The process of developing an instrument

Today, I listen to Dr. Wang's QOL course at year of 2010. He shared the procee of developing a PRO instrument. I think this process is very useful, since I may have to develop an instrument in the future. I wrote the notes here. I also highlight the points which I could not understand.

1. Hypothesize conceptual framework

• Outlinr hypoyhrsized concepts and potential cliams
• Determine intended population
• Determine intended application/characterostocs (type of scores, mode and frequency of administration)
• Peform literature/expert review
• Develop hypothesized conceptual framework
• Place PROs within preliminary endpoint model
• Document preliminary instrument development

2. Adjust conceptual framework and draft instrument

• Obtain patient input
• Fenerate new items
• Select recall period, response options and format
• Select mode/method of administration/data collection
• Conduct patient cognitive interviewing
• Pilot test draft instrument
• Document content validity

3. Confirm conceptual framework and assess measurement properties

• Confirm conceptual framework with scoring rule
• Assess socre reliability, construct validity and ability to dectect change
• Finalize instrument content, formats, scoring, procedures and training materials
• Document measurement development

4. Collect, analyze, and interpret data

• Prepare protocol and statistical analysis plan (final endpoint model and responder definition)
• Collect and analyze data
• Evaluate treatment response using cumulative distribution and responder definition
• Document interpretation of treatment benefit in relation to claim

5. Modify instrument

• Chang wording of items, populations, reponse options, recall period, or mode/method of administration/data collection
• Translate and culturally adapt to other languages
• Evalute modifications as appropriate
• Document all changes