title: Translating patient reported outcome measures: methodological issues explored using cognitive interviewing with three rheumatoid arthritis measures in six European languages.
abstract: OBJECTIVE
  Cross-cultural translation of patient-reported outcome measures (PROMs) is a lengthy process, often performed professionally. Cognitive interviewing assesses patient comprehension of PROMs. The objective was to evaluate the usefulness of cognitive interviewing to assess translations and compare professional (full) with non-professional (simplified) translation processes.
  
  
  METHODS
  A full protocol used for the Bristol RA Fatigue Multi-dimensional Questionnaire and Numerical Rating Scale (BRAF-MDQ, BRAF-NRS) was compared with a simplified protocol used for the RA Impact of Disease scale (RAID). RA patients in the UK, France, the Netherlands, Germany, Spain and Sweden completed the PROMs during cognitive interviewing (BRAFs in the UK were omitted as these were performed during development). Transcripts were deductively analysed for understanding, information retrieval, judgement and response options. Usefulness of cognitive interviewing was assessed by the nature of problems identified, and translation processes by percentage of consistently problematic items (⩾40% patients per country with similar concerns).
  
  
  RESULTS
  Sixty patients participated (72% women). For the BRAFs (full protocol) one problematic item was identified (of 23 items × 5 languages, 1/115 = 0.9%). For the RAID (simplified protocol) two problematic items were identified (of 7 items × 6 languages, 2/42 = 4.8%), of which one was revised (Dutch). Coping questions were problematic in both PROMs.
  
  
  CONCLUSIONS
  Conceptual and cultural challenges though rare were important, as identified by formal evaluation, demonstrating that cognitive interviewing is crucial in PROM translations. Proportionately fewer problematic items were found for the full than for the simplified translation procedure, suggesting that while both are acceptable, professional PROM translation might be preferable. Coping may be a particularly challenging notion cross-culturally.
authors.affiliation: Department of Nursing and Midwifery, University of the West of England, Bristol, UK sarah.hewlett@uwe.ac.uk.
authors.forename: Sarah
authors.initials: S
authors.lastname: Hewlett
authors.affiliation: Department of Nursing and Midwifery, University of the West of England, Bristol, UK.
authors.forename: Joanna
authors.initials: J
authors.lastname: Nicklin
authors.affiliation: Department of Psychology, Health & Technology, University of Twente, Enschede, The Netherlands.
authors.forename: Chistina
authors.initials: C
authors.lastname: Bode
authors.affiliation: Instituto de Salud Musculoesquelética, Madrid, Spain.
authors.forename: Loreto
authors.initials: L
authors.lastname: Carmona
authors.affiliation: Department of Nursing and Midwifery, University of the West of England, Bristol, UK.
authors.forename: Emma
authors.initials: E
authors.lastname: Dures
authors.affiliation: Department of Internal Medicine 3 and Institute of Clinical Immunology, University of Erlangen-Nuremberg, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Engelbrecht
authors.affiliation: Department of Clinical Sciences, Section of Rheumatology, Lund University and Skane University Hospital, Lund, Sweden.
authors.forename: Sofia
authors.initials: S
authors.lastname: Hagel
authors.affiliation: Academic Rheumatology, University of Bristol, Bristol, UK.
authors.forename: John
authors.initials: J
authors.lastname: Kirwan
authors.affiliation: Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique, GRC-UPMC 08 (EEMOIS) Department of Rheumatology, AP-HP, Pitié Salpêtrière Hospital, Paris, France.
authors.forename: Anna
authors.initials: A
authors.lastname: Molto
authors.affiliation: School of Psychology, Universidad Camilo José Cela, Madrid, Spain.
authors.forename: Marta
authors.initials: M
authors.lastname: Redondo
authors.affiliation: Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique, GRC-UPMC 08 (EEMOIS) Department of Rheumatology, AP-HP, Pitié Salpêtrière Hospital, Paris, France.
authors.forename: Laure
authors.initials: L
authors.lastname: Gossec
mesh_terms: D000328:Adult; D001172:Arthritis, Rheumatoid / Q000175:diagnosis / Q000523:psychology*; D003071:Cognition; D003431:Cross-Cultural Comparison; D005260:Female; D005602:France; D005858:Germany; D006801:Humans; D007407:Interviews as Topic / Q000379:methods*; D007802:Language; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D000071066:Patient Reported Outcome Measures; D012720:Severity of Illness Index; D013030:Spain; D013548:Sweden; D014177:Translations
keywords: Bristol Rheumatoid Arthritis Fatigue scales; Rheumatoid Arthritis Impact of Disease scale; cognitive interviewing; patient reported outcome measures; translation