This article appears in the February 2004 edition of the Catholic Medical Quarterly
Informed consent in medical training: myth or reality?
What are expectations of informed consent of patients, of doctors, of lawyers? Are they the same? On Monday 17 November 2003 the Open Section, the Student Members' Group and the Young Fellows' Committee of the Royal Society of medicine met to debate how the issue of informed consent affects students and trainees. The clientele was a healthy mix of experience and speciality. Emeritus Professors sat alongside students from The GKT Medical Ethics Group. Several Young Fellows were also in attendance including Dr Cullen O' Gorman, who gave the SMG ethics series its 'Future of Cloning' debate in early 2003.
Professor Len Doyal of QMUL Medical School introduced the evening, and fielded points and questions. There has always been interest from students in this issue but teachings haven't been reflected in practice- there has always been a fear of retribution for raising the issue. It is now given increased importance in both under- and post-graduate study. However, has practice changed to reflect this?
Dr Yvette Caldicott discussed Informed consent and the medical student Dr Caldicott had achieved some notoriety as a final-year student after co-writing a BMJ paper (BMJ 2003;326:97-101 ( 11 January ) Education and debate: The ethics of intimate examinations. Teaching tomorrow's doctors) The Paper claimed that 'The teaching of vaginal and rectal examinations poses ethical problems for students and educators, and guidelines exist to protect patients from unethical practice. Yvette Coldicott and colleagues report an exploratory survey, whose findings suggest that best practice is not always followed and that in many cases consent has not been given for procedures.'
According to Dr Caldicott, Medical Students should see patients as partners in education, not the subject of it. Patients participate in trials and student procedures by choice- it is not a necessary part of treatment. Tomorrow's Doctors understand that gaining full consent is important and needs to be approached in a structured way, Give patients time to digest information and feel fully 'in the picture' in regards to their treatment. Not gaining consent can be classed as assault.
In Dr Caldicott's study on 'intimate (i.e. vaginal and rectal) examinations', 25 Medical Schools were approached and asked whether they had formal written policies for either exam.17 of 25 had formal policy for vaginal exams, and one for rectal. A questionnaire was then distributed to students of all years of study as to:
How many students across which years had performed intimate exams? Who had obtained the consent (doctor or student)? This was translated as a percentage.
Did students feel that patients had had an opportunity to refuse if they didn't feel comfortable? Qualitative results suggested that in spite of consent procedures becoming more transparent, that 'in practice' change was slow. Students were still reluctant to speak out if they found something inappropriate or were uncomfortable. The potential of grades or review suffering, as well as intimidating teaching staff, contributed to this. Intimate examinations performed with anaesthetic had a much higher anecdotal reportage of no consent being gained.
Dr Fiona Moss, Editor of the journal Quality in Healthcare gave a talk entitled, 'Informed consent and the house officer: too much too soon?' which essentially outlined how in the past, informed consent for complicated procedures was a house officer's job, and a source of much stress. A decade ago about half of pre-registration house officers interviewed by Moss and colleagues were unhappy about eliciting consent for procedures they could not understand, much less perform. This has changed over the years. Dr Moss was keen to mention that house officers from St Bartholomew's, who had done Professor Doyal's ethics and law course, were more likely to be aware of the issues and what they could and could not do. Happily Dr Moss reported that the situation had changed in the last few years and far fewer PRHOs were asked to obtain consent for complicated surgical procedures.
What had precipitated this change? Dr Moss cited: Clinical Governance, new consent forms, Educational input at under- and post graduate levels, Changing patient and public expectations and 'Zeitgeist'- on the back of Bristol, Alder Hey etc.
None of the doctors interviewed, it seemed would take a '200.000 per annum job in the city rather than go on to Senior House Jobs. A couple of Young Fellows wryly commented after that this was probably because no one was actually offering junior doctors '200k per year to leave medicine.
Mr Andrew Raftery, Consultant General Surgeon, Northern General Hospital, Sheffield, asked his audience whether informed consent was 'a storm in a teacup' which would disappear in a few years. Mr Raftery concluded that it was not and would not, proceeding to outline the considerations that must be taken by any responsible and legally aware surgeon in obtaining consent from patients. The issue of informed consent is becoming increasingly important as patients seek more information about their treatment and become increasingly litiginous. Patients are becoming better informed and want to be more clearly involved with decision making regarding their treatment. In the past decade both English and Australian Courts have adopted a more patient-centred standard in deciding what risk doctors must disclose to patients, particularly as far as rare but serious risks are concerned. Recently the Government and the GMC have clarified procedures for obtaining informed consent including the introduction of a new form where 'serious or frequently occurring risks' can be documented. The GMC has made it clear in the document 'Seeking Patients Consent: The Ethical Considerations' that problems may occur if guidelines are not strictly followed. For instance, a doctor could be exposed to criminal proceedings, civil proceedings, or GMC proceedings.
Mr Raftery intentionally played devil's advocate by adopting the title as his theme and purporting to be from the 'old school' but concluded that in fact the issue of consent is something doctors need to be well aware of. He suggested some Doctors' views on the issue. It was perhaps viewed as just another management initiative. There is no time to explain. There is concern for patient anxiety. The patient won't understand anyway. There is an assumption that the clinical nurse will explain what they need to know. And in the emergency setting there is the issue of urgency of treatment. What if the patient is too ill to be able to give consent? What if the patient doesn't care?
The Australian Rogers vs. Whittaker case (1992) set a precedent and led to the '1% rule' when an ophthalmologist was successfully sued for neglecting to tell the patient of a 1% risk that she may lose her sight in her healthy eye following surgery for an eye problem.
Mr Raftery warmed his audience 'Gone are the days when a doctor could present a consent form to a patient and ask them merely to sign it. Public expectation is higher today. Full and frank discussion of the planned procedure, side effects, alternative methods of treatment and consequences of no treatment must be fully explained. The issues of informed consent are not a storm in a teacup. Informed consent is a serious issue that must be taken seriously to avoid litigation. Education about informed consent must be a part of undergraduate and postgraduate education. The issues are not going to go away and we owe it to ourselves and our patients to get it right and not treat it as a storm in a teacup.'
The new consent form has space for risk to be recorded, which increases the dialogue between doctor and patient and also ensures that the doctor not only explores this with the patient and makes any likely risk known, but this is also recorded. Mr Raftery advised any Junior Doctor taking consent to record all relevant dialogue, but concentrated on the importance of consent for the consultant, and the inadvisibility of the deferring the task to the most junior member of the team.
Discussion
Mostly the discussion centred on the issues of voluntariness and capacity, namely how freely a choice is made, and whether a patient is capable of making a choice. One of the students suggested that it was far more likely that a senior clinician might seek to influence a patient 'in their own interest'. She cited the hypothetical example of where the patient actually wants radical an indicated treatment, but a consultant 'persuades' a patient to adopt a more conservative course. The course of action is based on the idea of what the patient 'would want' and the patient feels 'obliged' to defer to the consultant's wisdom. The converse situation might arise where a patient feels bullied into a more invasive treatment.
Capacity, as stated involves the ability to understand, retain, and weigh information in the balance in order to come to a decision. It was suggested that fewer, rather than more, patients may be capable than previously thought. Doctors might address a growing problem with patient capacity by a number of strategies by finding a common language or common cultural ground, or use carers or family to help explain. This might have its own problems in situations where the translator had a conflicting agenda to the patient's. The issue of children's consent was raised. Sometimes parents want a procedure that isn't necessary to the health of the child (such cosmetic operations, religious circumcision etc). The same can be said of spouses, and the carers or family of elderly people ('don't tell Granny she has cancer'). Similarly there is a distrust of interpreters- how can a complicated explanation be relayed in one sentence? There were few easy answers.
It was suggested that responsibility for the provision of an appropriate surgical consent form lies with the Department of Health. Four consent forms have been issued- one of which is for people who can't give their own consent. It is vital however to separate academic needs (the impracticality of four different forms) and the needs of the real world. A signature on paper is 'evidence of consent' but not consent in per se. It was agreed that a pre-agreement that a patient will turn up a certain time, on a certain day constituted implied consent, but undocumented, this was legally hazardous. The advantage of documentation is that notes show the health care team, other doctors, patient and family that the issue has been discussed, and also the nature of any discussions.
Consent is a part of partnership in care. Even if the patient understands, will they remember? How can you check? How much needs to be explained? The way in which we enable people to ask questions and engage in dialogue may change their understanding of the answers. There was a consensus that more judicious use of patient information leaflets as a source of patient information is needed. There is a huge variation of the quality, source, and format of this information. Should there be one central (e.g. Royal College) source of this information? At what (reading/ comprehension) level should it be set? Currently very unstandardised information is being distributed. The Internet is emerging as a source of information and email is already playing a role in some consultations.
The example of a Friday afternoon patient was raised- a procedure is required, but there is no time to gain both consent and perform the procedure. So the patient is left to come back on Monday after a weekend of worrying. The example often cited is of a malignant melanoma which could be excised on the same day as diagnosis. Dr Moss commented that personally she wouldn't deliver that kind of news without the opportunity to offer appropriate support. It is important to convince a reluctant patient that they need a procedure, but not 'scare them' so that they never return.
As had been hoped, discussion continued after the presentations and floor debate, with supper. Most students stayed for this, and continued in earnest discussion with the speakers and each other. The meeting was enthusiastically supported by the Medical Protection Society and Pfizer Pharmaceuticals.
Dr Andrew Papanikitas MBBS
Wisome Grigor, Policy Development Coordinator, Pfizer Ltd