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A standard operating procedure for King's ALS clinical staging

Balendra, R; Al Khleifat, A; Fang, T; Al-Chalabi, A; (2019) A standard operating procedure for King's ALS clinical staging. Amyotrophic Lateral Sclerosis & Frontotemporal Degeneration , 20 (3-4) pp. 159-164. 10.1080/21678421.2018.1556696. Green open access

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Abstract

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.

Type: Article
Title: A standard operating procedure for King's ALS clinical staging
Open access status: An open access version is available from UCL Discovery
DOI: 10.1080/21678421.2018.1556696
Publisher version: https://doi.org/10.1080/21678421.2018.1556696
Language: English
Additional information: © 2019 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/ licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Keywords: Clinical trials, prognostic, staging, standard operating procedure, survival
UCL classification: UCL
UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > UCL Queen Square Institute of Neurology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > UCL Queen Square Institute of Neurology > Neurodegenerative Diseases
URI: https://discovery.ucl.ac.uk/id/eprint/10069905
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