DETERMINING DECISIONAL CAPACITY INFORMED CONSENT

Magid M, Dodd ML, Bostwick JM, Philbrick KL. Is your patient making the 'wrong' treatment choice? Curr Psychiatry Online. 2006;5(3).

Summary

Assessing a patient's capacity to make a decision about accepting or refusing a medical intervention should be performed quickly but systematically. Physicians from the department of psychiatry at the Mayo Clinic in Rochester, Minn, present a 3-dimensional model for evaluating capacity. This model includes the risk of the proposed treatment (high vs low), the benefit level of the treatment (high vs low), and the patient's decision about the treatment (accept vs refuse).

For example, if the treatment benefit level is high and the risk is low and the patient refuses treatment, the patient would have a low threshold for capacity, or be incapable of making a decision. If in the same scenario the patient accepts treatment instead of rejects treatment, the patient would have a high threshold for capacity and be considered capable of making decisions. If the benefit level and risk of treatment are both low (or both high), the patient would have a medium threshold for capacity, and the risks and benefits of the proposed treatment should be weighed carefully. This tool is intended for use by both consultant/liaison psychiatrists and the primary medical team.

Brown J. The spectrum of informed consent in emergency psychiatric research. Ann Emerg Med. 2006;47:68-74.

Summary

This study evaluates the variation in requirements for informed consent in trials evaluating chemical tranquilization of agitated patients. A literature search of the National Library of Medicine was performed using search terms such as "treatment of acute agitation," "psychiatric emergency," and "chemical restraint." Studies performed outside the United States and studies performed before November 1996, when the current FDA regulations came into effect, were excluded. Unpublished research presented at national meetings and data from an ongoing study were included.

Twelve studies, the common goal of which was to determine the best therapy for patients with acute agitation, met inclusion criteria. Of these 12 studies, 7 used informed consent, 3 used a waiver from informed consent (but the federal regulations cited for these waivers varied), 1 reported that informed consent was not required, and 1 did not specify the method of consent because data were from chart reviews.

Use of informed consent should be fairly consistent, but study results showed that there was little agreement about how to apply current regulations on informed consent in emergency psychiatric research. Because the interpretations of these regulations are so different, the regulations are rendered relatively immaterial.

Commentary

The article by Magid and colleagues and the study by Brown both deal with informed consent, which is based on two principles: each patient has the right to determine what is or is not done to his or her body, and a physician must provide accurate information to the patient so that rational decisions can be made. For informed consent to be valid, the patient must be competent, the physician must give adequate information, and the decision must be voluntary. Competence is a legal term, and incompetence can only be determined by a court.

In the clinical setting, it is more useful to think of decisional capacity. To demonstrate decisional capacity, a patient must be able to communicate his choice, understand the information given, appreciate the options available, and make a rational decision. Informed consent is not only necessary for therapeutic interventions but also for participation in research.

The article by Magid and colleagues considers informed consent in the treatment setting and discusses a common question: is this patient capable of making this decision? The paper presents a tool clinicians can use to assess decisional capacity, taking into account the risks, the benefits, and the patient's decision on the situation in question. Most consult psychiatrists consider the benefit and the risk of a proposed treatment, recognizing that in a high-benefit/low-risk situation, refusers should be scrutinized more than accepters; that in a low-benefit/high-risk situation, accepters need closer examination; and that those facing decisions with high benefit as well as high risk must be most closely examined. What makes the model proposed by Magid and colleagues unique is that the patient's wishes are seen as a third dimension.

The article provides a good overview of the process for assessing decisional capacity. It can be used by all physicians in determining whether a psychiatric consultation is necessary. The screening questions laid out in what the authors call the "5 Ws" are particularly helpful. After explaining the treatment and the risks and benefits of accepting or refusing the treatment, the primary team is directed to ask 5 questions. The team asks the patient what is the treatment, will the treatment help them, what will happen without the treatment, what alternatives are there, and why have they chosen to accept or refuse the treatment. If a patient is able to answer these questions in a consistent and appropriate manner, the authors believe that it is probable that the patient has the capacity to make a rational decision. This simple model and set of screening questions can be used by any physician who doubts a patient's decisional capacity. If the answer remains unclear, psychiatric consultation is appropriate.

The study by Brown deals with informed consent for psychiatric research in the emergency setting. As those of us who work in emergency departments know, there is limited research on the best approach to treating agitated patients. Research is needed to determine the safest and most effective treatments, but enrolling patients in clinical trials in this area is problematic, because almost by definition the severely agitated patient has impaired decisional capacity.

Federal statutes require informed consent before patients can be enrolled in clinical trials, although waivers are possible in some circumstances. Brown's study looks at recent research to better understand how consent was obtained. He found little consistency in how current regulations are followed and concluded that clarity in how to apply waivers for clinical trials in emergency settings, especially in emergency psychiatry research, is needed.

Both of these articles illustrate the difficulties that are encountered in caring for and studying patients with psychiatric symptoms in emergency settings. Patients with severe disorders of mood, thought, cognition, or behavior may not be able to give informed consent. As a profession, we must define the ethical approach to patient care and research when decisional capacity is in question.

Rachel Lipson Glick, MD

Clinical Associate Professor

Department of Psychiatry

University of Michigan

Ann Arbor

References:

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