Patients’ self-assessment versus investigators’ evaluation in a phase III trial in non-castrate metastatic prostate cancer (GETUG-AFU 15)

Gravis, Gwénaëlle; Marino, Patricia; Joly, Florence; Oudard, Stéphane; Priou, Franck; Esterni, Benjamin; Latorzeff, I.; Delva, R.; Krakowski, I.; Laguerre, Brigitte; Rolland, Frédéric; Théodore, Christine; Deplanque, Gaël; Ferrero, Jean Marc; Pouessel, Damien; Mourey, Loïc; Beuzeboc, Philippe; Zanetta, Sylvie; Habibian, Muriel; Berdah, Jean François; Dauba, Jérôme; Baciuchka, Marjorie; Platini, Christian; Linassier, Claude; Labourey, Jean-Luc; Machiels, Jean Pascal; Kouri, Claude El; Ravaud, Alain; Suc, Etienne; Eymard, Jean Christophe; Hasbini, Ali; Bousquet, Guilhem; Soulié, M.; Fizazi, Karim

doi:10.1016/j.ejca.2013.11.034

Cited by 62 publications

(44 citation statements)

References 29 publications

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“…Several other authors have reported a similar phenomenon [5][6][7][8][9][10][11] . For example, Di Maio and colleagues recently studied patients enrolled in three prospective clinical trials: one studying elderly patients with breast cancer receiving adjuvant chemotherapy and two studying patients with advanced non-small cell lung carcinoma receiving first-line treatment 9 .…”

Section: Discussionsupporting

confidence: 58%

“…Furthermore, the patient experience may not be fully captured by the physicians or nurses documenting clinical findings. Several papers from clinical trials have highlighted discrepancies in the side effects reported by medical staff and patients, with doctors frequently underestimating the incidence and severity of side effects [5][6][7][8][9][10][11] . Since underreporting of chemotherapy-related side effects is a problem even in the highly controlled clinical trial environment, it is likely to be even more pronounced in routine clinical practice, where reporting does not follow strict standards.…”

Section: Introductionmentioning

confidence: 99%

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Self-evaluation of Adjuvant Chemotherapy-Related Adverse Effects by Patients With Breast Cancer

et al. 2016

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Importance: The patient's perspective on chemotherapy-related side effects is becoming increasingly acknowledged both in experimental clinical trials and in the clinical practice.Objective: To evaluate how breast cancer patients receiving standard adjuvant chemotherapy report and grade side effects using a ten-item, paper questionnaire derived from the US National Cancer Institute's (NCIs) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 and to compare patient with doctor reports.Design, setting and participants: The questionnaire was administered to 604 patients at 11 sites after the first and third cycle of adjuvant chemotherapy between January 2011 and October 2013. CTCAE v4.0 definitions of grade of severity for nausea, vomiting, constipation, anorexia, dysgeusia, diarrhea, fatigue, pain, paresthesia, and dyspnea were translated into Italian and rephrased. Side effect information was also extracted from the medical charts to compare to patient-reported data. Main outcomes and measures:Differences in side effects reporting between paired questionnaires were studied by the McNemar Test and the Wilcoxon signed rank test.Agreement between patient and doctor side effect reporting (grade 0 vs. grade ≥1) was studied using Cohen's kappa statistic. The effect of the number of patients enrolled at each Institution on the magnitude of discrepancy in side effect reporting between patients and doctors was studied by linear regression.Results: 596 and 581 questionnaires were collected after cycles 1 and 3, respectively. A median of 82% of fields were filled in. A corresponding doctor questionnaire completed from chart data was available for 594 and 573 patient questionnaires. The frequency and severity of chemotherapy-related side effects were consistently greater in patient-reported than doctor-reported data. As a result, inter-rater agreement was low for most side effects, 3 ranging from 0.10 for anorexia to 0.51 for vomiting (Cohen's kappa statistic). There was a strong and significant positive correlation between the magnitude of the discrepancy in the frequency of reporting side effects and the number of patients enrolled at each site. Conclusions and relevance:Adherence to reporting adjuvant chemotherapy-related side effects using the CTCAE system is high in women undergoing adjuvant chemotherapy for breast cancer. Workload may contribute to agreement discrepancies by limiting the doctorpatient relationship.

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Section: Discussionsupporting

confidence: 58%

Section: Introductionmentioning

confidence: 99%

Self-evaluation of Adjuvant Chemotherapy-Related Adverse Effects by Patients With Breast Cancer

et al. 2016

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“…17 Recently, significant under-reporting of symptoms caused by androgen deprivation with or without docetaxel in patients with prostate cancer was also reported. 18 Our data suggest that reporting by physicians of subjective toxicity in clinical trials may be not accurate enough. With Ͼ 1,000 patients with cancer, evaluated for up to three cycles of treatment, our analysis was conducted in a large series of patients who were enrolled onto and prospectively observed in clinical trials.…”

Section: Discussionmentioning

confidence: 68%

Symptomatic Toxicities Experienced During Anticancer Treatment: Agreement Between Patient and Physician Reporting in Three Randomized Trials

Maïo

Gallo

Leighl

et al. 2015

JCO

405

254

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Purpose Information about symptomatic toxicities of anticancer treatments is not based on direct report by patients, but rather on reports by clinicians in trials. Given the potential for under-reporting, our aim was to compare reporting by patients and physicians of six toxicities (anorexia, nausea, vomiting, constipation, diarrhea, and hair loss) within three randomized trials. Patients and Methods In one trial, elderly patients with breast cancer received adjuvant chemotherapy; in two trials, patients with advanced non–small-cell lung cancer received first-line treatment. Toxicity was prospectively collected by investigators (graded by National Cancer Institute Common Toxicity Criteria [version 2.0] or Common Terminology Criteria for Adverse Events [version 3]). At the end of each cycle, patients completed the European Organisation for Research and Treatment of Cancer quality-of-life questionnaires, including toxicity-related symptom items. Possible answers were “not at all,” “a little,” “quite a bit,” and “very much.” Analysis was limited to the first three cycles. For each toxicity, agreement between patients and physicians and under-reporting by physicians (ie, toxicity reported by patients but not reported by physicians) were calculated. Results Overall, 1,090 patients (2,482 cycles) were included. Agreement between patients and physicians was low for all toxicities. Toxicity rates reported by physicians were always lower than those reported by patients. For patients who reported toxicity (any severity), under-reporting by physicians ranged from 40.7% to 74.4%. Examining only patients who reported “very much” toxicity, under-reporting by physicians ranged from 13.0% to 50.0%. Conclusion Subjective toxicities are at high risk of under-reporting by physicians, even when prospectively collected within randomized trials. This strongly supports the incorporation of patient-reported outcomes into toxicity reporting in clinical trials.

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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%

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

286

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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Patients’ self-assessment versus investigators’ evaluation in a phase III trial in non-castrate metastatic prostate cancer (GETUG-AFU 15)

Cited by 62 publications

References 29 publications

Self-evaluation of Adjuvant Chemotherapy-Related Adverse Effects by Patients With Breast Cancer

Self-evaluation of Adjuvant Chemotherapy-Related Adverse Effects by Patients With Breast Cancer

Symptomatic Toxicities Experienced During Anticancer Treatment: Agreement Between Patient and Physician Reporting in Three Randomized Trials

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

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