Draft safety review: delayed gastric emptying and procedural… — 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 search strategy as published cannot be re-run — arising from DRAFT-GASTROPARESI/005. 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.
2. A sponsor trial meeting the eligibility criteria was excluded — arising from DRAFT-GASTROPARESI/008. 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…
3. Regulatory assessment documents were not searched — arising from DRAFT-GASTROPARESI/007. 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. A surrogate outcome is used as the anchor without validation evidence — arising from DRAFT-GASTROPARESI/013. 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…
5. Patient-reported outcomes are collected by the trials and not reported by the review — arising from DRAFT-GASTROPARESI/003. 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.
6. Doses differing several-fold are pooled without examining dose-response — arising from DRAFT-GASTROPARESI/009. 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.
7. The search date is not on the face of the document — arising from DRAFT-GASTROPARESI/012. 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.
8. Risk-of-bias judgements are reported as an overall rating without the domains — arising from DRAFT-GASTROPARESI/004. 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.
9. Results at materially different follow-up durations are pooled — arising from DRAFT-GASTROPARESI/010. Estimates are now reported by duration band, with the number of contributing trials and participants in each band stated, and no estimate is pooled across bands.
10. Analytical surveys are treated as evidence about suppliers when they establish only what was in a… — arising from DRAFT-GASTROPARESI/014. 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…
11. The document is unreadable without specialist training — arising from DRAFT-GASTROPARESI/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.
12. Efficacy outcomes are rated for certainty and harms are not — arising from DRAFT-GASTROPARESI/015. 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. Statistical heterogeneity is treated as though it measured clinical heterogeneity — arising from DRAFT-GASTROPARESI/002. 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…

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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