Patient versus clinician symptom reporting using the national cancer institute common terminology criteria for adverse events: results of a questionnaire-based study

Basch, Ethan; Iasonos, Alexia; McDonough, Tiffani; Barz, Allison; Culkin, Ann; Kris, Mark G; Scher, Howard I; Schrag, Deborah

doi:10.1016/s1470-2045(06)70910-x

Cited by 653Cancer survivorship and carePharmacovigilance and Adverse Drug ReactionsStatistical Methods in Clinical Trials

Patient versus clinician symptom reporting using the national cancer institute common terminology criteria for adverse events: results of a questionnaire-based study

Basch, Ethan, Iasonos, Alexia, McDonough, Tiffani, Barz, Allison, Culkin, Ann, Kris, Mark G, Scher, Howard I, Schrag, Deborah·2006·The Lancet Oncology

DOI 10.1016/s1470-2045(06)70910-x

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Abstract

Background The Common Terminology Criteria for Adverse Events (CTCAE) are used as standard practice in trials of cancer treatments by clinicians to elicit and report toxic effects. Alternatively, patients could report this information directly as patient-reported outcomes, but the accuracy of these reports compared with clinician reports remains unclear. We aimed to compare the reporting of symptom severity reported by patients and clinicians.Methods Between March and May, 2005, a questionnaire with 11 common CTCAE symptoms was given to consecutive outpatients and their clinicians (physicians and nurses) in lung and genitourinary cancer clinics in the Memorial Sloan-Kettering Cancer Center, New York, NY, USA. Patients completed a version that used language adapted from the CTCAE for patient self-reporting. The results from the questionnaire were compared with clinician reporting of the same symptoms.Findings Of 435 patients and their clinicians asked to take part in the study, 400 paired surveys were completed. For most symptoms, agreement between patient and clinician was high, and most discrepancies were within a grade difference of one point. Agreement was higher for symptoms that could be observable directly, such as vomiting and diarrhoea, than for more subjective symptoms, such as fatigue and dyspnoea. Differences in symptom reporting rarely would have changed treatment decisions or dosing, and patients assigned greater severity to symptoms more than did clinicians. No significant differences were recorded between the results when the questionnaire was completed by the patient before or after the clinician.Interpretation Patient reporting of symptoms could add to the current approach to symptom monitoring in cancer treatment trials. Future research should assess the effect of self reporting on clinical outcomes and efficiency, and the use of real-time collection of patient-reported outcomes for early detection of potentially serious adverse events.

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Authors: Basch, E., Iasonos, A., McDonough, T., Barz, A., Culkin, A., Kris, M. G., Scher, H. I., & Schrag, D.
Affiliations: Memorial Sloan Kettering Cancer Center (US)
Corresponding author: Basch, Ethan
ORCID: Basch, Ethan
Iasonos, Alexia
McDonough, Tiffani
Kris, Mark G
Scher, Howard I
Schrag, Deborah
Venue: The Lancet Oncology
Publisher: Elsevier BV
Published: 2006-11
Volume: 7
Issue: 11
Pages: 903-909
ISSN: 1470-2045 (ISSN-L)
DOI: 10.1016/s1470-2045(06)70910-x
OpenAlex: W2118638289
Cited by: 653
References: 30
Citations by year: 2026: 25 · 2025: 41 · 2024: 52 · 2023: 43 · 2022: 56 · 2021: 53 · 2020: 45 · 2019: 47 · 2018: 42 · 2017: 39 · 2016: 40 · 2015: 32 · 2014: 25 · 2013: 23 · 2012: 20
FWCI: 5.04
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
Locations: The Lancet Oncology (publishedVersion)
PubMed (publishedVersion)
Funders: National Cancer Institute (K07CA124851)
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: CTCAE, patient-reported outcomes, symptom severity, cancer treatment toxicity, lung cancer, genitourinary cancer, fatigue, dyspnea, adverse event monitoring
MeSH terms: Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Clinical Trials as Topic, Female, Humans, Lung Neoplasms, Male, Middle Aged, Patients, Physicians, Surveys and Questionnaires, Research Design, Urogenital Neoplasms, Reproducibility of Results

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Patient versus clinician symptom reporting using the national cancer institute common terminology criteria for adverse events: results of a questionnaire-based study

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