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Project Title: Improving Measures of Hot Flashes
Program Officer:
Heather Miller, Ph.D.
Phone: 301-451-3453
E-mail: hmiller@mail.nih.gov
Background
Hot flashes or vasomotor symptoms are problematic for several patient populations, including breast cancer survivors, men undergoing androgen ablation therapy, menopausal women, women with chemotherapy-induced ovarian failure and surgically induced menopause. Many studies of hot flashes rely on self-reported measures of symptom frequency and severity. However, the instruments used to collect these data have not necessarily been validated, and these measures appear to be "unstable," subject to Hawthorne and placebo effects. Sternal skin conductance monitors have been used to collect objective data on hot flash frequency in laboratory and ambulatory studies. While laboratory studies have found a reasonable correlation between sternal skin conductance measures and self-reported hot flashes, ambulatory studies have found significant rates of false negative self-reports. Moreover, current monitors have physical limitations that prohibit long-term use in ambulatory settings. In the wake of the Women's Health Initiative findings, NCCAM will support trials of CAM modalities currently being used to reduce hot flashes. Improving both objective and subjective measures of hot flashes could improve the precision and economy of trials, especially for those treatments that may be relatively weak.
On January 20, 2004, NCCAM, in collaboration with seven other interested NIH ICs, convened a one-day workshop to assess existing measures of hot flashes and to think about how such measures could be improved. The workshop brought together scientists from a broad range of disciplines (e.g., bioengineering, physiology, clinicians, behavioral sciences). The group concluded that improving measures of hot flashes requires improved knowledge in several areas, including:
- The physical processes underlying hot flashes, which will also identify additional parameters to measure;
- Improved sternal skin conductance systems, with additional tools to be developed when other parameters of hot flashes are identified;
- The performance characteristics of questionnaires and diaries to collect self reported data on hot flash frequency;
- Improved and validated instruments for collecting data on intensity and interference with daily activities;
- The mechanism(s) of action of the placebo, which may also help distinguish natural attrition of symptoms from placebo effect;
- Animal models to elucidate triggers and mechanisms of hot flashes and to screen potential treatments.
This proposed initiative is consistent with the NIH Roadmap initiatives as it is directed at refining and validating self reported measures of symptoms through use of biomarkers and multidisciplinary research. This initiative is also responsive to the recommendations of the workshop, which concluded that this area warranted additional research to improve both our understanding of hot flashes and measurement systems used to evaluate potential therapies.
Purpose of Proposed Initiative
This initiative will support research on mechanisms and measurement of hot flashes.
Objectives
- To identify additional physiologic markers of hot flashes and develop tools to measure them that are suitable for use in ambulatory studies;
- To improve sensitivity and specificity of self-reported subjective measures;
- To improve basic understanding of hot flashes and the placebo effect reported in most clinical studies;
- To develop animal models of hot flashes to screen the myriad of CAM modalities proposed to manage hot flashes and the basic mechanisms associated with hot flashes.
Proposed Funding Mechanisms
R21, R01, SBIR.
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