The New England Journal of Medicine recently published research findings on prostate cancer screening. The results, from my reading at least, showed that screening was not terribly useful. So I was bewildered by subsequent media coverage that urged men to exercise “their right” to a prostate specific antigen blood test or PSA. A number of people called for the UK urgently to review its PSA screening policy.

The problem is that many prostate cancers are “benign” in their behaviour – men die with, rather than from, them – and the treatment is worse than the disease. The difficulty is in distinguishing these more placid tumours from aggressive ones.

The NEJM reported on two randomised controlled trials, one from Europe and the other from the US, where the PSA test is already widely used. The US study, involving almost 77,000 men, assigned half to PSA screening for six years and rectal examination for four years. The other group had “usual care”. After seven to 10 years’ follow-up, there was no significant difference in the mortality rate between the two groups.

The remainder of the article can be read here. Please post comments below.

Or perhaps not so much a makeover, but a radical shift in how drug research is decided upon, performed and reported. The suggestions come from Sir Iain Chalmers, who is editor of the James Lind Library in Oxford, and Silvio Garattini, director of the Mario Negri Institute for Pharmacological Research in Milan. Writing in the British Medical Journal, they say that their proposals would not only benefit patients but also industry, which is not winning any prizes for popularity at present.

They are:

1) Patients to be involved in shaping the research agenda – in other words, making sure research questions have resonance in real life and real-world situations

2) Legal requirements for research to be published, including trial protocols, by all (mandatory publication of trial data has had legal backing in the US since late 2007; no such protection for patients currently exists in the UK)

3) Independent evaluation of drugs. As the paper says: “The monopoly that the drugs industry has in evaluating its own products, and the secrecy surrounding this process, leads to biased evidence that is currently only rarely questioned by independent studies.”

4) A requirement to demonstrate “added value” for all new drugs – is this drug better than the current best drug treatment, or does it benefit in addition to it, and is it better than non-drug treatments? Too often, trials are done comparing a new treatment to placebo where there is a known intervention which is better than placebo. This means that uncertainty about how to use it best persists.

The authors say that these would help improve public confidence in pharma, would improve returns from investment in R&D, but could also improve efficiency in other ways. For example: “Tim Mant, a director of a major contract research organisation, has acknowledged how frustrating it is to be commissioned to organise a clinical trial that he knows is going up a scientific blind ally because he has been there previously with another company but cannot divulge information that is commercially confidential.”

I hope that people in the pharmaceutical industry take notice: I would genuinely love to write about the improvements that are being made.

Pleased to see that ripples from the UK have now reached the US.

I have been inspired by Harry Eyres’s piece on Slow London in the FT over the weekend. So much of working in medicine feels like a sprint. Short and overbooked appointments, busy clinics, multiple bits of administrative work to be ticked, crossed, signed and dated; e-mails and correspondence to deal with, questions from patients and carers and family members; equipment to be checked, replaced… it can feel frenzied.

Yet in medicine, seriously valuable things go missing in the fast pace. A detailed case history can be time-consuming to obtain but can save so much more on the wrong or unnecessary tests or investigations. Waiting to see if a symptom or test result improves may feel like a waste of time or even laziness, but can, in certain cases, be the most diagnositically useful thing to “do”. Allowing recovery from serious illness can sometimes feel frustrating: can nothing else be done? Yet it may be that “building in time” is the purest and most effective way back to a usual lifestyle.

Imagine if we could get rid of all the time-sapping, cash-depleting vogues in the NHS – Choose and Book and the tick boxes of the GP contract, for example – and invest instead in giving doctors and patients a bit more time to have adequate consultations?

“And so,” said my extremely pregnant friend while ordering lunch, “we’ve talked about it, and we’re going for nipple stimulation.” Nipples do not normally come up over coffee. I must have looked alarmed. No, no, my friend insisted, this was an evidence-based endeavour to bring on labour. She thought that I would approve. And what’s more, she said, lowering her voice conspiratorially, this method was free, easy and – quite possibly – fun. Gleefully, she ordered a large helping of curry to be washed down with raspberry tea.

So I had to go and look it up. And indeed, there is a reasonable amount of research showing that gentle breast stimulation, while not guaranteed to induce labour, does seem to have a better chance of beckoning baby out than no stimulation at all. The woman has to be at the right point in pregnancy for it to work. Also, more research on safety has been recommended – and no one, of course, should be trying to induce birth unless their midwife or doctor agrees. In any case, this method is not for the easily bored. Some studies suggest that between one-and-a-half and three hours of such stimulation a day are required to produce the desired effect.

But when it comes to the supposed methods women can use to induce labour, old wives tell many tall tales. Having sex is the most mentioned and near-mythical birth inducer. But there is not a lot of evidence to tell us whether the theory, which hinges on the labour-inducing effects of the prostaglandins in semen, is sound.

The remainder of the article can be read here. Please post comments below.

The FAST campaign wants you to call 999 if you can answer, about someone you’re with, “yes” to the question “Has their Face fallen on one side?”, “no” to “Can they raise both Arms and keep them there?”, or “yes” to “Is their Speech slurred?” The idea is to get people with strokes to hospital as quickly as possible.

Several readers have been in touch to say that they found the ads on TV frightening and guilt-inducing – had they done enough for a friend or relative who had an evolving stroke? Was it their fault that a stroke progressed as far as it did?

I hope that the effects of these adverts will be investigated, in particular to see if they have any lasting benefit to public health but also to see what the adverse effects are – like what the readers writing to me have experienced.

The Joseph Rowntree Reform Trust is today launching a report, “Database State”, which examines the rationale, security and consequences of 46 public sector databases. It is co-authored by Ross Anderson, professor of security engineering at Cambridge University, who is an outspoken critic of government databases.

The results are startling. Two databases, the NHS Detailed Care Record and the Secondary User Service (which holds summaries of treatment and is supposed to be used for administration and research) are given a “red light” rating. This means, according to the report, that they are “almost certainly illegal under human rights or data protection law and should be scrapped or substantially redesigned. The collection and sharing of sensitive personal data may be disproportionate, or done without our consent, or without a proper legal basis, or there may be other major privacy or operational problems.”

When I spoke to Prof Anderson yesterday, he had much to say on the subject, which he has been researching for almost 15 years. He told me that since about 1995, the Department of Health “has focused on driving control of medical records from doctors to government. It [the Dept of Health] has behaved as though doctors are impeding progress of the evolution of health”.

In Scotland, there has been one main supplier for computerised medical records – the General Practice Administration System for Scotland, or Gpass. Though the system is government sponsored, Ross doesn’t see this as an advantage. He believes that “it has rapidly fossilised. The only interest in upgrading the service has been to put into practice what the civil service has wanted.”

Anderson was adamant that centralised control is “going to be disastrous for medical records”. He gave me an example from Nuffield hospital in Oxford: “[They] put in the new system – and they found that records were suddenly kept on a remote server rather than locally. The server went down in Swindon, and they couldn’t access any records, and therefore couldn’t do any operations.”

But it is not the logistical minutiae of centralised records that concerns Anderson the most. He is more worried about whether they are a good idea in the first place. “In medicine, you have to make sure that the systems are responsive to needs. This is not like a McDonald’s franchise. Medicine is so complex that you can’t [have a "one size fits all" electronic medical record]. Also, when you look at hospital medicine, there are dozens of little specialities, and each wants its own best of breed system.”

Such choice is not going to be possible under the NHS’s new “Connecting for Health” plan. Anderson is also concerned about the plan’s feasibility. “You can build a system for security, or functionality or scale. If you are very good you can maybe do two out of the three. But not three. A GP centre with 10,000 records can cope with risks, maybe there will be a problem with confidentiality once in a career there. At least it is limited and local. But once you get to 50 million records with a large pool of access to them, you can’t realistically expect them to stay confidential”.

There have already been cases where NHS workers have accessed records they had no reason to look at. The few who fail to respect confidentiality will have access to more records, not less.

Connecting for Health says that it will be hugely beneficial to be able to access a person’s full medical record from anywhere in the UK. Yet you hardly ever need a full medical record in order to receive immediate treatment. If you arrive at Accident and Emergency so unwell that you can’t give your basic medical details, it’s unlikely you’d be able to give your name and date of birth either, so access to your computer health record wouldn’t be possible. The ideal may be to use something like medi-alert bracelts, where specific health information — say, about allergies or life-threatening conditions — is available no matter the state of the patient.

As is, the amount of information that the record plans to hold is so enormous that the record ceases to become clinically useful. So much of the data is simply administrative. But it also means that full — or almost full — medical records become accessible to just about anyone working in the NHS (and note, there are 1.3 million people employed in it).

The new records will be opt-out, rather than opt-in, which I think is immoral. There has there been no decent reassurance from the government that standards of confidentiality in medical records will be upheld. I think Anderson’s concerns are justified — and you can start the process of opting out of central systems by making your wishes known to your GP surgery.

 

 

 

 

 

 

 

 

 

 

 

Indoor swimming pools have many attractions. Heated and disinfected water, private changing space, and even the occasional Jacuzzi on the side. So why would anyone want to swim outdoors? Britain’s seas and rivers are often shockingly cold, and they are also inhabited by all manner of incontinent marine life. Add in the constant threat of exposure to chill winds and rain, and you do not have the ideal ingredients for a pleasant swim. Yet I must confess that I share the enthusiasm of the swimmers of Sandycove near Dublin, who are pictured here.

Even in the northern hemisphere, swimming outdoors has to be one of life’s most satisfying pleasures. It gives you the chance literally to submerge yourself in the beauty of the environment. One of my own favourite places is a bay on the western shore of a small island on the west coast of Scotland, where at sunset the colours of the sky appear to melt into the water.

Outdoor swimming is also brisk, invigorating and fun – and there is no doubt that regular exercise is good for you. The problem is that the medical literature seems filled with terrifying reasons to avoid it. But there is risk everywhere in life, and there are certainly multiple ones in doing no exercise or locking oneself indoors.

The remainder of the article can be read here. Please post comments below.

The investigation into the Mid Staffordshire NHS Trust makes for harrowing reading. The mortality rate at the hospital was found to be high in patients admitted as an emergency. The first data that showed an increase in the standardised mortality ratio was in 2005. The Healthcare Commission investigation was done during last year, 2008, and is reporting now, 2009. It can be difficult and labour-intensive to interpret statistics correctly. But it is not helped if the length of time it takes to analyse the numbers approaches the life of some health policies.

The report highlights what can happen when fulfilling targets becomes the chosen marker of quality. The target of no more than a “four-hour wait” in A+E led to unsafe practices, such as triage in A+E being done by a receptionist. Similarly, money was saved by getting rid of the hospitals’ clinical staff, as highlighted in the report. The irony is that it’s not difficult to envisage situations where receptionists could be given some training, welcomed as “clinical partners” in “skill mix”, and the system declared innovative and cutting-edge. But these kinds of terms are used to make cost-savings sound palatable: the training for being able to triage is better given via nursing or medical school. Meanwhile, Mid Staffordshire was given Foundation Trust status, and “focused on promoting itself as an organisation, with considerable attention given to marketing and public relations”.

Yet the Government is reluctant to admit that the target culture will not sort out all the NHS’s problems. Nor will shiny PR polish resolve understaffing and overstretching. Should we not just ditch ineffective policies, base healthcare policy on evidence, and move on?

The concept of doctor-rating websites seems to be gathering political momentum; in fact, it’s already a reality. The NHS is being offered this data, apparently to ensure that “patient choice” is offered and “patient experience” is good. I think it’s an unproven and potentially hazardous waste of money. There’s a piece that I wrote for the BMJ here; and you can also read Neil Bacon’s opposite point of view.

Margaret McCartney’s Blog

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A forum on healthcare policy and professional issues, by Glasgow-based GP and FT Weekend columnist Margaret McCartney.

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