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/001 | Dr Odalys Thorsby-Nakamura | The sampling frame of each contributing survey is not reported | Accepted |
| DRAFT-RECONSTITUTI/002 | Dr Anselm Thorsby-Nakamura | Results obtained by different methods are pooled without recording the method | Accepted |
| DRAFT-RECONSTITUTI/003 | Dr Jozef Brandvold-Achterberg | Risk-of-bias judgements are reported as an overall rating without the domains | Accepted |
| DRAFT-RECONSTITUTI/004 | Dr Oisín Rautavaara | Multiple vials from one lot are counted as independent observations | Accepted in part |
| DRAFT-RECONSTITUTI/005 | Dr Jolyon Grünbaum-Sowande | What the contributing methods could not have detected is not stated | Accepted in part |
| DRAFT-RECONSTITUTI/006 | Dr Ivo Quintanilha | The review question is drawn too broadly to be answerable | Not accepted |
| DRAFT-RECONSTITUTI/007 | Anselm Mountstephen | The review protocol is described but its registration record is not linked | Accepted in part |
| DRAFT-RECONSTITUTI/008 | Dr Quentin Enthoven | Declared interests should appear on the document rather than on a separate page | Noted, no amendment |
| DRAFT-RECONSTITUTI/009 | Dr Vittoria Quintanilha | The search was limited by publication date and the limit is not justified | Accepted in part |
| 9 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 3 | 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 | 4 | 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 sampling frame of each contributing survey is not reported — arising from DRAFT-RECONSTITUTI/001. Every contributing survey now carries a sampling row stating the frame, the number of sources approached and the number supplying, and the synthesis reports separately for surveys whose frames are not comparable.
- Results obtained by different methods are pooled without recording the method — arising from DRAFT-RECONSTITUTI/002. Every contributing result now carries its determination, pooling occurs only within a determination, and where a survey did not report the method the result is listed as method not stated and excluded from the pooled estimates.
- Risk-of-bias judgements are reported as an overall rating without the domains — arising from DRAFT-RECONSTITUTI/003. Risk of bias is now reported at domain level for every included study, with the text on which each judgement was based quoted and referenced, and the overall judgement derived from the domains rather than asserted alongside them.
- Multiple vials from one lot are counted as independent observations — arising from DRAFT-RECONSTITUTI/004. The unit of analysis is now the lot throughout, the number of lots is reported beside the number of vials, and within-lot variation is reported as a separate quantity rather than folded into the pooled interval.
- What the contributing methods could not have detected is not stated — arising from DRAFT-RECONSTITUTI/005. Every reported absence now carries the detection scope of the method behind it, and the review states in its abstract that an absence in this evidence base is an absence within a stated scope rather than an absence in the material.
- The review protocol is described but its registration record is not linked — arising from DRAFT-RECONSTITUTI/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.
- The search was limited by publication date and the limit is not justified — arising from DRAFT-RECONSTITUTI/009. 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.
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