Article Text

other Versions

PDF

Ascertainment of Cause-Specific Mortality in COPD -- Operations of the TORCH Clinical Endpoint Committee
  1. Lorcan P McGarvey (l.mcgarvey{at}qub.ac.uk)
  1. The Queen's University of Belfast, United Kingdom
    1. Matthias John (john{at}barmer-ostseeklinik.de)
    1. Respiratory Medicine, Barmer OstseeKlinik, Prerow, Germany, Germany
      1. Julie A Anderson (julie.a.anderson{at}gsk.com)
      1. Department of Medical Statistics, GlaxoSmithKline, Greenford, United Kingdom, United Kingdom
        1. Michael T Zvarich (michael.t.zvarich{at}gsk.com)
        1. GlaxoSmithKline, ResearchTriangle Park, NC, USA, United States
          1. Robert A Wise (rwise{at}jhmi.edu)
          1. Johns Hopkins University School of Medicine, Baltimore, MD, United States

            Abstract

            Background: TORCH (Towards a Revolution in COPD Health) is an international multicentre randomised placebo-controlled clinical trial of inhaled fluticasone propionate /salmeterol combination therapy and its monotherapy components for maintenance therapy 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 been previously described. Methods: A clinical end-point committee (CEC) was tasked with categorization of cause of death and 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 pre-defined 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. Conclusion: A CEC can provide standardized, reliable, and informative adjudication of COPD mortality that provides information that frequently differs from data collected from site investigators assessment.

            • Lung diseases
            • Mortality
            • adjudication
            • clinical endpoint committee
            • obstructive

            Statistics from Altmetric.com

            Request permissions

            If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

            Linked Articles