title: Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: results of a questionnaire-based study.
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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY, USA. basche@mskcc.org
authors.forename: Ethan
authors.initials: E
authors.lastname: Basch
authors.forename: Alexia
authors.initials: A
authors.lastname: Iasonos
authors.forename: Tiffani
authors.initials: T
authors.lastname: McDonough
authors.forename: Allison
authors.initials: A
authors.lastname: Barz
authors.forename: Ann
authors.initials: A
authors.lastname: Culkin
authors.forename: Mark G
authors.initials: MG
authors.lastname: Kris
authors.forename: Howard I
authors.initials: HI
authors.lastname: Scher
authors.forename: Deborah
authors.initials: D
authors.lastname: Schrag
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects*; D002986:Clinical Trials as Topic / Q000379:methods*; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010361:Patients; D010820:Physicians; D015203:Reproducibility of Results; D012107:Research Design; D011795:Surveys and Questionnaires; D014565:Urogenital Neoplasms / Q000188:drug therapy*
chemical_list: D000970:Antineoplastic Agents