Abstract
The purpose of this study was to translate/adapt and linguistically validate the Hemophilia Quality of Life questionnaire, a 41-item instrument measuring patient-reported hemophilia symptoms. Translations/Validations were made in eight languages: Afrikaans, Arabic, English, Hebrew, Russian, Portuguese, Sesotho, and Zulu; for five countries: Australia, Brazil, Israel, South Africa, and UK. The Haemo-QOL-A was translated based on the FACIT methodology: forward translation, reconciled translation, back-translation, independent review, harmonization across languages, formatting and proofreading. 58 participants completed the Haemo-QOL-A questionnaire and participated in cognitive interviews to assess the relevance, understandability, and appropriateness of the translations. Qualitative analyses of participants’ comments confirmed the linguistic equivalence of each translated version. Total study sample consisted of 58 participants (44 males/14 females), with (n=50) or without (n=8) a confirmed diagnosis of hemophilia. The mean age was 38.9 (19 – 78) years. Minor modifications to the translation of four Haemo-QOL-A items were necessary in some languages as a result of linguistic validation. Afrikaans and Russian respondents had difficulty understanding the medical term “infusions,” so the colloquial term added in parenthesis was deemed a good solution. Afrikaans and Sesotho respondents showed difficulty understanding the phrase “safety of my treatment” and revision to the wording in each language was required. Afrikaans respondents did not understand the phrase “being hit or bumped” accurately, thus the wording “my body could be hit or bumped by something” was implemented. Respondent commentary indicated a revision was needed to the Hebrew phrasing of “loss of joint mobility.” The remaining 37 translated Haemo-QOL-A items were well understood by respondents in each country. The translated versions of the Haemo-QoL-A questionnaire are conceptually equivalent to the English source version and are considered acceptable for PRO assessment in international research and clinical trials. The Haemo-QOL-A is also available in French, German, Italian, Japanese, and Spanish.
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