We have demonstrated that the level of patients' understanding of both KA and TKR procedures at the time of confirming consent was significantly improved by use of the procedure-specific consent forms available from <www.orthoconsent.com
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.
Statistical tests were used on these scores to demonstrate just how effective the use of Orthoconsent forms was at meeting the audit standard, although we acknowledge that the analysis is subject to some bias. Audit cycles were, by definition, run in series rather than in parallel and patients would have been subject to their individual variations as discussed above. Patients consented at other NHS Trusts may also score differently on our questionnaires owing to alternative consent practices and modes of information provision. Despite the wide variation in scores, however, we have shown a clear improvement in patients' knowledge of the relevant procedure after the introduction of Orthoconsent forms at our Trust. This audit was not powered to provide data on cases which might lead to litigation but, to the authors' knowledge, none of the patients involved in this audit have since filed complaints.