TY - JOUR
T1 - Classification of treatment-related mortality in children with cancer
T2 - A systematic assessment
AU - Alexander, Sarah
AU - Pole, Jason D.
AU - Gibson, Paul
AU - Lee, Michelle
AU - Hesser, Tanya
AU - Chi, Susan N.
AU - Dvorak, Christopher C.
AU - Fisher, Brian
AU - Hasle, Henrik
AU - Kanerva, Jukka
AU - Möricke, Anja
AU - Phillips, Bob
AU - Raetz, Elizabeth
AU - Rodriguez-Galindo, Carlos
AU - Samarasinghe, Sujith
AU - Schmiegelow, Kjeld
AU - Tissing, Wim
AU - Lehrnbecher, Thomas
AU - Sung, Lillian
N1 - Publisher Copyright:
© 2015 Elsevier Ltd.
PY - 2015
Y1 - 2015
N2 - 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.
AB - 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.
UR - https://www.scopus.com/pages/publications/84961615420
U2 - 10.1016/S1470-2045(15)00197-7
DO - 10.1016/S1470-2045(15)00197-7
M3 - Review article
C2 - 26678213
AN - SCOPUS:84961615420
SN - 1470-2045
VL - 16
SP - e604-e610
JO - The Lancet Oncology
JF - The Lancet Oncology
IS - 16
ER -