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 · §3

Draft synthesis: Gastrointestinal adverse events with… — disposition

The disposition of every submission and the amendments that resulted.

Document identifier
CEI-CP-100/3
Series
Public comment period
Version
1.0
Published
29 Mar 2025
Last reviewed
29 Mar 2025
Next review
29 Mar 2026
Identifier
10.71829/cei.cp.100
Certainty
Not rated
Cycle
2025 Q1
Window
24 Jan 2025 – 21 Feb 2025
Status
Closed
Submissions
12

§3Disposition and amendments

§3.1Disposition table

Table 1. Every submission with its disposition. Each row links to the submission in full.

ReferenceRespondentPoint raisedDisposition
DRAFT-GASTROINTEST/001Dr Yaa KettlewellBaseline imbalance in a small contributing trial is not remarked onNoted, no amendment
DRAFT-GASTROINTEST/002Dr Ivo QuintanilhaThe review question is drawn too broadly to be answerableNot accepted
DRAFT-GASTROINTEST/003Dr Evander Whitmarsh-ObiAnalytical surveys are treated as evidence about suppliers when they establish only what was in a sampleAccepted
DRAFT-GASTROINTEST/004Ivo MountstephenReferences should carry a persistent identifier for every cited sourceAccepted in part
DRAFT-GASTROINTEST/005Dr Adaeze Underhill-OkaforAttrition is assessed in the risk-of-bias domains and not reported as a numberAccepted
DRAFT-GASTROINTEST/006Dr Vasilisa ImmelmannRegulatory assessment documents were not searchedAccepted in part
DRAFT-GASTROINTEST/007Thaddeus Isaksen-BalogunStudies using different outcome definitions are pooled into one estimateAccepted
DRAFT-GASTROINTEST/008Dr Kolawole Isaksen-BalogunIntention-to-treat and efficacy-estimand results are combined without distinctionAccepted
DRAFT-GASTROINTEST/009Anselm MountstephenThe search strategy as published cannot be re-runAccepted
DRAFT-GASTROINTEST/010Eamon Sandringham-AduThe review protocol is described but its registration record is not linkedAccepted in part
DRAFT-GASTROINTEST/011Dr Jozef Brandvold-AchterbergAbsence of evidence is presented in a form a reader will take as negative evidenceAccepted
DRAFT-GASTROINTEST/012Dr Emiliana OllerenshawStudies not published in English were excluded without assessmentAccepted in part
12 submissions in total.

§3.2Summary by disposition

Table 2. Counts by disposition, with the meaning of each.

DispositionCountMeaning
Accepted6The 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 part4Part 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 amendment1The 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 accepted1The 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

  1. Analytical surveys are treated as evidence about suppliers when they establish only what was in a… — arising from DRAFT-GASTROINTEST/003. Provenance is now assessed for every included survey and reported as a study characteristic, surveys without establishable provenance are reported separately rather than pooled with those that have it, and no supplier-level inference is drawn from a…
  2. References should carry a persistent identifier for every cited source — arising from DRAFT-GASTROINTEST/004. 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.
  3. Attrition is assessed in the risk-of-bias domains and not reported as a number — arising from DRAFT-GASTROINTEST/005. The included-studies table now carries randomised, analysed and attrition columns, and the risk-of-bias judgement is made against the figure the reader can see.
  4. Regulatory assessment documents were not searched — arising from DRAFT-GASTROINTEST/006. Published regulatory assessment documents are now searched as a named source, are reported as a distinct evidence class in the included-studies table, and contribute to the assessment while being excluded from pooled estimates where risk of bias could not be…
  5. Studies using different outcome definitions are pooled into one estimate — arising from DRAFT-GASTROINTEST/007. Studies are now pooled only within an outcome definition, each definition is reported with its own estimate and certainty rating, and the summary of findings states which definition each row concerns.
  6. Intention-to-treat and efficacy-estimand results are combined without distinction — arising from DRAFT-GASTROINTEST/008. The treatment-policy estimand is used throughout as the primary analysis, the efficacy estimand is reported as a secondary analysis where available, and the estimand used is stated in every row of the summary of findings.
  7. The search strategy as published cannot be re-run — arising from DRAFT-GASTROINTEST/009. The full line-by-line strategy for each database is now published with the interface, the run date and the yield at each line, and the total retrieved is reconciled against the screening flow.
  8. The review protocol is described but its registration record is not linked — arising from DRAFT-GASTROINTEST/010. 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.
  9. Absence of evidence is presented in a form a reader will take as negative evidence — arising from DRAFT-GASTROINTEST/011. 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…
  10. Studies not published in English were excluded without assessment — arising from DRAFT-GASTROINTEST/012. 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.

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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