VM1 December: The Hospital Care Revolution

Introduction to the December issue of Virtual Mentor on the theme of hospitalists and patient care.

There's been a quiet revolution over the past dozen years in the way patients are cared for in hospitals. Its outcome is the growing presence of the hospitalist—a physician whose focused area of practice is caring for patients while they are hospitalized. Hospitalist management of inpatient care means fewer visits to the hospital by the patient's office-based, primary care physician. In some regions and hospital systems, so-called “outpatient” physicians transfer care of their patients to the new inpatient specialists the minute the patient becomes hospitalized and resume care when the patient is discharged.

The several efficiency- and patient safety-related reasons for the revolution are well documented in this month's Virtual Mentor. (No one mentions that central casting challenges and plot stability demands drove daytime drama to invent the hospitalist quite some time ago. The de facto hospitalist appeared on General Hospital before he showed up at Mass. General.)

The questions of greatest interest to this month's contributors concern the effect of the new model of hospital medicine on patients. Have patients lost something critical to their well-being now that their own primary care physicians do not stop in to visit once or twice a day? Is the loss more than offset by gains in safety and shortened length of hospital stay? What sort of relationship is possible between the patient and hospitalist, who has the best interest of many patients on his or her mind at the same time? Finally and importantly, how do these new focused-practice physicians relate professionally to their patients' primary care physicians, and how do they demonstrate to their profession and the public that they have the special knowledge and skills needed to care for people who are very sick?

In VM's first clinical case, two physicians, a hospitalist and a primary care physician, differ on a patient's treatment plan. Commentator Dawn Brezina, a hospitalist and educator at Duke University Health System, explains that hospitalists must constantly be on guard against conflict between the interests of the patient and those of the hospital, since a compromise in treatment plan may be a breach of obligations to the patient.

The next clinical case examines the new questions in professional relationships introduced by the hospitalist movement. When both hospitalist and family physician are involved, who is better suited to initiate a discussion about end-of-life issues? Mary Ehlenbach argues that the hospitalist may have greater skill in conducting such intense conversations, but she acknowledges and welcomes the participation of a family physician who has a long and close association with the patients who are facing the difficult decision.

Laborists, a subset of hospitalists, are the subjects of clinical case three. Laborists' expertise can add to patient safety in many labor and delivery cases, but they have “a duty to preserve the established relationship between the treating obstetrician and patient.” By doing so, Louise P. King and George D. Wendel Jr. maintain, laborists can preserve continuity of care even in emergent situations.

How do hospitalists demonstrate their competence? Jeffrey G. Wiese, a medical educator at Tulane University, explains the effort under way to assure that all hospitalists are trained to high standards. A “focused-practice certification” is planned by the American Board of Medical Specialties, the main tenets of which are that “physicians must (1) demonstrate competence as internists, and (2) have practice experience in hospital medicine.”

Robert M. Wachter is, by all accounts, a founder of the field. He summarized the key developments in hospital medicine in his 2008 article, The State of Hospital Medicine in 2008, which is reviewed by AMA intern Chloe White in this month's journal discussion.

The clinical pearl guides us through the benefits and limitations of transjugular intrahepatic portosystemic shunts (TIPS) in treating portal hypertension—the source of controversy in clinical case one. A physician training to be a transplant hepatologist, Elizabeth C. Verna encapsulates the most important indications and counterindications for use of this procedure.
In the health law article, Erin A. Egan uses Domby v. Moritz to show how the limits of hospitalists' liability are being defined—a vital step if this medical model is to survive legal challenges.

If hospitalists are so great, why not make their use mandatory? In this month's policy forum, Marc B. Royo, Laura L. Kimberly, and Alexandria Skoufalos, all from Jefferson Medical College of Thomas Jefferson University, in Philadelphia, explore why this option was tried in some places and then modified in the course of the field's evolution.

How far can the hospitalist concept go? C. Edward Wells confides the concerns that laborists—hospitalists who oversee labor and delivery—have about patient acceptance of their role, new in the past five years, in one of this month's history of medicine articles.

Another historical look highlights the rapid evolution of hospitalist medicine as a “site-of-care” specialty—a rise far more rapid than that of emergency medicine, the other well-known example of site-specific practice. Joseph Ming Wah Li explains the two key reasons for its birth and growth: efficiency and patient safety.

In the medicine and society section, Elmer Abbo discusses the new paradigm of health care delivery. He argues that physicians who practice in hospitals day in and day out are best positioned to mediate the inevitable conflict between an individual patient's needs and scarce resources. Dr. Abbo views the model of hospitalist medicine as central to a realistic medical ethics in our health care system.

While the profession has become accustomed to working with these new colleagues in the hospitalist field, there's still an element—part nostalgia, part unease—that says, “Something's not right. What happened to the old-time family doctor?” Robert M. Centor writes an op-ed article on the adjustments that are yet to be made. “I have heard tales of horrible hospitalists with lousy bedside manners. I have heard praise for wonderful hospitalists with superb bedside manners.” He is well placed to comment, having made the transition to hospital-based medicine himself.

We hope that this issue of Virtual Mentor helps readers understand the causes, outcomes, and ethical concerns raised by a revolution in hospital medicine so quiet that many may have not known it was occurring. Finally, we thank Erin A. Egan for the idea that led to this theme issue.


Sincerely,
Philip A. Perry, MSJJenny SchooleyFaith L. Lagay, PhD
Virtual Mentor editors

Is your parent overmedicated?

Use of multiple drugs, especially in older adults, can exacerbate ailments

By Siri Carpenter

Prevention

updated 8:34 a.m. ET, Mon., Nov. 17, 2008


About a year ago, my mother told my father there was a movie she really wanted to see and suggested they catch it that evening. Great idea — except that, as my dad gently reminded her, they had just seen it.

Though he tried to make light of it at the time, Mom's memory lapse was not an isolated event. She often repeated herself, misplaced one thing after another, and neglected commitments she didn't remember making. A woman with a gift for banter, she now found it difficult to carry on a conversation because she was so easily distracted. Most disturbing of all: She was only 61.

Mom, too, sensed something was wrong.

A teacher of English as a second language, she was known for her supple mind but now felt as if her brain was shrouded in fog. "I'm not as smart as I used to be," she told me recently. Fearing she might be suffering from some kind of early onset dementia, she made an appointment with a neuropsychologist and asked me to go with her.

I said I would, even though I suspected another culprit: the potent brew of medications she was taking for the litany of medical problems that has plagued her for years. She consumed so many drugs every day — 21 of them, prescribed to her by five different physicians—that she lugged them around in a toolbox. A partial list: two blood pressure medications, four for asthma, a cholesterol-lowering statin, and several others to treat her diabetes, fibromyalgia, depression, fatigue, and acid reflux. I assumed that, to coordinate this chemical assault upon her ailments, my mom's doctors talked to each other regularly, that her internist was closely monitoring her medications to prevent any dangerous interactions, and that every pill Mom popped was part of a carefully crafted treatment plan.

How naive.

When I took my mom to see the neuropsychologist, I was startled to learn just how naive my assumption was. The specialist dismissed outright my suggestion that polypharmacy (the use of multiple meds) might be to blame for Mom's porous memory and perhaps some of her other ailments as well. Without even knowing what my mom was taking (never mind the sheer quantity), she confidently asserted that drug-related problems come on more suddenly. I'm not a medical doctor, either, but I do have a PhD in psychology and know that complex situations can be unpredictable. The neuropsychologist's blithe dismissal irked me, so I did some research on my own.

Here's what I learned: The use of multiple, often unnecessary medications — especially among older people — is an entrenched, escalating, frightening, and mostly unexamined problem in modern health care. Although medications can ease many conditions, multiple-drug use often exacerbates existing ailments and causes troubling side effects that are treated with yet more drugs. Many doctors, researchers, and pharmacists I talked to agree. "Overmedication is a true epidemic," says Armon B. Neel Jr., PharmD, a clinical pharmacist in Georgia who evaluates medication plans for private and nursing home clients. "It's completely out of hand."

I also learned that, with the help of professionals, a determined patient can dramatically scale back her prescription drug use and eliminate, or at least reduce, the jumble of side effects that has clearly contributed to her downward spiral. That's what my mom did, emerging from her med-induced fog to reclaim her former vibrant self. This is the story of her comeback — a cautionary tale for everyone who takes several medications every day.

What's behind the Rx cascade

Polypharmacy is most common among people over age 65, about one-fifth of whom take at least 10 medications a week. Because the body absorbs, metabolizes, and rids itself of drugs more slowly with age, a dose considered safe for a middle-age woman can be toxic to her parent. In fact, the Institute of Medicine estimates that at least 1.5 million adverse drug events occur in the United States every year, thousands of them fatal. Studies indicate that about one-third of these drug reactions among senior citizens — and 42 percent of serious, life-threatening, or fatal events — are preventable. Doctors often mistake the ensuing physical response — memory lapse, fatigue, abdominal pain, swelling, or other ailments — as a sign of worsening disease. This can lead to a "prescribing cascade," says Jeffrey Delafuente, FCCP, a professor of pharmacy at Virginia Commonwealth University. "The solution is to reduce the number of drugs. Adding more just exacerbates the problem."

Seeing various doctors or specialists contributes to that cascade. According to the Agency for Healthcare Research and Quality, 81 percent of people with serious chronic conditions have two or more physicians, more than half have three or more, and a third have four or more. Specialists don't always know everything a patient is already taking, says Paul Takahashi, MD, a geriatrician at the Mayo Clinic. Primary care physicians are supposed to oversee the management of their patients' various medications, he says, but unless a new drug is clearly contraindicated, they're often reluctant to second-guess specialists' decisions. To be fair, doctors are not entirely to blame for rampant over-prescribing. In recent years, federal health panels have handed down more stringent targets for controlling chronic diseases such as hypertension and high cholesterol. Medication is often the quickest and surest way to get results — a strategy endorsed by insurance companies, which are reluctant to pay for less well-documented natural therapies.

Patients, too, unwittingly compound their own problems. "As a culture, we've come to expect that there's a pill for every ailment," says Stephen Bartels, MD, director of Dartmouth Medical School's Centers for Health and Aging. "Patients ask for medications they've seen advertised, and sometimes it's easiest for physicians to just prescribe them rather than encourage behavioral changes or preventive steps." Each added prescription increases the likelihood not only of a problematic interaction but also of misuse. Studies show that half of older people sometimes fail to follow their Rx instructions. It's no wonder. Consider my mom's regimen: She took 32 pills a day, at five different times — some once a day, some twice, some three times, and some as needed. One pill had to be split in half for the morning dose but not for the evening dose. Some were taken with food, others on an empty stomach. She also used three different asthma inhalers plus a nebulizer, all on different schedules. I'm half her age, and I couldn't keep that straight.

The more I learned about the risks inherent in taking a large number of prescription drugs, the more I saw how systemic the problem is. Seniors with five or more chronic health problems account for two-thirds of Medicare spending, yet doctors lack clear, evidence-based guidelines for coordinating their medications. A kind of head-in-sand ignorance is built into the system: Patients with multiple diseases are typically excluded from studies of a drug's safety and effectiveness, says Johns Hopkins geriatrician Cynthia Boyd, MD, MPH — and therefore are mostly ignored in the accepted guidelines that evolve from that research. "Every physician in the country is seeing these complex patients," she says, "but we have a long way to go in understanding how to integrate their care."

Paring down, one pill at a time

After our dispiriting visit with the neuropsychologist, who ordered tests, I wished my mom could go off most of her medications and just start over. Experts I interviewed said they could often simplify a patient's regimen but that changes are usually modest. I didn't think it would help her to go from 21 medications to, say, 19.

But I soon learned that some pharmacists, who typically know the products they dispense better than doctors do, often recommend more substantial changes. Neel, the Georgia consultant pharmacist, told me about patients who went from taking a dozen or more prescriptions to only a few, with marked improvements in health and quality of life. Sometimes, he said, removing just one inappropriate medication can eliminate the need for several others. "You send me your mom's information, and I'll see if I can help," he urged me.

Before I did, though, I had to know that Neel wasn't a quack. I talked at length with a couple of his clients, including 71-year-old Carla Moore, who related this riveting story: She hired Neel several years ago after a series of medical misfortunes left her on 13 medications, yet feeling worse and worse. "Every time I told the doctor how terrible I felt," Moore told me, "he wrote another prescription." Her health deteriorated for months, to the point that she told her husband she hoped she'd die. When Moore stumbled across a magazine article that called Neel "the pharmacist who says no to drugs," she picked up the phone.

Neel's analysis of Moore's medications suggested that some were redundant, others probably unnecessary. Still others, he believed, were doing more harm than good. But when Moore brought Neel's report to her longtime internist, "he took one look at it and threw it across the room at me," Moore says. "'I can't believe you'd insult me like this,' he said, and dismissed me from his office." The doctor later sent Moore a registered letter telling her to find another physician. The next eight doctors Moore consulted wouldn't even look at Neel's report. The ninth one did, and readily agreed to write the prescriptions necessary for her to follow the recommendations. Within a week, Moore felt substantially better, and within a month she was back to her old self. These days, she takes three prescription drugs, a daily aspirin, and a few vitamins and minerals — and feels 15 years younger. She walks on a treadmill and lifts weights at the gym several times a week, and blood tests confirm she is in excellent health for her age.

I was buoyed by Moore's turnaround but dismayed by her struggle to regain control over her medical decisions. Would we encounter the same resistance from our doctors?

Despite our concerns, my mom and I decided to hire Neel. One evening, we dumped the pills from her toolbox onto my kitchen counter and started cataloging them, recording each one's strength and dosing instructions. We sent this information to Neel, along with numerous lab results; a log of my mom's recent blood pressure and glucose readings; and a thorough description of her symptoms, medical diagnoses, and history.

In the 29-page report Neel sent us a week later, he identified 27 drug interactions among my mom's medications, most of moderate or high severity. It turned out that seven of her medications — fully a third! — sometimes cause memory loss, confusion, or impaired cognition. Neel recommended lower dosages of some drugs, taking others at new times of the day, and dropping some altogether. Among the most important suggestions:

Drop two of her blood pressure medications, which he believed were causing my mom's chronic cough, for which she was taking four asthma drugs (although she was never actually tested for asthma). He also thought one of these drugs was contributing to my mom's debilitating fatigue and weakness. He recommended replacing them with two others.

Discontinue the statin, which he felt was causing or exacerbating her muscle pain, which had long been attributed to fibromyalgia. He recommended that she manage her lipids through diet, exercise, and B vitamins instead.

Stop taking the medication for acid reflux, which was preventing her body from breaking down certain drugs, including, crucially, the enteric aspirin she took for cardiac protection. He recommended she instead eat a probiotic yogurt several times a day.

Neel's report was dense and nuanced, but its message was clear: My mom's medications were making her sicker. She, like me, was inclined to follow his recommendations, but the truth is that making such radical changes was intimidating. What if we were wrong?

Nonetheless, we plunged ahead and booked an appointment with my mother's internist. To our relief, the doctor said the plan was worth trying. She emphasized, though, that if Mom intended to reduce her use of medications, especially those aimed at controlling cholesterol, blood pressure, and blood sugar, she'd have to exercise regularly and keep a close watch on her diet.

So we left the doctor's office with a handful of new prescriptions, feeling both relieved and apprehensive. That night, I hammered out a 10-page spreadsheet to help Mom keep track of her new schedule, which would change daily for 2 weeks, then every 10 days for another month. She now takes six daily medications, plus a few vitamins. Neel believes that in time, she may be able to eliminate still more drugs.

A promising new start

A few days into her new regimen, the fog that enveloped my mom's mind receded and her mood brightened. The asthmatic cough that plagued her for years has vanished, and recent tests showed normal lung function — no asthma after all. Her muscle pain has dramatically diminished. When I asked recently how her acid reflux was, she retorted, "What reflux?"

Five months into the routine, it's too early to say whether she can keep her blood sugar and cholesterol in check without more meds. Although her cardiologist is satisfied with her blood pressure, her internist is not. If her systolic reading isn't down to 120 by her next visit, the doctor insisted, "You're going back on the old drugs."

This encounter left my mom profoundly discouraged. She still believes she's better off without the drugs. With the assistance of a credentialed health care provider, she has dedicated months to gaining control over her health. She's accepted a marginally higher cardiac risk in order to avoid a multitude of symptoms that impeded her quality of life. But her doctor still holds the trump card: She could decline to write the prescriptions that would allow my mom to continue to follow Neel's recommendations, or even ask her to find another doctor. Afraid she'll be "fired," Mom wants to appease the doctor somehow — surely not a solid basis for making medical decisions.

Still, things are looking up. A year ago, Mom was a wreck. Now she's simply a middle-aged woman who has to watch her blood pressure and her blood sugar. That qualitative shift has given her a fresh outlook. "My life has changed and will continue to," she confidently declared recently. In the past several months, she has renewed her commitment to controlling her diabetes with a healthy diet and exercise. Last weekend, she and I took an overnight bike trip together.

There was no room on her bike for a toolbox filled with pills — and no need for one. The toolbox is history.

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.

---

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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.

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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.

Related in VM

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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.

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.

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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.

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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.

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.

Cancer genetic blueprint revealed

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."