Qualitative study exploring which research outcomes best reflect women's experiences of heavy menstrual bleeding: stakeholder involvement in development of a core outcome set

ObjectiveThis work contributed to the development of a core outcome set (COS) for heavy menstrual bleeding (HMB). The objective was to determine which research outcomes best reflect how HMB affects women's lives and to identify additional research outcomes, not previously reported. It was important to explore and record participants' reasoning for prioritising outcomes and use this information to reinforce the patients' voice during later phases of the COS development. DesignPatient workshop discussions and telephone interviews. SettingEast London teaching hospital. ParticipantsInclusion criteria were that participants must be over 18 years old, that either they or their partner had a history of HMB and that they had a good understanding of written and spoken English. Results41 participants were recruited for the study. 8 women and 1 man completed the study. The eight female participants were representative of the different underlying causes and treatments for HMB. Participants ranged in age from their early 20s to their 60s and represented a range of ethnic groups. The five main themes that were identified as being important to patients were: 'restriction', 'relationships and isolation', 'emotions and self-perception', 'pain' and 'perceptions of treatment'. We identified eight coding nodes that did not correspond with our list of previously reported outcomes in studies of HMB. These nodes were consolidated and became five new outcomes for potential inclusion in the COS. ConclusionsHMB stops women living their lives as they would wish. It affects their relationships, education, careers, reproductive wishes, social life and mental health. This is a condition of girls and women in the prime of their lives, but for many, the constant threat of a heavy period starting means that they sacrifice that freedom. The societal and economic costs of women being incapacitated every month has an effect on everyone.

Automated summary

This study aimed to develop a core outcome set (COS) for heavy menstrual bleeding (HMB), determining the research outcomes that best reflect its impact on women's lives and identifying previously unreported outcomes. Patient workshop discussions and interviews were conducted to record participants' prioritization of outcomes. The study identified various important themes related to HMB and proposed new outcomes for potential inclusion in the COS. The findings highlight the significant impact of HMB on women's lives and the societal and economic costs associated with this condition.