Patients approve of data sharing and are willing to contribute their medical information to research projects, but according to a group of researchers from the University of California San Diego, there may be some strings attached.
These findings come in the context of the precision medicine and All of Us campaigns, which call for the use of patient data repositories to create targeted treatment approaches to improve care quality. Precision medicine efforts rely on patients being will to share data with medical researchers.
“The finding in this study that most patients were willing to share data from their EHRs and biospecimens with researchers is reassuring,” the researchers wrote. “Not only can biomedical research benefit from these resources but also a multisite learning health care system can continuously advance as a result of data-driven improvements to processes and associated outcomes.”
Overall, patients are willing to participate in precision medicine, but there are some caveats, the UCSD researchers reported in JAMA Open Network. A survey of over 1,200 patients revealed that most are willing to share at least some of their medical information with some interested research groups.
Patients filled out one of four surveys: a simple opt-in survey, a simple opt-out survey, a detailed opt-in survey, and a detailed opt-out survey.
The difference between simple and detailed surveys was the amount of data categories for which the patients outlined their data sharing preferences. Patients completing a simple survey had to opt into or out of sharing in 18 data categories, compared to 59 categories in a detailed survey.
Each survey also asked patients about with which types of researchers they would be willing to share individual survey items, including other researchers within their home organization, researchers at another non-profit organization, and researchers at for-profit organizations.
Overall, 67 percent of all survey respondents said they’d be willing to share all of their data with their own healthcare organizations, and 23.4 percent said they’d share all of their information with any interested research party.
This is good news for the precision medicine movement, which relies on a breadth of patient information for actionable insights, said study senior author Lucila Ohno-Machado, MD, PhD.
“These results are important because data from a single institution is often insufficient to achieve statistical significance in research findings,” Machado, who is also professor of medicine, associate dean for informatics and technology in the UC San Diego School of Medicine and chair of the Department of Biomedical Informatics at UC San Diego Health, said in a statement.
“When sample sizes are small, it is unclear whether the research findings generalize to a larger population. Additionally, in alignment with the concept of personalized medicine, it is important to see whether it is possible to personalize privacy settings for sharing clinical data.”
Seventy-three percent of respondents said they were willing to share their medical information, but selectively. They were willing to share at least one piece of data with at least one type of research group.
Most patients were most willing to share their data with researchers from their home institution, followed by separate non-profit institutions, and then finally with teams at for-profit organizations.
“The reluctance to share data and biospecimens with researchers from for-profit institutions needs further investigation because the category aggregates highly different industries and further refinement might reveal subgroups that have higher association with declining to share than others,” the research team said.
“Strategies to convey how data and biospecimens are being used or will be used for research that includes the development of commercial products to improve health outcomes need to be developed and implemented so that patients can provide consent that is truly informed.”
Additionally, the surveys showed that patients were willing to share some, but not all, of their personal information, which could have implications for research teams accessing patient EHRs.
“This finding is important,” wrote the authors, “because the item to withhold may not be of relevance to a certain study, but the current all-or-nothing option, if chosen, would remove that patient’s data from all research studies.”
The researchers pointed out that there needs to be a more sophisticated mechanism by which researchers can access patient EHRs. A medical record should not be prohibited from a study because the patient has withheld one singular piece of personal data, the team said, especially if that data point is not relevant to a specific study.
IT developers should look for ways to stratify patient data sharing to allow for researcher access to more patient records.
Furthermore, the surveys showed that how a provider asks for patient data access is important. Opt-out forms, which assume patient data access unless a patient says they do not want to participate, are more effective than opt-in.
Additionally, whether the patient used the simple or detailed questionnaire had little impact on whether the patient gave permission to share certain types of medical information.
“This is important because a simple form could be used in the future to elicit choices from all patients, saving their time without significantly affecting their privacy preferences,” said Ohno-Machado. “However, different rates of sharing are expected for opt-in and opt-out of sharing clinical records for research.”
These findings are not a panacea for eliciting patient data sharing, Ohno-Machado said. Instead, they point out contradictions that research teams will need to assess when designing data sharing and opt-in communication protocol.
“Institutions currently make decisions on sharing on behalf of all patients who do not explicitly decline sharing. It is possible that asking patients directly would increase the amount of data shared for research,” Ohno-Machado concluded. “On the other hand, it is also possible that some types of research would suffer from small sample sizes if patients consistently decline certain categories of items.”