scholarly journals The American College of Rheumatology Provisional Composite Response Index for Clinical Trials in Early Diffuse Cutaneous Systemic Sclerosis

2016 ◽  
Vol 68 (2) ◽  
pp. 167-178 ◽  
Author(s):  
Dinesh Khanna ◽  
Veronica J. Berrocal ◽  
Edward H. Giannini ◽  
James R. Seibold ◽  
Peter A. Merkel ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Systemic Sclerosis ◽  
Response Index ◽  
American College Of Rheumatology ◽  
Diffuse Cutaneous Systemic Sclerosis ◽  
Composite Response

scholarly journals The American College of Rheumatology Provisional Composite Response Index for Clinical Trials in Early Diffuse Cutaneous Systemic Sclerosis

2016 ◽  
Vol 68 (2) ◽  
pp. 299-311 ◽  
Author(s):  
Dinesh Khanna ◽  
Veronica J. Berrocal ◽  
Edward H. Giannini ◽  
James R. Seibold ◽  
Peter A. Merkel ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Systemic Sclerosis ◽  
Response Index ◽  
American College Of Rheumatology ◽  
Diffuse Cutaneous Systemic Sclerosis ◽  
Composite Response

New composite endpoint in early diffuse cutaneous systemic sclerosis: revisiting the provisional American College of Rheumatology Composite Response Index in Systemic Sclerosis

2020 ◽  
pp. annrheumdis-2020-219100
Author(s):  
Dinesh Khanna ◽  
Suiyuan Huang ◽  
Celia J F Lin ◽  
Cathie Spino
Keyword(s):  
Systemic Sclerosis ◽  
Health Assessment ◽  
Composite Endpoint ◽  
Response Index ◽  
American College Of Rheumatology ◽  
Core Set ◽  
Weighted Score ◽  
Modified Rodnan Skin Score ◽  
Diffuse Cutaneous Systemic Sclerosis ◽  
Composite Response

ObjectivesAmerican College of Rheumatology Composite Response Index in Systemic Sclerosis (ACR-CRISS) is a composite endpoint to assess the likelihood of improvement in diffuse systemic sclerosis. ACR-CRISS is a weighted score and includes five core set measures: modified Rodnan skin score, FVC% predicted, health assessment questionnaire–disability index, and patient and clinician global assessments.MethodsWe analysed core set measures from 354 participants who participated in three placebo-controlled trials. We generated 10 development datasets, randomly selected from 2/3 of the participants, stratified by study and treatment group. The remaining participants (1/3 of the participants) formed the validation sets. Risk differences (RDs) between active and placebo treatments were calculated by averaging over the replicate datasets; bootstrap 95% CIs for the RDs to estimate the magnitude of treatment effects.ResultsIn the development sets (n=237), the proportion of participants in the active group had statistically higher improvement in >1 of 5 core set measures versus the placebo group. For example, the proportion who improved by ≥20% in ≥3 core set measures was 49.4% in the active versus338.9% in the placebo; RD: 10.5%, 95% CI4.9 % to 16.1%. In the validation sets (n=117), the proportion who improved by ≥20% in ≥3 core set measures was 50.3% in the active versus35.63% in the placebo (RD:114.8%, 95% CI 3.1% to225.7%). Similar trends were seen with larger percentage cut-offs.ConclusionRevised CRISS, as assessed by the proportion of participants who improved by a certain percentage in ≥3 of 5 core set measures, is a potential new composite outcome measure.

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