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Informed consent: it’s not a reality for too many patients

The previous post highlighted the growing focus internationally on overuse of healthcare.

When I interviewed Carol Bennett, CEO of the Consumers Health Forum of Australia, for an article on related themes at Inside Story, she stressed the the need for patients and the public to have better information about the pros and cons of healthcare interventions, in order to enable true informed consent.

The findings of the recent Senate Committee inquiry into Poly Implant Prothese (PIP) breast implants and related matters have underscored her concerns about the quality of information available to patients and the broader community.

*** 

Informed consent: we need to do better

Carol Bennett writes:

The Chief Medical Officer’s factsheet on silicone gel filled breast implants is unequivocal:

“All silicone gel filled breast implants are considered high risk medical devices. They have a limited lifespan – the risk of rupture increases with time, with an estimate of 10-15 percent rupturing by 10 years.”

So the quotes below make compelling reading:

“He told me at my six week post-op check-up that ‘everything was fine and I would have them for life’.”

“He assured me breast implants were safe and that they would likely last a lifetime. I had no reason to doubt him.”

These quotes are from submissions to the Senate Community Affairs Committee Inquiry into ‘the role of Government and the Therapeutic Goods Administration (TGA) regarding medical devices, particularly Poly Implant Prosthese (PIP) breast implants’.

They come from women who had been implanted with PIP breast implants, and who are now experiencing considerable uncertainty and distress as a result of the major issues that have arisen with these implants.

There are many lessons to be learned from the PIP experience, including about how device safety is monitored on the market, and how safety concerns are communicated to consumers.

But there is another lesson that we can’t allow to be lost in the midst of these other issues – the question of informed consent.

Recommendation 1 of the PIP inquiry report is that there should be rigorous systems in place to ensure medical practitioners provide consumers with all the information needed to allow them to give fully informed consent.

Several women with PIP implants submitted to the Senate inquiry that they were told that issues with their implants were unlikely, and they would probably not need to have them replaced. The quotes above are just two examples.

But, as is clearly stated in the Chief Medical Officer’s report on the PIP implants, all silicone gel filled breast implants – not just PIP implants – are considered to be high risk medical devices.

They have a limited lifespan, and the risk of rupture increases with time, with an estimated rupture rate of 10 to 15 percent at the 10-year mark. Information provided to patients often contains only a general warning that reoperation might be necessary, without any indication of the likelihood.

The question we need to ask is whether these women had all the information they needed to make a truly informed choice about whether or not they would have breast implants.

If they were given accurate information about rupture rates – rather than comforting statements that they would have their implants ‘for life’ – would they have made different choices?

Informed consent is arguably of particular importance in relation to implantable medical devices – removing these when something goes wrong is often not straightforward – but the issue is certainly not limited to devices.

In CHF consultations over many years, consumers have raised concerns about a lack of informed consent when making decisions about their healthcare. The issue comes up again and again, in relation to medicines, diagnostic imaging, pathology testing, eHealth, choice of treatments… the list goes on.

But what is informed consent? At the most basic level, it is captured by two principles in the Australian Charter of Healthcare Rights: I have a right to be informed about services, treatment, options and costs in a clear and open way, and I have a right to be included in decisions and choices about my care.

How this takes place is more complex. Various guidelines and resources on informed consent (and the just as fraught question of informed financial consent) exist, but the College of Anaesthetists’ Guidelines on Consent for Anaesthesia and Sedation captures many of the key elements of what constitutes informed consent. The key point is:

The patient should be provided with the information that a reasonable patient in the position of that patient might wish to know, and to which she/he might attach significance. It is necessary to provide information about all material risks inherent in any proposed treatment.

There is further, useful detail about how to ensure consent is informed – including providing the information in a form that the patient/consumer is likely to understand, but the core principle is that consumers should be provided with all the information that they might wish to know and to which they might attach significance. If we apply this test to the women who were told their breast implants would last them a lifetime, we can see that their consent was not truly informed.

An increasing body of evidence suggests that health outcomes are improved when consumers are viewed as partners. However, when consumers do not have all the information that they need to make informed healthcare decisions, they are not empowered to play an active role in their healthcare.

We have to move beyond the ‘doctor knows best’ mentality and empower consumers to ask the right questions when they are not receiving the information that they need, so that they can provide truly informed consent and be confident that the decisions they are making about their healthcare are right for them.

Consumers who are informed and engaged in their healthcare are likely to play a greater role and be active partners in managing their own health – and everyone will benefit.

 

 

 

Comments 3

  1. ron batagol says:

    I wholeheartedly agree with Carol Bennett when she says, with regard to medical procedures or treatments, that “we have to move beyond the ‘doctor knows best’ mentality and empower consumers to ask the right questions when they are not receiving the information that they need, so that they can provide truly informed consent and be confident that the decisions they are making about their healthcare are right for them”.
    But we move into whole different dimension when she includes eHealth as an example of, presumably, passively acceding to consumer requests for empowerment and inclusion, because this desire needs to be balanced against the imperative of the oft-quoted Hippocratic oath, namely “first do no harm”.

    As I have pointed out many times on this and other forums, the concept of patients opting-in, opting-out etc. of eHealth records destroys the whole integrity of the medical record! It’s simply a nonsense, as is proposed, to endorse, as a matter of public policy, the purposeful exclusion by patients, of parts of medical records that may be vital in potentially diagnosing,identifying and possibly preventing current, possibly, life-threatening health issues, including significant adverse drug reactions/interactions, concomitant disease entities etc.that the patient may be embarrassed about or wish, for any reason at all, not to include in their e record! This issue has, frankly, been ignored, because Governments and, yes, consumer lobby groups want to take the easy way out to “sell” the benefits ( and there are potentially huge benefits!), of personal electronic health records without addressing the patently “too hard” issue of balancing the need for medical safety and data integrity against the need for informed patient choice!

    However I would challenge any pharmacist, doctor, pharmacist or other health professional to think of an occasion when they have EVER omitted to record a medical or drug consultation in their current recording systems, on the request of the patient? Because that is effectively what will be the end result of selectively making data available to an opt-in or even opt-out eHealth record system as proposed! That is the reason that doctors and the medical insurers are concerned and it’s an important issue central to the integrity of the proposed system, which needs to be addressed in a logical, systematic and informed way, and appropriate agreed security and encryption parameters worked out, in collaboration with all the stakeholders, BEFORE the new system is implemented!
    After all, if we can achieve that before we lock in the new eHealth system, empowerment of consumers should then, in this context, also include health advisors assisting consumers to ensure that they do indeed understand the questions they need to ask about eHealth, and to give them the information that they need to do so, so that they can indeed be confident that the decisions they are making about their healthcare are right for them”.

  2. Mia says:

    Esp. in the context of entrepreneurial medicine, the patient – doctor relationship and communication can get very… complex. This will be reflected in the quality of the text provided to the prospective client/patient. Yet, the patient-doctor relationship is never seen as a purely business relationship, the advertising as just another ad….as we are conditioned to view the medical professional as someone who ‘knows best’ and could only have altruistic motives – which is clearly a fallacy, but one that endures. This makes the patient more vulnerable.
    The problem with medical advertising and the text of ‘informed consent’ is that it is so subtle that to the general (conditioned) public the nuances will be imperceptible. We know that advertising works, and the “silken prose” of the medical advertising works even better. The aura of the authoritative figure in a white coat works its magic. And let’s not pretend that the majority will not be influenced by this.
    I could list here webpage after webpage for surgeons who are offering procedures; their information laced with half-truths, pseudoscience, and poorly veiled wish fulfillment, offering to transform your life, deliver happiness and fulfillment… It is clear that they are ‘selling’ more than the surgery, and their aim is to make you think that you would be happier with a new set of breasts or face or without being able to blush. They are marketing happiness, and I guarantee to you that none of them will tell you about the bad outcomes, or show you pictures – let alone video – of what exactly happens during the surgery, and how it looks when results do not turn out as well as the advertising might suggest. You will ONLY see the DESIRABLE, seductive IMAGES, that makes you think ‘OH, I WANT IT JUST LIKE THIS!’
    I do not agree that the patient EVER can be a partner in this exchange, as the information imbalance does not allow it. The patient knows infinitely less about the procedure and the possible outcomes and consequences than the doctor does. he patients also WANTS to look better, wants o be desired, or simply wants to conform to an idea of perfection or beauty. So to imply that there is a balance of power is simply ridiculous/naive and out of touch with reality.
    Patients, the public has to be protected from the predatory practices of the medical professionals, because it is clear that self-regulation DOES NOT WORK.

  3. ron batagol says:

    When you say that the patient can never a partner in the doctor/patient exchange, I guess that does encompass my concerns, but for an entirely different reason. My concerns are around the potential medical hazards that may arise because of doctors and other health professionals treating the patient during an, at yet, not fully diagnosed medical emergency, without being fully informed due to the patient’s prior decision to withhold from their electronic record certain aspects of their medical and/or therapeutic history for personal reasons related to privacy, embarrassment or whatever other reason for that decision.
    Let me just float one hypothetical scenario as to how might this be important in the future for ensuring the best and safest level of patient care? Imagine the situation where a treating doctor (or other health professional ) was, based on their clinical experience and expertise, concerned about interacting drugs or medical conditions which don’t appear on the e Health Record, as possible underlying factors for presenting symptoms. If they contacted a colleague (eg. regular or previous treating doctor or health professional) to clarify the completeness of data in the eHealth Record, and the health practitioner being contacted had further relevant medical ( or therapeutic) information which the patient had chosen to exclude from their eRecord, is the doctor or health professional breaching patient confidentiality or indeed their legal obligations, by disclosing these additional details to their colleague, against the expressed wishes of the patient, on the basis that they believe it may be important to the immediate diagnosis or treatment plan for that patient? On the other hand, what are the medico-legal implications and patient safety issues of NOT disclosing this information?
    I’m assuming that these are the sorts of reasons that medical groups and medical insurers are expressing concern. I have no problem with commencing an overall trial for e Health and developing and fine-tuning the system over time. But as we move into this whole different emerging dimension of eHealth, with all its potential benefits, rather than passively acceding to every aspect of consumer requests for empowerment and inclusion, this admirable and important social imperative needs to be balanced against the medical imperative of the oft-quoted Hippocratic oath- “first do no harm”. That’s why issues around the opt-in, opt-out concepts are central to the integrity of the proposed system. They need to be addressed in a logical, systematic and informed way and appropriate agreed and fully explained security, privacy, clinical and encryption parameters worked out, in collaboration with ALL the stakeholders, sooner rather than later, since down the track it will be well nigh impossible to “back track” or re-define parameters of opt-in/opt-out clauses after potential medical safety issues or adverse events arise.

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