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Biomedical subjects

Robert B Wallace

Publications and source records attributed to Robert B Wallace.

At least 19 recordsLinked to original sources
PubMed2007

What level of alcohol consumption is hazardous for older people? Functioning and mortality in U.S. and English national cohorts.

OBJECTIVES: To estimate disability plus mortality risks in older people according to level of alcohol intake. DESIGN: Two population-based cohort studies. SETTING: The Health and Retirement Study (United States) and the English Longitudinal Study of Aging (England). PARTICIPANTS: Thirteen thousand three hundred thirty-three individuals aged 65 and older followed for 4 to 5 years. MEASUREMENTS: Difficulties with activities of daily living (ADLs), instrumental activities of daily living (IADLs), poor cognitive function, and mortality. RESULTS: One-tenth (10.8%) of U.S. men, 28.6% of English men, 2.9% of U.S. women, and 10.3% of English women drank more than the U.S. National Institute on Alcohol Abuse and Alcoholism recommended limit for people aged 65 and older. Odds ratios (ORs) of disability, or disability plus mortality, in subjects drinking an average of more than one to two drinks per day were similar to ORs in subjects drinking an average of more than none to one drink per day. For example, those drinking more than one to two drinks per day at baseline had an OR of 1.0 (95% confidence interval (CI)=0.8-1.2) for ADL problems, 0.7 (95% CI=0.6-1.0) for IADL problems, and 0.8 (95% CI=0.6-1.1) for poor cognitive function. Findings were robust across alternative models. The shape of the relationship between alcohol consumption and risk of disability was similar in men and women. CONCLUSION: Functioning and mortality outcomes in older people with alcohol intakes above U.S. recommended levels for the old but within recommendations for younger adults are not poor. More empirical evidence of net benefit is needed to support screening and intervention efforts in community-living older people with no specific contraindications who drink more than one to two drinks per day.

Accidental Falls↗
PubMed2006

Effects of continuing or stopping alendronate after 5 years of treatment: the Fracture Intervention Trial Long-term Extension (FLEX): a randomized trial.

CONTEXT: The optimal duration of treatment of women with postmenopausal osteoporosis is uncertain. OBJECTIVE: To compare the effects of discontinuing alendronate treatment after 5 years vs continuing for 10 years. DESIGN AND SETTING: Randomized, double-blind trial conducted at 10 US clinical centers that participated in the Fracture Intervention Trial (FIT). PARTICIPANTS: One thousand ninety-nine postmenopausal women who had been randomized to alendronate in FIT, with a mean of 5 years of prior alendronate treatment. INTERVENTION: Randomization to alendronate, 5 mg/d (n = 329) or 10 mg/d (n = 333), or placebo (n = 437) for 5 years (1998-2003). MAIN OUTCOME MEASURES: The primary outcome measure was total hip bone mineral density (BMD); secondary measures were BMD at other sites and biochemical markers of bone remodeling. An exploratory outcome measure was fracture incidence. RESULTS: Compared with continuing alendronate, switching to placebo for 5 years resulted in declines in BMD at the total hip (-2.4%; 95% confidence interval [CI], -2.9% to -1.8%; P<.001) and spine (-3.7%; 95% CI, -4.5% to -3.0%; P<.001), but mean levels remained at or above pretreatment levels 10 years earlier. Similarly, those discontinuing alendronate had increased serum markers of bone turnover compared with continuing alendronate: 55.6% (P<.001) for C-telopeptide of type 1 collagen, 59.5% (P < .001) for serum n = propeptide of type 1 collagen, and 28.1% (P<.001) for bone-specific alkaline phosphatase, but after 5 years without therapy, bone marker levels remained somewhat below pretreatment levels 10 years earlier. After 5 years, the cumulative risk of nonvertebral fractures (RR, 1.00; 95% CI, 0.76-1.32) was not significantly different between those continuing (19%) and discontinuing (18.9%) alendronate. Among those who continued, there was a significantly lower risk of clinically recognized vertebral fractures (5.3% for placebo and 2.4% for alendronate; RR, 0.45; 95% CI, 0.24-0.85) but no significant reduction in morphometric vertebral fractures (11.3% for placebo and 9.8% for alendronate; RR, 0.86; 95% CI, 0.60-1.22). A small sample of 18 transilial bone biopsies did not show any qualitative abnormalities, with bone turnover (double labeling) seen in all specimens. CONCLUSIONS: Women who discontinued alendronate after 5 years showed a moderate decline in BMD and a gradual rise in biochemical markers but no higher fracture risk other than for clinical vertebral fractures compared with those who continued alendronate. These results suggest that for many women, discontinuation of alendronate for up to 5 years does not appear to significantly increase fracture risk. However, women at very high risk of clinical vertebral fractures may benefit by continuing beyond 5 years. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT 00398931.

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PubMed2006

Hip fracture risk among community-dwelling elderly people in the United States: a prospective study of physical, cognitive, and socioeconomic indicators.

OBJECTIVES: We determined risks of short-term (2-year) hip fracture in a nationally representative, prospective cohort of community-dwelling elderly people 70 years or older. METHODS: We used self-report data from 2 waves of the Asset and Health Dynamics Survey (n = 5630). Sample-weighted logistic regression analyses were conducted to determine risk of hip fracture in relation to several demographic, cognitive, physical, and socioeconomic indicators. RESULTS: During the 2-year study period, 102 participants reported a new hip fracture. Several indicators of physical functioning and cognitive status, including incorrect delayed word recall and inability to lift 10 lbs (4.5 kg), were significantly associated with hip fracture risk. In the final model, mobile home residents, individuals without Medicare part B insurance, and those without a high-school diploma were at more than a 2-fold risk of hip fracture. Educational level, physical functioning, and insurance status were the top 3 contributors to hip fracture risk. CONCLUSIONS: In addition to functional status measures, health insurance status, educational level, and type of residence appear to be independent predictors of hip fracture.

Activities of Daily Living↗
PubMed2006

Functional limitations in elderly female cancer survivors.

BACKGROUND: The elderly population, including many who are long-term cancer survivors, is increasing. Aspects of quality of life in elderly cancer survivors are not well understood. METHODS: Subjects were women who enrolled in a population-based cohort study in 1986. At follow-up in 1997, 25,719 women, at a median age of 72 years, reported on functional limitations. We used logistic regression to calculate prevalence odds ratios (ORs) and proportional hazards regression to calculate prevalence ratios (PRs) for associations between cancer survivor status and functional limitations, adjusting for baseline (precancer) characteristics including obesity, smoking, and diabetes. RESULTS: Women who were cancer survivors for less than 2 years reported the most functional limitations, but long-term (5 or more years) cancer survivors remained more likely than cohort members who had not had cancer to report that they were unable to do heavy household work (42% of 1068 5-year survivors, versus 31% of 23 501 who never had cancer, multivariable OR = 1.47, 95% confidence interval [CI] = 1.27 to 1.69; PR = 1.22, 95% CI = 1.10 to 1.34), unable to walk a half mile (26% versus 19%, OR = 1.31, 95% CI = 1.1 to 1.54; PR = 1.16, 95% CI = 1.02 to 1.32), and unable to walk up and down stairs (9% versus 6%, OR = 1.34, 95% CI = 1.05 to 1.72; PR = 1.25, 95% CI = 1.00 to 1.56). The increased prevalence of functional limitations was apparent for 5-year survivors of breast cancer and also certain other cancers. CONCLUSIONS: Our findings support the need to target elderly cancer survivors for interventions to maintain or regain physical function.

Activities of Daily Living↗
PubMed2006

Understanding cancer patients' experience and outcomes: development and pilot study of the Cancer Care Outcomes Research and Surveillance patient survey.

GOALS OF WORK: The National Cancer Institute's Cancer Care Outcomes Research and Surveillance (CanCORS) Consortium is conducting a population-based study of newly diagnosed patients with lung and colorectal cancer to describe the experience of persons living with cancer and to understand which barriers present the most significant obstacles to their receipt of appropriate care. The keystone to this effort is the baseline patient survey administered approximately 4 months after diagnosis. PATIENTS AND METHODS: We developed a survey to obtain information from patients newly diagnosed with lung and colorectal cancer about their personal characteristics, decision making, experience of care, and outcomes. We conducted a pilot study to evaluate the feasibility of a lengthy and clinically detailed interview in a convenience sample of patients within 8 months of diagnosis (n=71). MAIN RESULTS: The median length of the interviews was 75 min for patients with lung cancer (range 43-130) and 82 min for patients with colorectal cancer (range 46-119). Most patients had received some form of treatment for their cancer: 66.1% had undergone surgery, 28.2% had received radiation therapy, and 54.9% were treated with chemotherapy. In addition, 26.7% reported their overall health was less than 70 on a 0-100 scale, demonstrating that patients with substantial health impairment were able to complete the survey. CONCLUSIONS: A clinically detailed survey of newly diagnosed lung and colorectal cancer patients is feasible. A modified version of this survey is being fielded by the CanCORS Consortium and should provide much needed population-based data regarding patients' experiences across the continuum of cancer care and their outcomes.

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PubMed2006

Calcium plus vitamin D supplementation and the risk of fractures.

BACKGROUND: The efficacy of calcium with vitamin D supplementation for preventing hip and other fractures in healthy postmenopausal women remains equivocal. METHODS: We recruited 36,282 postmenopausal women, 50 to 79 years of age, who were already enrolled in a Women's Health Initiative (WHI) clinical trial. We randomly assigned participants to receive 1000 mg of elemental [corrected] calcium as calcium carbonate with 400 IU of vitamin D3 daily or placebo. Fractures were ascertained for an average follow-up period of 7.0 years. Bone density was measured at three WHI centers. RESULTS: Hip bone density was 1.06 percent higher in the calcium plus vitamin D group than in the placebo group (P<0.01). Intention-to-treat analysis indicated that participants receiving calcium plus vitamin D supplementation had a hazard ratio of 0.88 for hip fracture (95 percent confidence interval, 0.72 to 1.08), 0.90 for clinical spine fracture (0.74 to 1.10), and 0.96 for total fractures (0.91 to 1.02). The risk of renal calculi increased with calcium plus vitamin D (hazard ratio, 1.17; 95 percent confidence interval, 1.02 to 1.34). Censoring data from women when they ceased to adhere to the study medication reduced the hazard ratio for hip fracture to 0.71 (95 percent confidence interval, 0.52 to 0.97). Effects did not vary significantly according to prerandomization serum vitamin D levels. CONCLUSIONS: Among healthy postmenopausal women, calcium with vitamin D supplementation resulted in a small but significant improvement in hip bone density, did not significantly reduce hip fracture, and increased the risk of kidney stones. (ClinicalTrials.gov number, NCT00000611.).

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PubMed2006

Calcium plus vitamin D supplementation and the risk of colorectal cancer.

BACKGROUND: Higher intake of calcium and vitamin D has been associated with a reduced risk of colorectal cancer in epidemiologic studies and polyp recurrence in polyp-prevention trials. However, randomized-trial evidence that calcium with vitamin D supplementation is beneficial in the primary prevention of colorectal cancer is lacking. METHODS: We conducted a randomized, double-blind, placebo-controlled trial involving 36,282 postmenopausal women from 40 Women's Health Initiative centers: 18,176 women received 500 mg of elemental calcium as calcium carbonate with 200 IU of vitamin D3 [corrected] twice daily (1000 mg of elemental calcium and 400 IU of vitamin D3) and 18,106 received a matching placebo for an average of 7.0 years. The incidence of pathologically confirmed colorectal cancer was the designated secondary outcome. Baseline levels of serum 25-hydroxyvitamin D were assessed in a nested case-control study. RESULTS: The incidence of invasive colorectal cancer did not differ significantly between women assigned to calcium plus vitamin D supplementation and those assigned to placebo (168 and 154 cases; hazard ratio, 1.08; 95 percent confidence interval, 0.86 to 1.34; P=0.51), and the tumor characteristics were similar in the two groups. The frequency of colorectal-cancer screening and abdominal symptoms was similar in the two groups. There were no significant treatment interactions with baseline characteristics. CONCLUSIONS: Daily supplementation of calcium with vitamin D for seven years had no effect on the incidence of colorectal cancer among postmenopausal women. The long latency associated with the development of colorectal cancer, along with the seven-year duration of the trial, may have contributed to this null finding. Ongoing follow-up will assess the longer-term effect of this intervention. (ClinicalTrials.gov number, NCT00000611.).

Adenocarcinoma↗
PubMed2006

Low-fat dietary pattern and risk of invasive breast cancer: the Women's Health Initiative Randomized Controlled Dietary Modification Trial.

CONTEXT: The hypothesis that a low-fat dietary pattern can reduce breast cancer risk has existed for decades but has never been tested in a controlled intervention trial. OBJECTIVE: To assess the effects of undertaking a low-fat dietary pattern on breast cancer incidence. DESIGN AND SETTING: A randomized, controlled, primary prevention trial conducted at 40 US clinical centers from 1993 to 2005. PARTICIPANTS: A total of 48,835 postmenopausal women, aged 50 to 79 years, without prior breast cancer, including 18.6% of minority race/ethnicity, were enrolled. INTERVENTIONS: Women were randomly assigned to the dietary modification intervention group (40% [n = 19,541]) or the comparison group (60% [n = 29,294]). The intervention was designed to promote dietary change with the goals of reducing intake of total fat to 20% of energy and increasing consumption of vegetables and fruit to at least 5 servings daily and grains to at least 6 servings daily. Comparison group participants were not asked to make dietary changes. MAIN OUTCOME MEASURE: Invasive breast cancer incidence. RESULTS: Dietary fat intake was significantly lower in the dietary modification intervention group compared with the comparison group. The difference between groups in change from baseline for percentage of energy from fat varied from 10.7% at year 1 to 8.1% at year 6. Vegetable and fruit consumption was higher in the intervention group by at least 1 serving per day and a smaller, more transient difference was found for grain consumption. The number of women who developed invasive breast cancer (annualized incidence rate) over the 8.1-year average follow-up period was 655 (0.42%) in the intervention group and 1072 (0.45%) in the comparison group (hazard ratio, 0.91; 95% confidence interval, 0.83-1.01 for the comparison between the 2 groups). Secondary analyses suggest a lower hazard ratio among adherent women, provide greater evidence of risk reduction among women having a high-fat diet at baseline, and suggest a dietary effect that varies by hormone receptor characteristics of the tumor. CONCLUSIONS: Among postmenopausal women, a low-fat dietary pattern did not result in a statistically significant reduction in invasive breast cancer risk over an 8.1-year average follow-up period. However, the nonsignificant trends observed suggesting reduced risk associated with a low-fat dietary pattern indicate that longer, planned, nonintervention follow-up may yield a more definitive comparison. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov Identifier: NCT00000611.

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PubMed2006

Low-fat dietary pattern and risk of colorectal cancer: the Women's Health Initiative Randomized Controlled Dietary Modification Trial.

CONTEXT: Observational studies and polyp recurrence trials are not conclusive regarding the effects of a low-fat dietary pattern on risk of colorectal cancer, necessitating a primary prevention trial. OBJECTIVE: To evaluate the effects of a low-fat eating pattern on risk of colorectal cancer in postmenopausal women. DESIGN, SETTING, AND PARTICIPANTS: The Women's Health Initiative Dietary Modification Trial, a randomized controlled trial conducted in 48,835 postmenopausal women aged 50 to 79 years recruited between 1993 and 1998 from 40 clinical centers throughout the United States. INTERVENTIONS: Participants were randomly assigned to the dietary modification intervention (n = 19,541; 40%) or the comparison group (n = 29,294; 60%). The intensive behavioral modification program aimed to motivate and support reductions in dietary fat, to increase consumption of vegetables and fruits, and to increase grain servings by using group sessions, self-monitoring techniques, and other tailored and targeted strategies. Women in the comparison group continued their usual eating pattern. MAIN OUTCOME MEASURE: Invasive colorectal cancer incidence. RESULTS: A total of 480 incident cases of invasive colorectal cancer occurred during a mean follow-up of 8.1 (SD, 1.7) years. Intervention group participants significantly reduced their percentage of energy from fat by 10.7% more than did the comparison group at 1 year, and this difference between groups was mostly maintained (8.1% at year 6). Statistically significant increases in vegetable, fruit, and grain servings were also made. Despite these dietary changes, there was no evidence that the intervention reduced the risk of invasive colorectal cancer during the follow-up period. There were 201 women with invasive colorectal cancer (0.13% per year) in the intervention group and 279 (0.12% per year) in the comparison group (hazard ratio, 1.08; 95% confidence interval, 0.90-1.29). Secondary analyses suggested potential interactions with baseline aspirin use and combined estrogen-progestin use status (P = .01 for each). Colorectal examination rates, although not protocol defined, were comparable between the intervention and comparison groups. Similar results were seen in analyses adjusting for adherence to the intervention. CONCLUSION: In this study, a low-fat dietary pattern intervention did not reduce the risk of colorectal cancer in postmenopausal women during 8.1 years of follow-up. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov Identifier: NCT00000611.

Adenoma↗
PubMed2006

Hormone therapy and age-related macular degeneration: the Women's Health Initiative Sight Exam Study.

OBJECTIVE: To determine the effectiveness of treatment with conjugated equine estrogens (CEE) or with CEE combined with progestin (CEE + P) on age-related macular degeneration (AMD). METHODS: In an ancillary study to the Women's Health Initiative clinical trial of hormone therapy, 4262 women 65 years and older underwent fundus photography for the determination of AMD. Participants were recruited from April 2000 to June 2002 at 21 clinical sites an average of 5 years after randomization. Participants were randomized to treatment with CEE, CEE + P, or placebo. Participants had been treated for an average of 5 years at the ophthalmic evaluation for AMD. RESULTS: The overall prevalence of any AMD was 21.0%. No association was found between CEE + P (odds ratio [OR], 0.91; 95% confidence interval [CI], 0.75-1.11) or CEE alone (OR, 0.98; 95% CI, 0.78-1.25) and early-stage AMD. The CEE + P was associated with a reduced risk of soft drusen (OR, 0.83; 95% CI, 0.68-1.00) after adjustment for covariates and with a reduced risk of neovascular AMD (OR, 0.29; 95% CI, 0.09-0.92). CONCLUSIONS: Treatment with CEE alone or CEE + P does not affect early- or late-stage AMD. Treatment with CEE + P may reduce the risk of soft drusen or neovascular AMD.

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PubMed2006

Associations between intermediate age-related macular degeneration and lutein and zeaxanthin in the Carotenoids in Age-related Eye Disease Study (CAREDS): ancillary study of the Women's Health Initiative.

OBJECTIVE: To evaluate the relationship between dietary lutein plus zeaxanthin and intermediate age-related macular degeneration (AMD). DESIGN: Women aged 50 to 79 years in Iowa, Wisconsin, and Oregon with intake of lutein plus zeaxanthin above the 78th (high) and below the 28th (low) percentiles at baseline in the Women's Health Initiative Observational Study were recruited 4 to 7 years later into the Carotenoids in Age-Related Eye Disease Study (CAREDS), when the presence of AMD was determined by fundus photographs. Logistic regression analyses examined the prevalence of AMD in 1787 CAREDS participants, after accounting for potential covariates. RESULTS: The prevalence of intermediate AMD was not statistically different between the high and low lutein plus zeaxanthin intake recruitment groups after adjusting for age (odds ratio, 0.96; 95% confidence interval, 0.75-1.23). Limiting analyses to women younger than 75 years with stable intake of lutein plus zeaxanthin, without a history of chronic diseases that are often associated with diet changes, substantially lowered odds ratios (0.57; 95% confidence interval, 0.34-0.95). Exploratory analyses of advanced AMD in 34 participants resulted in protective, but statistically nonsignificant, associations in the overall sample and in women younger than 75 years. CONCLUSION: Diets rich in lutein plus zeaxanthin may protect against intermediate AMD in healthy women younger than 75 years.

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PubMed2006

Seasonal variations in black-faced black spider monkey (Ateles chamek) habitat use and ranging behavior in a southern Amazonian tropical forest.

Data are presented regarding the habitat use and ranging behavior of a spider monkey (Ateles chamek) community at Lago Caiman in northeastern Bolivia. Habitat use was driven primarily by fruit availability and distribution across the community home range. Strong seasonal variations occurred in fruit availability within all five of the floristically and phenologically distinct habitat types identified within the study site, and the spider monkeys dramatically shifted their ranging according to which habitat was richest in fleshy fruits. This use of local habitat diversity resulted in an unusually elongated shape for the home range that was otherwise typical of previous Ateles studies in terms of size. Ranging behavior was clumped and community core areas shifted seasonally across the focal community home range. Individual core areas were not relevant to the study due to dramatic community-wide shifts in ranging patterns. Day journey lengths were highly variable (460-5,690 m) and the distribution and abundance of fleshy fruit resources explained 81% of the monthly variations in mean day journey length. Keystone habitats for forest frugivores are identified and results are discussed with reference to previous studies on this genus, and the importance of considering keystone habitats and local habitat diversity within the management of forestry concessions in the region. Results are also discussed with reference to the behavioral ecology of the genus Ateles.

Animal Migration↗
PubMed2006

Effect of hormone therapy on risk of hip and knee joint replacement in the Women's Health Initiative.

OBJECTIVE: To determine the effect of hormone therapy on arthroplasty rates. METHODS: We examined data from the Women's Health Initiative placebo-controlled, double-blind, randomized trials. Community-dwelling women ages 50-79 years were enrolled at 40 US clinics. Women with prior arthroplasty were excluded, yielding a sample size of 26,321 subjects. Women who had had hysterectomies (n = 10,272) were randomly assigned to receive 0.625 mg/day conjugated equine estrogens (n = 5,076), or placebo (n = 5,196), with a mean followup of 7.1 years. Those who had not had hysterectomies (n = 16,049) were randomly assigned to receive estrogen plus progestin (n = 8,240), given as 0.625 mg/day conjugated equine estrogens plus 2.5 mg/day medroxyprogesterone acetate, or placebo (n = 7,809), with a mean followup of 5.6 years. Participants reported hospitalizations, and arthroplasties were identified by procedure codes. Arthroplasties due to hip fracture were censored. Cox proportional hazards regression was used to assess hazard ratios (HRs) and 95% confidence intervals (95% CIs) using intent-to-treat methods and outcome of time to first procedure. RESULTS: In the estrogen-alone trial, women receiving hormone therapy had significantly lower rates of any arthroplasty (HR 0.84 [95% CI 0.70-1.00], P = 0.05). However, this effect was borderline statistically significant for hip arthroplasty (HR 0.73 [95% CI 0.52-1.03], P = 0.07), and not significant for knee arthroplasty (HR 0.87 [95% CI 0.71-1.07], P = 0.19). In the estrogen-plus-progestin trial, there was no association for total arthroplasty (HR 0.99 [95% CI 0.82-1.20], P = 0.92) or for individual hip (HR 1.14 [95% CI 0.83-1.57], P = 0.41) or knee (HR 0.91 [95% CI 0.72-1.15], P = 0.41) arthroplasties. CONCLUSION: These data suggest that hormone therapy may influence joint health, but this observed decrease in risk may be limited to unopposed estrogen and may possibly be more important in hip than in knee osteoarthritis.

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PubMed2006

Memory complaint is not necessary for diagnosis of mild cognitive impairment and does not predict 10-year trajectories of functional disability, word recall, or short portable mental status questionnaire limitations.

OBJECTIVES: To evaluate the prevalence and utility of memory complaint in a geographically representative cohort and, in cases with mild cognitive impairment (MCI), to determine whether memory complaint alters 10-year trajectories of disability in activities of daily living (ADLs), Short Portable Mental Status Questionnaire (SPMSQ) score, and 20-item word recall. DESIGN: Prospective cohort study. SETTING: Washington and Iowa counties, Iowa. PARTICIPANTS: Iowa Established Populations for Epidemiologic Studies of the Elderly (N = 3,673; aged > or =65; 61.3% female; 99.9% white). MEASUREMENTS: Age, sex, education, SPMSQ score, 20-item word recall, ADL or instrumental ADL disability, and chronic medical conditions. RESULTS: The prevalence of memory complaint was 34%. Although proportionally more cognitively impaired individuals were in the memory complaint group (34% vs 27%), the pattern of subclassification into cognitively intact and MCI Stage 1 and 2 subgroups was similar for people with and without memory complaint. Median SPMSQ score and number of words recalled at baseline were comparable across memory complaint categories in each subgroup. MCI participants without subjective memory complaint constituted a larger proportion of the overall sample than individuals with subjective memory complaint (460 (14%) vs 295 (8.9%)) and of persons objectively classified as having MCI (61% vs 39%). The distribution of individual 10-year change in ADL disability, SPMSQ score, and word recall were similar for those with and without memory complaint across all subgroups of cognitive impairment. CONCLUSION: Memory complaint is not necessary for MCI diagnosis and does not distinguish cases with different progression rates in disability or cognitive impairment. 2006.

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PubMed2005

The Aging, Demographics, and Memory Study: study design and methods.

OBJECTIVE: We describe the design and methods of the Aging, Demographics, and Memory Study (ADAMS), a new national study that will provide data on the antecedents, prevalence, outcomes, and costs of dementia and "cognitive impairment, not demented" (CIND) using a unique study design based on the nationally representative Health and Retirement Study (HRS). We also illustrate potential uses of the ADAMS data and provide information to interested researchers on obtaining ADAMS and HRS data. METHODS: The ADAMS is the first population-based study of dementia in the United States to include subjects from all regions of the country, while at the same time using a single standardized diagnostic protocol in a community-based sample. A sample of 856 individuals age 70 or older who were participants in the ongoing HRS received an extensive in-home clinical and neuropsychological assessment to determine a diagnosis of normal, CIND, or dementia. Within the CIND and dementia categories, subcategories (e.g. Alzheimer's disease, vascular dementia) were assigned to denote the etiology of cognitive impairment. CONCLUSION: Linking the ADAMS dementia clinical assessment data to the wealth of available longitudinal HRS data on health, health care utilization, informal care, and economic resources and behavior, will provide a unique opportunity to study the onset of CIND and dementia in a nationally representative population-based sample, as well as the risk factors, prevalence, outcomes, and costs of CIND and dementia.

Aging↗
PubMed2005

Effects of estrogen with and without progestin on urinary incontinence.

CONTEXT: Menopausal hormone therapy has long been credited with many benefits beyond the indications of relieving hot flashes, night sweats, and vaginal dryness, and it is often prescribed to treat urinary incontinence (UI). OBJECTIVE: To assess the effects of menopausal hormone therapy on the incidence and severity of symptoms of stress, urge, and mixed UI in healthy postmenopausal women. DESIGN, SETTING, AND PARTICIPANTS: Women's Health Initiative multicenter double-blind, placebo-controlled, randomized clinical trials of menopausal hormone therapy in 27,347 postmenopausal women aged 50 to 79 years enrolled between 1993 and 1998, for whom UI symptoms were known in 23,296 participants at baseline and 1 year. INTERVENTIONS: Women were randomized based on hysterectomy status to active treatment or placebo in either the estrogen plus progestin (E + P) or estrogen alone trials. The E + P hormones were 0.625 mg/d of conjugated equine estrogen plus 2.5 mg/d of medroxyprogesterone acetate (CEE + MPA); estrogen alone consisted of 0.625 mg/d of conjugated equine estrogen (CEE). There were 8506 participants who received CEE + MPA (8102 who received placebo) and 5310 who received CEE alone (5429 who received placebo). MAIN OUTCOME MEASURES: Incident UI at 1 year among women without UI at baseline and severity of UI at 1 year among women who had UI at baseline. RESULTS: Menopausal hormone therapy increased the incidence of all types of UI at 1 year among women who were continent at baseline. The risk was highest for stress UI (CEE + MPA: relative risk [RR], 1.87 [95% confidence interval {CI}, 1.61-2.18]; CEE alone: RR, 2.15 [95% CI, 1.77-2.62]), followed by mixed UI (CEE + MPA: RR, 1.49 [95% CI, 1.10-2.01]; CEE alone: RR, 1.79 [95% CI, 1.26-2.53]). The combination of CEE + MPA had no significant effect on developing urge UI (RR, 1.15; 95% CI, 0.99-1.34), but CEE alone increased the risk (RR, 1.32; 95% CI, 1.10-1.58). Among women experiencing UI at baseline, frequency worsened in both trials (CEE + MPA: RR, 1.38 [95% CI, 1.28-1.49]; CEE alone: RR, 1.47 [95% CI, 1.35-1.61]). Amount of UI worsened at 1 year in both trials (CEE + MPA: RR, 1.20 [95% CI, 1.06-1.36]; CEE alone: RR, 1.59 [95% CI, 1.39-1.82]). Women receiving menopausal hormone therapy were more likely to report that UI limited their daily activities (CEE + MPA: RR, 1.18 [95% CI, 1.06-1.32]; CEE alone: RR, 1.29 [95% CI, 1.15-1.45]) and bothered or disturbed them (CEE + MPA: RR, 1.22 [95% CI, 1.13-1.32]; CEE alone: RR, 1.50 [95% CI, 1.37-1.65]) at 1 year. CONCLUSIONS: Conjugated equine estrogen alone and CEE + MPA increased the risk of UI among continent women and worsened the characteristics of UI among symptomatic women after 1 year. Conjugated equine estrogen with or without progestin should not be prescribed for the prevention or relief of UI.

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PubMed2005

Effect of estrogen therapy on gallbladder disease.

CONTEXT: Estrogen therapy is thought to promote gallstone formation and cholecystitis but most data derive from observational studies rather than randomized trials. OBJECTIVE: To determine the effect of estrogen therapy in healthy postmenopausal women on gallbladder disease outcomes. DESIGN, SETTING, AND PARTICIPANTS: Two randomized, double-blind, placebo-controlled trials conducted at 40 US clinical centers. The volunteer sample was 22,579 community-dwelling women aged 50 to 79 years without prior cholecystectomy. INTERVENTION: Women with hysterectomy were randomized to 0.625 mg/d of conjugated equine estrogens (CEE) or placebo (n = 8376). Women without hysterectomy were randomized to estrogen plus progestin (E + P), given as CEE plus 2.5 mg/d of medroxyprogesterone acetate (n = 14,203). MAIN OUTCOME MEASURES: Participants reported hospitalizations for gallbladder diseases and gallbladder-related procedures, with events ascertained through medical record review. Cox proportional hazards regression was used to assess hazard ratios (HRs) and 95% confidence intervals (CIs) using intention-to-treat and time-to-event methods. RESULTS: The CEE and the E + P groups were similar to their respective placebo groups at baseline. The mean follow-up times were 7.1 years and 5.6 years for the CEE and the E + P trials, respectively. The annual incidence rate for any gallbladder event was 78 events per 10,000 person-years for the CEE group (vs 47/10,000 person-years for placebo) and 55 per 10,000 person-years for E + P (vs 35/10,000 person-years for placebo). Both trials showed greater risk of any gallbladder disease or surgery with estrogen (CEE: HR, 1.67; 95% CI, 1.35-2.06; E + P: HR, 1.59; 95% CI, 1.28-1.97). Both trials indicated a higher risk for cholecystitis (CEE: HR, 1.80; 95% CI, 1.42-2.28; E + P: HR, 1.54; 95% CI 1.22-1.94); and for cholelithiasis (CEE: HR, 1.86; 95% CI, 1.48-2.35; E + P: HR, 1.68; 95% CI, 1.34-2.11) for estrogen users. Also, women undergoing estrogen therapy were more likely to receive cholecystectomy (CEE: HR, 1.93; 95% CI, 1.52-2.44; E + P: HR, 1.67; 95% CI, 1.32-2.11), but not other biliary tract surgery (CEE: HR, 1.18; 95% CI, 0.68-2.04; E + P: HR, 1.49; 95% CI, 0.78-2.84). CONCLUSIONS: These data suggest an increase in risk of biliary tract disease among postmenopausal women using estrogen therapy. The morbidity and cost associated with these outcomes may need to be considered in decisions regarding the use of estrogen therapy.

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