LINGUISTIC VALIDATION OF THE EMPHASIS-10 QUESTIONNAIRE- A PATIENT-REPORTED OUTCOME INSTRUMENT FOR ASSESSING QOL IN PULMONARY HYPERTENSION (PH)

Author(s)

Foster E1, Guillen A2, Lara K2, Oh P2, Popielnicki A3, Walker G2, Yorke J4
1TransPerfect, Atlanta, GA, USA, 2Gilead Sciences, Inc., Foster City, CA, USA, 3TransPerfect, Boston, MA, USA, 4The Christie NHS Foundation Trust, Manchester, UK

OBJECTIVES: The term “pulmonary hypertension” (PH) is applicable to a group of rare conditions that are both chronic and life-threatening. The emPHasis-10 questionnaire was designed to help clinicians assess and improve management of PH by measuring the impact that PH has on a person's life and how this changes over time. Our objective was to perform a cultural adaptation/linguistic validation of the questionnaire from the source UK English into Dutch (Netherlands), English and Spanish (US), English and French (Canada), French (France), German (Germany), and Italian (Italy). METHODS: The instrument was translated into Dutch (Netherlands), English and Spanish (US), English and French (Canada), French (France), German (Germany), and Italian (Italy) through a process of two forward translations, one reconciled forward translation, and one back translation. After the developer and project team reviewed the translated versions, the instruments were evaluated by cognitive debriefing interviews with representative samples of native speakers of each target language. There were five respondents per language, all of whom had been diagnosed with  pulmonary arterial hypertension (PAH). RESULTS: A few linguistic issues were identified during the cognitive debriefing process in the Italian (Italy) and the French (Canada) versions, so minor adjustments were made to those two translations for improved clarity and comprehension. The rest of the languages did not need to be revised. CONCLUSIONS: The translations of the emPHAsis-10 questionnaire into Dutch (Netherlands), English and Spanish (US), English and French (Canada), French (France), German (Germany), and Italian (Italy) demonstrate conceptual and linguistic equivalence, as well as cultural appropriateness, and may be used in global clinical trials and settings.

Conference/Value in Health Info

2015-11, ISPOR Europe 2015, Milan, Italy

Value in Health, Vol. 18, No. 7 (November 2015)

Code

PIH69

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Multiple Diseases

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