Summary Introduction/Aim Our aim was to generate, optimize and validate a self-administered bleeding assessment tool (BAT) for von Willebrand disease (VWD). Methods In Phase 1, medical terminology in the expert-administered ISTH-BAT was converted to a grade 4 reading level to produce the first version of the Self-BAT which was then optimized to ensure agreement with the ISTH-BAT. In Phase 2, the normal range of bleeding scores was determined and test-retest reliability analyzed. In Phase 3, the optimized Self-BAT was tested as a screening tool for first time referrals to the Hematology clinic. Results BS from the final optimized version of the Self-BAT showed an excellent intra-class correlation coefficient (ICC) of 0.87 with ISTH-BAT BS in Phase 1. In Phase 2, the normal range of bleeding scores for the optimized Self-BAT was determined to be 0 to +5 for females and 0 to +3 for males and excellent test-retest reliability was shown (ICC = 0.95). In Phase 3, we showed that a positive Self-BAT BS (≥ 6 for females, ≥ 4 for males) has a sensitivity of 78%, specificity of 23%, positive predictive value (PPV) of 0.15 and negative predictive value (NPV) of 0.86 for VWD; these figures improved when just the females were analyzed; sensitivity of 100%, specificity of 21%, PPV=0.17 and NPV=1.0. Conclusion We show an optimized Self-BAT can generate comparable BS to the expert-administered ISTH-BAT and is a reliable, effective screening tool to incorporate into the assessment of individuals, particularly women, referred for a possible bleeding disorder.

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