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This Article Free to Access Full Text Full Text (PDF) web only appendix All Versions of this Article: thx.2006.072348v1 62/5/411    most recent Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this link to a friend Similar articles in this journal Similar articles in PubMed Add article to my folders Download to citation manager Request Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by McGarvey, L. P Articles by Wise, R. A Search for Related Content PubMed PubMed Citation Articles by McGarvey, L. P Articles by Wise, R. A Topic Collections Unlocked Relevant Articles

Ascertainment of cause-specific mortality in COPD: operations of the TORCH Clinical Endpoint Committee

¹ The Queen’s University of Belfast, Belfast, UK
² Respiratory Medicine, Barmer Ostseeklinik, Prerow, Germany
³ GlaxoSmithKline, Greenford, UK
⁴ GlazoSmithKline, Research Triangle Park, North Carolina, USA
⁵ Johns Hopkins University, Baltimore, Maryland, USA

Correspondence to:
Correspondence to:
Dr Lorcan P McGarvey
The Queen’s University of Belfast, Grosvenor Road, Belfast BT12 6BJ, UK;l.mcgarvey{at}qub.ac.uk

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 ( = 0.80). COPD-relatedness was reproduced 84% of the time ( = 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.

Abbreviations: CEC, Clinical Endpoint Committee; COPD, chronic obstructive pulmonary disease; TORCH, Towards a Revolution in COPD Health

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