Prevalence and Descriptors of Aspirin Use as an Antiplatelet Agent in Two New England Communities

To determine the overall prevalence of aspirin use as an antiplatelet agent in a population-based sample of respondents between the ages of 18 and 64 years, and to describe their sociodemographic characteristics. Data were derived from five biennial cross-sectional household surveys conducted between 1981 and 1990 in two southeastern New England communities by the Pawtucket Heart Health Program. Individuals reporting aspirin use as an antiplatelet agent were identified using data from a structured medication interview. The prevalence of aspirin use per 1000 population was 2.5 (95 percent confidence interval [CI] 0.5,4.4), 5.0 (95 percent CI 2.4, 7.6), 7.8 (95 percent CI 4.6, 11.0), 7.5 (95 percent CI 4.3, 10.6), and 11.8 (95 percent CI 7.1, 16.5) in the first through the fifth survey periods, respectively (p=0.0002). The prevalence of aspirin use per 1000 men increased from 4.9 (95 percent CI 0.6, 9.1), 8.7 (95 percent CI 3.3, 14.1), 12.3 (95 percent CI 6.1, 18.5), 8.5 (95 percent CI 3.5, 13.5) to 23.2 (95 percent CI 13.4, 32.9) for the first through the fifth survey periods, respectively. The corresponding prevalence rates of aspirin use per 1000 women were 0.7 (95 percent CI 0, 2.1), 2.43 (95 percent CI 0.05, 4.80), 4.6 (95 percent CI 1.4, 7.8), 6.6 (95 percent CI 2.7, 10.6), and 2.7 (95 percent CI 0, 5.7). Both a gender trend (p=0.0002) and a survey trend (p=0.0001) were detected. A gender-survey interaction was not found. In this population, aspirin use was reported primarily by middle-aged men who had coexisting cardiovascular disease as indicated by concurrent medications. Aspirin use as antiplatelet therapy increased in the population-based samples of two New England communities over the past nine years, with slightly more than one percent of the respondents reporting its use in the fifth cross-sectional survey conducted in 1989–1990. This finding may reflect the publication of important clinical trials near the time the survey was performed and subsequent dissemination of the findings both in the professional and lay press. © 1993, SAGE Publications. All rights reserved

Effects of conjugated equine estrogen on health-related quality of life in postmenopausal women with hysterectomy: results from the Women's Health Initiative Randomized Clinical Trial.

BackgroundThe Women's Health Initiative (WHI) clinical trial of conjugated equine estrogens (CEEs), involving 10,739 postmenopausal women with hysterectomy, aged 50 to 79 years, was stopped early owing to lack of overall health benefit and increased risk of stroke. Because CEE is still prescribed for treatment of menopausal symptoms and prevention of osteoporosis, it is important to understand the overall impact of this therapy on health-related quality of life (HRQOL).MethodsAll participants completed 6 specific measures of quality of life at baseline and 1 year, and a subsample (n = 1189) also completed the questions 3 years after randomization. Changes in scores were analyzed for treatment effect.ResultsRandomization to CEE was associated with a statistically significant but small reduction in sleep disturbance at year 1 compared with baseline (mean benefit, 0.4 points on a 20-point scale) and a statistically significant but small negative effect on social functioning (mean effect, -1.3 points on a 100-point scale). There were no significant improvements due to CEE in the areas of general health, physical functioning, pain, vitality, role functioning, mental health, depressive symptoms, cognitive function, or sexual satisfaction at year 1. A subgroup examined 3 years after baseline had no significant benefits for any HRQOL outcomes. Among women aged 50 to 54 years with moderate to severe vasomotor symptoms at baseline, CEE did not improve any of the HRQOL variables at year 1.ConclusionIn this trial of postmenopausal women with prior hysterectomy, oral CEE did not have a clinically meaningful effect on HRQOL

Effects of conjugated equine estrogen on health-related quality of life in postmenopausal women with hysterectomy: results from the Women\u27s Health Initiative Randomized Clinical Trial

BACKGROUND: The Women\u27s Health Initiative (WHI) clinical trial of conjugated equine estrogens (CEEs), involving 10,739 postmenopausal women with hysterectomy, aged 50 to 79 years, was stopped early owing to lack of overall health benefit and increased risk of stroke. Because CEE is still prescribed for treatment of menopausal symptoms and prevention of osteoporosis, it is important to understand the overall impact of this therapy on health-related quality of life (HRQOL). METHODS: All participants completed 6 specific measures of quality of life at baseline and 1 year, and a subsample (n = 1189) also completed the questions 3 years after randomization. Changes in scores were analyzed for treatment effect. RESULTS: Randomization to CEE was associated with a statistically significant but small reduction in sleep disturbance at year 1 compared with baseline (mean benefit, 0.4 points on a 20-point scale) and a statistically significant but small negative effect on social functioning (mean effect, -1.3 points on a 100-point scale). There were no significant improvements due to CEE in the areas of general health, physical functioning, pain, vitality, role functioning, mental health, depressive symptoms, cognitive function, or sexual satisfaction at year 1. A subgroup examined 3 years after baseline had no significant benefits for any HRQOL outcomes. Among women aged 50 to 54 years with moderate to severe vasomotor symptoms at baseline, CEE did not improve any of the HRQOL variables at year 1. CONCLUSION: In this trial of postmenopausal women with prior hysterectomy, oral CEE did not have a clinically meaningful effect on HRQOL

Low-Fat Dietary Pattern Intervention and Health-Related Quality of Life: The Women\u27s Health Initiative Randomized Controlled Dietary Modification Trial

BACKGROUND: Intensive dietary intervention programs may lead to benefits in vitality and other components of health quality. The Women\u27s Health Initiative Dietary Modification (DM) intervention includes a large randomized controlled trial of an intensive intervention. OBJECTIVE: To evaluate whether the intervention is associated with improved health-related quality of life (HRQoL) subscales, overall self-reported health, depression symptoms, cognitive functioning, and sleep quality. DESIGN: This randomized controlled trial was analyzed as intent to treat. PARTICIPANTS: Between 1993 and 1998, 48,835 women aged 50 to 79 years were recruited by 40 clinical centers across the United States. Eligibility included having fat intake at baseline \u3e /=32% of total calories, and excluded women with any prior colorectal or breast cancer, recent other cancers, type 1 diabetes, or medical conditions with predicted survival \u3c 3 years. INTERVENTION: Goals were to reduce calories from fat to 20%, increase vegetables and fruit to 5+ servings, and increase grain servings to 6+ servings a day. During the first year, 18 group sessions were held, with quarterly sessions thereafter. MAIN OUTCOME MEASURES: The RAND 36-Item Health Survey was used to assess HRQoL at baseline, Year 1, and close-out (about 8 years postrandomization), and estimate differential HRQoL subscale change scores. STATISTICAL ANALYSES PERFORMED: Mean change in HRQoL scores (Year 1 minus baseline) were compared by randomization group using linear models. RESULTS: At 1 year, there was a differential change between intervention and comparison group of 1.7 units (95% CI 1.5, 2.0) in general health associated with the intervention. DM intervention improved physical functioning by 2.0 units (95% CI 1.7, 2.3), vitality by 1.9 units (95% CI 1.6, 2.2), and global quality of life by 0.09 units (95% CI 0.07, 0.12). With the exception of global quality of life, these effects were significantly modified by body mass index at baseline. CONCLUSIONS: DM intervention was associated with small, but significant improvements in three HRQoL subscales: general health, physical functioning, and vitality at 1 year follow-up, with the largest improvements seen in the women with the greatest baseline body mass index

The cross-sectional relationship of hemoglobin levels and functional outcomes in women with self-reported osteoarthritis: results from the Women's Health Initiative.

ObjectivesGastrointestinal blood loss is a recognized complication of the use of nonsteroidal anti-inflammatory drugs (NSAIDS) in patients with arthritis. We examined the cross-sectional relationship of patient-reported outcomes of overall health, physical function, vitality, and quality of life to hemoglobin (hgb) levels in postmenopausal women with self-reported osteoarthritis to determine whether hgb levels as potential markers of chronic blood loss were associated with these functional outcomes.MethodsPostmenopausal women (N = 64,850) with self-reported osteoarthritis (srOA) at baseline in the Women's Health Initiative study, excluding participants with chronic or hemolytic diseases associated with anemia, had hgb levels measured and completed Short-Form Health Surveys. General linear models analysis adjusting for potential confounders was performed.ResultsA nonlinear plateauing relationship between hgb levels and functional outcomes was found. Participants with srOA had statistically significantly worse overall health, physical function, and vitality, but not quality of life, for each gram of hgb below 14 g/dL, compared with those with hgb 14 g/dL (P < 0.001). Participants with srOA taking NSAIDS had worse functional outcomes for each level of hgb compared with those not reporting NSAIDS use.ConclusionsIn cross-sectional analyses of postmenopausal women with srOA, differences in hgb levels are related to differences in functional outcomes of overall health, physical function, and vitality at clinically important levels. Prospective studies evaluating whether changes in hgb levels result in changes in functional outcomes in participants with osteoarthritis are needed to confirm of our findings and before any changes in therapeutics based on hemoglogin levels are considered in the care of patients with osteoarthritis

Predictors of dietary change and maintenance in the Women\u27s Health Initiative Dietary Modification Trial

OBJECTIVE: To identify predictors of dietary change to and maintenance of a low-fat eating pattern (or = 5 servings fruits/vegetables daily, and \u3e or = 6 servings grains daily) among a cohort of postmenopausal women. Candidate predictors included intrapersonal, interpersonal, intervention program characteristics, and clinical center. DESIGN: Longitudinal study within the Women\u27s Health Initiative Dietary Modification Trial. Dietary change was evaluated after 1 year of participation in the Women\u27s Health Initiative Dietary Modification Trial, and dietary maintenance after 3 years. SUBJECTS: Postmenopausal women aged 50 to 79 years at baseline who were randomized to the intervention arm of the Women\u27s Health Initiative Dietary Modification Trial (n=19,541). STATISTICAL ANALYSIS: Univariate and multivariate linear regression analysis was performed and associations evaluated between candidate predictors and each of the three dietary goals: percent energy from fat, fruit/vegetable servings, and grain servings. RESULTS: Year 1 (change) predictors of percent energy from fat (PCONCLUSIONS: The strongest predictors of dietary change and maintenance were attending intervention sessions and self-monitoring dietary intake. Novel was the finding that optimism predicted dietary change

The cross-sectional relationship of hemoglobin levels and functional outcomes in women with self-reported osteoarthritis: results from the Women's Health Initiative.

ObjectivesGastrointestinal blood loss is a recognized complication of the use of nonsteroidal anti-inflammatory drugs (NSAIDS) in patients with arthritis. We examined the cross-sectional relationship of patient-reported outcomes of overall health, physical function, vitality, and quality of life to hemoglobin (hgb) levels in postmenopausal women with self-reported osteoarthritis to determine whether hgb levels as potential markers of chronic blood loss were associated with these functional outcomes.MethodsPostmenopausal women (N = 64,850) with self-reported osteoarthritis (srOA) at baseline in the Women's Health Initiative study, excluding participants with chronic or hemolytic diseases associated with anemia, had hgb levels measured and completed Short-Form Health Surveys. General linear models analysis adjusting for potential confounders was performed.ResultsA nonlinear plateauing relationship between hgb levels and functional outcomes was found. Participants with srOA had statistically significantly worse overall health, physical function, and vitality, but not quality of life, for each gram of hgb below 14 g/dL, compared with those with hgb 14 g/dL (P < 0.001). Participants with srOA taking NSAIDS had worse functional outcomes for each level of hgb compared with those not reporting NSAIDS use.ConclusionsIn cross-sectional analyses of postmenopausal women with srOA, differences in hgb levels are related to differences in functional outcomes of overall health, physical function, and vitality at clinically important levels. Prospective studies evaluating whether changes in hgb levels result in changes in functional outcomes in participants with osteoarthritis are needed to confirm of our findings and before any changes in therapeutics based on hemoglogin levels are considered in the care of patients with osteoarthritis

Developing, optimizing, and evaluating patient infographics for diagnosing cardiac amyloidosis

Objective: Advancements in diagnostics and treatment options for cardiac amyloidosis have improved patient outcomes, yet few patient education materials exist to help patients understand the disease and diagnosis process. We sought to develop and evaluate a set of plain language, patient-centered infographics describing the condition and common diagnostic tests. Methods: Using health literacy best practices, we developed 7 infographics which were further revised based on multilevel stakeholder feedback. To evaluate the materials, we recruited 100 patients from healthcare settings in Chicago, IL; participants completed a web-assisted interview during which they were randomized 1:1 to first view either our infographics or a standard material. Participants completed a knowledge assessment on their assigned material and subsequently reported impressions of both materials. Results: No differences were found between study arms in knowledge. The infographics took significantly less time to read and were more highly rated by participants in terms of appearance and understandability. Over two-thirds of participants preferred the infographics to the standard. Conclusions: The infographics created may improve the learning process about a complex condition and diagnosis process unknown to most adults. Innovation: These infographics are the first of their kind for cardiac amyloidosis and were created using health literacy best practices

The comparative burden of chronic widespread pain and fibromyalgia in the United States

BACKGROUND/PURPOSE: Little information exists on the comparative patient and economic burden of chronic widespread pain (CWP) and fibromyalgia (FM) in the United States. METHODS: This multistage, observational study included an online screening survey of a large geographically diverse US sample to assess CWP status, a physician/site visit to determine FM diagnosis, and an online subject questionnaire to capture clinical characteristics, pain, health status, functioning, sleep, healthcare resource use (HRU), productivity, and costs. Based on the screener and physician evaluation, mutually exclusive groups of subjects without CWP (CWP-), with CWP but without FM (CWP+), and with confirmed FM were identified. RESULTS: Disease burden was examined in 472 subjects (125 CWP-, 176 CWP+, 171 FM). Age, race, and ethnicity were similar across groups. Mean body mass index and number of comorbidities increased from CWP- to CWP+ to FM (P = 0.0044, P \u3c 0.0001, respectively). From CWP- to CWP+ to FM, there were reductions in health status (EQ-5D, SF-12) and sleep outcomes (MOS-SS, SSQ) (all P \u3c 0.05). Pain severity, interference with function (BPI-SF), and overall work impairment (WPAI:SHP) increased from CWP- to CWP+ to FM (all P \u3c 0.0001). Higher proportions of CWP+ (52.8%) and FM subjects (62.6%) were taking pain-related prescription medications relative to CWP- subjects (32.8%; P \u3c 0.0001). Significant differences in total direct and indirect costs across the three groups (both P \u3c 0.0001) were observed, with highest costs among FM subjects. CONCLUSION: Fibromyalgia subjects were characterized by the greatest disease burden with more comorbidities and pain-related medications, poorer health status, function, sleep, lower productivity, and higher costs

Estrogen plus progestin and the incidence of dementia and mild cognitive impairment in postmenopausal women: the Women\u27s Health Initiative Memory Study: a randomized controlled trial

CONTEXT: Postmenopausal women have a greater risk than men of developing Alzheimer disease, but studies of the effects of estrogen therapy on Alzheimer disease have been inconsistent. On July 8, 2002, the study drugs, estrogen plus progestin, in the Women\u27s Health Initiative (WHI) trial were discontinued because of certain increased health risks in women receiving combined hormone therapy. OBJECTIVE: To evaluate the effect of estrogen plus progestin on the incidence of dementia and mild cognitive impairment compared with placebo. DESIGN, SETTING, AND PARTICIPANTS: The Women\u27s Health Initiative Memory Study (WHIMS), a randomized, double-blind, placebo-controlled clinical trial, began enrolling participants from the Women\u27s Health Initiative (WHI) estrogen plus progestin trial in May 1996. Of the 4894 eligible participants of the WHI study, 4532 (92.6%) postmenopausal women free of probable dementia, aged 65 years or older, and recruited from 39 of 40 WHI clinical centers were enrolled in the WHIMS. INTERVENTION: Participants received either 1 daily tablet of 0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate (n = 2229), or a matching placebo (n = 2303). MAIN OUTCOME MEASURES: Incidence of probable dementia (primary outcome) and mild cognitive impairment (secondary outcome) were identified through a structured clinical assessment. RESULTS: The mean (SD) time between the date of randomization into WHI and the last Modified Mini-Mental State Examination (3MSE) for all WHIMS participants was 4.05 (1.19) years. Overall, 61 women were diagnosed with probable dementia, 40 (66%) in the estrogen plus progestin group compared with 21 (34%) in the placebo group. The hazard ratio (HR) for probable dementia was 2.05 (95% confidence interval [CI], 1.21-3.48; 45 vs 22 per 10 000 person-years; P =.01). This increased risk would result in an additional 23 cases of dementia per 10 000 women per year. Alzheimer disease was the most common classification of dementia in both study groups. Treatment effects on mild cognitive impairment did not differ between groups (HR, 1.07; 95% CI, 0.74-1.55; 63 vs 59 cases per 10 000 person-years; P =.72). CONCLUSIONS: Estrogen plus progestin therapy increased the risk for probable dementia in postmenopausal women aged 65 years or older. In addition, estrogen plus progestin therapy did not prevent mild cognitive impairment in these women. These findings, coupled with previously reported WHI data, support the conclusion that the risks of estrogen plus progestin outweigh the benefits