Evaluating cross-cultural adaptation and pooling of data from patient and clinician questionnaires in global clinical trials

Article type
Authors
Patrick D1, Conway K2, Acquadro C2, Martin M3, Eremenco S4
1Seattle Quality of Life Group, Department of Health Services, University of Washington
2MAPI, France
3Health Research Associates, USA
4Evidera, USA
Abstract
Objectives: Cochrane Reviews often include findings from cross-cultural studies in which data from questionnaires completed by both clinicians and patients are pooled. This workshop aims to acquaint participants with ways to evaluate and grade the methods used to translate and adapt patient- and clinician-reported outcome (PROs and ClinROs) measures used in clinical trials across language and cultural groups.
Description: Three 30 minute sessions will include:
1. a presentation of the concept of cultural adaptation based on linguistic validation, followed by a group exercise evaluating an item in cultural adaptation;
2. examination of selected Cochrane Reviews and discussion of how the methods of translation are reported and can be reviewed (if at all); and
3. discussion of the effects of variability in cross-cultural questionnaire data on pooling, including implications for trial sample size. An example of data pooling will be presented and discussed.