A standard operating procedure for King's ALS clinical staging

被引:31
作者
Balendra, Rubika [1 ,2 ]
Al Khleifat, Ahmad [3 ]
Fang, Ton [3 ]
Al-Chalabi, Ammar [3 ]
机构
[1] UCL Inst Neurol, Dept Neurodegenerat Dis, London, England
[2] UCL, Dept Genet Evolut & Environm, Inst Hlth Ageing, London, England
[3] Kings Coll London, Dept Basic & Clin Neurosci, Maurice Wohl Clin Neurosci Inst, Cutcombe Rd, London SE5 9RX, England
基金
欧盟地平线“2020”; 英国经济与社会研究理事会; 英国惠康基金; 美国国家卫生研究院; 英国医学研究理事会;
关键词
Clinical trials; survival; prognostic; staging;   standard operating procedure; AMYOTROPHIC-LATERAL-SCLEROSIS; SYSTEM; SURVIVAL;
D O I
10.1080/21678421.2018.1556696
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
Objective: Clinical stages in amyotrophic lateral sclerosis (ALS) can be measured using a simple system based on the number of CNS regions involved and requirement for gastrostomy or noninvasive ventilation (NIV). We aimed to design a standard operating procedure (SOP) to define the standardized use and application of the King's staging system. Methods: We designed a SOP for the King's staging system. We wrote case vignettes representative of ALS patients at different disease stages. During two workshops, we taught health care professionals how to use the SOP, then asked them to stage the vignettes using the SOP. We measured the extent to which SOP staging corresponded with correct clinical stage. Results: The reliability of staging using the SOP was excellent, with a Spearman's Rank coefficient of 0.95 (p<0.001), and was high for different groups of health care professionals, and for those with different levels of experience in ALS. The limits of agreement between SOP staging and actual clinical stage lie within a single stage, confirming that there is a clinically acceptable level of agreement between staging using the SOP and actual King's clinical stage. There were also no systematic biases of the SOP over the range of stages, either for over-staging or under-staging. Conclusions: We have demonstrated that the staging SOP provides a reliable method of calculating clinical stages in ALS patients and can be used prospectively by a range of health care professionals with different levels of experience, as for example may be the case in multicentre clinical trials.
引用
收藏
页码:159 / 164
页数:6
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