12/22/2008

Evaluation of the reliability and validity of the medical outcomes study sleep 
scale in patients with painful diabetic peripheral neuropathy during an 
international clinical trial.

Muriel Viala-Danten, Susan Martin, Isabelle Guillemin and Ron D Hays.

Health and Quality of Life Outcomes 2008, 6:113.

Background

Sleep 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. 

Methods

Clinical 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.

Results

Cronbach'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). 

Conclusions

The MOS-Sleep had good psychometric properties in this painful diabetic 
peripheral neuropathic population. Trial registration: As this study was 
conducted from 2000 to 2002 (i.e., before the filing requirement came out), no 
trial registration number is available.







8/17/2004


Hays, Ron D., Martin, Susan A., Sesti, Anne M., & Spritzer, Karen L. (2005). 
Psychometric properties of the Medical Outcomes Study sleep measure. 
Sleep Medicine, 6(1), 41-44.

Background and purpose: Sleep is an active and highly organized biological 
process that is an important component of life. Self-report measures of sleep 
provide information that can be useful for characterizing the quality of sleep 
in subgroups of the population. A 12-item self-report sleep measure, the Medical 
Outcomes Study (MOS) Sleep measure, was developed and evaluated previously in a 
sample of 3445 individuals with chronic illness.

Patients and methods: In this study, we evaluate the psychometric properties of 
the MOS Sleep measure in a nationally representative sample of 1011 US adults 
aged 18 and older and in a sample of 173 adults with neuropathic pain 
participating in a clinical drug trial.

Results: The average age of the general population sample was 46; 51% were 
female and 81% were white. The average age of the sample of adults with 
neuropathic pain was 72; 53% were female and 95% were white. Internal 
consistency reliability estimates for the MOS Sleep scales were 0.73 or higher, 
with the exception of the daytime somnolence scale in the US general population, 
which was 0.63. At baseline of the clinical trial, the neuropathic pain patients 
reported significantly more sleep disturbance and daytime somnolence, as well as 
less quantity and adequacy of sleep than patients in the general US population. 
The MOS Sleep scales were found to be responsive to change in the clinical trial 
with statistically significant improvements observed after administration of 
pregabalin for sleep disturbance (standardized response mean, SRM=-0.76, 
P=0.0007), shortness of breath (SRM=-0.20, P=0.0302), sleep adequacy (SRM=0.57, 
P=0.0014), sleep quantity (SRM=0.55, P=0.0086), and sleep problems (SRM=-0.62, 
P=0.0036).

Conclusions. This study provides further support for the reliability and 
validity of the MOS Sleep measure. The instrument can be used to assess 
important aspects of sleep perceived by adults in the general population or 
participating in clinical studies. 

Keywords: MOS sleep measure; Self-reports; Reliability; Validity; Patient 
reported outcomes