According to a new study, core outcome sets (COS) for clinical trials have become more structured, but there remains a need for greater transparency and public engagement in how COS are developed.
Clinical trials data are an important resource for decision-makers in health care, but if the outcomes measured in different trials for specific conditions are not consistent, it becomes far more difficult to compare, contrast, or combine the findings. Using COS can help to mitigate these problems by establishing an agreed-upon set of outcomes that should always be measured and reported in clinical trials.
A study published in PLOS One aimed to determine whether COS for clinical trials have improved in the last year. Researchers conducted a comprehensive literature review of studies on the development of COS for clinical trials or for other forms of health research; results were then compared to an earlier systematic review conducted in 2014.
Results showed a general increase in the number of COS studies as well as substantial improvements in the transparency, methodology, and development of COS in clinical areas. Studies in the updated review more clearly defined population characteristics (55% vs 25%) and were less likely to neglect reporting intervention characteristics (17% vs 58%) than in the previous review. There was also a greater inclusion of literature and systematic review to inform COS development in recent studies compared with the older studies (72% vs 33%). Additionally, recent studies were more likely to involve patient and public representatives in forming COS than the older studies (59% vs 18%).
Researchers stated that the updated review provides evidence that the development of COS for measurement and reporting in clinical trials is improving. However, there remains a need for more public engagement and greater clarity regarding the scope of COS for clinical trials.
