血管舒缩症状试验设计方法：绝经策略：寻找症状和健康网络的持久答案。
Methods for the design of vasomotor symptom trials: the menopausal strategies: finding lasting answers to symptoms and health network.
机构信息
From the 1Group Health Research Institute, Seattle, WA; 2School of Nursing, Indiana University, Indianapolis, IN; 3Data Coordinating Center, Fred Hutchinson Cancer Research Center, Seattle, WA; 4Division of Research, Kaiser Permanente of Northern California, Oakland, CA; 5Massachusetts General Hospital/Harvard Medical School, Boston, MA; 6VA Medical Center/University of Minnesota, Minneapolis, MN; 7Departments of Obstetrics/Gynecology and Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, PA; 8Department of Obstetrics/Gynecology and Department of Epidemiology, School of Public Health and Community Medicine, University of Washington, Seattle, WA; 9National Institute on Aging, US National Institutes of Health, Bethesda, MD; 10Center for Clinical Epidemiology and Statistics, University of Pennsylvania School of Medicine, Philadelphia, PA; and 11VA Center of Excellence for Implementing Evidence-Based Practice and Indiana University School of Medicine, Indianapolis, IN.
出版信息
Menopause. 2014 Jan;21(1):45-58. doi: 10.1097/GME.0b013e31829337a4.
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 ω-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.
目的
本报告描述了绝经策略：寻找持久缓解症状和健康网络以及在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而成立的，负责快速进行新型和研究不足的现有干预措施的随机试验，这些干预措施被推测可以缓解血管舒缩和其他绝经症状。包括干预措施和研究选择标准、常见的纳入和排除标准、常见的主要和次要结局指标、安慰剂反应的考虑、生物库的建立、试验持续时间、筛选和招募、统计方法和质量控制的描述和原理。所有试验设计均已呈现，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 5-羟色胺再摄取抑制剂艾司西酞普兰降低血管舒缩症状频率和严重程度的有效性；（2）一项两因素三因素析因设计试验，以测试三种不同干预措施（瑜伽、运动和 ω-3 补充剂）改善血管舒缩症状频率和困扰的效果；（3）一项比较三种有效性试验的研究，即 5-羟色胺-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相比，降低血管舒缩症状频率。还讨论了网络的结构和治理。
结论
分享绝经策略：寻找持久缓解症状和健康试验中使用的方法和经验教训，以鼓励和支持类似试验的进行，并鼓励与其他研究人员合作。
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