Errors seen in half of paper consent forms. It's time for digital consent.

Edward St John
by Edward St John, Chief Medical Officer
May 2021
BJS - digital consent paper

Every year 300 million patients undergo invasive treatment, following giving their consent to treatment. The consent process is a key element of care and has traditionally been recorded on paper - using blank template, carbon copy - consent forms.

Published in the BJS by academics including Professor Lord Ara Darzi, ‘Assessment of the introduction of semi-digital consent into surgical practice’ highlights significant concerns with the traditional paper-based consent process.

This paper adds to the growing evidence-base of the association of paper consent forms with patient safety risks due to errors of omission, unwarranted variation, and illegibility. It demonstrates the marked reduction of these risks with the introduction of a digital consent application (Opinform, which was an early prototype by members of the Concentric Health team) at Imperial College Healthcare NHS Trust, and demonstrates the feasibility of introducing a digital consent to treatment process (sometimes called econsent) in the NHS.

An error prone paper process

In the study, over half the paper consent forms contained a documentation error, in addition to 90% omitting at least one core risk that should have been discussed with the patient.

A significant improvement was seen with the introduction of a semi-digital application, with an error rate of 7.5% and omission rate of 13.6% respectively. Following its introduction, the quality and consistency of consent information improved, helping to ensure patients are informed about the procedure, consequences and possible complications.

The quality of shared decision making - the principle of clinicians supporting patients to make care decisions rather than paternalistic decisions being made for patients - was also assessed. Fewer than half the patients who gave consent via the paper process reported shared decision making scores that would be considered gold standard.

Reassurance around digital access

A concern regarding digitalisation of patient-facing healthcare services has been that they may exclude significant numbers of patients who are not computer literate or do not have access to digital devices. The study reassures in this regard, demonstrating that the large majority of patients (>90%) had personal access to web-enabled devices.

The human cost of inadequate consent processes are substantial and have significant consequences. Patients are making decisions to undergo major interventions without key information regarding the consequences to their future outcomes and quality of life.

This can lead to a lack of trust in the patient-doctor relationship, demonstrated by the cost of litigation due to deficiencies in consent. Data provided by NHS Resolution, shows that over a 5 years period (2013-18) there were 1025 claims as a direct result of ‘failure to warn,’ - i.e. issues with the informed consent process - at a cost of £226 million over 5 years. The cost of consent related cases is increasing significantly year-on-year.

Patients, doctors and healthcare providers all stand to be better protected both emotionally and financially by systems that improve the consent process.

For many reasons, it’s time for digital consent.

“Having a significant medical procedure is a daunting life event for patients. Making sure they understand the process, have confidence in it and are empowered to give their informed consent in a safe, secure way is key to delivering the very best of modern medicine.

“There is no longer an excuse for out-of-date paper processes that can lead to errors of form quality and content. Digital consent offers a solution to make one aspect of the hugely complex and multifaceted experience of surgery - agreeing to it - straightforward.”

Dr Austin Gibbs, Cardiologist in Jersey


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