Article Figures & Data
Tables
- Table 1.
Final core set of physician-derived domains and measurement tools for EPOSS, defined by the Delphi survey. Modified from Distler O, et al. Arthritis Rheum 2008; 15:867–75, with permission.
Cardiac function Right heart catheterization Echocardiography Dyspnea visual analog scale Discontinuation of treatment Adverse events Serious adverse events Dyspnea Dyspnea visual analog scale Exercise testing 6-minute Walk Test Oxygen saturation on exercise Global state of physician Survival Lung vascular Right heart catheterization Echocardiography Quality of life Short-Form-36 score Health Assessment Questionnaire Disability Index -
EPOSS: Expert Panel on Outcome Measures in PAH Related to SSc.
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- Table 2.
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;
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↵* if relevant to the study;
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↵** 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.
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- Table 3.
Proposed items for future research. Modified from Khanna, et al. Ann Rheum Dis 2008;67:703–9, with permission.
Research Agenda Biomarkers Markers of the collagen breakdown e.g., soluble IL-2 receptor levels, procollagen I and III aminopropeptide, CTGF levels, serum collagen I carboxyterminal telopeptide, urinary pyridinoline cross-link compounds of collagen, etc. Cardiac Serum probrain natriuretic peptide (Pro-BNP) or NT-Pro-BNP Noninvasive measures of cardiac function e.g., cardiac MRI, tissue Doppler Digital ulcers Development of digital ulcer condition score that captures activity, severity, and impact Gastrointestinal Scleroderma-gastrointestinal 1.0 questionnaire Gastric emptying time and/or 24-h small bowel transit time Global Health Medsger Severity Index Health-related Quality of Life and Function Measure of health utility e.g., SF-6D, EuroQol, Quality of Well Being Scale, time trade-off standard gamble Measure of fatigue e.g., Functional assessment of chronic illness therapy (FACIT)-Fatigue Measure of depression/anxiety e.g., Beck Depression Inventory, Center for Epidemiologic-Depression Scale Musculoskeletal Large joint contracture Michigan Hand Questionnaire Skin Measure of telangiectasia VAS/Likert patient global assessment for pruritus -
IL-2: interleukin 2; CTGF: connective tissue growth factor; SF-6D: Medical Outcome Study Short Form 6D; FACIT: Functional assessment of chronic illness therapy; VAS: visual analog scale.
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