Something about "development of a PRO instrument"

From: FDA PRO Guidance Documents
Development of a PRO Instrument: An Iterative Process
hypothesize conceptual framework→ adjust conceptual framework and draft→ confirm conceptual framework and assess other measurement properties→ collect, analyze, and interpret data→modify instrument

＊目前正在思考如何結合"Patient-reported outcome"和"了解個案在IADL performance上的治療需求及期待"
Idea: to develop "patient-reported" items for evaluating stroke patient's therapeutic needs and expectations on IADL performance