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Development of the Pediatric Restless Legs Syndrome Severity Scale (P-RLS-SS): a patient-reported outcome measure of
Robert Arbuckle1, Linda Abetz, Jeffrey S Durmer
1Mapi Values Ltd., Cheshire, United Kingdom. rob.arbuckle@mapivalues.com
Insights
A new questionnaire was developed to assess Pediatric Restless Legs Syndrome (P-RLS) symptoms and their impact on children. This tool, the P-RLS-SS, was created with input from patients, parents, and experts for clinical research.
Area of Science:
- Pediatric Neurology
- Clinical Psychology
- Psychometrics
Background:
- Pediatric Restless Legs Syndrome (P-RLS) significantly impacts children's quality of life.
- Existing assessment tools may not fully capture the nuances of P-RLS symptoms and their effects in pediatric populations.
- A validated instrument is needed for accurate clinical research and patient evaluation.
Purpose of the Study:
- To develop and refine a comprehensive questionnaire for measuring Pediatric Restless Legs Syndrome symptoms and impact.
- To ensure the questionnaire is clinically relevant and patient-centered for pediatric populations.
- To create a tool suitable for use in clinical research settings.
Main Methods:
- Qualitative interviews with 33 children/adolescents with RLS and their parents informed item generation.
- Cognitive debriefing interviews with 21 children/adolescents and 15 parents refined questionnaire clarity and understanding.
- Expert clinician guidance was integrated throughout the development process.
Main Results:
- The Pediatric Restless Legs Syndrome Severity Scale (P-RLS-SS) was developed, encompassing symptom severity and impact domains.
- The scale includes 17 morning and 24 evening items, with specific considerations for younger children (ages 6-8).
- A complementary parent questionnaire was also created.
Conclusions:
- The P-RLS-SS demonstrates strong content validity, derived from direct input from pediatric patients, parents, and clinicians.
- The scale is designed to be comprehensive, clinically relevant, and patient-important for assessing P-RLS.
- Further validation studies are recommended to confirm the psychometric properties of the P-RLS-SS.
Objective:
To develop a questionnaire to measure Pediatric Restless Legs Syndrome (P-RLS) symptoms and impact for use in clinical research.
Methods:
Questionnaire items were developed based on open-ended, qualitative interviews of 33 children and adolescents diagnosed with definite RLS (ages 6-17 years) and their parents. The draft questionnaire was then tested through cognitive debriefing interviews with 21 of the same children/adolescents and 15 of their parents. This involved the children and parents answering the draft items and then interviewing them about the child's ability to understand and interpret the questionnaire. Expert clinicians provided clinical guidance throughout.
Results:
Draft severity questions were generated to measure the four-symptom and four-impact domains identified from the concept elicitation interviews: RLS sensations, move/rub due to RLS, relief from move/rub, pain, and impact of RLS on sleep, awake activities, emotions, and tiredness. RLS descriptions, symptoms, and impact were compared between those who had comorbid attention-deficit/hyperactivity disorder and those who did not. Revisions to several questions were made based on the cognitive debriefing interviews and expert clinician review, resulting in a severity scale with 17 morning and 24 evening items. Caution regarding self-administration in children ages 6-8 years is recommended. To complement the child/adolescent measures, a separate parent questionnaire was also developed.
Conclusions:
The P-RLS-SS was constructed based on detailed input from children and adolescents with RLS, their parents, and clinical experts, thus providing a scale with strong content validity that is intended to be comprehensive, clinically relevant, and important to patients. Validation of this scale is recommended.
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