Measurement of changes to the menstrual cycle: A transdisciplinary systematic review evaluating measure quality and utility for clinical trials.

Abstract

Despite the importance of menstruation and the menstrual cycle to health, human rights, and sociocultural and economic wellbeing, the study of menstrual health suffers from a lack of funding, and research remains fractured across many disciplines. We sought to systematically review validated approaches to measure four aspects of changes to the menstrual cycle-bleeding, blood, pain, and perceptions-caused by any source and used within any field. We then evaluated the measure quality and utility for clinical trials of the identified instruments. We searched MEDLINE, Embase, and four instrument databases and included peer-reviewed articles published between 2006 and 2023 that reported on the development or validation of instruments assessing menstrual changes using quantitative or mixed-methods methodology. From a total of 8,490 articles, 8,316 were excluded, yielding 174 articles reporting on 94 instruments. Almost half of articles were from the United States or United Kingdom and over half of instruments were only in English, Spanish, French, or Portuguese. Most instruments measured bleeding parameters, uterine pain, or perceptions, but few assessed characteristics of blood. Nearly 60% of instruments were developed for populations with menstrual or gynecologic disorders or symptoms. Most instruments had fair or good measure quality or clinical trial utility; however, most instruments lacked evidence on responsiveness, question sensitivity and/or transferability, and only three instruments had good scores of both quality and utility. Although we took a novel, transdisciplinary approach, our systematic review found important gaps in the literature and instrument landscape, pointing towards a need to examine the menstrual cycle in a more comprehensive, inclusive, and standardized way. Our findings can inform the development of new or modified instruments, which-if used across the many fields that study menstrual health and within clinical trials-can contribute to a more systemic and holistic understanding of menstruation and the menstrual cycle.