Informed consent is a process whose regulations are clearly defined under the General Medical Council’s guidelines.1 It is a process which helps provide a satisfactory patient experience and is important to help limit adverse medico-legal consequences when complications do occur.

There is evidence to support the effectiveness of patient information leaflets in elective orthopaedic surgery, especially since recall of potential complications, despite explanations and literature, is low.2 3 However, the potential complications raised in consent, as well as the number of departments who distribute written leaflets for elective surgery, varies across UK practice.4

Little such evidence exists for the adequacy of consent and recall of information in orthopaedic trauma patients, who are a different demographic of patient from elective patient based on mechanism, age and the sudden nature of their injury. Studies into the effects of taking informed consent in patients with general surgical acute abdominal pain5 and emergency obstetric and gynaecological surgery6 show that recall of complications in an acute setting and even the discussion of complications is low and that improvements can be made in the process, by reinforcing verbal conversation with written information.

This paper presents the results of an audit carried out to test whether the consent process is carried out correctly and thus effectively in trauma versus elective patients, or whether further information is needed by patients in order for them to retain sufficient information to make the consent process valid.

PATIENTS AND METHODS

Selection of patients

Consecutive patients for both elective and trauma operations were identified from daily operating lists. Trauma patients who were unable to consent due to severity of injury or confusion were excluded. No patients had specialist prior medical knowledge (ie, was a doctor or a nurse). No patients declined to take part in the study. A post-operative questionnaire was completed by the doctor on the first post-operative day. The audit was registered and approved by the trust’s audit department.

Data collection

The patient was asked what procedure they underwent and where asked for a brief explanation into what it entailed to ensure understanding. Complications were listed from the consent form and the patient was asked which complications they could recall. Other factors such as satisfaction with the consent process and desire for further information were asked from a standard questionnaire.

Statistical analysis

Groups were compared using Student t tests, χ² tests and Fisher exact tests as appropriate. Significance was set as p<0.05 for two-tailed tests. Analysis was performed using Statview (Abacus Concepts, Inc, Berkely, California, 1996).

RESULTS

Patient details

In all, 41 elective and 40 trauma patients were identified and analysed (table 1). The median age of the elective and trauma groups were 68 years (range 47–87) and 66 years respectively (p = 0.704). There were more patients aged <50 years in the trauma group. Elective total hip or knee replacement (n = 30) and neck of femur fracture (n = 20) were the most common operations in the respective groups.

Patient recall

There was no significant difference in patients naming their operation. Recall of complications was significantly lower in the trauma versus elective group (22.4% vs 62.3%, p<0.001) (table 1; fig 1). Previous orthopaedic surgery was not related to correctly recalling the operation the patient had (p = 0.291).

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Figure 1 Box plot showing distribution of percentage recall of operation complications split by type of operation. The first 3 plots are elective groups, the second set are the trauma operations.

Information delivery

All of the elective patients were offered an information leaflet but none of the trauma patients were. Significantly more elective patients wanted an information leaflet as well as a verbal explanation (85% vs 35%, p<0.001). However, significantly more trauma patients wished for more information about their operation (30% vs 12%, p = 0.049). There was no significant difference in overall satisfaction with the consent process between the two groups (p = 0.055).

Subset analysis of the trauma group

The trauma group of patients can be split into patients with an operation for a neck of femur fracture (group one, 50% of patients) and other trauma operations (group two), and the two groups can be compared for the same factors as above. The mean age of trauma group two patients was significantly lower (table 2). However there were no significant differences in the recall of complications, desire for information leaflet, desire for more information, or overall satisfaction with the consent process.

DISCUSSION

The main aim of this paper was to assess the effectiveness of informed consent in orthopaedic trauma patients compared to elective patients and to assess the need for the provision of further information. This paper proves that recall of complications in orthopaedic trauma patients is poor and is significantly worse than in elective patients. It also adds to the evidence that patient recall in the elective setting is low despite the provision of information leaflets, so patients are still not remembering potentially serious consequences which may affect their later approach to these complications if they occur. Our rate of recall in elective patients reinforces that of previously published studies.2 3

Recall

The poor recall in trauma patients may be expected in patients who have acute admissions and were previously well, are in pain and have little time to absorb complicated information. This has proved the case in other acute medical situations, in particular research relating to acute medical events. Gammelgaard et al7 assessed patients’ experiences of consenting for research during acute myocardial infarction, finding that recall about the consent process is variable and sometimes poor, where many patients have no recollection about the process at all. This is in contrast to the well-prepared pathway that elective patients follow where there is ample pre-operative time (starting from clinic) to absorb information. However, trauma patients are prone to potentially serious complications and so this low rate of recall needs to be addressed in order to improve the consent process and increase its validity.

Written information/patient desires

Patient information leaflets have previously been proved effective for elective operations and this study showed there is a high desire for both verbal and written information in the elective group. Trauma patients desired further information but more wanted it verbally rather than verbally with an information leaflet. In a busy orthopaedic unit with weekend on-call cover and rapid discharge of patients, repeated thorough explanations to trauma patients may not always be immediately possible and so written information would provide a useful adjunct. However, this study shows that trauma patients often need repeated verbal explanations of the procedure and its potential complications. This preference for oral information has been found in other areas of acute medical practice.7 8 Gammelgaard, in the aforementioned study, found that only 28% of participating patients read the information leaflet before making a decision, and 25% did not read it at all.7 The authors reaffirm that clinicians and ethics committees should focus on the improving the delivery of oral information in such situations, findings which our study mirrors. The same study finds that only 50% of participants and 34% of non-participants found it acceptable that patients in their position had to make such decisions regarding research, and that some patients did not want to make any decisions under the circumstances. This is useful information for trauma surgeons conducting prospective clinical trials, since patients will need to be assessed for the ability to make a valid decision.

Particularly for elective hip and knee replacements, some patients desired further information despite repeated verbal explanations and leaflets during the lead up to their operation. For this group, DVDs/video cassettes explaining the procedure in greater detail would address this need, although with widespread internet access in the UK, an online patient access resource may be more cost-effective and allow greater access.

Sub-analysis of trauma

A subset analysis of patients with neck of femur fractures (group one) compared to other trauma patients (group two) was performed. Although group one patients were significantly older, there was no difference in the recall of complications or desire for further information compared to group two. This can be explained since confused patients were not tested, since by definition they cannot consent. Nevertheless, a high proportion of trauma patients were neck of femur patients, of which 35% desired a leaflet, which should thus be made available for this group of patients.

Conclusion

Patient recall of their operation and its compilations is significantly worse in orthopaedic trauma patients as compared to elective patients. Trauma patients need repeated verbal explanations of the procedure and its potential complications, as the initial explanation following injury is poorly remembered. Patient information leaflets should be provided routinely for elective patients and made available for trauma patients. For common operations, the provision of DVDs may be useful for those who desire still further information, although an online internet resource may be more cost effective and allow greater access. A randomised control trial into the effectiveness of information leaflets for trauma patients is proposed.