Wheel and Spokes Diagram: Clinical Outcome Assessments (text version)
(PDF version - 1MB)
Spoke I: Identify Context of Use (COU) and Concept of Interest (COI)
- Outline hypothesized concepts and potential claims
- Determine intended population
- Determine intended application/characteristics (type of scores, mode and frequency of administration)
- Perform literature/expert review
- Develop hypothesized conceptual framework
- Position COA within a preliminary endpoint model
- Document COU and COI
Spoke II: Draft Instrument and Evaluate Content Validity
- Obtain patient or other reporter input
- Generate new items
- Select recall period, response options and format
- Select mode/method of administration/data collection
- Conduct cognitive interviewing
- Pilot test draft instrument
- Finalize instrument content, format and scoring rule
- Document content validity
Spoke III: Cross-sectional Evaluation of Other Measurement Properties
- Assess score reliability (test-retest or inter-rater) and construct validity
- Establish administration procedures & training materials
- Document measure development
- Prepare a user manual
- Consider submitting to FDA for COA qualification for use in exploratory studies prior to longitudinal evaluation
Spoke IV: Longitudinal Evaluation of Measurement Properties/Interpretation Methods
- Assess ability to detect change and construct validity
- Identify responder definition(s)
- Provide guidelines for interpretation of treatment benefit and relationship to claim
- Document all results
- Update user manual
- Submit to FDA for COA qualification as effectiveness endpoint to support claims
Spoke V: Modify Instrument
- Identify a new COU
- Change wording of items, response options, recall period, or mode/method of administration/data collection
- Translate and culturally adapt
- Evaluate modifications using spokes I - IV
- Document all changes
- Consider submitting to FDA for qualification of new COA, as appropriate