Draft synthesis: weight change after discontinuation of an… — 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 document is unreadable without specialist training — arising from DRAFT-WEIGHT-REGAI/001. 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.
2. An indirect comparison is presented without an assessment of transitivity — arising from DRAFT-WEIGHT-REGAI/002. 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.
3. Regulatory assessment documents were not searched — arising from DRAFT-WEIGHT-REGAI/003. 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…
4. Studies not published in English were excluded without assessment — arising from DRAFT-WEIGHT-REGAI/004. 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. The search was limited by publication date and the limit is not justified — arising from DRAFT-WEIGHT-REGAI/005. Every date limit in the series now carries its justification in the search-strategy section. Limits that could not be justified on re-examination have been removed and the affected searches re-run.
6. The review protocol is described but its registration record is not linked — arising from DRAFT-WEIGHT-REGAI/006. Each synthesis now links its own protocol with the version in force at screening, and states explicitly where an external registration identifier is not held, so that the absence is a recorded fact.
7. Risk-of-bias judgements are reported as an overall rating without the domains — arising from DRAFT-WEIGHT-REGAI/007. 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.
8. Absence of evidence is presented in a form a reader will take as negative evidence — arising from DRAFT-WEIGHT-REGAI/009. A standing formulation has been adopted and is applied wherever an evidence gap is recorded, distinguishing an outcome assessed and not demonstrated from an outcome not assessed. The formulation is identical at every occurrence so that it can be recognised at…
9. Two included studies do not meet the registered eligibility criteria — arising from DRAFT-WEIGHT-REGAI/010. 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…
10. The conclusion is stated more strongly than the certainty rating supports — arising from DRAFT-WEIGHT-REGAI/011. 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.
11. A sponsor trial meeting the eligibility criteria was excluded — arising from DRAFT-WEIGHT-REGAI/012. The trial is added to the included set, the estimate and the certainty rating have been recomputed, and the screening record now states why the trial was missed, which was a database indexing gap rather than a screening judgement. The submission is identified…
12. Doses differing several-fold are pooled without examining dose-response — arising from DRAFT-WEIGHT-REGAI/013. Estimates are now reported by dose group, a dose-response examination is reported where three or more dose levels contribute, and the pooled across-dose estimate is removed rather than retained alongside.
13. Two factual descriptions of the sponsor's programme are inaccurate — arising from DRAFT-WEIGHT-REGAI/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

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

Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.