Development of a screening questionnaire to detect heavy menstrual bleeding in women of child-bearing age

Josep Perelló Capo (ES), Joan Rius Tarruella (ES), Pau Pujol Pineda (ES), Montserrat Carrasco Rodriguez (ES), Joaquin Calaf Alsina (ES)

[Perelló Capo] Sant Pau Hospital, [Rius Tarruella] Bayer Hispania, Medical Affairs Department, [Pujol Pineda] Bayer Hispania, Medical Affairs Department, [Carrasco Rodriguez] Bayer Hispania, Medical Affairs Department, [Calaf Alsina] Sant Pau Hospital

Context: Heavy menstrual bleeding (HMB) affects up to 30 % of women at some point in their lives, having an important impact on their HRQoL. Nevertheless, the complexity of its management, due to the inconvenience of the techniques to assess the real blood loss and the poor correlation between blood loss and women perception, is currently a problem for both women and HCPs. Objective: To develop a Spanish screening questionnaire to easily identify HMB in women of reproductive age. Methods: This study consists of two phases: the conceptual development of a set of items candidates to discriminate those women with HMB (current abstract) and the assessment of their sensitivity and specificity to detect HMB. An extensive literature research was done to find scales and items previously used to detect abnormal uterine bleeding or impact of HMB in HRQoL. Then, a workshop session was conducted with a committee of 12 gynecologist experts in HMB, in order to elicit new items, select from available items or redefine them. Cognitive interviews were held with 10 women with HMB and results were presented and discussed with the expert committee to develop a final revised version of the questionnaire. Patients: Ten women with HMB according to NICE Guidelines definition, confirmed with a pictorial blood assessment chart (PBAC). The women selected were different in age, sociocultural level and origin to have the most representativeness in the sample. Intervention: Interviews were done in order to test the set of questions, their understanding and their formulation and to help to identify those questions that were not meaningful for women and to add other questions that had not been taken into account. Main Outcome Measure: Set of HMB screening questions. Results: Literature review identified 46 different items of which the scientific committee selected 27 questions. Following the results of the cognitive interviews, 9 questions were erased, 8 questions were redefined and 3 new questions were added. At the end, a questionnaire of 21 items was developed: 7 of the items are related with quantity of bleeding and 14 items are related with the impact of HMB in their daily activities. Conclusions: A Spanish questionnaire of 21 items has been developed to screen women with HMB. This questionnaire is currently under psychometric validation to assess its sensitivity and specificity to detect HMB, as a second phase of this study.