Classification of treatment-related mortality in children with cancer: a systematic assessment

Sarah Alexander, Jason D Pole, Paul Gibson, Michelle Lee, Tanya Hesser, Susan N Chi, Christopher C Dvorak, Brian Fisher, Henrik Hasle, Jukka Kanerva, Anja Möricke, Bob Phillips, Elizabeth Raetz, Carlos Rodriguez-Galindo, Sujith Samarasinghe, Kjeld Schmiegelow, Wim Tissing, Thomas Lehrnbecher, Lillian Sung, International Pediatric Oncology Mortality Classification Group

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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.

Original languageEnglish
Pages (from-to)e604-e610
JournalLancet oncology
Issue number16
Publication statusPublished - Dec 2015

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