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

AU - International Pediatric Oncology Mortality Classification Group

N1 - Copyright © 2015 Elsevier Ltd. All rights reserved.

PY - 2015/12

Y1 - 2015/12

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.

KW - Adolescent

KW - Age Factors

KW - Antineoplastic Combined Chemotherapy Protocols

KW - Cause of Death

KW - Child

KW - Child Mortality

KW - Child, Preschool

KW - Consensus

KW - Drug-Related Side Effects and Adverse Reactions

KW - Hematopoietic Stem Cell Transplantation

KW - Humans

KW - Infant

KW - Infant Mortality

KW - Infant, Newborn

KW - Neoplasms

KW - Risk Assessment

KW - Risk Factors

KW - Terminology as Topic

KW - Time Factors

KW - Treatment Outcome

U2 - 10.1016/S1470-2045(15)00197-7

DO - 10.1016/S1470-2045(15)00197-7

M3 - Review

C2 - 26678213

VL - 16

SP - e604-10

JO - The Lancet Oncology

JF - The Lancet Oncology

SN - 1470-2045

IS - 16

ER -