Outcome parameters for trials in atrial fibrillation: executive summary
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Outcome parameters for trials in atrial fibrillation: executive summary. / Kirchhof, Paulus; Auricchio, Angelo; Bax, Jeroen; Crijns, Harry; Camm, John; Diener, Hans-Christoph; Goette, Andreas; Hindricks, Gerd; Hohnloser, Stefan; Kappenberger, Lukas; Kuck, Karl-Heinz; Lip, Gregory Y H; Olsson, Bertil; Meinertz, Thomas; Priori, Silvia; Ravens, Ursula; Steinbeck, Gerhard; Svernhage, Elisabeth; Tijssen, Jan; Vincent, Alphons; Breithardt, Günter.
in: EUR HEART J, Jahrgang 28, Nr. 22, 11.2007, S. 2803-2817.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Outcome parameters for trials in atrial fibrillation: executive summary
AU - Kirchhof, Paulus
AU - Auricchio, Angelo
AU - Bax, Jeroen
AU - Crijns, Harry
AU - Camm, John
AU - Diener, Hans-Christoph
AU - Goette, Andreas
AU - Hindricks, Gerd
AU - Hohnloser, Stefan
AU - Kappenberger, Lukas
AU - Kuck, Karl-Heinz
AU - Lip, Gregory Y H
AU - Olsson, Bertil
AU - Meinertz, Thomas
AU - Priori, Silvia
AU - Ravens, Ursula
AU - Steinbeck, Gerhard
AU - Svernhage, Elisabeth
AU - Tijssen, Jan
AU - Vincent, Alphons
AU - Breithardt, Günter
PY - 2007/11
Y1 - 2007/11
N2 - Atrial fibrillation (AF), the most common atrial arrhythmia, has a complex aetiology and causes relevant morbidity and mortality due to different mechanisms, including but not limited to stroke, heart failure, and tachy- or bradyarrhythmia. Current therapeutic options (rate control, rhythm control, antithrombotic therapy, 'upstream therapy') only prevent a part of this burden of disease. Several new treatment modalities are therefore under evaluation in controlled trials. Given the multifold clinical consequences of AF, trials in AF patients should assess the effect of therapy in each of the main outcome domains. This paper describes an expert consensus of required outcome parameters in seven relevant outcome domains, namely death, stroke, symptoms and quality of life, rhythm, left ventricular function, cost, and emerging outcome parameters. In addition to these 'requirements' for outcome assessment in AF trials, further, more detailed outcome parameters are described. In addition to a careful selection of a relevant primary outcome parameter, coverage of outcomes in all major domains of AF-related morbidity and mortality is desirable for any clinical trial in AF.
AB - Atrial fibrillation (AF), the most common atrial arrhythmia, has a complex aetiology and causes relevant morbidity and mortality due to different mechanisms, including but not limited to stroke, heart failure, and tachy- or bradyarrhythmia. Current therapeutic options (rate control, rhythm control, antithrombotic therapy, 'upstream therapy') only prevent a part of this burden of disease. Several new treatment modalities are therefore under evaluation in controlled trials. Given the multifold clinical consequences of AF, trials in AF patients should assess the effect of therapy in each of the main outcome domains. This paper describes an expert consensus of required outcome parameters in seven relevant outcome domains, namely death, stroke, symptoms and quality of life, rhythm, left ventricular function, cost, and emerging outcome parameters. In addition to these 'requirements' for outcome assessment in AF trials, further, more detailed outcome parameters are described. In addition to a careful selection of a relevant primary outcome parameter, coverage of outcomes in all major domains of AF-related morbidity and mortality is desirable for any clinical trial in AF.
KW - Anti-Arrhythmia Agents/therapeutic use
KW - Anticoagulants/therapeutic use
KW - Atrial Fibrillation/economics
KW - Catheter Ablation/methods
KW - Costs and Cost Analysis
KW - Electric Countershock/methods
KW - Electrocardiography
KW - Heart Failure/etiology
KW - Hospitalization
KW - Humans
KW - Quality of Life
KW - Randomized Controlled Trials as Topic
KW - Stroke/etiology
KW - Treatment Outcome
KW - Ventricular Dysfunction, Left/etiology
U2 - 10.1093/eurheartj/ehm358
DO - 10.1093/eurheartj/ehm358
M3 - SCORING: Journal article
C2 - 17897924
VL - 28
SP - 2803
EP - 2817
JO - EUR HEART J
JF - EUR HEART J
SN - 0195-668X
IS - 22
ER -