Optimizing data integration in trials that use EHR data: lessons learned from a multi-center randomized clinical trial.

Background: Despite great promise, trials that ascertain patient clinical data from electronic health records (EHR), referred to here as "EHR-sourced" trials, are limited by uncertainty about how existing trial sites and infrastructure can be best used to operationalize study goals. Evidence is needed to support the practical use of EHRs in contemporary clinical trial settings.

Main Text: We describe a demonstration project that used EHR data to complement data collected for a contemporary multi-center pharmaceutical industry outcomes trial, and how a central coordinating center supported participating sites through the technical, governance, and operational aspects of this type of activity.

Comparative Effectiveness of Aspirin Dosing in Cardiovascular Disease.

Background: The appropriate dose of aspirin to lower the risk of death, myocardial infarction, and stroke and to minimize major bleeding in patients with established atherosclerotic cardiovascular disease is a subject of controversy.

Methods: Using an open-label, pragmatic design, we randomly assigned patients with established atherosclerotic cardiovascular disease to a strategy of 81 mg or 325 mg of aspirin per day. The primary effectiveness outcome was a composite of death from any cause, hospitalization for myocardial infarction, or hospitalization for stroke, assessed in a time-to-event analysis.

Evaluating Foundational Data Quality in the National Patient-Centered Clinical Research Network (PCORnet®).

Introduction: Distributed research networks (DRNs) are critical components of the strategic roadmaps for the National Institutes of Health and the Food and Drug Administration as they work to move toward large-scale systems of evidence generation. The National Patient-Centered Clinical Research Network (PCORnet®) is one of the first DRNs to incorporate electronic health record data from multiple domains on a national scale. Before conducting analyses in a DRN, it is important to assess the quality and characteristics of the data.

Medicare utilization, screening, and costs among participants in the Southeastern Diabetes Initiative: A population-based evaluation.

Aims: Type 2 diabetes mellitus imposes significant burdens on patients and health care systems. Population-level interventions are being implemented to reach large numbers of patients at risk of or diagnosed with diabetes. We describe a population-based evaluation of the Southeastern Diabetes Initiative (SEDI) from the perspective of a payer, the Centers for Medicare & Medicaid Services (CMS).

The Effect of Clinical Care Location on Clinical Outcomes After Peripheral Vascular Intervention in Medicare Beneficiaries.

Objectives: Modifications in reimbursement rates by Medicare in 2008 have led to peripheral vascular interventions (PVI) being performed more commonly in outpatient and office-based clinics. The objective of this study was to determine the effects of this shift in clinical care setting on clinical outcomes after PVI.

Background: Modifications in reimbursement have led to peripheral vascular intervention (PVI) being more commonly performed in outpatient hospital settings and office-based clinics.

Significant variation in P2Y12 inhibitor use after peripheral vascular intervention in Medicare beneficiaries.

Unlabelled: There is no consensus regarding whether to use antithrombotic medications in patients with peripheral artery disease after lower-extremity peripheral vascular intervention.

Objectives: The main hypothesis is that significant variation exists regarding use of antithrombotic medications after lower-extremity peripheral vascular intervention. We sought to examine the patterns of postprocedural antithrombotic medication use and associated factors in Medicare patients.

Development and validation of a risk model for in-hospital worsening heart failure from the Acute Decompensated Heart Failure National Registry (ADHERE).

Background: A subset of patients hospitalized with acute heart failure experiences in-hospital worsening heart failure, defined as persistent or worsening signs or symptoms requiring an escalation of therapy.

Methods: We analyzed data from the Acute Decompensated Heart Failure National Registry (ADHERE) linked to Medicare claims to develop and validate a risk model for in-hospital worsening heart failure. Our definition of in-hospital worsening heart failure included events such as escalation of medical therapy (eg, inotropic medications) >12hours after admission.

Significant Morbidity and Mortality Among Hospitalized End-Stage Liver Disease Patients in Medicare.

Context: For end-stage liver disease (ESLD) patients, care focuses on managing the life-threatening complications of portal hypertension, causing high resource utilization.

Objectives: To describe the end-of-life trajectory of hospitalized ESLD patients in Medicare.

Methods: Using a 5% random sample of Medicare fee-for-service beneficiaries, we performed a retrospective cohort study, identifying hospitalized ESLD and heart failure (HF) patients (2007-2011).

TRENDS IN THE CARE AND OUTCOMES OF MEDICARE BENEFICIARIES WITH TYPE 2 DIABETES, 2002-2011.

Objective: To summarize characteristics of Medicare beneficiaries with type 2 diabetes and to describe changing trends in care and outcomes.

Methods: We conducted a retrospective cohort study of a nationally representative 5% sample of fee-for-service Medicare beneficiaries 65 years and older with prevalent type 2 diabetes, between January 1, 2002, and December 31, 2011. The main outcome measures were diabetes-related screening tests, mortality, hospital admissions, dialysis, and lower extremity amputation.

Appropriate baseline laboratory testing following ACEI or ARB initiation by Medicare FFS beneficiaries.

Background: Laboratory testing to identify contraindications and adverse drug reactions is important for safety of patients initiating angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs). Rates and predictors of appropriate testing among Medicare fee-for-service beneficiaries are unknown.

Purpose: The study's purpose was to examine baseline laboratory testing rates, identify predictors of suboptimal testing, and assess the prevalence of abnormal creatinine and potassium among beneficiaries initiating ACE inhibitors or ARBs.

Low-density lipoprotein cholesterol level and statin use among Medicare beneficiaries with diabetes mellitus.

At the time of this study, guidelines recommended a primary goal of low-density lipoprotein cholesterol level less than 100 mg/dL for all patients, an optional goal of low-density lipoprotein cholesterol less than 70 mg/dL for patients with overt cardiovascular disease and statins for patients with diabetes and overt cardiovascular disease and patients 40 years and older with diabetes and at least one risk factor for cardiovascular disease. This study examined statin use and achievement of lipid goals among 111,730 Medicare fee-for-service beneficiaries 65 years and older in 2011. Three-quarters of patients met the low-density lipoprotein cholesterol goal of less than 100 mg/dL.

Linkage of Laboratory Results to Medicare Fee-for-Service Claims.

Background: Medicare is the single largest purchaser of laboratory testing in the United States, yet test results associated with Medicare laboratory claims have historically not been available.

Objective: The purpose of this study was to describe both the linkage of laboratory results data to Medicare claims and the completeness of these results data. In a subgroup of beneficiaries initiating angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers, we also demonstrate the generalizability of Medicare beneficiaries with laboratory values compared with those without laboratory values.

Trends in settings for peripheral vascular intervention and the effect of changes in the outpatient prospective payment system.

Background: Peripheral vascular intervention (PVI) is an effective treatment option for patients with peripheral artery disease (PAD). In 2008, Medicare modified reimbursement rates to encourage more efficient outpatient use of PVI in the United States.

Objectives: The purpose of this study was to evaluate trends in the use and clinical settings of PVI and the effect of changes in reimbursement.

Relation of dyspnea severity on admission for acute heart failure with outcomes and costs.

Hospitalization for heart failure (HF) is frequently related to dyspnea, yet associations among dyspnea severity, outcomes, and health care costs are unknown. The aim of this study was to describe the characteristics of patients hospitalized for acute HF by dyspnea severity and to examine associations among dyspnea severity, outcomes, and costs. Registry data for patients hospitalized for HF were linked with Medicare claims to evaluate dyspnea and outcomes in patients ≥65 years of age.

Clinical effectiveness of cardiac resynchronization therapy versus medical therapy alone among patients with heart failure: analysis of the ICD Registry and ADHERE.

Background: Cardiac resynchronization therapy with defibrillator (CRT-D) reduces morbidity and mortality among selected patients with heart failure in clinical trials. The effectiveness of this therapy in clinical practice has not been well studied.

Methods And Results: We compared a cohort of 4471 patients from the National Cardiovascular Data Registry's Implantable Cardioverter-Defibrillator (ICD) Registry hospitalized primarily for heart failure and who received CRT-D between April 1, 2006, and December 31, 2009, to a historical control cohort of 4888 patients with heart failure without CRT-D from the Acute Decompensated Heart Failure National Registry (ADHERE) hospitalized between January 1, 2002, and March 31, 2006.

Associations between anticoagulation therapy and risks of mortality and readmission among patients with heart failure and atrial fibrillation.

Background: Patients with heart failure and atrial fibrillation are at higher risk of thromboembolic events than patients with heart failure alone. Yet, the use of anticoagulation therapy varies in clinical practice, especially among older patients, for whom its effectiveness is poorly understood.

Methods And Results: Using clinical registry data linked to Medicare claims from 2005 to 2011, we examined outcomes of older patients hospitalized with heart failure and atrial fibrillation who newly initiated anticoagulation therapy at discharge.

Periprocedural imaging and outcomes after catheter ablation of atrial fibrillation.

Objective: Catheter ablation of atrial fibrillation (AF) has become an increasingly safe and effective therapy. This has been partly attributed to the use of adjunctive imaging modalities. We aimed to describe the use and associated outcomes of periprocedural imaging for AF ablation.

In-hospital worsening heart failure and associations with mortality, readmission, and healthcare utilization.

Background: A subset of patients hospitalized with acute heart failure experiences worsening clinical status and requires escalation of therapy. Worsening heart failure is an end point in many clinical trials, but little is known about its prevalence in clinical practice and its associated outcomes.

Methods And Results: We analyzed inpatient data from the Acute Decompensated Heart Failure National Registry linked to Medicare claims to examine the prevalence and outcomes of patients with worsening heart failure, defined as the need for escalation of therapy at least 12 hours after hospital presentation.

Cost analysis of periprocedural imaging in patients undergoing catheter ablation for atrial fibrillation.

Cardiovascular imaging is an important part of procedural planning and safety for catheter ablation of atrial fibrillation (AF). However, the costs of imaging surrounding catheter ablation of AF have not been described. Medicare fee-for-service data were used to evaluate Medicare expenditures before, during, and after catheter ablation for AF from July 2007 to December 2009.

Anti-VEGF treatment patterns for neovascular age-related macular degeneration among medicare beneficiaries.

Purpose: To examine the use of anti-vascular endothelial growth factor (VEGF) therapy in clinical practice among patients with neovascular age-related macular degeneration (AMD).

Design: Retrospective cohort study.

Methods: Among 459 237 Medicare beneficiaries, we identified anti-VEGF treatment using claims for intravitreal injections of anti-VEGF medications with a supporting diagnosis of neovascular AMD.

Comparative effectiveness of cardiac resynchronization therapy with an implantable cardioverter-defibrillator versus defibrillator therapy alone: a cohort study.

Background: Trials comparing implantable cardioverter-defibrillator (ICD) therapy with cardiac resynchronization therapy with a defibrillator (CRT-D) are limited to selected patients treated at centers with extensive experience.

Objective: To compare outcomes after CRT-D versus ICD therapy in contemporary practice.

Design: Retrospective cohort study using the National Cardiovascular Data Registry's ICD Registry linked with Medicare claims.

Outcomes of medicare beneficiaries with heart failure and atrial fibrillation.

Objectives: This study sought to examine the long-term outcomes of patients hospitalized with heart failure and atrial fibrillation.

Background: Atrial fibrillation is common among patients hospitalized with heart failure. Associations of pre-existing and new-onset atrial fibrillation with long-term outcomes are unclear.

Predicting nursing home placement among home- and community-based services program participants.

Background: Several states offer publicly funded-care management programs to prevent long-term care placement of high-risk Medicaid beneficiaries. Understanding participant risk factors and services that may prevent long-term care placement can facilitate efficient allocation of program resources.

Objectives: To develop a practical prediction model to identify participants in a home- and community-based services program who are at highest risk for long-term nursing home placement, and to examine participant-level and program-level predictors of nursing home placement.

Self-reported health parameters compared with clinician measurements: methods in practice-based research.

Context: Self-reported health data are used by health insurance companies to assess risk. Most studies show underreporting compared with clinical measurements.

Objective: To compare self-reported height, weight, blood pressure, waist circumference, and dietary intake with registered dietitian's (RD's) measures of the same parameters.