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Friday, October 16, 2020
How do Project Baseline researchers use participant survey data?
Health isn’t all about the numbers in your chart when you visit the doctor. One of the ways researchers can get a holistic view of health, across different populations, is by designing scientifically valid surveys that can help answer research questions. We sat down with biostatistician Sarah Short to learn more.
Why is it important and valuable to get self-reported data from participants for research?
Historically, researchers focused more on clinical, objective data because there was less trust in the quality and usefulness of subjective, self-reported information. As research has matured, we’ve taken a more patient-centered focus, which means taking people’s perceptions and experiences into account when evaluating the effectiveness of treatments. There are important aspects of patient experience that cannot be captured through clinical measurements like temperature, blood pressure, or lab results.
For example, when we’re studying a new treatment, we can measure how effective it is clinically, but that doesn’t tell us about patient satisfaction with the treatment. If we discount that, we run the risk of creating something that doesn’t fit into people’s lifestyles. Also, with remote research increasing, it’s much easier to collect such data than it was when everything had to be collected at a physical study site.
What were some of the challenges associated with surveying people before?
Having a human interviewer or doctor in the room (or even on the phone), asking the questions, can introduce bias. Electronic surveys can lead to more honest results. They can also help us collect information about people who may not be as easy to include in typical trials, including people who face challenges with mobility issues or access to care.
One way we’re trying to use more inclusive, digital means of conducting research to reach underrepresented groups is through
Research Goes Red,
our collaboration with the American Heart Association. Heart disease is thought to be more of a problem for men, and women may not be aware of their risks. That's an important gap to fill. We’re focusing on learning about the community’s motivations and health concerns so researchers can get more insight on how to help.
One challenge we’ve always had, even with more remote research opportunities, is the digital divide. Many groups don’t have reliable access to the internet. While research is growing more inclusive, there’s still a lot of work to be done to engage traditionally underserved groups.
What’s the process for creating a scientific survey? How do you ensure the results are valid enough to draw conclusions for research?
It’s definitely not as simple as putting a few interesting questions together and sending out a poll! Some of the surveys we use are validated instruments — surveys that have been developed to serve a specific purpose and which have been rigorously evaluated for reliability and validity. However, to answer more specialized research questions, we often create our own surveys. This involves bringing together clinicians, researchers, survey design experts, statisticians, and user experience teams to collaborate on clear, unbiased questions that will lead to the right kind of data to answer your research question. This can be inherently challenging when you’re conducting experimental research and trying to uncover new markers of health and disease.
It’s also important to get surveys right the first time. Changing survey questions makes it more difficult to analyze them over time. Some surveys might measure more clinical information — for example, changes in symptoms — while others can be more qualitative. Both types of data are valuable to researchers.
Can you give an example of scientifically interesting insights or research we’ve gleaned from scientific surveys?
As part of the
Baseline COVID-19 Research Project
, survey data collection serves multiple purposes. With the intense pace of research to find vaccines and treatments — and save lives — it’s important to find the right people to join studies. We’re able to reach a broad sample of people and learn about their symptoms, which can help with pre-screening for research opportunities. The COVID-19 Research Project can give us a lot of interesting longitudinal,or long-term, population health data. For example, our surveys around social distancing and behaviors reveal that mask use is increasing in our cohort over time. This can help us understand how public health information is understood on an aggregate level.
We can also see patterns over time around people’s emotional experiences and coping mechanisms. We found an association between hours of exercise and improvements in mood. This isn’t necessarily a surprising finding, but it shows that even in this time, there are activities that can help reduce stress. Access to data can help us pinpoint strategies for addressing the virus’ impact and provide help where people need it. Based on the findings from our wellbeing surveys, we recently hosted a
webinar specifically focused on coping strategies
for the pandemic drawing from research data.
Why is it important to return data from research?
It can be tricky to return results when we’re asking people subjective questions about their feelings and experiences, particularly when asked repeatedly over time. We have to consider whether sharing results will influence further responses down the road. This is one reason why results usually are not shared until the end of a study. However, it’s important for us to prioritize navigating those challenges to identify data we can share without introducing bias. We value our participants, not just the data they provide. This is one way we show participants that they are valued, and that their contributions have a meaningful impact.
To learn more about participating in research through Project Baseline — including our COVID-19 focused efforts — visit
projectbaseline.com
.
Tuesday, April 14, 2020
Verily’s Baseline Platform: Investing in Security and Privacy
The Public Health Crisis
We are in the midst of the most significant health crisis in over a century. COVID-19 has been declared a global pandemic, and we have yet to understand how it will affect us today and in the future. The more we know, the better and sooner we can respond. At Verily, we are doing everything we can to assist in developing
smarter COVID-19 testing
to inform public health. In March, we launched the Baseline COVID-19 Program to expand availability of COVID-19 screening and testing, beginning in California.
Verily’s Baseline
Verily’s
Baseline platform
has been in development for almost five years and was envisioned as a new approach to bridge clinical research and clinical care. The platform is designed to benefit from the profound improvement in computing and the new digital environment, often referred to as the
Fourth Industrial Revolution
. A much more interactive approach to discovery is now achievable. Furthermore, a modern health data and clinical research platform can deal with the vast amount of data that must be stored and analyzed to develop new treatments and to understand which medicines, devices, digital tools, and care delivery are best for which people.
Privacy and Data Minimization
A primary goal of Baseline is to make it easier for people to engage in research so that we can ensure better representation in clinical studies, more comprehensive data collection, and faster evaluation and time-to-market for innovative tools and therapeutics. We understand that privacy and confidentiality of people’s data is critical to building the trust of the community we serve.
Verily has done extensive work over the past few years to develop private and secure platforms, and has published
Verily’s privacy commitments
. The Baseline platform has been employed in clinical research for years and hardened to protect data and users. Our privacy practices specific to Baseline are informed by the following frameworks:
FDA: The Baseline platform is
Part 11 compliant
, a key component of privacy and security in dealing with sensitive research data regulated by the Food and Drug Administration.
ISO 27001: The Baseline platform is
ISO 27001 certified
to ensure compliance with leading security standards.
CCPA: The Baseline platform supports compliance with the
California Consumer Privacy Act (CCPA)
, which enhances privacy rights and consumer protections. Verily is applying the protections of CCPA across our operation of the
Baseline COVID-19 Program
.
HIPAA: The Baseline platform supports HIPAA compliance, depending on partner needs. With regard to the Baseline COVID-19 Program, Verily is not acting as a covered entity or business associate within the context of HIPAA. Verily employs security controls that map to the HIPAA Security Rule (for more, please see the
HIPAA Security Rule Crosswalk to NIST Cybersecurity Framework
). Verily strives to go above and beyond the requirements of individual regulatory frameworks to appropriately safeguard user information and to help in this public health emergency.
For the Baseline COVID-19 Program, we have committed to minimizing the data we collect for the purpose of enabling this testing and only collecting what is necessary to enable people to get tested. We are committed to deleting this data once the public health emergency is over, except where individuals provide their explicit consent for additional uses of their data, such as clinical studies. To provide context, current expert projections are that this public health emergency will last at least 18 months; because COVID-19 is a new disease, we expect to retain the data throughout this time period to assist public health.
Authentication with Google Accounts
As we build products that are used for clinical research or healthcare delivery many people have asked why we require that a person have a Google account. As part of the sign-up flow for all Baseline clinical studies, including the Baseline COVID-19 Program, our platform requires individuals to link to an existing Google Account or to create a new Google Account (which can be done with any email address) for authentication purposes. This is important for two reasons:
Data Security:
We need world class authentication to protect people’s information. We are protecting health information, ordering tests, and returning health results. Without a strong authentication procedure, unknown people could send or receive information with serious consequences for health or well-being, and bots or fraudulent attacks could be made on the platform.
Proven Solution:
Verily uses Google for cloud services, including data storage, computing infrastructure and authentication services, as do many other organizations. Google provides best-in-class authentication and has a world-class team of security and privacy experts dedicated to building, maintaining and evolving defense for the Google ecosystem. Features such as
two-factor authentication
, account recovery,
fraud/bot detection
, and
phishing protection
are important. This authentication system enables clinicians, researchers and healthcare systems to securely and privately contact individuals and transfer information during the screening, testing and research process. Google’s access to data is strictly limited to the purpose of providing such services. All the data provided by Baseline COVID-19 Program users for screening is stored separately and not linked to a user’s Google Account, which is used for authentication purposes. Data will never be used for advertising purposes.
The Future
We are dealing with a crisis in the midst of a pandemic. This will take considerable work in a shorter period of time than “business as usual,” and there are many priorities vital to the public health. Given that the Baseline COVID-19 Program was built on Verily’s pre-existing Baseline platform to secure health information, it enabled us to quickly develop a reliable, secure and authenticated site. We feel fortunate that the Baseline platform was ready to go and fit for this public health purpose.
We appreciate the opportunity to help people, patients, health departments, clinicians, and researchers deal with this pandemic. We take our responsibility to protect data seriously and will continue to explicitly inform people as we take this journey together.
Wednesday, April 8, 2020
Developing smarter COVID-19 testing to inform public health
As we’ve rolled out a
community-based COVID-19 testing program
in conjunction with the State of California, we’ve received many questions about how we collect data during the screening process, why it matters, and who is eligible for testing through our program. In short, the process is designed to quickly, securely and accurately screen and test individuals with concerns about COVID-19 while also giving state public health officials high-quality information to respond to this crisis. As former Commissioner of the FDA during the Zika virus crisis, I have a healthy respect for the value of taking action to deal with an infectious epidemic. I also developed a deep appreciation for the importance of reliable data to support the best decisions about policy and healthcare.
The goal of our work with the California community-based testing program is to rapidly screen and test high-risk people who do not need immediate medical attention, such as those exposed to COVID-19 or frontline healthcare workers and first responders. It is also critical for health officials to have timely and accurate public health data to help determine where the novel coronavirus is likely to spread and where the most vulnerable communities are. While many public health departments have systems for tracking positive tests, more comprehensive information across counties and systems is
currently lacking
. Data from individual testing sites and aggregate data could inform decisions the local and state authorities will make about social distancing measures and provide a basis to adjust screening criteria to ensure that people with the greatest need for testing receive it.
Over the past few weeks, we and our partners have established four community-based COVID-19 drive-through testing sites in San Mateo, Santa Clara, Sacramento and Riverside Counties. We’ve quickly and responsibly scaled each site and intend to launch with three new sites in California this week.
As COVID-19 spreads exponentially, we must move fast to stand up more community-based testing centers. On March 31, there were more than 186,000 confirmed cases in the U.S. up from roughly 30 on March 1, according to the
Centers for Disease Control and Prevention
(CDC). As the pandemic continues to spread, hospitals will need to focus on people with significant illness and healthcare workers. During this acute phase, screening less symptomatic people away from a healthcare setting can help avoid spread of infection and consumption of stressed hospital resources.
Additionally, a secure and connected system that enables a person to register, get an appointment, complete the test quickly and receive a secure test result can help communities efficiently establish a systematic testing approach. Our
Community Based Testing Guide
provides publicly available information about what we have learned that will be useful to others setting up testing sites.
Why We Need Data for Public Health
Because COVID-19 represents a public health emergency, federal, state and county public health agencies are required to track the results of the tests and analyze data about people who are infected to inform decisions about how to manage the epidemic. Typically, there is a significant lag between the return of a test result and the collection of more detailed information, and little is known about what is different about people whose tests are positive versus those whose tests are negative. The Baseline COVID-19 Program’s technology platform is designed to collect this information, which by law is handled confidentially by public health authorities.
Anonymous screeners are readily available on the CDC.gov website and elsewhere, and some allow people to input information and find a potential testing site without identifying themselves. These screeners also have an important role in stemming the epidemic, but they do not enable receiving an appointment for the test, nor do they enable followup of a person linked to their test result. Accordingly, we support the use of available screeners, but the Baseline COVID-19 Program has a specific use in the testing and public health ecosystem.
Since our launch on March 15, more than 60,000* individuals have completed the public health screener through the online tool. The screener is dynamic and the criteria may change over time based on public health data and directives by the California Department of Public Health (CDPH) on
populations of greatest concern
. As we scale testing at these facilities and begin opening new ones, the triage algorithm will be adjusted in response to CDPH objectives. As a result, it’s possible that individuals who are not currently eligible for testing through this program may become eligible in the future, as public health guidance involving testing shifts.
In-depth data on COVID-19 spread and its impact on specific at-risk populations such as the elderly or people with multiple illnesses can help health authorities make more informed decisions and tailor containment efforts at the local, county, and state level. Data can also help determine which underlying health conditions pose the greatest risk to people infected with COVID-19. In the U.S., preliminary data show that those with diabetes mellitus, chronic lung disease and cardiovascular disease appear to be at higher risk for severe COVID-19-associated disease,
according to a March 31 report
by the CDC. Further data will help validate those findings.
Along with increasing visibility into positive results across counties, collecting public health data through smarter screening and testing can also help public health officials see how initial findings map to key risk factors.
We will continue to develop the Baseline COVID-19 Program and to share updates on our progress as the pandemic runs its course. We will provide individuals and public health authorities with information needed to improve decisions about individual health and to reduce the impact of the epidemic as much as possible. As the pandemic continues to evolve we will adapt our approach based on data and the guidance of public health officials who have
served California well
in order to help individuals who need to be tested for COVID-19 while also providing information for the critical role of evidence-driven policy that is so critical to successful management of health crises.
- Robert M. Califf, MD, MACC, Head of Clinical Policy and Strategy for Verily and Google Health
*Based on data collected as of 4/06/20.
Monday, March 30, 2020
The Baseline COVID-19 Program releases guide for establishing community testing sites with input from California public health authorities
Streamlining COVID-19 screening, testing, and return of results is a significant challenge nationwide. The California community-based COVID-19 testing program with support from Verily’s Project Baseline has rapidly and responsibly rolled out four testing sites in two weeks, testing more than 3700 individuals to-date*. Our team has learned a lot in the early days of this program and has established best practices to inform development of additional testing sites. We are now sharing these learnings to support other organizations’ efforts, who may find the information useful, as they expand testing within their own communities.
The COVID-19 Community-Based Testing Program Guide
is designed to help government officials, public health departments, and local communities establish drive-through testing sites, and includes instructions for integrating with the Baseline COVID-19 Program.
The guide consists of lessons we believe may help communities that are under immense pressure to quickly establish testing. The COVID-19 Community-Based Testing Program Guide includes a framework for:
Launching sites within a one-week timeframe
Optimizing site operations for more efficient testing, while maintaining safety
Creating a more automated, integrated process that spans dynamic screening that can be adjusted based on the latest epidemiology, scheduling, testing, and delivery of results
The COVID-19 Community-Based Testing Program Guide is the result of collaboration between Verily’s Project Baseline team of engineers, scientists, clinical operations specialists, and more, and the California Department of Public of Health (CDPH), California Department of Health and Human Services (CDHHS), California Office of Emergency Services (Cal OES) and county and city departments of public health. The guide also includes clinical and operational input from Stanford Medicine, based on its testing protocols and experience addressing COVID-19. We will continue to update the document as we iterate, learn, and launch additional sites.
To learn more about the Baseline COVID-19 Program, visit us at projectbaseline.com/covid19 and follow along with us on Twitter
@verilylifesci
.
*
Based on data collected as of 3/28/20
Friday, March 27, 2020
Go behind the scenes of the Baseline COVID-19 testing program
Expanding access to reliable screening and testing is critical to containing the spread of the COVID-19. At Project Baseline we are supporting the California community-based COVID-19 testing program in expanding to more locations, and we’ve created a
video to show how testing works.
Here are the steps involved in the program:
1. Take an online screener
The first step is to complete an online
screener
based on guidelines from public health officials. The screener helps prioritize testing needs based on direction from the California Department of Public Health.
2. Get an appointment
If individuals qualify for testing at this time through this program, they will receive a confirmation email with appointment details, including the time and location of the test.
3. Take the test
At testing sites there are three stations: an appointment check, an ID check, and sample collection.
In station one, individuals will be instructed to show their ID, keeping windows closed. This helps ensure that this step is done as safely as possible.
Once the appointment is confirmed, they will drive to station 2. Healthcare staff will match each individual a lab kit and attach a lab requisition to the car’s windshield. This document helps ensure tests are processed safely and correctly.
Then, individuals will drive to station 3, which is the sample collection area. Next, drivers will roll down their window and tilt their head back for a nasal swab. Site staff will then ship the samples to a lab for analysis.
4. The results
All results will be communicated, positive or negative, back to those who are tested. Individuals will receive the results about 2-5 days after testing, but this may take longer due to lab capacity. If you test positive, you’ll get a phone call from a qualified healthcare professional.
For more information on the Baseline COVID-19 Program and to learn if you are eligible for testing through this program, visit
projectbaseline.com/covid19
.
Monday, March 23, 2020
California opens two new community-based COVID-19 testing sites in collaboration with Verily’s Project Baseline and with federal support
The California community-based program to test high risk individuals for COVID-19, in collaboration with the
Baseline COVID-19 Program
, enters its second week of operations with two new testing sites, in Lake Elsinore City in Riverside County and in Sacramento County. With this expansion to the program — in partnership with federal, state, and local public health officials — we expect to be able to serve thousands more across four counties in California.
In the first week of operations, we scaled testing to 20X the capacity at launch, testing over 1,200 individuals at initial sites in San Mateo and Santa Clara counties. Now, we are adding a self-service scheduling capability for eligible individuals to the Baseline COVID-19 screening tool, further increasing efficiency across all testing sites.
Sample collection at a drive through California community-based testing site with support from Project Baseline.
We launched the program pilot with a limited number of appointments to allow us to quickly understand and adjust protocols and processes for safety and scalability. The program has involved medical centers and federal, state, and local public health officials to identify and to inform best practices for establishing local testing programs for broader population screening. We plan to share a consolidated report on our approach to support public health authorities in their efforts to quickly stand up testing initiatives.
The screening and testing criteria that inform the screener are directed by the California Department of Public Health (CDPH) and are updated in accordance with public health guidance as the situation develops. The California community-based testing program began by testing higher risk individuals as determined by CDPH. Eligibility requirements will continue to be updated based on public health needs and testing capacity.
We have identified a number of lessons learned from our first site launches that will help us ramp up quickly at Sacramento and Riverside:
Testing site design and flow
An incident command system oversees testing site operations. Each testing site consists of a command center for quick decision-making, and “hot zones,” accessible to testing personnel in personal protective equipment (PPE) for sample collection.
Hot zones are accessible only to a streamlined set of healthcare workers to minimize risk and to help conserve personal protective equipment.
Testing site layouts are designed to align with social distancing measures, limiting areas where multiple individuals can congregate.
The focus is on establishing drive-through testing sites, as that framework should reduce the risk of COVID-19 transmission. Sample collection has been adapted to work for multiple scenarios, including individual drivers seeking testing, drivers bringing loved ones for testing, and instances where both drivers and passengers are getting tested.
Foundational processes
Managing capacity at the testing sites is critical to balancing the need for efficiently testing the appropriate people and optimizing precious PPE resources while avoiding overcrowding — which can increase risk of contagion. We have a dedicated analytics team monitoring the time required to gather samples and other important testing site metrics to optimize scheduling, and these insights will be included in our report.
Our goal is to automate as much of the workflow possible. Often, placing orders for lab testing is a manual process. Direct integration between the Baseline platform’s software and test ordering systems helps get people tested more quickly.
Incorporating global best practices
Countries like South Korea are establishing sound procedures that we are working to integrate into our operations, such as temperature checks for on-site personnel as another safety measure in addition to social distancing and PPE.
As part of the California Community-Based Testing Program, we are privileged to work alongside numerous organizations who are contributing to increasing testing capacity in the state.
Thermo Fisher Scientific
and
Becton Dickinson
are rapidly producing critically needed testing kits.
PWNHealth
is the physician network that approves testing for individuals and provides post-test telehealth consults, and the nurses and healthcare providers from
Hawthorne Effect
and
Elligo
are onsite at the frontlines performing tests. Tests are then processed by
Quest Diagnostics
. Together, with federal, state, and local public health agencies, we are pushing forward to bring testing to the people who need it.
For more information, please visit the
Baseline COVID-19 Program
website, and follow Twitter
@VerilyLifeSci
for the latest updates.
Thursday, March 19, 2020
Baseline COVID-19 Pilot Program shares early screening and testing progress
Site personnel in personal protective equipment (PPE) direct individuals to mobile testing site.
The
Baseline COVID-19 Pilot Program
launched operations this week with an online screening tool and sample collection sites in the Bay Area. The early days of the pilot have been focused on an end-to-end protocol and playbook that can scale. A critical part of this process is adjusting the screening and scheduling of individuals to prioritize those at highest risk, as identified by the CA Department of Public Health (CDPH), to match with testing supply and lab analysis capacity and to prevent on-site congestion
—
work that is facilitated through the Baseline Platform. Our team is working in partnership with local, state, and federal public health officials to rapidly establish a robust public health delivery framework that could extend to other sites.
We’ve learned a lot over the past few days and want to share early results and learnings from our initial screening and testing efforts.*
Pop-up testing sites
We’ve established multiple Bay Area sites, staffed by healthcare professionals and Verily team members, including two large expo centers that facilitate drive through screening and sample collection. In the first days of on-site testing, more than 130 individuals were tested, with over 350 more scheduled for appointments this week. Our lab partners are analyzing the samples, and we expect the results to be available for those already tested in the coming days.
Online triage tool
More than 12,000 individuals have completed the public health screener through the online tool since launch. The screener is dynamic and the criteria may change over time based on epidemiological data and government directives. As we scale testing at these facilities and begin opening new ones, we will be adjusting the triage algorithm in response to CDPH objectives.
This program is meant to reduce the burden on our hospital system and is complementary to testing happening in a clinical care situation. People with acute symptoms need acute triage and should not visit the sample collection sites, as the sites are not prepared to provide medical care.
In order to safely execute each part of our workflow, we are continuing to make improvements and adapt on-site as we learn, while focusing on protecting individual privacy and ensuring safety for the teams. Building on learnings from these critical first few days, we expect an increase in our testing capacity in the coming days. Please check back for updates on the Baseline COVID-19 Pilot Program at
projectbaseline.com/covid-19
.
*
Note, statistics are based on data collected as of Wednesday, March 17, 2020.
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