Cases & Commentaries

Informed or Misled?

Commentary By Stuart M. White, FRCA, BSc, MA

The Case

A 50-year-old man arrived at the hospital for an
elective total knee replacement. Based on preoperative discussions,
the patient expected to receive spinal anesthesia. The patient
reportedly signed an anesthesia permit required by this hospital
that stated that any change in the anesthesia plan must occur in
writing. For unclear reasons, the patient ultimately received
general anesthesia and suffered the adverse outcome of permanent
unilateral hearing loss with tinnitus, an unusual complication. The
anesthesia records failed to note or explain any change in the
anesthesia plan. The patient was understandably upset about his
hearing deficit and also angry about the unexpected change in his
anesthesia plans.

The Commentary

"Consent" is fundamental to the process of shared
decision making between doctors and patients, allowing the former
to relay information about treatment, and the latter to decide what
can be physically done to them in the course of
treatment.(1)

Although national and international jurisdictions
emphasize the legal necessity of consent to varying degrees, the
process remains much more than simply a legalistic requirement for
a patient to sign a form.(2)
Consent may be legally valid when obtained verbally or even
non-verbally, such as when a patient holds out his or her arm for
intravenous cannulation. Documentation merely acts as evidence that
a discussion took place; it does not absolve the clinician or the
hospital from potential liability if a complication
occurs.(3)
Local and national guidelines pertaining to consent are just
that—guidelines, not law. However, they may help to interpret
relevant law and inform the standard of care provided by the
doctor.(4)

The Consent Process

What is important is that patients know what they
are agreeing (or refusing) to have done to them. This requires the
doctor to provide information to the patient and the patient
to have sufficient mental capacity to reach a
voluntary decision about whether or not to undergo the
treatment at the time proposed. Doctors, or any health care
provider seeking consent, must satisfy themselves that the patient
understands the information being provided and is using the
information to arrive at a decision about treatment.

Regardless, the consent process should provide
information about what is planned for the patient, why it is
required or being offered, and what risks may be incurred,
including potential complications. The actual amount of information
provided varies between jurisdictions. The litigious United States
tends to favor a more prescriptive and comprehensive approach,
whereas Europe and Australia tend toward providing information that
a particular patient might want to know. Advantages and
disadvantages exist for each approach. The former provides a lot of
information and may protect doctors from potential litigation but
may also overwhelm patients; the latter may not provide all the
information a patient wants but recognizes that information
concerning specific risk is not always available.(5)

Consent in Practice

In this case and based on the discussion above,
the anesthetist ought to inform the patient that the procedure will
involve a series of steps. For example, "you will be taken to
operating theatre awake, you will have an intravenous cannula (or
two) inserted, you will be attached to standard monitoring
equipment, you will be given an anesthetic, you will have the
operation, and you will recover in a special area after the
operation and before being sent back to the ward." Regarding the
specific type of anesthesia, the anesthetist should also inform the
patient that several options exist and fall into three broad
categories—regional, general, or a combination of both. The
discussion should state that it may be necessary in an emergency to
change from one to another of these approaches. More specific
information (possibly in written form) concerning risks and
complications should be provided about general anesthesia,
spinal/epidural anesthesia, sedation, urinary catheterization,
further analgesia, and blood transfusion. Operator-specific risks
could be quoted if they are available. Consideration should be
given to providing patient-specific risks, according to coexistent
pathology. Patients may ultimately require a period of reflection,
either alone or in conversation with their families, before
arriving at a decision. Standard written information, provided at
preassessment clinics or prior to surgery, could be given to
patients to help inform their decision.(6)

It should be reiterated that it is the
operator's responsibility to check consent: the anesthetist
must check what anesthetic or procedures the patient has given
consent for. This is particularly relevant if hospital policy
requires that consent be obtained in advance of the procedure, and
by a third party who may not actually be involved in the procedure
itself. The time period between obtaining consent and the procedure
occurring is irrelevant. Good "practice" allows sufficient time for
a patient to make an informed decision and also allows an
opportunity to recheck consent verbally if considerable time has
elapsed since consent was originally given.

Discussion

Informed consent is rarely an issue in anesthetic
practice. Nevertheless, patients have successfully sued for damages
in cases in which the doctor had not done what the patient had
asked.(7) In
addition, a duty remains for the doctor to inform the patient and
repeat a consent discussion if he or she intends to embark on a
course of treatment that differs from the original
agreement.(8) In
this case, the patient received a treatment to which he appeared
not to have consented, although it is unclear exactly what happened
(e.g., a failure to seek consent? a failure to understand what the
patient had previously consented to?), or if an error actually
occurred. Documentary evidence, in the form of a "full-disclosure"
style consent form would not be a sufficient defense to a legal
suit in battery in most jurisdictions. Without evidence of either
general anesthesia being emergently required for the patient, or
general anesthesia having been discussed as a treatment option at
the outset, the anesthetist may be liable in the civil or criminal
laws of battery or negligence.

It is unusual to quote the risk of unilateral
hearing loss after anesthesia during a consent discussion.
Ironically, the hearing loss that occurred is apparently less
prevalent following general anesthesia (approximately 1:10,000)
than after intrathecal anesthesia (approximately 1:7).(5) A
clever lawyer might argue that the alteration in anesthetic
management actually reduced the risk to the
patient—although the litigant's lawyer would also point out
that his client was not informed of the risk during the consent
process.

Take-Home Points

  • Consent must be obtained prior to
    touching a patient or providing treatment and requires the patient
    to make a choice based on information provided by the doctor about
    what is to be done and why, and what some of the risks and
    consequences might be.
  • The anesthetist giving the treatment is
    responsible for checking that the patient knows what he or she has
    consented to, particularly if consent was originally obtained by a
    third party.
  • A written record of any discussion
    concerning consent provides good documentary evidence in the event
    of future litigation.

Stuart M. White, FRCA, BSc, MA
Consultant Anaesthetist, Brighton and Sussex University Hospitals
NHS Trust, UK
Member of the AAGBI Consent Working Party
Royal College of Anaesthetists' Patient Information Group

References

1. White SM. Consent for anaesthesia. J Med
Ethics. 2004;30:286-290. [go to PubMed]

2. White SM, Baldwin TJ. Consent for anaesthesia.
Anaesthesia. 2003;58:760-774. [go to PubMed]

3. White SM, Baldwin TJ. Consent. In: Legal and
Ethical Aspects of Anaesthesia, Critical Care and Perioperative
Medicine. Cambridge, England: Cambridge University Press;
2004:49-71.

4. Samanta A, Mello MM, Foster C, Tingle J,
Samanta J. The role of clinical guidelines in medical negligence
litigation: a shift from the Bolam standard? Med Law Rev.
2006;14:321-366. [go to PubMed]

5. Jenkins K, Baker AB. Consent and anaesthetic
risk. Anaesthesia. 2003;58:962-984. [go to PubMed]

6. Royal College of Anaesthetists. You and your
anaesthetic. January 2003. http://www.rcoa.ac.uk/index.asp?PageID=614

7. Caplan RA. Informed consent: patterns of
liability from the ASA closed Claims Project. ASA Newsl.
2000;64:7-9.

8. Kennedy I, Grubb A, eds. Consent. In: Medical
Law. 3rd ed. London, England: Butterworths; 2000:678.