Satisfactory cross-cultural validity of the ACTG symptom distress module in HIV-1-infected antiretroviral-naive patients

Clinical Trials : Journal of the Society for Clinical Trials
Antoine RegnaultMuriel Viala-Danten

Abstract

Multinational clinical trials commonly include different language versions of patient-reported outcomes (PRO) instruments without considering the question of their cross-cultural validity. The inclusion of a PRO instrument, the Adult AIDS Clinical Trial Group Symptom Distress Module (SDM), in an multinational clinical trial in HIV-1 antiretroviral-naive patients offered an opportunity to explore the methods to assess cross-cultural validity of PRO instruments in the context of clinical trials. To assess the cross-cultural validity of the SDM across seven cultural groups in the setting of a multinational HIV clinical trial. Twenty-five language versions of the SDM were included in a Phase IIb/III trial comparing maraviroc with efavirenz (each in combination with zidovudine/ lamivudine) conducted in 12 countries to assess symptoms perceived by HIV-1-infected antiretroviral-naive patients. Differential item functioning (DIF) detection and the STATIS method were combined in a pragmatic approach to assess the cross-cultural validity of the SDM using pre-antiretroviral treatment data from 759 patients. Statistically significant DIF between cultural groups was observed for four items: fatigue; fevers; anxiety; and headache. However, e...Continue Reading

References

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Citations

Sep 6, 2014·Quality of Life Research : an International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation·Antoine RegnaultDonald L Patrick
Jun 5, 2014·Quality of Life Research : an International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation·Antoine Regnault, Michael Herdman

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