Can Patients Accurately Report Their AEs?

Tuesday, February 28, 2017
A group of US researchers conducted a study to determine if patients enrolled in clinical trials are willing and able to report symptomatic adverse events (AEs). Historically, this data has primarily been collected and documented by healthcare providers.

Patients enrolled in 1 of 9 multicenter clinical trials were eligible to participate, and 285 patients self-reported 13 common AEs using an adaptation of the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE). Patients entered their responses on tablet computers during 5 successive clinic visits. Patient adherence was tracked with reasons for missed self-reports. Agreement with clinician AE reports was analyzed, and patient and investigator perspectives were surveyed.

Across all patients and trials, there were 1280 visits during which patients had an opportunity to self-report; self-reports were completed during 1202 visits (93.9% overall adherence). Adherence was highest at baseline and declined over time because of staff forgetting to bring tablet computers to the patient, patients feeling ill or declining to enter data, or internet connectivity issues.

Patient–investigator CTCAE agreement was moderate or worse for most symptoms, with investigators reporting fewer AEs than patients across symptoms. Most patients found the system was easy to navigate and useful, and investigators noted that the patient-reported AEs were helpful and accurate.

The researchers concluded that patients in clinical trials are able to report their own AEs and report more AEs than clinical trial investigators, and note that patient reporting may improve clinical trial data collection. The study findings are available here.

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Lisa Schulmeister, MN, RN, ACNS-BC, FAAN
Blog Info
Lisa Schulmeister, MN, RN, ACNS-BC, FAAN is an oncology nursing consultant and editor-in-chief of Oncology Nursing News.
Author Bio
Lisa Schulmeister, MN, RN, ACNS-BC, FAAN, is the Editor-in-Chief for OncLive Nursing. She is an oncology nursing consultant and adjunct assistant professor of nursing at Louisiana State Health Sciences Center in New Orleans, LA. She provides continuing nursing education to nurses across the Unites States, is active in several professional nursing organizations, and is intrigued by the many ways nurses use technology to communicate.
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