Patient autonomy and complex decision making.

Publication: Research Practitioner

Publication Date: 01-MAR-08

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COPYRIGHT 2008 A Thomson Healthcare Company

Patient autonomy is the cornerstone of contemporary clinical ethics and the doctor-patient relationship, but substantial challenges remain to promoting the autonomy of patients and research subjects in practice. The amount of empirical research to better understand how technical information is communicated and utilized in the clinic is growing, but substantial gaps remain in understanding how to effectively communicate information about uncertainty and risk. Moreover, developing universal guidelines is complicated by the fact that individual patients and research subjects may have different preferred modes of decision making. More research is needed to better understand how clinical professionals can best assist patients and research subjects in exercising their autonomy in decisions about their own health care and research participation.

Key words: autonomy, communication, decision making, patients, research

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Patient autonomy is the cornerstone of contemporary clinical ethics and the doctor-patient relationship. Landmark legal decisions over the past four decades have reinforced patients' rights to make choices about their health care, even when their choices conflict with medical recommendations. At the same time, bioethicists have advocated for a greater role for patients in decision making about their care or research participation. The role of autonomy is even more salient in the clinical research context, where demonstration of informed consent is required to ensure that patients are aware that they are participating in a research study and are doing so voluntarily. While even a minimal risk study generally requires informed consent, this requirement is highest when the risks involved are significant, such as in a study of experimental chemotherapy.

However, it is in those circumstances where the stakes are high and the obligation for informed consent is greatest that this aim becomes most difficult to achieve. When a patient with a life-threatening illness enrolls in a study of an experimental therapy, it is in a context that may be fraught with anxiety and uncertainty. Indeed, inherent in the rationale for doing a clinical trial is the condition of equipoise, or therapeutic uncertainty. Additionally, weighing the risks and benefits of different treatment options often requires an understanding of complex scientific and technical information on the part of the patient or research subject. As medical science becomes increasingly complex and specialized, how will patients be able to utilize new scientific information in making decisions about their health behaviors and treatment?

Empirical studies to date suggest that there are substantial challenges to meeting the ideal of informed, shared decision making in practice. Despite the development of guidelines and training programs focused on improving doctor-patient communication and supporting patients in taking a more active role in decision making, there is limited evidence on the effectiveness of these efforts in practice. A study in the Netherlands analyzed existing videotapes that had been taken of general practice consultations in 1986 and 2002 to see whether there had been any measurable change during that period in doctor-patient communication in the practice setting. Contrary to their expectations, the investigators found that patients were actually less active in the more recent consultations, talking less and asking fewer questions. Physicians provided more medical information, but were less likely to express concern about the patient's condition and were less engaged in working collaboratively with the patient. (1) While most of the research in communication and patient advocacy has been conducted in the clinic rather than the research setting, these findings have important implications for patient autonomy in clinical research where informed consent is paramount. Additionally, clinical researchers should be aware of the challenges that can arise in applying clinical research findings in practice when doctor and patient are forced to make decisions based on complex and often incomplete information.

The history of truth-telling

Much of contemporary practice and scholarship in biomedical ethics--both clinical and research ethics--rests on the familiar four principles: respect for autonomy (respect for the patient's decision-making capacity), beneficence (benefits should outweigh risks and costs), nonmaleficence (avoid doing harm), and justice (benefits and risks should be equitably distributed). (2) However, these principles sometimes can come into conflict with each other; in fact, this is the source of many ongoing dilemmas in bioethics. Throughout history, doctors and patients have placed different degrees of emphasis on these principles. Arguably the most complex and contentious of these principles, however, is respect for autonomy. As we will see, promoting autonomy involves far more than the absence of coercion. That is, for the patient to exercise autonomy, they must have sufficient information to make informed decisions. Thus, the physician has a corresponding obligation to provide accurate and useful information to the patient. While early thinking on medical ethics was focused on the clinic, the development of ethical guidelines for human subjects research in the 20th century was to bring a greater emphasis on informed consent.

Earlier accounts of medical ethics typically neglected the role of patient autonomy. The Hippocratic Oath, one of the most influential documents in the history of medical ethics, makes no mention of patient consent or any obligation on the part of the physician to communicate information to the patient. Even in the 18th century, when Enlightenment era enthusiasm for the popularization of scientific knowledge prevailed, physicians still worried about the impact of telling patients the truth about their conditions. John Gregory, professor of medicine at the University of Edinburgh, cautioned in his "Lectures on the Duties and Qualifications of a Physician" that the physician must balance truthfulness with beneficence. A deviation from truth may be both justifiable and necessary, as "it often happens that a person is extremely ill; but may yet recover, if he be not informed of his danger." The concern for the benevolent physician was that disclosing too much to the patient might actually do harm, an even more objectionable outcome than deception.

Similarly, British physician Thomas Percival's influential writings on the responsibilities of physicians emphasized the need to convey to patients a sense of authority and confidence befitting their office, which left limited...

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