Context-of-Use Validity

Scientific meaning

What it measures

Assesses context-of-use validity using evidence appropriate to biomarker and endpoint validation, distinguishing random uncertainty from systematic error.

Why it matters

Material weakness in context-of-use validity can change the direction, magnitude, certainty, or biological interpretation of the research conclusion.

Measurement criteria

Clear intended use or estimand; accepted reference or criterion; prespecified acceptance thresholds; independent validation; performance across relevant conditions.

Typical methods of assessment

Structured critical appraisal; quantitative estimation with uncertainty; prespecified thresholds; independent replication; sensitivity and subgroup analyses.

Computation profile

Computation mode

RuleBasedRubricComputation

Readiness

RubricRequired

Formula status

ContextSpecificProtocolRequired

Method family

structured critical appraisal or rubric scoring

Output datatype

xsd:string_or_decimal

Unit or scale

Ordinal rubric, domain judgment, or normalized score

Numeric range

Context dependent

Directionality

ContextDependentDirection

Required inputs

• evidence_records
• assessment_context
• rubric_version
• operational_definition

Optional inputs

• weights
• thresholds
• expert_adjudication

Machine-readable expression

{
  "language": "BEMO-Expression-JSON",
  "operator": "external_protocol",
  "protocolRef": "REQUIRED",
  "allowed_outputs": [
    "ordinal_category",
    "normalized_score"
  ]
}

Computation policies

Aggregation

Not specified in source; must be defined and versioned before composite use.

Normalization

None by default; any normalization must be justified, versioned, and validated.

Missing data

Must be declared before computation; report missingness; no silent imputation; perform sensitivity analysis when material.

Uncertainty required

Yes

Uncertainty method

Confidence interval, credible interval, bootstrap distribution, inter-rater reliability, or sensitivity analysis as scientifically applicable.

Confidence interval required

No

Threshold policy

Prespecify, justify, version, and sensitivity-test thresholds; do not derive and evaluate on the same data without correction.

Decision thresholds

No universal threshold declared

Quality control

Source provenance; input validation; duplicate control; uncertainty reporting; independent or orthogonal validation where applicable.

Calibration

Required for normalized scores; inter-rater reliability required for human rubrics.

Applicability and validation

Evidence object

Result / experiment / study / body of evidence, as applicable

Evidence level

Result / experiment / study / body of evidence, as applicable

Study types

Biomarker development, qualification, endpoint and surrogate validation studies

Domain

Biomarker and Endpoint Validation

Required data sources

Context-specific; use source references, registered studies, primary data, and authoritative biomedical resources as applicable.

Validation status

Source maturity: Mature; BEMO computation profile requires independent validation.

Benchmark

A representative, versioned benchmark set is required before production use.

Reference standard

Use an independent reference standard when one exists; document expert-adjudicated alternatives.

External validation required

Yes

Interpretation safeguards

Common misinterpretations

Treating context-of-use validity as interchangeable with overall study quality, or interpreting a favorable value as proof that all other bias and validity domains are satisfactory.

Limitations

Depends on context, operational definition, thresholds, data quality, and evaluator judgment; it should not be used as a stand-alone summary score without domain-level evidence.

Dependency status

Not yet curated. Closely related metrics are represented; causal or computational dependencies require expert curation.

Source provenance

Source workbook

Pure_Biomedical_Evidence_Research_Metrics_Part_2(3).xlsx

Source worksheet

Biomedical Evidence Metrics

Source row

44

Source record SHA-256

170c4bee423f9901b11abd5c6c7203f1253da40dbd46a33c459bac07471058e8

Definition source

Pure_Biomedical_Evidence_Research_Metrics_Part_2(3).xlsx row 44; see source_references

Ontology IRI

https://w3id.org/bemo/BEMO_2000037

Profile IRI

https://w3id.org/bemo/profile/BEMO_2000037

SHACL shape

https://w3id.org/bemo/shapes/BEMO_2000037_AssessmentShape

Scientific references (4)

1. https://www.fda.gov/media/119271/downloadSource framework, standard, guideline, or originSource-preserved; URL reachability not asserted by this package
2. https://www.ncbi.nlm.nih.gov/books/NBK326791/Source framework, standard, guideline, or originSource-preserved; URL reachability not asserted by this package
3. https://www.ema.europa.eu/en/ich-e16-genomic-biomarkers-related-drug-response-context-structure-format-qualification-submissions-scientific-guidelineSource framework, standard, guideline, or originSource-preserved; URL reachability not asserted by this package
4. https://www.equator-network.org/reporting-guidelines/reporting-recommendations-for-tumor-marker-prognostic-studies-remark/Source framework, standard, guideline, or originSource-preserved; URL reachability not asserted by this package

Governance and FAIR status

Lifecycle

Candidate

Approval

Draft

Owner

BEMO Project

Curator

Unassigned

Reviewer

Unassigned

License

Pending owner approval; CC BY 4.0 recommended for OBO compatibility.

Findable

Provisional: stable local ID assigned; public namespace registration pending.

Accessible

Provisional: package is distributable; permanent public release location pending.

Interoperable

Yes: OWL 2, RDF, SKOS, SHACL, JSON-LD, CSV, and OBO-style identifiers.

Reusable

Provisional: rich metadata supplied; open-license owner approval pending.

Governance note

Candidate term pending scientific, ontology-engineering, and computation-method review.

Editor note

Source content preserved verbatim; computation metadata is a generated default and must be curated before normative use.