Showing posts with label quality. Show all posts
Showing posts with label quality. Show all posts

Sunday, October 21, 2012

Arrogance, Ignorance and Incompetence: The State of Practice in Medical Care?

A 2010 Stanford piece on "How Teaching Hospitals could lead Medicine's Metamorphosis" details their processes for improving Patient Safety, Quality Improvement and reducing costs/improving Productivity.

I was struck by a simple question about the Stanford protocols, especially in the ICU:
If they aren't the minimum standard for non-teaching hospitals everywhere, then what do they know that Stanford doesn't?
I think that, especially in ICU, there is now no excuse for hospitals anywhere not to be following, albeit with a delay, the Best Practices researched and adopted by leading teaching hospitals. Reasonable practice would be: pick just one, or two, major teaching hospitals and mirror exactly what they adopt, but delayed by 12-18 months. You get the benefit of pick others' brains and having them iron out the bugs in the protocols for you...

For any management, including the CEO, responsible for hospitals' Quality of Care and Patient Safety, isn't ignoring known, documented Best Practice either Ignorance, Negligence, or Indolence? Any of which you'd hope in an ideal world, would be cause for instant dismissal.

Saturday, August 11, 2012

The Professional Mandate: Don't repeat Known Mistakes, yours or anyone else's.

[Full post on other blog.]

My formulation of the Professional mandate:
It's "unprofessional" to repeat or allow, Known Faults, Failures and Errors.
That sounds complete, perhaps obvious, but let me unpack this some more...

Thursday, August 9, 2012

ISM/FoSiM: "Inversion" - Putting the Cart before the Horse in Healthcare Reform

One of the amazing arrogances and Blindspots of the fanatics and zealots of ISM and their "mini-me", FoSiM, is they've got the Healthcare Reform debate turned around completely. Colloquially, they've put the cart before the horse.

The FoSiM "Vision Statement" in their recruiting letter was:
"To reverse the current trend which sees government-funded tertiary institutions offering health care ‘science’ courses not based on scientific principles nor supported by scientific evidence”.
And from the ISM Policy paper on Regulation and Licensing all Healthcare Practitioners and Training:
As a consequence of these practitioners being legitimized through political rather than scientific means, the health of people worldwide has been put at significant risk.
Not hard to spot that both these statements aren't backed by any Evidence, any Theory but only Absolutist Assertion: it shows from the start that this is only Ideological based, not based in fact or need, nor indeed arrived at by any valid, credible process.

The "Inversion" of ISM/FoSiM is who they put at the centre of their Healthcare Reform proposal in their call for more "Science in Medicine", ignoring their one-eyed bias where they never examine the Practice or Science of their own, Medical Care.

ISM/FoSiM put "Science" at the centre of their Reform proposal and agenda.
Specifically, 'Science' applies to:
  • Practitioners,
  • Specialities,
  • Organisations,
  • Research, Academic or Commercial,
  • Professional Bodies,
  • Professions, and
  • Governance bodies and processes, such as defined by Government Agencies.
What's completely missing is The Patient. This is the Inversion. It's Practitioner- and Profession-centric, not Patient-centric.

This is the Big Lie, the massive horn-swoggle that ISM/FoSiM are attempting to pull off:
The Patient, their Outcomes, the Quality of their Care and their Safety under Medical Care is completely absent. And most importantly, Patient Accessibility and Affordability are missing.
ISM/FoSiM want to "Fix All Ills of Healthcare and its Systems" through More Science, amusingly without evidence that this can or will help. The evidence of the last sixty years of "More Science" in Medical Care is that costs rise astronomically (5% to 18% of GDP in the USA), while more people are untreated and Public Health outcomes do not seem commensurate change.

The ISM/FoSiM advocacy for more "Science in Medicine", even taken at face value, is a clear call for:
Better Healthcare!
Which is admirable in its intent.

Only, like all their efforts, it's vague, incomplete and unfocussed. It's posturing not a useful addition to the debate.

They are advocating for Better Healthcare:
  • For Whom?
  • Where?
  • How Measured?
  • Within what Cost and Resource envelope?
  • But mainly, How can their Reforms be delivered and Implmentation executed when the current Medical Care system is grossly understaffed, inefficient and already too expensive for ordinary folk?
More "Science" won't deliver Better Medical Care, it can only deliver more expensive, less accessible and less effective care, and further stress already over-worked and failing individuals and organisations.

"More Science" does involve more money for research, more expensive devices, drugs, equipment and services and, for the very few that can afford it, much more expensive interventions ("Rescue Care") for extreme conditions. It's a Bonanza for everyone making money out of the process, the Companies, Practitioners and Researchers, and a FAIL for everyone else: the Patients, the Healthcare workers and the Governments funding it.

The only group of Patients, the only reason this field of work exists at all, who might benefit aren't just the "Top 1%", but probably the "Top 0.1%".

This is a proposal that will cost a whole bunch of money, mostly Public (ISM/FoSiM are universally silent on Cost and Efficiency Improvement) and the two groups to benefit are: themselves and their rich mates.

That's a really interesting proposal for spending piles of Public Money with no sense of Accountability and where the only evidence available is "It won't help, but will cost a whole lot more."

How does "More Science" equate to "Better Healthcare"?
Not in the Real World and not at all for Ordinary People who'll be paying for it... 
This is a scheme dreamed up by the privileged, for the privileged, of the the privileged.



If you'd like to know what Better Healthcare looks like, here's the definitive guide, with actual research references:
"Managing Clinical Processes: Doing Good by Doing Well" by Dr Brent James.
What do we get for all that money? [slide 16]
  1. High touch -- patients value their relationship with a trusted clinical advisor more than any other element in health care delivery (the clinician-patient relationship)
  2. Rapid response -- the Rule of Rescue
Three classes of outcomes: [slide 65]
  • Physical outcomes
    • medical outcomes: complications and therapeutic goals
    • includes functional status measures (patient perceptions of medical outcomes)
  • Service outcomes
    • satisfaction: patients and families, communities, professionals, purchasers, and employees
    • includes access issues (e.g., waiting times)
  • Cost outcomes
    • just another outcome of a clinical process
    • includes the cost of the burden of disease
Medical outcomes are of four types: [slide 66]
  • appropriateness
    • (referral and procedure indications)
  • complications
    • (process failures / defects)
  • therapeutic goals / biologic function
    • (when stated in the negative, merges with defects)
  • the patient's ability to function
    • (functional status, as reported by the patient)
  • are process specific
    •  (different clinical conditions have different complications, different therapeutic goals, functional status measures)
  • Medical outcomes relate directly to health care costs
Service outcomes are of two types: [slide 67]
  • the clinician-patient relationship
    • (bedside manner: a "caring and concerned" clinician)
  • access issues: convenience vs. hassle
    • (scheduling, travel times, registration, physical comfort, wait times, etc.)
  • operate by a separate, general process that is independent of medical outcomes
  • Service outcomes directly affect market share, community perceptions and relations (that is, prestige and social status), and
  •  rates of malpractice law suits
Health care consumers seek value [slide 69]
  • Value = (Medical outcomes + Service outcomes) ÷ Cost outcomes
  • The goal is the best possible medical outcomes at the lowest necessary cost
It'd be interesting if ISM/FoSiM ever apply their considerable talent and resource to addressing just how their call for "More Science" will deliver better Healthcare outcomes in the structure given by DR James.

Sunday, August 5, 2012

ISM/FoSiM: The irrelevance of more "Science" in Healthcare Reform

ISM (Institute of Science in Medicine) and their Australian "mini-me", FoSiM (Friends of Science in Medicine), are advocating a rather extreme version of Healthcare reform:
Medicalisation of all Healthcare, under the guise of advancing "Science in Medicine".
These extreme views are published in an ISM Policy paper on the Licensing of non-Medical Healthcare practitioners. They advocate changing world-wide statues/regulation to only allow "science-based" Healthcare (code for Only Medical Care) and finish with:
Unscientific practices in health care should further be targets of aggressive prosecution by regulatory authorities. [italics added]
They don't just want to wind the clock back to The Grand Old Days of the Fifties, but a whole Century. The authority they cite is the 1910 Carnegie Foundation report on Medical Education by Flexner.

Flexner tossed around a bunch of concepts, many more than the State Regulation of Medicine and Medical Schools on which ISM/FoSiM base their calls for increased Healthcare Regulation, a.k.a. "Science in Medicine", as the definitive solution to all the ills of all Healthcare Systems in the world.

In the second half of this piece, Flexner's original thesis and concepts are examined - and not wholly surprisingly they support the opposite position of ISM/FoSiM.

Firstly, What do the world's best experts in Healthcare Reform identify as the local and/or common challenges to Healthcare?

And, How do the proposals of ISM/FoSiM address these Medical Millennium Challenges?

Dr Brent James, executive director of Research and Quality at Intermountain HealthCare, Utah, (IHI) has extensively published hard data on Quality Improvement in Medicine, won prestigious Quality and Medical awards and co-authored landmark works on Patient Safety, Quality of Care and delivery of Best Practice Medicine. After 3 decades of implementing and executing successful reform programs at IHI, Dr James easily qualifies as one of the experts on Healthcare Reform.

Dr James, in his initial slides for his Advanced Training Program, ["Managing Clinical Processes: Doing Well by Doing Good"], lays out a lot of diverse material that underpins his Quality Improvement methodology and forms a consistent, well-formed theory driving his decades of successful Reform, not like ISM/FoSiM, a set of untested Ideological assertions.

On Slide 9, "Total health: How long, how well we live", Dr James lays out what the Evidence says on the contributors to Good Health. They are:
  • 40% - Behaviour under control of the Individual (loosely, 'lifestyle choices'). Tobacco, Alcohol, Movement Deficit Disorder [humour!]
  • 30% - Genetics
  • 20% - Environment and Public Health
  • 10% - Health care Delivery (Hospitals and Clinics)
On the next slide (10), "The Great Equation", he states [with sources cited]:
  • Health = medical care and medical care = "access to care"
  • "But the Great Equation is wrong ..."
And then goes into a lot of detail about why that is so.

In slide 29, "Dr. John Wennberg", he describes Wennberg's research/analysis:
  • Geography is destiny ("Who you see is what you get")
  • There is no health care "system"
  • Supplier-induced demand: [many examples follow]
In slide 31, "Care-associated injuries in hospitals", Dr James describes one of the primary source of waste in Medical care, which he addressed at IHI, providing net savings of 20-32% in delivering services. Not to mention much better Patient outcomes.
  • Injuries drive direct health care costs totalling $9 - 15 billion per year [Thomas et al. 1999, Johnson et al. 1992]
Dr James is also quoted in a forum organised by his University, PANEL ON HEALTH CARE REFORM – FALL 2008, Continuum, Utah University.

This is what he has to say on the Challenges facing Healthcare around the world:
JAMES: Another point is that we’re getting exactly what we pay for. We tend to pay for procedures and rescue care, so we get lots of procedures and lots of rescue care. This is a key factor.
Another thing you need to know is that other countries have exactly the same problems. So don’t look for solutions in Europe. Don’t look for solutions in Canada.
I get a ton of those guys coming through visiting to see how care’s delivered in Utah, believe it or not, because they face exactly the same problems.
There’s a standard working list of the top five problems within health care, and nobody’s solved them.
Travel the world and it’s the same list of five things:
1. The first problem is variation in care on a geographic basis.
It’s so high that it’s impossible that all Americans are getting good care, even with full access.
2. The second biggest problem is high rates of care directly judged to be inappropriate.
This is where the medical risk treatment outweighed any potential benefit to the patient and we did it anyway . . . usually in a rescue setting.
3. The third problem is unacceptable rates of care-associated injury and death.
This is where the care delivered actively killed somebody, whose death was judged to be preventable upon review.
4. The fourth problem is that the system does it right only 55 percent of the time.
There are things that we know for a fact should be done every time but the system does right only 55 percent of the time.
Now, that’s better than zero, but it’s not nearly 95 percent or 98 percent, where it ought to be.
5. And the last one is that there’s at least 50 percent waste in the system.
This is non- value-adding from a patient’s perspective, and that’s where the opportunity exists.

Conclusion:

From the hard-data evidence presented by Dr James based on more than 3 decades of successful Healthcare Reform, we know:
  • The ISM/FoSiM proposals address the least important, least useful areas of change. 
  • Addressing Lifestyle Issues and Environment/Public Health would have six times the impact of attempting to improve "Health Care Delivery" through more "Science".  
    • Even then, ISM/FoSiM are either vague or silent on just what benefits their proposals, if adopted, can deliver. If they want to turn Healthcare around the world inside out, with considerable disruption, cost and upheaval, then they need to first inform us of the exact benefits we can expect.
  • The ISM/FoSiM proposals are irrelevant to the common "Top 5" Challenges faced by Healthcare Systems around the world: None benefit from more "Science", they are all about Quality of Care and Effectiveness of Delivery and Implementation.
  • All successful and effective Healthcare Reform, since and including Flexner, has been Patient-centric. The ISM/FoSiM proposals aren't just wrong, but exactly the opposite of what is documented to have worked. Practitioner- and Profession-centric reforms, such as "More Science in Medicine" do not deliver better outcomes for Patients.
ISM/FoSiM consistently demand high-quality Evidence and rigorous Science from those in its sights, yet fail to apply the Scientific Method and their Rules of Evidence to their own proposals and assertions.

To be consistent and credible, ISM/FoSiM must:
  • Meet the same standards of "Evidence", Research and adherence to the Scientific Method as they demand of others.
  • Demonstrate and Quantify how more "Science" will improve Quality of Care, Patient Safety, Equity of Access and Systemic Waste and Cost-Effectiveness issues identified as "Top 5" Healthcare Reform Challenges by the leading experts in the field.
  • First define their own "Top 5" Healthcare Challenges, and
  • provide research backed by verifiable, hard-data on the Efficacy of their own proposals, their own favourite criticism of non-Medical Healthcare.
If ISM/FoSiM criticise the Effectiveness of non-Medical Healthcare, we must in turn ask them to demonstrate the Effectiveness of their own proposals. If they set Rules and Standards for others, they need to follow them themselves, even better, demonstrate by superior example.



The Flexner report doesn't just say "Regulation and Licensing is necessary" as ISM/FoSiM seems to think, it also says many things still relevant today:
  • it asks for common standards and basic clinical education with laboratory practice,
  • suggests the 'Best Practices' as used by the Europeans,
  • says that Medicine is a Performance Discipline [my words] - that Theory and Practice/Experience together are needed by competent Professionals ("Head and Hands"),
  • that Medicine is not primarily a commercial enterprise, but has a very large "Public Service" component, with a Duty of Care not just to individuals treated, but the larger Community,
  • and explicitly recognises "all medical sects", and they be based on good clinical education.
It also contains an implicit commentary that demands:
  • As part of good Professional conduct, the systematic elimination of Known Errors, Faults and Failures, ("To Err is Human", but repeating preventable mistakes is malpractice of the highest order) and
  • From the Flexner principle of "licenses bear a uniform value":
    • Continuing certification retesting of all license holders, not a lifetime grant of license.
    • the adoption of practices that have been demonstrated to have value in assuring Professional competence and skills/knowledge currency at every point in time for all license holders. From Aviation, we know these techniques work:
      • Frequent (2 monthly) "Check Pilot" assessment of the in-situ performance of every Practitioner,
      • Simulator checks of "worst-case" situations. (Quarterly)
Why would we expect Medicine to have lower Quality and Practitioner Certification standards and processes than other fields? Heatlhcare should be the leader in Practice Efficacy, Quality, Safety and Cost-Effectiveness.

Flexner and the Carnegie Foundation were critical of the medical profession, its standards and ethics of practice: what we'd now call 'governance'.

They also called for the general public to be trained in assessing doctors and requiring professional practice from them. Something not included in the ISM/FoSiM proposals.

The report also emphasises that all medical professions owe a Duty of Care to their patients which requires much higher standards that other work:
it is a 'public service' on which people trust their lives, not merely a business.
Today, Flexner and the Carnegie Foundation might phrase their argument in terms of "Quality of Care", "Patient Safety" and whole system effectiveness, not just single element "efficacy".
By professional patriotism amongst medical men I mean that sort of regard for the honor of the profession and that sense of responsibility for its efficiency which will enable a member of that profession to rise above the consideration of personal or of professional gain.
As Bacon truly wrote, "Every man owes a duty to his profession," and in no profession is this obligation more clear than in that of the modern physician.
Perhaps in no other of the great professions does one find greater discrepancies between the ideals of those who represent it.
The interests of the general public have been so generally lost sight of in this matter that the public has in large measure forgot that it has any interests to protect.
Flexner notes the importance of the basic Professional Charter: It's professional malpractice to repeat or allow, Known Errors, Faults and Failures.
"There the Clinical professor comes in to the Aid of Speculation and demonstrates the Truth of Theory by Facts,"
he declared in words that a century and a half later still warrant repetition;
"he meets his pupils at stated times in the Hospital, and when a case presents adapted to his purpose,
he asks all those Questions which lead to a certain knowledge of the Disease and parts Affected;
and if the Disease baffles the power of Art and the Patient falls a Sacrifice to it,
he then brings his Knowledge to the Test,
and fixes Honour or discredit on his Reputation by exposing all the Morbid parts to View,
and Demonstrates by what means it produced Death,
and if perchance he finds something unexpected,
which Betrays an Error in Judgement,
he like a great and good man immediately acknowledges the mistake,
and, for the benefit of survivors, points out other methods by which it might have been more happily treated."" [ An essay on The Utility of Clinical Lectures, by Thomas Bond, 1766.]
The writer of these sensible words fitly became our first professor of clinical medicine,1 with unobstructed access to the one hundred and thirty patients then in the hospital wards.
Flexner rather strongly states that "Medical Care" goes much further than treating diseases/conditions presented to the surgery, a position that would make him outside today's AMA:
The overwhelming importance of preventive medicine, sanitation, and public health indicates that in modern life the medical profession is an organ differentiated by society for its own highest purposes, not a business to be exploited by individuals according to their own fancy.
Flexner advocates for reform and states categorically the underlying drivers - that Patient-centric, not Practitioner- or Profession-centric solutions and specifically not intransigent Ideologies are required:
The public interest is then paramount, and when public interest, professional ideals, and sound educational procedure concur in the recommendation of the same policy, the time is surely ripe for decisive action.
Flexner specifically notes:
  • that mere Science, 'the instrumental basis of medical education', is woefully inadequate for a good Practitioner.
  • that physicians must be much more broadly trained and well-rounded individuals.
  • and they their education starts with their graduation, not finishes.
Just how was that to be done isn't said in that section. [Or at all?]

This non-disease view of Flexner and the Carnegie Foundation on Preventative Medicine and treating communities, not just individuals, is wildly at odds with the prevailing medical paradigm and the polemic of ISM/FoSiM...
The practitioner deals with facts of two categories.
Chemistry, physics, biology enable him to apprehend one set;
he needs a different apperceptive and appreciative apparatus to deal with other, more subtle elements.
Specific preparation is in this direction much more difficult;
one must rely for the requisite insight and sympathy on a varied and enlarging cultural experience.
Such enlargement of the physician's horizon is otherwise important, for scientific progress has greatly modified his ethical responsibility.
His relation was formerly to his patient - at most to his patient's family; and it was almost altogether remedial.
The patient had something the matter with him; the doctor was called in to cure it.
Payment of a fee ended the transaction.
But the physician's function is fast becoming social and preventive, rather than individual and curative.
Upon him society relies to ascertain, and through measures essentially educational to enforce, the conditions that prevent disease and make positively for physical and moral well-being.
It goes without saying that this type of doctor is first of all an educated man.
Flexner often uses the phrase "scientific medicine", but what did he mean?

This was 15 years before Karl Popper's theory of Falsifiability and more than 6 decades before the current notion of "Evidence Based Medicine" rose from the 1972 paper by Cochrane and Sacket's 1996 definition of the term.

Flexner left us a definition, even emphasising that arrogance and dogmatic insistence on "One Truth" is anathema to the Scientific Method:
The modern point of view may be restated as follows:
medicine is a discipline, in which the effort is made to use knowledge procured in various ways in order to effect certain practical ends. [italics added]
It is precisely the function of scientific method - in social life, politics, engineering, medicine - to get rid of such hindrances to clear thought and effective action.
Science believes slowly; in the absence of crucial demonstration its mien is humble, its hold is light. [italics added]
"One should not teach dogmas; on the contrary, every utterance must be put to the proof.
One should not train disciples but form observers: one must teach and work in the spirit of natural science." [Johannes Orth: Berliner Klinische Wochenschrift, vol.xliii. p.818]
Flexner lays out the philosophical basis of his recommended Medical Education system, based on the Scientific Method. He specifically addressed Education in "Medical Sects" (e.g. Homeopathy and Osteopathy) - as good a name as the ISM/FoSiM term "CAM" (Complementary and Alternative Medicine).

ISM/FoSiM don't just ignore that Universities now teach "CAM" courses according to Flexner's requirements, rather the reverse, they have called for the banning of exactly those courses.
The logical position of medical sectarians to-day is self-contradictory.
They have practically accepted the curriculum as it has been worked out on the scientific basis.
They teach pathology, bacteriology, clinical microscopy.
They are thereby committed to the scientific method ; for they aim to train the student to ascertain and interpret facts in the accepted scientific manner.
He may even learn his sciences in the same laboratory as the non-sectarian.
But scientific method cannot be limited to the first half of medical education.
The same method, the same attitude of mind, must consistently permeate the entire process.
To emphasise the point, Flexner wrote about acceptable education of non-Medical practitioners, defining objective tests based on process, not Ideology and preconception.

Substitute "Medical Sect" for "CAM" and Flexner defines for ISM/FoSiM the requirements that are now met by University courses:
Sectarians, in the logical sense above discussed, are
(1) the homeopathists,
(2) the eclectics,
(3) the physiomedicals,
(4) the osteopaths.
All of them accept in theory, at least, the same fundamental basis. 
They admit that anatomy, pathology, bacteriology, physiology, must form the foundation of a medical education, to use the words broadly so as to include all varieties of therapeutic procedure.
They offer no alternative to pathology or physiology; there is, they concede, only one proper science of the structure of the human body, of the abnormal growths that afflict it.
So far, they make no issue as against scientific medicine. [italics added]
Much is involved in agreement up to this point.
The standards of admission to the medical school, the facilities which the schools must furnish in order effectively to teach the fundamental branches, are the same for all alike.
A student of homeopathy or of osteopathy needs to be just as intelligent and mature as a student of scientific medicine;
and he is no easier to teach; for during the first and second years, at least, he is supposed to be doing precisely the same things.
At the beginning of the clinical years, the sectarian interposes his special principle.
But educationally, the conditions he needs thenceforth do not materially differ from those needed by consistently scientific medicine.
Once more, whatever the arbitrary peculiarity of the treatment to be followed,
the student cannot be trained to recognize clinical conditions,
to distinguish between different clinical conditions,
or to follow out a line of treatment,
except in the ways previously described in dealing with scientific medicine. [italics added]
He must see patients and must follow their progress, so as to discover what results take place in consequence of the specific measures employed.
A sectarian institution, being a school in which students are trained to do particular things, needs the same resources and facilities on the clinical side as a school of scientific medicine. [italics added]
Flexner showed, like ISM/FoSiM, an innate dislike for, and bias against "non-Medical" Healthcare Professions, but very clearly defined a set of Professional Principles that, if complied with, would him to accept the practice of any Medical Sect.

Instead of an authority against "CAM" as ISM/FoSiM suppose, Flexner definitively supports non-Medical Healthcare, if its Education process meets his requirements:
The law may require that all practitioners of the healing art comply with a rigidly enforced preliminary educational standard;
that every school possess the requisite facilities;
that every licensed physician demonstrate a practical knowledge of the body and its affections.
To these terms no reasonable person can object;
the good sense of society can enforce them upon reasonable and unreasonable alike.
From medical sects that can live on these conditions, the public will suffer little more harm than it is destined to suffer anyhow from the necessary incompleteness of human knowledge and the necessary defects of human skill.
On Medical Boards and Regulation, Flexner wrote they needed legislative power, and unlike ISM/FoSiM, did not conflate his report recommendations with the political lobbying needed to implement them. He also continues to underline the importance to the Profession of Public Duty.

There is another powerful, central principle of Flexner's: Medical Practitioners are not 'free agents', they first owe a duty of Public Service.
The power that validates the diploma with its license must have the strength to protect its issues against either debasement or infringement.
The physician, like the lawyer, is an agent of the state. [italics added]
If he proves unworthy, the same board that vouched for him must have power to recall its act; and its function must extend to the prosecution of fraudulent or unwarranted attempts to practise without its official sanction.
The state must therefore provide funds that will enable the board to defend its action in the courts.
A model state board law must therefore guard the following points:
  • the membership of the board must be drawn from the best elements of the profession, including - not, as now, prohibiting - those engaged in teaching;
  • the board must be armed with the authority and machinery to institute practical examinations, to refuse recognition to unfit schools, and to insist upon such preliminary educational standards as the state's own educational system warrants;
  • finally, it must be provided either by appropriation or by greatly increased fees with funds adequate to perform efficiently the functions for which it was created.
The additional powers needed in order to deal as effectively with the practice of medicine, lie outside the present discussion. [italics added]
Flexner lays out more criteria for Regulation/Licensing of the Medical Profession, including a criteria who's implications have not been explored by the Regulators, nor mentioned by ISM/FoSiM: for licenses to have uniform value, they cannot be issued for life, frequent certification retesting is necessary.

If that premise is accepted, then it also demands the Regulation/Licensing process itself cannot be static. It must be continually examined, refreshed and updated with new Knowledge as it becomes available. As has been done for decades in Aviation.
The creation of separate boards is thus a roundabout method of recommitting the errors that the main currents of scientific thinking and effort are endeavoring to remedy.
A single board should subject all candidates, of whatever school, to the same tests at every point.
The license of the state is a guarantee of knowledge, education, and skill.
The layman is in no position to make allowances.
The state's M.D. and the state's D.O. offer themselves for essentially the same purposes.
The state stands equally as guarantor of both.
No citizen can indeed be wholly protected by the state against his own ignorance, fanaticism, or folly.
[referring to a previous comment: men who don't "believe" in doctors can't be forced into treatment]
The state is powerless there.
But having undertaken to vise practising physicians for the protection of those who summon them, it must see to it that the licenses to which it gives currency bear a fairly uniform value. [Italics added]
In conclusion, Flexner talks of Duties, Ethics and the need of the Medical Profession to guard against the corrupting effects of commerce. Exactly the same "Conflict of Interest" message that Arnold Relman and Marcia Angell started writing about in the New England Journal of Medicine in 1980.
Like the army, the police, or the social worker, the medical profession is supported for a benign, not a selfish, for a protective, not an exploiting, purpose.
The knell of the exploiting doctor has been sounded, just as the day of the freebooter and the soldier of fortune has passed away.
It's fitting to end with a quote from Arnold Relman ("A Drumbeat on Profit Takers"):
“It’s clear that if we go on practicing medicine the way we are now, we’re headed for disaster.”
If the things the best and brightest minds in the world of Medical Science are writing, researching and talking about, and have been doing so for 3 decades, are completely different to what ISM/FoSiM started advocating in 2009, then who should we give credence to?

My vote goes to the existing experts who can provide hard-data to back their stories, not mere puffery, exaggeration and "spin" as offered by ISM/FoSiM.

Saturday, July 21, 2012

I2P #1: First, Do No Harm.

This is my first post written for "Information to Pharmacists", an interesting Industry Newsletter with a typically idiosyncratic Aussie approach: they welcome authors of any viewpoint and profession, as long as they are respectful to others, not libellous and can write on medical/pharmaceutical issues. And "no dot points, please!" - a challenge for me, leaving behind my favourite organising technique.

Summary:
"Fist, do no Harm" not only embraces Systemic Quality, but better Economic outcomes and improved Efficiency and Effectiveness with reduced waste and Continuous Improvement. Learning and Process Improvement are common to both efforts as are monitoring outcomes: costs, clinical results and "process deviations", a.k.a. "errors".

Computing/I.T. and Medicine share a Fiduciary Duty to their clients, with the Amplifier effects of I.T. now the most cost-effective means of improving Patient Safety, Quality of Care and Treatment Effectiveness.

The enemy of Quality Improvement isn't only "Change Resistance" but faddism, like a cargo-cult adopting the outward signs whilst ignoring the underlying causes and principles.

This, not technical problems, will be the major obstacle to realising the benefits of e-Health initiatives here and overseas. Successful practice transformations have stemmed from Quality Improvement programs with electronic system assisting, not from the blind adoption of automation.


Who am I and what do I have to say that's interesting or useful to Pharmacists and related readers?

I'm a second-generation Computing professional, starting in 1974: in the first group since commercial computers arrived in 1950 to gain undergraduate degrees in Computing. It was still possible to cover in depth the whole field: transistors, hardware, systems, software, operations, business analysis and User Experience.

During a wide-ranging career, I developed an interest in Quality and Turnarounds, for the way out of a mess lies in Working Smarter and stopping wasted effort.
From working in one of the most technically demanding fields, Telco Exchanges where one hour of downtime a year is tolerated, I was imbued with the notion of "Client Service", the same "Fiduciary Duty" that underlies Medicine.
I also discovered for myself the maxim: "Quality isn't just Free, it's cheaper and faster to Do it Right, First Time" defining "Systemic Quality" that, through the work of James T. Reason and Charles Perrow, transformed Aviation after the mid-1970s.

Computers and I.T. are "Cognitive Amplifiers" in the same way that machines are force and skill amplifiers. They allow ordinary folk to easily perform extraordinarily, day after day.

Notionally, automated electronic systems are added to Business Processes to "provide a Business Benefit". Not unlike Marketing, for those Benefits to be realised, they have to be measured  and cannot be measured unless defined and designed in from the start, a practice rarely undertaken.

These ideas have often put me at odds with other technical staff and managers: they are antithetical to the untutored or Default Management Style of business which insists "Just Do It!" is more important than "think before you leap".



Don't all I.T. practitioners suffer the Occupational Hazard of "knowing everything about everything"?

Just about, with the worst offenders often in "Help Desks": everyone else is a fool, which is their experience from on-going "idiot user" calls.
This is a trap that I consciously try to avoid: any reminders from readers are welcomed.

Automated computing/I.T. systems cut across every part of an Organisation, often extending into other Organisations in ways few appreciate. No other Profession does this, not even management and accounting, requiring Business Analysts and Programmers to understand the work of other Professions better than they know themselves.

Programs and Systems are crystallised thought processes: they are exact, detailed, and hopefully complete, descriptions of the cognitive processes people use to execute tasks.
Often the hardest part of this work is uncovering Implicit Knowledge and converging on correct task definitions that will become universal for the first time.
Politics always trumps the Technical in this work, creating inconsistencies and contradictions in tasks.

To be good at Computing/I.T., you need to be both a 'quick study' of other Fields of Practice and be able to apply a raft of tools allowing you to understand their work better than they do.

Which often leads to a certain arrogance and hubris. It takes some humility and courage to admit that true Domain Experts have great talent and skill: Experts make their work look effortless and obvious, as seen in performances of sporting stars.

The irony is that the best Computing/I.T. experts have the same problem with 'management' and business owners: What they do looks simple and obvious to outsiders and is undervalued.

For completeness, many I.T. practitioners are not expert in this way. They make the job look hard, with the resulting systems being slow, difficult to use and wrong or buggy: for which they often get promoted for their "heroic efforts" slaying the Project Beast.


I.T. is fine, as long as it stays out of my way...

If this is you after too many fads, management or I.T., being foisted on you without consultation or thought for local consequences, you have my condolences and understanding.

I absorbed the many fads in the first 15 years of my career before wondering why nothing really changed and digging back into history. Fredrick W. Taylor and Henri Fayol wrote comprehensively about Management and Quality Improvement more than a century ago with Dr W Edwards Deming adding a definitive theoretical base sixty years ago.
Why then, did Michael Hammer re-invent, badly, the work of Taylor et al in the 1990's, then need to resile from it a decade later?

The Japanese transformed their Industrial processes this way, taking 3 decades to out compete the USA in making cars. During the 1990's, the US experienced fads of "the Japanese Way", but generally never understood or adopted Deming's core principles.
Then the "outsourcing" and "right sizing" fads took over with messy manufacturing being sent off-shore, becoming "Someone Else's Problem".


Systemic Quality: tying it all together.

Aviation proves three things about Systemic Quality: it can be achieved every day with ordinary people, it's the most cost-effective approach available and arises from a pervasive Safety Culture supported from the very top down.

There are some notable efforts to bring Systemic Quality to Medicine/Healthcare: Intermountain Healthcare with Dr Brent James, trained by Dr Deming, being responsible for 20 years of Quality Improvement, "Safety Leaders" website from Texas Medical Institute of Technology, National Academy of Science's Institute of Medicine and Donald Berwick's Institute for Healthcare Improvement.

Not only do they have hard data on their Cost, Safety and Error outcomes, they can show that it's 20-30% cheaper for them to Do it Right, First Time.


And for Pharmacists... You're important.

In the interview Dr James gave to Norman Swan in 2001, "Minimising Harm to Patients in Hospital", he said they used their Drug Information Systems to identify many Adverse Events, such as an opiate overdose requiring 'narcan' to be administered.

They also found these system-related Adverse Events 30-times more prevalent than reported Human Errors. Dr James said:

For ten consecutive years we tracked every adverse drug event and in parallel with that we tracked classic human errors. In ten years we had 4,155 confirmed human errors. In parallel with that we had 3,996 confirmed moderate or severe adverse drug events.
Norman Swan: In other words, what was actually happening to the patient him or herself?
Injuries. Those were injuries, those 3,996. The fascinating thing was the overlap. Among 3,996 confirmed injuries, 138 or 3.5% resulted because of a human error.
Norman Swan: So in other words most of the human errors didn't result in an injury.


Monday, July 9, 2012

Your money and your life: What the AMA and Friends of Science in Medicine won't tell you.

This piece in Business Spectator has a bunch of 'interesting' facts that both Friends of Science in Medicine and the Medical Industry body, the AMA, ignore.

Why is this??

I'd have thought it was in the Medical Profession's interest to run their operations as efficiently as possible in order to maximise their result and the benefit to individuals and to the community. That is, if that's what their Prime Mission is.

As Don Berwick formulated in 1996 with his Central Law of Improvement:
Every system is perfectly designed to achieve the results it achieves.
So, if Medical Healthcare and Hospitals aren't run efficiently and 'accidentally' kill far too many people, Why is this so?

Just what is the current system designed to achieve, if its not Patient Safety, Quality of Care or Efficient, Effective use of Public Monies?

A superficial, simplistic analysis can't tell us...
But we do know that incumbents must benefit from the system: How?

The currently quoted figure for Healthcare costs as percentage of GDP is 9% in Australia [vs 23% in the USA]. The two growth figures quoted (38% rise in 20 years and a 40% rise in last 15 years) should alarm every taxpayer, patient and politician.

Especially the internal inconsistency: Medical Healthcare costs have grown at an increasing rate per capita for many decades, why would the rate suddenly decrease? Based on the last 15 years, we should be expecting 12.6% GDP in 2027, if not higher due to increased end-of-life care costs of Baby Boomers.

Here are my take-aways from the article. It is notionally about the PCEHR (Personally Controlled Electronic Health Record) introduced on 1-July-2012 by the Federal Government, but I find the other facts the author quotes much more interesting:
  • health spending is forecast to rise to 12.4 per cent of GDP in the next two decades [from 9% in ~2007]
  • That’s on top of a 40 per cent rise in healthcare costs per capita since 1997 [15 just years!].
  • A review by the National Health and Hospitals Reform Commission found that in Australia each year, the equivalent of 350 jumbo jets crashing and killing all on board is attributable to highly preventable medical ‘adverse effects’
  • these events can account for up to 15 per cent of a hospital’s costs. 
  • One new private hospital – Medica Centre in Sydney’s South – is seeing huge efficiency gains from simple management tools like inventory control and more effective scheduling of surgeries.
  • Clinical director Matt McKay says that for the first time he truly knows what a procedure should cost.
  • Matt McKay at Medica Centre says that so far, he has seen an increase in efficiency of 30 to 40 per cent, not only from managing his inventory better but also scheduling his surgeries to minimise theatre turnaround times.
  • If such inventory management existed in a competitive business, the company would have been sent broke long ago.
    • But in the health sector, those costs get shifted onto the patients, the insurers or the taxpayer.
  • A report by the OECD suggests that as much as 42 per cent of costs could be cut from common hospital procedures.
  • Australia’s Productivity Commission says that figure is about 25 per cent.


PRODUCTIVITY SPECTATOR: Your money and your life
Jackson Hewett
Published 7:33 AM, 9 Jul 2012 Last update 7:33 AM, 9 Jul 2012
Three hundred and six. 
That’s the number of people who signed up last week to the government’s new program to slash the cost of our medical spending.
It was a very soft launch for the Personally Controlled E-Health Record but the motivation behind it is right. An easily accessible database that ensures medical professionals have access to all of our medical activities should, if utilised correctly, reduce the enormous amount of waste and duplicate activities that drain federal and state health budgets. It also should help reduce mistakes caused by patients forgetting what previous symptoms they’ve had or drugs they’ve taken. 
Why is it so important? Because health spending is forecast to rise to 12.4 per cent of GDP in the next two decades. That’s on top of a 40 per cent rise in healthcare costs per capita since 1997.
A review by the National Health and Hospitals Reform Commission found that in Australia each year, the equivalent of 350 jumbo jets crashing and killing all on board is attributable to highly preventable medical ‘adverse effects’ – things like bad reactions to medication, incidents of infection, and medical device problems. Aside from the terrible human toll, these events can account for up to 15 per cent of a hospital’s costs. 
More complete records such as the PEHCR will hopefully reduce such incidents.
But there are many more ways for our tax dollars to be better put to work. One new private hospital – Medica Centre in Sydney’s South – is seeing huge efficiency gains from simple management tools like inventory control and more effective scheduling of surgeries. 
Medica Centre uses a highly technologically advanced dispensary called Pyxiss to allocate products for a surgery. Nurses must fingerprint scan to access items, and a computer will only let them take the exact number of products as defined by the surgeon. That means the hospital can track costs by surgeon and by patient, something they say is a first in Australia.
Clinical director Matt McKay says that for the first time he truly knows what a procedure should cost. At his former employers in both public and private hospitals, the best figure he could get for a procedure like a knee arthroscopy was $250 per patient in terms of consumables like bandages, syringes, sutures and the like. That was a figure derived by simple stocktaking. After a year using the Pyxis system, McKay now knows that figure should be closer to $500. The knowledge allows McKay to be far more effective in monitoring which surgeons overuse products, and react accordingly. He’s also using just-in-time ordering to reduce working capital. 
If such inventory management existed in a competitive business, the company would have been sent broke long ago. But in the health sector, those costs get shifted onto the patients, the insurers or the taxpayer.
A report by the OECD suggests that as much as 42 per cent of costs could be cut from common hospital procedures. Australia’s Productivity Commission says that figure is about 25 per cent. Matt McKay at Medica Centre says that so far, he has seen an increase in efficiency of 30 to 40 per cent, not only from managing his inventory better but also scheduling his surgeries to minimise theatre turnaround times. One surgeon has become so efficient that he has that number down to two minutes, and can do an arthroscopy in 20 minutes. By comparison, another surgeon takes up to an hour for the same procedure, and 20 minutes between them. That means more nurses, more downtime and higher costs. 
As a private hospital, Medica Centre can pick and choose what surgeries it will take, and what doctors will do them. Good doctors like to work there because the quicker they can get patients through, the more money they can make.
The public sector has little choice in either doctor or patient. But that doesn’t mean it can’t use some private sector ideas to save money along the way.

Monday, June 25, 2012

An answer: Why not an NTSB for Healthcare? II

Continuing this topic: In the seminal Institute of Medicine (IOM) report, "An NTSB for Healthcare", a central question is posed:
Not Why an NTSB for Healthcare ... Why Not?
Medical Healthcare is often compared to Aviation on Quality of Care and Patient Safety, but the comparison is wrong and ineffectual: the story is poor and we're not yet ready to hear the message.

We, as travellers, wouldn't step onto any airplane if Safety and Quality were as variable and haphazard as Medical Healthcare in Hospitals, Primary Care Physicians, Specialists and other facilities.

So why, as individuals and a society, do we accept, seemingly without comment, 1000-fold worse Safety from Medical Healthcare than Aviation?

There are no "smoking craters", nor any vision/images for the media to build a story upon.
There is no big story for the six o'clock News, no individuals' story is 'newsworthy' enough.
"If it bleeds, it leads" cuts both ways...

Describing 100,000 "preventable deaths" from Medical Error/year as equivalent to "10 planes crashing per week" is numerically correct, but an invalid comparison.

Patients don't die all together, they die slowly, not instantly and they are widely scattered - there is a very low density of Medical Error on a daily basis. Each death, although tragic, is invisible.

Medical Error, or "preventable harm", is the leading single cause of death in US Hospitals and seems to be heading in the wrong direction. Which, because Medical Healthcare is a universal, not optional, service, should be causing concern and outrage, instead it goes unremarked and unnoticed in the Media and hence with the General Public.

The more subtle cause is: Preventable Deaths and Serious Injury from Medical Error as not centrally collated and reported.
Even the more complex story, the decline in Medical Quality of Care and Patient Safety, cannot be told because there are no data.

Because deaths and serious injury from Medical Error is so frequent, common and widespread, only the most egregious and sad are reported, like the 2010 preventable and foreseeable injury to Grace Wang, a young first-time mother who was paralysed in Sydney, NSW, through a repeat of a well known Error.

While tragic for the family and friends of victims, those individual stories have no "news value" outside direct acquaintances.
Plus, the sheer volume of individual stories means a cut-off is needed. The time taken to just read 2,000 names every week would be hours and hours of "dead time".

Should then Media report the statistics?
No, as even Stalin knew: A Single Death is a Tragedy; a Million Deaths is a Statistic.

We are our own worst enemies as a society, when we need to address endemic problems:
  • Without "something out of the ordinary", stories have no "news value".
  • We suffer boredom and "compassion fatigue" from long running stories, no matter how terrible.
  • Statistics are not personal, there is no emotional connection, hence little "news value".
  • Nobody is forcing Medical Healthcare to report and categorise 100% of Medical Errors. This removes the possibility of even a larger, investigative story.
Chip and Dan Heath, in "Made to Stick", Why some ideas survive and others die, layout a formula for successful story-telling, or getting ideas to resonate and spread:
  • Simple
    • Makes the story accessible.
  • Unexpected
    • Makes people pay attention.
  • Concrete
    • Makes people understand and remember.
  • Credible
    • Makes people agree and believe.
  • Emotional
    • Makes people care.
  • Stories
    • Be able to act upon it
    • A story's power is twofold: It provides stimulation (Knowledge) and inspiration (motivation to act). Both benefits are geared to generating action.
That these are very hard to do altogether is shown by how few "urban myths" there really are and how little we each retain in detail from the nightly news.

What the estimable brothers Heath don't make much of is a zeroth requirement:
There is nothing more powerful than an idea whose time has come, and
there is nothing less interesting than idea before its time.
The efforts being made to report and address the epidemic of Medical Healthcare Error are earnest, "real", well-crafted and creative. In another time they'd succeed, wildly.

The Public, and hence Politicians and legislators/regulators, are not yet ready to hear this message.
Perhaps we'll hit a tipping point when Healthcare either becomes generally unaffordable or 30% of people are directly affected by serious Medical Harm.

Until then, I hope those fighting this Good Fight can keep their spirits up and continue in the face of disinterest.

Sunday, June 24, 2012

An answer: Why not an NTSB for Healthcare?

In the seminal  Institute of Medicine (IOM) report, "An NTSB for Healthcare", a central question is posed:
Not Why an NTSB for Healthcare ... Why Not?
We believe that the question regarding an NTSB for healthcare is not why...but why not!
  • Why not use best practices that taxpayers have already paid for to prevent the more than 30 preventable deaths an hour in American hospitals?
  • Why not use methods that have been field-tested with proven results?
  • Why not save money while saving lives and bringing value to our communities?
  • Why not leverage great tools from aviation that clearly have application to healthcare?
  • Why not challenge common risk-management processes to prevent the national sharing of information?
  • Since current databases of healthcare accidents are so small, sparsely populated, and inaccessible to all hospitals, why not have a fast-track program generating "Red Cover Reports?"
  • Why not address the Health Information Technology (HIT) risks proactively, as we know unintended consequences occur when we introduce new technologies?
  • Why not learn the lesson from aviation – that we must move beyond reporting causes and aggressively move to prevention of accidents?
  • Why not give high net worth individuals like Warren Buffet who feel that tax rates are too low an opportunity to provide funds to create an NTSB-like demonstration project and prove what we already know and save lives in the process?
  • In a new report from the IOM HIT and Patient Safety; Safer Systems for better care, a committee of independent experts has called for an NTSB like body to investigate serious problems related to HIT – why not listen to them?
The Safety Leaders site has more great material than you can believe - its carefully selected, well structured and crafted; and finely targeted to various interest groups. It doesn't rely on assertion and dogma, but forceful and compelling hard-evidence from Healthcare and other high risk fields.

Watching the truly outstanding series, probably from 2010 and onwards, "Surfing the Tsunami", there's a panel discussing the IOM report  "an NTSB for Healthcare".

Where they note they didn't phrase the central question as "we need to do this", but "Why not do this?"
They are truly perplexed by the lack of take-up and enquire of the audience, "Why Not?"

In "An unnoticed crisis in Healthcare", I posit a systems effect based on "thrashing" that, whilst a very well know computing problem, is almost unknown outside.
In response to "Why not an NTSB for Healthcare", answers come from Change Management with insight form Human Behaviour and Organisational Dynamics.

The primary answer is:
  • What's in it for me?
    • What's the upside of doing this, of changing how I work?
and the concomitant:
  • Are there consequences for not doing this?
    • What's the downside of ignoring or not doing this, or continuing "Business as Usual"?
Without changing the rewards and penalty structure, there not only won't will be, there can not be any systemic change.
"There is no reason we can't do that in Healthcare"

The Organisation Dynamics driver to purse is mundane but pervasive:
  • Follow the Money!
    • Power, Influence and the ability to demand compliance or "say NO and make it stick" all track back to power over budget or positional power: Status is a proxy for pay-scale. We award high Status employees with money and, for principals and owners, individual and organisational Status determine the ability to attract paying customers and set billable rates.
The first answer to the most of the "Why not" questions, the practitioner, manager and Board answer is simple:
  • Why not? Because we don't have to.
A more insidious, subtle and ultimately deciding, not even pivotal, factor to consider is:
What are the blocks, active and passive, to change?
Reframing this question:
  • Who has the most to win or lose from maintaining the current Status Quo?
  • Who are the gatekeepers, individual, organisational and political, that can either enforce the current Status Quo, or prevent/limit change?
Again, the answers come down to self-interest and pecuniary interests.

My perception of the absolute blockers of this Change Programme are:
  • A pervasive "Medical Culture" of roughly:
    • The "Doctor as God": all others within the System must bow to them, to accept their unquestioned authority.
    • Doctors are Kings of their own Domain, with an inherent right to unquestioned authority and self-determination within their sphere of control.
    • Like Lords and fiefdoms of the Dark Ages, Lords do not interfere with, on comment on, the affairs in any other Domain, but still pay homage to those above them in the hierarchy.
    • "Doctors don't make Mistakes, just encounter 'difficult cases'".
  • The Medical suppliers, Big Pharma and services industries that do very nicely right now and have the inalienable commercial right to fight to retain that.
  • The all too many current Medicos in the "top 5%", and everyone with the ambition to join them.
  • The Hospital Administrators and Board Members who get paid based on how things are now.
  • The AMA, American Medical Association:
    • Is it an employee Trade Union, a Sole Practitioner or Small Business Association, a Business Owner Association or Medical Trade Association, or all of those?
    • How does it fulfil the primary role of a Professional Body in disseminating Knowledge and Current Practice, both What Works and What Doesn't?
    • How does it fulfil its Fiduciary Duty to Societal Groups that need representation and protection, but don't have the influence, knowledge or resources to make themselves heard?
    • When lobbying Government and Regulators, how does it resolve the inherent conflict of interest between "standing up for members interests" and its Fiduciary Duty to individuals and the Society its serves?
    • Does the AMA, through its elected officials, have a consistent, clear overarching vision of Serving the Public, or something else that allows savage internecine Politics and viscous wars within and without the Profession?
Clearly, the AMA is critical to the acceptance and implementation of a radical change in not just how Healthcare is delivered in the USA, but the Medical Culture and system of payments. Is it likely to recognise, let alone address, that it has inherent conflicts of interests at its core? Without acknowledging who it is and what it does, the organisation cannot change.

The obvious most effective Political change needed is in Funding.

To stop rewarding behaviours and practices that are dysfunctional or not supportive of Societal goals and to start rewarding those things that fix the system, that address known problems. The O'bama administration has attempted to change the Healthcare system, but with extreme opposition from 'conservative' interests. It is unclear that anything will be accomplished from this initiative.

To underline this point, consider the insights in, and impact of, the seminal article by IHI CEO, Don Berwick, over 15 years ago:

Berwick D. A primer on leading the improvement of systems. BMJ 1996;

Good systems are designed deliberately to produce high quality work.
By eliminating waste, delay and the need to redo substandard work, they achieve long-term cost effectiveness." 
The Central Law of Improvement: every system is perfectly designed to achieve the results it achieves
What has changed since 1996? Was there a revolution?
Quality Improvement is still an outlier activity. Medical Healthcare continues to kill and maim more people each year without seemingly garnering attention or comment. The "Doctor as God" Medical Culture continues unabated and new entrants are sill inculcated into it.

But the worst thing of all, the cost of Medical Healthcare, in absolute and relative terms, continues to rise unchecked. This is perhaps the greatest threat in 100 years to American Democracy and Sovereignty. Nobody "in Power" within the Roman Empire saw the end coming, the inexorable march of competitors into their heartlands. Nor did those "in Power" in the USSR and Eastern Block seem to notice or prepare for the acute disruption of their system following the fall of the Berlin Wall in 1990.

This is the shape of these disruptive "step" changes: Nobody inside seems them coming.

The AMA is the primary gatekeeper to Medical Healthcare in the USA: it has the resources and ability to block any and all changes. At some point, there will be a showdown: the current Status Quo versus Change and Improvement.

There is another important difference between Aviation and Healthcare than must be addressed before there can be any systemic changes in the US Medical Healthcare system:
There are very few personal consequences of "poor performance" or "failures" for Doctors.
Pilots, operations and maintenance staff and Organisations face real, immediate penalties when they are discovered to have repeated, or allowed, Known Errors, Faults or Failures.

Pilots, unlike Doctors, face immediate, dire personal consequences when they catastrophically fail in their mission: they die.

Fear of death "focuses the mind". No pilot ever did less than their best when attempting to avoid a crash.

For those that have listened to the voice-cockpit recordings of Capt. Chesley Sullenberger in the 208 seconds it took Flight 1549 to end up in the Hudson river, his very calm, focussed and steady state seems to contradict any acute stress reaction as he faced imminent death, "mission failure" and the responsibility for the lives of everyone "back there".

Capt. Sullenberger suffered an actue, on-going stress reaction to those 208 seconds. For nearly three months afterwards he had significantly elevated heart-rate and blood-pressure. The immediate aftermath, of the first fatality free ditching of a jet-liner - an outstanding success, was that he couldn't sleep for at least a week. He did not return to the flight-deck of commercial aircraft after he recovered, thought I believe the First Officer did. This is not uncommon amongst anyone in Aviation who feels responsible for a fatal accident, not just pilots.

Pilots not only care about the outcomes (safe passage) for those whom entrust their lives to them, they put their own lives on the line.

Doctors may care for their patients' outcomes, but don't have "skin in the game" in nearly the same way. Their motivation to reduce adverse patient outcomes is infinitesimal when compared to pilots.

So the answer has to be simple: let Doctors suffer dire personal consequences for their failures.

Only that is the worst possible action, as Dr Brent James pointed out to me, this would guarantee perverse outcomes and worse quality of care.
People optimise what is measured, a well known management principle.
As soon as the organisation measure Errors, Faults and Failures, and assigns individual blame, rational people (Doctors included) will modify their behaviour to avoid any censure: they'll devote the majority of their resources to CYA (Cover Your Arse).

Not only is a fundamental shift in the funding model of US Medical Healthcare required to create improved Quality of Care, real change is needed in the rewards and penalty structure:
  • Failure to promptly report "Adverse Event Incidents" by any Medical Staff must lead to Professional penalties.
  • Prompt personal reporting of real or potential "Errors, Faults and Failures" must be protected, to have no Professional or Personal consequence beyond retraining or reassignment.
  • Medical Error litigation against employed individuals must be banned, with only Organisations being held responsible and able to be sued.
    • The high-cost of "Professional Indemnity Insurance" has to be addressed.
    • Organisations and individual Medical Professionals need to be able speak to families and victims of Medical Errors openly and fully without concern for legal liabilities.
  • On-going care for, or compensation of, Medical Error victims and their families has to be automatic, fixed and reasonable. Awards are not windfalls of the legal lottery, nor an encouragement for the legal system.
    • A significant step forward must be removing the incentives for legal practices to pursue Medical Error litigation.
  • Hospital Administrators and to a lesser extent, Board Members, have to assume direct, personal liability for Patient Care outcomes.
    • This requires a legislative change.
    • Most importantly, the legal basis of evidence needs to be altered
      • This is not about single individuals, but the aggregate Quality of Care and Patient Safety delivered across all patients within a system.
      • People can be barred as Directors of Companies for poor behaviour, so should those in Positions of Trust within Medical Healthcare.
  • Collection and full public reporting of Patient Safety data is critical.
    • Falsifying, interfering with or manipulating Patient Safety data should be a severe criminal offence.
  • Public Root Causes Analyses of all fatalities and severely harmful Medical Errors need to be conducted and published within 'reasonable' timeframes by independent, properly resourced and trained experts.
    • Civil and Criminal charges must be possible against:
      • anyone repeating a Known Error, Fault of Failure.
      • anyone charged with preventing Known Errors etc from failing to do so.
      • Any and all owners and managers who fail in their Duty to Prevent Harm.
      • Organisations and managers/office bearers within them that fail to disseminate Harm Prevention information and processes/procedures in an effective and timely manner.
      • "Wilful Blindness" provisions are needed as well. Practitioners, Administrators and Owners/Managers that do not actively pursue Quality Improvement or Knowledge dissemination are culpable through an act of omission.
  • New Criminal Offences for Medical Practitioners are needed on the statue books:
    • intention to Harm, (ie. deliberate malfeasance) and
    • Professional Negligence demonstrated by persistently low Quality of Care indices or excessive Patient Safety violations.
As a community, there has to be consensus support and a willingness to hold all Medical Professionals to the basic Professional standard:
  • There is never an reason for a Professional to repeat, or allow, Known Errors, Faults and Failures.
Until the community embraces this as a minimum standard, nothing can change.

While this happens, all the incumbents that profit from maintaing the Status Quo will remain as active, vocal and trenchant Roadblocks to Change.

The path to "an NTSB for Healthcare" lies through Politics and a broad social demand for change, not empty promises and window dressing.

Wednesday, May 16, 2012

Egoless Practice: Becoming the Best in your Field

[Full post on other blog.]

Jerry Weinberg coined the term, "egoless programming" in his 1971 book "Psychology of Computer Programming". Jerry describes the practice and mindset, and in 1977 co-wrote with Friedman, the definitive manual for practitioners:  "Handbook of Walkthroughs, Inspections, and Technical Reviews: Evaluating Programs, Projects, and Products".

Is there a precise definition of "egoless programming" that could be expanded to a generic Professional Behaviour of "egoless practice"?

Johana Rothman is quoted by Jeff Atwood, presumably from a book, as saying:
Egoless programming occurs when a technical peer group uses frequent and often peer reviews to find defects in software under development. The objective is for everyone to find defects, including the author, not to prove the work product has no defects. [my italics]
When asked for a modern definition, Jerry pointed at Jeff's Ten Commandments of Egoless Programming.

The field of Reliability Engineering is aimed at creating near-Perfect (i.e. highly reliable) operation from imperfect parts and sub-systems. This approach can work very well, even when maintenance and fixes can't be done: the NASA Mars Rovers, Spirit and Opportunity, exceeded their 90-day design life by around 15 times, working from 2004-2010.

A working definition (unfortunately, of many parts).

Egoless Practice is:
  • a Professional Behaviour
  • designed to 
  • routinely and reliably achieve
  • as Perfect as Possible outcomes
  • for the Client or Service Recipient
  • by knowledgable and skilful
  • Practitioners
  • supported by systems, processes and procedures
  • that actively monitor, examine and report performances,
  • for both failures and successes,
  • to systematically and without-backsliding improve 
  • Quality, Performance and Process
  • of Individuals, Teams and Organisations.
To Err is Human isn't a syllogism, it is an Iron-Clad Law.

It's the basis of the unending, relentless Professional Challenge:
  • we're not machines,
  • we cannot ever exactly repeat a process, not even twice, let alone the many times every day needed in Professional Practice, and
  • our Minds and Bodies are always letting us down or tricking us in some way.
Simply stated: We are constantly making mistakes, inadvertently or not.

Monday, May 14, 2012

The unnoticed Crisis in Healthcare

This paper on solving the Quality of Care crisis in Healthcare, "An NTSB for Healthcare", made me wonder why nobody was talking about another long-running, endemic Crisis in Healthcare:
In trying to spend less, it costs more to provide less of a worse service.The more we try to cut costs, the more it will cost and there is no simple way out: the system is locked into this craziness.
Doing "more of the same" not only cannot break us out of the rut, it pushes us deeper into it
W. Edwards Deming, the person responsible for the Quality Improvement movement in Japan that also forced a revolution in manufacturing the United States in the 1980's, was very clear on this:
  • When people and organizations focus primarily on quality, defined by the ratio (Results of Work Effort / Total Effort), quality tends to increase and costs fall over time.
  • However, when people and organizations focus primarily on costs, costs tend to rise and quality declines over time.
Turning around any system spiralling out of control cannot be done by "more of the same", but needs careful attention to causes and the underlying systems. As Quality Improvement has repeatedly shown, focussing on "Doing Things Right First Time, Every Time", is a remarkably effective means of effecting even very large turn-arounds.

No sane Politician or Healthcare Administrator/Bureaucrat would intentionally do or allow this downward spiral, but the effect is slow and insidious starting and irreversible when started. That we have gone there in many US Hospital Systems is more than adequately documented in Dr. Otis Brawley's "How we Do Harm".

The good news is that there a number of high profile Hospital Systems that seem to have avoided this crisis: Mayo Clinic, Cleveland Clinic, Dartmouth-Hitchcock Medical Center, Denver Health, Geisinger Health System and Intermountain Healthcare.

All these Hospital Systems make Quality of Care their priority and indirectly achieve much better financial outcomes (20-30% less per service), illustrating Dr. Deming's assertion. Such "Systemic Quality" techniques not only yield better Patient Outcomes, but Optimal Care Costs because the Active Learning underpinning it necessarily includes Process and Performance Improvement.

You'd expect decision makers would want to lower costs, improve Quality and improve staff morale and employment conditions. And I believe they would, if they properly understood both the problem and the solution.

The central challenge with the theory posited here is twofold:
  • proving its more than a theory, and
  • convincing Decision Makers of the problem and that "more of the same" cannot be a solution.
The definitive theoretical works on how this counter-intuitive effect presents in Computing, Virtual Memory "Thrashing", started in 1968 with the first paper on "Working Set" theory. It's not overstating the fact that without this work (theory + proof-in-practice) computers as we know them could not exist.

A related computing theory, the "Universal Scalability Law" (USL), applies more widely than computers, as shown by this piece on Projects and the "Mythical Man Month" (adding more people to a late project makes it later).

This is the counter-intuitive world that in Computing we call "Thrashing", in Catastrophe Theory a "tipping point" and in everyday parlance "past the point of no return" or "starting down a slippery slope". Even sometimes, "in a flat spin", meaning "with no way out".

These all occur when a system or thing is irreversibly pushed past a critical point or limit and then the rules of the game change. Much like stretching out the small spring from a retractable ballpoint pen renders it useless. It cannot be properly remade because the steel has been stretched permanently past its elastic limit. There's a different effect in "Memory Metals" which return to their original shape when heated, but you can't make springs out of them, only automobile body panels.

There are a huge variety of examples of this that breakdown roughly into 4 types:
  • Dynamic systems that exceed a critical threshold. E.g.:
    •  a car, motorcycle, pushbike or skateboard "fishtails" or "tank slaps".
    • Aeroplanes and rockets experience violent, uncontrolled oscillations like a flag: "flutter".
    •  Ice Skating has the term "Death Spiral": a person can't get up from this without help once locked in.
  • Dynamic systems that go below a threshold. E.g.
    • Aircraft in "the Region of Reverse Command" or "behind the Power Curve". When flying too slow, with the nose pointing too high, planes are more like kites. Applying more power, pushes the nose higher and the plane flies slower. Reducing power puts you into a stall and if you're on take-off, you crash.
    • Riding a pushbike or motorcycle to a stop without putting your feet down (especially when you can't reach the ground). Because the centrifugal forces from the wheels are no longer holding you up, you can quickly overbalance and not be able to right yourself. 
  • Static systems that exceed a critical limit. E.g.:
    • The overstretched spring cannot be put back.
    • A paper-clip can be straightened, but never properly reformed without weak spots.
    • Plastic items or toys that are bent too far and crease, forming weak spots.
    • Letting Ice Cream melt. All the bubbles escape, it separates and won't reform easily.
    • Plastic Film and Duct or Gaffer Tape: is very strong until a small nick is made in it. Then it tears easily for as long as force is applied.
    • Nylon fabric in a tent or flag: very strong until nicked, then will tear along its whole length.
    • Touching the inside of a tent during rain makes it leak. While the surface tension isn't broken, water doesn't drip. Once broken, the drip cannot be stopped.
  • Static systems that go below a critical limit E.g.:
    • Chocolate that is cooled too far assumes a white, powdery appearance as the fats/oils separate out.
    • A drop of water in a hot skillet will happily float on a cushion of steam if small enough to start with, but when it gets too small it becomes unstable and explodes when it touches the skillet.
    • Soap bubbles support themselves and happily float around in the air, until the film becomes too thin (from evaporation or flow) to withstand the slightly higher internal air-pressure and they explode.
    • Snow Skis and sled runners 'glide' by  melting snow with pressure. In extreme cold, this effect stops because the pressure doesn't melt the snow. Unseasonably cold weather was a contributing factor in the failure of Robert Scott's Antarctic expedition. The man-hauled sledges became very hard to pull when they stopped sliding over the snow and started digging in like they were in sand. 
There are some other dynamic systems that most drivers are very aware of:
  • Overbraking leads to the tyres skidding as the friction melts the rubber and you're suddenly sliding on a thin film of liquid rubber. For drivers encountering this for the first time, the though of releasing the brakes, not pushing harder, is usually terrifying. "ABS" braking solves this by automatically releasing the brakes and re-applying them.
  • The opposite effect is high-powered cars spinning their wheels when accelerating. The wheels continue to slide until power is reduced enough to regain traction.
  • Cornering or swerving too fast, usually in slippery conditions like ice, mud or rain, results in some or all the wheels losing traction. There are no good recovery techniques for an all-wheel slide. When only the back wheels have lost traction, the classic "steer into the slide" technique works - which for those new to it, is usually counter-intuitive.
In all these situations, once "traction is lost", control is lost unless specific recovery measures are taken.
Once a rubber tyre starts to slide, it will continue to slide at that and previously tractable speeds.
Recovery isn't just a matter of reverting just a little, but often quite a lot until the rubber stops melting or sliding. Once traction is restored, it will again stay adhering until the critical limit is reached again. "Good car control" is often staying just below the critical limit and maintaining maximum friction without slipping.

These counter-intuitive effects are well understood in General Systems Theory. One of the essential understandings is that to optimise whole system output, at most one sub-system can be optimised. All others have to run with some "slack" to allow the best outcomes of the whole system.

The necessary ingredient to create a system which can sink into "Reversal of Command" type dysfunction is two opposing system response curves:
  • The "normal" response curve where increasing staff numbers (i.e.higher staff costs, more time per patient and more individual "slack" time) results in more throughput, but at the cost of lower "cost effectiveness" per patient, and
  • The "stressed" response curve, where low staff numbers creates higher absentee and sickness rates, increases Medical Errors and Adverse Events, increases staff-overtime for those able to work, increased time-pressure creates more stressed staff, reduces their job satisfaction and radically increases turn-over. Because the total demand for care has not reduced, extra staff have to be found: either through overtime, substitution of under-qualified staff or hiring expensive Agency staff. Overly tired staff not only work slower, but miscommunicate more, are worse at detecting errors and omissions  and make inordinately more clerical errors, requiring extra time to correct.
There is an Optimum Staff Cost point: the most cases are treated for the lowest staff costs.
Attempting to reduce staff costs below this point is counter-productive. The "stressed" response curve takes over and increases staff costs whilst the overworked staff produce significantly worse outcomes.

The problem with large Healthcare and Hospital systems, is that nobody is tracking the dysfunction curve, only the headline "staff costs".

Generally, you can reduce average treatment costs by reducing staff, at the cost of increasing patient wait time. But, the average cost of patient treatment increases with very long wait times. If you don't know what those limits are, and aren't providing staffing levels sufficient to keep below them, then the institution will blindly wander into the counter-productive zone.

An example from Dr. Brawley: A breast-cancer case caught early in stage-1 may be treated for $30,000 with very good patient outcomes. Each year the person has to wait for treatment, the cost of treatment increases and their outcomes reduce. Brawley tells the story of  woman who waited for 7-8 years until her breast cancer had become stage-5. The treating oncologist estimated a treatment cost of $150,000 at this time and survival of only 12-24 months...

At every level it was more expensive for her treatment to have been delayed, yet "the system" had no ability to properly measure and model these costs, nor to even notice that it had been 'efficient' by not 'effective' when she did finally consume a massive lump of funding.

Because these events go unnoticed and unreported, total System Costs are much higher than they need be.
But without measuring them, who's going to believe it?
And if you don't believe it, why would you measure?

Teams and Departments can suffer similar system breakdowns in their culture, as described in this: the "Blame Spiral".
The crucial point is that the "Do it Right, First Time" Quality Improvement methodology, because it is based in real measurement and relevant reporting, catches these issues early and prevents minor culture issues from descending into massive dysfunction.

Sunday, March 25, 2012

Systemic Quality and "The Iron Triangle" of Quality, Cost and Schedule.

[Full post on other blog.]

The work on Safety and Quality systems by James T. Reason and Charles H. Perrow redefined the world of Quality, showing up in acceleration Safety in Aviation post-1970.

But what do you call this approach?

I'd like to suggest, "Systemic Quality".

Perrow called them "Normal Accidents" and Reason "Organisational Accidents". Both were talking about System created Accidents. Where multiple events, not individuals, are the cause of unintended poor outcomes. But neither coined a term for this approach to Safety and Quality.
My reasoning for the naming is:
Name the approach after the cause addressed, Systems create the problems, so it's Systemic Quality.
The text below is adapted from a piece on suggesting Medicine become a Modern Profession, like Aviation.

What Dr W. Edwards Deming understood so well is that Quality, Process Improvement and Performance Improvement are linked through the same fundamental:
Deliberate, focussed review of work outcomes with intentional Learning and Adaption are necessary for, and common to, all three.
This is enshrined in Deming's P-D-S-A (Plan-Do-Study-Act) cycle, which he called the Shewhart Cycle.

Systemic Quality through its design and nature improves Safety, Performance/Productivity and Economic Performance/Profitability.
Something that Apple Inc knows and Microsoft, the long-time market leader, does not.

EBM's and RCT: Doubt, Scientism and unquestioned Ideologies

update 8-Apr-2012: Quotes from "Evidence-Based Medicine: Neither Good Evidence nor Good Medicine" by Steve Hickey, PhD and Hilary Roberts, PhD.

  • The current approach to medicine is "evidence-based." This sounds obvious but, in practice, it means relying on a few large-scale studies and statistical techniques to choose the treatment for each patient. Practitioners of EBM incorrectly call this process using the "best evidence."
  • Significant Does Not Mean Important...
  • Large trials are powerful methods for detecting small differences.
    • Now, tiny differences - even if they are "very highly significant" - are nothing to boast about, so EBM researchers need to make their findings sound more impressive.
    • They do this by using relative rather than absolute values.
    • Suppose a drug halves your risk of developing cancer (a relative value). Although this sounds great, the reported 50% reduction may lessen your risk by just one in ten thousand: from two in ten thousand (2/10,000) to one in ten thousand (1/10,000) (absolute values). 
    • Such a small benefit is typically irrelevant, but when expressed as a relative value, it sounds important. (By analogy, buying two lottery tickets doubles your chance of winning compared to buying one; but either way, your chances are miniscule.)
  • There is a further problem with the dangerous assertion implicit in EBM that large-scale studies are the best evidence for decisions concerning individual patients.
    • This claim is an example of the ecological fallacy, which wrongly uses group statistics to make predictions about individuals.
    • There is no way round this; even in the ideal practice of medicine, EBM should not be applied to individual patients.
    • In other words, EBM is of little direct clinical use.
  • As we have mentioned, EBM restricts variety to what it considers the "best evidence."
    •  However, if doctors were to apply the same statistically-based treatment to all patients with a particular condition, they would break the laws of both cybernetics and statistics. 
    • Consequently, in many cases, the treatment would be expected to fail, as the doctors would not have enough information to make an accurate prediction.
    • Population statistics do not capture the information needed to provide a well-fitting pair of shoes, let alone to treat a complex and particular patient.
    • As the ancient philosopher Epicurus explained, you need to consider all the data.
  • A doctor who arrives at a correct diagnosis and treatment in an efficient manner is called, in cybernetic terms, a good regulator. 
    • According to Roger Conant and Ross Ashby, every good regulator of a system must be a model of that system. Good regulators achieve their goal in the simplest way possible.
    • In order to achieve this, the diagnostic processes must model the systems of the body, which is why doctors undergo years of training in all aspects of medical science.
    • In addition, each patient must be treated as an individual.
    • EBM's group statistics are irrelevant, since large-scale clinical trials do not model an individual patient and his or her condition, they model a population-albeit somewhat crudely.
    • They are thus not good regulators.
    • Once again, a rational patient would reject EBM as a poor method for finding an effective treatment for an illness.
  • Diagnosing medical conditions is challenging, because we are each biochemically individual.
    •  As explained by an originator of this concept, nutritional pioneer Dr. Roger Williams,
    • "Nutrition is for real people. Statistical humans are of little interest."
    • Doctors must encompass enough knowledge and therapeutic variety to match the biological diversity within their population of patients.
    • The process of classifying a particular person's symptoms requires a different kind of statistics (Bayesian), as well as pattern recognition.
    • These have the ability to deal with individual uniqueness.



The Friends of Doctors espouse an uncritical Ideological belief in a simplistic doctrine:
Evidence Based Medicine is the only source of Good Science and hence Good Medicine.
All else is, by definition, irrelevant, invalid and, at worst, quackery.
Which is a variation on Scientism, "the universal applicability of the scientific method and approach".

In 1898 you might've excused a Great Expert from declaring "We know everything and have invented everything" [paraphrased] - but in the 21st Century, for anyone to have the arrogance and hubris to make universal/absolute statements that are not dissimilar is unbelievable.
Doubly so, if like FoSiM, they hold themselves up as Great Experts (Professors with many awards and decades of experience).

I have a very specific objection to the FoSiM position, roughly, EBM/RCT's are OK as far as they go, but are far from being the only thing:
Evidence Based Medicine (EBM) and Randomised Double-blind, placebo Controlled Trials (RCT's) are NOT definitive in themselves, they are far from the only source of valid evidence to support clinical practices and treatment.
While the underlying Science is necessary, a lot more is needed to arrive at safe treatments consistently delivered in Practice.
RCT's are a necessary, but not sufficient, way to gather evidence, but can never provide proof. Popper's "falsification" notion says theories can never be proven, only disprove with 1 counter-example. The source of the economics/finance term "Black Swan" - something completely new and unexpected.
Why would a group of eminent persons go out of their way to make themselves look complete fools, espousing an entrenched and immovable position that is obviously flawed?

The only reasonable answer I can come up with is:
They are fighting a Turf War and using EBM/RCT's as an overwhelming strength with which to beat-up their opponents. But if the opponents start to provide RCT's, then they can either play "Change the Rules" or "Move the Goal Posts" to force the opponents to waste time and resources.
The unreasonable explanation is these folks are uncritically and intractably wedded to the Ideology, "EBM and RCT's are everything".



So, if RCT's are a good experimental methodology and EBM beats the pants off what Establishment Medicine was doing 50 years ago, why isn't that the end of it?

There are two headline problems and a lot of "fineprint" to uncover with RCT's.

The headline summary is: EBM based solely on RCT's are fatally flawed - they completely ignore real-world Service Delivery and Patient Safety issues.
  • Good Practice does not automatically flow from "Good Science".
    • Just delivering good enough service, treatment and medicine, economically to all people in a population is a major challenge to which the underlying "Science" is at best tangential, at worst, irrelevant.
    • Practitioners like "Dr Death" of Bundaberg amply demonstrate the "Knowing, Doing Gap", let alone the "Potential vs Actual" service delivery problem.
    • For the worst doctors, efficacy of treatments is completely irrelevant. Patient Safety is of prime importance and absent if Safety and Quality systems are inadequate or absent.
  • Treatments and Medicines need to be Safe and Effective. RCTs only seek evidence for one half of the equation - efficacy.
    • RCT's do not, nor seek to, establish the real-world safety of treatments/medicines. It takes years of treatment and many iatrogenic injuries and deaths to establish a good view of Patient Safety. Then a judgement needs to be made if Efficacy trumps Safety or not.
    • Drugs like Vioxx, "linked to thousands of deaths", are the predictable and inevitable outcome of unquestioning acceptance of the Ideology of "RCT's and EBM is the only One True Base for Medicine".
RCT's, or more properly, Randomised Double-blind, placebo Controlled Trials sound pretty impressive. What could possibly be wrong with them?
Let's go back to the full name and pick it apart.
  • "Randomised Double-blind". Why? Because people can bias experimental results without knowing.
    • This sort of experiment is very sensitive to bias, accidental or systemic, throwing doubt onto the results of every Controlled Trial.
    • Psychological effects on experimenters and subjects is exceedingly subtle and complex, to say "there can be no bias because we know everything about doing this" is supreme arrogance. That there have been many significant effects uncovered in the last 50 years suggests that many more will be uncovered in the next 50 years.
      • The simplest of biases comes from the difference between the target population and the testing population.
      • The most subtle is the genetic differences in populations between countries. What works in Africa, may not in Asia or European countries, and vice versa.
    • The Elephant in the Room for RCT's is One Team, One Environment, One Test.
      • There is an iron-clad law of Quality: You cannot test your own work.
      • With experiments, this translates to, you cannot validate or check your own experimental data.
      • As a minimum, RCT's need to be Triplicated in diverse contexts with diverse populations to address even this simple type of bias.
  • "Placebo Controlled Trials". Why? Because "mere suggestion" has very powerful healing effects.
    • The baseline controlled against is never "no treatment" but a "sham treatment".
    • The reason "Controlled" trials are needed is because if people think they are getting treatment, their bodies start to heal themselves. It's a powerful enough effect that it cannot be ignored - it's enough to overwhelm normal statistical analyses.
    • Here's the nasty secret RCT-base EBM doesn't discuss: Nobody knows the mechanism of the Placebo Effect. Because its named, people think its explained.
    • So what if we don't know the exact mechanism, we've developed effective treatments for a century or more without knowing exact mechanisms?
      • But that's the whole point of RCT-backed EBM, to be very exact about what works, and how it works. Who's to say the efficacy of a large fraction of treatments/medicines who's can't be doubled or tripled by "tweaking" the placebo effect.
      • The secret is nastier: whatever the Placebo Effect mechanism is, it cuts both ways. It can promote or retard healing. Without knowing the mechanism(s), RCT results have all the validity of home-made magic potions. Is there something that normal research teams do that modifies the action of treatments but isn't replicated in normal Practice? Nobody knows - everyone pretends, without any certainty, the effect has been compensated for, which is wishful thinking, not Good Science.
      • This is a central contradiction of RCT's used for EBM: it gives the appearance of Science because there are number with a lot of decimals and many fine, complex statistical analyses, but its all smoke and mirrors to disguise the truth, "We really don't know what's going on, but are pretending its All Good."
  • In a Controlled Trial, drugs are tested alone. This is necessary to get "clean data" and verifiable, trustable results. It also isn't how drugs are used. Drugs are used in combination with many things, which are specifically untested in RCT's.
    • Drug interactions, especially increased side-effects, are a major problem with new drugs.
    • With the increasing numbers of drugs, treatments, supplements, exotic foods and traditional medicines in use, it isn't possible to test new drugs against all expected use-cases, let alone against all possible combinations.
    • EBM quietly overlooks that Controlled Trails, while presenting valid single-drug data, provide no evidence about real-world usage. Each patient is a new experiment.
  • What does a failed treatment experiment look like? When RCT's don't cut it?
    • Iatrogenic Injuries and deaths...
    • Proponents of EBM don't go near this, it just wouldn't look good in Journal. Of course, the papers are already published and the Trials shutdown, there is no way to go back in time and add those problems to the RCT when published. Each patient is a new experiment.
  • The reasons our species thrives and survives are many, but part of it is the constant genetic mixing from parents. We each have very individual physiologies - making us tolerant and sensitive to 'chemicals' in very individual ways. 
    • Controlled Trails make two exceeding dangerous and simplistic assumptions:
      • The trial and target populations correspond well enough. Until the trial is validated in practice, how can this assumption be validated? Each patient is a new experiment.
      • Individuals won't react outside the bounds seen in the trial. All the trial data needs to be reduced into simple dosage instructions "xx mg/kg body weight". How does your  treating Physician discover you are either exceptionally tolerant or sensitive to this new challenge to your system? Each patient is a new experiment.
      • Of course, we just don't mention abreactions, anaphylaxis and allergic reactions in Trials, or devise methods to avoid foreseeable problems. Each patient is a new experiment.
    • Individual sensitivity to drugs is not constant over time. For example, dosage of opiates needs to be reduced over time as liver function reduces with days spent in bed. Each patient is a new experiment.
But wait, there's more...
  • The bane of all experiments are Errors, Mistakes (in Design and Execution) and incorrect/incomplete models leading resulting in "knowledge gaps" - things that should be done, that aren't.
    • Systemic and systematic errors in methods, skills, execution can't be detected within the originating team. Like every individual, we cannot see ourselves from the outside. We need others to check our work, we are perceptually blind to our mistakes and problems/faults.
    • Normal RCT experiments fail basic Quality Systems design:
      • there have to be checks built into the process to validate "production".
      • This normally requires a separation of Design, Execution and Data Analysis.
    • Again, I think Triplicated Controlled Trials are the minimum requirement for this methodology. It is trying for Perfection when Service Delivery is so severely flawed and defective that it makes new Trials mostly irrelevant. For the next ten years, if we just did what is known to work, everywhere and all the time, that would provide orders of magnitude improvement in Patient outcomes.
  • Human Nature drives fraud, intellectual and commercial, it can never be eliminated from Science. medical or not, it can only detected and controlled. When the commercial rewards are high, the drive is much stronger and methods employed more subtle and devious. It becomes intentional, organised activity, not "rogue individuals" and "opportunistic amateurs".
    • Because there is so much at stake, both in human lives, pain and suffering and money, you'd think that extraordinary efforts would be made to prevent and detect all types of fraud and rigged results.
    • But you' be wrong. Major drug RCT's aren't subject to strict independent fraud checking. Just the usual and quaint "peer-reviewed academic journals".
    • What this says about the gullibility and naivety of Medical Science is debatable, but they are sorely lacking in insight and a sense of public duty.
In summary:
Medical Science uses RCT's because it's the best thing they've got, but belief in them "should be held lightly", they are not infallible nor free of serious deficiencies.

Evidence Based Medicine is a good servant and a poor Master. The emphasis must be on Medicine, not 'Evidence', on providing good patient care and outcomes. Chief of which is focussing on Patient Safety, not the glittering bauble of "efficacy". "First, do NO harm"...