InformedConsent in Anaesthesia: Should you tell patients they could die?
Dr. S. C. Parakh. M.D., FICS, LL.M.
Professor (Anaesthesiology)
Bhaskar Medical College, Hyderabad.

“Informed consent” means consent that is given after receiving information. Though most of the patients as well as the doctors believe that the doctor decides the treatment, it is not so. It is the patient who decides the treatment. Doctor only suggests it. Patients approach the doctor for treatment of their ailments. However, they have no knowledge about what has gone wrong with them and how it can be corrected. With no knowledge how can the patient make a decision?

There comes doctor’s role. Doctor has to help the patient in making a decision regarding his treatment. This he does by supplying information that the patient needs in order to make a decision.

What information should be given to the patient?
Since the purpose of giving information to the patient is to help him make a decision regarding the proposed treatment, the information will depend upon what the patient wants to know in order to make a decision. This will differ from patient to patient.

Most of the patients want to know what has gone wrong with their body and how it can be corrected, the advantages and disadvantages of following the proposed treatment and any risk involved in the proposed treatment.

For consent to be valid, it should be given by the patient’s free will, without suppression or concealment of any facts and without undue pressure or coercion. If these principles are not followed, the consent is not legally valid.

Anaesthesia is very safe these days. This is because of the advancement in our knowledge of functioning of organ systems of the body, introduction of safer drugs, safe anaesthesia practices and available technology. However, we all know that anaesthesia in not 100% safe. Every anaesthetic procedure carries some risk, however small it may be. Perfectly healthy individuals have died undergoing minor procedures under anaesthesia. There are many factors involved. In some cases anaesthesiologist is responsible and in some cases he is not.

The question is: Should you tell patients they could die?

Sections 87 to 92of Indian Penal Code (IPC) deal with consent. Section 88 explicitly deals with medical intervention done with consent that may result in harm to patient including death. Illustration given under this section clearly explains this.

Section 88 (IPC):

88. Act not intended to cause death, done by consent in good faith for person's benefit.--Nothing, which is not indented to cause death, is an offence by reason of any harm which it may cause, or be intended by the doctor to cause, or be known by the doer to be likely to cause, to any person for whose benefit it is done in good faith, and who has given a consent, whether express or implied to suffer that harm, or to take the risk of that harm.

Illustration

A, a surgeon, knowing that a particular operation is likely to cause the death of Z, who suffers under the painful complaint, but not intending to cause Z's death, and intending, in good faith, Z's benefit, performs that operation on Z, with Z's consent. A has committed no offence.

It is very clear that these sections protect doctors from acts done with the consent. However, consent is not valid if obtained by fraud misrepresentation of facts or concealing facts. Thus possibility of death should form part of the information to be given to the patient for obtaining consent.

But if every patient is informed about the rare possibility of death under anaesthesia, no patient will consent to undergo anaesthesia. Therefore it is important to quantify the risk of death for a particular patient undergoing a particular surgical procedure under anaesthesia. If this risk is significant as in high risk patient, one has to inform the patient. If the risk is insignificant or negligible, there is no need to inform the patient and scare him.

Whether the risk in significant or not will be known at the time of pre anaesthetic evaluation of the patient.

The Association of Anaesthetists of Great Britain and Ireland has brought out a document on consent. Clause 5.3.5 reads as under:

“Good clinical practice has moved in advance of the law withrespect to paternalism and the withholding of information onthe grounds of ‘therapeutic privilege’. Information must not bewithheld because the anaesthetist feels it may deter a patientfrom undergoing a beneficial procedure. Conversely, anyinformation which might lead a patient to cancel or defer aprocedure should be considered significant. Thus, basic information about the nature of the procedureshould always be provided: however, detailed informationshould not be forced upon patients who have repeatedlyindicated that they do not want to hear it.”

“In UK, the law currently still judges information provision by thestandards of the ‘prudent doctor’ (see 3.3.4), as long as thestandard can be shown to be rational and logical [10, 18].However, recent judgments have equated the term ‘significantrisk’ with the degree of risk to which a reasonable patient (in thepatient’s situation) would attach relevance, and it is likely thatthis is the standard which will increasingly apply.”

“Rare but serious complications such as awareness (with andwithout pain), nerve injury (for all forms of anaesthesia),disability (stroke, deafness and blindness) should be providedin written information, as should the very small risk of death.It is good practice to include an estimate of the incidence ofthe risk. Anaesthetists must be prepared to discuss theserisks at the pre-operative visit if the patient asks about them.”

 

In India, recently Supreme Court has dealt in detail about consent in the judgment in the case of SameeraKohli vs Dr. PrabhaManchanda. Relevent part of this judgment reads as follows:

1. “The ‘adequate information’ to be furnished by the doctor (or a member of his team) who treats the patient, should enable the patient to make a balanced judgment as to whether he should submit to the particular treatment or not. This means that the doctor should disclose (a) the nature and procedure of the treatment and its purpose, benefits, and effect; (b) alternatives, if any, available; (c) an outline of the substantial risks; and (d) adverse consequences of refusing treatment. But there is no need to explain remote or theoretical risks involved, which may frighten or confuse a patient and result in refusal of consent for the necessary treatment. Similarly, there is no need to explain the remote or theoretical risks of refusal to take treatment, which may persuade a patient to undergo a fanciful or unnecessary treatment. A balance should be achieved between the need for disclosing necessary and adequate information and at the same time avoid the possibility of the patient being deterred from agreeing to a necessary treatment or offering to undergo an unnecessary treatment.”
2. “The nature and extent of information to be furnished by the doctor to the patient to secure the consent need not be of the stringent and high degree mentioned in Canterbury but should be of the extent which is accepted as normal and proper by a body of medical men skilled and experienced in the particular field. It will depend upon the physical and mental condition of the patient, the nature of treatment, and the risk and consequences attached to the treatment.”

Conclusion:
Therefore, when a doctor is specifically questioned by the patient about the risks involved in a particular treatment proposed, the doctor's duty is to answer truthfully and as fully as the patient requires. Remote risk of harm (referred to as 1-2% risk) need not be disclosed, but if the risk of harm is substantial (referred to as 10% risk), it may have to be disclosed.
References:

1. Consent for Anaesthesia, revised edition 2006, published by The Association of Anaesthetists of Great Britain and Ireland.
2. Supreme Court of India, Samira Kohli vs Dr. PrabhaManchanda&Anr on 16 January, 2008
3. Indian Penal Code (IPC) sections 87 to 92