Ascertainment of Cause-Specific Mortality in COPD -- Operations of the TORCH Clinical Endpoint Committee

摘要: 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 moderately to severely impaired patients with chronic obstructive pulmonary disease (COPD). The primary outcome all-cause mortality. Cause-specific mortality deaths related are additional measures, but systematic methods ascertainment these outcomes have not previously been described. Methods: A Clinical Endpoint Committee (CEC) was tasked categorising the cause death relationship systematic, unbiased independent manner. key elements operation committee were use predefined principles definitions COPD-relatedness; review cases by all members development consensus opinion; substantial infrastructure collect medical information. Results: 911 reviewed reached all. was: cardiovascular 27%, respiratory 35%, cancer 21%, other 10% unknown 8%. 40% definitely or probably COPD. Adjudications identical 83% blindly re-adjudicated (κ = 0.80). COPD-relatedness reproduced 84% time (κ = 0.73). CEC adjudication equivalent recorded site investigator 52% cases. Conclusion: can provide standardised, reliable informative that provides information which frequently differs from data collected assessment investigators.