Real World Voice Allows Patients to be Part of the Cure

By Claire Harter

“The patient wants to be a partner in cure, just as with their doctors they want to be a partner in care.” – John Linnell, COPD Patient Advocate, talking about health literacy, eyeforpharma virtual conference, 4/14/2020

Where and how can patients partner with pharma for a cure? Where can pharma go to learn from patients about the patient experience?

One resource is Electronic health records (EHRs). As a resource, they provide critical information about patient diagnosis and treatment. But, EHRs reflect the healthcare provider’s point of view. EHRs are a provider’s interpretation of diagnostic findings and a highly filtered version of what a patient said during a very short encounter.

Though convenient for quantitative studies of health care trends because of the volume of data collected in them, EHRs lack the patient perspective required by the 21st Century Cures Act to inform FDA treatment approvals. For example, Ivan Cheung, Chairman of Eisai, noted in his keynote address at the eyeforpharma Philadelphia virtual conference last week, that patients with early signs of Alzheimer’s disease “…don’t bring up symptoms during primary care physician visits (PCPs) and may not share memory-related issues even if the PCP proactively asks.” These symptoms will not be recorded in an EHR. What is needed are data sources of patient-centric authentic experiences that can be analyzed to inform FDA approvals. A combination of data sources is optimal.

Patients may present a more realistic picture of patient lexicon and health literacy outside the office and away from the physician. Use of sociolinguistic research tools which analyze patient conversations with their peers can maintain privacy and obtain information that differs from what is said, and not said, during an office visit.

Think of this the way historians have pieced together the lives of people during the founding of the US. Abigail Adams, a prolific letter writer, provided historians with a glimpse of day-to-day living during those times through her correspondence. In a similar way, patient online communication can provide necessary information that is lacking elsewhere.

Patient experience data IS available but it is not in the EHRs and it is not in clinical trial data. It is continuously taking place outside the medical context in the form of peer-to-peer conversation, online. It is occurring naturally and because of that, it is close to the reality of what is actually happening in people’s lives.

At the Virtual ISPOR 2020 conference, being held virtually on May 18-20, Inspire and FDA will take the stage to discuss recent research on chronic pain. Supported by a grant from FDA, Inspire research analysts used in-house Natural Language Processing (NLP) toolkit to parse, analyze, and extract metadata from patient-generated text on Inspire and open social media. Combined with iterative and hands-on sociolinguistic analysis, the research team identified patient trends and actionable insights about what people living with chronic pain are actually experiencing in the US.

Real World Voice, the sociolinguistic analysis of communication between patients, adds the patient perspective to the body of evidence; it does not subtract from what is obtained in a study of EHR or from data obtained through randomized control trials. In fact, it enables more patients to directly contribute to the body of scientific evidence, and creates a holistic body of evidence enhancing and explaining what can be learned through quantitative clinical trials and analysis of patient records.