Multidimensional daily diary of fatigue-fibromyalgia-17 items (MDF-fibro-17): part 2 psychometric evaluation in fibromyalgia patients

BMC Musculoskeletal Disorders

Research Article

S. Hudgens¹  C. Burbridge²  T. Symonds²  S. Dube’³  J. Cole⁴  S. Morris⁵  Y. Li⁵  J. A. M. Smith⁵  W. Wang⁶ 

[1] Clinical Outcomes Solutions, 1790 E. River Rd., Suite 205, 85718, Tucson, AZ, USA;Clinical Outcomes Solutions, Unit 68 Basepoint, Shearway Business Park, Shearway Road, Folkestone, Kent, UK;Consulting Associate Professor, Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, 94305, Stanford, CA, USA;Adjunct Professor, University of Pittsburgh Schools of Medicine, 15260, Pittsburg, PA, USA;Former employees of Covance Market Access, San Diego, CA, USA;Former employees, current consultants of Theravance Biopharma US, Inc, 901 Gateway Boulevard, 94080, South San Francisco, CA, USA;Theravance Biopharma US, Inc., San Francisco, CA, USA;

关键词: Fibromyalgia;    Fatigue;    Diary;    Patient reported outcome (PRO);    Psychometrics;    Confirmatory factor analysis (CFA);    Validity;    Reliability, responder;    MDF-Fibro-17;   

DOI  :  10.1186/s12891-017-1545-x

 received in 2016-10-11, accepted in 2017-04-30,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundThe Multidimensional Daily Diary of Fatigue-Fibromyalgia-17 instrument (MDF-Fibro-17) has been developed for use in fibromyalgia (FM) clinical studies and includes 5 domains: Global Fatigue Experience, Cognitive Fatigue, Physical Fatigue, Motivation, and Impact on Function. Psychometric properties of the MDF-Fibro-17 needed to demonstrate the appropriateness of using this instrument in clinical studies are presented.MethodsPsychometric analyses were conducted to evaluate the factor structure, reliability, validity, and responsiveness of the MDF-Fibro-17 using data from a Phase 2 clinical study of FM patients (N = 381). Confirmatory factor analyses (CFA) were performed to ensure understanding of the multidimensional domain structure, and a secondary factor analysis of the domains examined the appropriateness of calculating a total score in addition to domain scores. Longitudinal psychometric analyses (test-retest reliability and responder analysis) were also conducted on the data from Baseline to Week 6.ResultsThe CFA supported the 17-item, 5 domain structure of this instrument as the best fit of the data: comparative fit index (CFI) and non-normed fit index (NNFI) were 0.997 and 0.992 respectively, standardized root mean square residual (SRMR) was 0.010 and the root mean square error of approximation (RMSEA) was 0.06. In addition, total score (CFI and NNFI both 0.95) met required standards. For the total and 5 domain scores, reliability and validity data were acceptable: test-retest and internal consistency were above 0.9; correlations were as expected with the Global Fatigue Index (GFI) (0.62-0.75), Fibromyalgia Impact Questionnaire (FIQ) Total (0.59–0.71), and 36-Item Short Form Health Survey (SF-36) vitality (VT) (0.43–0.53); and discrimination was shown using quintile scores for the GFI, FIQ Total, and Pain Numeric Rating Scale (NRS) quartiles. In addition, sensitivity to change was demonstrated with an overall mean responder score of -2.59 using anchor-based methods.ConclusionThe MDF-Fibro-17 reliably measures 5 domains of FM-related fatigue and psychometric evaluation confirms that this measure meets or exceeds each of the predefined acceptable thresholds for evidence of reliability, validity, and responsiveness to changes in clinical status. This suggests that the MDF-Fibro-17 is an appropriate and responsive measure of FM-related fatigue in clinical studies.

【 授权许可】

CC BY   
© The Author(s). 2017