Methods for developing new Clinical Outcome Assessments (COAs) are well-established and documented. While the COA development literature emphasizes the importance of linguistic and cultural equivalence, exact methods to achieve this are often not clearly presented.  For multinational or multicultural studies, Simultaneous Item Development (SID) of a COA in all languages and cultural groups required for the research program is the most efficient approach to ensure valid COA data and interpretable results. This is because SID increases the likelihood the COA data collected in multiple languages or cultures will be conceptually equivalent and culturally relevant. 

As published information explaining how to implement SID is limited, this presentation provides an overview of a purposeful and pragmatic (recognising the practical challenges associated with COA development) SID approach that incorporates both qualitative and quantitative methodologies.

In our experience, SID is valuable at four stages of COA development: concept elicitation, item generation, cognitive testing, and content harmonization. Generally, SID is most efficient when a single reference or ‘core’ version is used throughout the four stages (typically the English language version for the UK or USA). Activities at each stage are managed by researchers fluent in the language for the core version.  Their primary objective is to ensure that the core COA version has a clear conceptual framework that evolves in a consistent manner across language/culture versions at each stage so that measured concepts are equivalent in the different language versions.

We will discuss how use of SID at each stage can aid researchers in developing COAs that are patient-centred, understandable, and content relevant across languages and cultures. Challenges commonly faced in SID of COA will be discussed as will practical solutions to these challenges.