Abstract
Dear Editor,
Consent is a crucial aspect of any operation. In an increasingly litigious society, the quality of consent is constantly scrutinized. The British Orthopaedic Association recommend that written consent is completed before the day of admission for surgery and this has led to the use of formal consenting clinics (British Orthopaedic Association, 2016). These clinics give patient time to discuss the operation, including the associated benefits and risks. This helps ensure that the consent process remains in line with the latest General Medical Council guidance (General Medical Council, 2020). However, several factors, such as time constraints in busy hospitals, mean it is not always possible to provide this service. Furthermore, the ongoing COVID-19 crisis has placed increased pressure on healthcare services making formal consenting clinics more difficult to provide in the future.
In this study we compare satisfaction and recall of information given at the time of written consent completed in a preoperative consenting clinic to written consent completed on the day of operation. All patients who underwent carpal tunnel decompression or trigger finger release over a 6-month period between August 2019 and February 2020 were included. Exclusion criteria included patients who required an interpreter for consent and any patients with a history of cognitive impairment. Patients were not randomized and the decision on which method of consent was down to surgeon preference.
In both groups consent was handled as a process rather than a single event. Every patient was counselled on their operation throughout their surgical journey. This included a discussion of all the risks and benefits at the time the patient was placed on the waiting list for operation. The formal written consent was completed in either a preoperative consenting clinic or on the day of the operation. In the consenting clinic group, a repeat discussion of the consent was performed on the day of the operation to confirm the consent. The documented risks were standardized between both groups and were in line with British Orthopaedic Association recommendations (orthoconsent.com) (Atrey et al., 2008). Patients in both groups were reviewed for a routine wound check 2–3 weeks after operation, when risk recall was assessed and a patient satisfaction questionnaire completed.
Ninety-three patients were included in the study. Forty-four were consented in a formal consenting clinic and 49 had consent taken on the day of their operation. Both groups had a female pre-dominance and a similar mean age. The operation mix differed between groups with carpal tunnel decompressions being the most common. In the consent clinic group, the mean time between consent clinic and operation was 58 days (SD 10; range 25–68). The mean time between operation and questionnaire was 12 days (SD 0.5; range 10–18) for the consent clinic group and 16 days (SD 1; range 11–26) for the day of operation group.
Number of patients in the consent clinic and consent on day of operation groups recalling specific risks.
Data expressed as number (%). Statistically significant p-values shown in bold.
CRPS: complex regional pain syndrome.
Mann–Whitney U test.
We have shown that there is little difference in both patient satisfaction and consent recall when using a dedicated consenting clinic. Although generally poor, the results on risk recall are consistent with the literature showing that recall of consent remains poor regardless of the method used (Lemaire, 2006). Other factors against consenting clinics are both the financial and logistical costs to patients and hospitals. These implications are particularly important to consider following the COVID-19 pandemic.
However, informed consent relies on multiple factors and it is not clear how much of a role consent recall and patient satisfaction plays in the quality of the consent. Undoubtedly, the extra time offered by consent clinics makes the consent process easier and ensures patients can reflect on the operation and have any questions addressed. This would be particularly advantageous in more complex operations rather than the minor procedures in this study, that do not represent the entire breadth of hand surgery. Other limitations include the lack of randomization and the long average time between consent clinic and operation, which may have changed the effectiveness of these clinics. However, this potentially represents the reality of offering a consent clinic in a busy hospital such as ours.
Despite these limitations we feel our study shows that for minor elective hand operations, there is little difference between written consent taken in clinic or on the day of operation. However, the advantages of consent clinics are clear and, as per guidance, they should be utilized where possible to provide the optimum consent process. Exploring alternative methods of delivering this service (e.g. virtual clinics) may be useful following the impact of COVID-19 on health services.
Footnotes
Acknowledgements
We would like to thank Dr Chris Foy for his assistance and guidance in this research.
Declaration of conflicting interests
The authors declare no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Informed consent
Verbal informed consent was obtained from all subjects before the study. Written informed consent was not obtained because no patient identifiable details were recorded or presented.