Linguistic Validation of a British-English Version of the SAMANTA Questionnaire and HMB-VAS Tool: A Step Toward Improved Diagnosis of Heavy Menstrual Bleeding.

Abstract

Background: Heavy menstrual bleeding (HMB) is a common disorder interfering with physical, emotional and social domains, and overall quality of life (QoL). The Heavy Menstrual Bleeding-Visual Analog Scale (HMB-VAS) tool, including the VAS for menstrual bleeding intensity (VAS-Int) and the VAS for its interference with daily activities (VAS-Imp), is useful for HMB screening. The SAMANTA questionnaire (SAMANTA-Q) was developed and psychometrically validated in Spanish to easily identify women with HMB. However, these instruments have not been validated in other languages. This study seeks to linguistically validate the SAMANTA-Q and the HMB-VAS tool in British English.

Methods: Linguistic validation was conducted following the principles laid out by the International Society for Health Economics and Outcomes Research (ISPOR). This process included two forward translations by two independent native English-speakers; reconciled version; two backward translations by two independent native Spanish-speakers; review and reconciliation; 60-minute cognitive debriefing interviews with women with HMB balanced by educational levels; analysis and integration of changes in the reconciled version; proofreading, and creation of the final version.

Results: No major issues were found in the linguistic validation process. Overall, cognitive debriefing participants with HMB considered that the SAMANTA-Q and the HMB-VAS tool were easy to read, comprehensive, quick to answer, and covered most of the issues related to HMB.

Conclusions: Linguistically validated British-English versions of the SAMANTA-Q and HMB-VAS tool are now available for clinical practice and research. These validated tools will be useful to easily diagnose excessive menstrual blood loss impacting on QoL.