Table 1.

Types of outcome measures

Type of outcome measure	Example
Direct, objective	Mortality/survival
Biomarkers	Physiologic parameters such as blood pressure, laboratory tests on blood or other specimens or tissues
Clinical outcome assessments:*
Clinician-reported outcomes	Modified Ashworth scale for spasticity
Patient-reported outcomes	Short Form-36 general health survey for quality of life
Observer-reported outcomes	School Function Assessment to evaluate students’ participation in academic and social functions in elementary school
Performance outcomes†	Timed Up and Go test for mobility
	Amyotrophic Lateral Sclerosis Functional Rating Scale- Revised

*“Clinical Outcome Assessment (COA) is any assessment that may be influenced by human choices, judgment or motivation and may support either direct or indirect evidence of treatment benefit. COAs depend on the implementation, interpretation, and reporting from a patient, clinician or observer” (http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/ucm370262.htm)

^†Performance outcomes may be measured either by direct observation and quantification such as timed tests, or by reports from patients or caregivers.