title: Reliability of adverse symptom event reporting by clinicians.
abstract: OBJECTIVE
  Adverse symptom event reporting is vital as part of clinical trials and drug labeling to ensure patient safety and inform risk-benefit decision making. The purpose of this study was to assess the reliability of adverse event reporting of different clinicians for the same patient for the same visit.
  
  
  METHODS
  A retrospective reliability analysis was completed for a sample of 393 cancer patients (42.8% men; age 26-91, M = 62.39) from lung (n = 134), prostate (n = 113), and Ob/Gyn (n = 146) clinics. These patients were each seen by two clinicians who independently rated seven Common Terminology Criteria for Adverse Events (CTCAE) symptoms. Twenty-three percent of patients were enrolled in therapeutic clinical trials.
  
  
  RESULTS
  The average time between rater evaluations was 68 min. Intraclass correlation coefficients were moderate for constipation (0.50), diarrhea (0.58), dyspnea (0.69), fatigue (0.50), nausea (0.52), neuropathy (0.71), and vomiting (0.46). These values demonstrated stability over follow-up visits. Two-point differences, which would likely affect treatment decisions, were most frequently seen among symptomatic patients for constipation (18%), vomiting (15%), and nausea (8%).
  
  
  CONCLUSIONS
  Agreement between different clinicians when reporting adverse symptom events is moderate at best. Modification of approaches to adverse symptom reporting, such as patient self-reporting, should be considered.
authors: Department of Psychiatry and Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, 641 Lexington Ave., 7th Floor, New York, NY 10022, USA. atkinsot@mskcc.org
authors: Thomas M
authors: TM
authors: Atkinson
authors: Yuelin
authors: Y
authors: Li
authors: Charles W
authors: CW
authors: Coffey
authors: Laura
authors: L
authors: Sit
authors: Mary
authors: M
authors: Shaw
authors: Dawn
authors: D
authors: Lavene
authors: Antonia V
authors: AV
authors: Bennett
authors: Mike
authors: M
authors: Fruscione
authors: Lauren
authors: L
authors: Rogak
authors: Jennifer
authors: J
authors: Hay
authors: Mithat
authors: M
authors: Gönen
authors: Deborah
authors: D
authors: Schrag
authors: Ethan
authors: E
authors: Basch
mesh_terms: D002986:Clinical Trials as Topic; D003625:Data Collection / Q000592:standards*; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*; D010820:Physicians; D015203:Reproducibility of Results; D012189:Retrospective Studies; D018570:Risk Assessment