Published: October 2016

Last updated: October 2025

Content validity

Content validity refers to the evidence that both patients and experts involved in developing a patient-reported outcome measure (PROM) deemed its content relevant and comprehensive to the specific concept, population, and purpose of measurement. This includes documented evidence of:

  1. The qualitative and/or quantitative methods used to identify and confirm relevant attributes of the PROM for its intended application.
  2. The characteristics of the participants included in the evaluation (e.g. race/ethnicity, culture, age, gender, socio-economic status, literacy level), highlighting any similarities or differences compared with the target population.
  3. The justification for the recall period used in the measurement application.

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