Public comment period · §3
Draft certainty index — 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-CERTAINTY-IN/004 | Dr Fenella Lavrentiev | Absence of evidence is presented in a form a reader will take as negative evidence | Accepted |
| DRAFT-CERTAINTY-IN/001 | Dr Wilhelmina Wintringham industry | Two factual descriptions of the sponsor's programme are inaccurate | Accepted |
| DRAFT-CERTAINTY-IN/002 | Dr Matthias Whitmarsh-Obi | References should carry a persistent identifier for every cited source | Accepted in part |
| DRAFT-CERTAINTY-IN/006 | Dr Hamish Nyquist-Obiora | The front matter delays the reader from reaching the assessment | Accepted in part |
| DRAFT-CERTAINTY-IN/014 | Dr Lorcan Trelawney | The anchor outcome for an indication is not the outcome a decision turns on | Accepted in part |
| DRAFT-CERTAINTY-IN/003 | Ludmila Brackenridge | Indications for which compounds are supplied are absent from the set | Accepted |
| DRAFT-CERTAINTY-IN/015 | Dr Theodora Trelawney | An identifier that encodes the document type will have to change when the type does | Accepted |
| DRAFT-CERTAINTY-IN/010 | Dr Quintus Rautavaara | The same quantity is presented differently in two series | Accepted |
| DRAFT-CERTAINTY-IN/009 | Dr Gervase Crickhowell | The index shows ratings without the reasons behind them | Accepted |
| DRAFT-CERTAINTY-IN/012 | Dr Yaa Kettlewell | The registry is published only as pages and not in a form that can be processed | Accepted |
| DRAFT-CERTAINTY-IN/005 | Dr Marisol Dunmore-Ekpo | An index organised by certainty invites comparison between ratings that are not comparable | Accepted in part |
| DRAFT-CERTAINTY-IN/008 | Dr Frideswide Nordhagen | The search date is not on the face of the document | Accepted |
| DRAFT-CERTAINTY-IN/013 | Dr Séverin Oppenheimer-Ade | A surrogate anchor should not be permitted at all | Accepted in part |
| DRAFT-CERTAINTY-IN/011 | Vasilisa Sandringham-Adu | A withdrawn document should not simply disappear | Accepted |
| DRAFT-CERTAINTY-IN/007 | Dr Valentin Castellanos-Reid | The default ordering of a comparison table carries an implication | Accepted |
| 15 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 10 | 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 | 0 | 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 | 0 | 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
- Absence of evidence is presented in a form a reader will take as negative evidence — arising from DRAFT-CERTAINTY-IN/004. 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…
- Two factual descriptions of the sponsor's programme are inaccurate — arising from DRAFT-CERTAINTY-IN/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…
- References should carry a persistent identifier for every cited source — arising from DRAFT-CERTAINTY-IN/002. 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 front matter delays the reader from reaching the assessment — arising from DRAFT-CERTAINTY-IN/006. Every document now opens with its assessment statement and its certainty rating, with the identifiers, dates and declarations following immediately beneath rather than above, so that the first thing read is the finding and the second is its provenance.
- The anchor outcome for an indication is not the outcome a decision turns on — arising from DRAFT-CERTAINTY-IN/014. One anchor outcome is changed to the outcome proposed, and the second is retained with the alternative recorded as the preferred anchor and listed as an evidence gap, so that the reason for the compromise is on the record.
- Indications for which compounds are supplied are absent from the set — arising from DRAFT-CERTAINTY-IN/003. Uses observed in supply are now included in the indication set, marked as having no approved status and no anchor outcome, and each carries an explicit statement that no trial evidence was identified where that is the case.
- An identifier that encodes the document type will have to change when the type does — arising from DRAFT-CERTAINTY-IN/015. The identifier is now opaque and permanent from first publication, the series and type are recorded as fields that may change, and a reclassified document keeps the identifier it was issued with.
- The same quantity is presented differently in two series — arising from DRAFT-CERTAINTY-IN/010. Certainty ratings are now presented identically across every series, using the same badge, the same wording and the same accompanying formulation, and the presentation is specified in the series structure document rather than left to each series.
- The index shows ratings without the reasons behind them — arising from DRAFT-CERTAINTY-IN/009. Every index row now carries the downgrade domains alongside the rating, and the index can be filtered by domain so that a reader can see, for example, every outcome downgraded for imprecision across the document set.
- The registry is published only as pages and not in a form that can be processed — arising from DRAFT-CERTAINTY-IN/012. The registry fields are now emitted in a structured form alongside the rendered pages, carrying the identifier, series, type, version, dates, certainty rating and status for every document, and the structured record is regenerated with the site so that it…
- An index organised by certainty invites comparison between ratings that are not comparable — arising from DRAFT-CERTAINTY-IN/005. The index is now grouped by domain with certainty as the ordering within each group, and a standing statement records that ratings in different domains are not directly comparable and states why.
- The search date is not on the face of the document — arising from DRAFT-CERTAINTY-IN/008. The search date is now printed adjacent to every certainty rating and is carried in the document metadata, so that the interval between the search and the reading is visible without reference to the methods section.
- A surrogate anchor should not be permitted at all — arising from DRAFT-CERTAINTY-IN/013. A surrogate may now serve as an anchor only where the document states the evidence for the surrogate relationship in the population concerned and rates that evidence separately, and every document with a surrogate anchor carries the rating on its face.
- A withdrawn document should not simply disappear — arising from DRAFT-CERTAINTY-IN/011. A withdrawn document is now replaced at its own address by a notice recording its identifier, its title, the date and ground of withdrawal, and a link to whatever supersedes it, and the withdrawal is recorded in the corrections log.
- The default ordering of a comparison table carries an implication — arising from DRAFT-CERTAINTY-IN/007. The default ordering is now alphabetical, a standing statement above every comparison table records that the ordering is not a ranking, and the sort state is reset on reload so that a shared link does not carry an ordering the sender chose.
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-038/3 · https://compoundevidence.com/comment-periods/draft-certainty-index/disposition/ · retrieved 30 July 2026