This workshop is given on behalf of the Patient-Reported Outcomes Methods Group.

Workshop type: Training.

Objective: To (i) present a categorization of translation approaches and difficulties; (ii) introduce methods used to overcome these difficulties to ensure that the translations are equivalent to the original version; and (iii) discuss how to critically review the use of translated instruments in reports of clinical trials.

Summary:
Clinical trials are increasingly being conducted using pooled data from a heterogeneous global population obtained from patients in different countries. Cochrane review authors need assurance that patients’ self-assessment of their condition and the effects of treatment are valid across the different countries irrespective of the patients’ language and cultural background. Many questionnaires developed in English for Anglo-Saxon cultures have been extensively tested and found to be valid, reliable, and responsive in their intended ta rget setting. Patient-reported outcomes (PRO) questionnaires included in a clinical trial should be in the patients’ own language. Equivalence of international versions of PRO questionnaires is key to their use in cross-cultural research. How this equivalence can be reached is still under debate, and several taxonomies of equivalence have been developed, including levels: conceptual, semantic, operational, psychometric, item and criterion, and the basic methods for addressing each type of equivalence.  This workshop will address how to evaluate equivalence when judging the quality of clinical trials using cross-cultural populations.  The workshop will focus on the key issue of when pooling of data is supported by evidence of equivalence.

Intended audience: Review authors; instrument developers.

Technical level expected of participants: Basic/Intermediate.