Comparative safety of bowel cleansers: protocol for a systematic review and network meta-analysis
Bibliographic record
Abstract
INTRODUCTION: The US Food and Drug Administration has withdrawn the bowel cleansing kit HalfLytely (PEG 3500) with 10 mg bisacodyl tablets due to an increased risk of ischaemic colitis compared with the same kit with only 5 mg bisacodyl. This is of interest in Canada given that the bowel cleansing kit Bi-Peglyte (PEG 3500) with 15 mg bisacodyl is currently approved for use. The objective is to assess the comparative safety of various bowel cleansers with or without bisacodyl, with a primary interest inpolyethylene glycol (PEG)-based and sodium-picosulfate-based products. METHODS AND ANALYSIS: Given the existing volume of the literature, the review will be conducted in two stages. Stage 1 will consist of a scoping exercise by searching MEDLINE, Embase and the Cochrane Library (up to 21 November 2017) to identify randomised controlled trials, quasirandomised studies and non-randomised studies in which any bowel cleanser regimens were compared among persons undergoing colonoscopy. The outcomes will be mapped to establish a listing of the studies and their comparisons and outcomes currently available in the literature. From this, a data synthesis plan will be determined. In stage 2, a systematic review with meta-analyses will be pursued, focused on the bowel cleanser comparisons and outcomes of interest identified in stage 1. Two reviewers will screen, extract and quality assess the articles. Outcomes of interest include ischaemic colitis, electrolyte imbalances and their consequences, seizures, bowel perforation and patient tolerability. If sufficient data exist and studies are of sufficient homogeneity, network meta-analyses (NMAs) will be performed. ETHICS AND DISSEMINATION: Ethics approval was not necessary due to study design. Updating the safety profile of bowel cleansers among the generally healthy population undergoing colonoscopy is pertinent given recent approval changes. This will be the first NMA within this population. Policy considerations may be reconsidered to minimise risk during bowel cleanser use. PROSPERO REGISTRATION NUMBER: CRD42018084720.
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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 | 0.068 | 0.098 |
| Meta-epidemiology (narrow) | 0.007 | 0.005 |
| Meta-epidemiology (broad) | 0.024 | 0.029 |
| Bibliometrics | 0.011 | 0.013 |
| Science and technology studies | 0.003 | 0.004 |
| Scholarly communication | 0.007 | 0.006 |
| Open science | 0.006 | 0.004 |
| Research integrity | 0.006 | 0.008 |
| Insufficient payload (model declined to judge) | 0.078 | 0.008 |
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".