What is the Meaning of Informed Consent,Weight Loss Surgery,and the Pediatric Patient?

Introduction

From a clinical view, informed consent simply allows a person to make decisions with respect to clinical intervention or treatment. More specifically, this complicated process requires that the individual possess both the means and the information necessary to make a meaningful informed decision. Both of these requirements (means and information) may be threatened in the case of the adolescent consenting to weight loss surgery. An adolescent's capacity to provide valid consent for bariatric surgery is contingent in part on whether he or she can make a voluntary decision about the severity of co-morbid conditions and other weight-related issues, balanced with the nature of parental influence. These two factors have the power to compromise the voluntariness of the teen's decision. Issues of informed consent and care of a special and vulnerable patient population are presented. The ethical issues pertaining to these processes are described herein along with the special challenges that occur when things go wrong.

Role of the Bariatric Nurse

Bariatric nurses are confronted with complex ethical situations each day. They are often forced to deal with everything from religious and cultural conflicts to disputes among colleagues, informed consent, and other situations that may range from simply posing an ethically uncomfortable situation to a failure of one's ethical obligation to the patient. It is incumbent on the nurse to proactively recognize processes to appropriately handle these issues whenever possible. The pediatric weight loss surgical patient, a member of a vulnerable and protected patient population, requires special ethical consideration, especially around issues of consent. The concepts of informed parental permission, patient informed consent, and informed refusal are all part of this clinical enigma.

Defining Informed Consent

Both the historical roots and the primary justification of informed consent grow out of the bioethical principle of respect for personal autonomy. Informed consent has influences that originate in basic bioethical principles of autonomy, beneficence, non-maleficence, and justice; and it has historical roots in professional and international declarations such as the Hippocratic Oath and the Declaration of Helsinki, as well as legal considerations. (See “Laws Governing Consent and Confidentiality,” below.) Informed consent holds many functions, but from an ethical framework the primary function is the protection of individual autonomy.

Laws Governing Consent and Confidentiality

The laws governing consent and confidentiality in adolescent healthcare vary from state to state. Clinicians who treat adolescents must be aware of the federal and state laws related to adolescent consent and confidentiality. The circumstances in which adolescents may consent for their own care and in which confidentiality is protected vary from state to state depending upon the adolescent's status as a minor or adult, and the service involved. The basic laws governing consent for healthcare are state laws; clinicians who treat adolescents need to be aware of the laws in their state. Confidentiality provisions are found in both state and federal law.

In the United States and many other Western nations, autonomy is an important ethical ideal and legal mandate. It is regarded as a personal liberty, wherein an individual chooses his or her own plan and possesses the freedom to act upon that plan. In the broadest sense, autonomy is being one's own person, without restriction by either another person's action or one's own psychological or physical limitations. Institutions and professionals who respect a patient's autonomy recognize the patient's unconditional worth and the patient's capacity to determine his or her own destiny. ¹ Therefore, as long as an autonomous person's action does not interfere with the autonomous actions of another, that person is free to act as he or she wishes, even if such actions seem risky or foolhardy.

It is important, however, that the principle of respect for personal autonomy not be interpreted as either too broad, on one hand, or too absolute, on the other. Some people are not in a position to act in a sufficiently autonomous manner because they are immature, incapacitated, coerced, or under the age of consent. The principle of autonomy only applies to those capable of making a decision and then capable of acting on that particular decision. Herein lies the ethical dilemma around teens.

Medical codes as well as federal regulations have traditionally mandated that the act of consent have two components. The first is that the consent is genuinely voluntary, and the second is that information is adequately disclosed. Yet, in the case of patients who have impaired emotional maturity, which comes with adolescence, the bariatric nurse will want the consent process to adequately address and measure emotional maturity. For certain populations, such as teens, the freedom to make informed decisions may at times be restricted. Historically, informed consent continues to evolve from a practical and theoretical perspective, as we see with informed consent, weight loss surgery, and teens. Although legal and risk issues must be recognized, the discussion at hand strictly addresses ethics, and to that extent the bariatric nurse best serves the teenager when making sufficient means and information available to the patient to guarantee, to the extent possible, voluntariness and capacity. (See the sidebar “Is the Teen Competent to Make Decisions?”)

Is the Teen Competent to Make Decisions?

Does the teen understand the nature of his or her obesity and how the obesity affects his or her health and life?

Does the teen understand the nature of the weight loss surgery?

Does the teen understand the potential risks such as failure to reduce co-morbid conditions, side effects, discomfort, pain, and inability to lose weight?

Does the teen understand the potential benefits of weight loss surgery?

Does the teen understand the relative likelihood of risks or benefits occurring?

Does the teen appreciate the implications of rejecting or consenting to the alternative intervention?

To what extent does the teen understand the meaning of lifelong follow-up?

Understanding the Teen

Several issues impact voluntariness. The ability of an adolescent to provide informed consent may be affected by the extent to which the obesity has impacted his or her life and lifestyle. If he or she is enduring pain or embarrassment, his or her reasoning or desire for a quick fix may override any degree of mature rationality. The chronicity of the situation may also play a significant role, in that the extent of the condition may exaggerate the desire for the teen to escape the oppression of the condition. The patient and family members must clearly understand all the risks of potential benefits and harm associated with any bariatric procedure. In the profound desire for improvement in both health and appearance, the teen may opt for a procedure fraught with difficulties. It is because of inadequate pre-operatic selection, training, clearance, or understanding of lifelong follow-up that it is of the utmost importance that individuals dealing with the teen, especially those presenting the alternate choices to him or her, be mindful of and sensitive to the specific nature of the patient's unique physical and emotional health status.

When Things Go Wrong

Although hospitals, programs, and practices seek to reduce the risk of adverse outcomes, occasionally these unfortunate events occur. These events are particularly problematic when they involve younger patients, especially when there have been misunderstandings among family members and clinicians even before the event. Teens, who are categorically considered children, are considered a special and protected population. Therefore, in the event of conflicts around an unforeseen event, assign an individual who serves as a liaison and seeks to address dilemmas with the clinical team, teen, and other appropriate family members. This person should understand the unique needs of teens as well as those of morbidly obese individuals, and should be a person who is comfortable, empathetic, and supportive. Preferably, the liaison should be known to and respected by the adolescent and his or her family.

John Paris, a Catholic priest and medical ethicist, has a lot of experience with parents whose children have experienced catastrophic outcomes and insist on unrealistic intervention in the face of severely adverse situations. Sometimes this is because parents fail to understand the gravity of the situation. However, Dr. Norman Fost, director of the bioethics program at the University of Wisconsin, explains that sometimes surgeons, out of a sense of empathy, avoid telling parents the gravity of a prognosis. There are many reasons why parents or surgeons disagree on care steps. Parents might have cultural distrust of the medical profession, or religious objections, and these issues raise communication concerns at best. ² When parents and surgeons disagree, there is almost always some common ground, along with misunderstanding, on both sides. In the last 25 years, hospital ethics committees have become commonplace, utilizing experts and ethicists who are not involved in the particular case to help sort out the issues. ³

Putting It All Together

Often, in the midst of the real-life issue of balancing the informed consent process between parents, their teens, and clinicians, the situation can become stressful and the intent of informed consent can be lost. Understanding can be affected by overly long or complex forms or discussion, and by age-inappropriate or difficult language. There should be adequate time to consider and discuss content in an easily comprehensible informed consent. Because of the nature of bariatric surgery, there should be multiple sessions to go over the content of the informed consent document, which includes surgical and non-surgical options, risks, and benefits. (See the sidebar “The Surgeon's Dilemma.”) Allow the informed consent to serve as a learning document, and supplement it with a learning checklist to monitor teaching and learning progress and ensure that attention is paid to all details. Documentation of what is stated and of the mood and response of all involved parties is important.

The Surgeon's Dilemma

In the adolescent patient population, major issues with informed consent arise from weight loss surgery, particularly in those procedures that are not reversible. ⁴ The laparoscopic adjustable gastric band is reversible, but because the procedure utilizes an implant, it requires approval by the U.S. Food and Drug Administration (FDA) for use in this patient population, which currently it does not have. The laparoscopic Roux-en-Y gastric bypass, on the other hand, does not need approval from the FDA to be used in children or adolescents, but it is not reversible, and insurance coverage has been a barrier in some cases. Family involvement and counseling are very important steps in adolescent weight loss surgery cases. The adolescent must be involved and supportive of the decision to have weight loss surgery and recognize the commitment to longterm follow-up. If the family is not fully committed, meaning the patient and both parents, then threats to success exist.

Conclusion

Informed consent continues to support a number of important ethical ideals, including respect for personal autonomy. Inherent in the process of consent are means and information, which allow for an informed consent. Consent by an adolescent, from a legal perspective, varies from state to state. However, from an ethical perspective, most experts suggest that teens, working within the framework of a supportive family and bariatric team, do well when they are given the opportunity to learn about the nuances of weight loss surgery, the options, and their risks and benefits as long as voluntariness and capacity are established.