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Big data, Clinical Trials, Ethics, Public Health, Research, Stanford News

The public wants easier ways to participate in medical research, study shows

The public wants easier ways to participate in medical research, study shows

Informed consent, the time-consuming process for obtaining permission to conduct health-care research on a person, was developed long before computers, the Internet and smartphones. Last year, when government regulators proposed to add an even greater burden of paper, red tape and so-called patient protections to this process, a team of bioethicists cried foul. And they took the issue to the public via a cross-sectional survey study that was published today in the Annals of Internal Medicine.

What the survey respondents said surprised them: Keep the permissions simple, but always ask permission, even when the research only involves anonymized medical records.

“The good news was that most people said that they would accept simpler approaches to granting permission, even verbal permissions, if requiring written agreements would hinder this type of comparative-effectiveness research,” study author Mildred Cho, PhD, associate director of the Stanford Center for Biomedical Ethics, said in our press release.

Bioethicists from Stanford and the University of Washington are on the leading edge of addressing the ethical challenges of evolving research methods, where researchers will increasingly use data from wearable devices, electronic medical records, genomic databases and other sources to help improve our population’s health.

In an editorial accompanying Cho’s article, John Lantos, MD, from Children’s Mercy Hospitals and Clinics, summarized the importance of the study:

Cho and colleagues challenge us to think of a better way. Autonomy should mean participatory engagement. Respect for persons should mean empowering them to develop the rules. It is time to ask whether a system in which the fundamental principle is ‘respect for persons,’ can continue to ignore the preferences of many of the persons it claims to respect.

As a next step, the bioethicists will be developing media-rich tools to explain the risks and benefits of research that uses electronic medical records and stored biological samples. For example, the video above was developed to explain the concept of informed consent to survey respondents unfamiliar with research terminology.

Previously: Build it (an easy way to join research studies) and the volunteers will comeHarnessing mobile health technologies to transform human health and Video explains why doctors don’t always know best
Video by Booster Shot Media

Addiction, Events, Pain, Patient Care, Public Health, Stanford News

The problem of prescription opioids: “An extraordinarily timely topic”

The problem of prescription opioids: "An extraordinarily timely topic"

photo (2) 2Suffer from pain? Or become an addict? Bemoan the epidemic of pain? Or decry the epidemic of opioid addiction?

At first glance, pain and addiction appear to conflict, to occupy distinct never-overlapping planes. But in reality, pain and addiction anchor two ends of a spectrum, with a lot of gray area in between, said Anna Lembke, MD, director of the Stanford Addiction Medicine Program.

Lembke and Sean Mackey, MD, PhD, chief of pain medicine, squared off in a good-natured debate of sorts moderated by chief communications officer Paul Costello last week at a Stanford Health Policy Forum on “The Problem of Prescription Opioids.”

“This is an extraordinarily timely topic,” Dean Lloyd Minor, MD, said in his introduction. “These issues really reflect a dilemma of wanting to bring the best compassionate care and science to our patients, yet also needing to respect the adverse effects that can occur.”

The statistics on both sides are sobering. The two experts told the audience that in the U.S., more than 16,000 people per year die of opioid overdose and 100 million people live in pain.

And both Lembke and Mackey shared harrowing tales of the suffering of their patients. Lembke once was called to consult on a women suffering from low back pain who had a opioid addiction identified by two previous psychiatrists. Yet in the exam room, the patient threatened to sue if she didn’t receive an opioid prescription, Lembke said. Cases like that prompted her to pen a provocative 2012 essay titled “Why doctors prescribe opioids to known opioid abusers.”

But Mackey treats patients who are suffering deeply, including a woman whose foot injury from a vehicle accident morphed into a pain syndrome affecting her upper extremities.

The current opioid addiction problem stems from a historical pattern of failing to treat pain, even in dying patients, Lembke said. Yet the pendulum swung too far and now doctors feel obligated to prescribe drugs such as opioids, she said.

At the Stanford Pain Management Center, teams of specialists work together to treat pain as a complex condition that affects many parts of the body and mind, Mackey said. Patients are treated with physical therapy, psychiatry and a variety of other specialties to try to allow them to participate in meaningful life activities, he said.

Although care at Stanford is top notch, it is an outlier and thousands of other patients are exposed to poor pain management practices. In addition, pain is now widely recognized as a disease, but addiction remains stigmatized, Lembke said.

When doctors recognize a opioid-seeking patient, they should treat the addiction, not boot the patient out of their practice.

Lembke and Mackey stressed that education about both pain and addiction ought to receive increased attention in medical schools. And patients need to take a role in treating both their own pain, and their addictions, they said. They do share common ground, Lembke said.

“All we think about every day is how we’re going to do it better,” Mackey said.

Previously: Assessing the opioid overdose epidemic, Stanford addiction expert: It’s often a “subtle journey” from prescription-drug use to abuse, Is a push to treat chronic pain pressuring doctors to prescribe opioids to addicts?, Why doctors prescribe opioids to patients they know are abusing them and Study shows prescribing higher doses of pain meds may increase risk of overdose
Photo by Becky Bach

Emergency Medicine, Medicine and Society, Public Health, Public Safety, Research

Study: ER statistics could be used to help reduce gun violence

Study: ER statistics could be used to help reduce gun violence

ER shot

Emergency room doctors treat many patients who have been involved in violent assaults. New research shows that these patients are far more likely than other ER patients with otherwise similar demographics to seek treatment for gun-related injuries in the near future.

These findings “could help injury researchers, emergency department physicians, and social service agencies focus their intervention efforts to prevent future firearm incidents and other violent incidents among high-risk youth populations,” explains a University of Michigan press release published Monday.

The study, published in Pediatrics, followed nearly 600 drug-using youth in Flint, Mich. for two years after they were admitted to the emergency room. Nearly 60 percent of those admitted for assault-injury care became involved in a violent incident involving a firearm within the next two years, and of those, the majority did so within six months after the initial visit. Between two people with highly similar demographic factors, someone admitted for assault is 40 percent more likely to be involved in gun violence than someone admitted for a cold.

The results also calculated the statistical correlations of various markers, such as race, gender, drug abuse, PTSD, possession of a firearm, and tendency toward retaliation (see the release for the details). ERs that track such markers could identify the highest-risk youth and help them receive targeted treatment. The release quotes Patrick M. Carter, MD, an assistant professor of emergency medicine at UM, member of the UM Injury Center, and first author of the study, saying the results “support using the ER as the site for intervention, especially during the ‘teachable moment’ that immediately follows an initial assault or fight.”

Previously: Pediatricians’ role in gun control: Recommendations from the American Academy of Pediatrics, Emergency-room interventions may reduce alcohol-based violence among teens and Emergency room as soup kitchen
Photo by Military Health

Events, Health Policy, Pediatrics, Public Health, Research, Stanford News

“What we’re really talking about is changing the arc of children’s lives”: Stanford’s Childx kicks off

"What we're really talking about is changing the arc of children's lives": Stanford's Childx kicks off

Childx Guttmacher

Stanford’s Childx conference got off to a great start today. Shortly after Lloyd Minor, dean of the medical school, welcomed the attendees, keynote speaker Alan Guttmacher, MD, director of the Eunice Kennedy Shriver National Institute of Child Health and Development, took the stage to talk about how scientific research needs to evolve to continue to advance children’s health.

Pediatric research has reached an inflection point, Guttmacher said. “I really believe the fundamental questions we need to ask are different,” he said. “This isn’t about health in a narrowly defined way. What we’re really talking about is changing the arc of children’s lives, and the medical model is useful but not sufficient.”

He mentioned several successes from the history of pediatric medicine, including large reductions in infectious disease, better care for preterm babies, and the “Back to Sleep” public health campaign that cut newborn deaths from SIDS by more than half. But he also highlighted several areas where children’s health now needs research that goes beyond a strictly medical approach to integrate social and environmental factors, such as learning how to prevent preterm birth, help children with autism and intellectual and developmental disabilities participate more fully in society, understand how children’s lives are changed by cyberbullying, and make medical and ethical decisions about the possible use of newborns’ genomic data.

He anticipates that this type of research will bring new strength to pediatricians’ interactions with patients and their families. “I would hope that the pediatric practice of the future, in terms of anticipatory guidance, won’t be about the next six weeks, six months or even six years of [the child’s] life; it’ll be about the next six decades,” he said.

“We need to be a society that values children,” Guttmacher concluded, adding that we should view children as a shared societal responsibility and also a shared societal investment. He challenged the audience of pediatric researchers to ask themselves, “What do we need to do to … change the nature of research that would make real change, not just small blips, in the lives, especially of kids in the United States and globally?”

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Aging, Chronic Disease, Events, Health Policy, Neuroscience, Public Health, Women's Health

Alzheimer’s forum with Rep. Jackie Speier spurs conversation, activism

Alzheimer's forum with Rep. Jackie Speier spurs conversation, activism

10776927963_3dd8d244da_zWhat happens when you bring together a woman with Alzheimer’s, a congresswoman, a policy expert and two doctors? No, this isn’t a joke – but an intro to an informative and wide-ranging discussion on Alzheimer’s disease and its effects on women.

“I was pretty ignorant until fairly recently,” said Rep. Jackie Speier (D-CA), who organized the forum Alzheimer’s: A women’s health issue held in San Mateo, Calif. yesterday. She also penned an opinion piece published recently in the San Francisco Chronicle. “I had no idea that two out of three people diagnosed with Alzheimer’s are women.”

Although it’s the fifth leading cause of death in California, Alzheimer’s receives much less federal money than many other major diseases, she said.

To spur conversation and provide information, Speier invited Cynthia Ortiz Guzman, a former nurse who suffers from Alzheimer’s; Ruth Gay, director of public policy and advocacy for the Alzheimer’s Association; Elizabeth Landsverk, MD, medical director of ElderConsult, and Stanford’s Michael Greicius, MD, MPH, an associate professor of neurology and neurology and medical director of the Stanford Center for Memory Disorders. Greicius has done research on women’s risk of the disease.

Nearly all of the 150-plus people who attended the forum had a loved one who suffered from Alzheimer’s. “We still have a good life, but there is so much that needs to be done,” Guzman told them.

Greicius and Landsverk fielded questions about how to diagnose and treat Alzheimer’s as well as promising directions of research.

At Stanford, Greicius said a person with memory impairment would meet with a neurologist, take a several hour neuropsychological exam, have bloods tests and a brain scan, and meet with social workers and nurses. He emphasized that this is far above the level of care available in more community medical centers. Sometimes physicians are able to find biomarkers that signal Alzheimer’s presence more than a decade before symptoms appear he said.

Greicius urged attendees to find out if they’re eligible for a neurological research trial at Stanford and to consider donating their brains and the brains of their loved ones to use for research. He also thanked Speier for focusing attention on Alzheimer’s.

“We’ve got to get the attention of policymakers to address this issue,” Speier said, adding that she might try to secure federal funds as part of the defense budget.

Gay, who recently traveled to Washington, D.C. to advocate for the disease, agreed. “We know that today we need a game changer – we need people to step forward and speak out about this disease,” she said.

Previously: Science Friday explores women’s heightened risk for Alzheimer’s, The state of Alzheimer’s research: A conversation with Stanford neurologist Michael Greicius and The toll of Alzheimer’s on caretakers 
Photo by Marjan Lazarevski

Chronic Disease, In the News, Patient Care, Public Health

Physicians advocate for “more educated and deliberative decision making” about dialysis

Physicians advocate for "more educated and deliberative decision making" about dialysis

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More than 20 million Americans, one in 10 adults, have some form of chronic kidney disease. For those suffering from chronic kidney disease or end-stage renal disease, dialysis is a commonly recommended treatment. But a story published today in the New York Times reports that for older patients the treatment is increasingly being seen as an choice, not an imperative, and “a growing number of nephrologists and researchers are pushing for more educated and deliberative decision making when seniors contemplate dialysis.”

Paula Span writes:

Unquestionably, dialysis has helped save lives. The mortality rate for patients with chronic kidney disease decreased 42 percent from 1995 to 2012, according to the most recent report from the United States Renal Data System.

The picture for older patients, in particular, is less rosy. About 40 percent of patients over age 75 with end-stage renal disease, or advanced kidney failure, die within a year, and only 19 percent survive beyond four years, the renal data system has reported.

In a Canadian survey, 61 percent of patients said they regretted starting dialysis, a decision they attributed to physicians’ and families’ wishes more than their own. In an Australian study, 105 patients approaching end-stage kidney disease said they would willingly forgo seven months of life expectancy to reduce their number of dialysis visits. They would swap 15 months for greater freedom to travel.

In real-world hospitals and nephrologists’ offices, of course, patients aren’t offered such trade-offs. “People drift into these decisions because they’re presented as the only recourse,” said Dr. V. J. Periyakoil, a geriatrician and palliative care physician at Stanford University School of Medicine.

The moving video above, which was produced by Periyakoil, tells the story of one older man’s decision to stop dialysis after 12 years. (“It takes a lot out of you – it’s a long drawn-process,” Christopher Whitney explained in the piece. “If I would get a kidney now, it would be a waste… I’m not the person I used to be.”) About the difficult decision-making process that faces patients like Whitney, Periyakoil said in an email this morning:

Persons with kidney failure often struggle with making decisions related to dialysis. These decisions impact not only the patient but also their family members. For some, these decisions have ethical and moral implications as well. You may have questions like “Should I start dialysis right away or can I wait? Is it okay to refuse dialysis? I have been on dialysis and feel tired all the time and have poor quality of life – is it okay to stop dialysis? If I stop dialysis how long will live?”

Periyakoil urges patients to “think about what your life goals are as well as what matters most to you at life’s end. Be sure to discuss these important issues with your doctor so you can make your wishes known and make decisions that are right for you and your family.”

Previously: How best to treat dialysis patients with heart disease, Keeping kidney failure patients out of the hospital, Study shows higher Medicaid coverage leads to lower kidney failure rates and Benefits of dialysis for frail elderly debated

Global Health, Haiti, Infectious Disease, Public Health, Technology

A sanitation solution: Stanford students introduce dry toilets in Haiti

A sanitation solution: Stanford students introduce dry toilets in Haiti

sanitation-toilet-movedIn the United States, we often take for granted the relationship between health and sanitation. Not so in Haiti, where some people dispose of their feces in plastic bags they throw into waterways. As a result, waterborne diseases like cholera are common.

But what’s to be done? Flush toilets guzzle gallons of water and depend on an entire sewage system — an unfeasible option in many developing nations. To fill the gap, a pair of Stanford civil and environmental engineering graduate students have developed a program called re.source, which provides dry household toilets, and empties them for about $5 a month.

From a recent Stanford News story:

Unlike most sanitation solutions that only address one part of a dysfunctional supply chain, container-based sanitation models, such as the re.source service, tackle the whole sanitation chain. The re.source toilets separate solid and liquid waste into sealable containers, and dispense a cover material made of crushed peanut shells and sugarcane fibers that eliminates odors and insect infestations. The solid waste is regularly removed by a service, which takes it to a disposal or processing site to be converted to compost and sold to agricultural businesses.

The re.source students — Kory Russel and Sebastien Tilmans — work under the guidance of Jenna Davis, PhD, an associate professor of civil and environmental engineering. They started small, with a free pilot phase in 130 households in a Haitian slum, but the service has expanded to include 300 additional households with plans to introduce a service in the capital, Port-au-Prince.

The project is part of a larger Stanford focus on water issues ranging from safe drinking water to environmental concerns.

Previously: Waste not, want not, say global sanitation innovators, Stanford pump project makes clean water no longer a pipe dream and Award-winning Stanford documentary to air on PBS tonight
Photo by Rob Jordan

Global Health, In the News, Mental Health, Public Health, Research

Study links air pollution with anxiety; calls it a “leading global health concern”

Study links air pollution with anxiety;  calls it a "leading global health concern"

3280739522_c1f8001000_zI often find that natural spaces and fresh air have a calming, balancing effect, and judging by the cultural association between relaxation and the outdoors, I’m not alone. Now some new research backs up the connection. Yesterday, the British Medical Journal published an article linking air pollution with anxiety, as well as an editorial on air pollution’s health effects and another study elaborating on a previously-noted connection between pollution and stroke.

The anxiety study, conducted by researchers at Harvard and Johns Hopkins University, showed a significant connection between exposure to fine particulate pollution and symptoms of anxiety for more than 70,000 older women (mean age of 70 years) in the contiguous United States. Bigger particles appeared to have no effects, interestingly, nor did living close to a major road. The connection was present over a variety of time periods from one month to fifteen years, but was stronger in the short term. This evidence shows a clear need for studies to be done in other demographic groups, and to elaborate on the biological plausibility of the connection.

The stroke article, meanwhile, is a meta-analysis of 103 studies conducted in 28 countries and including 6.2 million events. Researchers found that both gaseous and particulate air pollution had a “marked and close temporal association” with strokes resulting in hospital admissions or death.

As stated in the editorial, particulate air pollution has already been shown to be a contributing factor in a variety of serious health conditions, including a well-supported link to cardiopulmonary diseases, but also diabetes, low birth weight, and pre-term birth. In fact, the World Health Organization estimates that one of every eight deaths is caused by air pollution. The body of research on the topic suggests that pollution may initiate systemic inflammation, thereby affecting multiple organ systems.

With such a broad range of detrimental effects, and because it affects such a significant percentage of the population, air pollution is becoming a top public health concern. As the University of British Columbia’s Michael Brauer, ScD, wrote in the editorial:

The findings of these two studies support a sharper focus on air pollution as a leading global health concern… One of the unique features of air pollution as a risk factor for disease is that exposure to air pollution is almost universal. While this is a primary reason for the large disease burden attributable to outdoor air pollution, it also follows that even modest reductions in pollution could have widespread benefits throughout populations. The two linked papers in this issue confirm the urgent need to manage air pollution globally as a cause of ill health and offer the promise that reducing pollution could be a cost effective way to reduce the large burden of disease from both stroke and poor mental health.

Photo by Billy Wilson

Cardiovascular Medicine, Chronic Disease, Genetics, Public Health, Research

International team led by Stanford researchers identifies gene linked to insulin resistance

International team led by Stanford researchers identifies gene linked to insulin resistance

261445720_2f253a1336_zBack in the 1970s and 1980s, Stanford’s Gerald Reaven, MD, had the darndest time convincing others that type 2 diabetes wasn’t caused by a lack of insulin. No one would believe him that, as we now know, type 2 diabetics are insulin resistant — their cells no longer respond to insulin’s cue to take in glucose.

Fast-forward a few years. Insulin resistance has been implicated in a slew of symptoms such as high blood pressure and heart troubles known as metabolic syndrome — it isn’t just a problem for diabetes. Scientists knew that about half of insulin resistance was governed by weight, exercise and diet. But the heredity half was a mystery — until now.

Thanks to an international collaboration and many months of work, a team of researchers led by Joshua Knowles, MD, PhD, and Thomas Quertermous, MD, have found the first gene known to contribute to insulin resistance. It’s called NAT2, and when mutated, it leads to a greater chance for carriers to become insulin resistant.

From the release:

“It’s still early days,” Knowles said. “We’re just scratching the surface with the handful of variants that are related to insulin resistance that have been found.”

Researchers found NAT2 by compiling data from about 5,600 individuals for whom they had both genetic information and a direct test of insulin sensitivity. Measuring insulin sensitivity takes several hours and is usually done in research settings. No genes met the high standards demanded by genome-wide association studies. Yet NAT2 appeared promising, so researchers followed up with experiments using mice.

When they knocked out the analogous gene in mice, the mice’s cells took up less glucose in response to insulin. These mice also had higher fasting-glucose, insulin and triglyceride levels.

“Our goal was to try to get a better understanding of the foundation of insulin resistance,” Knowlessaid. “Ultimately, we hope this effort will lead to new drugs, new therapies and new diagnostic tests.”

Previously: New insulin-decreasing hormone discovered, named for goddess of starvation, Stanford researchers identify a new pathway governing growth of insulin-producing cells and Faulty fat cells may help explain how type 2 diabetes begins
Image by Andy Leppard

Health Costs, Health Policy, In the News, Patient Care, Public Health

Health-care policy expert Arnold Milstein weighs in on Medicare’s plan to prioritize “value over volume”

Health-care policy expert Arnold Milstein weighs in on Medicare's plan to prioritize "value over volume"

8266476742_4967a82707_zAmerican health-care spending is the highest in the world, yet some question whether that money really leads to improved patient outcomes. But significant reforms taking place within Medicare, the US’s biggest healthcare payer, over the next few years aim to quell these concerns and reduce costs while improving quality of care.

Health policy experts explained the context of these changes last week in a webinar hosted by Reporting on Health and supported by the NIH’s Health Care Management Foundation. The panel featured Stanford’s Arnold Milstein, MD, MPH, director of the Clinical Excellence Research Center, as well as health economist Austin Frakt, PhD, professor at Boston University School of Medicine, and Jordan Rau, a correspondent for Kaiser Health News.

Health-care’s dominant “fee for service” (FFS) model has been around “since doctors were getting paid in chickens,” said Rau in the webinar, but it has no link whatsoever to quality. Many think this model needs to be changed because it incentivizes physicians to do more (and more expensive) procedures, regardless of the effect they have on patient outcomes. “Better, less expensive care is a national imperative,” said Milstein. “The cost to society of inefficiently delivered care is creating enormous opportunity cost.”

Starting in 2011, Medicare began to tie payments to quality: Doctors get paid 2 percent more if quality goes up, and 6 percent less when it goes down, based on patient ratings and rates of readmission and infection. In 2014, quality-linked FFS accounted for around 80 percent of care, of which around 20 percent featured some more radical change. The new plan is that 50 percent of payments will be non-FFS by 2018.

Options to reform this model could include bundled fees (a flat rate per “episode” that includes all complications and follow-up care), accountable care organizations (ACOs) that take responsibility for all patient needs and costs, incentives for cross-provider cooperation, and population-based payment in which doctors receive a set fee for any patient (currently being pioneered in Maryland).

How will we know which changes to push? Milstein used a graph to indicate “positive value outliers,” institutions with high quality and low cost, whose strategies and techniques will be emulated to see if they can be effective elsewhere. He explained what researchers found makes them different:

[Positive value outliers] tended to have deeper, more personal relationship with their patients; their patients trusted that if they called these doctors on nights and weekends, someone who knew something about them would be rapidly responsive. Doctors’ vision of their responsibility to their patients extended far beyond producing a perfect office visit; it really meant being a steward for their patients’ best interests as their patients traversed emergency room doctors, hospitalists and medical specialists. And lastly, these doctors were not trying to be solo heroes – they did a wonderful job hiring and training medical assistants and taking advantage of a team… and it was associated with a substantial improvement in value. Our next step is to splice this DNA into average performing primary care practices and verify that this is indeed the right stuff.

Some other ideas for achieving the targets were mentioned, such as sending physicians to homes so patients don’t get admitted, or in the longer term, having an intensive-care unit (ICU) “airline control tower” with more perspective than those on the “frontline” of critical care, an idea Milstein said was studied across 56 American ICUs and resulted in a 25 percent mortality reduction.

Milstein said such approaches could lower baseline health-care costs by 30 percent, but moreover could slow the rate at which health-care spending outgrows the economy, which is the real measure of success. Innovators in this area, he said, will need to draw from behavioral and computer science to think about problems differently.

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