A new tool to assess bleeding severity in patients with chemotherapy‐induced thrombocytopenia (CME)

Abstract

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). 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. 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. 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.