Efficacy and safety of PICOPREP tailored dosing compared with PICOPREP day-before dosing for colon cleansing: a multi-centric randomised study
Bibliographic record
Abstract
Abstract Background and study aims The success of any colonoscopy procedure depends upon the quality of bowel preparation. We evaluated the efficacy and safety of a new tailored dosing (TD) regimen compared with the approved PICOPREP day-before dosing regimen (DBD) in the European Union. Patient and methods Patients (≥ 18 years) undergoing colonoscopy were randomised (2:1) to TD (Dose 1, 10 – 18 hours; Dose 2, 4 – 6 hours before colonoscopy) or DBD (Dose 1 before 8:00AM on the day before colonoscopy; Dose 2, 6 – 8 hours after Dose 1). The primary endpoint of overall colon cleansing efficacy was based on total Ottawa Scale (OS) scores (0 – 14, excellent-worst). The key secondary endpoint was a binary endpoint based on the ascending colon OS (success 0 or 1, failure [≥ 2]). Convenience and satisfaction were evaluated similar to the primary and key secondary endpoints. Safety and tolerability were also evaluated. Results Use of the PICOPREP TD regimen resulted in a statistically significant reduction in the mean total Ottawa Scale score compared to the PICOPREP DBD regimen (–3.93, 95 % confidence intervals [CI]: – 4.99, – 2.97; P < 0.0001) in the intent-to-treat analysis set. The PICOPREP TD regimen also resulted in a statistically significant increase in the odds of achieving an ascending colon OS score ≤ 1, compared to the PICOPREP DBD regimen (estimated odds ratio 9.18, 95 % CI: 4.36, 19.32; P < 0.0001). There was no statistically significant difference in the overall rate of treatment-emergent adverse events (12 % (TD) and 5.7 % (DBD), respectively, P = 0.2988). The convenience and satisfaction were comparable in the two groups. Conclusion The TD regimen was superior to the DBD regimen for overall and ascending colon cleansing efficacy. ClinicalTrials.gov Identifier: NCT02239692
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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 | 0.004 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
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".