Statement

The Evidence Statement is a brief summary of the clinical implications of the Variant in the context of a specific Disease, Evidence Type and Clinical Significance as described in the cited literature source.

Understanding Evidence Statements

The evidence statement field is a description of evidence from published medical literature detailing the association of or lack of association of a variant with diagnostic, prognostic or predictive value in relation to a specific disease (and treatment for predictive evidence) The format used for an evidence statement can vary based on curator preference, but it is recommended that this statement contain the following: a reiteration of the evidence type, variant, gene, and disease, any comparison made or therapeutics used (e.g., arms of clinical trial), the number of individuals (or cell lines) in the trial, the conclusion from the trial, and statistical comparisons that support the conclusion (e.g., p-values, R2, confidence intervals, etc.). Detailed examples of specific types of evidence statements can be found below. Of note, data constituting protected health information (PHI) should not be entered in the evidence statement field.

Curating Evidence Statements

Evidence Statements should be:

  • derived from primary literature sources (not review articles) whenever possible.

  • as concise as possible while providing sufficient experimental detail to interpret and evaluate the evidence (N values, statistics, etc).

  • a single Predictive, Predisposing, Diagnostic or Prognostic assertion, not a combination.

  • aimed at a general audience, avoiding field-specific acronyms and colloquialisms.

Multiple, separate Evidence Items can be and often are derived from a single publication.

Generally, Statements involving drugs should be classified as being of the Predictive Evidence Type.