Session Information
Title: Systemic Sclerosis, Fibrosing Syndromes, and Raynaud’s - Clinical Aspects and Therapeutics II
Session Type: Abstract Submissions (ACR)
Background/Purpose: As part of the National Institutes of Health PROMIS¨ roadmap initiative, we developed GI Symptoms measures that assess 8 domains: Gastroesophageal reflux (13 items), disrupted swallowing (7 items), diarrhea (5 items), bowel incontinence/soilage (4 items), nausea and vomiting (4 items), constipation (9 items), belly pain (6 items), and gas/bloat/flatulence (12 items). All scales are calibrated using a two-parameter IRT graded response model and scored on a T-score metric with a mean of 50 and SD of 10 in the U.S. general population. This paper evaluates the construct validity of the GI measures in patients with SSc.
Methods: 165 patients with SSc were administered the PROMIS GI Symptoms measures and UCLA SCTC GIT 2.0 instrument. GIT 2.0 has 5 symptom scales: reflux, distention/ bloating, diarrhea, constipation, and fecal incontinence. Product-moment correlations of the PROMIS GI measures with the GIT 2.0 symptoms scales were used to evaluate construct validity. In a subset of patients (N=37), both instruments were administered at 2 time points. F-statistics was calculated from one-way ANOVAs to assess responsiveness to change
Results: Patients with SSc GI involvement had scale scores 0.2-0.7 SD worse than US population. Hypothesized correlations were larger than other scales and in the right direction (Table). F-statistics were greater for 6 of 8 PROMIS scales (range 0.45 for belly pain to 3.21 for reflux scale) vs. GIT 2.0 except for diarrhea scale (0.67 vs. 0.98 for GIT 2.0) and constipation scale (1.37 vs. 1.79 for GIT 2.0).
Conclusion: PROMIS GI Symptoms scales are significantly correlated with the hypothesized GIT 2.0 scales and 6 of 8 scales showed greater responsiveness to change than the GIT 2.0.
Table: Product-moment correlations between PROMIS GI Symptoms scales and UCLA SCTC GIT scales
|
|
Reflux* |
Distention/ bloating |
Diarrhea |
Constipation |
Fecal incontinence |
|
Reflux |
0.77
|
0.44 |
0.13 |
0.25 |
-0.03 |
|
Disrupted swallowing |
0.61
|
0.39 |
0.16 |
0.21 |
0.13 |
|
Nausea and vomiting |
0.66
|
0.44
|
0.20
|
0.22
|
0.18
|
|
Belly pain |
0.45
|
0.49
|
0.23
|
0.34
|
0.04
|
|
Gas/bloat/flatulence |
0.46 |
0.73
|
0.30 |
0.29 |
0.10 |
|
Diarrhea |
0.25 |
0.25 |
0.65
|
0.02 |
0.54 |
|
Constipation |
0.37 |
0.32 |
0.05 |
0.76
|
-0.01 |
|
Fecal incontinence |
0.12 |
0.11 |
0.43 |
-0.18 |
0.87
|
*GIT 2.0 Reflux scale asks about reflux, dysphagia to solid foods, and nausea/ vomiting
Disclosure:
D. Khanna,
NIH,
2,
Scleroderma Foundation,
2,
Actelion Pharmaceuticals US,
5,
Actelion Pharmaceuticals US,
8,
Gilead,
5,
United Therapeutics,
5,
United Therapeutics,
8,
Roche Pharmaceuticals,
5,
BMS,
5,
DIGNA,
5,
Merck Pharmaceuticals,
5;
P. Khanna,
None;
B. Spiegel,
None;
L. Chang,
None;
G. Y. Melmed,
Janssen, given imagine, Abbvie,
5,
Abbott, prometheus labs ,
9,
Pfizer Inc,
2;
R. Bolus,
NIH,
5;
R. Hays,
None.
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