Findings from a study of participants enrolled in 9 multicenter, oncology clinical trials show that the vast majority of patients can successfully and accurately self-report their adverse events (AEs) if given the opportunity, suggesting the potential for an elevated role for patient-reported outcomes in these investigations.
Under current protocol, AEs resulting from cancer clinical trials are reported by the investigators, not the patients, but the growing emphasis on patient-centered care has led some to question the necessity of this system, especially as some studies have shown that investigators’ reports of such data could be incomplete or inaccurate.
Against this backdrop, a group of researchers set out to test the feasibility of a system that allowed patients to report their own symptoms at each clinical visit, and published their results in JAMA Oncology.
In this study, 285 patients participating in cancer clinical trials were given the opportunity at each visit to answer plainly-worded questions about symptomatic AEs using a mobile tablet, while the investigators continued to note any adverse events as they normally would have. Subsequent analysis found that the clinicians tended to underreport symptoms compared with patients, especially for events like anorexia, fatigue, nausea, and pain.
The study authors explained that patient reports of symptoms that the investigators had overlooked, “reflect an area of the patient’s experience that may warrant particular attention in the future, both to alleviate patient discomfort and identify currently undocumented safety signals.” They added that a focus on patient-reported outcomes (PROs) could become even more important when investigating new therapies like immuno-oncology, since these treatments can have “long-standing, low-grade toxic effects” that might go unnoticed by clinicians.
Investigators surveyed about the new system responded with positive feedback, with 94% agreeing that the PROs were useful for monitoring toxicities and 83% stating they accurately reflected the patients’ clinical status. Similarly, patients had positive feelings about the experience, as 93% agreed that the reporting system was easy to use and helpful.
The idea of allowing clinical trial participants to report their own symptoms is not a novel one; in fact, trials in some fields other than oncology have already adopted this approach. A prior survey of cancer investigators and researchers found that more than 90% believed that patient-reported AE reporting “could improve data completeness, accuracy, meaningfulness, and actionability,” compared with the present system of clinician reporting.
The results of this study, the authors suggested, add to the evidence indicating that patient self-reporting could be successfully implemented in oncology trials. Collection of symptom reports from patients could provide a more complete picture of a trial treatment’s effects as well make patients and their families feel empowered by this patient-centered approach.
Basch E, Dueck AC, Rogak LJ, et al. Feasibility assessment of patient reporting of symptomatic adverse events in multicenter cancer clinical trials [published online ahead of print February 16, 2017]. JAMA Oncol.
Christina Mattina, is a writer and editor for the American Journal of Managed Care. Read more at AJMC.com.