OBJECTIVE: To determine the minimal important difference in the frequency and severity of hot flashes that postmenopausal women desire from a nonhormonal agent. DESIGN: 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. RESULTS: 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%. CONCLUSIONS: 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.
OBJECTIVE: To determine the minimal important difference in the frequency and severity of hot flashes that postmenopausal women desire from a nonhormonal agent. DESIGN: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. RESULTS: 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%. CONCLUSIONS: 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.
Authors: Susan D Reed; Andrea Z LaCroix; Garnet L Anderson; Kristine E Ensrud; Bette Caan; Janet S Carpenter; Lee Cohen; Susan J Diem; Ellen W Freeman; Hadine Joffe; Joseph C Larson; Susan M McCurry; Caroline M Mitchell; Katherine M Newton; Barbara Sternfeld; Katherine A Guthrie Journal: Menopause Date: 2020-04 Impact factor: 2.953
Authors: Janet S Carpenter; Giorgos Bakoyannis; Julie L Otte; Chen X Chen; Kevin L Rand; Nancy Woods; Katherine Newton; Hadine Joffe; JoAnn E Manson; Ellen W Freeman; Katherine A Guthrie Journal: Menopause Date: 2017-08 Impact factor: 3.310
Authors: Graeme L Fraser; Samuel Lederman; Arthur Waldbaum; Robin Kroll; Nanette Santoro; Misun Lee; Laurence Skillern; Steven Ramael Journal: Menopause Date: 2020-04 Impact factor: 3.310