Public comment period · §3
Draft synthesis: Oral compared with injectable presentations… — 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-ORAL-VS-INJE/001 | Dr Yaa Kettlewell | Subgroup findings are reported that were not registered in the protocol | Accepted in part |
| DRAFT-ORAL-VS-INJE/002 | Dr Melisande Kirkpatrick-Ola | Risk-of-bias judgements are reported as an overall rating without the domains | Accepted |
| DRAFT-ORAL-VS-INJE/003 | Dr Matthias Wintringham industry | The document should not describe uses outside the approved indication | Not accepted |
| DRAFT-ORAL-VS-INJE/004 | Dr Wojciech Kaltenbach-Mensah | A surrogate outcome is used as the anchor without validation evidence | Accepted in part |
| DRAFT-ORAL-VS-INJE/005 | Dr Vasilisa Sandringham-Adu | Studies not published in English were excluded without assessment | Accepted in part |
| DRAFT-ORAL-VS-INJE/006 | Dr Marisol Dunmore-Ekpo | Registered trials that never reported are not counted anywhere in the review | Accepted |
| DRAFT-ORAL-VS-INJE/007 | Dr Quentin Zimmerthal | Analytical surveys are treated as evidence about suppliers when they establish only what was in a sample | Accepted |
| DRAFT-ORAL-VS-INJE/008 | Dr Kolawole Isaksen-Balogun | Studies using different outcome definitions are pooled into one estimate | Accepted |
| DRAFT-ORAL-VS-INJE/009 | Dr Melisande Thorsby-Nakamura | Quantitative claims are reproduced without the method that produced them | Accepted |
| DRAFT-ORAL-VS-INJE/010 | Georgiana Zimmerthal | The document set should be published in translation | Not accepted |
| DRAFT-ORAL-VS-INJE/011 | Thaddeus Isaksen-Balogun | Point estimates are given without an interval | Accepted in part |
| DRAFT-ORAL-VS-INJE/012 | Dr Odalys Thorsby-Nakamura | The same concern is used to downgrade in two domains | Accepted in part |
| DRAFT-ORAL-VS-INJE/013 | Eamon Sandringham-Adu | The search strategy as published cannot be re-run | Accepted |
| DRAFT-ORAL-VS-INJE/014 | Dr Lorcan Zaleski-Mbeki | Efficacy outcomes are rated for certainty and harms are not | Accepted |
| DRAFT-ORAL-VS-INJE/015 | Dr Oisín Rautavaara | A funnel plot is presented for a set too small to interpret it | Accepted |
| 15 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 8 | 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 | 5 | 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
- Subgroup findings are reported that were not registered in the protocol — arising from DRAFT-ORAL-VS-INJE/001. Every subgroup analysis is now labelled as pre-specified or post hoc against the registered protocol, post hoc analyses are reported in a separate subsection without a certainty rating, and the protocol version against which the labelling was made is stated.
- Risk-of-bias judgements are reported as an overall rating without the domains — arising from DRAFT-ORAL-VS-INJE/002. 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.
- A surrogate outcome is used as the anchor without validation evidence — arising from DRAFT-ORAL-VS-INJE/004. Where the anchor is a surrogate, the synthesis now states the evidence for the surrogate relationship, rates it separately, and downgrades the anchor rating for indirectness accordingly rather than carrying the surrogate as though it were the outcome of…
- Studies not published in English were excluded without assessment — arising from DRAFT-ORAL-VS-INJE/005. Language restriction is removed from the protocol for the series, the records previously excluded on that ground are listed with their screening outcome, and the residual limitation is stated in the abstract of this review.
- Registered trials that never reported are not counted anywhere in the review — arising from DRAFT-ORAL-VS-INJE/006. Registered trials without posted results are now identified, counted and reported as a distinct category in the screening flow, with the proportion of registered participants they represent stated in the limitations.
- Analytical surveys are treated as evidence about suppliers when they establish only what was in a… — arising from DRAFT-ORAL-VS-INJE/007. Provenance is now assessed for every included survey and reported as a study characteristic, surveys without establishable provenance are reported separately rather than pooled with those that have it, and no supplier-level inference is drawn from a…
- Studies using different outcome definitions are pooled into one estimate — arising from DRAFT-ORAL-VS-INJE/008. Studies are now pooled only within an outcome definition, each definition is reported with its own estimate and certainty rating, and the summary of findings states which definition each row concerns.
- Quantitative claims are reproduced without the method that produced them — arising from DRAFT-ORAL-VS-INJE/009. Every quantitative claim now carries the determination that produced it at the point of use, and figures obtained by non-comparable methods are no longer presented in the same row or sentence.
- Point estimates are given without an interval — arising from DRAFT-ORAL-VS-INJE/011. 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 concern is used to downgrade in two domains — arising from DRAFT-ORAL-VS-INJE/012. The rating for the first outcome has been raised by one level and the domain reasoning restated, and the reasoning for the second has been rewritten to make clear that the two downgrades rest on different features of the evidence.
- The search strategy as published cannot be re-run — arising from DRAFT-ORAL-VS-INJE/013. 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.
- Efficacy outcomes are rated for certainty and harms are not — arising from DRAFT-ORAL-VS-INJE/014. 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.
- A funnel plot is presented for a set too small to interpret it — arising from DRAFT-ORAL-VS-INJE/015. The funnel plot is removed for every outcome contributed by fewer than ten studies, and replaced by a statement that small-study effects could not be assessed at that number, together with the count of registered trials identified without posted results.
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-101/3 · https://compoundevidence.com/comment-periods/draft-oral-vs-injectable-glp1-synthesis/disposition/ · retrieved 30 July 2026