Over the past two decades, there has been increasing focus on the patient’s perspective when they are undergoing a prescribed treatment. When that patient’s perspective is captured directly from the patient without interpretation by a clinician or anyone else, it is considered a “patient-reported outcome.” While the biological benefit of a treatment may be measured with survival time and biomarkers, incorporating patient-reported outcomes like quality of life or functional status allows for a more complete assessment of the intervention being studied. For example, a new drug may decrease the risk of death from a disease, but patient-reported outcomes could reveal that it is associated with severe side effects that prevent a patient from functioning independently, which would limit the drug’s usefulness.
Patient-reported outcomes sometimes conflict with biomarkers, physiological outcomes, or clinician-reported outcomes. In many respiratory diseases, such as asthma and chronic obstructive lung disease, the results of pulmonary function testing rarely match a patient’s perception of their quality of life. In some cases, patient-reported outcomes are the only way to judge an intervention when biological measurements are limited or unavailable, such as if a medication is effective at improving shortness of breath or exercise tolerance.
This self-reporting of health information, both in research studies and more broadly through the use of wearable devices and mobile apps, has raised the question of data ownership. Unlike owning a car or house, data—especially health data—is often “owned” by several different individuals and organizations at the same time, such as the patient, their healthcare team, and the pharmaceutical company who performed a study that the patient participated in. Although the HIPAA Privacy Rule governs how hospitals and physicians must handle patient requests for their own health information, these rules do not always extend to other companies such as drug companies, mobile applications, wearable devices, or commercial genetic testing platforms. Data ownership is a complex and continuously evolving topic in medicine, and must be balanced with the need to continuously improve medical care by using patient data to perform research.
Patient-generated health data are becoming more commonplace, and are now being used in patient-reported outcomes, leading to questions about data ownership. As more research studies include patient-reported outcomes, study outcomes are able to be applied to more patients, leading to broader adoption and better patient engagement. By incorporating the voices of patients and their caregivers throughout the research process, patient-centered outcomes research can ensure that therapies and interventions improve both patient and disease outcomes and equalize shared decision making between the patient and their healthcare team.
