Independent · non-commercial · publishes on a quarterly cycle|Current cycle 2026 Q3
Compound Evidence InstituteEvidence synthesis · established 2023Graded assessments of compounds, trials, methods and supply
Document set current to 30 July 2026
Public comment period · §3

Draft synthesis: Oral compared with injectable presentations… — disposition

The disposition of every submission and the amendments that resulted.

Document identifier
CEI-CP-101/3
Series
Public comment period
Version
1.0
Published
10 Oct 2024
Last reviewed
10 Oct 2024
Next review
10 Oct 2025
Identifier
10.71829/cei.cp.101
Certainty
Not rated
Cycle
2024 Q3
Window
18 Jul 2024 – 01 Sep 2024
Status
Closed
Submissions
15

§3Disposition and amendments

§3.1Disposition table

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

ReferenceRespondentPoint raisedDisposition
DRAFT-ORAL-VS-INJE/001Dr Yaa KettlewellSubgroup findings are reported that were not registered in the protocolAccepted in part
DRAFT-ORAL-VS-INJE/002Dr Melisande Kirkpatrick-OlaRisk-of-bias judgements are reported as an overall rating without the domainsAccepted
DRAFT-ORAL-VS-INJE/003Dr Matthias Wintringham industryThe document should not describe uses outside the approved indicationNot accepted
DRAFT-ORAL-VS-INJE/004Dr Wojciech Kaltenbach-MensahA surrogate outcome is used as the anchor without validation evidenceAccepted in part
DRAFT-ORAL-VS-INJE/005Dr Vasilisa Sandringham-AduStudies not published in English were excluded without assessmentAccepted in part
DRAFT-ORAL-VS-INJE/006Dr Marisol Dunmore-EkpoRegistered trials that never reported are not counted anywhere in the reviewAccepted
DRAFT-ORAL-VS-INJE/007Dr Quentin ZimmerthalAnalytical surveys are treated as evidence about suppliers when they establish only what was in a sampleAccepted
DRAFT-ORAL-VS-INJE/008Dr Kolawole Isaksen-BalogunStudies using different outcome definitions are pooled into one estimateAccepted
DRAFT-ORAL-VS-INJE/009Dr Melisande Thorsby-NakamuraQuantitative claims are reproduced without the method that produced themAccepted
DRAFT-ORAL-VS-INJE/010Georgiana ZimmerthalThe document set should be published in translationNot accepted
DRAFT-ORAL-VS-INJE/011Thaddeus Isaksen-BalogunPoint estimates are given without an intervalAccepted in part
DRAFT-ORAL-VS-INJE/012Dr Odalys Thorsby-NakamuraThe same concern is used to downgrade in two domainsAccepted in part
DRAFT-ORAL-VS-INJE/013Eamon Sandringham-AduThe search strategy as published cannot be re-runAccepted
DRAFT-ORAL-VS-INJE/014Dr Lorcan Zaleski-MbekiEfficacy outcomes are rated for certainty and harms are notAccepted
DRAFT-ORAL-VS-INJE/015Dr Oisín RautavaaraA funnel plot is presented for a set too small to interpret itAccepted
15 submissions in total.

§3.2Summary by disposition

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

DispositionCountMeaning
Accepted8The 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 part5Part 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 amendment0The 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 accepted2The 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

  1. Subgroup findings are reported that were not registered in the protocol — arising from DRAFT-ORAL-VS-INJE/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.
  2. Risk-of-bias judgements are reported as an overall rating without the domains — arising from DRAFT-ORAL-VS-INJE/002. 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.
  3. A surrogate outcome is used as the anchor without validation evidence — arising from DRAFT-ORAL-VS-INJE/004. 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…
  4. Studies not published in English were excluded without assessment — arising from DRAFT-ORAL-VS-INJE/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. Registered trials that never reported are not counted anywhere in the review — arising from DRAFT-ORAL-VS-INJE/006. 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.
  6. Analytical surveys are treated as evidence about suppliers when they establish only what was in a… — arising from DRAFT-ORAL-VS-INJE/007. 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…
  7. Studies using different outcome definitions are pooled into one estimate — arising from DRAFT-ORAL-VS-INJE/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.
  8. Quantitative claims are reproduced without the method that produced them — arising from DRAFT-ORAL-VS-INJE/009. 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.
  9. Point estimates are given without an interval — arising from DRAFT-ORAL-VS-INJE/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.
  10. The same concern is used to downgrade in two domains — arising from DRAFT-ORAL-VS-INJE/012. 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.
  11. The search strategy as published cannot be re-run — arising from DRAFT-ORAL-VS-INJE/013. 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.
  12. Efficacy outcomes are rated for certainty and harms are not — arising from DRAFT-ORAL-VS-INJE/014. 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.
  13. A funnel plot is presented for a set too small to interpret it — arising from DRAFT-ORAL-VS-INJE/015. 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.

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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