Asking and Answering Questions with Patient Data
Biomedical research requires large amounts of patient data to study links between risk factors and health outcomes and to gain insights into the diagnosis and treatment of disease.
In the case of sepsis — the leading cause of hospital deaths in the United States — the findings from a recent large-scale retrospective data analysis showed an increase in mortality for each hour sepsis treatment was delayed–an important factor in the Surviving Sepsis Campaign’s (SCC) move from a three-hour sepsis treatment bundle to a one-hour bundle in 2018.1
While the study provided important insights into the early mechanisms of sepsis, the change to a one-hour bundle also raised questions about the rapid administration of antibiotics without a definitive diagnosis of sepsis; in effect, underscoring a potential gap in medical science’s understanding of the physiological factors that lead to sepsis.2
Gaining insights into those factors might require obtaining data from populations with both known risk factors for sepsis as well as data from cohorts of otherwise healthy populations. But why and how would people donate their health data for such a study?
Increasingly, data donation, often defined as a form of “health-related altruism”– particularly in the case of high-mortality conditions such as sepsis–has become a timely, if not pressing, issue in this era of data-driven medicine.3
An Untapped Well of Health Information
The widespread conversion to electronic medical records (EMR) in hospitals, along with data from pharmaceutical clinical trials, insurance claims, mobile health apps, etc., has created vast amounts of patient data. Coupled with machine learning technologies that can rapidly aggregate and analyze large-scale data sets, the opportunities for expanding medical knowledge are potentially endless.
Yet, while medical researchers often use and share anonymized patient data, the concept of donating personal EMR and genetic data for medical research is complicated by legal, social, and ethical considerations, including regulations governing protected health information, as well as concerns over the potential consequences of the data being used in unforeseeable ways.3,4 While countries of the UK and several others maintain various types of donor biobanks—for both public health and commercial purposes–there are limited opportunities to donate data in the United States. For example, the National Institutes of Health “All of Us” data donation program, instituted in 2015, still faces many data collection and analysis challenges.5
Lessons Learned from Blood Donors
Based on their altruistic motivations, blood donors have been suggested as an appropriate group for recruiting healthy populations for medical research.6 Unlike blood and organ donations, however, there are few formalized regulatory or philanthropic frameworks for donating medical data voluntarily in the United States.3 In contrast, Finland’s Biobank Act of 2012, which provides a legal framework for the donation of human biological samples for medical research and product development and its Blood Service Biobank (BSB) is unique among nations.6 The “trustworthiness” of the BSB is cited as a key factor in its success. 6
Blood Donors Want to Give Back
“Everyone who donates has been touched by family members, friends, surgery, or accidents, and wants to give back,” said Lynne Briggs, vice president and chief information officer for Versiti Blood Center of Wisconsin, part of a group of blood donation centers in the Midwest. In addition to appealing to a donor’s sense of altruism, Ms. Briggs cites other factors that may encourage blood donations, such as placing donor centers close to where people live, use of social media and marketing, and the availability of “thousands of blood drives happening on a daily basis.” Versiti donors undergo a brief screening process mandated by the U.S. Food and Drug Administration (FDA) that includes a health history questionnaire and a brief physical exam. While blood donations are not covered by Health Insurance Portability and Accountability Act (HIPPA) privacy regulations, Ms. Briggs, stresses that Versiti makes every effort to maintain the privacy of patients; sharing of medical information is done only on a “need to know” basis, such as a positive HIV test.
“We work very hard to make people with needed blood types (such as O negative) know how special they are,” she said. “We let them know are they are needed.
A Starting Point
According to research, participation in biobanks is strongly influenced by the way a potential participant interprets the social and institutional context of the request. 6 Examining the blood donation system in the United States is an important starting point for understanding the potential motivations and processes for biobanking the United States. These include instilling a sense of trust in the system, engaging donors on a regular basis where they live and work and appealing to individuals on a personal level about the importance of “giving back” for medical research–and the for the good of everyone.
1. Time to Treatment and Mortality during Mandated Emergency Care for Sepsis, NEJM, June 2017. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5538258/pdf/nihms882574.pdf Accessed December 30, 2019.
2. Recent Advances in Understanding and Managing Sepsis, F1000Research, Open Access, 2018. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6173111/
3. “The Ethical Medical Data Donation: A Pressing Issue”, The Ethics of Medical Data Donation, Copyright 2019. https://www.springer.com/gp/book/9783030043629Accessed December 30, 2019.
4. The Tricky Ethics—and Big Risks—Of Medical ‘Data Donation’, The Advisory Board, July 2018. https://www.advisory.com/daily-briefing/2018/07/18/personal-dataAccessed December 31, 2019.
5. The “All of Us” Research Program, NEJM, August 2019. https://www.nejm.org/doi/full/10.1056/NEJMsr1809937Accessed December 31, 2019.
6. Attitudes of Blood Donors to Their Sample and Data Donation for Biobanking, European Journal of Human Genetics, May 2019. https://www.nature.com/articles/s41431-019-0434-1