Can Patients Accurately Report Their AEs?


A recent study aimed to evaluate whether patients were willing and able to report their adverse events while on a clinical trial.

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.

Related Videos
Meaghan Mooney, B.S.N., RN, OCN, during the Extraordinary Healer interview
Colleen O’Leary, DNP, RN, AOCNS, EBP-C, LSSYB, in an interview with Oncology Nursing News.
Michelle H. Johann, DNP, RN, PHN, CPAN, WTA, in an interview with Oncology Nursing News explaining surgical path cards
Jessica MacIntyre, DNP, MBA, APRN, NP-C, AOCNP, in an interview with Oncology Nursing News
Andrea Wagner, M.S.N., RN, OCN, in an interview with Oncology Nursing News discussing her abstract on verbal orders for CRS.
John Rodriguez in an interview with Oncology Nursing News discussing his abstract on reducing nurse burnout
Alison Tray, of Hartford Healthcare, discusses her team's research on a multidisciplinary team approach to manage the cancer drug shortage
© 2024 MJH Life Sciences

All rights reserved.