title: Ascertainment of cause-specific mortality in COPD: operations of the TORCH Clinical Endpoint Committee.
abstract: BACKGROUND
  TORCH (Towards a Revolution in COPD Health) is an international multicentre, randomised, placebo-controlled clinical trial of inhaled fluticasone propionate/salmeterol combination treatment and its monotherapy components for maintenance treatment of moderately to severely impaired patients with chronic obstructive pulmonary disease (COPD). The primary outcome is all-cause mortality. Cause-specific mortality and deaths related to COPD are additional outcome measures, but systematic methods for ascertainment of these outcomes have not previously been described.
  
  
  METHODS
  A Clinical Endpoint Committee (CEC) was tasked with categorising the cause of death and the relationship of deaths to COPD in a systematic, unbiased and independent manner. The key elements of the operation of the committee were the use of predefined principles of operation and definitions of cause of death and COPD-relatedness; the independent review of cases by all members with development of a consensus opinion; and a substantial infrastructure to collect medical information.
  
  
  RESULTS
  911 deaths were reviewed and consensus was reached in all. Cause-specific mortality was: cardiovascular 27%, respiratory 35%, cancer 21%, other 10% and unknown 8%. 40% of deaths were definitely or probably related to COPD. Adjudications were identical in 83% of blindly re-adjudicated cases (kappa = 0.80). COPD-relatedness was reproduced 84% of the time (kappa = 0.73). The CEC adjudication was equivalent to the primary cause of death recorded by the site investigator in 52% of cases.
  
  
  CONCLUSIONS
  A CEC can provide standardised, reliable and informative adjudication of COPD mortality that provides information which frequently differs from data collected from assessment by site investigators.
authors.affiliation: The Queen's University of Belfast, Grosvenor Road, Belfast BT12 6BJ, UK. l.mcgarvey@qub.ac.uk
authors.forename: Lorcan P
authors.initials: LP
authors.lastname: McGarvey
authors.forename: Matthias
authors.initials: M
authors.lastname: John
authors.forename: Julie A
authors.initials: JA
authors.lastname: Anderson
authors.forename: Michael
authors.initials: M
authors.lastname: Zvarich
authors.forename: Robert A
authors.initials: RA
authors.lastname: Wise
mesh_terms: D002423:Cause of Death; D032921:Consensus; D004311:Double-Blind Method; D006801:Humans; D011379:Prognosis; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy / Q000401:mortality*