MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

informed consent

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An article in the Daily Mail (I know, not my favorite newspaper either) reported about a UK court case against the father of an 11-year-old daughter who objected to her being given conventional life-saving treatments for her leukemia. The man was said to be worried about possible side effects and wanted to explore homeopathic and natural therapies, while his estranged wife favored the conventional approach.

Mr Justice Hayden decided that there is ‘no basis’ for the man’s homeopathic option and that specialists can lawfully carry out the conventional treatments. But the father said he believed that previous chemotherapy had already weakened his daughter’s immune system and that the conventional treatment proposed has further side effects. He, therefore, wanted to try homeopathic and natural therapies, including ozone therapy. ‘I am not waiting for her to deteriorate and get worse,’ he told the judge. ‘Chemotherapy is not the only way. There are so many other different therapies I am hoping to try – anything as long as it doesn’t really affect her.’

A specialist treating the girl told the judge that the treatments proposed are the best option and that they know of no homeopathic options which would help. Mr Justice Hayden approved Great Ormond Street’s plan and said doctors should start the treatments as soon as possible. ‘If she receives no treatment then her life expectancy is weeks,’ he said. ‘There is no basis for the father’s homeopathic option.’

This case highlights the indirect risks of homeopathy and similar treatments in an exemplary fashion. The therapies per se might be harmless but the therapists are clearly not. There are enough homeopaths who are deluded enough to persuade their patients that homeopathy can alter the natural history of even serious conditions such as cancer. And, as we have discussed recently, these irresponsible fools are not just from the ranks of the lay-homeopaths (homeopaths who have not been to medical school) who might not know better; they also include medically trained homeopaths and even professors at leading medical schools.

 

I have not often seen a paper reporting a small case series with such an impressively long list of authors from so many different institutions:

  • Hospital of Lienz, Lienz, Austria.
  • WissHom: Scientific Society for Homeopathy, Koethen, Germany; Umbrella Organization for Medical Holistic Medicine, Vienna, Austria; Vienna International Academy for Holistic Medicine (GAMED), Otto Wagner Hospital Vienna, Austria; Professor Emeritus, Medical University of Vienna, Department of Medicine I, Vienna, Austria. Electronic address: office@ordination-frass.at.
  • Resident Specialist in Hygiene, Medical Microbiology and Infectious Diseases, Außervillgraten, Austria.
  • St Mary’s University, London, UK.
  • Umbrella Organization for Medical Holistic Medicine, Vienna, Austria.
  • Shaare Zedek Medical Center, The Center for Integrative Complementary Medicine, Jerusalem, Israel.
  • Apotheke Zum Weißen Engel – Homeocur, Retz, Austria.
  • Reeshabh Homeo Consultancy, Nagpur, India.
  • Umbrella Organization for Medical Holistic Medicine, Vienna, Austria; Vienna International Academy for Holistic Medicine (GAMED), Otto Wagner Hospital Vienna, Austria; Chair of Complementary Medicine, Medical Faculty, Sigmund Freud University Vienna, Austria; KLITM: Karl Landsteiner Institute for Traditional Medicine and Medical Anthropology, Vienna, Austria.
  • WissHom: Scientific Society for Homeopathy, Koethen, Germany.

In fact, there are 12 authors reporting about 13 patients! But that might be trivial – so, let’s look at the paper itself. The aim of this study was to describe the effect of adjunctive individualized homeopathic treatment delivered to hospitalized patients with confirmed symptomatic SARS-CoV-2 infection.

Thirteen patients with COVID-19 were admitted. The mean age was 73.4 ± 15.0 (SD) years. The treating homeopathic doctor was instructed by the hospital on March 27, 2020, to adjunctively treat all inpatient COVID-19 patients homeopathically. The high potency homeopathic medicinal products were administered orally. Five globules were administered sublingually where they dissolved, three times a day. In ventilated patients in the ICU, medication was administered as a sip from a water beaker or 1 ml three times a day using a syringe. All ventilated patients exhibited dry cough resulting in respiratory failure. They were given Influenzinum, as were the patients at the general inpatient ward.

Twelve patients (92.3%) were speedily discharged without relevant sequelae after 14.4 ± 8.9 days. A single patient admitted in an advanced stage of septic disease died in the hospital. A time-dependent improvement of relevant clinical symptoms was observed in the 12 surviving patients. Six (46.2%) were critically ill and treated in the intensive care unit (ICU). The mean stay at the ICU of the 5 surviving patients was 18.8 ± 6.8 days. In six patients (46.2%) gastrointestinal disorders accompanied COVID-19.

The authors conclude that adjunctive homeopathic treatment may be helpful to treat patients with confirmed COVID-19 even in high-risk patients especially since there is no conventional treatment of COVID-19 available at present.

In the discussion section of the paper, the authors state this: “Given the extreme variability of pathology and clinical manifestations, a single universal preventive homeopathic medicinal product does not seem feasible. Yet homeopathy may have a relevant role to play precisely because of the number and diversity of its homeopathic medicinal products which can be matched with the diversity of the presentations. Patients with mild forms of disease can use homeopathic medicinal products at home using our simple algorithm. As this Case series suggests, adjunctive homeopathic treatment can play a valuable role in more serious presentations. For future pandemics, homeopathy agencies should be prepared by establishing rapid-response teams and efficacious lines of communication.”

There is nothing in this paper that would lead me to conclude that the homeopathic remedies had a positive effect on the natural history of the disease. All this article actually does do is this: it provides a near-perfect insight into the delusional megalomania of some homeopaths. These people are even more dangerous than I had feared.

The General Chiropractic Council’s (GCC) Registrant Survey 2020 was conducted in September and October 2020. Its aim was to gain valuable insights into the chiropractic profession to improve the GCC’s understanding of chiropractic professionals’ work and settings, qualifications, job satisfaction, responsibilities, clinical practice, future plans, the impact of the COVID-19 pandemic on practice, and optimism and pessimism about the future of the profession.

The survey involved a census of chiropractors registered with the GCC. It was administered online, with an invitation email was sent to every GCC registrant, followed by three reminders for those that had not responded to the survey. An open-access online survey was also available for registrants to complete if they did not respond to the mailings. This was promoted using the GCC website and social media channels. In total, 3,384 GCC registrants were eligible to take part in the survey. A fairly miserable response rate of 28.6% was achieved.

Here are 6 results that I found noteworthy:

  • Registrants who worked in clinical practice were asked if performance was monitored at any of the clinical practices they worked at. Just over half (55%) said that it was and a third (33%) said it was not. A further 6% said they did not know and 6% preferred not to say. Of those who had their performance monitored, only 37% said that audits of clinical care were conducted.
  • Registrants working in clinical practice were asked if any of their workplaces used a patient safety incident reporting system. Just under six in ten (58%) said at least one of them did, whilst 23% said none of their workplaces did. A further 12% did not know and 7% preferred not to say.
  • Of the 13% who said they had a membership of a Specialist Faculty, a third (33%) said it was in paediatric chiropractic, 25% in sports chiropractic, and 16% in animal chiropractic. A further 13% said it was in pain and the same proportion (13%) in orthopaedics.
  • Registrants who did not work in chiropractic research were asked if they intended to work in that setting in the next three years. Seven in ten (70%) said they did not intend to work in chiropractic research in the next three years, whilst 25% did not know or were undecided. Only 5% said they did intend to work in chiropractic research.
  • Registrants were also asked how easy it is to keep up to date with recommendations and advances in clinical practice. Overall, two-thirds (67%) felt it was easy and 30% felt it was not.
  • Registrants were asked in the survey whether they felt optimistic or pessimistic about the future of the profession over the next three years. Overall, half (50%) said they were optimistic and 23% were pessimistic. A further 27% said they were neither optimistic nor pessimistic.

Perhaps even more noteworthy are those survey questions and subject areas that might have provided interesting information but were not included in the survey. Here are some questions that spring into my mind:

  • Do you believe in the concept of subluxation?
  • Do you treat conditions other than spinal problems?
  • How frequently do you use spinal manipulations?
  • How often do you see adverse effects of spinal manipulation?
  • Do you obtain informed consent from all patients?
  • How often do you refer patients to medical doctors?
  • Do you advise in favour of vaccinations?
  • Do you follow the rules of evidence-based medicine?
  • Do you offer advice about prescribed medications?
  • Which supplements do you recommend?
  • Do you recommend maintenance treatment?

I wonder why they were not included.

 

On this blog we have seen just about every variation of misdemeanors by practitioners of so-called alternative medicine (SCAM). Today, I will propose a scale and rank order of these lamentable behaviours. As we regularly discuss chiropractic and homeopathy here, I decided to use these two professions as examples (but I could, of course, have chosen almost any other SCAM).

  1. Treating conditions which are not indicated: SCAM practitioners of all types are often asked by their patients to treat conditions which their particular SCAM cannot not affect. Instead of honestly saying so, they frequently apply their SCAM, wait for the natural history of the condition to do its bit, and subsequently claim that their SCAM was effective.
  2. Over-charging: asking too much money for services or goods is common (not just) in SCAM. It raises the question, what is the right price? There is, of course, no easy answer to it. Over-charging is therefore mostly a judgement call and not something absolute.
  3. Misleading a patient: there are numerous ways in which patients can be misled by their SCAM practitioners. A chiropractor who uses the Dr title, without explaining that it is not a medical title, is misleading his/her patients. A homeopath who implies that the remedy he/she is selling is a proven treatment is also misleading his/her patients.
  4. Being economical with the truth: the line between lying (see below) and being economical with the truth is often blurred. In my view, a chiropractor who does not volunteer the information that acute back pain, in most cases, resolves within a few days regardless of whether he/she mapipulates the patient’s spine or not, is economical with the truth. Similarly, a homeopath who does not explain up front that the remedy he/she prescribes does not contain a single active molecule is economical with the truth.
  5. Employing unreasonably long series of therapy: A chiropractor or homeopath, who treats a patient for months without any improvement in the patient’s condition, should suggest to call it a day. Patients should be given a treatment plan at the first consultation which includes the information when it would be reasonable to stop the SCAM.
  6. Failing to refer: A chiropractor or homeopath, who treats a patient for months without any improvement in the patient’s condition should refer the patient to another, better suited healthcare provider. Failing to do so is a serious disservice to the patient.
  7. Unethical behaviour: there are numerous ways SCAM practitioners regularly violate healthcare ethics. The most obvious one, as discussed often before on this blog, is to cut corners around informed consent. A chiropractor might, for instance, not tell his/her patient before sarting the treatment that spinal manipulation is not supported by sound evidence for efficacy or safety. A homeopathy might not explain that homeopathy is generally considered to be implausible and not evidence-based.
  8. Neglect: medical neglect occurs when patients are harmed or placed at significant risk of harm by gaps in their medical care. If a chiropractor or a homeopath, for instance, claim to be able to effectively treat asthma and fail to insist that all prescribed asthma medications must nevertheless be continued – as both often do – they are guilty of neglect, in my view. Medical neglect can be a reason for starting legal proceedings.
  9. Lying: knowingly not telling the truth can also be a serious legal issue. An example would be a chiropractor who, after beeing asked by a patient whether neck manipulation can cause harm, answers that it is an entirely safe procedure which has never injured anyone. Similarly, if a homeopaths informs his/her patient that the remedy he/she is prescribing has been extensively tested and found to be effective for the patient’s condition, he must be lying. If these practitioners believe what they tell the patient to be true, they might not technically be lying, but they would be neglecting their ethical duty to be adequately informed and they would therefore present an even greater danger to thier patients.
  10. Abuse: means to use something for the wrong purpose in a way that is harmful or morally wrong. A chiropractor who tells the mother of a healty child that they need maintenance care in order to prevent them falling ill in the future is abusing her and the child, in my view. Equally, I think that a homeopath, who homeopathically treats a disease that would otherwise be curable with conventional treatments, abuses his patient.
  11. Fraud: fraud is a legal term referring to dishonest acts that intentionally use deception to illegally deprive another person or entity of money, property, or legal rights. It relies on the use of intentional misrepresentation of fact to accomplish the taking. Arguably, most of the examples listed above are fraud by this definition.
  12. Sexual misconduct: the term refers to any behaviour which is sexual in nature and which is unwelcome and engaged in without consent. It ranges from unwanted groping to rape. There is, for instance, evidence that sexual misconduct is not a rarety in the realm of chiropractic. I have personally served once as an expert witness against a SCAM practitioner is a court case at the Exeter Crown Court.

The 12 categories listed above are not nearly as clearly defined as one would wish, and there is plenty of overlap. I am not claiming that my suggested ‘scale of misdemeanors by SCAM practitioners‘ or the proposed rank order are as yet optimal or even adequate. I am, however, hoping that readers will help me with their suggestions to improve them. Perhaps your input might then generate a scale of practical use for the future.

One of my last posts re-ignited the discussion about the elementary issue of informed consent, specifically about informed consent for chiropractors. As it was repeatedly claimed that, in Australia, informed consent is a legal requirement for all chiros, I asked on Wednesday 11 November 2020 at 07:12

FOUR QUESTIONS TO DC + CRITICAL CHIRO (CC):

1) what does the law say about informed consent for Australian chiros?
2) what info exactly do you have to provide?
3) who monitors it?
4) what published evidence do we have about compliance?

CC then posted this reply:

Here we go again you demand evidence while providing little if any for your own assumptions (poor case studies do not count. The pleural of anecdote does not equal evidence whether it’s from chiro’s or you).
We have been over this many times over many years, I cite research/provide links yet you still find it challenging to take it onboard. It is human nature to feel obligated once making a public statement to defend it no matter how much evidence is sent your way. So not surprising.

“1) what does the law say about informed consent for Australian chiros?”
It is all freely available on the national regulators website (as you know and as I have referenced in the past):
https://www.chiropracticboard.gov.au/Codes-guidelines/Code-of-conduct.aspx
https://www.chiropracticboard.gov.au/Search.aspx?q=Informed+consent
Some research by chiropractors on this topic (cited many times in the past):
Risk Management for Chiropractors and Osteopaths. Informed consent
A Common Law Requirement (2004):
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2051308/
Quick advanced PubMed with filters set to “Chiropractic” AND “Informed consent”.
https://www.ncbi.nlm.nih.gov/pmc/?term=(Chiropractic)+AND+Informed+consent
Not rocket science
Latest paper that you wrote an ill informed blog on and the comments were not going as you expected (So I expected you to double down like Donald Trump with a new blog within days. Your getting predictable).
https://chiromt.biomedcentral.com/articles/10.1186/s12998-020-00342-5
This paper questions the legal implications of vertebral subluxations with high powered legal input and is a broadside by evidence based chiropractors against vitalistic chiropractors. You respond a snide fantasy informed consent dialogue when you should be supporting the authors:
https://edzardernst.com/2020/11/informed-consent-why-chiropractors-dont-like-it/

“2) what info exactly do you have to provide?”
“4) what published evidence do we have about compliance?”
We have discussed this as well. It is a common law requirement for every profession and is checked upon re-registration by AHPRA every year and by the professional indemnity insurers every year. No informed consent, no registration and no professional indemnity insurance.
Checked AHPRA’s panel decisions and went back 5 YEARS and found ONE decision relating to informed consent:
https://www.ahpra.gov.au/Publications/Panel-decisions.aspx

“3) who monitors it?”
Another of your tired old arguments that we have discussed many times over the years.
In the UK there is the “‘Chiropractic Reporting and Learning System’ (CRLS)” but this is set up by the association representing chiropractors and not the registration board that advocates for patients. Right idea and step in the right direction, wrong organization.
Here years ago there was a trial of an adverse event reporting system in a Melbourne emergency department systematically collected relevant AE information on all professions which was sent to the relevant board for investigation.
It was supported by doctors and chiropractors while physio’s were not involved. A doctor involved told me it was killed off by ER doctors who “snivelled” about the extra paperwork.
There is no AE reporting system for physio’s, chiro’s, osteo’s, GP’s in private practice etc.
Over the years you have harped on and on about this topic as if it is a failing purely of the chiropractic profession when we have supported initiatives for its implementation.
You have also kept up with the research even commenting on an chiropractic researcher on AE’s Charlotte Leboeuf-Yde (who you highly regard) yet ignored until you could take issue with two sentences written in a blog then you wrote this hatchet blog:
https://edzardernst.com/2017/04/we-have-an-ethical-legal-and-moral-duty-to-discourage-chiropractic-neck-manipulations/
So you are asking for evidence yet willfully ignore an author who “I have always thought highly of Charlotte’s work”.

Stop the cynical cherry picked blogs and start supporting the researchers and reformers otherwise you are just someone standing on the sidelines blindly throwing grenades. You do not care who you hit or the damage you do to the chiropractors leading the reform you demand yet consistently fail to support.

____________________________________

I thought the tone of this response was oddly aggressive and found that CC had failed to understand some of my questions. Yet the link to the chiro’s code of conduct https://www.chiropracticboard.gov.au/Codes-guidelines/Code-of-conduct.aspx was useful. This is what it says about informed consent:

3.5 Informed consent
Informed consent is a person’s voluntary decision about healthcare that is made with knowledge and understanding of the benefits and risks involved. A useful guide to the information that chiropractors need to give to patients is available in the National Health and Medical Research Council (NHMRC) publication General guidelines for medical practitioners in providing information to patients.3 The NHMRC guidelines cover the information that chiropractors should provide about their proposed management or approach, including the need to provide more information where the risk of harm is greater and likely to be more serious, and advice about how to present information. Good practice involves:
a) providing information to patients in a way they can understand before asking for their consent
b) providing an explanation of the treatment/care recommended, its likely duration, expected benefits and cost, any alternative(s) to the proposed care, their relative risks/benefits, as well as the likely consequences of no care
c) obtaining informed consent or other valid authority before undertaking any examination or investigation, providing treatment/care (this may not be possible in an emergency) or involving patients in teaching or research, including providing information on material risks
 d) consent being freely given, without coercion or pressure
 e) advising patients, when referring a patient for investigation or treatment/ care, that there may be additional costs, which they may wish to clarify before proceeding
 f) obtaining (when working with a patient whose capacity to give consent is or may be impaired or limited) the consent of people with legal authority to act on behalf of the patient, and attempting to obtain the consent of the patient as far as practically possible
 g) being mindful of additional informed consent requirements when supplying or prescribing products not approved or made in Australia, and
h) documenting consent appropriately, including considering the need for written consent for procedures that may result in serious injury or death.
_______________________________________
This does indeed clarify some of my questions. Related to the fictional patient with neck pain who consults a chiropractor in my previous post, this means the chiro must inform the patient that:
  • the chiro suggests a manipulation of the neck;
  • this often involves forcing a spinal joint beyond its physiological range of motion;
  • the treatment will be short but needs repeating several times during the coming weeks;
  • the expected benefits are a reduction of pain and improvement of motion;
  • the total cost of the treatment series will be xy;
  • there are many other treatment options for neck pain;
  • most of these have a better risk/benefit profile than neck manipulation;
  • having no treatment for neck pain at all is likely to lead to full resolution of the problem over time.

Apart from any doubts that chiropractors would actually comply with these requirements, the question remains: is the listed information sufficient? Does it outline a truly a fully informed consent? I think that essential aspects of informed consent are missing.

  • The code does not explicidly require an explanation about the possible harms of spinal manipulation (i.e. 50% of all patients will suffer mild to moderate adverse effects lasting 2-3 days, and occasionally patients will have a stroke of which some have died).
  • Moreover, the code mentions EXPECTED benefits, but not benefits supported by evidence. Chiros may well EXPECT their treatment to work, but what does the evidence show? As often discussed on this blog, the evidence is negative or very week, depending how you want to interpret it. The code does not require a chiro to inform his patients about this fact.

So, the way I see it, the code does not expressedly demand the chiro to explain his patient that the treatment he is being asked to consent to is

  1. not supported by sound evidence for effectiveness,
  2. nor that the treatment is burdened with significant risks.

And what about the other questions listed above? An Australian chiropractor who will remain anonymous gave me the following answers:

Who monitors Informed Consent?
 
The short answer here is nobody monitors informed consent.  Typically informed consent is a side issue whenever a negligence claim is made.  Similarly, clinical records are a side issue as well.   Thus, when a patient alleges they were injured a complaint is lodged.  As part of the investigation consideration is given regarding the consent process.  If the analysis determines that the adverse outcome was maloccurence rather than negligence  but valid consent was not obtained, the practitioner will still face disciplinary action. 
 
As we are all too well aware, the Boards show little or no desire to be proactive.  I have yet to see any results from the pilot advertising audit project which began approximately 2 years ago.
 
What published evidence have we ab​out compliance?
 
Good question.  To my knowledge Langworthy & Flemming’s 2005 paper is the only one looking at compliance.  Their results suggest that the majority of respondents would be unable to successfully defend a negligence in consent liability charge.  In my experience providing expert opinions in Australian cases, valid consent was not obtained in a single case.  The most bizarre case had the practitioner their expert argue that consent obtained 7 years prior to the injury was still valid.  
 
Langworthy J.M., Cambron J. Consent: its practices and implications in United Kingdom and the United States chiropractic practice. J Manip Physiol Ther. 2007;(6):419–431.

_____________________________________

Yet, Australian chiropractors claim that they abide by the ethical imperative of informed consent. Are they taking the Mickey?

Perhaps not. Perhaps they are merely trying to make sure they do not lose the majority of their clientele. As I already pointed out in my previous post, fully informed consent would make most chiropractic patients turn round and run a mile.

I was alerted to an outstanding article by an unusual author, a law firm, on the subject of chiropractic. Allow me to quote a few passages from it (without changing a word or adding a comment):

When Katie May passed away suddenly from a stroke at just 34 years old, it was initially ruled an accident. After further investigation, a coroner determined the stroke that claimed the model and single mother’s life was caused by injuries sustained during neck manipulation by a chiropractor. And Ms. May is not the first to be affected by this seemingly harmless procedure…

What health issues can be caused by chiropractic manipulation?

Chiropractors typically use their hands to apply pressure to joints, aiming to help alleviate pain and improve body function. This is referred to as a chiropractic adjustment.

Adjustments are commonly performed for neck and/or back pain. Although the Mayo Clinic says the risk of a serious complication is relatively small, these complications can include:

  • A herniated disk, or worsening of an existing herniated disk
  • Compression of nerves in the lower spinal column
  • Stroke, which can result in paralysis or death

The last item on this list is particularly concerning.

Patients who receive neck manipulation are at risk for a stroke caused by vertebral artery dissection. Located in the neck, the vertebral arteries supply blood to the brain and can be torn by stretching and sudden force applied during a neck adjustment.

Studies have shown that vertebral artery dissection occurs in approximately 1 in 100,000 people and can be caused by something as simple as cracking your neck.

How could a chiropractor be responsible for a patient’s injury?

Although the risk of being seriously injured by a chiropractor is low, tragic accidents can and do happen. If you or a loved one believe you have been the victim of medical malpractice, please contact an experienced personal injury attorney.

Explaining how an injury or medical error occurred will help your attorney determine the potential liability of a chiropractor and any other involved parties. A chiropractor’s liability could fall into a legal category such as:

  • Failure to Diagnose a Medical Condition – The chiropractor breaches a duty of care to their patients by failing to diagnose an underlying medical condition. This could occur when a patient reveals or exhibits symptoms of a severe issue, such as a stroke, and is not referred for appropriate medical attention.
  • Lack of Informed Consent – A patient is treated without being properly informed of the potential risks or side effects, and experiences an injury from that treatment.
  • Negligent Manipulation – The patient’s body is adjusted by the chiropractor in such a way that it causes a new injury or worsens an existing injury. This could also include manipulation of a patient who is pregnant and goes into premature labor.
  • Chiropractic Induced Injury – A patient suffers injury, permanent irreversible damage such as paralysis or wrongful death as the direct result of a chiropractic manipulation.

To find out whether or not you may have a case, please discuss your concerns with a qualified personal injury attorney.

What should I do if I think I have been injured by chiropractic manipulation?

A personal injury attorney can help recover compensation for victims of medical malpractice, including those who have experienced a chiropractic injury. Surviving loved ones can also pursue their case after a family member’s wrongful death.

An attorney will help you collect documents, photos and other items pertaining to your case – but staying organized early in the process will be helpful. Try to preserve important documents, such as:

  • Photographs before and after treatment
  • Medical records and medical bills
  • Receipts, appointment confirmations and other paperwork from your chiropractor

There is a time limit to file a medical malpractice lawsuit, referred to as a statute of limitations…

The issue of informed consent has made regular appearances on this blog. It is important and has many intriguing aspects, particularly for so-called alternative medicine (SCAM). On the one hand, it is a ‘conditio sine qua non’ for any form of healthcare, while, on the other hand, it is a near impossibility in SCAM practice.

In this new article published in a chiro-journal, the authors review the origins of informed consent and trace the duty of disclosure and materiality through landmark medical consent cases in four common law (case law) jurisdictions. The duty of disclosure has evolved from a patriarchal exercise to one in which patient autonomy in clinical decision making is paramount. Passing time has seen the duty of disclosure evolve to include non-medical aspects that may influence the delivery of care. The authors argue that a patient cannot provide valid informed consent for the removal of vertebral subluxation. Further, vertebral subluxation care cannot meet code of conduct standards because it lacks an evidence base and is practitioner-centered.

The uptake of the expanded duty of disclosure has been slow and incomplete by practitioners and regulators. The expanded duty of disclosure has implications, both educative and punitive for regulators, chiropractic educators and professional associations. The authors discuss how practitioners and regulators can be informed by other sources such as consumer law. For regulators, reviewing and updating informed consent requirements is required. For practitioners it may necessitate disclosure of health status, conflict of interest when recommending “inhouse” products, recency of training after attending continuing professional development, practice patterns, personal interests and disciplinary findings.

The authors conclude that, ultimately such matters are informed by the deliberations of the courts. It is our opinion that the duty of a mature profession to critically self-evaluate and respond in the best interests of the patient before these matters arrive in court.

In their paper, the authors also provide a standard list of items required for ‘informed’ consent:

(1) emphasizing the patient’s role in shared decision-making

(2) disclosure of information

a. explaining the patient’s medical status including diagnosis and prognosis

b. describing the proposed diagnostic and therapeutic intervention, including the likelihood and effect of associated risks and benefits of the proposed action, including material risks

c. discussing alternatives to the proposed intervention, including doing nothing

(3) prompting and answering patient questions related to the proposed course of action (NB. this involves probing for understanding, not simply asking ‘do you have any questions’), and

(4) eliciting the patient’s preference (usually by signature). (NB. A signed form is not consent. The conversation between the clinician and the patient or carer is the true process of obtaining informed consent. The signature on the consent form is proof that the conversation took place and that the patient understood and agreed.)

The authors of this article – I do commend it to all chiropractors – take a mostly judicial view of informed consent (for an ethical perspective on the subject, I recommend our book). They do not discuss, whether chiropractors do, in fact, adhere to the ethical imperative of informed consent. As I have stated before, there is not much research on this issue. But the little that does exist fails to show that chiropractors care much about it.

But why?

If it’s an ethical imerative, why do chiropractors not abide by it?

The answer to this question is not difficult to find. Just imagine a conversation between a chiropractor (C) and a patient with neck pain (P):

  • P: What’s your diagnisis?
  • C: You are suffering from acute neck pain.
  • P: Thanks, that much was clear to me. What do you suggest I do?
  • C: I will perform a manipulation of your neck, if you agree.
  • P: Why would this help?
  • C: It can realign the vertebrae that are out of place, simply put.
  • P: And my pain will disappear?
  • C: Sometimes it does, yes.
  • P: But will it disappear quicker than without manipulation.
  • C: Some of the evidence says so.
  • P: Ok, but what does the most reliable evidence say?
  • C: It is not entirely clear cut.
  • P: Hmm, that does not sound too good.
  • P: So, tell me, are there any risks?
  • C: About 50% of patients suffer from minor to moderate pain for 2-3 days afterwards.
  • P: That’s a lot!
  • P: Anything else?
  • C: In some cases, neck manipulation was followed by a stroke.
  • P: Gee that’s bad; how often has this happened?
  • C: We know of about 500 such cases.
  • P: Heavens!
  • C: Now, do you want the treatment or not?
  • P: How much will you charge?
  • C: Only 60 Euros per session.
  • P: You mean I have to come back for more, each time risking a stroke?
  • C: Well… You don’t have to.
  • P: Thanks for the info; I am off. Cherio!

I rest my case. 

 

Hurray, homeopaths have a new study to be jubilant about!

But how far can we trust its findings?

Let’s have a look.

The aim of this study was to evaluate the effects of homeopathy (H) as an adjunct to non-surgical periodontal therapy (NSPT) in individuals with type 2 diabetes (DMII) and chronic periodontitis (CP). Eighty individuals with CP and DM II participated in this randomized, double-blind, placebo-controlled study. They were randomly divided into two groups: control group (CG) and the test group (TG), and both groups received the NSPT. TG also received homeopathic therapy, including Berberis, Mercurius solubilis/Belladonna/Hepar sulphur and Pyrogenium, while CG received placebo, while the TG received placebos. Clinical and laboratorial examinations were evaluated at baseline and after 1, 6 and 12 months of treatment.

Both groups showed significant improvement throughout the study for most of the parameters studied, but TG presented a significative gain of clinical attachment at 1 and 12 months compared to CG. Mean glucose and glycated haemoglobin significantly decreased in both groups after 6 and 12 months. However, there was a significant further reduction of these parameters in TG, as compared to CG.

The authors concluded that homeopathy as supplement of NSPT may further improve health condition, including glycemic control, in DMII patients with CP.

Over the years, I have learnt how to ‘sniff out’ studies that are odd. This is one of them, I fear; it smells strangely ‘fishy’.

Here are some of the reasons why I remain sceptical:

  1. There does not seem to be an approval by an ethics committee.
  2. I also could also not find any mention of informed consent.
  3. There is no mention of conflicts of interest
  4. Neither is the source of funding disclosed.
  5. There were zero drop-outs which I find hard to believe.
  6. The trial started in 2013, but was published only recently.
  7. The treatment with homeopathy lacks biological plausibility.
  8. The authors conducted > 50 tests for statistical significance without correcting for multiple testing.
  9. The clinical relevance of the findings is unclear.

Even if we accepted the results of this study, we would require at least one independent replication before we allow them to influence our clinical practice.

Arianne Shahvisi is a lecturer in Ethics and Medical Humanities at the Brighton & Sussex Medical School. She has long had an interest is so-called alternative medicine (SCAM) – see here, for instance. Now she has published another most intriguing paper.

In it, she explains that scientific medicine (SM) neglects the needs of women relative to those of men. Subsequently she discusses the many limitations of SCAM and describe concerns about its use. Despite SCAM’s shortcommings, it is the domain of women who not only use it more frequently than men but also tend to be the practitioners practising SCAM. Arianne Shahvisi argues that, despite being chosen by women in reaction to the shortcomings of SM, SCAM cannot offer greater patient autonomy and is more liable to be exploitative.

Here conclusions are unusually long and I provide them here in full (after changing her abbreviation ‘AM’ to mine ‘SCAM’):

Within this paper I have made the following argument: SM is patriarchal and under-serves women; women dominate SCAM, both as users and service providers; women who choose SCAM often cite dissatisfaction with SM and the desire for greater autonomy and personalization within the clinical encounter. Based on these premises, it is likely that women use SCAM because it promises to offer greater autonomy and personalization than SM. This segues into a second argument: autonomy in healthcare requires informed consent; informed consent is not possible for SCAM therapies since mechanisms are either not known or not plausible, and there is no evidence base. These premises entail that SCAM cannot help patients to realize autonomy. Combining these two conclusions, it seems that SCAM does not offer the control and autonomy that is sought. Whilst it may be argued that SCAM offers personalization and a satisfactory therapeutic encounter, it must also be noted that forfeiting an evidence base, plausible mechanisms, and the ability to make autonomous decisions is a heavy loss to patients and one for which SM must take some responsibility.

I have attempted to motivate each of the above premises in the preceding sections. In this section I reflect on the implications of these conclusions and make recommendations to ensure that women’s health needs are more adequately met.

First, to the extent that rejection of SM may be seen as a form of resistance, the cost of that resistance is borne largely by the resistors themselves. Those who begin witha sense of dissatisfaction with SM—in many cases stemming from SM’s failure to provide them with adequate healthcare or to inspire trust in its own decency—end up with healthcare that is on many counts less adequate.

With the ascendance of a post-factual culture, arguments relying on evidence, reproducibility, and consistency are liable to have ever less traction. By corollary, the features that have typically worked against SCAM—its lack of an evidence base—are likely to pose less of a barrier to its uptake. This ought to be a grave public health concern, since the well-being of entire populations depends on medicine earning and retaining the trust of all. To see this, one need only consider how easily herd immunity is lost when trust in vaccination is undermined, putting entire populations at risk of disease outbreaks (Casidayetal.2006). Recommending against vaccination is common amongst SCAM practitioners (especially within chiropractic, homoeopathy, and naturopathy) whose philosophies so often rely on emphasizing, and in many cases overstating, iatrogenic risk (Ernst 2001).

Not much can be done now to atone for medicine’s history except to openly accept its shortcomings and under take particular effortS to re-engage marginal health populations. While it is easy to suggest that researchers should be devoting more time to women’s health issues and their treatments, the bench-to-bedside timeline is long, and more immediate efforts are also necessary. As Ernst (2010) has noted, concentrating on the therapeutic relationship within SM seems like the most constructive way forward. Although patients often look to SM for the ‘science of medicine’, clearly many are turning to SCAM for the ‘art of medicine^ (Ernst 2010, 1473)—for a compassionate clinical encounter in which patients are humanized and power differentials are flattened. While SM may have the upper hand in terms of mechanisms, an evidence base, and social capital, there are inadequacies in the patient–practitioner relationship, and in this respect there is much to learn from SCAM modalities, where the therapeutic relationship is key to their appeal. Even the most resolute SCAM user inevitably encounters SM professionals on occasion. Provided broader pressures on health workers permit them the time and space, those encounters present the possibility of demonstrating that SM can be person-centred, equitable, and sensitive to the differential needs of marginalized patient groups.

As I described in section 4, many of those who choose SCAM do so following a long period of unsatisfactory encounters with medical professionals as they pursue the treatment or resolution of long-term chronic ailments (Furnham and Vincent 2000; Cant and Sharma 2004). The majority of these patients are women. While SCAM practitioners are unlikely to offer therapies that are effective beyond placebo, they are able to offer consultations which are longer, more participatory, and more personalized. It is likely that most of the placebo effect is interpersonal and stems from the ritual of healing within encounters with practitioners, rather than from any specific therapy (Miller et al. 2009). There is some evidence that open label placebos still confer a placebo effect, which suggests that the therapeutic relationship plays a significant role (Kaptchuk et al. 2010). In light of these insights, Blease (2012) suggests that the placebo effect instead be referred to as the ‘positive care effect’. Given the importance of communication and autonomy amongst patients choosing SCAM, it is interesting to note that a surgical study shows that the extent of the positive care effect is contingent on the quality of the clinical encounter, with communication skills aimed at empowering patients being predictive of better clinical outcomes (Trummer et al. 2006).

Focusing on the U.K. healthcare system, I therefore recommend that general practitioners, who are the gatekeepers of the medical profession, make efforts to address the inadequacies in the clinical encounter, specifically for those with long-term health conditions or medically unexplained symptoms. As it stands, general practitioners in the United Kingdom spend ten minutes with each patient and are encouraged to focus on a single health issue. It is therefore unsurprising to note that dissatisfaction with the clinical encounter is shared by clinicians. In a recent survey, 55 per cent of general practice surgeries in the United Kingdom reported concerns about the quality of care they could provide and described their workload as unmanageable most of the time; 13 per cent reported that it was unmanageable all of the time (Iacobucci 2016). In another study, 68 percent  of general practitioners expressed the view that care could be improved by longer, higher-quality consultations, while 67 percent felt that patients with long-term conditions should be afforded longer consultations (Rimmer 2015). It has been demonstrated that longer consultation times correlate with a greater likelihood of taking a thorough medical history and conducting examinations in accordance with good practice, a lower prescribing rate, a greater likelihood of offering advice about preventative healthcare, and fewer follow-up consultations (Wilson and Childs 2002).

General practitioners are currently able to make referrals to specialists in various clinical disciplines. In addition to lengthening standard consultation times, the option of making general referrals may be a constructive way forward, i.e. arranging for the patient to have a lengthier consultation with a general practitioner rather than being siloed into a specialist referral (which is liable to be  an even less holistic encounter) or sent away. Given the importance of the therapeutic encounter, it is also worth considering increasing the number of talking therapies referrals for long-term physical health problems. As it stands, talking therapies are recommended within the U.K. National Health Service for a range of social, mental, and physical conditions. This could be broadened, so that those whose physical symptoms are not being satisfactorily resolved within the biomedical paradigm are able to benefit from a personalized therapeutic relationship which does not rely on implausible mechanisms (NHS Choices 2016).

That women may be less likely to benefit from medicine and therefore more likely to spend time and money  seeking therapies whose claims are questionable, whose benefits are negligible, and whose potential for exploitation is considerable, is a grave matter. Researchers and clinicians must take responsibility by consciously modernizing biomedicine to ensure that its goods are accessible to all and that the benefits of a positive therapeutic encounter are acknowledged and prioritized in the delivery of care.

One does not need to be a feminist to see that Arianne Shahvisi is correct in her line of arguing. Her insights are important and very well-put. Yet, they represent merely one aspect of SCAM, and there are many others. For instance, many consumers are not motivated to try SCAM by a disenchantment with SM. In fact, most of the research shows that this is not the main reason for becoming a SCAM proponent.

But, whatever the reason, it seems clear to me that those who subscribe to SCAM are getting a poor bargain. Arianne Shahvisi is therefore entirely correct in demanding that SM has to get its act together to avoid this from happening. I must have written and said it hundreds of times: whatever SCAM is, it is a poignant criticism of SM which must be used constructively for improving SM.

We have discussed the tragic case of John Lawler before. Today, the Mail carries a long article about it. Here I merely want to summarise the sequence of events and highlight the role of the GCC.

  • In 2017, Mr Lawler, aged 79 at the time, has a history of back problems, including back surgery with metal implants and suffers from pain in his leg.
  • His GP recommends to consult a physiotherapist.
  • As waiting lists are too long, Mr Lawler sees a chiropractor shortly after his 80th birthday who calls herself ‘doctor’ and who he assumes to be a medic specialising in back pain.
  • The chiropractor uses a spinal manipulation of the neck with the drop table.
  • There is no evidence that this treatment is effective for pain in the leg.
  • No informed consent is obtained from the patient.
  • This is acutely painful and brakes the calcified ligaments of Mr Lawler’s upper spine.
  • Mr Lawler is immediately paraplegic.
  • The chiropractor who had no training in resuscitation is panicked tries mouth to mouth.
  • Bending the patient’s neck backwards the chiropractor further compresses his spinal cord.
  • When ambulance arrives, the chiropractor misleads the paramedics telling them nothing about a forceful neck manipulation with the drop and suspecting a stroke.
  • Thus the paramedics do not stabilise the patient’s neck which could have saved his life.
  • Mr Lawler dies the next day in hospital.
  • The chiropractor is arrested immediately by the police but then released on bail.
  • The expert advising the police is a prominent chiropractor.
  • One bail condition is not to practise, pending a hearing by the GCC.
  • The GCC decide not to take any action.
  • The police therefore release the bail conditions and she goes back to practising.
  • The interim suspension hearing of the GCC is being held in September 2017.
  • The deceased’s son wants to attend but is not allowed to be present at the hearing even though such events are normally public.
  • The coroner’s inquest starts in 2019.
  • In November 2019, a coroner rules that Mr Lawler died of respiratory depression.
  • The coroner also calls on the GCC to bring in pre-treatment imaging to protect vulnerable patients.
  • The GCC announce that they will now continue their inquiry to determine whether or not chiropractor will be struck off the register.

The son of the deceased is today quoted stating that the GCC “seems to be a little self-regulatory chiropractic bubble where chiropractors regulate chiropractors.”

I sympathise with this statement. On this blog, I have repeatedly voiced my concerns about the GCC – see here, for instance – which I therefore do not need to repeat. My opinion of the GCC is also coloured by a personal experience which I will quickly recount now:

A long time ago (I estimate 10 – 15 years), the GCC invited me to give a lecture and I accepted. I do not remember the exact subject they had given me, but I clearly recall elaborating on the risks of spinal manipulation. This was not too well received. When I had finished, a discussion ensued in which I was accused of not knowing my subject and aggressed for daring to ctiticise chiropractic. I had, of couse, given the lecture assuming they wanted to hear my criticism. In the end, I left with the impression that this assumption was wrong and that they really just wanted to lecture, humiliate and punish me for having been a long-term critic of their trade.

I therefore can fully understand of David Lawler’s opinion about the GCC. To me, they certainly behaved as though their aim was not to protect the public, but to defend chiropractors from criticism.

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