To review systematically the outcome reporting and measures used to assess menopausal vasomotor symptoms from randomised controlled trials of treatments.
We searched MEDLINE, Embase, and Cochrane Central Register of Controlled Trials from inception to May 2018.
Randomised 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 about study characteristics, primary vasomotor-related outcomes and methods of measuring them.
The 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.
There 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.
Menopausal hot flushes and night sweats have been reported in 49 different ways in clinical research. A core outcome set is urgently required.
对随机对照治疗试验中用于评估更年期血管舒缩症状的结果报告和措施进行系统回顾。
我们搜索了MEDLINE,Embase,和Cochrane中央受控试验登记册从开始到2018年5月。
随机对照试验的主要结果是女性更年期血管舒缩症状,每个研究小组的样本量至少为20名女性。
有关研究特征的数据,主要血管舒缩相关结局及其测量方法。
搜索确定了5591项研究,其中214个被包括在内。确定了49种不同的主要报告结果的血管舒缩症状,并使用了16种不同的工具来测量这些结果。最常报告的结果是频率(97/214),严重程度(116/214),血管舒缩症状的强度(28/114)或这些结果的复合(68/214)。血管舒缩症状的频率和严重程度/强度的定义几乎没有一致性。
在治疗试验中,更年期血管舒缩症状的报道和测量方式存在很大差异。未来的研究应包括反映患者优先事项的标准化结局指标,临床医生,和研究人员。这是通过制定核心成果集最有效地实现的。这项系统评价是开发针对更年期血管舒缩症状的核心结果集的第一步。
在临床研究中,已报道了49种不同方式的更年期潮热和盗汗。迫切需要一套核心成果。