To continue to support data-driven improvement and to expand the capacity of the Cystic Fibrosis Learning Network (CFLN) to conduct real-world research, the Cystic Fibrosis Foundation has invited the University of Virginia to serve as the Cystic Fibrosis Learning Network Data Management and Reporting Core (DMRC).
UVA has assembled a team of clinicians, analysts, biostatisticians, and coordinators to lead, develop, and maintain data systems supporting the activities undertaken by the CFLN. This group has extensive expertise in quality improvement (QI), steered by Dana Albon, MD, MS, a pulmonologist and director of UVA Adult Cystic Fibrosis Clinic, including QI data collection, which includes analysis and reporting, manuscript writing and publication. The team also includes Beth Horton, PhD, Shiyi Shen and David Brighton in the Department of Public Health Sciences who have significant expertise in data management, analysis, and reporting.
In addition, this group collaborated on a CFLN-related project, sponsored by CFF, related to CFLN ILab outcome data. A strength of this group is the ability to collaborate and engage in CFLN work with other statisticians in the biostatistics department at UVA if additional staff is needed for additional projects sponsored through CFF for CFLN-specific collaborative projects.
The Cystic Fibrosis Learning Network seeks to advance an existing initiative to accelerate the rate of improvement in CF care. A total of 37 CF care programs across the United States currently participate in the CFLN, representing the clinical care of over 20% of people with CF in the United States. Participating teams contribute to multiple collaborative improvement initiatives. Some of the past CFLN representative QI initiatives were related to recognizing pulmonary function indicators of potential exacerbations, successful administration of multidisciplinary telehealth visits, and some ongoing initiatives are assessing shared agenda setting with patients and family caregivers for upcoming clinic visits, and gathering data from patients about their health-related quality of life.
Measures of timely data entry, multidisciplinary visits, and coproduction, considered foundational to the CFLN, continue to be collected and used to inform network improvement activities. Subsets of programs are engaged in multi-site innovation labs to test interventions related to using highly effective modulators and improving patients’ health-related quality of life. All CFLN programs are testing processes to collect patients’ self-identified race and ethnicity. Subsets of programs in the CFLN are also testing remote monitoring processes (CFF Tools for Remote Monitoring Award), including home spirometry, microbiology cultures, use of applications to facilitate daily care reminders and early identification of changes in symptoms, and remoting screening and intervention to address social factors.
CFLN Data Management and Reporting Core Team Leaders
Dr. Horton, is an associate professor in the in the School of Medicine’s Department of Public Health Sciences Division of Translational Research & Applied Statistics. Dr. Horton will function as the DMRC lead statistician. She has a wealth of experience as the lead biostatistician on more than 20 multidisciplinary clinical trials, leading trial design development, protocol writing and variable selection for database development, routine report generation, data analysis, and manuscript writing. Dr. Horton will oversee all core statistical activities, including the creation of existing reports, QI procedures, data analysis, and development of databases for new reports, and participate in CFLN meetings. As the lead statistician, she will oversee the statistical team, the measure creation and operational definitions, data analysis, interpretation, /visualization, and data maintenance.
Dr. Albon, an associate professor in the Department of Medicine’s Division of Pulmonary Critical Care and the PI of the study, will function as the data core chair. She is responsible for the strategic direction of the core, leading the data team, and collaborating with CF Foundation Patient Registry Operation and Research teams, CF Patient and Family Experience of Care team members, quality improvement specialists, and the CFLN leadership team. The research is supported by a $1.18 million grant awarded to Dr. Albon.