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EVIDENCE-BASED-HEALTH  December 2009

EVIDENCE-BASED-HEALTH December 2009

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Subject:

Re: News release 1 hr ago: In wake of study concerns, Ontario delays seasonal flu shots for all but +65...f/u

From:

"Djulbegovic, Benjamin" <[log in to unmask]>

Reply-To:

Djulbegovic, Benjamin

Date:

Fri, 4 Dec 2009 07:22:06 -0500

Content-Type:

text/plain

Parts/Attachments:

Parts/Attachments

text/plain (476 lines)

Thanks, Neil
What you write is important and illuminating in many ways...no doubt,
the bounded rationality constraints played an important role although
were probably not decisive...in fact, I did try to approach the
question rationally... Typically, in situations like these I try to
imagine  the consequences of WRONG decisions (and regret associated
with recommending intervention vs. not)...in light of Tom Jefferson's
writing that evidence for the effectiveness of seasonal flu vaccine is
poor, one may argue that the decision here is an easy one and that we
should simply heed to the Canadian press release ... However, vast
majority of organizations and vast majority of practitioners came
resoundly in favor of vaccination... Perhaps, because they recognize
that poor quality of reporting does not necessary translate into
biased study results...(in which case the recommendations may have
rational basis)...or, perhaps this is a case of the cascade of errors
originating in the herd thinking based on the cognitive biases you
discussed in your post...but, my main point here is that there is no
satisfactory solution here...under the circumstances anything and
everything flies! Is this how public policies should be formulated?
That, however,  brings me back to the square one and the reason this
group exist at the first place: we need reliable evidence to settle
the issue! (this does not absolve the Canadian folks from their
ethical responsibility to release their data asap!)
Sorry for the long reply.
Best
Ben





On Dec 4, 2009, at 4:38 AM, "Maskrey Neal" <[log in to unmask]>
wrote:

> Hi Ben and group
>
> The metacognition does you great credit. But, maybe you need to be
> gentler on yourself Ben - as do we all.
>
> I'm not sure what you were expecting but when we're aware of the
> risk of
> cognitive biases, as I know from our e-conversations you are, that
> awareness doesn't somehow turn us into a super-being who is impervious
> to normal human traits. There are some data that teaching and learning
> traditional EBP improves some aspects of decisions and maybe patient
> care, but it doesn't transform all of an individual's practice
> instantly, nor does it change the practice across an organisation
> comprehensively and instantly. Similarly, it would be unrealistic to
> expect that once we are aware of the 43 cognitive biases identified so
> far that the last of them - "blind spot bias - biases apply to other
> people but not to me" - is false. :-)
>
> On the knowledge level we've accepted that Herbert Simon's bounded
> rationality concept is true - there's simply too much information to
> be
> able to know it all. And even if we could know it we couldn't
> process it
> adequately especially in the time available, and even if we could do
> all
> that it wouldn't necessarily mean better decision making. "Feeling
> comfortable with not knowing everything" was true before the Internet,
> but it sure as heck applies now. The EBM approaches help, but don't
> solve all issues.
>
> It's the same in the cognitive area. I find it hard to believe it's a
> bad thing to formally teach people who have to make lots of decisions
> (often quickly and in highly stressed and complex environments) how
> people make decisions. Working out how and when to do that optimally
> and
> measuring the benefits feels really important stuff. But equally we
> have
> to be realistic. Achieving the original Sackett definition of a
> decision
> based on the best possible evidence shaped by clinical expertise and
> patient values and needs is a highly complex problem. Complex problems
> simply are not amenable to relatively simple solutions.
>
> Human and fallible though we are, that doesn't and shouldn't stop us
> trying to move forward towards that goal of making decisions better.
>
> Bw
>
> Neal
>
> Neal Maskrey
> Director of Evidence-based Therapeutics
> National Prescribing Centre
> Liverpool UK
>
>
> -----Original Message-----
> From: Evidence based health (EBH)
> [mailto:[log in to unmask]] On Behalf Of
> Djulbegovic,
> Benjamin
> Sent: 02 December 2009 22:02
> To: [log in to unmask]
> Subject: Re: News release 1 hr ago: In wake of study concerns, Ontario
> delays seasonal flu shots for all but +65...f/u
>
> Dear Paul,
>
> about 2 months ago, you forwarded the message raising a possibility
> that
> "seasonal flu shot may raise the risk of catching swine flu" (see
> below). Ever since I was on look out for the release of the study you
> quoted, since your post disturbingly affected my own practice. This, I
> now feel, have been unwise on my part, since the major organizations
> such as CDC recommend (both) seasonal (and H1N1) vaccine.
> (http://www.cdc.gov/h1n1flu/vaccination/public/vaccination_qa_pub.htm)
>
> I am CC this e-mail to the group not only because I am interested in
> further information that you or someone else may know, but also to
> illustrate the problem of generating and communicating evidence when
> stakes are high. I consider myself as a fairly experienced person when
> it comes to the issue of evidence and decision-making, yet unconfirmed
> rumours have been very succesful in affecting my behavior/practice
> (probably not only in this case). I have been wondering why is this
> so.
> I am not sure, but I believe that this has to do to with some implicit
> trust to the source and fact that the message has appeared on this
> discussion group, which has run so succesfully for so many years. So,
> when should we act on unpublished information rumours, or inadequate
> information? Should we insist that the press releases are always
> accompanied with raw data, so that everyone can see for himself/
> herself
> where recommendations come from? Is it more important "who" provides
> guidelines vs. "what" they are based on?
>
> I realized that there is no easy solution here; neverthless, I hope,
> as
> always, to read insigtful comments from you and the rest of the EBH
> folks.
>
> Ben
>
> Ps Paul, this is , of course, not to criticize your post, but rather
> to
> use it to highlight the issue, which in different ways is practised on
> daily basis (as, for example, when an "expert" gives his advice
> based on
> "his experience", which likely amount to 2 cases vivibly remembered
> and
> many cases not remembered etc)
>
>
>
>
> -----Original Message-----
> From: Tom Jefferson [mailto:[log in to unmask]]
> Sent: Friday, September 25, 2009 9:56 AM
> To: Djulbegovic, Benjamin
> Cc: [log in to unmask]
> Subject: Re: News release 1 hr ago: In wake of study concerns, Ontario
> delays seasonal flu shots for all but +65
>
> You see Ben this is where the EBM bandwagon falls down. Evidence says
> one thing, experts another, so we do what experts say.....
>
>
>
> On 25/09/2009, Djulbegovic, Benjamin <[log in to unmask]> wrote:
>> Paul, this is really awful...I am not sure what was motivation of the
>> Ontario officials, but this reminds me of crying the "fire" in a
> crowded
>> theater... or of a manipulation of uncertainties, which was so
> successfully
>> exploited by the tobacco industry in the past and now being
> increasingly
>> done by big pharma [The lack of "definitive" scientific proof that
> smoking
>> is harmful to one's health resulted in postponement of tobacco
> legislation
>> for decades, with the unfortunate consequences of much avoidable
> disease;
>> see Michaels D. Doubt is their product, Sci Am 292 (6):96-101, 2005.
>> Michaels D. Manufactured uncertainty: protecting public health in the
> age of
>> contested science and product defense, Ann N Y Acad Sci 1076:149-162,
> 2005.]
>>
>> An increasing number of patients have asked me whether it is safe to
> have
>> both a seasonal flu and swine flu shots. We all know that the
>> evidence
> is
>> not there, but decisions/recommendations have to be made. This is
> where
>> experts/expertise (the second part of the famous EBM definition) come
> into
>> play. Our local experts concluded that it is OK to give both vaccines
> (the
>> swine flu is not available yet, but I told my patients that when it
> becomes
>> available it is OK to have it). Now, if the evidence speaks to
> foolishness
>> of this advice, this has to be worked out promptly...Why the findings
> could
>> not be posted or released for everyone to see them instead of
> releasing the
>> news that creates further confusion? I realize that the Ontario
> officials
>> may have worried that they will be accused of hiding data, and this
> does
>> raise an important question when and which evidence should be shared
> with
>> the public. Only reliable evidence? Everything and anything, even if
> it
>> later turns out the be false?
>>
>> ben
>>
>> Benjamin Djulbegovic, MD, PhD
>> Professor of Medicine and Oncology
>> University of South Florida & H. Lee Moffitt Cancer Center & Research
>> Institute
>> Co-Director of USF Clinical Translation Science Institute
>> Director of USF Center for Evidence-based Medicine and Health
>> Outcomes
>> Research
>>
>>
>> Mailing Address:
>> USF Health Clinical Research
>> 12901 Bruce B. Downs Boulevard, MDC02
>> Tampa, FL 33612
>>
>> Phone # 813-396-9178
>> Fax # 813-974-5411
>>
>> e-mail: [log in to unmask]<mailto:[log in to unmask]>
>>
>>
>> ______________________
>>
>> Campus Address:             MDC02
>>
>> Office Address :
>> 13101 Bruce B. Downs Boulevard,
>> CMS3057
>> Tampa, FL 33612
>>
>>
>> From: Evidence based health (EBH)
>> [mailto:[log in to unmask]] On Behalf Of Paul Elias
>> Sent: Thursday, September 24, 2009 8:48 PM
>> To: [log in to unmask]
>> Subject: News release 1 hr ago: In wake of study concerns, Ontario
> delays
>> seasonal flu shots for all but +65
>>
>>
>> I share....
>>
>> TORONTO - Faced with puzzling but unconfirmed evidence that
>> suggests a
>> seasonal flu shot may raise the risk of catching swine flu, Ontario
>> announced Thursday it is rescheduling its seasonal flu vaccine
>> program
> to
>> delay most of it until after pandemic vaccine has been administered.
>> At a news conference in Toronto, Dr. Arlene King, the province's
>> chief
>> medical officer of health, said the seasonal and pandemic vaccines
> will be
>> delivered in three waves, starting in October.
>> People 65 and older, who have been largely spared by swine flu but
>> who
> are
>> at greater risk from seasonal flu, will be offered seasonal shots
> then. All
>> residents of long-term care facilities will be included in that
>> group.
>> When the pandemic vaccine becomes available in November, all in
> Ontario who
>> want to be vaccinated will be given access to those shots.
>> Once the pandemic vaccination effort is completed, Ontario plans to
> resume
>> the seasonal flu shot program, which offers free vaccination to
>> anyone
> who
>> wants it. By then, said Dr. Vivek Goel, president of the Ontario
> Agency for
>> Health Protection and Promotion, the questions about a possible link
> between
>> seasonal shots and swine flu infection may have been answered.
>> Drawn from a series of studies from British Columbia, Quebec and
> Ontario,
>> the findings appear to suggest that people who got a seasonal flu
>> shot
> last
>> year are about twice as likely to catch swine flu as people who
> didn't. The
>> findings haven't yet been published and few people have actually seen
> them.
>> But they have been looming like a spectre over decisions about
>> vaccine
>> delivery timing in Canada and are a source of consternation
> internationally.
>> "This has been a very difficult decision," King said in an interview.
> "This
>> has been difficult for everyone across the country."
>> The head of the World Health Organization's vaccine research
> initiative, Dr.
>> Marie-Paule Kieny, said Thursday that researchers in the U.S.,
>> Britain
> and
>> Australia have looked for the same effect and have not observed it.
>> People who have seen the unpublished scientific paper say the
>> elevated
> risk
>> - if it exists - is only that people who've had flu shots catch swine
> flu.
>> It does not suggest they get more severe disease.
>> King admitted adjustments had been made, both to deal with the
> concerns
>> raised by the unpublished study and the worries that there may be a
> double
>> pronged flu season, with swine flu hitting children and adults under
> 60 or
>> so and seasonal flu viruses targeting people over 65.
>> "Is it typical that we adjust our program? No it isn't typical. But
>> we
> are
>> not dealing with a typical flu season this year," King said.
>> Influenza expert Dr. Allison McGeer said the compromise makes sense.
>> "It's a reasonable balance," said McGeer, who is head of infection
> control
>> at Toronto's Mount Sinai Hospital. "(But) it has some obvious
> logistical
>> challenges."
>> McGeer acknowledged there was discussion about whether giving
>> seasonal
> shots
>> to seniors in October might actually spark more infections in that
>> age
>> group, if the effect seen in the unpublished paper is valid. But she
> said on
>> balance it was thought that the risk seasonal flu viruses pose to
>> this
> group
>> outweighed the theoretical risk the studies showed.
>> And King noted that in the troubling data, the effect was not seen in
> people
>> 65 and older.
>> Earlier in the week when it first emerged that some provinces were
> thinking
>> of delaying their seasonal flu shot delivery efforts, a number of
> provinces
>> expressed hope a pan-Canadian approach could be adopted.
>> King said that would have been desirable, if it were possible, but it
> became
>> apparent that different jurisdictions were weighing factors
> differently and
>> a one-size-fits-all solution seemed out of reach.
>>
>>
>>
>> Best,
>>
>> Paul
>>
>>
>> --- On Thu, 9/24/09, Piersante Sestini <[log in to unmask]> wrote:
>>
>> From: Piersante Sestini <[log in to unmask]>
>> Subject: Re: Do the antivirals reduce mortality in flu?
>> To: [log in to unmask]
>> Received: Thursday, September 24, 2009, 11:41 PM
>> At 18.07 24/09/2009 +0100, Owen Dempsey wrote:
>>
>>> Thus: The idea that all views on e.g. use of Tamiflu; [i.e. the
> competing
>>> views that either everybody should have Tamiflu (as under the
> criteria of
>>> the guidelines) versus the decision/choice that Tamiflu is too risky
> for a
>>> given healthy individual and shouldn t be prescribed or taken] are
>>> of
>>> equal moral status,  is flawed.
>>
>> I don't see the them as the only options available. In fact, the
> options
>> could be just the opposite: on the community perspective, it would be
> better
>> *not* to use antiviral drugs to prevent the emergence of resistance
>> (possibly at the cost of a few casualities) and of side effects,
>> while
>> individuals could prefer to have it to reduce the small risk of
> serious
>> disease, despite the risks of side effects and of inducing
>> resistance.
>>
>>>  This liberal all views are fine by me stance assumes that everybody
> has
>>> equal access to and understanding of the real state of affairs when
> it
>>> comes to the risk benefit ratio of this intervention.  This is akin
> to
>>> pretending that we live in a real democracy (which is of course an
>>> impossible fiction to attain) instead of an organised democracy
>>> where
> the
>>> outcomes e.g. of elections are preordained and the people
> misinformed.
>>
>> It is the doctor's responsibility to get the best information
> available and
>> to pass it to individual patients in a way that they can understand
> and
>> decide. And, by the way, this is just what EBM is all about. It is
>> not
> in
>> the possibilities of EBM to make politicians or patients to behave
>> rationally, although it might help to make the choices more explicit.
>>
>>
>>>
>>>
>>> With Tamiflu, the government, health spokesmen and the drug industry
> with
>>> the help of the corporate media conspire to mislead the public by
>>> over-egging the dangers of e.g. Mexican/Swine Flu and overstating
> (even if
>>> it is by implication i.e. simply by recommending its use) the
> benefits of
>>> Tamiflu.
>>
>>
>> Politicians (and public health managers are often just that) probably
> just
>> anticipate what they expect to be "typical" reaction of the laymen:
>> as
> Ben
>> explained, omitting of doing something that could possibly prevent a
> serious
>> bad event is often considered more undesirable that having a side
> effect, no
>> matter how little is the chance of getting a benefit.
>> I agree with you that this behavior (of politicians) is incorrect (in
> fact,
>> most of the business of "EB-recommendations", as far as it fails to
>> integrate individual circumstances, is flawed), but I maintain with
> Neal
>> that is the patient, the owner of the problem, that has to be
>> informed
> of
>> the possible consequences (and uncertainty) of different choices and
> then
>> assisted unjudgementally in thinking and deciding which stance to
> assume.
>>
>> In this context, both choices are acceptable.
>>
>> regards,
>> Piersante Sestini
>>
>>
>> ________________________________
>> Looking for the perfect gift? Give the gift of
>> Flickr!<http://www.flickr.com/gift/>
>>
>
>
> --
> Dr Tom Jefferson
> Via Adige 28
> 00061 Anguillara Sabazia
> (Roma)
> Italy
> tel 0039 3292025051
> Ti sei iscritto alla newsletter di Attenti alle Bufale? No? Vai sul
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