2011年1月27日 星期四

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

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