RESUMEN
(1) Purpose: Lower limb deformities can have a severe impact on health-related quality of life (HRQL). LIMB-Q Kids is a new patient-reported outcome measure (PROM) aiming to elucidate the experience of 8-18-year-old patients before, during and after treatment, and to measure the different aspects of HRQL. The aim of this study was to translate and culturally adapt LIMB-Q Kids to German. (2) Methods: The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines were followed. Three forward translations, a backward translation, an expert panel meeting with eight participants, and twenty cognitive debriefing interviews led to the final German version of LIMB-Q Kids. (3) Results: In the forward translations, 4/159 items were difficult to translate, and 2/159 items in the backward translation differed from the original English version. Cognitive debriefing interviews with 20 patients identified 7/159 items that were difficult to comprehend/answer, and 2 of these items were changed. (4) Conclusions: Lower limb deformities can have a great impact on children, and it is important to measure and consider the impact on HRQL. In order to be able to use PROMs in different countries, conceptually equivalent translations and cultural adaptations should be performed in order to ensure comprehensibility. The final German version of LIMB-Q Kids is ready for use in an international field test.
RESUMEN
BACKGROUND: Patient-reported outcome measures are gaining increasing importance in clinical research and quality control. Clinical impairment through limb deformities can appear in various forms. This study aimed at translating and culturally adaptating the Limb Deformity-Scoliosis Research Society (LD-SRS) patient-reported outcome measure (PROM) into German by following the scientific rigor of the cross-cultural adaptation process as well as ensuring the reliability of the translated version. The LD-SRS is applicable in children and adults. METHODS: The translation was performed in accordance with the creators of the LD-SRS following the Professional Society for Health Economics and Outcomes Research (ISPOR) guidelines for translation and cultural adaptation. Two forward translations were performed, and after a consensus meeting, a professional translator translated the PROM back to English. The creators reviewed the back translation of the preliminary German version. Thirty patients with upper and lower limb deformities participated in cognitive debriefing interviews. The version was proofread and, finally, the test-retest reliability was estimated. RESULTS: The mean age was 19 years (range 6-61). Twenty-six patients (87%) completed the retest after 6 days (range 3-26). The internal consistency was estimated with a Cronbach's alpha of 0.96 (range 0.94-0.97), and the intraclass correlation was 0.92 (range 0.89-0.94), indicating an excellent reliability. The scores were normally distributed. Thereafter, the German version was proofread and finalized. CONCLUSIONS: The German translation and cross-cultural adaptation of the LD-SRS score resulted in a high reliability and internal consistency. The German LD-SRS score is readily usable and may be applied in future studies of German-speaking limb deformity patients.