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Biomedical subjects

Electra D Paskett

Publications and source records attributed to Electra D Paskett.

26 records · Page 2Linked to original sources
PubMed2003

The Osteoporosis Prevention and Arterial effects of tiboLone (OPAL) study: design and baseline characteristics.

The Osteoporosis Prevention and Arterial effects of tiboLone (OPAL) trial is a three-arm, randomized, placebo-controlled, double-blind study to determine the effect of tibolone 2.5 mg (Org OD 14) and continuous combined conjugated equine estrogens plus medroxyprogesterone acetate (0.625 mg/2.5 mg respectively) on progression of intima-media thickness of the carotid arteries and bone mineral density of the lumbar vertebrae and proximal femur in postmenopausal women. A total of 866 healthy postmenopausal women were recruited in six U.S. centers and five European centers. Duplicate carotid ultrasound examinations of the common carotid artery, the carotid bifurcation, and the internal carotid artery were performed at baseline. Single measurements of bone mineral density of the lumbar vertebrae and proximal femur were obtained at baseline. After randomization, ultrasound examinations were repeated every 6 months for 36 months following baseline, with a duplicate examination at the end of the study. Bone mineral density was measured every 12 months throughout the trial. The primary outcome is change in mean common carotid intima-media thickness (CIMT), defined as the average of the intima-media thickness measurements performed circumferentially at predefined angles for the near and far wall of 10-mm segments of the right and left distal common carotid arteries. Unique new features of the OPAL study are the specifically developed OPAL ultrasound protocol, yielding highly reproducible CIMT measurements, and the use of two experienced core laboratories for CIMT readings (one in the United States and one in Europe) with one common quality assurance and control program. The OPAL study is a large, placebo-controlled trial evaluating the effects of tibolone, as well as one of the first large randomized studies to determine the effects of continuous combined estrogen-progestin therapy on carotid atherosclerosis in healthy postmenopausal women. The OPAL study results are expected to complement other studies on atherosclerosis progression in healthy postmenopausal women.

Aged↗
PubMed2003

Participation in cancer trials: recruitment of underserved populations.

One approach to address cancer health disparities is to focus on the under-representation by minority populations in cancer trials. Recruitment strategies include: 1) characterizing the target populations, 2) involve members of the population in planning, 3) take the message to the population, 4) give something back to the community, 5) enhance credibility with a community spokesperson, 6) identify and remove barriers, 7) improve staff sensitivity, and 8) educate the population about the trial. To recruit minorities to clinical trials, we have developed the Accrual to Clinical Trials (ACT) framework for understanding and enhancing the recruitment of participants to cancer trials.

Clinical Trials as Topic↗
PubMed2002

Outcomes among African-American/non-African-American patients with advanced non-small-cell lung carcinoma: report from the Cancer and Leukemia Group B.

BACKGROUND: Among patients diagnosed with advanced non-small-cell lung carcinoma (NSCLC), African-Americans have lower survival rates than non-African-Americans. Whether this difference is due to innate characteristics of the disease in the two ethnicities or to disparities in health care is not known. We investigated whether the disparity in survival would persist when patients were treated with similar systemic therapies (i.e., in phase II and phase III Cancer and Leukemia Group B [CALGB] trials). METHODS: We assessed 504 consecutive patients (458 non-African-American and 46 African-American) receiving systemic chemotherapy in CALGB studies for advanced NSCLC during the period from 1989 through 1998. Clinical and demographic characteristics, treatment received, and survival data were obtained from the CALGB database. Cox's proportional hazards model was used to assess the effect of race/ethnicity on survival after adjustment for other known prognostic factors. All statistical tests were two-sided. RESULTS: The unadjusted 1-year survival rate was 22% (95% confidence interval [CI] = 13% to 38%) for African-American patients and 30% (95% CI = 26% to 35%) for non-African-American patients, a statistically significant difference (8%; 95% CI on the difference = 5% to 12%; P =.03). Multivariable adjustment for the effect of treatment arm, histology, and metastatic site at presentation did not alter the worse outcome for African-American patients. However, the effect of race/ethnicity disappeared after adjustment for performance status and weight loss. African-American patients were more likely than non-African-Americans to present with a poor performance status (83% versus 60%) and substantial weight loss (41% versus 27%) and to be unmarried (59% versus 28%), disabled (31% versus 15%), unemployed (17% versus 7%), and Medicaid recipients (30% versus 8%). CONCLUSIONS: The relationship that we observed between poor performance, weight loss, and socioeconomic status suggests that social circumstances lead to African-Americans presenting with poorer prognostic features.

Adult↗
PubMed2002

Adenomatous polyp recurrence and physical activity in the Polyp Prevention Trial (United States).

OBJECTIVE: To examine prospectively the association between physical activity and adenomatous polyp recurrence. METHODS: Information on past year total physical activity was collected annually through an interview-administered questionnaire from the 1905 men and women enrolled in a randomized dietary intervention study, the Polyp Prevention Trial. Multiple logistic regression analysis was used to examine the association between physical activity and polyp recurrence in up to three years of follow-up from baseline colonoscopy. RESULTS: There were no significant associations between moderate, vigorous, or total physical activity at the start of the trial and overall polyp recurrence in either men or women. Participants who reported consistent vigorous activity throughout the trial period had no significantly reduced risk of polyp recurrence compared to those who reported consistent sedentary activity (OR = 0.8, CI = 0.5-1.1). Consistent vigorous activity was also not significantly associated with either advanced or multiple polyps, nor with polyp recurrence at any specific anatomical location in the large bowel. CONCLUSIONS: These prospective data suggest that recent physical activity is not associated with polyp recurrence in a three-year period.

Adenomatous Polyps↗
PubMed2002

Cervical cancer risk as a predictor of Pap smear use in rural North Carolina.

Risk for invasive cervical cancer is reported to be higher in rural areas than urban ones, and cervical cancer-related mortality is higher in rural women due to poorer utilization of preventive services and subsequent presentation at late stages of the disease. This cross-sectional study examined the relationship between prevalence of risk factors for cervical cancer and the degree of compliance with risk-appropriate screening guidelines for cervical cancer. Secondary data were analyzed for 614 women from Robeson County, NC, aged 40 and older, and of mainly rural and low socioeconomic status. High-risk status was determined by the presence of any of the following five risk factors: a history of more than two sexual partners, age at first sexual intercourse under 18 years, history of sexually transmitted disease, history of sexually transmitted disease in sexual partner(s), and smoking. Low-risk status was the absence of all factors. A high-risk participant was considered compliant if she had had at least three Pap smears in the 3 years prior to the interview, while a low-risk participant was considered compliant if she had had at least one Pap smear within the previous 3 years. Overall, 82% of the participants were at high risk for cervical cancer. However, only 41% of all participants were compliant with the risk-appropriate screening guidelines. Low-risk status was significantly associated with compliance with cervical cancer screening guidelines (adjusted OR = 6.7; 95% CI = 3.7 to 11.1, p = .0001). Findings in this study population suggest rural women at high risk for cervical cancer are less likely to be compliant with appropriate Pap smear screening guidelines, indicating the need to target educational programs.

Adult↗
PubMed2002

Interpreting measures of treatment effect in cancer clinical trials.

The efficacy of a new cancer regimen is usually assessed by analyzing outcomes such as tumor response and overall survival. Many publications summarizing results of cancer clinical trials report measures such as odds ratios and hazard ratios, as these are the estimators of treatment effect obtained from regression models used to analyze the data. However, these measures are sometimes misinterpreted, as they are not necessarily familiar to many readers. The most common mistake is to interpret both measures as relative risks, an interpretation that can lead to an incorrect impression of the impact of the treatment on response and survival.

Clinical Trials as Topic↗
PubMedDate not supplied

Clinical trial enrollment of rural patients with cancer.

PURPOSE: The goal of this study was to examine the effect of a rural community clinical oncology program-based cancer-care intervention program that was launched to increase the number of rural patients with cancer enrolled in clinical trials. DESCRIPTION OF STUDY: Five rural counties in eastern North Carolina served as intervention communities, and five rural counties in South Carolina served as the comparison region. The intervention counties used a rapid tumor-reporting system, a nurse facilitator who identified and prompted oncologists to enter patients into clinical trials, a quarterly newsletter to primary-care physicians about cancer treatment and clinical trials, and a health educator who focused on community-wide education regarding cancer prevention, treatment, and clinical trial information. Outcomes included changes in knowledge and attitudes about clinical trials among the primary-care providers who were surveyed and enrollment in clinical treatment trials for breast and colorectal cancer, as analyzed by comparing practice pattern data from before and after the intervention. RESULTS: The results indicate that the intervention was not effective. The proportion of primary-care physicians who were aware of clinical trials for their patients with cancer rose slightly in comparison counties (26% to 34%) but remained constant (41% to 43%) in intervention counties. Perceived patient and actual physician barriers toward clinical trial participation were reported by the physicians. A minority of potentially eligible patients with breast or colon cancer in both North Carolina and South Carolina were enrolled in clinical trials. CLINICAL IMPLICATIONS: These data suggest that different types of interventions may be needed to improve accrual to cancer treatment trials in rural communities. In addition, the role that primary-care providers play in encouraging patients with cancer to participate in clinical treatment trials needs further exploration.

Breast Neoplasms↗