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Health and Quality of Life Outcomes
Published in: Health and Quality of Life Outcomes 1/2017

Open Access 01-12-2017 | Research

Psychometric properties of the single-item measure, severity of worst tiredness, in patients with moderately to severely active rheumatoid arthritis

Authors: Elizabeth D. Bacci, Amy M. DeLozier, Chen-Yen Lin, Carol L. Gaich, Xiang Zhang, Terence Rooney, Stephanie de Bono, Richard Hoffman, Kathleen W. Wyrwich

Published in: Health and Quality of Life Outcomes | Issue 1/2017

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Abstract

Background

To assess the reliability, validity, and responsiveness to treatment change of the single-item measure, Severity of Worst Tiredness, in patients with rheumatoid arthritis (RA).

Methods

Data from two Phase 3, randomized, placebo-controlled (RA-BUILD; and active-controlled [RA-BEAM]), clinical studies of the efficacy of baricitinib in adults with moderately to severely active RA were used. The psychometric properties of the single-item measure, Severity of Worst Tiredness, were assessed, including test-retest reliability, convergent and discriminant validity, known-groups validity, and responsiveness, using other patient- and clinician-reported outcomes frequently assessed in RA patients.

Results

Test-retest reliability of the Severity of Worst Tiredness was supported through large intraclass correlation coefficients (0.89 ≤ ICC ≤ 0.91). Moderate-to-large correlations were observed between this patient-reported outcome (PRO) and other related patient- and clinician-reported assessments of RA symptoms and patient functioning, supporting construct validity of the measure (│r│ ≥ 0.41). The instrument also displayed known-groups validity through statistically significant differences between mean values of the Severity of Worst Tiredness defined using other indicators of RA severity. Finally, responsiveness was supported by large and statistically significant differences in change scores from Day 1 to Week 12 for patients comparing responders and nonresponders using the American College of Rheumatology 20 (ACR20) criteria.

Conclusion

The Severity of Worst Tiredness PRO demonstrated adequate reliability, validity, and responsiveness in clinical trials of adults with moderately to severely active RA and is fit for purpose in this patient population.
Appendix
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Metadata
Title
Psychometric properties of the single-item measure, severity of worst tiredness, in patients with moderately to severely active rheumatoid arthritis
Authors
Elizabeth D. Bacci
Amy M. DeLozier
Chen-Yen Lin
Carol L. Gaich
Xiang Zhang
Terence Rooney
Stephanie de Bono
Richard Hoffman
Kathleen W. Wyrwich
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Health and Quality of Life Outcomes / Issue 1/2017
Electronic ISSN: 1477-7525
DOI
https://doi.org/10.1186/s12955-017-0807-5

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