Description of image titled: Figure 1: PRO Maturity Model

This graphic shows several boxes, each representing (from left to right) one of the three steps in the Patient-Reported Outcome Maturity Model.

PRO-CTCAE has completed development and initial evaluation (stage 1 of the maturity model), and is progressing through scientific activities designed to enhance our capacity to compare and interpret research findings across multiple study designs and populations. PRO-CTCAE is also undergoing validation across sub-populations receiving different treatment modalities, and qualitative and quantitative validation in various languages. As PRO-CTCAE continues to develop, we are focused on enhancing its interpretability and utility in various trial designs and cancer subpopulations.

• I. Basic Methods / Tool Development
  • Create tools using modern psychometrics
  • Item development
  • Qualitative studies of content validity
  • Test in broader population, and clinical samples and subpopulation
  • Analysis and interpretation of above results towards instrument refinement
• II. Dissemination
  • Validate in clinical samples
  • Measure adaptation for language, literacy
  • Standards for use (e.g. new items, retiring items, cut points)
  • Develop outside partnerships
  • Use in observational studies
  • Use in clinical trials
  • Methods to allow for clinical application (e.g. individual level change)
• III. Implementation and Adoption
  • Widespread use in observational studies and clinical trials
  • Comparative effectiveness research
  • Business models developed to ensure sustainability
  • Actionable for decision-making by clinicians, investigators and regulators
  • Incorporated into training and education curricula

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