Minimal decrease in hot flashes desired by postmenopausal women in family practice.
OBJECTIVE
To determine the minimal important difference in the frequency and severity of hot flashes that postmenopausal women desire from a nonhormonal agent.


METHODS
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.
Butt
Debra A
DA
Scarborough Hospital, Department of Family and Community Medicine, University of Toronto, Ontario, Canada. dbutt@tsh.to
Deng
Linda Y R
LY
Lewis
Jacqueline E
JE
Lock
Michael
M
D000368:Aged; D015914:Estrogen Replacement Therapy; D005194:Family Practice; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy* / Q000453:epidemiology / Q000473:pathology / Q000523:psychology*; D006801:Humans; D015994:Incidence; D008593:Menopause; D008875:Middle Aged; D009864:Ontario / Q000453:epidemiology; D010342:Patient Acceptance of Health Care; D017060:Patient Satisfaction; D017698:Postmenopause / Q000502:physiology; D011788:Quality of Life; D012720:Severity of Illness Index