Table 2.

Parallels between patient-reported outcome measure (PROM) development processes in the literature.

Phases (review paper [23]) and steps (US Food and Drug Administration Guide [10])		Stages (Scientific Advisory Committee of the Medical Outcomes Trust [21,26])
Phase 1: Establish correct health outcomes to measure
	Step 1: Hypothesize conceptual framework	Stage I: Conceptual model for the PROM and its initial items are developed
Phase 2: Develop PROM items
	Step 2: Adjust conceptual framework and draft instrument	Stage I: Conceptual model for the PROM and its initial items are developed
Phase 3: Test the PROM items on comprehensibility and a range of psychometric criteria
	Step 3: Confirm conceptual framework and assess other measurement properties	Stage III: Psychometric field-testing of the PROM being developed
	Step 4: Collect, analyze, and interpret data	Stage III: Psychometric field-testing of the PROM being developed
	Step 5: Modify instrument	All stages: PROM item revision activities
	Iteration back to Step 1, with further testing	Stage II: Revised PROM items from Stage I are field-tested on a larger cohort of patients