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December 2010

Highlights of the year in Evidence-Based Medicine

Carl Heneghan
Last edited 1st January 2011

The 1st of January saw the year start with a retweet from @david_colquhoun on a scary story on Big Pharma and US healthcare. We learnt authors of BMJ articles are reluctant to respond to criticisms. Reluctant in medical speak, to cebmblog, translates in to ‘can’t be bothered’. A linked editorial highlighted ‘that all aspects of post-publication review are wanting in medical research.’ Whislt the peer review process continued to create fuss, and may finally be broken.

Shriger and Altman in a linked editorial state ‘the majority of research articles receive no critique, and, for the minority that do, authors often do not reply or reply but do not respond to the criticism.’ Will we see more criticism in 2011, probably not.

In May, Isabelle Boutron, highlighted in JAMA the reporting and interpretation of randomized controlled trials with statistically nonsignificant results for primary outcomes. Guess what? Previous studies indicate the interpretation of trial results can be distorted by authors of published reports. Spin was identified in the conclusions sections for 58% of reports. Hold your hand up if you are guilty.

In terms of what drives health costs? You are twice as likely to have an x-ray, ultrasound or imaging after seeing a self-employed urologist as opposed to a salaried urologist Staying on the diagnostic theme, we learnt we should not be pooling diagnostic likelihood ratios in systematic reviews.

Small studies gave us the wrong answers, and Docs suggested women were hitting the pause button on osteoporosis drugs, which sounded very much like the HRT story.

On the drug front, we managed to give out 300,000 prescriptions for sibutramine in the UK in the last yr. Put me in charge of the drug budget, I’ll show you some cuts. Yet, nearly 1 in 10 prescribed meds were not taken by hospital inpatients. Hard to know what is the point of being in hospital but one of the major reasons was drugs were not available.

A pretty sobering statistic from 2010 is one-third of world's population is without access to surgical services

In contrast, a 10-year stroke prevention study after successful carotid endarterectomy had no surrogate, no early stopping, proper research for a change. But, bad news in that adherence statistics showed ¼ of stroke patients stopped taking their meds within 3 months and useful stroke studies remained unpublished: 1 in 5 studies were not published.

Jamie Oliver waded into the health debate @jamie_oliver: "not a day goes by I dont see a patient who could stop one med if they ate healthier." He needs to get out more, as he doesn’t see enough patients. Although his TED Prize wish: Teach every child about food was a great watch for Easter.

However, good news arrived by Xmas, despite all the snow, the FDA was aiming to keep us safe from harmful diet supplements which contain deceptively labeled ingredients, whilst the media was easily fooled by the Xmas BMJ edition. The BBC, at times, continued to produce shocking maths –why most research findings are false and, highlights for cebmblog were the prostate 'magic drug', the case of the changing headline

It’s a good job NHS choices continued to make sense of the news in 2010 : Put your feet up to slim down?

Oh, and Docs continue to be outed @ProPublicafor being paid by pharma despite government sanctions. However, they take fewer freebies, but disclosure is poor: really, 71% still accept gifts.

In addition, we learnt a bit more about ghost writers from @bengoldacre: Worst of all is the complicity of the academics And we became aware we had to be careful what you tweet ; when Bad Science clashed with Gillian McKeith.

Whilst the biggest problem may be consumer organizations: in 2010 2/3rds working with European Medicines Agency (the drug regulators) received partial or significant funding. Or is it Drug company study results are the major problem: drug company studies 85% positive, Government 50% positive. Must do more drug trials, if I want to get ahead. Or should I join the WHO: WHO admits to "inconsistencies" in its policy on conflicts of interest, whillt the BMJ editor pulled no punches WHO leadership may need to resign.

Finally the biggest change of the year saw the Avandia saga come to an end, well nearly, and four years to late. The recorded meeting between GSK and Dr Nissen in 2007 was published due to a subpoena, whilst Panorama ran the Avandia story asking why a million prescriptions were still issued in the UK.

And, after 16 yrs cebmblog thought he knew everything on calculating NNTs. Read this neat piece by Smeeth, I don't. Still more EBM to learn then for 2011, and my final thought for 2010 is: you better watch out, you better not lie. Here’s the reason I’m telling you why

Cheers cebmblog

Doctor discontent and EBM- challenges to acute medicine

Ami Banerjee
Last edited 30th December 2010

Over the Christmas period in hospitals up and down the country (and probably throughout the world) there is a feeling of bonhomie among patients and staff alike. The wards are brimming with mince pies and more food than necessary. It is often quieter than other times of year, because people tend to be busy enjoying themselves with their families and friends. I have worked that type of Christmas on-call shift in the past. This year has been very different. I have been working on-call shifts as a medical registrar just after Christmas until New Year, and other than lots of mince pies, it has been crazily hectic.

Having recently come out of a stint in research to the busy on-call life of the hospital doctor, I have had plenty of time to reflect on how evidence informs practice and on the differences between research and clinical life. My first thought is that it is still hard for clinicians in 2011 to take time to access best evidence on the job while they are working if the flow of patients is too high, or the beds are full or the waiting time targets have to be met. Since Sackett’s seminal paper in 1996 on “what EBM and what it is not”, there have been many analyses and initiatives to improve the uptake of EBM in daily clinical practice. Guyatt wrote in 2004, “Estimates based on current rates of publication of randomised trials and completion of systematic reviews indicate that it would take reviewers until 2015 to produce the 10 000 Cochrane reviews required to summarise existing evidence”. The situation is even more daunting now. There have been great improvements, but many challenges face the integration of EBM into acute clinical medicine, including the increasing chronic disease burden of our populations.

There are plenty of other places you can read about the usual complaints of too few staff, not enough beds, too much management and not enough clinical practice. These are all valid points but I think another underlying problem is that when pressures occur within health systems (and these can occur at Christmas or at any time of year), doctors and nurses do not seem to be happy in their jobs. I must have been told by everybody from the porter to the receptionist, the ward sister to the consultant that the shift was “horrendous” or “it has never been like this” at some point in the last few days. Objectively, the number of patients coming into the hospital was much higher than other times of the year and there have been extra workloads such as the peak of winter flu. But we doctors and nurses went into their professions to look after sick people and make them well so we should be happy with this situation, shouldn’t we? We chose these careers, didn’t we?

Actually there is a rich literature about “doctor discontent”. Health professionals definitely want to look after patients and in many ways, when the workload is high, the rewards of our professions are higher because (we feel that) collectively, we are going “more good”. That is our raison d’être or at least our reason to come to work. I think doctors and nurses and allied health professionals are often exasperated when they have to work in conditions where they are not in control. In these situations, they often have to make decisions based on guidelines or orders from higher authorities with inadequate resources. Nobel Prize-winning economist, Amartya Sen, has argued for many years that human welfare and happiness are linked not just to alleviation of poverty, but are more linked to capabilities and freedoms. There is an analogy in the health professions where people also need autonomy and to work within a framework where they can fulfil their capabilities, albeit with safeguards to protect patients and professional standards. Unhappy health professionals do not serve their patients well and they may even end up resenting their career choice. Much more attention needs to be paid to this important aspect of health system planning.

What governments can learn from scientific enquiry

Ami Banerjee
Last edited 22nd December 2010

The last couple of weeks has been an depressing time for those of us who believe in freedom of information (FOI). As Wikileaks founder, Julian Assange, awaits his fate in Dickensian conditions for publishing secret memos which various governments believe should not have been in the public domain, I have been thinking about FOI, conflict of interest (COI) and the parallels with the world of research evidence.

In the UK, under the Freedom of Information Act, any individual, anywhere in the world, is able to make a request to a public authority for information. The information may be withheld only if the public authority considers that the public interest in withholding the information is greater than the public interest in disclosing it. The objection of the US government and others to Wikileaks has largely been that sensitive information may “threaten national or even global security”, and so should have been withheld. To a doctor without diplomatic training, this seems like a knee-jerk response to any disclosure of information which could be of interest to the public and is an insult to our intelligence as well as an overused excuse for preventing FOI. The problem is that the powers that be in global politics often have COI, which is really the reason for stopping FOI, rather than any threat to security.

FOI and COI are not new concepts in scientific research or indeed, medical care of patients. There have been several welcome moves in recent months to make research data and the research process more transparent. Undoubtedly, the age of blogs and Twitter have pressured debate and change in a way we could not have imagined. The British Medical Journal has been encouraging online rapid responses for some years, but is largely alone in inviting immediate comment and debate regarding its articles. A recent Science publication regarding “A Bacterium That Can Grow by Using Arsenic Instead of Phosphorus” led to such a fervent online debate that even Nature, one of the most respected scientific journals, has had to admit that “Bloggers and online commentators have an important part to play in the assessment of research findings, and many researchers' blogs, in particular, contain better analyses of the true significance of a scientific finding or debate than is seen in much of the mainstream media”.

Although peer review has many strengths as a process, it has too often been the veil behind which other scientific journals hide information and COI, and it has its flaws. A Pubmed search with the terms “conflict of interest” leads to 8249 hits and “freedom of information” leads to 2583 hits, so these are clearly issues that occupy the minds of scientists. “Peer review” as a term reminds me of “national security”........In research, just as in government, COI is not just financial, although money does usually talk loudest.

Rather than resisting public pressure for greater freedom of information regarding political processes and imprisoning citizens without charge, perhaps governments would do well to invite debate and comment in the way that the scientific journals are now being forced to.

Television viewing: a risk factor for death?

Ami Banerjee
Last edited 5th December 2010

It is fascinating which health research grabs the media’s attention and which does not. The problem is twofold: there are so many journals and reporters are lazy and follow only the Lancet and the BMJ. The International Journal of Epidemiology published a great study from Cambridge this week, totally unnoticed by the media, showing that TV viewing time is independently associated with all-cause mortality and cardiovascular mortality. It deserves particular attention since I invested in a Sky TV subscription last month.

We already know that TV viewing is epidemic (55% of the waking day in the US!!) and is associated with risk factors for heart disease independent of physical activity. In other words, the harmful effect of TV watching is not just through reduced physical activity. Now this study adds that TV watching is associated with death in men and women, particularly from cardiovascular disease, again independent of physical activity.

In a prospective study of over 13000 men and women over 10 years, the authors gathered data about self-reported daily TV watching, risk factors, medications and cause of death. The clever way they present their data makes it even more compelling. Each 1 hour per day extra of TV watching was associated with a 4% increase in all-cause mortality and a 7% increase in cardiovascular mortality, but was not associated with cancer mortality. These results were calculated as hazard ratios. Importantly, they were independent of all major confounding factors: gender, age, education, smoking, alcohol, medication, diabetes or family history of cardiovascular disease and cancer, BMI and physical activity.

My favourite stat from this paper uses the population-attributable fraction (PAF). The PAF tells you how much reduction in the outcome (death in this case) would occur if exposure to a risk factor (TV watching time) were reduced to an alternative ideal exposure scenario. This study shows that all-cause mortality would be reduced by 5.4% if people reduced their TV viewing from >3.6 hours per day to <2.5 hours per day. More studies should report their numbers in a way so that policymakers can easily access and use like this.

Should we now be including TV watching as a risk factor for heart disease and aim to reduce it in CVD prevention guidelines? As a society, should we be targetting Rupert Murdoch and other players in the massive TV industry to take more responsibility for disease in the same way we target the tobacco and food industries? The worst bit is that I am tied into this Sky contract for a year now.

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