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It consists of a single-item with an 11-point numerical rating scale, ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) that allows the calculation of a weekly mean sleep interference score [ 21- 23].
Additionally, by week 1 and for the study's duration, 150 and 300 mg/day pregabalin significantly reduced weekly mean sleep interference scores.
The mean sleep interference score across countries was 5.59 (STD = 2.17).
Similar results were observed for improvements in endpoint mean sleep interference scores.
Baseline mean pain scores and mean sleep interference scores were comparable among age and dosage groups.
The weekly mean sleep interference score and the weekly mean pain score at baseline were used to define groups of patients differing in severity.
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End point mean sleep-interference score was derived from daily sleep diaries in which patients rated daily how much their pain had interfered with their sleep (also done using an 11-point NRS, with 0 = "pain does not interfere with sleep" to 10 = "pain completely interferes with sleep").
Baseline mean pain and sleep interference scores were comparable across treatment and age groups.
Demographics and baseline characteristics (mean DPRS and DSIS sleep interference scores) were summarized descriptively by treatment and disease groups.
As with change in mean pain score, improvement in sleep interference appeared to be positively correlated with dosage.
In the absence of published thresholds, the following groups of patients were defined based on the distribution of the changes in both the weekly sleep interference and pain diaries mean scores: 'much improved' (-10 ≤ mean sleep/pain score ≤ -4); 'improved' (-4 < mean sleep/pain score ≤ -1); 'stable' (-1 < mean sleep/pain score < 1); and 'worsened' (1 ≤ mean sleep/pain score ≤ 10).
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com