CONVERTING PAPER VERSIONS OF PATIENT REPORTED OUTCOME INSTRUMENTS TO ELECTRONIC VERSIONS- IDENTIFYING THE REQUIRED STEPS

Author(s)

Ross J1, O'Gorman HJ2, Peck R1, Ross E11Almac Clinical Technologies, Souderton, PA, USA, 2Almac Group, Craigavon, United Kingdom

OBJECTIVES: Electronic Patient Reported Outcomes (ePRO) is a growing to be a preferred selection for collection of Patient Reported Outcomes (PRO) data.  However, there are a number of PRO instruments that are only available in paper version. Researchers may be unaware of steps required for converting paper to electronic versions and that different steps may be required pending on level of modification involved.  This presentation intends to provide guidance for identifying required steps in converting paper to ePRO and to identify FDA’s PRO Guidance as a resource.  METHODS: Required actions can be determined with input from the following: original author, psychometrician, FDA reviewer, etc. It is the Researcher’s responsibility to determine the action plan on received input.  Actions to demonstrate measurement equivalence include: clinical reviews, cognitive debriefs, usability testing, equivalence testing and full psychometric testing.  Since the decision is determined based on the magnitude of modification, it is important to distinguish each level of modification. This session will provide examples with application of FDA’s PRO guidance. RESULTS: Examples: Small – modifications such as changing wording from "circle yes/no" to "press 1 for yes, press 2 for no"; clinical review, small scale cognitive and usability testing would likely be recommended. Medium – modifications such as changing sentence structure or format; clinical review, cognitive debrief, and some usability testing would likely be required.  Large – modifications such as removing items or scale anchors, changing question wording; a full validation study and large scale usability testing would likely be necessary. CONCLUSIONS: Classification of level of modification is based on the potential effect on the original version’s meaning.  Demonstration that the modified version has either equivalent or superior psychometric properties in respect to the original version is important, as failure to do so may result in serious consequences for trials where the modified version is used. 

Conference/Value in Health Info

2011-05, ISPOR 2011, Baltimore, MD, USA

Value in Health, Vol. 14, No. 3 (May 2011)

Code

PRM21

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Multiple Diseases

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