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The association between clinician-based common terminology criteria for adverse events (CTCAE) and patient-reported outcomes (PRO): a systematic review

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Abstract

Purpose

Symptomatic adverse events (AEs) are monitored by clinicians as part of all US-based clinical trials in cancer via the U.S. National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE) for the purposes of ensuring patient safety. Recently, there has been a charge toward capturing the patient perspective for those AEs amenable to patient self-reporting via patient-reported outcomes (PRO). The aim of this review was to summarize the empirically reported association between analogous CTCAE and PRO ratings.

Methods

A systematic literature search was conducted using PubMed, EMBASE, Web of Science, and Cochrane databases through July 2015. From a total of 5658 articles retrieved, 28 studies met the inclusion criteria.

Results

Across studies, patients were of mixed cancer types, including anal, breast, cervical, chronic myeloid leukemia, endometrial, hematological, lung, ovarian, pelvic, pharyngeal, prostate, and rectal. Given this mixture, the AEs captured were variable, with many common across studies (e.g., dyspnea, fatigue, nausea, neuropathy, pain, vomiting), as well as several that were disease-specific (e.g., erectile dysfunction, hemoptysis). Overall, the quantified association between CTCAE and PRO ratings fell in the fair to moderate range and had a large variation across the majority of studies (n = 21).

Conclusions

The range of measures used and symptoms captured varied greatly across the reviewed studies. Regardless of concordance metric employed, reported agreement between CTCAE and PRO ratings was moderate at best. To assist with reconciliation and interpretation of these differences toward ultimately improving patient care, an important next step is to explore approaches to integrate PROs with clinician reporting of AEs.

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Notes

  1. Questions 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 16, 17, 18, 19, 20, and 26 from the Downs and Black Study Quality Checklist were used to assess quality.

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Acknowledgments

This project was supported by a National Institutes of Health Research Training Grant (T32 CA009461-25), as well as a National Institutes of Health Support Grant (P30 CA08748-48), which provides partial support for the Behavioral Research Methods Core Facility used in conducting this investigation. The authors wish to thank Jan-Samuel Wagner for his early contributions to the project, as well as Dr. Jamie Ostroff for her support of this work. A portion of these results were presented at the 2013 Conference of the International Society for Quality of Life Research in Miami, FL.

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Correspondence to Thomas M. Atkinson.

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Atkinson, T.M., Ryan, S.J., Bennett, A.V. et al. The association between clinician-based common terminology criteria for adverse events (CTCAE) and patient-reported outcomes (PRO): a systematic review. Support Care Cancer 24, 3669–3676 (2016). https://doi.org/10.1007/s00520-016-3297-9

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