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首页> 外文期刊>BJOG: an international journal of obstetrics and gynaecology >Variation in menopausal vasomotor symptoms outcomes in clinical trials: a systematic review
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Variation in menopausal vasomotor symptoms outcomes in clinical trials: a systematic review

机译：临床试验中更年期血管运动症状结果的变异：系统审查

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Background 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. Objectives To review systematically the outcome reporting and measures used to assess menopausal vasomotor symptoms from randomised controlled trials of treatments. Search strategy We searched MEDLINE, Embase, and Cochrane Central?Register of Controlled Trials from inception to May 2018. Selection criteria 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 collection and analysis Data about study characteristics, primary vasomotor‐related outcomes and methods of measuring them. Main results 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. Conclusions 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. Tweetable summary Menopausal hot flushes and night sweats have been reported in 49 different ways in clinical research. A core outcome set is urgently required.
机译：背景技术在干预研究中如何报告并测量日常血管运动症状和测量的症状。这阻止了治疗和有限的数据合成之间有意义的比较。目的是系统地审查的结果报告和措施，用于评估来自随机对照治疗的随机对照试验的日期血管血管症状。搜索策略我们搜索了Medline，Emamase和Cochrane Central？从2008年5月开始的受控试验登记。选择标准随机对照试验，妇女中年期血管运动症状的主要结果以及至少20名妇女的样本量为每组臂。关于研究特征的数据收集和分析数据，初级血管相关结果和测量方法的方法。主要结果搜索确定了5591项研究，其中214名包括在内。鉴定了四十九种不同的主要报告的结果，用于血管运动症状，并使用16种不同的工具来衡量这些结果。最常见的结果是频率（97/214），严重程度（116/214）和激素症状的强度（28/114）或这些结果的综合（68/214）。如何定义血管运动症状的频率和严重程度/强度几乎没有一致。结论如何在治疗试验中报告和测量日常血管运动症状和测量的多余血管血管症状的变化。未来的研究应包括反映患者，临床医生和研究人员优先事项的标准化结果措施。这是通过开发核心结果集的最有效实现的。这种系统审查是迈向日期血管血管毒素症状的核心结果发展的第一步。临床研究中的49种不同方式报告了Tweelable Substmausal热冲洗和夜间汗水。迫切需要核心结果集。

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