A tailored process of consent

CONSENT has been in the spotlight in the last few months with the recent ruling on Montgomery v Lanarkshire Health Board (Scotland) [2015] and the ongoing implications for medical practice. In basic terms, the Montgomery ruling reaffirmed that the consent process must be patient-specific and tailored to the needs of each individual.

Demonstrating informed consent in a legal context is often difficult in hospital claims and recent analysis among our private medical cases at MDDUS has highlighted common failures across the consenting process.

Risks and benefits

By far, the highest percentage of hospital claims in our analysis involved surgical treatments where patients perceived that something had “gone wrong”. These ranged from a complete failure of the procedure to unsatisfactory outcomes in appearance or with rehabilitation. Common findings included failure to adequately manage patient expectations, insufficient clarity around patient needs and a lack of contemporaneous records.

Looking more specifically at the consent process, cases often involved a failure to effectively communicate the risks and benefits of procedures and a lack of discussion on the range of alternatives and other potential outcomes. Documentation and record-keeping of patient discussions were often found to be inadequate – and a failure to evidence this practice was a common legal challenge to the assumption of consent.

An MDDUS case

One MDDUS case which helps illustrate this involved a patient who was admitted as a day case for diagnostic colonoscopy. Consent was obtained via a signed patient consent form detailing the procedure and what it involved but not the associated risks or benefits. A separate information sheet was also provided to the patient but this was not attached to the consent form. The surgeon discussed the procedure with the patient following admission and prior to the operation but the details of this discussion were not recorded in the patient record.

One particular feature of note in this case was a timeframe of less than one hour between admission and the patient being taken to theatre. In that period the patient was admitted, gowned, briefed on the procedure and spoken to by the surgeon before a consent form was signed.

During the actual procedure, the patient sustained a bowel perforation which was further complicated by the development of peritonitis. The patient subsequently raised a claim citing breached duty of care, alleging that our member had failed to obtain valid consent.

Investigation revealed a number of vulnerabilities in the case. Questions were raised around what information was specifically shared and discussed with the patient and there was concern over the timing and documentation of consent.

In particular, there were vulnerabilities in regard to GMC Consent guidance as set out in paragraphs:

5b “…The doctor explains the options to the patient, setting out the potential benefits, risks, burdens and side effects of each option…”

18d “…give the patient time to reflect, before and after they make a decision, especially if the information is complex or what you are proposing involves significant risks”.

Due to these vulnerabilities a decision was taken, with our member, to settle the case without admission of liability.

Some points for consideration in regard to this case include:

• Where possible, the consent process and discussions should commence before a patient is admitted to hospital for the procedure.
• Ensure the information you present is clear and accurate and phrased in a way patients can understand and which encourages questions and feedback.
• Don’t make assumptions about what is and is not important to individuals. Patients may have a different perspective and other priorities.
• Don’t assume that the patient will read or understand documentation provided on the day of a proposed procedure. Emotion and anxiety may affect their ability to comprehend crucial information.
• Don’t assume that the patient will retain the information discussed on the day, and especially immediately prior to the procedure.
• If you delegate the consent process to someone else, ensure that they are suitably trained and qualified, have sufficient knowledge of the procedure and a clear understanding of the risks involved.
• To evidence your practice, fully document discussions that have taken place, including patient feedback, concerns and comments, and how these have been addressed; aim to have, and demonstrate, a dialogue rather than a monologue.

Write it down

The consent process is heavily reliant on clear, unambiguous and two-way communication. Face-to-face communication where the patient is encouraged to share concerns, observations or preferences and has time to reflect is vitally important.

Our experience shows that when things go wrong, defending such cases can be heavily reliant on written material, and that is purely and simply effective and contemporaneous record-keeping and documentation of relevant discussions and actions – including consent.

Cherryl Adams is a risk adviser at MDDUS