Regulatory awareness, counseling priorities, and treatment choices in menopausal hormone therapy: a cross-sectional survey of obstetricians and gynecologists

OBJECTIVE: To examine whether clinicians' awareness of a recent US Food and Drug Administration (FDA) regulatory communication on menopausal hormone therapy (MHT) was associated with reported changes in clinical practice, counseling priorities, and treatment choices in standardized clinical vignettes. METHODS: This cross-sectional, web-based survey included 600 practicing obstetricians and gynecologists providing menopause or perimenopause care. A composite Regulatory Awareness Score was created from survey items addressing recognition of the regulatory action, perceived relevance, understanding of its rationale, and appraisal of its correctness and timeliness. The primary outcome was self-reported change in routine clinical approach after the regulatory communication. Multivariable logistic regression was used to examine the association between awareness and reported practice change. Ranked counseling factors were compared across awareness tertiles, and vignette choices were examined using multinomial logistic regression. RESULTS: Regulatory awareness was not independently associated with reporting a change in clinical practice (adjusted odds ratio [aOR]: 0.89; 95% CI: 0.69-1.14; P=0.345). Higher odds of reported change were associated with use of a standard hormone therapy protocol (aOR: 1.50; 95% CI: 1.05-2.14; P=0.024), more favorable perceptions of compounded bioidentical hormone therapy (BHT) (aOR: 1.85; 95% CI: 1.35-2.54; P<0.001), stronger prioritization of patient preference (aOR: 1.21; 95% CI: 1.06-1.38; P=0.004), and higher menopause patient volume (aOR: 1.01; 95% CI: 1.00-1.01; P=0.042). Across awareness tertiles, counseling priorities were broadly similar, with only modest differences for symptom severity. In vignette analyses, higher awareness was associated with lower relative selection of compounded BHT in a context-dependent manner. CONCLUSION: Regulatory awareness alone did not explain self-reported change in menopausal hormone therapy practice after adjustment for clinician characteristics, protocol use, BHT perceptions, and counseling priorities. BHT perceptions, use of a standard protocol, and patient-preference prioritization showed stronger associations with reported change, whereas awareness was more clearly reflected in vignette-based treatment choices than in global self-reported practice change.