Questions about mesalazine and the irritable bowel syndrome: authors’ reply
Bibliographic record
Abstract
Sirs, We thank Dr Farup for his comment on our article.1 Our study was an experimental analysis of the effect of mesalazine on stool microbiota and proteolytic activity in irritable bowel syndrome (IBS) patients. A secondary analysis was to assess correlations between changes in microbiota composition and patient symptoms as a hypothesis-generating enquiry. We disagree with Dr Farup’s premise that inclusion of patients irrespective of response to treatment could have changed the conclusions,2 as we make no inference or claim that mesalazine caused a change in symptoms, but rather observed the association. Our outcome of interest is what mesalazine does to stool bacterial composition, and obviously larger secondary studies are warranted to confirm the effects seen in this study. Although inclusion of stool data in the patients whose diarrhoea worsened on treatment would have been of interest, obvious ethical reasons prevented continuation of the study in patients who dropped out. Efficacy trials for subjective symptom-based disorders, like IBS, absolutely require placebo-controlled designs and intention-to-treat analyses. However, this was not an efficacy trial. Expecting that same standard for exploratory, open-label studies of objective endpoints clearly loses the forest for the trees. In any case, imputing missing values in a multi-dimensional, mostly qualitative outcome measure, such as stool composition, is impossible. The design and scope of our study were clearly presented and its limitations were discussed, and we do not feel that reported conclusions overextend or misconstrue the data. Declaration of personal interests: KPR has received research funding from the Canadian Association of Gastroenterology, Canadian Institutes for Health Research, Crohn's and Colitis Foundation of Canada and Canadian Foundation for Innovation. KPR has participated in advisory boards for Abbott, UCB, Schering-Plough and Ferring Pharmaceuticals. CNA has received research support from GlaxoSmithKline, and has served as a speaker, consultant or advisory board member for Ferring Pharmaceuticals, Takeda, Janssen and Pfizer. Declaration of funding interests: None.
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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 | 0.017 | 0.101 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.003 | 0.008 |
| Scholarly communication | 0.004 | 0.011 |
| Open science | 0.005 | 0.004 |
| Research integrity | 0.049 | 0.067 |
| Insufficient payload (model declined to judge) | 0.006 | 0.004 |
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".