Draft synthesis: Counter-ion content and its effect on… — 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. References should carry a persistent identifier for every cited source — arising from DRAFT-COUNTERION-C/008. Every reference without a persistent identifier now carries an explicit statement that the identifier is not held by the Institute, so that its absence is a recorded fact rather than an apparent oversight.
2. Studies not published in English were excluded without assessment — arising from DRAFT-COUNTERION-C/010. 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.
3. A sponsor trial meeting the eligibility criteria was excluded — arising from DRAFT-COUNTERION-C/009. 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…
4. The review protocol is described but its registration record is not linked — arising from DRAFT-COUNTERION-C/007. 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. An indirect comparison is presented without an assessment of transitivity — arising from DRAFT-COUNTERION-C/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.
6. A funnel plot is presented for a set too small to interpret it — arising from DRAFT-COUNTERION-C/015. 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.
7. The same concern is used to downgrade in two domains — arising from DRAFT-COUNTERION-C/001. The rating for the first outcome has been raised by one level and the domain reasoning restated, and the reasoning for the second has been rewritten to make clear that the two downgrades rest on different features of the evidence.
8. Two factual descriptions of the sponsor's programme are inaccurate — arising from DRAFT-COUNTERION-C/016. 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…
9. The review does not say when it will be updated or what would trigger an update — arising from DRAFT-COUNTERION-C/014. Every synthesis now records a scheduled review date and a stated update trigger, being the reporting of a trial that would materially change the contributing evidence, and the registered trials capable of triggering an update are listed by name.
10. Statistical heterogeneity is treated as though it measured clinical heterogeneity — arising from DRAFT-COUNTERION-C/003. 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…
11. Analytical surveys are treated as evidence about suppliers when they establish only what was in a… — arising from DRAFT-COUNTERION-C/004. 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…
12. Patient-reported outcomes are collected by the trials and not reported by the review — arising from DRAFT-COUNTERION-C/012. 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.
13. The review does not say when it will be updated or what would trigger an update — arising from DRAFT-COUNTERION-C/006. Every synthesis now records a scheduled review date and a stated update trigger, being the reporting of a trial that would materially change the contributing evidence, and the registered trials capable of triggering an update are listed by name.

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.