Market-driven cardiac laboratory testing

George Cembrowski George.Cembrowski at ALBERTAHEALTHSERVICES.CA
Mon May 30 17:48:11 UTC 2016


Within the next several years, multiple diagnostic companies will be selling "high sensitivity" troponins in the USA.  These tests have a huge advantage in the emergency department in that patients with chest pain of noncardiac origin can easily get more appropriate care; patients with genuine cardiomyocyte damage can be more easily triaged.  High sensitivity troponin will allow the generation of normal ranges for multiple groups of patients, whether they are male or female, younger or older or of diverse racial backgrounds.  Perhaps in just a few years, an organization like Heart Canada might emulate the genuine organization "Prostate Canada" and extol patients to "know your number".  The pharmaco-medico-laboratory complex is extremely powerful and insidious - high sensitive troponin will (is) the next Trojan horse.

George Cembrowski, MD, PhD
Director, Medical Biochemistry
University of Alberta Hospital

From: Mario Plebani [mailto:mario.plebani at UNIPD.IT]
Sent: Sunday, May 29, 2016 11:27 PM
To: IMPROVEDX at LIST.IMPROVEDIAGNOSIS.ORG
Subject: [IMPROVEDX] R: [IMPROVEDX] Erroneous laboratory results

Dear Elisa

Now, we definitely agree. Regarding the chest pain, it was clear that cardiac troponin is needed in 100% of chest pain with symptoms and clinical history suggestive for a cardiac nature.
However, while I am working in laboratory medicine, I am and still thinks as a physician, not as a scientist; and this makes the difference.
Ciao
Mario

________________________________
Da: Elias Peter [mailto:pheski69 at GMAIL.COM]
Inviato: domenica 29 maggio 2016 19.42
A: IMPROVEDX at LIST.IMPROVEDIAGNOSIS.ORG
Oggetto: Re: [IMPROVEDX] Erroneous laboratory results
I suspect that we agree more than we disagree. The internet magnifies that.

I agree:
*         There is lots of value in this study.
*         It has to be read carefully and more than once.
*         Most clinicians have a poor understanding about the costs involved in laboratory testing. I suspect that clinicians tend to underestimate the cost of many individual tests and overestimate the overall cost of testing. (Institutions contribute to this by not putting the cost on the page/form where tests are ordered. We have asked for that for years in our institution, but can't even actually generate conversation about it.)
*         Clinicians would like to order the correct test and ONLY the correct test - and our systems are not just not designed to help, they are designed to make that nearly impossible.
*         We are just entering an era where complex (and probably expensive) testing will move from novelty to useful to necessary if we want to practice highly individualized genetically and epigenetically informed patient-specific safe and high quality medicine. (If we think it is hard to know what test to order now, just wait a decade.OMG.)

I don't agree that every patient with chest pain should have a troponin. If you mean, every patient where cardiac chest pains a consideration, yes, I would agree. The 14 year old with pleuritic chest pain, cough, fever and an infiltrate? The 22 year old non-smoker with no family history who has had four days of chest pain after falling off a horse? The 62 year old with no known cardiac disease and no risk factors (other than age and male) who has chest pain in the area of their classic zoster?  In the first two, a (+) troponin is almost surely a false (+). In the third, well, how do we balance the 'obvious' cause of the pain against the possibility that they have two ongoing processes?

I also don't agree that 70% of decisions ***in primary care*** are leveraged by or need to be informed by lab testing. In primary care, one of the biggest challenges is separating the medically (biologically) based illness from problems of living and feeling. In these settings, where the prevalence of *relevant* disease is so low, laboratory testing does not help and often hurts. I would estimate that easily 3 out of 4 patients I see with fatigue or insomnia or back pain or knee pain or indigestion or skin lesions or dizziness should not have lab testing at their initial evaluation.

Most importantly, I agree absolutely with the need to find ways to help clinicians better select and use the right test at the right time.  It would seem to me that we should be much further down this path than we are, given how many other algorithms are actively making suggestions to people who are not intentionally feeding information to the algorithm or depending for life-death decisions on the outcome. Amazon and Facebook are doing more than any EHR I have ever seen.

Let's not focus so much on the differences in our perspectives driven by my primary care experience and your laboratory experience that we do not get around to talking about how to make things better.

I'd like a system that allows me to enter data (and harvests it from the prior data in the record) and gives me information about things I need to consider, along with options about testing, including sensitivity, specificity, interferences, cost. I don't want this to slow me down with the patient with 24 hours of a runny nose and sore throat, no fever, and normal exam. But I want to be able to invoke it when they are getting worse 5 days later. And there are probably times when it should intrude itself on me regardless of whether or not I think it is necessary, not unlike the noise my car makes if I forget to buckle my seat belt.

Peter



On 2016.05.29, at 1:21 PM, Mario Plebani <mario.plebani at unipd.it<mailto:mario.plebani at unipd.it>> wrote:


Dear Peter,

again, I agree and disagree with you.
The study presents some limitations but if you rad it carefully, there
are some interesting messages. First and foremost, clinicians
overestimate the costs of laboratory tests but, even more important,
they would like to request only test that are useful for the decision
making.
from  this viewpoint, there is the need to improve the appropriateness
of test request and interpretation but also to recognize that the new
generation of laboratory tests, including genomics, strongly influence
the decision making and patient pathways. Think about cardiac
troponin. In this case 100% of patients with chest pain should be
tested. any generalization in medicine is wrong but the paper I sent
you it's useful to answer the request of some more evidence-based
evidence of the 70% claim.
The most intriguing question is how we should improve the appropriate
request and utilization of laboratory information to provide valuable
clinical information and reduce the risk of patient harm. And we must
work on this.
Thanks
Kind regards
M Plebani, MD


Elias Peter <pheski69 at gmail.com<mailto:pheski69 at gmail.com>> ha scritto:


My primary concern was not the cost statistic, as that is relatively
easy to obtain and verify. My concern was (and remains) the claim
that 70% of clinical decision making is dependent on laboratory
testing.

The study you provided is interesting but I don't think it answers
this question. It is limited to oncologists and cardiologists, so it
is not a representative sample and cannot be generalized to medical
care as a whole. And it is an interview, asking clinicians, in
effect, how often did the lab testing they arranged have an impact
on decision making. One would expect this to generate a high number,
as it would be unlikely that a large percentage of narrow-scope
specialists who practice in relatively laboratory intensive fields
would respond to an interview question by saying that most of the
lab they do has no impact on care.

Peter Elias



On 2016.05.28, at 3:30 AM, Mario Plebani <mario.plebani at unipd.it<mailto:mario.plebani at unipd.it>> wrote:

Dear Elias

while I agree with most of your sentences, I have to disagree with
the story of the 70% claim. There is a recently published paper
(attached) confirming that in oncology and cardiology (in the US
and Germany) about 65% of clinical decisions are based on
laboratory tests and that the costs compared with the total
spending for healthcare is about 2.4% in the US and lower (1.6%) in
Germany.
There is an overestimation of laboratory costs and an
underappreciation of the value of the laboratory information if
tests are appropriately requested and interpreted. This is a matter
of quality and patient safety, for sure. And this is particularly
true in an era of "omics" and personalised medicine if we really
would like to have early diagnoses, identification of risk factors
and not a reactive medicine.
We are working to improve the appropriate utilization of the
laboratory information and to reduce diagnostic errors.
Regards
Mario Plebani, MD

Da: Elias Peter [mailto:pheski69 at GMAIL.COM]
Inviato: venerdÄ› 27 maggio 2016 23.43
A: IMPROVEDX at LIST.IMPROVEDIAGNOSIS.ORG<mailto:IMPROVEDX at LIST.IMPROVEDIAGNOSIS.ORG>
Oggetto: Re: [IMPROVEDX] Erroneous laboratory results

Regarding the relative roles of history, exam and extra testing,
context matters. A lot.

For the majority of patients in a primary care office presenting
with a new issue, a properly done history and exam coupled with the
diagnostic device between our ears and allowed to work for
sufficient time will provide the diagnosis in an overwhelming
majority of cases. (Based both on 40 years personal experience and
a fair amount of literature.)

Further testing (lab, radiology, following the natural history by
seeing the patient back and repeating the initial process after a
suitable wait) are very useful to:

Confirm a suspected diagnosis, especially important if the
diagnosis is going to lead to treatment that could do harm if the
diagnosis is wrong.
Evaluate the extent of the diagnosis (anemia with a hemoglobin of 6
and MCV of 68 is different from anemia with a hemoglobin of 9 and a
normal MCV).
Differentiate among several possible diagnoses that could explain
the presentation.
Investigate why a treatment based on a diagnosis has not had the
expected result.
Reassure the patient or clinician.
Satisfy an external process ("What do you mean you started the
patient on a BP medicine for newly diagnosed hypertension without
checking an LDL and calcium?")

In primary care, however, additional testing at the initial visit
often reflects less admirable triggers:

No clue what's going on. Let's go fishing. (How many red herrings
can we catch along with the target fish?)
Too little time to do a good history and exam.
Too little training to do a good history and exam.
Too little experience to trust one's history and exam.
The reasonable possibility that there is a time-sensitive and life
threatening issue that will only be identified by further testing.
(Feared far more often than justified.)

That's in primary care and with a known patient presenting with a
new problem.  If I am on call for my local hospital and the ED
calls me to evaluate/admit a patient I do not know with severe
abdominal pain. that is a totally different story. If I am treating
a patient with a medicine that affects potassium or renal function
or can depress platelet production or Vitamin K metabolism,
laboratory studies can be essential and skipping them is like
driving with one's eyes closed.

With regard to the claim that 70% of medical decisions are based on
laboratory studies which represent 5% of costs, I believe that is
an example of a 'zombie' statistic that has been refuted but
refuses to die. A couple years ago in preparation for a talk, I
tried to find the origin. I think it comes from this paper by
Forsman in 1996 (http://www.clinchem.org/content/42/5/813.full.pdf
<http://www.clinchem.org/content/42/5/813.full.pdf>) where it is
stated but not referenced beyond saying that at Mayo they knew that
5% of their costs at Mayo (which are arguably not broadly
representative) were lab related and that 70% of 'critical
decisions' (admissions, discharges, drug therapy) were 'leveraged
by' lab results.  If someone has newer documentation about this, I
would love to hear.

One of the problems, and this is what I understood Jason Maude to
be referencing, is that laboratory testing -= because it is
concrete and easy to measure/monitor - is talked and written about,
used as a metric, specified in recipes far more often than the
cognitive processes which should occur prior to obtaining the
laboratory study, in order to be able to use the laboratory study
result.

Just my take. YMMV.

Peter Elias, MD




On 2016.05.27, at 2:14 PM, Knapp, Lucy <LKnapp at PEACEHEALTHLABS.ORG<mailto:LKnapp at PEACEHEALTHLABS.ORG>
<mailto:LKnapp at PEACEHEALTHLABS.ORG>> wrote:

As a medical technologist with close to 40 years' experience I am
so offended by this poorly educated comment I don't even know how
to respond. I do agree that history and physical are extremely
important, but objective data and the ability to correctly use the
data - both in ordering tests and interpreting results is just as
important. Recent studies (sorry, I can't quote a source, but I'm
sure anyone with laboratory experience will agree) have shown as
much as 70% of medical decisions are based on diagnostic testing
and at the same time the cost of that testing is 3% of the total
medical costs in the US.

Personal experience - History and physical diagnosed a painful
uterine "fibroid' in 2012. I had a hysterectomy using
morcellation; no danger of cancer, obviously. Pathology testing of
the removed tissue showed Leiomyosarcoma - unstageable because of
the morcellation, but undoubtedly spread by morcellation. I'm
currently trying to deal with recurrence. Additional pathology
testing for estrogen receptors has provided me an additional "gun"
in the fight.

Please - don't dismiss what you don't understand.

Lucy

Lucy Knapp, MT(ASCP)   |  Technical Specialist, Chemistry  |  Laboratory
PeaceHealth <http://www.peacehealth.org/>  |  400 NE Mother Joseph
Place  |  Vancouver, WA 98664
office 360-514-2732  |  fax 360-514-1646


From: Jason Maude [mailto:jason.maude at ISABELHEALTHCARE.COM
<mailto:jason.maude at ISABELHEALTHCARE.COM>]
Sent: Friday, May 27, 2016 2:55 AM
To: IMPROVEDX at LIST.IMPROVEDIAGNOSIS.ORG<mailto:IMPROVEDX at LIST.IMPROVEDIAGNOSIS.ORG>
<mailto:IMPROVEDX at LIST.IMPROVEDIAGNOSIS.ORG>
Subject: Re: [IMPROVEDX] Erroneous laboratory results
This message originated outside of PeaceHealth's email system and
contains web links. Use caution when clicking on links. VERIFY THE
SENDER before opening attachments, clicking links or providing
information.
How is it the profession has ended up placing such reliance on an
aspect which is shown to contribute so little and cost so much?

This study backs up the old adage that 80% of the diagnosis is
given by the history and physical with relatively little
contributed by tests
http://archinte.jamanetwork.com/article.aspx?articleid=1106285
<https://mail2.peacehealth.org/enduser/classify_url.html?url=SRKJG9+bKBsCsym7kQNOcDkS6NcPUsik/R0n2BFbRkRPfGwyYd2lLfnMCg+upqON3/dK89OabI4jSAPKTwURVA==>

To paraphrase Churchill, never in an industry has so much been
shown to contribute so little for so much expense!

Regards
Jason Maude


From: Tom Benzoni <benzonit at GMAIL.COM <mailto:benzonit at GMAIL.COM>>
Reply-To: Society to Improve Diagnosis in Medicine
<IMPROVEDX at LIST.IMPROVEDIAGNOSIS.ORG
<mailto:IMPROVEDX at LIST.IMPROVEDIAGNOSIS.ORG>>, Tom Benzoni
<benzonit at GMAIL.COM <mailto:benzonit at GMAIL.COM>>
Date: Wednesday, 25 May 2016 17:08
To: "IMPROVEDX at LIST.IMPROVEDIAGNOSIS.ORG
<mailto:IMPROVEDX at LIST.IMPROVEDIAGNOSIS.ORG>"
<IMPROVEDX at LIST.IMPROVEDIAGNOSIS.ORG
<mailto:IMPROVEDX at LIST.IMPROVEDIAGNOSIS.ORG>>
Subject: Re: [IMPROVEDX] Erroneous laboratory results

I'm a "thin" lab tester and 90% of what I order I don't need.
My junior confreres order easily double my volume.
Same outcomes narrowly defined; fully defined, worse outcomes.
(I don't order d-dimer on patients without at least moderate
likelihood PEs or DVT. My junior guys do so routinely and so do
many more CTA and U/S. We have the same rate of final diagnoses.
But I (likely) have fewer renal failures (we don't see followup)
and fewer bankruptcies.

Take, for example, ABGs. They are rarely needed; the same data is
available venously and from already done tests (BMP/MGA/SMA7),
pulse ox and EtCO2, yet I see 40% of our ICU tests are ABG.
CBC with diff when most folks can't interpret the diff but don't
know they can't. CBC without diff when you only need the Hgb.
EKG in my shop is an excellent predictor that you do NOT have ACS.
All LPs go to IR.

I could go on.

So overtesting is huge.

tom benzoni

On Wed, May 25, 2016 at 10:20 AM, Cameron Powell
<cameron at physiciancognition.com
<mailto:cameron at physiciancognition.com>> wrote:

Perhaps some of you have already seen this study on under- and
over-testing.

"First we found that the rate of overuse, meaning [medical
laboratory] tests that we performed that shouldn't have been
performed, average around 20%. That means out of every 10 tests
ordered about two tests on average should not have been ordered.

"Even more surprising was the rate of underuse [of medical
laboratory tests]. This is the rate of tests that should have
been ordered in a given time but weren't ordered. That rate was
over 40%. So, for every three tests performed, an additional two
tests should have been ordered."

http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0078962
<https://mail2.peacehealth.org/enduser/classify_url.html?url=BxZ18kZyS6/KbPy/1ujgfTFrANiURXwk9lu0BcA37sQiueOJlTGHIQYgv3MPwM/VOughlTjYANbZQFZKLC1gNg1hOHMtXP+U9p3xGL+KxP0=>


We've taken a run at solving suboptimal testing strategies and
it's going very well. We'll keep you posted on our progress.

Cameron



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Cameron Powell  |  CEO, Physician Cognition, Inc.
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On May 20, 2016, at 12:40 PM, DR WILLIAM CORCORAN
<williamcorcoran at SBCGLOBAL.NET
<mailto:williamcorcoran at sbcglobal.net>> wrote:

What do you think of the YouTube video and the comments posted?

WSJ journalist John Carreyrou shares year-long Theranos
investigation & breaks latest, stunning news
<https://mail2.peacehealth.org/enduser/classify_url.html?url=PXYTP0DfAoGKNy2qWUaxDadPXd0hfftNChM33MkbHcI=>

<https://mail2.peacehealth.org/enduser/classify_url.html?url=PXYTP0DfAoGKNy2qWUaxDadPXd0hfftNChM33MkbHcI=>
WSJ journalist John Carreyrou shares year-long Theranos ...
<https://mail2.peacehealth.org/enduser/classify_url.html?url=PXYTP0DfAoGKNy2qWUaxDadPXd0hfftNChM33MkbHcI=>
View on youtu.be
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Preview by Yahoo

Take care,

Bill Corcoran


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Windsor, CT 06095-1634
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On Friday, May 20, 2016 11:10 AM, Dwight Oxley
<dwight.oxley at GMAIL.COM <mailto:dwight.oxley at gmail.com>> wrote:


The link below details how a large number of erroneous results
were reported from a commercial medical laboratory. This report
is just the latest in the Wall Street Journal's coverage of the
Theranos Co. Lab results account for more than 50% of the
information in a medical record, thus the impact of these is
enormous.

Dwight Oxley


http://on.wsj.com/1TpKiL3
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