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Improving Data Quality for a Critical Multiple Sclerosis Endpoint

The Expanded Disability Status Scale (EDSS) is one of the most widely used endpoints in multiple sclerosis (MS) research and in clinical trials of investigational treatments for MS. The EDSS is an elaborate scoring system applied to a neurological examination that results in a score that quantifies the level of disability in patients with MS. It is a validated measure that is recognized for its ability to track MS progression over time.

One of the drawbacks of traditional implementations of the measure is that it is difficult to score and is prone to scoring and data quality issues. VeraSci worked with Neurostatus to develop an eCOA version of the EDSS that would be functionally identical to the paper version while providing the improvements in data quality and ease of administration associated with eCOA systems. Neurostatus-EDSS on the Pathway eCOA platform contains automatic score algorithms that help reduce rater error and improve data quality.

During the neurological exam, the rater taps the responses for sub-scores and functional system scores on the chapter pages as they progress through the assessment. The synopsis page, a feature available from any chapter page, allows the rater to track their progression throughout the administration.

Once all the functional system scores and ambulation scores have been assigned, the EDSS score is determined. At the end of the administration of the assessment, raters request algorithmic feedback on their scores. The algorithmic feedback indicates any discrepancies or inconsistencies in the data by color-coding the data in question on the synopsis and chapter pages. Raters can modify sub-scores and chapter scores flagged in the system, resulting in fewer inconsistencies. Expert data reviewers from Neurostatus review the assessment and query any questionable entries not automatically flagged by the system.