Adverse symptom event reporting by patients vs clinicians: Relationships with clinical outcomes Journal Article


Authors: Basch, E.; Jia, X.; Heller, G.; Barz, A.; Sit, L.; Fruscione, M.; Appawu, M.; Iasonos, A.; Atkinson, T.; Goldfarb, S.; Culkin, A.; Kris, M. G.; Schrag, D.
Article Title: Adverse symptom event reporting by patients vs clinicians: Relationships with clinical outcomes
Abstract: Background In cancer treatment trials, the standard source of adverse symptom data is clinician reporting by use of items from the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE). Patient self-reporting has been proposed as an additional data source, but the implications of such a shift are not understood.MethodsPatients with lung cancer receiving chemotherapy and their clinicians independently reported six CTCAE symptoms and Karnofsky Performance Status longitudinally at sequential office visits. To compare how patient's vs clinician's reports relate to sentinel clinical events, a time-dependent Cox regression model was used to measure associations between reaching particular CTCAE grade severity thresholds with the risk of death and emergency room visits. To measure concordance of CTCAE reports with indices of daily health status, Kendall tau rank correlation coefficients were calculated for each symptom with EuroQoL EQ-5D questionnaire and global question scores. Statistical tests were two-sided.ResultsA total of 163 patients were enrolled for an average of 12 months (range = 1-28 months), with a mean of 11 visits and 67 (41%) deaths. CTCAE reports were submitted by clinicians at 95% of visits and by patients at 80% of visits. Patients generally reported symptoms earlier and more frequently than clinicians. Statistically significant associations with death and emergency room admissions were seen for clinician reports of fatigue (P <. 001), nausea (P =. 01), constipation (P =. 038), and Karnofsky Performance Status (P <. 001) but not for patient reports of these items. Higher concordance with EuroQoL EQ-5D questionnaire and global question scores was observed for patient-reported symptoms than for clinician-reported symptoms.ConclusionsLongitudinally collected clinician CTCAE assessments better predict unfavorable clinical events, whereas patient reports better reflect daily health status. These perspectives are complementary, each providing clinically meaningful information. Inclusion of both types of data in treatment trial results and drug labels appears to be warranted.
Keywords: adult; cancer chemotherapy; controlled study; treatment outcome; aged; aged, 80 and over; middle aged; patient satisfaction; major clinical study; constipation; fatigue; cytotoxic agent; diarrhea; clinical trials as topic; outcome assessment; antineoplastic agent; pain; nausea; vomiting; antineoplastic combined chemotherapy protocols; lung neoplasms; proportional hazards models; risk factors; lung cancer; risk assessment; outcome assessment (health care); questionnaires; questionnaire; emergency ward; emergency service, hospital; disease severity; adverse drug reaction reporting systems; adverse outcome; correlation coefficient; health status; karnofsky performance status; medical information; professional practice; proportional hazards model; statistical analysis; statistical significance; confounding factors (epidemiology); data interpretation, statistical; death; longitudinal studies; physicians; severity of illness index
Journal Title: JNCI: Journal of the National Cancer Institute
Volume: 101
Issue: 23
ISSN: 0027-8874
Publisher: Oxford University Press  
Date Published: 2009-12-01
Start Page: 1624
End Page: 1632
Language: English
DOI: 10.1093/jnci/djp386
PUBMED: 19920223
PROVIDER: scopus
PMCID: PMC2786917
DOI/URL:
Notes: --- - "Cited By (since 1996): 2" - "Export Date: 30 November 2010" - "CODEN: JNCIA" - "Source: Scopus"
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MSK Authors
  1. Glenn Heller
    399 Heller
  2. Xiaoyu Jia
    46 Jia
  3. Ethan Martin Basch
    180 Basch
  4. Allison Barz
    11 Barz
  5. Alexia Elia Iasonos
    364 Iasonos
  6. Thomas Michael Atkinson
    155 Atkinson
  7. Shari Goldfarb
    151 Goldfarb
  8. Mark Kris
    870 Kris
  9. Laura S Sit
    22 Sit
  10. Ann E Culkin
    15 Culkin
  11. Mark Y Appawu
    2 Appawu