Biomedical subjects

Jacqueline E Lewis

Publications and source records attributed to Jacqueline E Lewis.

5 recordsLinked to original sources

PubMed2005

Further psychometric property development of the Menopause-Specific Quality of Life questionnaire and development of a modified version, MENQOL-Intervention questionnaire.

OBJECTIVES: To develop the 1996 MENQOL questionnaire further with advice regarding summary score computation, missing-data management, readability, recall period and assessment of the vasomotor domain reliability and construct validity. To develop a modified version, the MENQOL-Intervention questionnaire, for use where certain treatment side effects could negatively impact the quality of life. METHODS: MENQOL-Intervention modifications involved the addition of three items to the physical domain. For both questionnaires, psychometric property assessment was embedded in two randomized controlled trials of menopause interventions. Test-retest reliability and Cronbach's alpha were computed for all domains as was construct validity of the vasomotor domain for both questionnaires. RESULTS: The vasomotor intraclass correlation coefficient was 0.73 for the MENQOL-Intervention over 1 week and 0.78 for the MENQOL over 1 month. The altered physical domain of the MENQOL-Intervention questionnaire continued to show strong test-retest reliability and Cronbach's alpha consistent with the MENQOL. The MENQOL-Intervention demonstrated excellent face validity with high construct validity for the vasomotor domain of 0.78-0.80. For both instruments, comparisons of the vasomotor domains to hot flash scores, although statistically significant, were only moderate at 0.56 and 0.49. CONCLUSIONS: Both the MENQOL and the MENQOL-Intervention questionnaires show strong psychometric properties. We recommend using the MENQOL-Intervention questionnaire where intervention side effects might negatively impact a woman's quality of life. For both questionnaires, a summary score can be calculated.

Breast↗

PubMed2004

Supplementation with flaxseed alters estrogen metabolism in postmenopausal women to a greater extent than does supplementation with an equal amount of soy.

BACKGROUND: Phytoestrogens, which are abundant in flaxseed and soy, have chemical structures resembling those of endogenous estrogens and have been shown to exert hormonal effects, thereby affecting chronic diseases. OBJECTIVE: We compared the effects of consuming equal amounts of flaxseed or soy on estrogen metabolism and biochemical markers of bone metabolism in postmenopausal women. DESIGN: In a parallel design, the diet of postmenopausal women (n = 46) was supplemented with either a placebo, soy (25 g soy flour), or flaxseed (25 g ground flaxseed) muffin for 16 wk. Blood and 24-h urine samples were collected at baseline and at the endpoint. Urine samples were analyzed for phytoestrogens, estrogen metabolites (2-hydroxyestrone, 16alpha-hydroxyestrone), and serum hormones (estradiol, estrone, estrone sulfate). Serum and urine samples were also analyzed for biochemical markers of bone metabolism. RESULTS: Urinary concentrations of 2-hydroxyestrone, but not of 16alpha-hydroxyestrone, increased significantly in the flaxseed group (P = 0.05). In the flaxseed group, the ratio of 2-hydroxyestrone to 16alpha-hydroxyestrone was positively correlated with urinary lignan excretion (r = 0.579, P = 0.02). In the soy and placebo groups, no significant correlation was observed. No significant change in serum hormones or biochemical markers of bone metabolism was observed within or between the treatment groups. CONCLUSIONS: Supplementation with flaxseed modifies urinary estrogen metabolite excretion to a greater extent than does supplementation with an equal amount of soy. This modification by flaxseed is associated with an increase in urinary lignan excretion. Despite the shift in estrogen metabolism to favor the less biologically active estrogens, a negative effect on bone cell metabolism was not observed.

Bone and Bones↗

PubMed2002

Evaluation of a community-based automated blood pressure measuring device.

BACKGROUND: Automated devices are widely available in the community for people to measure their blood pressure. We assessed the accuracy and reproducibility of a brand of community-based automated device against the standard mercury sphygmomanometer. METHODS: Same-arm pairs of blood pressure readings were obtained with the Vita-Stat 90550 automated device, a sphygmomanometer and the Omron HEM-705CP automated device in random order on volunteers in 3 community pharmacies using a modified protocol for evaluating blood pressure devices. Comparison of readings between the Omron device and the sphygmomanometer served as a positive control of how well a laboratory-validated automated device could perform in the community. Both the Association for the Advancement of Medical Instrumentation (AAMI) and British Hypertension Society (BHS) criteria were used to assess the accuracy and reproducibility of readings. RESULTS: The mean blood pressure reading and standard error (SE) of the mean for the 108 volunteers (66 women and 42 men) was 133/77 (SE 2/1) mm Hg with the Vita-Stat device, 131/77 (SE 2/1) mm Hg with the Omron device and 129/76 (SE 2/1) mm Hg with the sphygmomanometer. The mean difference in readings was 4.4/1.0 (standard deviation [SD] 9.4/6.2) mm Hg between the Vita-Stat device and the sphygmomanometer and 1.6/0.6 (SD 9.3/6.4) mm Hg between the Omron device and the sphygmomanometer. Neither automated device met the AAMI accuracy criteria for the systolic readings. The BHS grades were C/A (systolic unacceptable/diastolic acceptable) for each automated device. According to the BHS analytical criterion, all devices achieved acceptable reproducibility grades. INTERPRETATION: Neither automated device met the AAMI or BHS criteria for accuracy while in use in the community, and neither performed as well in the community as in the laboratory.

Adult↗

PubMedDate not supplied

A randomized controlled trial of the effect of dietary soy and flaxseed muffins on quality of life and hot flashes during menopause.

OBJECTIVE: To compare the effects of daily ingestion of soy flour (S), ground flaxseed (F), or wheat flour (W) muffins, on quality of life and hot flash frequency and severity in postmenopausal women. DESIGN: This was a double-blind, randomized, controlled, intention-to-treat trial. Ninety-nine women, 1 to 8 years after menopause, ingested muffins with 25 g of flaxseed (50 mg of lignans), 25 g of soy (42 mg of isoflavones), or wheat (control) daily for 16 weeks. Subjects completed the Menopause-specific Quality of Life instrument monthly along with daily hot flash frequency and severity diaries. Compliance measures included a 3-day food diary and urinary isoflavone and lignan analyses at weeks 0 and 16 and returned muffin counts monthly. RESULTS: Eighty-seven women (28, ground flaxseed muffins; 31, soy flour muffins; and 28, wheat flour muffins) completed the trial. Multivariate analysis of variance of all quality-of-life domains yielded an insignificant treatment x time interaction (F46,122 = 0.92, P = 0.62) but a significant time main effect (P <.0001). Repeated-measures analyses of covariance controlling for body mass index showed no significant group x time interaction nor time nor group differences on all quality-of-life domains and hot flash measures except severity. Hot flashes were less severe with flaxseed (P = 0.001) compared to placebo; however, the group x by time interaction was not significant. Phytoestrogen excretion analysis showed treatment group exposure as allocated and no contamination. CONCLUSION: Neither dietary flaxseed nor soy flour significantly affected menopause-specific quality of life or hot flash symptoms in this study.

Diet Records↗

PubMedDate not supplied

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. 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.

Aged↗