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. Studies not published in English were excluded without assessment — arising from DRAFT-WEIGHT-REGAI/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.
2. The choice of effect measure is not justified and changes the appearance of the result — arising from DRAFT-WEIGHT-REGAI/012. Every outcome now reports the relative effect and, where an assumed baseline risk can be stated and sourced, the corresponding absolute effect, with the baseline risk and its source given in the same row.
3. The search date is not on the face of the document — arising from DRAFT-WEIGHT-REGAI/008. 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.
4. Two factual descriptions of the sponsor's programme are inaccurate — arising from DRAFT-WEIGHT-REGAI/005. 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…
5. A sponsor trial meeting the eligibility criteria was excluded — arising from DRAFT-WEIGHT-REGAI/001. 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…
6. The same concept is given three different names in one document — arising from DRAFT-WEIGHT-REGAI/016. 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. A funnel plot is presented for a set too small to interpret it — arising from DRAFT-WEIGHT-REGAI/002. 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.
8. Efficacy outcomes are rated for certainty and harms are not — arising from DRAFT-WEIGHT-REGAI/013. 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.
9. Analytical surveys are treated as evidence about suppliers when they establish only what was in a… — arising from DRAFT-WEIGHT-REGAI/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…
10. Two included studies do not meet the registered eligibility criteria — arising from DRAFT-WEIGHT-REGAI/003. 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…
11. A surrogate outcome is used as the anchor without validation evidence — arising from DRAFT-WEIGHT-REGAI/010. 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…
12. Registered trials that never reported are not counted anywhere in the review — arising from DRAFT-WEIGHT-REGAI/011. 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.
13. Intention-to-treat and efficacy-estimand results are combined without distinction — arising from DRAFT-WEIGHT-REGAI/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.

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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