Telephone Assessment of the Expanded Disability Status Scale (P04.141)

OBJECTIVE: To determine if nurse led telephone interview can reliably measure the Expanded Disability Status Scale (EDSS) in Multiple Sclerosis (MS) patients with severe motor disability. BACKGROUND: In clinical trials, drop out bias reduces the validity of results. This is a particular problem in long-term studies, especially when patients become progressively disabled and have increasing difficulty attending assessment clinics. Development of a telephone assessed expanded disability score (TEDSS) was driven by the need for complete data collection in MS clinical trials, and has previously been validated for trained physicians. Best agreement between face-to-face EDSS (FFEDSS) and TEDSS was noted at higher EDSS scores, where the need is greatest. However, we wanted to assess the use in a larger number of patients with higher EDSS scores and with nurse derived TEDSS. DESIGN/METHODS: We performed a prospective multicentre trial of MS patients with EDSS ≥ 6 comparing doctor assessed FFEDSS against nurse assessed TEDSS (both attained within 28 days). Prior to commencement, a standardised training program was provided to MS nurses. RESULTS: 74 patients were recruited (Primary Progressive MS n=10, Secondary Progressive MS n=64) and assessed by 9 physicians and 5 nurses. Mean FFEDSS and TEDSS scores were 7.3 and 7.2 respectively. Average time between FFEDSS and TEDSS assessments was 19 days. The kappa value for complete EDSS agreement was 0.295, 0.834 for +/-0.5 and 1.0 for +/-1. The ICC correlation was 0.788. CONCLUSIONS: These Kappa scores compare favorably with other studies assessing doctor to doctor inter-rater agreement for FFEDSS, as well as the previous validation study of doctor assessed telephone EDSS. Thus this study provides evidence to support nurse led telephone assessment in MS patients with severe motor disability. This has important implications for quality of care, retainment of patients in clinical trials, and service provision. Supported by: Department of Health. Disclosure: Dr. Huda has received personal compensation for activities with Medefield. Dr. Huda has received research support from Watney/Myasthenia Gravis Association/Oxford Biomedical Research Centre. Dr. Palace has received personal compensation from Teva, Biogen, Merck Serono, GSK, and Bayer Schering Pharma for clinical trials, running a database, attending advisory committees, giving lectures, and attending international meetings.