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July 2011

It is impossible to avoid the outrage and scandal of the News of the World if you were in the UK this week. One media organisation went too far in its pursuit of sensitive data by tapping phones, and there have been hourly revelations since then, revealing a much greater system problem. Has the media lost its way? Yes it has. The “big scoop” has become more important than respect for individuals and their lives, and the right to know has trumped the right to privacy.

As the scandal crosses the Atlantic and more people lose their jobs, the last few days made me reflect about analogies between the media and medical research, and possible lessons for EBM. Like the news headline writers, data is the major part of what medical research is about as well. It is sensitive data because the content is health information of patients. Thankfully, medical research has to go through multiple levels of ethical review before it is carried out and perhaps the rather lame Press Complaints Commission needs to be replaced with a proper code of ethics for journalism and a body that can enforce it.

The history of medical research has had plenty of ethical issues and scandals which have largely led to improvements in guidelines and the way in which research is conducted. Perhaps most importantly, the involvement of Nazi doctors in unethical research during the Holocaust led to the establishment of the Nuremberg code: ten principles of ethical conduct in medical research in 1949. The World Medical Association developed the Declaration of Helsinki to guide the medical research community regarding human experimentation. But scandals still continue to happen. The impact of Andrew Wakefield’s bogus Lancet paper about MMR has led to huge consequences for childhood immunisation across several countries. Conflicts of interest in research and clinical practice have led to inappropriate regulation of medical devices.

Medical researchers have the privilege of working in fields where their findings can genuinely impact human lives, and ethical research can be done in every area of medicine to make treatment and the patient experience better, even in end-of-life decisions in the intensive care unit.

As a researcher with an interest in epidemiology, a lot of my work involves using patient databases to formulate and test hypotheses. The aim is not “to publish or perish” and get as many papers from the data as possible, and nor is it financial reward. We as researchers should always remember why we are doing what we do: to discover more about health and disease in order to improve outcomes for patients.

Avoidable Waste in research

Carl Heneghan
Last edited 6th July 2011

It’s always a pleasure to listen to Sir Ian Chalmers but the topic of choice at SAPCprimary care conference is to irresistible to not blog about.

Most of you reading this blog will be involved in doing or reporting research: it seems you may be wasting a lot of resources. If you aren't involved in research then you may want to know, why does so much effort go to waste?

If you don’t know who Iain Chalmers is? He did this small thing, setting up the Cochrane ollabaration, and now directs the James Lind Library.

In 2009, Iain and Paul Glasziou published a piece you should consider reading in the Lancet which highlighted the problems: “85% of research investment is wasted worldwide.”

If you are an epidemiologist then the four questions you would want to ask are published some time ago by Austin Bradford Hill
1. Why did you start?
2. What did you do?
3. What answer did you get?
4. What does it mean?

If you can’t answer these questions about the research you are doing then it seems you should go back to the drawing board.

Part of the solution is to create better questions, relevant to patients, and developed by patients. You may be surprised that a resource to make uncertainties explicit and to help prioritise new research is actually available. It is called DUETs. It has been established to ‘ publish uncertainties about the effects of treatment which cannot currently be answered by referring to reliable up-to-date systematic reviews of existing research evidence’.

I am continually frustrated with the amount of guff published in the media about the latest ‘dramatic health cure’, Yet an imitative like DUETS never gets a jot of news space. However, this initiative is unlikely to away, and at some time in the future it is likely it will pervade all aspects of research.

The key take home messages are: there is substantial avoidable waste, research should address known uncertainties and engagement of patients and the public is essential.

EBM in critically unwell patients

Ami Banerjee
Last edited 6th July 2011

Evidence based medicine (EBM) was undoubtedly one of the major medical advances of the last century. EBM is at its best when it changes daily clinical practice and challenges well-established norms, but this only really happens every now and then. Two recent New England Journal papers about management of critically unwell patients have done just that.

Since medical school, doctors learn that the optimal treatment of patients with severe infection (sepsis) and low blood pressure (shock) is to pour in intravenous fluids. Not something that is up for debate, you would think. There are much more pressing things like drug-eluting stents to take to clinical trials. Well, think again. A paper by Maitland and colleagues reports a trial in Africa where over 3000 children with severe sepsis and shock were randomised to receive either boluses of fluid (albumin and saline) or no bolus in the early stages of treatment. Children with malnutrition or gastroenteritis were excluded. Amazingly, any bolus treatment led to an increase of 45% in the risk of mortality at 48 hours (relative risk 1.45; 95% CI, 1.13 to 1.86; P=0.003). The results were consistent across all subgroups of patients, and now researchers and clinicians all over the world are scratching their heads to understand whether what they have been doing since they were medical students is actually wrong and too much fluid is a bad thing in septic patients.

Intensive care, like surgery, is often cited as a difficult area of medicine for EBM to infiltrate. The traditional mantra is to give ITU patients nutritional support as soon as possible. In a trial of nearly 5000 patients, the two arms were either early initiation of intravenous (also known as parenteral) nutrition on days 1 and 2 of ITU admission, or late initiation of parenteral nutrition after day 7. Late initiation was associated with reduced complications and faster recovery. So EBM is possible in the ITU and it does change practice. What other areas of treatment of the critically unwell do we need to test?

Think about this? There is only one speciality where the patient isn’t discharged from the doctor’s care. The answer is general practice. Yet in most clinical jobs, the all important discharge, is the most important outcome.

Once the patient has left then it’s not my problem: until the next time.

There is tentative evidence that Patient outcomes can be improved, if after discharge to home, they are visited by the doctor who treated them in hospital in the first place.

Yet, it’s slightly confusing, although communication between Primary care docs and hospital docs was found to be pretty poor at the time of discharge. There’ no surprise in that. In one study it made no difference in terms of adverse outcomes, if the communication was good or bad.

In addition to this, many patients leave hospital with test results pending and doctors are often unaware of important actions once the patient has gone home.

Even simple things can make a difference: The risk of being admitted to hospital decreases when patients are seen after discharge by a clinician who has actually received the discharge summary. Common sense at its best.

A lot of people want to know how to save healthcare costs and reform the health service. Then the answer has to be: ask simple questions and think simple answers. If everyone in healthcare stopped seeing discharge as the outcome we’d be a lot better off.

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