A model for consent based on “prudent patient standard”: an unorthodox opinion.
The conclusion Edozien LC (1) came to in his editorial reveals how contrived informed consent actually is; a topic that has been so debated that over the years, it has become the stuff of legends, thanks in part to sentences passed down by the courts.
It was in an American court of law that the expression “informed consent” was first spawned (2), the outcome of much trial and tribulation – one might say a somewhat dystocial birth - in that it had proved impossible, in that instance, to prove the liability of the doctors who had performed an arteriography on a 55 year-old patient with vascular disease who had later become a paraplegic. The judges kept returning to the issue of the lack of information the doctors had provided regarding the known risks of the procedure.
So nothing is perfect, nothing is sacred: but what about the almighty dollar? According to the Emperor Vespasian, who introduced the tax on urine (3), “pecunia non olet” (money doesn’t smell).
Which brings us to the case of Nadine Montgomery. After two courts had already excluded any errors in the clinical management of the birth, the Supreme Court turned the case into one about the failure to provide details of an alternative to vaginal birth and presented a bill for £5.25 million (4). The sentence also means that a further million pounds can easily be added to the cost of that “oversight” thanks to the inevitable increase in Caesarean births that will result from it – in the form of defensive medicine.
Caesarean births are a surgical option usually taken in the interests of the unborn child, but which do present far from negligible risks to the mother (5), namely a greater risk of death and morbidity than there would be in a natural birth, not to mention all the risks associated with anaesthesia and those of supine hypotensive syndrome (6).
Ms. Montgomery was not provided with any information on the possibility that a Caesarean birth might have avoided the neurological damage incurred by the newborn. But, was that the only information about a Caesarean birth that she should have been given?
What would have happened if, in addition to explaining the potential benefits for her child, she had also been told about the main risks she herself would run if she had a Caesarean? Would she have chosen that option if she had known that there was a 0.1% risk she might die (5)?
Had she done so, she would have also known that in the short time the operation would take, she might have ended up with chronic abdominal pain, infections, bleeding – possibly even severe bleeding – endometritis, lesions of the bladder and / or the ureters, gastrointestinal problems and deep vein thrombosis (7)?
And, what if she had also known that in any hypothetical future pregnancies, she would have run the additional risk of pre-eclampsia and damage to her uterus (8)?
With hindsight, knowing about the neurological damage suffered by Ms. Montgomery’s child, we would probably all believe she would have consented anyway. But, going back to that moment in time in which all the clinical elements pointed to the successful outcome of a natural birth, can we really be sure that she would have given the same answer?
The myth of informed consent, this legal fiction, as determined by the courts, “requires that physicians operate a medical cafeteria, in which they must set out all the therapeutic options and let patients choose, each according to his or her own appetite” (9).
But that does not actually reflect reality. In a doctor-patient relationship, the doctor’s main role is not that of anchorman, but rather that of an advisor. According to Meisel and Kuczewski (9), “patients usually want more than information. They also want advice. They say: ‘Doctor, if you were in my position, what would you do?’ That does not mean that they should have just let the physician decide from the outset”.
So what is a reasonable standard for consent?
That of a process of human interaction, a “form of a conversation in which patients get information, ask questions, give information, and say ‘I want to think about it’ or ‘I've thought about it and I can't decide. What do you think I should do?’” (9).
In other words, consent given at the time and place in which doctor and patient reach a joint or shared decision.
The type of consent set out so well in the “bona fide” consent form.
References
1. Edozien LC. UK law on consent finally embraces the prudent patient standard. BMJ 2015;350:h2877;
2. Salgo v. Leland Stanford Jr. University Board of Trustees, 1957;
3. Svetonio GT. De vita Caesarum. 119; 8:23;
4. Cramb A. Mother whose son suffered brain damage wins £5.25m in landmark court battle. The Telegraph. 11.03.2015;
5. NICE - Clinical Guideline. Cesarean section: full guideline. 23 Nov 2011, http://www.nice.org.uk/guidance/cg132/evidence;
6. De-Giorgio F, Grassi VM, Vetrugno G, d'Aloja E, Pascali VL, Arena V. Supine hypotensive syndrome as the probable cause of both maternal and fetal death. J Forensic Sci. 2012 Nov;57(6):1646-9;
7. Quinlan JD, Murphy NJ. Cesarean delivery: counseling issues and complication management. Am Fam Physician, 2015; 91(3):178-84;
8. Cho GJ, Kim LY, Min KJ, Sung YN, Hong SC, Oh MJ, Seo HS, Kim HJ. Prior cesarean section is associated with increased preeclampsia risk in a subsequent pregnancy. BMC Pregnancy Childbirth. 2015 Feb 13;15:24;
9. Meisel A, and Kuczewski P. Legal and Ethical Myths About Informed Consent. Arch Intern Med.1996;156:2521-2526.
Rapid Response:
A model for consent based on “prudent patient standard”: an unorthodox opinion.
The conclusion Edozien LC (1) came to in his editorial reveals how contrived informed consent actually is; a topic that has been so debated that over the years, it has become the stuff of legends, thanks in part to sentences passed down by the courts.
It was in an American court of law that the expression “informed consent” was first spawned (2), the outcome of much trial and tribulation – one might say a somewhat dystocial birth - in that it had proved impossible, in that instance, to prove the liability of the doctors who had performed an arteriography on a 55 year-old patient with vascular disease who had later become a paraplegic. The judges kept returning to the issue of the lack of information the doctors had provided regarding the known risks of the procedure.
So nothing is perfect, nothing is sacred: but what about the almighty dollar? According to the Emperor Vespasian, who introduced the tax on urine (3), “pecunia non olet” (money doesn’t smell).
Which brings us to the case of Nadine Montgomery. After two courts had already excluded any errors in the clinical management of the birth, the Supreme Court turned the case into one about the failure to provide details of an alternative to vaginal birth and presented a bill for £5.25 million (4). The sentence also means that a further million pounds can easily be added to the cost of that “oversight” thanks to the inevitable increase in Caesarean births that will result from it – in the form of defensive medicine.
Caesarean births are a surgical option usually taken in the interests of the unborn child, but which do present far from negligible risks to the mother (5), namely a greater risk of death and morbidity than there would be in a natural birth, not to mention all the risks associated with anaesthesia and those of supine hypotensive syndrome (6).
Ms. Montgomery was not provided with any information on the possibility that a Caesarean birth might have avoided the neurological damage incurred by the newborn. But, was that the only information about a Caesarean birth that she should have been given?
What would have happened if, in addition to explaining the potential benefits for her child, she had also been told about the main risks she herself would run if she had a Caesarean? Would she have chosen that option if she had known that there was a 0.1% risk she might die (5)?
Had she done so, she would have also known that in the short time the operation would take, she might have ended up with chronic abdominal pain, infections, bleeding – possibly even severe bleeding – endometritis, lesions of the bladder and / or the ureters, gastrointestinal problems and deep vein thrombosis (7)?
And, what if she had also known that in any hypothetical future pregnancies, she would have run the additional risk of pre-eclampsia and damage to her uterus (8)?
With hindsight, knowing about the neurological damage suffered by Ms. Montgomery’s child, we would probably all believe she would have consented anyway. But, going back to that moment in time in which all the clinical elements pointed to the successful outcome of a natural birth, can we really be sure that she would have given the same answer?
The myth of informed consent, this legal fiction, as determined by the courts, “requires that physicians operate a medical cafeteria, in which they must set out all the therapeutic options and let patients choose, each according to his or her own appetite” (9).
But that does not actually reflect reality. In a doctor-patient relationship, the doctor’s main role is not that of anchorman, but rather that of an advisor. According to Meisel and Kuczewski (9), “patients usually want more than information. They also want advice. They say: ‘Doctor, if you were in my position, what would you do?’ That does not mean that they should have just let the physician decide from the outset”.
So what is a reasonable standard for consent?
That of a process of human interaction, a “form of a conversation in which patients get information, ask questions, give information, and say ‘I want to think about it’ or ‘I've thought about it and I can't decide. What do you think I should do?’” (9).
In other words, consent given at the time and place in which doctor and patient reach a joint or shared decision.
The type of consent set out so well in the “bona fide” consent form.
References
1. Edozien LC. UK law on consent finally embraces the prudent patient standard. BMJ 2015;350:h2877;
2. Salgo v. Leland Stanford Jr. University Board of Trustees, 1957;
3. Svetonio GT. De vita Caesarum. 119; 8:23;
4. Cramb A. Mother whose son suffered brain damage wins £5.25m in landmark court battle. The Telegraph. 11.03.2015;
5. NICE - Clinical Guideline. Cesarean section: full guideline. 23 Nov 2011, http://www.nice.org.uk/guidance/cg132/evidence;
6. De-Giorgio F, Grassi VM, Vetrugno G, d'Aloja E, Pascali VL, Arena V. Supine hypotensive syndrome as the probable cause of both maternal and fetal death. J Forensic Sci. 2012 Nov;57(6):1646-9;
7. Quinlan JD, Murphy NJ. Cesarean delivery: counseling issues and complication management. Am Fam Physician, 2015; 91(3):178-84;
8. Cho GJ, Kim LY, Min KJ, Sung YN, Hong SC, Oh MJ, Seo HS, Kim HJ. Prior cesarean section is associated with increased preeclampsia risk in a subsequent pregnancy. BMC Pregnancy Childbirth. 2015 Feb 13;15:24;
9. Meisel A, and Kuczewski P. Legal and Ethical Myths About Informed Consent. Arch Intern Med.1996;156:2521-2526.
Competing interests: No competing interests