A Concave Shaped Skin Barrier Provides Improved Clinical Outcomes for People Living With an Ostomy Who Have an Outward Peristomal Body Profile
Bibliographic record
Abstract
PURPOSE: The purpose of this study was to compare leakage rates, skin health, fit, patient impact and usability for a concave ostomy system versus the non-concave ostomy system subjects were using prior to the study. DESIGN: Single-arm, open-label, multicenter, prospective study with subjects acting as their own control. SUBJECTS AND SETTING: The sample comprised 20 subjects recruited from 3 outpatient clinics in Quebec, Canada. All participants were adults with an ostomy and had an outward peristomal body profile (OPBP). METHODS: Data were collected by investigators during in-person visits. Skin health was assessed using the Ostomy Skin Tool. Patient-reported outcomes were collected at each visit using a questionnaire designed for this study. Investigator-reported observations were also collected using a study-specific questionnaire at each visit. Generalized linear mixed model analyses were used to analyze the data. RESULTS: Use of the concave skin barrier significantly reduced leakage occurrences, improved peristomal skin health, provided a better fit, enhanced the users' sense of security, comfort, and ease of application of the concave pouching system when compared to a flat or convex skin barrier. CONCLUSIONS: The use of a concave ostomy system for patients with an OPBP significantly reduced leakage while improving skin health, fit, patient impact and usability.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".