Analysis of patient-generated data gives FDA insight into the patient experience

What can social media data and archival data reveal about the patient experience?

The 21st Century Cures Act, signed into law by President Barack Obama in December 2016, expanded the ability of the Food and Drug Administration (FDA) to use real-world evidence—including the patient perspective—to accelerate the development of new drugs, medical products, and therapies. The Act strengthened the FDA’s efforts to incorporate patient engagement and perspectives in the agency’s decision-making processes.

To help the FDA refine a method of collecting patient-generated data and acquire new insights into patient perspectives, Inspire and FDA researchers partnered to conduct two observational pilot studies. The goal was to assess methodologies on differing unstructured data sources. Research findings appeared in the July 2020 issue of Research in Social and Administrative Pharmacy (RSAP).


Observational study #1 focused on opioid use disorder (OUD). Researchers analyzed FDA archival data from public docket comments and compared the information to OUD online blogs and forums. 


Observational study #2 focused on a rare condition called pulmonary arterial hypertension (PAH). This condition causes high blood pressure in the lungs. Researchers analyzed FDA patient-focused drug development (PFDD) meeting transcripts and online user-generated content posts about PAH shared on Inspire, an online healthcare support community for patients and caregivers.

Project focus: Utilize social media data and archival data to understand patient perspectives on OUD and PAH

Researchers applied observational and social science methodology to social media (a new data source) and FDA public archival transcripts (an old data source). Public archive data included public docket comments shared by patients and participants at FDA advisory committee meetings and listening session transcripts.

Inspire solution: Mine data from community forums and archived data to identify patient experience themes related to OUD and PAH

Understanding the patient perspective requires the systematic gathering of patient experience data to learn more about the impacts of diseases, their treatments, and patient preferences for treating specific diseases. Patient experience data may come from patients, family members, caregivers, patient advocacy groups, disease research foundations, researchers, and drug manufacturers.

Observational study #1 (opioid use disorder) methodology

To conduct the observational study on opioid use disorder, researchers:

  1. Searched for and selected three active online OUD discussion forums and three OUD blog websites.
  2. Analyzed the 10 most recent threads on the discussion forums. 
  3. Analyzed the five blog posts with the most comments about medication-assisted treatment, as well as the top-10 user comments. 
  4. Identified 66 unique comments from FDA PFDD meeting transcripts.
  5. Coded each data set using a uniquely developed codebook.
  6. Imported data into NVivo 11 qualitative analysis software to generate a report for all coded text.

Observational study #2 (rare disease/PAH study) methodology

To conduct the rare disease observational study on pulmonary arterial hypertension, Inspire and FDA researchers:

  1. Identified 889,413 PAH-related posts across multiple Inspire communities, and narrowed them down to 1,813 posts from 1,087 users specifically addressing the PAH patient experience.
  2. Analyzed transcripts from the FDA’s PFDD meeting on PAH and the meeting’s Voice of the Patient summary report.
  3. Coded the data sets using a uniquely developed codebook.
  4. Created a topical model to analyze treatments, symptoms, and quality of life.
  5. Completed a linguistic analysis to compare the dataset results to the original FDA archived transcripts.

Inspire findings: Key themes related to the OUD and PAH patient experience

Both studies mark an innovative approach to analyzing data that previously existed in an unstructured narrative form. In particular, the PAH (rare disease) observational study was the first of its kind to transform narrative data into meaningful data by mining both unstructured archival data and social media data. The qualitative analysis highlighted correlations between online social media users and archived data. 

The two studies enabled researchers to refine well-established qualitative research methods to better understand the patient perspective. The exploratory methods identified new information resources and social context variables. This approach provided greater awareness of the unique needs of people living with rare or stigmatized conditions.

Observational study #1 (opioid use disorder) findings

The final discussion forum and blog site sample included 519 comments from 230 unique users. Researchers identified seven common patient experience themes:


Withdrawal: Online community members sought advice on managing withdrawal symptoms. FDA archive posts focused on non-FDA-approved treatments for managing withdrawal symptoms, such as kratom and marijuana.


Side effects: Online community posts, as well as FDA archives, showed users sought advice on side effects of medication-assisted treatments.


Stigma: Data revealed that patients often faced stigma when seeking treatment, including feeling stigmatized by their healthcare providers. 


Social support: Patients noted the importance of having the emotional support of a virtual community. Equally important was informational support to manage withdrawal symptoms and side effects, and appraisal support for achieving recovery milestones.


Treatment costs: Patients noted the cost of medication-assisted treatments as one reason they stopped treatment. 


Treatment discontinuation: Medication side effects and costs often led to the discontinuation of treatments.


Non-FDA-approved therapies: Patients shared information about how to taper off the drugs and the use of non-FDA-approved alternatives, such as marijuana.

Observational study #2 (rare disease/PAH study) findings

The FDA archived data analyzed narratives from 27 patients. The social media data analyzed 1,813 posts from 1,087 users focused specifically on the PAH patient experience.

Researchers identified these five patient-experience themes:


PAH perceptions: Patients stressed that the disease needs more attention, including research and education. They also noted that PAH often isn’t given priority when other comorbidities exist.


Symptom knowledge: Patients with more than one condition were often unclear as to which condition was causing their symptoms.


Treatment options: Patients prefer holistic treatments that incorporate medications, lifestyle changes, oxygen, and other therapies to improve quality of life.


Treatment barriers and successes: Patients cited access to treatments, costs, and side effects as barriers to care. They measured success in terms of improving quality of life.


Quality of life impact: Patients noted a loss of independence that correlated to a loss of purpose.

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