Original article Validation of the Augmentation Severity Rating Scale (ASRS): A multicentric, prospective study with levodopa on restless legs syndrome q Diego Garcı ´a-Borreguero a, * , Ralf Kohnen b , Birgit Ho ¨gl c , Luigi Ferini-Strambi d , Georgios M. Hadjigeorgiou e , Magdolna Hornyak f , Al W. de Weerd g , Svenja Happe h , Karin Stiasny-Kolster i , Viola Gschliesser c , Renata Egatz a , Belen Cabrero a , Birgit Frauscher c , Claudia Trenkwalder j , Wayne A. Hening k , Richard P. Allen l a Fundacio ´ n Jime ´nez Dı ´az, Madrid, Spain b IMEREM Institute for Medical Research Management and Biometrics, Nuremberg, Germany c Department of Neurology, University of Innsbruck, Innsbruck, Austria d Sleep Disorders Center, Universita ` Vita-Salute H San Raffaele, Milan, Italy e Department of Neurology, Medical School, University of Thessaly, Larissa, Greece f Sleep Disorder Unit, Department of Psychiatry and Psychotherapy, University of Freiburg, Freiburg, Germany g Sleep Center SEIN, Zwolle, The Netherlands h Department of Clinical Neurophysiology, Klinikum Bremen-Ost, and University of Goettingen, Bremen, Germany i Department of Neurology, Philipps University, Marburg, Germany j Paracelsus-Elena Hospital and University of Goettingen, Kassel, Germany k UMDNJ-Robert Wood Johnson Medical School, New Brunswick, NJ, USA l Department of Neurology, School of Medicine, Johns Hopkins University, Baltimore, USA Received 27 January 2007; received in revised form 6 March 2007; accepted 17 March 2007 Available online 31 May 2007 Abstract Background: Augmentation is the main complication during long-term dopaminergic treatment of restless legs syndrome (RLS) and reflects an overall increase in RLS severity. Its severity varies considerably from a minor problem to a devastating exacerbation of disease. Despite its clinical relevance, systematic evaluations have rarely been undertaken and there has been no development of methods to assess the severity of augmentation. To fill this gap, the European RLS Study Group (EURLSSG) has developed the Augmentation Severity Rating Scale (ASRS), using three items that assess the degree of change in three specific dimensions of augmentation. The changes in each dimension are summed to give an ASRS total score. Methods: The ASRS was developed to cover the basic dimensions defining RLS augmentation. The items were developed by an interactive process involving professional and patient input. The ASRS that was evaluated included four major items and two alter- native forms of one item. The validation was conducted using 63 (85%) mostly untreated RLS patients from six centers, who were treated for six months with levodopa (L-Dopa) (up to 500 mg/day, as clinically needed). Two consecutive assessments before and at baseline measured test–retest reliability. Consecutive ASRS ratings by two indepen- dent raters on a subsample of patients evaluated inter-rater reliability. Comparison with clinical severity ratings of two independent 1389-9457/$ - see front matter Ó 2007 Elsevier B.V. All rights reserved. doi:10.1016/j.sleep.2007.03.023 q Funding: The study was supported by an unrestricted educational grant from Pfizer USA to Diego Garcı ´a-Borreguero. Development of the study protocol and the case record forms, study management, statistical analysis and reporting was provided on a non-profit basis by IMEREM Germany (Ralf Kohnen). * Corresponding author. Present address: Sleep Research Institute, Alberto Alcocer 19, 28036 Madrid, Spain. Tel.: +34 913454129; fax: +34 913509593. E-mail address: dgb@iis.es (D. Garcı ´a-Borreguero). www.elsevier.com/locate/sleep Sleep Medicine 8 (2007) 455–463 Descargado para Anonymous User (n/a) en Universidad Nacional Autonoma de Mexico de ClinicalKey.es por Elsevier en septiembre 13, 2017. Para uso personal exclusivamente. No se permiten otros usos sin autorización. Copyright ©2017. Elsevier Inc. Todos los derechos reservados.