Draft synthesis: Nationally registered neuropeptides and the… — 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. Two factual descriptions of the sponsor's programme are inaccurate — arising from DRAFT-RUSSIAN-REGI/001. 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…
2. Two included studies do not meet the registered eligibility criteria — arising from DRAFT-RUSSIAN-REGI/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…
3. A surrogate outcome is used as the anchor without validation evidence — arising from DRAFT-RUSSIAN-REGI/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. Efficacy outcomes are rated for certainty and harms are not — arising from DRAFT-RUSSIAN-REGI/005. 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.
5. The comparator was given at a dose below the one in general use — arising from DRAFT-RUSSIAN-REGI/006. 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.
6. A sponsor trial meeting the eligibility criteria was excluded — arising from DRAFT-RUSSIAN-REGI/007. 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…
7. Overlapping primary studies across included reviews are counted more than once — arising from DRAFT-RUSSIAN-REGI/009. Overlap between included reviews is now assessed at primary-study level and reported in a citation matrix, and participant totals are reported for the union of primary studies rather than as a sum across reviews.
8. Subgroup findings are reported that were not registered in the protocol — arising from DRAFT-RUSSIAN-REGI/011. 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.
9. Absence of evidence is presented in a form a reader will take as negative evidence — arising from DRAFT-RUSSIAN-REGI/012. 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…
10. The review protocol is described but its registration record is not linked — arising from DRAFT-RUSSIAN-REGI/013. 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.
11. Registered trials that never reported are not counted anywhere in the review — arising from DRAFT-RUSSIAN-REGI/014. 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.
12. The timepoint at which each outcome was extracted was chosen after the data were seen — arising from DRAFT-RUSSIAN-REGI/015. The extraction timepoint is now prespecified in the protocol for new reviews. Where a review predates the requirement, estimates are reported at every timepoint the contributing trials report.
13. The choice of effect measure is not justified and changes the appearance of the result — arising from DRAFT-RUSSIAN-REGI/016. 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.

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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