Develop PRO Questionnaires

Questionnaires that capture patient outcomes must be developed by including relevant input from patients

Questionnaires designed to evaluate health outcomes are currently used primarily in Phase III clinical trials for chronic diseases where the intended effect of treatment is to slow the progress of the patient's disease or condition.  For use in multinational clinical trials, the content must be:  relevant globally, simple to complete and have the performance characteristics that support their intended use.  Additionally, the results should be understandable and meaningful for the medical community, patients and the regulatory agencies. 

 Requirements for PROs in Global Clinical Trials

  • Content that is globally relevant

  • Simple for patients to answer

  • Adequate performance characteristics for their use

  • Results that are easy to understand and meaningful

 Key Points in Choosing a PRO Questionnaire

  • What is the intended use of the questionnaire
     -    what magnitude of change is expected

  • What are the characteristics of the individuals
    who will complete the questionnaire

  • Is there an existing questionnaire that is adequate

How to Select Good Questions

Outcomes scientists often use the 'battery approach' where scales are selected from
several PRO questionnaires and combined to form a new questionnaire.  This approach
is appealing, but has many challenges.  Health Outcomes Group has developed the
Merit Method
for selecting good questions.  This method can be used to shorten questionnaires and improve the overall efficiency without loss of valuable information. 


 Benefits of the Merit Method

  • An objective method to select good questions

  • Can achieve significant efficency without sacrificing performance characteristics

  • Improves quality of the data

  • Reduces costs and the patient burden

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