Currently Viewing:
Currently Reading
Cancer Trial Participants Can Successfully Self-Report Adverse Events
February 20, 2017 – Christina Mattina
Pharma—PBM War on Drug Prices Picks Up Steam
February 17, 2017 – Surabhi Dangi-Garimella, PhD
This Week in Managed Care: February 17, 2017
February 17, 2017
Postmenopausal Weight Loss Cuts Risk of Endometrial Cancer by Half
February 16, 2017 – Surabhi Dangi-Garimella, PhD
UCSF Researchers Identify Determinants of Coverage for Hereditary Cancer Panels
February 15, 2017 – Surabhi Dangi-Garimella, PhD
Breast Cancer Survivors Report More Cognitive Impairment After Chemotherapy
February 15, 2017 – Christina Mattina
Sustained Response to Immune Checkpoint Inhibitors Could Influence Standard of Care
February 14, 2017 – Surabhi Dangi-Garimella, PhD
Navigator Program Lowered Costs, Utilization for Elderly Cancer Patients
February 13, 2017 – Christina Mattina
Predicting Response to SCT in Patients With MDS
February 13, 2017 – Surabhi Dangi-Garimella, PhD

Cancer Trial Participants Can Successfully Self-Report Adverse Events

Christina Mattina
Adverse events from cancer clinical trials are currently reported by trial investigators, but a recent feasibility study found that patients can successfully and accurately report their own symptoms if given the opportunity.
Under current protocol, adverse events resulting from cancer clinical trials are reported by the investigators, not the patients. However, a recent feasibility study found that patients can successfully and accurately report their own symptoms if given the opportunity.

Adverse events resulting from oncology trials must be reported by the clinical investigators, but the recent push towards 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. Therefore, 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 trials were given the opportunity at each visit to answer plainly-worded questions about symptomatic adverse events 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 useful and easy to use.

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 over 90% believed that patient-reported adverse event 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.

Copyright AJMC 2006-2020 Clinical Care Targeted Communications Group, LLC. All Rights Reserved.
Welcome the the new and improved, the premier managed market network. Tell us about yourself so that we can serve you better.
Sign Up