: 54.5% and 22.7% childhood group; 27.0% and 38.5% late-onset group. Mean per member per month costs in SMA vs. matched non-SMA patients was $25,517 vs. $406 (infantile); $6,357 vs. $188 (childhood-onset); $2,499 vs. $742 (late-onset).ConclusionsSMA patients, particularly with infantile onset, incurred significantly higher healthcare utilization and costs than the general population.

Healthcare Utilization, Costs of Care, and Mortality Among Patients With Spinal Muscular Atrophy.

Objectives: To understand treatment patterns, healthcare resource utilization, and costs of care among patients with spinal muscular atrophy (SMA). Methods: SMA patients were identified from a large managed care population using administrative claims data from January 2006 to March 2016. Patients were classified into infantile, childhood-onset, and late-onset groups based on age of first SMA diagnosis. They were matched 1:1 to non-SMA patients based on age, gender, geography, and health plan type. Results: In the infantile group, 17.4% and 26.1% were treated with invasive and non-invasive ventilation, respectively. Uses of orthotics/orthoses and orthopedic surgery were frequent: 54.5% and 22.7% childhood group; 27.0% and 38.5% late-onset group. Mean per member per month costs in SMA vs.matched non-SMA patients was $25,517 vs.$406 (infantile); $6,357 vs.$188 (childhood-onset); $2,499 vs.$742 (late-onset). Conclusions: SMA patients, particularly with infantile onset, incurred significantly higher healthcare utilization and costs than the general population.

A Multi-Level Fit-Based Quality Improvement Initiative to Improve Colorectal Cancer Screening in a Managed Care Population.

IntroductionColorectal cancer (CRC) is a common but largely preventable disease with suboptimal screening rates despite national guidelines to screen individuals age 50–75. Single-component interventions aimed to improve screening uptake only modestly improve rates; data suggest that multi-modal approaches may be more effective.MethodsWe designed, implemented, and evaluated the impact of a multi-modal intervention on CRC screening uptake among unscreened patients in a large managed care population. Patient-level components included a mailed letter with education about screening options and pre-colonoscopy telephone counseling. For providers, we facilitated communication of screening test results and work-flow for abnormal results. System-level modifications included establishment of a patient navigator, expedited work-up for abnormal results, and stream-lined colonoscopy scheduling. We measured the rate of screening uptake overall, screening uptake by modality, change in the proportion of the population screened, and positive fecal immunochemical test (FIT) follow-up rates in the 1-year study period.ResultsThere were 5093 patients in the intervention cohort. Of these, 33.2% participated in FIT or colonoscopy screening within 1 year of the mailing. A total of 1078 (21.2%) participants completed a FIT and 611 (12.0%) completed a screening colonoscopy. The screening rate in the managed care population increased from 65.1 to 76.6%. Fifty-nine patients (5.5%) had a positive FIT, of which 30 (50.8%) completed a diagnostic colonoscopy.ConclusionMulti-modal interventions can result in substantial improvement in CRC screening uptake in large and diverse managed care populations.Translational ImpactHealth systems should shift their focus from single-level to multi-level interventions when addressing barriers to CRC screening.

Healthcare resource utilization, costs of care, and treatment of mycosis fungoides cutaneous T-cell lymphoma patterns in a large managed care population: a retrospective US claims-based analysis

Purpose: To evaluate health care utilization, treatment patterns and costs among patients with mycosis fungoides-cutaneous T-cell lymphoma (MF-CTCL).Methods: This retrospective cohort study queried the HealthCore Integrated Research Database to identify patients ≥18 years with ≥2 diagnoses of MF-CTCL (ICD-9-CM code 202.1x, 202.2x) between 07 January 2006 and 07 January 2013. Index date was defined as first MF-CTCL diagnosis. Patients were continuously enrolled ≥6 months before and ≥12 months after index date. Severe MF-CTCL was identified via systemic therapy use postindex. Generalized linear model (GLM) was used to estimate the relationship between MF-CTCL severity and healthcare costs controlling for selected factors.Results: A total of 1981 MF-CTCL patients were evaluated: 493 (24.9%) severe and 1488 (75.1%) with mild to moderate disease. GLM analysis indicated severe MF-CTCL patients incurred higher all-cause healthcare total costs compared to patients with mild-to-moderate MF-CTCL (coefficient estimate: 4.19, p < .0001). About 51% of patients did not receive any MF-CTCL-specific treatment within 60 days after MF-CTCL diagnosis.Conclusions: MF-CTCL severity was associated with greater healthcare resource utilization and costs. These findings suggest that about half of MF-CTCL patients do not receive MF-CTCL-specific treatment within 60 days following initial diagnosis. Future studies are needed to understand reasons for delayed treatment initiation.

Su1578 - A Multilevel Quality Improvement Initiative to Improve Colorectal Cancer Screening in a Managed Care Population

Colorectal cancer (CRC) is a common but largely preventable disease with suboptimal screening rates despite national guidelines to screen individuals age 50–75. Single-component interventions aimed to improve screening uptake only modestly improve rates; data suggest that multi-modal approaches may be more effective. We designed, implemented, and evaluated the impact of a multi-modal intervention on CRC screening uptake among unscreened patients in a large managed care population. Patient-level components included a mailed letter with education about screening options and pre-colonoscopy telephone counseling. For providers, we facilitated communication of screening test results and work-flow for abnormal results. System-level modifications included establishment of a patient navigator, expedited work-up for abnormal results, and stream-lined colonoscopy scheduling. We measured the rate of screening uptake overall, screening uptake by modality, change in the proportion of the population screened, and positive fecal immunochemical test (FIT) follow-up rates in the 1-year study period. There were 5093 patients in the intervention cohort. Of these, 33.2% participated in FIT or colonoscopy screening within 1 year of the mailing. A total of 1078 (21.2%) participants completed a FIT and 611 (12.0%) completed a screening colonoscopy. The screening rate in the managed care population increased from 65.1 to 76.6%. Fifty-nine patients (5.5%) had a positive FIT, of which 30 (50.8%) completed a diagnostic colonoscopy. Multi-modal interventions can result in substantial improvement in CRC screening uptake in large and diverse managed care populations. Health systems should shift their focus from single-level to multi-level interventions when addressing barriers to CRC screening.

Biologic Cost per Effectively Treated Rheumatoid Arthritis Patient in a Large Managed Care Population: A Retrospective Cohort Study.

Background: Until recently, the lack of clinical outcomes information for rheumatoid arthritis (RA) in administrative claims databases limited their use in comparative effectiveness research. A validated claims-based algorithm has been developed to estimate the effectiveness of biologics for RA, allowing for estimation of cost and effectiveness in the same database. Objectives: To implement a validated claims-based effectiveness algorithm in a US managed care claims database to compute the 1-year biologic cost per effectively treated patient among first-line biologics approved for moderate-to-severe RA (abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, and infliximab). Methods: This retrospective cohort study used administrative claims data for individuals in the HealthCore Integrated Research Database (HIRDSM). The first claim for a first-line biologic between July 1, 2009, and January 31, 2013, after 6 months of continuous enrollment, was defined as the index event and date. Patients were aged 18-63 years on the index date and had at least one claim for RA in the 6-month pre- index period. Biologic costs included plan and patient paid amounts on claims for the biologic drug and administration. The algorithm defined effectiveness during the 12-month post-index period as achieving all six of the following: high adherence (medication possession ratio ≥80% or infusions consistent with the product label); no increase in biologic dose or decrease in dosing interval; no new biologic; no new nonbiologic disease-modifying antirheumatic drug; no new or increased oral glucocorticoid use; and ≤1 glucocorticoid injection. Cost per effectively treated patient was calculated as the total biologic cost (drug and administration) divided by the number of patients categorized by the algorithm as effectively treated. Results: The cohort comprised 4844 patients (mean age 48.6 years, 76.4% female). Average first-year biologic cost ranged from $14 795 (golimumab) to $19 520 (abatacept). Average first-year biologic cost per effectively treated patient was significantly lower for etanercept ($50 217) than for golimumab ($56 427, p<0.001) adalimumab ($56 879, p<0.001), abatacept ($68 062, p<0.001), certolizumab pegol ($76 427, p<0.001), and infliximab ($95 126, p<0.001). Conclusions: In this application of a validated claims-based algorithm to a large managed care population, etanercept had the lowest 1-year biologic cost per effectively treated patient among first-line biologics.

Insignificant medium-term vitamin D status change after 25-hydroxyvitamin D testing in a large managed care population.

ObjectivesTo examine the clinical utility of 25-hydroxyvitamin D (25(OH)D) testing in achieving medium-term vitamin D (VD) sufficiency in a managed care population.MethodsRetrospective study of a continuously-enrolled patient population in a 3-year period between 2011 and 2013. Primary outcome was VD status at ∼1 year after 25(OH)D testing. Patient demographics, comorbidities, medications, and 25(OH)D test results were gathered from relevant databases and multivariate logistic regression analysis used to study the risk factors of persistent VD deficiency or insufficiency.ResultsOf 22,784 patients, 7533 (females 69.3%) did 14,563 25(OH)D tests, with an estimated cost of $582,520. Of the 7533 patients, 1126 had another 25(OH)D test at 300–400 days after the first one. Based on the two test results, 234 patients (20.8%) maintained sufficient 25(OH)D levels; 132 (11.7%) turned from VD-sufficient into VD-insufficient or -deficient; 538 (47.8%) remained VD-insufficient or -deficient, and only 222 (19.7%) improved to be VD-sufficient. Overall, only 8.0% more patients were VD-sufficient at ∼1 year after 25(OH)D testing. Only younger age and higher BMI were independent risk factors for persistent low 25(OH)D levels and high-dose VD use was not associated with achieving VD sufficiency.Conclusions25(OH)D testing only benefits a small portion of patients thus lacks clinical utility in achieving VD sufficiency in the medium term but incurs a significant cost. A practical strategy to treat VD deficiency or insufficiency is needed; without it, 25(OH)D testing adds little value to most patients’ health and should be used with discretion.

Erratum to: Survival and hospitalization among patients with acute myeloid leukemia treated with azacitidine or decitabine in a large managed care population: a real-world, retrospective, claims-based, comparative analysis

Erratum to: Survival and hospitalization among patients with acute myeloid leukemia treated with azacitidine or decitabine in a large managed care population: a real-world, retrospective, claims-based, comparative analysis

Survival and hospitalization among patients with acute myeloid leukemia treated with azacitidine or decitabine in a large managed care population: a real-world, retrospective, claims-based, comparative analysis

BackgroundThis study examined patient outcomes using real world data for acute myeloid leukemia (AML) patients initiating treatment.MethodsA retrospective, administrative claims-based, comparative analysis was developed to study outcomes for AML patients initiating treatment with decitabine or azacitidine between January 2006 and June 2012.ResultsTreatment with azacitidine was associated with a longer median overall survival (10.1 versus 6.9 mos., p = 0.007) and a lower risk of hospitalization (HR 0.787, p = 0.02) compared to treatment with decitabine.ConclusionsThis analysis of the outcomes of real-world treatment of AML patients with demethylating agents suggests that azacitidine may result in clinically superior outcomes than decitabine.

Prevalence and incidence of adult attention deficit/hyperactivity disorder in a large managed care population

Objectives:To estimate longitudinal trends in prevalence and incidence rates of adult ADHD 2006–2009.Research design and methods:Kaiser Permanente Southern California (KPSC) electronic medical records were analyzed to assess prevalence and incidence rates for adult ADHD. Trends over time were estimated and compared using three case definitions (ADHD diagnosis only [DX], ADHD DX and ≥2 FDA-approved ADHD prescriptions [DX + RX], and ADHD DX and ≥1 behavioral therapy visit [DX + BT]).Main outcome measures:Prevalence and incidence rates of adult ADHD.Results:Prevalence ranged from 151 (DX + RX) to 312 (DX) cases per 100,000 members in 2006, increasing to 239 (DX + RX) and 415 (DX) cases in 2009. Prevalence based on DX + BT declined from 185 in 2006 to 94 cases per 100,000 in 2009. In 2006, incidence ranged from 15 (DX + BT) to 68 (DX) cases per 100,000 person-years. Incidence rates remained stable throughout the study period. Stratified analyses based on DX + RX revealed only slight variations by gender, but sharp differences by age, with younger adults demonstrating a higher prevalence overall as well as dramatic increases over the study period. Prevalence was highest among Caucasians, increasing substantially across all race groups over time.Limitations:A limitation of this study is that incidence rates may not be representative of new cases if diagnoses existed prior to enrollment in KPSC. Similarly, prevalence rates may be affected if patients sought care outside of the health plan.Conclusions:Adult ADHD prevalence in this managed care organization appears low, but showed increasing prevalence and incidence rates over time.

Bleeding as an Outcome Among Patients With Nonvalvular Atrial Fibrillation in a Large Managed Care Population

BackgroundPatients with nonvalvular atrial fibrillation (NVAF) are at increased risk for stroke and bleeding events, but bleeding as an outcome has not been extensively studied in this patient population. ObjectivesThe goal of this study was to estimate the incidence of bleeding events among patients with NVAF enrolled in managed care, investigate the relationships between bleeding incidence and bleeding and stroke risks, and estimate health care costs for patients who had a major bleeding event. MethodsAdults with commercial insurance or Medicare Advantage coverage and health care claims related to AF between January 2005 and June 2009 but with no evidence of valvular disease were included in this retrospective claims data analysis. Baseline stroke risk (CHADS2 [Congestive Heart Failure, Hypertension, Age >75 Years, Diabetes Mellitus, and Prior Stroke or Transient Ischemic Attack]) and bleeding risk (HAS-BLED [Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratios, Elderly, Drugs/Alcohol]) were estimated. Bleeding events were identified during the variable follow-up period, which lasted from the date of the first qualifying AF visit until the earlier of death, disenrollment from the health plan, or June 30, 2010. Bleeding events were classified as major, serious nonmajor, or minor. Health care costs for patients with major bleeding events were calculated. ResultsAmong 48,260 patients with NVAF (mean age, 67 years), 34% had an incident bleeding event during a mean (SD) follow-up period of 802 (540) days. Incidence rates for bleeding events of any severity and major events were 29.6 and 10.4 per 100 patient-years, respectively. Bleeding incidence rates increased with greater CHADS2 and HAS-BLED risk scores. All-cause health care costs for patients during a major bleeding event averaged $16,830. Average costs per patient with a major event increased from approximately $52 per day in the prebleeding period to approximately $63 per day in the postbleeding period. Costs for patients who did not experience a major bleeding event averaged approximately $38 per day. ConclusionsBleeding incidence among patients with NVAF in a real-world setting was high and increased with greater stroke and bleeding risk scores. Health care costs for patients with major bleeding events were elevated. All rights reserved.

Warfarin Use and Stroke Risk Among Patients With Nonvalvular Atrial Fibrillation in a Large Managed Care Population

Stroke prevention is a goal of atrial fibrillation (AF) management, but discontinuation of warfarin anticoagulation therapy is common. To investigate the association between warfarin discontinuation and hospitalization for stroke among nonvalvular AF (NVAF) patients enrolled in managed care. Patients with NVAF who initiated warfarin therapy from January 2005 through June 2009 were included. Warfarin discontinuation was defined as a supply gap >60 days without evidence of International Normalized Ratio measurements. Follow-up, which was a variable time period from warfarin initiation until the earlier of death, disenrollment from the health plan, or June 30, 2010, was divided into periods of warfarin treatment and discontinuation. Stroke events were identified based on claims for inpatient stays with a primary diagnosis of stroke or transient ischemic attack. Cox proportional hazards models were constructed to assess the relationship between warfarin discontinuation and incident stroke while adjusting for baseline demographics, stroke and bleeding risk, and comorbidities, as well as time-dependent antiplatelet use, stroke, and bleeding events in the previous warfarin treatment period. Among warfarin initiators with NVAF (N = 16,253), 51.4% discontinued warfarin therapy at least once during a mean follow-up of 668 days. Stroke risk was significantly greater during warfarin discontinuation periods compared with therapy periods (hazard ratio = 1.60; 95% CI, 1.35-1.90; P < 0.001). More than half of patients on warfarin had treatment gaps or discontinued therapy. Therapy gaps were associated with increased stroke risk.

Clinical and Economic Outcomes Among Patients With Diabetes Mellitus Initiating Insulin Glargine Pen Versus Vial

Background: Insulin pens may help patients reach glycated hemoglobin (HbA1c) target levels, but a substantial proportion of patients continue to use insulin vials/syringes. The objective of the current study was to evaluate real-world clinical and economic outcomes of patients with type 2 diabetes mellitus (T2DM) initiating insulin glargine via pen delivery (pen) or vial/syringe (vial) within a large managed-care population in the United States. Methods: This retrospective administrative claims study used data on adult, insulin-naïve patients with T2DM treated with ≥ 1 oral antidiabetic or glucagon-like peptide-1 receptor agonist at baseline. The index date was the earliest pen or vial prescription date. Propensity score matching (1:1) of patients in the pen and vial cohorts was used when comparing 1-year outcomes, including treatment persistence and adherence, HbA1c levels, hypoglycemia rates, and all-cause and diabetes-related health care costs (computed as paid amounts on claims). Results: Patients in the matched cohorts (n=73 3 per cohort) were well balanced with regard to demographics (mean age 52 years; 43% women), clinical measures (mean HbA1c level, 9.4%; mean Quan-Modified Charlson Comorbidity Index score, 0.9), and health care utilization at baseline. Following initiation of insulin glargine, pen patients were more persistent (60.6% vs 50.1%; P < 0.001) and adherent (medication possession ratio, 0.73 vs 0.57; P < 0.001), with lower HbA1c levels during follow-up (mean adjusted change, −1.05 vs −0.73; P < 0.001), compared with vial patients. Hypoglycemic events occurred at similar rates across pen and vial cohorts (3.8% vs 5.2%, respectively; P = 0.21). Study drug costs were higher among pen users ($1164 vs $762, respectively; P < 0.001), but this did not translate into higher total all-cause or diabetes-related costs. Conclusion: For patients with diabetes newly initiating insulin glargine, using an insulin pen device was associated with increased therapy persistence and adherence, and lower HbA1c levels relative to vial/syringe, without increasing total all-cause or diabetes-related costs.

Changes in serum prostate‐specific antigen levels and the identification of prostate cancer in a large managed care population

To determine whether the rate of change in total serum prostate-specific antigen (PSA) levels accurately detects prostate cancer and to evaluate whether it adds any predictive value to a single measurement of serum PSA alone, in general practice settings. A retrospective cohort of 219,388 community-dwelling men, aged ≥45 years, enrolled in the Kaiser Permanente Southern California health plan, with no history of prostate cancer and at least three PSA measurements, were followed from 1 January 1998 to 31 December 2007, for the development of biopsy-confirmed prostate cancer. Annual percent changes in total serum PSA levels were estimated using linear mixed models. The accuracy of prostate cancer prediction was assessed for prostate cancer overall and for aggressive disease (Gleason score ≥7) and compared with that of a single measure of PSA level using area under the receiver-operating characteristic curves (AUCs). The men in this cohort experienced a mean change of 2.9% in PSA levels per year and the rate of change in PSA increased modestly with age (P ≤ 0.001). Annual percent changes in PSA accurately predicted the presence of prostate cancer (AUC = 0.963) and aggressive disease (AUC = 0.955) and had more predictive accuracy for aggressive disease than did a single measurement of PSA alone (AUC = 0.727). Longitudinal measures of PSA improve the accuracy of aggressive prostate cancer detection when compared with a single measurement of PSA alone. Findings from this study provide insight into the usefulness of PSA velocity as a detection marker for aggressive prostate cancer.

Type of Bleeding Among Patients with Nonvalvular Atrial Fibrillation in a Large Managed Care Population

AbstractAbstract 2073 Background:Risk of bleeding is an important consideration among patients with nonvalvular atrial fibrillation (NVAF), and different anatomical sites may carry greater risk for bleeding. Objective:To describe the incidence of critical anatomical site bleeding events among patients with NVAF in the pre-NOAC (novel oral anticoagulation) era. Methods:Administrative claims data were used for this retrospective study. Adults with healthcare claims related to atrial fibrillation (ICD-9-CM 427.31) between Jan 2005 and Jun 2009 but no evidence of valvular disease were included. Patients were followed until the earliest of death, disenrollment from the health plan, or 30 Jun 2010. Bleeding events in the follow-up period were considered major if they were associated with any of the following: inpatient care, blood transfusion, decreased hemoglobin or hematocrit, physician guided medical or surgical treatment, intracranial bleed, or death. Anatomical bleeding sites were identified based on diagnosis codes. Results:The mean (SD) age of the study sample (N=48,260) was 67 (13) years and 62.2% of the patients were male. Mean (SD) follow-up duration was 802 (540) days (median 673 days). Over 105,419 patient-years, the critical site with the highest rate of major bleeding events was the gastrointestinal tract, followed by intracranial bleeding (TABLE).TableMajor Bleeding Event Rates by Critical SiteCritical Site/Bleeding DiagnosisMajor EventsRate Per 100 Patient-YearsGastrointestinal3,6923.50Intracranial1,1721.11Pericardial8180.78Hepatic4110.39Hemarthrosis1700.16Retroperitoneal1000.09Kidney890.08Intraocular/periocular370.04Intraspinal140.01Splenic80.01 Conclusions:Gastrointestinal, intracranial, and pericardial bleedings were the most frequently observed major bleedings in the pre-NOAC era. Patients with NVAF have a high rate of major gastrointestinal bleedings. Disclosures:Deitelzweig:Bristol-Myers Squibb/OptumInsight: Research Funding, Speakers Bureau. Pinsky:OptumInsight: Employment. Buysman:OptumInsight: Employment. Lacey:OptumInsight: Employment. Makenbaeva:Bristol-Myers Squibb: Employment, Equity Ownership. Wiederkehr:Pfizer: Employment, Equity Ownership. Graham:Bristol-Myers Squibb: Employment, Equity Ownership.