Developing core outcome sets for clinical trials: issues to consider

TLDR

Selecting appropriate outcomes is crucial for clinical trials to enable unbiased comparison of interventions, and outcomes must be relevant to stakeholders, highlighting a growing need for general guidance on core outcome set development. The study proposes developing and adopting core outcome sets—standardized outcome collections—to be measured and reported in all trials within a specific clinical area. The authors outline a framework for core outcome set development, addressing scope, stakeholder inclusion, consensus methods, and consensus attainment. The authors note a growing recognition that clinical trials have insufficiently focused on the outcomes they measure.

Abstract

The selection of appropriate outcomes or domains is crucial when designing clinical trials in order to compare directly the effects of different interventions in ways that minimize bias. If the findings are to influence policy and practice then the chosen outcomes need to be relevant and important to key stakeholders including patients and the public, health care professionals and others making decisions about health care. There is a growing recognition that insufficient attention has been paid to the outcomes measured in clinical trials. These issues could be addressed through the development and use of an agreed standardized collection of outcomes, known as a core outcome set, which should be measured and reported, as a minimum, in all trials for a specific clinical area. Accumulating work in this area has identified the need for general guidance on the development of core outcome sets. Key issues to consider in the development of a core outcome set include its scope, the stakeholder groups to involve, choice of consensus method and the achievement of a consensus.