Classification of treatment-related mortality in children with cancer: a systematic assessment - 01/12/15

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

Sarah Alexander, MD ^a, Jason D Pole, PhD ^b, Paul Gibson, MD ^c, Michelle Lee, MPH ^d, Tanya Hesser, MSW ^d, Susan N Chi, MD ^e, Christopher C Dvorak, MD ^f, Brian Fisher, DO ^g, Henrik Hasle, MD ^h, Jukka Kanerva, MD ⁱ, Anja Möricke, MD ^j, Bob Phillips, MD ^k, Elizabeth Raetz, MD ^l, Carlos Rodriguez-Galindo, MD ^e, Sujith Samarasinghe, PhD ^m, Kjeld Schmiegelow, MD ^n,^o, Wim Tissing, MD ^p, Thomas Lehrnbecher, MD ^q, Lillian Sung, DrMD ^a,^⁎
on behalf of the
International Pediatric Oncology Mortality Classification Group

^a Division of Haematology/Oncology, The Hospital for Sick Children, Toronto, ON, Canada

^b Pediatric Oncology Group of Ontario, Toronto, ON, Canada

^c Division of Haematology/Oncology, Children’s Hospital, London Health Sciences Centre, London, ON, Canada

^d Program in Child Health Evaluative Sciences, The Hospital for Sick Children, Peter Gilgan Centre for Research and Learning, Toronto, ON, Canada

^e Department of Hematology/Oncology, Dana-Farber Cancer Institute, Boston, MA, USA

^f Division of Pediatric Allergy, Immunology, and Bone Marrow Transplantation, University of California, San Francisco Medical Center—Mission Bay, San Francisco, CA, USA

^g Division of Infectious Diseases, Children’s Hospital of Philadelphia, Philadelphia, PA, USA

^h Department of Paediatrics, Aarhus University Hospital, Aarhus, Denmark

ⁱ Hospital for Children and Adolescents, Helsinki University Central Hospital, Helsinki, Finland

^j Department of Paediatrics, University Medical Centre Schleswig-Holstein, Kiel, Germany

^k Centre for Reviews and Dissemination, University of York, York, UK

^l Division of Pediatric Hematology/Oncology, University of Utah, Salt Lake City, UT, USA

^m Department of Paediatric Haematology, Great Ormond Street Hospital, London, UK

ⁿ Department of Pediatrics and Adolescent Medicine, University Hospital Rigshospitalet, Copenhagen, Denmark

^o Institute for Clinical Medicine, University of Copenhagen, Copenhagen, Denmark

^p Department of Paediatric Oncology, University Medical Center Groningen, Groningen, Netherlands

^q Department of Paediatric Haematology and Oncology, Johann Wolfgang Goethe University, Frankfurt, Germany

^* Correspondence to: Dr Lillian Sung, Division of Haematology/Oncology, The Hospital for Sick Children, 555 University Avenue, Toronto, ON, M5G 1X8, Canada Correspondence to: Dr Lillian Sung Division of Haematology/Oncology The Hospital for Sick Children 555 University Avenue Toronto ON M5G 1X8 Canada

Summary

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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Plan

Introduction

Methods

Development of treatment-related mortality definition

Development of a cause-of-death attribution system

Reliability and validity assessment

Findings

Discussion

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Vol 16 - N° 16

P. e604-e610 - décembre 2015 Retour au numéro

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Classification of treatment-related mortality in children with cancer: a systematic assessment - 01/12/15

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