eprintid: 10174132 rev_number: 14 eprint_status: archive userid: 699 dir: disk0/10/17/41/32 datestamp: 2023-07-27 11:05:36 lastmod: 2024-10-30 18:12:45 status_changed: 2023-07-27 11:05:36 type: article metadata_visibility: show sword_depositor: 699 creators_name: Pauling, John D creators_name: Yu, Lan creators_name: Frech, Tracy M creators_name: Herrick, Ariane L creators_name: Hummers, Laura K creators_name: Shah, Ami A creators_name: Denton, Christopher P creators_name: Saketkoo, Lesley Ann creators_name: Withey, Jane creators_name: Khanna, Dinesh creators_name: Domsic, Robyn T title: Construct validity and reliability of the Assessment of Systemic Sclerosis-Associated Raynaud’s Phenomenon (ASRAP) questionnaire ispublished: pub subjects: RFH divisions: UCL divisions: B02 divisions: C10 divisions: D17 divisions: G90 keywords: SSc, RP, patient-reported outcome instrument, clinical trial, validation note: This version is the author accepted manuscript. For information on re-use, please refer to the publisher's terms and conditions. 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 < 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. date: 2024-05 date_type: published publisher: Oxford University Press (OUP) official_url: https://doi.org/10.1093/rheumatology/kead371 oa_status: green full_text_type: other language: eng primo: open primo_central: open_green verified: verified_manual elements_id: 2040013 doi: 10.1093/rheumatology/kead371 medium: Print-Electronic pii: 7229563 lyricists_name: Denton, Christopher lyricists_id: CPDEN87 actors_name: Denton, Christopher actors_id: CPDEN87 actors_role: owner full_text_status: public publication: Rheumatology volume: 63 number: 5 pagerange: 1281-1290 event_location: England citation: Pauling, John D; Yu, Lan; Frech, Tracy M; Herrick, Ariane L; Hummers, Laura K; Shah, Ami A; Denton, Christopher P; ... Domsic, Robyn T; + view all <#> Pauling, John D; Yu, Lan; Frech, Tracy M; Herrick, Ariane L; Hummers, Laura K; Shah, Ami A; Denton, Christopher P; Saketkoo, Lesley Ann; Withey, Jane; Khanna, Dinesh; Domsic, Robyn T; - view fewer <#> (2024) Construct validity and reliability of the Assessment of Systemic Sclerosis-Associated Raynaud’s Phenomenon (ASRAP) questionnaire. Rheumatology , 63 (5) pp. 1281-1290. 10.1093/rheumatology/kead371 <https://doi.org/10.1093/rheumatology%2Fkead371>. Green open access document_url: https://discovery.ucl.ac.uk/id/eprint/10174132/1/Construct%20validity%20and%20reliability%20of%20the%20ASRAP%20questionnaire_RHE-2023%20accepted%20with%20figs.pdf