Independent · non-commercial · publishes on a quarterly cycle|Current cycle 2026 Q3
Compound Evidence InstituteEvidence synthesis · established 2023Graded assessments of compounds, trials, methods and supply
Document set current to 30 July 2026
Public comment period · §2

Draft scope of the analytical and methodological standards… — submissions

The 9 submissions received, published in full with declared interests and secretariat responses.

Document identifier
CEI-CP-015/2
Series
Public comment period
Version
1.0
Published
28 Dec 2023
Last reviewed
28 Dec 2023
Next review
28 Dec 2024
Identifier
10.71829/cei.cp.15
Certainty
Not rated
Cycle
2023 Q4
Window
09 Oct 2023 – 08 Dec 2023
Status
Closed
Submissions
9

§2Submissions and responses

9 submissions were received. Each is published in full below with its declared interest, the secretariat response and the disposition. The Institute publishes submissions it did not accept in the same form as those it did.

Dr Jacinta Steenkamp-Ferreira, PharmD, PhD University teaching hospital, department of endocrinology
DRAFT-ANALYTICAL-S/005 received 10 Oct 2023

The same concept is given three different names in one document

The draft refers to the same quantity as a response rate, a responder proportion and a categorical outcome in different sections. The respondent, who works in health-technology assessment, states that a reader cannot tell whether the three refer to one thing or to three.

The respondent proposes that the glossary term be used at every occurrence and that the glossary entry be linked at first use in each section rather than only at first use in the document.

Declared interest. Employed by a health technology assessment body that has issued guidance on a compound named in the draft.
Secretariat responseAccepted16 Dec 2023

The secretariat accepts this submission. The variation was stylistic and its cost to the reader exceeds any benefit.

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.

Dr Mordecai Bellingham-Ojo, RN, MSc (Advanced Practice) Sleep and respiratory medicine service
DRAFT-ANALYTICAL-S/006 received 18 Oct 2023

A multi-part document does not indicate how many parts it has

The respondent states that a reader landing on part two of a document from a search result has no indication that parts one and three exist.

The respondent proposes a parts index on every part.

Declared interest. No interest to declare. The respondent is a graduate student and states that the submission forms no part of any assessed work.
Secretariat responseNoted, no amendment01 Jan 2024

The secretariat notes this submission. Every part already carries the full parts list in the margin, which the respondent may not have seen at a narrow viewport where the margin is collapsed.

No amendment to structure arises. The parts list is now rendered above the body rather than collapsed at narrow viewports, so that it is visible in the setting where the respondent found it absent.

Yusuf Whitmarsh-Obi, PhD (Medicinal Chemistry) University department of public health
DRAFT-ANALYTICAL-S/002 received 27 Oct 2023

A withdrawn document should not simply disappear

The respondent states that a reader arriving from an external citation at a withdrawn document needs to know that it existed, that it was withdrawn and why, and that a redirect to an index gives none of that.

The respondent proposes a notice at the original address.

Declared interest. Is a trustee of a patient organisation that has received a restricted educational grant from a manufacturer in the class under assessment.
Secretariat responseAccepted17 Dec 2023

The secretariat accepts this submission. A silent removal makes the citation that led there unresolvable.

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.

Dr Jolyon Grünbaum-Sowande, MD, FRCP Independent evidence-synthesis consultancy
DRAFT-ANALYTICAL-S/009 received 31 Oct 2023

The document should state what a reader ought to do

The draft assesses evidence and stops. The respondent, a practising clinician, states that a reader arriving at the document with a decision to make is left to convert an assessment into an action without help, and proposes that each document close with a recommendation.

The respondent argues that other evidence bodies issue recommendations and that declining to do so transfers the difficult part of the work to the reader.

Declared interest. Holds a personal shareholding, below the Institute's materiality threshold, in a diversified fund with pharmaceutical sector exposure. No direct holding in any named company.
Secretariat responseNot accepted15 Dec 2023

The secretariat does not accept this submission, and records that the point is a reasonable one rather than a misunderstanding.

The Institute assesses evidence and does not issue recommendations, because a recommendation embeds values and a resource context that the Institute does not hold and cannot state. That constitutional limit is published on the methodology page and is not varied by consultation. The submission remains published in full.

Dr Amara Quaresma, MD, MRCP Independent analytical consultancy
DRAFT-ANALYTICAL-S/001 received 02 Nov 2023

The document is unreadable without specialist training

The respondent, a trustee of a patient organisation, states that the draft is written for a reader who already understands certainty grading, and that the people most affected by the subject matter will not reach the assessment at all.

The respondent proposes a plain-language summary at the head of every document, written to the same standard of accuracy as the document itself and not as a promotional abstract.

Declared interest. Holds a patent relating to a delivery technology referenced in the draft.
Secretariat responseAccepted in part16 Dec 2023

The secretariat accepts this submission in part. A plain-language summary is added. The proposal that it replace the technical abstract is declined, because the abstract is the part of the document other assessors read and cite.

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.

Dr Katarzyna Yorkstone, MD, MRCP Independent analytical consultancy
DRAFT-ANALYTICAL-S/008 received 04 Nov 2023

The series scope is drawn widely enough to absorb documents that belong elsewhere

The respondent states that the scope as drafted would admit documents that are neither assessments nor standards, and that a series which admits everything ceases to tell a reader anything about what a document is.

The respondent proposes a narrower scope with an exclusion list.

Declared interest. No financial or non-financial interest to declare in relation to the subject of this consultation.
Secretariat responseAccepted in part31 Dec 2023

The secretariat accepts this submission in part. An exclusion list is added. The scope itself is not narrowed further, because the excluded classes are better handled by naming them than by tightening a boundary that would then be argued over.

The series scope now carries an explicit exclusion list naming the document classes that do not belong to it and stating where each belongs instead, so that a placement decision is checkable rather than editorial.

Dr Lorcan Zaleski-Mbeki, MPharm, MRPharmS Academic nephrology unit
DRAFT-ANALYTICAL-S/007 received 06 Nov 2023

The same quantity is presented differently in two series

The respondent states that a certainty rating is displayed one way in the monograph series and another in the synthesis series, and that a reader moving between them cannot be sure the two mean the same thing.

The respondent proposes a single presentation across all series.

Declared interest. Has received travel support to attend a scientific meeting from a manufacturer of a compound named in the draft.
Secretariat responseAccepted25 Dec 2023

The secretariat accepts this submission. A difference in presentation is read as a difference in meaning.

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.

Dr Wolfram Kaltenbach-Mensah, PhD (Toxicology) Health-technology assessment agency
DRAFT-ANALYTICAL-S/003 received 29 Nov 2023

The search date is not on the face of the document

The draft carries a publication date and a review date but not the date on which the evidence was last searched. Those are three different dates and only the third tells a reader how current the assessment is. A document published in one quarter may rest on a search run two quarters earlier, and nothing on the page allows that gap to be measured.

The respondent proposes that the search date be printed adjacent to every certainty rating rather than in the methods section, on the ground that a reader who acts on a rating is unlikely to have read the methods section first.

Declared interest. No financial interest. Has published a systematic review reaching a different conclusion from the draft, which the respondent declares as a non-financial interest.
Secretariat responseAccepted14 Dec 2023

The secretariat accepts this submission. The distinction between publication, review and search dates is real and the draft did not make it visible where it mattered.

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.

Quentin Gwynne-Sarpong, MD, DPhil Metabolic medicine service, tertiary centre
DRAFT-ANALYTICAL-S/004 received 06 Dec 2023

A printed copy loses the information that makes it checkable

The respondent states that printing a document produces pages without the identifier, the version or the retrieval date, so that a printed copy cannot be tied back to what it was printed from.

The respondent proposes that these be printed in a fixed position on every page.

Declared interest. Employed by a national competent authority. This submission is made in a personal capacity and does not represent the position of that authority.
Secretariat responseAccepted30 Dec 2023

The secretariat accepts this submission. A printed assessment circulates for longer than the browser tab it came from.

The print stylesheet now carries the identifier, version, publication date and retrieval date on every page, expands link destinations into the text, and prints the full reference list rather than a link to it.

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.

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