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Drilling for Answers (Sep-08)

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.

You are asked to participate in either an open study or a blinded (sham surgery) study. Which study would you choose to participate in?
  • 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.

Funded by Patient-Centered Outcomes Research Institute (PCORI).

Funding Years: 2013-2017

The birth of a child with a disorder of sex development (DSD) is stressful for parents and members of the healthcare team. The "right" decisions about gender assignment (is it a boy? a girl?) and the best course of action (e.g., should there be surgery? what kind? when?) are not obvious. While there have been large advances in diagnostic assessments like genetic and endocrine testing, the tests do not always show what caused the DSD. And, even when the tests do reveal an explanation for the DSD, knowing what happened genetically or hormonally does not usually lead to a single "correct" treatment plan. Instead, it is likely that there are different acceptable treatment options - and parents will need to make decisions based, in part, on their personal preferences, values, and cultural background. Adding more stress to the situation is knowledge that many of the decisions that need to be made by parents early in a child's life are irreversible and exert life-long consequences for the child and the family.

To support parents becoming actively involved in making such decisions, and to reduce the likelihood of future worry and regret about decisions that have been made, the investigators will create a decision support tool (DST). The DST will help educate families about typical and atypical sex development of the body, the process by which DSD are diagnosed (especially how to interpret genetic test results), and possible relationships between diagnostic/genetic testing, decisions about care, and known consequences of those decisions on their child and entire family. The DST will be used by parents of young children together with their child's health care provider.

The investigators will bring together a network of researchers, health care providers, representatives of patient support and advocacy organizations, and parents of children with DSD to share their experiences. Participants of this network will be involved at each stage of creating the DST, revising it, and putting it into practice. At the end of this project, the investigators will have a fully formed and tested DST that will be available for parents to use with their child's health care team as they are first learning their child may have a DSD.

PI(s): David Sandberg

Co-I(s): Edward Goldman, Catherine Keegan, Beth Tarini, Beverly Yashar

 

Funded by the Department of Veterans Affairs.

Funding Years: 2012-2013.

Diabetes is a complex, chronic disease encompassing many domains of treatment. VHA and others have created diabetes guidelines to help support providers and patients in making choices about optimal treatment approaches. However, most guidelines are broad in nature, and offer relatively little guidance on how to personalize care in order to maximize treatment benefits, minimize the intensity and negative effects of treatment, and best align with individual treatment preferences. 

We will test the effectiveness of a personalized decision support program. Our long term goals are:

  • To test and implement a decision support program, including decision coaching supported by an interactive, personalized decision support tool, in clinical practice via our Patient-Aligned Care Team (PACT) laboratory.
  • To assess the impact of personalized decision support on patient-centeredness, patient satisfaction, and the effectiveness of risk communication and treatment decision making.

We propose an interventional study to examine the effectiveness of personalized decision support. The intervention will consist of two key components: a decision coach  and a personalized diabetes decision support tool. The decision support tool has mostly been developed via AHRQ and local pilot funding mechanisms, and is informed by personalized estimation of treatment benefits for blood glucose, blood pressure, and lipid treatment based on extensive modeling work done by our investigative team. The personalized benefit information is communicated through graphical risk communication methods (pictographs).  

PI(s): Angela Fagerlin 

Funded by NIH - Department of Health and Human Services

Funding Years: 2012-2017

Treatments for cancer impose substantial burden and morbidity but net survival benefit of different strategies is often small and virtually always uncertain. Thus, clinicians may do more harm than good if treatment is too aggressive. There are a number of management strategies for breast cancer aimed at reducing unnecessary morbidity and burden on patients with favorable disease. A key barrier to advancing these initiatives is the need for a better understanding of the challenges of individualizing cancer care. The goal of this program is to improve population health by helping clinicians and their patients address the challenges of individualizing treatment of breast cancer for patients with favorable prognosis. Objective 1: To examine the challenges of individualizing treatment for women with breast cancer. Two projects will each undertake an observational study of patients newly diagnosed with breast cancer (including their attending clinicians) who were reported to the SEER registries of Georgia and New Jersey during an 18 month period to examine patient and clinician factors associated with key evaluative tests, treatments, and patient appraisal of decision quality. Project 1 will focus on challenges for surgeons and their patients with regard to locoregional therapy. Project 2 will focus on challenges for medical oncologists and their patients with regard to systemic therapy. Objective 2: To improve treatment decision quality. Project 3 will perform a randomized controlled trial of a practice based online decision tool for patients newly diagnosed with breast cancer in the Detroit and Atlanta SEER regions intended to improve decision quality. Objective 3: To accelerate the dissemination of SEER-based research findings by implementing and evaluating a tailored online portal aimed at all surgeons and medical oncologists who treated the patient samples in P1 and P2 to evaluate whether our research findings can more directly and promptly inform clinicians knowledge and attitudes about individualizing treatment. Objective 4: To advance methods in SEER population translational research focused on quality of cancer care. We propose four shared resource cores that will support program project activities, advance innovative methods in oncology population sciences, and advance team mission and long-term strategic planning.

PI(s): Steven Katz

Co-I(s): Lawrence An, Michael Elliott, Angela Fagerlin, Sarah Hawley, Timothy Hofer, Reshma Jagsi, Nancy Janz, Yun Li, Kenneth Resnicow, Jeremy Taylor, Christopher Friese

Thu, February 01, 2018

Breast cancer patients face complex decisions about their treatment. Sarah Hawley, Reshma Jagsi, and colleagues developed an interactive online tool to help patients understand their treatment options. In a study published in the Journal of Clinical Oncology, they found that patients using the interactive tool had higher knowledge and felt more informed about options and felt better prepared to make a treatment choice.

Should this patient get a liver transplant? (Nov-08)

There aren't enough donor organs to go around for patients who need aliver transplant. This sometimes forces doctors to make tough choices.If you were the doctor, how would you decide in the following scenario?  There aren't enough donor organs to go around for patients who need a liver transplant. This sometimes forces doctors to make tough choices. If you were the doctor, how would you decide in the following scenario?Suppose there is a person who develops acute liver failure (ALF). While waiting for a liver transplant, this person gets sicker and sicker. When an organ is finally available, the chance that this person will survive WITH a transplant is only 42% at five years after the transplant. Since the average survival for most patients who receive a liver transplant is 75% at five years, the doctor wonders if it would be better to save the liver for someone else. Two possible ethical principles may guide the doctor in making this decision. 

Using the principle of URGENCY, the doctor would give the first available organ to the sickest patient on the transplant waiting list, the ALF patient, because she/he is otherwise likely to die within a few days.

Using the principle of UTILITARIANISM, the doctor would try to maximize the quality and quantity of life of all the people on the transplant list. Let's say there are 25 other patients currently on the waiting list, and transplanting the ALF patient increases their risk of death by 2% each, for a cumulative harm of 50%. Since this harm of 50% is more than the benefit to the ALF patient (42%), the liver should be saved for someone else on the list.

A third possibility is for the doctor to weigh both URGENCY and UTILITARIANISM in making a decision about a transplant.

If you were the ALF patient's doctor, what would you base your decision about a transplant on?
 
  • URGENCY (sickest patient on the list gets preference)
  • UTILITARIANISM (maximize benefit for the entire waiting list)
  • A combination of URGENCY and UTILITARIANISM

How do your answers compare?

There's no absolutely right or wrong answer in this case—the choice depends on which of several competing ethical principles or which combination of principles you follow. In choosing a combination of URGENCY and UTILITARIANISM, you've decided to try to balance the needs of the sickest patient with the needs of all the people on the transplant waiting list.

CBDSM researcher Michael Volk, MD, is the lead author on a recent article that tackles difficult decisions like this one. Volk and his colleagues examined a method to incorporate competing ethical principles in a decision analysis of liver transplantation for a patient with ALF. Currently, liver transplantation in the United States is determined by the principle of “sickest first," with patients at highest risk for death on the waiting list receiving first priority. In other words, the principle of URGENCY is paramount. However, most experts agree that, given the limited supply of organs, there should be a cutoff for posttransplant survival below which transplantation is no longer justified.

Where does society draw this line? And what framework can we use for ethical guidance?

Decision analysis of resource allocation would utilize the principle of UTILITARIANISM, to maximize the broad social benefit. But surveys of the general public have shown that most people prefer to temper utilitarianism with other considerations, such as equal opportunity, racial equity, and personal responsibility. Another factor that might be considered is the principle of fair chances. This is the idea that patients who have not had a chance at a liver transplant should receive priority over those who have already had once chance at a transplant.

Volk constructed a mathematical model (Markov model) to test the use of competing ethical principles. First he compared the benefit of transplantation for a patient with ALF to the harm caused to other patients on the waiting list, to determine the lowest acceptable five-year survival rate for the transplanted ALF patient. He found that giving a liver to the ALF patient resulted in harms to the others on the waiting list that cumulatively outweighed the benefit of transplantation for the ALF patient. That is, using UTILITARIANISM as the sole guiding ethical principle gave a clear threshold for the transplant decision: if the ALF patient did not have a five-year survival rate of at least 48%, she/he should not receive a transplant under this principle.

But UTILITARIANISM is not always the sole guiding ethical principle. When Volk adjusted the model to incorporate UTILITARIANISM, URGENCY, and other ethical principles such as fair chances, he got different thresholds. Depending on the combination of ethical principles used, Volk and his colleagues have shown that the threshold for an acceptable posttransplant survival at five years for the ALF patient would range from 25% to 56%.

The authors of this study conclude:

"Our model is an improvement over clinical judgment for several reasons. First, the complexity of the various competing risks makes clinical decision making challenging without some form of quantitative synthesis such as decision analysis. Second, a systematic approach helps ensure that all patients are treated equally. Most important, this study provides moral guidance for physicians who must simultaneously act as patient advocates and as stewards of scarce societal resources."

Volk ML, Lok ASF, Ubel PA, Vijan S, Beyond utilitarianism: A method for analyzing competing ethical principles in a decision analysis of liver transplantation, Med Decis Making 2008;28, 763-772.

Online: http://mdm.sagepub.com/cgi/content/abstract/28/5/763

More information:

Beyond utilitarianism: A method for analyzing competing ethical principles in a decision analysis of liver transplantation.
Volk M, Lok AS, Ubel PA, Vijan S. Medical Decision Making 2008;28(5):763-772.

 

Parents' decision-making about medicating infants (Jul-13)

Imagine that you are the parent of a 1-month-old infant. Your infant spits up a lot. Often there is so much spit-up that you are amazed that there is anything left in your infant’s stomach.  After spitting-up, your infant cries a lot. The crying and spitting seems especially bad after eating. But sometimes it seems like she is uncomfortable most of the time. It seems like there is nothing that you can do to stop the crying or to soothe your infant. You are worried that an infant who is this uncomfortable, and that spits up this much, might not be healthy. So, you decided to take your infant to the doctor to be checked.

After listening to your story and examining your infant, your doctor says, “You infant has something called GERD, or Gastroesophageal Reflux Disease. GERD happens when infants have a weak valve at the entrance to their stomach and, as a result, food and acid from the stomach can travel back up toward the infant’s mouth. When this happens, the infant may spit-up, and the acid in the spit-up may make her uncomfortable, and cause her to cry. Some doctors prescribe a medication that is often used to treat infants with GERD. Most infants grow out of GERD on their own, but medication is an option if you want it. However, studies have shown that this medicine probably doesn’t do anything to help improve symptoms in babies with GERD. This is the same medication that is taken by adults who have bothersome heartburn. This medication is generally considered safe for infants, and rarely causes serious side effects. I’ll give you this prescription and leave it up to you to decide whether or not you want to give it to your infant.”

Funded by American Cancer Society.

Funding Years: 2014-2017.

The study will examine how informal decision supporters (e.g., partners, family, and friends) contribute decisions about surgery, radiation, and chemotherapy treatment, and how these roles may vary by race and ethnicity. The project will utilize existing resources from the Cancer Surveillance and Outcomes Research Team's (CanSORT) Program Project Grant "The Challenge of Individualizing Treatments for Patients with Breast Cancer," a $13 million award received from NCI in 2012.

PI(s): Sarah Hawley

Co-I(s): Jennifer Griggs, Nancy Janz, Steven Katz, Yun Li

 

CBSSM joined 75+ exhibitors from labs and offices of the Medical School and across campus for the 2017 Researchpalooza.

Sponsored by the Office of Research, Researchpalooza is the perfect opportunity for colleagues and friends to have a great time and meet, mingle, and learn more about many of the organizations that offer their stellar services to faculty, students, and staff, all at one convenient time and location.

Funded by Health and Human Services, Department of-National Institutes of Health

Funding Years: 2014 - 2017.

Suicide is a leading cause of death and suicide attempts are a major cause of disability, lost productivity, and health care costs. Suicide prevention is a research priority of the National Institutes of Health, and the US Surgeon General's National Strategy for Suicide Prevention calls for a shift towards recovery-oriented prevention efforts which promote hope and social support. Hopelessness and social isolation are two proximal risk factors for suicide which may be improved via peer mentorship, a form of peer support effective for preventing depression and repeat psychiatric hospitalizations. The primary aims of this study are to develop and pilot test a peer mentorship intervention for psychiatrically hospitalized patients at high risk for suicide. The intervention will be adapted by an expert panel from existing peer support training protocols to target suicide risk factors and to enhance suicide risk management. Protocols for training and supervising peer mentors and measures of intervention fidelity will also be developed. The intervention will then be pilot teste among 60 participants randomly assigned to receive the peer mentorship intervention plus usual care or usual care alone. Participants will be recruited from the inpatient psychiatry unit at the University of Michigan Health System. Inclusion criteria will include medical record documentation of suicidal ideation or suicide attempt at admission, and exclusion criteria will include significant cognitive impairment (according to the Mini-Cog), current receipt of peer support, or determination that peer mentorship may cause distress to the patient or the peer mentor. The peer mentorship intervention will include an in-person visit on the inpatient unit and regular in-person or telephone follow-up for 3 months post-discharge. The intervention will be delivered by peer specialists--individuals in stable recovery from serious mental illness who have received formal training and certification in peer support from the state of Michigan--with at least 6 months of professional peer support experience. The primary outcomes of the pilot study are acceptability and feasibility of the intervention as determined by: 1) >50% of eligible participants enroll in the study, 2) >70% of enrollees complete final follow- up measures at 6 months, and 3) among those assigned to the peer mentorship intervention, >80% complete an inpatient session and the median number of total sessions is at least 4. Peer mentorship sessions will be recorded and rated for fidelity. Measures of suicidal ideation and suicide attempts (the intended primary outcomes of a subsequent efficacy study) and secondary outcomes such as quality of life, functioning, depression, and service use will be obtained at baseline, 3 months, and 6 months post-enrollment by a research assistant blinded to study arm. An exploratory aim will be to measure potential mediators of intervention effectiveness including belongingness, burdensomeness, and hopelessness according to the interpersonal theory of suicide. If acceptability and feasibility are demonstrated, the study will result in a novel recovey-oriented suicide prevention intervention ready for a fully-powered randomized controlled efficacy trial.

PI(s): Paul Pfeiffer

Co-I(s): Mark Ilgen, H. Myra Kim, Cheryl King, Marcia Valenstein

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