DIFFICULTIES IN IDENTIFYING THE ORIGINAL SOURCE QUESTIONNAIRE FOR USE IN TRANSLATIONS- THE ADAS-COG CASE STUDY

Author(s)

Anfray C1, Giroudet C1, Berne C2, Acquadro C21MAPI Institute, Lyon, France, 2MAPI Research Trust, Lyon, France

OBJECTIVES: Since its development in the 80’s, variations of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog), a Clinician-Reported Outcome (ClinRO) measure, have been used to monitor disease progression and treatment efficacy in Alzheimer's disease. The objective of this study was to identify all versions used as a basis for translation in Mapi Institute projects and to take stock of existing translations. METHODS: The review was based on all ADAS-Cog translation projects performed by Mapi Institute. RESULTS: Sixteen projects were identified representing a total of 70 languages and 219 translations. Translations were based on 11 source versions which differed in terms of content (number of items, order of items and instructions), and format. The number of items ranged from 11 to 15. Four studies used 13 items, but only in two cases the same items were used although in a different order. Four studies used 12 items: only two studies used the same items (with a different list of words for the Word Recognition Task), but again in a different order. Format and instructions differed in all cases. In most projects the source version provided by the sponsor was a single document mixing instructions with the rater and response forms. Only in 3 cases the original consisted in a separate instruction manual and response forms. With regard to available translations, more than one translation was identified in 56 of the 70 available languages and in one language (Swedish) as many as 7 translations. CONCLUSIONS: The abundance of different versions of the same questionnaire both in its original US English form as in translations makes comparisons between studies or pooling of data difficult for both researchers and users. In the light of FDA’s recent PRO guidance it would be beneficial to demand the same scientific rigor when using ClinROs in international studies.

Conference/Value in Health Info

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

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

Code

PND38

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Neurological Disorders

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