title: A new tool to assess bleeding severity in patients with chemotherapy-induced thrombocytopenia.
abstract: BACKGROUND
  Current scales to measure bleeding in clinical trials are inadequate. The aim of this study was to develop a simple, valid, and reliable measurement tool to categorize the severity of bleeding in patients with chemotherapy-induced thrombocytopenia (CIT).
  
  
  METHODS
  Measurement theory was used to develop the Bleeding Severity Measurement Scale (BSMS) in four steps: 1) identification of the patient population, 2) item generation and reduction, 3) reviewing the items and formatting the scale, and 4) evaluation of psychometric properties. Feasibility was tested in a pilot study. Content and face validity were assessed by expert review. Psychometric evaluation included determination of intra- and interrater reliability and construct and criterion validity.
  
  
  RESULTS
  The final BSMS defined two grades of bleeding: not clinically significant (Grade 1) and clinically significant (Grade 2). Grade 2 bleeds were defined as bleeds resulting in morbidity, requiring interventions, or directly causing death. The BSMS had excellent interrater (intraclass correlation coefficient [ICC], 0.80) and intrarater (ICC, 1.0) reliability and good construct and criterion validity. The BSMS distinguished between patients with different bleeding severities.
  
  
  CONCLUSIONS
  Using rigorous methods, we designed a simple bleeding assessment tool with excellent psychometric properties for patients with CIT. Use of this scale in clinical trials should provide valid and reliable assessments of bleeding.
authors.affiliation: Department of Medicine, McMaster University, Hamilton, Ontario, Canada. webertk@mcmaster.ca
authors.forename: Kathryn E
authors.initials: KE
authors.lastname: Webert
authors.forename: Donald M
authors.initials: DM
authors.lastname: Arnold
authors.forename: Yang
authors.initials: Y
authors.lastname: Lui
authors.forename: Julie
authors.initials: J
authors.lastname: Carruthers
authors.forename: Emmy
authors.initials: E
authors.lastname: Arnold
authors.forename: Nancy M
authors.initials: NM
authors.lastname: Heddle
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects*; D004502:Education, Medical, Continuing; D034742:Electronic Mail; D006306:Health Surveys; D006470:Hemorrhage / Q000139:chemically induced / Q000175:diagnosis* / Q000188:drug therapy / Q000401:mortality; D006490:Hemostatics / Q000627:therapeutic use; D006801:Humans; D009017:Morbidity; D009369:Neoplasms / Q000188:drug therapy / Q000401:mortality; D015588:Observer Variation; D017713:Platelet Transfusion; D011594:Psychometrics / Q000379:methods / Q000592:standards* / Q000706:statistics & numerical data; D015203:Reproducibility of Results; D012720:Severity of Illness Index; D013921:Thrombocytopenia / Q000139:chemically induced / Q000175:diagnosis* / Q000188:drug therapy / Q000401:mortality
chemical_list: D000970:Antineoplastic Agents; D006490:Hemostatics