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.
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.