Systemic sclerosis & Raynaud's

Construct validity and reliability of the Assessment of Systemic Sclerosis-Associated Raynaud’s Phenomenon (ASRAP) questionnaire

Rheumatology (Oxford)Published Validation study

Authors' conclusion

ASRAP and ASRAP-SF questionnaires are valid and reliable novel PRO instruments for assessing the severity and impact of SSc-RP.

Study context

Population
SSc subjects with SSc-associated RP
Participants
420 subjects
Comparison
ASRAP vs ASRAP-SF
Outcome
Construct validity and reliability of a novel patient-reported outcome (PRO) instrument for assessing the severity and impact of RP in SSc
Methodological detailsinternational, multicentre, Repeatability evaluated at 1 week, Anchor-based statements of health status for ASRAP thresholds of meaning
  • International
  • Multicentre
  • Repeatability evaluated at 1 week
  • Anchor-based statements of health status for ASRAP thresholds of meaning

Performance

As reported in the abstract

Construct validity and reliability
Correlation of ASRAP (and ASRAP-SF) with RP visual analogue scale (VAS) and Scleroderma HAQ RP VAS (rho range)
0.648-0.727, P < 0.001
Correlation with diary-based SSc-RP attack frequency and duration (rho range)
0.258-0.504, P < 0.001
Correlation with instruments for disability, hand function, pain and global health assessment (rho range)
0.427-0.575, P < 0.001
Significantly higher ASRAP scores in smokers, active digital ulceration (DU), previous history of DU and calcinosis
P < 0.05 for all comparisons
Repeatability at 1 week among stable SSc-RP symptoms, intra-class coefficients
0.891 and 0.848, P < 0.001
Patient-acceptable symptom state threshold, ASRAP
45.34
Patient-acceptable symptom state threshold, ASRAP-SF
45.77
Preliminary Minimally Important Clinical Difference threshold
4.17 (95% CI 0.53, 7.81, P = 0.029)

Original publication

Construct validity and reliability of the Assessment of Systemic Sclerosis-Associated Raynaud’s Phenomenon (ASRAP) questionnaire. Rheumatology (Oxford). Published 22 July 2023. doi:10.1093/rheumatology/kead371

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