RCCM trustee Lianne Aquilina outlines the importance of the new NICE Real-World Data Framework for complementary and integrative medicine.
All research has core principles, from ensuring the correct design to answer a pertinent question, and utilising appropriate methodology along the way to minimise or eradicate risk of bias.
A randomised controlled trial or systematic review are not immune to bias, quite the opposite.
Randomised controlled trials are a hierarchical form of evidence to assess efficacy of an intervention, yet design components can be poorly understood, and have implementation issues to overcome.
NICE’s aim is that their real-word data framework will help problem-solve issues with guidance around evidence. Also, it is expected that this new framework will be opportunistic and fast track public access to both different and new treatments for patients within the NHS. One aim of the real-world data framework is to minimise uncertainties around the available evidence base NICE committees use to make judgments. All research methods face challenges and have limitations, yet evidence is built on to inform decision making in the health and social care sector.
“Real-world data” is a term used by NICE for insight, to better understand health and social care in practice. The framework can be applied to assess patient health care outcomes in the settings they are delivered. Pragmatic randomised controlled trials are considered real-world data. Real-world data is a high priority in the health care sector.
The real-world data framework can be applied to the complementary and integrated medicine sphere to encourage research development from the frontline. A range of research methods can be applied, and NICE offer up a framework to ensure quality control.
So, if you like me, are unable to propose or execute a double blind randomised controlled trial right now, and/or have concerns about the relevance of the RCT anyway, all is not lost.
In the next blog series “Informing NICE Guidance” I will expand by outlining key research considerations within the NICE Framework to enable a complementary medicine practitioner, and education establishments, to be able to start the thinktank process and contribute to the real-world data evidence base movement in the UK.
For now, if you are inspired by the prospect, you can access the corporate document NICE real-world evidence framework here. And look out for RCCM workshops on conducting service evaluations, or if you are an RCCM member please contact us for advice.
Lianne Aquilina is a researcher, an acupuncturist, with an award in health, life, and social science. She has a Master of Science in Applied Health Research, MSc research supervisor, visiting guest lecturer with leadership roles in the sector. Lianne is a Trustee of the Research Council for Complementary Medicine, Governing Board Director of the British Acupuncture Council and Executive of the Health Subcommittee of the World Federation of Chinese Medicine Societies.