Patient-reported outcomes before treatment for localized prostate cancer: are there differences among countries? Data from the True North Global Registry.

INTRODUCTION: Similar Patient-Reported Outcomes (PROs) at diagnosis for localized prostate cancer among countries may indicate that different treatments are recommended to the same profile of patients, regardless the context characteristics (health systems, medical schools, culture, preferences…). The aim of this study was to assess such comparison. METHODS: We analyzed the EPIC-26 results before the primary treatment of men diagnosed of localized prostate cancer from January 2017 onwards (revised data available up to September 2019), from a multicenter prospective international cohort including seven regions: Australia/New Zealand, Canada, Central Europe (Austria / Czech Republic / Germany), United Kingdom, Italy, Spain, and the United States. The EPIC-26 domain scores and pattern of three selected items were compared across regions (with Central Europe as reference). All comparisons were made stratifying by treatment: radical prostatectomy, external radiotherapy, brachytherapy, and active surveillance. RESULTS: The sample included a total of 13,483 men with clinically localized or locally advanced prostate cancer. PROs showed different domain patterns before treatment across countries. The sexual domain was the most impaired, and the one with the highest dispersion within countries and with the greatest medians' differences across countries. The urinary incontinence domain, together with the bowel and hormonal domains, presented the highest scores (better outcomes) for all treatment groups, and homogeneity across regions. CONCLUSIONS: Patients with localized or locally advanced prostate cancer undergoing radical prostatectomy, EBRT, brachytherapy, or active surveillance presented mainly negligible or small differences in the EPIC-26 domains before treatment across countries. The results on urinary incontinence or bowel domains, in which almost all patients presented the best possible score, may downplay the baseline data role for evaluating treatments' effects. However, the heterogeneity within countries and the magnitude of the differences found across countries in other domains, especially sexual, support the need of implementing the PRO measurement from diagnosis.

Identification of an endogenous inhibitor of prostatic carcinoma cell growth.

The rate of expansion of primary prostatic carcinoma is comparatively slow, with tumours frequently taking years or decades to reach clinically relevant size. We now report the presence of an endogenous inhibitor, derived from aqueous extracts of human prostate tissue, which blocks prostatic carcinoma cell proliferation in vitro and prevents subcutaneous tumour expansion in vivo. Purification and characterization revealed the inhibitor to be spermine, a polyamine known to be locally abundant in the prostate. These results suggest that endogenous polyamine can negatively regulate the growth of prostatic carcinoma cells at their primary site in vivo and may explain the slow rate of primary tumour expansion in the prostate.

Disparities in the utilization of live donor renal transplantation.

Despite universal payer coverage with Medicare, sociodemographic disparities confound the care of patients with renal failure. We sought to determine whether adults who realize access to kidney transplantation suffer inequities in the utilization of live donor renal transplantation (LDRT). We identified adults undergoing primary renal transplantation in 2004-2006 from the United Network for Organ Sharing (UNOS). We modeled receipt of live versus deceased donor renal transplant on multilevel multivariate models that examined recipient, center and UNOS region-specific covariates. Among 41 090 adult recipients identified, 39% underwent LDRT. On multivariate analysis, older recipients (OR 0.62, 95% CI 0.56-0.68 for 50-59 year-olds vs. 18-39 year-old recipients), those of African American ethnicity (OR 0.54, 95% CI 0.50-0.59 vs. whites) and of lower socioeconomic status (OR 0.72, 95% CI 0.67-0.79 for high school-educated vs. college-educated recipients; OR 0.78, 95% CI 0.71-0.87 for lowest vs. highest income quartile) had lower odds of LDRT. These characteristics accounted for 14.2% of the variation in LDRT, more than recipient clinical variables, transplant center characteristics and UNOS region level variation. We identified significant racial and socioeconomic disparities in the utilization of LDRT. Educational initiatives and dissemination of processes that enable increased utilization of LDRT may address these disparities.

Delayed hypersensitivity to 5-fluorouracil following topical chemotherapy of cutaneous cancers.

Skin tests to various common antigens, dinitrochlorobenzene, and 5-fluorouracil (5-FU) were performed on patients being treated for cutaneous neoplasms with topical 5-FU cream. Eleven of 15 patients tested both before and after therapy converted from skin test negative to positive with respect to 5-FU. This conversion correlated with positive dinitrochlorobenzene skin tests and therapeutic cure. The relation between the induction of delayed hypersensitivity reactions to 5-FU following treatment with topical 5-FU and the cure rate for cutaneous neoplasms showed a trend toward correlation.

Accuracy of recall in health-related quality-of-life assessment among men treated for prostate cancer.

PURPOSE: To determine the accuracy of patient recall of health-related quality of life (HRQOL) in men who have undergone radical prostatectomy for early-stage prostate cancer. PATIENTS AND METHODS: Patients enrolled onto a longitudinal, observational cohort study of HRQOL after radical prostatectomy for early-stage prostate cancer were asked to assess their baseline HRQOL before surgery. They were later asked to recall their baseline HRQOL at intervals of 7 to 37 months after surgery. The two views of baseline HRQOL (actual and recall) were compared. HRQOL was measured with established instruments (the RAND 12-Item Short-Form Health Survey and a validated short form of the University of California Los Angeles Prostate Cancer Index) that addressed impairment in the physical, mental, urinary, bowel, and sexual domains. RESULTS: Overall, recall was poor. Patients tended to remember their baseline HRQOL as being better than it actually was. This effect was particularly striking for urinary and sexual function. Greater education and younger age diminished this effect in some domains. The effect did not vary with time since surgery. CONCLUSION: Men undergoing radical prostatectomy for early-stage prostate cancer do not accurately recall their pretreatment HRQOL when asked several months or years later. This recall bias is constant throughout a period of 6 months to 3 years after surgery. By collecting data before treatment and observing subjects longitudinally, investigators can ensure that HRQOL changes are analyzed in the context of any impairment that may have been present at baseline. If a longitudinal study is not feasible, then great caution must be used if patients are asked to recall their pretreatment HRQOL.

Impact of diet on prostate cancer: a review.

Epidemiological studies suggest that environmental factors may mediate the transformation of latent prostate cancer into clinically apparent tumors and that diet appears to influence this progression. Close correlations between average per capita fat intake and prostate cancer mortality internationally generated interest in underlying mechanisms for this link, such as through serum levels of androgens, free radicals, proinflammatory fatty acid metabolites, or insulin-like growth factor. Much interest currently lies in the potential of HMG-CoA reductase inhibitors (statins) to play a chemopreventative role in prostate cancer. Lycopene, a potent antioxidant found in tomatoes, may exert a protective effect in the prostate. Selenium and vitamin E have also been shown to decrease the risk of prostate cancer in some men. Calcium may support vitamin D-related antiproliferative effects in prostate cancer. Certain soy proteins, common in the Asian diet, have been shown to inhibit prostate cancer cell growth. Finally, green tea may also have a chemopreventive effect by inducing apoptosis. Despite confounding factors present in clinical studies assessing the effect of diet on cancer risk, the data remain compelling that a variety of nutrients may prevent the development and progression of prostate cancer.

Sociodemographic factors associated with postprostatectomy radiotherapy.

PURPOSE: To determine if nonclinical factors affect the use of adjuvant radiation therapy after surgical resection of the prostate gland. METHODS: Using the National Cancer Institute's Surveillance Epidemiology and End Results (SEER) public use data files, we identified men with localized/regional prostate cancer who underwent postprostatectomy radiotherapy within 4 months of surgery. We used 2000 Census information to ascribe a median education and income level to these men based on the county of residence and ethnicity. RESULTS: Of 34,763 men who underwent surgical resection, 1549 received postprostatectomy radiotherapy. Those with higher tumor grade and from certain geographic regions (Seattle and Hawaii) had significantly higher rates of radiotherapy while being older and from other geographic regions (Detroit, Utah, and New Mexico) was protective. The use of additional radiation therapy was not affected by ethnicity, income level, or educational attainment. CONCLUSIONS: We found no socioeconomic or demographic disparities in the receipt of postprostatectomy radiotherapy. Geographic variation in postprostatectomy radiotherapy may be explained by limited evidence supporting its use in clinical practice.

Racial parity in tumor burden, treatment choice and survival outcomes in men with prostate cancer in the VA healthcare system.

BACKGROUND: African-American men with prostate cancer typically have higher tumor risk at diagnosis, lower rates of surgical treatment and poorer cancer-specific survival compared with Caucasians. Receipt of care within the Veterans Affairs (VA) healthcare system may reduce barriers that influence these disparities. METHODS: We sampled 1258 men with nonmetastatic prostate cancer diagnosed at the Greater Los Angeles and Long Beach VA Medical Centers between 1998 and 2004. We compared African Americans and Caucasians with respect to tumor characteristics using ordinal logistic regression, treatment choice across substrata of tumor risk using logistic regression, and cancer-specific and other-cause mortality using competing risks regression analysis. RESULTS: Multivariate ordinal logistic regression revealed no significant differences in odds of higher tumor risk (odds ratio (OR) 1.22, 95% confidence interval (CI) 0.98-1.53, P=0.08), Gleason score (OR 0.90, 95% CI 0.7-1.16, P=0.4) or clinical stage (OR 1.04, 95% CI 0.79-1.38, P=0.8) for African Americans compared with Caucasians. African-American men had similar odds of aggressive treatment as did Caucasians for low-risk (OR 0.92, 95% CI 0.57-1.53, P=0.8), intermediate-risk (OR 0.75, 95% CI 0.44-1.26, P=0.3) and high-risk disease (OR 0.87, 95% CI 0.52-1.44, P=0.6). In competing risks regression analysis, African Americans had a lower but nonsignificant hazard of cancer-specific mortality compared with Caucasians (sub-hazard ratio 0.6, 95% CI 0.28-1.26, P=0.2) and nearly identical risk of other-cause mortality (sub-hazard ratio 0.98, 95% CI 0.78-1.22, P=0.8). CONCLUSIONS: We found no significant differences in tumor burden, treatment choice or survival outcomes between African Americans and Caucasians cared for in the equal-access VA Healthcare setting.

Nationally representative trends and geographic variation in treatment of localized prostate cancer: the Urologic Diseases in America project.

BACKGROUND: Several treatment options for clinically localized prostate cancer currently exist under the established guidelines. We aim to assess nationally representative trends in treatment over time and determine potential geographic variation using two large national claims registries. METHODS: Men with prostate cancer insured by Medicare (1998-2006) or a private insurer (Ingenix database, 2002-2006) were identified using International Classification of Diseases-9 and Current Procedural Terminology-4 codes. Geographic variation and trends in the type of treatment utilized over time were assessed. Geographic data were mapped using the GeoCommons online mapping platform. Predictors of any treatment were determined using a hierarchical generalized linear mixed model using the logit link function. RESULTS: The use of radical prostatectomy increased, 33-48%, in the privately insured i3 database while remaining stable at 12% in the Medicare population. There was a rapid uptake in the use of newer technologies over time in both the Medicare and i3 cohorts. The use of laparoscopic-assisted prostatectomy increased from 1% in 2002 to 41% in 2006 in i3 patients, whereas the incidence increased from 3% in 2002 to 35% in 2006 for Medicare patients. The use of neoadjuvant/adjuvant androgen deprivation therapy was lower in the i3 cohort and has decreased over time in both i3 and Medicare. Physician density had an impact on the type of primary treatment received in the New England region; however, this trend was not seen in the western or southern regions of the United States. CONCLUSIONS: Using two large national claims registries, we have demonstrated trends over time and substantial geographic variation in the type of primary treatment used for localized prostate cancer. Specifically, there has been a large increase in the use of newer technologies (that is, laparoscopic-assisted prostatectomy and intensity-modulated radiation therapy). These results elucidate the need for improved data collection on prostate cancer treatment outcomes to reduce unwarranted variation in care.

The association between socioeconomic status, health insurance coverage, and quality of life in men with prostate cancer.

The objective of this study was to examine the effect of socioeconomic status and insurance status on health-related quality of life (HRQOL) outcomes in men with prostate cancer. The design was a retrospective cohort study using multiple sites, including both academic and private practice settings. A cohort of 860 men with newly diagnosed, biopsy-proven prostate cancer of any stage was identified within CaPSURE, a longitudinal disease registry of prostate cancer patients. HRQOL was assessed with validated instruments, including the RAND 36-item Health Survey (SF-36) and the UCLA Prostate Cancer Index. Covariates included insurance status, education level, annual income, age, stage, comorbidity, Gleason grade, baseline PSA, marital status, ethnicity and primary treatment. HRQOL measurements were taken at 3-6-month intervals. Analysis of covariance was used to determine the effect of SES and insurance status on the HRQOL domains at baseline and over time. Patients with lower annual income had significantly lower baseline HRQOL scores in the all of the domains of the SF-36 and four of eight disease-specific HRQOL domains. No relationship was seen between annual income and HRQOL outcomes over time. Conversely, health insurance status was associated with HRQOL over time, but not at baseline. Health insurance status appears to have a unique effect on general HRQOL outcomes in men after treatment for prostate cancer. This study confirms the commonly held belief that patients of lower SES tend to have worse quality of life at baseline and following treatment for their disease. These findings have important ramifications for clinicians, researchers and policy makers.

Racial differences in the cost of treating men with early-stage prostate cancer.

OBJECTIVE: To compare the cost and resource utilization in the evaluation, treatment, and 6-month follow-up of African-American and White men undergoing either external beam radiation therapy (XRT) or radical prostatectomy (RP) for early-stage prostate cancer. DESIGN: Retrospective analysis of cost and resource utilization data from encrypted patient-specific hospital inpatient, hospital outpatient, and physician/supplier data files. SETTING: National Medicare claims data from 1993 through 1996. PARTICIPANTS: A random 5% national sample of Medicare beneficiaries from the Health Care Financing Administration Public Use Files for 1993 through 1996. MEASUREMENTS: Inpatient, outpatient, and physician/supplier Medicare costs. RESULTS: African-American men undergoing RP for early-stage prostate cancer had significantly higher costs ($21,878 vs $18,786, P < .0001) than did White men. Most of the difference occurred in the inpatient setting. African-American men undergoing XRT had significantly greater costs ($18,131 vs $15,734, P < .0001) than did White men. Most of this difference was generated by longer duration of XRT treatments. CONCLUSIONS: In early-stage prostate cancer, charges for RP and XRT in African-American men are higher when compared with those for White men.

Gunshot wounds of the abdomen. A review of 277 cases.

During a five-year period from July 1968 throuhgh June 1973, 277 abdominal gunshot wounds (GSWs) occurred, the overall fatality of which was 10%. Abdominal exploration was done in all patients. No intra-abdominal injury was found in 40 patients (14%) and no death occurred in this group. There were 28 fatalities (12%) in 237 patients (86%) who had intra-abdominal injuries. Morbidity and mortality were related not only to the number of organs injured, but also to specific organs injured. The leading cause of early death was hypovolemia due to major vessel injuries. Septicemia was the most common cause of death if the patient survived the first 24 hours of hospitalization. Penetrating abdominal stab wounds and gunshot wounds must be considered separately, and mandatory routine abdominal exploration for all penetrating gunshot wounds is advised. In stab wounds to the abdomen, conservative management may be preferable.

Increased pulmonary arteriovenous shunting in humans following blood transfusion. Relation to screen filtration pressure of transfused blood and prevention by Dacron wool (Swank) filtration.

Transfusion through standard filters to dogs of stored blood containing microaggregates results in an increase in pulmonary arteriovenous shunting (Qs/Qt) and a decreased diffusion capacity of the lung for O2. These effects are due to microemboli that pass the filters and are prevented by use of Dacron wool (Swank) micropore transfusion filters. It was the purpose of this study to determine whether alterations in pulmonary shunting occur in humans following transfusions of stored blood through standard transfusion filters. In eight patients transfused over 20% of blood volumes through standard filters, Qs/Qt and alveolar-arterial O2 tension differences increased significantly. These changes did not occur in patients transfused comparable amounts of blood through Dacron wool (Swank) filters or in patients transfused less than 20% of blood volumes. A direct correlation was found between the absolute percent change in Qs/Qt and the quantity of microaggregates passing the filter and present in the transfused blood. It is concluded that removal from stored blood of microaggregates by administration of the blood through effective micropore transfusion filters prevents an increase in Qs/Qt caused by administration of such material.

Filtration characteristics of polyester mesh (Pall) micropore blood transfusion filter.

Stored human blood of varying age was passed through polyester mesh (Pall) micropore blood transfusion (pore size, 40 mu). Passage through the filter resulted in decreased screen filtration pressure (SFP) of the blood and increased filter weight. Mumerous microaggregates were removed, but SFP did not return to normal after filtration. On the basis of this research, we conclude that polyester mesh micropore blood transfusion filters are not as effective as Dacron wool (Swank) transfusion filters in removal of micro-aggregates from stored human blood. If a polyester mesh filter must be used, it is recommended that once occlusion of the filter has occurred, the filter should then be discarded and another inserted.

Polyurethane foam (Bentley) micropore blood transfusion filter: filtration characteristics.

Stored human blood of varying age was passed through polyurethane foam (Bentley) micropore blood transfusion filters. Passage through these filters resulted in decreased screen filtration pressure (SFP) of the blood and increased filter weights. Numerous microaggregates were removed and SFP returned to normal after filtration. Occlusion of the filter occurred after passage of only 2 units of whole blood. On the basis of this research, we conclude that polyurethane foam (Bentley) micropore blood transfusion filters are effective in removal of microaggregates from stored human blood. Because the filtering capacity is not great, it is recommended that when these filters are used during transfusion a new filter be used for each unit of blood administered.

Patient satisfaction with short stays for radical prostatectomy.

OBJECTIVES: We evaluated the effects on patient satisfaction of shortened postoperative hospital stays after radical retropubic prostatectomy (RRP). METHODS: A previously validated, self-administered instrument was used to assess satisfaction with care in a retrospective, cross-sectional study of 129 men who had undergone RRP after implementation of a short-stay clinical care pathway. Health-related quality of life outcomes, comorbidity, and sociodemographic data were also measured with established instruments. RESULTS: Satisfaction with care was uniformly high and did not vary with length of stay (LOS), time since surgery, or health-related quality of life. CONCLUSIONS: Decreased LOS mandated by the need for a cost-efficiency path does not adversely affect patient satisfaction.

The CaPSURE database: a methodology for clinical practice and research in prostate cancer. CaPSURE Research Panel. Cancer of the Prostate Strategic Urologic Research Endeavor.

OBJECTIVES: Implicit in the modern concept of patient outcome assessment is a shift from primary reliance on clinical indicators to a broader definition that includes physical, psychological, and social well-being. This is especially true of prostate cancer, where treatment can profoundly alter patient well-being. We have initiated a longitudinal observational database, CaPSURE (Cancer of the Prostate Strategic Urologic Research Endeavor) to document the impact of prostate cancer on resource utilization, clinical outcomes, health-related quality of life and survival in typical practice settings. METHODS: Observational databases have been used in the treatment of other conditions. We have incorporated many well-tested elements in our study. Data are collected from two sources: the physician and the patient. The urologist enrolls eligible patients into the study, completes a medical history, and records current status, treatment, and laboratory results at each office visit. Patients complete quarterly questionnaires on health-related quality of life, resource utilization, work loss, and satisfaction with care. RESULTS: Currently 21 sites participate in CaPSURE with 1419 patients enrolled by April 1996. Twenty percent of patients are newly diagnosed with prostate cancer. Time since diagnosis averages 3.0 years (SD = 3.1); mean age at diagnosis is 68.9 years (SD = 7.9, range = 39.6 to 90.7). The majority of patients (72%) are diagnosed with Stage B cancer. Patients receive a variety of treatments including surgery, irradiation, hormonal therapy, and watchful waiting. CONCLUSIONS: Information available from CaPSURE will assist practicing urologists who must make clinical decisions on the basis of data such as the results of treatment in typical care settings, the effect of prostate cancer and its treatment methods on patient quality of life, and the effect on health care costs of the early detection of prostate cancer.

Changes in health-related quality of life in the first year after treatment for prostate cancer: results from CaPSURE.

OBJECTIVES: Treatment for prostate cancer has a significant impact on health-related quality of life (HRQOL). We examined HRQOL immediately after diagnosis and treatment and 1 and 2 years after treatment for a cohort of men with early and late-stage prostate cancer. METHODS: We studied 692 men enrolled in CaPSURE, a large national observational data base of patients with prostate cancer. General and disease-specific HRQOL were measured with validated instruments at study entry and quarterly thereafter. Individuals were grouped by initial treatment: radical prostatectomy, radiotherapy, hormonal therapy, and observation (ie, no treatment in first year). Trends in HRQOL scores were evaluated immediately after treatment through 2 years, adjusting for age and length of follow-up. RESULTS: Patients who underwent radical prostatectomy demonstrated statistically significant increases in functioning in general and in disease-specific components during the year after treatment when compared with scores immediately after treatment. Patients receiving radiotherapy and hormonal therapy had significant improvements in patient reports of health change during the year. CONCLUSIONS: Patients undergoing radical prostatectomy have low HRQOL scores just after treatment in almost all general and disease-specific areas, but at 1 year there is a sharp improvement. Patients undergoing observation, radiotherapy, or hormonal therapy remain stable over time. All treatment groups continue to have decrements in sexual function.

Academic medicine and managed care: seeking common ground.

The authors report the highlights of a one-day symposium, "Academic Medicine and Managed Care: Seeking Common Ground," sponsored in early 1997 by Tulane University Medical Center. The meeting was held to foster better understanding of the gap between managed care organizations (MCOs) and academic health centers (AHCs) and to define their common ground. There were 62 participants, mainly executives froin AHCs and MCOs, plus government officials and policy researchers interested in the interface of academic medicine and managed care. The participants agreed that there are indeed some common areas in which the two types of organizations can develop programs and interests that serve the missions of both. These include (1) a commitment to high-quality health care, objectively measured by outcomes; (2) issues of "customer service"; (3) certain areas of research (e.g., examining outcomes of medical interventions; measuring cost and cost-effectiveness; measuring quality of care); and (4) preventive medicine, an area in which both AHCs and MCOs are still relatively weak. On the other hand, large elements of AHCs' basic missions of education and research are not seen by MCOs as areas for developing a common agenda. Participants agreed that AHCs must do their best to improve and demonstrate the quality of their care, address the challenges of the market (i.e., take "customer service" seriously), address the issue of how many specialists and how many generalists should be trained, and define the cost of each of their missions. On the other hand, managed care must acknowledge that the missions of AHCs greatly benefit patients and society. Participants agreed that all approaches to AHC-MCO interfaces must be flexible and local, that common ground does exist, and that understanding can grow between these two kinds of organizations if acrimonious exchanges are avoided and serious efforts are made to work together for solutions.

An instrument to measure patient satisfaction with healthcare in an observational database: results of a validation study using data from CaPSURE.

OBJECTIVE: To validate a satisfaction measure for use in longitudinal, prospective studies of patient care. STUDY DESIGN: Patients with biopsy-confirmed prostate cancer (n = 228) who were enrolled in CaPSURE (Cancer of the Prostate Strategic Urologic Research Endeavor) completed a self-administered questionnaire that included a health-related quality-of-life and satisfaction measure. A subset of patients completed the questionnaire again within 30 days. METHODS: The satisfaction measure contained 6 individual subscales: overall satisfaction with care, contact with providers, confidence in providers, communication skills, humaneness, and a summary scale. Six items surveyed patients' willingness to participate in decision making (participatory style), and these were averaged into a single score. Variability, reliability, stability, and validity were evaluated. RESULTS: Responses to the items varied substantially. The overall satisfaction scale demonstrated good internal consistency reliability (Cronbach alpha = 0.82) and moderate test-retest reliability (0.62), and it could discriminate between groups of individuals expected to differ with regard to satisfaction (by age and disease stage). Subscale internal consistency reliability (0.37-0.54) and stability (0.38-0.63) were weaker, suggesting that only a single scale should be reported. The participatory scale performed poorly and could not be recommended for future use. CONCLUSION: The overall satisfaction measure developed for this study demonstrated good reliability and validity and should be useful in other population-based studies in conjunction with other outcome measures.