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
2008

Evaluating the Medical Outcomes Study Sleep Scale in Diabetic Neuropathy Patients

Sample size: 396 publication Evidence: high

Author Information

Author(s): Viala-Danten Muriel, Martin Susan, Guillemin Isabelle, Hays Ron D

Primary Institution: Mapi Values

Hypothesis

The study aims to evaluate the reliability and validity of the Medical Outcomes Study Sleep Scale (MOS-Sleep) in patients with painful diabetic peripheral neuropathy.

Conclusion

The MOS-Sleep had good psychometric properties in this painful diabetic peripheral neuropathic population.

Supporting Evidence

  • Cronbach's alpha ranged from 0.71 to 0.81 for the multi-item dimensions and the sleep problems index.
  • Construct validity was supported with lower sleep adequacy scores associated with higher sleep problems index scores.
  • Responsiveness was supported by effect sizes greater than 0.80 for patients who improved according to sleep interference and pain scores.

Takeaway

This study looked at how well a sleep questionnaire works for people with painful diabetes-related nerve damage, and it found that the questionnaire is reliable and valid.

Methodology

The study was a double-blind, randomized, placebo-controlled, multicenter, phase III clinical trial with 396 patients, assessing the psychometric properties of the MOS-Sleep Scale.

Limitations

The study did not evaluate test-retest reliability due to the design lasting 12 weeks, and the cross-cultural validity of the MOS-Sleep was not fully addressed.

Participant Demographics

{"mean_age":59,"gender_distribution":{"male":55,"female":45},"ethnicity":{"white":96,"black":1,"asian_or_pacific":2,"other":2},"countries":{"Australia":19,"Germany":17,"Hungary":9,"Poland":42,"South Africa":8,"United Kingdom":5}}

Statistical Information

P-Value

p<0.0001

Statistical Significance

p<0.0001

Digital Object Identifier (DOI)

10.1186/1477-7525-6-113

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