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Abstract Details

Telephone Assessment of the Expanded Disability Status Scale
MS and Related Diseases
P04 - (-)
141
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.
Authors/Disclosures
Saif Huda, MD (NHS)
PRESENTER
Dr. Huda has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen.
Jacqueline Palace (John Radcliff Hospital Oxford Univeristy Hospitals Trust) Dr. Palace has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merck Serono, Medimmune, Argenx, Janssen, AMgen, UCB, Roche, Novartis, Amplo, Alexion, . Dr. Palace has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Argenx, Sanofi. Dr. Palace has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Roche, UCB, Alexion, Amgen. Dr. Palace has or had stock in Astra Zenica. The institution of Dr. Palace has received research support from Roche, AMPLO, Alexion, UCB,. argenx, amgen. Dr. Palace has received intellectual property interests from a discovery or technology relating to health care.
Maria P. Amato, PhD (Ospedale Di Careggi) Dr. Amato has received personal compensation for serving as an employee of AOUCareggi. Dr. Amato has received personal compensation for serving as an employee of AOUCareggi. Dr. Amato has received personal compensation for serving as an employee of AOUCareggi. Dr. Amato has received personal compensation for serving as an employee of AOU Careggi. Dr. Amato has received personal compensation for serving as an employee of AOUCareggi. Dr. Amato has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Amato has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Amato has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi Genzyme. Dr. Amato has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Amato has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Amato has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Dr. Amato has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Amato has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Amato has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi genzyme. The institution of Dr. Amato has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Celgene BMS. The institution of Dr. Amato has received research support from Merck. The institution of Dr. Amato has received research support from Biogen. The institution of Dr. Amato has received research support from Roche.