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Using Self-Reported Patient Data to Advance Lung Disease Care

The Pulmonary Fibrosis Foundation is leveraging self-reported patient data to support clinical care and research for pulmonary fibrosis and interstitial lung diseases.

Shania Kennedy
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Published: 03 Oct 2022

Lung disease is a significant source of morbidity, mortality, and financial burden in the United States. However, those working to advance patient care and research in this area posit that many of the hurdles faced by patients, families, and caregivers are not adequately measured and that self-reported data is crucial to answering key questions for those living with interstitial lung disease (ILD).

ILDs, a group of conditions characterized by progressive scarring of lung tissue, can be particularly debilitating for patients and their families. Pulmonary fibrosis (PF) is one of the most common ILDs, affecting an estimated 207,000 patients in the US, with approximately 58,000 new cases diagnosed each year, according to the American Lung Association.

Junelle Speller, vice president of the Pulmonary Fibrosis Foundation (PFF) Registry, is one advocate for the use of self-reported patient data for advancing ILD and PF care. In July, the foundation launched the PFF Community Registry, a subset of its PFF Registry, focused on collecting data via online surveys of patients with PF or ILD, their caregivers and family members, and lung transplant recipients previously diagnosed with PF or ILD.

“The PFF Community Registry gives participants the opportunity to provide vital information that will impact current and future patients with PF or ILD, their families, and caregivers,” Speller stated in an email interview with HealthITAnalytics. These self-reported data, she posited, are critical to advancing clinical care for future lung disease patients.

THE ROLE OF SELF-REPORTED DATA

Self-reported data is, as the name suggests, information about an individual that that the individual reports for analysis or research purposes. Self-reported data is a type of real-world data which is particularly useful for research and clinical care as it can provide key insights into specific populations, diseases, and care strategies that may not be well represented otherwise.

In the case of the PFF Community Registry, these self-reporters are PF and ILD patients, their caregivers, and their loved ones. A major challenge for lung disease patients and those around them is combating the various burdens of such a diagnosis.

These burdens are mainly medical, and much research has been invested in alleviating the medical strain of lung disease. Still, the financial, emotional, and community-based burdens are not always given the same attention. However, advocates such as Speller note that these challenges significantly impact patients after a lung disease diagnosis and must be measured accordingly to inform future interventions.

To address this, PFF launched its Community Registry, which is made up entirely of self-reported data, Speller stated.

MARRYING SELF- AND PROVIDER-REPORTED DATA

The Community Registry is part of a larger research initiative, the PFF Registry. The PFF Registry also includes another database known as the Patient Registry.

“The PFF Patient Registry launched in 2016 by collecting physician-reported medical information from more than 2,000 patients who obtain care at some PFF Care Centers across the country,” Speller explained. “Data collected includes demographics, medical and family history, diagnosis and comorbidities, medications, lab, and other test results, medical events, blood sample[s], HRCT scans, and patient-reported outcomes.”

In July, the PFF Registry expanded to introduce the PFF Community Registry to provide a more comprehensive look at patients and their communities.

These registries provide additional insights because being included in them does not require patients to follow particular treatments, take additional medications, or receive further medical care outside of what is prescribed by their providers, Speller noted. Those requirements, which are present in other data collection efforts, can limit participation by people in underserved populations.

“There is no limit to the number of participants who can join the PFF Community Registry, and participants can receive care anywhere in the U.S., giving researchers access to more participants and, ultimately, more data. The types of data collected in the Community Registry align with the Patient Registry except for the collection of blood samples and HRCT scans,” Speller said.

Together, the two databases are designed to provide a wealth of data on PF and ILD and advance the initiative’s goal of improving diagnosis, care, and outcomes for these diseases.

USING THE REGISTRIES TO ADVANCE PATIENT CARE

Collecting comprehensive data is an important first step to improving any aspect of healthcare but putting that data to use is crucial. Data from the PFF Registry, including the Community and Patient databases, are already seeing interest from academia and the industry to bolster advances in patient care and outcomes.

Participants in the PFF Community Registry complete informed consent forms online, then fill out surveys and screenings via a secure web portal. These surveys “include questions about education and employment, patient-reported outcomes related to quality-of-life metrics, and participation in support groups,” Speller explained. From there, participants are asked to complete follow-up surveys every six months to capture any changes in this information.

Participants are also invited to be a part of optional sub-studies, which examine more specific issues that may be relevant to them, such as those evaluating specific diagnoses or lifestyle factors like military service.

So far, the PFF Registry’s data has already seen significant use among various stakeholders, Speller stated. PFF data has been or is being used for research on characteristics of patients selected for transplants, outcome differences based on sex, race, or smoking status, characteristics associated with people using supplemental oxygen, and effects of anticoagulants on survival in patients with ILDs.

Examples of research efforts using PFF Patient Registry data include the PROLIFIC Consortium.  

“Now in its second year, the PROLIFIC Consortium is comprised of 12 industry partners and two foundations, including the PFF, working to cooperatively develop and validate tests that can detect biomarkers in patients with PF and ILD utilizing blood samples from the PFF Patient Registry," Speller said. "To date, PROLIFIC is studying 12 potential biomarkers of [idiopathic pulmonary fibrosis] in four categories: epithelial damage, fibrosis, inflammation, and thrombosis. This year, researchers will screen blood samples from the PFF Patient Registry to identify and validate blood protein biomarkers.”

Patients from the PFF Registry are also participating in the PRECISIONS trial, a project applying precision medicine principles to diagnosing and treating idiopathic pulmonary fibrosis (IPF). The trial aims to determine whether the over-the-counter supplement N-acetylcysteine (NAC) can treat people with IPF who have a specific gene variant.

PFF has also utilized the data to improve patient care within its own network.

“Investigators recently utilized data from the PFF Patient Registry to examine differences in patient outcomes across the PFF Care Center Network,” Speller stated. “A poster was presented at the May [American Thoracic Society] conference suggesting that site-level variation exists with respect to key clinical outcomes for patients with ILD managed at PFF CCN sites. This research supports further investigation to identify practice patterns and resources that are associated with improved patient outcomes.”

The use of self-reported data is a key part of the solution for PF and ILD, Speller concluded.

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