ACCESS TO PATIENT-REPORTED OUTCOME (PRO) INSTRUMENTS AND THEIR TRANSLATIONS IN THE LIGHT OF FDA RECOMMENDATIONS

Author(s)

Caroline Anfray, MA, Information Unit Manager, Marie Pierre Emery, MSc, Information Resources Centre Director Mapi Research Trust, Lyon, France

Following the FDA recommendations of having exhaustive, reliable and documented information on an instrument and its translations when using these in an international study (draft PRO guidance in 2006), the accessibility of this information for instrument users has become increasingly important. The quality of this information is however directly impacted by how a developer chooses to release the latter into the scientific community and the way he decides to protect his instrument. It is thus necessary to review current ways in which this is done, to determine if FDA recommendations can actually be met or not and explore ways in which to facilitate this. Methods included to conduct a review of existing ways in which developers release information into the scientific community; 2) to comment on the pros and cons for each identified system with concrete examples; and 3) to make recommendations for instrument developers. Out of the 50 different cases identified and reviewed, two trends emerge with all possible variations between the following two extremes: on the one hand, the uncontrolled, de-centralised, free access to non-updated information without developer input and on the other controlled, copyright-protected, centralized, fee-paying access to reliable and updated information with input of the developer. Whilst both extremes have advantages and disadvantages, results demonstrate that the latter extreme seems to be more compliant with FDA recommendations. Concrete examples will be discussed in the presentation. Findings indicate that the way in which a developer organises (or not) the release of information on his instrument and its translations is directly related to whether a user can comply or not with FDA recommendations. Promoting a controlled, centralized system with input from the developers will facilitate access to reliable and updated information on instruments and their translations.

Conference/Value in Health Info

2008-05, ISPOR 2008, Toronto, Ontario, Canada

Value in Health, Vol. 11, No. 3 (May/June 2008)

Code

PMC37

Topic

Methodological & Statistical Research

Topic Subcategory

PRO & Related Methods

Disease

Multiple Diseases

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