Friday, July 16, 2010
Thursday, July 15, 2010
For several years now and with a growing messianic fervor, physicians and health care experts have been responding to the need to deliver more efficient and better primary care with one response: patient-centered medical homes.
Not long ago, I found myself doing the same with a friend who prides himself on being a well-informed patient. But instead of an overwhelmingly enthusiastic or even mildly interested response, my friend stared at me blankly.
"What in the world are you talking about?" he finally asked. "A hospice? A halfway house? Some kind of group home for patients?"
I explained that a patient-centered medical home can be any primary care doctor's office, but it is run with a different philosophy. Care is team-based, preventive and comprehensive, rather than one-on-one, fee-for-service or managed. Record keeping and sharing is seamless and electronic, rather than unwieldy and paper-based. Clinicians from the team are easily accessible in person, on the phone or via the Internet within 24 hours, rather than hidden behind labyrinthine automatic answering services and overbooked clinic schedules.
My friend suddenly became very interested.
Call it a P.R. issue, an information disconnect or simply an unfortunate choice of a name, but in all the discussions about patient-centered medical homes, one group of individuals has been conspicuously missing: the patients themselves. And it's hard not to notice the irony; in a model of care premised on the strength of the patient-doctor relationship, few people other than doctors and experts are even sure what it is or how it affects their care.
Now, as dozens of pilot projects across the country are transforming traditional doctors' offices into medical homes and putting this theory of practice to the test, one thing has become apparent: even this most promising of reforms is unlikely to take hold without the active involvement of patients.
The need to get patients involved was made startlingly clear last month when the American Academy of Family Physicians, a national medical society devoted to primary care, and TransforMED, a nonprofit consulting firm created by the society to help physicians turn their practices into medical homes, published the first report on their national demonstration project. Beginning in 2006, 36 traditional primary care offices began adopting the hallmarks of patient-centered medical home practices. They installed electronic medical record systems and reorganized deeply entrenched scheduling routines. Teams made up of nurses, medical managers, physician assistants and doctors, rather than a single physician authority figure, began working with patients. And care was focused not on single acute episodes of illness but on the patients' comprehensive and ongoing management.
As the study progressed, the researchers found that the vast majority of doctors' offices could successfully incorporate most of the changes into their practice, and early signs of the model's success were promising. Quality of care and preventive health ratings revealed small improvements. Office staff became more streamlined, efficient and satisfied. Most notably, physicians were more content than ever before with their work, despite still having to deal with an unchanged fee-for-service or managed care reimbursement system. The doctors' enthusiasm persisted even after the study closed, with many maintaining contact with one another through a listserv and twice-yearly self-organized meetings.
Yet despite these successes, there was also one unexpected early finding: the patients were unhappy.
Yes, they were getting into their doctors' offices more quickly and were being followed more closely than ever before, but many patients reported feeling disoriented. Some felt displaced as they saw the old one-to-one doctor-patient interactions replaced with one-to-three or one-to-four relationships involving not only the doctor but also a whole host of other providers. As offices switched from paper-based to electronic medical records, other patients reacted to the distracted clinicians who seemed more focused on learning the new computer system than on listening to them. Satisfaction fell because, like my friend, few patients were cognizant of, much less involved in, the changes going on around them.
In working so hard to adopt changes on their patients' behalf, clinicians had temporarily lost their focus on the patients themselves.
"The Achilles heel of all of this is a lack of patient understanding and engagement," said Dr. Terry McGeeney, a primary care physician and chief executive of TransforMED. "Patient-centered medical homes are a massive paradigm shift in how primary care practices function." As one of the first national studies of patient-centered medical homes, "we were starting at ground zero, and we weren't aware of what we needed to do other than support the physicians' personal motivation."
With the patient survey results in hand, the researchers began encouraging medical practices to involve patients in the changes. They asked clinicians to discuss the premise of medical homes with their patients and encouraged them to create patient advisory councils, groups of patients who would meet regularly with clinicians to discuss how their needs might be better served.
"We were surprised by how many patients wanted to be part of it," said Dr. Barbara Saul, a primary care physician in Troy, Mich., who was initially part of the study. "Patients would say over and over, 'It's about time you started these kind of changes.' "
The researchers also created a five-minute, 20-question assessment survey that asks patients for their views on patient-provider communication, clinician access and care of the whole person. Practices could use the survey regularly to gauge the effects of any changes, adjusting and refining what they do according to the patients' experiences and not what the clinicians might believe was most important to them.
"Nowadays a lot of patients end up getting things done to them, almost forced on them," said Dr. Joseph Mambu, a practicing family physician in Lower Gwynedd, Pa., a suburb of Philadelphia. "I think if we could see a situation the way a patient does, a lot of the things we do would not be done." Based on his experience with the national demonstration project, Dr. Mambu went on to help create a national coalition of patient advocacy groups, payers and providers, the Patient-Centered Primary Care Collaborative, devoted to creating more medical homes across the country.
While Dr. McGeeney and his co-investigators believe that such work and ongoing research will yield even more significant results in terms of improving the quality and decreasing the costs of primary care, the lesson from this first experiment is clear.
"The model can improve quality while becoming more efficient, but practices need support," Dr. McGeeney observed. "Providers need to want to provide this kind of care, payers need to pay for this kind of care and, most importantly, patients need to demand and expect this kind of care."
But the information about the amount of time the men spent being inactive remained largely unexplored. Recently, however, scientists from the University of South Carolina and the Pennington Biomedical Research Center in Baton Rouge, La., parsed the full data. In a study published in May in the journal Medicine and Science in Sports and Exercise, they reported that, to no one's surprise, the men who sat the most had the greatest risk of heart problems. Men who spent more than 23 hours a week watching TV and sitting in their cars (as passengers or as drivers) had a 64 percent greater chance of dying from heart disease than those who sat for 11 hours a week or less. What was unexpected was that many of the men who sat long hours and developed heart problems also exercised. Quite a few of them said they did so regularly and led active lifestyles. The men worked out, then sat in cars and in front of televisions for hours, and their risk of heart disease soared, despite the exercise. Their workouts did not counteract the ill effects of sitting.
A federal medical advisory panel recommended Wednesday that Avandia, a controversial diabetes drug, should either be withdrawn from the market or have sales severely restricted because it increases the risks of heart attacks.
The panel's votes, taken after two days of intensive scientific discussions, were a blow to GlaxoSmithKline, which makes Avandia. The company argued that Avandia is a safe and needed option in treating diabetes.
But panel members voiced great skepticism about the company's trustworthiness after questions were raised about its clinical trials. And internal company documents showed that the company for years kept crucial safety information about Avandia from the public.
The panel took six votes on a variety of issues, but its most important came near the end of the meeting when asked what the Food and Drug Administration should do. Of the panel's 33 members, 12 voted that Avandia should be withdrawn; 10 voted that its sales should be restricted and the warnings on its label enhanced; 7 voted only to support enhanced warnings on the drug's label; and 3 voted that the drug should continue to be sold with its present warnings unchanged. One member abstained, and no one voted for a final option, to weaken the label's present heart warnings.
Dr. Janet Woodcock, director of the drug center at the F.D.A., said that the agency took the panel's advice seriously and that it would consider its regulatory options.
The F.D.A. often takes the advice of its advisory panels, but in this case it was hard to predict what the agency would do, given the split nature of the vote. The agency allowed competing visions to spill out in the advisory hearing — something unheard of just a few years ago, when the F.D.A. nearly always spoke with a single voice.
"We will come to a decision as soon as possible, and we will announce that publicly," Dr. Woodcock said.
Approved in 1999, Avandia helps control blood sugar levels in diabetics by making patients more sensitive to their own insulin. It is one of a class of three drugs, the first of which, Rezulin, was withdrawn because it caused liver damage. The other drug in the class, Actos, made by Takeda, has appeared safe.
Avandia, which was once the biggest-selling diabetes medicine in the world, saw its sales abruptly decline in 2007 after a study by Dr. Steven Nissen, a Cleveland Clinic cardiologist, found that it increased the risk of heart attacks. An advisory committee in 2007 decided that Avandia did increase heart risks but voted to keep it on the market.
Many of the same experts who decided to keep the drug on the market in 2007 voted Wednesday that it should be withdrawn or restricted. Those restrictions could mean that patients would have to apply for special permission to use the drug.
Reactions were as mixed as the vote.
In a statement shortly after the committee adjourned, GlaxoSmithKline noted that a majority of committee members had voted to keep Avandia on the market.
Dr. Nissen said the committee's vote was the best he could hope for. "Effectively, this drug is gone," he said.
Dr. Sanjay Kaul, who voted to require stronger warnings, said that the F.D.A. must ensure that Avandia was used far less regularly. "Make sure this is available as second-line and not as first-line," Dr. Kaul urged.
The F.D.A. generally undertakes programs to restrict a drug's sales only when a drug offers a unique benefit, something no study has shown about Avandia. Among the examples of drugs the F.D.A. has restricted are Accutane, an acne drug that can cause birth defects, and Lotronex, a drug for irritable bowel disease that in rare instances is fatal. A majority of the committee found that Avandia increased the risk of heart attacks but a majority also said that studies had failed to prove it increased the risk of death. A majority also decided that if Avandia were to continue to be sold, the company should complete a clinical trial to prove it was safe. But several members said that the vote probably made a trial impossible because patients would not want to risk taking Avandia.
GlaxoSmithKline said it was in the midst of a clinical trial that would test definitively if Avandia caused heart attacks. Several panel members said the trial came too late.
"The best time to do the trial would have been when the first signal about lipids came up way back in the 1990s," said Dr. Peter J. Savage, a member from the National Institute of Diabetes, Digestive and Kidney Diseases.
In the 1990s, GlaxoSmithKline decided against just such a study because it feared that the results might hurt sales, according to internal company documents.
Throughout the meeting, GlaxoSmithKline was criticized over repeated findings by federal officials that the company had failed to conduct its Avandia studies appropriately.
At one point, Dr. Murray Stewart, a vice president at GlaxoSmithKline, was given five minutes to explain why a crucial trial called Record was done properly.
But he was immediately followed by Dr. Thomas A. Marciniak, a team leader at the F.D.A., who found numerous mistakes in the study that served to hide Avandia's risks.
Time and again, GlaxoSmithKline overruled doctors who had concluded that patients had been harmed by Avandia, Dr. Marciniak said.
Dr. Stewart tried to respond, but the committee's chairman silenced him.
Dr. William Knowler, a panel member who is chief of diabetes epidemiology at the National institute of Diabetes and Digestives and Kidney Diseases, described a different study done by GlaxoSmithKline as "totally incorrect and deceptive."
Dr. David Capuzzi, a panel member who treats diabetics, said that clinicians need as many choices of drugs as possible, and he voted to keep Avandia on the market with no new restrictions.
Chuck Keyserling, a diabetes patient, echoed those concerns during a brief public part of the meeting. He said that he had been taking Avandia for 10 years.
"Please think about those of us who have flourished on Avandia," Mr. Keyserling told the panel. "For those people, a negative position on Avandia may be a death sentence."
Dr. John Teerlink, a panel member who voted Wednesday to restrict the drug, said he had served on the advisory panel in 2007 that voted to continue to allow Avandia to be marketed. But he said he made the earlier vote with the understanding that GlaxoSmithKline would use the added time to prove that its drug was safe and that he had not been convinced.
This March, a report on chronic disease and the Internet by the Pew Internet and American Life Project and the California HealthCare Foundation showed that people fighting such illnesses are using social media to find information and connect with others who suffer similar ailments.
While the research showed that people who have chronic illness are less likely, on average, to haveInternet access, once they're online they are more likely to blog about chronic disease and participate in online discussions or other forums. According to the report, "Living with chronic disease is also associated, once someone is online, with a greater likelihood to access user-generated health content such as blog posts, hospital reviews, doctor reviews, and podcasts. These resources allow an internet user to dive deeply into a health topic, using the internet as a communications tool, not simply an information vending machine."
Finding the right balance between individual privacy rights and community benefit will, however, require online services to thread regulatory needles and provide clear guidance to users about how their information will be used. Below are five examples of online services, platforms or projects that are working to strike that balance, providing a means for patients and citizens to share their experiences.
Placebos Are Getting More Effective. Drugmakers Are Desperate to Know Why - Steve Silberman, Wired Magazine
Wednesday, July 14, 2010
Joining Mr. Starr in his 70s next year will be the still-performing Bob Dylan ("May you stay forever young") and Paul Simon ("How terribly strange to be 70"). Following soon after will be Roger Daltrey ("Hope I die before I get old") and Mick Jagger, who is reported to have said, several grandchildren ago, "I'd rather be dead than singing 'Satisfaction' at 45."
A rock 'n' roll septuagenarian was someone the gerontologist Robert Butler could have only dreamed of in 1968, when he coined the term "ageism" to describe the way society discriminates against the old.
Dr. Butler, a psychiatrist, died, at age 83, a few days before Ringo's big bash. No one, his colleagues said, had done more to improve the image of aging in America. His work established that the old did not inevitably become senile, and that they could be productive, intellectually engaged, and active — sexually and otherwise. His life provided a good example: He worked until three days before his death from acute leukemia.
But as much as Dr. Butler would have cheered an aging Beatle onstage, his colleagues said he would have also cautioned against embracing the opposite stereotype — the idea that "aging successfully," in his phrase, means that you have to be banging on drums in front of thousands — or still be acting like you did at 22 or 42.
That stereotype is almost as enduring as ageism itself.
"The stories that we hear tend to pull us toward the extreme," said Anne Basting, the director of the Center on Age and Community at the University of Wisconsin at Milwaukee. "It's either the stories of young-onset Alzheimer's, or it's the sky-diving grandmas. We don't hear enough about the huge middle, which is the vast majority of folks."
In fact, for most people, the 70s represents the end, not a beginning. Life expectancy in this country is still 78 — higher for white women, lower for men and blacks. It is rising, but not as fast, perhaps, as our expectations. As Gloria Steinem said of her 70th birthday in 2004, "This one has the ring of mortality."
Yet with Clint Eastwood directing films at 80 and Betty White starring in a new sitcom at 88, the pressure for 70-year-olds is not to face mortality, but to kick up those slightly arthritic heels ever higher.
The eighth decade, said Dr. Basting, is "now seen as an active time of life: you're just past retirement, that's your time to explore and play mentally." But while many will be healthy, others will not. "There will be an increase in frailty and disability because people are living longer," said S. Jay Olshansky, a demographer at the University of Illinois at Chicago who studies aging. For some people, an increased risk of stroke and Alzheimer's "is going to be the price they pay for extended longevity," he said.
The risk, gerontologists say, is that in celebrating the remarkable stories, we make those not playing Radio City, and certainly those suffering the diseases that often accompany old age, feel inadequate.
Social policy may only contribute to that pressure. The European Commission recommended last week that European workers not be allowed to retire before 70, to keep state pension funds solvent. In this country, Representative John Boehner of Ohio, the Republicans' leader in the House, suggested raising the retirement age for Social Security benefits to 70 to keep the program afloat.
Thomas R. Cole, director of the McGovern Center for Health, Humanities and the Human Spirit at the University of Texas Health Science Center in Houston and the author of a cultural history of aging, said he hailed anyone who, borrowing a phrase from his mother, age 85, "is playing above the grass."
At the same time, he said, "if we don't pay attention to the dark side of our 70s and 80s, we're not going to pay enough attention to the people who need help."
"We're going to make it look like if you're sick, it's your own fault; if you're not having orgasms or running marathons, there's something wrong with you. We need to think carefully about how to take care of people who are frail. We need to allow people to not feel like failures when they can't do the things they used to do."
He traces the origins of this "splitting apart" of the reality of old age — good and bad — to the mid-1800s, when people in the United States first experienced what he calls "the legitimization of longevity."
Life expectancy was only 40, but people began to believe that humans could live to be old — which they defined as 80 or more.
"People first began to say, 'I'm here to live a long life, and if I work hard and am a good person and am middle class, I will die a good death,' " Dr. Cole said, " 'and if I don't do these things, I deserve a short life and a painful death.' "
That split persists, he said, in our obsession with health and longevity, visible to anyone glancing across a magazine stand.
"It assumes you can control these things through willpower," he said.
Gerontologists tend to think of successful aging as taking advantage of what potential there is, staying as socially and intellectually engaged as possible. Our culture tends to measure it more in terms of how active people are.
"It wouldn't do us a whole boatload of harm to reinstate some values to contemplation," said Dr. Basting. "Part of the pressure on older people to be successful and give back and volunteer and be active and play tennis is that we are a culture of doing. We don't really know how to be. That's something that late life gives us, is time to be. But that's stigmatized."
We might take a new model from musicians and other artists growing older. Creative types tend not to retire, but their later work often reflects their different stage of life. Dr. Cole cited the roles and films of Clint Eastwood, and the songs of Mr. Simon. "Old Friends" reflected on the strangeness of 70 from a young adult's perspective, but on an album released when he was 60, he sang of "growing old" from a first-person perspective.
On the other hand, Dr. Basting said, Mick Jagger might test the limits — can he really strut like that when he's 75?
For boomers, it can be particularly jarring to watch the icons of the rock 'n' roll era aging. Robert Kastenbaum, a 77-year-old psychologist who has written extensively on aging, compares it to a 50th high school reunion and meeting the girl you had a crush on.
"This bubble-headed girl who was too sexy to exist, there she is now as the most mature, sensible grandmother," he said. "You think you can't believe the difference. The fact is both of these things are true. She was truly adorable, now she is admirable."
We need to recognize all those stages, he said, and not think there is some dissonance. "It's tolerance of ambiguity."
Dr. Butler might have agreed. In a recording of what was apparently his last interview, conducted less than two weeks before he died, and posted on The New Old Age, the New York Times blog on aging, he told Joshua Tapper, "Sometimes the oldest person in the room comes up with the most thoughtful thing — not always.
"I think we ought to have a realistic portrait of all different periods of life and not try to romanticize old age as the most wonderful, all these great old wise people," he said. "I think that goes too far."
Does the pressure ever let up? Maybe.
Dr. Basting, who has studied elderly theater troupes, recalled that one member declared that the age of 90 was "true freedom."
"Anything you do, people are just shocked that you're alive," Dr. Basting said. "There's no expectations at 90."
In July 1998, McKenna was a workaholic who had recently moved to North Carolina after winning a competitive postdoctoral fellowship from the National Institutes of Health. Only 3 weeks earlier, at the annual meeting of the Endocrine Society, the tall, blue-eyed brunette had presented her work on the responses of estrogen receptors to environmental compounds that mimic the hormone.
But on July 10th, a driver hit the back of McKenna's car going 40 miles (65 kilometers) per hour, without braking. McKenna's neck was thrown forward, slamming her brain against her forehead. As her body recoiled from the impact, the soft brain tissue ricocheted backwards, contorting again as it hit the back wall of her skull. When an emergency worker arrived, McKenna declined treatment and drove her still-operable car home. On the way, she stopped at a friend's house. The friend asked if she was okay. McKenna's eyes looked vacant.
After a few days off, McKenna returned to work, but things weren't the same. She began to spell phonetically. She couldn't remember her phone number or address. At a lab meeting, she was shocked to look down at her notebook to see scribbled numbers and symbols instead of words. "I thought I was going crazy," says McKenna. And her head continued to hurt.
On July 10, 1998, McKenna was one of the 4,700 people who sustain a traumatic brain injury (TBI) in the United States every day—that's 3 people per minute. In Europe, brain injuries cause 66,000 deaths and land 1.6 million people in emergency rooms every year. Overall, 1.7 million Americans suffer a TBI annually, more than the number diagnosed with breast, lung, prostate, brain, and colon cancercombined. In 2009, those five cancer fields received $2 billion in NIH funding. Traumatic brain injury research received just 4 percent of that—$86 million.1
TBI is an epidemic—the number one killer of young adults and children in the US—but it is not a new epidemic. A scant quarter inch of bone and a layer of fibrous membranes protect our brains from sudden trauma caused by a jolt, blow, or penetrating object. TBIs result from falls and car accidents, even an act as simple as a child tumbling off a swing.
Yet for the millions affected by TBI, science and medicine have little to offer. Methods for classifying patients remain rough and antiquated. And there are no effective drugs for TBI: Since the 1970s, not a single Phase III clinical trial has shown a significant benefit.2It's not from a lack of trying, though. From 1980 to 2009, there were at least 27 Phase III trials in TBI. Doctors have tested steroids, hyperbaric oxygen therapy, magnesium, calcium-channel blockers, and other receptor-blocking agents. None showed significant treatment effects.
It's time to pause and step back, researchers say. "We are surrounded by years and years of failure," says Geoff Manley, codirector of the Brain and Spinal Injury Center at the University of California, San Francisco. "When you have 28 failed drug trials based on really good preclinical data done by smart investigators, you can either say none have worked or take a fundamental look around and admit something is going horribly wrong."
Tuesday, July 13, 2010
Two years ago, the supply system atSeattle Children's Hospital was so unreliable that Susanne Matthews, a nurse in the intensive care unit, would stockpile stuff — catheters in the closet, surgical dressings in patients' dresser drawers and clamps in the nurse's office. And she wasn't the only one.
"Nurses get very anxious when we can't get our hands on the tools we need for our patients," Ms. Matthews says, "so we grabbed them when we saw them, and stashed them away." This, in turn, made the shortages more acute.
On a busy day last month in the I.C.U., it took Ms. Matthews just a few seconds to find the specialized tubing she needed to deliver medicine to an infant recovering from heart surgery. The tubing was nearby, in a fully stocked rack, thanks to a new supply system instituted by the hospital early last year following practices typically used in manufacturing or retailing, not health care.
There are two bins of each item; when one bin is empty, the second is pulled forward. Empty bins go to the central supply office and the bar codes are scanned to generate a new order. The hospital storeroom is now half its original size, and fewer supplies are discarded for exceeding their expiration dates.
The system is just one example of how Seattle Children's Hospital says it has improved patient care, and its bottom line, by using practices made famous by Toyota and others. The main goals of the approach, known as kaizen, are to reduce waste and to increase value for customers through continuous small improvements.
Manufacturers, particularly in the auto and aerospace industries, have been using these methods for many years. And while a sick child isn't a Camry, Seattle Children's Hospital has found that checklists, standardization and nonstop brainstorming with front-line staff and customers can pay off.
"It turns out the highest-quality care also is the most cost-effective because we make fewer mistakes and create better outcomes," says Patrick Hagan, the hospital's president.
The program, called "continuous performance improvement," or C.P.I., examines every aspect of patients' stays at the hospital, from the time they arrive in the parking lot until they are discharged, to see what could work better for them and their families.