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Adjudication of mortality events in a heart failure-arrhythmia trial by a multiparameter descriptive method: comparison with methods used in heart failure trials and methods used in arrhythmia trials.

Boehmer, John P (author)
Carlson, Mark D (author)
De Marco, Teresa (author)
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Jaski, Brian E (author)
Higgins, Steven L (author)
Kennergren, Charles, 1948 (author)
Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för molekylär och klinisk medicin,Institute of Medicine, Department of Molecular and Clinical Medicine
Epstein, Andrew E (author)
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 (creator_code:org_t)
2008-07-04
2008
English.
In: Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing. - : Springer Science and Business Media LLC. - 1383-875X. ; 23:2, s. 101-10
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  • Journal article (peer-reviewed)
Abstract Subject headings
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  • INTRODUCTION: Mortality events in studies of cardiovascular disease are currently adjudicated using different methodologies depending on the investigators' preferences. Traditionally, deaths have been categorized by a single term, such as sudden, ischemic, or pump failure, a method that can be referred to as "categorical". In contrast, deaths may be categorized using several specific pieces of information about the event, a method that can be referred to as "multiparameter descriptive." Herein, we describe an adaptation of this descriptive method in a trial of patients with heart failure and arrhythmias. METHODS AND RESULTS: Case examples were selected from two clinical trials of an investigational implantable cardioverter-defibrillator (ICD)-biventricular pacing system in patients with symptomatic heart failure and a class I indication for ICD implantation, and the complete results for one of the trials are given. Deaths were classified according to the new descriptive method, and also according to published categorical methods for heart failure and arrhythmia trials. The descriptive method preserved traditional arrhythmia and heart failure trial single category classifications of death. Furthermore, there was agreement between the arrhythmia and heart failure category classifications in 126 of the 148 of the mortality events adjudicated (85%). CONCLUSION: A descriptive method for the classification of death retains more data and allows for comparison among trials using different classification schemes. This may allow greater mechanistic insight into study populations that have diverse and frequently multiple etiologies of death.

Keyword

Arrhythmias
Cardiac
mortality
therapy
Cause of Death
Classification
methods
Clinical Trials as Topic
Death
Sudden
Cardiac
etiology
Defibrillators
Implantable
Heart Failure
mortality
therapy
Humans
Risk Factors

Publication and Content Type

ref (subject category)
art (subject category)

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