Contributed by Joshua Grill, PhD
An article in the October 3 New York Times highlights recent developments in providing patients legal access to their medical records. Brought about by the 21St Century Cures Act, this effort aims to remove barriers to citizens having access to their own health data. Implementation of the 21St Century Cures Act essentially mandates that medical test results be made available through electronic health records in near real time, giving patients access almost immediately to their health information without context. This is producing challenges for clinicians and their practices.
Some of these challenges were highlighted in a 2021 article related to presymptomatic testing for Huntington’s disease, an inherited fatal neurological condition for which genetic tests can determine whether a person will someday develop disease. UCI MIND investigators recently contributed to another article, working closely with colleagues in the Alzheimer’s Clinical Trial Consortium to outline key challenges related to use of the electronic health record and the conduct of preclinical Alzheimer’s disease (AD) trials. These studies test promising therapies for their ability to slow or delay onset of cognitive problems in people determined to be at increased risk based on biomarker tests. At the core of the issues in these papers is the reality that some test results (gene tests for HD and biomarker tests for AD) need to be delivered with sensitivity and compassion by a trained clinician. If patients receive alerts through apps that results are available at the same time that the clinician who ordered the test is first able to access the result, it can circumvent the traditional approach of having a skilled clinician interpret, disclose, and explain that result to the patient. Doing so brings risk of misinterpretation or misunderstanding by patients and could have serious negative implications for patients’ health and well-being.
These concerns are particularly relevant to test results that could be perceived as “bad news” and diseases that may be fatal and/or considered “sensitive diagnoses” because of risk for stigma and other challenges that accompany disease. AD, of course, meets both of these criteria.
Clinically, the field will grapple with these issues in the years to come. The need for timely diagnosis and the availability of tools such as blood tests will magnify the importance of the debate. In some settings, it may be perfectly acceptable to get AD biomarker results without a clinical interaction. Yet, in other cases results may be ambiguous, conflict with other information, or at minimum bring a host of important questions that require expert interpretation and answers.
In the research setting, placing study test results in the electronic health record may create opportunities to enhance participant safety; for example, by making some results available to Emergency Room physicians, so that these clinicians know how best to treat a person enrolled in a study who comes for an emergent visit. But there are also many risks that come from including research test results in the medical record. These include inadvertent unblinding of study information (placing the integrity of the study at risk), unwanted disclosure of personal results (placing a person’s autonomy at risk), and inappropriate labeling of patients that could carry stigma or affect the quality of their care.
Progress in AD and other fields necessarily brings new challenges. Research identifies these challenges, tests solutions, and leads to improvements in clinical practice. The approach to AD clinical practice will be reimagined in the coming years. Research will lead the way to improve this care through new treatments and technologies but must also address the appropriate use of these tools and protect the interest of the people who make these advances possible by participating in studies. In the end, this will benefit millions of people who receive the best possible care.