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Compound Evidence InstituteEvidence synthesis · established 2023Graded assessments of compounds, trials, methods and supply
Document set current to 30 July 2026
Trial abstract · §4

TED-PAEDIATRIC — certainty assessment

Domain-by-domain assessment of the certainty of the evidence this trial contributes.

Document identifier
CEI-TR-0154/4
Series
Trial abstract
Version
3.2
Published
13 Feb 2023
Last reviewed
13 Dec 2023
Next review
13 Dec 2025
Identifier
10.71829/cei.trial.154
Certainty
Moderate
Cycle
2023 Q1
Phase
Phase 3
Status
Reported

§4Certainty assessment

Certainty assessment by domainDowngrading decision recorded for each certainty domain.Certainty domainNo concernSeriousVery seriousEffect on ratingRisk of biasno downgradeInconsistencyno downgradeIndirectnessno downgradeImprecisiondowngrade one levelPublication biasno downgradeTotal downgrading: 1 levelModerate certainty
Figure 1. Domain-by-domain certainty assessment for the primary endpoint of TED-PAEDIATRIC. Randomised evidence starts at high; each serious concern reduces the rating by one level and each very serious concern by two.

§4.1Reasoning by domain

Table 6. Certainty domains, the rating recorded against each, and the reasoning.

DomainRatingReasoning
Risk of biasLimitations in the design and conduct of the contributing studies.No concernNo serious concern identified in this domain.
InconsistencyUnexplained heterogeneity of results across contributing studies.No concernNo serious concern identified in this domain.
IndirectnessDifferences between the population, intervention, comparator or outcome studied and those of the assessment question.No concernNo serious concern identified in this domain.
ImprecisionWidth of the confidence interval relative to the decision threshold, and the number of events.SeriousA single small trial contributes the whole estimate.
Publication biasRisk that results were selectively reported or that unpublished studies exist.No concernNo serious concern identified in this domain.

§4.2Sponsorship

Manufacturer-sponsored. The Institute does not downgrade certainty for sponsorship as a separate domain, because doing so would double-count risk of bias as conventionally assessed. It records sponsorship on the front matter of every trial abstract, and treats the uniformity of sponsorship across this compound class as a limitation of the evidence base rather than of any individual trial. The reasoning is set out in the methodological review of sponsor-generated evidence.

§4.3What this trial does not establish

Compound Evidence Institute · CEI-TR-0154/4 · https://compoundevidence.com/trials/ted-paediatric/certainty/ · retrieved 30 July 2026
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