Core set items selected for 11 domains for the CRISS. Modified from Khanna, et al. Ann Rheum Dis 2008; 67:703–9, with permission.
| Soluble biomarkers |
| Acute phase reactants ESR and/or CRP |
| Cardiac |
| Cardiac echocardiogram with Doppler† |
| Right heart catheterization |
| 6-Minute Walk Test* |
| Borg Dyspnea Instrument* |
| Digital ulcers |
| Active digital tip ulcer count on the volar surface |
| VAS digital ulcer (part of Scleroderma HAQ-DI) |
| Gastrointestinal |
| Body mass index |
| Validated GI tract VAS or other SSc-validated GI questionnaire |
| Global health |
| VAS/Likert scale for patient global severity |
| VAS/Likert scale for physician global severity |
| Scleroderma-related health transition by patient |
| Scleroderma-related health transition by physician** |
| Health-related quality of life and function |
| HAQ-DI |
| VAS pain scale from the HAQ-DI |
| Short Form-36 score, version 2 |
| Musculoskeletal |
| Tender Joint Count |
| Tendon friction rubs assessed by the physician** |
| Serum creatinine phosphokinase, aldolase |
| Pulmonary |
| Pulmonary function testing |
| Validated measure of dyspnea |
| Breathing VAS from the Scleroderma HAQ |
| HRCT of the lungs: quantifiable scale* |
| Raynaud’s phenomenon |
| Raynaud’s condition score |
| VAS (part of S-HAQ) |
| Renal |
| Calculated creatinine clearance based on serum creatinine (Cockroft-Gault or MDRD formula) |
| Pre-defined renal crisis (presence or absence) |
| Skin |
| Modified Rodnan Skin Score (range 0–51) |
| VAS/Likert of patient global assessment for skin activity** |
| VAS/Likert of physician global assessment for skin activity** |
| Durometer |
↵† Standardized central reading mechanism strongly encouraged;
↵* if relevant to the study;
↵** Items were based on Steering Committee and SCTC consensus despite lack of full validation. CRISS: Combined Response Index for SSc; ESR: erythrocyte sedimentation rate; HAQ-DI: Health Assessment Questionnaire Disability Index; VAS: visual analog scale; HRCT: high resolution computed tomography; MDRD: modification of diet in renal disease.