TY - JOUR T1 - The development of translated, cross-cultural patient-reported outcome measures for patients with primary ciliary dyskinesia JF - European Respiratory Journal JO - Eur Respir J DO - 10.1183/13993003.congress-2016.PA4161 VL - 48 IS - suppl 60 SP - PA4161 AU - Laura Behan AU - Alexandra L. Quittner AU - Audrey Dunn Galvin AU - Claudia E. Kuehni AU - Elisabeth Maurer AU - Anu Jose AU - Eric G. Haarman AU - Tamara Paff AU - N.W.P. Rutjes AU - Claudius Werner AU - Anika Lofruthe AU - Christine Edelbusch AU - Lea Heisch AU - Helene Elgaard Kobbernagel AU - Maria Philipsen AU - Bridget Contreras AU - Panayiotis Yiallouros AU - Panayiotis Kouis AU - Konstantinos Giannakou AU - Aristoula Toliopoulou AU - Guillaume Thouvenin AU - Aline Tamalet AU - Claire O'Neill AU - Jane S. Lucas Y1 - 2016/09/01 UR - http://erj.ersjournals.com/content/48/suppl_60/PA4161.abstract N2 - Introduction: Quality of life is an important parameter in the evaluation of health care and treatments. We have developed the first primary ciliary dyskinesia (PCD) health-related quality of life (HRQoL) measure for children, parents, teenagers and adults (QOL-PCD) in English.Clinical trials on rare diseases like PCD must be conducted in international settings to enrol enough patients, and outcome measures only assess the same thing if translation accounts for the socio-cultural context in which it is understood. This study aims to conduct socio-cultural translations of QOL-PCD into German, Swiss German, Danish, Dutch, French, and Greek.Methodology: We conducted (a) forward translations by 2 independent translators (b) back translation to English of the consensus versions by 1 translator, and (c) cognitive interviews of each age/language version by >5 patients to ensure the “meaning” attributed to each item is similar in different languages and cross-culturally understood. This involved 20 translators, 24 chaired meetings and interviews with 120 patients.Results: Each stage of translation involved comprehensive discussions (>2 hours), resulting in adjustments. 172 items (39-49 items across 4 age groups) were translated averaging 65 working hours per language. Cognitive interviews demonstrated face validity and no missing aspect of HRQoL were identified. International testing additionally provided valuable input on how to proceed for future improvement of QOL-PCD.Conclusion: To meet standards set by international guidelines, this extensive process has produced practical, cross-cultural and equivalent measures for future use as outcome measures in clinical trials. ER -