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Friday, May 17, 2019
Building the participant-researcher feedback loop for Project Baseline Fitness Reports
Project Baseline is a collaboration between researchers and participants.
Nearly ninety percent of U.S. adults now use
at least one digital tool
to monitor health—from steps to sleeping patterns and more. But beyond optimizing personal wellbeing, can the “quantified self” push the boundaries of science more broadly?
At Project Baseline, we’re on a mission to gather comprehensive health data to create a “baseline” that defines what it truly means to be healthy, and delineate the transition to disease. Our participants take a number of endurance, strength, agility, and balance tests at their annual study site visits, so researchers can aggregate and track changes over time. A key part of this effort is ensuring that participants have insight to their personal data—as well as a voice in how it’s delivered.
In
part 1 of our series on returning results
, we covered Project Baseline’s philosophy on sharing data, and how it differs from the norm in clinical trials. Now, we’ll cover the latest set of individualized health information we returned to participants: the results of their physical fitness tests, or "Fitness Reports.”
Building with participants
For us, delivering useful, interesting information starts by collaborating directly with participants. We aligned on our guiding principles for returning Fitness Reports by interviewing participants and prioritizing what information matters most to them. Our research showed that participants want to understand what their data means in context, and how it may impact both scientific discovery and health. With this foundation in mind, we were able to align on core design questions and considerations, including:
Do participants understand what results mean for their health?
Do reports answer questions participants may have?
Do participants understand what the visual charts are showing them?
What data comparisons do participants want to see?
Delivering more engaging reports
Final Fitness Reports were co-designed by Project Baseline user experience teams and study participants through
user testing and iterations
. We invited diverse participants to review early designs and provide feedback on everything from report navigation to specific data points.
The Fitness Reports cover endurance, agility, balance, and strength. Early versions of these modules included three core portions: a brief summary of the test, the participant’s individual results, and a chart showing how their score compared to those with similar backgrounds.
When giving initial feedback on this structure, participants found much of this data helpful—but questions remained. For instance, people wanted to know whether the comparison data were population averages or study-specific values, an important factor for interpreting the results. They also wanted a more textured explanation of why standing on one leg, for instance, could be an important data point for researchers.
We iterated based on participant input to update the modules with more context all around. When we had comparative data to show participants’ results against other “people like you” across the US population, we included it, and defined these groupings. We also enhanced the test descriptions to include more valuable information on what they can mean for health, including resources for further learning. The final Fitness Reports included the following categories:
Description of the test
, how researchers arrived at results, and what the numbers mean
Results
of each test
Comparisons
to similar individuals
Why this information is helpful
for understanding human health
Useful information
and fun facts about fitness and health
Additional resources
to learn more
The types of information shared and specific components of the reports—such as the additional resources—were often a direct result of participant feedback. Here’s what one module of a Fitness Report on balance looks like today:
Project Baseline participants have detailed health data on physical activity at their fingertips via Fitness Reports.
Prioritizing return of results
Tackling the challenge of returning results takes teamwork and dedicated resources. Along with conducting participant interviews, we established an expert Return of Results Committee focused on establishing clear guidelines and processes. Our committee includes participant advocates and thought leaders in medicine, clinical research, bioethics, and genetics. Read about progress to date and where we’re headed next in
this article
by Dr. Charlene Wong, co-chair of the Return of Results Committee.
Working with participants and experts to share data in an engaging way is one of the most rewarding aspects of Project Baseline. If you’re a Health Study participant, check your app to access your personal Fitness Report. To our participants especially, thank you for your partnership—mapping human health begins with you!
Posted by Tina Karimi, Contributing Editor, Verily
Tuesday, May 14, 2019
Breaking new ground in returning study results to participants
Now more than ever, patients are considered key partners in healthcare. Ninety three percent of hospitals provide patients with
access to health records online
, and evidence shows that highly engaged patients have
better treatment outcomes
.
However, in clinical research, this move toward greater collaboration is still just beginning. Typically, participants in clinical trials have limited visibility into study outcomes and how their data are used in research.
This is where Project Baseline comes in. Project Baseline is unusual because of the breadth and complexity of the data we use to understand human health—as well as our commitment to sharing that data with participants.
Because this hasn’t been done before to this magnitude in clinical research, there are no widespread norms to follow. We’re thinking through how to return data thoughtfully, ethically, and responsibly to minimize unintended consequences—all while exploring what it means to conduct truly human-centric research.
From the beginning of the Project Baseline Health Study in 2017, we made it a priority to return any serious medical findings that require urgent follow-up with a doctor. We also convened a dedicated Return of Results Committee including participant advocates and thought leaders in medicine, clinical research, bioethics, and genetics. This committee is
focused on creating clear standards
that can serve as a new foundation for future clinical research. Their initial findings were
published in 2018
, and additional guidelines are set to follow this year.
In 2018, we also began returning lab results, activity trends, and fitness data with all participants. We’re excited to continue to evolve and expand on these efforts in 2019 and beyond.
Take a look inside how we’re designing our approach to deliver meaningful information.
Returning results starts with participants
Health Study participants contribute data in a number of ways, like lifestyle and health habit surveys, blood samples, and tests completed at their local Project Baseline study site. These tests can include standard assessments of physical strength as well as more specialized tests like eye exams and heart imaging.
Following their initial site visit, Health Study participants receive the full results of their CLIA lab test, which is a comprehensive blood panel including cholesterol, key vitamin levels, liver function, and more. While Project Baseline does not take the place of clinical care, we know participants are interested in what their data may mean for their health. Blood panel results provide a view of a number of health values, which participants can discuss with their healthcare providers if needed.
Next, we wanted to learn more about participants’ preferences in order to deliver useful data on an ongoing basis. Knowing we were navigating new territory—and that participants care deeply about receiving this data—it was important to give participants a voice in the process.
Ultimately, Project Baseline’s mission is to make participation in research easy and engaging. One way we’re aiming to break with tradition is by giving our participants a range of different ways to give us feedback—from quarterly surveys, to interviews, to regular check-ins with participants from the Project Baseline team.
From the Project Baseline enrollment questionnaire, we knew that the opportunity to receive results is the #2 top reason people join, after contributing to research. We probed deeper in a survey last year focusing on what data participants were most interested in getting back. Physical activity data from the Study Watch was one of the top-ranked requests. Data gathered by the Study Watch—a device participants wear to capture step count and other activity data—was also the #1 request from participants in calls and emails to the Project Baseline support team.
To move towards giving participants the visibility they wanted, we launched Study Watch step count in the Project Baseline app in August 2018. More recently, we delivered more detailed reports of participants’ individual physical fitness data. These Fitness Reports outlined the results of the strength and coordination tests participants took part in during their site visits.
Study Watch step count data gives participants insight into their physical activity.
Not only did participants help us prioritize the sequence of results to return, they also played an integral role in the actual design of the reports. The result of close partnership between the Project Baseline team and participants, Fitness Reports were delivered after months of participant-focused research and iteration.
The process involved rounds of participant interviews, as well as hands-on sessions where participants navigated through draft reports and provided feedback on how useful, interesting, and understandable they were. Participants also had the opportunity to review multiple versions of report designs.
To learn more, stay tuned for part 2—we’ll dive deeper into fitness data, collaboration, and how the reports were designed.
Posted by Tina Karimi, Contributing Editor, Verily
Thursday, May 2, 2019
Project Baseline launches Heart Biomarker Study to advance research around new heart disease risk factor
Heart disease causes
one in four
deaths in the United States annually. To combat America’s greatest health threat, Project Baseline today announced the
Heart Biomarker Study
to advance research around a little-understood blood particle that’s considered an emerging risk factor for heart disease: lipoprotein(a).
Lipoprotein(a), or Lp(a), is a biological marker (or “biomarker”) similar to cholesterol: when elevated, it increases the risk of blockages in the arteries that cause heart attacks and strokes.
One in five Americans
is estimated to have high levels of Lp(a), which are determined by genetics
1
. And although existing research suggests that Lp(a) plays a pivotal role in heart health, no targeted treatments are currently available. Today, individuals with high Lp(a) are mostly treated with
statin medications
to manage cholesterol
2
.
As the director of the Duke Adult Cardiovascular Genetics Clinic, I care for patients with heart-related genetic disorders, and their families. Helping patients prevent a recurrence of cardiac events is an important part of my practice, and my core focus as a researcher. For patients with a greater genetic risk profile, I strongly believe that we need more effective preventive treatments. Over the past two years, I’ve worked closely with the Project Baseline team to determine how we may be able to help improve outcomes for the
85.6 million Americans
affected by heart disease. Learning more about Lp(a) — and particularly how it impacts heart patients — could be a key piece of this.
The Heart Biomarker Study is an observational research study that will collect the health records of eligible participants who have experienced a heart attack or stroke. Participants will also learn their Lp(a) level through a specialized blood test at their local lab.
For a cardiology researcher, the opportunity to focus on Lp(a) in heart attack and stroke survivors is compelling. To date, Lp(a) research has not been able to completely understand how levels of the biomarker impact the risk of a second heart attack or stroke among those who have already suffered a cardiac event.
One in four
of the more than 795,000 strokes that occur per year are actually experienced by people who have had a previous stroke. Similarly, about
27% of yearly heart attacks
happen to people who have experienced a heart attack before. The Heart Biomarker Study is specifically designed to help identify how Lp(a) affects this population, in order to better understand how to potentially reduce the risk of subsequent events.
To improve health for all, there are many areas that require deeper scientific exploration. Heart disease, which causes
more than one death per minute
, is one of the most critical. Building on the
Project Baseline Health Study
— a landmark endeavor to delineate the transition from health to disease — the Heart Biomarker Study is an important step in Project Baseline’s mission to map human health.
Research Goes Red
, Project Baseline’s collaboration with the American Heart Association’s Go Red for Women movement, launched in February to improve the representation of women in heart research. Now, the Heart Biomarker Study joins these efforts to increase the speed of discoveries, and ultimately improve healthcare.
If you’ve experienced a heart attack or stroke, you may be eligible to participate in the Heart Biomarker Study.
Learn more
about the Heart Biomarker Study and Lp(a), and consider getting involved.
1. “Understanding Lipoprotein(a),” Lipoprotein(a) Foundation.
2. “Guidelines and Lp(a),” Lipoprotein(a) Foundation.
Posted by Svati Shah, MD, MHS, Professor of Medicine, Division of Cardiology, Duke University School of Medicine
Monday, April 22, 2019
Dr. Reed Tuckson’s insights from the first Project Baseline Advisory Board meeting
Introducing Dr. Reed Tuckson, Chairman of the Project Baseline Advisory Board
When healthcare works, it’s the result of collaboration. From hospital networks to health authorities, patients, payers and more, we all share a common goal: improving outcomes. What we’re not always aligned on is how to get there.
But increasingly, as a result of new partnerships, that’s changing.
As a physician, I’ve had the opportunity to engage in nearly every domain of healthcare over the past 35 years—from clinical practice, to public health policy, to academic research, to private industry. Today, I’m encouraged to see more and more blending of expertise across these traditionally siloed areas. According to the American Hospital Association, for instance,
seven in 10
hospitals and health systems will increase collaboration with other providers and payers on population health by 2023.
Because clinical studies are at the forefront of scientific discovery, I believe research can play a pivotal role in both improving patient outcomes and sparking greater collaboration in healthcare. So does Project Baseline. Recently, Project Baseline convened an Advisory Board representing the healthcare spectrum, from patient advocates and ethicists to leaders in science, public health, and research.
This Board came together for the first time last month to discuss how we close the gap between clinical research and clinical care, strategies for making healthcare data useful, and our obligations to participants and patients who engage in research. Our goal is to create an ongoing forum for sharing insights and ensuring Project Baseline stays focused on people. Here are some of the core takeaways from the discussion.
Closing the gap between research and care
Up-to-date information and clinician-focused resources on clinical studies can be difficult to find. As a Board, we discussed how researchers may be able to create a feedback loop to keep clinicians informed of the latest scientific innovations.
Making data actionable
From wearables to electronic health records and beyond, patient data is growing at a staggering pace. But as we increase our ability to capture more and more information, do we have a strategy for making it useful? Within Project Baseline, we are working to collect and organize many types of health data, from biometric data, to genomic data, to clinical data like medical images. By marrying different data sources, our hope is to break through silos to understand health in new ways.
Staying transparent and providing value to research participants
Patients are more engaged than ever in their own health. Within the United States alone, hundreds of patient advocacy groups have emerged as critical resources, especially within the rare disease community. We have a responsibility to approach participants and patients as true partners.
Each board member brought a unique perspective on approaching research in ways that truly center participants. I’m pleased to introduce them to the Project Baseline community:
Posted by Dr. Reed Tuckson, Chairman, Project Baseline Advisory Board
About Dr. Reed Tuckson:
Reed V. Tuckson, MD, FACP is the managing director of Tuckson Health Connections, LLC, a health and medical care consulting business.
Previously, he served as executive vice president and chief of medical affairs for UnitedHealth Group; senior vice president for professional standards of the American Medical Association; president of the Charles R. Drew University of Medicine and Science; senior vice president of the March of Dimes Birth Defects Foundation; and commissioner of Public Health for the District of Columbia.
Dr. Tuckson is active on numerous public and private boards that encompass biotechnology, data and analytics, clinical research, hospital and ambulatory-based care delivery, and health policy.
Dr. Tuckson has been identified several times by
Modern Healthcare
magazine as one of the “50 Most Powerful Physician Executives” in healthcare, and is active with the National Institutes of Health and the National Academies of Medicine.
Monday, March 25, 2019
Faces of Baseline: Nor
Dr. Nor Chiao came across a
New York Times story on the Project Baseline Health Study
while stuck in standstill LA traffic. She was familiar with clinical studies as a former researcher at MD Anderson Cancer Center—but this was different from any other research program she’d encountered. A four-year observational study, the Health Study was a long-term initiative to map human health by collecting deep medical data. Still sitting in gridlock, Nor finished the story and immediately pulled up the Health Study application on her phone.
“Right away, I connected with the Project Baseline Health Study’s mission to impact how we understand health, and its longitudinal nature really stood out,” said Nor. “You’re not just getting a point-in-time snapshot of an individual. Rather, the objective is seeing how health evolves over time across thousands of participants.”
Nor was fascinated with science from a young age and highly driven to succeed, immigrating from Taiwan to Southern California at 8 years old. By high school, she had been selected to attend a summer biomedical research program for students sponsored by the City of Hope cancer genetics center. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, delivered a lecture to Nor’s program on the transformation of genetic research.
“Because of my early exposure to the breakthrough of gene sequencing—and all the innovation that followed—I wanted to be part of this movement to advance human health,” said Nor.
Her ambitions led her to Johns Hopkins’ pre-medical program, where she earned internships at the National Cancer Institute and Howard Hughes Biomedical Institute. She would continue her studies at Harvard Medical School and MD Anderson.
As a physician, Nor has seen the impact of preventative care and early detection of disease firsthand. She hopes her health data will contribute to a more precise delineation of health and the transition to disease.
“I’m excited to be part of the Baseline community,” said Nor. “And as a participant, I’m really interested to get results back and see how they inform the overall picture I have of my health.”
Posted by Tina Karimi, Contributing Editor, Verily
Friday, March 8, 2019
How research helped map my family’s heart health
Clinical research is key to my family's heart health story.
At some point in my childhood, I lost count of the number of research trials I consented for. As a chronic heart disease patient with an exceptionally rare confluence of a double genetic mutation, I am a prime candidate for many studies launched at my primary care center. I have a folder nearly as thick as my medical record containing copies of all of the consent forms I have signed over the years. I understand my value to these studies. Not only am I a rare genetic presentation of a common heart disease, but I also “am rare” to still be alive.
I was born in a small town just outside of San Francisco, in the days before the dot com boom. Both Bay Area natives, my parents were (and still are) incredibly active. My father went all-American in football during his college years and my mother, sister, and I danced at the same studio. My family firmly believes that a healthy mind is cultivated alongside healthy movement, so my sister and I played sports year round.
It was, therefore, completely shocking to us when — at age 13 — I experienced my first cardiac arrest while running on a treadmill. I shortly thereafter was diagnosed with
hypertrophic cardiomyopathy
, a surprisingly common and serious heart disease which can lead to episodes of cardiac arrest and sudden death. HCM affects the left ventricle of the heart and there currently aren’t any cures. Without proper screening or family history, this disease is often diagnosed too late.
While my diagnosis was shocking to us all, the biggest surprise was that I was likely not alone. HCM is an autosomal dominant mutation, which means that the genetic variance is passed down from generation to generation. However, many people diagnosed with HCM do not have any genetic markers as all (that we can yet identify with today’s knowledge). My family was one of the first at our hospital to be tested, as part of a research study, for the presence of HCM in our genes. To our surprise, the results showed that each of my parents carried an identifiable, unique mutation on the same gene for the exact same disease. While my sister managed to avoid either mutation, I received both.
The research was giving us a pristine map of how HCM was affecting our family. But while both my parents carried the gene for HCM, only my father’s heart showed evidence of the disease. Naturally, we were filled with questions. How had he lived so many years without knowing his heart condition? What did this mean for the future? Was he also in danger of a sudden cardiac arrest?
Thanks to advances in research we can now try to predict the trajectory for many people with HCM. For me, it meant knowing around what age I’d be when I’d go into heart failure and require a transplant (spoiler alert: I eventually did have a heart transplant and three years later I’m still here!). It meant having the awareness to test our extended family members for the disease.
It also meant taking the responsibility of spreading awareness: that heart disease can happen to anyone at any age, of any race, of any gender, and for various reasons. The importance of heart health lies in more than just prevention: it is also important to know your family history and to encourage friends and loved ones to get basic testing, in addition to living an active and heart-healthy lifestyle.
As a patient advocate and a survivor of multiple heart conditions, I am so excited about the work Project Baseline and the American Heart Association are venturing into with
Research Goes Red
. Because heart disease can happen to anyone, but disproportionately affects women, people of color, and young athletes
1
, the research community needs to start finding more equitable solutions for all of those affected. Research has saved my life and my loved ones’ lives more times than I can count. I am happy to keep adding to my consent form collection.
1. “
Heart Disease Facts
,” Close the Gap.
Posted by Leilani Graham, Patient Advocate and Community Coordinator, Verily
Tuesday, February 26, 2019
Project Baseline and the American Heart Association’s Go Red For Women movement collaborate to include more women in research
Women have been underrepresented in heart health research. That stops now.
Less than half of American women know the major symptoms of their greatest health threat.
1
While sometimes considered a “man’s disease,” cardiovascular disease causes one in three female deaths annually.
2
To call on women across the United States to join the fight against heart disease, the American Heart Association’s Go Red for Women movement and Project Baseline are joining forces on
Research Goes Red
. A heart-health collaboration focusing specifically on women and heart disease, Research Goes Red aims to empower women to contribute to health research.
Historically, clinical studies have not adequately enrolled women or analyzed women-specific heart health data. Beginning in February, which is American Heart Month, women can
join Research Goes Red
. They may have opportunities to take part in surveys and focus groups, contribute data for clinical research projects, and test new tools and technologies in the years to come. With Research Goes Red, contributing to heart research doesn’t have to involve taking medication or donating blood—just a desire to advance women’s heart health.
Improving the diversity of clinical studies is key to creating health solutions that work for everyone. “This is an opportunity for women to stand up for their health and participate in research that could increase our understanding of heart disease and prevention,” said Nancy Brown, chief executive officer, American Heart Association. “We are thrilled to collaborate with Verily on bringing Research Goes Red to Project Baseline, in a world-class clinical research effort that augments the momentum we’ve built with the Go Red for Women movement over the last 15 years.”
At its core, Project Baseline is an initiative dedicated to making research more inclusive and accessible. “Through clinical research we have an opportunity to uncover new insights about health, and by making it easy for individuals to participate, we can develop a comprehensive map that could inform treatment or care decisions,” said Jessica Mega, chief medical and scientific officer, Verily. “Collaborating with the American Heart Association through Project Baseline will help inform more women about the value of participating in research, how to contribute, and a new way to ‘Go Red.’”
Want to know more about how the American Heart Association and Project Baseline are working to improve women’s heart health? Learn more about
Research Goes Red
and join us on the American Heart Association’s
Facebook page
on February 28 to wrap up American Heart Month! Nancy Brown and Jessica Mega are teaming up for a 30-minute Research Goes Red Facebook Live at 3 p.m. PST / 6 p.m. EST. We hope to see you there!
1. American Heart Association and American Stroke Association, “
Cardiovascular Disease, Women’s No.1 Health Threat
.”
2. Liu, K. A., & Mager, N. A. (2016). Women's involvement in clinical trials: historical perspective and future implications. Pharmacy practice, 14(1), 708.
Posted by Tina Karimi, Contributing Editor, Verily
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