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:
Announcement of Position: Faculty Ethicist
The Clinical Ethics Service within the Center for Bioethics and Social Sciences in Medicine (CBSSM) promotes a culture of patient-centered excellence by performing a comprehensive set of ethics-related activities. The aims of this service are to: liaise with and provide support to the adult and pediatric ethics committees; provide clinical ethics consultation and engage in preventative ethics endeavors; assist with ethics-related policy development on a regular and proactive basis; organize and administer structured educational programs in clinical ethics; and coordinate empiric research with relevance to clinical ethics within CBSSM.
The Clinical Ethics Service is led by Christian J. Vercler, MD MA and Andrew G. Shuman, MD. A dedicated clinical ethicist will manage the program on a daily basis. A cadre of faculty ethicists will rotate on service throughout the year and work closely with the clinical ethicist. Trainees and students will rotate as well. Dedicated administrative support is organized through CBSSM.
The Clinical Ethics Service employs a roster of faculty ethicists who are responsible for staffing ethics consultations arising from any of the clinical venues (inpatient and outpatient; adult and pediatric) within Michigan Medicine during their time on service. They will supervise and participate in the institutional educational endeavors and preventative ethics rounds in a regular and on-going manner. Faculty ethicists will also develop and provide clinical rotations for medical students and house officers on a cohesive ethics service. Each faculty member will be expected to rotate on service for four to six weeks per year, and attend/participate in committee meetings and other events throughout the academic year (this will not necessarily require suspension of other activities when on-service). Depending on the total number appointed, each faculty ethicist will receive $15,000-$20,000 of direct salary support annually, to be distributed and allocated in conjunction with their home department. The initial appointment will last two and a half years and is renewable. Additional appointments will last two years.
Candidates are expected to have faculty appointments at University of Michigan and be in good academic standing; any professional background is acceptable. Candidates are expected to have qualifications that meet the standards outlined by The American Society for Bioethics and Humanities (ASBH) for accreditation for clinical ethics consultants. Direct experience with clinical ethics consultation is required. Familiarity with ethics education and related clinical research would be helpful. Excellent organizational and communication skills across multidisciplinary medical fields are required.
Candidates will be vetted and chosen by a selection committee. Candidates are asked to submit:
- Curriculum vitae or resume
- One page maximum summary of (1) education/training related to ethics consultation; (2) clinical ethics consultation experience; and (3) motivation/interest in the position
- Letter of support from Department Chair/Division Head/Center Director or equivalent
- Submit formal application via email to: firstname.lastname@example.org
- Application is due September 25, 2017
- Appointment will take effect January 1, 2018
- Leaders of the Clinical Ethics Service: Christian J. Vercler, MD MA & Andrew G. Shuman, MD
- Administrative contact: Valerie Kahn – email@example.com 734 615 5371
It's 2009. Early in the year, a 9-year-old girl from California became the first person with a confirmed case of H1N1 ("swine") influenza in the United States. Shortly thereafter, the U.S. declared a public health emergency and the World Health Organization declared a phase 6 pandemic (the highest level possible). By September 2009 a vaccination was developed and was available within a month.
You've been following the news about the H1N1 influenza as developments have unfolded throughout the year, and you feel some concern. You have been wondering about the risk of coming down with the H1N1 flu yourself and have been thinking about whether you should be vaccinated.
Raymond De Vries is co-author on a new publication in Academic Medicine, highlighting a successful model for collaboration which was developed in the early phases of a grant funded by the Bill & Melinda Gates Foundation nearly five years ago. The Collaborative Health Alliance for Reshaping Training, Education, and Research (CHARTER) project expanded the partnerships between the University of Michigan and several Ghanaian academic institutions to enhance health care provider education and build and/or increase research capacity. One of the early goals of the grant was to establish guiding principles for engagement through a Charter of Collaboration.