Mrs. D is 75 years old and lives at home with her husband. She has a remote history of gastric ulcers and has mild renal insufficiency as a consequence of hypertension. She visits her family physician because of acute worsening of chronic arthritis in her right shoulder. She is having trouble lifting and carrying objects. Her family physician is considering treating Mrs. D with a non-steroidal anti-inflammatory drug.
Mrs. E is 80 years old and lives alone in an apartment. She is fully independent and has never had a serious illness. She prefers not to see doctors. She is admitted to hospital after falling on the stairs and suffering a fracture of the femoral neck. A consultant in internal medicine diagnoses critical aortic stenosis; this is confirmed by echocardiography. The anesthetist visits Mrs. E to discuss the proposed surgery and anesthesia. When he says that serious risks are associated with the surgery, Mrs. E says she does not want to know about them. She wants her hip fixed because she simply cannot live with reduced mobility. The anesthetist feels that he has a duty to disclose the risks of anesthesia.
Disclosure refers to the process during which physicians provide information about a proposed medical investigation or treatment to the patient. Disclosure, along with capacity, understanding, voluntariness, and consent, makes up the main elements of informed consent (Beauchamp and Childress, 2001).
The justification for disclosure related to proposed diagnostic tests and treatments is the same as that for consent generally. The patient has a right to decide about available treatment options grounded in respect for autonomy (Snyder and Leffler, 2005). Physicians have a duty to inform patients about their illness and available treatment options and to help patients to decide which of the options is best for them based on the patient’s goal and values. In these ways, physicians show respect for the patient and moreover, show “they see and care about the person not solely as a patient but more importantly, as a unique person” (Anderson, 2000, p. 6). In addition to respect for autonomy, disclosure is also grounded in beneficence and the physician’s primary obligation of service to their patients (Royal College of Physicians and Surgeons of Canada, 2006). Further, consistent disclosure is necessary for developing a continuing and trusting relationship between the patient and his or her physician (Parascandola et al., 2002).
Legal standards of disclosure concerning informed consent differ in different jurisdictions (Doyal, 2001). For example, the legal right of patients to information about their healthcare is stronger in North America than in the UK, Europe, and other parts of the world (Doyal, 2001; Miyata et al., 2005). However, laws are constantly evolving and the trend in ethical and legal thinking has led to increased information disclosure and involvement of patients in healthcare decision making. Three general aspects can be identified: the elements of disclosure, the standards of disclosure to maintain, and the consequences of a failure in disclosure (causation).
A valid consent given for a medical treatment or procedure provides a defense to the tort of battery. In order for consent to be valid, the patient must be informed in “broad terms” of the nature of the procedure. This is a fairly basic level of information, but nevertheless it highlights the significance of bodily integrity of the patient.
In addition, the patient must also be informed about the inherent risks, alternatives, and consequences of the proposed treatment. This is a higher level of information than that which is necessary to make the patient’s consent valid. It is referred to as “informed consent” and underscores the need to respect the autonomous choice of the patient – whether or not to undergo the treatment or procedure, based on his/her assessment of whether the risks are worth taking. Benefits flowing from disclosure to the patient, thus enabling an exchange of information, include the establishment of trust, the cooperation of the patient in proposed treatment options, and the empowerment of the patient in what is essentially an unequal relationship.
Certain risks are considered so “obvious” that the patient is taken to be aware of them and need not specifically be informed of them. However, this will depend on current practice. In 1985, in the important English House of Lords decision of Sidaway v. Board of Governors, Lord Keith said that it was “generally accepted that there is no need to warn of the risks inherent in all surgery under general anaesthesia … on the ground that the patient may be expected to be aware of such risks or that they are relatively remote.” A patient leaflet produced by the UK Royal College of Anaesthetists, 21 years later (2006), gives the statistical risks of death and brain damage during surgery and states “your surgeon and anaesthetist will be able to tell you more about your individual risks and then you can decide whether you want to go ahead with the operation.” Disclosure generally “has tended to a greater degree of frankness over the years, with more respect being given to patient autonomy” (Chester v. Afshar, 2005).
Failure to provide the patient with treatment information may give rise to a claim in negligence, but only if disclosure has fallen below the required standard. The standard could be what the medical profession considers appropriate (the “reasonable doctor” standard), or what a reasonable person in the patient’s position would want to know (the “prudent patient” standard). In Sidaway, the judges considered that primarily the standard of disclosure should be set on the basis of medical evidence, in other words what is the practice of disclosure of a “responsible body of medical opinion”? However, the House of Lords did recognize that there may be some risks that the patient should always be informed about those risks which are “so obviously necessary to an informed choice on the part of the patient,” regardless of the medical view. The English courts have considered both the seriousness of the risk and the likelihood of it eventuating in deciding whether such a risk should be disclosed. An inherent 10% risk of a stroke from an operation should be disclosed (Sidaway v. Board of Governors, 1985), so too should a 1–2% risk of paralysis (Chester v. Afshar, 2005).
But the “reasonable doctor” standard fails to acknowledge the importance to a particular patient of information that may be highly relevant to his/her choice. Certainly the courts in Canada (Reibl v. Hughes, 1980) and Australia have adopted a patient-led standard of disclosure. In Rogers v. Whitaker (1992) the Australian High Court held that the doctor’s duty was to “warn a patient of a material risk inherent in the proposed treatment; a risk is material if, in the circumstances of the particular case, a reasonable person in the patient’s position if warned of the risk, would be likely to attach significance to it.” This approach increasingly appears to find favor in the English courts. In Pearce v. United Bristol Healthcare N.H.S. Trust (1999) the Court of Appeal said that “if there is a significant risk which would affect the judgment of the reasonable patient, then in the normal course it is the responsibility of a doctor to inform the patient of that significant risk.”
To succeed in an action alleging that the healthcare professional negligently failed to disclose information, the claimant must prove that a duty to disclose was owed (this is part of the general duty of care), that the duty to disclose was breached (i.e., the healthcare professional did not meet the standard of disclosure), and also that, if the claimant had been properly informed, he would not have consented to the operation or procedure. In the case of Chester v. Afshar (2005) the House of Lords extended the boundaries of causation and allowed the claimant to succeed by showing that, if she had properly been informed of the risks, she would have sought further advice and would not have agreed to undergo that operation on that particular day.
The importance of patient-focused consent procedures is highlighted by guidance from professional bodies. In the UK, the General Medical Council (GMC) maintains that doctors “must take appropriate steps to find out what patients want to know and ought to know about their condition and its treatment” (paragraph 3) and that “existing case law gives a guide to what can be considered minimum requirements of good practice in seeking informed consent from patients” (paragraph 2) (General Medical Council, 1998).
Information should not be withheld from patients. The few legal exceptions to this obligation include (i) an emergency situation; (ii) waiver, where the patient expresses directly to that physician he/she does not want the offered information (however, such decisions should be documented along with the patient’s consent to go forward without detailed information); and (iii) incompetency (Beauchamp and Childress, 2001; National Health and Medical Research Council, 2004).
In addition, therapeutic privilege has been recognized by the courts (Canterbury v. Spence, 1972; Sidaway v. Board of Governors, 1985) in some countries as an exception to the usual standard of disclosure: “‘Therapeutic privilege’ refers to the withholding of information by the clinician during the consent process in the belief that disclosure of this information would lead to the harm or suffering of the patient” (Etchells et al., 1996, p. 388). The deliberate withholding of information, and the resulting reduction in the exercise of autonomous choice, is based on the justification of patient welfare. GMC guidance (paragraph 10) also recognizes the doctrine: “You should not withhold information necessary for decision making unless you judge that disclosure of some relevant information would cause the patient serious harm. In this context serious harm does not mean the patient would become upset, or decide to refuse treatment.” Although therapeutic privilege may have legal recognition, it is arguable whether the deliberate withholding of information from a competent patient can be ethically justified. Johnston and Holt (2006, p. 150) commented: “There are only a limited number of clinical situations where providing specific information to a patient under certain circumstances can arguably be expected to cause foreseeable and preventable serious harm to him or her.”
Evidence continues to show that most patients value candidness about their medical situation and wish to be given the appropriate information necessary to making an informed choice (Edwards et al., 2001). Even in Japan, where the trend toward disclosure of information (e.g., cancer diagnosis) has been slow to gain acceptance by the medical profession, a population survey revealed that full disclosure was preferred by 86.1% of respondents, while only 2.7% wanted non-disclosure (Miyata et al., 2005). Similarly, some studies suggest that patients want more detailed information than they currently receive and that physicians may overestimate how much they provide (Ende et al., 1989; Fallowfield et al., 1995; Makoul et al., 1995; Butow et al., 1997; Jenkins et al., 2001).
A qualitative study in the palliative care setting revealed that information disclosure serves several important purposes. Patients in such a situation described information as important not only to meaningful involvement in decision making but also for keeping a sense of control (Kirk et al., 2004). It was also seen as necessary for family communication and involvement (Clarke et al., 2004; Kirk et al., 2004). In contrast, a perception of insufficient information was reported to add stress, frustration, and uncertainty. It implied powerlessness and a lack of control (Thorne et al., 2006).
Interestingly, this study also revealed that the process of disclosure was equally as important as the content. The timing, management, and delivery of the information, and the perceived attitude of physicians, were crucial to the process. This applied to information sharing and disclosure at all stages of the illness. The importance of process in effective communication and information disclosure has been described elsewhere (Edwards et al., 2001; Weiner et al., 2005).
While most patients value disclosure and candidness about their illness, research also indicates that a small percentage prefers not to engage actively in decision making nor wishes to know about the risk of treatment (Farnill and Inglis, 1993; Dawes and Davison, 1994; Miyata et al., 2005). Moreover, many of those who value information may not do so in all situations and may prefer to let the physician take the lead at different stages of their illness (Towle and Godolphin, 1999; Edwards et al., 2001; Parascandola et al., 2002). In such cases, respect for autonomy does not mean forced patient involvement but rather accepting each person’s preferences for information and involvement in decision making. Understanding how best to assess patients’ information needs or determine their preferences, however, is difficult. While further research is needed in this area, a few tools exploring patients’ preferences and information needs have been developed (Sayers et al., 2001; Murtagh and Thorns, 2006).
The goal of disclosure is to ensure that patients have appropriate information to make an informed choice about their healthcare. While information disclosure needs to be individualized to each situation (Towle and Godolphin, 1999; Kirk et al., 2004), it should include the following elements (Dickens, 1985):
Effective disclosure requires open and balanced communication. In the medical consultation, the clinicians must decide what ought to be communicated and the patient must integrate that information into their medical and social life experiences. Thus, communication is not a morally neutral dispensation of information but, rather, a highly complex ethical situation (Edwards and Elwyn, 2001) Good patient–physician communication can dispel the uncertainty and fear and improve patient satisfaction (Snyder and Leffler, 2005). While a full discussion of communication skills is beyond the scope of this article, a few “principles” are important when providing information to the patient (Anderson, 2000):
The physician has an ethical and legal obligation to make reasonable efforts to ensure understanding. Supplementing verbal information with written material might be helpful as it enables the patient to read or review the information if desired. Educational video or computer programs may assist patients who face a complicated decision (Jonsen et al., 1998; Woolf et al., 2005).
Disclosure should be seen as a process, not an event (Etchells et al., 1996). Each patient is different and may wish for varying amounts of information at different times. Further, if therapy is given over a prolonged period, it is important that the disclosure process continues. The physician should regularly seek feedback from patients about their treatment and desire for more information. Similarly, disclosure about new information or relevant uncertainties concerning treatment will contribute to long-term trust between physicians and patients (Parascandola et al., 2002).
Patients bring their cultural, religious, and ideological beliefs with them as they enter into a relationship with the physician (Kagawa-Singer and Blackhall, 2001). Occasionally, these beliefs may challenge or conflict with the physician’s professional duty to disclose. For example, autonomy is a principle highly valued in European and North American cultures, and thus it is expected that the person experiencing the illness is the best person to whom to disclose pertinent medical information. However, many non-Western cultures do not support the idea of full disclosure when it comes to illness, while others hold the family or community responsible for receiving and disclosing information, and for making decisions about patient care (Kagawa-Singer and Blackhall, 2001). In order to provide ethical cross-cultural care, applying the concept of autonomy will mean negotiating and accepting each person’s terms of preference for information and decision making. In situations in which the family demands that the patient not be told, one strategy is to offer to provide the information to the patient, allowing the patient “informed refusal” (Kagawa-Singer and Blackhall, 2001). If the patient designates someone else be given the task of decision making, this preference should be documented in the patient’s chart. The impact of cultural differences on bioethics is explored in greater depth in Section IX.
Mrs. D has no questions about the “arthritis pill” because she trusts her physician, whom she has known for many years. The physician initiates a discussion of the risks – in particular, gastrointestinal bleeding and renal insufficiency. Mrs. D appears concerned, and the clinician invites her to discuss this concern. Mrs. D explains that the shoulder pain must be relieved so that she can care for her young granddaughter, who will be visiting next month. The physician mentions that acetaminophen (paracetamol) may also be effective and has a lower risk of side effects. Although pain relief is a high priority, Mrs. D would prefer to avoid side effects, particularly because she was once admitted to hospital because of her gastric ulcer. She agrees to try acetaminophen therapy for two weeks and, if there is no effect, then to try the non-steroidal anti-inflammatory drug. The physician makes a note of their discussion and arranges a follow-up appointment for two weeks hence.
Mrs. E has asked the anesthetist not to disclose further the risks associated with hip surgery. She says that her goal is to be able to walk and that further suffering from pain and immobility is not acceptable to her. She tells the anesthetist that any further discussion of risks will not change her mind but might upset her. The anesthetist respects Mrs. E’s request but tells her that she can change her mind regarding the discussion of risks at any time. He also asks her if there are family members whom Mrs. E would like to involve in the decision-making process. Mrs. E wants her daughters to participate in the decision, and so the proposed surgery and its possible risks are disclosed to them. The entire discussion is documented, including Mrs. E’s reasons for waiving further disclosure of the risks of surgery. Mrs. E undergoes uncomplicated repair of her hip fracture and returns home to live independently.