Abstract
BackgroundSleep is an important element of functioning and well-being. The Medical Outcomes Study Sleep Scale (MOS-Sleep) includes 12 items assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. A sleep problems index, grouping items from each of the former domains, is also available. This study evaluates the psychometric properties of MOS-Sleep Scale in a painful diabetic peripheral neuropathic population based on a clinical trial conducted in six countries.MethodsClinical data and health-related quality of life data were collected at baseline and after 12 weeks of follow-up. Overall, 396 patients were included in the analysis. Psychometric properties of the MOS-Sleep were assessed in the overall population and per country when the sample size was sufficient. Internal consistency reliability was assessed by Cronbach's alpha; the structure of the instrument was assessed by verifying item convergent and discriminant criteria; construct validity was evaluated by examining the relationships between MOS-Sleep scores and sleep interference and pain scores, and SF-36 scores; effect-sizes were used to assess the MOS-Sleep responsiveness. The study was conducted in compliance with United States Food and Drug Administration regulations for informed consent and protection of patient rights.ResultsCronbach's alpha ranged from 0.71 to 0.81 for the multi-item dimensions and the sleep problems index. Item convergent and discriminant criteria were satisfied with item-scale correlations for hypothesized dimensions higher than 0.40 and tending to exceed the correlations of items with other dimensions, respectively. Taken individually, German, Polish and English language versions had good internal consistency reliability and dimension structure. Construct validity was supported with lower sleep adequacy score and greater sleep problems index scores associated with measures of sleep interference and pain scores. In addition, correlations between the SF-36 scores and the MOS-Sleep scores were low to moderate, ranging from -0.28 to -0.53. Responsiveness was supported by effect sizes > 0.80 for patients who improved according to the mean sleep interference and pain scores and clinician and patient global impression of change (p < 0.0001).ConclusionThe MOS-Sleep had good psychometric properties in this painful diabetic peripheral neuropathic population.Trial registrationAs this study was conducted from 2000 to 2002 (i.e., before the filing requirement came out), no trial registration number is available.
Highlights
Sleep is an important element of functioning and well-being
Sleep disturbance is common in chronic pain and is of particular concern in painful diabetic peripheral neuropathy (DPN) as it may influence the progression of type II diabetes [19]
The present study examines perceptions of sleep in an international clinical trial aimed at evaluating the efficacy and safety of the pregabalin, a treatment for pain relief in patients with painful DPN
Summary
Sleep is an important element of functioning and well-being. The Medical Outcomes Study Sleep Scale (MOSSleep) includes 12 items assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. This study evaluates the psychometric properties of MOS-Sleep Scale in a painful diabetic peripheral neuropathic population based on a clinical trial conducted in six countries. Sleep is an important element of functioning and wellbeing and is associated with clinical status and general health. Sleep problems have been found to be associated with depression, anxiety, impaired social functioning, hospitalizations, chronic medical conditions and mortality [1,2,3]. Painful DPN may affect sleep, work, social activities and relations, physical mobility, levels of anxiety and depression and energy [14,15,16], leading to the substantial impairments in patients' health-related quality of life (HRQoL) [17,18]. A recent study confirmed the association of painful DPN with sleep impairment [15]
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