JMIR Publications

ABSTRACT

Background:

Electronic Patient-Reported Outcomes (ePROs) are a relatively novel form of data and have the potential to improve clinical practice for cancer patients. In this prospective, multicenter, observational clinical trial, efforts were made to demonstrate the reliability of patient-reported symptoms.

Objective:

The primary objective of this study was to assess the level of agreement κ between symptom ratings by physicians and patients via a shared review process in order to determine the future reliability and utility of self-reported electronic symptom monitoring.

Methods:

Patients receiving systemic therapy in a (neo-)adjuvant or non-curative intention setting captured ePROs for 52 symptoms over an observational period of 90 days. At three-weekly intervals, randomly selected symptoms were reviewed between the patient and physician for congruency on severity of the grading of adverse events according to the Common Terminology Criteria of Adverse Events (CTCAE). The patient-physician agreement for the symptom review was assessed via Cohen’s κ, calculating the interrater reliability. Chi-square tests investigated whether patient reported outcome was different among symptoms, type of cancer, demographics, and physicians’ experience.

Results:

Among 181 patients (158 women, 23 men, median age 54.4 years), there was a fair scoring agreement (? = 0.24 (0.16 to 0.33)) for symptoms that were entered two to three weeks before the intended review (1st rating), and a moderate agreement (? = 0.41 (0.34 to 0.48)) for symptoms that were entered within one week of the intended review (2nd rating). However, the level of agreement increased from moderate (1st rating, ? = 0.43) to substantial (2nd rating, ? = 0.68) for common symptoms including pain, fever, diarrhea, obstipation, nausea, vomiting and stomatitis. Similar congruency levels of ratings were found for the most frequently entered symptoms (1st rating: ? = 0.42 vs. 2nd rating: ? = 0.65). The symptom with the slightest agreement was hair loss (κ = -0.05). With regard to the latency of symptom entry to the review, hardly any difference was demonstrated for symptoms that were either entered from days 1 to 3, or from days 4 to 7 before the intended review (κ = 0.40 vs. κ = 0.39). In contrast, for symptoms that were entered 15 to 21 days before the intended review, no congruency was demonstrated (κ = -0.15). Congruency levels seemed to be unrelated to the type of cancer, demographics, and physicians’ review experience.

Conclusions:

The shared monitoring and review of symptoms between patients and clinicians merits the potential to improve the understanding of patient self-reporting. Our data indicates that the integration of ePROs in oncological clinical research and continuous clinical practice provides reliable information for self-empowerment as well as the timely intervention of symptoms. Clinical Trial: clinicaltrials.gov: NCT03578731