Determining what works: guidance for health research design gets an overhaul
29 September 2008
New guidance from the Medical Research Council (MRC) on how best to conduct research into complex health and social interventions is published today in the British Medical Journal and the MRC website.
Whether it’s reducing risky sexual behaviour, improving self-management in patients with diabetes, or encouraging the implementation of clinical guidelines, researchers, practitioners and policy-makers are interested in measuring accurately the effects of complex interventions. Guidance from the Medical Research Council (MRC) has in the past been seen as the cornerstone of research design in this fast-growing field. The MRC’s framework for assessing the impact of complex health and social interventions has now been updated by researchers from the MRC Population Health Sciences Research Network, following consultation with many of the country’s leading experts in research design.
The MRC has long been a leading international authority in research design since it pioneered the randomised controlled trial (RCT) – still the gold standard for clinical trial design. The RCT has proved to be versatile as well as effective. Variations of the basic method have been developed to address a wide range of situations. Complex clinical interventions from surgery through to methods for managing depression in primary care have been assessed using RCTs. So too have social interventions such as providing home insulation, free smoke alarms, or peer education to prevent young people from starting smoking. However, some interventions do not lend themselves readily to being assessed in this way.
Professor Paul Dieppe, of the University of Oxford, who initiated the process of revising and updating the framework, said: “Excellent methods are available for evaluating complex interventions, but researchers need to be aware of all the options, and choose according to the specifics of the intervention they are looking to assess. If you are evaluating a complex intervention, you have to think about all the features that might affect outcomes – how well it is implemented, how much this varies between people and places, what influence the local context is having, whether patients have strong preferences, and so on – and build this into your research design.”
Dr Peter Craig, of the MRC Population Health Sciences Research Network, who co-ordinated the revision of the framework, said: “There is a greater need than ever to determine which policies, procedures or treatments benefit health most in order to focus scarce resources on the ones that really work. But when you want to assess the impact of air pollution legislation or the ban on smoking in enclosed public places, you can’t conduct a randomised controlled trial, and don’t really need to. Our guidelines are there to help researchers recognise and adopt the most appropriate methods for testing the whole range of modern health interventions.”
The guidance will also help policy-makers in health, education and housing consider what the best way to implement a particular initiative might be, and set up interventions in such a way that they may be evaluated robustly and produce reliable information to guide future decisions.
Finally, in further recognition of the unique methodological challenges posed by the development and evaluation of complex interventions, the MRC has just published a request for submission of ideas on what the key methodological needs and gaps in knowledge in this area are.
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Notes:
• Peter Craig, Paul Dieppe, Sally Macintyre, Susan Michie, Irwin Nazareth, Mark Petticrew Developing and evaluating complex interventions: the new Medical Research Council guidance, BMJ advance online publication. doi=10.1136/bmj.a1655
• The MRC Population Health Sciences Research Network is a consortium of twelve MRC units and centres working in the population health sciences. It was established by Council in 2005. Its aims are to add value to the members’ individual work programmes, and to the MRC’s overall investment in the population health sciences, by encouraging collaborative research projects, and by providing a forum for discussing and responding to research and policy issues relating to epidemiology, public health and health services research.
• The MRC call for research priorities in the area of complex interventions is being taken forward in the context of the Methodology Research Programme (MRP), a key part of the developing MRC-NIHR joint strategy for health research. MRP supports the development of new and improved methods and theories in health research. The scope of the programme is broad, covering methods development research across MRC’s and NIHR’s remit.
