Methods for the design of vasomotor symptom trials: the Menopausal Strategies: Finding Lasting Answers to Symptoms and Health network
Methods for the design of vasomotor symptom trials: the Menopausal Strategies: Finding Lasting Answers to Symptoms and Health network
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DOI：
10.1097/gme.0b013e31829337a4
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发表时间：
2014-01-01
影响因子：
2.7
通讯作者：
LaCroix, Andrea Z.
中科院分区：
文献类型：
--
作者：
Newton, Katherine M.;Carpenter, Janet S.;LaCroix, Andrea Z.
目的：本报告描述了更年期策略：寻找症状和健康的持久答案网络以及设计和实施血管舒缩症状试验中解决的方法学问题。方法：该网络是应美国国立卫生研究院的申请要求而建立的，负责对假定可减轻血管舒缩和其他更年期症状的新型且未经充分研究的现有干预措施进行快速通量随机试验。其中包括干预措施和研究选择所用标准的描述和理由、常见的资格和排除标准、常见的主要和次要结局指标、安慰剂反应的考虑、生物样本库的建立、试验持续时间、筛选和招募、统计方法和质量控制。列出了所有试验设计，包括以下内容：（1）一项随机、双盲、安慰剂对照临床试验，旨在评估选择性血清素再摄取抑制剂艾司西酞普兰在降低血管舒缩症状频率和严重程度方面的有效性； (2) 一项二乘三析因设计试验，测试三种不同的干预措施（瑜伽、锻炼和补充 omega-3）对血管舒缩症状频率和困扰的改善情况； (3) 血清素-去甲肾上腺素再摄取抑制剂文拉法辛和低剂量口服雌二醇与安慰剂在降低血管舒缩症状频率方面的三组疗效比较试验。还讨论了该网络的结构和治理。 结论：分享“更年期策略：寻找症状和健康的持久答案”试验中使用的方法和从中吸取的教训，以鼓励和支持类似试验的进行，并鼓励与其他研究人员的合作。
Objective: This report describes the Menopausal Strategies: Finding Lasting Answers to Symptoms and Health network and methodological issues addressed in designing and implementing vasomotor symptom trials.Methods: Established in response to a National Institutes of Health request for applications, the network was charged with conducting rapid throughput randomized trials of novel and understudied available interventions postulated to alleviate vasomotor and other menopausal symptoms. Included are descriptions of and rationale for criteria used for interventions and study selection, common eligibility and exclusion criteria, common primary and secondary outcome measures, consideration of placebo response, establishment of a biorepository, trial duration, screening and recruitment, statistical methods, and quality control. All trial designs are presented, including the following: (1) a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effectiveness of the selective serotonin reuptake inhibitor escitalopram in reducing vasomotor symptom frequency and severity; (2) a two-by-three factorial design trial to test three different interventions (yoga, exercise, and omega-3 supplementation) for the improvement of vasomotor symptom frequency and bother; and (3) a three-arm comparative efficacy trial of the serotonin-norepinephrine reuptake inhibitor venlafaxine and low-dose oral estradiol versus placebo for reducing vasomotor symptom frequency. The network's structure and governance are also discussed.Conclusions: The methods used in and the lessons learned from the Menopausal Strategies: Finding Lasting Answers to Symptoms and Health trials are shared to encourage and support the conduct of similar trials and to encourage collaborations with other researchers.