To Örebro University

Aims: We describe the first large-scale translation and cross-cultural adaptation into Swedish of ten pediatric PROMIS item banks: Anger (9-items), Anxiety (15-items), Depressive symptoms (14-items) ,Cognitive function (43-items), Family relationships (47-items), Fatigue (25-items), Pain interference (20-items), Peer relationships (15-items), Physical activity (10-items), Positive affect (38-items) and Profile-25.

Methods: ISPOR recommendations were followed. There view was carried out in multi-professional small groups of twelve health-related quality-of-life researchers, pediatric clinicians and linguists from different geographical regions in a two-day workshop. Cross-cultural comparisons were made to identify problems and to produce a consensus-derived version, which was then back translated, evaluated, and revised where necessary. Prior translations and review of version 1 of the item-banks were utilized (4 item-banks). There viewed item-banks were presented in four sessions of cognitive debriefings over 2 years with twenty-two young people (8-18 years) in three dialectically different regions of Sweden before finalization.

Results: One hundred and seventy-five items were translated. All item banks had translation issues to be resolved. Sixty-six items (38%) needed resolution at the cognitive debriefing stage, the majority of issues were in the area of unclear definitions in the English items (35 items), followed by language and cultural differences (16 issues) and age appropriate language (14 items). The cultural issues identified were 1) identifying suitable word alternative to match the English where Swedish lacked the volume of words to choose from; 2) adjectival agreement on intensity levels of the concept to be translated; 3) culturally specific idiomatic phrases; 4) use of linguistically specific homonyms in English that did not match Swedish word usage; 5) cultural differences in describing members of the family unit and the family unit itself.

Conclusion: The Swedish translations of ten PROMIS Pediatric item banks and Profile-25 were rigorously translated using internationally standardized methods. Close consideration of the translations, and multiple translations helped to ensure conceptual equivalence and comprehensibility. The banks are culturally adapted and appropriate for the age range 8 to 18 years. They can be used for clinical trials and routine pediatric health care.