Performance of the UCLA Scleroderma Clinical Trials Consortium Gastrointestinal Tract 2.0 Instrument as a Clinical Decision Aid in the Routine Clinical Care of Patients With Systemic Sclerosis

Norina Zampatti; Alexandru Garaiman; Suzana Jordan; Rucsandra Dobrota; Mike Oliver Becker; Britta Maurer; Oliver Distler; Carina Mihai

Disclosures

Arthritis Res Ther. 2021;23(125) 

In This Article

Results

Patients and Baseline Characteristics

Out of 494 patients in the database, 346 were fulfilling the inclusion criteria. For these, 940 visits with a completed UCLA GIT 2.0 questionnaire were available. The median number of visits per patient was 2 (Q1, Q3: 1–4), with 89/346 patients having one visit. Median follow-up time was 3.4 years (Q1, Q3: 1.8–4.9).

The demographic and clinical data of the patients are displayed in Table 1. The majority of participants were female (82.4%) and Caucasian (94.5%), 23% had the diffuse cutaneous subtype of SSc, with a median age of 63 years and a median disease duration of 10 years. Nine out of 343 patients had a history of Barrett's esophagus. Of 346 patients, 261 patients (75.4%) reported GI symptoms and 311/346 patients (89.9%) had UCLA GIT 2.0 scores > 0 in at least one visit, GI symptoms recorded from the patients' charts and UCLA GIT 2.0 scores (median and interquartile range) are displayed in Table 2. The reflux and distention/bloating subscales and the total score of UCLA GIT 2.0 had medians of 0.25, 0.50, and 0.22, respectively, while the medians of the other subscales were zero. Approximately 10% of the components of the UCLA GIT 2.0 questionnaire were missing overall. Of 940 visits, treatment with PPI was present in 588 (62.6%) visits at the time of completing the UCLA GIT 2.0 questionnaire at the annual assessment.

Evaluation of the UCLA GIT 2.0 as a Potential Decision-aiding Instrument for EGD

Of 940 visits with completed UCLA GIT 2.0 questionnaires, 31 were excluded from this part of the analysis because patients had an EGD within 3 months before the visit. In the 909 remaining visits, EGD was recommended in 169, of which 120 were carried out (Figure S1 in the online supplement). Patients with a recommendation for EGD had significantly more frequent heartburn, dysphagia, and regurgitation, a history of Barrett's esophagus, as well as higher mRSS scores and erythrocyte sedimentation rates; they also had significantly higher values of the UCLA GIT 2.0 score and all its subscales except the subscale for fecal soilage (Table 3).

We next aimed to identify independent parameters associated with the expert recommendation to perform EGD. We found in multivariable GLMM models that mRSS, individual gastroesophageal symptoms (heartburn, dysphagia, and regurgitation, respectively) and upper gastrointestinal tract symptoms as recorded in the EUSTAR database ("esophageal symptoms" and "stomach symptoms"), significantly associated with the recommendation to perform EGD. Except the emotional wellbeing subscale, all the examined subscales of UCLA GIT 2.0, as well as the total score, correlated significantly with the recommendation to perform EGD (Table 4).

To identify optimal cutoffs for the reflux and total UCLA GIT 2.0 score, discriminating best between patients with recommendation to perform EGD and those without, we performed ROC analysis. For the reflux subscale, the best results were found for the cutoff of 0.163 (AUC [95% CI] of 0.64 [0.60–0.68]), with a sensitivity of 73% and specificity of 50%. Similarly, for the total UCLA GIT 2.0 score, we identified the optimal cutoff of 0.161, with an AUC [95%CI] of 0.64 [0.59–0.68], sensitivity 78%, and specificity 46%. As the range for these scores is 0–3 and 0–2.83 respectively, this shows that even patients with a low symptom burden have been referred to further evaluation by EGD.

Evaluation of the UCLA GIT 2.0 as a Potential Predictor of Endoscopic Esophagitis and Pathologic EGD

Of all 346 patients, 241 had undergone EGD at least once during the entire observation period. We identified 177 EGD matching the inclusion criteria, performed in 145 patients.

Of these, 128 were performed on indication from the SSc-expert rheumatologist of our center, and 49 were performed on indication from another physician, of which 31 were done during the 3 months preceding the visit (Figure S2 in the online supplement). A single EGD was performed in 118 patients, 22 patients had undergone two EGDs, and five patients had undergone three EGDs. The median time between the visit and the corresponding EGD was 2 days (Q1, Q3: − 0.5, 36), with a mean of 9.7 days.

Esophagitis was found in 52/177 EGD (in 50 patients), GAVE in 15/177 EGD (in 12 patients), and biopsy-verified Barrett's esophagus in 24/177 EGD (in 19 patients). Other EGD findings were fungal esophagitis in 7, esophageal strictures in 2, peptic ulcers of the stomach or bulbus duodeni in 3, and gastritis in 6 EGD, leading to a total of 94/177 pathologic EGD.

Patients with endoscopic esophagitis had significantly more frequently EUSTAR reported esophageal symptoms ("reflux and/or dysphagia") and slightly higher mRSS scores, while the distribution of individual upper gastrointestinal tract symptoms (heartburn, dysphagia, and regurgitation), as well as that of the UCLA GIT 2.0 score and subscales, did not reach statistical significance (Table 5). Patients with esophagitis also tended to be less frequently under treatment with PPI (52.7% vs. 72.4%, p = 0.057) while, surprisingly, they had slightly but significantly higher Hb values vs. patients without esophagitis (median Hb value13.6 g/dl vs 12.9 g/dl, p = 0.008).

We next wanted to analyze whether clinical parameters can be identified that are independently associated with the presence of esophagitis or other pathologic GI tract findings. In multivariable GLMM analysis on the outcome of endoscopic esophagitis, mRSS and EUSTAR reported esophageal symptoms ("reflux and/or dysphagia") were the only parameters associated with endoscopic esophagitis; however, the associations were very weak (with an OR of only 1.1 for mRSS and a low AUC of 0.61 for esophageal symptoms) (Table 6). Hemoglobin correlated with endoscopic esophagitis in the univariable model, but not in the multivariable model. The UCLA GIT 2.0 total score and its subscales showed no association with endoscopic esophagitis. Similar negative results were obtained in the GLMM analysis for the outcome of pathologic EGD (Table S1 in the online supplement), suggesting that in our real-life cohort, the UCLA GIT 2.0 failed to identify patients with EGD findings.

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