The highest incidence rate of childhood brain tumours is in children below the age of five years, who are particularly vulnerable to the effects of treatments. The assessment of quality of survival (QoS) in multiple domains is essential to compare the outcomes for different tumour types and treatment regimens. The aim of this position statement is to present the domains of health and functioning to be assessed in children from birth to five years, to advance the collection of a common QoS data set in European brain tumour trials. The QoS group of the European Society of Paediatric Oncology (SIOP-E) Brain Tumour group conducted consensus discussions over a period of six years to establish domains of QoS that should be prioritised in clinical trials involving children under 5 years. The domains of health and functioning that were agreed to affect QoS included: medical outcomes (e.g. vision, hearing, mobility, endocrine), emotion, behaviour, adaptive behaviour, and cognitive functioning. As for children aged five years and older, a 'core plus' approach is suggested in which core assessments are recommended for all clinical trials. The core component for children from birth to three years includes indirect assessment which, in this age-group, requires proxy assessment by a parent, of cognitive, emotional and behaviour variables and both direct and indirect endocrine measures. For children from four years of age direct cognitive assessment is also recommended as 'core'. The 'plus' components enable the addition of assessments which can be selected by individual countries and/or by, age-, treatment-, tumour type- and tumour location-specific trials.

中文翻译：

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欧洲儿童脑肿瘤试验中 5 岁以下儿童的生存评估质量

儿童脑肿瘤的发病率最高的是五岁以下的儿童，他们特别容易受到治疗的影响。多个领域的生存质量 (QoS) 评估对于比较不同肿瘤类型和治疗方案的结果至关重要。本立场声明的目的是介绍从出生到 5 岁的儿童要评估的健康和功能领域，以推进欧洲脑肿瘤试验中通用 QoS 数据集的收集。欧洲儿科肿瘤学会 (SIOP-E) 脑肿瘤小组的 QoS 小组进行了为期六年的共识讨论，以建立 QoS 领域，这些领域应在涉及 5 岁以下儿童的临床试验中优先考虑。同意影响 QoS 的健康和功能领域包括：医疗结果（例如视力、听力、活动能力、内分泌）、情绪、行为、适应性行为和认知功能。对于 5 岁及以上的儿童，建议采用“核心加”方法，其中建议对所有临床试验进行核心评估。从出生到三岁儿童的核心组成部分包括间接评估，在这个年龄组中，需要父母对认知、情绪和行为变量以及直接和间接内分泌测量进行代理评估。对于 4 岁以上的儿童，也建议将直接认知评估作为“核心”。“plus”组件可以添加评估，这些评估可以由各个国家和/或年龄、治疗、