TY  - JOUR
UR  - https://doi.org/10.1093/rheumatology/kead371
JF  - Rheumatology
A1  - Pauling, John D
A1  - Yu, Lan
A1  - Frech, Tracy M
A1  - Herrick, Ariane L
A1  - Hummers, Laura K
A1  - Shah, Ami A
A1  - Denton, Christopher P
A1  - Saketkoo, Lesley Ann
A1  - Withey, Jane
A1  - Khanna, Dinesh
A1  - Domsic, Robyn T
VL  - 63
SP  - 1281
IS  - 5
N1  - This version is the author accepted manuscript. For information on re-use, please refer to the publisher's terms and conditions.
N2  - 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?<?0.001). Correlation with diary-based assessment of SSc-RP attack frequency and duration was lower (rho range 0.258?0.504, P?<?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?<?0.001). Significantly higher ASRAP scores were identified in smokers, patients with active digital ulceration (DU), previous history of DU and calcinosis (P?<?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?<?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.
ID  - discovery10174132
PB  - Oxford University Press (OUP)
KW  - SSc
KW  -  RP
KW  -  patient-reported outcome instrument
KW  -  clinical trial
KW  -  validation
TI  - Construct validity and reliability of the Assessment of Systemic Sclerosis-Associated Raynaud?s Phenomenon (ASRAP) questionnaire
AV  - public
Y1  - 2024/05//
EP  - 1290
ER  -