Joseph joined CBSSM as a Research Area Specialist in November 2017. As a project manager, he coordinates the daily operations of Dr. Jeffrey Kullgren’s project “Provider, Patient, and Health System Effects of Provider Commitments to Choose Wisely,” a grant funded research project using novel approaches to reduce the overuse of low-value services in healthcare.
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Dr. Jeff Kullgren and Dr. John Ayanian testified before the Michigan Health Care Cost and Quality Advisory Committee regarding the feasibility of and policy options for creating an All-Payer Claims Database (APCD) in Michigan.
Established by the Healthy Michigan Legislation (PA 107 of 2013), the Committee is composed of cabinet-level leadership from the state's Departments of Community Health and Insurance and Financial Services, as well as leadership from the Michigan House and Senate Health Policy Committees. The Committee is tasked with reviewing existing efforts across the United State to make health care cost and quality more transparent. Dr. Ayanian and Dr. Kullgren shared their research and practical expertise with the Committee by discussing a broad range of issues related to the feasibility of an APCD in Michigan, including governance structure; funding sources; data collection, storage, and security issues; and opportunities for research and innovation.
[ From IHPI Policy Corner]
[ From IHPI Policy Corner]
In the January-February issue of IRB: Ethics & Human Research, Scott Y.H. Kim, Raymond de Vries, Renee Wilson, Sonali Parnami, Samuel Frank, Karl Kieburtz, and Robert G. Holloway present results of a study about the therapeutic orientation of research participants.
The authors examined the relationship between understanding and appreciation of randomization probabilities in 29 individuals recruited for a sham surgery controlled intervention study in Parkinson's disease. 83% provided the correct, quantitative answer to the understanding question; of those, one group (55%) answered the appreciation question correctly using quantitative terms, whereas the remaining group (45%) provided only qualitative comments.
The therapeutic orientation of research participants raises concerns about the adequacy of consent because such an orientation could cloud understanding of key elements of research. Further, even if participants understand (i.e., intellectually comprehend) elements of research, they may not appreciate them because they fail to apply such facts to themselves.
Study participants frequently made "unrealistic" probability statements, even while providing correct quantitative responses. Analysis showed that this apparent "irrationality" may in fact hide a deeper rationality -- namely, conversational rationality, which is part of the contextual nature of meaning conveyed in everyday language. Ignoring conversational rationality may lead to wrongly labeling research subjects as irrational. Click here for more information.
Michele Heisler, MD, MPA, is Professor of Internal Medicine at the University of Michigan Medical School, Professor, School of Public Health, and Research Scientist at the Ann Arbor VA's Center for Clinical Research Management. Dr. Heisler's clinical interest is chronic disease, with a focus on diabetes. Her research centers on patient self-management of chronic illnesses, patient-doctor relations and disparities in processes and outcomes in chronic illnesses.
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.
What's the difference between opting in and opting out of an activity? Who decides if people will be put automatically into one category or another? Click this interactive decision to learn how default options work.
Imagine that you're a US Senator and that you serve on the Senate's Committee on Health, Education, Labor, and Pensions. The Infectious Diseases Society of America has come before your committee because they believe that too many health care workers are getting sick with influenza ("flu") each year and infecting others. As a result, your Senate committee is now considering a new bill that would require that all health care workers get annual influenza vaccinations ("flu shots") unless the worker specifically refuses this vaccination in writing.
Do you think you would support this bill for mandatory flu shots for health care workers?
Imagine that you're the human resources director at a mid-sized company that's initiating an employee retirement plan. Management is concerned that many employees are not saving enough for retirement. They're considering a policy that would automatically deduct retirement contributions from all employees' wages unless the employee fills out and submits a form requesting exemption from the automatic deductions.
Do you think a policy of automatic retirement deductions is reasonable for your company to follow?
Organ transplants save many lives each year, but there are always too many deserving patients and too few organs available. To try to improve the number of organs available for donation, the state legislature in your state is considering a new policy that all people who die under certain well-defined circumstances will have their organs donated to others. The system would start in three years, after an information campaign. People who do not want to have their organs donated would be given the opportunity to sign a refusal of organ donation when they renewed their drivers' licenses or state ID cards, which expire every three years. Citizens without either of these cards could also sign the refusal at any drivers' license office in the state. This is a policy similar to ones already in place in some European countries.
Does this seem like an appropriate policy to you?
How do your answers compare?
For many decisions in life, people encounter default options-that is, events or conditions that will be set in place if they don't actively choose an alternative. Some default options have clear benefits and are relatively straightforward to implement, such as having drug prescriptions default to "generic" unless the physician checks the "brand necessary" box. Others are more controversial, such as the automatic organ donation issue that you made a decision about.
Default options can strongly influence human behavior. For example, employees are much more likely to participate in a retirement plan if they're automatically enrolled (and must ask to be removed, or opt out) than if they must actively opt in to the plan. Researchers have found a number of reasons for this influence of default options, including people's aversion to change.
But default options can seem coercive also. So, an Institute of Medicine committee recently recommended against making organ donation automatic in the US. One reason was the committee's concern that Americans might not fully understand that they could opt out of donation or exactly how they could do so.
The policy scenarios presented to you here have been excerpted from a 2007 article in the New England Journal of Medicine titled "Harnessing the Power of Default Options to Improve Health Care," by Scott D. Halpern, MD, PhD, Peter A. Ubel, MD, and David A. Asch, MD, MBA. Dr. Ubel is the Director of the Center for Behavioral and Decision Sciences in Medicine.
This article provides guidance for policy-makers in setting default options, specifically in health care. Generally, default options in health care are intended to promote the use of interventions that improve care, reduce the use of interventions that put patients at risk, or serve broader societal agendas, such as cost containment.
In this NEJM article, the researchers argue that default options are often unavoidable-otherwise, how would an emergency-room physician decide on care for an uninsured patient? Many default options already exist but are hidden. Without either returning to an era of paternalism in medicine or adopting a laissez-faire approach, the authors present ways to use default options wisely but actively, based on clear findings in the medical literature.
Some examples of default policies that may improve health care quality:
- routine HIV testing of all patients unless they opt out.
- removal of urinary catheters in hospital patients after 72 hours unless a nurse or doctor documents why the catheter should be retained.
- routine ventilation of all newly intubated patients with lung-protective settings unless or until other settings are ordered.
Drs. Halpern, Ubel, and Asch conclude, "Enacting policy changes by manipulating default options carries no more risk than ignoring such options that were previously set passively, and it offers far greater opportunities for benefit."
Read the article:
Harnessing the power of default options to improve health care.
Halpern SD, Ubel PA, Asch DA. New England Journal of Medicine 2007;357:1340-1344.
Dr. Sandberg is a pediatric psychologist and clinical researcher. As a pediatric psychologist, he delivers psychoeducational and behavioral health services to persons with endocrine disorders and their families, in particular, conditions affecting linear growth or disorders of sex development (DSD), i.e., congenital conditions in which development of sex chromosomes, gonads or sex anatomy is atypical.
Click to decide between death and living with a colostomy. Which would you choose? Are you sure?
Given the choice, would you choose immediate death,or living with a colostomy (where part of your bowel is removed and you have bowel movements into a plastic pouch attached to your belly)?
- Immediate Death
Think about what it would be like if you were diagnosed with colon cancer. You are given the option of choosing between two surgical treatments.The first is a surgery that could result in serious complications and the second has no chance of complications but has a higher mortality rate.
|Possible outcome||Surgery 1
|Cure without complication||80%||80%|
|Cure with colostomy||1%|
|Cure with chronic diarrhea||1%|
|Cure with intermittent bowel obstruction||1%|
|Cure with wound infection||1%|
|No cure (death)||16%||20%|
If you had the type of colon cancer described above, which surgery do you think you would choose?
- Surgery 1
- Surgery 2
How do your answers compare?
Are you saying what you really mean?
CBDSM investigators Brian Zikmund-Fisher, Angela Fagerlin, Peter Ubel, teamed up with Jennifer Amsterlaw, to see if they could reduce the number of people choosing the surgery with the higher rate of death and therefore reducing the discrepancy. A large body of past research has shown that people are notoriously averse to uncertainty. The investigators had a hunch that uncertainty could account for some of the discrepancy. Surgery 1 has a greater number of ambiguous outcomes, perhaps causing people to be averse to it. In an effort to minimize this uncertainty, the investigators laid out a series of scenarios outlining different circumstances and presentations of the two surgeries. For example the research presented some of the participants with a reframing of the surgery information, such as:
|Possible outcome||Surgery 1
|Cured without complication||80%||80%|
|Cured, but with one of the following complications: colostomy, chronic diarrhea, intermittent bowl obstruction, or wound infection||4%|
|No cure (death)||16%||20%|
The investigators believed by grouping all of the complications together that people would be more apt to chose the surgery with the lower mortality rate, because seeing a single group of undesirable outcomes, versus a list, may decrease some of the ambiguity from previous research.
Although none of the manipulations significantly reduced the percentage of participants selecting Surgery 2, the versions that yielded the lowest preference for this surgery all grouped the risk of the four possible complications into a single category, as in the example shown above.
Why these findings are important
Over the past several decades there has been a push to give patients more information so they can make decisions that are consistent with their personal preferences. On the other hand there is a growing psychological literature revealing people's tendency to make choices that are in fact inconsistent with their own preferences; this is a dilemma. Because the present research suggests that the discrepancy between value and surgery choice is extremely resilient, much research still needs to be done in order to understand what underlies the discrepancy, with the goal of eliminating it.
The research reported in this decision of the month is currently in press. Please come back to this page in the near future for a link to the article.
Read the article:
Can avoidance of complications lead to biased healthcare decisions?
Amsterlaw J, Zikmund-Fisher BJ, Fagerlin A, Ubel PA. Judgment and Decision Making 2006;1(1):64-75.