Abstract
Assessing outcomes in multinational studies on traumatic brain injury (TBI) poses major challenges and requires relevant instruments in languages other than English. Of the 19 outcome instruments selected for use in the observational Collaborative European NeuroTrauma Effectiveness Research in TBI (CENTER-TBI) study, 17 measures lacked translations in at least one target language. To fill this gap, we aimed to develop well-translated linguistically and psychometrically validated instruments. We performed translations and linguistic validations of patient-reported measures (PROMs), clinician-reported (ClinRO), and performance-based (PerfO) outcome instruments, using forward and backward translations, reconciliations, cognitive debriefings with up to 10 participants, iterative revisions, and international harmonization with input from over 150 international collaborators. In total, 237 translations and 211 linguistic validations were carried out in up to 20 languages. Translations were evaluated at the linguistic and cultural level by coding changes when the original versions are compared with subsequent translation steps, using the output of cognitive debriefings, and using comprehension rates. The average comprehension rate per instrument varied from 88% to 98%, indicating a good quality of the translations. These outcome instruments provide a solid basis for future TBI research and clinical practice and allow the aggregation and analysis of data across different countries and languages.
Highlights
Traumatic brain injury (TBI) is a major cause of lifelong disability worldwide [1].It is defined as “an alteration in brain function, or other evidence of brain pathology, caused by an external force” [2] (p. 1637)
The present study describes the first part of the linguistic validation process of the outcome instruments administered in the CENTER-traumatic brain injury (TBI) study
As the translation and linguistic validation procedures were laborand resource-intensive, they could only be accomplished thanks to the dedication and using the personal resources of contributing CENTER-TBI participants, investigators, and Overall, the freely available clinician-reported outcomes (ClinROs), its questionnaire version, a clinical amnesia test, patient-reported measures (PROMs), and PerfOs and the results of the present study provide many opportunities for future translations and linguistic validations in other languages
Summary
Traumatic brain injury (TBI) is a major cause of lifelong disability worldwide [1].It is defined as “an alteration in brain function, or other evidence of brain pathology, caused by an external force” [2] (p. 1637). Traumatic brain injury (TBI) is a major cause of lifelong disability worldwide [1]. It is defined as “an alteration in brain function, or other evidence of brain pathology, caused by an external force” [2] Given the broad range of areas affected, the complexity and heterogeneity of TBI and its consequences cannot be adequately captured by unidimensional outcome assessments [14]. Outcomes after TBI can be assessed using instruments based on clinician-reported outcomes (ClinROs), patient-reported outcomes measures (PROMs), and performance-based physical and cognitive outcomes (PerfOs). Comment on the translation of the term “you” (using pronominal courtesy form would be more appropriate). Term “overall” replaced by “in general” All items. Because many of these symptoms occur normally, we would like you to compare yourself with before the accident.
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