Informed Refusal: Just as Important as Informed Consent

By Kevin Klauer, MD, Chief Medical Officer, Emergency Medicine Physicians, Canton, OH

Informed refusal is the antithesis of informed consent, a natural extension of the doctrine. Informed consent is discussed in great detail in the medical, legal, and risk-management literature; whereas informed refusal has received less attention. Certainly, informed consent is critical to recognizing patient autonomy, protecting the patient’s status as a human being, and providing a means for rational decision making while protecting the health care provider from risk associated with misaligned expectations.1 The informed consent process deals with the provision of appropriate disclosure of risks and benefits of a proposed treatment, often in patients who are relatively likely to accept the proposed treatment. In other words, if a patient is having an informed discussion about a proposed treatment, it seems logical that the patient is expressing interest in the suggested treatment and is seeking the necessary information to make a rational, informed decision. Quite the contrary, when a patient is not interested in the procedure and is not engaged in the informed consent process, adequate attention may not be paid to obtaining an informed refusal. The concern is that the informed refusal process is not approached similarly or regarded with the same degree of importance as informed consent.

The basis for informed consent is from common law, emphasizing that “every human being of adult years and sound mind has a right to determine what shall be done with his own body.”2 In this context, informed consent was applied in terms of battery, as opposed to the current and more appropriate context, the tort of negligence. In the 1960s, this doctrine further evolved to include that information be provided about the associated risks of the proposed treatment and any treatment alternatives that may be available.3 In 1972, Canterbury v. Spence further defined this concept by using the “reasonable patient” standard to define the scope of required disclosure. Although every obscure detail or remote risk need not be disclosed, the practitioner must disclose what a reasonable patient would want to know about a particular treatment or procedure.4 The patient, Mr. Canterbury, was to have a laminectomy performed. However, despite the physician’s knowledge that the procedure may result in paralysis in 1% of patients, he did not disclose this risk. The patient had the procedure and then fell out of bed, resulting in paralysis. Although it is not possible to know if the fall or the procedure was the cause of his paralysis, this case placed the focus on the patient, identifying the need to recognize that a material risk is one that a reasonable person would consider a risk. Furthermore, a physician is to recognize the patient’s position. Thus, recognizing what a reasonable person would consider a risk and would need to know in order to make an informed decision is critical to this process.

A modern day corollary to the previous examples is the current debate regarding whether or not consent is needed for the delivery of tPA for ischemic stroke. There is growing popularity in the belief that because tPA is the standard of care, consent is no longer necessary. Such statements only reflect a fundamental misunderstanding of both the concepts of standard of care and informed consent. These two legal terms are related, but are mutually exclusive, except when considering the standard of care for the process of obtaining informed consent. This concept will be addressed shortly.

First, let’s define standard of care. A standard of care is what a reasonable provider with similar training, in a similar situation would do. It can be easily debated whether tPA is truly the standard of care, particularly with ongoing debate and controversy regarding its safety and efficacy. Let’s suppose for a moment that the debate had been settled and tPA administration is undoubtedly the standard of care, and not to offer or deliver the drug would be deemed below that standard. Would this obviate the need to inform the patient about the risks of the drug, obtaining their consent? Absolutely not.

Some less complex procedures or treatments do not require obtaining specific informed consent. In many circumstances, the treatment provided, and its associated risks, are intuitive to the patient and general population. In other words, it’s common knowledge, and a reasonable person would understand the risks and benefits. For instance, when a patient presents to the emergency department with a facial laceration, we accept their general consent for treatment as their consent for the procedure as well. The reason is that most reasonable patients understand that the wound will be inspected, cleansed by some means, and closed. This is such a commonly understood process that additional consent just isn’t necessary. However, if the provider decides that using moderate sedation will be necessary, consent would be required for providing the sedation.

In contrast, the risks associated with procedural sedation are not intuitive and need to be explained. Once the informed discussion has occurred, the patient can make a reasonable decision whether he or she would like sedation or not. Another way to look at this is that informed consent is less likely if the patient presents with a specific expectation and the provider does not deviate from those expectations. If the patient presents for a laceration repair and procedural sedation is not added into the equation, then consent for the repair is not required. Although some may disagree, I would extend this same theory to shoulder dislocations.

I suspect that common practice is to consent for the sedation, when necessary, but not for the reduction itself. This seems to make reasonable sense, as the reasonable patient with a shoulder dislocation understands, in general, that he or she would like to have it put back in place and that reasonable care will be taken to perform the procedure safely and effectively. For the same reason, consent is not needed for a laceration repair. I believe it isn’t necessary to obtain patients’ consent for other obvious procedures without unknown risk (i.e., intravenous line insertions, urinary catheter insertions, etc.). Providers have to be careful not to extend this theory beyond its scope. The procedures we perform become very familiar to us, as do their indications and potential complications. However, what is routine for us may be novel, complex, and otherwise non-intuitive to the average person. A lumbar puncture, for example, is a fairly safe test, and it is frequently performed in emergency medicine, so frequently that we may refer to it as routine. Although rare, complications can occur, and most patients want to be informed about those potential complications before agreeing to the test. Thus, informed consent is necessary.

Now, let’s revisit the tPA dilemma. Is tPA routinely administered, and are the indications and potential complications intuitive and common knowledge? The answer is no. If the medical community has continued to debate this concept since the NINDS trial was published in 1995, one must agree that there is sufficient complexity that a reasonable patient cannot be expected to make a reasonable decision about accepting the drug without being appropriately informed. It simply is unethical and unreasonable to consider giving the drug without obtaining informed consent. Recognizing the exposure and liability associated with stroke cases and the non-delivery of tPA, obtaining an informed refusal is recommended for those declining the drug.

Previously, it was noted that the legal concepts of standard of care and consent are related. How so? Any legal duty has a standard of care associated with it, and obtaining consent from patients is no different. A provider must also meet the standard of care when obtaining informed consent. The inability to do so will result in significant liability exposure should a bad outcome occur.

Currently, state statutes are evenly split between the professional standard and the reasonable patient standard. However, recognizing patient autonomy and a focus on patient-centered care may have invoked momentum in favor of the more patient-centric approach. A minority of states have adopted a hybrid approach, using the professional standard but incorporating the requirement to include additional information that the practitioner knows the patient may want. Although the “reasonable professional” or “professional standard,” what a reasonable and prudent physician in a similar situation would feel necessary to disclose, is the historical approach, the Canterbury case has given ample notice to all physicians that considering the patient’s position is critically important to obtaining informed consent.

Although less case law is available about informed refusal, the same general principles should apply. What is required to obtain informed consent is very likely required to obtain an informed refusal of treatment. The holding in Cobbs v. Grant was, “divulge ... all information relevant to a meaningful decisional process.” It is no less the prerogative of the client “to determine for himself the direction in which he believes his interests lie,” focused on the need to disclose risks beyond the general nature of the procedure.5,6 The patient consented to abdominal surgery for gastric ulcers but was not informed of any risks. He suffered a splenic injury, underwent splenectomy, and had a very rocky course thereafter. In Truman v. Thomas, it was held that a duty exists to inform the patient of the risks of not undergoing the recommended treatment or procedure. In this case, the patient had declined a Pap smear to ultimately die of cervical cancer at age 30.5,7

The importance of obtaining informed consent is taught in medical school, entrenched in traditional medical practice, and enforced by hospital policy. Although the standards of elements of informed consent may not always be correctly applied, the general process is uncommonly omitted altogether. The converse is true for informed refusal. This concept is not routinely represented in medical school curriculums, is not entrenched in medical practice, and is left unaddressed by many hospital standard operating procedures. Furthermore, when refusals are obtained, they frequently do not comport with the doctrine of informed consent. Simply accepting a patient’s decision to forego the proposed treatment, test, or procedure, or having the patient sign an against medical advice (“AMA”) form, is not adequate. Unfortunately, such practices are common with respect to patient refusals.

In general, the following components should be included in the informed discussion with a patient for consent or refusal of a proposed treatment or procedure: an explanation of the proposed treatment, the risks and benefits associated with the proposed treatment, the anticipated outcomes, and any treatment alternatives, including non-treatment.8

Two important concepts deserving adequate treatment with respect to informed consent or refusal are delegation and documentation. The consent or refusal process should be performed by the practitioner who will perform the procedure, and that consent is valid only for that specific practitioner to perform the procedure, unless otherwise disclosed and agreed to by the patient. It is not appropriate to delegate this process to another individual, such as a hospital employee (e.g., a nurse).9

Frequently debated is whether or not a consent form is actually necessary. In particular, with respect to patients leaving against medical advice, and refusing a portion or all proposed treatments, is an “AMA” form necessary? In general, consent forms are preferred, as they are a universally accepted standard.9 To deviate from that standard may call into question whether or not informed consent was actually obtained. However, documentation of the informed consent process in the medical record may be an excellent surrogate for a consent form. What is lacking in many consent forms is a description of the informed consent process. Although a patient has signed the form indicating a particular procedure or treatment has been agreed to, a signature alone does not verify that the consent is valid. In an ideal world, both would be entered into the medical record. However, given the choice of one or the other, documentation of the informed discussion, including the patient’s medical decision-making capacity and ability to understand the information provided, has distinct advantages. So, isn’t a signature on an “AMA” form enough? A signed refusal of care, without documentation of what the potential consequences of that refusal may entail, is tantamount to no informed refusal at all.

Furthermore, some commentators have reported the concern that “AMA” forms appear adversarial, negatively impacting the physician-patient relationship. Particularly in high-risk patients, avoiding any conflict is advisable from a risk-management perspective.

Medical providers frequently use “AMA” forms to document total refusal of care. However, such documentation is frequently omitted for patients refusing a portion of their care or a particular test, treatment, or procedure. Physicians often overlook the relevance and importance of documenting the patient’s refusal of a procedure or of some other significant portion of their care. Finally, a common myth associated with refusals or “AMAs” is that refusal of care will result in denial of coverage by a patient’s health insurance carrier, making the patient solely responsible for the charges. This just simply isn’t true.

From a practical perspective, a few relevant, actual case examples may help illustrate the concern and appropriate clinical application of the informed refusal process.

Case 1

A 64-year-old male patient presented to emergency department #1 with a headache and neck pain. A CT scan of the brain was obtained and was negative. The physician advised the patient that they should consider the possibility of meningitis, requiring a lumbar puncture to analyze his spinal fluid. The physician stated his suspicion was low for meningitis. The patient stated, “If you are not that concerned, I’m not either.” He declined the lumbar puncture. The patient presented to emergency department #2 via ambulance 48 hours later. He was comatose and was diagnosed with a subarachnoid hemorrhage.

Meningitis and subarachnoid hemorrhage may have similar presentations, and both can be diagnosed with lumbar puncture. The informed refusal obtained at hospital #1 was not adequate, as the patient was never informed about the risk of missed subarachnoid hemorrhage. Even if the patient had meningitis, the informed refusal did not include the potential consequences of refusal and the associated lack of identification and early treatment of meningitis.

Case 2

A 49-year-old man presented to the emergency department at 2 a.m. per the insistence of his wife. He had experienced 10 minutes of chest pain. His diagnostic evaluation, including a chest radiograph, laboratory testing, and electrocardiogram (ECG), were normal. Due to his risk factors for coronary artery disease and the characteristics of the pain, the patient was offered admission to the hospital for further investigation. He declined. During the informed refusal process, he stated, “If I’m going to die, I want to do it at home with my boys.” His wife was asked to assist with convincing him to consent to admission. Below is the documented refusal note from the medical record.

“The patient was offered admission x 2. He was alert and oriented x 4 and had the capacity to consent and refuse. We discussed the possibility of acute coronary syndrome, the risks of treatment and non-treatment, and the possibility of death. His wife was present and wanted him admitted. She was enlisted to try and convince him.”

The patient returned to the same emergency department 24 hours later in the back seat of his wife’s car in cardiac arrest. He could not be resuscitated and was pronounced dead.

The patient did not sign an “AMA” form. The documented refusal note included the patient’s capacity to refuse, the proposed treatment (admission), the concerns and risks about refusal, and the efforts taken to inform and persuade the patient. Although an incident report was filed for tracking, no claim or lawsuit was ever filed in this case. If an informed refusal had not been obtained and meticulously documented, a different legal outcome may have resulted.

Informed consent and refusal are critical from a risk-management perspective to ensure patients are provided autonomy to make rational health care decisions. Although informed consent has received much more attention than informed refusal, practitioners must realize that case law supports the importance of obtaining and documenting an appropriate informed refusal whenever a patient refuses all care offered or a critical portion of their evaluation or treatment.

References

1. Furrow BR. Health Law: Cases, Materials and Problems, 6th edition. St. Paul: West Publishing; 2008:231.

2. Schloendorff v. Society of New York Hospital, 105 N.E. 92 (1914)

3. Sfikas PM. A duty to disclose: Issues to consider in securing informed consent. J Am Dent Assoc 2003;134: 1329-1333.

4. Furrow BR. Health Law: Cases, Materials and Problems, 6th edition. St. Paul; West Publishing, 2008. Pg 233.

5. Furrow BR. Health Law: Cases, Materials and Problems, 6th edition. St. Paul: West Publishing; 2008:243.

6. Cobbs v. Grant, 8 Cal. 3d 229, 502 P.2d 1, 104 Cal. Rptr. 505 (Cal. 1972).

7. Truman v. Thomas, 611 P.2d 902 (Cal. 1980)

8. Youngberg. The Risk Manager’s Desk Reference, 2nd edition. Gaithersburg: Aspen Publishing; 1998:190.

9. Furrow BR. Health Law: Cases, Materials and Problems, 6th edition. St. Paul: West Publishing; 2008:286.