Psychometric Validation of PRO Instruments

Understanding  your patient population and the evolution of their disease or condition over time

Psychometric validation is the term that psychologists give to defining the perfomance characteristics of a measurement.  The methods used to evaluate the qualities of a test can be used in a wide variety of circumstances, including for defining the measurement properties of a questionnaire used to capture patient outcomes. 

By evaluating the different operating characteristics of a questionnaire you will have the information that is necessary to determine if the questionnaire is appropriate to answer you research questions.  You will also have the information necessary to estimate the size of the study required to detect the change that you expect. 

 Required Performance Characteristics

  • Reliability
        - test-retest reliability

  • Validity
        - content validity
        - construct validity
        - internal consistency

  • Responsiveness
        -ability to detect meaningful change

  • Conditions of use
        - specification of target audience

      Key Points in Evaluating a Questionnaire

  • What is the intended use of the questionnaire
     -    measure change over time
     -    discriminate among different groups
     -    diagnose diseased individuals

  • What are the characteristics of the individuals who will complete the questionnaire
    (age, disease-specific or general population, gender, one language and cultural or international use where data will be pooled)

  • Many performance characteristics can be defined outside of a clinical trial

In the context of clinical trials you need to be sure that a questionnaire has the required sensitivity to detect the treatment response that you expect.
The responsiveness attribute is the key characteristic that you need to examine. The chart on the left displays the differential responsiveness of a PRO questionnaire used in osteoarthritis. The results are from several clinical trials in North America using the English version of the questionnaire compared with comparable trials in Japan using the Japanese version of the same questionnaire. We observe that the Japanese patients report significantly lower pain than similar patients in North America.

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