DESCRIPTION OF THE PRINCIPLES OF GOOD PRACTICE FOR TRANSLATION AND CULTURAL ADAPTATION OF PRO MEASURES- ISPOR QOLSIG GROUP

Author(s)

Wild DJ1, Ford S2, Martin M3, Eremenco S4, Verjee-lorenz A1, 1Oxford Outcomes Ltd, Cassington, Oxford, United Kingdom; 2Pfizer Global Pharmaceuticals, Kalamazoo, MI, USA; 3Health Research Associates, Inc (HRA), Seattle, WA, USA; 4Evanston Northwestern Health care, Evanston, IL, USA

OBJECTIVES: A series of quality of life special interest groups were set up by ISPOR in 1999. The translation and cultural adaptation group has met six times and has been working towards a set of Principles of Good Practise. METHODS: The translation and cultural adaptation process was divided into requisite components: forward translation and reconciliation, back translation, harmonisation, and cognitive debriefing and each component was given to a member of the working group. The working group took a consensus of the guidelines and using their knowledge and experience to summarise and suggest the criteria for achieving success. The draft document was then reviewed by all of the members of the QoL special interest groups at ISPOR. RESULTS: Eleven sets of guidelines were identified and critiqued. The document produced by the group is tabular in format and includes four columns: name of step, key components, rationale, and risks of failing to complete the step. CONCLUSION: The document is now being submitted for publication. Further work will continue in order to expand the document to include discussion of a wide range of PRO's and cultural adaptation of translations where an existing version exists but which has been developed for use in another culture.

Conference/Value in Health Info

2003-11, ISPOR Europe 2003, Barcelona, Spain

Value in Health, Vol. 6, No. 6 (November/December 2003)

Code

PMD39

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Multiple Diseases

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