A SIMPLIFIED SEVERITY SCALE FOR THE ASSESSMENT OF RESTLESS LEGS SYNDROME - THE DESYR STUDY GROUP

Author(s)

Montplaisir J1, Crochard A2, Arnulf I3, Huas D4, Krieger J5, Lainey E6, Leger D7, Pouchain D2, Tison F8, Schwalm M9, Schuck S10, El Hasnaoui A2, 1 Hopital du Sacré-Coeur, Montreal, QC, Canada; 2 GlaxoSmithKline, Les Ulis, France; 3 Hopital de la Pitié-Salpétrière, Paris, France; 4 Université Xavier Bichat, Paris, France; 5 Université Louis Pasteur, Strasbourg, France; 6 Hopital européen Georges Pompidou, Paris, France; 7 Hotel dieu, Paris, France; 8 Université de Bordeaux 1, Talence, France; 9 BKL Thalès, Paris, France; 10 Kappa Santé, Paris, France

OBJECTIVES: To develop a simple dichotomous scale for the assessment of RLS severity to be used for facilitating therapeutic decisions. METHODS: A prospective epidemiological study was conducted in primary healthcare in France. First, patients fulfilling the RLS diagnostic criteria from the International Restless Legs Study Group were identified. Secondly, severity of identified RLS subjects was assessed using the IRLS rating scale. This scale includes ten items, each rated on a five point Lickert scale from zero to four (“non” to “very severe”) and summed in a global score from zero to 40 (0-20 : non-severe ; 21-40: severe). Using a segmentation analysis applied to the rating scale items and other measures of RLS impact, we attempted to find a small number of items able to distinguish severe from non-severe RLS patients as the rating scale would have done. RESULTS: A total of 537 patients were analyzed. Three items came up from the segmentation analysis, consolidated into “RS-3”. All three were part of the rating scale. They dealt with: overall RLS severity, overall sleep disturbance and mood disturbance. The decision rule was that an answer zero,one or two (ie. none, mild or moderate) to at least one of the three items assigned an RS-3 grade of 'non-severe'. The sensitivity and specificity of RS-3 were 82% and 95% respectively. The positive and negative predictive values (PPV and NPV) were 92% and 88%. Sensitivity analyses with thresholds of 15, 25 and 30 were performed without improving sensitivity and specificity. The reproducibility of the RS-3 was assessed in another RLS population (731 subjects from the INSTANT Study) with sensitivity / specificity of 88% and 91%; and PPV and NPV of 73% and 97%, respectively. CONCLUSIONS: The metrology of the RS-3 scale appears to be strong enough to be used in larger sample.

Conference/Value in Health Info

2004-10, ISPOR Europe 2004, Hamburg, Germany

Value in Health, Vol. 7, No. 6 (November/December 2004)

Code

PNL20

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Neurological Disorders

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