Michael Volk was an Assistant Professor of Medicine in the Division of Gastroenterology and Hepatology at the University of Michigan. His clinical practice focuses on the care of patients with liver disease, including those undergoing liver transplantation and those with hepatocellular carcinoma. His research interests focus on the ethics of resource allocation, patient and physician decision making, and chronic disease management. In particular, he has conducted a series of studies designed to improve the way decisions are made about using high risk liver transplant organs.
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Do you think that your life is worth more than the amount that the government usually uses as the maximum to spend to provide one year of life?
Imagine that you are a member of a government panel that is trying to decide how cost-effective a medical treatment must be in order for the government to cover the costs of the treatment. Suppose that a certain treatment could provide one additional year of life to an otherwise healthy person. What is the highest amount the government should be willing to pay per person for this treatment?
How do your answers compare?
For the past twenty years, the figure most often used as the maximum amount to spend to provide one year of life has been $50,000. This figure was originally proposed since it was the cost of a year of kidney dialysis, a lifesaving treatment that the U.S. government funds in Medicare.
Should the number be higher or lower than the current standard?
Conventional wisdom would suggest that the number be higher to take into account the inflation that has occurred in the years since the standard was developed. Current practices such as annual Pap smear screening for women with low risk for cervical cancer, which has a cost of $700,000 per year of life gained, also suggest that society is willing to pay more than the current standard for a year of life. The authors of the cited article recommend, based on current treatment practices and surveys of the general public, that the cost-effectiveness threshold should be revised to be around $200,000.
Should the number increase, decrease, or stay the same over time?
Again, it seems that the threshold amount should increase over time due to inflation. However, other factors come in to play that affect the value.
Since new technologies are emerging all the time, some of which will be deemed cost-effective, there will be more and more treatments to be offered in the future. Also, the rate of use of treatments is an important consideration, because even if a new treatment is more cost-effective than an old one, if it is used more often it will end up costing more to society overall. With more treatments becoming available and more people being given treatments, the threshold cost will probably have to decrease so that insurance companies and the government can keep up with the increasing availability and demand.
Why is this important?
Insurance companies and government health care entities face a continuing struggle when trying to determine which medical treatments to cover. Health care costs are increasing rapidly, so these groups will be facing even tougher decisions in the future. Establishing cost-effectiveness guidelines would be extremely helpful as an aid to making the decisions about treatment coverage. Evidence shows that the current threshold is probably not an accurate reflection of the desires of society or actual prescribing practices. It needs to be adjusted to become useful once again, and must be reevaluated periodically to make sure the value keeps up with trends in the health care market, rather than being left alone without question for two decades as is the current situation.
For more information see:
Ubel PA, Hirth RA, Chernew ME, Fendrick AM. What is the price of life and why doesn't it increase at the rate of inflation? Archives of Internal Medicine. 163:1637-1641, 2003.
Funded by National Caner Institute
Funding Years: 2003-2014
PI: Angela Fagerlin
Brian Zikmund-Fisher gave an oral presentation at The Forum 10 hosted by DMAA: The Care Continuum Alliance, Washington, DC.
Funded by the National Institutes of Health/Brigham and Women's Hospital/Boston University
Funding years: 2010-2013
The rapid identifcation of genetic risk factors for common, complex diseases poses great opportunities and challenges for public health. Genetic information is increasingly being utilized as part of commercial effors, including direct-to-consumer (DTC) genetic testing to provide risk information on common diseases to consumers. Very few empirical data have been gathered to understand the characteristics of DTC test consumers, the psychological, behavioral and health impact (clinical utility), and the ethical, legal and social issues associated with DTC services.
In the proposed research, we will survey users of the two leading US companies providing DTC genetic testing (23andMe and Navigenics) regarding their response to genetic test s for common diseases of interest, including heart disease, diabetes, Alzheimer's disease (AD), arthritis, and breast, colon, lung and prostate cancers. Each company now has thousands of customers and each anticipates extensive sales in coming years. Each has agreed to allow our group to survey consumers using third-party data collection and analysis procedures that will enable an independent consideration of the benefits and risks of DTC testing in this format. The companies have also agreed to provide genetic test information (with respondents' permission) for analyses. A total of 1000 consumers (500 from each company) website will be surveyed via the Internet at three time points: 1) before receipt of genetic test results; 2) approximately two weeks following receipt of test results; and 3) six months following receipt of results.
More information: http://www.psc.isr.umich.edu/research/project-detail/35031
PI: Scott Roberts
Co-I: Mick Couper
Darin Zahuranec, MD
Assistant Professor, Neurology
Title: Improving decisions on life-sustaining treatments after stroke
Abstract: Individuals with acute stroke face the sudden onset of new deficits, along with a need to make many decisions about medical treatments with impact on the potential for survival and long-term disability. This talk will review the challenges in decision-making after acute stroke and discuss possible solutions for the future.
Funded by the U.S. Centers for Medicare and Medicaid Services
Funding Years: 2015-2016
The central objective of the Healthy Michigan Plan is to improve the health and well-being of Michigan residents by extending health care coverage to low-income adults who are uninsured or underinsured. The program also introduces a number of reforms, including cost-sharing for individuals with incomes above the Federal Poverty Level, the creation of individual MI Health Accounts to record health care expenses and cost-sharing contributions, and opportunities for beneficiaries to reduce their cost-sharing by completing health risk assessments and engaging in healthy behaviors. This project conducts the evaluation of Michigan's Medicaid expansion, the Healthy Michigan Plan (HMP).
PI(s): John Ayanian
Co-I(s): Tammy Chang, Sarah Clark, Matthew Davis, A M Fendrick, Susan Goold, Adrianne Haggins, Richard Hirth, Edith Kieffer, Jeffrey Kullgren, Sunghee Lee, Ann-Marie Rosland
Funded by the National Science Foundation
Funding years: 2010-2013
Increasingly people are communicating with one another through new media such as text messages exchanged via mobile devices. At the same time, survey response rates continue to drop. These phenomena are related to the extent that respondents only use mobile devices (21% of US households no longer have a landline phone) and frequently rely on modes other than voice, most notably text (which is certainly the norm among some subgroups in the US and increasingly among entire populations in other countries). Yet we know little about the impact of multimodal mobile devices on survey participation, completion, data quality and respondent satisfaction.
The proposed research will explore these issues in two experiments that will collect survey data on iPhones in four modes defined by whether the interviewing agent is a live human or a computer, and whether the medium of communication is voice or text. The resulting modes are telephone interviews, instant message (IM) interviews, speech integrated voice response (IVR), and automated IM. This way of defining modes enables us to isolate the effects of the agent and medium. The first experiment explores the effect of the four modes on participation, completion, data quality and satisfaction; the second explores the impact on the same four measures of allowing participants to choose the response mode.
More information: http://www.psc.isr.umich.edu/research/project-detail/34963
PI: Kathryn Moseley
Co-I: Mick Couper
Tanner Caverly and colleagues performed a systematic review to determine how U.S. cancer prevention and screening recommendations present the potential benefits and harms associated with the procedures. They found that 69% of recommendation statements either did not quantify benefits and harms or presented them in an asymmetric manner. They conclude that improved presentation of benefits and harms in guidelines would better ensure that clinicians and patients have access to the information required for making informed decisions.
Caverly TJ, Hayward RA, Reamer E, Zikmund-Fisher BJ, Connochie 2, Heisler M, Fagerlin A. Presentation of Benefits and Harms in US Cancer Screening and Prevention Guidelines: Systematic Review. J Natl Cancer Inst. 2016 Feb 24;108(6). pii: djv436. doi: 10.1093/jnci/djv436.
Find out about some experimental treatments for Parkinson's Disease. And then decide how you'd respond if you had a chance to participate in this research. In this interactive decision, we’re going to ask you about some experimental treatments for Parkinson’s Disease.
What is Parkinson’s Disease?
Up to 1 million Americans are currently diagnosed with Parkinson’s Disease, a brain disease that gradually worsens over many years and causes tremors, stiffness, slowness of movement, and balance problems. Some people with Parkinson’s Disease also experience changes in memory, concentration, and mood.
The average age at onset of symptoms is 65, but 5% to 10% have onset before the age of 45. The symptoms are caused by the death of cells in the brain that make a chemical called dopamine. Medications that are available to treat Parkinson’s Disease provide more dopamine to the brain or mimic the action of dopamine in the brain. In early stages of Parkinson’s Disease, symptoms generally respond well to medications. Over time, the medications become less effective and may cause more side effects.
What treatments are researchers developing?
One experimental procedure to treat moderate to advanced Parkinson’s Disease is gene transfer, which involves neurosurgery to insert a gene into the brain, to lower the side effects of medications and to increase the effectiveness of medications. Note that no stem cells or fetal cells are used. The patient is sedated but remains awake. The scalp is numbed by injections of local anesthetics (like Novocaine), so the patient should not feel discomfort. The surgeon drills two small holes into the skull and injects a liquid containing the gene on each side of the brain into areas known to be affected in Parkinson’s Disease.
How would gene transfer surgery be tested?
To see if the gene transfer surgery is truly effective, investigators need to compare a group that receives the gene transfer surgery with a group that does not. People would be randomly assigned (e.g., by flipping a coin) to one of the two groups. This kind of study could be done in two ways.
An open study could be done, where everyone knows who has and who has not received the gene transfer. One half of the patients would receive their usual medications only. The other half would receive their usual medications plus the gene transfer surgery.
A blinded study could be done, where neither the patient nor the evaluating researcher knows who has and who has not received the gene transfer. One half of the patients would receive their usual medications plus gene transfer surgery. The other half of the patients would receive their usual medications plus “sham surgery.” Patients receiving sham surgery have the two small holes drilled into the skull. But the protective coverings in the brain are not disturbed, and there is no insertion of any material into the brain.
In a blinded study, only the surgeon would know who has received the gene transfer surgery and who has received sham surgery. If the gene transfer surgery is found to be both safe and effective, those in the sham surgery group would have the option of receiving the gene transfer at a later date without cost, using the holes drilled during the sham surgery.
What are the risks of these studies?
For surgery patients in both an open study and a blinded study, the surgery poses potential risks. There is a 1% to 4% risk of bleeding into the brain (usually minor, but there is a less than 1% chance that it could result in death or substantial disability). There is also a 1% to 5% risk of infection developing in the skin or brain, which would be treated with antibiotics. Overall, the risk of bleeding and infection is smaller for sham surgery than for actual gene transfer surgery.
Those subjects receiving the gene transfer surgery would face additional risks, including the possibility of brain tumors, inflammation of the brain, and a worsening of the Parkinson’s Disease. Patients in pilot studies have been followed for only one year, so longer-term effects are not known.
What are the pros and cons of the two kinds of studies?
When deciding whether or not to adopt a new procedure, it’s important to get accurate, unbiased evidence. If we adopt a new procedure that is unsafe or ineffective, people will end up receiving unnecessary surgeries. If we fail to adopt an effective procedure, we miss the opportunity to offer people a treatment that could benefit them.
Most, but not all, researchers in the field believe that the blinded study, using sham surgery, would provide better quality data than the open study. These researchers worry that if people know which procedure they receive, the results of the study may be difficult to interpret because expectations of both the patient and the evaluating researcher can unintentionally bias the results.
However, some people, including some researchers, worry that a study using sham surgery may not be worth the risks and burdens. The patients with Parkinson’s Disease who get the sham surgery undergo a neurosurgical procedure that provides no benefit to them, while being exposed to the risks and burdens of the procedure. There is also the worry that people with moderate to advanced Parkinson’s Disease are vulnerable to exploitation because having a serious, incurable illness may put them in a desperate situation.
Now, you decide!
Imagine that you have moderate to advanced Parkinson’s Disease. You can do most things independently, but involuntary movements interfere with your routine activities. Daily chores take twice as long compared to people without Parkinson’s Disease. For some parts of the day, your movement is extremely slow and you need help with daily activities.
- Blinded study (sham surgery)
- Open study
- Would not participate
Researchers have found that only about 35% of the general population would choose, as you did, to participate in the blinded study. As reported in a 2008 article in the journal Movement Disorders, about 55% of the general population would choose the open study, and the remaining 10% said they would not participate.
When these same questions were posed to people who actually have Parkinson’s Disease, the response was quite different: 24.5% picked the blinded study, 41.5% picked the open study, and 34% said they would not participate. The researchers observe that patients with chronic illness adapt to their disabilities; the people with Parkinson’s Disease might have felt that they had less to gain or more to lose from the benefits and risks associated with a trial involving surgery. Alternatively, people without Parkinson’s Disease may have over-estimated the impact that disability might have on them or underestimated their ability to function.
In this study, people were also asked to imagine that they were members of an ethics review committee deciding whether to allow certain studies. About 81% of respondents said that they would definitely or probably allow the open study for gene transfer. 55% said that they would definitely or probably allow the blinded (sham surgery) study. These results were the same for both the general population and people with Parkinson’s Disease. In other words, a very large majority of both Parkinson’s patients and non-Parkinson’s patients endorsed the open study as ethically acceptable. A majority endorsed sham surgery as an ethically acceptable control condition.
In analyzing these results and reading the written remarks added by the respondents, the researchers comment, “Education seems to play a strong role in people’s willingness to take a more societal perspective and balance the burdens to participants with the overall scientific and societal benefit. . . Those opposed to sham surgery appeared to have an intrinsic objection to blinding, and to focus on the invasive nature of the sham surgery per se . . .Given the complexity of the topic, it may be that laypersons, especially those with less education, may need more opportunity to learn and deliberate on the issues.”
Interestingly, scientists researching Parkinson’s Disease were presented with these same questions in a related study (Kim SY, Frank S, Holloway R, Zimmerman C, Wilson R, Kieburtz K. Science and ethics of sham surgery: A survey of Parkinson disease clinical researchers. Arch Neurol 2005;62:1357-1360.) Only 50% of these clinical researchers would allow open studies, and 94% would support controlled studies using sham surgery.
In conclusion, “Future research needs to determine whether eliciting more considered judgments of laypersons would reveal different levels of support for sham surgery.”
For a complete discussion of this research, see Frank S, Wilson R, Holloway R, Zimmerman C, Peterson A, Kieburtz K, Kim SY. Ethics of sham surgery: Perspective of patients. Movement Disorders 2008;23(1):63-68. The senior author, Scott Y. Kim, MD, PhD, is a faculty member at the Center for Behavioral and Decision Sciences at the University of Michigan.
Read the article:
Ethics of sham surgery: Perspective of patients.
Frank S, Wilson R, Holloway RG, Zimmerman C, Peterson DR, Kieburtz K, Kim SY. Movement Disorders 2008;23:63-8.