Public comment period · §3
Draft methodology document, version 4 — 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| DRAFT-METHODOLOGY-/019 | Dr Hyacinth Oyelaran-Steen | A superseded version should remain reachable from the version that replaced it | Noted, no amendment |
| DRAFT-METHODOLOGY-/013 | Kolawole Jankowiak-Osei | The same concept is given three different names in one document | Accepted |
| DRAFT-METHODOLOGY-/001 | Dr Theodora Ingelbrecht industry | The document should not describe uses outside the approved indication | Not accepted |
| DRAFT-METHODOLOGY-/020 | Dr Amara Vandergraaf | It is not clear which provisions bind the assessment committee | Accepted |
| DRAFT-METHODOLOGY-/002 | Dr Quintus Kettlewell | Preprints and conference abstracts are excluded categorically | Accepted in part |
| DRAFT-METHODOLOGY-/014 | Dr Ngozi Zetterlund | The rating conflates absence of evidence with conflicting evidence | Accepted |
| DRAFT-METHODOLOGY-/016 | Dr Ludmila Tollemache | The document should state what a reader ought to do | Not accepted |
| DRAFT-METHODOLOGY-/003 | Dr Theodora Ximenes | A superseded version should remain reachable from the version that replaced it | Noted, no amendment |
| DRAFT-METHODOLOGY-/004 | Dr Jerome Petrossian | The document set should be published in translation | Not accepted |
| DRAFT-METHODOLOGY-/015 | Dr Jolyon Grünbaum-Sowande | The document is unreadable without specialist training | Accepted in part |
| DRAFT-METHODOLOGY-/017 | Dr Georgiana Mountstephen | References should carry a persistent identifier for every cited source | Accepted in part |
| DRAFT-METHODOLOGY-/018 | Dr Jolanta Uttridge | The same concept is given three different names in one document | Accepted |
| DRAFT-METHODOLOGY-/006 | Dr Frideswide Nordhagen | Screening is described in terms that two people would apply differently | Accepted |
| DRAFT-METHODOLOGY-/010 | Dr Ludmila Castellanos-Reid | The treatment of imprecision does not work where the event did not occur | Accepted |
| DRAFT-METHODOLOGY-/009 | Dr Vasilisa Immelmann | Point estimates are given without an interval | Accepted in part |
| DRAFT-METHODOLOGY-/005 | Dr Valentin Castellanos-Reid industry | Two factual descriptions of the sponsor's programme are inaccurate | Accepted |
| DRAFT-METHODOLOGY-/007 | Dr Marisol Dunmore-Ekpo | A sortable table implies a comparison the underlying data do not support | Noted, no amendment |
| DRAFT-METHODOLOGY-/011 | Rosalind Petrossian | Declared interests should appear on the document rather than on a separate page | Noted, no amendment |
| DRAFT-METHODOLOGY-/012 | Dr Rukayat Zaleski-Mbeki | Quantitative claims are reproduced without the method that produced them | Accepted |
| DRAFT-METHODOLOGY-/021 | Dr Rosalind Grünbaum-Sowande | Quantitative claims are reproduced without the method that produced them | Accepted |
| DRAFT-METHODOLOGY-/008 | Dr Hamish Nyquist-Obiora | The conditions for upgrading observational evidence are too permissive | Accepted in part |
| 21 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 9 | 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 | 4 | 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 | 3 | 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 same concept is given three different names in one document — arising from DRAFT-METHODOLOGY-/013. 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.
- It is not clear which provisions bind the assessment committee — arising from DRAFT-METHODOLOGY-/020. Binding provisions are now stated in a fixed form, are listed together in an annex, and a departure from any of them must be recorded in the document it affects with the reason, while descriptive passages are marked as descriptions of practice.
- Preprints and conference abstracts are excluded categorically — arising from DRAFT-METHODOLOGY-/002. Preprints and conference abstracts are now screened, listed and reported as a distinct evidence class with their status stated, contribute to the narrative assessment, and are excluded from pooled estimates with the reason recorded rather than excluded at…
- The rating conflates absence of evidence with conflicting evidence — arising from DRAFT-METHODOLOGY-/014. A standing formulation has been adopted and is applied to every low and very low certainty rating in the document set. The rating scale itself is unchanged, so that Institute ratings remain readable against published assessments using the same scale.
- The document is unreadable without specialist training — arising from DRAFT-METHODOLOGY-/015. 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.
- References should carry a persistent identifier for every cited source — arising from DRAFT-METHODOLOGY-/017. 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.
- The same concept is given three different names in one document — arising from DRAFT-METHODOLOGY-/018. 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.
- Screening is described in terms that two people would apply differently — arising from DRAFT-METHODOLOGY-/006. Screening criteria are now operationalised as tests that can be applied without further judgement, screening is performed in duplicate, and the agreement observed together with the resolution of disagreements is reported in every review.
- The treatment of imprecision does not work where the event did not occur — arising from DRAFT-METHODOLOGY-/010. The framework now states the rule for zero-event outcomes: the rating is determined by the total exposure and the frequency that exposure could have detected, and the resulting statement records that the evidence is uninformative rather than reassuring.
- Point estimates are given without an interval — arising from DRAFT-METHODOLOGY-/009. Every estimate now carries its interval where the source reported one, and where it did not, the estimate is annotated as reported without an interval rather than left to appear as a precise figure.
- Two factual descriptions of the sponsor's programme are inaccurate — arising from DRAFT-METHODOLOGY-/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…
- Quantitative claims are reproduced without the method that produced them — arising from DRAFT-METHODOLOGY-/012. Every quantitative claim now carries the determination that produced it at the point of use, and figures obtained by non-comparable methods are no longer presented in the same row or sentence.
- Quantitative claims are reproduced without the method that produced them — arising from DRAFT-METHODOLOGY-/021. Every quantitative claim now carries the determination that produced it at the point of use, and figures obtained by non-comparable methods are no longer presented in the same row or sentence.
- The conditions for upgrading observational evidence are too permissive — arising from DRAFT-METHODOLOGY-/008. An upgrade for a large effect now requires an explicit statement of the confounding structure that would be needed to produce the observed effect and a reason for regarding it as implausible, and the statement is published with the rating.
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-032/3 · https://compoundevidence.com/comment-periods/draft-methodology-v4/disposition/ · retrieved 30 July 2026