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• W4367305499 abstract "<h3>Objective:</h3> To assess self-reported patient reported outcome measures (PROs) as an equivalent and complementary alternative metric to the clinical Expanded Disability Status Scale (EDSS) for disability in neurology clinic, registries and clinical trials. <h3>Background:</h3> Clinical measures of outcome eg the EDSS are the gold standard in multiple sclerosis (MS) assessement. However, the EDSS requires a clinical examination and varies within patient, and between clinicians, centres and countries. PROs are self-reported measures that can be performed online, frequently and at low cost. It is not known how PROs compare to clinical measures and whether they have the potential to replace them. <h3>Design/Methods:</h3> Participants had to have had at least 3 visits in the longitudinal cohort spaced no more than 270 days apart; the MS-SMART clinical trial [NCT01910259] collected scores every 48 weeks. A progression or improvement event was measures by a +/− 6 point change in the PRO normalised MS impact scale (MSIS)-29 Physical score; a +/− 1 point change in the web EDSS; and a worsening in the clinical EDSS score (if base score < 6.0 then +/− 1 else +/− 0.5). <h3>Results:</h3> 234 patients from NHS clinics and 1315 pwMS with self-reported PRO data; and 161 participants from the MS-SMART trial were included. There was no significant difference in confirmed worsening (p=0.83) or confirmed improvement (p=0.21) between clinical EDSS scores and self-reported webEDSS. The MS-SMART participants were propensity score matched with the MSIS-29 PRO data and there was no difference (p=1) between time to a confirmed MSIS-29 worsening when self-reported or trial reported. <h3>Conclusions:</h3> There is no significant difference in the time to confirmed to time to worsening and improvement using PROS and clinical EDSS data. PROs have the potential to complement clinical data collection. <b>Disclosure:</b> Dr. Nicholas has nothing to disclose. The institution of Mr. Middleton has received research support from MS Society. Dr. Chataway has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janseen. Dr. Chataway 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. Chataway 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. Chataway has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for NerveGen. Dr. Chataway has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Chataway has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janseen. Dr. Chataway 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. Chataway 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. Chataway has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for NerveGen. Dr. Chataway has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Jeff Rodgers has nothing to disclose." @default.
• W4367305499 created "2023-04-29" @default.
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• W4367305499 date "2023-04-25" @default.
• W4367305499 modified "2023-09-27" @default.
• W4367305499 title "Patient-reported outcomes and clinical disability outcomes in Multiple Sclerosis (MS) demonstrate the same rates of worsening when performed in, neurology clinic, patient registry and a clinical trial. (S46.001)" @default.
• W4367305499 doi "https://doi.org/10.1212/wnl.0000000000203545" @default.
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