Public comment period · §3
Draft synthesis: Percentage weight change as a surrogate… — 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-SURROGATE-OU/001 | Dr Adaeze Underhill-Okafor | Two included studies do not meet the registered eligibility criteria | Accepted in part |
| DRAFT-SURROGATE-OU/002 | Dr Matthias Wintringham industry | A sponsor trial meeting the eligibility criteria was excluded | Accepted in part |
| DRAFT-SURROGATE-OU/003 | Dr Wolfram Quintanilha industry | The document should not describe uses outside the approved indication | Not accepted |
| DRAFT-SURROGATE-OU/004 | Dr Constança Glendinning-Uche | The same concept is given three different names in one document | Accepted |
| DRAFT-SURROGATE-OU/005 | Dr Oisín Rautavaara | Overlapping primary studies across included reviews are counted more than once | Accepted |
| DRAFT-SURROGATE-OU/006 | Thaddeus Isaksen-Balogun | Crossover trials are pooled with parallel-group trials without adjustment | Accepted in part |
| DRAFT-SURROGATE-OU/007 | Dr Lorcan Zaleski-Mbeki | Efficacy outcomes are rated for certainty and harms are not | Accepted |
| DRAFT-SURROGATE-OU/008 | Dr Kolawole Isaksen-Balogun | Intention-to-treat and efficacy-estimand results are combined without distinction | Accepted |
| DRAFT-SURROGATE-OU/009 | Dr Leonhard Quenneville | Doses differing several-fold are pooled without examining dose-response | Accepted |
| 9 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 5 | 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 | 3 | 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
- Two included studies do not meet the registered eligibility criteria — arising from DRAFT-SURROGATE-OU/001. 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…
- A sponsor trial meeting the eligibility criteria was excluded — arising from DRAFT-SURROGATE-OU/002. 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…
- The same concept is given three different names in one document — arising from DRAFT-SURROGATE-OU/004. 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.
- Overlapping primary studies across included reviews are counted more than once — arising from DRAFT-SURROGATE-OU/005. Overlap between included reviews is now assessed at primary-study level and reported in a citation matrix, and participant totals are reported for the union of primary studies rather than as a sum across reviews.
- Crossover trials are pooled with parallel-group trials without adjustment — arising from DRAFT-SURROGATE-OU/006. 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.
- Efficacy outcomes are rated for certainty and harms are not — arising from DRAFT-SURROGATE-OU/007. 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.
- Intention-to-treat and efficacy-estimand results are combined without distinction — arising from DRAFT-SURROGATE-OU/008. 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.
- Doses differing several-fold are pooled without examining dose-response — arising from DRAFT-SURROGATE-OU/009. Estimates are now reported by dose group, a dose-response examination is reported where three or more dose levels contribute, and the pooled across-dose estimate is removed rather than retained alongside.
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-111/3 · https://compoundevidence.com/comment-periods/draft-surrogate-outcomes-in-obesity-synthesis/disposition/ · retrieved 30 July 2026