Cervix BT - 2016

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 subjective symptoms Patient reported objective 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