Population-level summary: term and definition disagree
https://kerfors.github.io/usdm-overlay/id/finding/population-summary-term-vs-definition
Estimand.populationSummary has the preferred term "Population-Level Summary", the ICH E9(R1) estimand attribute. Its definition, "A synopsis of the clinical endpoint of interest within the analysis target study population", describes a narrative synopsis. The attribute is left unclassified in the overlay until the two are reconciled.
- standing
- Ready to raise: One USDM_CT.xlsx row carries two meanings: the preferred term is the ICH E9(R1) attribute, the definition a narrative synopsis.
- rationale
- ICH E9(R1), section A.3.3, describes the attribute as a population-level summary for the variable, providing a basis for comparison between treatment conditions. Read that way the value is a statistical summary measure, close to a classification. Read by the NCI definition it is prose.
- evidence
- Authored
- holds
- true
- observation
- C188853 Population-Level Summary: A synopsis of the clinical endpoint of interest within the analysis target study population. Has Value List N.
- about
- Estimand
- sources
- https://github.com/cdisc-org/DDF-RA/blob/v4.0.0/Deliverables/CT/USDM_CT.xlsx
https://www.ema.europa.eu/documents/scientific-guideline/ich-e9-r1-addendum-estimands-sensitivity-analysis-clinical-trials-guideline-statistical-principles_en.pdf
Test
Check function population_summary_term_vs_definition in scripts/check_findings.py.