title: Satisfactory cross-cultural validity of the ACTG symptom distress module in HIV-1-infected antiretroviral-naive patients.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  To assess the cross-cultural validity of the SDM across seven cultural groups in the setting of a multinational HIV clinical trial.
  
  
  METHODS
  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.
  
  
  RESULTS
  Statistically significant DIF between cultural groups was observed for four items: fatigue; fevers; anxiety; and headache. However, examination of these items by linguists did not lead to meaningful explanations for the statistical differences. With the STATIS approach, the Bantu and European Germanic groups were the furthest from the Occidental English group.
  
  
  CONCLUSIONS
  The assessment of cross-cultural validity had to be performed on some very small samples and on data aggregated by cultural groups, which suggests the need for a cautious interpretation of the results.
  
  
  CONCLUSIONS
  Given the heterogeneity of cultures considered, the absence of meaningful explanations for statistically significant differences between cultural groups supports the cross-cultural validity of the SDM versions included in this trial. Thus, this study demonstrated that it is feasible to conduct assessment of crosscultural validity of PRO instruments using data collected in the setting of multinational clinical trials.
authors.affiliation: Statistics & Psychometrics, Mapi Values, Lyon, France. aregnault@mapi.fr
authors.forename: Antoine
authors.initials: A
authors.lastname: Regnault
authors.forename: Shalaka
authors.initials: S
authors.lastname: Marfatia
authors.forename: Michael
authors.initials: M
authors.lastname: Louie
authors.forename: Isabelle
authors.initials: I
authors.lastname: Mear
authors.forename: Juliette
authors.initials: J
authors.lastname: Meunier
authors.forename: Muriel
authors.initials: M
authors.lastname: Viala-Danten
mesh_terms: D000328:Adult; D000480:Alkynes; D044966:Anti-Retroviral Agents / Q000627:therapeutic use; D048588:Benzoxazines / Q000627:therapeutic use; D017322:Clinical Trials, Phase II as Topic / Q000379:methods*; D017326:Clinical Trials, Phase III as Topic / Q000379:methods*; D054521:Cultural Competency; D003510:Cyclohexanes / Q000627:therapeutic use; D003521:Cyclopropanes; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy / Q000523:psychology*; D015497:HIV-1; D006801:Humans; D019259:Lamivudine / Q000627:therapeutic use; D007802:Language; D008297:Male; D000077592:Maraviroc; D008875:Middle Aged; D015337:Multicenter Studies as Topic / Q000379:methods; D011594:Psychometrics / Q000379:methods; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D015203:Reproducibility of Results; D013315:Stress, Psychological / Q000175:diagnosis* / Q000209:etiology; D011795:Surveys and Questionnaires; D014230:Triazoles / Q000627:therapeutic use; D015215:Zidovudine / Q000627:therapeutic use
chemical_list: D000480:Alkynes; D044966:Anti-Retroviral Agents; D048588:Benzoxazines; D003510:Cyclohexanes; D003521:Cyclopropanes; D004338:Drug Combinations; D014230:Triazoles; D019259:Lamivudine; D015215:Zidovudine; C098320:efavirenz; D000077592:Maraviroc