| Literature DB >> 26678213 |
Sarah Alexander1, Jason D Pole2, Paul Gibson3, Michelle Lee4, Tanya Hesser4, Susan N Chi5, Christopher C Dvorak6, Brian Fisher7, Henrik Hasle8, Jukka Kanerva9, Anja Möricke10, Bob Phillips11, Elizabeth Raetz12, Carlos Rodriguez-Galindo5, Sujith Samarasinghe13, Kjeld Schmiegelow14, Wim Tissing15, Thomas Lehrnbecher16, Lillian Sung17.
Abstract
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.Entities:
Mesh：
Year: 2015 PMID： 26678213 DOI： 10.1016/S1470-2045(15)00197-7
Source DB: PubMed Journal: Lancet Oncol ISSN： 1470-2045 Impact factor: 41.316