What do subjects need to know in order to agree to participate in research? An informed consent document is assumed to communicate the essential information, but it is not clear how carefully research participants read these documents.
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Traditional ethical teaching suggests that a physician's assessment of a patient's best interest should guide the decision of whether to administer emergency life-sustaining therapy, absent guidance by the patient or family members. In pediatric medicine, physicians may insist on life-saving therapy if they believe it is in a child's best interest to receive it, even if the parents seek to refuse it. It is unclear exactly how physicians make such assessments, however, and whether/how these assessments influence decision-making in critical situations. Consider the following scenario:
The government requires that potential kidney transplant recipients be informed if an organ donor engaged in CDC categorized "high risk" behaviors. Are these "high risk" donor kidneys associated with worse survival rates following transplantation? Does this label "high risk" result in usable kidneys being discarded?
People in the U.S. make decisions about their health on a regular basis. For example,they are often asked to consider taking medication to treat common health problems, such as hypertension. But do patients have sufficient information to make these decisions? And what factors might influence the knowledge patients have, and their treatment decisions?
Consider this scenario:
Bob is a 52-year-old man who went to see his physician for a routine check-up. Bob’s doctor told him his cholesterol levels were slightly elevated and suggested cholesterol medication. Bob wondered how long he would have to take the medication, and whether there would be any side effects. Please answer the following two questions about cholesterol medications.
When people start taking cholesterol medications, how long is it usually recommended that they take them?
- less than 6 months
- 6-12 months
- 1-3 years
- for the rest of their lives
How do your answers compare?
Making an informed medical decision about whether to take cholesterol medications depends, at least in part, on understanding how long a medication should be taken and whether there are side effects. CBSSM investigators Angela Fagerlin, Mick Couper, and Brian Zikmund-Fisher recently published an article on patient knowledge from the DECISIONS study, a large survey of U.S. adults about common medical decisions. One main objective of the study was to determine adults’ knowledge about information relevant to common types of medication, screening, or surgery decisions they recently made. Data were collected from 2575 English-speaking adults aged 40 years and older who reported having discussed common medical decisions with a health care provider within the previous two years. Participants answered knowledge questions and rated the importance of their health care provider, family/friends, and the media as sources of information about common medical issues.
People taking cholesterol medications usually should take them for about 3 or more years, and perhaps even for the rest of their lives. A little more than 60% of the study respondents accurately identified the time to take cholesterol medications.
Many people have trouble with this question and do not know that muscle pain is the most commonly reported side effect of cholesterol medications. Only 17% of DECISIONS study respondents were able to answer this question correctly. About 1 in 5 respondents incorrectly identified liver problems as the most common side effect of cholesterol medications.
Overall, the investigators found that patient knowledge of key facts relevant to recently made medical decisions was often poor. In addition, knowledge varied widely across questions and decision contexts. For example, 78% of patients considering cataract surgery correctly estimated typical recovery time, compared to 29% of patients considering surgery for lower back pain or 39% of patients considering a knee or hip replacement. Similarly, in thinking about cancer screening tests, participants were more knowledgeable of facts about colorectal cancer screening than those who were asked about breast or prostate cancer. Respondents were consistently more knowledgeable on questions about blood pressure medication than cholesterol medication or antidepressants.
The impact of demographic characteristics and sources of information also varied substantially. For example, black respondents had lower knowledge than white respondents about cancer screening decisions and medication, even after controlling for other demographic factors. Researchers found no race differences for surgical decisions, however.
The authors concluded by noting that improving patient knowledge about risks, benefits, and characteristics of medical procedures is essential to support informed decision making.
For more information:
Cancer screening is generally recommended for people over the age of 50. Screening tests, such as colonoscopies, mammograms and PSAs (prostatespecific antigen), can help detect cancer at an early stage andprevent deaths. These screening tests, however, do have risks so,along with their doctor, people need to make a decision about howoften to get screened and when or if one should stop gettingscreened.
Consider the question:
Now, imagine that you were screened for cancer about a year ago and no cancer was found. You and your doctor are talking about when you should come back for screening in the future. Your doctor explains that cancer screening guidelines recommend that you do come back for more screening tests but as you get older, screening for cancer is no longer a good option. Your doctor states that you should follow this recommendation as you age. Now, imagine that you were screened for cancer about a year ago and no cancer was found. You and your doctor are talking about when you should come back for screening in the future. Your doctor explains that cancer screening guidelines recommend that you do come back for more screening tests but as you get older, screening for cancer is no longer a good option. Your doctor states that you should follow this recommendation as you age.
How do your answers compare?
To learn more about this study, see:
At our October Bioethics Grand Rounds, we had the wonderful opportunity to do something a bit different. This BGR involved a musical program of songs and readings reflecting various perspectives on death and dying. Performers included Charlotte De Vries, Jeanne Mackey, Merilynne Rush and friends.
Dr. Jason Karlawish, Professor of Medicine and Medical Ethics at the University of Pennsylvania, will discuss his forthcoming novel, "Open Wound: The Tragic Obsession of Dr. William Beaumont" on Thursday, October 20, 3-5 pm, at the Biomedical Research Science Building (BSRB), Room 1130. "Open Wound" is a fictional account of true events along the early 19th century American frontier, tracing the relationship between Dr. William Beaumont and his illiterate French Canadian patient. The young trapper sustains an injury that never heals, leaving a hole in his stomach that the curious doctor uses as a window both to understand the mysteries of digestion and to advance his career. A reception will follow the talk, and books will be available for purchase on site from Nicola's Books. The event is co-sponsored by the Center for Bioethics and Social Sciences in Medicine, the Center for the History of Medicine, and the University of Michigan Press. Click here for more information about the book.
The 2012 CBSSM Research Colloquium took place on Thursday, May 10, and was attended by over 130 people. This year's colloquium focused on research around medical decision making, and featured presentations by numerous faculty, fellows, and students. In addition, the CBSSM Research Colloquium featured the annual Bishop Lecture in Bioethics as its keynote address. Drs. Jerome Groopman and Pamela Hartzband of Harvard Medical School jointly presented the Bishop Lecture with a talk entitled, "When Experts Disagree: The Art of Medical Decision Making." For more information about the event and to view photos and a video of the Bishop Lecture, click here.