The University Library (UBA) goes Mobile.

4 04 2010
UBA mobielOur Medical Library at the AMC hospital is one of main (autonomous) libraries of the UBA, the University Library of the University of Amsterdam.

The UBA developed the Spoetnik (library 23 things-like) course -inspiring the start of this blog-, has a library-coach with chat function, a library blog (UBA-e), and is now on Twitter as @bibliotheekuva.
Plus, as I just learned, a small team of the UBA recently launched a mobile version of the library website.

I like their approach. This team consisting of Driek Heesakkers (project leader), Lukas Koster, Gre Ootjers, Roxana Popistasu en Alice Doek, realized this “perpetual beta version” in no more than 7 weeks (from first meeting till launch at April 1st). There aim was not to strive for perfection, but to develop a version first and to learn from their mistakes and the feedback from the users. Thus highly interactive.

Another excellent principle was that they designed ONE mobile app for all smart phones.

This is what UBA mobile offers right now:

  • The library catalog (searching; reserve items; renew loans)
  • Opening hours and addresses of library locations
  • Locations (on a map)
  • Contact phone numbers
  • Questions, feedback
  • News via @bibliotheekuva-tweets

The most important feature, full access to the digital library (with link to all subscriptions) is not yet realized.

I hope our medical library will follow this shining example. Many medical students and doctors use smart-phones and I’m sure a digital version of our medical library website would surely be appreciated by our clients.

Mobile is the future. What do you think?

Below a short and clear presentation by Lukas Koster at UGUL (UGame ULearn) 2010.

The web address of the mobile site is: http://cf.uba.uva.nl/mobiel.

Short notice about UBA mobile at the news section of the UBA.

Janneke Staaks (librarian for: Psychology, Cultural Anthropology and Pedagogical and Educational Sciences) has dealt more in depth with this subject. See this post at her (Dutch) blog FMG Library.

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Health Care Reform 2010- Obama, USA, Bill, Dutch, Plan, Doctors, Letterman, Pills, $ & other Random Thoughts

30 03 2010

“I do believe the only way we can end all preventable deaths and the suffering of millions is to provide decent health care to all.”
Hilary Benn, 2006
———————

The next Grand Rounds will be hosted by Evan Falchuk at SEE FIRST (Insights into the Uncertain World of Healthcare).  Evan’s theme is Health Care Reform.

How will it affect your life, your medical practice, your experience as a patient, as an insured, an employer, an employee, someone without insurance?  What are your reactions to the politics, and what do you think will happen next?  I’m asking for your candid views on health care reform seen from whatever perspective you bring.  Medicine, politics, business, humor, left, right, center, up, down, you name it.

Health Care Reform has been a theme more than once in this Grand Rounds, i.e. February 10th at the Health Care Blog, and at Obama’s inauguration day (Ten Suggestions For Healthcare Reform) by Val Jones, MD.

The question is which health care reform? Because after all, this is an international Grand Round with bloggers from the US, Europe, Africa, Australia & Asia.
Probably, just as Google.nl (Dutch) already suggests the theme is meant to be about the USA health care bill of Obama, the future plan, and its costs (see Google Fig).

Since I’m from the Netherlands my non-US readers probably need an introduction first:

Recently  the Patient Protection and Affordable Care Act (known as the “Senate bill”) became law on March 23, 2010 and was shortly thereafter amended by the Health Care and Education Reconciliation Act of 2010 and passed by both houses on March 25 without any support from republicans (source: Wikipedia).  Please see Reuters and CNN for an overview of the March 2010 reforms and the year in which they take effect  and the New York Times [1] for the effect per types of household (i.e. Fig. at the right)

The legislation will tighten regulation of insurance companies and is expected to extend medical coverage to more than 30 million uninsured Americans. As explained by Barack Obama in the CNN-video [2] below, it will take 4 years to implement fully may of these reforms, but some desperately needed reforms will take effect right away.  For instance, having a child with a pre-existing medical condition will no longer be the basis for denial of coverage or higher premiums in the old system.

Vodpod videos no longer available.
more about “Health Care:What happens when”, posted with vodpod

As a Dutch citizen, I simply can’t imagine that an insurance would be refused because my girl has asthma and I would to have pay a lot more because I happen to have a chronic disease. I can’t imagine that so many people (from a rich country) are uninsured.

As of January 2006 Our Dutch Health Care has been reformed as well. (Officially) there is no longer a fragmented system with compulsory social insurance for the majority and private health care insurance for people with a higher income. Now there is a standard insurance for all, where the insurers have to accept all patients, with no difference in premium, and no surcharges. Children up to the age of 18 years are insured for free.
Both employer and  government will contribute to the Health Insurance fund, and the insured will pay a nominal premium for their standard insurance directly to the health insurer. People with a low income can apply for a care allowance.
To avoid that health insurers seek to avoid less healthy clients, insurers are entitled to compensation for expensive customers. Although not as ideal as conveyed by the Dutch Government in their commercial-like video [3] (a too central role for the insurers, considerably less covered by the basic health insurance) it still is a pretty good and affordable health care system.

Vodpod videos no longer available.

more about “MinVWS | The new health care system i…“, posted with vodpod [press T for English translation]

It is often difficult to imagine how things work in another country unless you’ve been there or hear it through somebody else.

A Dutch correspondent in the US, Tom-Jan Meeus wrote a eye-opening article in the Dutch NRC newspaper [4] about the US health care.

When Meeus collected his first prescriptions from a US pharmacy, he had to pay six times as much for the same pills (same brand, logo, packing) as in the Netherlands. And he was even more surprised that the prices were negotiable. But he got used to the US health care system: he gets an expensive check-up each 2 months instead of the once yearly (when needed) doctor visit back in Holland. In this way his doctor safeguards himself against health insurance claims. Furthermore, his doctor “has to keep the pot boiling too”.
This man knows many influential people and has valuable inside information, i.e. about the health status (botox, psychoses) of some of the key players in the health care system. In addition, he was one of the doctors who thwarted Clintons Health Reform: his glory years. This friendly conservative doctor wants freedom of choice, for himself and his patients. When Meeus objects that this freedom of choice becomes a little expensive, the doctor argues that top health care costs a little (US doctors know they are “the best in the world”)  and continues: “do you really think the health care becomes any cheaper when Obama subsidizes 30 million people to get insured? Hanky Panky, that is what it is.” But he knows a way to circumvent the rules. He cut the ties with two insurance companies that reimburse too little. “Perhaps, we can’t stop Obama, but we can undermine him. Why should we help people when we don’t make money out of it…”.

Hopefully not all the doctors think this way (I’m sure the blogging doctors that I know, don’t), but lets give a moments thought to two statements: That the US Healthcare is “the best” (as it is) and that the new health care system costs too much.

We first have to find out whether the money was well spend before the health care renewal.

I’ve shown the figures before (see [5] and [6]), but here are some other representations.

1. According to the Organization for Economic Cooperation and Development (OECD), the US spent 15.3 percent of its GDP on health care in 2006 and this number is rising. As you can see this is far more than the other countries spend.

This trend was already visible in the early eighties: the last 10-20 years the US spend far more money on health care than other rich countries..


And although the U.S. Medicare coverage of prescription drugs began in 2006, most patented prescription drugs are more costly in the U.S. than in most other countries. Factors involved are the absence of government price controls (Wikipedia).

Perhaps, surprisingly, the higher health expenditure hasn’t lead o a higher life expectancy. (78 years in the US versus 82 years in Japan in 2007). The differences are huge if one plots health spending per capita against life expectancy at birth.

Just like the international comparison, higher health care expenditures in different parts of America don’t result in a better health care for all this extra spending. Miami spends 3 times as much money per person health care than Salem (Oregon). Many doctors in Miami, for instance, perform a bunch of tests, like ECG’s, after chest complaints, because they have the necessary devices, not because all these tests have proven useful. Despite all expensive tests and treatments, Miami (and comparable great spenders)  has the worst death rate following a heart attack.* [ source, video in ref 5 and the Organisation for Economic Co-operation and Development’s Health Data 2009 site.]

And this is how the US health care works:  simply more treatments and tests are available, but the incentives are wrong: physicians are paid for the quantity of care not the quality.

Just like the doctor of Tom-Jan Meeus, who did a two-monthly unnecessary check-up.

Or as the internist Lisa Bernstein suggests in the New York Times [7]:

For instance, if an asymptomatic, otherwise healthy, patient comes to me wanting a whole-body CT scan to make sure they do not have something bad hiding inside of them, I would decline and educate him or her that there is no data to show that this test has any significant benefit to offset the potential radiation or other harm and the major medical societies do not recommend this test.”

Mind you this is the situation before the current health care reform.

But there is another thing not yet addressed: the expectations of the US-citizens. Americans (and more and more Europeans too) want those check-ups and screenings, because it gives them a (false) feeling of security and because they feel they have the right. That is why it is so difficult for people to give up unnecessary CT-scans, PSA-screening and mammograms.

One reason why Americans have a higher risk for certain diseases (diabetes, overweight, cardiovascular diseases) might be their lifestyle. And lifestyle is something you can change to a certain extent and can have great effects on your health. Lifestyle is also something you can learn. You can learn to enjoy good food, you can avoid the 3 times daily coca cola  and it can be fun to do some exercise or for children to play outside. But still some people rather have a pill to stay healthy or  undergo all kind of (poor performing) tests to see how they’re doing.

Am I exaggerating?

No. This is reality. A few days ago. I saw Letterman in his show [8] telling Jamie Oliver (on his crusade to change the US diet habits) that “he believed diet pills were the only successful way to lose weight in the U.S. and that he expected humans to ‘evolve to the point where 1,000 years from now we all weigh 500-600lbs and it will be OK’ and that “If you would go to doctor they would be happy to give you as many pills as you need and you weight 80 pounds”

Do I fail to see Lettermans warped sense of humor?

Does he really belief this? And, more important, does the majority of Americans believe this?

For here is much to gain, both in health and health care costs.

* As far as I can tell these are only associations; other possible reasons are not taken into consideration: busy live in a metropolis or the population composition might also play a role.

Main References (all accessed 29 March 2010)

  1. NY-Times (2010/03/24) How Different Types of People Will Be Affected by the Health Care Overhaul.
  2. CNN.com (2010/03/23) Health care timeline (including video)
  3. Ministerie van VWS: The new health care system in the Netherlands
  4. NRC (2010/03/20) Tom-Jan Meeus: Mijn dokter won ook van Clinton (Dutch; subscription required).
  5. Laika’s MedLibLog (2009/09/10) Visualization of  paradoxes behind US Health Care.
  6. Laika’s MedLibLog (2009/09/25) Friday Foolery [4]: Maps & Mapping.
  7. NY Times.com (2010/03/27) health/27patient.html?src=twt&twt=nytimeshealth.
  8. The dail Mail UK (Last updated 210-03-25). Simon Cable. Don’t cry Jamie! Now David Letterman lectures Oliver and says his healthy eating crusade won’t work in America

Photo Credits

This map shows the ability of the health service of each territory to provide good basic health care to a number of people. The health service quality score for 1997 was applied to the population. The world average score for health service quality was 72 out of 100. This means that the equivalent of 4.5 billion people had access to good basic health care.The populations with the poorest health care provision live in Sierra Leone and the Central African Republic. The Sierra Leonean health system scored 36 out of 100 – that is half the world average score. Note that only the most basic care is measured here.
“I do believe the only way we can end all preventable deaths and the suffering of millions is to provide decent health care to all.” Hilary Benn, 2006 Territory size shows the proportion of people worldwide who receive good basic health care that live there.




#SillySaturday #17 – Social Media Stats per Second

13 02 2010
Vodpod videos no longer available.
more about “Garys Social Media Count“, posted with vodpod

Some time ago I saw the above Real Time Social Media Stats Counter at Heidi Allen Online (see here), the blog of Heidi Allen. The live stats meter is actually from Gary Hayes at Personalize Media (see post: Garys Social Media Count).

You can find the embed code at Gary Hayes post. I used the above Vodpod video, because WordPress won’t allow flash.

Yesterday, I saw a similar stats counter (in Dutch) at the excellent Dutch Education Blog  Trendmatcher tussen ICT en Onderwijs (see here) of @trendmatcher (Willem Karrsenberg). Willem saw these real time stats presented in a powerpoint presentation by Toine Maes, director of  “Kennisnet” (~”Knowledge network”). Later he asked Toine how he managed to get these dynamic stats in his slide. Of course it is great to show such a slide in a class room, or at other occasions.

At his blog Willem explains what it takes to make a slide with real life counters yourself. You need the Cortona 3D viewer (download here), that can be embedded in a browser or in Powerpoint. And you need the definition file with the actual formulas.  He made an example of a presentation and has made all files public (download here).

For people (like me) who find this all too complicated he made a simple one minute Flickr-video (FF) you can use instead. I converted this again to a Vodpod video, which easily picks up the embed code (Add-on in FireFox) and can be directly imported into WordPress.

Vodpod videos no longer available.

Willem  notes that he doesn’t know if the actual figures are correct. Bas Jonkers of Kennislink commented that the numbers are based on recent data, mostly from indirect sources. With the Cortona 3D viewer you can see the updated data here

Gary Hayes at Personalize Media shares his sources at his blog. The dates are less recent because his post dates from September 2009, but he will update the data from time to time.

For instance:

  • 20 hours of video uploaded every minute onto YouTube (source YouTube blog Aug 09)
  • Facebook 600k new members per day, and photos, videos per month, 700mill & 4 mill respectively (source Inside Facebook Feb 09)
  • Twitter 18 million new users per year & 4 million tweets sent daily (source TechCrunch Apr 09)
  • 900 000 blogs posts put up every day (source Technorati State of the Blogosphere 2008)
  • UPDATE: YouTube 1Billion watched per day SMH (2009)- counter updated!
  • Flickr has 73 million visitors a month who upload 700 million photos (source Yahoo Mar 09)
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#NotSoFunny #16 – Ridiculing RCTs & EBM

1 02 2010

I remember it well. As a young researcher I presented my findings in one of my first talks, at the end of which the chair killed my work with a remark, that made the whole room of scientists laugh, but was really beside the point. My supervisor, a truly original and very wise scientist, suppressed his anger. Afterwards, he said: “it is very easy ridiculing something that isn’t a mainstream thought. It’s the argument that counts. We will prove that we are right.” …And we did.

This was not my only encounter with scientists who try to win the debate by making fun of a theory, a finding or …people. But it is not only the witty scientist who is to *blame*, it is also the uncritical audience that just swallows it.

I have similar feelings with some journal articles or blog posts that try to ridicule EBM – or any other theory or approach. Funny, perhaps, but often misunderstood and misused by “the audience”.

Take for instance the well known spoof article in the BMJ:

“Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials”

It is one of those Christmas spoof articles in the BMJ, meant to inject some medical humor into the normally serious scientific literature. The spoof parachute article pretends to be a Systematic Review of RCT’s  investigating if parachutes can prevent death and major trauma. Of course, no such trial has been done or will be done: dropping people at random with and without a parachute to proof that you better jump out of a plane with a parachute.

I found the article only mildly amusing. It is so unrealistic, that it becomes absurd. Not that I don’t enjoy absurdities at times, but  absurdities should not assume a live of their own.  In this way it doesn’t evoke a true discussion, but only worsens the prejudice some people already have.

People keep referring to this 2003 article. Last Friday, Dr. Val (with whom I mostly agree) devoted a Friday Funny post to it at Get Better Health: “The Friday Funny: Why Evidence-Based Medicine Is Not The Whole Story”.* In 2008 the paper was also discussed by Not Totally Rad [3]. That EBM is not the whole story seems pretty obvious to me. It was never meant to be…

But lets get specific. Which assumptions about RCT’s and SR’s are wrong, twisted or put out of context? Please read the excellent comments below the article. These often put the finger on the spot.

1. EBM is cookbook medicine.
Many define EBM as “make clinical decisions based on a synthesis of the best available evidence about a treatment.” (i.e. [3]). However, EBM is not cookbook medicine.

The accepted definition of EBM  is “the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients” [4]. Sacket already emphasized back in 1996:

Good doctors use both individual clinical expertise and the best available external evidence, and neither alone is enough. Without clinical expertise, practice risks becoming tyrannised by evidence, for even excellent external evidence may be inapplicable to or inappropriate for an individual patient. Without current best evidence, practice risks becoming rapidly out of date, to the detriment of patients.


2. RCT’s are required for evidence.

Although a well performed RCT provides the “best” evidence, RCT’s are often not appropriate or indicated. That is especially true for domains other than therapy. In case of prognostic questions the most appropriate study design is usually an inception cohort. A RCT for instance can’t tell whether female age is a prognostic factor for clinical pregnancy rates following IVF: there is no way to randomize for “age”, or for “BMI”. 😉

The same is true for etiologic or harm questions. In theory, the “best” answer is obtained by RCT. However RCT’s are often unethical or unnecessary. RCT’s are out of the question to address whether substance X causes cancer. Observational studies will do. Sometimes cases provide sufficient evidence. If a woman gets hepatic veno-occlusive disease after drinking loads of a herbal tea the finding of  similar cases in the literature may be sufficient to conclude that the herbal tea probably caused the disease.

Diagnostic accuracy studies also require another study design (cross-sectional study, or cohort).

But even in the case of  interventions, we can settle for less than a RCT. Evidence is not present or not, but exists on a hierarchy. RCT’s (if well performed) are the most robust, but if not available we have to rely on “lower” evidence.

BMJ Clinical Evidence even made a list of clinical questions unlikely to be answered by RCT’s. In this case Clinical Evidence searches and includes the best appropriate form of evidence.

  1. where there are good reasons to think the intervention is not likely to be beneficial or is likely to be harmful;
  2. where the outcome is very rare (e.g. a 1/10000 fatal adverse reaction);
  3. where the condition is very rare;
  4. where very long follow up is required (e.g. does drinking milk in adolescence prevent fractures in old age?);
  5. where the evidence of benefit from observational studies is overwhelming (e.g. oxygen for acute asthma attacks);
  6. when applying the evidence to real clinical situations (external validity);
  7. where current practice is very resistant to change and/or patients would not be willing to take the control or active treatment;
  8. where the unit of randomisation would have to be too large (e.g. a nationwide public health campaign); and
  9. where the condition is acute and requires immediate treatment.
    Of these, only the first case is categorical. For the rest the cut off point when an RCT is not appropriate is not precisely defined.

Informed health decisions should be based on good science rather than EBM (alone).

Dr Val [2]: “EBM has been an over-reliance on “methodolatry” – resulting in conclusions made without consideration of prior probability, laws of physics, or plain common sense. (….) Which is why Steve Novella and the Science Based Medicine team have proposed that our quest for reliable information (upon which to make informed health decisions) should be based on good science rather than EBM alone.

Methodolatry is the profane worship of the randomized clinical trial as the only valid method of investigation. This is disproved in the previous sections.

The name “Science Based Medicine” suggests that it is opposed to “Evidence Based Medicine”. At their blog David Gorski explains: “We at SBM believe that medicine based on science is the best medicine and tirelessly promote science-based medicine through discussion of the role of science and medicine.”

While this may apply to a certain extent to quack or homeopathy (the focus of SBM) there are many examples of the opposite: that science or common sense led to interventions that were ineffective or even damaging, including:

As a matter of fact many side-effects are not foreseen and few in vitro or animal experiments have led to successful new treatments.

At the end it is most relevant to the patient that “it works” (and the benefits outweigh the harms).

Furthermore EBM is not -or should not be- without consideration of prior probability, laws of physics, or plain common sense. To me SBM and EBM are not mutually exclusive.

Why the example is bullshit unfair and unrealistic

I’ll leave it to the following comments (and yes the choice is biased) [1]

Nibu A George,Scientist :

First of all generalizing such reports of some selected cases and making it a universal truth is unhealthy and challenging the entire scientific community. Secondly, the comparing the parachute scenario with a pure medical situation is unacceptable since the parachute jump is rather a physical situation and it become a medical situation only if the jump caused any physical harm to the person involved.

Richard A. Davidson, MD,MPH:

This weak attempt at humor unfortunately reinforces one of the major negative stereotypes about EBM….that RCT’s are required for evidence, and that observational studies are worthless. If only 10% of the therapies that are paraded in front of us by journals were as effective as parachutes, we would have much less need for EBM. The efficacy of most of our current therapies are only mildly successful. In fact, many therapies can provide only a 25% or less therapeutic improvement. If parachutes were that effective, nobody would use them.
While it’s easy enough to just chalk this one up to the cliche of the cantankerous British clinician, it shows a tremendous lack of insight about what EBM is and does. Even worse, it’s just not funny.

Aviel Roy-Shapira, Senior Staff Surgeon

Smith and Pell succeeded in amusing me, but I think their spoof reflects a common misconception about evidence based medicine. All too many practitioners equate EBM with randomized controlled trials, and metaanalyses.
EBM is about what is accepted as evidence, not about how the evidence is obtained. For example, an RCT which shows that a given drug lowers blood pressure in patients with mild hypertension, however well designed and executed, is not acceptable as a basis for treatment decisions. One has to show that the drug actually lowers the incidence of strokes and heart attacks.
RCT’s are needed only when the outcome is not obvious. If most people who fall from airplanes without a parachute die, this is good enough. There is plenty of evidence for that.

EBM is about using outcome data for making therapeutic decisions. That data can come from RCTs but also from observation

Lee A. Green, Associate Professor

EBM is not RCTs. That’s probably worth repeating several times, because so often both EBM’s detractors and some of its advocates just don’t get it. Evidence is not binary, present or not, but exists on a heirarchy (Guyatt & Rennie, 2001). (….)
The methods and rigor of EBM are nothing more or less than ways of correcting for our
imperfect perceptions of our experiences. We prefer, cognitively, to perceive causal connections. We even perceive such connections where they do not exist, and we do so reliably and reproducibly under well-known sets of circumstances. RCTs aren’t holy writ, they’re simply a tool for filtering out our natural human biases in judgment and causal attribution. Whether it’s necessary to use that tool depends upon the likelihood of such bias occurring.

Scott D Ramsey, Associate Professor

Parachutes may be a no-brainer, but this article is brainless.

Unfortunately, there are few if any parallels to parachutes in health care. The danger with this type of article is that it can lead to labeling certain medical technologies as “parachutes” when in fact they are not. I’ve already seen this exact analogy used for a recent medical technology (lung volume reduction surgery for severe emphysema). In uncontrolled studies, it quite literally looked like everyone who didn’t die got better. When a high quality randomized controlled trial was done, the treatment turned out to have significant morbidity and mortality and a much more modest benefit than was originally hypothesized.

Timothy R. Church, Professor

On one level, this is a funny article. I chuckled when I first read it. On reflection, however, I thought “Well, maybe not,” because a lot of people have died based on physicians’ arrogance about their ability to judge the efficacy of a treatment based on theory and uncontrolled observation.

Several high profile medical procedures that were “obviously” effective have been shown by randomized trials to be (oops) killing people when compared to placebo. For starters to a long list of such failed therapies, look at antiarrhythmics for post-MI arrhythmias, prophylaxis for T. gondii in HIV infection, and endarterectomy for carotid stenosis; all were proven to be harmful rather than helpful in randomized trials, and in the face of widespread opposition to even testing them against no treatment. In theory they “had to work.” But didn’t.

But what the heck, let’s play along. Suppose we had never seen a parachute before. Someone proposes one and we agree it’s a good idea, but how to test it out? Human trials sound good. But what’s the question? It is not, as the author would have you believe, whether to jump out of the plane without a parachute or with one, but rather stay in the plane or jump with a parachute. No one was voluntarily jumping out of planes prior to the invention of the parachute, so it wasn’t to prevent a health threat, but rather to facilitate a rapid exit from a nonviable plane.

Another weakness in this straw-man argument is that the physics of the parachute are clear and experimentally verifiable without involving humans, but I don’t think the authors would ever suggest that human physiology and pathology in the face of medication, radiation, or surgical intervention is ever quite as clear and predictable, or that non-human experience (whether observational or experimental) would ever suffice.

The author offers as an alternative to evidence-based methods the “common sense” method, which is really the “trust me, I’m a doctor” method. That’s not worked out so well in many high profile cases (see above, plus note the recent finding that expensive, profitable angioplasty and coronary artery by-pass grafts are no better than simple medical treatment of arteriosclerosis). And these are just the ones for which careful scientists have been able to do randomized trials. Most of our accepted therapies never have been subjected to such scrutiny, but it is breathtaking how frequently such scrutiny reveals problems.

Thanks, but I’ll stick with scientifically proven remedies.

parachute experiments without humans

* on the same day as I posted Friday Foolery #15: The Man who pioneered the RCT. What a coincidence.

** Don’t forget to read the comments to the article. They are often excellent.

Photo Credits

ReferencesResearchBlogging.org

  1. Smith, G. (2003). Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials BMJ, 327 (7429), 1459-1461 DOI: 10.1136/bmj.327.7429.1459
  2. The Friday Funny: Why Evidence-Based Medicine Is Not The Whole Story”. (getbetterhealth.com) [2010.01.29]
  3. Call for randomized clinical trials of Parachutes (nottotallyrad.blogspot.com) [08-2008]
  4. Sackett DL, Rosenberg WM, Gray JA, Haynes RB, & Richardson WS (1996). Evidence based medicine: what it is and what it isn’t. BMJ (Clinical research ed.), 312 (7023), 71-2 PMID: 8555924
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are very well edged off




Haiti still needs help

21 01 2010

Usually, I don’t grant requests for help “to get the word out”. But I will make an exception for a good cause: Haiti.

You could help Haiti by supporting the International Medical Corps (IMC).

The IMC is a global, humanitarian, nonprofit organization, founded by volunteer doctors and nurses in 1984 and dedicated to saving lives and relieving suffering through relief and development programs. Their emergency response team is in Haiti responding in force, but there are still thousands of patients seeking treatment of which approximately 80% are in need of surgery and are running out of time – especially with the tremendous aftershocks still devastating this country. The team is treating crush injuries, trauma, substantial wound care, shock and other critical cases with the few available supplies – And they’re in it for the long haul.

You can help by donating funds, volunteering in Haiti, or just spreading the word (i.e. putting a widget on your site or or Tweeting this )

Want to know more about IMC’s rescue efforts, see:  http://www.imcworldwide.org/haiti

Here you can also donate to help people of Haiti.

Donating $10 to help the people of Haiti is as simple as sending a text message of the word “haiti” to 85944. But other ways are also possible, i.e. click on the red widget on the left.

Importantly, IMC is highly efficient as 92% of their resources go directly to program activities.

————————————
Nederlanders kunnen ook deze internationale organisatie ondersteunen.

Daarnaast kunt ook terecht bij het oude vertrouwde noodhulp gironummer 555, dat nu speciaal opengesteld is voor Haiti (zie bijvoorbeeld NRC-next). U steunt daarmee wel andere organisaties, die noodhulp geven.

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NOT ONE RCT on Swine Flu or H1N1?! – Outrageous!

16 12 2009

Last week doctorblogs (Annabel Bentley) tweeted: “Outrageous- there isn’t ONE randomised trial on swine flu or #H1N1

Annabel referred to an article at Trust the Evidence, the excellent blog of the Centre for Evidence-Based Medicine (CEBM) in Oxford, UK.

In the article “Is swine flu the most over-published and over-hyped disease ever?Carl Heneghan first showed the results of a quick PubMed search using the terms ‘swine flu’ and ‘H1N1’: this yielded 4,475 articles on the subject, with approximately one third (1,437 articles) published in the last 7 months (search: November 27th). Of these 107, largely news articles, were published in the BMJ, followed by the Lancet and NEJM at 35 each.

Top News stories on H1N1 generated appr. 2000 to 4000 news articles each (in Google). Items included outbreak of a new form of ‘swine flu’ which prompted the United States and the World Health Organization to declare a public health emergency (April), Southern Hemisphere being mostly spared in the swine flu epidemic (May), Tamiflu, i.e. the effects of Tamiflu in children in the BMJ (co-authored by Carl) in August and the availability of the vaccine H1N1 vaccine clinics to offer seasonal flu shots in November.

According to Heneghan this must be the most over-hyped disease ever, and he wonders: “are there any other infections out there?”

Finally he ends with: Do you know what the killer fact is in all of this? There isn’t one randomized trial out there on swine flu or H1N1 – outrageous.”

My first thoughts were: “is H1N1 really so over-published compared to other (infectious) diseases?”, “Is it really surprising that there are no RCTs yet? The H1N1-pandemics just started a few months ago!” and even “are RCT’s really the study designs we urgently need right now?”

Now the severity of the H1N1 flu seems less than feared, it is easy to be wise. Isn’t is logic that there are a lot of “exploratory studies” first: characterization of the virus, establishing the spread of H1N1 around the world, establishing mortality and morbidity, and patterns of vulnerability among the population? It is also understandable that a lot of news articles are published, in the BMJ or in online newspapers. We want to be informed. In the Netherlands we now have a small outbreak of Q-fever, partly because the official approach was slow and underestimated the public health implications of Q-fever. So the public was really underinformed. That is worse than being “overexposed”.

News often spreads like wildfire, that is no news. When I google “US Preventive Services Task Force” (who issued the controversial US breast cancer screening guidelines last month) 2,364 hits still pop up in Google News (over the last month). All papers and other news sources echo the news. 2,000 hits are easily reached.

4,475 PubMed articles on ‘swine flu’ and ‘H1N1’ isn’t really that much. When I quickly search PubMed for the rather “new” disease Q-fever I get 3,752 hits, a search for HPV (Alphapapillomavirus OR papilloma infections OR HPV OR human papilloma virus) gives 19,543 hits (1,330 over the last 9 months), and a quick search for (aids) AND “last 9 months”[edat] yields 4,073 hits!

The number of hits alone doesn’t mean much, certainly not if news, editorials and comments are included. But lets go to the second comment, that there is “not ONE RCT on H1N1.”

Again, is it reasonable to expect ONE RCT published and included in PubMed over a 9 month period? Any serious study takes time from concept to initiation, patient-enrollment, sufficient follow-up, collection of data, writing and submitting the article, peer review, publication, inclusion in PubMed and assignment of MeSH-terms (including the publication type “Randomized Controlled Trial”).

Furthermore RCTs are not always the most feasible or appropriate study designs for answering certain questions. For instance for questions related to harm, etiology, epidemiology, spreading of virus, characteristics, diagnosis and prognosis. RCTs may be most suitable to evaluate the efficacy of treatment or prevention interventions. Thus in case of H1N1 the efficacy of vaccines and of neuraminidase inhibitors to prevent or treat H1N1 flu. However, it may not always be ethical to do so (see below).

I’ve repeated the search, and using prefab “My NCBI filters” for RCTs discussed before I get the following results:

Using the Randomized Controlled Trials limits in PubMed I do get 7 hits, and using broader filters, like the Therapy/Narrow Filter under  Clinical Queries I even find 2 more RCTs that have not yet been indexed by PubMed. With the Cochrane Highly sensitive Filter even more hits are obtained, most of which are “noise”, inherent to the use of a broad filter.

The found RCTs are safety/immunogenicity/stability studies of subunit or split vaccines to H1N1, H3N2, and B influenza strains. This means they are not restricted to H1N1, but this is true for the entire set of H1N1 publications. 40 of the 1443 hits are even animal studies. Thus the total number of articles dealing with H1N1 only -and in humans- is far less than 1443.
By the way, one of the 15 H1N1-hits in PubMed obtained with the SR-filter (see Fig) is a meta-analysis of RCTs in the BMJ, co-authored by Heneghan. It is not about H1N1, but contains the sentence: “Their (neuraminidase inhibitors) effects on the incidence of serious complications, and on the current A/H1N1 influenza strain remain to be determined.”

More important, if studies have been undertaken in this field they are probably not yet published. Thus, the place to look is a clinical trials register, like Clinical trials.gov (http://clinicaltrials.gov/), The International Clinical Registry Platform Search Portal at the WHO (www.who.int/trialsearch) , national or pharmaceutical industry trials registers.

A search for H1N1 OR swine flu in Clinical trials.gov, that offers the best searching functions, yields 132 studies, of which 116 were first recieved this year.

Again, most trials concern the safety and efficacy of H1N1 vaccines and include the testing of vaccines on subgroups, like pregnant women, children with asthma and people with AIDS. 30 trials are phase III.
Narrowing the search to H1N1
OR swine flu | neuraminidase inhibitors OR oseltamivir OR zanamivir (treatment filled in in the filed “Interventions”) yields 8 studies. One of the studies is a phase III trial.

This yield doesn’t seem bad per se. However, numbers of trials don’t mean a lot and a more pertinent issue is, whether the most important and urgent questions are investigated.

Three issues are important with respect to interventions:

  1. Are H1N1 vaccines safe and immunogenic? in subpopulations?
  2. Do H1N1 vaccines lower morbidity and mortality due to the H1N1 flu?
  3. Are neuraminidase inhibitors effective in preventing or treating H1N1 flu?
Question [1] will be answered by current trials.
Older Cochrane Reviews on the seasonal influenza flu (and updates) cast doubt on the efficacy of [2] vaccines (see the [poor*] Atlantic news article) ànd [2] neuraminidase inhibitors in children (Cochrane 2007 and BMJ 2009) ànd adults  (Cochrane 2006, update 2008 and BMJ 2009) against symptoms or complications of the seasonal flu. The possibility has even been raised that seasonal flu shots are linked to swine flu risk.
However, the current H1N1 isn’t a seasonal flu. It is a sudden, new pandemic that requires different actions. Overall H1N1 isn’t as deadly as the regular influenza strains, but it hits certain people harder: very young kids, people with asthma and pregnant women. About the latter group, Amy Tuteur (obstetrician-gynecologist blogging at The Skeptical OB) wrote a guest post at Kevin MD:
(…) the H1N1 influenza has had an unexpectedly devastating impact among pregnant women. According to the CDC, there have been approximately 700 reported cases of H1N1 in pregnant women since April.** Of these, 100 women have required admission to an intensive care unit and 28 have died. In other words, 1 out of every 25 pregnant women who contracted H1N1 died of it. By any standard, that is an appalling death rate. (……)
To put it in perspective, the chance of a pregnant woman dying from H1N1 is greater than the chance of a heart patient dying during triple bypass surgery. That is not a trivial risk.
The H1N1 flu has taken an extraordinary toll among pregnant women. A new vaccine is now available. Because of the nature of the emergency, there has not been time to do any long term studies of the vaccine. Yet pregnant women will need to make a decision as soon as possible on whether to be vaccinated. (Emphasis mine)
…. Given the dramatic threat and the fact that we know of no unusual complications of vaccination, the decision seems clear. Every pregnant woman should get vaccinated as soon as possible.
Thus the anticipated risks must be balanced against the anticipated benefits, Amy urges pregnant women to get vaccinated, even though no one can be sure about side effects ànd about the true efficacy of the vaccine.
For scientific purposes it would be best to perform a double randomized trial with half of a series of pregnant women receiving the vaccine, and the other half a placebo. This would provide the most rigid evidence for the true efficacy and safety of the vaccine.
However it would not be ethical to do so. As “Orac” of Orac Knows explains so well  in his post “Vaccination for H1N1 “swine” flu: Do The Atlantic, Shannon Brownlee, and Jeanne Lenzer matter?” RCTs are only acceptable from an ethical standpoint if we truly do not know whether one treatment is superior to another or a treatment is better than a placebo. There is sufficient reason to believe that vaccination for H1N1 will be more efficacious than “doing nothing”. Leaving a control group unvaccinated will certainly mean that a substantial percentage of pregnant women is going to die. To study the efficacy of the H1N1 among pregnant women observational studies (like cohort studies) are also suitable and more appropriate.
Among the studies found in ClinicalTrials.gov there are a few H1N1 Vaccine Clinical Studies in Pregnant Women, including RCTs. But these RCT’s never compare vaccinated women with a non-vaccinated women. All pregnant women are vaccinated, but the conditions vary.
In one Danish study the arms (study groups) are as follows:
Thus two doses of H1N1 with adjuvant are compared with a higher dose H1N1 without adjuvant. As a control non-pregnant women are vaccinated with the adjuvant H1N1.*** The RCT is performed within a prospective, birth-cohort study recruiting 800 pregnant mothers between Q1- 2009 and Q4-2010. As a natural control women pregnant in the H1N1 season (Q4) will be compared with women outside the season. Please note that the completion date of this study will be 2012, thus we will have to wait a number of years before the study describing the results will be found in PubMed….
To give an impression of the idea behind the study, here is the summary of that trial in the register (not because it is particularly outstanding, but to highlight the underlying thoughts):
“Pregnant women are at particular risk during the imminent H1N1v influenza pandemic. The new H1N1v virus requires urgent political and medical decisions on vaccination strategies in order to minimize severe disease and death from this pandemic. However, there is a lack of evidence to build such decisions upon. A vaccine will be provided in the fourth quarter of 2009, but there is little knowledge on the immunogenicity. Particularly its clinical effectiveness and duration of immunity in pregnant women and their newborn infants is unknown. Therefore, it will be important to study the optimal vaccination regimens with respect to dosing and use of adjuvant to decide future health policies on vaccination of pregnant women. We have a unique possibility to study these aspects of H1N1v infection in pregnant women in our ongoing unselected, prospective, birth-cohort study recruiting 800 pregnant mothers between Q1- 2009 and Q4-2010. Pregnant women from East-Denmark are being enrolled during the 2nd trimester and their infant will undergo a close clinical follow-up. The H1N1v pandemic is expected to reach Denmark Q4-2009. The timing of this enrollment and the imminent pandemic allows for an “experiment of nature” whereby the first half of the mothers completes pregnancy before the H1N1v pandemic. The other half of this cohort will be pregnant while H1N1v is prevalent in the community and will require H1N1v vaccination.The aim of this randomized, controlled, trial is to compare and evaluate the dose-related immune protection conferred by vaccine and adjuvant (Novartis vaccine Focetria) in pregnant women and non-pregnant women. In addition the protocol will assess the passive immunity conferred to the newborn from these vaccine regimes. The study will provide evidence-based guidance for health policies on vaccination for the population of pregnant women during future H1N1v pandemics.”
Although with regard to H1N1-vaccination, appropriate studies are being done, it is feasible that certain measures might not be appropriate on basis of what we know. For instance, pretreating people in the non-risk groups (healthy young adults) with neuraminidase-inhibitors, because they are “indispensable employees”. Perhaps Heneghan, who as you remember is a co-author of the BMJ paper on neuraminidase -inhibitors in children with the seasonal flu, was thinking of this when writing his post.
If Heneghan would have directed his arrows at certain interventions in certain circumstances in certain people he might have had a good point, but now his arrows don’t hit any target. Revere from Effect Measure and Orac from Orac Knows might well have diagnosed him as someone who suffers from “methodolatry,” which is, as Revere puts it, the “profane worship of the randomized clinical trial as the only valid method of investigation.”
Notes
* But see the excellent post of Orac who trashes the Atlantic paper in Flu vaccination: Do The Atlantic, Shannon Brownlee, and Jeanne Lenzer matter? (scienceblogs.com). He also critiques the attitude of the Cochrane author Jefferson, who has a different voice in the media compared to the Cochrane Reviews he co-authors. Here he is far more neutral.
** There is no direct link to the data in the post. I’m not sure whether all pregnant women in the US are routinely tested for H1N1. (if not the percentage of H1N1 deaths among H1N1 infected pregnant women might be overestimated)
***In the US, vaccins given to pregnant women are without adjuvant.

45,982

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Empathy

13 12 2009

The next Grand Rounds will be hosted by Barbara Olson of Florence dot com. The theme will be Simplify, identical to the theme of the annual conference of the Institute for Healthcare Improvement in Orlando. We are invited to share what’s on our mind about any healthcare-related topic indicating with one word why it is important.

My word is Empathy, because it is a versatile,  important skill doctors should have (besides knowledge and technical expertise to name a few other important skills). Empathy is especially important with vulnerable patients, the old and very young.

It strikes me that pediatricians are often very kind and pleasant doctors. They know how to ‘handle’ kids. GP’s also have to deal with kids a lot, but they’re often less patient and kind. At least that applies to our GP. I have had various issues with him, although never outspoken. He is a good doctor, but can be rude at times.

This is a funny story.

Once upon a time, we had to regularly visit our doctor, because my daughter, then 4 to 5 years old, had all kinds of small complaints.

Once she had (innocent) warts. He had to scrape them, but because my daughter found this painful, we had to pretreat the warts with EMLA plasters that numb the skin. I had to do that at home, but the plaster at the inner side of her knee had loosened after a half our walk to the doctor’s practice. He grumbled that I didn’t do it right and that I had to come back another time, meanwhile hard-handedly removing the other warts, forgetting half of them. My daughter didn’t enjoy the scrapings, the corners of her mouth trembling in her attempts not to cry.

After most of the warts had been removed, the doctor took a big flat box with all kinds of little presents, he obviously gave to children at the end of the ordeal.

“Here. You can choose a present!”

My daughter looked at all the minute presents, pondering which one to choose.

There were a lot of rings, with blue stones, red stones, pink stones. There were necklaces, little toys, games….

“Choose one”.

She choose a ring with a pink stone. But wait, that blue ring was nicer and she returned the ring with the pink stone .

But the little patience my doctor had was at an end.

He grabbed something from the box and put it into my daughter’s hand: “Here!”

It was a simple round cardboard with the most silly sheep drawing I have ever seen. With open mound my daughter received the present. Speechless she stared at the gift.

The doctor gestured we could leave the room. He apparently met his obligations with the gift.

With the door handle in my hand, I saw my daughter making a sudden turn. She took one last look at the sheep to throw it as an experienced pitcher straight at the doctor’s desk.

We heard a loud “Well, I never!”, when we left the room.

Added 2009-12-15:

Summary by Barbara at Florence.dot.com:

Jacqueline at Laika’s MedLibLog captures the arachnoid spirit, giving her post a one word title: empathy. The post shows how much we long for care that considers more about who we are than our “chief complaint” often reveals. If Jacqueline had been in the mood to spin longer, she could have called this post, “What comes around, goes around!”
Hit the nail on the head, Barbara!

Photo Credits:

“You are a lamb”, adapted from: http://www.flickr.com/photos/onegoodbumblebee/ / CC BY-NC-SA 2.0

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