The UCSD shortness of breath questionnaire has longitudinal construct validity in idiopathic pulmonary fibrosis.

Background: Idiopathic pulmonary fibrosis (IPF) is a progressive interstitial lung disease that often causes disabling dyspnea. In IPF and other lung diseases, patient-reported outcomes (PROs)-questionnaires designed to gather information from the patient's perspective-can determine whether therapies affect dyspnea or other outcomes meaningful to patients. Before a PRO can be used confidently as an outcome measure in a longitudinal trial, studies must demonstrate the PRO's ability to capture change over time in the target population.

Prednisone, azathioprine, and N-acetylcysteine for pulmonary fibrosis.

Background: A combination of prednisone, azathioprine, and N-acetylcysteine (NAC) has been widely used as a treatment for idiopathic pulmonary fibrosis. The safety and efficacy of this three-drug regimen is unknown.

Methods: In this randomized, double-blind, placebo-controlled trial, we assigned patients with idiopathic pulmonary fibrosis who had mild-to-moderate lung-function impairment to one of three groups -- receiving a combination of prednisone, azathioprine, and NAC (combination therapy), NAC alone, or placebo -- in a 1:1:1 ratio.

A placebo-controlled randomized trial of warfarin in idiopathic pulmonary fibrosis.

Rationale: Animal and human studies support the importance of the coagulation cascade in pulmonary fibrosis.

Objectives: In a cohort of subjects with progressive idiopathic pulmonary fibrosis (IPF), we tested the hypothesis that treatment with warfarin at recognized therapeutic doses would reduce rates of mortality, hospitalization, and declines in FVC.

Methods: This was a double-blind, randomized, placebo-controlled trial of warfarin targeting an international normalized ratio of 2.

Patient-focused intervention to improve long-term adherence to evidence-based medications: a randomized trial.

Background: Nonadherence to cardiovascular medications is a significant public health problem. This randomized study evaluated the effect on medication adherence of linking hospital and community pharmacists.

Methods: Hospitalized patients with coronary artery disease discharged on aspirin, β-blocker, and statin who used a participating pharmacy were randomized to usual care or intervention.

Idiopathic pulmonary fibrosis: clinically meaningful primary endpoints in phase 3 clinical trials.

Definitive evidence of clinical efficacy in a Phase 3 trial is best shown by a beneficial impact on a clinically meaningful endpoint-that is, an endpoint that directly measures how a patient feels (symptoms), functions (the ability to perform activities in daily life), or survives. In idiopathic pulmonary fibrosis (IPF), we believe the endpoints that best meet these criteria are all-cause mortality and all-cause nonelective hospitalization. There are no validated measures of symptoms or broader constructs such as health status or functional status in IPF.

Characteristics and long-term outcomes of percutaneous revascularization of unprotected left main coronary artery stenosis in the United States: a report from the National Cardiovascular Data Registry, 2004 to 2008.

Objectives: This study sought to assess percutaneous coronary intervention (PCI) for unprotected left main coronary artery (ULMCA) stenosis in routine U.S. clinical practice.

Linking the National Cardiovascular Data Registry CathPCI Registry with Medicare claims data: validation of a longitudinal cohort of elderly patients undergoing cardiac catheterization.

Background: The National Cardiovascular Data Registry CathPCI Registry was recently linked with longitudinal Centers for Medicare & Medicaid (CMS) claims data. The degree to which this linked cohort is representative of the overall CathPCI Registry and CMS PCI populations is unknown.

Methods And Results: CathPCI Registry records were linked to CMS inpatient claims using indirect identifiers.

Percutaneous coronary intervention and drug-eluting stent use among patients ≥85 years of age in the United States.

Objectives: This study assessed the comparative effectiveness of drug-eluting stents (DES) versus bare-metal stents (BMS) among patients ≥85 years of age.

Background: Despite an aging population, little is known about the comparative effectiveness of DES versus BMS among patients age ≥85 years undergoing percutaneous coronary intervention (PCI).

Methods: We examined 471,006 PCI patients age ≥65 years at 947 hospitals in the National Cardiovascular Data Registry between 2004 and 2008 and linked to Medicare claims data.

Nonfatal myocardial infarction and long-term outcomes in coronary artery disease.

Background: Therapies may reduce short-term rates of nonfatal myocardial infarction (MI) without a detectable effect on mortality. We sought to estimate the long-term clinical implications of nonfatal MI occurring within the first 3 and 6 months after initial cardiac catheterization.

Methods: We included consecutive patients with significant coronary artery disease (≥75% stenosis in ≥1 epicardial segments) undergoing diagnostic catheterization between January 1, 1999, and September 30, 2006.

Treatment with adenosine diphosphate receptor inhibitors-longitudinal assessment of treatment patterns and events after acute coronary syndrome (TRANSLATE-ACS) study design: expanding the paradigm of longitudinal observational research.

Background: Platelet inhibition is critical in reducing both short- and long-term atherothrombotic risks after acute myocardial infarction (MI), especially among patients managed with percutaneous coronary intervention (PCI). Currently available antiplatelet medications, including adenosine diphosphate (ADP) receptor inhibitors, have demonstrated variability in efficacy and safety in clinical trials, yet few studies have examined contemporary "real-world" approaches to platelet inhibition and associated outcomes.

Methods: TRANSLATE-ACS is a prospective observational study that will track up to 17,000 MI patients managed with PCI, from the inhospital to outpatient settings for up to 12 months postdischarge to provide a comprehensive picture of current treatment patterns and outcomes in routine clinical practice.

Safety and efficacy of drug-eluting stents in older patients with chronic kidney disease: a report from the linked CathPCI Registry-CMS claims database.

Objectives: The purpose of this study was to determine the safety and efficacy of drug-eluting stents (DES) compared with bare-metal stents (BMS) in older patients with chronic kidney disease (CKD).

Background: DES may be associated with late death and myocardial infarction (MI) secondary to stent thrombosis. However, data on outcomes in older patients with CKD are limited.

Diuretic strategies in patients with acute decompensated heart failure.

Background: Loop diuretics are an essential component of therapy for patients with acute decompensated heart failure, but there are few prospective data to guide their use.

Methods: In a prospective, double-blind, randomized trial, we assigned 308 patients with acute decompensated heart failure to receive furosemide administered intravenously by means of either a bolus every 12 hours or continuous infusion and at either a low dose (equivalent to the patient's previous oral dose) or a high dose (2.5 times the previous oral dose).

Improving Medication Adherence in a Regional Healthcare Information Exchange using a Scalable, Claims-Driven, and Service-Oriented Approach.

Evidence-based pharmacotherapy is a central aspect of optimal patient care for many chronic conditions. However, medication non-adherence frequently inhibits the attainment of optimal pharmacotherapy regimens. In this study, we designed, developed, and implemented a multifaceted clinical decision support (CDS) intervention that supports evidence-based pharmacotherapy and enhanced medication adherence through the use of a scalable, claims-driven, and service-oriented approach.

Clinical and economic results from a randomized trial of clinical decision support in a rural health network.

Background: Replication studies evaluate technologies in usual use settings.

Methods: We conducted a clinical trial to determine whether reductions in clinical and economic results observed in a previous study could be replicated in a larger setting. Subjects were randomized to receive intervention (email notifications for sentinel health events sent to their care managers) or control.

Mortality benefits from implantable cardioverter-defibrillator therapy are not restricted to patients with remote myocardial infarction: an analysis from the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT).

Background: The implantable cardioverter-defibrillator (ICD) is an effective therapy for preventing sudden cardiac death (SCD) in patients with prior myocardial infarction (MI) and reduced left ventricular function; however, the optimal timing of ICD implantation after MI remains unknown.

Objective: The purpose of this study was to determine whether the benefit of single-lead conservatively programmed ICD therapy varies as a function of time from MI to ICD implantation.

Methods: We compared time to all-cause death and SCD between the ICD and placebo arms in the Sudden Cardiac Death in Heart Failure Trial.

Central hair loss in African American women: incidence and potential risk factors.

Background: Although central scalp hair loss is a common problem in African American women, data on etiology or incidence are limited.

Objective: We sought to determine the frequency of various patterns and degree of central scalp hair loss in African American women and to correlate this with information on hair care practices, family history of hair loss, and medical history.

Methods: Five hundred twenty-nine subjects at six different workshops held at four different sites in the central and/or southeast United States participated in this study.

Economic assessment of thrombocytopenia: CATCH Registry.

Thrombocytopenia is associated with increased patient risk. However, the costs of this complication are not well defined. This study assessed the impact of thrombocytopenia on in-hospital costs using results from CATCH, an observational study that examined 1988 consecutive patients receiving prolonged heparin therapy (> or =96 h).

A controlled trial of sildenafil in advanced idiopathic pulmonary fibrosis.

Background: Sildenafil, a phosphodiesterase-5 inhibitor, may preferentially improve blood flow to well-ventilated regions of the lung in patients with advanced idiopathic pulmonary fibrosis, which could result in improvements in gas exchange. We tested the hypothesis that treatment with sildenafil would improve walk distance, dyspnea, and quality of life in patients with advanced idiopathic pulmonary fibrosis, defined as a carbon monoxide diffusion capacity of less than 35% of the predicted value.

Methods: We conducted a double-blind, randomized, placebo-controlled trial of sildenafil in two periods.

Discriminative capacity of biomarkers for acute stroke in the emergency department.

Background: Acute ischemic stroke remains largely a clinical diagnosis.

Objective: To assess the potential of several biomarkers to distinguish acute ischemic stroke from mimics in the emergency department (ED).

Methods: In this prospective study, 63 patients with suspected acute stroke were enrolled.

Quality of life effects of automatic external defibrillators in the home: results from the Home Automatic External Defibrillator Trial (HAT).

Background: Public access automatic external defibrillators (AEDs) can save lives, but most deaths from out-of-hospital sudden cardiac arrest occur at home. The Home Automatic External Defibrillator Trial (HAT) found no survival advantage for adding a home AED to cardiopulmonary resuscitation (CPR) training for 7,001 patients with a prior anterior wall myocardial infarction. Quality of life (QOL) outcomes for both the patient and spouse/companion were secondary end points.

Clopidogrel use and clinical events after drug-eluting stent implantation: findings from the HealthCore Integrated Research Database.

Background: Relationships between long-term use and level of dual antiplatelet therapy and outcomes after drug-eluting stent implantation are not well established.

Methods: This is a retrospective cohort study of 9,256 patients receiving drug-eluting stents between January 2003 and August 2006. We classified patients according to tertiles of clopidogrel use during the 12 months after stent implantation.

Optimal timing of implantable cardioverter-defibrillator implantation after myocardial infarction: a decision analysis.

Background: The optimal timing of implantable cardioverter defibrillator (ICD) placement for the primary prevention of sudden cardiac death after myocardial infarction (MI) remains unknown.

Methods And Results: We developed a Markov model to investigate the optimal timing of ICD implantation after MI (no ICD, ICD at 60 days, 6 months, and 1 year) in patients who meet current guidelines. Estimates of arrhythmic death (baseline risk 6%, range 1-20% per year), nonarrhythmic death, and ICD efficacy were based upon MADIT-II and other contemporary post-MI clinical trials.

Late safety, efficacy, and cost-effectiveness of a zotarolimus-eluting stent compared with a paclitaxel-eluting stent in patients with de novo coronary lesions: 2-year follow-up from the ENDEAVOR IV trial (Randomized, Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions).

Objectives: The aim of this study was to assess, after 2 years of follow-up, the safety, efficacy, and cost-effectiveness of a zotarolimus-eluting stent (ZES) compared with a paclitaxel-eluting stent (PES) in patients with native coronary lesions.

Background: Early drug-eluting stents were associated with a small but significant incidence of very late stent thrombosis (VLST), occurring >1 year after the index procedure. The ZES has shown encouraging results in clinical trials.