Butt Debra A, Deng Linda Y R, Lewis Jacqueline E, Lock Michael
Scarborough Hospital, Department of Family and Community Medicine, University of Toronto, Ontario, Canada.
Menopause. 2007 Mar-Apr;14(2):203-7. doi: 10.1097/01.gme.0000235370.32103.4c.
To determine the minimal important difference in the frequency and severity of hot flashes that postmenopausal women desire from a nonhormonal agent.
Women recorded their number of hot flashes daily, along with their degree of severity, using a diary for 1 week and completed the Menopause-Specific Quality of Life Questionnaire. Women were asked to report the percentage reduction in hot flashes that they would find clinically important. Distribution-based estimates were used to estimate the minimal important difference.
Approximately 69% of the postmenopausal women who reported their hot flashes as moderate to severe responded that they wanted a nonhormonal agent that provided at least a 50% mean reduction in the frequency of hot flashes (95% CI, 32% to 66%). Median hot flash reduction for all respondents was 50%.
The minimal clinically important difference in hot flashes is approximately 50%. This estimate can provide the basis to calculate sample size in clinical trials of anti-hot flash agents and in selecting possible candidates for investigation.
确定绝经后女性期望从非激素药物中获得的潮热频率和严重程度的最小重要差异。
女性使用日记记录其潮热的每日发作次数及其严重程度，持续1周，并完成特定于更年期的生活质量问卷。要求女性报告她们认为在临床上具有重要意义的潮热减少百分比。基于分布的估计用于估计最小重要差异。
约69%将潮热报告为中度至重度的绝经后女性表示，她们希望有一种非激素药物能使潮热频率平均降低至少50%（95%可信区间，32%至66%）。所有受访者潮热减少的中位数为50%。
潮热的最小临床重要差异约为50%。这一估计可为计算抗潮热药物临床试验的样本量以及选择可能的研究对象提供依据。
