Public comment period · §3
Draft synthesis: Amylin analogues as monotherapy and in… — 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-AMYLIN-ANALO/006 | Dr Leonhard Quenneville | The conclusion is stated more strongly than the certainty rating supports | Accepted |
| DRAFT-AMYLIN-ANALO/005 | Dr Ilona Mbatha-Fredriksen | Subgroup findings are reported that were not registered in the protocol | Accepted in part |
| DRAFT-AMYLIN-ANALO/008 | Dr Lorcan Whitmarsh-Obi | Declared interests should appear on the document rather than on a separate page | Noted, no amendment |
| DRAFT-AMYLIN-ANALO/007 | Dr Kolawole Isaksen-Balogun | The document should state what a reader ought to do | Not accepted |
| DRAFT-AMYLIN-ANALO/004 | Xiomara Fairweather-Duru | Results at materially different follow-up durations are pooled | Accepted |
| DRAFT-AMYLIN-ANALO/009 | Dr Séverine Oduya-Kaltenbrunner | The same concern is used to downgrade in two domains | Accepted in part |
| DRAFT-AMYLIN-ANALO/003 | Dr Stellan Cholmondeley-Ade | The choice of effect measure is not justified and changes the appearance of the result | Accepted in part |
| DRAFT-AMYLIN-ANALO/002 | Dr Fenella Steenkamp-Ferreira | Intention-to-treat and efficacy-estimand results are combined without distinction | Accepted |
| DRAFT-AMYLIN-ANALO/001 | Ms Rhiannon Okoye-Vandergraaf | Point estimates are given without an interval | Accepted in part |
| 9 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 3 | 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 | 1 | 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 | 1 | 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
- The conclusion is stated more strongly than the certainty rating supports — arising from DRAFT-AMYLIN-ANALO/006. Conclusion wording is now drawn from a fixed set of formulations tied to the certainty rating, so that a low certainty rating produces a statement that the evidence may suggest an effect and that the estimate is likely to change with further research.
- Subgroup findings are reported that were not registered in the protocol — arising from DRAFT-AMYLIN-ANALO/005. 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.
- Results at materially different follow-up durations are pooled — arising from DRAFT-AMYLIN-ANALO/004. Estimates are now reported by duration band, with the number of contributing trials and participants in each band stated, and no estimate is pooled across bands.
- The same concern is used to downgrade in two domains — arising from DRAFT-AMYLIN-ANALO/009. 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 choice of effect measure is not justified and changes the appearance of the result — arising from DRAFT-AMYLIN-ANALO/003. Every outcome now reports the relative effect and, where an assumed baseline risk can be stated and sourced, the corresponding absolute effect, with the baseline risk and its source given in the same row.
- Intention-to-treat and efficacy-estimand results are combined without distinction — arising from DRAFT-AMYLIN-ANALO/002. The treatment-policy estimand is used throughout as the primary analysis, the efficacy estimand is reported as a secondary analysis where available, and the estimand used is stated in every row of the summary of findings.
- Point estimates are given without an interval — arising from DRAFT-AMYLIN-ANALO/001. 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.
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-112/3 · https://compoundevidence.com/comment-periods/draft-amylin-analogue-evidence-synthesis/disposition/ · retrieved 30 July 2026