Evaluations, validations and verifications of diagnostic tests – except ISO accreditation

 

“Where two kits have equivalent performance characteristics, the one which is easier to use, cheaper, faster or requires a more easily obtainable sample might be preferred.”   UK Standards for Microbiology Investigations Q 1: Evaluations, validations and verifications of diagnostic tests, p9.

This guidance document describes the work necessary for the evaluation, validation and verification of laboratory tests.  It’s all good stuff, heavy and demanding.  Such thinking pre-existed the ISO management standards and UKAS.  But before accreditation, all of it wasn’t applied in every lab, all the time.

Maybe all previous testing must be suspect.  Maybe it was quite sufficient for specialist labs to do this work and for other labs to rely on their assurances.  Maybe great science doesn’t need it.  Who knows?

Now UKAS has to inspect every lab’s validation and verification of every variation in every test method.

It’s not putting labs out of service, so we may assume this extra work is making little difference to test results.  Internal quality control and external quality assurance would give labs an idea about that.

You’ll have to search elsewhere if you want to know how much difference this approach makes to the usefulness of laboratory testing.

Searching, you will find almost none of this laborious and necessary work applied to the inspection of ISO laboratory standards.

Here is a useful document.  Figure out how to apply it to UKAS inspections themselves.  Publish the results.

For all we know, millons are being wasted on screening labs for “quality” that actually makes no difference.  You’ll find a little evidence for that, but nobody cares.

It’s an equality issue – laboratory tests must always be validated.  Inspections of the ISO standards themselves must never be validated.

“Where two kits have equivalent performance characteristics, the one which is easier to use, cheaper, faster or requires a more easily obtainable sample might be preferred.”p9.

 

Posted in Forensic science, Laboratory medicine, Science | Tagged , , , , | Leave a comment

Spinal Manipulation for Back and Neck Pain: Does It Work?

Two American traditions of spinal manipulation.  Osteopathy, developed by a physician and surgeon.  Chiropractic, developed by a magnet healing quack who may have modified osteopathy or got ideas from his spirit guides.  Laird Harrison explains in the Medscape article, Spinal Manipulation for Back and Neck Pain: Does It Work?

In the comments that follow, Dr Mark Crislip has critically analysed claims in the article that such practices work.

Pubmed shows a gradually increasing number of low-quality studies supposedly validating the effects of ISO accreditation.  Just like spinal manipulation and the shift in wealth derived from it, the evidence for accreditation “keeps growing and growing”.  As UKAS spreads the ISO disease through laboratories and hospitals, this is the sort of analysis we need doctors to be doing for the claims of accreditation:

Dr. Mark Crislip,  Infectious Diseases
Feb 17, 2017

An excerpt from  Spinal Manipulation for Back and Neck Pain: Does It Work? Annotated.  https://sciencebasedmedicine.org/spinal-manipulation-for-back-and-neck-pain-does-it-work-annotated/

The article starts with:

In her office at McMaster University in Toronto, Anita Gross, MSc, has logged paper after paper showing that spinal manipulation can help control neck pain. “The evidence keeps growing and growing,” she says.

I have a eponymous law on RationalWiki. Another law of pseudo-medicine, eponymous 2, states that when a pseudo-medical intervention says there is growing evidence, there isn’t. It is a corollary to Betteridge’s law of headlines.

Well, perhaps the growing evidence is more of a Kellyanne Conway statement, an alternative fact, because while it is true that there is growing evidence, it is usually terrible evidence.

The question is whether an intervention is better than a sham or placebo intervention. To really know if an intervention is effective, especially an intervention that is not based in the known reality of anatomy, physiology, and biochemistry, you want to do placebo/sham controlled studies, preferably blind.

Let’s check out the ‘growing’ literature of chiropractic manipulation compared with sham chiropractic for neck pain.

And if you think there is no valid sham chiropractic manipulation, think again.

There is “Short-term usual chiropractic care for spinal pain: a randomized controlled trial” from 2013:

Short-term chiropractic treatment was superior to sham; however, treatment effects were not clinically important.

And it was those who knew they were getting treatment who had the most improvement. A classic placebo effect.

That’s it for manipulation vs. sham manipulation for neck pain. But that is growth. From zero to one.

Manipulation vs. sham manipulation for back pain? There is “Spinal Manipulation A Systematic Review of Sham-Controlled, Double-Blind, Randomized Clinical Trials” which included two studies of back pain. They found:

The most rigorous of these studies suggest that spinal manipulation is not associated with clinically-relevant specific therapeutic effects.

Or the recent review “The effectiveness of complementary manual therapies for pregnancy-related back and pelvic pain: A systematic review with meta-analysis” where:

Meta-analyses found positive effects for manual therapy on pain intensity when compared to usual care and relaxation but not when compared to sham interventions.

Here is the classic interpretation: When an intervention is equal to sham/placebo, it is not effective; the intervention does not work. It is why, for example, we no longer do mammary artery ligation for angina.

Or “Spinal Manipulative Therapy for Chronic Lower Back Pain in Older Veterans: A Prospective, Randomized, Placebo-Controlled Trial.”

The SMT did not result in greater improvement in pain when compared to our sham intervention; however, SMT did demonstrate a slightly greater improvement in disability at 12 weeks. The fact that patients in both groups showed improvements suggests the presence of a nonspecific therapeutic effect.

Again. Not better than sham equals no efficacy. And “nonspecific therapeutic effect” is code for placebo effect.

That’s it for the growing literature of clinical trials with meaningful methodologies, sham controlled studies, that I

found on Pubmed. There are numerous ‘A + B versus B’ studies, but they tell you nothing.

So the literature that is growing and growing is less than impressive in numbers or outcomes.

On to the second paragraph:

Gross, a physiotherapist and associate professor of rehabilitation science, helped write a 2015 Cochrane review of the literature and is already at work on updating that paper.

It implies, and maybe this is just me, that the Cochrane review is favorable for manipulation, since it follows the growing and growing quote. Just what does that review say?

No high-quality evidence was found, so uncertainty about the effectiveness of mobilisation or manipulation for neck pain remains.

Color me unimpressed.

The third paragraph?

Mounting evidence also supports spinal manipulation for low back pain, says Roger Chou, MD, professor of medicine at Oregon Health & Science University in Portland, Oregon, who led a similar review for the Agency for Healthcare Research and Quality last year.

And that similar review?

These include exercise, yoga, and tai chi; various psychological therapies; multidisciplinary rehabilitation; acupuncture; spinal manipulation (vs. an inert treatment); and low-level laser therapy. Effects were small to moderate in magnitude.

And they point to a table.

In that table there is spinal manipulation vs. inert treatment (7 trials) which had “small” effects BUT spinal manipulation vs. sham manipulation (1 SR (3 RCTs) 1 RCT), the gold standard for showing efficacy, had…

*…pause for dramatic effect while we decide which baker has to leave the tent…*

No effect.

Let me repeat: manipulation and sham manipulation are equal. That means it doesn’t work.

And that begs the question. You have back pain. I am going to send you for manipulation, but how do I order the manipulation that is vs an inert treatment and avoid the manipulation that is vs sham because it is the former works and the latter that does not. I can do that how? Puh-lease.

Kellyanne, Kellyanne, did it rain at the inauguration? Were the crowds yuuuuge? Was it the greatest Electoral College victory ever? Does chiropractic work better than sham? Is supportive literature growing and growing? Do these:

findings counter decades of accusations of quackery mounted against healers who massage or manipulate patients’ muscles or joints[?]

No. It is, at least in its chiropractic form, still quackery. But more on that later. But it does support the accusations that manipulation does nothing.

 

 

Posted in Medicine, Science | Tagged , , , , , , | Leave a comment

Disgruntled rogue scientists, but accredited

Uncertainty of measurement or just uncertainty?

“Rogue scientists” disgruntled with management at Randox forensic services allegedly doctored samples.  Unsurprisingly this led to hundreds of false convictions and other major injustices.  Here is the Daily Mail’s account.

Maybe privitising the forensic service wasn’t so smart.

Naturally, services so important to justice are accredited by UKAS to ISO 17025.  Here is Randox’s UKAS schedule of accreditation to prove it.

We pointed out previously problems with UKAS accrediting labs that issued false results.

And don’t forget that, since it can render up inspection fees, gold counterfeiting can be accredited.

Did Randox management look to UKAS to sort out their quality problem?  No, more sensibly they called the police to investigate this criminal activity.  Arrests have been made and the full story remains to be told after the investigation.

Randox management had more confidence in the police than the quality inspectors.

What is unlikely to be made clear is how the accreditation of falsified tests will be dealt with.  Will UKAS withdraw accreditation from Randox and sacrifice their inspection fees for the sake of probity?

Here is where you can check on the latest sanctions levied by UKAS.  Do you think Randox will appear?

Will the courts now wake up to the scam that is accreditation?

UPDATE 21 February 2017: Randox have issued a statement, Gross inaccuracies in media coverage of RTS, on the criminal act that is being investigated in their business.

Posted in Forensic science, Laboratory medicine, Law, Management | Tagged , , , , , | Leave a comment

Failing to repay

As university educations become impossibly expensive for ordinary people, Gary North advises,

“Here is a general rule. Any barrier to entry into any field that cannot be legally penetrated by means of a competitive examination is there for only one reason: to line the pockets of the people who have created the barrier to entry. Legal barriers to entry are marks of an unfree society. Politicians have abolished individual liberty for the sake of lining the pockets of members of cartels. They are using coercion to steal from excluded victims.”

As universities, so ISO-accredited organisations.

External quality assurance and user recommendations are the best indicators of the technical competence that ISO 9000 is inadequate to assure.  These are the equivalent of the difficult entrance exam that served some organisations well for centuries.

Accreditation is open to all who pay the inspection cartel and put up with its interminable, petty bureaucracy.

Coil of rope lies in ever-decreasing circles - Stock Image

 

Posted in Bureaucracy, Cartel, Economics, Education, History, Laboratory medicine | Tagged , , , | Leave a comment

Forensic deficiencies of ISO 17025

Justin McShane explains some of the deficiencies of ISO 17025 in a forensic setting in this video.  Inspectors obsess over uncertainties of measurement but cannot address their qualitative interpretation or several other important scientific issues. Worth a watch, especially for the relevant quotes from Kelvin and Einstein at the end.

Pathologists are behind forensic scientists in understanding the limitations of the ISO.

Quote by Lord Kelvin on the importance of measurement : National ...

Posted in History, Law, Science | Tagged , , , | Leave a comment

UKAS Imaging Services Accreditation Scheme

mri-scanner-appeal-logo-new

Have you ever helped a charity raise money to buy a hospital a scanner?  Hospitals have a lot of other things to spend money on besides diagnostic equipment – accreditation, managers, translators, overpriced drug contracts, negligence claims…

UKAS’s Imaging Services Accreditation Scheme is here to undo the work of diligent radiology staff and charity donors.  Patients can now distract themselves from worry during long waiting times with the knowledge that the imaging their diagnosis relies on is accredited.

Being accredited won’t change the outcomes for patients because the staff spend years qualifying and maintaining their expertise.  And spending substantial sums of their own money to other compulsory professional registration schemes.  Reliable diagnosis relies on the experience of healthcare teams, not the visits of inspectors.

You can read how the time and money will be wasted to support the UKAS inspectorate in their ISAS 1 document below.  But wouldn’t you rather your tax money and charitable giving went to help patients rather than employing staff to provide fodder for hungry inspectors?

Accreditation is like the halal tax for healthcare.  Will the western inspection cartel ever manage to squeeze a tax from the corrupt halal racket which even islamic leaders are now criticising?  Click the link and see how much halal and ISO certification have in common.  ISO could make halal respectable.  They could share the loot.

Click below for the UKAS document:

ISAS1.png

Posted in Cartel, Medicine, NHS, Science | Tagged , , , | Leave a comment

Royal Statistical Society is initiated into the inspection cartel

The ISO has initiated the Royal Statistical Society into the inspection cartel.  Its role will be to certify those who wish to be recognised as Six Sigma and Lean practitioners to ISO 18404:2015: Quantitative methods in process improvement – Six Sigma – competencies for key personnel and their organizations in relation to Six Sigma and Lean implementation.

This is the latest example of the ISO’s embrace-extend-extinguish strategy against ideas that don’t pay tax to the cartel.  Through it, the cartel can shift income from competitors, even in cases where their methods are superior to the ISO’s.

images.duckduckgo.jpg

Read more here.

Is President Trump up to the job nobody else will take on?

images.duckduckgo.jpg

Posted in Bureaucracy, Cartel, Management | Tagged , , | Leave a comment

Blogger driven out by Teamworking®

Blogger driven out by Teamworking®; sub-ISO management idiocy:

“To cut a long story short, customers were being taken for a ride. I was getting more and more frustrated by the incompetence of the company, so I started keeping a blog – and this was before the word “blog” had been coined. However, one of my colleagues knew I was doing it, and one day he saw something he didn’t like and reported it. It was completely anonymous – but I had made the mistake of editing it using a works computer. So I was sacked for it.

“It was probably the best thing that damned company and those cretins I reported to ever did for me.

“Becoming a driving instructor is the best thing I ever did!”

 

Posted in Bureaucracy, Management | Tagged | Leave a comment

Proper work ethic has been slowly eroded

In the public service, in all its wide ramifications, we live in an era of the inept, the square peg, the careless and the bluffer. And, as bluffers in turn appoint bluffers, the system becomes self-perpetuating.

The “whistleblower” is ostracised. Authority is eroded. Nobody takes responsibility. Nobody is accountable. Somebody else is to blame.

Few things, even simple things, seemingly straightforward ones, go smoothly. Things creak. What once took days now takes weeks, months and longer.

We have become a nation of “box-tickers”, form-fillers and report-writers. To little avail. Who reads these mountains of papers, one may ask? Actual work and performance gets buried in the “bumph”.

Unfortunately a “mindset” appears to exist nowadays as the right and proper way to get things done. On all-too-rare occasions, quick and professional efficiency appears to be something of the past. Rules and regulations take over from personal initiative. There is an inbuilt fear of stepping out of line.

Society, particularly those responsible for shaping it, needs to have a good long look at itself.

J CRAIG WALLACE

Posted in Bureaucracy, History, Management | Tagged , , | Leave a comment

Old news

The Emperor’s New Clothes is a recurring theme with ISO management standards.

Researchers, Bozena Poksinska and Jens J.Dahlgaard, published ISO 9001:2000 – The emperor’s new clothes? describing their investigation of three companies.

“The managers interviewed had difficulties linking organisational improvements with the QMS. It was found that ISO 9001 requirements weren’t a reason for making improvements.

The QMS helps to keep order in an organisation and this may affect quality to a small degree. But ISO 9000 is not a “cause” of some considerable, measurable changes.

“If I were to be honest, I think, there are not many benefits, which I see from ISO. Some things became really good, but I can’t say it was because of ISO. It is because we have thought and recognised that this needs to be done…”(Quality manager, GAMMA ).”

More gently than some, these authors reached the conclusion that ISO 9001 really wasn’t much good for improving quality.  While they noted peer-pressure as the main reason for gaining certification, they did not enquire more deeply into the ethics and role of marketplace coercion for the inspection cartel.

How long must this thing go on?

Posted in Bureaucracy, Management | Tagged , , | Leave a comment