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Poster Presentations
Validation of outcome measures and biomarkers
THU0695 The RA FLARE questionnaire (RA-FQ) is responsive to change in ra symptoms and impacts in clinical and observational trials
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  1. SJ Bartlett1,2,
  2. VP Bykerk3,
  3. B Fautrel4,
  4. F Guillemin5,
  5. A den Broeder6,
  6. R Alten7,
  7. R Christensen8,
  8. E Choy9,
  9. D Furst10,
  10. S Hewlett11,
  11. A Leong12,
  12. L March13,
  13. T Woodworth10,
  14. BIO Clifton1,
  15. on behalf of CATCH, STPR, & DRESS Investigators
  1. 1Johns Hopkins, Baltimore, United States
  2. 2McGill University, Montreal, Canada
  3. 3HSS, New York, United States
  4. 4Pierre & Marie Curie Universite, Paris
  5. 5Universite de Lorraine, Nancy, France
  6. 6Maartens Kliniek, Nijmegen, Netherlands
  7. 7Schlosspark Klinik, Berlin, Germany
  8. 8Parker Institute, Copenhagen, Denmark
  9. 9Cardiff University, Cardiff, United Kingdom
  10. 10UCLA, Los Angeles, United States
  11. 11University of the West of England, Bristol, United Kingdom
  12. 12Healthy Motivation, Santa Barbara, United States
  13. 13University of Sydney, Sydney, Australia

Abstract

Background The RA-FQ is a new tool to measure RA flares. We have previously provided evidence of construct validity and reliability.1

Objectives We evaluated sensitivity to change of the RA-FQ in clinical trials and observational studies of RA patients with low disease activity.

Methods RA patients in observational studies [CATCH-Canada (n=896) and STPR-France (n=138)], and an RCT (DRESS-Netherlands; n=178) completed 5 items asking whether they were in flare (yes/no), and if so, the severity and duration. We selected patients who said they were not in flare and had a DAS28 <3.2 at thefirst visit (V1). Flare at the next study visit (V2) was defined three ways: 1) patient report (yes/no); 2) patient report-stringent (Boolean: patient report yes AND severity ≥4/10 AND duration >7 days [to increase this reflected increased inflammatory disease activity]; and c) DAS definition often used in studies (DAS28<3.2 at V2 required increase of 1.2; DAS≥3.2 at V2 required increase of 0.6). We compared RA-FQ scores with other PROs and disease activity indicators between flaring and non-flaring patients at V2. Effect size was estimatedusing Cohen's SMD. We hypothesized that at V2, RA-FQ scores would be similar in patients not flaring at both visits, and would be significantly higher in those flaring at V2.

Results The mean difference in RA-FQ scores at V2 ranged from 7.3 (95% CI 1.4, 13.2) in STPR (DAS def) to 19.6 (95% CI 16.7, 22.6) in CATCH (patient report-stringent). The standardized mean difference effect sizes (SMDES) ranged from 0.82–1.95, and were largest for patient report-stringent in 2 studies. SMDE were strong (range 0.84–2.42) for patient global, MD global, HAQ, DAS28, and other clinical indicators except ESR.

The mean difference in RA-FQ scores at V2 ranged from 7.3 (95% CI 1.4, 13.2) in STPR (DAS def) to19.6 (95% CI 16.7, 22.6) in CATCH (patient report-stringent). The standardized mean difference effect sizes (SMDES) ranged from 0.82–1.95, and were largest for patient report-stringent in 2 studies. SMDE were strong (range 0.84–2.42) for patient global, MD global, HAQ, DAS28, and other clinical indicators except ESR.

Figure

Conclusions Data from clinical and observational studies support the responsiveness of the RA-FQ in detecting change over time. The robust psychometric properties of the RA-FQ suggest it reliably detects clinically relevant worsening of RA symptoms consistent with increased disease activity and support its use in research and clinical care.

References

  1. Bykerk V et al. RMD Open 2016;2(1):e000225.

References

Disclosure of Interest None declared

https://doi.org/10.1136/annrheumdis-2017-eular.6921

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