J.W. Frew , R. Cepeda-Valdes , G. Fortuna , J.C. Salas-Alanis , D.F. Murrell
Introduction: The Quality of Life in Epidermolysis Bullosa (QOLEB) Questionnaire is a validated Quality of Life (QOL) measurement tool for individuals with Epidermolysis Bullosa (EB). Published in English, it is the world ’ s ﬁ rst validated quantitative questionnaire for the range of condi- tions which comprise the spectrum of EB . It has great utility for evaluating burden of disease and overall patient satisfaction with current management strategies and emerging medical therapies in multinational clinical trials.
Methods: Ad-hoc translation of questionnaires can lead to a loss of validity and reliability, decreasing the overall accuracy of the questionnaire as a useful measurement tool. We present a pre-formulated methodology consisting of (1) Independent Forward and Backward Translation, (2) Expert Committee Review (3) Patient Pre-testing, and (4) Statistical Analysis of the Final Questionnaire; in order to yield valid and reliable versions of the QOLEB. This is important in order to provide a standardised outcome measure for future international clinical trials for emerging therapies in such a rare condition.
Results and conclusion: Currently, our techniques have developed valid and reliable versions of the QOLEB in Hispanic (Mexican-Spanish), with a Dutch version also currently in press . The Hispanic questionnaire demonstrates stratiﬁ cation of scores between different subtypes as seen with the English version with minor variations in respon- siveness of individual items due to the prevailing cultural mileu. Further translations and cross cultural adaptations in other languages are underway in order to further increase the utility of this questionnaire.