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Patient reported
subjective symptoms
Patient reported
objective symptoms
Physician assessed
objective symptoms
Analytic outcomes
(lab / imaging)
Patient Reported Outcomes (PRO)
Patient reported impact of
symptoms on ADL
objective
subjective
Patient reported complex
multidimensional concepts
PRO considered as Gold standard
“…any report of the status of a patient’s health
condition that comes
directly from the patient,
without interpretation
of the patient’s response
by a clinician or anyone else.”
Final
FDA PRO Guidance, Dec 2009
Objectifying the subjective experience
by questionnaires
with predefined response categories
and robust psychometric properties