ACCESS TO HEALTH-RELATED QUALITY OF LIFE (HRQL) INSTRUMENTS AND THEIR TRANSLATIONS IN THE LIGHT OF EMEA RECOMMENDATIONS
Author(s)
Caroline Anfray, MA, Information Unit Manager, Marie Pierre Emery, MSc, Information Resources Centre DirectorMapi Research Trust, Lyon, France
INTRODUCTIONThe EMEA reflection paper on HRQL specifies that the claim in the Summary of Product Characteristics (SmPC) with respect to HRQL will always be considered depending on the strength of the evidence, which should be based on 6 criteria, amongst these are the justification of the choice of the HRQL instrument(s), and the evidence of validation (including for translation). To meet these requirements, users should have access to reliable and updated information. To determine if these can be met, it is necessary to review how users access information about HRQL instruments. OBJECTIVES: 1) To investigate how developers organize the release of information about their instrument; 2) to comment on the pros and cons for each identified dissemination strategy; 3) To make recommendations for instrument developers to facilitate users’ access to information. METHODS: we conducted a review of the 2,850 information requests addressed to our Information Resources Centre in 2007. The requests were categorized according to the type of information needed: 1) information about the original instrument; 2) conditions of access/use of instruments/translations; 3) validity of instruments/translations; 4) translation certification; 5) intellectual property. To address these, we made 900 contacts with developers, translators, publishers and other licensing authorities. RESULTS: Out of the dissemination strategies identified and reviewed, five trends emerged between two extremes: 1) uncontrolled, de-centralized, free access to non-updated information without developer’s input; 2) controlled, copyright-protected, centralized, fee-paying access to reliable and updated information with developer’s input. Advantages and disadvantages of strategies will be discussed. Examples demonstrate that the controlled strategy is more compliant with the EMEA evidence requirements. CONCLUSION: Findings indicate that how a user can comply or not with the EMEA requirements is directly related to how developers organize the release of information about their questionnaire and translations. Promoting a controlled, centralized system with developers’ input may facilitate access to reliable and updated information.
Conference/Value in Health Info
2008-11, ISPOR Europe 2008, Athens, Greece
Value in Health, Vol. 11, No. 6 (November 2008)
Code
QL3
Topic
Methodological & Statistical Research
Topic Subcategory
PRO & Related Methods
Disease
Multiple Diseases