Today, medical research and medicine in general are seeking to develop an approach more patient-centered. There is a trend in concepts such as collaborative decision-making, precision medicine or patients having the ability to access their medical records and even to play an active role in their own health.

Indeed, patients can generate data (Patient-Generated Health Data (PGHD)) and can even contribute themselves to better health outcomes. Patients can also improve communication between them and healthcare providers through self-reported data.

1. Patient generated data

Patient-Generated Health Data (PGHD) is characterized as information produced by patients themselves. It is “health-related data created, recorded, or gathered by or from patients (or family members or other caregivers) to help address a health concern”. The notion of Patient-Generated Health Data was introduced by the Office of the National Coordinator for Health Information in the USA.

The primary origin of PGHD is the use of mobile health applications and internet of things such as connected objects, medical and/or wearable devices. The benefits of PGHD are diverse, including improved monitoring of chronic health conditions outside clinical environments. PGHD represents a variety of information, including medical history, treatment records, biometric data, symptoms, and lifestyle choices. Examples include monitoring blood glucose or blood pressure using home health equipment and tracking exercise and diet through mobile apps or wearable devices (watches).

 

2. Self-reported data

Self-reporting is a method used for data collection in epidemiological and medical research. This approach is based on participants answering the researcher’s questions without the researcher intervening directly. Examples of self-reporting methods encompass questionnaires, surveys, and interviews.

Self-reported data may originate from various sources, including social networks or online studies. For instance, platforms like Carenity can conduct surveys directly with patients thanks to their large community of over 500,000 members.

One of the best-known forms of self-reported data are patient-reported outcomes (PROs). PROs are defined by the FDA as “any report of the status of a patient’s health condition that originates directly from the patient, without interpretation by a clinician or any other party.” PRO instruments are validated questionnaires or scales that ask patients to report their symptoms, physical functioning, emotional well-being, preferences and health-related quality of life. (For more information on PROs and how Carenity can help you choosing one, see our article).

 

3. Benefits of patient-generated health data and self-reported data

A patient-centric approach using patient-generated health data and self-reported health data is beneficial because, as the patient is responsible for capturing and recording the data, they decide whether or not to share their health data. It is a prospective approach based on patient explicit consent meaning less complex regulatory requirements and faster access to data (compared to secondary databases), as well as less complex data linkage methods.

Plus, Carenity will soon offer the ability to collect Personal Health Records (PHR) from patients, encompassing a wide range of data including images of prescriptions, medical reports, clinical data, and medication information. These diverse datasets will be consolidated to create a more comprehensive patient profile, integrating complementary information for enhanced understanding and management of individual health needs.

 

4. Real word data

Patient generated and Self-reported data participate to the contribution of real-world data (RWDs). RWDs are data collected on an observational basis rather than as part of a traditional randomized controlled trial.

According to the FDA “Real-World Data (RWD) are the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources”. There are various forms of RWDs such as texts, imaging, and networks from electronic health records, medical claims, data extracted from product and disease registries.

Figure 1: RWD potential sources

Real-world data (RWD) serve a variety of purposes, including acting as historical controls and reference groups in controlled trials. They constitute a valuable and extensive source of data, offering a cost-effective alternative to conventional clinical trials for data collection.

When appropriately utilized and analyzed, RWD have the potential to generate reliable and unbiased real-world evidence (RWE). This evidence encompasses clinical insights into the usage, as well as the potential benefits or risks, of medical products. It is derived through thorough analysis of RWD, providing valuable insights into real-world healthcare scenarios.

 

Conclusion

Patient-Generated Health Data (PGHD) holds significant potential for facilitating the delivery of an efficient and patient centered care according to the National Academy of Medicine, in addition to the possibility to increase patient awareness. Patient reported outcomes (PROs) also permit to improve patient care through assessing the real-life experiences of the patients.

Real-world evidence (RWE), as clinical evidence, can be generated and is useful throughout the full drug development cycle. RWE can play a role during the drug development phase, to enhance the comprehension of diseases by integrating the patients’ perspective. Obviously, during the Health Technology Assessment phase and the access phase, RWE can permit to have a deeper perspective about the management of a disease and various treatments. And, even in the post-access phase, to evaluate whether and how a new treatment, once integrated into a healthcare system, fulfills its objectives.

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