Table 2 Cross-cultural content development solutions used during PRO development

Option 1: Address cultural issues using a rigorous translation and testing process for item content developed in a single source country

Initial PRO content design is less time-consuming since attempts to revalidate in different cultures does not involve patient reassessment of PRO content

- Poor face validity and complaints that the PRO does not address cultural issues (cultural bias)

- Differences in measure performance across cultures are difficult to explain and require use of statistical patches to address such differences

- Entanglement of disease, treatment and cultural effects

Option 2: Use content-specific items that are identified as equally relevant across all cultures

May work well for assessment of physical manifestations of disease and treatment since these are often similar across cultures

- Content may seem to duplicate clinical information gleaned through patient-reports

- The impacts of illness and treatment on the psychological and social domains of life may not be fully characterized

Option 3: Use more generally worded (domain) summary items that allow for interpretation based on respondents' cultural perspective

- Good estimation of the general impact of illness and treatment across cultures

- Comparable domain estimates across cultural settings

- Uncertainty about what cultural and disease-specific events respondents are referring to when making summary ratings

Option 4: Use a different set of content-specific items for each culture

Measures are high relevance in the cultural settings where item content was developed

- Duplication of content validation and psychometric development is required for each country

- Assessment results may not be comparable across countries if item difficulty is not equivalent

Option 5: Use a blend of all item types, which may include:

1. A set of culturally-specific items

2. A set of content-specific items relevant across all cultures

3. A set of general summary items

- High cultural relevance of the resulting measure

- The general impacts of disease and treatment effects are comparable across cultures

- Ability to evaluate the relative importance of specific item content with the cultural context using rating on general summary items

- Requires careful planning and execution of cross-cultural content validation studies

- The tasks associated with item and scale design may be more complex than for other options although, following construct validation, the resulting measures may not be more complex or burdensome