This study aims to determine the positive and negative predictive values of self-reported diabetes during the Women's Health Initiative (WHI) clinical trials.All WHI trial participants from four field centers who self-reported diabetes at baseline or during follow-up, as well as a random sample of women who did not self-report diabetes, were identified. Women were surveyed regarding diagnosis and treatment. Medical records were obtained and reviewed for documented treatment with antidiabetes med...

The objectives of this study are to assess the impact of pre-existing diabetes and diabetes treatment on breast cancer prognosis. 8,108 women with centrally confirmed invasive breast cancer in the Women's Health Initiative diagnosed between 1998 and 2013 were followed through the date of death or September 20, 2013. Information on diabetes and diabetes therapy were obtained via self-report and face-to-face review of current medication containers, respectively. Cox proportional hazard regression ...

INTRODUCTION: Our objective was to compare Medicare claims to physician review and adjudication of medical records for identifying venous thromboembolism (VTE), and to assess VTE incidence, recurrence, and mortality in a large national cohort of post-menopausal women followed up to 19years. MATERIALS AND METHODS: We used detailed clinical data from the Women's Health Initiative (WHI) linked to Medicare claims. Agreement between data sources was evaluated among 16,003 women during 1993-2010. A cl...

Data collected as part of routine clinical practice could be used to detect cardiovascular outcomes in pragmatic clinical trials or clinical registry studies. The reliability of claims data for documenting outcomes is unknown.We linked records of Women's Health Initiative (WHI) participants aged =65 years to Medicare claims data and compared hospitalizations that had diagnosis codes for acute myocardial infarction or coronary revascularization with WHI outcomes adjudicated by study physicians. W...

Background:: Breast cancer mortality is substantially higher in Black compared to White women due in part to higher rates of poor prognosis triple-negative breast cancer (TNBC) in Black women. The influence of African ancestry on this disparity has not been adequately examined. Methods:: Using the Women’s Health Initiative cohort of 161,808 postmenopausal women, we examined risk of TNBC in 6,166 Black participants with information on African ancestry, of whom 374 had incident localized breast ca...

Background: Inflammatory cytokines play a role in atrial fibrillation (AF). Interleukin (IL)-1β, which is targeted in the treatment of ischemic heart disease, has not been well-studied in relation to AF. Methods: Postmenopausal women from the Women's Health Initiative were included. Cox proportional hazards regression models were used to evaluate the association between log-transformed baseline cytokine levels and future AF incidence. Models were adjusted for body mass index, age, race, educatio...

In the Women's Health Initiative (WHI) Life and Longevity After Cancer (LILAC) cohort we examined predictors of guideline-concordant treatment among endometrial cancer (EC) survivors and associations between receipt of guideline-concordant treatment and survival. Receipt of guideline-concordant EC treatment was defined according to year-specific National Comprehensive Cancer Network (NCCN) guidelines. Multivariable logistic regression was used to estimate odds ratios (ORs) and 95% confidence int...

Background: Whether DCIS is associated with higher breast cancer-specific and all-cause mortality is unclear with few studies in older women. Therefore, we examined DCIS and breast cancer-specific, cardiovascular (CVD)-specific, and all-cause mortality among Women's Health Initiative (WHI) Clinical Trial participants overall and by age (< 70 versus ≥ 70 years). Methods: Of 68,132 WHI participants, included were 781 postmenopausal women with incident DCIS and 781 matched controls. Serial screenin...

OBJECTIVE: To examine the association between leisure-time physical activity (PA) and survival to age 85 with mobility limitation or death before age 85 after total knee (TKR) or total hip replacement (THR) for osteoarthritis (OA). METHODS: This was a prospective study among participants from the Women's Health Initiative (WHI), recruited 1993-1998 (baseline age 65-79 yrs) and followed through 2012. Medicare claims data were linked to WHI data to determine TKR (n = 1986) and THR (n = 1034). Self...

OBJECTIVE: To examine associations of high-sensitivity C-reactive protein (CRP) levels and polygenic CRP genetic risk scores (GRS) with risk of end-stage hip or knee osteoarthritis (OA), defined as incident total hip (THR) or knee replacement (TKR) for OA. DESIGN: This study included a cohort of postmenopausal white, African American, and Hispanic women from the Women's Health Initiative. Women were followed from baseline to date of THR or TKR, death, or December 31, 2014. Medicare claims data i...

Atrial fibrillation (AF) is less prevalent in women versus men, but associated with higher risks of stroke and death in women. The role hormone therapy plays in AF is not well understood.The Women's Health Initiative randomized postmenopausal women to placebo or conjugated equine estrogens (0.625 mg/d) plus medroxyprogesterone acetate (2.5 mg/d) if they had a uterus (N=16 608) or to conjugated equine estrogens only if they had prior hysterectomy (N=10 739). Incident AF was identified by ECG and ...

Atrial fibrillation (AF) is the most common arrhythmia in women. Large studies evaluating key AF risk factors in older women are lacking. We aimed to identify risk factors for AF in postmenopausal women and measure population burden of modifiable risk factors.Prospective observational study.The Women's Health Initiative (WHI) Observational Study.93 676 postmenopausal women were followed for an average of 9.8 years for cardiovascular outcomes. After exclusion of women with prevalent AF or incompl...

BACKGROUND: Atrial fibrillation (AF) is the most common arrhythmia in adults. Although vitamin D deficiency is associated with AF risk factors, retrospective studies of association with AF have shown mixed results. We sought to determine the efficacy of calcium and vitamin D (CaD) supplementation for AF prevention in a randomized trial. METHODS: We performed a secondary analysis of the Women's Health Initiative trial on CaD supplementation versus placebo. We linked participants to their Medicare...

BACKGROUND: The incidence of atrial fibrillation (AF) is higher in non-Hispanic whites (NHWs) compared with other race-ethnic groups, despite more favorable cardiovascular risk profiles. To explore reasons for this paradox, we compared the hazards of AF from traditional and other risk factors between 4 race-ethnic groups in a large cohort of postmenopausal women. METHODS: We included 114,083 NHWs, 11,876 African Americans, 5,174 Hispanics, and 3,803 Asians from the Women's Health Initiative free...

IMPORTANCE: Carpal tunnel syndrome (CTS) is a common and debilitating condition that commonly affects postmenopausal women. OBJECTIVE: To determine the effect of menopausal hormone therapy (HT) in healthy postmenopausal women on CTS risk. DESIGN: We conducted a secondary analysis of the Women's Health Initiative's (WHI) HT trials linked to Medicare claims data. Separate intention-to-treat analyses were performed for the two trials; the conjugated equine estrogens alone (CEE alone) and the trial ...

The objective of this study was to assess the impact of pre-existing diabetes on breast cancer prognosis.Women (n=2833) with centrally confirmed invasive breast cancer in the Women's Health Initiative, who were linked to Medicare claims data (CMS) were followed from the date of breast cancer diagnosis to date of death or 20 September 2013. Information on diabetes was identified through the CMS Chronic Condition Warehouse algorithm. Cox proportional hazard regression was used to estimate adjusted...

OBJECTIVES: Higher body mass index (BMI) is an important risk factor for atrial fibrillation (AF). The adipokines leptin, adiponectin and resistin are correlates of BMI, but their association with incident AF is not well known. We explored this relationship in a large cohort of postmenopausal women. METHODS: We studied an ethnically diverse cohort of community-dwelling postmenopausal women aged 50-79 who were nationally recruited at 40 clinical centres as part of the Women's Health Initiative in...

PURPOSE: We conducted a secondary analysis of a randomized, placebo-controlled trial to test if hormone therapy (HT) altered the risk of open-angle glaucoma (OAG), and if the risk reduction varied by race. DESIGN: Secondary analysis of randomized controlled trial data Methods: We linked Medicare claims data to 25,535 women in the Women's Health Initiative. Women without a uterus were randomized to receive either oral conjugated equine estrogens (CEE 0.625mg/day) or placebo, and women with a uter...

Capturing long-term outcomes from large clinical databases by use of claims data is a potential strategy for improving efficiency while reducing study costs. We sought to compare the use of Medicare data with data from the Women's Health Initiative (WHI) to determine peripheral vascular events, as defined by the WHI study design.We studied participants from the WHI with both adjudicated outcomes and links to Medicare enrollment and utilization data through 2007. Outcomes of interest included hos...

BACKGROUND AND PURPOSE: Many studies use medical record review for ascertaining outcomes. One large, longitudinal study, the Women's Health Initiative (WHI), ascertains strokes using participant self-report and subsequent physician review of medical records. This is resource-intensive. Herein, we assess whether Medicare data can reliably assess stroke events in the WHI. METHODS: Subjects were WHI participants with fee-for-service Medicare. Four stroke definitions were created for Medicare data u...

Importance: Understanding changes in frailty in relation to cancer diagnosis can inform optimal selection of cancer treatments and survivorship care. Objective: To investigate associations of prediagnostic frailty and change in frailty status with mortality after a cancer diagnosis. Design, setting, and participants: This multicenter, prospective cohort study included 7257 community-dwelling, postmenopausal women in the United States who had frailty assessed at the Women's Health Initiative (WHI...

Higher trait optimism and/or lower cynical hostility are associated with healthier behaviors and lower risk of morbidity and mortality, yet their association with health care utilization has been understudied. Whether these psychological attitudes are associated with breast cancer screening behavior is unknown. To assess the association of optimism and cynical hostility with screening mammography in older women and whether sociodemographic factors acted as mediators of these relationships, we us...

BACKGROUND: The aims of this study are to investigate the impact of pre-existing diabetes and diabetes treatments on lung cancer prognosis. METHODS: A total of 2484 women with confirmed incident lung cancer from the Women's Health Initiative were followed for an average of 2.9 years through the date of death or 29 August 2014. RESULTS: Compared with women with lung cancer but without diabetes, women with lung cancer and diabetes had significantly increased risk of overall mortality (HR=1.27, 95%...

Atrial fibrillation (AF) is the most common cardiac arrhythmia and is associated with increased risk of stroke and death. Obesity is an independent risk factor for AF, but modifiers of this risk are not well known. We studied the roles of obesity, physical activity, and their interaction in conferring risk of incident AF.The Women's Health Initiative (WHI) Observational Study was a prospective observational study of 93 676 postmenopausal women followed for an average of 11.5 years. Incident AF w...

BACKGROUND: The majority of women diagnosed with endometrial cancer (EC) have low cancer-specific mortality; however, a high prevalence of cardiovascular disease (CVD) risk factors places EC patients at high risk of developing CVD. In the Women's Health Initiative (WHI), we assessed the hypothesis that CVD risk was higher among women who developed EC compared with women who did not develop EC. METHODS: We compared the incidence of fatal and non-fatal CVD events among 1,179 women who developed Ty...

Estrogen level fluctuations have been linked to psoriasis (1); however, the association between menopausal hormone therapy and risk of psoriasis is largely unexplored. We analyzed data from the Women's Health Initiative's (WHI) randomized controlled trials comparing conjugated equine estrogens (CEE) vs. placebo and CEE plus medroxyprogesterone acetate (MPA) vs. placebo to investigate the association between hormone therapy use and psoriasis. This article is protected by copyright. All rights res...

Background: Meta-analyses of observational studies associate adherence to several dietary patterns with cognitive health. However, limited evidence from full scale, randomized controlled trials precludes causal inference regarding dietary effects on cognitive function. Methods: The Women's Health Initiative (WHI) Dietary Modification (DM) randomized trial, in 48,835 postmenopausal women, included a subset of 1,606 WHI Memory Study (WHIMS) participants >= 65 years old, to assess low-fat dietary p...

Background: Triple-negative breast cancer (TNBC) has a high recurrence risk and poor clinical outcomes. Associations between metabolic syndrome (MetS) risk components and mortality in postmenopausal women with TNBC were examined in the Women's Health Initiative. Methods: Five hundred forty-four postmenopausal women were diagnosed with nonmetastatic TNBC. Baseline risk components included a high waist circumference (=88 cm), high blood pressure, hypercholesterolemia, and diabetes. Groups were ca...

Importance: Although racial/ethnic differences in functional outcomes after total knee arthroplasty (TKA) exist, whether such differences are associated with differences in presurgical physical function (PF) has not been thoroughly investigated. Objective: To examine trajectories of PF by race/ethnicity before and after TKA among older women. Design, setting, and participants: This cohort study was conducted among the prospective Women's Health Initiative with linked Medicare claims data. A tota...

Objective: Few studies have prospectively examined associations of lipoprotein(a) [Lp(a)] levels with risk of abdominal aortic aneurysm (AAA), particularly in women. Accounting for commonly recognized risk factors, we investigated baseline Lp(a) levels with risk of AAA among postmenopausal women participating in the ongoing national Women's Health Initiative (WHI). Methods: WHI participants with baseline Lp(a) levels who were beneficiaries of Medicare Parts A&B fee-for-service at study enrollmen...

PURPOSE: Observational studies of dietary fat intake and breast cancer have reported inconsistent findings. This topic was addressed in additional analyses of the Women's Health Initiative (WHI) Dietary Modification (DM) clinical trial that evaluated a low-fat dietary pattern influence on breast cancer incidence. METHODS: In the WHI DM trial, 48,835 postmenopausal women, ages 50-79 years, with no prior breast cancer, and a dietary fat intake of = 32% of energy were randomly assigned at 40 US cen...

Background: The association of pelvic radiation with pelvic fracture risk has not been examined in prospective cohort settings with comprehensive fracture risk assessment, cancer-free comparison populations, and long-term follow-up. Our objective is to better characterize pelvic fracture and overall mortality risks in postmenopausal women participating in the Women's Health Initiative (WHI). Methods: 135,743 WHI participants, aged 50 to 79 years enrolled from 40 US clinical centers from 1993 to ...

High body mass index (BMI) is a risk factor for atrial fibrillation (AF). The aim of this study was to determine whether lean body mass (LBM) predicts AF.The Women's Health Initiative is a study of post-menopausal women aged 50-79 enrolled at 40 US centres from 1994 to 1998. A subset of 11 393 participants at three centres underwent dual-energy X-ray absorptiometry. Baseline demographics and clinical histories were recorded. Incident AF was identified using hospitalization records and diagnostic...

Importance: Dementia affects a large and growing population of older adults. Although past studies suggest an association between vision and cognitive impairment, there are limited data regarding longitudinal associations of vision with dementia. Objective: To evaluate associations between visual impairment and risk of cognitive impairment. Design, setting, and participants: A secondary analysis of a prospective longitudinal cohort study compared the likelihood of incident dementia or mild cogni...

Background: Breast cancer (BC) survivors experience an increased burden of long-term comorbidities, including heart failure (HF). However, there is limited understanding of the risk for the development of HF subtypes, such as HF with preserved ejection fraction (HFpEF), in BC survivors. Objectives: This study sought to estimate the incidence of HFpEF and HF with reduced ejection fraction (HFrEF) in postmenopausal BC survivors and to identify lifestyle and cardiovascular risk factors associated w...

Objectives: To evaluate sleep and affective (mood/anxiety) disorders as clinical predictors of incident Parkinson's disease (PD) among women ≥65 years of age. Methods: We performed secondary analyses with available data from the Women's Health Initiative Clinical Trials and Observational Study linked to Medicare claims. Sleep, mood and anxiety disorders at baseline were defined using diagnostic codes. Incident PD was defined using self-reported PD, first PD diagnosis, use of PD medications, and/...

BACKGROUND: Racial disparities in functional outcomes after total knee arthroplasty (TKA) exist. Whether differences in rehabilitation utilization contribute to these disparities remains to be investigated. METHODS: Among 8349 women enrolled in the prospective Women's Health Initiative cohort who underwent primary TKA between 2006 and 2013, rehabilitation utilization was determined through linked Medicare claims data. Postacute discharge destination (home, skilled nursing facility, and inpatient...

Background: We examined common patterns of home environmental modification (HEM) use and associated major (including disability-, cardiovascular-, and cancer-related) health conditions and events among older women. Methods: Women, aged 78.6 ± 6.3 years (n = 71,257), self-reported utilization of nine types of HEMs (hand rails, grab bars, ramps, nonslip surfaces, tacking carpets/rugs, decreasing clutter, increasing lighting, raised sink/counter heights, other). Concurrent history of major health ...

Small-scale studies offer conflicting evidence regarding the relationship/association between psoriasis and insulin resistance by HOMA-IR (homeostasis model assessment of insulin resistance). The purpose of this study was to assess the association between baseline HOMA-IR and psoriasis incidence in a large-scale longitudinal cohort of postmenopausal women. The analysis included 21,789 postmenopausal women from the Women's Health Initiative. Psoriasis diagnosis was defined by fee-for-service Medi...

OBJECTIVE: To evaluate racial and ethnic disparities in utilization of total knee arthroplasty (TKA) in relation to demographic, health, and socioeconomic status variables. DESIGN: Prospective study of 102,767 Women's Health Initiative postmenopausal women initially aged 50-79, examining utilization rates of primary TKA between non-Hispanic Black/African American, non-Hispanic White, and Hispanic/Latina women (hereafter referred to as Black, White, and Hispanic). A total of 8,942 Black, 3,405 Hi...

In the Women's Health Initiative (WHI), we investigated associations between baseline dual-energy X-ray absorptiometry (DXA) appendicular lean mass (ALM) and risk of incident fractures, falls, and mortality (separately for each outcome) among older postmenopausal women, accounting for bone mineral density (BMD), prior falls, and Fracture Risk Assessment Tool (FRAX® ) probability. The WHI is a prospective study of postmenopausal women undertaken at 40 US sites. We used an extension of Poisson reg...

Objective: The objective was to determine whether baseline fatty acid intake and erythrocyte omega-3 and omega-6 polyunsaturated fatty acids (PUFAs) can predict risk for total hip arthroplasty (THA) and total knee arthroplasty (TKA) in older women. Methods: This was a prospective analysis of 34,990 women in the Women's Health Initiative (WHI). Dietary fatty acids were estimated from food frequency questionnaires. Imputed erythrocyte PUFAs were available in a sub-cohort of 3428 women. Arthroplast...

PURPOSE: Delays in adjuvant breast cancer (BC) therapy have been shown to worsen outcomes. However, thus far studies have only evaluated delays to initial treatment, or a particular modality, such as chemotherapy, leaving uncertainty about the role of delay to subsequent therapy and the effects of cumulative delay, on outcomes. We investigated the associations of delays across treatment modalities with survival. METHODS: We included 3368 women with incident stage I-III BC in the Women's Health I...

To examine cross-sectional and longitudinal relationships of psychotropic medications with physical function after menopause. Analyses involved 4557 Women's Health Initiative Long Life Study (WHI-LLS) participants (mean age at WHI enrollment (1993-1998): 62.8 years). Antidepressant, anxiolytic, and sedative/hypnotic medications were evaluated at WHI enrollment and 3-year follow-up visits. Performance-based physical function [Short Physical Performance Battery (SPPB)] was assessed at the 2012-201...

Purpose: We tested if dietary modification (DM) altered the risk for incident primary open-angle glaucoma (POAG). Design: Secondary analysis of a randomized intervention trial. Subjects: We linked Medicare claims data to 45,203 women in the Women's Health Initiative Dietary Modification Trial, of 23,776 participants were enrolled in fee-for-service Medicare Part B and had physician claims. Methods: Women were randomized to follow either DM (a low-fat diet, with increased vegetable, fruit, and gr...

Background: The association of alcohol with psoriasis has been inconsistent among studies.Objectives: We aimed (1) to determine whether alcohol consumption (by status, frequency, and subtype of alcohol) modulates smoking-related psoriasis risk in postmenopausal women while stratifying for smoking status and pack-years and (2) to evaluate the effect of smoking cessation on psoriasis risk in postmenopausal women. Methods: This prospective cohort study included 106,844 postmenopausal women enrolled...

Purpose: Colorectal cancer (CRC) survivors often experience long-term symptoms after cancer treatments. But gastrointestinal (GI) symptom experiences are under-investigated in CRC survivors. We described persistent GI symptoms after cancer treatments in female CRC survivors and assessed GI symptoms' risk and life-impact factors. Methods: A cross-sectional study utilized data from the Women's Health Initiative (WHI) Life and Longevity After Cancer (LILAC) study that recruited postmenopausal women...

Objectives: End-stage Fuchs' endothelial corneal dystrophy is a leading cause of corneal blindness, with a higher prevalence in females than in males. Few modifiable risk factors have been identified. We examined associations between menopausal hormone therapy use (never/past/current), duration of hormone therapy use, estimated lifetime exposure to endogenous estrogen, and serum estradiol with incident Fuchs' endothelial corneal dystrophy in a cohort of postmenopausal women. Study design: This w...

Background Sedentary behavior is associated with cardiovascular disease, but its association with incident atrial fibrillation is not well studied. Our aim was to measure the association between objectively measured sedentary behavior and incident atrial fibrillation. Methods and Results Sedentary behavior was measured by a triaxial accelerometer worn on a belt for 1 week. Incident atrial fibrillation was ascertained from Medicare claims. The associations between total sedentary time (or pattern...