S0498 Validation of a Point of Service, Disposable Rectal Expulsion Device (RED) to Identify Constipated Individuals With an Evacuation Disorder
Bibliographic record
Abstract
INTRODUCTION: More than a third of chronically constipated patients who fail to improve with laxatives have an evacuation disorder. Balloon Expulsion Testing (BET) is an effective means of identifying patients with an evacuation disorder. Currently available BET devices are not designed for point of service use and require a separate visit to a GI physiology laboratory. To bring testing for an evacuation disorder to any community gastroenterologist, we created a disposable, self-inflating Rectal Expulsion Device (RED) which is intended for in-office use. We compared results and comfort of RED with a predicate, commercially available BET. METHODS: Six healthy volunteers (HVs) & 14 CC patients underwent BET and RED from September 2019 to November 2019. HVs had no GI symptoms. CC patients had significant constipation symptoms despite laxative therapy. Each subject underwent BET (Mui Scientific, Mississauga, Ontario) and RED in randomized order. An abnormal test was defined as the inability to pass the BET device (50 ml water filled balloon) or RED in < 60 seconds. If a subject was unable to pass BET or RED after 120 seconds, it was removed by the investigator. Following BET & RED, each subject self-reported device smoothness (SM), shape (SH), size (SZ), overall comfort (OC), and procedure duration (PD) (1 = Unbearable and 10 = Highly Acceptable). Kappa (k) and independent t-tests were performed. P-values <0.05 were considered statistically significant. RESULTS: Mean age of subjects was 50.2 ± 12.3 years (Range: 28-76). Most subjects were female (95.0%) & Caucasian (85.0%). Using a normal threshold of 60 sec, device agreement between BET & RED was 100% (Table 1). All HVs had normal BET & RED. For the entire study cohort, 11/20 (55.0%) had an abnormal BET and RED. Mean time to device passage in those with an abnormal BET was 119.1 (SD = 3.1) seconds & 116.4 (SD = 12.1) seconds for RED (P = 0.45). For those with a normal test (45.0%), the mean time to expel BET or RED were similar (24.8 seconds; SD = 14.3 vs. 14.7 seconds; SD = 6.0, P = 0.14). There were no significant differences in patient-perceptions of BET or RED (Table 2). CONCLUSION: RED offered excellent test agreement with a commercially available BET device. RED will allow community gastroenterologists an easy, quick test to identify constipated patients with an evacuation disorder who are most likely to benefit from biofeedback training rather than continued laxative therapy.Table 1Table 2
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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 | 0.009 | 0.016 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.001 | 0.000 |
| Insufficient payload (model declined to judge) | 0.004 | 0.002 |
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".