Agreement Between Physician Evaluation and the Composite Response Index in Diffuse Cutaneous Systemic Sclerosis. Issue 11 (12th July 2022)

• Record Type: Journal Article
• Authors: Zheng, Boyang; Wang, Mianbo; McKenna, Kerry; Shapiro, Lee; Silver, Richard; Csuka, Mary Ellen; van den Hoogen, Frank; Robinson, David; Pauling, John D.; Hummers, Laura; Krieg, Thomas; Del Galdo, Francesco; Spiera, Robert; Jones, Niall; Khalidi, Nader; Vacca, Alessandra; de Vries‐Bouwstra, Jeska K.; Gordon, Jessica; Baron, Murray
• Other Names: Pope Janet E. investigator.; Hudson Marie investigator.; Gyger Geneviève investigator.; Larché Maggie J. investigator.; Masetto Ariel investigator.; Sutton Evelyn investigator.; Rodriguez‐Reyna Tatiana S. investigator.; Maltez Nancy investigator.; Smith Doug investigator.; Thorne Carter investigator.; Ikic Alena investigator.; Fortin Paul R. investigator.; Fritzler Marvin J. investigator.
• Is Part Of: Arthritis care & research. Volume 74:Issue 11(2022)
• Page Start: 1806
• Page End: 1812
• Publication Date: 2022-07-12
• Subjects: Arthritis -- Periodicals; Rheumatism -- Periodicals; 616.72
• DOI: 10.1002/acr.24638
• Languages: English
• ISSNs: 2151-464X

Abstract

Abstract : Objective: Diffuse cutaneous systemic sclerosis (SSc) is a highly heterogeneous disease. A provisionally approved Composite Response Index in diffuse cutaneous SSc (CRISS) was developed as a 1‐year outcome measure for clinical trials. Our goal was to further validate the CRISS by examining agreement between CRISS definitions for improved/non‐improved with physicians' evaluation of disease. Methods: Patient profiles from a large observational cohort were created for 50 random diffuse cutaneous SSc patients of <5 years disease duration with improved CRISS scores after 1 year and 50 with non‐improved CRISS scores. Profiles described disease features used during the initial CRISS development at baseline and at 1 year. Each profile was independently rated by 3 expert physicians. Majority opinion determined whether a patient was improved or not improved, and kappa agreement with the CRISS cutoff of 0.6 was calculated. Results: Patients had mean ± SD disease duration of 2.2 ± 1.3 years. There was substantial agreement between the physician majority opinion about each case and the CRISS (κ = 0.76 [95% confidence interval (95% CI) 0.64–0.88]). The agreement between each individual physician opinion and the CRISS was also substantial (κ = 0.70 [95% CI 0.62–0.78]). All CRISS non‐improvers were also rated as non‐improved by physician majority; however, 12 CRISS improvers were rated as non‐improved by physicians. Conclusion: There was substantial agreement between the dichotomous CRISS rating and physician assessment of diffuse cutaneous SSc patients after 1 year. This supports the use of a CRISS cutoff at 0.6 for improvement versus non‐improvement, although the CRISS tended to rate more patients as improved than did physicians.