Question

Case 7

Cases From AHRQ WebM&M:                               Informed or Misled?

Posted: 09/26/2007; AHRQ CME © 2007

Case and Commentary

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

Continued Case 7

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.

Continued Case 7

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.

Reprint Information

Reprinted with permission of AHRQ WebM&M. Original citation: White SM, Informed or Misled?. AHRQ WebM&M [online journal]. June 2007.

AHRQ WebM&M is produced for the Agency for Healthcare Research and Quality by a team of editors at the University of California, San Francisco. The AHRQ WebM&M site was designed and implemented by Silverchair.

References

1. White SM. Consent for anaesthesia. J Med Ethics. 2004;30:286-290.
2. White SM, Baldwin TJ. Consent for anaesthesia. Anaesthesia. 2003;58:760-774.
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.
5. Jenkins K, Baker AB. Consent and anaesthetic risk. Anaesthesia. 2003;58:962-984.
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.

QUESTIONS to ANSWER:

1. Does the 50-year-old man have a case to bring a lawsuit as a result of his adverse outcome? Why or why not?

2. Who would likely be named as the defendants if a suit is brought? Explain your answer.

3. In the commentary there is the statement, “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.” Explain this statement in terms of what happened with the 50-year-old man.

4. In the information presented, the author explains that the consent process consists of three main components:
   1. Information that is presented to the patient
   2. Patient’s mental capacity
   3. Patient has reached a voluntary decision

Explain the steps a surgeon might undertake to ensure that the steps of the consent process are complete for a patient who is to undergo surgery.

5. Explain the use of the legal term “battery” as used in conjunction with surgery or other actions that might take place in a healthcare facility. Will an informed consent protect a surgeon or a healthcare facility from a patient bringing a lawsuit based on the charge of battery?

Answer 1

CONSENT

separate consent for anesthesia from consent for surgery

No surgeon will operate without your informed consent. You will be asked to sign a form that describes the procedures and the devices that will be used. In signing this document, you acknowledge that you understand the operation and recognize the risks. In almost every state, the law requires that some type of documented informed consent take place. Although it’s impossible to cover the full spectrum of risks involved, it’s important that you know about the procedure and the most frequent complications. The consent process may include questions about your willingness to accept blood transfusions and, in a worst-case scenario, your desires involving life support.

Surgical Approach

Where will the incision be and what will its size be?

What type of surgical approach will you take?

What type of surgical planning will you do?

Will you use a computer-assisted method?

How long will the surgery take?

Risks and Complications

What is your infection rate? (For reference — 0.5 percent or less is considered good.)

What risks do I face and how likely is it that I’ll face complications?

What type of anesthesia will you use? What are the risks of anesthesia?

Recovery

How long will I be in the hospital?

How long will the recovery process last? What will it entail?

How much pain will I have following surgery? What will the pain be like when I get home and start rehab?

When will the pain go away? What can I do to manage the pain?

What mobility or movement restrictions or limitations will I have and how long will they last?

When can I re-start the activities I want to do (i.e., golf, walking)? What activities should I avoid?

Will there be follow-up appointments needed? When will the first follow-up appointment be? And how regularly after that?

Obtaining patient consent for anesthesia interventions is the ethical and legal obligation of the anesthesiologists. Legal guidelines mandate that this is informed consent, which means that the proposed procedure and available alternatives be fully discussed along with their benefits and risks and all the questions answered in simple language to help patients make a decision to accept or reject the proposed plan. Patient's ability to understand the discussion and voluntary acceptance of the plan is of utmost importance

Consent for anesthesia has traditionally been considered as “implied” once the patient consents to surgery, with the surgical consent stating that anesthesia will be needed for the surgery and there are associated risks with anesthesia.

The next challenge is about the accurate documentation of the informed consent process, for which there are three options: a customized handwritten note, a separate anesthesia consent document, or documentation in the medical record of the patient. obtaining a separate anesthesia consent had a positive impact on the patients' understanding of the nature and purpose of the intended anesthesia procedures. In addition, satisfaction with the adequacy of information provided about common side effects and complications was better

We may think that having the signed document may help in cases of litigation. but this may not be entirely true. Patients may state that they did not have complete understanding of the process and there may be arguments about their capacity to understand the discussion in its entirety