Public comment period · §3
Draft safety review: the rodent thyroid C-cell signal and its… — 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-THYROID-C-CE/006 | Dr Frideswide Grünbaum-Sowande | Risk-of-bias judgements are reported as an overall rating without the domains | Accepted |
| DRAFT-THYROID-C-CE/005 | Dr Delphine Ravensworth | References should carry a persistent identifier for every cited source | Accepted in part |
| DRAFT-THYROID-C-CE/010 | Dr Quentin Zimmerthal | A surrogate outcome is used as the anchor without validation evidence | Accepted in part |
| DRAFT-THYROID-C-CE/011 | Dr Emiliana Ollerenshaw | Point estimates are given without an interval | Accepted in part |
| DRAFT-THYROID-C-CE/003 | Dr Abimbola Sotomayor-Ekwueme | An indirect comparison is presented without an assessment of transitivity | Accepted |
| DRAFT-THYROID-C-CE/016 | Dr Lorcan Whitmarsh-Obi | The search strategy as published cannot be re-run | Accepted |
| DRAFT-THYROID-C-CE/009 | Brigitta Grünbaum-Sowande | Analytical surveys are treated as evidence about suppliers when they establish only what was in a sample | Accepted |
| DRAFT-THYROID-C-CE/004 | Dr Ulysses Bellingham-Ojo industry | A sponsor trial meeting the eligibility criteria was excluded | Accepted in part |
| DRAFT-THYROID-C-CE/001 | Dr Wojciech Kaltenbach-Mensah | Results at materially different follow-up durations are pooled | Accepted |
| DRAFT-THYROID-C-CE/013 | Dr Séverine Oduya-Kaltenbrunner | A funnel plot is presented for a set too small to interpret it | Accepted |
| DRAFT-THYROID-C-CE/002 | Dr Wolfram Tollemache | Two included studies do not meet the registered eligibility criteria | Accepted in part |
| DRAFT-THYROID-C-CE/015 | Dr Kolawole Isaksen-Balogun | Efficacy outcomes are rated for certainty and harms are not | Accepted |
| DRAFT-THYROID-C-CE/012 | Dr Quentin Enthoven | The document is unreadable without specialist training | Accepted in part |
| DRAFT-THYROID-C-CE/008 | Dr Jerome Lavrentiev | Statistical heterogeneity is treated as though it measured clinical heterogeneity | Accepted in part |
| DRAFT-THYROID-C-CE/014 | Dr Liesbeth Achterberg | Registered trials that never reported are not counted anywhere in the review | Accepted |
| DRAFT-THYROID-C-CE/007 | Professor Chukwuemeka Rasmussen-Adeyemi | The same concept is given three different names in one document | Accepted |
| 16 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 9 | 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 | 7 | 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 | 0 | 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
- Risk-of-bias judgements are reported as an overall rating without the domains — arising from DRAFT-THYROID-C-CE/006. 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.
- References should carry a persistent identifier for every cited source — arising from DRAFT-THYROID-C-CE/005. Every reference without a persistent identifier now carries an explicit statement that the identifier is not held by the Institute, so that its absence is a recorded fact rather than an apparent oversight.
- A surrogate outcome is used as the anchor without validation evidence — arising from DRAFT-THYROID-C-CE/010. 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…
- Point estimates are given without an interval — arising from DRAFT-THYROID-C-CE/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.
- An indirect comparison is presented without an assessment of transitivity — arising from DRAFT-THYROID-C-CE/003. 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 search strategy as published cannot be re-run — arising from DRAFT-THYROID-C-CE/016. 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.
- Analytical surveys are treated as evidence about suppliers when they establish only what was in a… — arising from DRAFT-THYROID-C-CE/009. 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…
- A sponsor trial meeting the eligibility criteria was excluded — arising from DRAFT-THYROID-C-CE/004. 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…
- Results at materially different follow-up durations are pooled — arising from DRAFT-THYROID-C-CE/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.
- A funnel plot is presented for a set too small to interpret it — arising from DRAFT-THYROID-C-CE/013. 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.
- Two included studies do not meet the registered eligibility criteria — arising from DRAFT-THYROID-C-CE/002. 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…
- Efficacy outcomes are rated for certainty and harms are not — arising from DRAFT-THYROID-C-CE/015. 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.
- The document is unreadable without specialist training — arising from DRAFT-THYROID-C-CE/012. 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.
- Statistical heterogeneity is treated as though it measured clinical heterogeneity — arising from DRAFT-THYROID-C-CE/008. The decision to pool is now justified in prose against the population, intervention, comparator and outcome before any statistic is presented, and the heterogeneity statistic is reported with its confidence interval and a note of the number of contributing…
- Registered trials that never reported are not counted anywhere in the review — arising from DRAFT-THYROID-C-CE/014. 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.
- The same concept is given three different names in one document — arising from DRAFT-THYROID-C-CE/007. 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.
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-019/3 · https://compoundevidence.com/comment-periods/draft-thyroid-c-cell-review/disposition/ · retrieved 30 July 2026