RESUMO
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.
Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Mortalidade da Criança , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/mortalidade , Transplante de Células-Tronco Hematopoéticas/mortalidade , Mortalidade Infantil , Neoplasias/mortalidade , Neoplasias/terapia , Terminologia como Assunto , Adolescente , Fatores Etários , Protocolos de Quimioterapia Combinada Antineoplásica/classificação , Causas de Morte , Criança , Pré-Escolar , Consenso , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/classificação , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Transplante de Células-Tronco Hematopoéticas/efeitos adversos , Transplante de Células-Tronco Hematopoéticas/classificação , Humanos , Lactente , Recém-Nascido , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do TratamentoRESUMO
The nomenclature describing hematopoietic stem cell transplantation has evolved, adding precision and definition in research and regulation. The lack of coordination and standardization in terminology has left some gaps in the definition of episodes of clinical care. These voids have caused particular problems in contracting for payment and billing for services rendered. The purpose of this report is to propose definitions for cell products, cell infusions, and transplantation episodes.