Date: Friday, November 6, 2020
Session Title: Systemic Sclerosis & Related Disorders – Clinical Poster I
Session Type: Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose: Diffuse cutaneous Systemic Sclerosis (dcSSc) is a morbid disease involving the skin and internal organs. The American College of Rheumatology has provisionally approved a Composite Response Index in dcSSc (CRISS) (1) as a global endpoint for trials in dcSSc. Based on changes after 1 year, a CRISS score of ≥0.6 is considered improved and < 0.6 not improved. While the CRISS has been adopted in several trials, it lacks definite validation. Our goal is to assess the agreement between the CRISS score and physicians’ evaluation of dcSSc patient profiles. We hypothesized that there will be agreement on whether a patient has improved after 1 year. This would further validate the CRISS.
Methods: Patient profiles were created for 100 randomly selected dcSSc patients with < 5 years disease duration from a multicenter cohort. Patients were selected such that after 1 year of observation, 50 had improved and 50 had non-improved CRISS. The profiles described features used during the development of the CRISS at baseline and 1 year: patient and physician global; HAQ; modified Rodnan skin score; forced vital capacity; body mass index; patient assessed score (0-10) of their breathing, gastrointestinal symptoms, Raynaud’s, pain, digital ulcers; number of digital ulcers; presence of renal crisis and tendon friction rubs; SF-36 Vitality and Physical component scores. A total of 15 physicians with SSc expertise were involved and each patient profile was rated by 3 different physicians. The majority opinion determined consensus on whether a patient was improved (physician rated “improved”) or not improved (physician rated “stable”, “worsened”, or “unable to tell”). Kappa agreement between the CRISS and physician ratings was calculated.
Results: The mean age of patients was 51.8 ± 12.3 years with mean disease duration of 2.2 ± 1.3 years. Physician consensus was obtained in all patient profiles. All CRISS non-improvers were also rated as non-improved by physician consensus (Table 1). 12 CRISS improvers were rated as non-improved by physician consensus because their profiles were rated as “stable” or “unable to tell”. The kappa agreement was substantial, κ (95%CI) =0.76 (0.64, 0.88). The agreement between physician assessment prior to consensus and the CRISS remained substantial, κ (95%CI) = 0.70 (0.62, 0.78).
Conclusion: There was substantial agreement between the dichotomous CRISS rating and physician assessment of dcSSc patients after 1 year. This supports the use of a dichotomous CRISS cut-off at 0.6 for improvement versus non-improvement. All CRISS non-improvers were also rated as not improved by physicians, although the CRISS was less conservative than physicians in assessing improvement. Physicians were more likely to report patients as stable or report that improvement was difficult to determine.
- Khanna D, Berrocal VJ, Giannini EH, Seibold JR, Merkel PA, Mayes MD, et al. The American College of Rheumatology Provisional Composite Response Index for Clinical Trials in Early Diffuse Cutaneous Systemic Sclerosis. Arthritis Rheumatol. 2016;68(2):299-311.
To cite this abstract in AMA style:Zheng B, Wang M, McKenna K, Shapiro L, Spiera R, Silver R, Csuka M, van den Hoogen F, Robinson D, Hummers L, Krieg T, Del Galdo F, Jones N, Khalidi N, Vacca A, Gordon J, Pauling J, Baron M. Agreement Between Physician Evaluation and the Composite Response Index in Diffuse Cutaneous Systemic Sclerosis (CRISS) [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/agreement-between-physician-evaluation-and-the-composite-response-index-in-diffuse-cutaneous-systemic-sclerosis-criss/. Accessed May 15, 2021.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/agreement-between-physician-evaluation-and-the-composite-response-index-in-diffuse-cutaneous-systemic-sclerosis-criss/