This episode features guests Dr. Karen Kelly-Blake, Associate Professor in the Center for Ethics and Humanities in the Life Sciences, and Dr. Masahito Jimbo, Professor in the Department of Family Medicine at University of Michigan Medical School. Drs. Kelly-Blake and Jimbo discuss their NIH-funded study known by the acronym DATES—Decision Aid to Technologically Enhance Shared Decision Making—which addressed shared decision-making, decision aids, and patient-physician communication regarding colorectal cancer screening. The two researchers provide insight into the study and its results, also reflecting on what the process of shared decision-making means to them in the present day.
This episode was produced and edited by Liz McDaniel in the Center for Ethics. Music: “While We Walk (2004)” by Antony Raijekov via Free Music Archive, licensed under a Attribution-NonCommercial-ShareAlike License. Full episode transcript available.
About: No Easy Answers in Bioethics is a podcast series from the Center for Ethics and Humanities in the Life Sciences in the Michigan State University College of Human Medicine. Each month Center for Ethics faculty and their collaborators discuss their ongoing work and research across many areas of bioethics. Episodes are hosted by H-Net: Humanities and Social Sciences Online.
Center Professor Dr. Tom Tomlinson has a new commentary in the September 2018 American Journal of Bioethics. In “Getting Off the Leash,” Dr. Tomlinson discusses “digital medicines” and what such technologies mean for patient privacy. He asks questions such as: do patients have a right to deceive their clinicians? Why would patients be deceptive?
The full text is available via Taylor & Francis Online (MSU Library or other institutional access may be required to view this article).
Medicine has long been one of the most self-regulating of all professions. In the 1970s, the new field of bioethics was designed to challenge this prevailing system. As Senator Ted Kennedy explained at the founding of Georgetown’s Kennedy Institute of Ethics, “Human life is too precious and the decisions regarding it too important to leave to any one group of specialists.” Still, even fifty years later, medicine remains largely self-regulating. And patients have suffered. In this presentation, Professor Pope will discuss recent initiatives to constrain the scope of physician discretion and how these initiatives improve patient safety and protect patient rights. He will place particular emphasis on the growing transition from traditional informed consent to shared decision-making with patient decision aids.
Join us for Dr. Pope’s lecture on Wednesday, October 10, 2018 from noon until 1 pm in person or online.
Thaddeus Mason Pope, JD, PhD, is Director of the Health Law Institute and Professor of Law and at Mitchell Hamline School of Law in Saint Paul, Minnesota. He is also: (1) Adjunct Professor with the Australian Centre for Health Law Research at Queensland University of Technology; (2) Adjunct Associate Professor with the Alden March Bioethics Institute at Albany Medical College; and (3) Visiting Professor of Medical Jurisprudence at St. Georges University. Professor Pope has over 140 publications in: leading medical journals, law reviews, bar journals, nursing journals, bioethics journals, and book chapters. He coauthors the definitive treatise The Right to Die: The Law of End-of-Life Decisionmaking. And he runs the Medical Futility Blog (with over three million page views).
In person: This lecture will take place in E4 Fee Hall on MSU’s East Lansing campus. Feel free to bring your lunch! Beverages and light snacks will be provided.
It’s something we’ve all been told: be sure to finish taking your antibiotic prescription. Don’t just stop when you begin to feel better. Doing so, we’re warned, may mean that the bacteria causing the infection have not been completely eradicated. Once treatment stops, they will begin to multiply again, causing a relapse. Worse, it may result in the development of antibiotic-resistant bacteria, which is dangerous both to the individual taking the medication and to the public as a whole.
But a recent article in The BMJ argues against this common wisdom, saying that advice to “complete the course” is not evidence-based—and that doing so may actually have the opposite effect of increasing, rather than decreasing, the risk of antibiotic resistance.
I find this piece—and reactions to it in on the journal’s website—interesting for bioethics because it illuminates the complex relationship between evidence and patient care. The article recommends changing treatment practices because of evidence that they may do more harm than good, but doesn’t really have a plan for what to change them to. This conundrum leads the authors of the article to make some interesting, but incomplete, suggestions related to physician-patient communication and shared decision-making. The commentaries on the paper challenge both the authors’ claims about the available evidence and their suggestions about sharing doubts about current practice with patients.
Changing Clinical Practice?
The randomized controlled trial (RCT) is currently thought to be the “gold standard” of evidence in medicine. It is not uncommon for discussions of medical evidence to cite examples of treatments that were in common use before an RCT was conducted, that were then shown by the trial to be useless or even harmful. This time last year, I blogged about a report that suggested that there is no evidence that flossing your teeth has any benefits. In response to this report, a number of people suggested that we should just stop flossing. In the late 1980s, a large RCT showed that two drugs commonly used to treat arrhythmia actually increase the risk of cardiac death and the authors recommended that their use be discontinued.
The question addressed in the BMJ paper is more complex than either of these cases. The recommendation is not to stop using antibiotics altogether, but to change the way that they are used. And the recommendation is not based on RCTs, but on the lack of evidence for current practice; on the flawed reasoning that linked early discontinuation with antibiotic resistance; and on evidence that overuse of antibiotics is actually the most important causal factor in the development of resistance. The authors identify only seven conditions for which researchers have conducted RCTs that directly compared a shorter with a longer course of treatment. Moreover, even in cases where the shortest effective course of an antibiotic treatment for a health condition has been identified, it’s not possible to extrapolate from this situation to the use of other antibiotics, or the use of that antibiotic for other diseases.
The authors of the BMJ paper do emphasize that more evidence is needed. But until that research has been done (if it ever is done), it’s not clear how doctors should change their current prescribing habits. As the discussion in the article makes clear, the answer to this question will depend on a number of factors, including the kind of infection and the specific antibiotic being used. Moreover, it will depend on the individual patient, as “patients may respond differently to the same antibiotic, depending on diverse patient and disease factors” (p. 2).
Talking with Patients
Given the number of factors that might affect patient outcomes, it would not be surprising if the authors of the article were unwilling to make specific recommendations for clinical practice. In fact, they don’t make a recommendation in terms of what doctors should prescribe for their patients. Instead, they end their paper with a section titled “How should we advise patients?” While prescribing a medication regimen certainly counts as giving a patient advice (at least implicitly), they couch their discussion in terms of general communication strategies, rather than of specific practice guidelines. In this section of the paper, they suggest that part of the reason that the traditional advice to “complete the course” has been so resilient is that “it is simple and unambiguous, and the behavior it advocates is clearly defined and easy to carry out” (p. 3). In addition to recommending further research on the appropriate dose of antibiotic, the authors also recommend research to identify “the most appropriate simple alternative messages” (p. 3). One possibility is to tell patients to stop when they feel better–exactly the opposite of what we have generally been told. More immediately, however, they say that doctors should begin to educate patients about the problems with the traditional advice, telling them that antibiotic overuse is the real problem that leads to antibiotic resistance. They suggest that honesty about our current lack of knowledge is better than “simply substituting subtle alternatives” such as the instruction to “take exactly as prescribed” (p. 3).
Take as directed…
A number of the commentaries on the BMJ website express frustration with the article–and with the situation it describes. Some of the commentaries emphasize that the article title is misleading or that the article itself overstates the conclusion that can be drawn based on the available evidence. Others worry that patients will take this article (and the media coverage that suggests that they should stop taking their antibiotics when they feel better) as license to ignore their doctor’s recommendations. One commenter even suggests that patient-centered decision-making is dangerous, and an illusion, when there is still medical debate on a topic. Yet many also agree that there is a problem with current practice.
The problem is that, if Llewelyn et al. are even close to correct, there is no clear direction for physicians or for patients. Confusingly, this seems like a case in which the growing evidence leave us knowing less, rather than more.
Robyn Bluhm, PhD, is an Associate Professor in the Department of Philosophy and Lyman Briggs College at Michigan State University.
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Note: some articles linked in this commentary may require MSU Library or other institutional access to view the full text.