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

Maïo, Massimo Di; Gallo, Ciro; Leighl, Natasha B.; Piccirillo, Maria Carmela; Daniele, Gennaro; Nuzzo, Francesco; Gridelli, Cesare; Gebbia, Vittorio; Ciardiello, Fortunato; Placido, Sabino De; Ceribelli, Anna; Favaretto, Adolfo; Matteis, A. De; Feld, Ronald; Butts, Charles; Bryce, Jane; Signoriello, Simona; Morabito, Alessandro; Rocco, Gaetano; Perrone, Francesco

doi:10.1200/jco.2014.57.9334

Cited by 374 publications

(252 citation statements)

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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%

“…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 . The authors compared patient and doctor reporting of six chemotherapy-related side effects (anorexia, nausea, vomiting, constipation, diarrhea, and hair loss) after each of the initial three cycles of chemotherapy.…”

Section: Discussionmentioning

confidence: 99%

“…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: Discussionmentioning

confidence: 99%

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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“…Published studies have consistently demonstrated that health professionals underestimate the incidence and severity of symptoms, when compared with the report by patients [14][15][16][17]. More specifically, a number of publications have been focused on the comparison between patients' and physicians' reporting of treatment adverse events experienced by cancer patients, allowing the description of under-reporting by physicians [18][19][20][21].…”

Section: Agreement Between Patients and Physiciansmentioning

confidence: 99%

“…In a recent pooled analysis of three randomized trials, patients' and clinicians' reporting of six toxicities (anorexia, nausea, vomiting, constipation, diarrhea, and hair loss) experienced during anti-cancer treatment were subsequently compared [21]. Agreement between patients and clinicians was low, and toxicity rates based on physicians' report were consistently lower than those reported by patients themselves.…”

Section: Agreement Between Patients and Physiciansmentioning

confidence: 99%

Patient-reported outcomes in the evaluation of toxicity of anticancer treatments

et al. 2016

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Several studies have shown that symptomatic toxicities associated with anti-cancer treatments, such as nausea and vomiting, are frequently under-reported by health care providers, even when prospectively collected within clinical trials. Such under-reporting can produce underestimation of the absolute rate of toxicity, which is highly relevant information for patients and their physicians in clinical practice, as well as for regulatory authorities. Systematic collection of patient-reported outcomes (PROs) has been demonstrated to be a valid, reliable, feasible, and more precise approach to tabulating symptomatic toxicities, compared to health care provider reporting. The U.S. NationalCancer Institute has developed a PRO version of the Common Terminology Criteria for Adverse Events (the "PRO-CTCAE") to improve toxicity measurement in clinical trials. The PRO-CTCAE is an item bank with 124 individually validated toxicity questions for patients, with an accompanying software system for directly collecting information about symptomatic adverse events from patients. The barriers and challenges that need to be addressed when considering broad integration of PRO toxicity monitoring in cancer clinical trials are discussed, including challenges related to data collection logistics, analytic approaches, and resource utilization. The advent of instruments like the PRO-CTCAE, conceived to describe therapy side effects from the patient perspective, brings the potential both to improve the quality of data for risk-benefit evaluation in clinical research, and to provide future patients facing treatment decisions with information about prior experiences of their peers.3

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Effect of Electronic Symptom Monitoring on Patient-Reported Outcomes Among Patients With Metastatic Cancer

Basch

Schrag

Henson

et al. 2022

JAMA

126

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IMPORTANCE Electronic systems that facilitate patient-reported outcome (PRO) surveys for patients with cancer may detect symptoms early and prompt clinicians to intervene. OBJECTIVE To evaluate whether electronic symptom monitoring during cancer treatment confers benefits on quality-of-life outcomes. DESIGN, SETTING, AND PARTICIPANTS Report of secondary outcomes from the PRO-TECT (Alliance AFT-39) cluster randomized trial in 52 US community oncology practices randomized to electronic symptom monitoring with PRO surveys or usual care. Between October 2017 and March 2020, 1191 adults being treated for metastatic cancer were enrolled, with last follow-up on May 17, 2021. INTERVENTIONSIn the PRO group, participants (n = 593) were asked to complete weekly surveys via an internet-based or automated telephone system for up to 1 year. Severe or worsening symptoms triggered care team alerts. The control group (n = 598) received usual care. MAIN OUTCOMES AND MEASURESThe 3 prespecified secondary outcomes were physical function, symptom control, and health-related quality of life (HRQOL) at 3 months, measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30; range, 0-100 points; minimum clinically important difference [MCID], 2-7 for physical function; no MCID defined for symptom control or HRQOL). Results on the primary outcome, overall survival, are not yet available. RESULTS Among 52 practices, 1191 patients were included (mean age, 62.2 years; 694 [58.3%] women); 1066 (89.5%) completed 3-month follow-up. Compared with usual care, mean changes on the QLQ-C30 from baseline to 3 months were significantly improved in the PRO group for physical function (PRO, from 74.27 to 75.81 points; control, from 73.54 to 72.61 points; mean difference, 2.47 [95% CI,]; P = .02), symptom control (PRO, from 77.67 to 80.03 points; control, from 76.75 to 76.55 points; mean difference, 2.56 [95% CI, 0.95-4.17]; P = .002), and HRQOL (PRO, from 78.11 to 80.03 points; control, from 77.00 to 76.50 points; mean difference, 2.43 [95% CI, 0.90-3.96]; P = .002). Patients in the PRO group had significantly greater odds of experiencing clinically meaningful benefits vs usual care for physical function (7.7% more with improvements of Ն5 points and 6.1% fewer with worsening of Ն5 points; odds ratio [OR], 1.35 [95% CI, 1.08-1.70];

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

Cited by 374 publications

References 20 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

Patient-reported outcomes in the evaluation of toxicity of anticancer treatments

Effect of Electronic Symptom Monitoring on Patient-Reported Outcomes Among Patients With Metastatic Cancer

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