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January 2011

The gaps between evidence, quality and policy

Ami Banerjee
Last edited 21st January 2011

Microcredit is an idea that has won the brains behind it, Professor Muhammad Yunus, a Nobel Peace Prize, and has received billions of dollars in terms of global funding. The idea was simple: very small loans could make a disproportionate difference to a poor person, and so the Grameen Bank and many similar institutions like it have opened around the world. However, only one randomised control trial has ever been done for this intervention in Hyderabad and actually showed no benefit. So what we are saying is that billions of dollars have been spent with potentially no effect. Shouldn’t this study have been done earlier?

It got me thinking that regardless of the arena, whether policy, clinical practice, healthcare or economic, lack of the right kind of evidence can lead to the wrong intervention. As large-scale NHS reforms are upon us, this is particularly important.

Quality improvement is something which all adaptive organisations should be doing as part of their daily work, but it turns out that this fairly new discipline is gaining huge popularity because this vital component of clinical practice has been neglected.

In JAMA this week, the results of an RCT of a multi-centre, multi-component intervention to improve quality of intensive care were published. Like Atul Gawande’s surgical checklist, the authors took 6 quality measures that have been proven to improve patient outcomes(prevention of ventilator-associated pneumonia (VAP), prophylaxis for deep venous thrombosis (DVT), daily spontaneous breathing trials, prevention of catheter-related bloodstream infections, early enteral feeding, and prevention of decubitus ulcers) and looked at over 9000 ITU (intensive therapy unit) admissions across 15 Canadian hospitals.

ITUs were randomised to receive an intensive programme (including audit, video-conferencing and expert-led education) to increase adherence to these 6 measures or to continue normal practice. The authors found that the adoption of the 6 target measures was twice as likely in the intervention group, compared with the control group.

In an accompanying editorial, the urgent need for high quality science such as this complex trial, in quality improvement is highlighted. If it can be done in critical care medicine, then it can be done in any area of healthcare or policy. The fact that it was funded by a healthcare organisation as opposed to a central funding agency is also seen as a positive aspect, since all stakeholders have a part to play in improving quality and reducing costs. Those parties that argue that evidence is too difficult or takes too long might end up making costly mistakes.

The debate on the best way forward for primary prevention continues, and today cebmblog published:

Heneghan C. Considerable uncertainty remains in the evidence for primary prevention of cardiovascular disease [editorial]. The Cochrane Library 2011 19 Jan.

Cardiovascular disease (CVD) remains the leading cause of morbidity and mortality worldwide, and therefore strategies that aim to improve prevention in people without existing disease (primary prevention) are important for managing the overall burden of disease. This edition of The Cochrane Library adds to the evidence-base in this area with publication of two Cochrane Reviews on such preventive strategies: multiple risk factor interventions for primary prevention of coronary heart disease, and statins for the primary prevention of CVD. read more

One of my major issues with primary prevention is:
'Given the current limitations of the evidence-base, the alternative approach for policy is to focus on population-wide prevention. Widely publicised by Geoffrey Rose,legislating for smoke-free public spaces, re-designing public spaces to improve exercise or reducing daily dietary salt intake prove generally effective and can be cost-saving interventions.'

If you haven't already read a copy of Rose's book, you should,
get yourself a copy now. It should be compulsary reading for commissioners, docs and anyone involved in health prevention.

Ensuring safe and effective drugs: who can do what it takes?

Carl Heneghan
Last edited 12th January 2011

Today in the BMJ we have published on the current saga of ensuring the data and the problems we have found with the inconsistencies between what is published and what is in the Clinical study reports

In the last six months I have been working with a collabaration which includes Peter Doshi, Tom Jefferson Chrsi Del Mar, Matthew Thompson and a few other folk round the world. We have been busy returning to the problems with the evidence-base of Neuraminidase Inhibitors (e.g tamiflu) used extensively last year for swine flu and this year.

We met in Oxford in September to work out the methods for the analysis, this is what Tom Clarke of Channel 4 reported about the meeting at the time:

‘An international group of scientists has today raised further concerns about the lack of evidence supporting the safety and effectiveness of the blockbuster anti-flu drug Tamiflu.’

Our proposed new approach involves compiling a complete list of drug trials (published and unpublished) and requesting full clinical study reports. We have published a full protocol of what we are trying to do, prepared by the Acute Respiratory Infections Cochrane Review Group is available This will appear in issue 1, 2011 of the Cochrane Database of Systematic Reviews, due to be released on 19 January 2011.

"We do not yet know whether sound scrutiny is feasible with a journal's resources, but we intend to use the proposed review of neuraminidase inhibitors to attempt to quantify these tasks. We will be keeping a journal of our review with a resource tally, and proposing methods for in-depth scrutiny of a whole trial programme of a new drug. It is time the media, the Cochrane Collaboration, and any reader interested in knowing what they are prescribing or are being prescribed increase the pressure on policy makers. If you swallow a medication, you need to know how it works - for real."

We are therefore proposing a new approach that would allow in-depth scrutiny of the complete set of trial data for a new drug. As a result, Roche (oseltamivir’s manufacturer) publicly pledged to make full results for ten unpublished clinical trials available for scrutiny. Yet, to date, they have failed to fulfil this promise.

We are urging you as researchers, the public, and the media to work together to put pressure on industry to embrace the ethical responsibility to release data in the public interest. We are also calling on medical journals to require submission of the most detailed report available to allow independent scrutiny.

If you’ve got time we’d like you to comment on the protocol – the more feedback the better. Comments and feedback, should be send back to: cdelmar@bond.edu.au; jefferson.tom@gmail.com

Two years in blogging

Ami Banerjee
Last edited 7th January 2011

All great thoughts start in the pub. That is my conclusion nearly two years after I started blogging about evidence-based medicine and broader issues relating to healthcare with Carl Heneghan. Not satisfied with generally putting the world to rights over a pint, Carl and I decided that there was probably a space for our thoughts about EBM in the current blogsphere. After a process much like choosing the name for a newborn, we named our blog “Trusttheevidence.net” and enrolled help with the website side of things from our friend and IT expert, Al Pirrie. From the outset, we set out to give examples of good and bad research in the media relating to healthcare, with a particular emphasis on unpacking the numbers. The key was “giving it a go” and being prepared to learn and evolve.

A strength of our blog is that we are two different people with different outlooks and different ways of writing. Carl is a GP and Director of the Centre for Evidence Based Medicine, whereas I am a hospital-based cardiology registrar with a big interest in global health. Therefore, we are often drawn to different areas of the medical literature and news media. It is fair to say that we did not know where the blog would take us, but we wanted to take advantage of blogging as a means of disseminating stories about clinical evidence, and set out to try to write one story per week, which we have often exceeded when stories are too interesting to miss! From the dirth of research evidence for use of Tamiflu in swine flu to Barack Obama’s interest in EBM, from research ethics to cardiac rehabilitation, the stories have kept coming.

The first learning point for me has been the considerable connectivity that comes from having a blog. A blog is a totally blank canvas left to the individual’s discretion. We have used ours to give opinions, write educational pieces about EBM, dissect the statistics in scientific articles, exchange ideas with other interested parties and much more. The speed and breadth of response to the blog has often impressed us. A blog on swine flu which I wrote in August 2009 had over 1000 online hits within a couple hours. Timing seems to be important not only in the publication of research and news, but also blogs.

We are able to accurately map who is reading our blog and when, so that we can find out if we can “do it better”. Trusttheevidence.net has synergistically made us improve our methods of horizon scanning the news media, other blogs and scientific literature in the most efficient way possible. The speed of communication is phenomenal and we can now make use of all channels of research dissemination. The model of a journal publishing an article and waiting a few months for correspondence to be published in response is a dated, but largely universal concept, and blogging has opened my eyes to the possibilities of quicker peer review, greater openness of data and more discussion between researchers. The recent Evidence 2010 conference in November illustrated how greatly in need of change the existing culture of medical evidence really is, with representatives from all stakeholders in healthcare and from all over the world in agreement.

The surprise has been that keeping up-to-date does not have to be time-consuming although it does require organisation and having the right tools in the form of a smart phone, Twitter applications etc. This has allowed me to blog while at conferences, abroad or even during my clinical job as a cardiology trainee. It did however mean that laptops and smart phones were banned on my honeymoon this summer!

Our blog is transmitted via our blog website, Facebook and Twitter. We have been tweeting since June last year. The power of Twitter as a quick exchange of information and flagging up interesting new evidence or stories was totally unexpected, and it has probably surpassed blogging as a means of rapid scientific communication. Carl now manages the “cebmblog” Twitter account which now has over 1000 followers, and I recently decided to enter the brave new world of Twitter myself as “amibanerjee1”. I am totally sold on the tremendous scope of Twitter for good in EBM.

Carl is an experienced writer and blogging has given me the opportunity to firstly learn from him, but also to develop and practice my own style. I have particularly enjoyed the balances between opinion and evidence and between power of story and statistics. The chance to experiment which a blog affords is unparalleled, whether in the teaching of EBM or in posting immediate replies to controversial new research, such as vitamin B in Alzheimer’s disease or the predictive value of brain scanning in autism. We look forward to plenty more blogging in 2011!

The great swapthon: why the vouchers don't add up to much

Carl Heneghan
Last edited 3rd January 2011

The great swapthon

The BBC 'Great Swapathon' voucher bid to boost healthy living
A child eating a healthy lunch Families are being urged to swap the sugary snacks for strawberries or other healthy options

Families in England are to be offered £250m in vouchers in a bid to encourage them to eat healthily and exercise.

Apparently 4 million £50 voucher books will be on offer through the News of the World and Asda stores.

Health Secretary Andrew Lansley said: "It's a great example of how government, the media, industry and retailers can work together to help families to be healthy.

Is there any evidence-base for this?

Basically the money could go to 5 million familes if you give them £50. Therefore of the 16.5 million families in the UK about one in every three could get the money. see familes in Britain publication.

I filled in the questionnaire for me and my two kids, and this is the sort of advice I got

'Swap Fizzy drinks (and drinks with added sugars) for water, unsweetened juicds or milk',

'Swap fry up for grill-ups',

Swap creamy indian dishes for tomat-based sauces or grilled dishes

They then ask you to:

Tell us how it went?

Once you’ve tried your swap for a week, it’s time to share how it went. Your experiences and ideas are a valuable part of the Swapathon. Your shared tips help support everyone taking part, and encourage others on to make their own changes. See what our Swapathon community are saying.

The website annoying, it is slow, and its pretty one dimensional and repetitive. If I tried this for a week I'd be swapping my computer. In fact save your breath and swap this site for some exercise instead.

Are we surprized or do they think the public is stupid. Food policy experts have previously questioned the wisdom of allowing big brands to become involved in telling the public how to eat more healthily.

I say give the money to schools, they could do something useful with £250 million. I'll let you know when the adverts start to my email address

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