DO>IT, the coordination project of the Big Data for Better Outcomes (BD4BO) programme, has delivered a toolkit to support the other BD4BO projects in the identification, selection and measurement of outcomes. The BD4BO programme currently has projects focusing on Alzheimer’s disease, blood cancers, prostate cancer, and heart disease. The new toolkit represents a practical guide which will help the projects to adopt a standardised approach when developing core outcome sets (COS) in their disease areas. The toolkit proposes six main stages for developing a COS, from scoping to dissemination, with a focus on stakeholder input across all stages to ensure a wide range of perspectives are taken into account. Whilst the toolkit highlights any existing best practice for developing COS, it also presents a range of methodological options which BD4BO projects can consider depending on the scope of the work and resources available. Each stage includes decision-making flowcharts, summaries of key considerations and case studies to highlight the key factors and considerations when developing COS. These typically reflect aspects that are of importance to BD4BO projects around the use of data from a range of sources from ‘real world’ settings in addition to clinical trials.

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