Background: core outcome sets (COS) define the minimum number of outcomes that should be measured and reported in all clinical trials in a specific condition. This allows research to be compared and combined as appropriate, ensuring that all studies provide usable information. The implications of COS go beyond research, as an increasing number of COS also intend their recommendations for use in routine clinical practice. The Core Outcome Measures in Effectiveness Trials (COMET) initiative aims to collate and stimulate the development, application and promotion of COS, and provides an online database of COS. In this abstract, we consider the inclusion of participants by continent, with a focus on South American participation; particularly the scope, methods and participants included.
Methods: we searched electronic databases to identify studies reporting COS development. Studies were eligible for inclusion if they reported the development of a COS, regardless of any restrictions by age, health condition or setting.
Results: of 307 published COS, 34 (11%) included participants from South America. This is in stark contrast to participation from Europe (81%) and North America (77%) (Table 1). The scope of the 34 COS that included participants from South America is provided in Table 2.
The majority of COS used the Delphi method (56%), most often in combination with another method(s). Other forms of semi-structured discussion methods such as workshops and meetings were the second most common method used (24%). Almost all studies (n = 30, 94%) included clinical experts in COS development, with 23 including researchers (72%) and 20 (63%) including patient and public participants. Of the 20 COS studies that included patients, seven (35%) did not include patients from South America. The location of participants was not clear in the reporting on the remaining thirteen (65%) studies.
Conclusions: COS increase the efficiency and value of research. South American participation in COS development is low compared to European and North American. COS developed with participants from multiple countries might improve the global applicability of the COS and, consequently, the global relevance and impact of the research that these are used in. The Delphi method is one technique that can facilitate global participation. Poor reporting made it difficult to analyse the full extent of patient participation in these studies, but it is clear that there is much need for improvement in South American patient participation in COS development.
Patient or healthcare consumer involvement: South American patient participation in COS development is low. This needs to be improved to enhance the global relevance, uptake and impact of COS.