Public comment period · §3
Draft synthesis: Gastrointestinal adverse events with… — disposition
The disposition of every submission and the amendments that resulted.
§3Disposition and amendments
§3.1Disposition table
Table 1. Every submission with its disposition. Each row links to the submission in full.
| Reference | Respondent | Point raised | Disposition |
|---|---|---|---|
| DRAFT-GASTROINTEST/006 | Xenia Nyquist-Obiora industry | A sponsor trial meeting the eligibility criteria was excluded | Accepted in part |
| DRAFT-GASTROINTEST/003 | Dr Wilhelmina Erlingsson | References should carry a persistent identifier for every cited source | Accepted in part |
| DRAFT-GASTROINTEST/008 | Dr Oisín Marchetti-Bassey industry | The document should not describe uses outside the approved indication | Not accepted |
| DRAFT-GASTROINTEST/005 | Dr Rurik Underhill-Okafor industry | Two factual descriptions of the sponsor's programme are inaccurate | Accepted |
| DRAFT-GASTROINTEST/002 | Dr Rosalind Grünbaum-Sowande | Point estimates are given without an interval | Accepted in part |
| DRAFT-GASTROINTEST/009 | Dr Eamon Immelmann | The same concept is given three different names in one document | Accepted |
| DRAFT-GASTROINTEST/007 | Dr Rurik Haverkamp-Diallo | The search strategy as published cannot be re-run | Accepted |
| DRAFT-GASTROINTEST/012 | Dr Eamon Immelmann | The document set should be published in translation | Not accepted |
| DRAFT-GASTROINTEST/001 | Ignatius Erlingsson | The search date is not on the face of the document | Accepted |
| DRAFT-GASTROINTEST/010 | Dr Liesbeth Zaleski-Mbeki | Risk-of-bias judgements are reported as an overall rating without the domains | Accepted |
| DRAFT-GASTROINTEST/004 | Dr Adaeze Dunmore-Ekpo | The review protocol is described but its registration record is not linked | Accepted in part |
| DRAFT-GASTROINTEST/011 | Dr Liesbeth Zaleski-Mbeki | Efficacy outcomes are rated for certainty and harms are not | Accepted |
| 12 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 6 | The submission is accepted and the draft is amended as proposed. The amendment is recorded in the amendment log of the document it changed and is traceable to the numbered submission. |
| Accepted in part | 4 | Part of the submission is accepted and part is not. The secretariat response states which part is which and on what ground the remainder was declined. |
| Noted, no amendment | 0 | The submission raises a point the Institute accepts but that does not require a change to the draft, most often because the draft already states it elsewhere. The location is given in the response. |
| Not accepted | 2 | The submission is not accepted. The secretariat response gives the reason. A submission that is not accepted remains published in full; the Institute does not remove a submission because it disagrees with it. |
§3.3Resulting amendments
- A sponsor trial meeting the eligibility criteria was excluded — arising from DRAFT-GASTROINTEST/006. The trial is added to the included set, the estimate and the certainty rating have been recomputed, and the screening record now states why the trial was missed, which was a database indexing gap rather than a screening judgement. The submission is identified…
- References should carry a persistent identifier for every cited source — arising from DRAFT-GASTROINTEST/003. Every reference without a persistent identifier now carries an explicit statement that the identifier is not held by the Institute, so that its absence is a recorded fact rather than an apparent oversight.
- Two factual descriptions of the sponsor's programme are inaccurate — arising from DRAFT-GASTROINTEST/005. The trial status now reads as completed at a pre-specified interim analysis, with the analysis identified, and the dose is stated in the unit used in the approved labelling. The submission is identified as an industry submission on its face in accordance with…
- Point estimates are given without an interval — arising from DRAFT-GASTROINTEST/002. Every estimate now carries its interval where the source reported one, and where it did not, the estimate is annotated as reported without an interval rather than left to appear as a precise figure.
- The same concept is given three different names in one document — arising from DRAFT-GASTROINTEST/009. A single term is now used throughout for each defined concept, and the glossary entry is linked at first use within each section rather than once per document.
- The search strategy as published cannot be re-run — arising from DRAFT-GASTROINTEST/007. The full line-by-line strategy for each database is now published with the interface, the run date and the yield at each line, and the total retrieved is reconciled against the screening flow.
- The search date is not on the face of the document — arising from DRAFT-GASTROINTEST/001. The search date is now printed adjacent to every certainty rating and is carried in the document metadata, so that the interval between the search and the reading is visible without reference to the methods section.
- Risk-of-bias judgements are reported as an overall rating without the domains — arising from DRAFT-GASTROINTEST/010. Risk of bias is now reported at domain level for every included study, with the text on which each judgement was based quoted and referenced, and the overall judgement derived from the domains rather than asserted alongside them.
- The review protocol is described but its registration record is not linked — arising from DRAFT-GASTROINTEST/004. Each synthesis now links its own protocol with the version in force at screening, and states explicitly where an external registration identifier is not held, so that the absence is a recorded fact.
- Efficacy outcomes are rated for certainty and harms are not — arising from DRAFT-GASTROINTEST/011. Every reported harm now carries a certainty rating on the same scale as the efficacy outcomes, with the downgrade reasons stated, and discontinuation for adverse events appears in the summary of findings rather than in an annex.
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- International Organization for Standardization. ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories. ISO/IEC Standard 2017;3rd edition. identifier not held by the Institute
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.
Compound Evidence Institute · CEI-CP-100/3 · https://compoundevidence.com/comment-periods/draft-gastrointestinal-tolerability-incretins-synthesis/disposition/ · retrieved 30 July 2026