title: Cultural adaptation of patient and observational outcome measures: a methodological example using the COMFORT behavioral rating scale.
abstract: BACKGROUND
  There is little empirical evidence regarding the translation and cultural adaptation of self-report and observational outcome measures. Studies that evaluate and further develop existing practices are needed.
  
  
  OBJECTIVE
  This study explores the use of cognitive interviews in the translation and cultural adaptation of observational measures, using the COMFORT behavioral scale as an example, and demonstrates a structured approach to the analysis of data from cognitive interviews. The COMFORT behavioral scale is developed for assessment of distress and pain in a pediatric intensive care setting.
  
  
  METHODS
  Qualitative, descriptive methodological study.
  
  
  METHODS
  One general public hospital trust in southern Norway.
  
  
  METHODS
  N=12. Eight nurses, three physicians and one nurse assistant, from different wards and with experience caring for children.
  
  
  METHODS
  We translated the COMFORT behavior scale into Norwegian before conducting individual cognitive interviews. Participants first read and then used the translated version of the COMFORT behavioral scale to assess pain based on a 3-min film vignette depicting an infant in pain/distress. Two cognitive interview techniques were applied: Thinking Aloud (TA) during the assessment and Verbal Probing (VP) afterwards. In TA the participant verbalized his/her thought process while completing the COMFORT behavioral scale. During VP the participant responded to specific questions related to understanding of the measure, information recall and the decision process. We audio recorded, transcribed and analyzed interviews using a structured qualitative method (cross-case analysis based on predefined categories and development of a results matrix).
  
  
  RESULTS
  Our analysis revealed two categories of problems: (1) Scale problems, warranting a change in the wording of the scale, including (a) translation errors, (b) content not understood as intended, and (c) differences between the original COMFORT scale and the revised COMFORT behavioral scale; and (2) Rater-context problems caused by (a) unfamiliarity with the scale, (b) lack of knowledge and experience, and (c) assessments based on a film vignette.
  
  
  CONCLUSIONS
  Cognitive interviews revealed problems with both the translated and the original versions of the scale and suggested solutions that enhanced the validity of both versions. Cognitive interviews might be seen as a complement to current published best practices for translation and cultural adaptation.
authors.affiliation: Department of Child and Adolescent Health Services, Telemark Hospital, Skien, Norway; Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden. Electronic address: anrd@sthf.no.
authors.forename: Randi Dovland
authors.initials: RD
authors.lastname: Andersen
authors.affiliation: Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.
authors.forename: Leena
authors.initials: L
authors.lastname: Jylli
authors.affiliation: Department of Family & Community Medicine, Medical College of Wisconsin, WI, USA.
authors.forename: Bruce
authors.initials: B
authors.lastname: Ambuel
mesh_terms: D000223:Adaptation, Psychological; D001519:Behavior; D003466:Cultural Characteristics; D006801:Humans
keywords: Behavior; COMFORT behavioral scale; Cognitive interview; Patient Reported Outcomes Measures; Pediatrics; Qualitative study; Translation; Validity