Draft synthesis: Oral compared with injectable presentations… — 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. Analytical surveys are treated as evidence about suppliers when they establish only what was in a… — arising from DRAFT-ORAL-VS-INJE/011. 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…
2. Two factual descriptions of the sponsor's programme are inaccurate — arising from DRAFT-ORAL-VS-INJE/003. 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…
3. The same concern is used to downgrade in two domains — arising from DRAFT-ORAL-VS-INJE/014. The rating for the first outcome has been raised by one level and the domain reasoning restated, and the reasoning for the second has been rewritten to make clear that the two downgrades rest on different features of the evidence.
4. The same concept is given three different names in one document — arising from DRAFT-ORAL-VS-INJE/002. 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.
5. Risk-of-bias judgements are reported as an overall rating without the domains — arising from DRAFT-ORAL-VS-INJE/012. 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.
6. The document is unreadable without specialist training — arising from DRAFT-ORAL-VS-INJE/013. 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.
7. Two included studies do not meet the registered eligibility criteria — arising from DRAFT-ORAL-VS-INJE/007. 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…
8. Intention-to-treat and efficacy-estimand results are combined without distinction — arising from DRAFT-ORAL-VS-INJE/004. 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.
9. Subgroup findings are reported that were not registered in the protocol — arising from DRAFT-ORAL-VS-INJE/010. 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.
10. Patient-reported outcomes are collected by the trials and not reported by the review — arising from DRAFT-ORAL-VS-INJE/015. 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. The conclusion is stated more strongly than the certainty rating supports — arising from DRAFT-ORAL-VS-INJE/006. 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.
12. Statistical heterogeneity is treated as though it measured clinical heterogeneity — arising from DRAFT-ORAL-VS-INJE/009. 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…
13. Efficacy outcomes are rated for certainty and harms are not — arising from DRAFT-ORAL-VS-INJE/001. 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.

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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