Can the Expanded Disability Status Scale be assessed by telephone?

Area of Science:

• Neurology
• Clinical Trials
• Patient-Reported Outcomes

Background:

• Maintaining patient data in multiple sclerosis (MS) clinical trials is vital, especially when participants cannot attend study centers.
• The Expanded Disability Status Scale (EDSS) is a key metric in MS research, but requires trained assessment.

Purpose of the Study:

• To validate a telephone-based questionnaire for assessing the Expanded Disability Status Scale (EDSS).
• To determine the reliability of telephone EDSS assessments compared to in-person examinations for MS patients.

Main Methods:

• Trained raters independently assessed 110 MS patients (70 women, 40 men) using a telephone questionnaire and a subsequent in-person neurological examination.
• Data were collected from five European centers, with patients having a mean age of 43.7 years and a mean EDSS score of 4.5.

Main Results:

• Telephone EDSS assessments showed a high correlation with physical examination findings (Pearson's r = 0.95).
• Intraclass correlation coefficient (ICC) was 94.8% for the total sample, with higher agreement for EDSS scores > 4.5.
• Kappa values indicated substantial agreement, particularly for variations of 1.0 step (0.90).

Conclusions:

• A telephone questionnaire is a valid and reliable tool for assessing EDSS scores in MS clinical trials.
• This method is particularly useful for patients unable to visit study centers or for long-term follow-up.
• Telephone assessments can ensure the continuity of data collection and interpretation in MS research.