Jens Croenlein

Development of the Pediatric Restless Legs Syndrome Severity Scale (P-RLS-SS)©: A patient-reported outcome measure of pediatric RLS symptoms and impact

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 childs 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.

Pediatric Restless Legs Syndrome: Analysis of Symptom Descriptions and Drawings

The specific aims of this study were to collect and analyze detailed symptom descriptions from patients with pediatric restless legs syndrome, ages 6 to 17 years, as well as assess symptom impact and the usefulness of drawings. Trained qualitative interviewers conducted face-to-face audio-recorded interviews of children and adolescents who met criteria for definite restless legs syndrome. Thirty-three patients in 3 age groups used 16 different categories of descriptors for restless legs sensations, with a mean of 3 or more categories used per patient in each age group. “Need to move/kick,” “pain/hurts,” “uncomfortable/cannot get comfortable,” and “like bugs or ants/crawling” were the most common descriptors. Two-thirds reported daytime sensations, and nearly half had arm involvement. They described impact on sleep, cognitive function, and affect. Drawings provided useful diagnostic information. These detailed empirical data will be useful in clinical practice, as well as in the development of formal diagnostic tools and severity measures.

Time course of improvement of different symptom clusters in patients with major depression and pain treated with duloxetine or placebo

Abstract Objective: This post hoc analysis assessed improvements in a broad range of psychopathological dimensions and in interference of pain with functioning as well as the time course of these improvements in patients with major depressive disorder (MDD) and pain treated with duloxetine versus placebo. Research design and methods: Data were derived from an 8-week, double-blind, placebo-controlled study in adult outpatients with MDD and non-specific physical pain. Mean times between improvement in Brief Pain Inventory (BPI) pain severity and interference of pain with functioning, depression severity, and dimensions of the Symptom Checklist-90 Revised (SCL-90-R) subscales were evaluated by responder analysis. Results: For all SCL-90-R subscores, a higher percentage of duloxetine-treated patients reached responder status (50% improvement) as compared to placebo, of these anger/hostility and interpersonal sensitivity had the highest response rates. In the duloxetine-treated group, response for anger/hostility, phobic anxiety, psychoticism, and most items assessing interference of pain with functioning was reached earlier than response for pain severity. The times to response for Montgomery–Asberg Depression Rating Scale (MADRS) and for pain severity were similar. In the placebo-treated group, times to response for depression, anxiety, and MADRS were longer than response for pain severity. Conclusions: Duloxetine, and to a lesser degree placebo, not only improved depressive symptomatology and pain severity but also a much broader range of psychopathological symptoms. Time courses of improvements were different for duloxetine and placebo, in that depression and interference of pain with functioning improved earlier than pain severity in duloxetine-treated patients but not in placebo-treated patients. These results suggest that time to response is a valuable means of characterizing treatment effects. Limitations: Pain was only assessed as a symptom and no further clinical diagnosis for pain syndromes were performed. Clinical trial registry ID: www.clinicaltrial.gov - NCT00191919