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

doi:10.1016/S1470-2045(15)00197-7

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

Department of Clinical Medicine

44 Citations (Scopus)

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.

Original language	English
Journal	Lancet Oncology
Volume	16
Issue number	16
Pages (from-to)	e604-10
Number of pages	7
ISSN	1470-2045
DOIs	https://doi.org/10.1016/S1470-2045(15)00197-7
Publication status	Published - Dec 2015

Keywords

Adolescent
Age Factors
Antineoplastic Combined Chemotherapy Protocols
Cause of Death
Child
Child Mortality
Child, Preschool
Consensus
Drug-Related Side Effects and Adverse Reactions
Hematopoietic Stem Cell Transplantation
Humans
Infant
Infant Mortality
Infant, Newborn
Neoplasms
Risk Assessment
Risk Factors
Terminology as Topic
Time Factors
Treatment Outcome

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/S1470-2045(15)00197-7

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Alexander, S., Pole, J. D., Gibson, P., Lee, M., Hesser, T., Chi, S. N., Dvorak, C. C., Fisher, B., Hasle, H., Kanerva, J., Möricke, A., Phillips, B., Raetz, E., Rodriguez-Galindo, C., Samarasinghe, S., Schmiegelow, K., Tissing, W., Lehrnbecher, T., Sung, L., & International Pediatric Oncology Mortality Classification Group (2015). Classification of treatment-related mortality in children with cancer: a systematic assessment. Lancet Oncology, 16(16), e604-10. https://doi.org/10.1016/S1470-2045(15)00197-7

Alexander, S, Pole, JD, Gibson, P, Lee, M, Hesser, T, Chi, SN, Dvorak, CC, Fisher, B, Hasle, H, Kanerva, J, Möricke, A, Phillips, B, Raetz, E, Rodriguez-Galindo, C, Samarasinghe, S, Schmiegelow, K, Tissing, W, Lehrnbecher, T, Sung, L & International Pediatric Oncology Mortality Classification Group 2015, 'Classification of treatment-related mortality in children with cancer: a systematic assessment', Lancet Oncology, vol. 16, no. 16, pp. e604-10. https://doi.org/10.1016/S1470-2045(15)00197-7

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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

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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.

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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

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KW - Terminology as Topic

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JO - The Lancet Oncology

JF - The Lancet Oncology

IS - 16

ER -

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

Abstract

Keywords

UN SDGs

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