TO WHAT EXTENT CAN TECHNOLOGY IMPROVE THE VALIDITY OF CLINROS?

Author(s)

Wild D1, Langel K21Oxford Outcomes Ltd, Oxford, Oxon, United Kingdom, 2CRF Health, Helsinki, Finland

OBJECTIVE: ClinROs are the most commonly observed endpoint in FDA approved product labels but few have been adequately scrutinized in terms of their suitability as endpoints.  This study evaluates two widely used ClinROs (the Expanded Disability Status scale (EDSS), and the Hamilton Rating scale for Depression (HAM-D)) and provides an assessment on how migrating the measures onto an electronic platform might be able to improve their validity and reliability. METHODS: A literature review was conducted on both measures to evaluate the availability of information on their content validity and reliability and validity. An assessment was made on how the measures could be improved if they were to be migrated onto an electronic platform: RESULTS: The EDSS has shown varying results for validity and inter-rater reliability and  it involves a complex scoring procedure. The migration of the EDSS onto an electronic format would enable a automated scoring system which could improve its validity. The HAM-D was found to be lacking in evidence of content validity and to have some complexity in the scoring system. Transferring the HAM-D onto an electronic platform could simplify the scoring system which could improve its validity. CONCLUSIONS: This study has highlighted some of the issues with validity and reliability of two widely used ClinROs. The migration of ClinROs to an electronic platform in addition to the ePRO migration cognitive debriefing and usability testing might go some way to improving the clarity of ClinROs which may go some way to improving the validity of the measures. It cannot however resolve all of the issues such as lack of content validity and its impact would vary widely according to the complexity of the ClinRO itself. 

Conference/Value in Health Info

2010-11, ISPOR Europe 2010, Prague, Czech Republic

Value in Health, Vol. 13, No. 7 (November 2010)

Code

PMC42

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Multiple Diseases

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