@article{discovery10174132,
          volume = {63},
            note = {This version is the author accepted manuscript. For information on re-use, please refer to the publisher's terms and conditions.},
           pages = {1281--1290},
          number = {5},
           month = {May},
       publisher = {Oxford University Press (OUP)},
           title = {Construct validity and reliability of the Assessment of Systemic Sclerosis-Associated Raynaud's Phenomenon (ASRAP) questionnaire},
            year = {2024},
         journal = {Rheumatology},
             url = {https://doi.org/10.1093/rheumatology/kead371},
          author = {Pauling, John D and Yu, Lan and Frech, Tracy M and Herrick, Ariane L and Hummers, Laura K and Shah, Ami A and Denton, Christopher P and Saketkoo, Lesley Ann and Withey, Jane and Khanna, Dinesh and Domsic, Robyn T},
        abstract = {Objectives:
Assessment of construct validity and reliability of a novel patient-reported outcome (PRO) instrument for assessing the severity and impact of RP in SSc. /

Methods:
An international multicentre study validation study of the 27-item Assessment of Systemic Sclerosis-Associated Raynaud's Phenomenon (ASRAP) and 10-item short-form (ASRAP-SF) questionnaires. The relationship between ASRAP questionnaires and demographics, clinical phenotype and legacy instruments for assessing SSc-RP severity, disability and pain was assessed. Repeatability was evaluated at 1 week. Anchor-based statements of health status facilitated assessment of ASRAP thresholds of meaning. /

Results:
A total of 420 SSc subjects were enrolled. There was good correlation between ASRAP (and ASRAP-SF) with RP visual analogue scale (VAS) and Scleroderma Health Assessment Questionnaire RP VAS (rho range 0.648-0.727, P {\ensuremath{<}} 0.001). Correlation with diary-based assessment of SSc-RP attack frequency and duration was lower (rho range 0.258-0.504, P {\ensuremath{<}} 0.001). ASRAP questionnaires had good correlation with instruments for assessing disability, hand function, pain and global health assessment (rho range 0.427-0.575, P {\ensuremath{<}} 0.001). Significantly higher ASRAP scores were identified in smokers, patients with active digital ulceration (DU), previous history of DU and calcinosis (P {\ensuremath{<}} 0.05 for all comparisons). There was excellent repeatability at 1 week among patients with stable SSc-RP symptoms (intra-class coefficients of 0.891 and 0.848, P {\ensuremath{<}} 0.001). Patient-acceptable symptom state thresholds for ASRAP and ASRAP-SF were 45.34 and 45.77, respectively. A preliminary Minimally Important Clinical Difference threshold of 4.17 (95\% CI 0.53, 7.81, P = 0.029) was estimated. /

Conclusion:
ASRAP and ASRAP-SF questionnaires are valid and reliable novel PRO instruments for assessing the severity and impact of SSc-RP.},
        keywords = {SSc, RP, patient-reported outcome instrument, clinical trial, validation}
}