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Page Background

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