Evidence map›Paper›PMID 28521738›Full record

Trial reportBMC musculoskeletal disorders2017

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

Y Li, S Morris, J Cole, S Dube', J A M Smith, C Burbridge, T Symonds, S Hudgens, W Wang

Abstract readClinical Trial
In one paragraph

Trial report in BMC musculoskeletal disorders, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Questionnaires for the subjective evaluation of patients with fibromyalgia: a systematic review.European journal of physical and rehabilitation medicine · 2023
    Pooled it
  4. Review
  5. Article
  6. Exploring the Relationship between Fibromyalgia-Related Fatigue, Physical Activity, and Quality of Life.International journal of environmental research and public health · 2022
    Article
  7. Article
  8. Article
  9. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Y LiFormer employees, current consultants of Theravance Biopharma US, Inc, 901 Gateway Boulevard, South San Francisco, CA, 94080, USA. YLi@theravance.com.
S MorrisFormer employees, current consultants of Theravance Biopharma US, Inc, 901 Gateway Boulevard, South San Francisco, CA, 94080, USA.
J ColeFormer employees of Covance Market Access, San Diego, CA, USA.
S Dube'Consulting Associate Professor, Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, 94305, CA, USA.
J A M SmithFormer employees, current consultants of Theravance Biopharma US, Inc, 901 Gateway Boulevard, South San Francisco, CA, 94080, USA.
C BurbridgeClinical Outcomes Solutions, Unit 68 Basepoint, Shearway Business Park, Shearway Road, Folkestone, Kent, UK.ORCID 0000-0003-0117-7169
T SymondsClinical Outcomes Solutions, Unit 68 Basepoint, Shearway Business Park, Shearway Road, Folkestone, Kent, UK.
S HudgensClinical Outcomes Solutions, 1790 E. River Rd., Suite 205, Tucson, AZ, 85718, USA.
W WangTheravance Biopharma US, Inc., San Francisco, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

AdultComputers, HandheldFatigueFemaleFibromyalgiaHumansLongitudinal StudiesMaleMedical RecordsMiddle AgedPsychometricsSelf ReportConfirmatory factor analysis (CFA)DiaryFatigueFibromyalgiaMDF-Fibro-17Patient reported outcome (PRO)PsychometricsReliability, responderValidity

Identifiers

PMID28521738
PMCPMC5437630

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.