Although, at present, verbal consent is the minimum legal requirement before most invasive procedures, written consent is preferred where significant risk is involved.^1,2 The UK Department of Health (DH) guidelines¹ and the 2008 General Medical Council guidance on consent² state that valid consent revolves around sharing and discussing information, rather than simply obtaining a written signature from a patient.¹ They also emphasise that side-effects, complications and other risks should be discussed and that a record of such dialogue should be made.^1,2

A recent article has described new procedure-specific consent forms for orthopaedic procedures,⁴ which are available online free-of-charge at <www.orthoconsent.com>. These Orthoconsent forms adhere to the parameters of consent recommended by the DH¹ and are intended to constitute a more efficient mode of information provision, with up-to-date descriptions of each procedure including its benefits, risks, and alternatives in simple layman's terms.⁴ The forms are also a means to reduce variability of hand-written, and often incomplete, consent forms with respect to any legal disputes. Orthoconsent has been endorsed by the British Orthopaedic Association (BOA) and the standard of information has been passed by their professional practices and medicolegal and patient liaison groups. It is intended (for elective procedures at least) that patients read their form at home between their initial appointment with the surgeon and the pre-operation assessment clinics, and again between then and the morning of surgery, thus consolidating much of the information which is discussed in person with the patient. Hence, Orthoconsent forms are not intended to replace these discussions but to compliment them. As their signature on the day of surgery constitutes the patient's written consent, it denotes that they have indeed read the form and give their consent in the knowledge of the information.

In this audit, we assessed how closely our department was achieving the standard of complete patient understanding prior to either a knee arthroscopy (KA) or total knee replacement (TKR) procedure. During the first audit cycle, consent was discussed and then documented on traditional yellow forms supplied by the NHS Trust, in accordance with practice at the time, and patients were assessed using questionnaires on the morning of surgery. During the second audit cycle, Orthoconsent forms were supplied to patients in addition to the usual discussion. Patients were told that they must read the Orthoconsent form and would be required to sign it in order to confirm consent. Information recall was tested with the same questionnaires as used in the first cycle.

In practice, achieving a standard of fully-informed consent is not straightforward. Patients vary considerably with respect to how much they want to know about their operation, the extent to which they are able to acquire extra information about it (such as books or internet resources) and how much they will actually remember factually at the point of confirming consent. The wide range of scores collected in all patient groups during this study indeed reflects these, perhaps inevitable, variables. Equally, doctors taking consent will not always give exactly the same information or be able to discuss some of the much rarer complications. A balance must be struck in which the procedure is explained along with its common and serious side-effects in a digestible format to the patient who must then decide whether to proceed in spite of the risks. These discussions should ideally be spread over several sessions,⁵ enable the patient to express any concerns they may have,⁶ and be documented thoroughly in their case notes. This is especially important for those patients who are keen to ‘do what the doctor thinks best’. Although consent to surgery does ultimately rely on patients trusting in the expertise of their surgeons, consent is still only valid if the necessary information is disclosed. Medicolegal challenges arise when a patient experiences an adverse outcome and there is no documentary evidence to refute the claim that they were unaware of it as a risk. About 4% of surgical negligence claims settled by the Medical Defence Union between 1990 and 2000 were the result of inadequate consent.³

Orthoconsent forms available online at <www.orthoconsent.com> comprise a suitable level of information for patients, which is endorsed by the BOA. However, they are not intended to replace careful discussion between the surgeon and patient in out-patient clinics, pre-operative assessment clinics and on the morning of surgery, but to be used as an adjunct. They should be issued as soon as surgical management is indicated to enable patients to assimilate the relevant facts in between appointments. The forms have a reading age of 14 years and itemise the common, less common and rare side-effects.⁴ This is in line not only with advice from the General Medical Council,⁷ but also with what patients actually wish to know about their procedure.⁸ El-Wakeel and colleagues⁸ showed that amongst patients' most important considerations were major risks, alternative options, rank of surgeon performing the procedure, type of anaesthetic used and technical details of the operation. We have shown that Orthoconsent forms can increase patient understanding of all of these parameters and, in particular, awareness of all the risk factors mentioned. Our questionnaires were not intended to test recall of long lists of complications from memory and, as such, we felt it necessary to introduce the prompting score so that a fairer assessment of patients' actual knowledge could be realised. The questions also had to be worded carefully and required a specific response in order to avoid ‘giving the answer away’ or eliciting a string of unreliable ‘yes/no’ responses. Patients were approached within minutes of confirming consent and their overall scores thus reflect their knowledge at this crucial time.