We must widen research methods: BMJ editorial

The gold standard scientific research tool to test how drugs affect a single, well defined disease is the randomised control trial (or RCT). But this has worrying limitations, not least because patients are often excluded from RCT trials if they have multiple problems or are already using other treatments. These limitations especially apply to people with long term conditions.

In an editorial in the British Medical Journal, Professor David Peters, says that evidence of what works is crucial to medical progress. But the over-valuing of a single research method is so unsuited to the complexities of everyday practice that it now threatens to turn medicine into drug-prescribing, and little else. He said:

'It is, quite simply, bad science to rely exclusively on one particular type of research, valuable though it might be in assessing single interventions. Good science should aim to serve both the every day practice of medicine and policy development.

'That means closing the evidence gap by broadening the base of the evidence we use.'

Professor Peters and his co-authors, Dr Hugh MacPherson and Dr Catherine Zollman – all Fellows of the Prince’s Foundation for Integrated Health – say that there is often insufficient research evidence available to support every day treatment decisions, particularly where integrated medicine and complementary therapies are involved. Yet these approaches may prove to be particularly relevant in treating chronic diseases, which account for 78% of NHS costs.

The answer is to encourage other techniques. Randomisation and control groups can still provide rigour and reduce bias, even when collecting evidence from typical populations receiving treatment in ways that reflect normal medical practice. Observational studies and basic research into mechanisms of action are valuable approaches too. Narrative research and patient reported outcome measures take what patients have to say about their health seriously. The notion of researching with people rather than on them has much to recommend it.

That view was recently backed by NICE chairman Professor Sir Michael Rawings. Talking about hierarchies of evidence – where the classic randomised trial is at the top and reviews of groups of such trials even higher – he said that they were: "an attempt to replace judgement with over-simplistic, pseudo-quantitative assessment of the quality of evidence".

ENDS

Notes to editors:

1. The Prince's Foundation for Integrated Health was founded by the Prince of Wales in 1993.  Its principal aim is to make sure that all patients can access good integrated healthcare.  That means treating patients as whole human beings - paying attention to body, mind and soul.  It may include access  to proven complementary therapies, but the Foundation does not suggest that is necessarily the best course of action for all conditions and all patients. 

2. Professor David Peters is professor of integrated healthcare at the University of Westminster; Dr Hugh MacPherson is a senior research fellow at the University of York; Dr Catherine Zollman is a GP who practises in Bristol. They are among more than twenty Fellows of The Prince’s Foundation for Integrated Health.

3. Closing the evidence gap in integrative medicine, BMJ 2009;339:b3335, was published by the British Medical Journal 1st September 2009. http://www.bmj.com/cgi/content/full/339/sep01_2/b3335

4. For more information and for interviews with Professor Peters, Dr MacPherson or Dr Zollman, please contact Pat Goodall, 01246 410 707 or pat.goodall@fih.org.uk

5. All other enquiries to contactus@fih.org.uk or call 020 7024 5755.