Consent for surgery: time for a standardized NHS consent checklist

A surgeon who fails to consent a patient adequately for an operation is in breach of his duty of care to that patient. In a national health service a standard system of consent should be possible, but there is evidence for variability in the process of obtaining and documenting consent.¹ Some hospitals use written information leaflets, whilst others rely principally on verbal consent, with scant written documentation of risks and outcomes discussed. The introduction of a standardized NHS consent form in April 2002 has not eliminated this variability.²

The dilemma for the surgeon is how to impart adequate information to ensure understanding, while not overloading patients with so much information that they are too frightened to undergo an operation from which they might derive substantial benefit and without which they could suffer harm. The surgeon must judge how much an individual patient wants to know - a patient-centred approach based on the patient's objectives. At the same time what is said must be documented, as evidence that consent was informed. The capricious nature of human memory in relation to consent consultations is well documented. Although contemporary studies suggest that many patients feel adequate information is given,³ some patients when questioned in the weeks after surgery are convinced the consent process has been cursory, despite documentary evidence to the contrary.^4,5

How can information about the nature, risks, outcomes and alternatives of a procedure be communicated efficiently and effectively while minimizing anxiety? Many studies^6,7 suggest that structured consent interviews and written consent information sheets enhance understanding and improve recall, in some cases substantially so. Written information must be readable by patients with a range of educational backgrounds. The current, standardized NHS consent form² has a Flesch readability score of just 45 (low scores representing poor readability), equivalent to a difficult college level of literacy.⁸ Since nearly half of adults in the UK have levels of literacy low enough to interfere with daily work tasks,⁹ many patients may be unable to understand the current NHS consent form. As it is currently written and structured, obtaining a patient's signature will in many cases represent little more than a paper exercise rather than confirmation of understanding. Visual prompts (text with still images or videos) can enhance comprehension and retention of information both during the consent consultation itself and for some time after. This is particularly so in patients with poorer reading skills.^10,11

Are anxiety levels increased by information overload? What evidence there is suggests the reverse - that more information and greater patient understanding reduce anxiety.^6,12 Again, with a patient-centred approach the quantity and quality of information given can be modified to the patient's expressed objectives. The challenge for the surgeon is to avoid assumptions about what the patient should know, particularly for seemingly ‘minor’ surgery when the benefits of an operation are obvious to the surgeon, but on deeper exploration with the patient may seem less so.

Every surgeon forgets, from time to time, to mention a particular complication. High reliability organizations use checklists to ameliorate this aspect of human behaviour. A standardized NHS consent checklist could overcome this problem, acting as a prompt during the consent consultation so that important information is not omitted. It could be modified to be specialty- and procedure-specific, with images and diagrams replacing text where appropriate and inclusion of a list of generic surgical complications. Patient recall would be enhanced by giving the patient a copy, an approach endorsed by the Department of Health.²

The level of disclosure remains the great variable while the current standard of consent lies somewhere between that endorsed by a reasonable body of medical opinion and that judged by the courts as the standard required by the reasonable patient. The Department of Health guide to consent acknowledges this. The courts will continue to debate the amount of information they think should be given to a reasonable patient in any given situation. No amount of guidance from the Department of Health can avoid this element of uncertainty for the surgeon. In an era where the pendulum has swung towards patient autonomy, the default position for the sensible surgeon will be to err on giving too much rather than too little information, with professional judgment continuing to be exercised in those cases where he or she deems a patient wants less or indeed more information. This need not be a paternalistic, surgeon-based definition of the need to know, but can be based upon a patient's stated (and documented) objectives for treatment. A UK-wide standardized consent information checklist, supplemented with text and images relevant to specific procedures, should form the basis for this process.