Ethics and informed consent in patients with hepatocellular carcinoma: Changing roles for hepatologist and radiologist

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Abbreviations

HCC

hepatocellular carcinoma

RFA

radiofrequency ablation

Treatment options for hepatocellular carcinoma (HCC) include resection, chemoembolization, radioembolization, ethanol and thermal ablation with or without (neo)adjuvant medical therapy, and transplantation.1, 2, 3 Patients were often treated with a “delegated responsibility”: A procedure was ordered by a “clinician” and performed by a radiologist or other specialist with no clearly delineated responsibilities; all would feel uncomfortable in case of an unfortunate outcome.4 The radiologist has become a key clinician with major impact on the practice of HCC management, including the question: Who is responsible for obtaining informed consent incorporating appropriate ethical standards?

Answer(s) to moral dilemmas require an ethical framework. The application of a model, such as the “four‐quadrant approach” (see Fig. 1),5 helps to identify critical issues facing patient and family. The medical team assembles information to fill in “quadrants,” cornerstones in decision making: (1) What are the diagnostic and prognostic facts? (2) What does the patient want? (3) What is the impact of treatment on quality of life? and (4) Are there special considerations such as costs or organ shortage?

Figure 1.

Approach to clinical ethical decisions in patient with liver tumor. Adapted from Clinical Ethics.5 Copyright 2010, The Royal Society of Medicine.

HCC management is done by a multidisciplinary team (“liver tumor team”) (Fig. 2).6 The team strength lies in creating an optimal forum where all members contribute expertise and responsibilities of their own discipline. For example, the hepatologist knows about specific antiviral therapy and liver transplant candidacy, whereas the radiologist knows about specifics of the placement of probes for radiofrequency ablation (RFA). This complementary expertise is brought together for an optimized, individual‐tailored treatment plan.

Figure 2.

The approach of hepatocellular carcinoma by a liver tumor team involves diverse complementary aspects. No individual participant can decide to initiate treatment without involvement of another who helps in the optimal decision making. Performing a chemoembolization may lead to major liver failure with a single rescue option of liver transplant. That needs to be considered before the procedure, including a decision whether the patient would be a good transplant candidate if needed. Knowledge of pre‐existing liver disease/fibrosis may be needed and can change management plans. Biopsy may cause spillage, and proactive measures may be needed. Personal values, identification of clear treatment goals, and pain may all need attention to enable many other options.

Figure 3.

Take‐home messages: ethics, liver tumor team, and informed consent.

The interventional radiologist has, now more than before, clinical skills that include pain management and resuscitation, in addition to adequate understanding of the management of liver disease, traditionally deemed to be the responsibility of clinicians. This includes the risks of agents such as nonsteroidal anti‐inflammatory drugs, diuretics, and sedatives in the patient with advanced liver disease.

Preceding interventions, the team needs to review need and implications of more invasive procedures. Should a biopsy of a liver lesion of 7‐cm diameter, not fulfilling all imaging criteria for HCC in a patient with cirrhotic liver and significantly elevated alpha‐fetoprotein, really be performed? Could intravenous contrast harm the patient with decompensated cirrhosis? Is magnetic resonance imaging better and safer? Should a backup for transplantation be discussed?

Recommendations need to be communicated with the patient and this brings the team to the informed consent issues. Hallmarks include assessment of patient's competence, adequate disclosure of the nature of the recommendations, understanding by the patient, and the voluntary nature of patient's decision. The implications of intervention(s) versus forgoing treatment need to be understood. The earlier suggested clinical framework should greatly facilitate the process of informed consent.

It is important to emphasize that recommendations come from an expert team. This is especially important if “nothing” can be done. Patient and family need clear understanding of the reasoning why procedures are (not) believed to benefit the patient, and may do harm. Consolation can be provided, knowing that all options were reviewed. Where possible, at least two team members could jointly communicate this. Good communication may reduce costly and exhaustive shopping around by the patient and relatives. Places without a liver tumor team should consider aligning with a team elsewhere. Current communication tools should, if complexity of issues requires the input of more than one team member, facilitate a conference call where data can be presented. Patient and family need to feel comfortable that the off‐site team based its recommendations on all relevant information at hand.

If a specific recommendation is made, the hepatologist may convey recommendations in general terms. However, if RFA is recommended, it is typically the radiologist who is best qualified to discuss the specifics of the intervention, anticipated pain management (local versus general anesthesia), duration, complications, and best‐ and worst‐case scenarios of the procedure. Be it during a joint meeting of hepatologist, radiologist, and patient or during a separate session, consent will be obtained by the radiologist.

Unlike in the past, when the interventional radiologist would sometimes spend 5 to 10 minutes before the procedure obtaining a signed “informed” consent from the patient on a gurney, the interventional radiologist/team now has a face‐to‐face encounter with the patient at an earlier stage in the clinic setting.7, 8 Key issues and indicators that issues were raised should be noted in the record.

Beyond the scope of this review but increasingly complex, there needs to be a clear understanding what obligations there may be in case of research or quality improvement projects.9

Ethical practice includes avoiding raising inappropriate expectations and adding to physical and financial burdens. Physicians may provide information that is too optimistic, with a study suggesting as much as a 530% overestimation of life expectancy.10 A recent book11 called for stronger consideration of quality of life, also suggesting possibly improved life expectancy and quality of life with this approach.12

The radiology team provides periprocedural care, discharges the patient after the procedure, and formulates the follow‐up plan in conjunction with other team members. The patient should be provided with written documentation (beware of illiteracy) and be given the name of a physician/team members. A primary responsible physician (“physician of record”) needs to be in place and clearly identifiable by the patient (“Who is your doctor?”), with coordinators playing a vital role in assisting patients and families. However, coordinators do not replace the physician(s). Excellent lines of communication with the primary care team and/or the palliative care team are important.

In summary, in the liver tumor team setting as described in this article, it will mostly be the radiologist who obtains informed consent for interventions such as biopsy, RFA, and embolization. The radiologist will have full personal, legal, and ethical accountability for the procedure after multidisciplinary recommendations in compliance with ethical standards. “Informed” includes providing the patient with the possibility to forgo interventions and focusing on quality of life and end‐of‐life care. However, the radiologist may count on the support of and share the responsibility for optimal management with all members of the liver tumor team. The ethical issues surrounding ethical practice and consent involve many complex considerations.