Validating the Post Sleep Questionnaire for Restless Legs Syndrome
Author Information
Author(s): Canafax Daniel M, Bhanegaonkar Abhijeet, Bharmal Murtuza, Calloway Michael
Primary Institution: XenoPort, Inc.
Hypothesis
The study aimed to validate the Post Sleep Questionnaire (PSQ) for assessing sleep dysfunction in subjects with moderate-to-severe Restless Legs Syndrome (RLS) symptoms.
Conclusion
The PSQ demonstrated robust psychometric properties and is a valid instrument for assessing sleep and sleep improvements in subjects with moderate-to-severe RLS symptoms.
Supporting Evidence
- Convergent validity was demonstrated by significant correlations between baseline PSQ items and total scores of IRLS, POMS, RLSQoL, and the MOS-Sleep Scale.
- Divergent validity was shown through the lack of significant correlations between PSQ items and demographic characteristics.
- Correlations between RLS severity groups and PSQ items demonstrated known-group validity.
- Mean changes in investigator- and subject-rated CGI-I scores for each PSQ item demonstrated the PSQ's responsiveness to patient change.
Takeaway
This study created a questionnaire to help understand how restless legs syndrome affects sleep, and it showed that the questionnaire works well.
Methodology
The study analyzed pooled data from two 12-week, randomized, placebo-controlled trials involving gabapentin enacarbil, where subjects completed the PSQ and other validated health surveys.
Limitations
The analyses were limited by the use of clinical trial data and not prospective data from a study conducted solely for validation purposes.
Participant Demographics
The mean age of subjects was approximately 50 years, predominantly non-Hispanic, white, and female, with about 92% having moderate or severe RLS symptoms.
Statistical Information
P-Value
p < 0.0001
Statistical Significance
p < 0.0001
Digital Object Identifier (DOI)
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