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Biomedical subjects

Paul A Godley

Publications and source records attributed to Paul A Godley.

14 recordsLinked to original sources
PubMed2006

Case-control prostate cancer screening studies should not exclude subjects with lower urinary tract symptoms.

OBJECTIVE: Prostate-specific antigen (PSA)/digital rectal exam (DRE) screening for prostate cancer has become standard medical practice; however, its effectiveness in terms of reducing prostate cancer mortality remains undetermined. Case-control screening studies may help determine screening efficacy, though the proper disposition of symptomatic subjects is unclear. This paper presents a prostate cancer-specific methodological modification for analyzing symptomatic case-control screening subjects. METHODS: Prostate cancer detection studies and case-control studies of PSA/DRE screening were reviewed, and the results for symptomatic and asymptomatic subjects were compared. RESULTS: Most PSA/DRE detection studies have found that the prostate cancer detection rate among symptomatic patients is the same as or lower than that among asymptomatic patients. Lower urinary tract symptoms (LUTS), often referred to as early prostate cancer symptoms, occur more often in benign prostatic hyperplasia (BPH), a more commonly diagnosed, nonmalignant disease. Screened symptomatic subjects are usually removed from the "screened" category in case-control studies even though BPH-related symptoms do not confer increased prostate cancer risk and odds ratios do not change with inclusion of symptomatic subjects in the analysis. CONCLUSION: Screened subjects with LUTS should remain in the "screened" category in case-control prostate cancer screening studies since these symptoms may not be associated with increased risk of prostate cancer or validity of the odds ratio.

Biomarkers, Tumor↗
PubMed2006

The North Carolina-Louisiana Prostate Cancer Project (PCaP): methods and design of a multidisciplinary population-based cohort study of racial differences in prostate cancer outcomes.

BACKGROUND: The North Carolina-Louisiana Prostate Cancer Project (PCaP) is a multidisciplinary study of social, individual, and tumor-level causes of racial differences in prostate cancer aggressiveness. METHODS: A population-based sample of incident prostate cancer cases from North Carolina and Louisiana will include 1,000 African Americans and 1,000 Caucasian Americans. Study nurses administer structured questionnaires and collect blood, adipose tissue, urine, and toenail samples during an in-home visit. Clinical data are abstracted from medical records, diagnostic biopsies are reviewed and assayed, and tissue microarrays are constructed from prostatectomy samples. Prostate cancer aggressiveness is classified based on PSA, clinical stage, and Gleason grade. RESULTS: Preliminary data demonstrate between- and within-group differences in patient characteristics, screening, and treatment by race and state. Participation exceeds 70% in all groups. CONCLUSIONS: Preliminary data support the feasibility of this comprehensive study to help determine the focus of public health efforts to reduce racial disparities in prostate cancer mortality.

Black People↗
PubMed2006

The effect of physician permission versus notification on research recruitment through cancer registries (United States).

OBJECTIVE: To determine how physicians responded when investigators inquired about contacting patients identified through a central cancer registry, and to examine participation rates under physician permission versus notification approaches. METHODS: We analyzed existing data from seven observational epidemiologic studies conducted in North Carolina between 1993 and 2004, capitalizing on a 'natural experiment' that arose when the state registry changed from a policy requiring investigators to obtain physician permission to one requiring only physician notification. RESULTS: When a notification approach was used, physicians approved researcher contact with a higher proportion of patients, and a higher proportion of physicians approved contact with or provided eligibility information about all patients requested, compared with a permission approach. Among physicians who were contacted under both approaches, the proportion of patients for whom they approved contact or provided information was significantly higher when they were notified. Physician notification was also associated with higher patient contact and overall response rates. Patient cooperation rates did not differ between the two approaches, suggesting that patients did not respond negatively to the fact that their physician was not explicitly asked to provide permission. CONCLUSION: Notification is likely an efficient way of involving patients' physicians, providing opportunity for physician input but avoiding the burdens associated with requiring their permission.

Clinical Trials as Topic↗
PubMed2006

Racial differences in clinical progression among Medicare recipients after treatment for localized prostate cancer (United States).

OBJECTIVE: Prostate cancer recurrence impacts patient quality of life and risk of prostate-cancer specific death following definitive treatment. We investigate differences in disease-free survival among white, black, Hispanic, and Asian patients in a large, population-based database. METHODS: Merged Surveillance, Epidemiology, and End Results Program (SEER) and Medicare files provided data on 23,353 white patients, 2,814 black patients, 480 Hispanic patients, and 566 Asian patients diagnosed at age 65-84 years with clinically localized prostate cancer between 1986 and 1996 in five SEER sites. Patients were followed through 1998. Racial differences in disease-free survival were assessed using Kaplan-Meier survival curves and Cox regression models. RESULTS: The 75th percentile disease-free survival time for black patients was 13 months less than that for white patients (95% confidence interval [CI]: 6.2-19.8 months), 29.7 months less than that for Hispanic patients (95% CI: 4.4-55.0 months), and 39.1 months less than that for Asian patients (95% CI: 12.1-66.1 months). In multivariate analysis, black race predicted shorter disease-free survival among surgery patients, but not among radiation patients. CONCLUSIONS: Black patients experienced shorter disease-free survival compared to white, Hispanic, and Asian patients, and the disease-free survival of white, Hispanic, and Asian patients were not statistically different. Earlier recurrence of prostate cancer may help explain black patients' increased risk of mortality from prostate cancer.

Black or African American↗
PubMed2005

Developing effective interuniversity partnerships and community-based research to address health disparities.

Health disparities are an enormous challenge to American society. Addressing these disparities is a priority for U.S. society and especially for institutions of higher learning, with their threefold mission of education, service, and research. Collaboration across multiple intellectual disciplines will be critical as universities address health disparities. In addition, universities must collaborate with communities, with state partners, and with each other. Development of these collaborations must be sensitive to the history and unique characteristics of each academic institution and population. The authors describe the challenges of all three types of collaboration, but primarily focus on collaboration between research-intensive universities and historically black colleges and universities. The authors describe a four-year collaboration between Shaw University and the University of North Carolina at Chapel Hill (UNC-CH). These universities strategically developed multiple research initiatives to address health disparities, building on modest early success and personal relationships. These activities included participation by Shaw faculty in faculty development activities, multiple collaborative pilot studies, and joint participation in securing grants from the Agency for Health care Research and Quality of the federal Department of Health and Human Services and the National Institutes of Health, including a P-60 Project EXPORT center grant. These multiple activities were sometimes led by UNC-CH, sometimes by Shaw University. Open discussion of problems as they arose, realistic expectations, and mutual recognition of the strengths of each institution and its faculty have been critical in achieving successful collaboration to date.

Academic Medical Centers↗
PubMed2005

Renal cell carcinoma.

PURPOSE OF REVIEW: This review focuses on recent developments in the biology and clinical therapeutics of renal cell carcinoma. Given historically limited advances in this disease, a more thorough understanding and testing of rationally targeted agents is needed. RECENT FINDINGS: Von Hippel-Lindau gene inactivation is observed in most clear cell renal carcinoma, driving the malignant phenotype. The resulting vascular endothelial growth factor overexpression has been targeted though various approaches, with a clear signal of anti-tumor activity. In addition, immunotherapy remains a therapeutic standard in renal cell carcinoma and an area of ongoing investigation. Observation of small renal masses may represent a viable clinical option. SUMMARY: Renal cell carcinoma has become a model disease for rationally targeted therapeutics based on significant understanding of the underlying biology. Recent advances have increased the potential for meaningful improvements in clinical outcomes for renal cell carcinoma patients.

Angiogenesis Inhibitors↗
PubMed2004

Renal cell carcinoma.

PURPOSE OF REVIEW: Renal cell carcinoma continues to be a devastating cancer, which currently has few effective treatment options. Recent developments in our understanding of the molecular biology of renal cell carcinoma, particularly clear cell renal cell carcinoma, have led to the development of new agents targeting portions of the hypoxic response pathway. RECENT FINDINGS: Although high-dose bolus interleukin-2 remains the mainstay of treatment for metastatic disease, the number of patients deriving long-term benefit from this treatment are few, and the use of cytokine therapy in the adjuvant setting has been disappointing. However, the expanding use of minimally invasive surgical techniques has continued to improve patient care. Systemic advances include antibody therapeutics such as bevacizumab, which targets vascular endothelial growth factor signaling, as well as emerging small molecule inhibitors of angiogenesis-related signaling events. SUMMARY: In addition to progress in surgical techniques and supportive care of patients with renal cell carcinoma, a host of promising targeted therapies for renal cell carcinoma are on the horizon.

Carcinoma, Renal Cell↗
PubMed2003

A phase II study of estramustine, docetaxel, and carboplatin with granulocyte-colony-stimulating factor support in patients with hormone-refractory prostate carcinoma: Cancer and Leukemia Group B 99813.

BACKGROUND: The authors determined the safety and efficacy of estramustine, docetaxel, and carboplatin with granulocyte-colony-stimulating factor (G-CSF) support in patients with hormone-refractory prostate carcinoma. METHODS: In the current multicenter, cooperative group study, patients with advanced prostate carcinoma whose disease progressed despite androgen deprivation therapy were treated with a combination of oral estramustine(240 mg three times per day for 5 days), 70 mg/m2 of docetaxel, and carboplatin at a dose of (area under the curve) 5. G-CSF was used to minimize the neutropenia associated with this regimen. Each cycle was repeated every 21 days. RESULTS: Forty patients were treated with a median of 7 cycles of therapy. Of the 34 evaluable patients with elevated pretreatment prostate-specific antigen (PSA) levels, 23 (68%) had a > or = 50% decline in PSA and 20 (59%) had a > or = 75% decline. Twenty-one patients had measurable disease, with 1 complete response (5%) and 10 partial responses (47%), for an overall measurable response rate of 52% (95% confidence interval [95% CI], 30-74%). The most common Grade 3 or Grade 4 toxicities (according to the National Cancer Institute Common Toxicity Criteria) included neutropenia in 23% of patients, thrombocytopenia in 13%, and fatigue in 13%. Febrile neutropenia occurred in 1 patient (3%). The overall median time to disease progression was 8.1 months (95% CI, 6-10 months) and the overall survival period was 19 months (95% CI, 13-26 months). CONCLUSIONS: The combination of estramustine, docetaxel, and carboplatin with G-CSF support was found to have significant clinical activity with an acceptable toxicity profile in patients with progressive hormone-refractory prostate carcinoma.

Aged↗
PubMed2003

Racial differences in mortality among Medicare recipients after treatment for localized prostate cancer.

BACKGROUND: Prostate cancer mortality is higher among black American men than among white American men. We investigated whether racial disparities in outcomes of clinically localized prostate cancer vary by treatment (surgery, radiation therapy, or nonaggressive treatment). METHODS: Merged Surveillance, Epidemiology, and End Results Program (SEER) and Medicare files provided data (on treatment modality, age, race, cancer stage, tumor grade, census tract socioeconomic status, and date of death) on 5747 black and 38 242 white patients diagnosed at age 65-84 years with clinically localized prostate cancer between 1986 and 1996 in five SEER sites. Patients were followed through 1998. Racial differences in survival outcomes were assessed using Kaplan-Meier survival curves and Cox regression models. RESULTS: The median survival time for black patients was 1.7 years (95% confidence interval [CI] = 1.6 to 1.9 years) less than that for white patients. Median survival in black patients relative to white patients was 1.8 years (95% CI = 1.5 to 2.0 years) less among those who had surgery, 0.7 years (95% CI = 0.5 to 1.0 years) less among those who had radiation therapy, and 1.0 years (95% CI = 0.7 to 1.1 years) less among those who had nonaggressive treatment. Racial disparities were evident both in overall survival and in prostate cancer-specific survival, before and after statistical adjustment for covariates. CONCLUSIONS: Black patients' poorer overall survival from localized prostate cancer varies by initial treatment, with the survival gap being largest among patients undergoing surgery. Investigating these treatment-specific differences may clarify the mechanisms underlying worse outcomes for black patients in the health care system.

Aged↗
PubMed2003

Management of the clinically inapparent adrenal mass ("incidentaloma").

The National Institutes of Health Consensus Development Program convened surgeons, endocrinologists, pathologists, biostatisticians, radiologists, oncologists, and other health care professionals, as well as members of the general public, to address the causes, prevalence, and natural history of clinically inapparent adrenal masses, or "incidentalomas"; the appropriate evaluation and treatment of such masses; and directions for future research. Improvements in abdominal imaging techniques have increased detection of adrenal incidentalomas, and because the prevalence of these masses increases with age, appropriate management of adrenal tumors will be a growing challenge in our aging society. To address six predetermined questions, the 12-member nonfederal, nonadvocate state-of-the-science panel heard presentations from 21 experts in adrenal incidentalomas and consulted a systematic review of medical literature on the topic provided by the Agency for Healthcare Research and Quality and an extensive bibliography developed by the National Library of Medicine. The panel recommended a 1-mg dexamethasone suppression test and measurement of plasma-free metanephrines for all patients with an adrenal incidentaloma; additional measurement of serum potassium and plasma aldosterone concentration-plasma renin activity ratio for patients with hypertension; and surgery for patients with biochemical evidence of pheochromocytoma, patients with tumors greater than 6 cm, and patients with tumors greater than 4 cm who also meet other criteria. The panel also advocated a multidisciplinary approach to managing adrenal incidentalomas. The statement is an independent report of the panel and is not a policy statement of the National Institutes of Health or the federal government.

Adrenal Gland Neoplasms↗
PubMed2003

Renal cell carcinoma.

Renal cell carcinoma (RCC) continues to present a diagnostic and therapeutic challenge. The increased use of abdominal imaging studies does not appear to completely account for the rising incidence of RCC. Alcohol consumption has been found to be a possible protective factor among women in a recent study, but among women with children, RCC risk may increase with each child born when compared with nulliparous women. An alternative staging system shows promise, and two randomized clinical trials clarify the role of removing the primary tumor in the setting of metastatic RCC. New agents have shown promise in early clinical trials such as CCI-779, pegylated interferon, thalidomide, and anti-VEGF antibody.

Adult↗
PubMed2003

Barriers and strategies for sustained participation of African-American men in cohort studies.

BACKGROUND: Prostate cancer incidence is about 70% higher among African Americans compared to Whites. Factors associated with this differential remain unclear, although several studies suggest that genetic factors may play a role. Before epidemiologic research can adequately identify factors associated with this differential, we need studies to determine the feasibility of recruiting and retaining African-American men in cohort studies, especially those that collect biological and questionnaire data. METHODS: We conducted 4 focus group discussions among African-American men aged 40 to 64 years in North Carolina, and an additional group comprised of their partners, using a semi-structured interview protocol (total N=55 subjects). Data were analyzed with QRS NU*DIST to identify themes. RESULTS: Participants' willingness to participate in cohort studies seemed to be motivated by a perceived risk of prostate cancer. Barriers to participation included mistrust of the research community, poor knowledge of cancer-site specific heterogeneity, anticipated time commitment, and the invasive nature of disease detection procedures. To foster trust and increase disease knowledge, recommended strategies included: partnering with known civic organizations that provide education on risk factors; discussing early signs and symptoms at the point of recruitment; recruiting participants from community clusters; and providing periodic feedback on biologic samples (if collected) to reassure participants of their proper usage. CONCLUSION: Observational cohort studies focused on African-American men are feasible if certain barriers to participation are addressed.

Adult↗
PubMedDate not supplied

The challenges of eliminating racial and ethnic health disparities: inescapable realities? Perplexing science? Ineffective policy?

Despite the accomplishments of American medical science and the impressive array of healthcare facilities and service delivery models available in this country, the existence of significant health disparities is a matter of urgent national and state health policy priority. Policies to address these issues should address fundamental problems having to do with access to care (such as health insurance coverage and the availability and the geographic and culturally-appropriate accessibility of personal health services), the educational preparation of healthcare professionals for the challenge of caring for the increasing diversity of patients in a truly "patient-centered" healthcare system of the future, efforts to deal with widespread problems of health literacy that reduce the likely impact and effectiveness of healthcare, and a more aggressive effort to assure that future medial science continues to include minorities and women (and they continue to participate) as subjects in clinical trials of innovative therapeutic interventions. The policy agenda to address these issues is both broad and demanding, as would be expected of any set of problems which is so widespread and complex. But, America is no stranger to challenges, and few are more worthy of the effort than this.

Ethnicity↗