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1.  Perineal Powder Use and Risk of Ovarian Cancer 
Case-control studies have reported an increased risk of ovarian cancer among talc users; however, the only cohort study to date found no association except for an increase in serous invasive ovarian cancers. The purpose of this analysis was to assess perineal powder use and risk of ovarian cancer prospectively in the Women’s Health Initiative Observational Study cohort.
Perineal powder use was assessed at baseline by self-report regarding application to genitals, sanitary napkins, or diaphragms and duration of use. The primary outcome was self-reported ovarian cancer centrally adjudicated by physicians. Cox proportional hazard regression was used to estimate risk, adjusting for covariates, including person-time until diagnosis of ovarian cancer (n = 429), death, loss to follow-up, or September 17, 2012. All statistical tests were two-sided.
Among 61576 postmenopausal women, followed for a mean of 12.4 years without a history of cancer or bilateral oophorectomy, 52.6% reported ever using perineal powder. Ever use of perineal powder (hazard ratio [HR]adj = 1.06, 95% confidence interval [CI] = 0.87 to 1.28) was not associated with risk of ovarian cancer compared with never use. Individually, ever use of powder on the genitals (HRadj = 1.12, 95% CI = 0.92 to 1.36), sanitary napkins (HRadj = 0.95, 95% CI = 0.76 to 1.20), or diaphragms (HRadj = 0.92, 95% CI = 0.68 to 1.23) was not associated with risk of ovarian cancer compared with never use, nor were there associations with increasing durations of use. Estimates did not differ when stratified by age or tubal ligation status.
Based on our results, perineal powder use does not appear to influence ovarian cancer risk.
PMCID: PMC4200058  PMID: 25214560
2.  Racial/Ethnic disparities in association between dietary quality and incident diabetes in postmenopausal women in the United States: The Women's Health Initiative 1993- 2005 
Ethnicity & health  2013;19(3):328-347.
To examine the association of dietary quality and risk of incident diabetes overall and by race/ethnicity among postmenopausal women enrolled in the Women's Health Initiative (WHI).
Research Methods & Procedures
The WHI recruited 161,808 postmenopausal women between 1993 and 1998, and followed them until 2005. Incident diabetes was determined annually over an average of 7.6 years from enrollment. At baseline, all participants completed a Food Frequency Questionnaire (FFQ). Dietary quality was assessed by the Alternate Healthy Eating Index, (AHEI) calculated from the baseline FFQ responses.
There were 10,307 incident cases of self-reported treated diabetes over 1,172,761 person-years of follow-up. Most participants did not meet the AHEI dietary goals; i.e., only 0.1% of women met or exceeded the recommended consumption of vegetables, and few (17.3%) met or exceeded the recommended level for total fiber. After adjusting for potential confounders, women in the highest quintile of the AHEI score were 24% less likely to develop diabetes relative to women in the lowest quintile of AHEI [hazard ratio (HR) = 0.76 (95% CI: 0.70-0.82)]. This association was observed in Whites [HR= 0.74 (95% CI: 0.68-0.82)] and Hispanics [HR= 0.68 (95% CI: 0.46-0.99)] but not in Blacks [HR= 0.85 (95% CI: 0.69-1.05)] or Asians [HR= 0.88 (95% CI: 0.57-1.38)].
These findings support a protective role of healthful eating choices in reducing the risk of developing diabetes, after adjusting for other lifestyle factors, in White and Hispanic postmenopausal women. Future studies are needed to investigate the relationship between dietary quality and risk of diabetes among Blacks and Asians in relationship to other lifestyle factors.
PMCID: PMC3883944  PMID: 23697968
Dietary quality; diabetes; postmenopausal women; women's health; epidemiology
3.  Urinary Levels of Melatonin and Risk of Postmenopausal Breast Cancer: Women’s Health Initiative Observational Cohort 
Results from prospective studies on the association between urinary levels of melatonin and risk of postmenopausal breast cancer have been mixed. Several although not all studies have found lower urinary levels of melatonin in women who developed breast cancer compared to cancer-free women.
We examined the association between urinary levels of melatonin and breast cancer risk in postmenopausal women in a case-control study nested in the Women’s Health Initiative Observational Cohort. Levels of 6-sulfatoxymelatonin were measured in first morning voids from 258 women who later developed breast cancer and from 515 matched controls. Multivariable conditional logistic regression was used to calculate odds ratios and 95% confidence intervals.
Fully adjusted risk estimates of breast cancer, relative to the lowest quartile level of creatinine-adjusted melatonin, were 1.07 (95% CI 0.67–1.71), 1.26 (95% CI 0.79–2.01), and 1.25 (95% CI 0.78–2.02) for women in the second, third and highest quartile [p for trend =.27]. Comparable results for cases diagnosed less than four years after urinary collection and matched controls were 1.0, 1.25 (95%CI 0.51–3.06, 1.85 (95%CI 0.75–4.57), and 1.94 (95%CI 0.75–5.03) [p for trend = 0.11]. Melatonin levels and breast cancer were not associated in cases diagnosed four or more years after urinary collection and matched controls [p for trend = 0.89].
We found no evidence that higher urinary levels of melatonin are inversely associated with breast cancer risk in postmenopausal women.
Accumulating discrepancies in results across studies warrant further exploration.
PMCID: PMC3985556  PMID: 24510738
4.  Teaching tobacco dependence treatment and counseling skills during medical school: rationale and design of the Medical Students helping patients Quit tobacco (MSQuit) group randomized controlled trial 
Contemporary clinical trials  2014;37(2):284-293.
Physician-delivered tobacco treatment using the 5As is clinically recommended, yet its use has been limited. Lack of adequate training and confidence to provide tobacco treatment are cited as leading reasons for limited 5A use. Tobacco dependence treatment training while in medical school is recommended, but is minimally provided. The MSQuit trial (Medical Students helping patients Quit tobacco) aims to determine if a multi-modal and theoretically-guided tobacco educational intervention will improve tobacco dependence treatment skills (i.e. 5As) among medical students.
10 U.S. medical schools were pair-matched and randomized in a group-randomized controlled trial to evaluate whether a multi-modal educational (MME) intervention compared to traditional education (TE) will improve observed tobacco treatment skills. MME is primarily composed of TE approaches (i.e. didactics) plus a 1st year web-based course and preceptor-facilitated training during a 3rd year clerkship rotation. The primary outcome measure is an objective score on an Objective Structured Clinical Examination (OSCE) tobacco-counseling smoking case among 3rd year medical students from schools who implemented the MME or TE.
MSQuit is the first randomized to evaluate whether a tobacco treatment educational intervention implemented during medical school will improve medical students’ tobacco treatment skills. We hypothesize that the MME intervention will better prepare students in tobacco dependence treatment as measured by the OSCE. If a comprehensive tobacco treatment educational learning approach is effective, while also feasible and acceptable to implement, then medical schools may substantially influence skill development and use of the 5As among future physicians.
PMCID: PMC4048818  PMID: 24486635
tobacco dependence treatment and counseling; 5As; medical school education; medical students; tobacco control; group randomized controlled trial
5.  All-Cause, Cardiovascular, and Cancer Mortality Rates in Postmenopausal White, Black, Hispanic, and Asian Women With and Without Diabetes in the United States 
American Journal of Epidemiology  2013;178(10):1533-1541.
Using data from the Women's Health Initiative (1993–2009; n = 158,833 participants, of whom 84.1% were white, 9.2% were black, 4.1% were Hispanic, and 2.6% were Asian), we compared all-cause, cardiovascular, and cancer mortality rates in white, black, Hispanic, and Asian postmenopausal women with and without diabetes. Cox proportional hazard models were used for the comparison from which hazard ratios and 95% confidence intervals were computed. Within each racial/ethnic subgroup, women with diabetes had an approximately 2–3 times higher risk of all-cause, cardiovascular, and cancer mortality than did those without diabetes. However, the hazard ratios for mortality outcomes were not significantly different between racial/ethnic subgroups. Population attributable risk percentages (PARPs) take into account both the prevalence of diabetes and hazard ratios. For all-cause mortality, whites had the lowest PARP (11.1, 95% confidence interval (CI): 10.1, 12.1), followed by Asians (12.9, 95% CI: 4.7, 20.9), blacks (19.4, 95% CI: 15.0, 23.7), and Hispanics (23.2, 95% CI: 14.8, 31.2). To our knowledge, the present study is the first to show that hazard ratios for mortality outcomes were not significantly different between racial/ethnic subgroups when stratified by diabetes status. Because of the “amplifying” effect of diabetes prevalence, efforts to reduce racial/ethnic disparities in the rate of death from diabetes should focus on prevention of diabetes.
PMCID: PMC3888272  PMID: 24045960
diabetes; health disparities; menopause; mortality; obesity; women's health
6.  Implementing State Tobacco Treatment Services: Lessons from the Massachusetts Experience 
Health promotion practice  2011;12(6):802-810.
This case study was conducted between 2000 and 2003 to examine the implementation of community based tobacco treatment programs funded by the Massachusetts Department of Public Health Tobacco Control Program (MTCP). Four dimensions of implementation, drawn from several models of program evaluation are explored: (1) quantity of services, (2) quality of services, (3) implementation/use of systems, and (4) sustainability. The quantity of services delivered was high, reflecting MTCP's focus on increasing availability of services, particularly in underserved populations. The quality of physician-delivered tobacco intervention did not meet national benchmarks for delivery of all 5As (Ask, Advise, Assess, Assist, Arrange follow-up) and only about half of organizations reported routine systems for auditing tobacco use documentation. Implementation of systems to identify tobacco users and deliver tobacco treatment varied widely by community health settings, with low rates of tobacco use documentation found. Finally, in an era of greater competition for scarce prevention dollars, sustainability of services over time must be planned for from the outset, as indicated by the success of programs that sustained services by proactively and creatively incorporating tobacco treatment into their organizations. This case study can inform states' policies in their design of tobacco treatment services in community health settings.
PMCID: PMC4184237  PMID: 21571986
Tobacco treatment policy; Program implementation; Comprehensive tobacco control; Case Study
7.  The Women’s Health Initiative Hormone Therapy Trials: Update and Overview of Health Outcomes During the Intervention and Post-Stopping Phases 
Menopausal hormone therapy continues in clinical use but questions remain regarding its risks and benefits for chronic disease prevention.
To provide a comprehensive, integrated overview of findings from the two Women’s Health Initiative (WHI) hormone therapy (HT) trials with extended post-intervention follow up.
27,347 postmenopausal women, age 50–79 years, were enrolled at 40 US centers. Interventions were conjugated equine estrogens (CEE, 0.625 mg/day) with medroxyprogesterone acetate (MPA, 2.5 mg/day) for women with an intact uterus (N = 16,608) and CEE alone for women with hysterectomy (N= 10,739), or their placebos. Intervention continued for 5.6 and 7.2 years (median), respectively, with cumulative follow-up of 13 years through September 30, 2010.
The primary efficacy and safety outcomes were coronary heart disease (CHD) and invasive breast cancer, respectively. A global index also included stroke, pulmonary embolism, colorectal cancer, endometrial cancer, hip fracture, and deaths. Secondary and quality-of-life outcomes were also assessed.
During the intervention phase for CEE+MPA, the hazard ratio (HR) for CHD was 1.18 (95% confidence interval [CI] 0.95–1.45) and overall risks outweighed benefits, with increases in invasive breast cancer, stroke, pulmonary embolism, and the global index. Other risks included increased dementia (in women >65 years), gallbladder disease, and urinary incontinence, while benefits included decreased hip fractures, diabetes, and vasomotor symptoms. Post-intervention, most risks and benefits dissipated, although some elevation in breast cancer risk persisted (cumulative hazard ratio [HR] =1.28; 95% confidence interval, 1.11–1.48). During intervention for CEE alone, risks and benefits were more balanced, with a HR for CHD of 0.94 (0.78–1.14), increased stroke and venous thrombosis, decreased hip fractures and diabetes, and over cumulative follow-up, decreased breast cancer (HR=0.79 [0.65–0.97]). Neither regimen affected all-cause mortality. With CEE, younger women (50–59 years) had more favorable results for all-cause mortality, myocardial infarction, and the global index (nominal P values for trend by age <0.05), but not for stroke and venous thrombosis. Absolute risks of adverse events (measured by the global index) per 10,000 women per year on CEE+MPA ranged from 12 excess cases for age 50–59 to 38 for age 70–79 and, for CEE, from 19 fewer cases for age 50–59 to 51 excess cases for age 70–79. Results for quality of life outcomes in both trials were mixed.
Menopausal hormone therapy has a complex pattern of risks and benefits. While appropriate for symptom management in some women, its use for chronic disease prevention is not supported by the WHI randomized trials.
clinical Identifier: NCT00000611
PMCID: PMC3963523  PMID: 24084921
8.  Smoking and Diabetes: Does the Increased Risk Ever Go Away? 
American Journal of Epidemiology  2013;178(6):937-945.
Recent studies reported that smoking cessation leads to higher short-term risk of type 2 diabetes than continuing to smoke. However, the duration of increased diabetes risk following smoking cessation needs further investigation. We followed 135,906 postmenopausal women aged 50–79 years enrolled in the Women's Health Initiative between September 1, 1993, and December 31, 1998, over an average of 11 years to examine the association between smoking cessation and risk of diabetes using Cox proportional hazard multivariable-adjusted regression models. Compared with that for never smokers, the risk for diabetes was significantly elevated in current smokers (hazard ratio = 1.28, 95% confidence interval: 1.20, 1.36) but was even higher in women who quit smoking during the first 3 years of follow-up (hazard ratio = 1.43, 95% confidence interval: 1.26, 1.63). Among former smokers, the risk of diabetes decreased significantly as the time since quitting increased and was equal to that of never smokers following a cessation period of 10 years. In new quitters with low cumulative exposure (<20 pack-years), diabetes risk was not elevated following smoking cessation. In conclusion, the risk of diabetes in former smokers returns to that in never smokers 10 years after quitting, and even more quickly in lighter smokers.
PMCID: PMC3816526  PMID: 23817918
risk factors; smoking; smoking cessation; type 2 diabetes
Menopause (New York, N.Y.)  2013;20(9):911-921.
The relatively modest benefit in vasomotor symptom relief seen in clinical trials of isoflavones may reflect once-daily dosing as well as low percentages of participants able to metabolize daidzein to equol, a potentially more biologically active isoflavone. This pilot study examined whether symptom reduction was greater with more frequent administration as well as with higher daily doses. In addition, we explored possible effect modification by equol producer status.
We randomized 130 peri- (no menses in past three months) and postmenopausal (12+ months amenorrhea) women with an average of 5+ moderate/severe hot flashes per day to treatment arms with varying total daily isoflavone doses and dosing frequency, separately for equol producers and non-producers. Participants recorded daily frequency and severity of hot flashes. Analyses compared mean daily hot flash intensity scores (sum of hot flashes weighted by severity) by total daily dose and by dosing frequency. Dose- and frequency-related differences also were compared for equol producers and non-producers.
Hot flash intensity scores were lowest in women randomized to the highest total daily dose (100-200mg) and in women randomized to the highest dosing frequency (2-3 times daily), with greater benefits in nighttime than in daytime scores. Dose-related and frequency-related differences were somewhat larger in equol producers than in non-producers.
These results suggest that a 2-3 times per day dosing frequency may improve the benefit of isoflavones for vasomotor symptom relief, particularly in equol producers and for nighttime symptoms. Larger studies are needed to confirm these findings.
PMCID: PMC3723773  PMID: 23511704
Vasomotor symptoms; isoflavones; equol producers
10.  Relations of Depressive Symptoms and Antidepressant Use to Body Mass Index and Selected Biomarkers for Diabetes and Cardiovascular Disease 
American journal of public health  2013;103(8):e34-e43.
We investigated whether depressive symptoms and antidepressant use are associated with biomarkers for glucose dysregulation and inflammation, body mass index (BMI), and waist circumference.
Postmenopausal women were recruited into the Women’s Health Initiative from 1993 to 1998, and data were collected at regular intervals through 2005. We used multiple linear regression models to examine whether depressive symptoms and antidepressant use are associated with BMI, waist circumference, and biomarkers.
Analysis of data from 71 809 women who completed all relevant baseline and year 3 assessments showed that both elevated depressive symptoms and antidepressant use were significantly associated with higher BMI and waist circumference. Among 1950 women, elevated depressive symptoms were significantly associated with increased insulin levels and measures of insulin resistance. Analyses of baseline data from 2242 women showed that both elevated depressive symptoms and antidepressant use were associated with higher C-reactive protein levels.
Monitoring body habitus and other biomarkers among women with elevated depression symptoms or taking antidepressant medication may be prudent to prevent diabetes and cardiovascular disease.
PMCID: PMC3791588  PMID: 23763394
11.  Tobacco Dependence Treatment Teaching by Medical School Clerkship Preceptors: Survey Responses from more than 1,000 US Medical Students 
Preventive medicine  2013;57(2):81-86.
To determine factors associated with tobacco cessation counseling in medical school clerkships
Third-year medical students at 10 medical schools across the United States completed a 100-item survey, measuring the frequency with which they experienced their preceptors’ providing clinical teaching components: clear instruction, feedback, modeling behavior, setting clear objectives, and responding to questions about tobacco dependence counseling as well as frequency of use of tobacco prompts and office systems. Our primary dependent measure was student self-reported skill level for items of tobacco dependence treatment (e.g. “5As”).
Surveys were completed by 1213 students. For both family medicine and internal medicine clerkships, modeling and providing clear instruction on ways to provide tobacco counseling were reported most commonly. In contrast, providing feedback and clear objectives for tobacco dependence treatment lagged behind. Overall, students who reported preceptors’ provision of optimal clinical teaching components and office system prompts in both family medicine and internal medicine clerkships had higher self-reported skill (p<0.001) than students with no exposure or exposure during only one of the clerkships.
Future educational interventions intended to help students adopt effective tobacco dependence treatment techniques should be engineered to facilitate these critical precepting components.
PMCID: PMC3767283  PMID: 23623894
12.  Better Population Health Through Behavior Change in Adults A Call to Action 
Circulation  2013;128(19):2169-2176.
PMCID: PMC4074536  PMID: 24100544
AHA Scientific Statements; behavior; population health; prevention
13.  Does neighborhood walkability moderate the effects of intrapersonal characteristics on amount of walking in post-menopausal women? 
Health & place  2013;21:39-45.
This study identifies correlates of walking among postmenopausal women and tests whether neighborhood walkability moderates the influence of intrapersonal factors on walking. We used data from the Women’s Health Initiative Seattle Center and linear regression models to estimate associations and interactions. Being white and healthy, having a high school education or beyond and greater non-walking exercise were significantly associated with more walking. Neighborhood walkability was not independently associated with greater walking nor did it moderate influence of intrapersonal factors on walking. Specifying types of walking (e.g., for transportation) can elucidate the relationships among intrapersonal factors, the built environment, and walking.
PMCID: PMC3622785  PMID: 23416232
Walkability; postmenopausal women; walking; built environment
14.  Breast Cancer after Use of Estrogen plus Progestin in Postmenopausal Women 
The New England journal of medicine  2009;360(6):573-587.
Following the release of the 2002 report of the Women’s Health Initiative (WHI) trial of estrogen plus progestin, the use of menopausal hormone therapy in the United States decreased substantially. Subsequently, the incidence of breast cancer also dropped, suggesting a cause-and-effect relation between hormone treatment and breast cancer. However, the cause of this decrease remains controversial.
We analyzed the results of the WHI randomized clinical trial — in which one study group received 0.625 mg of conjugated equine estrogens plus 2.5 mg of medroxy-progesterone acetate daily and another group received placebo — and examined temporal trends in breast-cancer diagnoses in the WHI observational-study cohort. Risk factors for breast cancer, frequency of mammography, and time-specific incidence of breast cancer were assessed in relation to combined hormone use.
In the clinical trial, there were fewer breast-cancer diagnoses in the group receiving estrogen plus progestin than in the placebo group in the initial 2 years of the study, but the number of diagnoses increased over the course of the 5.6-year intervention period. The elevated risk decreased rapidly after both groups stopped taking the study pills, despite a similar frequency of mammography. In the observational study, the incidence of breast cancer was initially about two times as high in the group receiving menopausal hormones as in the placebo group, but this difference in incidence decreased rapidly in about 2 years, coinciding with year-to-year reductions in combined hormone use. During this period, differences in the frequency of mammography between the two groups were unchanged.
The increased risk of breast cancer associated with the use of estrogen plus progestin declined markedly soon after discontinuation of combined hormone therapy and was unrelated to changes in frequency of mammography.
PMCID: PMC3963492  PMID: 19196674
15.  Geriatric Syndromes and Incident Disability in Older Women: Results from the Women’s Health Initiative Observational Study 
Geriatric syndromes are common in older women and contribute to disability risk. Little is known about how the number of geriatric syndromes is associated with incident disability in community-based populations of older adults.
Longitudinal analysis from the Women’s Health Initiative Observational Study (WHI).
29,544 women aged 65 or older, who were enrolled in the WHI and free of disability in activities of daily living (ADL) at baseline.
Geriatric syndromes were self-reported at baseline and three year follow-up and included high depressive symptoms, dizziness, falls, hearing or visual impairment, osteoporosis, polypharmacy, syncope, sleep disturbance, and urinary incontinence. Disability was defined as dependence in any ADL and was assessed at baseline and follow-up. Chronic diseases were measured by a modified Charlson index.
Geriatric syndromes were common in this population of women; 76.3% had at least one syndrome present at baseline. Increased number of geriatric syndromes at baseline was significantly associated with increased risk of incident ADL disability at follow-up (p ≤ 0.001). The adjusted risk ratio (RR) and 95% confidence interval (CI) for a single syndrome compared to no syndromes was 1.21 (0.78, 1.87). For women with five or more geriatric syndromes, the RR (CI) was 6.64 (4.15, 10.62). These results were only slightly attenuated after adjustment for number of chronic diseases or pain.
Geriatric syndromes are significantly associated with onset of disability in older women; this association is not simply a result of chronic disease or pain. A better understanding of how these conditions contribute to disablement is needed. Geriatric syndrome assessment should be considered along with chronic disease management in the prevention of disability in older women.
PMCID: PMC3602348  PMID: 23452034
Geriatric syndromes; disability; aging; women’s health
16.  Smoking Status, Physical Health–Related Quality of Life, and Mortality in Middle-Aged and Older Women 
Nicotine & Tobacco Research  2012;15(3):662-669.
Women who smoke, particularly older women, have been relatively neglected in smoking research. There is a lack of knowledge concerning the relation of level of smoking to quality of life and mortality among middle-aged and older women smokers.
This study examined the relation of smoking status to physical health–related quality of life (PHRQL) and total mortality in women in the Women’s Health Initiative (WHI) Observational Study. Participants were 90,849 postmenopausal women, who were an average age of 63.6 years at baseline. Analyses used multiple linear and Cox proportional hazards regression and controlled for age, educational level, and ethnicity. Never-smokers were the reference group.
We found that smoking status was significantly related to PHRQL cross-sectionally at baseline and prospectively at a 3-year follow-up, with those who smoked having lower PHRQL. Heavier smokers showed large, clinically meaningful associations with PHRQL and light smokers showed small associations. In addition, we found that the smoking status at baseline was significantly related to 10-year total mortality. Both light and heavier smoking at baseline significantly correlated with higher mortality risk; however, the relationship of smoking to mortality was dose dependent. Among former smokers, those who had smoked longer showed significantly lower PHRQL and significantly increased mortality risk.
Findings suggest that the risks of smoking may not be evident to light smokers and that educational interventions targeted to middle-aged and older women stressing the consequences of light smoking may be particularly beneficial.
PMCID: PMC3611990  PMID: 22965789
17.  Can attention control conditions have detrimental effects in behavioral medicine randomized trials? 
Psychosomatic medicine  2012;75(2):137-143.
Attention control conditions are used to balance nonspecific attention in randomized trials of behavioral interventions. Very little guidance is available in the literature about which behavioral interventions and outcomes merit an attention control. The primary aim of the present paper is to demonstrate a scenario in which use of attention control in a behavioral randomized trial was unnecessary and possibly detrimental.
Exploratory analyses were performed in a randomized controlled trial that tested whether a patient-centered telephone counseling (PC) intervention reduced low-density lipoprotein cholesterol (LDL-C) levels in 355 participants with peripheral arterial disease (PAD), compared to attention control (AC) and usual care (UC) conditions. The PC intervention was designed to activate participants to ask their physician for lipid-lowering medication and/or increase dose intensity, increase medication adherence, and reduce fat intake. The AC condition involved attention-matched phone-delivered health education, and the UC condition consisted of an educational pamphlet.
At 12-month follow-up, mean LDL-C changes were −11.1, and −6.8 mg/dl in the UC and AC conditions, respectively (p=.17). The proportion of participants who increased use or dose intensity of medication was significantly lower in AC than UC, 17.5% versus 30.5% (p=0.03). No significant difference between AC and UC were observed on other outcomes.
The AC had significantly worse medication outcomes and there was no indication of a therapeutic effect on other endpoints. Implications for use of attention control in behavioral randomized trials are discussed.
PMCID: PMC3570637  PMID: 23197844
Attention control; control groups; placebo; behavioral interventions; randomized controlled trials
18.  Determinants of Racial/Ethnic Disparities in Incidence of Diabetes in Postmenopausal Women in the U.S. 
Diabetes Care  2012;35(11):2226-2234.
To examine determinants of racial/ethnic differences in diabetes incidence among postmenopausal women participating in the Women’s Health Initiative.
Data on race/ethnicity, baseline diabetes prevalence, and incident diabetes were obtained from 158,833 women recruited from 1993–1998 and followed through August 2009. The relationship between race/ethnicity, other potential risk factors, and the risk of incident diabetes was estimated using Cox proportional hazards models from which hazard ratios (HRs) and 95% CIs were computed.
Participants were aged 63 years on average at baseline. The racial/ethnic distribution was 84.1% non-Hispanic white, 9.2% non-Hispanic black, 4.1% Hispanic, and 2.6% Asian. After an average of 10.4 years of follow-up, compared with whites and adjusting for potential confounders, the HRs for incident diabetes were 1.55 for blacks (95% CI 1.47–1.63), 1.67 for Hispanics (1.54–1.81), and 1.86 for Asians (1.68–2.06). Whites, blacks, and Hispanics with all factors (i.e., weight, physical activity, dietary quality, and smoking) in the low-risk category had 60, 69, and 63% lower risk for incident diabetes. Although contributions of different risk factors varied slightly by race/ethnicity, most findings were similar across groups, and women who had both a healthy weight and were in the highest tertile of physical activity had less than one-third the risk of diabetes compared with obese and inactive women.
Despite large racial/ethnic differences in diabetes incidence, most variability could be attributed to lifestyle factors. Our findings show that the majority of diabetes cases are preventable, and risk reduction strategies can be effectively applied to all racial/ethnic groups.
PMCID: PMC3476929  PMID: 22833490
19.  Vitamin D Supplementation and Depression in the Women’s Health Initiative Calcium and Vitamin D Trial 
While observational studies have suggested that vitamin D deficiency increases risk of depression, few clinical trials have tested whether vitamin D supplementation affects the occurrence of depression symptoms. The authors evaluated the impact of daily supplementation with 400 IU of vitamin D3 combined with 1,000 mg of elemental calcium on measures of depression in a randomized, double-blinded US trial comprising 36,282 postmenopausal women. The Burnam scale and current use of antidepressant medication were used to assess depressive symptoms at randomization (1995–2000). Two years later, women again reported on their antidepressant use, and 2,263 completed a second Burnam scale. After 2 years, women randomized to receive vitamin D and calcium had an odds ratio for experiencing depressive symptoms (Burnam score ≥0.06) of 1.16 (95% confidence interval: 0.86, 1.56) compared with women in the placebo group. Supplementation was not associated with antidepressant use (odds ratio = 1.01, 95% confidence interval: 0.92, 1.12) or continuous depressive symptom score. Results stratified by baseline vitamin D and calcium intake, solar irradiance, and other factors were similar. The findings do not support a relation between supplementation with 400 IU/day of vitamin D3 along with calcium and depression in older women. Additional trials testing higher doses of vitamin D are needed to determine whether this nutrient may help prevent or treat depression.
PMCID: PMC3385159  PMID: 22573431
antidepressive agents; calcium; clinical trial; depression; dietary supplements; postmenopause; vitamin D; women
20.  Laxative use and incident falls, fractures and change in bone mineral density in postmenopausal women: results from the Women’s Health Initiative 
BMC Geriatrics  2013;13:38.
Laxatives are among the most widely used over-the-counter medications in the United States but studies examining their potential hazardous side effects are sparse. Associations between laxative use and risk for fractures and change in bone mineral density [BMD] have not previously been investigated.
This prospective analysis included 161,808 postmenopausal women (8907 users and 151,497 nonusers of laxatives) enrolled in the WHI Observational Study and Clinical Trials. Women were recruited from October 1, 1993, to December 31, 1998, at 40 clinical centers in the United States and were eligible if they were 50 to 79 years old and were postmenopausal at the time of enrollment. Medication inventories were obtained during in-person interviews at baseline and at the 3-year follow-up visit on everyone. Data on self-reported falls (≥2), fractures (hip and total fractures) were used. BMD was determined at baseline and year 3 at 3 of the 40 clinical centers of the WHI.
Age-adjusted rates of hip fractures and total fractures, but not for falls were similar between laxative users and non-users regardless of duration of laxative use. The multivariate-adjusted hazard ratios for any laxative use were 1.06 (95% confidence interval [CI], 1.03-1.10) for falls, 1.02 (95% CI, 0.85-1.22) for hip fractures and 1.01 (95% CI, 0.96-1.07) for total fractures. The BMD levels did not statistically differ between laxative users and nonusers at any skeletal site after 3-years intake.
These findings support a modest association between laxative use and increase in the risk of falls but not for fractures. Its use did not decrease bone mineral density levels in postmenopausal women. Maintaining physical functioning, and providing adequate treatment of comorbidities that predispose individuals for falls should be considered as first measures to avoid potential negative consequences associated with laxative use.
PMCID: PMC3645973  PMID: 23635086
Laxative use; Falls; Fractures; Bone mineral density; Aging
21.  Elevated Depressive Symptoms, Antidepressant Use, and Diabetes in a Large Multiethnic National Sample of Postmenopausal Women 
Diabetes Care  2011;34(11):2390-2392.
To examine elevated depressive symptoms and antidepressant use in relation to diabetes incidence in the Women’s Health Initiative.
A total of 161,808 postmenopausal women were followed for over an average of 7.6 years. Hazard ratios (HRs) estimating the effects of elevated depressive symptoms and antidepressant use on newly diagnosed incident diabetes were obtained using Cox proportional hazards models adjusted for known diabetes risk factors.
Multivariable-adjusted HRs indicated an increased risk of incident diabetes with elevated baseline depressive symptoms (HR 1.13 [95% CI 1.07–1.20]) and antidepressant use (1.18 [1.10–1.28]). These associations persisted through year 3 data, in which respective adjusted HRs were 1.23 (1.09–1.39) and 1.31 (1.14–1.50).
Postmenopausal women with elevated depressive symptoms who also use antidepressants have a greater risk of developing incident diabetes. In addition, longstanding elevated depressive symptoms and recent antidepressant medication use increase the risk of incident diabetes.
PMCID: PMC3198287  PMID: 21911776
22.  Interaction Between Smoking and Obesity and the Risk of Developing Breast Cancer Among Postmenopausal Women 
American Journal of Epidemiology  2011;174(8):919-928.
Obesity is a well-established risk factor for postmenopausal breast cancer. Recent studies suggest that smoking increases the risk of breast cancer. However, the effect of co-occurrence of smoking and obesity on breast cancer risk remains unclear. A total of 76,628 women aged 50–79 years enrolled in the Women's Health Initiative Observational Study were followed through August 14, 2009. Cox proportional hazards regression models were used to estimate hazard ratios and 95% confidence intervals. Over an average 10.3 years of follow-up, 3,378 incident cases of invasive breast cancer were identified. The effect of smoking on the risk of developing invasive breast cancer was modified significantly by obesity status among postmenopausal women, regardless of whether the obesity status was defined by body mass index (Pinteraction = 0.01) or waist circumference (Pinteraction = 0.02). A significant association between smoking and breast cancer risk was noted in nonobese women (hazard ratio = 1.25, 95% confidence interval: 1.05, 1.47) but not in obese women (hazard ratio = 0.96, 95% confidence interval: 0.69, 1.34). In conclusion, this study suggests that the effect of smoking exposure on breast cancer risk was modified by obesity among postmenopausal women. The modification effect did not differ by general versus abdominal obesity.
PMCID: PMC3218630  PMID: 21878422
breast neoplasms; obesity; risk factors; smoking
24.  Depressive Symptoms and Smoking in Middle-Aged and Older Women 
Nicotine & Tobacco Research  2011;13(8):722-731.
Smoking research and intervention efforts have neglected older women. Depressive symptoms, which are common in middle-aged and older women, are related to the maintenance of adult smoking.
This study investigated the relation of a composite measure of current depressive symptoms, derived from a short form of the Center for Epidemiological Studies Depression Scale, and history of depressive symptoms, derived from two items from the Diagnostic Interview Schedule, to smoking outcomes in the Women's Health Initiative Observational Study (N = 90,627). Participants were postmenopausal with an average age of 63.6 years at baseline. Participants were recruited from urban, suburban, and rural areas surrounding 40 clinical centers in the United States. Analyses controlled for age, educational level, and ethnicity.
In multinomial logistic regression analyses, depressive symptoms were related cross-sectionally to current light (odds ratio [OR] = 1.19, 95% CI = 1.14–1.23) and heavier (OR = 1.28, 95% CI = 1.23–1.32) smoking at baseline compared with nonsmokers. In prospective multiple logistic regression analyses, baseline depressive symptoms were negatively predictive of smoking cessation at a 1-year follow-up (OR = .85, 95% CI = 0.77–0.93) and at participants’ final assessments in the study (OR = .92, 95% CI = 0.85–0.98). Light smokers had more than 2 times higher odds of smoking cessation than did heavier smokers.
The present findings demonstrate a consistent link between depressive symptoms and negative smoking-related behaviors among middle-aged and older women at both light and heavier smoking levels.
PMCID: PMC3150691  PMID: 21504881
25.  Weight Change and Cognitive Function: Findings from the Women's Health Initiative Study of Cognitive Aging 
Obesity (Silver Spring, Md.)  2011;19(8):1595-1600.
Although studies exploring relationships between obesity and cognitive impairment in the elderly are conflicting, literature suggests that overweight and obesity may be protective against cognitive impairment and dementia in older women. We examine the associations between changes in weight and waist circumference with global and domain-specific cognitive function in a large, well-defined cohort of 2283 older, post-menopausal women (age 65-79) prospectively followed through the Women's Health Initiative (WHI) Study of Cognitive Aging (WHISCA). We assessed the associations between changes in weight and waist circumference collected up to 5 years prior to WHISCA enrollment and mean levels of global and domain-specific cognitive performance across an average of 5.4 years of subsequent follow-up. There was a lack of associations between weight and cognition in women who remained stable or gained weight. The only significant relationships observed were in association with weight loss (p≤0.05), most likely signaling incipient disease. Moreover, cognition was not related to changes in waist circumference. Relationships were largely independent of initial BMI, self-reported caloric intake or dieting. The lack of associations between weight gain and cognition in women is consistent with the existent literature.
PMCID: PMC3175491  PMID: 21394095

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