Lillian Savic
FACITtrans
The purpose of this study was to translate and linguistically validate the EXAcerbations of Chronic pulmonary disease Tool (EXACT) instrument into Hausa, Igbo, Swahili, and Yoruba for use with patients in Kenya and Nigeria, as well as to discuss issues arising from linguistic validation across multiple languages. The EXACT is a 14-item patient-reported outcome (PRO) daily diary developed to evaluate frequency, severity, and duration of acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD), including chronic bronchitis. It was designed as an electronic patient-reported outcome (ePRO) to be completed on a handheld device (i.e., smart phone or tablet) each evening before bedtime. Evidera, the owner of the EXACT, and Genentech/Roche sponsored and facilitated the translations involved in this study. FACITtrans conducted the translation and linguistic validation.
The EXACT was translated according to industry standard methodology, consisting of two forward translations, one reconciled version of the two forward translations, back-translation into English, independent review, harmonization across languages, and cognitive interviewing. Patients completed the translated questionnaire and participated in cognitive interviews to assess understandability, cultural relevance, and appropriateness of the translations. Qualitative analyses were performed to ensure the content validity of the instrument and linguistic equivalence across language versions.
Overall, the translated items were well understood and were endorsed by patients in each country. Concepts such as “chest feeling congested,” “bring up mucus (phlegm),” “personal care activities (washing),” “indoor activities (household work),” “yard work,” “errands,” and “sleep being disturbed” required additional discussion with the linguistic team and alternative translation solutions to ensure conceptual equivalence, cultural appropriateness, and harmonization across languages. Translations were revised as needed based on patients’ feedback during cognitive interviews and linguists’ input. The translated versions of the EXACT demonstrated conceptual equivalence to the English source version and are considered acceptable for patient-reported outcomes assessment in international research and clinical trials.
The translation and linguistic validation process aims to ensure that the EXACT instrument is culturally inclusive and patient-centered, aligning with ISOQOL’s goals. Translating and linguistically validating the EXACT instrument in African countries allows for standardized data collection, cross-cultural research, and collaboration. This process enhances the instrument’s linguistic appropriateness, which in turn improves the validity and reliability of research findings.
The development of EXACT translations in African languages contributes to advancing health related quality of life research and clinical practice in COPD patients. It enables data collection on COPD exacerbations and measures their impact on quality of life, leading to a deeper understanding of the condition in Africa and to guiding tailored interventions and treatments. By using a linguistically validated instrument, researchers and clinicians can accurately assess COPD exacerbations, track patient progress, and improve treatment outcomes and overall quality of life for African COPD populations. Prioritizing translation and linguistic validation generates valuable insights to improve respiratory health outcomes in African populations and beyond.
Abstract will be presented in Thursday Poster Session II on Thursday, 19 October, 3:20 pm – 4:00 pm.
This newsletter editorial represents the views of the author and does not necessarily reflect the views of ISOQOL.
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