IRT-BASED ASSESSEMENT OF DIFFERENTIAL ITEM FUNCTIONING IN HRQL STUDIES Christophe Lalanne, Martin Duracinsky, Andrew R. Armstrong, Olivier Chassany Department of Clinical Research and Development, Assistance Publique-Hôpitaux de Paris, Paris, France AIMS. We sought to provide sample-free estimates of uniform DIF on a newly developed HRQL questionnaire, PROQOL-HIV. We considered patients characteristics supposed to modulate HRQL, such as gender, country of residence but also ethnicity, given the high prevalence of HIV in migrant populations. METHODS. We used an iterative ordinal logistic regression framework where nested models are compared in order to test for significance of person covariates, while persons parameters are estimated using the Graded Response Model. DIF was tested on two constructs extracted from factor analysis: physical health and symptoms (PHS, 14 items accounting for 17% of the total variance) and emotional distress (ED, 10 items, 9%), on a subset of N=505 patients (71% males, median age 43 yrs.) from 5 countries (Australia, USA, France, Brazil, Thailand). Missing responses (<1%) were imputed using median scale score. RESULTS. Items belonging to the ED dimension were more frequently flagged as exhibiting bias compared to PHS items, especially when referring to ethnicity. Country-related biases were equally distributed on the two scales. In both cases, however, no DIF effects were found for gender. We reached similar conclusions when comparing the results to those obtained when using sum or rest scores as conditioning ability levels. Correlations between scores computed with or without flagged items were above 0.5. Restricting analysis on Western countries, however, yielded smaller hits. This suggests that, for these two dimensions of PROQOL-HIV, DIF effects should have a small to moderate influence on HRQL scores reporting, although more studies are needed to estimate DIF effect size and provide cut-off values specific to the questionnaire. CONCLUSIONS. The relevance of DIF effects need to be carefully studied through expert reviewing, and their higher frequency on bio-psychological constructs raise interesting questions for questionnaire development. Moreover, DIF can bring additional information about HRQL when testing also ethnic origin and not only country of residence in international clinical trials.