So, what makes up a patient-reported outcomes (PRO) strategy?

  • Determine burden of illness
  • Identify potential impact of the product
  • Develop conceptual model
  • Realise product’s potential for PRO claims and studies
  • Identify potential PRO instruments
  • Evaluate and select appropriate instruments
  • Develop/adapt, translate and validate instruments
  • Elicit various perspectives (e.g. key opinion leaders, patients)
  • Develop a protocol and statistical analysis plan
  • Formulate dissemination and marketing plans