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Mon, June 23, 2014

Brian Zikmund-Fisher was interviewed by Reuters Health for the article "Shared decision making still lacking for cancer screening." He discusses his research and trade-offs in cancer screenings. "What this study does is it shows that despite all of the initiatives and the discussion of shared decision making that has been going on, we don't seem to be moving the needle very much," he states. 

His interview also received press in the Chicago Tribune and New York Daily News.

Funded by: NIH

Funding Years: 2016-2021

 

There is a fundamental gap in understanding how Mild Cognitive Impairment (MCI) influences treatment and Decision Making for serious illnesses, like Cardiovascular disease (CVD), in older patients. Poor understanding of Clinical Decision Making is a critical barrier to the design of interventions to improve the quality and outcomes of CVD care of in older patients with MCI. The long-term goal of this research is to develop, test, and disseminate interventions aimed to improve the quality and outcomes of CVD care and to reduce CVD-related disability in older Americans with MCI. The objective of this application is to determine the extent to which people with MCI are receiving sub-standard care for the two most common CVD events, Acute myocardial infarction (AMI) and acute ischemic stroke, increasing the chance of mortality and morbidity in a population with otherwise good quality of life, and to determine how MCI influences patient preferences and physician recommendations for treatment. AMI and acute ischemic stroke are excellent models of serious, acute illnesses with a wide range of effective therapies for acute management, Rehabilitation, and secondary prevention. Our central hypothesis is that older Adults with MCI are undertreated for CVD because patients and physicians overestimate their risk of dementia and underestimate their risk of CVD. This hypothesis has been formulated on the basis of preliminary data from the applicants' pilot research. The rationale for the proposed research is that understanding how patient preferences and physician recommendations contribute to underuse of CVD treatments in patients with MCI has the potential to translate into targeted interventions aimed to improve the quality and outcomes of care, resulting in new and innovative approaches to the treatment of CVD and other serious, acute illnesses in Adults with MCI. Guided by strong preliminary data, this hypothesis will be tested by pursuing two specific aims: 1) Compare AMI and stroke treatments between MCI patients and cognitively normal patients and explore differences in Clinical outcomes associated with treatment differences; and 2) Determine the influence of MCI on patient and surrogate preferences and physician recommendations for AMI and stroke treatment. Under the first aim, a health services research approach- shown to be feasible in the applicants' hands-will be used to quantify the extent and outcomes of treatment differences for AMI and acute ischemic stroke in older patients with MCI. Under the second aim, a multi-center, mixed-methods approach and a national physician survey, which also has been proven as feasible in the applicants' hands, will be used to determine the influence of MCI on patient preferences and physician recommendations for AMI and stroke treatment. This research proposal is innovative because it represents a new and substantially different way of addressing the important public health problem of enhancing the health of older Adults by determining the extent and causes of underuse of effective CVD treatments in those with MCI. The proposed research is significant because it is expected to vertically advance and expand understanding of how MCI influences treatment and Decision Making for AMI and ischemic stroke in older patients. Ultimately, such knowledge has the potential to inform the development of targeted interventions that will help to improve the quality and outcomes of CVD care and to reduce CVD-related disability in older Americans.

PI: Deborah Levine

CO(s): Darin Zahuranec, Lewis Morgenstern & Ken Langa

Fri, March 12, 2010

Peter Ubel, MD, spoke recently at the DeVos Medical Ethics Colloquy at Grand Valley State University in Grand Rapids, Michigan. Dr. Ubel's presentation, "Rationing vs. Rationalizing Health Care," was covered by news outlets in western Michigan. To see a clip from television reports, go to http://www.peterubel.com.

Tue, October 31, 2017

In a recent US Department of Health and Human Services symposium, Kayte Spector-Bagdady discussed the need for consistent informed consent and disclosure regulations for biospecimens and health data.

Sat, March 03, 2018

Reshma Jagsi's work was recently highlighted in Emergency Medicine News: "Special Report: Sexual Harassment a Muddle of Fear, Guilt, and Shame."

Research Topics: 
Fri, March 30, 2018

CBSSM Director, Reshma Jagsi, was one of six innovative women highlighted in Michigan Medicine Headline News for playing a vital role in patient care, education and research.

Would you participate if you knew this? (Mar-04)

When you decide to participate in a research study, what do you think the reserachers should inform you about?

Imagine that you have been diagnosed with depression. You see an ad in the local newspaper that a research group is studying a new drug for the treatment of depression and is recruiting people like yourself to participate. The study will investigate how effective the drug is at treating depression and will also look at whether the drug has any negative side effects.

Suppose the new drug is made by a small biotechnology company. The researcher owns a substantial portion of the stocks of the company. The value of the company's stocks can rapidly go up or down by large amounts depending on whether the drug is seen to be safe and effective for treating depression.

How important is it for you to know about the researcher's stock investment in the company before you consent to be in this study?

Do you think that the researcher should be required to tell you about his stock investment in the company before you are asked to participate?

Which option best reflects what you would do, given the researcher's stock investment in the drug company?How important is it for you to know about the researcher's stock investment in the company before you consent to be in this study?

  • Extremely important.
  • Very important
  • Somewhat important
  • Not very important
  • Not at all important

Do you think that the researcher should be required to tell you about his stock investment in the company before you are asked to participate?

  • Yes
  • No

Which option best reflects what you would do, given the researcher's stock investment in the drug company?

  • I would not participate in this study.
  • I'm not sure
  • I would still consider participating in this study

First, a little background:

The scenario you read and the questions you just answered were similar to ones that were asked to participants who have actually been diagnosed with depression. Also, individuals with coronary heart disease and breast cancer were given scenarios in which the researcher was said to be studying drugs that treated these health conditions. In the actual study, participants read seven scenarios, each having to do with a researcher's or university's personal financial investment in the drug being investigated. For instance, other scenarios included the university medical centre owning stocks of the drug company, the researcher receiving a lump sum of money per person enrolled in the study, and the drug company paying for the study.

Why were those questions important to ask?

Much of clinical research depends on patient volunteers to serve as research subjects. Patients must rely on the trustworthiness of the researchers who recruit them to help them decide whether to enroll in the study. This is especially true since benefit from participation can be uncertain. If an investigator or institution does not disclose that they have personal financial connections to the drug being studied, this could potentially undermine the trust of the participants. At the time that this study was submitted, there were no federal requirements on investigators or their institutions to disclose such financial conflicts of interest to potential research participants. This may continue to be the case in the future.

What can we say based on this study?

This study found two important trends: (1) Most potential research participants desired to be informed (and believed this should be required) regarding financial conflicts of interest in research, and yet (2) most still wanted to participate in such research. A clear majority still wanted to participate even in the most controversial scenario, which was the one you read on the previous screen. From these findings, then, it seems that the current practice of non-disclosure of financial conflicts of interest do not conform to the values and wishes of potential patient volunteers. It is not clear, however, whether disclosure, management, or elimination of financial conflicts of interest is the best solution. This study should not be taken to mean that only disclosure is required.

For more information see:

SYH Kim, RW Millard, P Nisbet, C Cox, ED Caine. Potential Research Participant's Views Regarding Researcher and Institutional Financial Conflicts of Interest. Journal of Medical Ethics, 30. 73-79. 2004.

When Money is Tight (Jul-04)

Because of the high cost of many prescription drugs, some people take fewer pills than prescribed. What are the health implications?

Imagine that four months ago, you started getting chest pains whenever you exerted yourself physically, and at the time you decided this was serious enough to see a doctor. After your doctor examined you and ran some tests, you were told that you have angina, a kind of heart disease. This disease can develop when the coronary arteries become narrow and clogged from high cholesterol and the heart can't get the oxygen that it needs. Your doctor helped you plan some lifestyle changes to treat your condition. You have been very devoted to the new way of life, eating healthier and doing the proper kinds of exercise regularly. Also, part of your treatment involves regularly taking the medication that your doctor prescribed for you. You were told to take one pill each day.

The trouble is your prescription drug insurance is limited and you find yourself having to pay the majority of the cost for the angina medication out of pocket. What's more, you have been struggling just to break even every month after accounting for all of your living expenses. Now you are worried about being able to afford the medication if you take it as regularly as prescribed. A pill a day may be doctor's orders, but it is getting costly for you.
 
Would you take the pill as often as prescribed or would you skip some days to try to save money?
 
  • I would take the pill every day as prescribed.
  • I would skip some days to save some money.

How do your answers compare?

You have to save money somehow, right? Perhaps you would just have to cut back on other expenses in your life, but apparently you felt the medication had to be taken as prescribed. Research has found, however, that especially among the elderly, a significant portion of the population reports restricting medications due to cost. An important question is whether this leads to adverse health outcomes. Policy debates have been largely divided on this issue.

Do those who restrict their medications due to cost experience adverse health outcomes?

A research team led by Dr. Michele Heisler and Dr. Kenneth Langa conducted a study to investigate this question. Prior to this study, no one had examined this question by studying the same individuals at different points in time to see if those who restricted medication due to cost were more likely to develop adverse health outcomes. The researchers obtained nationally representative data that was the result of nearly 8000 interviews. Each respondent was interviewed in 1995 or 1996 and then re-interviewed in 1998. At both times, individuals were asked about cost-related medication restriction and about their health. The health questions assessed overall health, angina and other cardiovascular diseases, diabetes, arthritis, and depression.

The researchers found that cost-related medication restriction was associated with almost twice the odds of experiencing a significant decline in overall health. The association between restricting medication due to cost and poor health outcomes was strongest for those who had cardiovascular disease. Of these individuals, those who restricted their medication had a 50% increased odds of suffering angina and a 51% increased odds of having a stroke. Aren't you glad on the previous page you said you wouldn't restrict your angina medication?

Those who had arthritis or diabetes and restricted their medication due to cost did not report worse disease-related outcomes at the second interview. For arthritis, this might have been because of equally effective over-the-counter pain medications, and for diabetes, higher rates of kidney disease would likely require a longer period of follow-up to detect. When looking at age as a factor, the results showed that older adults experienced significant declines in overall health, worse cardiovascular outcomes, and increased depression. The study showed that younger people who restrict are also at risk for a decline in their health.

One limitation of this study is the lack of data about how often individuals restricted medications. If an individual restricted only once or twice, it is not clinically plausible that this would have led to an adverse health outcome. Also, the data on health outcomes were self-reported, and thus subject to bias. Previous studies, however, have shown excellent agreement between medical records and self-reports for conditions such as hypertension, diabetes, and stroke.

Implications on policy

This study provides evidence that, contrary to some claims, adults with chronic illnesses who restrict medications due to cost experience adverse health outcomes. As drug costs continue to escalate and individuals continue to lack full prescription coverage from their health insurance, it will be increasingly important for healthcare systems and physicians to develop strategies to screen patients for cost-related underuse of medications and to provide assistance to these patients. Moreover, insurance companies will need to create benefit packages that provide appropriate coverage, taking into account the cost of prescription medications.

For more information see:

Michele Heisler, Kenneth M. Langa, Elizabeth L. Eby, A. Mark Fendrick, Mohammed U. Kabeto, John D. Piette. The Health Effects of Restricting Prescription Medication Use Because of Cost. Medical Care, 42(7). 2004.

A New Drug for the New Year (Jan-04)

Out with the old drugs and in with the new! How is your doctor prescribing for you?

Imagine that you are a physician and your patient is a 55-year-old white male with high blood pressure. He has no other medical problems, is on no medications, and has completed a 1-year program of diet and exercise to control his condition, but his blood pressure remains elevated at 170/105 (140/90 is the definition of high blood pressure).

As his physician, you have to decide on a medication to prescribe him in order to lower his blood pressure. You have the following options to choose from:

Diuretics: Diuretics are medications that lower blood pressure by getting rid of excess fluid in your body, making it easier for your heart to pump. They were first introduced in the 1950s.

Beta-blockers: Beta-blockers are medications that lower blood pressure by helping the heart to relax and pump more effectively, and by also reducing heart rate. They were first introduced in the 1960s.

ACE inhibitors: Angiotensin converting enzyme (ACE) inhibitors are medications that lower blood pressure by widening blood vessels and increasing blood flow. They were first introduced in 1981.

Calcium channel blockers: Calcium channel blockers are medications that lower blood pressure by relaxing blood vessels, reducing the heart's workload, and increasing the amount of blood and oxygen that reach the heart. They were also first introduced in 1981.
 
What type of medication would you prescribe this patient?
 
  • A diuretic
  • A beta-blocker
  • An ACE inhibitor
  • A calcium channel blocker

How do you compare to the physicians surveyed?

Of the physicians surveyed, 18% chose the same medication as you did. 38% chose an ACE inhibitor, 29% chose a beta-blocker, and 11% chose a calcium channel blocker. Most physicians chose an ACE inhibitor, a newer type of medication, rather than beta-blockers or diuretics, which are older types of medication.

Why is this important? When asked how they made their decision, the majority of physicians believed that diuretics were less effective and that beta-blockers were less likely to be tolerated by a patient's body than the other medications. However, a number of important studies have shown that beta-blockers and diuretics are as effective at lowering blood pressure as newer medications like ACE inhibitors and calcium channel blockers. Studies have also shown that beta-blockers and diuretics are equally or even better tolerated than the newer types of medications. Yet, the use of beta-blockers and diuretics has declined steadily in the past 15 years in favor of the newer and more expensive types of medications.

Why do physicians believe these things when the studies say otherwise?

The answer to this question is not fully known. One possibility is that physicians may be prescribing newer medications because these are the medications actively promoted by pharmaceutical companies. By providing free samples of the newer medications for physicians to give to patients, these companies may be influencing which medications physicians actually decide to prescribe. To test this possibility, after physicians had decided between diuretics, beta-blockers, ACE inhibitors, and calcium channel blockers, they were asked if they ever provide their patients with free medication samples from these companies to treat their high blood pressure. It was found that physicians who used free samples were more likely to believe that ACE inhibitors are more effective. This isn't proof that physicians are influenced by pharmaceutical companies when prescribing medication for high blood pressure, but it does urge us to seriously consider if physicians may need to be re-educated about the effectiveness and tolerability of beta-blockers and diuretics.

For more information see:

Ubel, PA, Jepson, C, Asch, DA. Misperceptions about beta-blockers and diuretics. Journal of General Internal Medicine, 18, 977-983. 2003.

 

Geoffrey Barnes has been selected as one of 12 IHPI junior faculty members to serve on the Junior Faculty Advisory Council (JFAC) to advocate for junior faculty professional development programs and activities within IHPI, and to provide perspective and feedback on issues and opportunities identified and brought to the JFAC by the Institute Leadership Team.

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