This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Fromme, E. K. Articles by Beer, T. M. Search for Related Content PubMed PubMed Citation Articles by Fromme, E. K. Articles by Beer, T. M. Social Bookmarking                            What's this?

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

From the Department of Medicine, Divisions of General Medicine and Geriatrics, and Hematology and Medical Oncology, Oregon Health & Science University; the Oregon Health & Science University Center for Ethics in Health Care; and Biostatistics & Bioinformatics Shared Resource, Oregon Health & Science University Cancer Institute, Portland, OR

Address reprint requests to Tomasz M. Beer, MD, Department of Medicine, Oregon Health & Science University, Mail Code CR145, 3181 SW Sam Jackson Park Rd, Portland, OR 97239; e-mail: beert{at}ohsu.edu

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 , 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.

Supported in part by grant 3M01RR00334-33S2, and a Cancer Center Support grant (P30 CA 69533) from the National Institutes of Health.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				M. Cirillo, M. Venturini, L. Ciccarelli, F. Coati, O. Bortolami, and G. Verlato Clinician versus nurse symptom reporting using the National Cancer Institute--Common Terminology Criteria for Adverse Events during chemotherapy: results of a comparison based on patient's self-reported questionnaire Ann. Onc., July 17, 2009; (2009) mdp287v1. [Abstract] [Full Text] [PDF]

				B. H. Gronberg, R. M. Bremnes, O. Flotten, T. Amundsen, P. Fr. Brunsvig, H. H. Hjelde, S. Kaasa, C. von Plessen, F. Stornes, T. Tollali, et al. Phase III Study by the Norwegian Lung Cancer Study Group: Pemetrexed Plus Carboplatin Compared With Gemcitabine Plus Carboplatin As First-Line Chemotherapy in Advanced Non-Small-Cell Lung Cancer J. Clin. Oncol., July 1, 2009; 27(19): 3217 - 3224. [Abstract] [Full Text] [PDF]

				J M Dixon and D. Montgomery Follow-up after breast cancer BMJ, January 19, 2008; 336(7636): 107 - 108. [Full Text] [PDF]

				F. Joly, J. Vardy, M. Pintilie, and I. F. Tannock Quality of life and/or symptom control in randomized clinical trials for patients with advanced cancer Ann. Onc., December 1, 2007; 18(12): 1935 - 1942. [Abstract] [Full Text] [PDF]

				A. Trotti, A. D. Colevas, A. Setser, and E. Basch Patient-Reported Outcomes and the Evolution of Adverse Event Reporting in Oncology J. Clin. Oncol., November 10, 2007; 25(32): 5121 - 5127. [Abstract] [Full Text] [PDF]

				S. M. Bentzen and A. Trotti Evaluation of Early and Late Toxicities in Chemoradiation Trials J. Clin. Oncol., September 10, 2007; 25(26): 4096 - 4103. [Abstract] [Full Text] [PDF]

				M. J. Hassett, A. J. O'Malley, J. R. Pakes, J. P. Newhouse, and C. C. Earle Frequency and cost of chemotherapy-related serious adverse effects in a population sample of women with breast cancer. J Natl Cancer Inst, August 16, 2006; 98(16): 1108 - 1117. [Abstract] [Full Text] [PDF]

				P. G. Richardson, H. Briemberg, S. Jagannath, P. Y. Wen, B. Barlogie, J. Berenson, S. Singhal, D. S. Siegel, D. Irwin, M. Schuster, et al. Frequency, Characteristics, and Reversibility of Peripheral Neuropathy During Treatment of Advanced Multiple Myeloma With Bortezomib J. Clin. Oncol., July 1, 2006; 24(19): 3113 - 3120. [Abstract] [Full Text] [PDF]

				D. P. Steensma and J. M. Bennett The Myelodysplastic Syndromes: Diagnosis and Treatment Mayo Clin. Proc., January 1, 2006; 81(1): 104 - 130. [Abstract] [Full Text] [PDF]

				E. Basch, D. Artz, D. Dulko, K. Scher, P. Sabbatini, M. Hensley, N. Mitra, J. Speakman, M. McCabe, and D. Schrag Patient Online Self-Reporting of Toxicity Symptoms During Chemotherapy J. Clin. Oncol., May 20, 2005; 23(15): 3552 - 3561. [Abstract] [Full Text] [PDF]