Minimally Important Differences of the UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Tract Instrument

Abstract

Purpose To provide minimally important difference (MID) estimates for the UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Tract 2.0 (UCLA SCTC GIT 2.0) in a longitudinal observational cohort. Methods We administered the UCLA SCTC GIT 2.0 to 115 patients with SSc at 2 time points 6 months apart. UCLA SCTC GIT 2.0 has 7 multi-item scales: Reflux, Distention/Bloating, Diarrhea, Fecal Soilage, Constipation, Emotional Well-being, and Social Functioning and a Total GIT score. All scales are scored from 0 (better HRQOL) to 3 (worse HRQOL) except the diarrhea and constipation scales (ranges are 0–2 and 0– 2.5, respectively). Patients also rated their overall, upper, and lower GIT involvement during the 2nd visit using a “Much better, somewhat better, almost the same, somewhat worse, or much worse” response scale. The minimally changed group was defined by those reporting they were somewhat better or somewhat worse compared to 1st visit. Results Study participants were 84% female and 81% white with a mean disease duration of 6.9 years. The MID estimates for improvement ranged from 0.07 for the Social Functioning scale to 0.36 for Emotional Well-Being scale. For worsening, the MID estimates ranged from 0.06 for Fecal Soilage scale to 0.21 for the Social Functioning Scale. Conclusion We provide MID estimates for the UCLA SCTC GIT 2.0 scales. This information can aid in interpreting scale scores in future RCTs and observational studies.

Responsiveness to Change and Minimally Important Differences of the Patient-Reported Outcomes Measurement Information System Gastrointestinal Symptoms Scales

“…We also assessed the overall severity of the underlying GI illness at baseline and at the follow-up visit using a single global item [“In the past 7 days, how would you rate your gastrointestinal condition?” ( excellent, very good, good, fair , or poor )]. This item was included during the validation of the UCLA GIT 2.0 questionnaire in SSc [10]. …”

“…We used three different anchors. At the second of two visits, we administered two retrospective recall anchors (one reported by the patient and another by the physician): “Compared to last visit, how is your/your patient’s overall GI condition at this time?” ( completely better , considerably better , somewhat better , about the same , somewhat worse , considerably worse , or completely worse ) [10]. In addition, we prospectively assessed change in GSRS at two time points (i.e., both clinic visits).…”

An Open-label, Phase II Study of the Safety and Tolerability of Pirfenidone in Patients with Scleroderma-associated Interstitial Lung Disease: the LOTUSS Trial

“…Patient assessment of GI side effects using the UCLA SCTC GIT 2.0 score suggested the GI effects were stable between baseline and Week 16. This tool has previously been shown to be sensitive to changes in GI symptoms in SSc 2,30,31 . However, because the UCLA SCTC GIT questionnaire only identified AE occurring within 7 days prior to its use at the baseline and final visits, it is possible that the symptoms reported as AE during our study may have resolved in the intervening weeks.…”

Quality of life in systemic sclerosis

“…Gastrointestinal involvement (GI) occurs in 90% of patients with SSc [89][90][91] and is associated with increased morbidity and mortality as well as a negative impact on HR-QoL [89,92], although the correlation between symptoms and GI motility disorders is difficult to establish [90].…”

“…It has validity in SSc. [44,89,105] is a 7-multi-item scale with a total of 34 items that include reflux, distention/bloating, diarrhea, fecal soilage, constipation, emotional well-being and social functioning. It was designed to assess the range of problems that can occur in SSc, their severity and their impact in HR-QoL.…”