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• W4387392904 abstract "ABSTRACTBackground The 13-MD is a new instrument designed to measure more globally the various aspects of the health-related quality of life. Its structure is balanced around physical, mental, and social aspects of health and it was developed in Quebec, a Canadian French-speaking province.Objective To translate the 13-MD into Canadian English and to ensure that it is conceptually equivalent to the original version in Canadian French.Methods Forward and back translations were conducted. A linguistic validation was performed in both Canadian French and Canadian English following an iterative process. This validation was conducted with 15 participants in each group (French and English speakers) using face-to-face cognitive debriefing interviews. This process was done in accordance with academic standards and the guidance of the Food and Drug Administration (FDA) for patient-reported outcome instruments.Results The two forward translations resulted in 35.8% of identical sentences (59/165). Back translation indicated that 83.6% of the sentences were identical or almost identical to the original Canadian French version. The review of the back translation led to a few changes in the reconciled forward translation (4/165) and the original version (11/165), while the linguistic validation process with 15 adults in each group led to 24 changes over a possibility of 165 sentences in the Canadian English version and 6 over 165 in the Canadian French version. Most changes provided were minimal and were done to ensure a better understanding of the 13-MD.Conclusion The translation and linguistic validation processes were successful in creating a valid 13-MD in Canadian English (13-MD-CE) that is conceptually equivalent to the original version.KEYWORDS: Health-related quality of lifetranslationvalidationEnglishFrenchCanadaDisclaimerAs a service to authors and researchers we are providing this version of an accepted manuscript (AM). Copyediting, typesetting, and review of the resulting proofs will be undertaken on this manuscript before final publication of the Version of Record (VoR). During production and pre-press, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal relate to these versions also. Article highlights● The 13-MD is a new health-related quality of life measurement instrument.● The 13-MD was translated in Canadian English in accordance to international guidelines.● The 13-MD in Canadian English is conceptually equivalent to the original version.● Cognitive debriefing interviews led to minimal changes.● Next step will be to develop a value set for use in cost-utility analysis.Declaration of interestThe authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.AcknowledgementsWe thank Liang Wang and Lucien Coulibaly for their support during data collection. Many thanks to Jason R. Guertin and Luna Bégin for their comments about the 13-MD and the fruitful discussion we had. TG Poder is a member of the FRQ-S-funded Research center of the IUSMM.EthicsParticipation was voluntary and participants could withdraw from the study at any moment. The study was approved by our local ethics committee at the CIUSSS de l’Est de l’île de Montréal (project 2021-2389) and followed the principles of the Helsinki Declaration for research involving human subjects. Data were analyzed as a group to impede the identification of participants. Data collection was also rendered anonymous for the linguistic validation.Availability of data and materialsData and materials will be available upon reasonable request to the corresponding author.Reviewer disclosuresPeer reviewers on this manuscript have no relevant financial or other relationships to disclose.Additional informationFundingThis study was funded by the Unité Soutien SSA Québec." @default.
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• W4387392904 date "2023-10-06" @default.
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• W4387392904 title "Canadian English translation and linguistic validation of the 13-MD to measure global health-related quality of life" @default.
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• W4387392904 doi "https://doi.org/10.1080/14737167.2023.2268275" @default.
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