For a study, researchers sought to describe the design and lessons learned for the Pediatric Palliative Care Research Network’s Shared Data and Research (SHARE) project, a multicenter prospective cohort study of children receiving pediatric palliative care (PPC) and their parents, and to describe key features of this system, with specific considerations for future study design.
The SHARE trial included 643 PPC patients and up to two of their parents who registered at seven children’s hospitals across the United States between April 2017 and December 2020. Data on demographics, patient symptoms, objectives of care, and other variables were acquired directly from parents or patients at six-time points over a 24-month period and electronically recorded in a centralized place. Primary gathered data was connected to administrative hospitalization data encompassing diagnosis and procedure codes and other data elements, using medical record numbers. Linking primary and administrative data; centralized availability of multilingual questionnaires; electronic data collection and storage system; time-stamping of instrument completion; and a separate but connected study administrative database used to track enrollment are all important features of the data infrastructure.
When creating their data management system, investigators conducting future multicenter prospective cohort studies can consider aspects of the data architecture we describe.