Protocol - Symptoms of Restless Legs Syndrome
Protocol Name from Source:
The Restless Legs Syndrome Rating Scale
The Restless Legs Syndrome Rating Scale (Investigator Version 2.1) is a 10-item, interviewer-administered questionnaire that rates the primary features, the intensity and frequency of symptoms, and the impact of the disorder on the patient’s quality of life for the most recent 2-week period. Numerical answer values can be summed for all 10 questions to obtain an overall score.
Patients rate their overall experience with various aspects of restless legs syndrome, including discomfort in arms or legs, need for movement, and sleep disturbance. Each question is scored on a scale of none (0) to very severe (4).
Personnel and Training Required
The interviewer must be able to describe what restless legs are to the patient. The interviewer must be trained to conduct personal interviews with individuals from the general population. The interviewer must be trained and found to be competent (i.e., tested by an expert) at the completion of personal interviews.
Either a paper-and-pencil or computer-assisted instrument may be used. If a computer-assisted instrument is used, computer software may be necessary to develop the instrument. The interviewer will require a laptop computer/handheld computer to administer a computer-assisted questionnaire.
|Average time of greater than 15 minutes in an unaffected individual||No|
|Specialized requirements for biospecimen collection||No|
Mode of Administration
The Restless Legs Syndrome Rating Scale is a proprietary instrument that is available from the MAPI Research Institute.
June 30, 2010
This is a questionnaire to assess restless legs syndrome, which is an uncontrollable urge to move the legs to stop uncomfortable burning, itching, or tickling sensations.
This measure is used to assess the severity of an individual’s symptoms of restless legs syndrome. Restless legs syndrome has been reported to affect up to 15% of the general adult population and is one of the most common sleep disorders (Chokroverty, 2003). The gene for restless legs syndrome has not been defined. A genetic component is likely because first-degree relatives of those affected with restless legs syndrome are at higher risk for developing the syndrome compared with the general population and because there is a high concordance among affected twins (Hening et al., 2002; Ondo et al., 2000).
The Restless Legs Syndrome Rating Scale (Investigator Version 2.1) was vetted against similar instruments and chosen because it is a short, validated protocol that has been previously used in a multinational, multicenter study.
|Common Data Elements (CDE)||Person Restless Leg Syndrome Symptom Assessment Score||3076119||CDE Browser|
|Logical Observation Identifiers Names and Codes (LOINC)||Restless legs syndrome proto||62786-9||LOINC|
Process and Review
[link[phenx.org/node/103|Expert Review Panel 4]] (ERP 4) reviewed the measures in the Neurology, Psychiatric, and Psychosocial domains.
Guidance from ERP 4 includes the following:
· No changes
Hening, W. A., & Allen, R. P. (2003). Restless legs syndrome (RLS): The continuing development of standards and severity measures. Sleep Medicine, 4(2), 95-97.
Restless Legs Syndrome Rating Scale is a proprietary instrument. Copies of this scale and its translations into several languages can be obtained from:
MAPI Research Institute
27 rue de la Villette 69003
Fax: +33 (0) 472 13 66 8
Chokroverty, S. (2003). Editor’s corner: Restless legs syndrome, a common disease uncommonly diagnosed. Sleep Medicine, 4(2), 91-93.
Hening, W. A., Washburn, T., Allen, R. P., & Earley, C. (2002). A family study of RLS: Presence of an elevated prevalence of affected first and second degree relatives. Neurology, 58(Suppl. 3), A513-A514.
Ondo, W. G., Vuong, K. D., & Wang, Q. (2000). Restless legs syndrome in monozygotic twins: Clinical correlates. Neurology, 55, 1404-1406.
Walters, A. S., LeBrocq, C., Dhar, A., Hening, W., Rosen, R., Allen, R. P., & Trenkwalder, C.; International Restless Legs Syndrome Study Group. (2003). Validation of the International Restless Legs Syndrome Study Group rating scale for restless legs syndrome. Sleep Medicine, 4(2), 121-132.
Winkelman, J., Muller-Myhsok, B., Wittchen, H. U., Hock, B., Prager, M., Pfister, H., Strohle, A., Eisensehr, I., Dichgans, M., Gasser, T., & Trenkwalder, C. (2002). Complex segregation analysis of restless legs syndrome provides evidence for an autosomal dominant mode of inheritance. Annals of Neurology, 52, 297-302.
|Variable Name||Variable ID||Variable Description||Version||dbGaP Mapping|
|PX131401000000||Protocol 131401 - proprietary. Check DCW for contact.||4||N/A|