Saturday, July 27, 2013

The Gulf Between Doctors and Nurse Practitioners -

Not long ago, I attended a meeting on the future of primary care. Most of the physicians in the room knew one another, so the discussion, while serious, remained relaxed.
Toward the end of the hour, one of the physicians who had been mostly silent cleared his throat and raised his hand to speak. The other physicians smiled in acknowledgment as their colleague stood up.
"Nurse practitioners," he said. "Maybe we need more nurse practitioners in primary care."
Smiles faded, faces froze and the room fell silent. An outraged doctor, the color in his face rising, stood to bellow at his impertinent colleague. Others joined the fray and side arguments erupted in the back of the room. A couple of people raised their hands to try to bring the meeting back to order, but it was too late.
The physician had mentioned the unmentionable.
I remembered the discord and chaos of that meeting when I read a recent study in The New England Journal of Medicine of nurses' and physicians' opinions about primary care providers.
For several years now, health care experts have been issuing warnings about an impending severe shortfall of primary care physicians. Policy makers have suggested that nurse practitioners, nurses who have completed graduate-level studies and up to 700 additional hours of supervised clinical work, could fill the gap.
Already, many of these advanced-practice nurses work as their patients' principal provider. They make diagnoses, prescribe medications and order and perform diagnostic tests. And since they are reimbursed less than physicians, policy makers are quick to point out, increasing the number of nurse practitioners could lower health care costs.
If only it were that easy.
Three years ago, a national panel of experts recommended that nurses be able to practice "to the full extent of their education and training," leading medical teams and practices, admitting patients to hospitals and being paid at the same rate as physicians for the same work. But physician organizations opposed many of the specific suggestions, citing a lack of data or well-designed studies to support the recommendations.
In an effort to build consensus, the Robert Wood Johnson Foundation then invited a dozen leaders from national physician and nursing groups to discuss their differences. The hope was that face-to-face discussions would help physicians and nurses understand one another better and see beyond the highly charged and emotional rhetoric. The approach worked, at least initially; after three meetings, the group drafted a report filled with suggestions for reconciling many of the differences.
But an early confidential draft was leaked to the American Medical Association, a group that had not been invited to participate, and the A.M.A. immediately expressed its opposition to the report.Soon after, three of the participating medical organizations — the American Academy of Family Physicians, the American Osteopathic Association and the American Academy of Pediatrics — withdrew their support, and the effort to bring physicians and nurse practitioners together and complete the report collapsed.
Nonetheless, many health care experts remained confident, believing that the large professional organizations had grown out of touch with grass-roots-level health care providers. The guilds might oppose one another, but every day in medical practices, clinics and hospitals across the country, physicians and nurse practitioners were working side by side without bickering. Surely, the experts reasoned, providers who knew and liked one another would be receptive to trying new ways of working together.
Analyzing questionnaires completed by almost 1,000 physicians and nurse practitioners, researchers did find that almost all of the doctors and nurses believed that nurse practitioners should be able to practice to the full extent of their training and that their inclusion in primary care would improve the timeliness of and access to care.
But the agreement ended there. Nurse practitioners believed that they could lead primary care practices and admit patients to a hospital and that they deserved to earn the same amount as doctors for the same work. The physicians disagreed. Many of the doctors said that they provided higher-quality care than their nursing counterparts and that increasing the number of nurse practitioners in primary care would not necessarily improve safety, effectiveness, equity or quality.
A third of the doctors went so far as to state that nurse practitioners would have a detrimental effect on the safety and effectiveness of care.
"These are not just professional differences," said Karen Donelan, the lead author of the study and a senior scientist at the Mongan Institute for Health Policy at Massachusetts General Hospital in Boston. "This is an interplanetary gulf," she said, echoing a point in an editorial that accompanied her study.
The findings bode poorly for future policy efforts, since physicians are unlikely to support efforts to increase the responsibilities and numbers of advanced-practice nurses in primary care. And most nurse practitioners are unlikely to support any proposals to expand their roles that do not include equal pay for equal work.
Peter I. Buerhaus, senior author of the study and a professor of nursing at Vanderbilt University Medical Center in Nashville, is chairman of a commission created almost three years ago under the Affordable Care Act to address health care work force issues. But his group has yet to convene because a divided Congress has not approved White House requests for funding.
"We're running out of time on these issues," Dr. Buerhaus said. "If the staffing differences remain unresolved, we are just going to cause harm to the public."
Still, by providing a clearer picture of the extent of these professional differences, the study should help future efforts. "It's too easy to say that everyone should just get along," Dr. Donelan said. "These arguments touch on the whole nature of these professions, their core values and how they define themselves."
"It's like when family members are warring over a sick patient," she added. "We need first to acknowledge the others' position and the full extent of our differences before we can reach any kind of resolution."

Medical Procedures May Be Useless, or Worse -

We usually assume that new medical procedures and drugs are adopted because they are better. But a new analysis has found that many new techniques and medicines are either no more effective than the old ones, or worse. Moreover, many doctors persist in using practices that have been shown to be useless or harmful.
Scientists reviewed each issue of The New England Journal of Medicine from 2001 through 2010 and found 363 studies examining an established clinical practice. In 146 of them, the currently used drug or procedure was found to be either no better, or even worse, than the one previously used. The report appears in the August issue of Mayo Clinic Proceedings.
More than 40 percent of established practices studied were found to be ineffective or harmful, 38 percent beneficial, and the remaining 22 percent unknown. Among the practices found to be ineffective or harmful were the routine use of hormone therapy in postmenopausal women; high-dose chemotherapy and stem cell transplant, a complex and expensive treatment for breast cancer that was found to be no better than conventional chemotherapy; and intensive glucose lowering in Type 2 diabetes patients in intensive care, which not only failed to reduce cardiovascular events but actually increased mortality.
In some instances, doctors routinely refused to give beneficial therapies despite a lack of evidence that they were harmful. Vaccines were unnecessarily withheld from multiple sclerosis patients in the belief that they increased flare-ups; women with lupus were denied oral contraceptives for fear they increased the severity of the disease; and epidural anesthesia was delayed during childbirth on the theory it increased the rate of Caesarean sections. Yet good studies showed that none of these fears was justified..
"Contradicted practices don't disappear immediately," said the lead author, Dr. Vinay Prasad. "There's an inertia, a 10-year period of time when the contradicted procedure continues to be practiced."
Dr. William E. Boden, chief of medicine at the Stratton VA Medical Center in Albany, who was not involved in the work, found the study useful and provocative. "It's challenging us to look at things we've done and attempt to find whether there's evidence to support their use," he said. "There's going to be increasing pressure to come forward with making sure that the health care dollars we're allocating are being well utilized."
Dr. Prasad, chief fellow in medical oncology at the National Cancer Institute, said that new medical appliances present a special problem. "Devices are particularly bad because they can be approved if they're similar to ones already on the market," he said. He cited as an example the Swan-Ganz catheter, a device threaded into the heart to monitor heart function and blood flow. It gives accurate information, Dr. Prasad said, "but that information doesn't help. We continue to introduce new catheters all the time, lacking good evidence that they work. This is a tremendous waste of resources."
Often doctors persist with procedures that lack evidence because they seem to make sense, Dr. Prasad said. "They all sound good if you talk about the mechanisms," he said. "You have cholesterol-clogged arteries, it makes sense that if you open them up it will help. But when that was studied, it didn't improve survival."
Patients, too, like to talk about mechanisms, Dr. Prasad added. "They tend to gravitate toward the nuts and bolts — what does it do, how does it work?" he said. "But the real question is: Does it work? What evidence is there that it does what you say it does? What trials show that it actually works? You shouldn't ask how does it work, but whether it works at all."

Wednesday, July 24, 2013

Black-White Divide Persists in Breast Cancer -

Breast cancer survival is, over all, three years shorter for black women compared with white women, mostly because their cancer is often more advanced when they first seek medical care, new research shows.
While cancer researchers have known for two decades that black women with breast cancer tend to fare worse than white women, questions remain about the reasons behind the black-white divide. The new report, from researchers at the University of Pennsylvania, begins to untangle some of the issues by using an analytic method to filter the influence of demographics, treatment differences and variations in tumor characteristics, among other things.
The findings, published in The Journal of the American Medical Association, suggest that while a significant number of black women still get inferior cancer care, the larger problem appears to be that black women get less health care over all, and that screening and early detection campaigns may have failed to reach black communities.
Using data from Medicare patients tracked in the Surveillance, Epidemiology and End Results database, the researchers analyzed 107,273 breast cancer cases, which included 7,375 black women. The larger number of cases involving white women allowed researchers to find nearly perfectly matched controls against which to compare the outcomes of black women with breast cancer.
The findings were striking. Over all, white women with breast cancer lived three years longer than black women. Of the women studied, nearly 70 percent of white women lived at least five years after diagnosis, while 56 percent of black women were still alive five years later.
The difference is not explained by more aggressive cancers among black women. Instead, the researchers found a troubling pattern in which black women were less likely to receive a diagnosis when their cancer was at an early stage and most curable. In addition, a significant number of black women also receive lower-quality cancer care after diagnosis, although those differences do not explain the survival gap.
"Something is going wrong," said Dr. Jeffrey H. Silber, a professor at the University of Pennsylvania and the director of the Center for Outcomes Research at the Children's Hospital of Philadelphia, which studies disparities in health care. "These are huge differences. We are getting there too late. That's why we are seeing these differences in survival."
The data show that black patients are twice as likely to never receive treatment. The records of 12.6 percent of black patients did not show evidence of treatment, compared with 5.9 percent of whites.
Black patients were also more likely to have at least a three-month delay in receiving treatment. Among black and white women with similar tumors, 5.8 percent of black women had not started treatment after three months, compared with just 2.5 percent of whites.
One notable finding of the report is that while the introduction of new treatments has improved the outcome for both white and black breast cancer patients since 1991, those improvements have not narrowed the survival gap between the two groups.
But solving disparities in cancer care would not immediately have a major effect on overall survival for black women, the study showed. If black women began receiving exactly the same quality and level of breast cancer treatment as white women, that would lengthen their lives by two to three months, the study showed.
However, two additional years of life could be gained among black women if their breast cancers were detected earlier and if their health were better over all, as is the case with white women with breast cancer. Among the black women studied, 20 percent received a diagnosis of Stage III or IV disease, when the cancer is far less likely to be cured. Among the white women, only 11.4 percent had late-stage disease.
One reason may be that the black women studied were less likely to seek medical care for any reason.
Although all the patients in the analysis had Medicare coverage, blacks were significantly less likely than white women to have seen a primary care doctor in the 6 to 18 months before diagnosis, and they had far lower rates of cholesterol and colon cancer screening. Black women also had far lower rates of breast cancer screening — 23.5 percent had been screened 6 to 18 months before diagnosis, compared with 35.7 percent of white women. Black women with breast cancer were, over all, in poorer health than white women. Of the black women studied, 26 percent had diabetes, compared with 12.6 percent of white women.
"These patients have insurance," Dr. Silber said. "We need to improve screening for these women and improve their relationships with a primary care provider."
In an accompanying editorial, the authors, who included Dr. Jeanne S. Mandelblatt of the Cancer Prevention and Control Program at Georgetown University's Lombardi Cancer Center, said the rigorous study offered "additional clues to the black-white differences in breast cancer outcomes."
However, the authors wrote that the report may still understate the effect of lower-quality cancer care for black women, in part because some treatment data are missing from the database it used.
"Ratings of patient-physician communication and trust have been related to black women's, but not white women's, patterns of chemotherapy use," the authors wrote. These findings further reinforce "the idea that black women may have different cancer care experiences than white women."

Monday, July 22, 2013

Why is the rich US in such poor health? - opinion - 15 July 2013 - New Scientist

In the wake of a startling report highlighting the US's poor health compared with other wealthy nations, its study director searches for answers

AMERICANS die younger and experience more injury and illness than people in other rich nations, despite spending almost twice as much per person on healthcare. That was the startling conclusion of a major reportreleased earlier this year by the US National Research Council (NRC) and the Institute of Medicine (IOM).

It received widespread attention. The New York Times concluded: "It is now shockingly clear that poor health is a much broader and deeper problem than past studies have suggested."

What it revealed was the extent of the US's large and growing "health disadvantage", which shows up as higher rates of disease and injury from birth to age 75 for men and women, rich and poor across all races and ethnicities. The comparison countries – Australia, Austria, Canada, Denmark, Finland, France, Germany, Italy, Japan, Norway, Portugal, Spain, Sweden, Switzerland, the Netherlands and the UK – generally do much better, although the UK isn't far behind the US.

The poorer outcomes in the US are reflected in measures as varied as infant mortality, the rate of teen pregnancy, traffic fatalities and heart disease. Even those with health insurance, high incomes, college educations and healthy lifestyles appear to be sicker than their counterparts in other wealthy countries. The US Council on Foreign Relations, a non-partisan think tank, described the report as "a catalog of horrors".

Findings that prompted this reaction include the fact that the rate of premature births in the US is the highest among the comparison countries and more closely resembles those of sub-Saharan Africa. Premature birth is the most frequent cause of infant death in the US, and the cost to the healthcare system is estimated to top $26 billion a year.

As distressing as all this is, much less attention has been given to the obvious question: why is the US so unwell? The answer, it turns out, is simple and yet deceptively complex: it's almost everything.

Our health depends on much more than just medical care. Behaviours such as diet, physical activity and even how fast we drive all have profound effects. So do the environments that expose us to health risks or discourage healthy living, as well as social determinants of health, such as education, income and poverty.

The US fares poorly in almost all of these. In addition to many millions of people lacking health insurance, financial barriers to care and a lack of primary care providers compared with other rich countries, people in the US consume more calories, are more sedentary, abuse more drugs and shoot one another more often. The US also lags behind on many measures of education, has higher child poverty and income inequality, and lower social mobility than most other advanced democracies.

The breadth of these causal factors, and the scope of the US health disadvantage they produce, raises some fundamental questions about US society. As the NRC/IOM report noted, solutions exist for many of these health problems, but there is "limited political support among both the public and policymakers to enact the policies and commit the necessary resources".

One major impediment is that the US, which emphasises self-reliance, individualism and free markets, is resistant to anything that even appears to hint at socialism. Interestingly, as a group, classically liberal nations like the US and the UK – free market-oriented with less regulation, tax and government services – are the least healthy among wealthy democracies.

By contrast, social democratic countries such as Sweden – in which the state emphasises full employment, income protection, housing, education, health and social insurance – enjoy better overall health, although health inequalities within these nations are not always the smallest.

Debates about the relative merits of "cut-throat" US versus "cuddly" Swedish capitalism contend that there are important trade-offs between economic growth and innovation on the one hand, and growing inequality, high poverty and a weak social safety net on the other. Unfortunately, these debates often fail to factor in our health. That needs to change.

And, as it turns out, the US spends plenty on social welfare. It may tax less and spend less on social programmes than most rich democracies, but when you add in tax-based subsidies and private social spending, it ranks as the fifth highest in the world, just after Sweden. What distinguishes the US is how that money is spent. More goes on healthcare – while still leaving many without health insurance or access to care – and less on children, families and the disadvantaged.

Digging into the social determinants of health can be tricky. Social scientists and other researchers are rightly trained not to confuse correlation with causation. But the evidence on the biology of disadvantage – how social and economic conditions affect our health and survival – is rapidly building.

Following the World Health Organization's 2008 Commission on Social Determinants of Health, countries such as Finland, Australia and Canada are taking a "health in all policies" approach that promotes health through public policies in areas as diverse as transportation, housing and agriculture. In the US these ideas have yet to gain much traction.

Moving beyond the dismal headlines generated by the NRC/IOM report, we can hope that the evidence of a health disadvantage in the US is now so compelling that the terms of the conversation and even the political calculus will begin to change. Then, perhaps, we can start addressing that disadvantage and stop paying for it with our lives.

This article appeared in print under the headline "Paying with our lives?"

Laudan Aron is a senior research associate with the Urban Institute in Washington DC, and was study director for the NRC/IOM report. The opinions are the author's and do not represent those of the NRC/IOM panel or Urban Institute

Sunday, July 21, 2013

Dissent Over a Device to Help Find Melanoma -

TO the casual observer's eye, the small brownish mole on Tanna Oppel's upper left arm looks like an insignificant, ovoid blotch. But on the screen of MelaFind, a new computer vision system for imaging skin lesions, a jagged blue line shows the actual border of the mole, revealing an irregular lesion roughly the shape of Texas.

Ms. Oppel is a medical assistant in Manhattan in the office of Dr. Doris Day, one of the first dermatologists to buy the machine. Developed by Mela Sciences of Irvington, N.Y., the system uses pattern-recognition algorithms to help a dermatologist who has picked out a suspicious pigmented spot to decide whether to perform a biopsy. The device may find an audience among sun-seekers worried about developing an aggressive skin cancerthe National Cancer Institute estimates that about 9,500 Americans this year will die of melanoma of the skin.

Yet the device is polarizing the field of skin-cancer detection.

For decades, dermatologists have used their eyes, along with a magnifier called a dermatoscope, to try to distinguish abnormal but benign lesions from potential melanoma in order to avoid unneeded biopsies. Some dermatologists argue that these low-tech tools are still the most useful and worry that their colleagues are falling for expensive, cool-looking gadgets that may simply offer extraneous, and perhaps incorrect, data.

"This technology should still be considered to be in the developmental stage," said Dr. Roberta Lucas, an instructor of clinical dermatology at the Northwestern University Feinberg School of Medicine in Chicago. "We are better off when the system supports doctors who are thorough and unhurried; who examine and listen carefully and who empower patients to practice good surveillance and sun protection."

In fact, some members of an expert medical panel asked to review MelaFind a few years ago for the Food and Drug Administration warned that the device had the potential to give doctors and patients a false sense of security. While MelaFind can analyze small pigmented spots identified by dermatologists as having signs of melanoma, it is not designed to evaluate other problems: large melanomas, colorless melanomas or two other types of skin cancer — basal and squamous cell carcinoma.

Dr. Amy E. Newburger, a dermatologist in Scarsdale, N.Y., who was a member of that F.D.A. panel, told me that she was concerned that a doctor could inadvertently use MelaFind on a non-melanoma skin cancer, receive a score indicating that the spot was not irregular, and erroneously decide not to biopsy it. She voted against recommending the device for F.D.A. approval.

Some biostatisticians are also critical of MelaFind, saying the device can recognize a high percentage of melanomas correctly because it also falsely scores as positive so many non-melanomas — potentially prompting doctors to perform unnecessary biopsies.

To help me visualize that issue, Jason Connor, a biostatistician at Berry Consultants, a biostatistics consulting firm, compared the accuracy of MelaFind in distinguishing non-melanomas to a hypothetical pregnancy test which, used on 100 nonpregnant women, would mistakenly conclude that 90 of them were pregnant.

"My concern with MelaFind is that it just says everything is positive," Mr. Connor said. A member of the F.D.A. panel, he abstained on a vote about whether the device's intended uses outweighed the risks.

"I don't think this helps an aggressive doctor," Mr. Connor told me, "and unaggressive doctors could do just as well if they were more diligent without the device."

To develop MelaFind's current algorithm, researchers trained the system on digital images of more than 10,000 pigmented lesions, programming it to recognize irregularities like asymmetry, color variability and cellular disorganization characteristic of melanomas. Company executives said Mela Sciences deliberately calibrated the machine to catch as many melanomas as possible, understanding that such a high setting could lead doctors to biopsy normal tissue.

"It will err on the side of caution," said Claudia Beqaj, director of commercialization at Mela Sciences. "We wanted to set the system to have such a high sensitivity that we didn't miss any melanomas."

(In a company-financed study submitted to the F.D.A., the device missed two out of 127 evaluable melanomas. One F.D.A. reviewer concluded: "There is inadequate data to determine any true value added for MelaFind for use by a dermatologist or other provider.")

Ms. Beqaj emphasized that MelaFind was intended as a supplementary test that provided extra information about a mole, not as a substitute for a dermatologist's own expertise.

"If they blindly followed MelaFind, they would be biopsying more," Ms. Beqaj said. "The doctor has to make their own clinical judgment."

Dr. Day finds the system quite informative. Last week, she gave me a demonstration in her office on the Upper East Side of Manhattan.

Dr. Day picked out what she called an "ugly duckling" mole on the left arm of Ms. Oppel, who had kindly agreed to play the role of patient. Another medical assistant removed a hand-held scanner from the MelaFind console and pressed it against the mole.

The device uses 10 different wavelengths of light to see up to 2.5 millimeters deep into the skin and capture images of its different layers. Within a minute, the machine displayed a numerical score, indicating that Ms. Oppel's mole was irregular, but not highly likely to be a melanoma. Since the images on the screen indicated that the darkest part of the mole was concentrated around a hair follicle, an expected pigmentation pattern, Dr. Day concluded there was no immediate need for a biopsy.

"It helps me see what I cannot see with my eye," Dr. Day said. "I have great comfort that I am not missing a melanoma."

(Dr. Day has been a paid device investigator and speaker for Mela Sciences; she appears inpromotional videos on the MelaFind Web site).

In late 2011, the F.D.A. approved MelaFind for sale in the United States. But, given the concerns that general physicians not trained as skin experts might miss a skin cancer, the agency restricted the use of the device to dermatologists — and then only after the doctors had successfully completed a MelaFind training program. So far, Ms. Beqaj says, the company had sold about 150 of the devices, which cost about $10,000, in the United States and Germany.

Since health insurance does not currently cover the service, patients are paying $25 to $175 for the first mole evaluation and around $25 for subsequent moles, doctors say.

WHETHER or not MelaFind eventually gains traction among dermatologists, the device is nevertheless significant, said Dr. Hensin Tsao, the director of the melanoma and pigmented lesion center at Massachusetts General Hospital in Boston, because it introduces the idea of artificial intelligence in dermatology.

Unlike an X-ray or mammography device that requires a medical professional to read the images and identify abnormalities, Dr. Tsao said, MelaFind both captures images and analyzes the likelihood of melanoma. That extra intelligence, its accuracy notwithstanding, is bound to change doctors' interactions with patients.

Dr. Tsao's clinic is participating in a post-marketing study of MelaFind, financed by Mela Sciences. And he said he and his colleagues were thinking hard about how to develop a role for such new devices in informing physicians and patients.

"Until now, you trusted the doctor to make the decision," Dr.  Tsao said. "Now you've got a three-way interaction. It's a brand new paradigm."