Canadian IBS Observational Study Shows Tegaserod Patients Have Greater Improvements in QoL as Compared to the Control Group
Bibliographic record
Abstract
Purpose: Abdominal pain/discomfort, bloating and constipation are gastrointestinal (GI) symptoms related to irritable bowel syndrome (IBS), associated with impaired health-related quality of life (QoL) and work productivity. LOGIC (Longitudinal Outcomes Study of GI Symptoms in Canada) is a prospective, observational study that followed patients (pts) for 1 year and evaluated the treatment patterns and health outcomes of pts with IBS symptoms in Canada. Methods: LOGIC enrolled 1556 pts from 147 community and specialist physician sites in Canada. Clinical data and pt-reported outcomes were collected at baseline (BL) and Months 1, 3, 6, 9 and 12. QoL was assessed with the IBS-QOL. Tegaserod pts (T) at BL and non-tegaserod pts (Non-T) were compared. Unadjusted mean QoL at BL and Month 12 (M12) were compared between groups using the Wilcoxon rank-sum test. The within-subject slope of the QoL scores was compared using a mixed model ANOVA. The model compared the average slope of the T and Non-T pts after adjusting for IBS severity (measured by the Total Symptom Severity score), usual bowel pattern (normal, constipated, diarrhea, alternating), duration of symptoms, gender, history of T use, and BL IBS-QOL. Results: Of 1556 pts enrolled, 1375 were either T-users (n = 362) or Non-T-users (n = 1013). At BL, T pts had a mean IBS-QOL score of 61.46 compared to Non-T pts (68.36, p < 0.001). By M12, the unadjusted mean scores were 70.65 for T and 72.63 for Non-T pts (p= 0.476). After adjusting for BL covariates, T pts showed significantly greater improvement in IBS-QOL scores over the 12 months compared with non-T pts (mean improvement of 0.69 vs. 0.31 points/month or 8.28 vs. 3.72 over 12 months, respectively, p < 0.001). Conclusions: The LOGIC study followed treatment in a real-world setting with physicians treating pts with IBS symptoms. Pts using T at BL showed more improvement in their IBS-QOL scores than the Non-T pts at 12 months. This significant difference was also observed when data up to month 6 were analyzed, suggesting that the effect appears fairly early and is stable over time. This is the first long-term prospective observational study to show that T has a positive impact on health-related QoL in a usual care setting. This research was funded by Novartis.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".