Continued Validation of the RBD Symptom Severity Scale (RBDSSS) in Participants of the North American Prodromal Synucleinopathy (NAPS) Consortium (P6-13.004)

Objective: The objective of this study is to assess the validity of the REM Sleep Behavior Disorder (RBD) symptom severity scale (RBDSSS) and its correlation to the clinical global impression of severity (CGI-S) in a cohort of participants from the North American Prodromal Synucleinopathy (NAPS) study. Background: REM sleep behavior disorder (RBD) is a parasomnia characterized by dream enactment and is a prodromal marker of α-synucleinopathies. There is currently no standardized tool for assessing symptom severity in clinical or research practice. To fill this gap, the International RBD Study Group developed the RBDSSS, an 8-item questionnaire which assesses frequency and severity of dream content, vocalizations, movements, and injuries associated with RBD. Design/Methods: Participants and their bedpartners enrolled in the NAPS cohort filled out the RBDSSS questionnaire. Total scores for participant (maximum score=54) and bedpartner (maximum score=38) questionnaires are derived by multiplying frequency and severity scores for each question. A clinical global severity index and RBD symptom frequency was assessed by clinical interview with patients +/− bedpartners. Descriptive analysis and correlations between scores and sub-items were assessed, and item response analysis was conducted. Results: Among 261 study participants, the median (interquartile range) score for the RBDSSS-participant was 10 (4–18), and that of the RBDSSS-bedpartner was 8 (4–15). The median CGI-S was 3 (3–4), indicating moderate severity. RBDSSS-bedpartner scores were significantly lower in women (6 vs. 9, p=0.02) while there were no sex differences in RBDSSS-participant scores (8 vs. 10.5, p=0.615). We found strong correlations between RBDSSS-participant vs. RBDSSS-bedpartner (Spearman rs=0.561), RBDSSS-participant vs. CGI-S (rs=0.556), and RBDSSS-bedpartner vs. CGI-S (rs=0.491, all p<0.0001). Item response analysis showed a high discriminatory value for RBDSSS-participant (range 1.40–2.12) and RBDSSS-bedpartner (1.29–3.47). Conclusions: The RBDSSS has adequate psychometric properties to quantify RBD severity, with good concordance between participant and bedpartner questionnaires and between scale scores and global severity. Disclosure: Ms. Busicescu has nothing to disclose. The institution of Dr. Choudhury has received research support from Lewy Body Dementia Association. The institution of Dr. Choudhury has received research support from Arizona Alzheimer’s Consortium. Dr. Lee-Iannotti has nothing to disclose. Dr. Rangan has nothing to disclose. Maria Livia Fantini has nothing to disclose. Dr. Shprecher has received personal compensation for serving as an employee of Banner Health. Dr. Shprecher has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal. Dr. Shprecher has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Forensis. Dr. Shprecher has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurocrine. Dr. Shprecher has received personal compensation in the range of $500-$4,999 for serving as a Consultant for US World Meds. Dr. Shprecher has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Emalex. Dr. Shprecher has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. Dr. Shprecher has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Neurocrine. Dr. Shprecher has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Acorda. Dr. Shprecher has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sunovion. Dr. Shprecher has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for US World Meds. Dr. Shprecher has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amneal. The institution of Dr. Shprecher has received research support from Arizona Alzheimer’s Consortium. The institution of Dr. Shprecher has received research support from MJFF. The institution of Dr. Shprecher has received research support from Abbvie. The institution of Dr. Shprecher has received research support from Acadia. The institution of Dr. Shprecher has received research support from Axovant. The institution of Dr. Shprecher has received research support from Biogen. The institution of Dr. Shprecher has received research support from Eisai. The institution of Dr. Shprecher has received research support from Eli Lilly. The institution of Dr. Shprecher has received research support from Enterin. The institution of Dr. Shprecher has received research support from Neurocrine. The institution of Dr. Shprecher has received research support from Teva. The institution of Dr. Shprecher has received research support from Nuvelution. The institution of Dr. Shprecher has received research support from Theravance. The institution of Dr. Shprecher has received research support from Eisai. The institution of Dr. Shprecher has received research support from Sanofi. The institution of Dr. Shprecher has received research support from Neuraly. Dr. Lim has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Applied Cognition. Dr. Lim has stock in Applied Cognition. The institution of Dr. Lim has received research support from NIH. The institution of Dr. Lim has received research support from VA. The institution of Dr. Lim has received research support from Department of Defense. The institution of Dr. Lim has received research support from National Science Foundation. Dr. Lim has received publishing royalties from a publication relating to health care. John Elliott has nothing to disclose. Dr. Avidan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Eisai. Dr. Avidan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Avadel. Dr. Avidan has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Harmony. Dr. Avidan has received personal compensation in the range of $0-$499 for serving as a Consultant for Merck. Dr. Avidan has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Eisai. Dr. Avidan has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Harmony. Dr. Avidan has received publishing royalties from a publication relating to health care. The institution of Dr. Huddleston has received research support from NIH-NINDS 1K23NS105944-01A1. The institution of Dr. Huddleston has received research support from Michael J. Fox Foundation (MJFF-010556). The institution of Dr. Huddleston has received research support from Lewy Body Dementia Association Research Center of Excellence (Emory). The institution of Dr. Huddleston has received research support from American Parkinson’s Disease Association. Donald Biwise has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eisai. Donald Biwise has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Donald Biwise has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Huxley. Donald Biwise has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ferring. Donald Biwise has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Idorsia. Dr. Howell has received personal compensation in the range of $500-$4,999 for serving as a Consultant for neurodiem. Dr. Howell has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alzecure. Dr. Howell has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for medlink. Dr. Howell has stock in Sleep Performance Institute. Dr. Howell has received publishing royalties from a publication relating to health care. Dr. Schenck has received personal compensation for serving as an employee of Physicians’ Educational Resource, LLC.. Dr. Schenck has received personal compensation for serving as an employee of Eisai Global Medical Affairs. Dr. Criswell has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Chengjie Xiong has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for DIADEM. Ms. McLeland has nothing to disclose. Dr. During has nothing to disclose. Dr. Mignot has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Takeda. Dr. Mignot has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Jazz Pharmaceutical. Dr. Mignot has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eisai Pharmaceuticals, Inc. . Dr. Mignot has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Takeda. Dr. Mignot has stock in Dreem. Dr. Mignot has stock in Centessa. Ms. Pelletier has nothing to disclose. The institution of Jean-Francois Gagnon has received research support from Canadian Institute of Health Research. The institution of Jean-Francois Gagnon has received research support from Canada Research Chair. The institution of Jean-Francois Gagnon has received research support from National Institutes of Health. Ms. Forsberg has nothing to disclose. The institution of Dr. Fields has received research support from National Institutes of Health. The institution of Dr. Fields has received research support from Patient-Centered Outcomes Research Institute. Dr. St. Louis has received publishing royalties from a publication relating to health care. Dr. St. Louis has received publishing royalties from a publication relating to health care. Dr. Videnovic has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Jazz. Dr. Videnovic has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion pharmaceuticals . The institution of Dr. Ju has received research support from National Institutes of Health. Dr. Boeve has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for Rainwater Charitable Foundation. The institution of Dr. Boeve has received research support from Alector. The institution of Dr. Boeve has received research support from GE Healthcare. The institution of Dr. Boeve has received research support from Transposon. The institution of Dr. Boeve has received research support from Cognition Therapeutics. Dr. Boeve has received publishing royalties from a publication relating to health care. Dr. Postuma has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche, Biogen, Takeda, Theranexus, GE, Jazz, Curasen, Paladin, Inception Sciences, Phytopharmics, Vaxxinity, Merck. Dr. Postuma has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen/Partners. The institution of Dr. Postuma has received research support from CIHR, Weston Foundation, Webster Foundation, Roche, MJFF, Parkinson Canada, FRSQ, NIH.

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