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

被引：72

作者：

Alexander, Sarah ^{[1
]}

Pole, Jason D. ^{[2
]}

Gibson, Paul ^{[3
]}

Lee, Michelle ^{[4
]}

Hesser, Tanya ^{[4
]}

Chi, Susan N. ^{[5
]}

Dvorak, Christopher C. ^{[6
]}

Fisher, Brian ^{[7
]}

Hasle, Henrik ^{[8
]}

Kanerva, Jukka ^{[9
]}

Moericke, Anja ^{[10
]}

Phillips, Bob ^{[11
]}

Raetz, Elizabeth ^{[12
]}

Rodriguez-Galindo, Carlos ^{[5
]}

Samarasinghe, Sujith ^{[13
]}

Schmiegelow, Kjeld ^{[14
,15
]}

Tissing, Wim ^{[16
]}

Lehrnbecher, Thomas ^{[17
]}

Sung, Lillian ^{[1
]}

机构：

[1] Hosp Sick Children, Div Haematol Oncol, Toronto, ON M5G 1X8, Canada

[2] Pediat Oncol Grp Ontario, Toronto, ON, Canada

[3] London Hlth Sci Ctr, Div Haematol Oncol, Childrens Hosp, London, ON, Canada

[4] Hosp Sick Children, Peter Gilgan Ctr Res & Learning, Program Child Hlth Evaluat Sci, Toronto, ON M5G 1X8, Canada

[5] Dana Farber Canc Inst, Dept Hematol Oncol, Boston, MA 02115 USA

[6] Univ Calif San Francisco, Med Ctr, Div Pediat Allergy Immunol & Bone Marrow Transpla, San Francisco, CA USA

[7] Childrens Hosp Philadelphia, Div Infect Dis, Philadelphia, PA 19104 USA

[8] Aarhus Univ Hosp, Dept Paediat, DK-8000 Aarhus, Denmark

[9] Univ Helsinki, Cent Hosp, Hosp Children & Adolescents, Helsinki, Finland

[10] Univ Med Ctr Schleswig Holstein, Dept Paediat, Kiel, Germany

[11] Univ York, Ctr Reviews & Disseminat, York YO10 5DD, N Yorkshire, England

[12] Univ Utah, Div Pediat Hematol Oncol, Salt Lake City, UT USA

[13] Great Ormond St Hosp Sick Children, Dept Paediat Haematol, London WC1N 3JH, England

[14] Rigshosp, Univ Hosp, Dept Pediat & Adolescent Med, DK-2100 Copenhagen, Denmark

[15] Univ Copenhagen, Inst Clin Med, Copenhagen, Denmark

[16] Univ Groningen, Univ Med Ctr Groningen, Dept Paediat Oncol, NL-9713 AV Groningen, Netherlands

[17] Goethe Univ Frankfurt, Dept Paediat Haematol & Oncol, D-60054 Frankfurt, Germany

来源：

LANCET ONCOLOGY | 2015年 / 16卷 / 16期

关键词：

ACUTE MYELOID-LEUKEMIA; ACUTE LYMPHOBLASTIC-LEUKEMIA; DEATH CERTIFICATE COMPLETION; SAMPLE-SIZE REQUIREMENTS; PEDIATRIC ACUTE-LEUKEMIA; NORDIC COUNTRIES; CLINICAL-TRIALS; CHILDHOOD; ACCURACY; THERAPY;

D O I：

10.1016/S1470-2045(15)00197-7

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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 (kappa=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.

引用

页码：E604 / E610

页数：7

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