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

Build it (an easy way to join research studies) and the volunteers will come

Build it (an easy way to join research studies) and the volunteers will come

stanford-myheart-counts-iphone6-hero

Just nine days after the launch of Stanford Medicine’s MyHeart Counts iPhone app, 27,836 people have consented to participate in this research study on cardiovascular health.

“To recruit that many patients into a traditional clinical trial would take years and hundreds of thousands of dollars,” said Michael McConnell, MD, professor of cardiovascular medicine and principal investigator for the MyHeart Counts study.

MyHeart Counts was built with Apple’s new ResearchKit, a software development framework that can be used to create apps that turn an iPhone into a research and data collection tool. Leveraging a smartphone’s built-in accelerometers, gyroscopes, camera and GPS sensors, medical researchers can easily and inexpensively collect streams of data on exercise, diet and biometrics. Unlike most traditional clinical trials, which capture only a snapshot of patient data, ResearchKit studies are able to collect data from thousands of participants simultaneously, over long periods of time.

While the potential for this technology to accelerate medical research is tantalizing, the ethical issues of this shift in researcher-volunteer interactions took Stanford researchers and collaborator Sage Bionetworks nine months to work out.

“One of the big challenges in designing this study was to develop an ethical mechanism for informed consent on mobile devices,” David Magnus, PhD, director of the Stanford Center for Biomedical Ethics, told me. “It was essential that volunteers understand the nature of the research and what it means for them.”

The concept of informed consent is an important tenet of any research institution’s commitment to respect individuals and to “do no harm.” Without face-to-face meeting between a researcher and volunteer, there could be misunderstandings about risks, benefits and time commitments.

Stanford bioethicists are on the leading edge of addressing the communications challenges of these new frontiers in medical research. Rethinking long, text-based consent forms, they are exploring alternatives, such as audio, video, animation and interactivity.

For example, a team of bioethicists from Stanford and the University of Washington recently released animated videos that explain comparative-effectiveness research within medical practices to potential volunteers. Next, they’ll be developing media-rich tools to explain the risks and benefits of research that uses electronic medical records and stored biological samples.

To solicit ideas on how to best regulate this brave new world of informed consent, the U.S. Food and Drug Administration just posted draft guidance on “Use of Electronic Informed Consent in Clinical Investigations.” Public comments will be accepted through May 7, 2015.

To sign up for the MyHeart Counts study, visit the iTunes store.

Previously: Harnessing mobile health technologies to transform human healthMyHeart Counts app debuts with a splashStanford launches iPhone app to study heart health and Video explains why doctors don’t always know best
Photo by iMore

Applied Biotechnology, Bioengineering, Medical Education, Stanford News, Videos

An online film festival for medtech inventors

An online film festival for medtech inventors

biodesign-process

The Stanford Biodesign program recently posted 296 short education videos on medical technology innovation. From needs finding through business planning, it offers entrepreneurs hours of useful advice on developing medical products.

This video library, which was launched with the second edition of the Biodesign textbook, is free to all. Its well-designed online interface makes it easy to access the advice that medtech innovators need, when they need it.

To create the video library, Biodesign hired filmmakers from both inside and outside of Stanford to capture the essence of the 2013-14 Biodesign fellowship program. During this ten-month program, multidisciplinary teams undergo a process of sourcing clinical needs, inventing solutions and planning for implementation of a business strategy. The program’s track record for bringing new medical devices and technologies to patients is impressive: Biodesign fellows have founded more than 30 companies in the last 14 years.

Each three- to four-minute video features interviews with faculty, fellows, CEOs, investors and alumni who have gone on to launch companies. A few of my favorites are:

The Biodesign video library, which was supported by the Walter H. Coulter Foundation, is an extension of the program’s mission — to help train the next generation of leaders in biomedical technology innovation. While the Stanford-based Biodesign program admits only 12 full-time postgraduate fellows a year, now these lessons-learned can be shared with medtech entrepreneurs around the globe. Just B.Y.O.P. (Bring your own popcorn.)

Previously: A medical invention that brings tears to your eyesBiodesign fellows take on night terrors in children, Stanford Biodesign Program releases video series on the FDA systemHeart devices get at mobile makeover
Illustration from Cambridge University Press

Autoimmune Disease, Chronic Disease, Immunology, Stanford News, Videos

Chronic fatigue syndrome gets more respect (and a new name)

Chronic fatigue syndrome gets more respect (and a new name)

As has been widely reported, an Institute of Medicine (IOM) report released yesterday acknowledged that chronic fatigue syndrome is a real and serious disease and renamed the disorder “systemic exertion intolerance disease” to better reflect its key symptoms.

Stanford professor José Montoya, MD, who served as a reviewer on the IOM report, is featured in the video above, which accompanied Washington Post coverage of the development. The Post article goes on to say:

“We just needed to put to rest, once and for all, the idea that this is just psychosomatic or that people were making this up, or that they were just lazy,” said Ellen Wright Clayton, a professor of pediatrics and law at Vanderbilt University, who chaired the committee of the Institute of Medicine, the health arm of the National Academy of Sciences.

Although the cause of the disorder is still unknown, the panel established three critical symptoms for the condition (also known as myalgic encephalomyelitis):

  • A sharp reduction in the ability to engage in pre-illness activity levels that lasts for more than six months and is accompanied by deep fatigue that only recently developed.
  • Worsening of symptoms after any type of exertion, including “physical, cognitive or emotional stress.”
  • Sleep that doesn’t refresh the sufferer.

The panel also requires that a patient have one of two other disease manifestations, either cognitive impairment or orthostatic intolerance. Orthostatic intolerance is an autonomic nervous system disorder that is caused by an abnormal increase in heart rate and low blood pressure, believed to be triggered by the disease.

Susan Kruetzer, an SEID patient interviewed by Erin Allday in this San Francisico Chronicle article, expressed guarded optimism about the report’s ability to generate more research funding and patient support, saying “What I want to see is someone in Congress get pretty riled up by this report — have them see how many people are affected, how these people are really ill, how they’ve been mistreated,” Kreutzer said. “I’d just like to light a fire. I don’t know if this report will do that, but I suppose it gives us some ammunition.”

Previously: Some headway on chronic fatigue syndrome: Brain abnormalities pinpointed, Unbroken: A chronic fatigue syndrome patient’s long road to recovery and Deciphering the puzzle of chronic fatigue syndrome

Applied Biotechnology, Bioengineering, Ophthalmology, Stanford News, Videos

A medical invention that brings tears to your eyes

A medical invention that brings tears to your eyes

dry-eye-implantMore than 20 million Americans suffer from dry eye, a painful condition where a personal’s lacrimal glands don’t create enough tears to lubricate the surface of the eye.

But relief is around the corner for these sufferers – a tiny implantable device that stimulates natural tear production on a long-term basis is currently in clinical trials. The device increases tear volume by delivering micro-electrical pulses to the lacrimal gland. It’s inserted into the mucus lining of the sinus cavity or under the skin beneath the eyebrow. Tear delivery rates can be adjusted manually with a wireless controller. (You can watch a video of this device producing tears, below.)

This clever invention is the brainchild of bioengineer and former Stanford Biodesign fellow Michael Ackermann, PhD, who says he spent a good part of his boyhood in Louisville, Kentucky, taking apart things like VCRs, radios and weed-whackers.

“My parents wanted me to be a doctor, but it was very clear from a young age that I was going to be an engineer,” said Ackermann.

He’s now at the helm of Oculeve, a 20-person startup dedicated to helping people with dry-eye. Ackermann’s tale of how he took one crazy idea and turned it into a product that has the potential to help millions of people is featured in the latest issue of Inside Stanford Medicine.

More than one person’s story, it’s another example of the efficacy of the Stanford Biodesign training program, whose fellows have started 36 medtech companies and filed more than 200 patents, all of which have reached 250,000-plus patients.

Previously: Crying without tears unlocks the mystery of a new genetic disease, Instagram for eyes: Stanford ophthalmologists develop low-cost device to ease image sharing and Stanford-developed eye implant could work with smartphone to improve glaucoma treatments
Photo and video by Michael Ackermann

Applied Biotechnology, Bioengineering, Global Health, Microbiology, Stanford News

Foldscope beta testers share the wonders of the microcosmos

Foldscope beta testers share the wonders of the microcosmos

Foldscopes-TanzaniaChristmas came early for citizen-scientists who received the first batch of Foldscope build-your-own paper microscope kits from Stanford’s Prakash Lab over the last several months. These beta testers have begun sharing a variety of fascinating images, videos, tips and ideas on the Foldscope Explore website.

From this site, you can watch Foldscope videos of fluid pulsing through the brain of a live ant or the suction mechanism of a fly foot. One citizen scientist analyzes the structural differences between his brown and gray hair follicles. Another provides a tutorial on FBI bird-feather forensics. (Germophobes might want to skip the close-ups of a face mite or the fungus that grows in half-eaten yogurt cartons.)

Half the fun of receiving a Foldscope kit is the unboxing and building process, which has been captured in YouTube videos by Foldscope fans Christopher and Eric.


lens-mounterEach kit includes parts for building two microscopes, multiple lenses, magnets that attach a Foldscope to a smartphone camera lens, slide mounts, and a battery-powered light module. This allows users to view magnified images with the naked eye or projected on a wall. Photos or videos of Foldscope images can easily be captured and shared via smartphones.

For those of you who haven’t received your Foldscopes yet, rest assured that those who signed up on the beta test site will receive them soon. It’s taking longer than anticipated to build and ship 50,000 microscopes. (The gadget on the right was custom-designed to insert the tiny spherical ball lenses into the magnetic smartphone-mounting platform.)

For Foldscope updates, sharing and inspirations, bookmark Foldscope Explore.

Previously: Stanford bioengineer develops a 50-cent paper microscopeStanford microscope inventor invited to first White House Maker Faire, The pied piper of cool science tools and Free DIY microscope kits to citizen scientists with inspiring project ideas
Photo of Foldscope co-inventor Jim Cybulski and Tanzanian children building foldscopes by Manu Prakash; photo of lens mounting gadget by Kris Newby

Chronic Disease, Imaging, Immunology, Neuroscience, Research, Stanford News

Patients' reaction to ME/CFS coverage in Stanford Medicine magazine

Patients' reaction to ME/CFS coverage in Stanford Medicine magazine

me-cfs-brain-zeineh

In the last few weeks, Stanford published two articles on chronic fatigue syndrome, a.k.a. myalgic encephalomyelitis, and the outpouring of positive feedback from ME/CFS patients has been tremendous. In my long-form Stanford Medicine story and video, I describe a young woman’s seven-year battle with the disease and the groundbreaking research being done by her physician, José Montoya, MD, and immunologist Mark Davis, PhD, to identify the biomarkers and root causes of ME/CFS. My colleague Bruce Goldman followed up with an elegantly written article describing the distinct differences between the brains of ME/CFS patients with those of healthy people, in a newly released study from this same research team.

While our primary job as medical science writers is to explain new research accurately, it’s a bonus to know that we captured the patient experience in a compassionate way, and that we have in some way eased their suffering with hope.

Here is a sampling of a few of these letters from around the world:

From British Columbia, Canada:
Thank you for an article that is very well done. I will be printing it for my MD and forwarding it to family and a few close friends because it captures this devastating illness so well. I will keep a copy for myself to remind me (on those dark days) that Dr. Montoya is in my corner.

From Sweden:
I would like to thank you for your very informative and interesting article! This kind of information of what research is going on at Stanford, etc., is very important for us patients with ME all over the world! There is a lot of disinformation coming out about this disease and I therefore very much appreciate your article and especially Dr. Montoya’s passionate engagement with this disease.

From Cali, Colombia:
Here in Cali, Colombia, the city of birth of Dr. Montoya, I feel very happy reading your excellent article, and learning the marvelous and difficult investigation performed by these brilliant scientists. I was moved to tears. Thank you.

From the San Francisco Bay Area:
I want to thank you very much for the powerful piece you wrote about ME/CFS. You tell the story in a very engaging way, which is so compelling. It’s not the usual doom/gloom/dark room story which my daughter and I have encountered frequently in what people write about ME/CFS. Family and friends with whom I have shared the article are appreciative of your writing so descriptively and articulately about all aspects of ME/CFS: the science, the inequity of research funding, the personal experience of a patient, the work of Drs. Montoya/Mark Davis/Holden Maecker.

From India:
Today I have gone through your article about Erin’s story. How she recovered from CFS had given me a ray of hope as I am also suffering from such an ailment for the last 6-8 years.

From Atlanta, Georgia:
I just read your beautifully written article on Immune System Disruption. First soccer caught my eye, then “swimming in the primordial soup of creative disruption” locked me in. I read every word … and I am going to spend the rest of the night in Atlanta copying [my internal medicine doctor] on the article.

From Australia:
Just wanted to thank you for your excellent article. It could really make a difference in raising awareness and I appreciate the quality of your writing. I have suffered from CFS/ME for many years in Australia and find the research project and your understanding very encouraging.

From the blogosphere:
I just wanted to thank you for taking the time to write such an in-depth, accurate article on our oft-ignored illness. Dr. Montoya is a hero within the ME/CFS community, but I didn’t know about the others at Stanford also working on ME/CFS — that gives me some hope for a better future! I plan to share your article on my ME/CFS blog and in several Facebook groups for ME/CFS that I belong to.

Previously: Some headway on chronic fatigue syndrome: Brain abnormalities pinpointedUnbroken: A chronic-fatigue patient’s long road to recovery, Deciphering the puzzle of chronic-fatigue syndrome and Stanford Medicine magazine traverses the immune system
Image, showing white matter differences between a ME/CFS patient sample an a healthy control, by Michael Zeineh/Stanford

Autoimmune Disease, Chronic Disease, Immunology, Stanford News, Videos

Unbroken: A chronic fatigue syndrome patient’s long road to recovery

Unbroken: A chronic fatigue syndrome patient’s long road to recovery

“Fatigue is what we experience, but it is what a match is to an atomic bomb,” said Laura Hillenbrand, the author of Unbroken, about how it feels to live with chronic fatigue syndrome.

I recently finished a Stanford Medicine story and video (above) about another CFS patient, “Erin,” who asked that her real name not be used. After an acute illness in rural Mexico, Erin went from being an elite soccer player to one of the 17 million people worldwide who suffer from the condition.

Most people who acquire hit-and-run infections go back to their normal lives after a few days. But these patients don’t. They become virtual shut-ins, prisoners of a never-ending cycle of flu-like symptoms, many of them bedridden for years. CFS, also called myalgic encephalomyelitis or ME/CFS, has no known cause or cure, frustrating both patients and physicians.

What makes Erin’s CFS story somewhat rare is its happy ending. With the help of Stanford infectious disease expert José Montoya, MD, and cardiac electrophysiologist Karen Friday, MD, Erin is back to working fulltime and playing soccer.

“Dr. Montoya and doctors like him are heroes for taking up an unpopular disease and patients that most doctors shun,” said Lori Chapo-Kroger, a registered nurse and CEO of the patient charity, PANDORA Org. “He combines his medical expertise and a creative approach with a truly caring heart for suffering patients.”

Dr. Montoya is also collaborating with immunologist Mark Davis, PhD, on the Stanford Initiative on Infection-Associated Chronic Diseases, a research project using cutting-edge technologies to identify the biomarkers and root causes of ME/CFS. Working at the Human Immune Monitoring Center, team members are searching 600 blood samples for infectious microbes, inflammation-related molecules and genetic flaws. In addition, they’re conducting brain scans and physical exams to look for physical abnormalities among these patients.

Early results are promising — the team has discovered a number of measurable biological markers that indicate that ME/CFS patients may be suffering from out-of-control inflammation.

The team’s goal: To find out what is wrong with the immune systems of patients with infection-triggered diseases such ME/CFS and Lyme disease, then figure out how to help them get better.

Previously: Deciphering the puzzle of chronic fatigue syndrome

The HIMC is partially funded by Spectrum, Stanford’s NIH Clinical and Translational Science Award.

Applied Biotechnology, Bioengineering, Events, Medical Education, Stanford News, Technology

Stanford physicians and engineers showcase innovative health-care solutions

Stanford physicians and engineers showcase innovative health-care solutions

scholar-poster

A “breathalyzer” that noninvasively determines if patients have unsafe levels of ammonia in their blood. The discovery of a previously approved drug that also fights the Dengue virus. A smartphone-based eye-imaging system that can be used to diagnose vision problems remotely.

These are a few of the 40-plus inventions and clinical solutions presented at the first annual Spectrum Innovation Research Symposium, held last Friday at the Stanford School of Medicine. The event demonstrated the power of bringing together teams of physicians, bioinformaticists and engineers to apply new technologies and ideas to challenging medical problems. Also showcased were budding physician-scientists supported by the Spectrum KL2 and TL1 clinical research training awards. (In the photo above, Colleen Craig, MD, an endocrinology fellow, describes a novel treatment that she’s developing for gastric-bypass patients who suffer from severely low blood sugar.)

The buzz is that it’s going to be a good year for health-care breakthroughs

Spectrum, the recipient of Stanford’s NIH Clinical and Translational Science Award, annually gives up to $50,000 to investigator teams for year-long projects in the areas of drug discovery, medical technologies, predictives/diagnostics, population health sciences and community engagement. This program also provides these teams with training and mentoring to help them move their ideas rapidly from bench to bedside and into the community.

“These modest pilot awards have been immensely successful in stimulating innovative ideas across the spectrum of translational research,” said Spectrum’s director, Harry Greenberg, MD. “They have lead to new inventions that promote individual’s health, new ways of improving the health of the populations and new efforts to assist our surrounding community on health issues.”

As this year’s grantees were rolling up their poster presentations, next year’s scholars were rolling up their sleeves to finish their 2014-15 Spectrum grant proposals, which are due in a few days.

It’s been a pivotal year in medical technology, with the launch of an unprecedented number of game-changing inventions, such as the Mini-ION, a $900 USB-powered DNA sequencer, and Apple HealthKit, a health-and-fitness dashboard and developer kit. In the coming year, these will provide Stanford scholars with amazing technology platforms from which to launch medical solutions that are better, faster and cheaper.

“We are in the middle of amazing biomedical innovation here in Silicon Valley,” said Atul Butte, MD, PhD, and faculty director of the diagnostics/predictives program. “Spectrum enables us to fund the earliest of early technologies, more risky than even the usual angel investments, but with higher potential impacts. In the end, this gets technologies to patients and families that much sooner.”

Because of this, anticipation among the grant-approval committee members at the symposium was high — the buzz is that it’s going to be a good year for health-care breakthroughs.

Previously: Spectrum awards innovation grants to 23 projects, Stanford awarded more than $45 million to spur translational research in medicine, As part of annual tradition, budding physician-scientists display their work, and New class of physician-scientists showcase research
Photo by Kris Newby

Clinical Trials, Ethics, Health Policy, Stanford News, Videos

Video explains why doctors don’t always know best

Video explains why doctors don’t always know best

“Over 85 percent of our major medical guideline recommendations are not based on high-quality evidence,” said Robert Califf, MD, director of the Duke Translational Medicine Institute, in an article I recently wrote for Inside Stanford Medicine.

This was the inconvenient truth that Stanford bioethicist David Magnus, PhD, had to explain to patients during focus groups, as he began developing policy recommendations for conducting ethical comparative-effectiveness research within physician practices.

“We had to dispel the myth that doctors always know which treatments are most effective for individual patients,” Magnus told me. “The truth is, in the absence of good evidence, these choices are often influenced by advertising, insurance coverage and local preferences.”

Gathering better treatment evidence is a key objective of the Affordable Care Act’s health-care reform mandate. It provides incentives for medical practices to continually evaluate the relative effectiveness of competing medical interventions as a way of delivering better, less costly care to more people. The widespread adoption of electronic medical records is enabling researchers to conduct these head-to-head comparisons in more automated ways, reducing the time and expense associated with the highly controlled clinical trials used to evaluate new drugs and devices.

A communications challenge with these new approaches, however, is how to explain the risks and rewards of participation to patients. In focus groups, Magnus found that no meaningful discussions could take place until his research team had educated patients on some fundamental concepts of medical research, such as standards-of-care, randomization and informed consent. To help with this process, his team produced three short, animated videos that would rapidly get everyone up to the same level of understanding. Magnus and his collaborators are making these videos available to all for educational purposes.

The first video, “Which Medication is Best?,” explores the influences and uncertainty associated with physicians’ prescribing preferences. “Research on Medical Practices” explains medical record reviews, study randomization and randomization of clinics and hospitals; and “Informing or Asking” describes ways to explain study participation to patients.

Magnus and his bioethicist collaborators from the Seattle Children’s Research Institute and University of Washington expect to publish their final ethics policy recommendations later this year.

Previously: Bioethicists say criticisms of preemie oxygen study could have “chilling effect” on clinical researchStanford biomedical ethicist discusses Choosing Wisely Initiative and Will new guidelines lead to massive statin use?
Videos by Booster Shot Media

Applied Biotechnology, Bioengineering, Global Health, In the News, Stanford News

Stanford bioengineer among Popular Science magazine’s “Brilliant 10”

Stanford bioengineer among Popular Science magazine’s “Brilliant 10”

prakash-popsci

Manu Prakash, PhD, a prolific inventor of low-cost scientific tools, has been named one of Popular Science magazine’s “Brilliant 10” for 2014 – an award that recognizes the nation’s brightest young minds in science and engineering.

In the last year Prakash has introduced two novel science tools made from everyday materials.

The first was a fully functional paper microscope, which costs less than a dollar in materials, that can be used for diagnosing blood-borne diseases such as malaria, African sleeping sickness and Chagas. It can also be used by children — our future scientists — to explore and learn from the microscopic world.

The second was a $5 programmable kid’s chemistry set, inspired by hand-crank music boxes. Like a music box, users crank a wheel that feeds a strip of hole-punched paper through the mechanism. When a pin hits a hole, it activates a pump that releases a precise, time-sequenced drop of a liquid onto a surface. This low-cost device can be used to test water quality, to provide affordable medical diagnostic tests, or to design chemistry experiments in schools.

The inventions are brilliant in both their elegant simplicity and their use of emerging technologies, such as 3D printers, microfluidics, laser cutters and conductive-ink printing.

“In one part of our lab we’ve been focusing on frugal science and democratizing scientific tools to get them out to people around the world who will use them,” Prakash told Amy Adams in a recent Stanford News story. “I’d started thinking about this connection between science education and global health. The things that you make for kids to explore science are also exactly the kind of things that you need in the field because they need to be robust and they need to be highly versatile.”

Sometimes, just for the fun of it, I’ll wander over to the Prakash lab to check out the team’s new inventions. They never fail to impress.

I heartily agree with the Popular Science editors on this year’s choices for the Brilliant 10: “Remember their names: they are already changing the world as we know it.”

Previously: Manu Prakash on how growing up in India influenced his interests as a Maker and entrepreneur, Dr. Prakash goes to Washington, The pied piper of cool science tools, Music box inspires a chemistry set for kids and scientists in developing countries and Free DIY microscope kits to citizen scientists with inspiring project ideas
Illustration courtesy of Popular Science magazine

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