CELIAC-PH2B-DDI — certainty assessment
Domain-by-domain assessment of the certainty of the evidence this trial contributes.
Institute-constructed programme record. This document is not a report of a published trial. It is a record the Institute has constructed to represent an instalment, sub-study or extension of a real development programme, published in order to carry a methodological point that the parent trial report does not address. No effect estimate on this page is attributable to any publication, and its reference-list entry carries a programme-record label rather than a citation. The policy governing these records was settled through a public comment period.
§4Certainty assessment
§4.1Reasoning by domain
Table 6. Certainty domains, the rating recorded against each, and the reasoning.
| Domain | Rating | Reasoning |
|---|---|---|
| Risk of biasLimitations in the design and conduct of the contributing studies. | Serious | Differential attrition exceeded the pre-specified threshold in one arm. |
| InconsistencyUnexplained heterogeneity of results across contributing studies. | Serious | Too few contributing studies to assess consistency formally. |
| IndirectnessDifferences between the population, intervention, comparator or outcome studied and those of the assessment question. | No concern | No serious concern identified in this domain. |
| ImprecisionWidth of the confidence interval relative to the decision threshold, and the number of events. | Serious | The confidence interval spans values that would support different decisions. |
| Publication biasRisk that results were selectively reported or that unpublished studies exist. | No concern | No 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.