Public comment period · §3
Draft synthesis: Weight-reducing agents for obstructive sleep… — 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-SLEEP-APNOEA/007 | Dr Gaspard Wintringham | The document is unreadable without specialist training | Accepted in part |
| DRAFT-SLEEP-APNOEA/006 | Dr Lorcan Uttridge industry | The document should not describe uses outside the approved indication | Not accepted |
| DRAFT-SLEEP-APNOEA/012 | Dr Vittoria Ylönen industry | A sponsor trial meeting the eligibility criteria was excluded | Accepted in part |
| DRAFT-SLEEP-APNOEA/013 | Dr Katarzyna Oppenheimer-Ade | Subgroup findings are reported that were not registered in the protocol | Accepted in part |
| DRAFT-SLEEP-APNOEA/008 | Dr Oisín Rautavaara | A surrogate outcome is used as the anchor without validation evidence | Accepted in part |
| DRAFT-SLEEP-APNOEA/005 | Dr Jacinta Grünbaum-Sowande | The search strategy as published cannot be re-run | Accepted |
| DRAFT-SLEEP-APNOEA/001 | Dr Sigrún Lavrentiev | Results at materially different follow-up durations are pooled | Accepted |
| DRAFT-SLEEP-APNOEA/014 | Dr Ivo Quintanilha | Regulatory assessment documents were not searched | Accepted in part |
| DRAFT-SLEEP-APNOEA/002 | Radoslava Palmgren-Kofi | A sortable table implies a comparison the underlying data do not support | Noted, no amendment |
| DRAFT-SLEEP-APNOEA/015 | Dr Anselm Ashworth-Danquah | Overlapping primary studies across included reviews are counted more than once | Accepted |
| DRAFT-SLEEP-APNOEA/010 | Dr Ursina Ellsworth-Vance | Absence of evidence is presented in a form a reader will take as negative evidence | Accepted |
| DRAFT-SLEEP-APNOEA/009 | Dr Piotr Hollingworth | Studies using different outcome definitions are pooled into one estimate | Accepted |
| DRAFT-SLEEP-APNOEA/003 | Dr Yehudit Yorkstone | The review does not say when it will be updated or what would trigger an update | Accepted |
| DRAFT-SLEEP-APNOEA/004 | Dr Melisande Thorsby-Nakamura | A single-trial result is presented in the visual form of a pooled estimate | Accepted |
| DRAFT-SLEEP-APNOEA/016 | Dr Bertrand Steenkamp-Ferreira | Intention-to-treat and efficacy-estimand results are combined without distinction | Accepted |
| DRAFT-SLEEP-APNOEA/011 | Dr Mordecai Glendinning-Uche | The choice of effect measure is not justified and changes the appearance of the result | Accepted in part |
| 16 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 | 6 | 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 document is unreadable without specialist training — arising from DRAFT-SLEEP-APNOEA/007. Every document now opens with a plain-language summary of not more than 150 words, placed above the technical abstract and carrying the same certainty language, so that the two cannot diverge.
- A sponsor trial meeting the eligibility criteria was excluded — arising from DRAFT-SLEEP-APNOEA/012. 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…
- Subgroup findings are reported that were not registered in the protocol — arising from DRAFT-SLEEP-APNOEA/013. 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.
- A surrogate outcome is used as the anchor without validation evidence — arising from DRAFT-SLEEP-APNOEA/008. 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…
- The search strategy as published cannot be re-run — arising from DRAFT-SLEEP-APNOEA/005. 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.
- Results at materially different follow-up durations are pooled — arising from DRAFT-SLEEP-APNOEA/001. 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.
- Regulatory assessment documents were not searched — arising from DRAFT-SLEEP-APNOEA/014. Published regulatory assessment documents are now searched as a named source, are reported as a distinct evidence class in the included-studies table, and contribute to the assessment while being excluded from pooled estimates where risk of bias could not be…
- Overlapping primary studies across included reviews are counted more than once — arising from DRAFT-SLEEP-APNOEA/015. 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.
- Absence of evidence is presented in a form a reader will take as negative evidence — arising from DRAFT-SLEEP-APNOEA/010. A standing formulation has been adopted and is applied wherever an evidence gap is recorded, distinguishing an outcome assessed and not demonstrated from an outcome not assessed. The formulation is identical at every occurrence so that it can be recognised at…
- Studies using different outcome definitions are pooled into one estimate — arising from DRAFT-SLEEP-APNOEA/009. 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.
- The review does not say when it will be updated or what would trigger an update — arising from DRAFT-SLEEP-APNOEA/003. Every synthesis now records a scheduled review date and a stated update trigger, being the reporting of a trial that would materially change the contributing evidence, and the registered trials capable of triggering an update are listed by name.
- A single-trial result is presented in the visual form of a pooled estimate — arising from DRAFT-SLEEP-APNOEA/004. Outcomes contributed by a single trial are now reported without a pooled diamond, labelled as unreplicated, and downgraded for imprecision or inconsistency according to the framework rather than presented as a synthesis.
- Intention-to-treat and efficacy-estimand results are combined without distinction — arising from DRAFT-SLEEP-APNOEA/016. 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.
- The choice of effect measure is not justified and changes the appearance of the result — arising from DRAFT-SLEEP-APNOEA/011. 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.
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-104/3 · https://compoundevidence.com/comment-periods/draft-sleep-apnoea-weight-agents-synthesis/disposition/ · retrieved 30 July 2026