Draft synthesis: incretin receptor agonists in adolescents — 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. Regulatory assessment documents were not searched — arising from DRAFT-ADOLESCENT-S/001. 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…
2. The timepoint at which each outcome was extracted was chosen after the data were seen — arising from DRAFT-ADOLESCENT-S/002. The extraction timepoint is now prespecified in the protocol for new reviews. Where a review predates the requirement, estimates are reported at every timepoint the contributing trials report.
3. Registered trials that never reported are not counted anywhere in the review — arising from DRAFT-ADOLESCENT-S/003. 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.
4. The conclusion is stated more strongly than the certainty rating supports — arising from DRAFT-ADOLESCENT-S/004. 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.
5. The same concept is given three different names in one document — arising from DRAFT-ADOLESCENT-S/005. 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.
6. The search strategy as published cannot be re-run — arising from DRAFT-ADOLESCENT-S/006. 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.
7. The comparator was given at a dose below the one in general use — arising from DRAFT-ADOLESCENT-S/007. Comparator dose is now a column in the included-studies table, and a sensitivity analysis restricted to comparators at the dose in general use is reported wherever the trials permit it.
8. Attrition is assessed in the risk-of-bias domains and not reported as a number — arising from DRAFT-ADOLESCENT-S/008. 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.
9. The review does not say when it will be updated or what would trigger an update — arising from DRAFT-ADOLESCENT-S/010. 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.
10. Point estimates are given without an interval — arising from DRAFT-ADOLESCENT-S/012. 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.
11. Risk-of-bias judgements are reported as an overall rating without the domains — arising from DRAFT-ADOLESCENT-S/013. 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.
12. Subgroup findings are reported that were not registered in the protocol — arising from DRAFT-ADOLESCENT-S/014. 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.
13. Two factual descriptions of the sponsor's programme are inaccurate — arising from DRAFT-ADOLESCENT-S/015. 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

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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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