OBJECTIVES: The majority of PRO measures are developed using a sequential rather than a cross-cultural approach and have been developed in the US and/or UK. When using these measures in multi-national trials, the assumption is made that the translated measure is acceptable for use in a multi-national trial, providing the translation has been conducted in a rigorous manner and that linguistic validation interviews have been conducted in the target country. The objective of this study was to ascertain whether there are particular areas of concern with respect to using these PROs outside of North America and Western Europe. METHODS: Specialists in outcomes research from nine countries within Eastern Europe, Asia and Africa completed a questionnaire and interview about difficulties which occur with the cultural relevance of concepts included in PROs and other health questionnaires. RESULTS: Numerous cultural and linguistic issues became apparent, including: 1)The concept of witchcraft is particularly important in many places in Africa; 2)Japanese people have a tendency to be more positive about their disease or emotional health which may affect their responses to measures;  3)the concept of family is much more important in some countries, e.g. Malaysia and Ukraine; 4) the idea of ‘God’s will’ is particularly important to the way people think about health in Saudi Arabia and Sudan; 5)In Saudi Arabia and Sudan women rarely play sports (a topic sometimes included in PRO measures); and questions about alcohol use cannot be used in Islamic countries.  CONCLUSIONS: A number of issues should be considered during the sequential development of PRO measures. This can be achieved using an extended translatability check which would include representatives from countries outside of North America and Western Europe to help bridge the gap between the cultural specificity of a sequentially developed measure and a cross-culturally developed measure.