‘PRO-ceed’ with Patient-Reported Outcomes in Oncology Adverse Events

A patient-reported outcomes measure has been successfully integrated into the Common Terminology Criteria for Adverse Events

medwireNews: A patient-reported outcomes version of the US National Cancer Institute’s Common Terminology Criteria for Adverse Events (PRO-CTCAE) has been shown to accurately convey the patient’s experience of side effects during chemotherapy or radiotherapy.

This expands on the historic role of the CTCAE in physician recording of AEs in oncology patients using standard terminology that can be compared between trials, the team explains in JAMA Oncology.

“Having a measurement system that integrates the patient perspective into AE reporting and that fosters consistency, transparency, and comparability across trials is similarly an important objective”, emphasise Amylou Dueck, from Mayo Clinic in Scottsdale, Arizona, USA, and co-authors.

The PRO-CTCAE asks patients to detail the AEs experienced in the past 7 days, including the frequency of 25 symptomatic AEs, the interference of 25 symptomatic AEs in usual or daily activities, and the severity of 51 AEs.

When administered to patients using tablet computers in outpatient waiting rooms on two oncology appointments up to 6 weeks apart, 96.4% of 975 patients completed the 124-item questionnaire on the first visit and 90.6% of 940 patients completed it on the second. The vast majority of patients (96.2%) reported at least five symptoms on the PRO-CTCAE on the first visit.

“[T]his large-scale multicenter validation study in individuals undergoing active cancer therapy provides robust evidence for the validity, reliability, and responsiveness of items in the PRO-CTCAE library”, the authors say.

Specifically, all items on the PRO-CTCAE showed at least one expected correlation with one or more of the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30) scales, and 98.4% did so with the QLC-C30 health-related quality of life summary score.

The strongest associations were found between PRO-CTCAE items and their related QLQ-C30 scales. For example, PRO-CTCAE items such as shortness of breath showed the strongest correlation with the QLQ-C30 physical functioning scale, whereas AEs related to concentration or memory were linked to the QLC-C30 cognitive functioning scale.

In addition, 94 of the 124 PRO-CTCAE items scored higher in patients with an Eastern Cooperative Oncology Group Performance Status (ECOG PS ) score of 2 to 4 than in patients with a score of 0 to 1.

Most of the 124 PRO-CTCAE items had a “statistically significant and meaningful” effect size on one or more construct validity criteria; all five items that did not meet these criteria had a low prevalence in the population that limited the analysis.

In a subset of 80 patients who completed the test on two consecutive business days, there was a test–retest reliability of at least 0.7 for 36 of 49 prespecified items. And analysis of responsiveness showed that changes on the PRO-CTCAE significantly correlated with changes on the QLQ-C30 scales for all 27 prespecified items.

In an invited commentary, Benjamin Movsas, from Henry Ford Hospital in Detroit, Michigan, USA, writes that the PRO-CTCAE could help informed decision-making in the clinic and potentially allow “real-time” recording of AEs and symptom management.

“Importantly, randomized data have demonstrated that when inquiries are made regarding PROs in the clinic, not only did physician-patient communication significantly improve, but almost all patients also expressed interest in continuing this approach”, he observes.

“One thing is reasonably clear: when it comes to optimally understanding and appreciating the patient experience, our patients want us to “PRO”ceed with PROs.”


Dueck AC, Mendoza TR, Mitchell SA, et al. Validity and reliability of the US National Cancer Institute’s patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). JAMA Oncol 2015; Advance online publication 13 August. doi:10.1001/jamaoncol.2015.2639

Movsas B. PROceeding with the patient-reported outcomes (PROs) version of the Common Terminology Criteria for Adverse Events. JAMA Oncol 2015; Advance online publication 13 August. doi:10.1001/jamaoncol.2015.2689

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