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Abstract
ObjectiveUterine fibroids are the most common benign tumours in women of the reproductive age. Symptoms of heavy menstrual bleeding, abdominal discomfort and infertility may seriously affect a woman’s quality of life. Uterine artery embolization is a safe and effective alternative treatment to hysterectomy or myomectomy for symptomatic uterine fibroids. Which treatment provides the highest quality of life, least complications, symptom reduction and least chance intervention, has not been established and might depend on strict patient selection. This study aims to identify which specific subgroups benefit most of each treatment by analyzing individual participant data derived from randomized controlled trials of women undergoing embolization or surgical treatment. This study will primarily assess the effectiveness of both treatment groups by evaluating the effect on quality of life of embolization in comparison to surgery on specific patient and fibroid characteristics and the possible need for re-intervention for fibroid-related symptoms. Data sourcesPubMed/MEDLINE, Embase and The Cochrane Library were searched up to August 2020. Study eligibility criteriaWe will collect individual participant data from randomized controlled trials that studied clinical and procedural outcomes of premenopausal women with symptomatic uterine fibroids, who were randomized between uterine artery embolization and surgery. Study appraisal and synthesis methodsIndividual participant data from all eligible trials will be sought and analysed according to intention-to-treat principle. Risk of Bias will be done by using version 2 of the Cochrane tool for Risk of Bias in randomized trials. Subgroup analyses to explore the effect of e.g. age, fibroid characteristics and fibroid complaints will be performed, if data is available. This individual patient data meta-analysis will be analysed according to a one-stage model.
Highlights
Treatment options range from medicinal treatment, to minimally invasive procedures such as uterine artery embolization (UAE), and more invasive surgical treatment in the form of myomectomy or hysterectomy [5]
Treatment options can depend on fibroid characteristics, which can complicate the counselling of patients [6]
This study aims to assess the efficacy of UAE compared with surgical treatment in women with uterine fibroids
Summary
Treatment options can depend on fibroid characteristics, which can complicate the counselling of patients [6]. Uncertainty remains with regards to whether specific patient characteristics and the underlying nature of the fibroid impact treatment outcomes. To enable that women requiring treatment make informed choices, it is essential to identify which patients experience greatest benefit for either treatment method. This individual participant data meta-analysis (IPD-MA) will be an international collaboration involving all trial investigators who conducted eligible RCTs and the IPD-MA research team (MAM; WH; BWM; JM, OW) to evaluate all available data. If sufficient data are available, a network meta-analysis will compare all treatment options (UAE, hysterectomy and myomectomy) and patient characteristics
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