Freedman Robert R, Wasson Samuel
Departments of Obstetrics and Gynecology and Psychiatry and Behavioral Neurosciences, Wayne State University School of Medicine, Detroit, Michigan, USA.
Fertil Steril. 2007 Aug;88(2):494-6. doi: 10.1016/j.fertnstert.2006.11.184. Epub 2007 Apr 18.
To design and test a miniature ambulatory hot flash recorder that uses neither electrodes nor gel.
In the first study, putative hot flashes recorded by using a relative humidity sensor were compared with patient event marks. In the second study, relative humidity recorded by using a complete prototype recorder was compared with sternal skin conductance recordings made on a Biolog recorder, as well as with event marks.
University medical center.
PATIENT(S): Ten healthy postmenopausal women reporting frequent hot flashes and using no medication.
INTERVENTION(S): Body heating in laboratory.
MAIN OUTCOME MEASURE(S): Positive predictive value (PPV), sensitivity, specificity.
RESULT(S): In both laboratory studies, the PPV, sensitivity, and specificity among all three measures (relative humidity, skin conductance level, event) were 100%. In the field, a relative humidity increase of 3% per minute compared with skin conductance level-detected hot flashes yielded a PPV of 95.6%, a specificity of 95.2%, and a sensitivity of 90.9%.
CONCLUSION(S): This device should be useful as an endpoint in clinical trials of treatments for hot flashes.
设计并测试一种既不使用电极也不使用凝胶的微型动态潮热记录仪。
在第一项研究中,将使用相对湿度传感器记录的假定潮热与患者事件标记进行比较。在第二项研究中,将使用完整原型记录仪记录的相对湿度与在生物记录仪上进行的胸骨皮肤电导记录以及事件标记进行比较。
大学医学中心。
10名健康的绝经后女性,报告频繁潮热且未使用药物。
在实验室进行身体加热。
阳性预测值(PPV)、敏感性、特异性。
在两项实验室研究中,所有三项指标(相对湿度、皮肤电导水平、事件)的PPV、敏感性和特异性均为100%。在实际应用中,与皮肤电导水平检测到的潮热相比,相对湿度每分钟增加3%时,PPV为95.6%,特异性为95.2%,敏感性为90.9%。
该设备应可作为潮热治疗临床试验的一个终点。