Development and Psychometric Validation of a Screening Questionnaire to Detect Excessive Menstrual Blood Loss That Interferes in Quality of Life: The SAMANTA Questionnaire

Abstract

Background: Heavy menstrual bleeding (HMB) affects up to 35% of women at some point in their lives, and has an important impact on their quality of life (QoL). Current techniques to assess and quantify menstrual blood loss are inconvenient and the correlation between actual and perceived blood loss is poor. This study aimed to develop and validate a screening questionnaire in Spanish to identify HMB in women of reproductive age. Methods: The study consisted of two phases: the conceptual development of a set of items to discriminate between women with and without HMB and the assessment of the sensitivity and specificity of these items. Correlation of the screening tool with women's perception of the intensity of bleeding and the interference in their daily life activities was also assessed. Results: An initial set of 46 items were identified, from which 21 items were selected following the cognitive interviews. For the psychometric validation phase, 389 patients were enrolled, of whom 364 were assessable: 211 cases with Pictorial Blood loss Assessment Chart-confirmed excessive menstrual loss (EML) and 153 controls. Six items met entry criteria in the model and together yielded a sensitivity of 86.7% and specificity of 89.5% to identify cases and controls. These items were weighted according to their contribution to the final model to yield a tool that can be scored from 0 to 10 being 3 the cutoff point to diagnose EML that interferes in QoL. Conclusions: The 6-item SAMANTA questionnaire represents a valid screening tool to easily identify women with EML that interfere with QoL.

Keywords: gynecology; heavy menstrual bleeding; psychometric validation; questionnaire; screening.