Classification of treatment-related mortality in children with cancer: a systematic assessment
医学
临床试验
癌症
重症监护医学
儿科
内科学
作者
Sarah Alexander,Jason D. Pole,Paul Gibson,Michelle Lee,Tanya Hesser,Susan Chi,Christopher C. Dvorak,Brian T. Fisher,Henrik Hasle,Jukka Kanerva,Anja Möricke,Bob Phillips,Elizabeth A. Raetz,Carlos Rodríguez‐Galindo,Sujith Samarasinghe,Kjeld Schmiegelow,Wim J. E. Tissing,Thomas Lehrnbecher,Lillian Sung
Treatment-related mortality is an important outcome in paediatric cancer clinical trials. An international group of experts in supportive care in paediatric cancer developed a consensus-based definition of treatment-related mortality and a cause-of-death attribution system. The reliability and validity of the system was tested in 30 deaths, which were independently assessed by two clinical research associates and two paediatric oncologists. We defined treatment-related mortality as death occurring in the absence of progressive cancer. Of the 30 reviewed deaths, the reliability of classification for treatment-related mortality was noted as excellent by clinical research associates (κ=0·83, 95% CI 0·60–1·00) and paediatric oncologists (0·84, 0·63–1·00). Criterion validity was established because agreement between the consensus classifications by clinical research associates and paediatric oncologists was almost perfect (0·92, 0·78–1·00). Our approach should allow comparison of treatment-related mortality across trials and across time.