Abstract
BackgroundThere is substantial variation in how menopausal vasomotor symptoms are reported and measured among intervention studies. This has prevented meaningful comparisons between treatments and limited data synthesis.ObjectivesTo review systematically the outcome reporting and measures used to assess menopausal vasomotor symptoms from randomised controlled trials of treatments.Search strategyWe searched MEDLINE, Embase, and Cochrane Central Register of Controlled Trials from inception to May 2018.Selection criteriaRandomised controlled trials with a primary outcome of menopausal vasomotor symptoms in women and a sample size of at least 20 women per study arm.Data collection and analysisData about study characteristics, primary vasomotor‐related outcomes and methods of measuring them.Main resultsThe search identified 5591 studies, 214 of which were included. Forty‐nine different primary reported outcomes were identified for vasomotor symptoms and 16 different tools had been used to measure these outcomes. The most commonly reported outcomes were frequency (97/214), severity (116/214), and intensity (28/114) of vasomotor symptoms or a composite of these outcomes (68/214). There was little consistency in how the frequency and severity/intensity of vasomotor symptoms were defined.ConclusionsThere is substantial variation in how menopausal vasomotor symptoms have been reported and measured in treatment trials. Future studies should include standardised outcome measures which reflect the priorities of patients, clinicians, and researchers. This is most effectively achieved through the development of a Core Outcome Set. This systematic review is the first step towards development of a Core Outcome Set for menopausal vasomotor symptoms.Tweetable summaryMenopausal hot flushes and night sweats have been reported in 49 different ways in clinical research. A core outcome set is urgently required.
Highlights
There is general agreement that vasomotor symptoms are the most common and problematic menopausal symptom.[1,2] Vasomotor symptoms are the leading patient priority for treatment.[3]
BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd on behalf of Royal College of Obstetricians and Gynaecologists
We included all randomised controlled trials (RCTs) with a primary outcome of female menopausal vasomotor symptoms and a sample size of at least 20 women per study arm to minimise the likelihood of including feasibility or pilot studies[14]
Summary
There is general agreement that vasomotor symptoms (hot flushes and night sweats) are the most common and problematic menopausal symptom.[1,2] Vasomotor symptoms are the leading patient priority for treatment.[3] Oestrogencontaining menopausal hormone therapy (MHT) is an effective treatment for menopausal vasomotor symptoms; use of MHT has fallen substantially following concerns about safety.[4] There is a growing focus on the development and evaluation of nonpharmacological and nonhormonal treatments for vasomotor symptoms.[5] In a 2019 The Authors. There is substantial variation in how menopausal vasomotor symptoms are reported and measured among intervention studies. This has prevented meaningful comparisons between treatments and limited data synthesis
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