Translation and socio-linguistic adaptation of the Maltese version of the decision regret scale

Background and aim: Decision regret (DR) is critical in patient-centred care, especially among individuals with chronic diseases who face complex healthcare decisions. Despite growing interest in DR as a measurable construct, no validated instrument exists in the Maltese language. This study aimed to translate the 5-item Decision Regret Scale (DRS) into Maltese and to evaluate its content validity, following a structured methodological approach. Methods: The study adopted a two-phase methodological design. In Phase One, the DRS was translated into Maltese using a collaborative and iterative model, as described by Douglas and Craig, which involved forward translation, synthesis, expert adjudication, and back-translation. Phase Two evaluated both quantitative and qualitative content validity. A panel of eight experts assessed the relevance and clarity of each item using the Content Validity Ratio (CVR), Item-and Scale-level Content Validity Indexes (I-CVI and S-CVI). Qualitative feedback was also collected to explore face validity and semantic nuances. Results: All items demonstrated acceptable CVR, I-CVI, and S-CVI values after two rounds of expert review. Items 3 and 5 required further discussion due to initial concerns about semantic overlap, resulting in the revision of item 3. Additionally, minor changes were introduced to enhance conceptual clarity. Final indices confirmed the content validity of all five items. Conclusions: The Maltese version of the DRS was found to be culturally appropriate, linguistically accurate, and content-valid. Further psychometric studies are recommended to assess construct validity, reliability, and responsiveness in clinical populations. (www.actabiomedica.it).