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1.  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.
doi:10.1016/j.healthplace.2012.12.007
PMCID: PMC3622785  PMID: 23416232
Walkability; postmenopausal women; walking; built environment
2.  Breast Cancer after Use of Estrogen plus Progestin in Postmenopausal Women 
The New England journal of medicine  2009;360(6):573-587.
BACKGROUND
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.
METHODS
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.
RESULTS
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.
CONCLUSIONS
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.
doi:10.1056/NEJMoa0807684
PMCID: PMC3963492  PMID: 19196674
3.  Geriatric Syndromes and Incident Disability in Older Women: Results from the Women’s Health Initiative Observational Study 
Background/Objectives
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.
Design
Longitudinal analysis from the Women’s Health Initiative Observational Study (WHI).
Setting
Community-based.
Participants
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.
Measurements
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.
Results
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.
Conclusion
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.
doi:10.1111/jgs.12147
PMCID: PMC3602348  PMID: 23452034
Geriatric syndromes; disability; aging; women’s health
4.  Smoking Status, Physical Health–Related Quality of Life, and Mortality in Middle-Aged and Older Women 
Nicotine & Tobacco Research  2012;15(3):662-669.
Introduction:
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.
Methods:
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.
Results:
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.
Conclusions:
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.
doi:10.1093/ntr/nts182
PMCID: PMC3611990  PMID: 22965789
5.  Can attention control conditions have detrimental effects in behavioral medicine randomized trials? 
Psychosomatic medicine  2012;75(2):137-143.
Objective
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.
Methods
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.
Results
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.
Conclusions
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.
doi:10.1097/PSY.0b013e3182765dd2
PMCID: PMC3570637  PMID: 23197844
Attention control; control groups; placebo; behavioral interventions; randomized controlled trials
6.  Determinants of Racial/Ethnic Disparities in Incidence of Diabetes in Postmenopausal Women in the U.S. 
Diabetes Care  2012;35(11):2226-2234.
OBJECTIVE
To examine determinants of racial/ethnic differences in diabetes incidence among postmenopausal women participating in the Women’s Health Initiative.
RESEARCH DESIGN AND METHODS
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.
RESULTS
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.
CONCLUSIONS
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.
doi:10.2337/dc12-0412
PMCID: PMC3476929  PMID: 22833490
7.  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.
doi:10.1093/aje/kwr482
PMCID: PMC3385159  PMID: 22573431
antidepressive agents; calcium; clinical trial; depression; dietary supplements; postmenopause; vitamin D; women
8.  Elevated Depressive Symptoms, Antidepressant Use, and Diabetes in a Large Multiethnic National Sample of Postmenopausal Women 
Diabetes Care  2011;34(11):2390-2392.
OBJECTIVE
To examine elevated depressive symptoms and antidepressant use in relation to diabetes incidence in the Women’s Health Initiative.
RESEARCH DESIGN AND METHODS
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.
RESULTS
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).
CONCLUSIONS
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.
doi:10.2337/dc11-1223
PMCID: PMC3198287  PMID: 21911776
9.  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.
doi:10.1093/aje/kwr192
PMCID: PMC3218630  PMID: 21878422
breast neoplasms; obesity; risk factors; smoking
11.  Depressive Symptoms and Smoking in Middle-Aged and Older Women 
Nicotine & Tobacco Research  2011;13(8):722-731.
Introduction:
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.
Methods:
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.
Results:
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.
Conclusions:
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.
doi:10.1093/ntr/ntr066
PMCID: PMC3150691  PMID: 21504881
12.  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.
doi:10.1038/oby.2011.23
PMCID: PMC3175491  PMID: 21394095
13.  Vasomotor symptoms and cardiovascular events in postmenopausal women 
Menopause (New York, N.Y.)  2011;18(6):603-610.
Objective
Emerging evidence suggests that women with menopausal vasomotor symptoms (VMS) have increased cardiovascular disease (CVD) risk as measured by surrogate markers. We investigated the relationships between VMS and clinical CVD events and all-cause mortality in the Women's Health Initiative Observational Study (WHI-OS).
Methods
We compared the risk of incident CVD events and all-cause mortality between four groups of women (total N=60,027): (1) No VMS at menopause onset and no VMS at WHI-OS enrollment (no VMS [referent group]); (2) VMS at menopause onset, but not at WHI-OS enrollment (early VMS); (3) VMS at both menopause onset and WHI-OS enrollment (persistent VMS [early and late]); and (4) VMS at WHI-OS enrollment, but not at menopause onset (late VMS).
Results
For women with early VMS (N=24,753), compared to no VMS (N=18,799), hazard ratios (HRs) and 95% confidence intervals (CIs) in fully-adjusted models were: major CHD, 0.94 (0.84, 1.06); stroke, 0.83 (0.72, 0.96); total CVD, 0.89 (0.81, 0.97); and all-cause mortality, 0.92 (0.85, 0.99). For women with persistent VMS (N=15,084), there was no significant association with clinical events. For women with late VMS (N=1,391) compared to no VMS, HRs and 95% CIs were: major CHD, 1.32 (1.01, 1.71); stroke, 1.14 (0.82, 1.59); total CVD, 1.23 (1.00, 1.52); and all-cause mortality, 1.29 (1.08, 1.54).
Conclusions
Early VMS were not associated with increased CVD risk. Rather, early VMS were associated with decreased risk of stroke, total CVD events, and all-cause mortality. Late VMS were associated with increased CHD risk and all-cause mortality. The predictive value of VMS for clinical CVD events may vary with onset of VMS at different stages of menopause. Further research examining the mechanisms underlying these associations is needed. Future studies will also be necessary to investigate whether VMS that develop for the first time in the later postmenopausal years represent a pathophysiologic process distinct from classical perimenopausal VMS.
doi:10.1097/gme.0b013e3182014849
PMCID: PMC3123435  PMID: 21358352
Vasomotor symptoms; Hot flashes; Cardiovascular disease; Women's health
14.  ACTIVATING PERIPHERAL ARTERIAL DISEASE PATIENTS TO REDUCE CHOLESTEROL: A RANDOMIZED TRIAL 
The American journal of medicine  2011;124(6):557-565.
Background
Peripheral arterial disease patients are less likely than other high-risk patients to achieve ideal low density lipoprotein cholesterol (LDL-cholesterol) levels. This randomized controlled trial assessed whether a telephone counseling intervention, designed to help peripheral arterial disease patients request more intensive cholesterol lowering therapy from their physician, achieves lower LDL-cholesterol levels than two control conditions.
Methods
355 peripheral arterial disease participants with baseline LDL-cholesterol ≥ 70 mg/dl were enrolled. The primary outcome was change in LDL-cholesterol level at twelve-month follow-up. There were three parallel arms: telephone counseling intervention, attention control condition, and usual care. The intervention consisted of patient-centered counseling, delivered every six weeks, encouraging participants to request increases in cholesterol-lowering therapy from their physician. The attention control condition consisted of telephone calls every six weeks providing information only. The usual care condition participated in baseline and follow-up testing.
Results
At 12-month follow-up, participants in the intervention improved their LDL-cholesterol level, compared to those in attention control (−18.4 mg/dl vs. −6.8 mg/dl, p= 0.010) but not compared to those in usual care (−18.4 mg/dl vs. −11.1 mg/dl, p= 0.208). Intervention participants were more likely to start a cholesterol-lowering medication or increase their cholesterol-lowering medication dose than those in the attention control (54% vs. 18%, p=0.001) and usual care (54% vs. 31%, P<0.001) conditions.
Conclusion
Telephone counseling that helped peripheral arterial disease patients request more intensive cholesterol-lowering therapy from their physician achieved greater LDL-cholesterol declines than an attention control arm that provided health information alone.
doi:10.1016/j.amjmed.2010.11.032
PMCID: PMC3225919  PMID: 21605733
Intermittent claudication; secondary prevention; peripheral arterial disease
15.  Behavior Matters 
Behavior has a broad and central role in health. Behavioral interventions can be effectively used to prevent disease, improve management of existing disease, increase quality of life, and reduce healthcare costs. A summary is presented of evidence for these conclusions in cardiovascular disease/diabetes, cancer, and HIV/AIDS as well as with key risk factors: tobacco use, poor diet, physical inactivity, and excessive alcohol consumption. For each, documentation is made of (1) moderation of genetic and other fundamental biological influences by behaviors and social–environmental factors, (2) impacts of behaviors on health, (3) success of behavioral interventions in prevention, (4) disease management, (5) and quality of life, and (6) improvements in the health of populations through behavioral health promotion programs. Evidence indicates the cost effectiveness and value of behavioral interventions, especially relative to other common health services, as well as the value they add in terms of quality of life. Pertinent to clinicians and their patients as well as to health policy and population health, the benefits of behavioral interventions extend beyond impacts on a particular disease or risk factor. Rather, they include broad effects and benefits on prevention, disease management, and well-being across the life span. Among priorities for dissemination research, the application of behavioral approaches is challenged by diverse barriers, including socioeconomic barriers linked to health disparities. However, behavioral approaches including those emphasizing community and social influences appear to be useful in addressing such challenges. In sum, behavioral approaches should have a central place in prevention and health care of the 21st century.
doi:10.1016/j.amepre.2010.12.031
PMCID: PMC3137947  PMID: 21496745
16.  Combined Impact of Geriatric Syndromes and Cardiometabolic Diseases on Measures of Functional Impairment 
Background.
Examine the independent and joint effects of geriatric syndromes (GS) and cardiometabolic diseases (CMDs) on functional impairment.
Methods.
Cross-sectional analysis of baseline data from the Women's Health Initiative, including 62,829 women aged 65 years or older. GS (urinary incontinence, falls, and depression measured by the shortened Center for Epidemiological Studies-Depression scale/Diagnostic Interview Schedule screening instrument) and CMD (coronary artery disease, coronary heart failure, and diabetes) were self-reported. Physical and social functioning and general health subscales of the Short Form-36 dichotomized at the median for the study sample were used to assess functional impairment. Additive interaction between burden of GS and CMD was assessed using logistic regression models.
Results.
Forty-three percent of women had at least one GS; 14.1% had at least one CMD; and 6.9% had at least one of each. Compared with women with no GS or CMD, women with one or more GS but no CMD were as likely to have physical functioning impairments (odds ratio [OR] = 1.79; 95% confidence interval [CI] = 1.73, 1.86) as those with CMD alone (OR = 1.97; CI = 1.84, 2.10). The association with social functioning was stronger for GS alone (OR = 2.10; CI = 2.02, 2.18) compared with CMD (OR = 1.60; CI = 1.50, 1.71). The association with general health was stronger for CMD alone (OR = 2.15; CI = 2.01, 2.29) compared with GS (OR = 1.68; CI = 1.62, 1.74). Significant interactions between GS and CMD were observed for all functional measures with 20%–30% of observed ORs attributable to additive interaction.
Conclusion.
GSs alone are associated with functional impairment in older women; the association is stronger in the presence of even one CMD.
doi:10.1093/gerona/glq230
PMCID: PMC3041502  PMID: 21317242
Geriatric syndromes; Cardiometabolic disease; Physical functioning
17.  Estrogen Plus Progestin and Lung Cancer in Postmenopausal Women 
Lancet  2009;374(9697):1243-1251.
Background
In the post intervention period of the Women’s Health Initiative (WHI) clinical trial, estrogen plus progestin increased total cancer incidence and an adverse influence on lung cancer mortality was suggested.
Methods
We conducted post hoc analyses over the full follow-up period of the WHI randomized, placebo-controlled clinical trial evaluating daily conjugated equine estrogen (CEE, 0.625 mg) plus medroxyprogesterone acetate (MPA, 2.5 mg) influence on lung cancer incidence and mortality in 16,608 postmenopausal women.
Findings
After 5.6 years intervention and 2.4 years additional follow-up (mean), there were 109 lung cancers in the hormone group and 85 in the placebo group (hazard ratio (HR) 1.23, 95% confidence interval (CI), 0.92, 1.63, P=0.16). While the difference was not statistically significant, for non-small cell lung cancer a possible divergence emerged over time, with more diagnoses in the CEE plus MPA group (96 vs 72 cases, respectively, HR 1.28, 95% CI 0.94, 1.73, P=0.12) and these cancers were more commonly poorly differentiated and more commonly had distant metastasis. Deaths from lung cancer were significantly increased in the CEE plus MPA group (73 vs 40 deaths, respectively, HR 1.71, 95% CI 1.16, 2.52, P=0.01) as were deaths from non-small cell lung cancer (62 vs 31 deaths, respectively, HR 1.87, 95% CI 1.22, 2.88, P=0.004). Small cell lung cancer incidence and mortality was comparable between randomization groups.
Interpretation
Use of estrogen plus progestin did not increase lung cancer incidence but significantly increased deaths from lung cancer. The effect may primarily be through influence on non-small cell lung cancer outcome.
doi:10.1016/S0140-6736(09)61526-9
PMCID: PMC2995490  PMID: 19767090
18.  Influence of stressors on breast cancer incidence in the Women’s Health Initiative 
Objective
To examine associations among life events stress, social support, and breast cancer incidence in a cohort of postmenopausal women.
Design and main outcome measure
Women’s Health Initiative observational study participants, breast cancer free at entry, who provided assessment of stressful life events, social support, and breast cancer risk factors, were prospectively followed for breast cancer incidence (n=84,334).
Results
During an average of 7.6 years of follow-up, 2,481 invasive breast cancers were diagnosed. In age-adjusted proportional hazards models, one stressful life event was associated with increased risk, but risk decreased with each additional stressful life event. After adjustment for confounders the decreasing risk was not significant. Stressful life events and social support appeared to interact in relation to breast cancer risk such that women who had greater number of stressful life events and low social support had a decreased risk of breast cancer.
Conclusions
This study found no independent association between stressful life events and breast cancer risk. The results are compatible with a more complex model of psychosocial factors interacting in relation to breast cancer risk.
doi:10.1037/a0012982
PMCID: PMC2657917  PMID: 19290705
19.  Association between dietary fiber and markers of systemic inflammation in the Women’s Heath Initiative Observational Study 
Objective
Systemic inflammation may play an important role in the development of atherosclerosis, type 2 diabetes, and some cancers. Few studies have comprehensively assessed the direct relationships between dietary fiber and inflammatory cytokines, especially in minority populations. Using baseline data from 1,958 postmenopausal women enrolled in the Women’s Heath Initiative Observational Study, we examined cross-sectional associations between dietary fiber intake and markers of systemic inflammation (including serum C-reactive protein (hs-CRP), interleukin 6 (IL-6), and tumor necrosis factor α receptor 2 (TNF-α-R2)), as well as differences in these associations by ethnicity.
Method
Multiple linear regression models were used to assess the relationship between fiber intake and makers of systemic inflammation.
Results
After adjustment for covariates, intake of dietary fiber were inversely associated with both IL-6 (P values for trend were 0.01 for total fiber, 0.004 for soluble fiber, and 0.001 for insoluble fiber) and TNF-α-R2 (P values for trend were 0.002 for total, 0.02 for soluble, and <0.001 for insoluble fiber). Although the sample sizes were small in minority Americans, results were generally consistent with that found among European-Americans. We did not observe any significant association between intake of dietary fiber and hs-CRP.
Conclusions
These findings lend support to the hypothesis that a high-fiber diet is associated with lower plasma levels of IL-6 and TNF-α-R2. Contrary to previous reports, however, there was no association between fiber and hs-CRP among postmenopausal women. Future studies on the influence of diet on inflammation should include IL-6 and TNF-α-R2 and enroll participants from ethnic minorities.
doi:10.1016/j.nut.2008.04.005
PMCID: PMC2603616  PMID: 18562168
dietary fiber; C-reactive protein; interleukin-6; tumor necrosis factor-alpha receptor 2; inflammation; cytokines; epidemiology; cardiovascular disease; nutrition
20.  Resting heart rate as a low tech predictor of coronary events in women: prospective cohort study 
Objective To evaluate resting heart rate as an independent predictor of cardiovascular risk in women.
Design Prospective cohort study.
Setting The Women’s Health Initiative was undertaken at 40 research clinics in the United States.
Participants 129 135 postmenopausal women.
Main outcome measure Clinical cardiovascular events.
Results During a mean of 7.8 (SD 1.6) years of follow up, 2281 women were identified with myocardial infarction or coronary death and 1877 with stroke. We evaluated associations between resting heart rate and cardiovascular events in Cox regression models adjusted for multiple covariates. Higher resting heart rate was independently associated with coronary events (hazard ratio 1.26, 95% confidence interval 1.11 to 1.42 for highest [>76 beats per minute] v lowest quintile [≤62 beats per minute]; P=0.001), but not with stroke. The relation between heart rate and coronary events did not differ between white women and women from other ethnic groups (P for interaction=0.45) or between women with and without diabetes (P for interaction=0.31), but it was stronger in women aged 50-64 at baseline than in those aged 65-79 (P for interaction=0.009).
Conclusion Resting heart rate, a low tech and inexpensive measure of autonomic tone, independently predicts myocardial infarction or coronary death, but not stroke, in women.
Trial registration ClinicalTrials.gov NCT00000611.
doi:10.1136/bmj.b219
PMCID: PMC2640113  PMID: 19193613
21.  Enrollment in a Brain Magnetic Resonance Study: Results From the Women's Health Initiative Memory Study Magnetic Resonance Imaging Study (WHIMS-MRI)1 
Academic radiology  2007;14(5):603-612.
Rationale and Objectives
The rates of enrollment of volunteers for brain magnetic resonance imaging (MRI) studies vary by demographic and clinical characteristics. We use data from a large MRI study to identify factors associated with differential enrollment and to examine potential biases this may produce in study results.
Materials and Methods
Results from recruitment of 1,431 women into the MRI substudy of the Women's Health Initiative Memory Study (WHIMS-MRI) are described. A sensitivity analysis was conducted to estimate the degree of bias associated with missing data on estimates of risk factor relationships.
Results
Of 2,345 women contacted from an established cohort of women older than 70 years of age, 72% consented to undergo screening for WHIMS-MRI. Scanning was ultimately completed on 61%. Completion rates varied according to a range of sociodemographic, lifestyle, and clinical characteristics that may be related to study outcomes. Plausible levels of selective enrollment in magnetic resonance imaging studies may produce moderate biases (< ±20%) in characterizations of risk factor relationships. Adverse events, such as claustrophobia, occurred during 1.7% of the attempted scans and, in 0.8% of instances, led to lost data.
Conclusions
Enrollment of older women into brain imaging studies is feasible, although selection biases may limit how well study cohorts reflect more general populations.
doi:10.1016/j.acra.2007.02.001
PMCID: PMC1934046  PMID: 17434074
Informed consent; magnetic resonance imaging; clinical trial
22.  Organizational Systems to Support Publicly Funded Tobacco Treatment Services 
Background:
Professional societies and government organizations have promoted guidelines and best practices that encourage clinicians to routinely integrate cessation counseling into patient encounters. While research in health maintenance organizations has demonstrated that the development and maintenance of office systems do enable clinicians’ smoking-cessation services, little is known about the adoption of system strategies in diverse organizations serving disadvantaged populations.
Methods:
Data were collected via face-to-face interviews from November 2001 to October 2002 using a standardized systems assessment checklist at service delivery sites of 83 funded community health service agencies, which included hospitals, community health centers, and other organizations (e.g., substance abuse, mental health, and multiservice). The content of the structured assessment reflected system elements with proven effectiveness that have been included in guidelines and best practices recommendations. Detailed information was collected on the implementation strategies.
Results:
This study found considerable attention to systems that support cessation services in diverse healthcare organizations, but much remains to be done. There is a wide diversity of implementation strategies employed, with varied degrees of sophistication.
Conclusions:
A major challenge is to develop systems capable of providing population-based feedback to, and between, providers, which will enable further quality improvement efforts.
doi:10.1016/j.amepre.2005.01.008
PMCID: PMC1635789  PMID: 15831338
23.  Brief Physician and Nurse Practitioner–delivered Counseling for High-risk Drinking 
BACKGROUND
The objective of this study was to determine the effects of a brief primary care provider–delivered counseling intervention on the reduction of alcohol consumption by high-risk drinkers. The intervention was implemented as part of routine primary care medical practice.
METHODS
We performed a controlled clinical trial with 6- and 12-month follow-up. Three primary care practices affiliated with an academic medical center were randomly assigned to special intervention (SI) or usual care (UC). A total of 9,772 primary care patients were screened for high-risk drinking. A fourth site was added later. From the group that was screened, 530 high-risk drinkers entered into the study, with 447 providing follow-up at 12 months. The intervention consisted of brief (5–10 minute) patient-centered counseling plus an office system that cued providers to intervene and provided patient educational materials.
RESULTS
At 12-month follow-up, after controlling for baseline differences in alcohol consumption, SI participants had significantly larger changes (P =.03) in weekly alcohol intake compared to UC (SI=−5.7 drinks per week; UC=−3.1 drinks per week), and of those who changed to safe drinking at 6 months more SI participants maintained that change at 12 months than UC.
CONCLUSIONS
Project Health provides evidence that screening and very brief (5–10 minute) advice and counseling delivered by a patient's personal physician or nurse practitioner as a routine part of a primary care visit can reduce alcohol consumption by high-risk drinkers.
doi:10.1111/j.1525-1497.2005.21240.x
PMCID: PMC1490034  PMID: 15693921
high-risk drinking; primary care; provider-delivered intervention
24.  Atherosclerotic Risk Factor Reduction in Peripheral Arterial Disease 
OBJECTIVE
Individuals with peripheral arterial disease (PAD) have a 3- to 6-fold increased risk of coronary heart disease and stroke compared to those without PAD. We documented physician-reported practice behavior, knowledge, and attitudes regarding atherosclerotic risk factor reduction in patients with PAD.
DESIGN
National physician survey.
PATIENTS/PARTICIPANTS
General internists (N = 406), family practitioners (N = 435), cardiologists (N = 473), and vascular surgeons (N = 264) randomly identified using the American Medical Association's physician database.
MEASUREMENTS AND MAIN RESULTS
Physicians were randomized to 1 of 3 questionnaires describing a) a 55- to 65-year-old patient with PAD; b) a 55- to 65-year-old patient with coronary artery disease (CAD), or c) a 55- to 65-year-old patient without clinically evident atherosclerosis (no disease). A mailed questionnaire was used to compare physician behavior, knowledge, and attitude regarding risk factor reduction for each patient. Rates of prescribed antiplatelet therapy were significantly lower for the patient with PAD than for the patient with CAD. Average low-density lipoprotein levels at which physicians “almost always” initiated lipid-lowering drugs were 121.6 ± 23.5 mg/dL, 136.3 ± 28.9 mg/dL, and 149.7 ± 24.4 mg/dL for the CAD, PAD, and no-disease patients, respectively (P < .001). Physicians stated that antiplatelet therapy (P < .001) and cholesterol-lowering therapy (P < .001) were extremely important significantly more often for the CAD than for the PAD patient. Perceived importance of risk factor interventions was highly correlated with practice behavior. Compared to other specialties, cardiologists had lowest thresholds, whereas vascular surgeons had the highest thresholds for initiating cholesterol-lowering interventions for the patient with PAD. Cardiologists were significantly more likely to report “almost always” prescribing antiplatelet therapy for the patient with PAD than were all other physicians.
CONCLUSIONS
Deficiencies in physician knowledge and attitudes contribute to lower rates of atherosclerotic risk factor reduction for patients with PAD. Reversing these deficiencies may reduce the high rates of cardiovascular morbidity and mortality associated with PAD.
doi:10.1046/j.1525-1497.2002.20307.x
PMCID: PMC1495143  PMID: 12472925
peripheral vascular disease; quality of care; cardiovascular disease
25.  Alcohol Counseling 
OBJECTIVE
To assess the use of a brief provider-delivered alcohol counseling intervention of 5 to 10 minutes with high-risk drinking patients by primary care providers trained in the counseling intervention and provided with an office support system.
DESIGN
A group randomized study design was used. Office sites were randomized to either a usual care or special intervention condition, within which physicians and patients were nested. The unit of analysis was the patient.
SETTING
Primary care internal medicine practices affiliated with an academic medical center.
PARTICIPANTS
Twenty-nine providers were randomized by practice site to receive training and an office support system to provide an alcohol counseling special intervention or to continue to provide usual care.
INTERVENTION
Special intervention providers received 2 1/2 hours of training in a brief alcohol-counseling intervention and were then supported by an office system that screened patients, cued providers to intervene, and made patient education materials available as tip sheets.
MEASUREMENTS AND MAIN RESULTS
Implementation of the counseling steps was measured by patient exit interviews (PEI) immediately following the patient visit. The interval between the date of training and the date of the PEI ranged from 6 to 32 months. Special intervention providers were twice as likely as usual care providers to discuss alcohol use with their patients. They carried out every step of the counseling sequence significantly more often than did usual care providers (p < .001). This intervention effect persisted over the 32 months of follow-up.
CONCLUSIONS
Physicians and other health-care providers trained in a brief provider-delivered alcohol intervention will counsel their high-risk drinking patients when cued to do so and supported by a primary care office system.
doi:10.1046/j.1525-1497.1998.00206.x
PMCID: PMC1500899  PMID: 9798817
alcoholism; problem drinking; counseling

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