Informed Consent




© Springer-Verlag Berlin Heidelberg 2014
Ahmed Ammar and Mark Bernstein (eds.)Neurosurgical Ethics in Practice: Value-based Medicine10.1007/978-3-642-54980-9_5


5. Informed Consent



Patrick McDonald 


(1)
Section of Neurosurgery, Department of Surgery, Manitoba Institute of Child Health, Winnipeg Children’s Hospital, University of Manitoba, GB-138, 820 Sherbrook Street, R3A 1R9 Winnipeg, MB, Canada

 



 

Patrick McDonald




5.1 Introduction


The requirement to obtain informed consent before a therapeutic intervention or participation in research is a relatively new phenomenon and is part of a more general shift over the last century from physician-centered care to patient-centered care. Consent is at the very center of value-based medicine. The modern concept of consent came about largely in response to atrocities committed by Nazi physicians in the Second World War and is articulated in the Nuremberg Code. Although initially designed to address medical research, the aspects of the Code that speak to consent apply equally to therapeutic interventions. The consent must be voluntary, the patient must have capacity, there must be sufficient knowledge and comprehension, and the decision to consent must be free from coercion and potential hazards are outlined (Annas and Grodin 1992; Etchells et al. 1996a, b and c).

Informed consent can be given for an intervention if and perhaps only if one is competent to act, receives a thorough disclosure, comprehends the disclosure, acts voluntarily, and consents to the intervention. Thus, five elements in the process of informed consent are required: (1) competence, (2) disclosure, (3) understanding, (4) voluntariness, and (5) authorization. To this, we would add the importance of appropriate documentation of the consent process (Etchells et al. 1996a, b and c). Although not an ethical requirement, most legal jurisdictions require such documentation in a contemporaneous note.

The bioethical foundation of informed consent is the principle of respect for autonomy. Autonomy, in relation to the health-care setting, allows persons to make decisions regarding their care “without controlling interference from others and from limitations, such as inadequate understanding, that prevent meaningful choice.” The ability to make an autonomous decision requires both liberty (independence from controlling influences) and agency (capacity for intentional action).

Obtaining informed consent from neurosurgical patients can pose particular challenges. Diseases of the brain are far more likely to alter a patient’s capacity or competence thus their ability to provide consent. The stakes are higher in neurosurgery, with the risk of permanent significant morbidity or death higher than in other illnesses. “Neurosurgical manipulations of the CNS usually have some irreversibility and always at least run a significant risk of irreversibility” (Ford 2009). Many patients and families still perceive the brain to be a mysterious almost mystical organ that is poorly understood. By their very nature, neurosurgical patients may be considered a vulnerable population (Ford 2009).

This chapter deals primarily with the ethical issues involved with informed consent, but informed consent also has legal implications and definitions that may vary depending on jurisdiction. The legal standard must be considered specifically in the jurisdiction an individual neurosurgeon practices, especially as it relates to standards of disclosure and statutory ages of consent for young adults.


Pearl

The ethical basis for informed consent is respect for autonomy. Informed consent requires competence, disclosure, understanding, voluntariness, and authorization.


5.2 Illustrative Case (Family Requests to Withhold Information from a Patient)


A 68-year-old male widower is admitted to the neurosurgical service with a right frontal enhancing mass, consistent with a glioblastoma multiforme. His imaging shows a significant amount of edema and midline shift. He is intermittently confused and drowsy with headache and a left hemiparesis. His family arrives for a discussion regarding management options and surgery is proposed. When you tell them that the mass is likely malignant, they ask you not to tell their father this.


5.3 Approach to the Case


This case poses a number of challenges to the usual consent process. First, the patient’s capacity to make autonomous decisions is in question because of the effects of his tumor. A determination must be made as to whether the patient has capacity and if not, whether he will regain capacity with therapy such as dexamethasone to reduce peritumoral edema and ultimately be able to participate in the consent process. A number of tools are available to assess capacity in a patient with cognitive impairment (Appelbaum and Grisso 1988; Marson et al. 1995) and will be detailed further in the chapter.

If the patient is incapable of decision-making independently, then a surrogate decision maker, in this case, a member of the family, is asked to make a decision for the patient, and not necessarily what they themselves would do, but what they think, knowing the patient, they would request to have done if they had the capacity. Second, the family has asked that information be withheld from the patient. In a patient with competence or capacity, the withholding of information does not allow the patient to make an informed decision. Disclosure cannot occur, and as such, consent would be ethically and legally invalid. Certain cultural preferences or norms may allow for limits to disclosure. Where a patient lacks capacity, it may also be reasonable to withhold certain information.

The elements required in the informed consent for patients are considered a right for patients but not necessarily a duty, that is, physicians are obligated to disclose information regarding risks and benefits, but a patient may indicate that they do not wish to have this information. Surgeons should take extra caution to ensure it is truly what the patient wants when the right to consent is waived, and this situation should be well documented.


5.4 Discussion



5.4.1 Elements of Informed Consent



5.4.1.1 Capacity


At present, there are no universally accepted guidelines on assessment or definition of capacity (Etchells et al. 1996 c; Johnson-Greene 2010) and no instruments specific to neurosurgery. The definition of competence and determinations of competence are legal decisions, whereas a determination of capacity is one made regularly by physicians. A lack of capacity can be permanent or temporary. Neurosurgeons commonly encounter patients whose capacity to consent to therapy is in question because of their underlying condition, be it a traumatic brain injury, malignancy, hydrocephalus, or infection. A person with the capacity to consent to therapy has the ability to (1) communicate choices, (2) understand relevant information, (3) appreciate the situation they are in and its consequences, and (4) reach rational conclusions (Appelbaum and Grisso 1988). A specific instrument to assess capacity has been developed, and although validated for patients with Alzheimer’s disease, it has been widely used in the traumatic brain injury population and could be used in other neurosurgical patients where capacity is in question (Johnson-Greene 2010; Marson et al. 1995). In this instrument, patients are presented with a clinical vignette that either they read or is read to them, and then they are asked a series of questions regarding the scenario. The instrument tests the ability to make a reasonable treatment choice, appreciate the consequences of that choice, provide reasons for the choice, and understand the clinical situation.

When a patient does not have the capacity to consent to treatment and no previously made directives, written or otherwise, exist, decisions are left to a surrogate. Usually a spouse, partner, or close family member is asked to serve as a surrogate and make a decision that, given their knowledge of the patient, they believe the patient would make if they were to regain capacity.


Pearl

Capacity or competence requires the ability to communicate choices, understand relevant information, appreciate the consequences of action or inaction, and make rational decisions.


5.4.1.2 Disclosure of Information


The standard required for disclosure of relevant information to patients, both in the therapeutic and research setting, has evolved over time (Bock 2008; Etchells et al. 1996a; Samuels 2003). The “professional practice” standard, sometimes known as the “reasonable doctor” standard, requires disclosure of information that most other physicians would provide in a similar situation. This standard has been largely replaced or augmented by the “reasonable person” standard – the physician must disclose all information that a hypothetical “reasonable person” would want to know under the circumstances. Unfortunately, what constitutes a “reasonable” person has never been well defined and is dependent on cultural, religious, and other factors. As a minimum, the following information should be provided to the patient or their surrogate decision maker: (1) the diagnosis or likely diagnosis, (2) the proposed intervention or options for intervention, (3) the risks and benefits of the proposed treatment and risks and benefits of not undergoing treatment, and (4) reasonable alternatives to the proposed treatment and the risks and benefits of the alternatives.

There is good evidence that patient retention of disclosed information is poor. In a study of neurosurgical patients’ recall of a perioperative discussion, an average of only 4 of 32 risks for cranial surgery and 25 for spinal neurosurgery was remembered. Sixty-five percent of patients could recall only two of six major risks (Krupp et al. 2000). Similarly, a qualitative study of the informed consent process in neuro-oncology clinical trials demonstrated that recall of risks by participants was low (Knifed et al.2008).

Although recall of disclosed information can be poor, it remains important to explain and ensure patients understand the risks, benefits, and alternatives to surgical intervention. A study of patients with high-grade gliomas demonstrated lower anxiety levels in patients who had a higher degree of comprehension of the information presented and those who showed a desire to receive information regarding their illness (Diaz et al. 2009). Some have argued that full disclosure for a surgical procedure is an unrealistic and unattainable expectation in either the clinical or research context (Bernstein 2005; Schmitz and Reinacher 2006) given the number of potential complications of a procedure, both foreseen and unanticipated.


Pearl

Patients’ recollection of risks of surgical procedures is consistently low. Neurosurgeons should be mindful of this and make extra efforts to make sure the patient understands the important risks.


5.4.1.3 Understanding


As illustrated above, patient retention of disclosed information in the informed consent process is often poor, in both the clinical and research context (Knifed et al. 2007; Krupp et al. 2000). Understanding or comprehension is related to many factors, including age, educational level, intelligence, cognitive function, and anxiety level (Etchells et al. 1996c; Hall et al. 2012). It is important that the neurosurgical clinician or researcher ensure that an adequate amount of information has been received and understood. Simple checks such as asking the patient to repeat what they heard and understand and asking if they have any questions related to the procedure can be effective (Diaz et al. 2009; Schmitz and Reinacher 2006). Other tools that have been shown to be of some benefit to increasing understanding of disclosed information include patient educational curricula, multimedia decision aids such as videos, repeat consent discussions, and test-feedback techniques (Hall et al. 2012).

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Mar 11, 2017 | Posted by in NEUROSURGERY | Comments Off on Informed Consent

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