The February 2019 issue of the Journal of the American Medical Informatics Association (JAMIA) features a study using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), which SemanticBits developed for the National Cancer Institute’s Division of Cancer Control and Population Sciences (NCI-DCCPS).
PRO-CTCAE is a patient-reported outcome measurement system that directly captures treatment side effects—also known as symptomatic adverse events (AEs)—experienced by patients on cancer clinical trials. The JAMIA article, “Patient free text reporting of symptomatic adverse events in cancer clinical research using the National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)”, is a collaboration among researchers from the National Cancer Institute, University of North Carolina School of Medicine, Mayo Clinic, Harvard Cancer Center, Winship Cancer Institute at Emory, Memorial Sloan Kettering Cancer Center, Duke Cancer Institute, and SemanticBits.
The study asked clinical trials patients to complete surveys in PRO-CTCAE regarding side effects from their cancer treatment. Patients were asked about specific side effects but were also able to type in additional adverse events in a free text box. Through extensive user research, SemanticBits developed and refined the free text box so that it would capture and save exactly what the patient typed, but would also use advanced mapping logic to suggest mappings of free-text to side effect terms from the PRO-CTCAE library and the Medical Dictionary for Regulatory Activities (MedDRA). 1760 patients participated in the study, of which 1024 entered supplemental information. Of those that used dropdown terms, a third could be mapped to the PRO-CTCAE and the remaining to MedDRA.
The study confirmed the feasibility and benefit of providing patients with a text box that maps to existing terminology. This functionality will enhance the ability to accurately capture the side effects experienced by patients during treatment. More information about the study can be found at JAMIA.