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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.

Is it disgusting? (May-08)

People vary in their attitudes toward physical disabilities. Give us your reactions, and we'll tell you the results of surveys of the general public--and of actual patients.

 

Strongly

disagree

Mildly

disagree

Mildly

agree

Strongly

agree

I try to avoid letting any part of my body touch the toilet seat in a public restroom, even when it appears clean.

1

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4

It would make me uncomfortable to hear a couple making love in the next room of a hotel.

1

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3

4

It would bother me tremendously to touch a dead body.

1

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3

4

Even if I were hungry, I would not eat a bowl of my favorite soup if it had been stirred by a used-but thoroughly washed- fly-swatter

1

2

3

4

I am bothered by the odor caused by passing gas.

1

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4

The smell of other persons' bowel movements disgusts me.

1

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4

Consider the following

Now we'd like you to think about a specific health condition. Please read this scenario carefully so that you can answer some questions. Imagine you have a colostomy. A colostomy is an operation involving the surgical redirection of your bowels through a hole created in your gut. This hole is called a stoma. Waste passes through your intestines and out the stoma into a bag, which you must empty several times a day. If you wear relatively loose clothing, this bag won't be visible underneath your garments. Occasionally, you'll experience odors and noises caused by gas and waste passing through the stoma into the bag. There's also the chance that the colostomy bag may leak if it's allowed to fill past capacity. Although you'll be restricted from lifting very heavy objects, your daily activities won't otherwise be greatly affected by the colostomy.

To what extent does your colostomy make you feel embarrassed or socially uncomfortable?
Not at all 1       2       3       4       5       6       7       8       9        10 Very Much
 
To what extent does your colostomy make you feel stigmatized?
Not at all 1       2       3       4       5       6       7       8       9        10 Very Much
 

How do your answers compare?

Do your responses to the six questions on the disgust scale correlate with the stigmatization you expressed related to your imaginary colostomy?

In their national survey of the general public (people without colostomies), CBDSM researchers found that people who reported a higher level of disgust sensitivity responded more negatively to colostomy.

Current and former colostomy patients were also surveyed. In these groups, patients with higher disgust sensitivity had more difficulty adjusting to life with a colostomy. Specifically,colostomy patients with higher disgust sensitivity felt more stigmatized in society by their colostomy and felt more bothered by colostomy symptoms, such as leakage. Dr. Dylan Smith and his colleagues postulate that people who have a pre-existing high sensitivity to disgusting stimuli will be less likely to adjust well to life with a colostomy. Alternatively, it could be that people who adjust successfully to a colostomy do so in part by reducing their sensitivity to certain kinds of disgusting stimuli.

If future studies show that we can predict that patients with high disgust sensitivity are likely to have more difficulty adjusting to a colostomy, health-care teams can then seek ways to de-sensitize responses to bowel functioning, in order to aid patients in their adaptation to life with a colostomy. Further, many people with inflammatory bowel syndrome can choose whether or not to have a colostomy for relief of their symptoms. For these patients, a clear understanding of disgust sensitivity could be a factor in helping to make an informed choice about elective colostomy.

Certainly this research suggests that disgust plays a role in perceived and actual stigmatization of disabled patients. Previous studies of patients' adjustment to disability have focused on general responses to adversity, taking into account their social support, their coping style, or their optimism, for example. The uniqueness of this recent CBDSM study is that it considers how the specific challenges of a disability interact with a personality trait relevant to that disability: disgust sensitivity. This personality trait might also be linked to other health conditions, such as amputation or incontinence. In addition, personality traits other than disgust might affect patients' adaptation to other disabilities.

Read the article:

Sensitivity to disgust, stigma, and adjustment to life with a colostomy
Smith DM, Loewenstein G, Rozin P, Sherriff RL, Ubel PA. Journal of Research in Personality 2007;41(4):787–803.

The Disgust Scale used here is adapted from the work of Haidt J, McCauley C, Rozin P. Individual differences in sensitivity to disgust: A scale sampling seven domains of disgust elicitors. Personality and Individual Differences. 1994; 16(5): 701-713.

 

Angela Fagerlin was listed as one of the top 1% of most-cited researchers worldwide.

More than 3,200 researchers worldwide were included in the Thompson Reuters list, which ranks an individual’s impact based on a survey of Highly Cited Papers (defined as being in the top 1 percent by citations in the Web of Science database) between 2002-2012.

The University of Michigan ranks No. 11 in a new list of most-cited researchers produced by Thompson Reuters, with 27 U-M scientists determined by the company to be in the top 1 percent of their fields.

Link: http://research.umich.edu/blog/2014/07/31/u-m-ranks-no-11-in-new-list-of-most-cited-researchers/

Link: https://www.umhsheadlines.org/2014/08/angela-fagerlin-ph-d-listed-as-one-of-the-top-1-of-most-cited-researchers-worldwide/

 

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.

Dr. Andrew Barnosky stepped down from his role as Adult Ethics Committee chair, which is a position he has served for the last 16 years. CBSSM Faculty member Dr. Andrew G. Shuman will be the new committee chair. Dr. Barnosky will continue as a member of the faculty and a member of the Committee. The UMHS press release can be found here.

Kathryn Moseley and Ed Goldman are co-authors on an NEJM Sounding Board article, “No Appointment Necessary? Ethical Challenges in Treating Friends and Family.” Full author list includes Katherine J. Gold, M.D., M.S.W., Edward B. Goldman, J.D., Leslie H. Kamil, J.D., Sarah Walton, M.D., Tommy G. Burdette, M.Div., and Kathryn L. Moseley, M.D., M.P.H. The link to the article can be found here.

Maria Silveira, MD, MPH, is the lead author on an article in the New England Journal of Medicine (April 1, 2010) on end-of-life decision making. Silveira and her colleagues found in a large-scale study that more than a quarter of the elderly lacked decision-making capacity as they approached death. Those who had advance directives were very likely to get the care that they wanted. Co-authors on the study are Kenneth Langa, MD, PhD, and Scott Y.H. Kim, MD, PhD. Read a press release about the article here.

Wed, June 04, 2014

The Huffington Post blog by Dr. Phillip Sharp marks the sixth anniversary of Stand Up To Cancer (SU2C), funded by the American Association for Cancer Research (AACR). CBSSM faculty Scott Roberts, Scott Kim, and Ray DeVries and staff are involved with the SU2C-PCF Dream Team (Precision Therapy of Advanced Prostate Cancer).

Research Topics: 

The Genetics in Primary Care Institute recently launched its new website, featuring co-chairperson Beth Tarini, M.D., assistant professor of pediatrics at the University of Michigan’s C.S. Mott Children’s Hospital.

Along with Robert Saul, M.D., Tarini co-chairs the Institute, which aims to take genetic advances made during the last decade and help make them useful in the practice of primary care pediatrics.

The new website, www.geneticsinprimarycare.org, features information for primary care providers related to genetics testing, ethical, legal and social issues, patient communication and family history.

Tarini’s research focuses on the communication process and the health outcomes associated with genetic testing in pediatrics. She is particularly interested in pediatric population-based screening programs, such as newborn screening. Through her research, Tarini seeks to optimize communication about genetic testing between parents and providers in an effort to maximize health and minimize harm.

The UMHS press release can be found here. Dr. Tarini's featured page can be found here

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