A Primer for Managed Care Residents: How to Conduct Research Using Live Medical and Pharmacy Claims Data.

Managed care organizations are growing more sophisticated in their ability to analyze data. There are increasing numbers of data analysts at managed care organizations, as well as more types of real-time, or "live," data available. These data range from pharmacy claims and enrollment files to medical claims, medical records, and linkages to external data.

Determination of fasiglifam-induced liver toxicity: Insights from the data monitoring committee of the fasiglifam clinical trials program.

Background: Different approaches to safety event collection influence the determination of liver toxicity within drug development programs. Herein, a description of how fasiglifam-induced liver injury was detected is provided.

Methods: This eight-trial drug development program was intended to evaluate fasiglifam (25 mg, 50 mg) against placebo or active comparators (glimepiride, sitagliptin) in approximately 11,000 suboptimally controlled patients with type 2 diabetes (terminated Dec 2013 due to liver toxicity).

Using a Budget Impact Model Framework to Evaluate Antidiabetic Formulary Changes and Utilization Management Tools.

Background: Traditional budget impact models predict the financial consequences of a new drug entering the market. This study provides an example of applying the budget impact framework to a new research question of interest to managed care organizations-what is the budget impact of our formulary and utilization management (UM) policy changes?

Objective: To predict the 3-year annual budgetary impact of TRICARE's antidiabetic formulary and UM policy changes using TRICARE claims data.

Methods: A budget impact model was built in Microsoft Excel using health plan claims data for a 3-year time horizon.

Rethinking Cognitive Impairment in the Management of Older Patients With Cardiovascular Disease.

See Article by Gu et al.

Association of Primary Care Providers' Beliefs of Statins for Primary Prevention and Statin Prescription.

Background The 2013 American College of Cardiology/American Heart Association Cholesterol Treatment Guideline increased the number of primary prevention patients eligible for statin therapy, yet uptake of these guidelines has been modest. Little is known of how primary care provider ( PCP ) beliefs influence statin prescription. Methods and Results We surveyed 164 PCP s from a community-based North Carolina network in 2017 about statin therapy.

Association Between Driving Distance From Nearest Fire Station and Survival of Out-of-Hospital Cardiac Arrest.

Background Firefighter first responders dispatched in parallel with emergency medical services ( EMS ) personnel for out-of-hospital cardiac arrests ( OHCA ) can provide early defibrillation to improve survival. We examined whether survival following first responder defibrillation differed according to driving distance from nearest fire station to OHCA site. Methods and Results From the CARES (Cardiac Arrest Registry to Enhance Survival) registry, we identified non- EMS witnessed OHCA s of presumed cardiac cause from 2010 to 2014 in Durham, Mecklenburg, and Wake counties, North Carolina.

High-Sensitivity Troponin I in Hospitalized and Ambulatory Patients With Heart Failure With Preserved Ejection Fraction: Insights From the Heart Failure Clinical Research Network.

Background We sought to study the prevalence of high-sensitivity troponin and its association with cardiac structure and outcomes in ambulatory and hospitalized patients with heart failure with a preserved ejection fraction ( HF p EF ). Methods and Results A post hoc analysis utilized data from HF p EF patients: DOSE (Diuretic Optimization Strategies Evaluation) and CARRESS - HF (Cardiorenal Rescue Study in Acute Decompensated Heart Failure) enrolled patients hospitalized with acute HF p EF , and RELAX (Phosphodiesterase-5 Inhibition to Improve Clinical Status and Exercise Capacity in Heart Failure With Preserved Ejection Fraction) enrolled ambulatory patients with HF p EF . High-sensitivity troponin I (hs-TnI) was measured in hospitalized patients at baseline, at 72 to 96 hours, on day 7, and on day 60.

Effect of Once-Weekly Exenatide on Clinical Outcomes According to Baseline Risk in Patients With Type 2 Diabetes Mellitus: Insights From the EXSCEL Trial.

Background In the EXSCEL (Exenatide Study of Cardiovascular Event Lowering), exenatide once-weekly resulted in a nonsignificant reduction in major adverse cardiovascular events ( MACEs ) and a nominal 14% reduction in all-cause mortality in 14 752 patients with type 2 diabetes mellitus (T2 DM ) with and without cardiovascular disease. Whether patients at increased risk for events experienced a comparatively greater treatment benefit with exenatide is unknown. Methods and Results In the EXSCEL population, we created risk scores for MACEs and all-cause mortality using step-wise selection of baseline characteristics.

Measurement of Low-Density Lipoprotein Cholesterol Levels in Primary and Secondary Prevention Patients: Insights From the PALM Registry.

Background The 2013 American College of Cardiology/American Heart Association Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults recommended testing low-density lipoprotein cholesterol ( LDL -C) to identify untreated patients with LDL -C ≥190 mg/dL, assess lipid-lowering therapy adherence, and consider nonstatin therapy. We sought to determine whether clinician lipid testing practices were consistent with these guidelines. Methods and Results The PALM (Patient and Provider Assessment of Lipid Management) registry enrolled primary and secondary prevention patients from 140 US cardiology, endocrinology, and primary care offices in 2015 and captured demographic data, lipid treatment history, and the highest LDL -C level in the past 2 years.

Association of Bystander and First-Responder Efforts and Outcomes According to Sex: Results From the North Carolina HeartRescue Statewide Quality Improvement Initiative.

Background The Institute of Medicine has called for actions to understand and target sex-related differences in care and outcomes for out-of-hospital cardiac arrest patients. We assessed changes in bystander and first-responder interventions and outcomes for males versus females after statewide efforts to improve cardiac arrest care. Methods and Results We identified out-of-hospital cardiac arrests from North Carolina (2010-2014) through the CARES (Cardiac Arrest Registry to Enhance Survival) registry.

Advanced Practice Provider Versus Physician-Only Outpatient Follow-Up After Acute Myocardial Infarction.

Background Physician shortages and reimbursement changes have led to greater use of advanced practice providers ( APP s). Prevalence of and outcomes associated with APP care following myocardial infarction are unknown. Methods and Results We examined outpatient cardiology or primary care visits within 90 days post-myocardial infarction among 29 477 Medicare-insured patients aged ≥65 years from 364 hospitals in Acute Coronary Treatment Intervention Outcomes Network Registry.

Association of Gout With Long-Term Cardiovascular Outcomes Among Patients With Obstructive Coronary Artery Disease.

Background Epidemiological studies demonstrating a relationship between gout and cardiovascular disease are older and predate modern cardiovascular preventive therapy. We assessed the contemporary association between gout and cardiovascular disease in patients with obstructive coronary artery disease. Methods and Results Data were from the Duke Databank for Cardiovascular Diseases, which followed up patients undergoing cardiac catheterization with obstructive coronary artery disease at Duke University Medical Center (1998-2013).

Stroke Risk and Treatment in Patients with Atrial Fibrillation and Low CHADS-VASc Scores: Findings From the ORBIT-AF I and II Registries.

Background Current American College of Cardiology/American Heart Association guidelines suggest that for patients with atrial fibrillation who are at low risk for stroke (CHADSVASc=1) (or women with CHADSVASc=2) a variety of treatment strategies may be considered. However, in clinical practice, patterns of treatment in these "low-risk" patients are not well described. The objective of this analysis is to define thromboembolic event rates and to describe treatment patterns in patients with low-risk CHADSVASc scores.

Glycopyrrolate/eFlow CS: The First Nebulized Long-Acting Muscarinic Antagonist Approved to Treat Chronic Obstructive Pulmonary Disease.

Objective: To review the pharmacology, efficacy, and safety of the first nebulized long-acting muscarinic antagonist (LAMA), glycopyrrolate (GLY)/eFlow closed system (CS) nebulizer, approved for maintenance treatment of chronic obstructive pulmonary disease (COPD).

Data Sources: A PubMed search was conducted (January 2000 to July 2018) using the following terms/phrases: nebulized glycopyrrolate, inhalation devices in COPD, long-acting muscarinic antagonists COPD, and COPD survey. Retrieved articles were reviewed to identify additional references.

Novel approach to classifying patients with pulmonary arterial hypertension using cluster analysis.

Pulmonary arterial hypertension (PAH) patients have distinct disease courses and responses to treatment, but current diagnostic and treatment schemes provide limited insight. We aimed to see if cluster analysis could distinguish clinical phenotypes in PAH. An unbiased cluster analysis was performed on 17 baseline clinical variables of PAH patients from the FREEDOM-M, FREEDOM-C, and FREEDOM-C2 randomized trials of oral treprostinil versus placebo.

Assessment and provision of rehabilitation among patients hospitalized with acute ischemic stroke in China: Findings from the China National Stroke Registry II.

Background Stroke rehabilitation improves functional recovery among stroke patients. However, little is known about clinical practice in China regarding the assessment and provision of rehabilitation among patients with acute ischemic stroke. Aims We examined the frequency and determinants of an assessment for rehabilitation among acute ischemic stroke patients from the China National Stroke Registry II.

Model selection in multivariate semiparametric regression.

Variable selection in semiparametric mixed models for longitudinal data remains a challenge, especially in the presence of multiple correlated outcomes. In this paper, we propose a model selection procedure that simultaneously selects fixed and random effects using a maximum penalized likelihood method with the adaptive least absolute shrinkage and selection operator penalty. Through random effects selection, we determine the correlation structure among multiple outcomes and therefore address whether a joint model is necessary.

Maximizing value and minimizing barriers: Patient-centered community consultation for research in emergency settings.

Background: Patients with cardiac arrest and other life-threatening emergencies are unable to provide prospective consent for clinical trials. In the United States and other countries, regulations permit an exception from the requirement for informed consent in emergency settings. However, many potential barriers exist, as evidenced by the scarcity of US trials conducted under exception from the requirement for informed consent.

The impact of a failing right heart in patients supported by intra-aortic balloon counterpulsation.

Background: Intra-aortic balloon pumps (IABPs) provide primarily left ventricular support, yet few data detail the efficacy of this temporary mechanical circulatory support device in patients with concomitant right ventricular failure. We compared the efficacy of IABPs in cardiogenic shock patients with isolated left ventricular versus biventricular failure.

Methods: IABP-treated cardiogenic shock patients were identified from our center between 2006 and 2012, with patients stratified by either isolated left ventricular failure or biventricular failure.

A generalized semiparametric mixed model for analysis of multivariate health care utilization data.

Health care utilization is an outcome of interest in health services research. Two frequently studied forms of utilization are counts of emergency department (ED) visits and hospital admissions. These counts collectively convey a sense of disease exacerbation and cost escalation.

Adjuvant chemotherapy after resection of N1 non-small cell lung cancer: differential impact of new evidence on physician and patient decisions.

Background: Adjuvant cisplatin-based chemotherapy (ACT) after resection of stages II-IIIA non-small cell lung cancer (NSCLC) modestly increased survival in several clinical trials. This study evaluated the subsequent impact of those trials on ACT use in clinical practice.

Methods: Patients who underwent lobectomy or more extensive lung resection without induction chemotherapy for pathologically confirmed N1 positive NSCLC between 2000 and 2012 were reviewed.

VAD therapy 20/20: moving beyond the myopic view of a nascent therapy.

The past five years have seen remarkable growth in the use of durable, continuous flow left ventricular assist devices (LVAD) with associated improvements in mortality, quality of life, functionality and end-organ function. To sustain the growth of this important therapy, the LVAD community must now address key issues focused around the costs of LVAD care, refined patient selection, and reducing complications associated with this therapy. In this perspective piece, we discuss many of these issues.

Malignant struma ovarii: a population-level analysis of a large series of 68 patients.

Background: Malignant struma ovarii (MSO) is a germ cell tumor of the ovary histologically identical to differentiated thyroid cancers. There is a paucity of data on this neoplasm, with fewer than 200 reported cases. The primary objective of this study was to examine the survival rate of women diagnosed with MSO using data from the Surveillance, Epidemiology, and End RESULTS (SEER) database.

Informed consent for biobanking: consensus-based guidelines for adequate comprehension.

Purpose: Federal regulations and best practice guidelines identify categories of information that should be communicated to prospective biobank participants during the informed consent process. However, uncertainty remains about which of this information participants must understand to provide valid consent.

Methods: We conducted a Delphi process to define "adequate comprehension" in the context of biobanking consent.