Prevalence of Patient-Reported Gastrointestinal Symptoms and Concordance With Clinician Toxicity Assessments in Radiation Therapy for Anal Cancer

Tom, Ashlyn; Bennett, Antonia V.; Rothenstein, Diana; Milgrom, Sarah A.; Law, Ethel; Mangarin, E.; Wu, Abraham J.; Goodman, Karyn A.

doi:10.1016/j.ijrobp.2013.06.1513

Cited by 1 publication

(2 citation statements)

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“…This included disease specific modules of the European Organization for Research and Treatment of Cancer (EORTC) [12–20] and Functional Assessment of Cancer Therapy (FACT) [21–23] instruments, as well as the dermatology-specific Skindex-16, [24, 25] the EuroQol EQ-5D, [26] the Short-Form 36 Health Survey (SF-36) [27], and two recently developed bowel symptom inventories [28, 29]. Patient-adapted versions of the CTCAE were used in four studies [27, 30–32], with visual analog scales used to capture patient-rated AEs in three studies [11, 33, 34].…”

Section: Resultsmentioning

confidence: 99%

“…Independent studies that made use of the Bowel Problem Scale in cohorts of patients with rectal [28] or anal [29] cancer found poor agreement with clinician ratings for proctitis (κ = 0.22 and 0.11, respectively) and moderate agreement for diarrhea (κ = 0.64 and 0.68, respectively). Additionally, independent studies of neuropathy reported a poor to moderate relationship between PRO and CTCAE reports, as measured by the FACT Gynecologic Oncology Group – Neurotoxicity Module (FACT/GOG-Ntx) ( r ’s range 0.23–0.69) [23, 36].…”

Section: Resultsmentioning

confidence: 99%

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

Atkinson

Ryan

Bennett

et al. 2016

Support Care Cancer

287

177

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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 5,658 articles retrieved, 28 studies met 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 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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