title: 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.
abstract: BACKGROUND
  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.
  
  
  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%).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Division of Cardiology, The Milton S. Hershey Medical Center, The Pennsylvania State College of Medicine, Rm 1512, 500 University Drive, Hershey, PA, 17033, USA, jboehmer@psu.edu
authors.forename: John P
authors.initials: JP
authors.lastname: Boehmer
authors.forename: Mark D
authors.initials: MD
authors.lastname: Carlson
authors.forename: Teresa
authors.initials: T
authors.lastname: De Marco
authors.forename: Brian E
authors.initials: BE
authors.lastname: Jaski
authors.forename: Steven L
authors.initials: SL
authors.lastname: Higgins
authors.forename: Charles
authors.initials: C
authors.lastname: Kennergren
authors.forename: Andrew E
authors.initials: AE
authors.lastname: Epstein
mesh_terms: D001145:Arrhythmias, Cardiac / Q000401:mortality* / Q000628:therapy; D002423:Cause of Death; D002965:Classification / Q000379:methods; D002986:Clinical Trials as Topic; D016757:Death, Sudden, Cardiac / Q000209:etiology; D017147:Defibrillators, Implantable; D006333:Heart Failure / Q000401:mortality* / Q000628:therapy; D006801:Humans; D012307:Risk Factors