Draft synthesis: incretin receptor agonists for metabolic… — 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. Quantitative claims are reproduced without the method that produced them — arising from DRAFT-MASH-SYNTHES/002. Every quantitative claim now carries the determination that produced it at the point of use, and figures obtained by non-comparable methods are no longer presented in the same row or sentence.
2. Point estimates are given without an interval — arising from DRAFT-MASH-SYNTHES/005. 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. Studies using different outcome definitions are pooled into one estimate — arising from DRAFT-MASH-SYNTHES/008. 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.
4. The choice of effect measure is not justified and changes the appearance of the result — arising from DRAFT-MASH-SYNTHES/007. 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.
5. The search date is not on the face of the document — arising from DRAFT-MASH-SYNTHES/010. The search date is now printed adjacent to every certainty rating and is carried in the document metadata, so that the interval between the search and the reading is visible without reference to the methods section.
6. A single-trial result is presented in the visual form of a pooled estimate — arising from DRAFT-MASH-SYNTHES/009. 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.
7. Intention-to-treat and efficacy-estimand results are combined without distinction — arising from DRAFT-MASH-SYNTHES/011. 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.
8. Subgroup findings are reported that were not registered in the protocol — arising from DRAFT-MASH-SYNTHES/001. 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.
9. Regulatory assessment documents were not searched — arising from DRAFT-MASH-SYNTHES/006. 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…
10. Two factual descriptions of the sponsor's programme are inaccurate — arising from DRAFT-MASH-SYNTHES/012. 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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