THE TRANSLATION AND LINGUISTIC VALIDATION OF THE SATISFACTION WITH ORAL ANTI-DIABETIC AGENTS (SOADA) QUESTIONNAIRE

Author(s)

Caroline Houchin, MA, Translation and Linguistic Validation Coordinator1, Diane Wild, MSc, Director1, Ruslan Horblyuk, MBA, Health Outcomes Scientist21Oxford Outcomes Ltd, Oxford, Oxfordshire, United Kingdom; 2 GlaxoSmithKline, Philadelphia, PA, USA

OBJECTIVES: The objective of the study was to translate and linguistically validate the Satisfaction with Oral Anti-Diabetic Agents (SOADA) questionnaire for use in 11 countries. The questionnaire was developed in the United States in 2005 in order to assess satisfaction with oral anti-diabetic medication in patients with type 2 diabetes. METHODS: The accepted standard methodology was used: 2 forward translations, reconciliation, 2 back translations, back translation review, developer review, harmonisation meeting, linguistic validation interviews with 5 or 6 patients with type 2 diabetes and 2 proof readings. A universal approach was used for French and Spanish with the aim of developing a single Spanish and a single French version. RESULTS: While the majority of wording was easily agreed upon, certain words and phrases were more troublesome. Issues and solutions included: • The first French suggestion, “medicament,” did not take into account the possibility of more than one medication. The final agreement was on “medicament(s).” • “Extremely [satisfied]” cannot be translated literally in Mexico as it is too formal. “Muy satisfecho” was selected as the best alternative for Mexico and Spain. • “How quickly” was misunderstood in pilot testing in Korea so this was changed to a more idiomatic “the ‘fastness'.” • “Tolerabilidad,” the original Spanish translation, was found to be problematic during cognitive debriefing interviews and a simpler alternative was found. • The universal approach produced a single final version for French and Canadian French and very similar final translations for Spanish (for Spain) and Mexican Spanish. CONCLUSIONS: The SOADA has been translated and linguistically validated and is now available for use in 11 countries. The universal approach used for Spanish and French was successful. A number of cultural and linguistic issues became apparent and were resolved. The measure is now appropriate for use in multinational trials.

Conference/Value in Health Info

2006-10, ISPOR Europe 2006, Copenhagen, Denmark

Value in Health, Vol. 9, No.6 (November/December 2006)

Code

PDB36

Topic

Methodological & Statistical Research

Topic Subcategory

Modeling and simulation

Disease

Diabetes/Endocrine/Metabolic Disorders

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