Unsolicited advice for the new Queensland Government

[Full post on other blog.]

Last night in Queensland, the Liberal National Party (it could only happen in QLD), won in a landslide, led by Campbell "Can Do" Newman, son of Federal Politicians and with 13 years distinguished service as an Engineer in the Army.

One of the candidates I graduated with from school, 40 years ago has a very successful legal practice, I'm an underemployed I.T. consultant.

I sent him this unsolicited advice [On ICT and Healthcare]
Not very original of me I know, but I hope it gives a useful insight to them.

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"...

Friends of Doctors: What the figures say...

An analysis of the 11-March-2012 members list of "Friends of Science in Medicine":

• They can claim 28 'Friends' outside the field or their parent body and who still work.

Calling the group "Friends of Doctors" is far more accurate.

Note: A full count of members of the parent Organisation, "Australian Skeptics" is not possible without a public membership list (4,000 subscribers are claimed to "The Sketpic").

The organisation's own analysis, (494 members, 25-Feb-2012) is:

Of the 494 individuals were a total of 226 (45%) medical doctors (212 Australian, 14 Overseas) and other disciplines (243 Australian, 25 Overseas).

My analysis:

• 502 unique names,
• 1 duplicate record, "Prof Jon Emery"
• 123 with title "Dr"
• 2  declare or publicly state membership of the parent Organisation, "Australian Skeptics"
• 92 MD, MBBS, MBBCh, Physician, Psychiatrist, RN, Dentist
• 4 retired
• 6 "medical" research in entry
• 14 other Health related
•    1 Anatomy
•    1 Biochemistry
•    1 Gender, Health and Ageing
•    2 Genetics
•    2 Neuroscience
•    1 Nutrition and Dietetics
•    1 Optometrist
•    2 Pharmacist
•    1 Prosthetics & Orthotics
•    2 Veterinary Surgeon
• 5 non-health related
•    1 Chemistry
•    1 Computational Physicist
•    1 Economics
•    2 Science writer
• 334 with title "Prof" (including A/Prof)
• 4 FoSiM Executive members
• 34 Emeritus or retired
• 165 MBBS, MD, BMedSci, FRACP, FRCP, FANZCA, FRACGP, Obstetrics & Gynaecology, Medical Oncology, Psychiatry, Pharmacy/Pharmacology, RN
• 131 remaining:
• 26 work in a "Dept/College/School/Faculty of Medicine"
• 16 Psychology
• 9 Biological Sciences, Biology
• 8 at  Meical Research Institutes, "Walter and Eliza Hall Institute of Medical Research", "Baker IDI Heart & Diabetes Institute", "QLD Brain Institute", "Women's and Children's Health Research Institute"
• 6 Microbiology
• 6 in a NHMRC unit
• 6 Physiology
• 5 work in a "Faculty/School of of Health Sciences"
• 5 Biochemistry or Biomolecular, Molecular Science
• 4 Immunology
• 4 Cancer research
• 3 Exercise and Nutrition Sciences, Nutrition and Dietetics
• 2 Veterinary Science
• 2 Genetics
• 14 other Health related areas
• Clinical Epidemiology and Biostatistics
• Cognitive Science, Cognition and its Disorders
• Experimental Ophthalmology
• Health Economics
• Human Movement Studies
• Human Variome Project
• Medical Technology and Physics
• Mental Health
• Mother and Child Health Research
• Deaf Studies and Sign Language
• Optometry and Vision Sciences
• Paediatrics
• Public Health, Biostatistics
• Reproductive Biotechnology 
• Sex, Health and Society
• 15 in non-health areas
• Anatomy and Histology
• Applied Ecology
• Australian Museum
• Australian Studies
• Climate Science
• Computer Assisted Research Mathematics and Applications
• Earth Sciences
• Environmental Management and Ecology
• Law (2)
• Pianist/composer
• Social and Economic Modelling
• Special Education Centre
• Statistics
• Tropical Crops and Biocommodities
• 41 not "Dr", "Prof" or on the Executive.
• 7 declare or publicly state membership of the parent Organisation, "Australian Skeptics"
• 17 are in Medicine/Medical Science or allied disciplines (Pharmacy, Nursing, paramedic)
• 18 "non medical" vocations [counts not given].
• health/biology related
• Critical Care Dietitian
• Musculoskeletal Physiotherapist
• PhD Candidate, Environmental Futures
• PhD candidate, Psychophysiology
• Physiotherapist, Private Practice
• Registered Psychologist
• Senior Health Content Producer, Choice
• Veterinary Services
• 8 non-health related
• Information Technology 
• MSc(Astronomy) BSc(Finance & Economics) 
• Science, eLearning Officer
• legal researcher, solicitor
• science writer/editor/creative director

Censorship in 300 words or less. What's up at Fairfax?

An article in the Fairfax media entitled "Homeopathy | Alternative Medicine | Ian Gawler" drew my attention. I went to the effort of registering and making a comment. It didn't appear, having been "moderated", presumably breaking the Fairfax Rules for Commenting on articles and blogs :-

... any comments that can be reasonably considered offensive, threatening or obscene will not be allowed.

• Do not post material that may incite violence or hatred.
• Gratuitous abuse - be it of the author, subjects of the story or other commentators - will not be accepted.
• Please keep your comments relevant to the discussion at hand.
• Do not use the comments section for commercial purposes or spam.

Herewith my comment and the original article...

---

Dick,

First, this is an ideological debate. Nobody is going to be convinced by anything written here, but I'll make an effort.

You are conflating and confusing Science and Medicine. One is about Theory and Knowledge, the other is a an Applied Performance Discipline.

"it is strange that Western medicine is so on the nose with so many people."
No, the Science may be good, but the Practice and Delivery are often appalling, if not deadly. Check the Medical Error Action Group site. If Aviation were run like Medicine, we'd have 20+ 747's crashing every year in Australia.

"Why do people believe in ..."
Because they get compassion, care and concern from the practitioners. Ever waited 12 hours in an ER? It's not about the patient or good care.

"So how do we strive for truth?"
A Question based on a false assumption: people are looking for care, not data.

"How can the state deal with such popular therapies when there are
questions over efficacy?"
Because it's not about the Absolute Theoretical Potential of treatment, but the reality of Delivered Service, like "Dr Death" and others named by the QLD Commission of Inquiry, there is often a huge gulf.

"What is the role of freedom and hope in this equation?"
People already vote with their feet and wallets, use these market forces. Establishment Medicine is hugely subsidised ($50+B/yr), yet a large fraction of people choose to pay more and go elsewhere.

That would seem to be a comprehensive market failure of a whole Industry/Profession.

As taxpayers and voters, why do we accept this woeful state of affairs?

---

Potions, pills and promises
March 19, 2012
OPINION: Dick Gross

Beliefs in the promises of untested cures are as resilient as any faith.  Trust in "alternative medicines" is sufficiently widespread that it is now a significant industry.

At the same time, a group of eminent scientists "Friends of Science in Medicine" have received worldwide attention for their attempt to remove alternative medicine from university courses.

This debate touches upon the nature of belief.  I am not a medical practitioner but merely an observer of faith.  Epistemology or the study of knowledge looks at the role of faith when we can't be sure of things.  Because we cannot know about creation or death we inevitably turn to faith.  As members of the laity, most people cannot know about the cause or cures of our woes.  We take cures, orthodox or alternative, believing as we must, in the advice of our practitioners.

Advertisement: Story continues below
Where science is silent on an alternative medical practice, practitioner and patient alike must embark on a journey of faith.  Some practices such as Vitamin D pills are put under scientific scrutiny and survive.  Vitamin D, therefore, is no longer an alternative treatment for it has been given the green light by medical science.  Other treatments are either untested or fail scientific scrutiny and yet are resiliently popular.  Newspaper front pages were full last week with an attack on the efficacy and indeed the legitimacy of homeopathy. I have never been persuaded by homeopathy, the use of highly diluted medications, and it was no surprise to me it was being attacked as nothing but a placebo.

Even the great Steve Jobs was initially a believer in the untested.  There is evidence that his life could have been extended if he did not waste months trying unproven cures when his cancer was first spotted.  Valuable months were eaten up while he played around with severe diets and non-mainstream treatments.  This is the ultimate paradox – one of science's greatest promoters may have died prematurely because he turned his back on science.

How is it that a rational scientist can harbour in the same mind the two conflicting schools of science and alternative non science?  It happened with Isaac Newton (who dropped his maths, moved from Cambridge and repaired to London to pursue all sorts of weird beliefs) and it may have brought down Steve Jobs.

So how can we of the less lofty minds hope to resist the blandishments of untested cures especially when not only do alternative medicines hold out vaulting hope but don't give us the unvarnished truth?  The Therapeutic Goods Administration in December 2010 found that 90 per cent of alternative medicines breached advertising rules.

It must be conceded that science has its problems.  Over selling by Big Pharma, unexpected side effects, burst breast augmentations, medical negligence and over servicing are real issues.  Yet it is strange that Western medicine is so on the nose with so many people.  Why is it that we are still so prone to belief in therapies that have not been subject to the implacable scrutiny of science?
Science struggles to win hearts and minds.  It has struggled in the carbon debate and still struggles to win the creation debate in many parts of the world.  For me, a fan of science and a devotee, this is a mystery.

Epistemologists would argue that the adherence to untested therapies is not just faith but is augmented by the human weakness for hope.  Hope is a bedrock human quality.  The phrase "faith, hope and charity" exemplifies the importance of hope in the traditional perception of human emotions and demonstrates why faith, built on hope, will be a human weakness until the end of time.

The sceptic within me rails against, not just faith, but false hope.  I despair when those with hearing impairment worship and offer plastic ears at the Portuguese shrine of Santo Ovido (the patron saint of hearing problems) when cochlear implants exist.  I boil with anger when parents refuse to have their kids inoculated on the basis of unscientific claims.  They are undermining public health.  I despair to see the billion-dollar alternative pill and potion industry flower in the absence of scientific testing.

In a great article, psychiatrist Tanveer Ahmed on the National Times site argued that alternative medicine is the superstition of this age.  His argument is that in a society where religions and their pastoral care are in decline, alternative therapies seem to hit the mark.

As an articled clerk in 1980, my firm acted for a group of alternative therapists dealing with some negligence cases.  We also helped negotiate with the government on the registration system for the practitioners.  Clearly the state grappled with the issue of efficacy at the time and came up with the idea of vocational licensing.  It looked, however, to me more like an anti-competitive device rather than a genuine consumer protection measure.

As last year was ending, a story broke about one of Australia's most eminent alternative therapists.  Ian Gawler contracted cancer at the age of 24.  After the amputation of his leg he seemingly contracted a secondary cancer, which it was claimed was cured by a "self help program with key principles: good food, positive attitudes, meditation and loving support".

From that moment a virtual industry has grown around Ian Gawler including four bestselling books among them You Can Conquer Cancer using techniques such as meditation.  Relaxation is great but whether we can relax our way to a cancer cure is another thing.

Two oncologists, Professors Lowenthal and Haines have written a scathing attack on the Gawler claims. In it they allege that the secondary cancer that was supposedly cured by the Gawler method was in fact tuberculosis or some other lung infection.  No biopsy was taken (as was the practice in those far off days) so no one can know for sure.  These are credible men who confront the science of life and death daily and have seen cancer victims financially exploited by hope merchants and their orthodox treatment delayed.  Their attack has come and gone and been the subject of insufficient discussion and debate.

So how do we strive for truth?

What do we invest our medical faith in?

How can the state deal with such popular therapies when there are questions over efficacy?

What is the role of freedom and hope in this equation?

Over to you . . .

The Accountability Paradox: Personal Consequences and Blame

[Full post on other blog.]

A recent piece in The Journal of Patient Safety, "An NTSB for Healthcare, Learning from Innovation: Debate and Innovate or Capitulate" by experienced, highly-competent Aviators and Medicos prompted me to ask a question about on the subject of Dr Brent James, Chief Quality Officer of Intermountain Healthcare:

The NTSB only recommends, the FAA makes sure those things (and more) are done.
As a regulatory and compliance organisation, the FAA is able to hand out "direct, personal consequences" - and make them stick. [Natural Justice suggests proportionality as well].

Any Aviation Professional who repeats, or allows, a Known Error, Fault or Failure will be discovered and will suffer the consequences. [Hence would a medical version need two bodies?]

Dr James kindly responded to me and I was gently reminded of James Reason's "Blame Cycle" [below] and Dr James own comments on the 2001 ABC's Health Report, "Minimising Harm to Patients in Hospital":

Norman Swan: So remove the culture of blame, sort out the legal liability problems, without ignoring the fact that there will be the odd rogue doctor or rogue nurse who needs to be sorted out. What we should be seeing here, we haven't really emphasised it up till now, is that most of the problems that occur when injuries occur, are system problems, the hospital, the management, the organisation of the hospital, rather than an individual going wrong?

Brent James: Exactly. We know that the individuals will have problems. How do we create an environment in which it's easier to do it right, and hard to fail? That's the real issue. It's an institutional responsibility not an individual responsibility. The next thing that we need is an organisational structure. In the United States we're calling them Patient Safety Officers, and in the Institute of Medicine Report we asked that all care delivery groups appoint Patient Safety Officer, usually from existing personnel, usually a good clinician.

My central concern with the NTSB-for-Medicine proposal is the necessity for the organisation to not be a "toothless tiger", to have the power to cause change, but simultaneously engender a "Safety Culture" where Openness and Transparency are the norm and individuals do not feel threatened by the system.

Audit reports and Commissions of Inquiry into major failures (QLD) say what's wrong, but have no powers to cause change. They are equivalent to the NTSB, but lack the ability of the FAA to implement, to cause or require necessary change and to check that it is done.

Reason's "Blame Cycle", and my own more extreme "Blame Spiral", require Dr Demings' exhortation to "Drive out Fear" be scrupulously and systemically be applied.

How can these two conflicting objectives be achieved? I've no experience in this.

This is The Accountability Paradox:

For real change in the system, any person who repeats, or allows, a Known Error, Fault or Failure, must be held personally liable (including criminally if they caused death or severe injury/disability),
BUT if that is perceived as the Primary Role of the compliance and governance organisation, then it will be ineffective, instead it will engender the "Blame Cycle" as a minimum.

---

Some references to Prof. Reasons' "Blame Cycle":
"Diagnosing “vulnerable system syndrome”: an essential prerequisite to efffective risk management" (2001, Qual Health Care 2001;10:ii21-ii25 doi:10.1136/qhc.0100021) and
"Managing the Risks of Organizational Accidents" [1997].

The "Blame Spiral": How a blame culture destroys Projects and what to do about them.

[Full post on other blog.]

James T. Reason has a very well developed model of the "Blame Cycle", e.g. "Diagnosing “vulnerable system syndrome”: an essential prerequisite to eVective risk management" (2001, Qual Health Care 2001;10:ii21-ii25 doi:10.1136/qhc.0100021) and "Managing the Risks of Organizational Accidents" [1997].

It is based on:

• The Fundamental Attribution Error: misidentifying the root cause of an event (a person who chose to do it, rather than a multi-factorial Organisational Error).
• A "Person Model" not "Organisation Model" of errors, and
• if informed, people will just stop making mistakes.
• [and there is much more to it than this]

The remedy to the "Blame Cycle" is creating a "Safety Culture" which is where, in Deming's words, "Drive out Fear", is conscientiously and consistently practised.

All of which is correct, but doesn't explain three things:

• Why after around 25 years of writing, research and implementations by Reason and Perrow and around 75 years since H.W. Henrich's "Industrial Accident Prevention, A Scientific Approach" (1931) are Blame Cultures still the norm, rather than the exception, even in High Safety environments like Healthcare. Aviation and space flight (e.g. NASA) seem to be leaders in the implementation and practice of the "Safety Culture" approach.

• After more than a century of definitive, proven Management Science theories, why does the Default Management Style, of which the "Blame Culture" is one aspect, still prevail? It isn't just that better techniques/systems aren't known or aren't practiced, but that organisations revert from their good practices. World leaders, like Kodak and General Motors, stop their successful practices and go back to known worst practices and suffer terminal decline. How can this be so in a rational, well-informed world?

• Individuals in teams and projects start out with good intentions and high hopes, only to end up mired in the tarpits of Blame. How can this happen over and over again? What is the common, systematic element, or where are the payoffs?

---

Summary:

James Reasons' "Blame Cycle" is detailed, correct and useful, but misses two important points clearly seen in I.T. Projects:

• The interaction of Blame with the non-rational, uninformed "Default Management Style", and 
• the psychological dimension: the predictable reaction of individuals, groups and organisations to Blaming in circumstances that can spiral out of control.

Simplistic Safety and Quality systems, based on formulaic, inflexible action/response "protocols" not only cannot cope with the complex, variable everyday challenges of systems with intangible, undefined Outcomes, but push the organisation down the "Blame Spiral" into Toxic collapse and overwhelm.

Demings' exhortation of "Drive out Fear" is the solution, but must be imposed from the top down. This requires determination and consistency of purpose all through the management chain. Along with the identification and elimination of perverse incentives and outcomes.