That patients have the right to be involved in decisions about their care and treatment is recognised by every doctor. And yet 'flaws' in the consent process remain a persistently common feature of clinical negligence allegations and claims.
One increasingly frequent complaint is that a patient wasn't properly warned about a 'material risk' that would have affected their decision-making. Since the Montgomery judgment (Montgomery v Lanarkshire Health Board  UKSC 11) superseded the old Sidaway test (Sidaway v Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital  AC 871) for negligence in the context of obtaining consent, it's no longer enough to meet the standard of a reasonable body of medical opinion when telling a patient about potential complications.
Doctors are now expected to disclose any risk to which a reasonable person in the patient's position would attach significance or if the doctor is or should reasonably be aware that the patient would be likely to attach significance to it.
With their actions and record-keeping under closer scrutiny by solicitors and regulators, it's an opportune time for doctors to reflect on what makes a good consent process.
Dr Michael Quinn has been interested in this area since he was a junior doctor and found himself tasked with consenting patients for procedures that were beyond his experience. "I thought if I don't understand this, how can they?" he remembers. "Thankfully we've moved on, but the consent process still needs to evolve, particularly the way we share information with patients.
"We currently spend an awful lot of time talking, but they don't always get the time to ask questions and check what was said. I want there to be a level playing field where people can have a transparent conversation about what they want, just as they would in other areas of life."
A consultant in acute medicine and nephrology at Belfast Trust and clinical lecturer in medical informatics at Queens University Belfast, Michael believes the problem is that consent is often seen as a transactional event, which isn't conducive to meaningful dialogue and shared decision-making.
"The patient will go into hospital to have something done, they are given the details, a form to sign and on we go," he explains. "It's in the nature of the business, especially in many 'craft specialties' like surgery, but over time we need to get used to having more open conversations because that's what engenders trust.
"One thing we sometimes do in medicine, for example, which is a bit paternalistic, is trying to make things easy, either to get the right outcome for the patient or just so we can get through our day. But medicine isn't easy, and you have to make sure patients realise the complexities and go with them on that journey.
"When I'm explaining the process of inserting a central line, for example, I will talk about the small risk of death. It's never happened in my experience, but the risk is real and I need them to understand there are no guarantees.
"And there's the materiality question that arises from Montgomery. For example, if I needed an angiogram, it would usually go through the wrist, which carries a tiny risk that I wouldn't be able to use my hand afterwards. Alternatively, they could use the femoral artery, as they used to, where there is a small risk of bleeding.
"Personally, I play a musical instrument and I need my hands, so I would choose the femoral artery while another patient might make a different choice. How is the doctor supposed to know that unless consent is a conversation and not just a tick-box exercise?"
Medicine isn't easy, and you have to make sure patients realise the complexities and go with them on that journey.
Another situation that can present challenges is where patients have some kind of cognitive impairment. "It can get really complicated," Michael agrees. "Someone might have dementia but still have the capacity to decide if they want a hip replacement. The two things are not incompatible, but clinicians sometimes think they are. It's another example of the type of conversations we need to have to support patient autonomy in decision-making."
After being involved in a number of digital healthcare projects over the years, Michael believes technology can help enhance the consent process. He helped write the business case for the National Electronic Health Record programme in Northern Ireland (now Encompass) and is currently a member of BT's Clinical Advisory Board, looking at how health tech can best meet the needs of the NHS.
Last year, he jointly found a start-up, Round Safely, with the idea of recording ward rounds, clinic visits and interactions using audio and video technology, and sharing these with patients and their families, as well as for training purposes. "Rather than a summarised note that covers 10% of what happened, we record the whole thing and the patient can have a copy," he explains.
"We know up to 80% of what gets said during a consultation can be forgotten when the patient goes out the door, and if we say anything scary it can stop the patient taking in the rest of it. With a recording, patients can go back and hear what was said or ask a family member to do so for them. This issue is, how do we scale it?"
Michael believes there is a compelling case for recording consent discussions, but he acknowledges there are barriers, including privacy concerns and some doctors' willingness to accept what they might regard as an unwelcome intrusion.
Photo credit: Shutterstock
He acknowledges that the introduction of technology in healthcare settings has often been problematic, which has led to widespread scepticism of ambitious IT projects that promise transformation. "There's so much to unpick about why technology hasn't yet delivered on its potential. In the past, we've bought big systems that have cost huge amounts of money but didn't coordinate it well enough from the centre.
"Clinicians get frustrated when we have one system that collects data but doesn't talk to another. And the public don't trust us: they think we're just going to spend money and nothing will change. We need to decide the outcomes we are planning to deliver and start proving this stuff works.
"We also have to be specific about data privacy issues and how we deal with those. As I see it, data is ultimately owned by the patient and held by the Trust or the vendor on a cloud. By now, the big vendors are used to NHS security compliance and cloud storage is highly efficient as the amount of storage you pay for is based on use.
"It's also flexible because we can optimise for voice or video depending on the environment and people can choose whether they want a record of the whole conversation or what to transcribe. And after a period of time, it gets deleted."
And while some doctors may shudder at the prospect of their consultation being recorded, Michael points out it's already happening. "Patients can record us whenever they like and it's not uncommon for people to turn up to my clinic with their phone, press the screen and I see a wee red light. When that happens, I say to the patient that I don't mind them recording but I'd like a copy, and I think most clinicians wouldn't object provided there is some equity."
Of course, patients also can and do record consultations without the doctor's knowledge, which also isn't ideal. Michael is clear that there should be agreement on both sides, as that helps build mutual trust and confidence - but where recordings are made in secret it is likely to have the opposite effect.
It's not just about reducing claims but evolving a consent methodology that is fit for modern practice.
"With Round Safely, we are on a journey to find the best way to record and share - do we use video or voice, what do we record and what do we do with the information? For example, we can convert a conversation into text and create a PDF for the patient record. In another scenario, the recording could be stored in a kind of safety box equipped with clever tech so no one can access it unless there is a claim and both sides consent."
Even if the mechanism is yet to be agreed, Michael is adamant that something must be done to improve the consent process to address the increasing claim burden on the NHS. "Solicitors know they can pursue a claim on failure to inform, rather than just a negative outcome, and will often include this as a secondary issue. In an environment where there's no money, we're running out of time, we need to learn quicker and we should use tech to do that.
"The system we have at the minute doesn't work," he emphasises. "It might work for you until you get sued but it isn't working for patients; it doesn't work for the organisation that indemnifies you; and if you look at the last NHS Resolution Annual Report [which shows £128.6 billion has been earmarked to cover the total cost of NHS clinical negligence claims in England], it doesn't work for taxpayers either."
Michael is also anxious to avoid a free-for-all where some patients take it into their own hands to record consultations, but nothing is shared, so there is no opportunity for discussion or learning. However, he is hopeful that technological solutions will prove themselves over time, starting in confined areas like outpatient clinics where it's easy to control, and with particular patient groups, and then expanding.
"I think there are others like me out there trying to change things, and that doesn't matter as long as we come up with a sensible way forward. I think you have to build something and trial it to see if people want to use it, and then hopefully it will be taken up by a larger organisation.'
Meanwhile, he observes that the use of recording technology is becoming more widely accepted. For example, the Cumberledge Review into Medicines and Medical Devices Safety included the recommendation (accepted by the government) that, "Where appropriate and with the agreement of both parties, conversations around consent should be audio or video recorded to allow the patient to take it away and reflect upon it. In future a copy of this discussion should be stored on the patient's electronic record."
"It's not just about reducing claims but evolving a consent methodology that is fit for modern practice," says Michael. "If there is something we can do to help us learn from the most effective communicators and improve patient care then we should figure out how to do that in the best way for everybody and incentivise people to do it.
"The last thing I want to do is be a burden to clinicians, but I do want to put tech specialists, clinicians and patients in a partnership to find a balance that delivers better care and moves away from the transactional approach to consent.
"It may feel strange at the outset but we've all got a lot to gain from recording consultations, including doctors. My wife is a GP and there have been occasions where a concern has been raised about a telephone consultation where the recording has protected her. We might worry about the level of scrutiny, but in the vast majority of circumstances, it will show we've done the right thing."
Interview by Susan Field
The views expressed in this article are those of the author and do not necessarily reflect those of the MDU.
Any clinicians or hospital groups interested in Round Safely can contact Michael via the website: roundsafely.com/about/
View from the MDU
Dr Quinn is right to shine a light on how we might improve on our processes for obtaining patients' consent. GMC ethical guidance emphasised the importance of doctors getting informed consent from patients long before the Supreme Court judgement in Montgomery.
At its heart, informed consent is about a dialogue, which explores a particular patient's understanding and needs. As was neatly illustrated with Dr Quinn's example of a hand injury impacting on a patient who is a musician, there is no one-size-fits-all approach to making sure consent is truly informed.
There may be some anxiety about technology intruding into the consultation itself, but where patients are better informed as a result of it, and doctors have a more complete record of what was discussed, then it could be genuinely better for everyone.
Dr Michael Devlin, MDU head of professional standards and liaison