Improving clinical practice within a completed audit cycle
A study of the consent process

GA Georgeu, S Benyon, N El-Muttardi, KWD Ramsey, G Howard-Alpe

ABSTRACT

The practice of obtaining informed consent is often left to the most junior and least experienced member of staff. New consent forms introduced in our trust stimulated a study examining the process of consent within the plastic surgery department. A full, prospective, blind audit cycle was performed to identify the principal surgeon, the consenting surgeon and their surgical grade for both emergency and elective operations. The results showed a statistical improvement in the actions of the principal surgeon signing the consent form for both elective and emergency operations. A further significant shift occurred with increased consenting being performed by the surgical registrar and less by the senior house officer in emergency operations. This completed audit cycle has lead to an improved and safer clinical code of practice.

Keywords: Consent, Audit cycle, Principal surgeon

INTRODUCTION

As a result of recent public scandals, such as the Bristol and Alder Hey affairs, awareness on the issues of consent is at an all time high. Guidelines on the consenting process have been produced by the Department of Health include the fact that the principal surgeon (i.e. that person performing the operation) should be consenting the patient. Alternatively, a suitably experienced doctor who can perform the surgery and understands all the benefits and risks associated with the procedure may also obtain consent. 1

The introduction of a new consent form in our trust, gave us the opportunity to review current clinical consenting practice in both emergency and elective situations.

PATIENTS AND METHODS

First Audit period (prospective, blind study) - June 2002

76 (41 elective / 35 emergency) patients undergoing plastic surgery had their consent forms assessed prospectively by the anaesthetist responsible for the list. The study proforma (see below) was completed prior to anaesthesia in the induction room without the surgeon having any knowledge of this audit being performed.

These results were presented at a departmental audit meeting and confirmed our suspicion of a poor consenting process. A renewed emphasis was placed on the importance of consent being the primary responsibility of the principal surgeon. A further audit was established to assess if there had been any improvement in clinical practice.

Second audit period (prospective) - November 2002

142 (79 elective / 63 emergency) patients had their consent forms assessed prospectively using the same proforma by the anaesthetist responsible for the operating list.

RESULTS (See table 1 -5)

There was a statistically significant improvement in that the principal surgeon had signed the consent form in both elective and emergency patients. Chi-squared for elective surgery = 5.08 (p = 0.024), emergency surgery = 8.27 (P=0. 004)

There was also a significant improvement in the presence of the consenting surgeon at the operation in emergency cases but not in the elective cases. Chi-squared test for emergency surgery = 9.15 (p = 0.0025)

Table 2 Question 1: The principal surgeon did sign the consent in emergency (EM) and elective (EL) operations. Audit period June designated 1, November 2.

Table 3 Question 2: The surgeon who signed consent was at the emergency and elective operations

During the first audit period, most elective surgery was performed by the consultant (56%) and registrar (42%). This changed during the second audit period to consultant (34%) and registrar (57%). This may be case load orientated or may relate to a combination of increasing confidence of the surgical trainer in his/her juniors and surgical experience of the surgical trainees. In emergency surgery for both periods almost all operations were performed by registrars.

Table 4 Question 3: The grade of principal surgeon at the emergency and elective operations

The grade of consenting surgeon showed a move towards registrar from SHO in both elective and emergency groups, the most significant change being in the emergency group with SHO consent dropping from 57% to 5% and a concomitant rise in the registrar consent from 43% to 93%.

Table 5 Question 4: The grade of consenting surgeon for both emergency and elective operations

DISCUSSION

Guidelines on consent published by the Department of Health give us a reference guide to clinical practice in this process. 1 However, in the increasingly stressed National Health Service, this task is often left to the most junior member in many surgical specialities, (SHO), who is often not sufficiently experienced or knowledgeable to perform this important task. 2, 3

In this ever-increasing litigious world of medicine a fundamental change in consent is needed. The principal surgeon needs to set aside time to obtain the patients' consent. Many departments already have or are in the process of developing standardised consent checklists for common operations. Adjuncts to this may come in the form of information leaflets/advice sheets that reiterates what has been discussed in the consultation and even a videotape of the event has been suggested.4, 5, 6, 7.

In emergency situations, patients and doctors may not be faced with an ideal situation or have the time to fully describe the operation and its risks and benefits. We know from previous studies, that retention of information by the patient is poor even in elective surgery. 5, 8, 9 Nevertheless, an attempt must be made to obtain informed and valid consent and the process must be documented in the clinical notes. If an emergency patient's surgery is delayed or postponed, the next surgeon on duty has the ideal opportunity to run through the procedure again and sign in the "confirmation of consent" section in the new consent form.

CONCLUSION

In our first part of our audit we identified that consent was not being afforded a high priority and many juniors performing the act did not fully understand the operation and the risks thereof. A departmental change of practice ensued placing the onus on the principal surgeon to obtain consent for all elective and emergency cases. The completed audit cycle has led to a statistically improved and safer clinical code of practice.

ACKNOWLEDGEMENTS

Dr. Tim Marshall, Research and Development Department, City and Sandwell NHS Trust, for assistance with statistical analysis.

REFERENCES

1. Reference guide to consent for examination or treatment. Published by the Department of Health, London. United Kingdom, March 2001. Also available online at: www.doh.gov.uk/consent

2. Chadha NK, Pratap R, Narula AA. Consent processes in common nose and throat procedures. Journal of Laryngology and Otology 2003; 117(7): 536-539.

3. Haddow K, Crowther JA. Consent-who, what, where, when? Health Bulletin (Edinburgh) 2000; 58(3): 218-220.

4. Ward CM. Consenting and consulting for cosmetic surgery. British Journal of Plastic Surgery 1998; 51(7): 547-550.

5. Armstrong AP, Cole AA, Page RE. Informed consent: are we doing enough? British Journal of Plastic Surgery 1997; 50(8): 637-640.

6. Rayner C. Informed consent. British Journal of Plastic Surgery 2000; 53(6): 540.

7. De Souza BA, Aspuld O. Consenting made easy: using a sticky label. British Journal of Plastic Surgery 2002; 55(2): 176.

8. Godwin Y. Do they listen? A review of information retained by patients following consent for reduction mammoplasty. British Journal of Plastic Surgery 2000; 53(2): 121-125

9. Fleischman M, Garcia C. Informed consent in dermatological surgery. Dermatol Surg. 2003; 29(9): 952-955.