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

Institut for Klinisk Medicin

44 Citationer (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.

Originalsprog	Engelsk
Tidsskrift	Lancet Oncology
Vol/bind	16
Udgave nummer	16
Sider (fra-til)	e604-10
Antal sider	7
ISSN	1470-2045
DOI	https://doi.org/10.1016/S1470-2045(15)00197-7
Status	Udgivet - dec. 2015

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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, bind 16, nr. 16, s. e604-10. https://doi.org/10.1016/S1470-2045(15)00197-7

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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.",

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",

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

year = "2015",

month = dec,

doi = "10.1016/S1470-2045(15)00197-7",

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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

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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.

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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

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SN - 1470-2045

VL - 16

SP - e604-10

JO - The Lancet Oncology

JF - The Lancet Oncology

IS - 16

ER -

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

Abstract

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