A new tool to assess bleeding severity in patients with chemotherapy-induced thrombocytopenia

Transfusion. 2012 Nov;52(11):2466-74; quiz 2465. doi: 10.1111/j.1537-2995.2012.03634.x. Epub 2012 Apr 9.

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).

Study design and 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.

Conclusion: 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.

Publication types

  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • Antineoplastic Agents / adverse effects*
  • Education, Medical, Continuing
  • Electronic Mail
  • Health Surveys
  • Hemorrhage / chemically induced
  • Hemorrhage / diagnosis*
  • Hemorrhage / drug therapy
  • Hemorrhage / mortality
  • Hemostatics / therapeutic use
  • Humans
  • Morbidity
  • Neoplasms / drug therapy
  • Neoplasms / mortality
  • Observer Variation
  • Platelet Transfusion
  • Psychometrics / methods
  • Psychometrics / standards*
  • Psychometrics / statistics & numerical data
  • Reproducibility of Results
  • Severity of Illness Index*
  • Thrombocytopenia / chemically induced
  • Thrombocytopenia / diagnosis*
  • Thrombocytopenia / drug therapy
  • Thrombocytopenia / mortality

Substances

  • Antineoplastic Agents
  • Hemostatics