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. A surrogate outcome is used as the anchor without validation evidence — arising from DRAFT-GASTROPARESI/001. 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…
2. Attrition is assessed in the risk-of-bias domains and not reported as a number — arising from DRAFT-GASTROPARESI/002. The included-studies table now carries randomised, analysed and attrition columns, and the risk-of-bias judgement is made against the figure the reader can see.
3. The document is unreadable without specialist training — arising from DRAFT-GASTROPARESI/003. 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.
4. The review protocol is described but its registration record is not linked — arising from DRAFT-GASTROPARESI/004. 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.
5. Crossover trials are pooled with parallel-group trials without adjustment — arising from DRAFT-GASTROPARESI/005. The methods section now states the handling of every non-parallel design. A sensitivity analysis is reported where crossover trials contribute more than a fifth of the weight.
6. The same concept is given three different names in one document — arising from DRAFT-GASTROPARESI/006. 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.
7. Studies not published in English were excluded without assessment — arising from DRAFT-GASTROPARESI/007. 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.
8. 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…
9. The conclusion is stated more strongly than the certainty rating supports — arising from DRAFT-GASTROPARESI/009. 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.
10. The search was limited by publication date and the limit is not justified — arising from DRAFT-GASTROPARESI/010. 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.
11. Results at materially different follow-up durations are pooled — arising from DRAFT-GASTROPARESI/011. 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.
12. A single-trial result is presented in the visual form of a pooled estimate — arising from DRAFT-GASTROPARESI/012. 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.
13. The comparator was given at a dose below the one in general use — arising from DRAFT-GASTROPARESI/013. Comparator dose is now a column in the included-studies table, and a sensitivity analysis restricted to comparators at the dose in general use is reported wherever the trials permit it.
14. A funnel plot is presented for a set too small to interpret it — arising from DRAFT-GASTROPARESI/014. 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.
15. Studies using different outcome definitions are pooled into one estimate — arising from DRAFT-GASTROPARESI/015. 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.

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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