Usefulness of the Heavy Menstrual Bleeding Diagnostic Tools SAMANTA Questionnaire and Heavy Menstrual Bleeding-Visual Analog Scale Tool for Iron Deficiency Screening: An Exploratory Analysis from the COLIBRI Study.

BACKGROUND: The SAMANTA questionnaire and the Heavy Menstrual Bleeding-Visual Analog Scale (HMB-VAS) tool have been validated for diagnosing heavy menstrual bleeding (HMB). We assessed their value for screening iron deficiency (ID). MATERIAL AND METHODS: Post hoc analysis of the prospective, randomized, phase 4 Cooper and Levonorgestrel Intrauterine Device (IUD) Barcelona Research Iniciative (COLIBRI) study, which assessed the bleeding profile of two intrauterine devices. We used information collected during the last follow-up visit (month 36): sociodemographics, hemoglobin/ferritin levels, SAMANTA questionnaire, HMB-VAS tool, and EuroQoL five-dimension five-level scores. The primary outcome was the accuracy of these diagnostic tools in identifying ID. We also assessed their relationship with EQ-5D-5L. RESULTS: We analyzed information from 57 women, 18 (31.6%) and 14 (24.6%) with HMB according to the SAMANTA questionnaire and the HMB-VAS tool, respectively. Ferritin levels showed better inverse correlation than hemoglobin with these HMB diagnostic tools' scores: r = -0.539 and r = -0.557, respectively, both p < 0.001. In women with HMB according to these tools, the ferritin threshold showing the best sensitivity and specificity to identify ID was <10 ng/mL with the SAMANTA questionnaire (71.4% [Confidence Interval (CI) 95% 35.2-93.5] and 78% [CI 95% 65.2-87.7], respectively) and <15 ng/mL for the HMB-VAS tool (58.3% [CI 95% 31.2-87.7] and 82.2% [CI 95% 69.2-91.2], respectively). Only the EQ-VAS scores correlated inversely with the scores of both HMB diagnostic tools (r = -0.308, p = 0.02, and r = -0.294, p = 0.026, respectively). CONCLUSIONS: This exploratory analysis shows the SAMANTA questionnaire's good potential for ID screening. The scores of both HMB diagnostic tools correlated with the EQ-VAS, demonstrating their value in capturing the HMB impact on quality of life.