Agreement between public register and adjudication committee outcome in a cardiovascular randomized clinical trial Erik Kjøller, MD, DMSc, Jørgen Hilden,

Slides:

Advertisements

Similar presentations

Chronic Lyme Disease: A Survey of Connecticut Primary Care Physicians Michael Johnson, MD, Henry M. Feder, MD The Journal of Pediatrics Volume 157, Issue.

Advertisements

Validity of the LaFarge equation for estimation of oxygen consumption in ventilated children with congenital heart disease younger than 3 years—A revisit.

Recurrence of pulmonary vein conduction and atrial fibrillation after pulmonary vein isolation for atrial fibrillation: A randomized trial of the ostial.

Dose-dependent effects of omega-3-polyunsaturated fatty acids on systolic left ventricular function, endothelial function, and markers of inflammation.

Rationale, design, and baseline characteristics of the Canagliflozin Cardiovascular Assessment Study (CANVAS)—A randomized placebo-controlled trial Bruce.

Prevalence, characteristics, and predictors of early termination of cardiovascular clinical trials due to low recruitment: Insights from the ClinicalTrials.gov.

Effects of β-erythropoietin treatment on left ventricular remodeling, systolic function, and B-type natriuretic peptide levels in patients with the cardiorenal.

Atrial fibrillation and quality of life after pacemaker implantation for sick sinus syndrome: Data from the Mode Selection Trial (MOST) Kirsten E. Fleischmann,

Downstream coronary effects of drug-eluting stents

Overview of the 2012 Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting on the Edwards SAPIEN.

Routine invasive management early after fibrinolysis: Relationship between baseline risk and treatment effects in a pooled patient-level analysis of 7.

Balloon aortic valvuloplasty in the era of transcatheter aortic valve replacement: Acute and long-term outcomes Hélène Eltchaninoff, MD, Eric Durand,

Overweight and obesity as risk factors for atrial fibrillation or flutter: The Danish Diet, Cancer, and Health Study Lars Frost, MD, PhD, Lone Juul Hune,

Ali Ahmed, MD, MPH, Gilbert J. Perry, MD, Jerome L. Fleg, MD, Thomas E

The impact of peripheral arterial disease on early outcome after transcatheter aortic valve implantation Jan-Malte Sinning, MD, Martin Horack, MS, Eberhard.

Efficacy of vaginal probiotic capsules for recurrent bacterial vaginosis: a double-blind, randomized, placebo-controlled study Wang Ya, MD, Cheryl Reifer,

Infective endocarditis in patients receiving chronic hemodialysis: A 21-year observational cohort study in Denmark Lene Ugilt Pagter Ludvigsen, MD, Lars.

The outcome of primary percutaneous coronary intervention for stent thrombosis causing ST-elevation myocardial infarction Mehmet Ergelen, MD, Sevket.

Neutral impact on systolic and diastolic cardiac function of 2 years of intensified multi- intervention in type 2 diabetes: The randomized controlled Asker.

Rationale and design of the FreezeAF trial: A randomized controlled noninferiority trial comparing isolation of the pulmonary veins with the cryoballoon.

Outcomes in patients with heart failure with preserved, borderline, and reduced ejection fraction in the Medicare population Richard K. Cheng, MD, MS,

Impact of weight reduction on pericardial adipose tissue and cardiac structure in patients with atrial fibrillation Hany S. Abed, BPharm, MBBS, PhD,

Variation among hospitals in selection of higher-cost, “higher-tech,” implantable cardioverter-defibrillators: Data from the National Cardiovascular Data.

Incidence, Frequency, and Clinical Characteristics of Type 3 Myocardial Infarction in Clinical Practice Nikolaj Jangaard, MD, Laura Sarkisian, MD, Lotte.

Rationale and design of the ATTRACT Study: A multicenter randomized trial to evaluate pharmacomechanical catheter-directed thrombolysis for the prevention.

Gender differences in adverse outcomes after contemporary percutaneous coronary intervention: An analysis from the Blue Cross Blue Shield of Michigan.

Evaluating the safety and efficacy of sodium-restricted/Dietary Approaches to Stop Hypertension diet after acute decompensated heart failure hospitalization:

Admission heart rate and in-hospital outcomes in patients hospitalized for heart failure in sinus rhythm and in atrial fibrillation Anh L. Bui, MD, Maria.

Prevalence and predictors of nonobstructive coronary artery disease identified with coronary angiography in contemporary clinical practice Manesh R.

Risk reduction of cardiac events by screening of unknown asymptomatic coronary artery disease in subjects with type 2 diabetes mellitus at high cardiovascular.

Effect of high-dose oral multivitamins and minerals in participants not treated with statins in the randomized Trial to Assess Chelation Therapy (TACT)

Manuel J. Antunes, MD, PhD, DSc

National evaluation of adherence to β-blocker therapy for 1 year after acute myocardial infarction in patients with commercial health insurance Judith.

Roy D. Ayalon, MD, Frederick Friedman, MD

Single-bolus tenecteplase plus heparin compared with heparin alone for normotensive patients with acute pulmonary embolism who have evidence of right.

Rationale and design of a randomized clinical trial to assess the safety and efficacy of frequent optimization of cardiac resynchronization therapy: The.

Fish oil supplementation during pregnancy and allergic respiratory disease in the adult offspring Susanne Hansen, MSc, Marin Strøm, PhD, Ekaterina Maslova,

Impact of More Restrictive Blood Transfusion Strategies on Clinical Outcomes: A Meta- analysis and Systematic Review Shelley R. Salpeter, MD, Jacob S.

Efficacy and safety of recombinant factor XIII on reducing blood transfusions in cardiac surgery: A randomized, placebo-controlled, multicenter clinical.

Aruna D. Pradhan, MD, Nader Rifai, PhD, Julie E. Buring, ScD, Paul M

Systematic Review and Meta-analysis of Adverse Events of Low-dose Aspirin and Clopidogrel in Randomized Controlled Trials Kenneth R. McQuaid, MD, Loren.

Overweight and obesity as risk factors for atrial fibrillation or flutter: The Danish Diet, Cancer, and Health Study Lars Frost, MD, PhD, Lone Juul Hune,

Trend in Mortality after Stroke with Atrial Fibrillation

A Randomized, Double-Blind, Placebo-Controlled Trial of Nutritional Supplementation During Acute Illness Salah Gariballa, MD, Sarah Forster, MSc, Stephen.

The Impact of Race on the Prognosis of Preclinical Diastolic Dysfunction: A Large Multiracial Urban Population Study Jian Shan, MD, Lili Zhang, MD, MSc,

Probiotics during the first 7 years of life: A cumulative risk reduction of eczema in a randomized, placebo-controlled trial Marko Kalliomäki, MD, PhD,

Clinical application of oocyte vitrification: a systematic review and meta-analysis of randomized controlled trials Ana Cobo, Ph.D., César Diaz, M.D.

Amiodarone Significantly Decreases Atrial Fibrillation in Patients Undergoing Surgery for Lung Cancer Lars P. Riber, MD, PhD, Thomas D. Christensen,

Surgical treatment is decisive for outcome in chondrosarcoma of the chest wall: A population-based Scandinavian Sarcoma Group study of 106 patients Björn.

Rikke E. Mols, RN, MSc, Jesper M

Incidence, Frequency, and Clinical Characteristics of Type 3 Myocardial Infarction in Clinical Practice Nikolaj Jangaard, MD, Laura Sarkisian, MD, Lotte.

Repeated Hemoglobin A1C Ordering in the VA Health System

Daniel E. Weiner, MD, MS American Journal of Kidney Diseases

William M. DeCampli, MD, PhD

Outcomes in lung transplantation after previous lung volume reduction surgery in a contemporary cohort Leah Backhus, MD, Jonathon Sargent, BS, Aaron.

Databases for Clinical Research

One-year results of thoracic endovascular aortic repair for blunt thoracic aortic injury (RESCUE trial) Ali Khoynezhad, MD, PhD, FACS, Carlos E. Donayre,

Debra J. Palmer, PhD, Thomas R. Sullivan, BMa&CompSc(Hons), Michael S

Intermediate-Term Outcome Of Mitral Reconstruction In Cardiomyopathy

Get it right the first time

Eagle's Syndrome The American Journal of Medicine

Aorta–Aorta Fistula: Another Uncommon Cause of Heart Failure

Primary Care Management of Skin Abscesses Guided by Ultrasound

Development of a patient-centered aggregate score to predict survival after lung resection for non–small cell lung cancer Alessandro Brunelli, MD, Michele.

Syphilitic aortitis: The bigger picture

The origins of open heart surgery at the University of Minnesota 1951 to 1956 Richard A. DeWall, MD The Journal of Thoracic and Cardiovascular Surgery

The Robin Hood principle in the treatment of congenital heart disease: Taking technologic developments intended for adults and using it in kids Paul.

Dialysis Research and N-of-1 Trials: Made for Each Other?

Short-term neuropsychologic differences after normothermic versus hypothermic cardiopulmonary bypass Dagmar Buschbeck, Friedrich-Christian Riess, MD,

Clinical outcomes after closed, staged, and open forefoot amputations

Presentation transcript:

Agreement between public register and adjudication committee outcome in a cardiovascular randomized clinical trial Erik Kjøller, MD, DMSc, Jørgen Hilden, MD, Per Winkel, MD, DMSc, Søren Galatius, MD, Phd, Niels Jørgen Frandsen, MD, Phd, Gorm B. Jensen, MD, DMSc, Jørgen Fischer Hansen, MD, DMSc, Jens Kastrup, MD, DMSc, Christian M. Jespersen, MD, DMSc, Per Hildebrandt, MD, DMSc, Hans Jørn Kolmos, MD, DMSc, Christian Gluud, MD, DMSc American Heart Journal Volume 168, Issue 2, Pages 197-204.e4 (August 2014) DOI: 10.1016/j.ahj.2013.12.032 Copyright © 2014 Mosby, Inc. Terms and Conditions

Figure Flow chart for data acquisition. The public registers at the bottom left are the same registers as were originally monitored by the CLARICOR coordinators, but for adjudication (right), they procured the underlying documents as specified by the arrows. American Heart Journal 2014 168, 197-204.e4DOI: (10.1016/j.ahj.2013.12.032) Copyright © 2014 Mosby, Inc. Terms and Conditions

American Heart Journal 2014 168, 197-204.e4DOI: (10.1016/j.ahj.2013.12.032) Copyright © 2014 Mosby, Inc. Terms and Conditions

Supplementary Figure Kaplan-Meier estimate of the primary outcome. Cumulative occurrence of the primary outcome on clarithromycin and placebo according to the AC and as deduced from public register records. American Heart Journal 2014 168, 197-204.e4DOI: (10.1016/j.ahj.2013.12.032) Copyright © 2014 Mosby, Inc. Terms and Conditions