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.
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.