Treatment options for women with heavy menstrual bleeding: a protocol for comprehensive systematic review, network meta-analyses and health economic assessment

Abstract

Introduction: A quarter of women experience heavy periods in their lifetime, often significantly impairing their well-being, productivity and quality of life.Several treatment options are offered for heavy menstrual bleeding; however, there is limited evidence on the effectiveness, safety and cost of available treatments. We aim to conduct a comprehensive systematic review, network meta-analyses and health economic evaluation to compare all available treatment options while considering the views and treatment preferences of women with heavy menstrual bleeding.

Methods and analysis: We will systematically search electronic databases (MEDLINE, EMBASE, CENTRAL) as well as the grey literature, conference proceedings and trial registries to identify all relevant randomised trials that evaluated any medical or surgical treatment for women with heavy menstrual bleeding regardless of their cause compared with placebo or other active treatments.We will perform pairwise and network meta-analyses using standard methods. We will report primarily on changes in menstrual blood loss (using Pictorial blood loss assessment chart scores or the Alkaline-Haematin method), quality-of-life measures, safety in addition to other important clinical outcomes.We will develop a health economic model to evaluate the cost-effectiveness of available treatments within a healthcare perspective using data inputs from the planned meta-analyses. We will calculate the incremental cost per change in alternative outcomes and present the net monetary benefit for a range of cost-effectiveness thresholds for quality-adjusted life-year gained. We will conduct consultations and a discrete choice experiment involving patient representatives to capture the factors influencing women's decision-making and treatment preferences in real life.

Ethics and dissemination: The project was approved by the UCL Institute for Women's Health Low-Risk Research Ethics Committee (reference: 004_2023_24) and UCL Research Ethics Committee (ID 16351/003) for the planned patient involvement and qualitative research. We will produce an evidence-based decision aid toolkit and will publish the findings in peer-reviewed journals, as well as lay media outputs to inform health professionals, policymakers and the patient community. PROSPERO REGISTRATION NUMBERS: https://doi.org/10.17605/OSF.IO/4MUSF, CRD42023468055, CRD42024519622, CRD42024520558 and CRD42024520634.

Keywords: GYNAECOLOGY; Health economics; Reproductive medicine; Systematic Review.