Ascertainment of cause-specific mortality in COPD

Operations of the TORCH Clinical Endpoint Committee

Lorcan P. McGarvey, Matthias John, Julie A. Anderson, Michael Zvarich, Robert A Wise

Research output: Contribution to journalArticle

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 (κ = 0.80). COPD-relatedness was reproduced 84% of the time (κ = 0.73). The CEC adjudication was equivalent to the primary cause of death recorded by the site investigator in 52% of cases. Conclusion: 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.

Original languageEnglish (US)
Pages (from-to)411-415
Number of pages5
JournalThorax
Volume62
Issue number5
DOIs
StatePublished - May 2007

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Chronic Obstructive Pulmonary Disease
Mortality
Health
Cause of Death
Consensus
Research Personnel
Randomized Controlled Trials
Placebos
Outcome Assessment (Health Care)
Therapeutics
Neoplasms

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

Cite this

Ascertainment of cause-specific mortality in COPD : Operations of the TORCH Clinical Endpoint Committee. / McGarvey, Lorcan P.; John, Matthias; Anderson, Julie A.; Zvarich, Michael; Wise, Robert A.

In: Thorax, Vol. 62, No. 5, 05.2007, p. 411-415.

Research output: Contribution to journalArticle

McGarvey, Lorcan P. ; John, Matthias ; Anderson, Julie A. ; Zvarich, Michael ; Wise, Robert A. / Ascertainment of cause-specific mortality in COPD : Operations of the TORCH Clinical Endpoint Committee. In: Thorax. 2007 ; Vol. 62, No. 5. pp. 411-415.
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