Public comment period · §3
Draft synthesis: incretin receptor agonists for metabolic… — 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-MASH-SYNTHES/001 | Dr Ludmila Tollemache | An indirect comparison is presented without an assessment of transitivity | Accepted |
| DRAFT-MASH-SYNTHES/002 | Dr Constança Glendinning-Uche | The same concept is given three different names in one document | Accepted |
| DRAFT-MASH-SYNTHES/003 | Thaddeus Isaksen-Balogun | Intention-to-treat and efficacy-estimand results are combined without distinction | Accepted |
| DRAFT-MASH-SYNTHES/004 | Dr Vittoria Quintanilha | Risk-of-bias judgements are reported as an overall rating without the domains | Accepted |
| DRAFT-MASH-SYNTHES/005 | Dr Perpetua Haverkamp-Diallo industry | A sponsor trial meeting the eligibility criteria was excluded | Accepted in part |
| DRAFT-MASH-SYNTHES/006 | Dr Wojciech Kaltenbach-Mensah | A surrogate outcome is used as the anchor without validation evidence | Accepted in part |
| DRAFT-MASH-SYNTHES/007 | Dr Ndidi Ravensworth-Ilunga | One trial appears to be included twice under two publications | Accepted |
| DRAFT-MASH-SYNTHES/008 | Dr Zdenka Ximenes | Efficacy outcomes are rated for certainty and harms are not | Accepted |
| DRAFT-MASH-SYNTHES/009 | Dr Jozef Brandvold-Achterberg | Two included studies do not meet the registered eligibility criteria | Accepted in part |
| DRAFT-MASH-SYNTHES/010 | Eamon Sandringham-Adu | The search date is not on the face of the document | Accepted |
| DRAFT-MASH-SYNTHES/011 | Bertrand Ollerenshaw industry | The document should not describe uses outside the approved indication | Not accepted |
| DRAFT-MASH-SYNTHES/012 | Dr Oisín Rautavaara | Crossover trials are pooled with parallel-group trials without adjustment | Accepted in part |
| 12 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 7 | 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 | 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
- An indirect comparison is presented without an assessment of transitivity — arising from DRAFT-MASH-SYNTHES/001. Transitivity is now assessed against a stated list of effect modifiers and reported before any indirect estimate, and where the assessment fails the contrast is reported as unestimable with the reason rather than estimated with a caveat.
- The same concept is given three different names in one document — arising from DRAFT-MASH-SYNTHES/002. 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.
- Intention-to-treat and efficacy-estimand results are combined without distinction — arising from DRAFT-MASH-SYNTHES/003. 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.
- Risk-of-bias judgements are reported as an overall rating without the domains — arising from DRAFT-MASH-SYNTHES/004. 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 sponsor trial meeting the eligibility criteria was excluded — arising from DRAFT-MASH-SYNTHES/005. 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…
- A surrogate outcome is used as the anchor without validation evidence — arising from DRAFT-MASH-SYNTHES/006. 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…
- One trial appears to be included twice under two publications — arising from DRAFT-MASH-SYNTHES/007. Included studies are now recorded against a trial identifier, with publications listed beneath it, and the included-studies table reports the number of trials and the number of reports separately.
- Efficacy outcomes are rated for certainty and harms are not — arising from DRAFT-MASH-SYNTHES/008. 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.
- Two included studies do not meet the registered eligibility criteria — arising from DRAFT-MASH-SYNTHES/009. One study has been removed from the included set and the estimate recomputed, the exclusion reason for the third study has been corrected in the excluded-studies table, and the screening decisions are now recorded against the protocol version in force at the…
- The search date is not on the face of the document — arising from DRAFT-MASH-SYNTHES/010. 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.
- Crossover trials are pooled with parallel-group trials without adjustment — arising from DRAFT-MASH-SYNTHES/012. The methods section now states the handling of every non-parallel design. A sensitivity analysis is reported where crossover trials contribute more than a fifth of the weight.
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-025/3 · https://compoundevidence.com/comment-periods/draft-mash-synthesis/disposition/ · retrieved 30 July 2026