Public comment period · §3
Draft synthesis: Reconstitution practice and delivered dose — disposition
The disposition of every submission and the amendments that resulted.
§3Disposition and amendments
§3.1Disposition table
Table 1. Every submission with its disposition. Each row links to the submission in full.
| Reference | Respondent | Point raised | Disposition |
|---|---|---|---|
| DRAFT-RECONSTITUTI/009 | Dr Gaspard Wintringham | Declared interests should appear on the document rather than on a separate page | Noted, no amendment |
| DRAFT-RECONSTITUTI/003 | Dr Sigrún Lavrentiev | The document is unreadable without specialist training | Accepted in part |
| DRAFT-RECONSTITUTI/005 | Dr Yehudit Yorkstone | The same concern is used to downgrade in two domains | Accepted in part |
| DRAFT-RECONSTITUTI/006 | Dr Melisande Thorsby-Nakamura | Studies not published in English were excluded without assessment | Accepted in part |
| DRAFT-RECONSTITUTI/007 | Dr Jacinta Grünbaum-Sowande | An indirect comparison is presented without an assessment of transitivity | Accepted |
| DRAFT-RECONSTITUTI/008 | Dr Lorcan Uttridge industry | The document should not describe uses outside the approved indication | Not accepted |
| DRAFT-RECONSTITUTI/004 | Radoslava Palmgren-Kofi industry | A sponsor trial meeting the eligibility criteria was excluded | Accepted in part |
| DRAFT-RECONSTITUTI/001 | Dr Jacinta Steenkamp-Ferreira | Patient-reported outcomes are collected by the trials and not reported by the review | Accepted in part |
| DRAFT-RECONSTITUTI/002 | Dr Mordecai Bellingham-Ojo | Overlapping primary studies across included reviews are counted more than once | Accepted |
| 9 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 2 | The submission is accepted and the draft is amended as proposed. The amendment is recorded in the amendment log of the document it changed and is traceable to the numbered submission. |
| Accepted in part | 5 | Part of the submission is accepted and part is not. The secretariat response states which part is which and on what ground the remainder was declined. |
| Noted, no amendment | 1 | The submission raises a point the Institute accepts but that does not require a change to the draft, most often because the draft already states it elsewhere. The location is given in the response. |
| Not accepted | 1 | The submission is not accepted. The secretariat response gives the reason. A submission that is not accepted remains published in full; the Institute does not remove a submission because it disagrees with it. |
§3.3Resulting amendments
- The document is unreadable without specialist training — arising from DRAFT-RECONSTITUTI/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.
- The same concern is used to downgrade in two domains — arising from DRAFT-RECONSTITUTI/005. 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.
- Studies not published in English were excluded without assessment — arising from DRAFT-RECONSTITUTI/006. 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.
- An indirect comparison is presented without an assessment of transitivity — arising from DRAFT-RECONSTITUTI/007. 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.
- A sponsor trial meeting the eligibility criteria was excluded — arising from DRAFT-RECONSTITUTI/004. 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…
- Patient-reported outcomes are collected by the trials and not reported by the review — arising from DRAFT-RECONSTITUTI/001. 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.
- Overlapping primary studies across included reviews are counted more than once — arising from DRAFT-RECONSTITUTI/002. 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.
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.
- 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.
Compound Evidence Institute · CEI-CP-114/3 · https://compoundevidence.com/comment-periods/draft-reconstitution-practice-and-content-synthesis/disposition/ · retrieved 30 July 2026