Article Figures & Data
Tables
- Table 1.
Spearman correlation coefficients between the UCLA SCTC GIT 2.0 scales and ratings of overall gastrointestinal (GI), upper GI, and lower GI involvement. Scores are calculated as the difference between Time 1 and Time 2 and anchors were administered at Time 2.
Scales Overall GI Involvement Upper GI Involvement Lower GI Involvement Reflux 0.40 0.41 0.28 Distension/Bloating 0.25 0.24 0.21 Diarrhea 0.27 0.25 0.23 Constipation 0.05* 0.04* 0.11* Fecal soilage 0.20 0.09* 0.17 Emotional well-being 0.34 0.31 0.36 Social functioning 0.31 0.37 0.28 Total GIT score 0.48 0.52 0.40 -
↵* p ≥ 0.05.
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- Table 2.
Baseline and followup gastrointestinal scores for 115 patients who completed the UCLA SCTC GIT 2.0 instrument at 2 timepoints.
Baseline Followup Period Scales Mean Score SD Range Mean Score SD Range p Reflux 0.71 0.54 0, 2.63 0.66 0.53 0, 2.75 0.6 Distension/Bloating 1.09 0.83 0, 3.00 1.09 0.83 0, 3.00 0.8 Diarrhea 0.57 0.68 0, 2.00 0.47 0.56 0, 2.00 0.1 Fecal soilage 0.3 0.67 0, 3.00 0.28 0.61 0, 3.00 0.9 Constipation 0.44 0.50 0, 2.25 0.42 0.47 0, 2.00 0.5 Emotional well-being 0.49 0.65 0, 2.78 0.41 0.60 0, 2.78 0.6 Social functioning 0.26 0.51 0, 3.00 0.24 0.46 0, 2.5 0.8 Total score* 0.67 0.47 0, 2.18 0.62 0.47 0, 2.01 0.5 -
↵* Sum of 6 of 7 scales (excludes Constipation scale).
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- Table 3.
Minimally important differences for UCLA SCTC GIT 2.0 scales and total gastrointestinal tract score. A negative sign indicates improvement in the scale scores.
UCLA SCTC GIT 2.0 Overall GI Anchor Upper GI Anchor Lower GI Anchor Scale Patient-rated* Mean Change (95% CI) Effect Size Mean Change (95% CI) Effect Size Mean Change (95% CI) Effect Size Overall Mean Change† Reflux Much better (n = 11–12) −0.35 (−0.69, 0) −0.68 −0.26 (−0.54, 0.02) −0.52 −0.3 Somewhat better (n = 15–18) −0.26 (0.44, −0.07) −0.58 −0.27 (−0.56, 0.03) −0.58 −0.26 About the same (n = 66–71) 0.02 (−0.06, 0.1) 0.03 −0.02 (−0.01, 0.05) −0.04 −0.001 Somewhat worse (n = 15–19) 0.15 (0, 0.29) 0.29 0.22 (0.05, 0.39) 0.32 0.19 Much worse (n = 0–1) NA NA 0.41 −0.52 NA Distension/Bloating Much better (n = 11–15) −0.71 (−1.15, 0.27) −0.74 −0.41 (−0.74, 0.08) −0.52 −0.56 Somewhat better (n = 15–18) −0.04 (−0.44, 0.37) −0.05 −0.24 (−0.75, 0.26) −0.34 −0.14 About the same (n = 66–71) 0.11 (−0.05, 0.26) 0.14 0.04 (−0.11, 0.2) 0.06 0.08 Somewhat worse (n = 13–19) −0.03 (−0.29, 0.23) −0.03 0.27 (0.05, 0.49) 0.34 0.12 Much worse (n = 0–1) NA 0 NA NA Diarrhea Much better (n = 11–15) −0.41 (−0.74, −0.08) −0.61 −0.43 (−0.76, −0.1) −0.64 −0.42 Somewhat better (n = 16–18) −0.22 (−0.72, 0.28) −0.29 −0.16(−0.7, 0.38) −0.19 −0.19 About the same (n = 66–69) −0.1 (−0.25, 0.05) −0.16 −0.03 (−0.16, 0.1) −0.05 −0.06 Somewhat worse (n = 12–18) 0.14 (−0.15, 0.43) 0.21 0 (−0.56, 0.56) 0 0.07 Much worse (n = 0) NA NA NA Constipation Much better (n = 11–15) −0.11 (−0.55, 0.32) −0.22 −0.11 (−0.43, 0.21) −0.24 −0.11 Somewhat better (n = 16–18) −0.15 (−0.47, 0.16) −0.28 −0.19 (−0.53, 0.15) −0.34 −0.17 About the same (n = 66–69) −0.01 (−0.11, 0.1) −0.02 −0.05 (−0.13, 0.03) −0.11 −0.03 Somewhat worse (n = 13–19) 0.03 (−0.14, 0.21) 0.08 0.23 (−0.14, 0.6) 0.37 0.13 Much worse (n = 0) 0.41 NA NA NA Fecal soilage Much better (n = 11–15) −0.36 (−0.82, 0.09) −0.56 −0.2 (−0.57, 0.17) −0.35 −0.28 Somewhat better (n = 15–17) −0.18 (−0.55, 0.2) −0.21 −0.2 (−0.57, 0.17) −0.21 −0.19 About the same (n = 64–67) 0.06 (−0.06–0.19) 0.11 0.01 (−0.1, 0.13) 0.03 0.04 Somewhat worse (n = 13–19) 0.05 (−0.14, 0.25) 0.07 0.08 (−0.09, 0.24) 0.09 0.06 Much worse (n = 0) NA NA NA NA Emotional well-being Much better (n = 11–15) −0.28 (−0.56, −0.01) −0.53 −0.3 (−0.57, 0.03) −0.58 −0.27 (−0.49, −0.06) −0.56 −0.29 Somewhat better (n = 14–18) −0.4 (−0.79, 0) −0.57 −0.26 (−0.64, 0.11) −0.36 −0.42 (−0.81, 0.02) −0.58 −0.36 About the same (n = 66–71) 0 (−0.09, 0.08) 0 −0.05 (−0.16, 0.06) −0.08 0 (−0.09, 0.1) 0.01 −0.02 Somewhat worse (n = 13–19) 0.14 (−0.07, 0.35) 0.23 0.15 (−0.1, 0.4) 0.19 0.2 (−0.07, 0.46) 0.24 0.16 Much worse (n = 0–1) NA 0.44 NA NA NA NA Social functioning Much better (n = 11–15) −0.23 (−0.5, 0.05) −0.54 −0.27 (−0.55, 0) −0.65 −0.2 (−0.4, 0) −0.52 −0.23 Somewhat better (n = 14–18) −0.04 (−0.15, 0.08) −0.1 −0.11 (−0.22, 0) −0.33 −0.07 (−0.18, 0.03) −0.24 −0.07 About the same (n = 64–69) 0.02 (−0.04, 0.07) 0.04 0.03 (−0.04, 0.1) 0.09 0.09 (0.01, 0.17) 0.31 0.05 Somewhat worse (n = 13–19) 0.24 (−0.1, 0.57) 0.39 0.33 (−0.02, 0.68) 0.43 0.08 (−0.33, 0.48) 0.08 0.21 Much worse (n = 0–1) NA −0.17 NA NA NA NA Total GIT score Much better (n = 11–15) −0.51 (−0.85, −0.16) −0.86 −0.36 (−0.56–0.17) −0.82 −0.33 (−0.48, −0.17) −0.81 −0.40 Somewhat better (n = 15–18) −0.18 (−0.32, −0.03) −0.5 −0.28 (−0.57, 0.01) −0.56 −0.16 (−0.32, 0.01) −0.44 −0.20 About the same (n = 66–71) 0.02 (−0.04, 0.08) 0.04 0 (−0.07, 0.07) 0 0.01 (−0.07, 0.1) 0.03 0.01 Somewhat worse (n = 13–19) 0.12 (−0.03, 0.27) 0.22 0.2 (0.99, 0.31) 0.36 0.05 (−0.16, 0.25) 0.07 0.12 Much worse (n = 0–1) NA NA NA -
↵* n represents patients who are categorized into 5 different responses. n are presented as a range because the number of patients in each category is different based on their responses to the anchors. For Reflux and Distension/Bloating scales, we used overall and upper GI anchor; for Diarrhea, Constipation, and Fecal soilage, we used overall and lower GI anchors.
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↵† Overall mean change is the average of mean scores for different anchors. NA: not applicable.
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- Table 4.
Minimally important difference estimates for the UCLA SCTC GIT 2.0 scales. Negative score denotes improvement.
UCLA SCTC GIT 2.0 MID Estimates Reflux Somewhat better −0.26 Somewhat worse 0.19 Distension/bloating Somewhat better −0.14 Somewhat worse 0.12 Diarrhea Somewhat better −0.19 Somewhat worse 0.07 Constipation Somewhat better −0.17 Somewhat worse 0.13 Fecal soilage Somewhat better −0.19 Somewhat worse 0.06 Emotional well-being Somewhat better −0.36 Somewhat worse 0.16 Social functioning Somewhat better −0.07 Somewhat worse 0.21 Total GIT score Somewhat better −0.20 Somewhat worse 0.12 -
UCLA SCTC GIT: University of California at Los Angeles Scleroderma Clinical Trial Consortium Gastrointestinal Tract; MID: minimally important difference.
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