RT Journal Article
SR Electronic
T1 Discordance in investigator-reported and adjudicated sudden death in TIOSPIR
JF ERJ Open Research
JO erjor
FD European Respiratory Society
SP 00073-2016
DO 10.1183/23120541.00073-2016
VO 3
IS 1
A1 Robert A. Wise
A1 Peter R. Kowey
A1 George Austen
A1 Achim Mueller
A1 Norbert Metzdorf
A1 Andy Fowler
A1 Lorcan P. McGarvey
YR 2017
UL http://openres.ersjournals.com/content/3/1/00073-2016.abstract
AB Accurate and consistent determination of cause of death is challenging in chronic obstructive pulmonary disease (COPD) patients. TIOSPIR (N=17 135) compared the safety and efficacy of tiotropium Respimat 5/2.5 µg with HandiHaler 18 µg in COPD patients. All-cause mortality was a primary end-point. A mortality adjudication committee (MAC) assessed all deaths. We aimed to investigate causes of discordance in investigator-reported and MAC-adjudicated causes of death and their impact on results, especially cardiac and sudden death.The MAC provided independent, blinded assessment of investigator-reported deaths (n=1302) and assigned underlying cause of death. Discordance between causes of death was assessed descriptively (shift tables).There was agreement between investigator-reported and MAC-adjudicated deaths in 69.4% of cases at the system organ class level. Differences were mainly observed for cardiac deaths (16.4% investigator, 5.1% MAC) and deaths assigned to general disorders including sudden death (17.4% investigator, 24.6% MAC). Reasons for discrepancies included investigator attribution to the immediate (e.g. myocardial infarction (MI)) over the underlying cause of death (e.g. COPD) and insufficient information for a definitive cause.Cause-specific mortality varies in COPD, depending on the method of assignment. Sudden death, witnessed and unwitnessed, is common in COPD and often attributed to MI without supporting evidence.Investigator-attributed causes of death may lead to unreliable estimates of cause-specific mortality in COPD http://ow.ly/uzt9308TePH