Laboratory and ambulatory evaluation of vasomotor symptom monitors from the Menopause Strategies Finding Lasting Answers for Symptoms and Health network.
Laboratory and ambulatory evaluation of vasomotor symptom monitors from the Menopause Strategies Finding Lasting Answers for Symptoms and Health network.
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DOI：
10.1097/gme.0b013e31823dbbe3
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发表时间：
2012-06
期刊：
影响因子：
--
通讯作者：
Milata JL
中科院分区：
文献类型：
--
作者：
Carpenter JS;Newton KM;Sternfeld B;Joffe H;Reed SD;Ensrud KE;Milata JL
在使用MsFLASH网络临床试验测试血管运动症状(VMS)疗法之前，评估实验室和门诊环境中用于评估血管运动症状(VMS)的监测器。这是一项分三个阶段进行的研究：第一阶段--弗里德曼和BAHER MONITOR™原型的实验室测试；第二阶段--商用BHHER MONITOR™和BIOLOG™的实验室测试；以及第三阶段--BAHER MONITOR™和BIOLOG™的非卧床测试。所有阶段都有患有VMS的中年女性、没有VMS的中年女性和没有VMS的年轻女性。参与者通过按下事件标记按钮自我报告VMS。调查问卷评估了人口统计情况(所有阶段)并监测可接受性(阶段2和阶段3)。由于弗里德曼装置对环境湿度变化的敏感性，以及缺乏原型机BHAIR MONITOR™的分析软件，第一阶段测试被停止。在第2和第3阶段，在实验室中，事件标记的VMS和商业的BAHR或BIOLOG™记录的VMS之间的一致性高于门诊环境，然而，在3组实验室中的2组(中年无VMS和年轻的无VMS)和所有活动组中，监测仪之间的一致性较差。在动态监测中，BHHER MODITOR™VMS的平均数量在患有VMS的中年妇女中为16.33，在未患VMS的中年妇女中为9.61，在未患VMS的年轻妇女中为14.63(软件版本，2011年3月)。巴尔显示器™比更大的Biolog™更容易接受，但反馈反映了不得不佩戴一个让人发痒并且在衣服下面可以看到的设备的烦恼。BAHER MONITOR™和BIOLOG™似乎适合在受控的实验室条件下短时间内使用。然而，目前版本的这些监护仪可能不适合此时进行门诊临床试验。
To evaluate monitors for assessing vasomotor symptoms (VMS) in laboratory and ambulatory settings prior to use in the MsFLASH network clinical trials testing VMS therapies. This was a 3-phase study: Phase 1 - laboratory testing of the Freedman and prototype Bahr Monitor™; Phase 2 - laboratory testing of the commercial Bahr Monitor™ and Biolog™; and Phase 3 - ambulatory testing of the commercial Bahr Monitor™ and Biolog™. All phases enrolled midlife women with VMS, midlife women without VMS, and young women without VMS. Participants self-reported VMS by pressing event marker buttons. Questionnaires assessed demographics (all phases) and monitor acceptability (phases 2 and 3). Phase I testing was stopped due to sensitivity of the Freedman device to ambient humidity changes and lack of analytic software for the prototype Bahr Monitor™. In phases 2 and 3, agreement between event-marked and commercial Bahr or Biolog™-recorded VMS was higher in the laboratory than the ambulatory setting, however, agreement between monitors was poor in 2 of 3 laboratory groups (midlife no VMS and young no VMS) and all ambulatory groups. During ambulatory monitoring, the mean number of Bahr Monitor™ VMS was 16.33 in midlife women with VMS, 9.61 in midlife women without VMS, and 14.63 in young women without VMS (software version March, 2011). The Bahr Monitor™ was more acceptable than the larger Biolog™, but feedback reflected annoyance at having to wear a device that itched and was visible under clothing. The Bahr Monitor™ and Biolog™ appear suitable for use in controlled, laboratory conditions over short periods of time. However, the current versions of these monitors may not be suitable for ambulatory clinical trials at this time.
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影响因子：
7.2
作者：
Carpenter, JS;Monahan, PO
通讯作者：
Monahan, PO
DOI：
10.1097/gme.0b013e3181cbb3c6
发表时间：
2010-05-01
影响因子：
2.7
作者：
Sievert, Lynnette L.;Reza, Angela;Brown, Daniel E.
通讯作者：
Brown, Daniel E.
DOI：
10.1097/00042192-199906030-00006
发表时间：
1999-09-01
影响因子：
2.7
作者：
Carpenter, JS;Andrykowski, MA;Munn, R
通讯作者：
Munn, R
影响因子：
6.7
作者：
Freedman, Robert R.;Wasson, Samuel
通讯作者：
Wasson, Samuel
影响因子：
3.7
作者：
FREEDMAN, RR
通讯作者：
FREEDMAN, RR