Menopause: The Journal of The North American Menopause Society Vol. 22, No. 2, pp. 207/211 DOI: 10.1097/gme.0000000000000299 * 2014 by The North American Menopause Society
Miniature hygrometric hot flush recorder as an objective indicator of hot flushes: a validation study Moniek van der Zanden, MD,1 Petri van Gastel, MD,2 Laszlo Bancsi, MD,1 and Hans de Boer, MD, PhD2 Abstract Objective: Hot flushes are a very common symptom of menopause for which many women seek medical help. Accurate assessment of clinical severity and of the impact of treatment is limited by a lack of methods for objective hot flush recording. The aim of the current study is to test the diagnostic value of a miniature hygrometric hot flush recorder (HFR). Methods: The HFR was tested in 50 women with severe postmenopausal hot flushes. Results were compared with recordings in 27 asymptomatic postmenopausal women, 12 premenopausal women, and 12 age-matched healthy men. The number of HFR events was compared with the number of diary-reported hot flushes. Results: Healthy young women and men had a mean (SEM) of 17.3 (1.3) HFR events/day. Asymptomatic postmenopausal women had 13.6 (1.4) HFR events/day, whereas symptomatic postmenopausal women had 21.0 (1.0) HFR events/day (P G 0.001). The number of HFR events in symptomatic women was significantly higher than the number of diary-reported hot flushes (mean [SEM], 13.8 [0.6] hot flushes/d) (P G 0.001). HFR sensitivity to diary-reported hot flushes was 55.1%, with 61.4% specificity. Conclusions: The miniature hygrometric HFR has limited sensitivity and specificity. It detects sweating in general but does not differentiate between natural sweating and hot flushYrelated sweating. However, it may become useful as a tool for improving the data quality of diary-reported hot flushes. Key Words: Hot flushes Y Hot flush recorder Y Menopause.
M
ost postmenopausal (PMP) women are at least transiently affected by hot flushes. Although hot flushes are commonly accepted as a natural but uncomfortable phenomenon that will pass in time, their severity is problematic and reduces quality of life in up to 40% of women.1 Many treatment options, with substantial differences in efficacy and safety profiles, are available. Hormone therapy is the most effective treatment by far, but most doctors and symptomatic women are reluctant to use this treatment because it increases the risk of breast cancer.2 The choice of treatment is a balanced decision based on symptom severity, drug efficacy, and drug adverse effects. New treatment strategies are currently under investigation, but assessment of efficacy is hampered by methodological difficulties. Hot flush severity is usually evaluated by diary reports, where women record the frequency and severity of hot flushes, and the combined data are used to calculate the hot flush severity score.3 In addition, menopause-specific questionnaires are used to assess the degree of bother that is caused by PMP Received March 28, 2014; revised and accepted May 29, 2014. From the Departments of 1Obstetrics and Gynecology and 2Internal Medicine, Rijnstate Hospital, Arnhem, the Netherlands. Funding/support: None. Financial disclosure/conflicts of interest: None reported. Address correspondence to: Petri van Gastel, MD, Department of Internal Medicine, Rijnstate Hospital, PO Box 9555, Arnhem 6800 TA, the Netherlands. E-mail: [email protected]
hot flushes.4,5 Although these methods provide valuable information, they have significant limitations. A reliable assessment of the hot flush severity score requires a great deal of discipline to avoid underreporting during daytime, when focused attention is required for the work at hand. Accurate recording of hot flushes at night is even more challenging. Both overreporting and underreporting of symptoms occur frequently.6 Next to self-reports (diary or event marker), several recording devices have been developed.7
Miniature hygrometric hot flush recorder as an objective indicator of hot flushes: a validation study Moniek van der Zanden, MD,1 Petri van Gastel, MD,2 Laszlo Bancsi, MD,1 and Hans de Boer, MD, PhD2 Abstract Objective: Hot flushes are a very common symptom of menopause for which many women seek medical help. Accurate assessment of clinical severity and of the impact of treatment is limited by a lack of methods for objective hot flush recording. The aim of the current study is to test the diagnostic value of a miniature hygrometric hot flush recorder (HFR). Methods: The HFR was tested in 50 women with severe postmenopausal hot flushes. Results were compared with recordings in 27 asymptomatic postmenopausal women, 12 premenopausal women, and 12 age-matched healthy men. The number of HFR events was compared with the number of diary-reported hot flushes. Results: Healthy young women and men had a mean (SEM) of 17.3 (1.3) HFR events/day. Asymptomatic postmenopausal women had 13.6 (1.4) HFR events/day, whereas symptomatic postmenopausal women had 21.0 (1.0) HFR events/day (P G 0.001). The number of HFR events in symptomatic women was significantly higher than the number of diary-reported hot flushes (mean [SEM], 13.8 [0.6] hot flushes/d) (P G 0.001). HFR sensitivity to diary-reported hot flushes was 55.1%, with 61.4% specificity. Conclusions: The miniature hygrometric HFR has limited sensitivity and specificity. It detects sweating in general but does not differentiate between natural sweating and hot flushYrelated sweating. However, it may become useful as a tool for improving the data quality of diary-reported hot flushes. Key Words: Hot flushes Y Hot flush recorder Y Menopause.
M
ost postmenopausal (PMP) women are at least transiently affected by hot flushes. Although hot flushes are commonly accepted as a natural but uncomfortable phenomenon that will pass in time, their severity is problematic and reduces quality of life in up to 40% of women.1 Many treatment options, with substantial differences in efficacy and safety profiles, are available. Hormone therapy is the most effective treatment by far, but most doctors and symptomatic women are reluctant to use this treatment because it increases the risk of breast cancer.2 The choice of treatment is a balanced decision based on symptom severity, drug efficacy, and drug adverse effects. New treatment strategies are currently under investigation, but assessment of efficacy is hampered by methodological difficulties. Hot flush severity is usually evaluated by diary reports, where women record the frequency and severity of hot flushes, and the combined data are used to calculate the hot flush severity score.3 In addition, menopause-specific questionnaires are used to assess the degree of bother that is caused by PMP Received March 28, 2014; revised and accepted May 29, 2014. From the Departments of 1Obstetrics and Gynecology and 2Internal Medicine, Rijnstate Hospital, Arnhem, the Netherlands. Funding/support: None. Financial disclosure/conflicts of interest: None reported. Address correspondence to: Petri van Gastel, MD, Department of Internal Medicine, Rijnstate Hospital, PO Box 9555, Arnhem 6800 TA, the Netherlands. E-mail: [email protected]
hot flushes.4,5 Although these methods provide valuable information, they have significant limitations. A reliable assessment of the hot flush severity score requires a great deal of discipline to avoid underreporting during daytime, when focused attention is required for the work at hand. Accurate recording of hot flushes at night is even more challenging. Both overreporting and underreporting of symptoms occur frequently.6 Next to self-reports (diary or event marker), several recording devices have been developed.7
