Ethics: A Patient’s Right to Not Know

Ethics: A Patient’s Right to Not Know.

Excerpt

Writing in Science, the chair of the Presidential Commission for the Study of Bioethical Issues notes it is increasingly common for physicians and medical researchers to discover a disease that was not the original target of a medical test or screening.

Amy Guttman Ph.D. notes these surprise clinical test results are called incidental and secondary findings. Guttman explains the surprise discovery of an unexpected illness from screening and similar tests is called an ‘incidental’ finding. Guttman adds when clinicians deliberately seek to discover a second or third disease in addition to the primary target, these results are called ‘secondary’ findings.

Guttman, who is the president of the University of Pennsylvania, writes (and we quote): ‘Improved technologies are making incidental and secondary findings increasingly common. They are becoming a growing certainty in clinical practice as well as in the distinct contexts of research and direct-to-consumer testing’ (end of quote). For example, Guttman notes an array of unexpected clinical findings may be generated by new CT scans intended to detect lung cancer in heavy smokers. The increased screening will occur because of recent recommendations from the U.S. Preventive Services Task Force, which we discussed in last week’s podcast.

Guttman writes before CT scans or other medical tests, clinicians should alert patients about the possibility of surprise findings regardless whether screening deliberately seeks (or accidentally finds) new, unexpected illnesses.

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Guttman notes while some persons will ask a physician to tell them about whatever clinical tests discover, some patients do not want to learn about incidental or secondary findings.

As a result, the Presidential Bioethics Commission recommends physicians and medical practitioners need to know a patient’s health priorities and tolerance to manage surprising results prior to clinical testing. Guttman writes (and we quote) ‘A patient who does not wish to learn about information related to the primary purpose of the test should not undergo the test. If a patient wishes to opt out of receiving incidental or secondary findings that are clinically significant and actionable, then clinicians should exercise their discretion whether to proceed with testing’ (end of quote).

Guttman notes health care providers should explain both the risks and rewards of finding unexpected illnesses that can occur from a new generation of sophisticated clinical tests, such as human genome screenings. While false positive findings are among the risks, Guttman explains the rewards include the detection of diseases and illness that could be clinically actionable.

In terms of biomedical ethics, Guttman concludes (and we quote):’ In keeping with shared decision-making, clinicians live up to their highest calling when they discuss how they will handle incidental findings with their patients’ (end of quote). While the Presidential Bioethics Commission provides more specific recommendations in their report, their overall intent is to improve patient-provider disclosure and communication as well as help patients anticipate the possibility of unexpected findings from routine testing.

The Commission’s report is available at bioethics.gov.

Meanwhile, a link to a website that explains some of the ethical issues associated with patient and provider health decision making (from Beth Israel Medical Center) is available in the ‘specific conditions’ section of MedlinePlus.gov’s medical ethics health topic page.

Similarly, a link to a website that explains some of the ethical issues associated with patient and provider treatment decisions (also from Beth Israel Medical Center) can be found in the ‘specific conditions’ section of MedlinePlus.gov’s medical ethics health topic page.

MedlinePlus.gov’s medical ethics health topic page also provides links to the latest pertinent journal research articles, which are available in the ‘journal articles’ section. You can sign up to receive updates about medical ethics as they become available on MedlinePlus.gov.

To find MedlinePlus.gov’s medical ethics health topic page type ‘medical ethics’ in the search box on MedlinePlus.gov’s home page. Then, click on ‘medical ethics (National Library of Medicine).’ MedlinePlus.gov additionally contains a health topic page on talking with your doctor, which provides tips to enhance provider and patient communication.

Related articles

• Bioethics Commission on incidental findings: Anticipate and communicate
• Panel Discussions – Bioethics at Huntington Hospital and Neurological Disorders with PALAC
• Improving the quality of clinical ethics consultants

Reduce Unnecessary Lab Tests, Decrease Costs by Modifying Software

From the 4 November 2013 ScienceDaily article

When patients undergo diagnostic lab tests as part of the inpatient admission process, they may wonder why or how physicians choose particular tests. Increasingly, medical professionals are using electronic medical systems that provide lists of lab tests from which medical professionals can choose. Now, a University of Missouri researcher and her colleagues have studied how to modify these lists to ensure health professionals order relevant tests and omit unnecessary lab tests, which could result in better care and reduced costs for patients.

“Ordering numerous lab tests can result in unnecessary testing and can cause physical discomfort and financial stress to patients,” said Victoria Shaffer, an assistant professor of health sciences in the MU School of Health Professions. “We found that by changing the way electronic order set lists were designed, we could significantly alter both the number and quality of lab tests ordered by clinicians.”

Shaffer and her research team studied how physicians selected lab tests using three order set list designs on the same electronic medical system. The first order set list design was an opt-in version in which no lab tests were pre-selected; this is the standard method of lab test ordering in electronic health records for most healthcare facilities. A second option was an opt-out version in which physicians had to de-select lab tests they believed were not clinically relevant. In the third design, only a few tests were pre-selected based on recommendations by pediatric experts. On average, clinicians ordered three more tests when using the opt-out version than the opt-in or recommended versions. However, providers ordered more tests recommended by the pediatric experts when using the recommended design than when using the opt-in design.

 

Read entire article here

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9-part series on over-diagnosis (short reads from a health care journalist)

Over-diagnosis happens when people are diagnosed with diseases or conditions that won’t actually harm them. 

www.shutterstock.com

 

From the 3 October 2012 blog article by Gary Schwitzer at HealthNewsReview.org

Ray Moynihan, a terrific health care journalist who is now pursuing his PhD on overdiagnosis and working as a Senior Research Fellow at Bond University in Australia, kicks off the first of a nine-part series, “Over-diagnosis Epidemic” on TheConversation.edu.au website.

The first part is an introduction, “Preventing over-diagnosis:  how to stop harming the healthy.”

“To put it simply, over-diagnosis happens when people are diagnosed with diseases or conditions that won’t actually harm them. It happens because some screening programs can detect “cancers” that will never kill, because sophisticated diagnostic technologies pick up “abnormalities” that will remain benign, and because we are routinely widening the definitions of disease to include people with milder symptoms, and those at very low risk.”

Other colleagues author the subsequent parts in the series:

Part two: Over-diagnosis and breast cancer screening: a case study

“…But what we found was that the greatest relative reduction in breast cancer mortality (44%) occurred in the youngest age group. These women (aged 40 to 49 years) are not invited for screening. In contrast, women aged 60 to 69 years, who areinvited to screen, had the smallest relative reduction in mortality (19%).

Given that three times as many women aged 60 to 69 (about 60%) participated in Breastscreen (compared to 20% of women aged 40 to 49 years), our finding is not consistent with screening having a major impact on the reduction in breast cancer mortality since 1991.”…

Part three: The perils of pre-diseases: forgetfulness, mild cognitive impairment and pre-dementia

“…Most studies show that only one in ten cases of mild cognitive impairment progress to dementia each year, and many improve. One study that followed outcomes for ten years concluded – “The majority of subjects with MCI do not progress to dementia at the long term.”…

Part four: How genetic testing is swelling the ranks of the ‘worried well’

“..A major concern with such tests is that they’re the beginning of a path toward over-diagnosis, where the potential to develop a disease or being at risk for the disease is strong enough to constitute a label of sickness.

Over-diagnosing includes, but is not limited to, widening disease definitions, early detections of abnormalities that may or may not cause symptoms or death and the use of increasingly sensitive technologies that detect “abnormalities,” the causes and consequences of which are unknown at this time…”

Part five: PSA screening and prostate cancer over-diagnosis

Part six: Over-diagnosis: the view from inside primary care

“..The most common reason general practitioners are sued is because of missed diagnoses. Missed diagnoses also invoke a strong sense of professional failure. So how can general practitioners manage in this sea of uncertainty?

One way is to perform more tests. This is also popular with patients, who perceive that tests ensure nothing serious is missed. What is not well understood by patients (and sometimes also by clinicians) is the potential harm from testing.

The most obvious harm is the cost and resources required; we would quickly overwhelm the health system if we performed an MRI on every patient with back pain. A strong system of primary care results in a health-care system that’s both more efficient and less costly because primary-care physicians are skilled at filtering those with severe disease needing further tests, from those with self-limiting illnesses…

…

The greatest harm from the increased use of testing, however, is not costs, resources or false positives. Rather, it’s the problem of over-diagnosis.

Clinicians and patients both believe that finding a disease earlier in its process means it will be more successfully treated. But there’s increasing evidence that finding disease early or at a milder stage has paradoxical harmful effects, even reducing survival and quality of life.

Wider availability of more sophisticated tests results in “incidentalomas”, incidental findings that would not have otherwise been diagnosed. The detection of thyroid cancers, for instance, has more than doubled in the past 30 years. But most of these diagnoses are incidental findings from imaging…”

Part seven: Moving the diagnostic goalposts: medicalising ADHD

Part eight: The ethics of over-diagnosis: risk and responsibility in medicine

Part nine: Ending over-diagnosis: how to help without harming

 

 

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Fast Tests Are Latest Weapons Against Infections

Janice Carr/CDC  A new lab test could quickly detect methicillin-resistantStaphylococcus aureus, or MRSA, bacteria like these in the blood.

From the 29 June 2012 article at National Public Radio (NPR)

Show up at the emergency room or your doctor’s office with symptoms of a serious infection, and there’s a good chance you’ll get an antibiotic. You might even get a few.

But antibiotics don’t work on viruses. And a particular antibiotic may be suited for one kind of germ, but not another.

The problem for your doctor — and you — is that it can take days to grow enough of the germs afflicting you to identify them conclusively using traditional tests. And if you’re really sick, the doctor may try a bunch of antibiotics right away, just to be sure one of them starts getting you back on the road to health….

…

Faster, more specific tests would help. And the Food and Drug Administration has recently approved some. This week, while you might have been distracted by the Supreme Court, the agency cleared a test for a dozen bacteria that cause infections in the blood.

“Bloodstream infections are always treated with antimicrobial drugs, and it is essential to identify which antimicrobial drug is appropriate for a specific patient as quickly as possible,” FDA’s Alberto Gutierrez said in a statement. “This new test is an important tool that will help physicians treat patients quickly with the correct antibiotics.”

The test, made by Nanosphere, works in a few hours instead of days. It fingerprints the germs’ DNA and can even detect when the bugs carry genes that render them resistant to some antibiotics. The test costs less than $100….

Related articles

• Fast Tests Are Latest Weapons Against Infections (wnyc.org)
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What Doctors Don’t Know & Journalists Don’t Convey About Screening May Harm Patients

From the 8 March 2012 blog item by Gary Schwitzerat at HeatlhNewsReview.org

A paper in the Annals of Internal Medicine this week asked (and partially answered): “Do Physicians Understand Cancer Screening Statistics?”

The authors – familiar names like Woloshin, Schwartz, Gigerenzer – are from the Harding Center for Risk Literacy at the Max Planck Institute for Human Development in Berlin and from the Dartmouth Institute for Health Policy and Clinical Practice.

It’s a shame this paper isn’t freely, publicly available to all readers because it may help explain some of the foundation of the dilemma we face in this country about miscommunication about the tradeoffs involved in screening tests.

Reuters Health reported:

“…three-quarters of the more than 400 doctors surveyed believed better survival rates prove screening is a lifesaver although that’s not the case, researchers say.

And nearly half thought early detection translates into saving lives — another common misperception.

“This is really unfortunate because one of the things we always say is, ‘Discuss it with your doctor,’” said Dr. Otis Brawley, chief medical officer of the American Cancer Society. “This is evidence that your doctor doesn’t know.”…

…

Dr. Steven Woloshin, of Dartmouth Medical School in Hanover, New Hampshire, who worked on the new survey…told Reuters Health that death rates gleaned from clinical trials are the only reliable way to judge if a screening test is effective. But organizations that promote screening, such as the breast cancer charity Susan G. Komen for the Cure, tend to prefer survival rates, which sound more impressive…

…

 Dr. Virginia Moyer of Baylor, also chair of the US Preventive Services Task Force, wrote an accompanying editorial, “What We Don’t Know Can Hurt Our Patients: Physician Innumeracy and Overuse of Screening Tests.“  In it, she mentioned our work:

“Excellent work on how to effectively communicate statistical data to both patients and physicians has been done, but more is needed. Work of this sort is being supported by the Agency for Healthcare Research and Quality and such groups as the Foundation for Informed Medical Decision Making. To temper the unbridled enthusiasm of patients for screening tests, and especially for cancer screening, we need to reach beyond medicine to the public, which of course gets a substantial amount of medical information from the media. Educational efforts should focus not just on medical students and physicians but also on journalists. Several medical journals have taken the lead in making it easier for journalists to get the statistics right and to recognize the limitations of the studies they report. Watchdog groups, such as HealthNewsReview.org, help to monitor press reports and should be encouraged to add interpretation of screening statistics to the criteria they use to assess health news stories.”…

 

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• Most U.S. Doctors Baffled by Cancer Screening Stats (nlm.nih.gov)
• Many Docs Order Unneeded Lung Cancer Screening Tests: Survey (news.health.com)
• Many Primary-Care Docs Don’t Understand Cancer-Screening Stats: Study (blogs.wsj.com)
• Ovarian Cancer Screening Popular Despite Guidelines (nlm.nih.gov)
• New Guidance For Colorectal Cancer Screening (medicalnewstoday.com)
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Do You Really Need a Yearly Checkup? | Yahoo! Health

Do You Really Need a Yearly Checkup? | Yahoo! Health By Lisa Collier Cool

Excerpt

Typically, a routine visit with your primary care doctor involves a slew of tests and screenings. While patients are often told that all this poking and prodding is crucial to protect their health, is there any scientific evidence to support that? A decade ago, the US Preventative Services Task Force (USPSTF), an independent group of medical experts appointed by Congress, concluded that yearly physicals are unnecessary for healthy, symptom-free adults.

What’s more, a new study published in Archives of Internal Medicine*** reports that primary care doctors often order unnecessary and inappropriate tests, screenings and treatments, costing the healthcare system—and patients—$6.8 billion in 2009. The annual checkup is a prime culprit in needlessly driving up medical bills, the researchers found, with dubious or worthless tests ordered in up to 56 percent of these exams.

Find out how to save big on rising healthcare costs.

Instead of a yearly checkup, the new thinking is that healthy patients should “check in” with their doctors periodically, on a schedule tailored to their individual needs, to discuss any medical concerns and which tests truly are appropriate for their age, gender, and family history. Here’s a look at routine screenings that primary care doctors are most likely to use needlessly, according to analysis by the National Physicians Alliance (NPA)—and when these tests are worthwhile….

Read the article (it includes comments about specific tests)

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***The article, “Top 5” Lists Top $5 Billion, is available online only through paid subscription.
Click here for suggestions on how to get this article (and other science/medicine articles) for free or at low cost 

Here are the first 150 words of the Top 5 article from the Archives of Internal Medicine Web page

Minal S. Kale, MD; Tara F. Bishop, MD, MPH; Alex D. Federman, MD, MPH; Salomeh Keyhani, MD, MPH 

Arch Intern Med. 2011;171(20):1856-1858. doi:10.1001/archinternmed.2011.501

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

The Good Stewardship Working Group presented the top 5 overused clinical activities across 3 primary care specialties (pediatrics, internal medicine, and family medicine), as chosen by physician panel consensus.¹ All activities were believed to be common in primary care but of little benefit to patients. We examined the frequency and associated costs of these activities using a national sample of ambulatory care visits.

Methods

We performed a cross-sectional analysis using data from the 2009 National Ambulatory Medical Care Survey (NAMCS) and the National Hospital Ambulatory Medical Care Survey (NHAMCS). The NAMCS and NHAMCS survey patient visits to physicians in non–federally funded, non–hospital-based offices and non–federally funded hospital outpatient departments, respectively.²

We limited our sample to visits by patients to their primary care physicians. Visits for each “top 5” primary care activity were identified . . . [Full Text of this Article]

Self-Affirmation May Break Down Resistance to Medical Screening

From the 21 December 2011 News article

People resist medical screening, or don’t call back for the results, because they don’t want to know they’re sick or at risk for a disease. But many illnesses, such as HIV/AIDS and cancer, have a far a better prognosis if they’re caught early. How can health care providers break down that resistance?

Have people think about what they value most, finds a new study by University of Florida psychologists Jennifer L. Howell and James A. Shepperd. “If you can get people to refocus their attention from a threat to their overall sense of wellbeing, they are less likely to avoid threatening information,” says Howell. Do that, and people are more likely to face a medical screening even if it means undertaking onerous treatment and even if the disease is uncontrollable. The findings will appear in Psychological Science, a journal published by the Association for Psychological Science.

The researchers undertook three studies, each with about 100 students of both sexes. In all three studies, they asked the participants to think of a trait they valued; they chose traits such as honesty, compassion, and friendliness. Participants then wrote either about how they demonstrated the trait (expressing self-affirmation) or a friend (not affirming themselves) demonstrated the trait….

Read the entire news article

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Should Patients Get Direct Access to Their Laboratory Test Results? An Answer With Many Questions

From the November 28 article in the Journal of the American Medical Association 

In the outpatient setting, between 8% and 26% of abnormal test results, including those suspicious for malignancy, are not followed up in a timely manner.^1​,2Despite the use of electronic health records (EHRs) to facilitate communication of test results, follow-up remains a significant safety challenge. In an effort to mitigate delays, some systems have adopted a time-delayed direct notification of test results to patients (ie, releasing them after 3 to 7 days to allow physicians to review them).^3​,4

On September 14, 2011, the Department of Health and Human Services jointly with the Centers for Medicare & Medicaid Services, the Centers for Disease Control and Prevention, and the Office for Civil Rights^5​ proposed a rule allowing patients to access test results directly from the laboratory by request (paper or electronic). …

Read the entire commentary

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  “The study found that doctors worried that open visit notes would result in greater confusion and worry among patients and they anticipated more patient questions between visits.  But the patients overwhelmingly wanted to see the notes and were not worried about being confused.   They thought seeing their own record would provide information that would help them be healthier.  They could see the treatment plans and the test results directly.”

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