Sunday, November 30, 2008

Motivating Prevention: from Carrots and Sticks to “Carrots” and “Sticks”

Incentives used by private and public wellness promotion programs should offer unnecessary extras as “carrots” and should employ “sticks” that do not deprive individuals of needed services or resources.

Nir Eyal, DPhil

When patients do not follow sound medical advice that would help prevent and treat disease, is it ethical to deny them benefits that more adherent patients enjoy? Some argue that making benefits contingent on adherence increases adherence without any unfairness: non-recipients have only themselves to blame.

Learning Objective: Understand the argument that incentives used by private and public wellness promotion programs should offer unnecessary extras as “carrots” and should employ “sticks” that do not deprive individuals of needed services or resources.

Recent years have seen growing support for the idea of patient responsibility. Some writers argue that patients with alcohol-related end-stage liver disease should receive lower priority on waiting lists for livers than other end-stage liver disease patients [1]. Corporate wellness programs are sweeping the country, offering employees DVDs, iPods, plane tickets, and $150 to participate in on-site exercise programs and health screenings or to sign up their children for anti-obesity programs [2]. A reduction in the rate of increase in national health expense was partly credited to programs such as these [3].

West Virginia currently operates a pilot program in three counties that gives enhanced benefits to adherent Medicaid patients who keep medical appointments, take their medications, and follow health-improvement plans. The enhanced-benefits package includes weight-loss programs, cardiac rehabilitation, chemical-dependency treatment, mental-health services, diabetes-management classes, and waiver of the general cap on reimbursed prescription drugs at $4 per month [4]. Other states are eying developments in West Virginia closely. Redesigned Medicaid programs that incorporate patient responsibility are being introduced in Florida, Idaho, and Kentucky. Also of interest are patient-responsibility reforms in Germany and Scotland [5].

Offering carrots and sticks to encourage adherence to medical advice makes sense in some ways. Epidemiologists recognize the dramatic contribution of personal and lifestyle choices to health, particularly in relation to chronic conditions like diabetes, hypertension, and cardiovascular disease and also in preventing and treating HIV/AIDS and other infectious diseases. Many ethicists and political philosophers, including some egalitarians, see no injustice in holding people responsible for their voluntary choices [6-9].

Traditionally, physicians and ethicists opposed holding patients responsible for unhealthy choices, often pointing to factors within and external to the patient that limited his or her capacity for compliance and healthy behaviors. Is it really just, they asked, to treat the unhealthy choice of an addict as voluntary and to hold her fully responsible for it? If not, is it just to treat the failure of an impoverished patient to maintain a healthy diet or keep appointments as voluntary when she has two jobs, a family, and little access to healthful food, childcare, and adequate transportation to the clinic? Given the well-established correlation across cultures between poverty and unhealthy lifestyles, can it be just to hold individuals responsible for choices typical of their socioeconomic sector [10]?

And even if risky choices of certain kinds—climbing mountains, driving recklessly, becoming pregnant—are typically voluntary, can an insurer tell in a specific case whether the choice was fully voluntary? If it were truly voluntary, would it not still be cruel to deny treatment to those who, owing to their own choices, need it [11]? Aren't patient-responsibility programs simply conspiracies to cut back Medicaid or shrink benefits to the poor [12, 13]?

There are problems from the care-provider perspective as well. Would it really boost health outcomes or cut costs if physicians monitored and reported their own patients' adherence, or would it only build distrust, stigma, and humiliation [10, 14]? If health is affected by personal choice, isn't it best to institute policies "upstream" that encourage healthy choices through increasing access to education, sufficient income, and attractive, user-friendly health services [15]? In short, where some see promise of significant financial and health gains in holding patients responsible for (non)adherence, others see injustice, cruelty, and little if any gain [16].

Which Incentives?

Assessments of patient-responsibility programs seldom focus on the kinds of incentives used to motivate adherence, when, in fact, the choice of incentive can be wise or harmful. Consider one incentive in West Virginia's Medicaid reform program: funding for chemical-dependency services—presumably for smoking cessation and substance-abuse rehabilitation programs. Prior to the reform, all West Virginian Medicaid patients in need were entitled to such services [17]. Now, access to chemical-dependency services, both inpatient and outpatient, is among the "prizes" for adherent patients [4]. Those who are addicted to drugs need detoxification to restore themselves physically, emotionally, and socially. Blocking their access to chemical-dependency services is cruel and may contravene their rights to urgent care.

By definition, those addicted to chemical substances enjoy only partial control over certain unhealthy choices, so denial of chemical-dependency services typically remains unjust even if we accept that fully voluntary, unhealthy choices could have justified sanctions. (West Virginia makes no formal exceptions for patients who develop addiction before the age of maturity or by using prescription medications for medical conditions.) Continued addiction produces negative consequences for others, ranging from secondhand smoke to domestic violence. Affected family, friends, and coworkers clearly made no choices that might have justified holding them responsible.

From Carrots and Sticks to "Carrots" and "Sticks"

West Virginia's use of chemical-dependency programs as an incentive for adherence is inopportune. If Medicaid and other public programs wish to offer incentives to encourage adherence, what kinds of incentives might they use instead? I propose that incentives for adherence should be products or services that patients desire strongly but that have little or no intrinsic value and small impact on their health and well-being. Such incentives are desired but not truly desirable. Rather than real carrots and sticks, they constitute stimulating, yet illusory, "carrots" and "sticks."

Consider a health practitioner's deliberate use of patients' embarrassment as a "stick" that motivates healthy choice. Last year, a new dentist got me finally to start flossing regularly by looking convincingly perturbed at my poor adherence and inviting me to frequent follow-ups until I become adherent. I am still under "probation," but I flossed regularly this past year and feel good about my chances to stick to the new patterns, because after a couple of meetings it became too embarrassing to return without results.

Health-system design can also use our superficial but often overwhelming sense of embarrassment to promote healthy behavior. In directly observed therapy (DOT), patients are watched when they take medication or receive treatment. A form of this method is central to the World Health Organization's Stop TB Strategy [18]. DOT is now used in the treatment of many additional infectious and chronic diseases. Consider how this method works. Admittedly, the visit from a health worker reminds patients to take their medication, but it seems to ensure they take it mainly by creating a situation in which it would be too embarrassing not to take it.

Patients with obstructive sleep apnea provide another example. These patients benefit from connecting to oxygenation machines during sleep hours, but adherence is often poor. Here, direct observation of patient compliance would have been too intrusive. Nevertheless, many new oxygenation machines are equipped with an embedded card that registers both sleep patterns and the patient's use of the machine. If physicians regularly read the card in front of patients it might increase adherence.

Automatic registration of apnea patients' behavior might also improve adherence through a very different route: by allowing insurers to deny coverage or increase premiums for nonadherent patients. I propose that the first kind of disincentive—embarrassment from one's physician—is preferable to the latter, which can result in real harms to patients. Hence, instead of using real carrots and sticks, it is usually better to use "carrots" and "sticks"—outcomes that patients strongly desire or dread, but that do not benefit or harm them dramatically. Unlike steep fines (or profound stigma and humiliation), embarrassment is usually benign.

Medicaid and other public programs could also use these "carrots" and "sticks." Their standard packages could dramatically improve for all patients, so long as adherent patients alone receive something that most target patients strongly desired. Suppose that in West Virginia the prize for adherence was exclusive funding, not for chemical-dependency services, but for using a "dream" private hospital. Suppose also that public facilities for Medicaid patients greatly improved. While the products and services offered at the private hospital could not be far superior to those at highly improved public facilities, the private hospital's advertising could make them appear far more attractive. Advertisements could feature the private hospital's newer, shinier equipment (which achieves the same results as the equipment in the public hospital); the even shorter wait periods (for non-emergent conditions); alternative treatments that it alone performs (to little medical effect); and plush lobbies, greater food choice, and fancier cutlery. Advertisements would neglect to mention that public institutions reach similar or better clinical outcomes, handle patients' records more efficiently, and never offer unnecessary procedures.

Many Medicaid patients might take better care of themselves to win prizes they desire strongly, and at the same time justice and compassion would be respected so long as the highly desired prizes are not highly desirable: there is little inequity or cruelty in denying nonadherent patients a benign "prize," or even in visiting a benign "burden" on them. Justice and compassion matter only in the distribution of real benefits—genuinely desirable goods and privileges; "misdistribution" of things with little or no real value is neither iniquitous nor harsh. Thus, tying distribution of desired but nondesirable products and services to patients' adherence may suffice to motivate patients, while avoiding gross injustice and cruelty.

The Possibility of "Carrots" and "Sticks" in Health Care

One reason why products and services can be desired but not desirable is our "bounded rationality." For example, experiments in behavioral economics show that we put more weight on losing benefits that are already ours and that how available options are framed affects our decisions dramatically [19].

Physicians are aware of their own bounded rationality, as well as that of their patients and research participants—for example, their difficulties and systematic biases in calculating and grasping probabilities. Bounded rationality often leads us to desire treatments more or less than they are desirable given their risks and benefits. Judging from the dearth of kidneys for transplantation, it seems fair to conclude that few people fully realize that the 1-in-3,000 risk of death due to kidney extraction is lower than other risks they regularly confront. It is surprisingly rare to find a research participant who fully grasps that, if 50 percent of participants in a trial are in the placebo arm, she stands a 50 percent chance of not receiving the trial treatment [20]. Patients' desire to avoid health problems and unpleasant procedures is notoriously "adaptive," weakening as they grow accustomed to them [21]. Either before or after adaptation, there was mismatch between the respective levels of desire and desirability.

The potential in using patients' systematic biases to promote health is also increasingly recognized. Cafeteria design that tends to manipulate diners into making healthier food choices (salad bars are located at the entrance to the cafeteria, complete with big salad containers) exploits our bounded rationality. So do opt-out programs for kidney donation already in place in several European countries. By requiring a positive action to opt out of donating, these programs use our biases to boost the pool of organs available for transplantation [22].

Conclusion

One important desideratum in incentives for healthy choice is that many members of the target group desire them although the incentives are not truly desirable. Using incentives that patients strongly crave increases health outcomes and cost-efficiency by motivating adherence—but it involves little injustice or cruelty when these incentives lack real value.

There are two caveats. My examples of such incentives are merely illustrative. To establish that these particular incentives are strongly desired but nondesirable lies beyond the scope of the present hypothesis-generating article. If the particular incentives I mentioned do not answer that description, then the proposed principle still stands: desired but nondesirable is usually an important desideratum in incentives for healthy choice.

A second caveat is that this is only one desideratum in incentives for adherent choice. An incentive that satisfies this desideratum may remain problematic in other respects. For example, many cosmetic treatments are strongly desired and arguably not truly desirable, but some are so objectively undesirable as to be dangerous; Medicaid clearly should not use dangerous treatments as incentives. Nor should Medicaid use other desired and nondesirable incentives if using them would foil initiatives to educate the public against desiring them. It is for that reason that benign but wholly unnecessary cosmetic treatments may also disqualify as incentives. Finally, use of many—but not all—benign "carrots" and "sticks" as incentives would involve regular reliance on manipulation, which would count somewhat against their use [23].

Having said that, "desired-but-nondesirable" remains a valuable attribute, other things being equal, of incentives to prevent disease. Certainly we should not prevent disease by threatening to deny the nonadherent access to products and services that are lifelines to a dignified, minimally autonomous existence. Chemical-dependency treatments often fall under that category.


References

  1. Moss AH, Siegler M. Should alcoholics compete equally for liver transplantation? JAMA. 1991;265(10):1295-1298.
  2. Firms use carrot, stick to encourage healthy habits. Morning Edition. National Public Radio. October 31, 2007. http://www.npr.org/templates/story/story.php?storyId=15800056. Accessed August 17, 2008.
  3. PRNewswire. Employers face 10.6 percent health care cost increases, says Aon Consulting. 2008. http://aon.mediaroom.com/index.php?s=43&item=1285. Accessed September 8, 2008.
  4. Centers for Medicare & Medicaid Services. Approval of West Virginia 's Medicaid plan amendment. Letter from Dennis G. Smith. http://www.wvdhhr.org/bms/oAdministration/bms_admin_WV_SPA06-02_20060503.pdf. Accessed August 6, 2008.
  5. Schmidt H. Patients' charters and health responsibilities. BMJ. 2007;335(7631):1187-1189.
  6. Cohen GA. On the currency of egalitarian justice. Ethics. 1989;99(4):906-944.
  7. Dworkin R. What is equality? Part 2: equality of resources. Philos Public Aff. 1981;10(4):283-345.
  8. Arneson RJ. Equality and equality of opportunity for welfare. Philos Stud. 1989;56:77-93.
  9. Eyal N. Egalitarian justice and innocent choice. J Ethics Soc Philos. 2007;2(1):1-18.
  10. Bishop G, Brodkey AC. Personal responsibility and physician responsibility—West Virginia's Medicaid plan. N Engl J Med. 2006;355(8):756-758.
  11. Anderson ES. What is the point of equality? Ethics 1999;109:287-337.
  12. Inglehart JK. Medicaid revisited—skirmishes over a vast public enterprise. N Engl J Med. 2007;356(7):734-740.
  13. Solomon J. West Virginia's Medicaid changes unlikely to reduce state costs or improve beneficiaries'health. Center on Budget and Policy Priorities. 2006. http://www.cbpp.org/5-31-06health.pdf. Accessed August 6, 2008.
  14. Wolff J. Fairness, respect, and the egalitarian ethos. Philos Public Aff. 1998;27:97-122.
  15. Mechanic D. Disadvantage, inequality, and social policy. Health Aff. 2002;21(2):48-59.
  16. Wikler D. Personal and social responsibility for health. In: Anand S, Peter F, Sen AK, eds. Public Health, Ethics, and Equity. New York, NY: Oxford University Press; 2006.
  17. The Henry J. Kaiser Foundation. Medicaid Benefits: Online Database. 2008. www.kff.org/medicaid/benefits. Accessed August 6, 2008.
  18. Raviglione MC. The new stop TB strategy and the global plan to stop TB, 2006-2015. Bull World Health Organ. 2007;85(5):327.
  19. Tversky A, Kahneman D. Judgment under Uncertainty: Heuristics and Biases. Cambridge, UK: Cambridge University Press; 1982.
  20. Lidz CW, Appelbaum PS, Grisso T, Renaud M. Therapeutic misconception and the appreciation of risks in clinical trials. Soc Sci Med. 2004;58(9):1689-1697.
  21. Menzel P, Dolan P, Richardson J, Olsen JA. The role of adaptation to disability and disease in health state valuation: a preliminary normative analysis. Soc Sci Med. 2002;55(12):2149-2158.
  22. Thaler RH, Sunstein CR. Nudge: Improving Decisions about Health, Wealth, and Happiness. New Haven, CT: Yale University Press; 2008.
  23. Eyal N. Poverty reduction and equality with strong incentives: the brighter side of false needs. In: Ryberg J, Petersen TS, Wolff C, eds. New Waves in Applied Ethics. London, UK: Palgrave MacMillan; 2008.

Further Reading

  • Annas G. Hunger strikes at Guantanamo—medical ethics and human rights in a “legal black hole.” N Engl J Med. 2006;355(13):1377-1382.

Nir Eyal, DPhil, is an assistant professor in global health and social medicine at Harvard Medical School and is affiliated with the program in ethics and health at Harvard University in Boston. Dr. Eyal’s work focuses on informed consent, markets in organs, ownership over the body, the global medical brain-drain crisis, health resource allocation, egalitarianism, consequentialism, and respect for persons.

Acknowledgment

The author is grateful to Yaron Klein, Faith Lagay, Anna Shifrin, and Dan Wikler for their helpful comments.

Practicing Preventive Medicine through Preventive Employment Practices, November 2008

First, Do Not Punish: Individual Incentives in Health Policy, November 2008

Thursday, November 27, 2008

Google adds voice, video chat for Gmail; flu tracking to Web

Houston Business Journal

Search engine giant Google Inc. has added voice and video chatting to Gmail as well as launched a free Web service to track the flu around the country.

Users can now have free voice and video conversations by clicking on a new "Video & more" menu in a Gmail chat window. They can get a full screen view or a pop out that can be sized and positioned according to user preference. The voice option can be used in tandem with e-mail and regular chat without a Web cam.

Google Flu Trends was developed with the help of the U.S. Centers for Disease Control and Prevention and is based on the number of search queries made about influenza. The company said it noticed that there was a correlation between the frequency of such searches and incidence of the flu.

Instead of the one or two week lag that traditional flu surveillance systems have, Mountain View, Calif.-based Google (NASDAQ: GOOG) said its reports will be updated daily. They are available at www.google.org/flutrends.

Monday, November 24, 2008

Uncertainties in the Absence of Data: Use of Pravastatin in Young Children

When risks and benefits of prevention are not fully known, physicians must provide patient decision makers with existing information such as the Number Needed to Treat and the Number Needed to Harm and leave the decision to those whom the intervention will affect.

Anna Shifrin and Darshak Sanghavi, MD

Ethical dilemmas arise when there is insufficient scientific evidence to support a clear clinical decision. When a treatment is nearly perfect in its efficacy and outcome and bears tolerable adverse side-effects—such as surgery for acute appendicitis—there is little left to argue against its implementation in the clinical setting. When data is unavailable or particularly difficult to gather, however, physicians face clinical uncertainty. Questions of this sort come up frequently in the pediatric population due to the shortage of clinical pediatric data, difficulty in obtaining data over lengthy follow-up periods, and the vulnerable nature of children.

Learning Objective: Understand that, when risks and benefits of prevention are not fully known, physicians must provide patient decision makers with existing information such as the Number Needed to Treat and the Number Needed to Harm and leave the decision to those whom the intervention will affect.

Preventive medicine is also particularly prone to clinical dilemmas, since the future benefits of prevention must compete with potential present risks and discomforts inherent in the intervention. In many cases, this competition pits individual rights against the collective good, as demonstrated in such interventions as vaccination, gun control, and antismoking measures. When we look at prevention and the pediatric population together, the clinical and ethical questions multiply. How do physicians manage this degree of uncertainty? Often it is possible to resolve seemingly complex ethical dilemmas through re-examination or a better presentation of the existing evidence. Better data presentation can help us weigh the pros and cons objectively. Data allow us to put a price, whether in terms of lives, dollars, or other values, on the proposed preventive interventions. It is crucial to exhaust the data before turning to the ethical questions.

Consider the case of heart disease—the leading cause of death in the United States. We can agree on the obvious: prevention of cardiovascular disease is a worthwhile goal. Numerous longitudinal studies such as the Framingham Heart Study and the Nurses Health Study have identified an assortment of physiological factors that correlated with higher risk of cardiovascular disease (CVD) and heart attack, including obesity, cigarette smoking, hypertension, and a family history of CVD, among others [1]. In some populations, such as men over age 50, the relationship of hyperlipidemia to heart disease appears causative based on prospective clinical trials of cholesterol-lowering drugs. No long-term prospective studies have been conducted with other groups such as children, leaving only retrospectively identified correlations of individual risk factors to guide clinical practice.

Based on this kind of retrospective data, the American Academy of Pediatricians (AAP) published updated guidelines in July 2008, titled "Lipid Screening and Cardiovascular Health in Childhood" [2]. This document contains a variety of recommendations for pediatricians tending to children aged 2 and older with cardiovascular risk factors. The measures range from dietary and lifestyle modifications (e.g., switching to low-fat milk after the first year); to systematic serum lipid screenings starting at age 2 if there are certain cardiac risk factors such as a positive family history of CVD, hypertension, diabetes mellitus or obesity; to prescribing an LDL cholesterol-lowering pharmacologic agent, or statin. These guidelines provoke concerns for at least two reasons: first, the screening strategy is not validated for widespread use in asymptomatic young children, and second, the benefits of this drug therapy are not well defined.

The AAP's guidelines raise ethical concerns about the fundamental purpose of prevention and its role in balancing individual autonomy with the benefits of society at large. By improving quality of life and freeing up hospital resources, preventive measures fulfill the ethical concepts of justice and beneficence. Prior to beneficence, however, is nonmaleficence—doing no harm—and the benefits of prevention to the individual and to society must be weighed against its risks and side-effects before we can employ the preventive measure or make it a standard. In the absence of certainty, or if the potential for harm exists, all available data must be clearly presented to the patient to assure that he or she can make a truly informed, autonomous decision.

One rarely publicized but highly informative measure for determining the efficacy of screening and preventive efforts is the Number Needed to Treat, or NNT. This statistical tool determines how many individuals must receive a clinical treatment in order to save one life or prevent one undesired outcome. For pravastatin, the statin recommended for at-risk children by the AAP, the NNT has been measured only in men aged 50 or older, and it comes out to 50 [3]. That is, for every 50 men with CVD risk factors who take the drug for 1 decade, one man will be spared the heart attack he would have suffered without the medication. The other 49 will receive no measurable benefit. In the pediatric population, where few studies of pravastatin use have been conducted and and extremely lenghty follow-up periods render future studies unlikely or impossible, the NNT remains an estimate—but one that is bound to be high. It is quite unlikely that a pravastatin study will ever be conducted in children since it would require administering pravastatin before age 10 and then tracking this cohort of children (study subjects) for more than a half century.

To help parents make an informed decision about treating their children with pravastatin, the NNT can serve as an easy-to-understand presentation of the current data. Parents also need to know about the potential risks of the medication, which include liver problems, gastrointestinal discomfort, muscle aches, and, in extreme cases, rhabdomyolysis, perhaps by presentation of the Number Needed to Harm (NNH). Finally, children taking pravastatin must be monitored with blood tests, which translates to costs and physical discomfort. These facts, presented in an understandable way, are critical to empowering patients and allowing true decision-making autonomy.

Hormone replacement therapy (HRT) is a well-known example of neglecting autonomy for the sake of easing the burden of disease on society. HRT was widely recommended to help alleviate cardiac risk factors in postmenopausal women but later associated with an increase in breast cancer risks [4]. While the intention was good, a crucial step was left out in the process of popularizing HRT: a lack of long-term data precluded women from making informed decisions about whether or not to subscribe to the therapy. More clear data allowing women to make autonomous decisions was not easily accessible.

Prescribing statins to children based on evidence gathered from men over age 50 undoubtedly constitutes an ethical dilemma, and, for now, the best we can do is help individuals make up their own minds by presenting the available data clearly and thoroughly—a goal not yet satisfied by current practice.


References

  1. Lauer MS. Clinical practice. Aspirin for primary prevention of coronary events. N Engl J Med. 2002;346(19):1468-1474.
  2. Daniels SR, Greer FR; Committee on Nutrition. Lipid screening and cardiovascular health in childhood. Pediatrics. 2008;122(1):198-208.
  3. Ford I, Murray H, Packard C, et al. Long-term follow-up of the West of Scotland Coronary Prevention Study. N Engl J Med. 2007;357(15):1477-1486.
  4. Clemons M, Goss P. Estrogen and the risk of breast cancer. N Engl J Med. 2001;344(4):276-285.

Anna Shifrin is in her second year of study at the University of Massachusetts Medical School in Worcester. Her interest is in the relationship between the humanities and medicine.

Darshak Sanghavi, MD, is the chief of pediatric cardiology and assistant professor of pediatrics at the University of Massachusetts Medical School in Worcester. He writes on children's health issues for the public and is author of A Map of the Child: A Pediatrician’s Tour of the Body.

Saturday, November 22, 2008

Nasty gut bug spikes in U.S. hospitals

Diarrhea-causing C. diff germ much more common than thought, study says
By JoNel Aleccia

Health writer
updated 8:46 a.m. ET, Tues., Nov. 11, 2008

A virulent, drug-resistant gut infection that causes potentially deadly diarrhea, especially among the old and sick, is up to 20 times more common than previously thought, a large survey of U.S. hospitals and health care centers finds.

Thirteen in every 1,000 patients were infected or colonized with Clostridium difficile, known as C. diff, according to surveys by nearly 650 U.S. acute care and other centers, the Association for Professionals in Infection Control and Epidemiology, or APIC, reported Tuesday.

That’s between 6.5 and 20 times higher than previous estimates of the nasty bacterial infection tied to overuse of antibiotics and improperly cleaned hospital rooms, said Dr. William R. Jarvis, the study’s lead author.

“Hopefully this will be a wake-up call about the importance of preventing this organism,” said Jarvis, a private consultant who was formerly in charge of fighting hospital infections at the federal Centers for Disease Control and Prevention.

On average, there may be more than 7,000 infections and 300 deaths in U.S. hospitals on any single day from C. diff., which can cause problems ranging from severe diarrhea and colitis to blood-poisoning and death, the study indicated.

Epidemiologist Dr. L. Clifford McDonald, the CDC’s C. diff expert, said previous analyses have estimated about 520,000 infections and up to 30,000 deaths a year, far lower than the APIC figures suggest.

The APIC study was the largest, most comprehensive review of its kind, Jarvis said. Other studies have been limited to a single hospital or a single state, or they used health care discharge data that overcounted some patients and left out others, he noted.

What no one questions, McDonald said, is the idea that C. diff is increasing.

“It’s important data that confirms that there’s an awful lot of this, that’s the bottom line,” McDonald said.

In recent years, McDonald and other infection control experts increasingly have been worried by the spread of C. diff, particularly the virulent NAP1 strain that produces roughly 20 times the toxins of a common, more benign variety.

The toxic strain is becoming resistant to all but the most powerful antibiotics, putting it the same category as methicillin-resistant Staphylococcus aureus, or MRSA, the so-called superbug that riveted the nation's attention last year.

C.diff second only to MRSA
An APIC prevalence study in 2007 found that MRSA was present in 46 patients in 1,000, a rate about 10 times higher than previous estimates.

“C. diff is a lot less than MRSA, but, having said that, it is still the No. 2 multi-drug-resistant organism,” Jarvis said.

The new APIC survey asked the agency’s 12,000 infection preventionists to count the number of patients with C. diff on any single day between May and August to provide the first-ever snapshot of the extent of the bug’s reach.

Of some 110,550 patients in hospitals and health care centers in 47 states, C. diff was detected in 1,443 patients, with more than 94 percent infected rather than simply colonized with the germ.

Nearly 70 percent of those patients were older than 60, with many far older than that, Jarvis said. Nearly 70 percent had underlying diseases, such as kidney failure, diabetes or heart failure that made them more susceptible to infection.

More than a quarter of the patients had to be admitted to intensive care units, nearly 20 percent developed shock and more than 16 percent required aggressive treatment to combat plummeting blood pressure, the study showed.

C. diff infections typically lead to higher costs and longer hospital stays. If infections reported in the survey were extrapolated to all U.S. hospitals on a single day, patients would rack up an average of more than $32 million in costs and 40,000 extra days in the hospital.

The APIC survey confirms what many infection control professionals already believe: that the infection is sparked by antibiotic use that disturbs the normal flora in the gut. About 80 percent of the patients with C. diff in the APIC study had recently received antibiotics.

“We’ve long been encouraging the public not to demand antibiotics as a solution to all of their problems,” McDonald said. “This brings it home to roost, doesn’t it?”

The study also confirms suspicions that most cases of C. diff are contracted in health care settings. More than 72 percent of the infections in the APIC study were considered to be hospital-acquired, and more than 54 percent were acquired less than 48 hours after admission, the survey showed.

That means people are picking up the bug in the environment, mostly likely from inadequately cleaned surfaces. C. diff produces hard-to-kill spores that are transmitted through feces. People become infected when they ingest the spores, usually by touching surfaces and then touching their mouths, or by eating contaminated food.

Most common hospital cleaners don't eradicate C. diff, which is best cleaned with a strong bleach solution.

Antibiotic use, hospital hygiene are key
There are several keys to preventing C. diff infection, said Dr. Brian Koll, chief of infection control at Beth Israel Medical Center in New York.

Making environmental hygiene a priority that involves staff at all levels is vital, he said. So is emphasizing efforts such as proper hand hygiene for staff, patients and visitors; wiping down equipment between uses; and ensuring that staff members use bleach to kill the C. diff bugs.

“In many respects, our rooms are inspected with as much rigor, if not more, as the kitchen is,” said Koll, whose hospitals have lowered C. diff infection rates to 4 of per 1,000 patients.

Patients also have to take steps to protect themselves, Koll said. Limit antibiotic use whenever possible, insist on proper hand hygiene and speak up about any cleaning concerns.

“Patients and their family members should know they can ask whether or not a piece of equipment has been cleaned or hands washed from any and every health care worker,” he said.

Thursday, November 20, 2008

Cancer genetic blueprint revealed

Leukaemia cells
Leukaemia targets cells in bone marrow which form blood

Scientists have decoded the complete DNA of a cancer patient and traced her disease to its genetic roots.

The Washington University team identified 10 gene mutations which appeared key to the development of the woman's acute myeloid leukaemia.

Just two of these had been linked to the disease before.

The sequencing technique, described in the journal Nature, could be applied to other cancers and aid the design of targeted drugs.

This achievement ushers in a new era of comprehensive understanding of the fundamental nature of cancer
Dr Francis Collins
Geneticist

The researchers took two samples from the woman in her 50s - who later died from the disease - and examined the DNA for differences.

One sample was taken from healthy skin cells, the other from bone marrow tissue made up of cancerous cells.

They found that virtually every cell in the tumour sample had nine of the key mutations.

Like most cancers, acute myeloid leukaemia (AML) - a cancer of blood-forming cells in the bone marrow - arises from mutations that accumulate in people's DNA over the course of their lives.

However, little is known about the precise nature of those changes and how they disrupt biological pathways to cause the uncontrolled cell growth that is the hallmark of cancer.

Previous efforts to decode individual human genomes have looked at common points of DNA variation that may be relevant for disease risk.

In contrast the Washington team, using a gene sequencing technique, were able to sift through the three billion pairs of chemical bases that make up the human genome to pull out the mutations that contributed to the patient's cancer.

True landmark

Geneticist Dr Francis Collins, a former director of the US National Human Genome Research Institute, called the study a "true landmark in cancer research".

This is a very important piece of research, not only for our understanding of leukaemia but for many other types of cancer
Kat Arney
Cancer Research UK

He said: "In the past, cancer researchers have been 'looking under the lamp-post' to find the causes of malignancy - but now the team from Washington University has lit up the whole street.

"This achievement ushers in a new era of comprehensive understanding of the fundamental nature of cancer, and offers great promise for the development of powerful new approaches to diagnosis, prevention and treatment."

Three of the newly-discovered mutations were in genes that normally suppress tumour growth, and four were in genes linked to the spread of cancer.

The other appears to affect the transport of drugs into the cells, possibly fuelling resistance to cancer therapy.

The researchers are still looking for other gene mutations which may also play a part.

They also examined tumour samples from another 187 AML patients, but found none had any of the eight new mutations.

Lead researcher Dr Richard Wilson said: "This suggests that there is a tremendous amount of genetic diversity in cancer, even in this one disease.

"There are probably many, many ways to mutate a small number of genes to get the same result, and we're only looking at the tip of the iceberg in terms of identifying the combinations of genetic mutations that can lead to AML."

The researchers suspect that the mutations occurred one after another, with each pushing the cell closer to malignancy.

Kat Arney, of the charity Cancer Research UK, said: "This is a very important piece of research, not only for our understanding of leukaemia but for many other types of cancer.

"Thanks to advances in technology it is now possible to unlock the genetic secrets within cancer cells, which will be the key to better diagnostic tools and treatments in the future."

Ken Campbell, of Leukaemia Research said: "Although it is very early days, it is realistic to think that these findings could lead to new treatments.

"Its wider application to other cancers may be limited though - the technique is particularly valuable for blood cancers in which the chromosome changes are usually simpler than in solid tumours at the time of diagnosis."

Wednesday, November 19, 2008

One Cure for Vertigo: Playing Pinball Inside Your Head.

By manipulating your head just so, a doctor can sometimes cure chronic dizziness.

by Anna Reisman

Right osseous labyrinth. Lateral view.

20th U.S. edition of Gray's Anatomy of the Human Body


Thomas Riccio, a lanky 84-year-old, was dozing off in the waiting room. A former crane operator at a steel mill and a World War II veteran, he had been in for a physical six months earlier and everything was fine. His only chronic medical problem was high blood pressure.

When I called his name, he stood up and swayed, almost losing his balance. His wife and I lunged, each grabbing one of his arms.

“I’m OK, I’m OK,” he insisted. “Just when I get up sometimes, I almost lose my balance, but I haven’t fallen.”

His wife told me it was the fourth time in three months that he’d come to the VA clinic with dizziness. At our regular visits he always said that everything was good. He wasn’t one to complain.

Slowly we made our way down the hall, Mr. Riccio sliding one hand along the wall.

Dizziness is the third most common symptom in primary care, and it’s one that doctors love to hate. That is because each of the three main cate­gories of dizziness—vertigo, disequilibrium, and light-headedness—has its own lengthy list of diagnoses.

Vertigo is an illusory sensation of motion or spinning, often accompanied by nausea. It can be caused by inner-ear problems, mi­graines, or, if accompanied by other symp­toms, a stroke. Disequilibrium—which is particularly common in elderly patients with arthritis or problems with vision, hearing, or balance—is a feeling of unsteadiness while walking unaided across an open space. Light-headedness is the sensation of near fainting, such as one might experience when standing up suddenly after a day of gardening in the hot sun. It most often results from problems in blood flow to the brain caused by anemia, low blood sugar, hyperventilation, dehydration, or cardiac problems.

Which of these three was Mr. Riccio experiencing? I wasn’t the first doctor to consider the question. Mr. Riccio told me he had gone to the emergency room three months earlier, complaining of dizziness and headaches he’d had off and on for several days. Given the patient’s history of high blood pressure, the emergency room doctor suspected a stroke, so he asked for a CT scan of Mr. Riccio’s brain to see if there were any blocked or burst blood vessels. He also requested blood tests for signs of anemia or low blood sugar. The CT scan and the blood work both came back normal. Mr. Riccio was discharged with instructions to take Tylenol, in case he was experiencing a migraine. During the next three weeks, both the headache and the dizziness eased, but then the dizziness returned.

Over the next few months, he saw three more doctors. One ascribed the headache and dizziness to sinusitis. Another thought it could be inflammation of the inner ear. Another believed elevated blood pressure was the cause. Mr. Riccio tried various treatments to no avail.

Now it was my chance to solve the puzzle.

“It comes and goes,” Mr. Riccio told me. “Last night in bed, I thought I was going to pass out. The room suddenly whizzed around. Just for about 10 seconds, but it felt a lot longer.”

Did it happen more if he turned his head to one side or the other?

He thought for a moment. “To the right,” he said. “When I turn my head to the right fast, I get dizzy.”

“When you stood up in the waiting room, you looked pretty dizzy,” I said. “When you stand up fast, do you usually get kind of light-headed, like you’re going to faint?”

He shook his head.

What happened when he walked across a large open space? Did he feel unsteady? He said that he didn’t.

I asked Mr. Riccio to follow my forefinger with his eyes. A jerking in his eye movements when he tracked my finger could indicate a problem with the balancing system of the inner ear. The other doctors hadn’t noted any rhythmic jerkiness, called nystagmus, but I wanted to double-check. I repeated the test a couple of times. Mr. Riccio’s eye movements were smooth.

Sometimes the information we get from a patient’s history doesn’t match up with the physical, and we have to go with our gut feeling. My gut was telling me that this was vertigo, even without nystagmus. Could it be benign paroxysmal positional vertigo (BPPV)? This is the most common type of positional vertigo, and it occurs most frequently in the elderly. In almost half of all cases, there is no known cause.

There is one leading hypothesis about how it happens. Inside the inner ear are three fluid-filled, semicircular canals that serve as balance sensors. In patients with BPPV, tiny chunks of calcium carbonate crystals, called otoconia, float into the canals. The crystals are normally attached to a membrane in the inner ear, but they can be dislodged, perhaps by head injury or infection or through the normal degeneration of aging.

+++

“You know those little handheld pinball games?” I asked. Mr. Riccio nodded. “The crystals are like the tiny metal balls in one of those games. Once they’re in the wrong spot, it’s hard to get them back. They roll around every time you move your head and unintentionally set off motion sensors. So your brain gets the wrong information about balance. It thinks you’re moving in one direction when you’re really not. So it overcorrects, and you end up with the spinning sensation.”

He leaned forward and pursed his lips.

“Is there another pill to try?” He sounded tired, a little frustrated.

“Something even better.”

In 1983, John Epley, an otolaryngologist in Portland, Oregon, found that a precise series of guided head movements could rid patients of vertigo by directing the disruptive crystals out of the semicircular canals. Initially the local medical community dismissed his finding. To many physicians, any technique based on a maneuver or manipulation smacks of hocus-pocus. But the treatment was backed up by scientific studies, and by 1992 doctors had come to accept it.

The Epley maneuver is now the standard treatment for BPPV. Because it involves manipulating the head and neck into certain positions, in rare instances it is not recommended for patients with unstable heart disease, severe blockage of the carotid arteries, or neck disease. Otherwise the maneuver is safe and quite effective, re­lieving vertigo in 80 percent of patients with BPPV.

It was worth a try.

I asked Mr. Riccio to sit on the exam table again. I explained that we needed to position him so he was lying on his back with his head hanging to one side and gently tilted backward. I warned him that the changes in position would momentarily trigger the dizziness, if my suspicion about the cause of his vertigo was correct.

Standing at his side, I said, “Hold my right forearm,” as I braced my left hand on his back. “Now turn your head to the right and keep it turned as you lie down.” I guided him down until he was flat on his back, his head tilted back over the edge, his right ear pointing at the floor.

“Whoa, there it goes,” he said, opening his eyes wide. “That’s the feeling. That’s the one.” As I moved his head into the different positions, I pictured a little pinball game and imagined I was directing the tiny balls—the crystals—back into their designated holes.

After 30 seconds I turned his head gently so his left ear was pointing down. Then I instructed him to keep his head still and to roll over onto his left shoulder, keeping his head angled down to the exam table. Another 30 seconds.

“Now please sit up without changing the position of your head and tell me if you still feel dizzy.” I helped him up.

“Oh yeah, very dizzy.” He braced himself, clutching the edge of the exam table.

We repeated the whole sequence two more times, and by the last time Mr. Riccio sat up, the dizziness was gone. It might come back, I told him, but it would probably be less intense. I printed a diagram showing how he could do a modified version of the Epley maneuver at home, using a pillow under the shoulders to position his head at the correct angle. If he did this a few times a day until the dizziness was gone for 24 hours, it would probably stay away for a while, and in some cases for good.

Two months later he was back for his regular checkup. We walked briskly from the waiting room to my office. He was beaming.

“Doctor, can I give you a hug?” he asked. “You cured me!”

Just call me a pinball wizard.

Anna Reisman is an internist in Woodbridge, Connecticut. The cases described in Vital Signs are real, but names and certain details have been changed.

Monday, November 17, 2008

Practice Incentives and Professional Responsibility

Steps can be taken to reach an ethically and professionally sound decision about participation in a pay-for-performance practice incentive program.

Commentary by David Satin, MD, and Justin Miles

Drs. Adler, Jones, and Pollman routinely met to discuss their internal medicine practice. One discussion in particular focused on recent measures from Medicare that reward practitioners financially if they adopt new screening and prevention guidelines that result in fewer rehospitalizations and other outcome improvements. Ideally, each of the three physicians could decide whether to adopt the Medicare plan on his own, but since they see each other's patients, one doctor's abstention from the new measures would make it impossible for the others to comply.

Learning Objective: Identify the steps in making an ethically and professionally sound decision about participation in a pay-for-performance practice incentive program.

If adopted, the new guidelines would significantly expand the amount of screening and prevention performed at each patient visit for many prevalent diseases such as diabetes, congestive heart failure, coronary artery disease, and hypertension. A diabetic patient, for example, would be subjected to 10 different screening or prevention measures, including management of HbA1c, blood pressure, lipids and cholesterol levels, eye and foot exams, immunizations for influenza and pneumonia, and a test for urine protein. Without the guidelines, the clinic doctors would perform only a few of the aforementioned tests, focusing on those indicated for a specific patient.

Since the majority of the clinic's patients are insured by Medicare, Drs. Jones and Adler both supported the new guidelines, arguing that the "pay-for-performance" plan will ensure more effective care for patients and simultaneously bring financial rewards for this small, busy clinic in an underserved, low-income community.

Dr. Pollman, on the other hand, was not supportive of the new measures. While he recognized the potential benefits to his patients, he could not imagine forcing his patients to undergo the extensive list of tests and procedures outlined in the Medicare plan. Providing medical care to patients is one thing, he argued, but assuming rigid control over their health care and subjecting them to strict regimens without offering a choice in the matter is frank paternalism.

Adopting the Medicare plan would mean applying the new guidelines to virtually every patient who visited the clinic. When Dr. Pollman asked his colleagues what would be done if a patient declined a particular screening measure, they suggested that such patients be weeded out of their clinic and referred to other health care centers. "We can't afford to allow our patients to weasel out of these rules," Dr. Jones argued. "Besides, it's not as if we're forcing harm on anyone. It's been shown that systematic screening and prevention can significantly improve care, especially for chronic conditions like diabetes."

Pollman felt torn between supporting his colleagues in a new plan that could bring more effective care to patients, but he was hesitant to adopt the blanket guidelines and compromise his patients' rights to decide on screening and prevention for themselves.

Commentary

One of our favorite references is the bestselling popular economics book Freakonomics [1]. Its authors explain that there are three types of incentives: financial, social, and moral. The case at hand illustrates how tensions can develop when pay for performance (P4P) raises the possibility that these incentives may conflict with one another.

Drs. Adler, Jones, and Pollman struggle with aligning the financial, social, and moral incentives of a new P4P program that offers financial compensation for reaching particular clinical outcomes in their patients. First, they consider the financial benefits and burdens of adopting the P4P program, including maximizing P4P profits by reluctantly "forcing patients to undergo the extensive list of tests" and not allowing patients "to weasel out of these rules." Second, there are social incentives to consider. Although not explicit in this case description, the social impact of scoring poorly on publicly reported measures often weighs heavily on clinicians who consider P4P programs [2]. Third, the doctors wrestle with the moral incentives. Drs. Jones and Adler cite the moral benefits of P4P to their patients' health and the financial health of their clinic that serves a low-income, underserved community. Dr. Pollman, however, expresses concerns about the moral cost of transforming their practice into one that is paternalistic, performs unnecessary tests, and fires non-compliant patients.

Which incentive is most important: financial, social, or moral? As a bioethicist, I (Satin) am partial to the third, but this does not mean we should turn a blind eye to the first two. Moral judgments must take all factors into account, including the financial and social impact of our decisions. For example, if you knew in advance that participating in a voluntary P4P program would result in your clinic's financial ruin or in you becoming a social pariah to your patients, it would be immoral to implement it, especially if the clinic served a patient population in great need. Therefore, the issue at hand can ultimately be understood as a moral question. For Drs. Jones, Adler, and Pollman, is participating in this P4P program ethical?

Eliminating Bad Choices and Facilitating a Good Choice

Although bioethicists cannot typically recommend a single best choice in cases as complex as this, they can eliminate clearly bad options. Bioethicists can also refine questions and clarify ethical issues to facilitate a good choice. This commentary illustrates how two common conceptual tools—respect for patient autonomy and medical professionalism—can help eliminate some potentially bad choices described in this case, and refine a very specific question to facilitate a good choice.

Respecting Patient Autonomy

In this case, Dr. Pollman's concerns about forcing his patients to undergo screening tests can be understood as a concern about respect for patient autonomy. Autonomy is not my (Satin) favorite conceptual tool. It is often wielded as a trump card to resolve moral dilemmas by alluding to the primacy of a patient's right to self-determination. But of course there are limits to patient autonomy. A patient cannot compel you to prescribe antibiotics for his or her viral pharyngitis. So when respect for patient autonomy appears to be an issue, one must narrow the scope of the discussion to a specific exercise of patient autonomy such as informed consent.

Informed Consent: Full Disclosure

The principle of informed consent says that clinicians must provide patients with full disclosure; that is the degree of information about the risks and benefits of treatment, non-treatment, and alternative treatments that a reasonable person in that patient's position would want to know [3, 4]. Following this principle, the three clinic doctors would have to explain the risks and benefits of each screening test, alternatives to each test, as well as the risks and benefits of omitting each test. P4P reimbursements should not factor into the recommendation for screening tests. If a test is clinically indicated, physicians should recommend it and explain why. If it is not, physicians should not recommend it. So, are Medicare's "10 different screening" tests clinically indicated? Only clinicians can answer that by examining the evidence from the literature and determining if it applies to each individual patient in light of his or her age, sex, and clinical conditions [5, 6]. Which screening tests are reimbursed under P4P changes neither the evidence nor the patient. If Dr. Pollman felt that a particular guideline was either scientifically invalid or did not apply to his patient, he ought not to have recommended it then and he ought not to recommend it now.

One reason P4P exists is to bring clinicians up-to-date on the importance of following particular guidelines. Many expect that P4P will accomplish with financial incentives what continuing medical education has so far failed to do. For example, why didn't Dr. Pollman offer all 10 screening tests? If his concern was that 10 tests are too many for his poor, underserved patients, perhaps he should be concerned about his current paternalistic practices. If he chooses to focus on the "most relevant" tests, perhaps he should take note that Medicare has done that job for him, by employing hundreds of national experts selected by the American Medical Association who painstakingly combed through the primary literature and fiercely debated the evidence to determine the best screening tests, which were submitted for public commentary, third-party review, revision, and final submission to Medicare, who then further pared down the recommendations to the 10 most relevant tests [7]. Our question to Dr. Pollman and his colleagues is, "Why weren't you recommending these tests before?"

Informed Consent: Non-Coerced Choice

Once patients understand the information that has been fully disclosed, they must make a non-coerced choice [3, 4]. Coercion is typically described as undue or inappropriate influence. If a patient must decide on a screening test under the threat of being fired from the clinic, I think most experts and laymen would call that coercion. Here Dr. Pollman's moral intuition is accurate in that, "assuming rigid control over their health care and subjecting them to strict regimens without offering them a choice in the matter is frank paternalism." Moreover, proceeding with an invasive test without obtaining proper informed consent is malpractice. Not only must the three doctors know the latest clinical guidelines, they must also determine which guidelines apply to each patient and facilitate a non-coerced decision by the patient.

Dr. Pollman is appropriately concerned by this daunting task. How will he and his partners feel if they make a concerted effort to meet the P4P measures only to be thwarted by their patients' right to self-determination? How will the clinic fare if it hires nurse educators to help facilitate informed patient choices, only to discover it missed the P4P bonus and cannot afford to keep its doors open? How will they cope with public reports of their poor performance on preventative health measures, unaccompanied by an asterisk denoting the demographic and clinical factors that contributed to the missed intervention? Indeed, what would enable clinicians to enter a quality improvement game they could lose?

Professionalism

All reimbursement systems create conditions for financial conflicts of interest [8]. The fee-for-service approach to reimbursement tempts us to see as many patients in as short a period of time as possible, while salaried clinicians are motivated to see fewer patients. Capitation tempts us to spend as little as possible on testing and treating patients. What keeps physicians from giving in to these temptations and maximizing profits? The moral ideal of professionalism.

As professionals, we have a fiduciary responsibility to patients—an implicit contract that places their interests above our own. Professionalism also entails self-regulation, whereby we pledge, both as individual physicians and as a group, that we will police ourselves. Quite simply, we promise not to lie, cheat, or steal. If we do, we expect colleagues to report us to medical boards who will sanction us for the protection of the public [9, 10].

The fact that physicians are professionals keeps us from gaming the system in P4P, despite financial and perhaps even social incentives to do otherwise. Britain implemented P4P in 2004, and a recent study suggests that its clinicians have not taken advantage of ways to game the system [11]. The professionalism of American physicians will be tested with every elderly patient whose risk of falling from hypotension outweighs the benefit of lowering blood pressure below the P4P target. Our integrity is at stake every time we consider not accepting into our practice a diabetic patient whose blood sugar is hopelessly far from the P4P goal [12].

Professionalism also entails that we strive to keep up with the latest improvements in patient care. The basis of requiring continuing medical education is our medical boards' commitment and therefore our commitment to maintain medicine as a reputable profession. Although professionalism does not demand that we participate in P4P, it does demand continuous quality improvement [9, 10].

Conclusions, Bioethics Style

P4P is one small part of a quality revolution dedicated to improving patient care through clinical outcomes measurement. With that in mind, we have seen that professionalism implies a moral imperative of continuous quality improvement. Moreover, it is unethical to improve outcomes at the expense of informed consent—either by withholding information that a reasonable person in that patient's position would want to know or by coercing patients with the threat of dismissal from the clinic. These are the bad choices that ethical reasoning exposes.

Now to refine a question that will help facilitate a good choice. A professional who chooses to participate in a P4P program must participate honestly. Even if P4P were to become mandatory, physicians would still have a professional obligation not to game the system, just as they do within our current systems of reimbursement. Drs. Adler, Jones, and Pollman have a difficult decision to make and need to consider many pragmatic factors discussed elsewhere [13, 14]. But to make a wise choice, the overarching moral question each must ask himself is, "Will my participation in this P4P program render me unable to fulfill my professional responsibilities?"


References

  1. Levitt SD, Dubner SJ. Freakonomics: A Rogue Economist Explores the Hidden Side to Everything. New York, NY. HarperCollins Pub; 2005.
  2. Terry K. Physician report cards: help, ho-hum, or horror? Med Econ. 2006. http://medicaleconomics.modernmedicine.com/memag/article/articleDetail.jsp?id=359028. Accessed October 3, 2008.
  3. Etchells E, Sharpe G, Walsh P, Williams JR, Singer PA. Bioethics for clinicians: 1. consent. CMAJ. 1996;155(2):177-180.
  4. American Medical Association Council on Ethical and Judicial Affairs. Fundamental elements of the patient-physician relationship. JAMA. 1990;264(24):3133.
  5. Schneider CE. Some realism about informed consent. J Lab Clin Med. 2005;145(6):289-291.
  6. Satin DJ. More realism about informed consent. J Lab Clin Med. 2005;145(6):292-294.
  7. Endsley S, Baker G, Kershner BA, Curtin K. What family physicians need to know about pay for performance. Fam Pract Manag. 2006;13(7):69-74.
  8. Goold S. Trust and physician payment. Healthc Exec. 1998;13(4)40-41.
  9. American Medical Association. Opinion 9.00 Professional rights and responsibilities. Code of Medical Ethics. Chicago, IL. American Medical Association; 2001. http://www.ama-assn.org/ama1/pub/upload/mm/369/section_9.pdf.
  10. Medical Professionalism Project. Medical professionalism in the new millennium: a physicians' charter. Lancet. 2002;359(9305):520-522.
  11. Doran T, Fullwood C, Reeves D, Gravelle H, Roland M. Exclusion of patients from pay-for-performance targets by English physicians. N Engl J Med. 2008:359(3)274-284.
  12. Satin DJ. Paying physicians and protecting the poor. Minn Med. 2006;89(4):42-44.
  13. Guglielmo WJ. This Doctor made P4P work—you can too. Med Econ. 2008;85(14):34-36, 42-44.
  14. Satin DJ. The impact of pay for performance beyond quality markers: a call for bioethics research. University of Minnesota Bioethics Examiner. 2006;10(1).

David Satin, MD, is a post-doctoral fellow at the University of Minnesota’s Center for Bioethics and an assistant professor in the University’s Department of Family Medicine and Community Health. He practices at Smiley’s Family Medicine Residency Program, serving the inner-city Minneapolis community. Dr. Satin sits on local, state, and national pay-for-performance committees, researches, and speaks publicly on ethical issues in pay for performance.

Justin Miles is a second-year medical student at the University of Minnesota in Minneapolis. His research interests include pay for performance and medical student knowledge of pay for performance.

Friday, November 14, 2008

Genome of cancer patient decoded for first time

Scientists ID genes never before linked to deadly acute myeloid leukemia

Reuters
updated 5:44 p.m. ET, Wed., Nov. 5, 2008

WASHINGTON - Scientists for the first time have decoded the entire genome of a cancer patient, identifying a series of genes never before linked to the type of white blood cell cancer that ultimately killed the woman.

The study, published on Wednesday in the journal Nature, represents a new approach to grasp the genetic underpinning of cancer and pave the way for better treatments, researchers at Washington University School of Medicine in St. Louis said.

The patient was a woman in her 50s who died 23 months after she was diagnosed with acute myeloid leukemia, according to Dr. Timothy Ley, who led the study. Only one in five patients who get this disease, also called AML or acute myelogenous leukemia, lives more than five years after diagnosis.

Ley and colleagues aimed to find genetic mutations that might initiate the development of AML. They sequenced the genes in a sample of normal skin tissue from the woman as well as the genes in her tumor cells taken from bone marrow.

The technique is called high-throughput sequencing.

By comparing tumor tissue to normal tissue, they pinpointed 10 mutated genes in the cancerous tissue apparently involved in triggering AML. Previous research had linked two of them to AML, but the rest never before had been implicated.

"The other eight were all things that caught us off guard. They're all new. And they are all in genes that we didn't really have on our radar for this particular kind of cancer. In retrospect, they all make sense," Ley said.

Three of them normally act to suppress tumor growth, four are involved in promoting cell growth and the final one may affect how drugs enter a cell, the researchers said.

"This is the only way we would have found these mutations. There's no other path to get this information. I think it really has begun to tell us how little we know about cancer," Ley added in a telephone interview.

The treatment of AML has changed little in the past two decades because most of the genetic events behind the disease had remained unknown, the researchers said.

"This is the first human cancer genome that's been sequenced. In the past, we've always looked at parts of the genome for mutations. But this is the first time that we've been able to look at everything," Ley said.

A deeper genetic understanding of cancer -- now possible with speedier, cheaper DNA sequencing technology -- can serve as the foundation for developing more effective ways to diagnose and treat cancer, the researchers said.

"There are probably many, many ways to mutate a small number of genes to get the same result, and we're only looking at the tip of the iceberg in terms of identifying the combinations of genetic mutations that can lead to AML," Richard Wilson, one of the researchers, said in a statement.

AML, a common kind of leukemia in adults, begins inside bone marrow, tissue inside bones that helps form blood cells. Each year in the United States, about 13,000 people are diagnosed with AML -- usually in people age 60 and older -- and it kills about 8,800 people.

Monday, November 10, 2008

Prevention Finds a New Place in Medicine

Medicine's traditional focus on diagnosing and treating illness has succeeded in increasing life expectancy significantly. More recently, however, life expectancy in developed countries—particularly the United States—has slowed in its growth and is predicted by some to enter a decline in the coming decade, a phenomenon that can be attributed partly to the higher prevalence of chronic conditions such as obesity, hypertension, diabetes, and cardiovascular disease [1]. In a certain sense, it is not incorrect to say that a different approach—prevention—may contribute as much to further improvements in quality and quantity of life as curative medicine.

Preventive medicine is integrated into routine medical care and garners much attention from the media on topics that range from smoking cessation to the controversial ban on trans fats. Most of us have been confronted with prevention in our own medical encounters—counseled to exercise more, for example, follow a better diet, or monitor our own health by breast or testicular self-exams—despite having no overt symptoms or health complaints. How many girls and young women have been offered the HPV vaccine? How many older patients have been prescribed pravastatin to help control their cholesterol or an ACE-inhibitor to lower their blood pressure? As the media continue to fight the so-called "obesity epidemic" and hospitals across the country enact smoking bans, it is not surprising that prevention has emerged as one of the most debated topics in medicine. And its consequences, for both the individual and society, are subjects of moral, financial, practical, and ethical scrutiny.

The focus on prevention represents an essential next step for the medical field, but its implementation has raised many concerns and been met with a fair share of criticism and ethical inquiry. Preventive medicine differs from traditional medicine in that its goals are to identify and control risk factors of disease rather than diseases themselves. Implementing preventive measures often means intervening in patient behavior or administering treatment before the onset of symptoms—a measure seen by some as a benefit to public health and by others as an intrusion into personal freedom. Because of this fundamental difference, preventive practice treads upon contested ethical grounds. This issue of Virtual Mentor delves into the ethical questions prevention raises and provides insight on how such questions might be tackled in the future by physicians and medical students.

Ethical questions in preventive medicine reach far and wide, touching physicians, patients, employers, insurers, hospital administrators, policy makers, and society. The three clinical cases in this issue present concrete dilemmas that physicians face in balancing treatment of individual patients with preventive measures that, in general, have wider population goals. Case 1 discusses the conflicts that can arise when prevention becomes the rule for directing physicians' practices and a measure for evaluating their performance. Case 2 examines the challenges that a hospitalwide smoking ban poses to physicians caring for smokers and considers the tensions between hospital policy and the treatment of an individual patient. Case 3 considers expedited partner therapy for sexually transmitted diseases and weighs the physician's obligations to prescribe only for those with whom he has established a patient-physician relationship against his duties to promote public health.

The interplay between insurers and employers in preventive medicine is further explored in the health law and op-ed pieces as well as in the winning entry in the Conley Ethics Essay Contest for medical students. The health law article explains why legal challenges to employer-imposed restrictions on employee smoking have failed. The op-ed presents an overview of the currently attempted carrot and stick methods for encouraging prevention by providing benefits or curtailing privileges based on patient and physician compliance. The winning Conley contest essay seeks to define the physician's role when a patient has been penalized by an employer-based wellness program.

The medicine and society article elaborates on the physician's role—and perhaps obligation—in counseling patients about how to overcome financial obstacles to healthier lifestyles and access to care.

The clinical pearl identifies the characteristics of hypertension and prehypertension and describes preventive practices for managing these widespread conditions. More unusual and controversial applications of preventive medicine are examined in the policy forum, which considers the validity of introducing preventive measures typically reserved for adults into the pediatric population, and the journal discussion, which considers the implications of prevention in the psychiatric and psychological realms through use of drugs to suppress formation of bad memories and prevent posttraumatic stress disorder.

Given the myriad everyday applications of prevention as well as its more rare and contested uses, it is clear that preventive medicine has taken root in today's society and will become a health care centerpiece. Moreover, the prevalence of preventable acute and chronic illness that dominates health care suggests that there is a great need for this focus. Unfortunately, the United States suffers from an appalling shortage of physicians specifically trained in preventive medicine, as the medical education piece affirms in highlighting the shortcomings of preventive medicine education and the need to direct more resources to this field.

As more Americans succumb to the epidemics of chronic disease, and improvements in science allow us to identify more concrete risk factors, prevention will continue to gain momentum. More ethical dilemmas surrounding prevention will surely emerge in the clinical, financial, and administrative settings, and it is my sincere hope that this issue of Virtual Mentor will help to engage the medical community, and particularly medical students and residents, in a dialogue about the application of preventive medicine to our society.


Reference

  1. Olshansky SJ, Passaro DJ, Hershow RC, et al. A potential decline in life expectancy in the United States in the 21st century. N Engl J Med. 2005;352(11):1138-1145.

Anna Shifrin, MS-II University of Massachusetts Medical School Worcester, Massachusetts

Wednesday, November 5, 2008

Battling the Worms Inside You

An infectious disease specialist must tackle her patient's parasites head-on.



Head region the nematode Enterobius vermicularis, or human pinworm.

Not long ago I received two messages at my medical office about an earthy problem. One was from a patient who said a colonoscopy had turned up a small herd of tiny white worms in his gut. Needless to say, he was not pleased to learn that he was sharing his cecum (the segment of bowel from which the appendix dangles as a thin sac) with a pack of nematodes. I agreed to see him as soon as possible.

The next message was from the doctor who had performed the colonoscopy. “Urgent!” he texted. “Need help with enterobius and strongyloides.”

Now we’re getting somewhere, I thought. To a Latin-loving parasite specialist like myself, the exotic names were familiar, as were the necessary treatments. But deep down, something felt wrong. It wasn’t the anxiety surrounding the worm sighting. That seemed natural enough. No, I decided, it was the actual pair of intestinal squatters. An odd combination indeed.

Enterobius vermicularis, or pinworm, is a surprisingly common stowaway in the bowels of temperate-world residents, especially children. Ask any veteran North American schoolteacher: At some time or another, most have dealt with a fidgety youngster with the threadlike pest. Fortunately, aside from an itchy bottom, sufferers rarely experience serious harm. And pinworms are easily banished. A few pills and they’re history.

On the other hand, the tropical parasite Strongyloides stercoralis is, without question, one of the most dangerous of intestinal nematodes that affect humans. Reason number one: The minuscule, soilborne path­ogens invade an entry point such as bare feet, then move through blood vessels and lung tissue on their way to the human gut, and they sometimes repeat their journey over and over, cycling between the gut and the rest of the body. Reason number two: Minus treatment, strongyloides can stay in the host body for a lifetime. Reason number three: In immunosuppressed patients, the tiny creatures go wild. In the worst-case scenario, their zigzagging offspring wreak mayhem and can even cause death, usually from overwhelming bacterial infections that follow in their wake.

As I mulled the surprising pair of helminths, my mind registered one more puzzling detail: their dissimilar sizes. As any parasitology textbook can attest, strongyloides are a heck of a lot smaller than pinworms—so small that they are generally not visible through the fiber-optic scope used by a gastroenterologist for a colonoscopy.

My puzzlement continued later, after I interviewed the patient. As far as I could tell, his opportunity to encounter strongyloides was close to nil. The final Sherlock Holmes­ian clue involved his feet. On the rare times when he vacationed in the tropics, he always wore waterproof beach shoes. Strongyloides larvae usually enter humans by penetrating bare feet because the infective larvae are present in the soil. Occasionally infection occurs via ingestion.
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Something felt wrong: The pair of intestinal squatters made an odd combination indeed.

The neatnik side of my patient’s personality, his obvious preference for cleanliness and order, made his infestation especially poignant. No one likes the idea of harboring worms, but highly meticulous people suffer most of all. Finally, on top of everything else, the man was having on-and-off stomach pain. Before the colonoscopy, he’d had two emergency CT scans. When I asked why, he replied, “Frankly, doc, I was sure I had appendicitis.” Then he gingerly pressed his abdomen. “Sometimes I still do.”

Ouch, another curveball. In my experience, the localized tenderness in his lower right quadrant didn’t fit either parasite.

OK, enough second-guessing, I finally decided; there was no mystery about the next step. The ultimate proof of infection resided on microscope slides at another laboratory. After two or three phone calls, they were en route to my hospital for a second opinion.

A week later, our senior parasitology tech reported back. “Well, there’s no strongyloides in these specimens,” she said in a voice faintly tinged with regret, “but he’s sure loaded with pinworms, including really young larvae. I can see how the other folks got confused.” Soon a blood test negative for strongyloides confirmed her finding.

Now it was time to tell the patient. Not surprisingly, anger was his first reaction to the news that he’d been misdiagnosed. After all, by then he had spent many a sleepless night picturing evil strongyloides swarming his internal organs. His mood quickly brightened once he grasped that he had only pinworms, a far less ominous pathogen.

There was just one more mystery to solve: my patient’s continuing abdominal pain. Once in a while the attacks were so severe he felt he had no choice but to page me late at night. I was not about to rouse a surgeon from bed. But I started to wonder: Could a really bad case of pinworms mimic appendicitis? I went online and began to read.

Yes and no, according to recent research studies. In surveys published between 1991 and 2006, as many as 4 percent of surgically removed appendixes contained pinworms—an impressive statistic until one recalls that, in the United States alone, up to 20 million people are thought to harbor them. In other words, in terms of cause and effect, merely finding enterobius in an excised human appendix proves nothing.

But before abandoning my hypothesis altogether, I had one more mission—a trip to our medical school library. There, in a lonely corner of the stacks, I hit pay dirt: a 1950 paper titled “Pathology of Oxyuriasis: With Special Reference to Granulomas Due to the Presence of Oxyuris vermicularis (Enterobius vermicularis) and Its Ova in the Tissues,” by W. S. Symmers, an early 20th-century dean of tropical medicine pathologists.

In his masterful paper Symmers re­viewed the autopsy findings of patients with incidental pinworm infection diagnosed after death, describing several whose postmortem tissues revealed inflammatory nodules around worms that had “strayed from their usual haunts and died, and around ova deposited in the course of such anomalous wanderings.”

Symmers’s elegant prose provided just the insight I had been seeking. After all, who could say my patient’s gut had not harbored stray, wandering pinworms for decades since childhood—just as Symmers’s subjects had harbored their worms up to and beyond the grave? And surely, after so long an infestation, I reasoned, cast-off eggs, dying worms, and little patches of inflammation near the appendix would trigger periodic pain in at least a few pinworm victims, right?

It was hardly proof positive, but, thus armed, I felt ready to tell my patient two things. First of all, that he should be thankful that his colonoscopy had revealed his strange case. And second, that with modern drugs and the tincture of time, I believed his painful attacks would slowly subside.

I like to think I was right. In any event, over the past year his midnight pages have stopped.

Claire Panosian Dunavan, an infectious diseases specialist at UCLA Medical Center, is president of the American Society of Tropical Medicine and Hygiene. The cases described in Vital Signs are real, but the patients’ names and other details have been changed.