Intended for healthcare professionals

Opinion

Will obtaining digital consent from patients in advance of undergoing procedures improve the quality of the consent process?

BMJ 2022; 377 doi: https://doi.org/10.1136/bmj.o1060 (Published 26 April 2022) Cite this as: BMJ 2022;377:o1060
  1. Tessa Richards, associate editor
  1. The BMJ

I'm due to be taken to the cardiac catheter theatre this morning. Yesterday evening, a scan showed a kink in the right coronary ostial stent that was put in last week. My consultant has decided a repeat angiography and some sort of “re-do” procedure is needed. I've not yet signed a consent form and am very reluctant to do so.

Any sort of re-do will surely be much riskier than the first procedure? And over a sleepless night on the acute cardiac ward, I got a second opinion via a WhatsApp exchange suggesting that the scan findings may not be a cause for concern.

The cardiologist comes to my bedside with a biro and a consent form and starts to reel off the standard list of risks associated with coronary angiography. Do I have the strength to refuse?

I voice concern. He suddenly asks if anyone has assessed my shortness of breath—the symptom that prompted yesterday's scan after a teleconsult. I say “No.” He takes me for a walk along the corridor and on our return says he thinks “we should reconsider the decision to intervene.” I am close to weeping with relief.

During my patient journey I have always (as here) been “consented” for procedures on the day. While I have read up about—and mentally committed to—the interventions in advance, pre-operative anxiety has meant I have been quite unable to take in information, let alone pose questions, as my doctors have sped through the standard spiel on potential risks and harms.

When you are lying in bed in a shapeless surgical gown waiting to be wheeled to the anaesthetic room, the die is cast. Going through a consent process feels surreal. Who is likely to get up off the bed and refuse a procedure at this stage?

The legal obligation to give patients information about the benefits and risks of procedures dates back to 1957.1 Since then the guidance has been tightened incrementally, with emphasis put on patient autonomy, and shared decision making.

Until the early 2000s consenting patients was usually a task delegated to junior doctors. But since 2008 guidance from the General Medical Council (GMC) states that the doctor who will be doing the procedure should consent the patient, or one of his or her team, who fully understands what is entailed. The GMC’s most recent guidance, issued in 2020, is crystal clear on what consent procedures should entail and is a useful resource for patients as well as doctors.

The Montgomery ruling in 2015 enshrined in law patients’ rights as decision makers.2 Guidance from the GMC, the medical royal colleges, and medical defence bodies all now stipulate that consent should not only be informed, but also personalised. Individual patients should be told what they want to know—not what professional opinion deems “appropriate and sufficient” for patients in general.

Discussing the rationale for, and nature of, elective procedures, and associated risks and harms (and documenting the discussion in clinic letters) is relatively straightforward. Yet it's often not done well.

While the decision to give consent is a high stakes one for patients, “consenting” patients is a routine, repetitive task for busy doctors. It's hardly surprising that the quality of the process is often far from ideal. Important information which has not been imparted to me in the past, is the consequences of not undergoing treatment, and the omission of common and distressing post procedure complications.3

In acute settings, time pressures are even higher, “But in any setting, it's hard for doctors to remember to mention, and document, every possible risk and harm associated with the procedures we carry out, and ensure patients are told about the frequency with which they occur where the average morbidity and mortality statistics given may not reflect the experience of individual units.” Daniel Baird, consultant general and colorectal surgeon at Worthing Hospital told me.

It's also hard for doctors to ensure that patients fully understand (to the extent they wish) both the nature, and impact, of complex procedures, associated side effects, inherent uncertainties, and potential complications and adverse events. And give them the time and support to pose questions.

Failure to obtain fully informed consent for procedures is costly, and spurring new approaches to improve the process

Medico-legal costs due to failure to provide informed consent are rising in the NHS.4 And it's a problem shared by many countries.

Consent processes need to improve, and new approaches include getting “digital consent” in advance. A US study comparing e-consent forms for same day surgery with paper consent showed the former contained fewer omissions and errors. It concluded their use could reduce operative room delays and medicolegal risk for surgeons and institutions.5

A UK company called Concentric Health has developed a new shared decision making and digital consent tool. Its founder Dafydd Loughran, a former surgical trainee, set the company up out of frustration with how poor current consent processes often are.

He describes surgical pathways as “too much, and too little, all at the wrong times. Brief moments of intense information delivery and offers of support, followed by much longer periods of no information and no support, whilst feeling frustrated at being unable to remember what was shared in that intense 10 minute consultation.”

The tool was co-developed in collaboration with the Assistive Technologies Innovation Centre in South Wales. Caroline Hagerman, a former fellow at the centre, explained the approach to The BMJ and the importance of “user testing” with patients.

“We dug deep into understanding patients' surgical journeys, and clinicians’ experience of both consent and decision-making. In interviews I explored not just their stories of what happened, but also how it made them feel, what caused them stress and anxiety, and the support that helped them through. It was a privilege to hear these (in many cases shocking) stories. Clinicians and patients all wanted better conversations, where information, priorities, and trust was exchanged.”

Concentric's consent tool provides structured information around key steps on the surgical journey for 1500 different standard procedures. It was launched in 2020 and is now being used in 16 NHS trusts.

Baird has experience of using both the usual paper-based system and the Concentric system and says he “greatly prefers” the latter. Patients can read through comprehensive information well in advance of undergoing planned procedures. Live links embedded in the text give them the opportunity to get further information on what procedures entail and their benefits, risks, and harms.

Some NHS Trusts are embedding e-consent specialty by specialty, others have rolled it out across the Trust and left the choice of whether to use it or not to individual consultants.

The plurality and complexity of different IT systems in use within a single hospital causes problems. Furthermore, a paper patient consent form, which needs to be in the notes for all patients, may be missing when the patient is taken down to theatres; despite the fact that e-consent has been given in advance. Concentric is currently evaluating “real world” use of its new tool.

E-consent forms look set to be welcomed by most patients and clinicians although embedding them will require Trusts to tackle digital divides. As workload pressures continue to rise, it's a way to provide patients with much better information than busy doctors can give them, at a time when they can take it in. It has to beat googling in the middle of the night and agonised last minute WhatsApp exchanges.

But better information won't, on its own, guarantee better decision making. This will always depend on meaningful two-way discussions between patients and doctors, where trust is fostered, and patients are supported to make decisions based on their own preferences and priorities.

Footnotes

  • Competing interests: none declared.

  • Provenance and peer review: commissioned, not peer reviewed.

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