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1.  Physical impairment and body weight history in postmenopausal women: The Women's Health Initiative 
Public health nutrition  2016;19(17):3169-3177.
To examine whether weight history and weight transitions over adult lifespan contribute to physical impairment among postmenopausal women.
Body mass index (BMI; kg/m2) categories were calculated among postmenopausal women who reported their weight and height at age 18. Multiple-variable logistic regression was used to determine the association between BMI at age 18 and BMI transitions over adulthood on severe physical impairment (SPI), defined as scoring < 60 on the Physical Functioning Subscale of the Random 36-Item Healthy Survey.
Participants were part of the Women's Health Initiative Observational study (WHI OS), where participants’ health were followed over time via questionnaires and clinical assessments.
Postmenopausal women (n=76,016; 63.5 ± 7.3 years)
Women with overweight (BMI=25.0-29.9) or obesity (BMI≥30) at 18 years had greater odds of SPI [odds ratio (OR) = 1.51, 95% confidence interval (CI): 1.35-1.69 and 2.14, 95% CI: 1.72-2.65, respectively] than normal weight (BMI=18.5-24.9) counterparts. Transitions from normal weight to overweight/obese or to underweight (BMI <18.5) were associated with greater odds of SPI (1.97 [1.84-2.11] and 1.35 [1.06-1.71], respectively) compared to weight stability. Shifting from underweight to overweight/obese also had increased odds of SPI (1.52 [1.11-2.09]). Overweight/obese to normal BMI transitions resulted in a reduced SPI odds (0.52 [0.39-0.71]).
Higher weight history and transitions into higher weight classes were associated with higher likelihood of severe physical impairment, while transitioning into lower weight classes for those with overweight/obesity was protective among postmenopausal women.
PMCID: PMC5135627  PMID: 27269298
Body weight; weight change; body mass index; physical impairment; physical function; disability
2.  Depression and quality of life before and after breast cancer diagnosis in older women from the Women's Health Initiative 
Distress and reduced quality of life (QOL) are common among people with cancer. No study has compared these variables after breast cancer diagnosis to pre-cancer diagnosis levels.
Data on women with breast cancer 50 years of age or older (n=6949) were analyzed from the Women's Health Initiative (1993-2013). Health-related QOL (physical function, mental health) was measured using Rand-36. Depressive symptoms were measured with the 6-item Center for Epidemiologic Studies Depression. Assessments occurred before and after the cancer diagnosis. Hierarchical linear modeling compared pre-cancer QOL and depressive symptoms to levels post-diagnosis and tested whether pre-cancer physical activity, stressful life events, sleep disturbance, and pain predicted post-diagnosis outcomes.
Compared with pre-cancer levels, depressive symptoms increased (20.0% increase at 0-6 months, 12.9% increase at 6-12 months), while physical function (−3.882 points at 0-6 months, −3.545 at 6-12 months) and mental health decreased (−2.899 points at 0-6 months, −1.672 at 6-12 months) in the first year after diagnosis (p's<.01). Depressive symptoms returned to pre-cancer levels after 10 years but QOL remained significantly lower. At more than 10 years post-diagnosis, physical function was 2.379 points lower than pre-cancer levels (p<0.01) while mental health was 1.922 points lower (p<0.01). All pre-cancer predictors were associated with all outcomes. Pain predicted uniquely greater decreases in physical function post-diagnosis.
Depressive symptoms increased and QOL decreased following breast cancer diagnosis compared with pre-cancer levels, particularly in the first year.
Implications for Cancer Survivors
QOL may remain lower for years after breast cancer diagnosis, though decreases are small.
PMCID: PMC4547920  PMID: 25708515
breast cancer; neoplasm; depression; distress; health-related quality of life; women's health
3.  Construct Validation of the Dietary Inflammatory Index among Postmenopausal Women 
Annals of epidemiology  2015;25(6):398-405.
Many dietary factors have either pro- or anti-inflammatory properties. We previously developed a dietary inflammatory index (DII) to assess the inflammatory potential of diet. In this study we conducted a construct validation of the DII based on data from a food frequency questionnaire and three inflammatory biomarkers in a subsample of 2,567 postmenopausal women in the Women’s Health Initiative Observational Study.
We used multiple linear and logistic regression models, controlling for potential confounders, to test whether baseline DII predicted concentrations of interleukin-6 (IL-6), high-sensitivity C-reactive protein (hs-CRP), tumor necrosis factor alpha receptor 2 (TNFα-R2), or an overall biomarker score combining all three inflammatory biomarkers.
The DII was associated with the four biomarkers with beta estimates (95%CI) comparing the highest with lowest DII quintiles as follows: IL-6: 1.26 (1.15, 1.38), Ptrend<0.0001; TNFα-R2: 81.43 (19.15, 143.71), Ptrend=0.004; dichotomized hs-CRP (odds ratio for higher versus lower hs-CRP): 1.30 (0.97, 1.67), Ptrend=0.34); and the combined inflammatory biomarker score: 0.26 (0.12, 0.40), Ptrend=0.0001.
The DII was significantly associated with inflammatory biomarkers. Construct validity of the DII indicates its utility for assessing the inflammatory potential of diet and for expanding its use to include associations with common chronic diseases in future studies.
PMCID: PMC4433562  PMID: 25900255
dietary inflammatory index; inflammatory biomarkers; construct validation; Women’s Health Initiative
4.  Tobacco Counseling Experience Prior to Starting Medical School, Tobacco Treatment Self-Efficacy and Knowledge among First-Year Medical Students in the United States 
Preventive medicine  2015;73:119-124.
To explore students’ tobacco dependence counseling experiences prior to medical school and their associations with tobacco counseling self-efficacy, and familiarity with and perceived effectiveness of tobacco dependence treatment among first-year medical students in the United States.
In 2010, 1266 first-year medical students from 10 U.S. medical schools completed a survey reporting their clinical experiences with specific tobacco counseling skills (e.g., 5As) prior to medical school. The survey also included questions on tobacco counseling self-efficacy, perceived physician impact on smokers, and familiarity and effectiveness of tobacco-related treatments.
Half (50.4%) reported some tobacco counseling experiences prior to medical school (i.e. at least one 5A). Students with prior counseling experiences were more likely to have higher tobacco counseling self-efficacy, and greater familiarity with medication treatment, nicotine replacement treatment, and behavioral counseling for smoking cessation, compared to those with no prior experiences. Perceived physician impact on patient smoking outcomes did not differ by prior tobacco counseling experiences.
Many first-year medical students may already be primed to learn tobacco dependence counseling skills. Enhancing early exposure to learning these skills in medical school is likely to be beneficial to the skillset of our future physicians.
PMCID: PMC4378235  PMID: 25666737
Tobacco dependence treatment; self-efficacy; perceived effectiveness; medical students
5.  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
6.  Medical school curriculum characteristics associated with intentions and frequency of tobacco dependence treatment among 3rd year U.S. medical students 
Preventive medicine  2015;72:56-63.
Physicians play a critical role in addressing tobacco dependence, yet report limited training. Tobacco dependence treatment curricula for medical students could improve performance in this area. This study identified student and medical school tobacco treatment curricula characteristics associated with intentions and use of the 5As for tobacco treatment among 3rd year U.S. medical students.
Third year medical students (N=1065, 49.3% male) from 10 U.S. medical schools completed a survey in 2009-2010 assessing student characteristics, including demographics, tobacco treatment knowledge, and self-efficacy. Tobacco curricula characteristics assessed included amount and type of classroom instruction, frequency of tobacco treatment observation, instruction, and perception of preceptors as role models.
Greater tobacco treatment knowledge, self-efficacy, and curriculum-specific variables were associated with 5A intentions, while younger age, tobacco treatment self-efficacy, intentions, and each curriculum-specific variable was associated with greater 5A behaviors. When controlling for important student variables, greater frequency of receiving 5A instruction (OR = 1.07; 95%CI 1.01-1.12) and perception of preceptors as excellent role models in tobacco treatment (OR = 1.35; 95%CI 1.04-1.75) were significant curriculum predictors of 5A intentions. Greater 5A instruction (B = .06 (.03); p< .05) and observation of tobacco treatment (B= .35 (.02); p< .001) were significant curriculum predictors of greater 5A behaviors.
Greater exposure to tobacco treatment teaching during medical school is associated with both greater intentions to use and practice tobacco 5As. Clerkship preceptors, or those physicians who provide training to medical students, may be particularly influential when they personally model and instruct students in tobacco dependence treatment.
PMCID: PMC4562320  PMID: 25572623
tobacco dependence treatment; medical school curriculum and education; medical students
7.  The Association between Dietary Inflammatory Index and Risk of Colorectal Cancer among Postmenopausal Women: Results from the Women’s Health Initiative 
Cancer causes & control : CCC  2014;26(3):399-408.
Inflammation is a process central to carcinogenesis, and in particular to colorectal cancer (CRC). Previously, we developed a dietary inflammatory index (DII) from extensive literature review to assess the inflammatory potential of diet. In the current study, we utilized this novel index in the Women’s Health Initiative (WHI) to prospectively evaluate its association with risk of CRC in postmenopausal women.
The DII was calculated from baseline food frequency questionnaires administered to 152,536 women aged 50–79 years without CRC at baseline between 1993 and 1998 and followed through September 30, 2010. Incident CRC cases were ascertained through a central physician adjudication process. Multiple covariate-adjusted Cox proportional hazards regression models were used to estimate hazard ratios (HR) and 95% confidence intervals (95%CI) for colorectal, colon (proximal/distal locations), and rectal cancer risk, by DII quintiles(Q).
During an average 11.3 years of follow-up, a total of 1,920 cases of colorectal cancer (1,559 colon and 361 rectal) were identified. Higher DII scores (representing a more pro-inflammatory diet) were associated with an increased incidence of colorectal cancer (HRQ5-Q1, 1.22; 95% CI, 1.05, 1.43; Ptrend=0.02) and colon cancer, specifically proximal colon cancer (HRQ5-Q1, 1.35; 95% CI, 1.05, 1.67; Ptrend=0.01) but not distal colon cancer (HRQ5-Q1, 0.84; 95% CI, 0.61, 1.18; Ptrend=0.63) or rectal cancer (HRQ5-Q1, 1.20; 95% CI, 0.84, 1.72; Ptrend=0.65).
Consumption of pro-inflammatory diets is associated with an increased risk of CRC, especially cancers located in the proximal colon. The absence of a significant association for distal colon cancer and rectal cancer may be due to the small number of incident cases for these sites. Interventions that may reduce the inflammatory potential of the diet are warranted to test our findings, thus provide more information for colon cancer prevention.
PMCID: PMC4334706  PMID: 25549833
dietary inflammatory index; colorectal cancer; Women’s Health Initiative
8.  Assessing Medical Students’ Tobacco Dependence Treatment Skills Using a Detailed Behavioral Checklist 
Teaching and learning in medicine  2015;27(3):292-298.
This paper describes the development and implementation of an assessment intended to provide objective scores that would be valid indications of medical students’ abilities to counsel patients about tobacco dependence.
Assessing medical students’ advanced communication skills, particularly in the context of providing tobacco dependence treatment, consistently and accurately is challenging; doing so across multiple medical schools is even more difficult.
Ten medical schools implemented a tobacco dependence treatment case as part of an Objective Structured Clinical Examination (OSCE) for third year medical students. A 33-item checklist with detailed criteria and examples was developed for scoring students’ performances. Trained coders viewed and coded 660 videotaped encounters; approximately 10% also were coded by the coding supervisor to check accuracy.
Average time required to code an encounter was approximately 31 minutes; accuracy (i.e., agreement with the gold standard coder) was excellent. Overall, students performed an average of 1 in 4 of the 33 behaviors included on the checklist, and only 1 in 10 discussed setting a quit date. Most students (almost 9 in 10) asked how much the patient smoked in a day, and just over 7 in 10 informed the patient that the cough was due to smoking.
The authors developed and implemented a rigorous assessment that will be used to evaluate medical students’ tobacco dependence treatment skills. Operationalizing the specific counseling behaviors, training coders to accurately capture students’ performances using a structured checklist, and conducting the coding all required substantial time commitments, but will provide confidence in the objectivity of the assessment results. Additionally, this assessment can be used to provide formative information on medical students’ tobacco dependence treatment skills, and to tailor ongoing training for medical students in this area.
PMCID: PMC4685671  PMID: 26158331
9.  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
10.  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
11.  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.
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.
Enrollment of older women into brain imaging studies is feasible, although selection biases may limit how well study cohorts reflect more general populations.
PMCID: PMC1934046  PMID: 17434074
Informed consent; magnetic resonance imaging; clinical trial
12.  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
13.  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
14.  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
15.  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
16.  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
17.  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
19.  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
20.  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
21.  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
22.  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
23.  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
24.  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
25.  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

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