Purpose

To provide an exhaustive review of the neuropsychological examination as conducted in brain tumor clinical trials over the last 30 years and to provide objective ratings about the reliability and suitability of such tests in neurooncological research and clinical practice.

Methods

Methodologies and tools provided by the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) were exploited in order to assess the measurement properties of questionnaires and performance-based instruments used to evaluate cognitive functioning in brain tumor clinical trials from 1997 to 2017.

Results

Twenty-six brain tumor clinical trials were analyzed and an overall set of 10 neuropsychological tests was identified. A list of 24 studies concerning the reliability of such tests was analyzed. Reliability and level of evidence scores for each study and for each test were obtained. The results revealed relevant faults about the quality of measurements and the suitability of the neurocognitive assessment batteries most commonly used in brain tumor clinical trials.

Conclusion

Our findings suggest that the cognitive assessment in brain tumor clinical trials should be implemented according to specific endpoints and should be addressed to investigate all the cognitive domains known to be affected by brain tumor and treatment.

中文翻译：

---

最近30年间脑肿瘤临床试验中神经认知评估的测量属性质量：一种基于COSMIN清单的方法。

目的

提供对过去30年在脑肿瘤临床试验中进行的神经心理学检查的详尽综述，并提供有关此类检查在神经肿瘤学研究和临床实践中的可靠性和适用性的客观评分。

方法

为了评估1997年至2017年脑肿瘤临床试验中认知功能的问卷和基于性能的仪器的评估属性，采用了基于COnsensus的标准提供的用于选择健康测量仪器（COSMIN）的方法和工具。 。

结果

分析了二十六个脑肿瘤的临床试验，并确定了总共十项神经心理学测试。分析了涉及此类测试可靠性的24项研究的清单。获得了每个研究和每个测试的可靠性和证据评分的水平。结果揭示了有关测量质量和脑肿瘤临床试验中最常用的神经认知评估电池的适用性的相关缺陷。

结论

我们的发现表明，脑肿瘤临床试验中的认知评估应根据特定的终点进行，并应针对调查已知受脑肿瘤和治疗影响的所有认知领域进行研究。