Draft safety review: the rodent thyroid C-cell signal and its… — disposition

§3Disposition and amendments

§3.1Disposition table

Table 1. Every submission with its disposition. Each row links to the submission in full.

§3.2Summary by disposition

Table 2. Counts by disposition, with the meaning of each.

§3.3Resulting amendments

1. The conclusion is stated more strongly than the certainty rating supports — arising from DRAFT-THYROID-C-CE/001. 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.
2. Point estimates are given without an interval — arising from DRAFT-THYROID-C-CE/002. 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.
3. Crossover trials are pooled with parallel-group trials without adjustment — arising from DRAFT-THYROID-C-CE/004. 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.
4. Studies not published in English were excluded without assessment — arising from DRAFT-THYROID-C-CE/005. Language restriction is removed from the protocol for the series, the records previously excluded on that ground are listed with their screening outcome, and the residual limitation is stated in the abstract of this review.
5. References should carry a persistent identifier for every cited source — arising from DRAFT-THYROID-C-CE/006. 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.
6. Attrition is assessed in the risk-of-bias domains and not reported as a number — arising from DRAFT-THYROID-C-CE/007. The included-studies table now carries randomised, analysed and attrition columns, and the risk-of-bias judgement is made against the figure the reader can see.
7. The search strategy as published cannot be re-run — arising from DRAFT-THYROID-C-CE/009. 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.
8. The axis of the forest plot exaggerates a small difference — arising from DRAFT-THYROID-C-CE/011. Forest plots now carry a marked minimally important difference wherever a published one exists for the outcome, with its source cited. Where none exists the figure says so beneath the axis.
9. Results at materially different follow-up durations are pooled — arising from DRAFT-THYROID-C-CE/012. 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.
10. Patient-reported outcomes are collected by the trials and not reported by the review — arising from DRAFT-THYROID-C-CE/013. Patient-reported outcomes measured by any contributing trial are now reported narratively by instrument, with the instrument named and its minimum important difference stated where one is published, and the absence of a pooled estimate explained.
11. An indirect comparison is presented without an assessment of transitivity — arising from DRAFT-THYROID-C-CE/014. 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.
12. Risk-of-bias judgements are reported as an overall rating without the domains — arising from DRAFT-THYROID-C-CE/015. 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.
13. Two factual descriptions of the sponsor's programme are inaccurate — arising from DRAFT-THYROID-C-CE/016. The trial status now reads as completed at a pre-specified interim analysis, with the analysis identified, and the dose is stated in the unit used in the approved labelling. The submission is identified as an industry submission on its face in accordance with…

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.

1. 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

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