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A standard operating procedure for King's ALS clinical staging
Rubika Balendra1,2, Ahmad Al Khleifat3, Ton Fang3
1a Department of Neurodegenerative Disease , UCL Institute of Neurology , London , UK.
Amyotrophic Lateral Sclerosis & Frontotemporal Degeneration
|February 19, 2019
Summary
A new standard operating procedure (SOP) for the King's staging system demonstrated excellent reliability for staging amyotrophic lateral sclerosis (ALS) patients. This validated SOP ensures consistent clinical stage assessment across healthcare professionals in multicenter trials.
Area of Science:
- Neurology
- Clinical Trials
Background:
- Amyotrophic lateral sclerosis (ALS) staging is crucial for patient management and research.
- The King's staging system offers a method for ALS clinical staging.
- Standardization of staging is needed for reliable clinical trial assessments.
Purpose of the Study:
- To design and validate a standard operating procedure (SOP) for the King's staging system in ALS.
- To ensure consistent and reliable application of the King's staging system.
- To facilitate accurate clinical staging in multicenter ALS studies.
Main Methods:
- A standard operating procedure (SOP) for the King's staging system was developed.
- Case vignettes of ALS patients at various disease stages were created.
- Healthcare professionals were trained on the SOP and used it to stage vignettes, with staging accuracy assessed.
Main Results:
- The SOP demonstrated excellent reliability for staging ALS patients, with a Spearman's Rank coefficient of 0.95 (p < 0.001).
- High reliability was observed across different healthcare professional groups and experience levels.
- Agreement between SOP staging and actual clinical stage was within a single stage, indicating clinical acceptability.
Conclusions:
- The developed SOP provides a reliable method for calculating clinical stages in ALS patients.
- The SOP can be prospectively used by healthcare professionals with varying experience levels.
- This standardized staging method is suitable for use in multicenter clinical trials for amyotrophic lateral sclerosis.