Patient Self-Reporting of Adverse Events Feasible and Highly Informative

A new study demonstrates the feasibility of patient self-reporting of adverse events (AE) using computers at their care sites both during and after treatment. In a recent study that involved 152 lung cancer patients at 226 study sites, compliance was high, patients submitting their AE data at 86 percent of visits. Kevin Stephans, MD, associate staff in Cleveland Clinic Cancer Center’s Department of Radiation Oncology, co-authored the study published in the International Journal of Radiation Oncology.

“Earlier studies have shown that having patients directly report on adverse events actually improves both the reliability and the precision of this kind of the important information,” says Dr. Stephans.

While clinicians use the National Cancer Institute’s (NCI) Common Terminology for Adverse Events (CTCAE) for standardized reporting of adverse events during clinical trials, the NCI has developed a library of patient-reported outcome items to supplement the CTCAE. Known as the PRO-CTCAE™ (Patient-Reported Outcomes CTCAE), it includes adverse events that are amenable to patient self-reporting. When patients self-report information about a certain adverse event, they submit data on its frequency, severity and interference with their daily lives.

Study design

Between February 2012 and October 2013, 152 lung cancer patients enrolled in NRG’s Oncology Radiation Therapy Oncology Group (RTOG) 1012, a national clinical trial, joined the study about patient self-reporting of AEs. RTOG 1012 is a trial designed to evaluate the effectiveness of using Manuka honey prophylactically to reduce esophagitis-related pain during chemoradiation. The 152 participating patients were randomly assigned to receive liquid honey, a honey lozenge or placebo during treatment.

Each of the 226 participating clinical sites had a clinical research associate who had been trained to educate patients to self-report their AEs using either wireless tablets or waiting room computers.

Participant patients had six opportunities to self-report their AEs, first at a baseline visit, then at four weekly visits thereafter, and finally at one post-treatment visit twelve weeks after the baseline visit.

Researchers identify obstacles, next steps

The study identified certain common obstacles and problems and suggested solutions. In the end, patients self-reported their AEs at 715 out of 849 possible time points, for a compliance rate of 84 percent. Various reasons accounted for missed opportunities for patient reporting of AE. These included missed clinic appointments (21 percent); staff errors such as forgetting to provide the tablet computers (21 percent); patients being “too sick” to self-report (13 percent); and technical problems, including malfunctioning computers and lack of connectivity (13 percent).

A sizeable majority of the clinical research staff at the various sites found the software systems easy-to-use (79 percent), although about a third of the staff did experience technical difficulties. The median amount of time needed to teach a patient to use the system was 10 minutes. Older, sicker patients and those lacking in computer experience found self-reporting harder than others but manageable with encouragement and support.

“It really took minimal effort on the part of the local clinic staff to support the use of the patient self-reporting system,” said Dr. Stephans.

Sixty-seven of the participating patients completed a patient survey about their experiences with PRO-CTCAE, and 94 percent of them had positive impressions. Of those surveyed, 79 percent found the system easy to use. Notably, many participants said that self-reporting their AEs led to improved discussions with their physicians and nurses.

Dr. Stephans says that allowing supplementation from a web-based or automated telephone reporting system might overcome one problem revealed in this study, which was data that was not submitted because of missed appointments. Another possible refinement will be the development and implantation of a downloadable app for patient self-reporting. While the PRO-CTCAE software used in this trial required a continuous, active internet connection, with such a downloadable app in place, internet connectivity would not be necessary.