Gynae BT 2017
Patient reported outcomes (PRO)
Analytic outcomes (lab / imaging)
PRO considered as Gold standard
objective subjective
“…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
Physician assessed objective symptoms
Patient reported objective symptoms
Patient reported subjective symptoms
Objectifying the subjective experience by questionnaires with predefined response categories and robust psychometric properties
Patient reported impact of symptoms on ADL
Patient reported complex multidimensional concepts
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