INTRODUCTION: Heavy menstrual bleeding (HMB) affects up to 30% of women at some point in their lives, having an important impact on their HRQoL. Despite the importance of this menstrual disorder, its management is complex due to the inconvenience of the techniques to assess real blood loss and the poor correlation between blood loss and women’s perception.

OBJECTIVES: To develop and validate a screening questionnaire to easily identify women of reproductive age with HMB in Spain.

METHODS: In the first phase of the study, literature research and discussion by an expert committee provided a set of items expected to discriminate women with HMB. In the second phase, a multicenter, observational study was conducted in order to assess the sensitivity and specificity of the selected items. After patients with and without HMB answered the questionnaire, a multivariate discriminant analysis was done by means of a logistic regression model to identify the subset of screening questions that better discriminated among HMB cases and controls.

RESULTS: The initial questionnaire contained 21 items, related to both quantity of bleeding and impact of bleeding in women’s daily activities. A total of 364 women (211 cases and 153 controls) answered this set of questions. All items showed significant differences between cases and controls (p<0.0001). The logistic regression model identified 6 items as the most important factors in discriminating between women with and without HMB, with a sensitivity of 86.7%, a specificity of 89.5% and an 87.9% of correct classification. Coefficients were rounded with natural numbers in order to facilitate score calculation in routine clinical practice, obtaining a score from 0 (no HMB) to 10 (maximum HMB) and a cut-off point of ≥ 3.

CONCLUSIONS: A valid questionnaire of 6 items has been developed to easily diagnose and identify women with HMB in a few minutes.