Background: Most previous studies concerning the validity of the EQ-5D-3L items refer to applications of only a single language version of the EQ-5D-3L in only one country. Therefore, there is little information concerning the extent to which the results can be generalised across different language versions and/or different countries. Here the validity of the EQ-5D-3L items is investigated for six different language versions in six different countries.
Methods: Data came from 1341 type 2 diabetes patients (England: 289; Finland: 177; Germany: 255; Greece: 165; the Netherlands: 354; Spain: 101). The relationships of the five EQ-5D-3L items with seven different test variables (age, gender, education, previous stroke, problems with heart, problems with lower extremities, problems with eyes), were analysed for each combination of item and test variable. For each combination two logistic regression models with the dichotomised EQ-5D-3L item as dependent variable were computed. The first model contained the test variable and dummy coded countries as independent variables, the second model additionally the terms for the interaction between country and test variable. Statistically significant better fit of the second model was taken as evidence for country specific differences regarding the relationship. When such differences could be attributed mainly to one country the analyses were repeated without the data from this country. Validity was investigated with the remaining data using results of the first models.
Results: Due to lack of variation in the Spanish data only 31 of the originally intended 35 interaction tests could be performed. Only three of these yielded a significant result. In all three cases the Spanish data deviated most. Without the Spanish data only 1 of the 35 interaction tests yielded a significant result. With 3 exceptions, the tendency of reporting problems increased with age, female gender, lower education, previous stroke, heart problems, problems with lower extremities and problems with eyes for all EQ-5D-3L items.
Conclusion: The results concerning the European Spanish version are ambiguous. However, the items of the English, Finnish, German, Greek and Dutch versions of the EQ-5D-3L relate in substantially the same way to the test variables. Mostly, these relationships indicate the items' validity.