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Biomedical subjects

S A Shumaker

Publications and source records attributed to S A Shumaker.

At least 19 recordsLinked to original sources
PubMed2003

No effect of HRT on health-related quality of life in postmenopausal women with heart disease.

AIM: Previous clinical studies suggest hormone replacement therapy (HRT) alleviates menopausal symptoms and may improve health-related quality of life (HRQL). Most studies on HRT and HRQL were limited in duration (12 months or less) and scope (few and non-standard HRQL measures). The aim of this paper is to assess HRQL in the Estrogen Replacement and Atherosclerosis (ERA) trial. METHODS: A subset of women within a randomized, blinded, placebo-controlled secondary prevention trial has been studied in outpatient and community settings at 5 US sites. A total of 246 postmenopausal women with angiographically documented heart disease (mean age 66 years, 83% Caucasian) were enrolled in the ERA trial. Participants received either 0.625 mg/day conjugated equine estrogen only, estrogen plus 2.5 mg/day medroxyprogesterone acetate, or placebo. HRQL was assessed using validated questionnaire instruments at baseline and follow-up (mean 3.2 years of trial). Physical and mental functioning, life satisfaction, depressive symptoms, urinary incontinence, sleep disturbance, and frequency and intensity of physical symptoms were evaluated. RESULTS: In this group of women with established coronary disease, active therapy was not significantly associated with more favorable outcomes for any HRQL. The estrogen-only group reported more urinary incontinence than the placebo group (p<0.05). Analyses restricted to adherent women (those who took > or = 80% of pills) showed a similar pattern of results, showing that the estrogen only group reported significantly higher urinary incontinence compared to placebo (p<0.01). CONCLUSION: The hormone replacement regimens in the ERA trial did not improve HRQL of postmenopausal women with heart disease.

Adult↗
PubMed2002

The health-related quality of life and survival of small-cell lung cancer patients: results of a companion study to CALGB 9033.

The purposes of this study were 2-fold: to evaluate the impact of the schedule dependency of etoposide (3-day IV short course vs. a 21-day oral prolonged course) with cisplatin on the quality of life of small-cell lung cancer (SCLC) patients; and to examine the effect of baseline quality of life variables on long-term survival, after adjustment for known demographic and clinical prognostic factors. Participants were 70 patients enrolled in the cancer and leukemia group B (CALGB) protocol 9033. Quality of life was assessed at baseline, 6 and 12 weeks by: the EORTC QLQ-30, the Centers for epidemiology studies--Depression short form, the medical outcomes study (MOS) social support questionnaire, and a scale of sleep quality. Contrary to expectations, study results suggested no significant differences in the patients' life quality and treatment response based on whether they received etoposide in a 3-day IV vs. a 21-day oral regimen. The use of the baseline variables in predicting overall survival indicated that patients who were non-white and with liver involvement had decreased survival. Brain involvement, being male, and higher depressive symptoms were also found to be borderline significant in predicting decreased survival in this patient population.

Adult↗
PubMed2001

Promoting adherence and retention to clinical trials in special populations: a women's health initiative workshop.

This paper describes a Women's Health Initiative workshop on promoting adherence and retention in randomized clinical trials among ethnic minority women, participants of lower socioeconomic status, and older women. Workshop objectives were: (1) to increase knowledge of demographic and cultural characteristics of diverse groups, (2) to increase awareness of how diversity can affect interactions in clinical research, (3) to explore how research staff behavior can influence adherence and retention, and (4) to increase knowledge of strategies to enhance adherence and retention in special populations. The workshop emphasized the importance of understanding beliefs, values, and experiences that are common in diverse groups of individuals, while at the same time recognizing and respecting individual differences that result from varying life circumstances and experiences. We discuss strategies to increase cultural competence, reduce stereotypes and discrimination, and create a culturally relevant and sensitive research environment.

Age Distribution↗
PubMed2000

Effects of estrogen replacement on the progression of coronary-artery atherosclerosis.

BACKGROUND: Heart disease is a major cause of illness and death in women. To understand better the role of estrogen in the treatment and prevention of heart disease, more information is needed about its effects on coronary atherosclerosis and the extent to which concomitant progestin therapy may modify these effects. METHODS: We randomly assigned a total of 309 women with angiographically verified coronary disease to receive 0.625 mg of conjugated estrogen per day, 0.625 mg of conjugated estrogen plus 2.5 mg of medroxyprogesterone acetate per day, or placebo. The women were followed for a mean (+/-SD) of 3.2+/-0.6 years. Base-line and follow-up coronary angiograms were analyzed by quantitative coronary angiography. RESULTS: Estrogen and estrogen plus medroxyprogesterone acetate produced significant reductions in low-density lipoprotein cholesterol levels (9.4 percent and 16.5 percent, respectively) and significant increases in high-density lipoprotein cholesterol levels (18.8 percent and 14.2 percent, respectively); however, neither treatment altered the progression of coronary atherosclerosis. After adjustment for measurements at base line, the mean (+/-SE) minimal coronary-artery diameters at follow-up were 1.87+/-0.02 mm, 1.84+/-0.02 mm, and 1.87+/-0.02 mm in women assigned to estrogen, estrogen plus medroxyprogesterone acetate, and placebo, respectively. The differences between the values for the two active-treatment groups and the value for the placebo group were not significant. Analyses of several secondary angiographic outcomes and subgroups of women produced similar results. The rates of clinical cardiovascular events were also similar among the treatment groups. CONCLUSIONS: Neither estrogen alone nor estrogen plus medroxyprogesterone acetate affected the progression of coronary atherosclerosis in women with established disease. These results suggest that such women should not use estrogen replacement with an expectation of cardiovascular benefit.

Adult↗
PubMed2000

The estrogen replacement and atherosclerosis (ERA) study: study design and baseline characteristics of the cohort.

The Estrogen Replacement and Atherosclerosis (ERA) trial is a three-arm, randomized, placebo-controlled, double-blind trial to evaluate the effects of estrogen replacement therapy (0.625 mg/day oral conjugated estrogen) with or without continuous low-dose progestin (2.5 mg oral medroxyprogesterone acetate/day) versus placebo on progression of atherosclerosis. A total of 309 postmenopausal women at five sites underwent baseline coronary angiography and were randomized. Participants will have repeat coronary angiography after an average of 3.25 years of treatment. The primary outcome of interest will be change in minimum diameter of the major epicardial segments, as assessed by quantitative coronary angiography. The primary aim is to test the hypothesis that either form of hormone therapy will slow the progression or induce regression of coronary atherosclerosis compared to placebo. The secondary aims are to assess the effects of the two treatments versus placebo on endothelial function (measured using flow-mediated vasodilator responses), on several presumed mediators of estrogen's effect on atherosclerosis (i.e., plasma lipids and lipoproteins, blood pressure, glucose metabolism, hemostatic factors, and antioxidant activity), on other factors that influence the development of coronary heart disease (i.e., diet, smoking status, exercise, weight, and health-related quality of life issues), and on clinical cardiovascular events. The ERA trial is the first angiographic endpoint clinical trial to examine the effects of postmenopausal hormone replacement on coronary atherosclerosis in women. It will provide an unparalleled opportunity to determine if either regimen of hormone therapy is effective in slowing the progress of angiographically defined coronary atherosclerosis. This study will complement other estrogen replacement trials, such as the PEPI, HERS, and Women's Health Initiative studies, to provide a more comprehensive examination of the effects of estrogen replacement on cardiovascular risk factors, anatomic and functional manifestations of atherosclerosis, and risk for coronary heart disease in postmenopausal women. Control Clin Trials 2000;21:257-285

Aged↗
PubMed2000

Enhancing adherence in randomized controlled clinical trials.

This paper identifies individual and systematic primary, secondary, and tertiary prevention approaches that can be used to enhance adherence in randomized controlled trials. Specifically, strategies such as these are discussed: careful screening during enrollment, use of a run-in period, fully informing participants of the study burden, explaining randomization, determining the participant's prior history with treatment interventions, establishing and using a tracking system, clearly specifying adherence measures, and staff training in communication and negotiation. These strategies have been gathered over time from our experiences working in multiple randomized controlled trials. Research on factors that promote or detract from adherence should be a standard part of randomized controlled trials. Control Clin Trials 2000;21:226S-232S

Aged↗
PubMed2000

Factors related to sleep disturbance in older adults experiencing knee pain or knee pain with radiographic evidence of knee osteoarthritis.

OBJECTIVES: To describe the types and frequencies of sleep complaints and the biopsychosocial factors associated with sleep disturbance in a large community sample of older adults experiencing knee pain or knee pain with radiographic evidence of knee osteoarthritis (OA). DESIGN: Baseline analyses of an observational prospective study. SETTING AND PARTICIPANTS: Participants were 429 men and women aged 65 years and older experiencing knee pain or knee pain with radiographic evidence of OA enrolled in the Observational Arthritis Study in Seniors (OASIS). MEASUREMENTS: Demographic variables (age, gender, ethnicity, education), health (X-rays of knee rated for OA severity, medical conditions, medication use, smoking status, body mass index, self-rated health), physical functioning (self-rated physical functioning, physical performance), knee pain, and psychosocial functioning (social support, depression) were measured. RESULTS: Problems with sleep onset, sleep maintenance, and early morning awakenings occurred at least weekly among 31%, 81%, and 51% of participants, respectively. Bivariate correlates of greater sleep disturbance in those with OA were less education, cardiovascular disease, more arthritic joints, poorer self-rated health, poorer physical functioning, poorer physical performance, knee pain, depression, and less social support. In regression analyses, each set of variables representing the domains of health, physical functioning, pain, and psychosocial functioning contributed to the prediction of sleep disturbance beyond the demographic set. Finally, in a simultaneous model, white race (trend, P = .06), poorer self-rated health, poorer physical functioning, and depressive symptoms were predictive of sleep disturbance. CONCLUSIONS: Sleep disturbance is common in older adults experiencing knee pain or knee pain with radiographic evidence of OA and is best understood through the consideration of demographic, physical health, physical functioning, pain, and psychosocial variables. Interventions that take into account the multidetermined nature of sleep disturbance in knee pain or knee OA are most likely to be successful.

Activities of Daily Living↗
PubMed2000

Profile of men randomized to the prostate cancer prevention trial: baseline health-related quality of life, urinary and sexual functioning, and health behaviors.

PURPOSE: To describe men who agreed to be randomized to the Prostate Cancer Prevention Trial (PCPT), a 7-year, double-blind placebo-controlled study of the efficacy of finasteride in preventing prostate cancer. METHODS: Comprehensive health-related quality-of-life data are presented for 18,882 randomized PCPT participants. RESULTS: PCPT participants are highly educated, middle to upper income, and primarily white (92%). Participants reported healthy lifestyles. The mean American Urological Association Symptom Index score was well below the maximum entry score of less than 19; existing urinary symptoms were generally not bothersome. The scores for two sexual functioning scales could range from 0 to 100, with higher scores reflecting worse sexual functioning. The mean score for the Sexual Problem Scale was 19.2 out of 100, and the mean Sexual Activities Scale was 44.1 out of 100. Scores for seven of the eight Medical Outcomes Study 36-item Short-Form Health Survey scales (higher scores are better) were 10 to 20 points higher than those reported by a general population sample and differed minimally by race but not by age. Previously reported associations between sexual dysfunction and hypertension, diabetes, and depression were also observed. Men who never smoked reported less sexual dysfunction than did those who either had quit or still smoked. CONCLUSION: Individuals who are likely to enroll in primary prevention trials have a high socioeconomic status, healthy lifestyle behaviors, and better health than the general population. These data help oncologists design chemoprevention trials with respect to the selection of health-related quality-of-life assessments and recruitment strategies.

Aged↗
PubMed1998

The Women's Health Initiative Memory Study (WHIMS): a trial of the effect of estrogen therapy in preventing and slowing the progression of dementia.

Evidence from animal, human cross-sectional, case-control, and prospective studies indicate that hormone replacement therapy (HRT) is a promising treatment to delay the onset of symptoms of dementia. The Women's Health Initiative Memory Study (WHIMS) is the first double-masked, randomized, placebo-controlled, long-term clinical trial designed to test the hypothesis that HRT reduces the incidence of all-cause dementia in women aged 65 and older. WHIMS, an ancillary study to the Women's Health Initiative (WHI) funded by the National Institutes of Health, will recruit a subgroup of women aged 65 and older from among those enrolling in the HRT trial of the WHI. The WHI clinical centers and 10 affiliated satellites plan to enroll approximately 8300 women into WHIMS over a 2-year period. Participants will be followed annually for 6 years, receiving cognitive assessments via the Modified Mini-Mental State (3MS) Examination. Women who screen positively for cognitive impairment on the basis of an educational and age-adjusted 3MS cutpoint proceed to more extensive neuropsychological testing and neurologic evaluation. Each woman suspected to have dementia then undergoes a series of laboratory tests that confirm the clinical diagnosis and classify the type of dementia. WHIMS is designed to provide more than 80% statistical power to detect a 40% reduction in the rate of all-cause dementia, an effect that could have profound public health implications for older women's health and functioning.

Aged↗
PubMed1998

The Kidney Outcomes Prediction and Evaluation (KOPE) study: a prospective cohort investigation of patients undergoing hemodialysis. Study design and baseline characteristics.

PURPOSE: The purpose of the Kidney Outcomes Prediction and Evaluation (KOPE) study, was to more fully characterize the end-stage renal disease (ESRD) population with respect to social, psychological, and clinical characteristics, and to prospectively study the biomedical, social, and psychological factors that influence a range of ESRD outcomes in a large observational study of black and white patients on hemodialysis. This paper focuses on the KOPE study design as well as characteristics of patients at baseline. METHODS: KOPE was a prospective cohort investigation of patients treated at four dialysis centers in Forsyth County, North Carolina. Participants were interviewed at the dialysis centers, semi-annually over a 3 1/2 year period. Prevalent cases who were being treated with hemodialysis at the initiation of the study were enrolled into KOPE. Incident cases were subsequently enrolled as they presented to the participating units for hemodialysis. A total of 304 prevalent and 162 incident cases were enrolled into the study. The baseline health and sociodemographic characteristics of KOPE participants reported in this paper were obtained from medical records and Southeast Kidney Council data. Laboratory values taken within a 30-day interval around the baseline interview are also reported. RESULTS: KOPE participants differ from national statistics on race, age, and gender. Differences between KOPE participants and patients living in the region, but who did not participate in the study, can be explained by our recruitment criteria. CONCLUSIONS: KOPE will enable the characterization of the ESRD population, identification of factors related to poor outcomes, and identification of opportunities for interventions to prevent death and morbidity.

Adult↗
PubMed1997

Comparison of preoperative characteristics of men and women undergoing coronary artery bypass grafting (the Post Coronary Artery Bypass Graft [CABG] Biobehavioral Study).

A cohort of 759 coronary artery bypass grafting (CABG) patients (269 women and 490 men) was enrolled in the prospective POST CABG Biobehavioral Study at 5 clinical centers in the United States and Canada. Sociodemographic and medical data were obtained by interview and from medical charts. Health-related quality of life and psychosocial data were ascertained preoperatively by interview and questionnaire for those patients whose condition allowed preoperative assessment and was compared among patients from hospitals enrolling both male and female patients (143 women and 267 men). Women enrolled in the Biobehavioral Study were older than men (65.4 +/- 9.0 vs 61.8 +/- 9.7 years, p < 0.001) and more likely to have a preoperative medical condition which precluded biobehavioral evaluation (47% vs 34%, p < 0.001). Women were less likely to be high school graduates (59% vs 74%, p < 0.001), were less likely to be earning > or = $25,000 per year (39% vs 69%, p < 0.001), and were married less often at the time of surgery (59% vs 85%, p < 0.001). Fewer women than men were able to perform basic self-care activities (p < 0.001) and social activities (p < 0.001). Women were also less able to perform the more demanding activities required for independent living, recreation, and maintaining a household (p < 0.001). Women were also more anxious (p = 0.01) and reported more depressive symptoms (p < 0.001) than men. These data suggest that plans for perioperative and convalescent care for women undergoing CABG should take into account their less favorable medical and psychosocial status relative to men.

Activities of Daily Living↗
PubMed1997

Assessment of health-related quality of life in orthopaedic outcomes' studies.

The assessment of health-related quality of life is becoming increasingly important in evaluating the effectiveness of orthopaedic interventions. This report provides an overview of issues related to the assessment of quality of life in orthopaedic populations. Discussed are the definition and dimensions of health-related quality of life: the usefulness of collecting quality of life data; methodological considerations in designing outcomes' studies; the selection of quality of life instruments; modes of instrument administration; and scoring.

Health Status Indicators↗
PubMed1997

Hormone replacement therapy and other potential treatments for dementias.

The past decade has seen a substantial increase in the number of individuals affected by dementia. Dementia places a tremendous personal and economic burden on millions of patients and caregivers annually. Consequently, many scientists have been searching for a treatment for dementia to avoid the imminent public health crisis that will occur if this trend continues. Primary and secondary prevention studies, as well as animal research, demonstrate the potential for hormone replacement therapy (HRT) as an efficacious treatment for dementia. Recently, the Women's Health Initiative-Memory Study began the first randomized, longterm clinical trial to test the hypothesized role of HRT at the onset and in the progression of dementia in women. Researchers also are investigating the potential of other treatments for dementias, such as nonsteroidal anti-inflammatory drugs and free radical scavengers.

Alzheimer Disease↗
PubMed1997

Assessing health-related quality of life in HIV disease: key measurement issues.

The reliable and valid assessment of health-related quality of life (HRQoL) in human immunodeficiency virus (HIV) clinical research presents both familiar and unique challenges. Consistent with HRQoL research in general, measures of HRQoL in HIV disease must meet a set of standard psychometric properties, produce interpretable results, and be responsive to relatively small treatment effects. Furthermore, as clinical research for a range of diseases and conditions becomes increasingly global, HRQoL investigators are confronted with the formidable task of developing measures that are applicable across a range of cultures and languages within and across national boundaries. In this paper, we present a model of HRQoL to be applied across disease and conditions, with a discussion of the key measurement issues. We then briefly consider the natural history and treatment aspects of HIV that are relevant to HRQoL research. In the final sections of the paper, we describe the elements needed in an 'ideal' HRQoL/HIV instrument and propose a method for evaluating the degree to which current HRQoL measures address the challenges posed by HIV clinical research.

Culture↗
PubMed1997

Women's health initiative. Why now? What is it? What's new?

Studies collectively named the Women's Health Initiative (WHI) are currently enrolling 164,500 postmenopausal women in several overlapping clinical trials and an observational study. The overall goals of WHI are to understand the determinants of postmenopausal women's health and to evaluate the efficacy of practical interventions in preventing the major causes of morbidity and mortality in older women. This article reviews the research leading to the WHI studies; describes the study designs and protocols, with an emphasis on what's new about WHI from a psychological perspective; and outlines the major psychosocial hypotheses under investigation and the major challenges WHI presents to psychological science.

Aged↗
PubMed1997

Baseline correlates with quality of life among men and women with medication-controlled hypertension. The trial of nonpharmacologic interventions in the elderly (TONE).

OBJECTIVES: To examine Quality of Life (QOL) and its correlates among older adults with medication-controlled hypertension. DESIGN: Baseline data from the TONE clinical trial. MEASUREMENTS: Demographic variables (age, race, income), hypertension treatment (medication class, years treated), health status (obesity, physical symptoms), and QOL status (MOS-Short-Form 36, Jenkins Sleep Disturbance, and CES-D Depression). PARTICIPANTS: A total of 975 men and women, aged 60 to 81 years and free of major diseases and disability, with a screening blood pressure (BP) of < or = 145/85 mm Hg, treated medically for hypertension with antihypertensive medication. RESULTS: On average, TONE participants reported a QOL level on the SF-36 that was similar to or better than that reported by older adults in the general population. However, there was a strikingly high prevalence of physical complaints or symptoms: 90.3% of men and 93.3% of women experienced one or more physical symptoms or complaints, and nearly 50% reported that such symptoms had disrupted their daily functioning. Among variables-considered, only the physical symptoms index score, number of severe symptoms, and obesity status were correlated consistently with QOL among TONE men and women. Lower QOL scores were associated with higher symptom scores and with obesity. Neither medication class nor age were appreciably associated with QOL status. CONCLUSIONS: Physical symptoms, rather than medication class and age, were the strongest correlates of QOL in TONE. This underscores the importance of identifying the etiology of symptoms as a means to improve the QOL of order hypertensive persons rather than substituting medication. The association of poorer physical well-being with obesity suggests that weight reduction to manage BP may also improve QOL for some individuals.

Activities of Daily Living↗