LINGUISTIC VALIDATION OF AN INSTRUMENT TO EVALUATE HEALTH-RELATED QUALITY OF LIFE IN PEDIATRIC PATIENTS WITH GROWTH HORMONE INSUFFICIENCY IN 7 LANGUAGES FOR 5 COUNTRIES

Author(s)

Brandt B1, Yohe Moore E2, Jacobs K1, McKown S1, Poepsel T1
1Corporate Translations Inc, East Hartford, CT, USA, 2Corporate Translations Inc, Chicago, IL, USA

OBJECTIVES: To translate and linguistically validate a pediatric HRQOL instrument for paper administration in 7 languages for 5 countries, intended for use by children with growth hormone insufficiency or idiopathic short stature. Pediatric instruments are often intended for respondents with a wide range of developmental abilities, demanding varied approaches to cognitive testing. To enrich our understanding of pediatric populations, we seek a cognitive interview approach with the goal of consistently yielding more robust qualitative data. METHODS: Corporate Translations translated, harmonized, and back translated the instrument into 7 languages for 5 countries, with an emphasis on age-appropriate terminology. The harmonizations were subjected to in-person cognitive debriefing interviews with children. Informed by the Report of the ISPOR PRO Good Research Practices for the Assessment of Children and Adolescents Task Force (Matza, et al., 2013), age-based interview criteria were developed for subjects aged 3-12 years. Subjects aged 3-6 years completed the instrument via interviewer administration, with follow-up questions targeting difficulty in comprehension. Subjects 7-12 years self-completed the instrument, with probes targeting difficulty in comprehension and the impact of short stature on QOL. A caregiver was present at all interviews. Item and probe responses, suggestions for translation revisions, and additional substantive comments were recorded and analyzed. RESULTS: Cognitive debriefing was successfully completed with 35 subjects, 14 children aged 3-6 years and 21 children aged 7-12 years. Both groups provided substantive comments to confirm understanding. As a result, revisions were made to the questionnaire translations in favor of age-appropriate language and improved conceptual clarity. CONCLUSIONS: Cognitive interviews were conducted successfully with pediatric patients with shorter stature. This approach provided evidence that a single instrument can be accessible for a wide age range, given that interviewer- and self-administered options are available. This instrument is considered linguistically validated for use in 7 languages for 5 countries.

Conference/Value in Health Info

2017-05, ISPOR 2017, Boston, MA, USA

Value in Health, Vol. 20, No. 5 (May 2017)

Code

PRM132

Topic

Methodological & Statistical Research

Topic Subcategory

PRO & Related Methods

Disease

Diabetes/Endocrine/Metabolic Disorders, Pediatrics

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