Study: Emergency doctors overstate treatment benefits
Possible harms often not discussed
Emergency physicians overstated the risks of myocardial infarction and potential benefit of hospital admission to chest pain patients, according to a recent study of 425 patient-physician pairs.1
“Admission to the hospital is arguably the single most expensive decision that most physicians routinely make. We wondered whether the communications surrounding that decision reflected its potential value, either in terms of health or in terms of resources,” says David H. Newman, MD, FACEP, the study’s lead author. Newman is associate professor of emergency medicine and director of clinical research in the Department of Emergency Medicine at Icahn School of Medicine at Mount Sinai in New York City.
Physicians did not discuss the possible harms of admission, such as the possibility the patient would catch a hospital-acquired infection. “We didn’t record all details of the verbal exchanges that occurred during the study period. But to the best of our ability to ascertain, these factors were never discussed,” says Newman.
Overestimating benefits and underestimating or glossing over harms is “common in healthcare,” says Newman. “It is essentially par for the course.”
It’s very difficult for physicians and patients to break out of this mold, and take a more dispassionate approach when talking about medical treatments — “but that’s exactly what we’ll need to do,” says Newman.
It is essential that physicians provide a balanced overview of the risks and benefits of every single treatment, says Kevin R. Campbell, MD, FACC, assistant professor in the Division of Cardiology at UNC Health Care in Chapel Hill, NC.
“It is important for physicians to discuss the data from clinical trials that support the use of a particular treatment or the performance of a particular procedure to treat a condition or disease state,” he says.
A strong doctor-patient relationship allows for more candid discussions. “It is clear that we must do a better job,” Campbell says. “Sometimes physicians assume that common risks, such as hospital-acquired infections, are implicit in consent. In reality, many patients have absolutely no idea of these risks.”
When informed consent law began to develop about 50 years ago, “there was the notion that it was pretty simple,” says Alan Meisel, JD, Dickie, McCamey & Chilcote professor of bioethics and director of the Center for Bioethics and Health Law at University of Pittsburgh.
The concept was that all the doctor had to do was tell the patient the risks, benefits, and alternatives of treatment. “The patient said yes or no, and that would be the end of it,” says Meisel. “We now realize that it’s a lot more complicated and nuanced than that.”
Time-pressured physicians face the challenge of conveying increasingly complex information to their patients. “It is very difficult to instruct doctors on what information patients need to know, and it’s very difficult for patients to understand the information,” says Meisel.
Multiple factors inhibit a physician’s ability to have detailed informed discussions. “Declining reimbursement forces providers to see more patients in less time and does not allow for the time needed to have complete discussions,” says Campbell.
Patients need time to process information and apply it to their own situation. “It is not enough to cognitively understand information,” says Meisel. “Patients need to appreciate what it means to them.”
He gives the example of the risk of being harmed by a hospital-acquired infection or adverse psychological consequences from being hospitalized. “How do you explain that to people?” he asks. “It gets pretty hard to convey this information in a way that is neutral, and doesn’t prejudice people so much that they make bad decisions.”
Meisel says the primary role of bioethicists is education. “Have discussions with physicians about how to adequately inform patients without unnecessarily frightening patients,” he says.
The model of patient autonomy highlights the patient’s involvement in decision-making, replacing the previous long-standing model of physician paternalism, notes Gerard Magill, PhD, Gallagher Chair at Pittsburgh-based Duquesne University’s Center for Healthcare Ethics.
“A third model is becoming more widely adopted today: the model of partnership between clinician and patient,” says Magill. This requires time to allow the clinician to explain relevant risks in a meaningful way, allowing the patient to engage in an effective conversation.
“This model avoids the excesses of paternalism, where the patient had less participation; and autonomy, where the patient has more participation but may not properly understand the complex disclosures in medicine,” says Magill.
The partnership consent model places responsibility upon the patient to be generally informed about risks such as hospital-acquired infections. “While relevant for each patient, this could take too long to explain in every case,” explains Magill.
The expected benefits and possible harms that ought to be disclosed depends in large part on the type of physician-patient relationship that has formed, according to John Holmes, PhD, director of ethics for PeaceHealth’s Oregon Region in Springfield.
In certain circumstances, physicians feel obligated not to disclose some unlikely risks of harm, to avoid scaring a patient needlessly. “But a physician needs to navigate the reluctance to disclose risks of harms carefully,” says Holmes. When a physician knows the patient well, and both the physician and patient have a shared value system, the physician is better able to judge which particular risks ought to be disclosed to the patient.
“Unfortunately, today’s modern medical system does not always lend itself to the formation of deep, close relationships between physicians and patients,” says Holmes. Physicians often find themselves in the position of treating a patient who is not well-known to them, and cover every possible risk no matter how unlikely it may be.
“This approach to information disclosure may meet the legal obligations related to information disclosure, but it may result in information overload,” says Holmes. This makes it difficult for patients to put risks and benefits into proper perspective, he says.
“Tailoring information disclosure to the type of physician-patient relationship is critical to achieving proper informed consent,” says Holmes. For example, if the patient trusts the physician to disclose information in a manner that matches the values of the patient, there may be no obligation to disclose very unlikely risks of harm.
“On the other hand, a patient might demand a lot of information about risks of harm because the patient wants to do their own personal discernment about whether to go forward with treatment,” says Holmes. In this type of relationship, there might be an obligation to disclose very unlikely risks of harm.
The same approach can be applied to disclosure of risks of harm that are not directly related to treatment, such as the rate of nosocomial infections or rate of medical error at a particular hospital. “However, the burden to disclose such information need not fall on the physician directly,” says Holmes. “Hospitals are obligated to make such information readily available to patients.”
Physicians tend to view the risk of harm to a patient from a wider perspective than the patient, says Madelyn Quattrone, risk management analyst at Plymouth Meeting, PA-based ECRI Institute.
“Numerous factors come into play,” she says. The following are some reasons why physicians might over-emphasize benefits of treatment, according to Quattrone:
- The physician’s own positive clinical experience, or awareness of outcomes of peer-reviewed studies, could cause the physician to reasonably view the potential harm of a proposed treatment as extremely low.
“For most patients, however, the risk of harm from a proposed treatment is more likely viewed from a much narrower perspective than the physician’s,” says Quattrone.
- Physicians may experience difficulty or lack adequate time to communicate statistical risk to patients.
“Many people have a poor or limited understanding of statistical risk,” says Quattrone. “That limitation may result in their exaggerating or underestimating of the true risk of harm.”
- Appropriate alternative treatment options may be non-existent, very limited, or present greater risk than the proposed treatment.
- A physician’s personal view of risk versus benefit might subconsciously influence the discussion.
“A confident and optimistic physician might tend toward de-emphasizing potential risk of harm,” says Quattrone.
Physicians have a legal and ethical requirement to obtain a patient’s informed consent, she says. State laws typically require the patient be informed of the diagnosis, the proposed treatment, the likelihood of success, risks and benefits of the proposed treatment, alternatives and their risks and benefits, and the consequences of not receiving treatment.
“The legal requirement is grounded in the ethical concept of autonomy: that the patient has the right to control what is done to her body, and to make decisions about healthcare treatment free of coercion or ‘coaxing,’” says Quattrone.
Ethical considerations and obligations may exceed legal requirements, however. Is a physician ethically obligated to discuss potential risks of harm that are not required to be discussed by law, regulation, or facility policy on informed consent? This depends on the specific risks weighed against ethics principles of autonomy, beneficence, nonmalfeasance, and social justice, says Quattrone.
“These ethics principles might be also considered with the view of informed consent as a pinnacle of patient-centered care and a patient safety practice,” says Quattrone. She gives the example of a physician who holds surgical staff privileges at two hospitals and is aware that one of the hospitals has a slightly higher rate of surgical infection than the other.
“Is it reasonable to impose an ethical obligation on the physician to translate that information into a statistical risk factor that is meaningful for an individual patient, for one procedure?” she asks.
Physicians should be guided by legal mandates, ethics principles, the individual patient’s goals of care, and exercise prudent judgement when discussing potential risks of and benefits with patients, says Quattrone. “As in many matters requiring the application of ethics principles in healthcare, there are no fixed answers that apply to all circumstances,” she says.
REFERENCE
- Newman DH, Ackerman B, Kraushar ML, et al. Quantifying patient-physician communication and perceptions of risk during admissions for possible acute coronary syndromes. Annals Emerg Med 2015; 66(1):13-18.
SOURCES
- John Holmes, PhD, Director of Ethics, Oregon Region, PeaceHealth, Springfield, OR. Phone: (541) 222-2262. Email: [email protected].
- Gerard Magill, PhD, Vernon F. Gallagher Chair & Professor, Center for Healthcare Ethics, Duquesne University, Pittsburgh, PA. Email: [email protected].
- Alan Meisel, JD, Professor of Law and Dickie, McCamey & Chilcote Professor of Bioethics/Director, Center for Bioethics and Health Law, University of Pittsburgh. Phone: (412) 648-1384. Email: [email protected].
- David H. Newman, MD, FACEP, Associate Professor of Emergency Medicine/Director of Clinical Research, Department of Emergency Medicine, Icahn School of Medicine at Mount Sinai, New York City. Phone: (212) 824-8067. Email: [email protected].
Emergency physicians overstated the risks of myocardial infarction and potential benefit of hospital admission to chest pain patients, according to a recent study of 425 patient-physician pairs.
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