The National Institute for Health and Care Excellence (NICE) Real-World Evidence Framework helps deliver the use of real-world data to inform decisions about patient health and experiences.
Associate Professor Maxime Taquet, NIHR Academic Clinical Lecturer at the Department of Psychiatry, University of Oxford, and Dr William Pettersson-Yeo, Academic Clinical Fellow at the Department of Psychiatry have worked closely with the NICE team and Akrivia Health (an industry leader that uses AI-curated real-world data to accelerate research into mental health and dementia) to address two critical gaps in the previous framework.
Previously there was no guidance on using information extracted from clinical free text (such as the notes that doctors write after seeing their patients), despite this being where much of the relevant psychiatric data reside. Now there is clear information on how to report data elements that have been extracted from free text and how to undertake and report studies that aim to validate the extraction of information from free text.
There was also no reporting tool for researchers undertaking target trial emulations, which are important for drawing causal inferences from observational data. A standard reporting checklist has now been included, which will enhance reporting transparency, facilitate peer review, and help interpret and apply the results.
The updated framework represents a significant step forward for the generation of high-quality, transparent, and trustworthy real-world evidence.
Associate Professor Taquet, who also works across the Oxford Health BRC Molecular Targets and Oxford Health BRC Data Science Themes, said:
Working with NICE, we have provided scientific and clinical input to ensure that the new guidance promotes the highest standards of quality and transparency in real-world data and the studies that rely on them, thereby fostering trust among patients, the public, and regulators.
This update represents an important milestone for everyone working with real-world healthcare data. Such data are key to understanding healthcare delivery, patient experiences, and the effectiveness of interventions in routine clinical practice.
This collaboration with NICE is ongoing, and we continue to support their efforts to strengthen the use of real-world data in mental health and beyond.”