The influence of mistrust, racism, religious participation, and access to care on patient satisfaction for African American men: the North Carolina-Louisiana Prostate Cancer Project.

OBJECTIVE: The purpose of this study was to explore whether a particular combination of individual characteristics influences patient satisfaction with the health care system among a sample of African American men in North Carolina with prostate cancer. Patient satisfaction may be relevant for improving African American men's use of regular care, thus improving the early detection of prostate cancer and attenuating racial disparities in prostate cancer outcomes. METHODS: This descriptive correlation study examined relationships of individual characteristics that influence patient satisfaction using data from 505 African American men from North Carolina, who prospectively enrolled in the North Carolina-Louisiana Prostate Cancer Project from September 2004 to November 2007. Analyses consisted of univariate statistics, bivariate analysis, and multiple regression analysis. RESULTS: The variables selected for the final model were: participation in religious activities, mistrust, racism, and perceived access to care. In this study, both cultural variables, mistrust (p=<.0001, F=95.58) and racism (p=<.002, F=5.59), were significantly negatively associated with patient satisfaction and accounted for the majority of the variability represented by individual characteristics. CONCLUSION: Mistrust and racism are cultural factors that are extremely important and have been negatively associated with patient satisfaction and decreased desires to utilize health care services for African American men. To overcome barriers in seeking health care services, health care providers need to implement a patient-centered approach by creating a clinical environment that demonstrates cultural competence and eliminating policies, procedures, processes, or personnel that foster mistrust and racism.

Guideline-discordant androgen deprivation therapy in localized prostate cancer: patterns of use in the medicare population and cost implications.

Background Androgen deprivation therapy (ADT) in localized prostate cancer improves overall survival and is recommended by National Comprehensive Cancer Network guidelines in certain situations. However, ADT is without benefit in other situations and can actually cause harm. This study examines recent trends in the ADT use and quantifies the cost of guideline-discordant ADT. Patients and methods Patients, aged 66-80 years, in the Surveillance Epidemiology and End Results-Medicare database with non-metastatic prostate cancer diagnosed between 2004 and 2007 were included for analysis. Prostate-specific antigen, Gleason score, and stage were used to define D'Amico risk categories. Logistic regression was used to examine factors associated with guideline-discordant ADT. Annual direct cost was estimated using 2011 Medicare reimbursement for ADT. Results Of 28 654 men included, 12.4% received guideline-discordant ADT. In low-risk patients, 14.9% received discordant ADT, mostly due to simultaneous ADT with radiation. Discordant use was seen in 7.3% of intermediate and 14.9% of high-risk patients, mostly from ADT as primary therapy. The odds of receiving guideline-discordant ADT decreased over time (2007 versus 2004; OR 0.69; 95% CI 0.62-0.76). The estimated annual direct cost from discordant ADT is $42 000 000. Conclusion Approximately one in eight patients received ADT discordant with published guidelines. Elimination of discordant use would result in substantial savings.

Patient Satisfaction Influenced by interpersonal treatment and communication for African American men: the North Carolina-Louisiana Prostate Cancer Project (PCaP).

The purpose of this study was to determine if a particular set of health behaviors of health care providers and African American men (AAM) influence patient satisfaction from the AAM's perspective. This descriptive, correlational study consisted of 505 AAM in North Carolina diagnosed with prostate cancer and enrolled in the North Carolina-Louisiana Prostate Cancer Project (PCaP). Analyses consisted of bivariate analyses and multiple regression. Patient-to-provider communication, interpersonal treatment, and provider-to-patient communication accounted for 45% (p ≤ .0001) of the variability in patient satisfaction. Interpersonal treatment (provider focusing on the patient) explained the greatest amount (F = 313.53, R² = .39) of patient satisfaction. Since interpersonal treatment focuses on the patient and demonstrated to be the strongest predictor in patient satisfaction, it is noteworthy to consider the emphasis that should be placed on patient-centered care. In addition, knowing important variables positively affecting patient satisfaction provides useful information for developing appropriate interventions to improve AAM health care experiences.

Opportunities for improving the quality of hypertension care in a managed care setting.

Hypertension management practices and patient health outcomes in a managed care setting were evaluated. Health-system pharmacists analyzed plan medical and pharmacy claims data for September 1, 1998, to August 31, 1999, to identify hypertensive enrollees (n = 23,316). Reviews of pharmacy claims and medical charts of a sample of hypertensive patients (n = 374) determined blood pressure control status, prevalence of cardiovascular risk factors, and comorbidities. The majority of patients treated for hypertension (66%) did not achieve blood pressure control. Analysis revealed a high prevalence of cardiovascular risk factors among hypertensive patients, with 92.2% of study patients having two or more risk factors. Reviews of 132,512 pharmacy claims revealed that one half of all prescribed therapies were for monotherapy, and 21% of hypertensive patients were prescribed combination therapy with two different agents. Data from a large managed care organization revealed that more than half of all hypertensive patients had inadequate blood pressure control. A quality improvement program for hypertension care that can improve patient health outcomes must educate patients and health care providers about the implications of the disease, identify patients with compelling comorbidities, evaluate pharmacologic regimens, and recommend therapeutic changes when necessary.

Retrospective classification of prostate-specific antigen tests: differentiating screening from diagnostic clinical encounters.

To assess the validity of retrospective medical chart review as a method of classifying prostate-specific antigen (PSA) tests as screening or diagnostic services, we reviewed PSA tests ordered at a university hospital (n = 95). PSA tests were reviewed by four raters: medicine resident (RES), oncologist (ONC), urologist (UR), medicine attending (GM)-and the physician who ordered the PSA test (ATTEND) using predefined standardized criteria. Agreement rates by individual rater and ATTEND were 0.79 (GM), 0.80 (ONC), 0.74 (UR), 0.83 (RES), for a composite percent agreement of 0.79. ATTEND incorrectly classified seven tests; exclusion of these tests raised agreement rates to 0.86 (GM), 0.86 (ONC), 0.80 (UR), 0.90 (RES), for a group composite percent agreement of 0.86. Of note, two raters had higher agreement rates when evaluating screening PSA tests than when evaluating diagnostic PSA tests. Standardized criteria applied to medical charts provide a valid method of retrospectively classifying PSA tests.

The impact of docetaxel, estramustine, and low dose hydrocortisone on the quality of life of men with hormone refractory prostate cancer and their partners: a feasibility study.

OBJECTIVES: The quality of life (QoL) of 44 men with HRPC and 37 partners (primary caregivers, most residing with the patient) was assessed in a multicenter Phase II trial of docetaxel, estramustine and low dose hydrocortisone (CALGB 9780). A secondary objective was to test the feasibility of assessing partners' QoL in a cooperative group setting. PATIENTS AND METHODS: Patients and partners were separately interviewed by telephone at baseline, two, four and six months by a single trained research interviewer. Patients' QoL was measured by the FACT-P, Mental Health Inventory-17 (MHI-17), Brief Pain Inventory (BPI), a two-day log of pain medications, and the OARS for co-morbid conditions. Partners' QoL was measured by the MHI-17, Caregiver Burden Interview, and co-morbid conditions. RESULTS: The QoL study refusal rates were low for patients (4%) and partners (3%). Although patients tended to experience greater treatment side effects in the first two months (FACT Physical Well-Being item, P = 0.057), their cancer-specific emotions (e.g., worrying about worsening health) significantly improved at two and four months (FACT-Emotional Well-Being, P = 0.003, P = 0.03, respectively), as did their prostate cancer-specific physical problems (e.g., urination, pain), at two and four months (FACT-P, P = 0.001, P = 0.005, respectively). Partners' anxiety significantly decreased over time (MHI, P < 0.05). Patients' quality of life at two months was significantly related to their clinical response (FACT-P total and prostate cancer-specific problems, P < 0.05), and their clinical response was significantly related to a decrease in their partners' anxiety at two months (MHI, P < 0.05). CONCLUSIONS: Despite feeling worse from side effects, patients' prostate cancer-specific problems and emotional state significantly improved in the first four months of treatment. With treatment significantly affecting both patients' and partners' lives. and the successful assessment of partners' QoL, QoL of both patients and partners could be used as important endpoints in selected clinical trials.

Phase II study of docetaxel, estramustine, and low-dose hydrocortisone in men with hormone-refractory prostate cancer: a final report of CALGB 9780. Cancer and Leukemia Group B.

PURPOSE: To investigate the combination of docetaxel, estramustine (EM), and low-dose hydrocortisone in men with hormone-refractory prostate cancer (HRPC). PATIENTS AND METHODS: Combinations of EM with other antimitotic agents such as docetaxel are synergistic in vitro and show significant clinical activity in patients with HRPC. We studied intravenous administration of docetaxel 70 mg/m(2), oral estramustine, and low-dose daily hydrocortisone in men with HRPC who demonstrated progression after initial hormone therapy. RESULTS: Of the 47 men enrolled onto this multicenter cooperative group study, 46 were assessable for response and/or toxicity. In the 24 patients with measurable disease, there were three complete and nine partial responses for a measurable disease response rate of 50% (12 of 24 patients; 95% confidence interval [CI], 27% to 73%). In the 44 patients in whom pretreatment prostate-specific antigen (PSA) was elevated, 30 (68%) had a 50% or greater decrease, and 25 (57%) had a 75% or greater decrease in PSA. The combined measurable disease and biochemical response rate in all 46 assessable patients was 54% (three complete responses, 22 partial responses, 95% CI, 37% to 71%). The predominant toxicity was neutropenia, with 26% of patients having grade 3 and 30% having grade 4 granulocytopenia; there were no episodes of febrile neutropenia. Other common but mild adverse effects included malaise/fatigue, peripheral edema, and hyperglycemia. The incidence of thromboembolic events during therapy was 9%. With a median follow-up of 17 months, the median survival was 20 months. The median time to disease progression was 8 months for all patients, and 10 months for those with measurable disease. CONCLUSION: This therapy is efficacious and moderately well tolerated in HRPC and should be compared in a phase III trial with mitoxantrone and prednisone.

Renal cell carcinoma.

Several renal cell carcinoma (RCC) prognostic factors show promise, including K1-67, p53/mdm-2, and vascular endothelial growth factor. The combination of increased incidence of RCC and diagnosis during earlier stages has generated interest in local therapeutic options. Nephron-sparing surgery and laparoscopic nephrectomy continue to gain support and may become the standard of care in select patients. Standard therapy for metastatic disease continues to be cytokine-based therapy with little benefit gained from adding granulocyte-macrophage-colony-stimulating factor, retinoic acid, or adoptive immunotherapy. The addition of chemotherapy, such as capecitabine, floxuridine, and vinblastine, may increase the effectiveness of immunotherapy; nonmyeloablative stem cell transplantation has shown early promise in metastatic disease.

Using north carolina medicare data to assess excess prostate cancer mortality among african americans.

PURPOSE: To investigate the basis for the higher prostate cancer mortality rate for African American (AA) men, which is twice the rate for White men.METHODS: 221 AA and 979 White men with a primary diagnosis code of prostate cancer ("patients") in the North Carolina Medicare Hospitalization claims from 1997 were compared with 1,326 AA and 5,874 White men of the same age with no cancer hospitalizations ("beneficiaries") selected from the NC Medicare Enrollment files. Mortality rates were calculated as the cumulative percent of deaths using the hospital discharge date as day 1. AA and White age distributions were similar.RESULTS: Cumulative mortality percentages at 6, 12, and 18 months were, respectively, 4.5, 7.7, 10.9 for AA patients; 2.8, 6.5, 9.2 for White patients; 2.3, 3.8, 7.4 for AA beneficiaries; and 1.8, 3.1, 6.1 for White beneficiaries.CONCLUSIONS: AA prostate cancer patients had higher overall mortality than did White prostate cancer patients during the first year, but by 12-months the White-Black survival advantage for prostate cancer patients was similar in magnitude to the White-Black survival advantage among the non-cancer Medicare beneficiaries. AAs' higher prostate cancer mortality may derive from higher short-term case fatality rates, which may reflect differences in treatment and access to quality medical care, co-morbidities, and tumor characteristics such as stage and grade at diagnosis, and in part from the survival disadvantage for AA in the general population.

Renal cell carcinoma.

The overall incidence of renal cell carcinoma is rising, for reasons not fully explained by increased abdominal imaging. Risk factors associated with renal cell carcinoma include hypertension, smoking, increased body mass index, and diet. There is an inverse association of renal cell carcinoma risk with consumption of a variety of carotenes. In addition, increased red meat intake has been associated with increased risk. Partial nephrectomy may be as effective as radical nephrectomy as treatment for localized disease, and radiosurgery may be as effective as surgical resection in the management of brain metastases. Immunotherapy remains the mainstay for systemic treatment, with response rates between 5% and 20%. Survival in renal cell carcinoma is related to pathologic stage, nuclear grade, microscopic vascular invasion, DNA content, nuclear morphometry, and histologic pattern. In addition, patients with deletion (8p)/-8, +12, and +20 appear to have a worse prognosis.

Prostate cancer screening: promise and peril--a review.

This review summarizes the current status of and recommendations for prostate cancer screening with prostate-specific antigen in light of recent reductions in prostate cancer incidence and mortality. It describes how the uncertain effectiveness of aggressive treatment for prostate cancer and a reservoir of unsuspected indolent cancers make prostate cancer fit poorly into conventional screening models. The large proportion of men with unsuspected prostate cancers that may not cause morbidity or mortality and are unlikely to benefit from aggressive treatment decrease the effectiveness of a screening program. In addition, indolent, unsuspected prostate cancers in the screening population accentuate the detrimental effects of length bias on studies evaluating the effectiveness of prostate cancer screening. Screening tests for prostate cancer will continue to improve, but chemoprevention or nutritional prevention with vitamins and micronutrients such as tocopherols or selenium may prove to be effective methods of reducing prostate cancer incidence and should be aggressively investigated.

Renal cell carcinoma.

In addition to the known risk factors for renal cell carcinoma, hypertension, obesity, and tobacco use, a diet high in consumption of fried or sautéed meat and the frequent consumption of poultry may increase the risk for renal cell carcinoma. A diet high in consumption of fruits and vegetables appears to have a protective effect. Molecular markers, in particular markers of cell proliferation, may have prognostic value and be of assistance in identifying patients who would benefit from more aggressive therapy. Surgery continues to the mainstay of treatment of localized disease, and may be the optimal treatment for patients with isolated solitary metastatic disease. Response rates to systemic therapy with cytokines vary from 5% to 20% with significant adverse effects.

Adjusted odds ratios under nondifferential misclassification: application to prostate cancer.

The high prevalence of unsuspected prostate cancer among middle-aged and elderly men is unique among cancers. With their uncertain natural history, unsuspected prostate cancer cases may be misclassified into control groups in which they can obscure the identification of prostate cancer risk factors in case-control studies. Assuming that the exposure experience of diagnosed and of unsuspected prostate cancers is the same (nondifferential misclassification), case-control odds ratios are biased toward the null, which may provide a rationale for reexamining findings in negative case-control studies of prostate cancer. This article reviews the evidence supporting a high prevalence of prostate cancer and describes formulae that can be used to adjust for misclassification bias in completed case-control studies and to estimate required sample sizes in proposed studies.

Renal cell carcinoma.

Renal cell carcinoma (RCC) continues to be a frustrating tumor for clinicians to manage and treat. Progress has been made in the identification of risk factors, particularly dietary risk factors. An increased risk has been seen with frequent consumption of fried meat and poultry. Citrus fruits, vitamin C, beta-carotene, and alpha-tocopherol have demonstrated a protective effect against RCC. Other factors that have been associated with the risk of RCC are smoking (which doubles the risk), obesity, hypertension, and exposure to asbestos and petroleum products. Response rates for systemic treatment of RCC continue to hover at about 20%; however, some nonchemotherapy treatments may provide palliation with few side effects. In addition, lower dose combinations of interleukin-2 and interferon alfa may be as beneficial as higher dose regimens, but with less toxicity. Molecular prognostic factors, including proliferation markers, karyometric analyses, oncogenes, and cell adhesion molecules and proteases are areas of intense investigation and may provide mechanisms for identifying patients who require more (or less) aggressive treatment.

Biomarkers of essential fatty acid consumption and risk of prostatic carcinoma.

Animal studies have suggested that omega-6 fatty acids found in vegetable oils may promote prostate cancer. Our goal was to use erythrocyte membrane and adipose tissue fatty acid composition as biomarkers to investigate whether essential fatty acids modulated prostate cancer risk. An outpatient clinic-based study of 89 cases and 38 controls was conducted in North Carolina between July 1989 and December 1991. Cases were recruited from a university-based urology outpatient clinic. Eligible cases were more than 45 years of age and had histological confirmation of a prostate cancer diagnosis within 1 year of entry into the study. Controls were histologically confirmed free of prostate cancer. Erythrocyte membranes from venous blood and adipose tissue fatty acids from s.c. fat samples were analyzed in batches using capillary gas chromatography. Unconditional logistic regression analysis was used to calculate odds ratios for the association of each fatty acid with prostate cancer while controlling for potential confounders. Linoleic acid consumption was positively associated with prostate cancer risk. The odds ratios comparing the first and fourth quartiles of linoleic acid consumption were 3.54 (95% confidence interval, 1.0-12.53) with P trend < 0.04 for erythrocyte membranes, and 2.47 (95% confidence interval, 0.66-9.26) with P trend < 0.08 for adipose tissue. These data suggest that linoleic acid consumption may increase prostate cancer risk, which is consistent with results from animal experiments. Linoleic acid is found in vegetable oils used in cooking and in cereals, snack foods, and baked goods. Our data failed to demonstrate consistently a protective effect of marine omega-3 fatty acids on prostate cancer.

Correlation between biomarkers of omega-3 fatty acid consumption and questionnaire data in African American and Caucasian United States males with and without prostatic carcinoma.

Results from animal studies suggest that omega-3 fatty acids from marine sources are protective against cancer. To determine whether adipose tissue and erythrocyte membrane fatty acid composition could serve as biomarkers of essential fatty acid consumption in subjects with prostate cancer, we compared fish consumption, which was estimated using a food frequency survey, to the omega-3 fatty acid content of adipose tissue and erythrocyte membranes. The study was conducted using 127 men who had undergone a prostate biopsy. All subjects were recruited from a university hospital urology clinic. African Americans comprised 23% of the subjects, and 70% were diagnosed with prostate cancer. We found a correlation of 0.44 with 95% confidence intervals (CIs) = 0.29-0.57 between reported fish consumption and the omega-3 fatty acid eicosapentaenoic acid composition in erythrocyte membranes and 0.38 with 95% CI = 0.21-0.53 when the dietary survey was compared to eicosapentaenoic acid in adipose tissue. The survey/biomarker correlations in cases were not significantly different from the correlations in controls. The study had 90% power to detect a 0.35 difference between correlations. These results suggest that the presence of prostate cancer does not affect the adipose tissue or erythrocyte membrane biomarkers of fatty acid consumption, and that erythrocyte membranes are as useful as biomarkers as is adipose tissue. Our findings corroborate previous studies that found that tissue biomarkers can reflect past fatty acid consumption and support the use of biomarkers in case-control studies using cancer patients.

Essential fatty acid consumption and risk of breast cancer.

Animal and ecological studies of essential fatty acids suggest that omega-3 fatty acids found in fish oils and omega-6 fatty acids found in vegetable oils may be playing a role in the etiology of breast cancer. Essential fatty acids may modulate breast cancer risk by interacting with prostaglandins, which have immunosuppressive and platelet aggregative capabilities. The fatty acid composition of adipose tissue reflects the dietary consumption of essential fatty acids over a period of years. Biochemical techniques have been used in epidemiological studies to accurately estimate fatty acid consumption. However, analytical epidemiology studies that have used biochemical measurements of adipose tissue fatty acid composition, have not supported a relationship between consumption of these essential fatty acids and breast cancer risk.

Adequacy of recommended aminophylline loading doses in children.

The adequacy of a loading dose of aminophylline 6 mg/kg i.v. in hospitalized pediatric patients with reactive airway disease was studied. Children six months to 14 years of age were studied to determine their serum theophylline concentrations after they were given an aminophylline loading dose of 5-7 mg/kg i.v. and to see whether they had to receive additional bolus doses. Bolus doses were infused over 20-30 minutes and were followed by a continuous infusion. Additional bolus doses were administered if the patient's serum theophylline concentration and clinical condition indicated they were necessary. Data from two separate phases of the study were combined for analysis. Phase 1 was designed for estimating population pharmacokinetic values. Some 72% of the 64 patients studied had subtherapeutic serum theophylline concentrations (< 10 mg/L) within 5.5 hours of the loading dose, and 78% required at least one additional bolus dose. Males had significantly lower serum theophylline concentrations than females; of the patients with subtherapeutic concentrations, 67% were males. Patients five years of age or younger were more likely than older children to have subtherapeutic theophylline concentrations. A 6-mg/kg loading dose of i.v. aminophylline did not produce adequate serum theophylline concentrations or eliminate the need for a second bolus dose in most pediatric patients with acute exacerbations of asthma.