Integration of patient-generated health data into safety and efficacy studies

Integration of patient-generated health data into safety and efficacy studies

In this article, Alison Bourke, Scientific Director of the Center for Advanced Evidence Generation at IQVIA Health, explores how digitally connected active and passive data sources are shaping the development of patient-centered treatment and care.

The evolution of connectivity in healthcare over the past decade has been a milestone in patient care. Connected medical technologies and Channels for Patient Reported Outcomes (PRO) have served as the foundation for a shift towards a patient-centered approach in medicine. This allows individual patients to shape and influence their personal experience of care and treatment, as well as their overall health and well-being. Additionally, as in-person visits almost came to a halt during the COVID-19 pandemic, these technologies have proven to be critical tools for continuing care and communication between patients and providers.

The proliferation of connected medical technologies is expected to increase as the devices themselves become more sophisticated and accessible – and the transition to patient-centered care will continue. However, the value of these devices to individual patients is only the beginning in terms of their potential in this space. Technology quickly turned every patient care experience into an opportunity to collect Patient Generated Health Data (PGHD).

Definition of patient-generated health data (PGHD)

The obvious definition of PGHD is data that is generated by the patients themselves rather than recorded by a member of a healthcare team. PGHD understands patient interactions, outcomes and side effects with existing treatments. It can also incorporate contextual information, such as demographics, environmental conditions, behaviors, and general health. These data points range from actively reported patient information, such as quality of life surveys, to data passively collected from sources such as wearable devices and smartphones. A third, but less used, data source is information that was previously recorded for non-medical purposes; for example, people can provide access to their grocery records to provide insight into their diet.

Epidemiologists see the value of collecting PGHD, as it can help them gain person-centered information that is not otherwise readily available in routine health data sets. This includes information such as whether patients followed a prescribed treatment plan as directed and, if not, why. Accessing patient-provided data outside of clinical settings enables the collection of more diverse datasets, with greater frequency and continuity than would otherwise be available or practical in a more traditional healthcare setting.

PGHD can help epidemiologists reduce bias and minimize false conclusions that might arise from misclassification, unrepresentative patient cohorts, and missing data. The incorporation of PGHD creates a more holistic picture of real-world results that allows researchers to not only draw more precise conclusions, but also explore questions they might not otherwise have asked.

The accuracy of compliance data when taking prescriptions as written is particularly important when assessing the effectiveness and safety of medications. PGHD allows researchers to ask if the patient has taken the drug and, more importantly, to determine the reasons why they are not taking it as directed or if they stop completely. Enriched information on the use of off-label and over-the-counter or herbal medicines can also be …

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