Evidence Live 2015 for students – Join us in Oxford in April!

The first time I heard about ‘Evidence-Based Medicine’ was at 8:03 am on a cold November morning in my first year of medical school. The professor who ran our EBM course sighed as he discussed the course objectives: understand sensitivity and specificity, learn how to calculate a Number Needed to Treat, and be able to do critical appraisal of an RCT. At the time, all I could think about was that I should have had an extra coffee before showing up to class. The preponderance of empty seats made it clear that many of my colleagues had decided to avoid the situation altogether.

That was 5 years ago. In between then and now I went to graduate school, working with the Centre for Evidence-Based Medicine at the University of Oxford – the hosts, along with the BMJ, of Evidence Live 2015 – and my outlook has completely changed on EBM.

It turns out that these skills – as dry as they initially sounded to my junior med student ears – are the fundamental building blocks of clinical practice. And the basics of EBM are important, but what it took me a long time to learn is that EBM is much, much more than calculations and algorithms for critical appraisal. EBM is about how to figure out what statin to prescribe and in whom to prescribe it. But it’s just as much about being able to help a patient decide to stop taking a statin, if their risk of cardiovascular events is low and they are experiencing side effects. It’s as much about identifying that a new chemotherapeutic agent is effective against a certain cancer as it is knowing when a patient would be better served by palliative interventions, focusing on quality of life.

The trouble is, though, that increasingly, EBM has come to mean something very different. As recently outlined in the BMJ (by several of our Evidence Live speaker faculty), EBM is in a state of crisis, having been co-opted for the good of corporations, rather than patients. Algorithms have replaced clinical reasoning at an alarming rate, leaving patients at the business end of whatever management-approved clinical pathway is available for their particular presentation. You can read more about the crisis facing EBM in their paper, entitled Evidence based medicine: a movement in crisis?

Now this is where you come in. As students and junior doctors, these problems are ours – this is the state of healthcare at the start of our careers. Think back to what healthcare looked like a generation ago; how many more effective treatments are available, how treatment for acute and chronic illness has completely changed.

What is our generation’s legacy towards healthcare going to be? What can we – indeed, should we – do to get EBM, and by extension all of healthcare, back on the right track?

Evidence Live 2015 offers reduced-rate places to students and junior doctors, and all you have to do is write a 300 word response to the following question:

“What is the most important intervention/change/idea required to ‘fix’ Evidence Based Medicine over the next 10 years, and how should it be implemented?”

Further details are available on the Evidence Live website. The top 3 submissions will be featured in the Student BMJ in mid-2015.

Come join the conversation, and join us in Oxford in April.

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Medical journals are like magazines. Here’s why they don’t need to be.

Professional medical journals are full of advertisements for treatments. A typical issue of a journal- such as the British Medical Journal (BMJ) or the Lancet, two of the world’s most prestigious, based right here in the United Kingdom- consists of news, opinion pieces, peer-reviewed scientific research, and ads for medications and devices. Many may be surprised to learn that these journals often read more like magazines, with full-page and even centrefold adverts for the latest, greatest drugs.

It has long been known that the information in these adverts may be misleading. Drug companies often use various tricks in them, such as reporting ‘relative’ rather than ‘absolute’ effect sizes, which can make treatments seem more effective, often by an order of magnitude. While peer-reviewed research isn’t perfect- one only needs to read recent articles about how pharmaceutical companies continue to be allowed to withhold data, thereby making drugs seem better than they are- it is at least subject to some degree of independent review, usually by two or more scientists. The quality of information available to doctors and policymakers is an important issue in the UK right now, given the scathing conclusions of the recent House of Commons public accounts committee report on access to clinical trial information. For example, it has become increasingly clear that the decision to spend £424 million on Tamiflu, an antiviral medicine used for influenza treatment, was based on misleading and biased information, and that the drug may not be effective.

Despite the increasing popularity of online journal content, print medical journal readership continues to rise, and they remain an important source of information for practitioners. One way of improving the quality of information presented in them might be to eliminate medical journal adverts entirely. But publishers say adverts are a vital source of revenue, and without them, journals would cease to be financially viable.

To investigate whether this claim is true, our international research team from several universities in the UK, Canada, and the United States (University of Oxford, the University of Toronto, York University and other institutions) went through print editions of six of the world’s most prestigious medical journals, going back to the 1970’s. We calculated the volume of each journal taken up by adverts, opinion pieces, job listings, and peer-reviewed research. Using the price guide listed by each journal, we estimated their advertising revenue. We then calculated how much it would cost, per subscriber, to remove adverts entirely. What we found surprised us was and was completely contrary to what journal editors and publishers say in public.

Take the BMJ, for example. This journal has been at the absolute forefront of medical research, publishing groundbreaking articles debunking the connection between the MMR vaccination and autism. It was also one of the first to question the evidence base supporting the use of Tamiflu- that same flawed evidence base used by the government to spend £424 million on a drug that may not work. We determined the cost to eliminate adverts in the BMJ would be £13 per subscriber per year. Considering the salary of an NHS general practitioner is between £54,319 to £81,969 (consultants make a basic salary of between £75,249 and £101,451) this represents a tiny fraction of salary even for the lowest paid doctors in the UK. We found similar figures in other countries: it would cost each subscriber to Canada’s largest journal, the Canadian Medical Association Journal, £20 per year to eliminate adverts entirely. (In case you are wondering, the average Canadian doctor makes £194,000 per year.)

Journal publishers say without this income, they may be forced to shut their doors and stop publishing research on medical breakthroughs and new treatments. It is clear, however, that this is far from the truth. Adverts could be completely removed from print journals for less than the cost of a couple of issues of Hello magazine. I certainly think this is a price worth paying to improve the quality of medical information provided to doctors around the world.

Here’s a link to the paper, and a link to some media coverage.

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ObamaCare and the limits of technology

It is well known that population health in the United States remains poor in comparison with high-income countries, and that improvements in health outcomes have not kept pace with those in similar nations. The recently implemented Affordable Care Act (ACA), President Obama’s signature legislative success in an administration marred with partisan gridlock, is an attempt to improve healthcare access for people who currently lack access, which is estimated to be at least 48 million Americans.

The ACA- ObamaCare, as it is popularly known- was implemented on 1 October 2013. The legislation contains something called an “individual mandate”, which makes it a legal requirement to have health insurance. The idea is that by having everyone sign up for insurance- the young and healthy as well as the elderly with chronic conditions- health insurance will be made less expensive for everyone. For those for whom the cost is still prohibitive, subsidies are included to bring the cost within reach.

Its successful implementation rests heavily on the performance of a federal website, healthcare.gov, which enables people to sign up for health insurance online. The substantial problems encountered by website users have been widely reported; internal documents show, for example, that on the first day it was available, only 6 people were able to successfully obtain insurance. Since then, improvements have been made, including allowing people to browse estimated prices before signing in and providing personal details.

But the real issue with ObamaCare’s implementation isn’t about the fact that the website doesn’t work. It’s that by making the success of something so important depend on a website, that the whole point of the legislation is jeopardized. And it doesn’t matter if the legislation is perfect, or the provision of new, affordable health insurance policies is dramatically improved.

There is no question that what the website has to do is highly complex. But here is the major problem: people from disadvantaged populations are less likely to have access to computers and to the internet. Even if they do have access, they are more likely to have literacy deficits that make it more difficult for them to effectively navigate and use websites.

The Obama administration included provisions for this in the legislation for providing funding for patient navigators, whose role is to support people to access the insurance- and in turn, the healthcare- they need. But their work has been held up by (largely Republican) opposition, which has come in the form of state-level legislation that inhibits legislators from getting started, either through mandating them to take out expensive malpractice insurance, or to engage in burdensome educational programs prior to starting work.

So there are two major issues: the political and the technological. But both of them miss the real point, which is that millions of people in a prosperous country are still being denied the healthcare they need. Relying on technology to engage people who lack digital access and skills, without providing substantial support to ensure these issues are resolved, will continue to mean that the ACA will not meet its targets.

This is something I have been looking at recently in my own research about internet use for health by people with low health literacy. In the United States it is estimated that a third of the population falls into that category. What we have found, soon to be published, suggests that people with low health literacy are likely to have at least the same difficulty with websites as with printed health information, regardless of how it is designed. So if ObamaCare’s successful implementation relies on people obtaining health insurance through a website, the people who need it most are going to continue to be excluded. Access is everything.

People need more than a website; and fixing every technical glitch in healthcare.gov is not going to fix the problem. So instead of putting all the effort- the political and the technological- to fix the website, the administration needs prioritize getting navigators out there, in order to support those who need it most. Otherwise, no matter how well the website is designed, it’s not going to achieve the aim of getting people the insurance they need.

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Music decreases kids’ pain during IV starts? Not so fast…

For those of us who don’t practice pediatrics day in and day out (and, I would imagine, for a fair number who do as well), having to do an IV start on a sick kid is a tough task. It’s both technically and emotionally challenging. I remember my first few times doing this in medical school, and you can’t help but feel bad when your young patient starts crying and fussing as you try to get the IV start going.

A new paper in JAMA Pediatrics suggests that playing music during an IV start in a pediatric ED population may reduce children’s pain. 42 children were enrolled in this study, where 21 were exposed to a few songs during their IV start, and the other 21 received usual care.

This sounds like a great idea (after all, wouldn’t you prefer to listen to some Fleetwood Mac during the procedure if you had to have an IV inserted), and the spin on the paper makes it sound like the intervention should be adopted everywhere tomorrow.

Here’s why that’s not necessarily true. From reading the abstract we can see that analyses were undertaken “when children who had no distress during the procedure were removed from the analysis”.

This is the core problem- it means that mean the authors of the study removed the people whom they didn’t expect to respond positively to the intervention. This increases the risk of bias; that is, that the results of the study will not provide the real effect of the treatment, and may overestimate its effectiveness. In order to reduce this, properly carried out randomized controlled trials are analyzed through an “Intention to Treat” approach, where everyone who starts the study is included in the analysis at the end. That way, regardless of what happens to people (they die, they move away, or they don’t like the music being played), their data is included when calculating the treatment effect.

As if that wasn’t enough, we find out in the full text that some parents of kids in the control group were encouraged by emergency department staff to sing to their children. Again, this contamination between treatment and control groups increases the risk of bias.

Maybe playing music is a good thing, and maybe it isn’t- but this study doesn’t give us the answer, and its methodological flaws unfortunately make it unsuitable to tell us if this intervention works.

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Patient stories on the internet: ‘people power’ or ‘pester power’?

Social media, including YouTube, Facebook, and Twitter, have democratized the production of health information, making it possible for anyone with an internet connection and a computer to post their own health stories online. Much of this information comes in the form of experiences of illness and treatments, particularly about chronic conditions.

Our new research, published in the peer-reviewed journal ‘Patient Education and Counseling’, looks at this growing trend of people going online to share their experiences of treatments. We looked at one specific condition- multiple sclerosis, a debilitating and often progressive neurodegenerative disease- and one controversial treatment, known as the ‘liberation procedure’. This treatment is based on a theory called CCSVI (Chronic Cerebrospinal Venous Insufficiency), which suggests that blocked veins in the neck are responsible for MS symptoms and progression.

Although there is little ‘conventional’ medical evidence to support the effectiveness of this procedure for improving symptoms or reducing progression, tens of thousands of people around the world have gone, often at great expense, to have this procedure done. Hundreds of these people have posted YouTube videos about their experiences, and we looked at what makes these videos so compelling, given that many have over 80000 views. We watched 100 of these videos to figure out what’s going on.

Nearly all the videos (97%) adopted a positive stance towards the procedure and the theory behind it, describing that the theory makes sense, and that it should be adopted more widely. There were three key aspects to the videos- they provide visual evidence of treatment effectiveness (people demonstrate they are better with before and after videos of their disabilities), they describe concerns that neurologists and Big Pharma do not have MS patients’ best interests in mind, and they show what it’s like to live in daily life with MS.

If you’re interested in learning more, here’s the link to the paper .

What’s the take home message? Health experiences on YouTube are here, and they’re here to stay. Practitioners alike should engage with this content, should know that it’s out there and tens of thousands of patients are watching it, and that it can be very compelling. This is particularly true in a condition such as MS, where currently available treatments aren’t very effective, and where the promise of a new way of looking at the disease provides hope to those who are suffering.

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Homeopathic “vaccines” and Health Canada: Just say no

Vaccines have widely been considered the greatest advance in healthcare in the 20th century. Polio, mumps, measles: these are just three examples of serious conditions that harmed and killed thousands before the advent of safe, effective vaccines to prevent them.

But concerns that vaccines are harmful, or that they are merely a product of the pharmaceutical industry’s limitless appetite for profits, have grown in recent years. These claims, which took off after a British doctor engaged in fraudulent research and published a made-up research study in one of the most prestigious medical journals in the world, have cost vaccines their credibility. In Canada and other places around the world, anti-vaccine sentiment has reduced the uptake of vaccination amongst the general public. The Canadian Public Health Agency has found that only 62% of Canadian two year olds are up-to-date with their recommended immunizations. A recent measles outbreak in Wales, in which over 1000 people contracted this preventable disease, highlights the danger of inadequate vaccination.
In order to regain the public’s trust, health regulators around the world must be diligent at reviewing the evidence for any vaccine licensed for use, to ensure that only safe, effective vaccines are available for public use. That’s what makes Health Canada’s continued decision to license homeopathic “vaccines” for use in Canada so concerning.

First of all, homeopathic “vaccines”, called “nosodes”, don’t work. They consist of concoctions of bodily fluids (such as blood, pus, and saliva) from people who have contracted a disease, which are then sterilized and diluted, often until there isn’t a single molecule of the original compound left. Their manufacturers- for-profit corporations every bit as committed to their shareholders as traditional pharmaceutical companies- suggest they are effective at preventing illnesses. But this isn’t true, and never has been. It is not the case that the medical community wants to ignore evidence to the contrary- it’s that this evidence doesn’t exist, despite attempts by the homeopathic industry to convince us otherwise. Health Canada currently licenses over 80 of these products as safe and effective for the prevention of various diseases including polio, mumps, and measles.

So what, you’re thinking: if they don’t work, then at least they don’t cause harm. But ‘not working’ does not mean they are neutral. Precisely because the act of taking a homeopathic product means you are not getting a safe, effective vaccine means that they are actually harmful. Although we have not yet seen an outbreak in Canada like the one in Wales, it is not difficult to see that Health Canada’s decision to license these products, thereby declaring them to be safe and effective, could end up with the same tragic results. The strength of vaccines relies on something called “herd immunity”, in which a population is only protected if a large proportion of the individuals are immunized. We are all in this together, and one person’s decision to use something that doesn’t work can impact the health of everyone else.

It is inappropriate for Health Canada to license these products, and Canadians deserve better. Already this year we have seen Health Canada refuse to review emerging evidence that Tamiflu, a commonly-prescribed antiviral medication purported to reduce the severity of influenza symptoms, may be ineffective. As Canadians we have spent hundreds of millions of dollars stockpiling this drug, and now that evidence has come to light that puts its effectiveness in doubt, our national regulator has been silent.

We should be focusing on interventions that are safe, effective, and have been demonstrated to save lives; and the regulatory body in which we put our trust as Canadians seems to have forgotten this. More worryingly: if Health Canada isn’t figuring out what is safe and effective in this case, what else are they getting wrong?

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Exercise improves brain function? Maybe…

One of my colleagues brought to my attention a recent article on the New York Times Well blog. The article reports results of a study in which castrated rats are randomized to do some running on a treadmill, or to be sedentary. The rats’ brains were then tested for DHT and testosterone content, and it was found that the rats who did exercise had more DHT in their hippocampi. You can read the article here. The original study is here.

Here’s my problem, illustrated by an excerpt from the blog post: “But one aspect of the new experiment is already resoundingly clear and reassuring, Dr. McEwen points out. “The exercise in this experiment was quite mild,” he says — the equivalent of jogging at a pace at which someone could speak (or squeak) to a companion. “That’s achievable for most people,” he concludes, “and the evidence suggests that it will improve brain health.”

The study was in castrated rats. The study author goes from rats with no testes, straight to recommending that people jog around, and says that the study provides evidence that for humans, jogging will improve brain health.

One of my colleagues has just written an excellent article on the use of mechanistic reasoning in evidence-based medicine and I’d encourage you to take a look. It tries to solve this problem- that it’s simply inappropriate to suggest that an animal study provides evidence that something ‘works’ in humans. I’m disappointed in the study author that he made this baseless statement, but we all have to do our part in ensuring scientific results are reported accurately and fairly.

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Stockpiling in the dark? Tamiflu and the Public Health Agency of Canada

The Government of Canada reported last week that they are working with pharmaceutical manufacturer Roche to release the neuraminidase inhibitor Tamiflu (oseltamivir) from Canadian stockpiles to ensure availability of the drug for a particularly severe flu season in Canada this year. This move was facilitated by the Public Health Agency of Canada (PHAC) and Health Canada in response to higher than expected demand for the drug.

The agency’s Director of Pandemic Preparedness stated that “given that we are still in the midst of influenza season and given that we certainly do not want to have any kind of supply disruption at this point in time, the Public Health Agency Canada … has elected to work with Roche to ensure that there will be no supply disruption.”

The primary maxim of Evidence-Based Medicine- the whole point of EBM, really- is that clinical decisions should be made according to the best available evidence. We don’t profess to know all the evidence behind what should be stockpiled at a national level in Canada or elsewhere. This complex practice requires an enormous amount of evidence review and surveillance data to determine what will (and could) be needed to safeguard a country.

But we do know something about the evidence base for neuraminidase inhibitors, and the recent controversy about Roche’s withholding of clinical trial data on the use of these drugs to treat influenza. Tom Jefferson and colleagues’ 2009 systematic review and meta-analysis of available data is a great starting point, and notes that publicly available studies, taken together, suggest “modest effectiveness of neuraminidase inhibitors against the symptoms of influenza in otherwise healthy adults”. More importantly, though, their study goes on to note that a “paucity of good data has undermined previous findings for oseltamivir’s prevention of complications from influenza” and that “independent randomized trials to resolve these uncertainties are needed.”

When they reviewed the evidence again in 2012, they were unable to access full clinical study reports despite requesting them from the manufacturer. They concluded that “a high risk of publication and reporting biases in the trial programme of oseltamivir” precluded being able to properly assess the evidence of its effectiveness.

Without this data being available, then, the evidence to support using Tamiflu is questionable at best, and certainly not strong enough to justify stockpiling hundreds of millions of dollars of it for national pandemic preparedness.

What has the PHAC done about this? In 2010, the CMAJ reported that the PHAC reviewed the results of the aforementioned systematic review but “the articles published in the BMJ do not change [the] Public Health Agency of Canada’s advice with respect to the use of antivirals with the H1N1 flu virus.”

The BMJ has taken up this issue of missing clinical trial data, and is pressing Roche to release all its data on Tamiflu trials, and clinical epidemiologists are trying to obtain this data to properly analyze it. Only then, will we know if this drug is truly effective, and if the enormous sum spent on stockpiles around the world was worth it.

The Alltrials petition we wrote about last week is another example of an attempt to remove this critical impediment to scientific progress, and ensure all the necessary evidence is available for decision-making.

Ultimately the decision to prescribe is made by a practitioner acting in patient’s best interest. Beyond understanding relevant guidelines and public health recommendations, we encourage individual practitioners to familiarize themselves with the best available evidence to be the best for their patients. As it stands, we’re slightly bewildered as to PHAC’s decision to promote Tamiflu so strongly, and that’s why we encourage individual practitioners to make their own decisions using the best, most recent evidence.

 

-Originally posted on the EvidenceLive blog at http://www.evidencelive.org/blog

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Mammography- more harm than good?

Since its development, mammography has been considered one of the most impressive advances in cancer screening. It is thought of as an essential tool in reducing morbidity and mortality from this highly prevalent disease.

Every woman who has undergone mammography knows the anxiety of waiting for her test results. For most people in this situation, the results are anxiety- relieving, and no further management is indicated. But for a few, the results will mean more tests, and more anxiety. Some of these women will turn out to have invasive breast cancer, and their lives will be saved because of screening. Others will undergo additional testing and it will turn out that they did not have invasive (or potentially invasive) breast cancer, because all screening carries with it the risk of false positives. When the benefits outweigh the harms, screening is justified.

This is why we are so excited to have Peter Gøtzsche- Director of the Nordic Cochrane Centre in Copenhagen and author of Mammography Screening: Truth, Lies and Controversy – speaking at EvidenceLive 2013. He has a different take on breast cancer screening, and is very concerned with the possibility that theharms of mammography outweigh its benefits. According to Gøtzsche, this is a big problem, and one that we should take very seriously in developing health services and deciding what is best for individual patients.

But not everyone supports these findings. Jack Cuzick, Professor at Barts and the London School of Medicine and a leading researcher in cancer screening (having been one of the first to show that tamoxifen reduces the risk of contralateral tumours), recently raised concerns regarding the Cochrane systematic review that supports Gøtzsche’s claims. Cuzick recently asserted that Gøtzsche’s desire to abandon screening altogether “has detracted from efforts to improve breast cancer screening” and has been detrimental to what should be the real goal: to refine and advance screening in order to reduce morbidity and mortality from breast cancer.

Here’s my question to you: What do you think about the role of mammography in modern healthcare?

 

-Originally posted on the EvidenceLive blog at http://www.evidencelive.org/blog

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Autism and vaccination again? Really?

Most readers will be all too familiar with Dr Andrew Wakefield’s absurd, now fully retracted and discredited (the same goes for his medical license, thankfully) 1998 study suggesting a link between autism and vaccination. Dr Wakefield’s science was shoddy, and his conflicts of interest were both remarkable and undisclosed. In short, we feel confident describing this as low quality evidence with a high risk of bias if we have ever seen it. When a ‘researcher’ takes blood samples from guests at his child’s birthday party you know there’s trouble.

Unfortunately, Wakefield’s study was published by one of the highest-impact journals in medicine, and the story took off and became the cause celebre of Hollywood celebrities and pseudo-practitioners. Whereas measles had been all but eliminated and vaccination rates reassuringly high before this, there are now more and more reports of measles outbreaks due to reduced vaccine uptake.

Which is why we find it so disturbing that the New York Times recently ran an article entitled “An immune disorder at the root of autism” .The author, who is noted at the end of the article as having a forthcoming book on the topic (“An Epidemic of Absence: A New Way of Understanding Allergies and Autoimmune Diseases”), espouses baseless conspiracy theories loosely based on Wakefield’s discredited work, combining it with the “hygiene hypothesis” into a new form of propaganda. He even goes as far as to suggest that there is a “subset of autism–perhaps one third and very likely more—[that] looks like a type of inflammatory disease. And it begins in the womb.” What references, what science to back this up? It’s entirely unclear. Maybe you have to buy the book to find out.

As clinicians, researchers, and patients, we depend on methodologically sound studies to sort out what is effective and what is spurious or harmful. Then, conclusions need to be supported by the data, rather than baseless generalizations and conjectures. If the evidence isn’t there, or people (even unintentionally) mislead the public through overreaching the available evidence, researchers fail to fulfill our obligation to help people make the best choices possible. Effectively communicating evidence to the public for this purpose is a major part of evidence-based medicine.

That’s why we are privileged to have investigative journalist Brian Deer speaking at Evidence Live 2013. He was responsible for bringing forward the truth about Dr Wakefield’s gross scientific misconduct. His work exemplifies the importance of effectively communicating evidence to the people who need it most. If you’re interested in these issues, you should join us.

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