Surgical consent: why organisations MUST have a digital consent process

Surgical consent: why organisations MUST have a digital consent process
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Placing a much-needed spotlight on surgical consent, Stephen Lake, consultant surgeon of Worcestershire Acute Hospitals NHS Trust, UK, talks about implementing digital consent.

The principle of consent is one of the most important elements of both medical ethics and international human rights law. However, the processes that underpin its practice in the UK healthcare system are needlessly archaic.

It is an area where medical practitioners’ approaches vary wildly; where traditional manual processes can act as a barrier to a more collaborative, integrated and crucially, accurate culture. Hospitals that evolve to digitised consent processes can deliver more efficiency, more accuracy and more integration of different data sources.

The cost of implementing a digital consent process might be cited as one of the reasons for delaying a deployment. But given that failures in the consent process can bring about poor patient outcomes and costly litigation, the question should be ‘can any NHS organisation afford not to implement digital consent?’ As a highly experienced clinician, my answer, is a resounding ‘no’.

Understanding consent

Ensuring that consent is informed, voluntarily given and made by someone with the capacity to do so is one of the central tenets of medical procedure and a vital requirement for all clinicians.

Consent processes are a vital barrier against one of the biggest costs facing hospitals and NHS organisations – i.e. litigation. Although numbers of patients pursuing litigation has decreased within the NHS, the costs associated with litigation are continuing to rise. The NHS paid out more than £1.63 billion in damages to claimants in 2017/2018, up from £1.08 billion in 2016/2017. These are financial bills that the NHS can ill afford.

While effective consent procedures by no means eliminate litigation, they do make it far easier to demonstrate precisely what patients were and were not aware of and can prevent incidents from escalating to a litigious stage. Digital consent procedures potentially dramatically reduce the risk of cost and complexity and as such are an essential part of modern healthcare, not a luxury extra.

The case for digital consent

A study by St John et al (2017) found that handwritten surgical consent forms are liable to ‘suffer from missing or inaccurate information, poor legibility and high variability’. By contrast, web-based applications were found to produce ‘no domain failures’ and ‘no variability in the documentation of potential complications.’

Similarly, Bajada et al (2016) found that a quarter of consent forms in a study of 140 were not fully legible, particularly when it came to look at the potential complications of their proposed procedures.

Studies have also found that procedure specific consent forms (PSCFs), rather than standardised forms, improve consenting practice for standardised lists of complications, and yet they are not widely used across the NHS (Courtney and Royle, 2018). This may be in part because paper-based forms are more costly and complicated to tailor to the requirements of different procedures than, for example, a digitised consent form which can be easily amended on a procedure by procedure basis.

Clearly these latter examples rely on consent being accurately and comprehensively recorded and those records being available to all key stakeholders whenever required. Consequently, this is where the traditional manual consent procedure of a clinician filling in a paper form at the patient’s bedside can run into difficulties.

One can therefore see that the argument of paper processes being adequate is a fallacy. Paper-based processes are ineffective – they lead to errors and the possibility of consent not being as informed as it should be. Such processes therefore engender far greater risk of litigation, something that hospitals and NHS organisations can ill afford, particularly in the current environment of ‘do more with less’.

As such, questions of whether an organisation can afford to implement digital consent are misplaced. The real question is whether they can afford the risk of not doing so – I would argue that few can.

Digital surgical consent: the litigation barrier organisations can’t afford to ignore

Hospitals and NHS organisations alike should be looking to evolve to electronic consent processes, which enable consent forms to be created dynamically, pre-populated with set information fields and even individual patient demographics.

Digital forms – like those supplied by Wellbeing Software for example – can be presented to the patient in the context of their proposed procedure, along with any relevant information leaflets in addition to, not as a replacement of, dialogue with the clinician.

There are multiple advantages of digitised consent in other areas of society. Greater accuracy, consistency and improved outcomes are all powerful drivers for the deployment of this technology. But when it comes to making the strongest possible case for investment, digitised consent’s ability to provide a clear line of defence against litigation means that organisations truly cannot afford to ignore it.

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