INFORMED CONSENT: ARE WE DELUDING OURSELVES? A RANDOMIZED CONTROLLED STUDY
Version of Record online: 6 DEC 2006
Volume 99, Issue 1, pages 4–5, January 2007
How to Cite
Masood, J., Hafeez, A., Wiseman, O. and Hill, J. T. (2007), INFORMED CONSENT: ARE WE DELUDING OURSELVES? A RANDOMIZED CONTROLLED STUDY. BJU International, 99: 4–5. doi: 10.1111/j.1464-410X.2007.06516.x
- Issue online: 6 DEC 2006
- Version of Record online: 6 DEC 2006
- Accepted for publication 28 July 2006
transurethral resection of bladder tumour.
Informed consent is central to the operative process, and the paternalistic ‘doctor knows best’ approach is no longer acceptable. Patients expect to be told of material risks , and a risk is material if ‘in the circumstances of a particular case, a reasonable person in the patient’s position, if warned of the risk, would attach significance to it’. Recent judgements have also stated that the risks of surgery should be described in percentage terms wherever possible, rather than by ‘subjective terminology, such as small risk, slight risk, and rare’.
Informed consent implies that healthcare professionals spend the necessary time and effort for patients to understand proposed treatment, with consideration of their abilities. The three key elements of consent are competence, that it is voluntary, and that the patient is informed. It is this last point which causes most concern amongst doctors, as the amount of information required to ensure that they are fully informed is not clear. Some studies suggested that written information sheets contribute to the process of informed consent. The aim of the present study was to determine the degree to which patients understood the nature and risks associated with routine urological surgical procedures and whether providing additional detailed written information improved their understanding.
Patients undergoing TURP or transurethral resection of bladder tumour (TURBT) for the first time were randomized to obtain either routine standardized verbal consent only or in addition written standardized consent as produced by The BAUS, which was modified to include information on their urological problem and why they needed surgery, as well as how their procedure was going to be performed, and the follow-up arrangements. Just before discharge, patients completed a questionnaire testing their knowledge of the nature of the condition, with the surgical and anaesthetic risk.
In all, 45 patients undergoing TURP and 35 undergoing TURBT were recruited. Of those undergoing TURP, 25 men (median age 73 years, range 61–86) were randomized to receive verbal consent only and the other 20 (median age 74 years, range 60–82) were randomized to receive both verbal and written consent.
Of the patients undergoing TURBT, 20 (12 men, mean age 69 years, range 59–78; eight women, 71 years, range 69–78) were randomized to receive verbal information only and 15 (11 men, 70 years, range 60–82; four women, 68 years, range 50–80) were randomized to receive both verbal and written consent.
There was no significant difference in the mean ages or social class stratification between the groups. Overall, 14% of those receiving verbal and 23% of those receiving verbal and written consent did not know what operation was performed; 35% in the verbal consent group and 30% of in the verbal and written group could not give a satisfactory explanation of how the surgery was performed. Overall, 52% of patients remembered one or fewer surgical complications. However, 91% of patients felt that complications were adequately explained and nobody had any criticism of the consent procedure.
Bringing well-informed patients to the operating room is a challenge for all of us who participate in the care of surgical patients. Although the issue of informed consent has been present for a long time, it was not until the latter half of the 20th century that healthcare professionals and patients began to focus on informed consent as a central concern in healthcare . Informed consent is based on a shared decision between the physician and the patient, with the physician understanding the relevant values of the patient and the patient understanding the nature of the disease and intervention, including risks and benefits. The purpose of the written consent form is to document that a process of informed consent has taken place .
We have a clear ethical and legal duty to fully inform our patients before any surgical procedure. The patient’s right to undergo or decline a surgical procedure is protected by law, and doctors are expected to be aware of the legal principles set by relevant case law in this area .
Some investigators suggested that written information sheets contribute to the process of informed consent. As patients’ recall of information is generally poor, the sheets might be useful medicolegally, as a permanent record of what was discussed . Other studies suggested that additional written or verbal information does not improve a patient’s understanding of the risks and complications of surgical procedures .
Studies on orthopaedic patients showed that patients feel they receive an appropriate amount of information on the nature of their injury and the actual operative procedure, but little information on possible complications and postoperative care . Other studies show that visual aids to assess patients’ understanding of the risks of surgery do not improve patients’ understanding and recall of the risks of the surgery .
A significant relationship might exist between the patient’s education level and age and the rate of patient recall of the potential complications of surgery . It is generally recommended that information directed to the general public should have a readability index of < 40 (approximately the level of the popular press) . Patients’ anxiety levels are unaltered by the increase in the information they are given . The information provided to patients should be simple, easy to understand and list any possible major complications to enable the patient to determine whether to undergo or decline a procedure .
The present study showed clearly that additional written consent does not improve patients’ understanding of the nature of the surgery or the risks and complications of the procedure.
Verbal and written information supplied to a patient might be understood, but is easily and quickly forgotten. In an increasingly medicolegal environment, it is essential to gain informed consent from a patient before an intervention. The provision of an information booklet might provide nothing more than proof for the surgeon of information provided to the patient. Verbal and written information seems inadequate for obtaining informed consent, and the whole informed consent issue needs revisiting.
- 1Rogers v Whittaker 1992 175 CLR 479
- 4General Medical Council. http://www.gmc-uk.org