Cited by 555Cancer survivorship and carePharmacovigilance and Adverse Drug ReactionsStatistical Methods in Clinical Trials

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How Accurate Is Clinician Reporting of Chemotherapy Adverse Effects? A Comparison With Patient-Reported Symptoms From the Quality-of-Life Questionnaire C30

Fromme, Erik K., Eilers, Kristine M., Mori, Motomi, Hsieh, Yi-Ching, Beer, Tomasz M.·2004·Journal of Clinical Oncology

DOI 10.1200/jco.2004.03.025

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Abstract

Purpose: Adverse events in chemotherapy clinical trials are assessed and reported by clinicians, yet clinician accuracy in assessing symptoms has been questioned. We compared patient reporting of eight symptoms using a validated instrument, the European Organization for the Research and Treatment of Cancer Quality-of-Life Questionnaire C30 (QLQ-C30 or QLQ) with physicians' reporting of the same symptoms in the study's adverse events log. Patients and Methods: Thirty-seven men with metastatic, androgen-independent prostate cancer enrolled onto a phase II trial of weekly calcitriol and docetaxel completed the QLQ every 4 weeks for up to 28 weeks. A patient-reported symptom was defined as an increase in a QLQ symptom score by at least 10 points (0 to 100 scale), sustained for at least 4 weeks. A physician-reported symptom was considered present if it was ever documented in the adverse event log. Results: Forty-nine (new or worsened) symptoms were detected by both physician and QLQ, 48 symptoms were detected by the physician alone, and 55 symptoms were detected by the QLQ alone. They agreed on the absence of a symptom in 102 instances of 254 possible opportunities. Their uncorrected agreement was 59.4%, but Cohen's κ, a coefficient of agreement that corrects for chance, was 0.15, indicating only slight agreement. Using the QLQ as the standard, overall physician sensitivity and specificity was 47% and 68%, respectively, although it varied considerably among symptoms. Conclusion: Even in a tightly controlled clinical trial, physician reporting was neither sensitive nor specific in detecting common chemotherapy adverse effects. Tools for collecting patient-reported adverse event data in chemotherapy clinical trials should be developed.

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Authors: Fromme, E. K., Eilers, K. M., Mori, M., Hsieh, Y.-C., & Beer, T. M.
Affiliations: Oregon Health & Science University (US)
Corresponding author: Beer, Tomasz M.
ORCID: Fromme, Erik K.
Mori, Motomi
Beer, Tomasz M.
Venue: Journal of Clinical Oncology
Publisher: American Society of Clinical Oncology (ASCO)
Published: 2004-09-01
Volume: 22
Issue: 17
Pages: 3485-3490
ISSN: 0732-183X (ISSN-L)
1527-7755
DOI: 10.1200/jco.2004.03.025
OpenAlex: W2150906637
Cited by: 555
References: 32
Citations by year: 2026: 12 · 2025: 15 · 2024: 40 · 2023: 35 · 2022: 56 · 2021: 41 · 2020: 45 · 2019: 34 · 2018: 38 · 2017: 44 · 2016: 32 · 2015: 32 · 2014: 17 · 2013: 17 · 2012: 14
FWCI: 4.16
Type: journal article
Language: en
Open access: closed
Locations: Journal of Clinical Oncology (publishedVersion)
PubMed (publishedVersion)
Funders: National Cancer Institute (P30 CA 69533, P30CA069533)
National Center for Research Resources (3 M01RR00334-33S2, M01RR000334)
Topics: Health Sciences › Medicine › Oncology › Cancer survivorship and care
Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Keywords: chemotherapy side effects, patient-reported symptoms, EORTC QLQ-C30, castration-resistant prostate cancer, metastatic prostate cancer, docetaxel, 1,25-dihydroxyvitamin D3, adverse event reporting, quality of life assessment
MeSH terms: Antineoplastic Combined Chemotherapy Protocols, Humans, Male, Physicians, Prostatic Neoplasms, Quality of Life, Surveys and Questionnaires, Sensitivity and Specificity, Adverse Drug Reaction Reporting Systems

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How Accurate Is Clinician Reporting of Chemotherapy Adverse Effects? A Comparison With Patient-Reported Symptoms From the Quality-of-Life Questionnaire C30

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