White Paper: Equivalence of Computerized and Paper and Pencil PRO Measures, June 2006

Summary

The FDA draft guidance on PROs states that migrating from paper to computer will be considered a modification of the measure, which may require additional validation evidence. This paper is an overview of a meta-analysis of published studies that compared the two modes of administration. concluding that use of computerized measures in clinical trials should not be impeded by concerns about equivalence.

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