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.

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.

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.

Updated trends in imaging use in men diagnosed with prostate cancer.

BACKGROUND: Previous studies have found persistent overuse of imaging for clinical staging of men with low-risk prostate cancer. We aimed to determine imaging trends in three cohorts of men. METHODS: We analyzed imaging trends of men with prostate cancer who were a part of Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) (1998-2006), were insured by Medicare (1998-2006), or privately insured (Ingenix database, 2002-2006). The rates of computed tomography (CT), magnetic resonance imaging (MRI) and bone scan (BS) were determined and time trends were analyzed by linear regression. For men in CaPSURE, demographic and clinical predictors of test use were explored using a multivariable regression model. RESULTS: Since 1998, there was a significant downward trend in BS (16%) use in the CaPSURE cohort (N=5156). There were slight downward trends (2.4 and 1.7%, respectively) in the use of CT and MRI. Among 54 322 Medicare patients, BS, CT and MRI use increased by 2.1, 10.8 and 2.2% and among 16 161 privately insured patients, use increased by 7.9, 8.9 and 3.7%, respectively. In CaPSURE, the use of any imaging test was greater in men with higher-risk disease. In addition, type of insurance and treatment affected the use of imaging tests in this population. CONCLUSIONS: There is widespread misuse of imaging tests in men with low-risk prostate cancer, particularly for CT. These findings highlight the need for examination of factors that drive decision making with respect to imaging in this setting.

Long-term quality of life in disadvantaged men with prostate cancer on androgen-deprivation therapy.

BACKGROUND: To explore the effects of androgen-deprivation therapy (ADT) on general, disease-specific and hormone-specific health-related quality of life (HRQOL) among minority men. METHODS: Men enrolled in a state-funded program, providing free prostate cancer treatment for underserved men, were recruited, if they had received at least 3 months of continuous ADT and/or other forms of primary treatment. HRQOL was assessed with validated measures including the RAND Medical Outcomes Study 12-item Health Short Form Survey (SF-12), the UCLA Prostate Cancer Index Survey and the Expanded Prostate Cancer Index Composite Survey. Repeated measures analysis was performed to evaluate the association between clinical and sociodemographic covariates with HRQOL. RESULTS: We enrolled 322 men, including 94 on ADT and 228 who received other forms of treatment. When controlling for patient characteristics, men receiving ADT had poorer outcomes relative to sexual function (P<0.01), sexual bother (P<0.01), hormonal function (P<0.01) and hormonal bother (P=0.02). ADT use was significantly associated with worsening sexual function (P<0.01) and sexual bother (P=0.01) over two years compared with non-ADT users. Analysis also demonstrated significant differences between whites, Hispanics and Others (African American (n=43, 16%), Asian (n=13, 5%), multiracial (n=1, 0.4%), Native American (n=1, 0.4%) and other (n=9, 3%)) relative to urinary bother (P=0.01), urinary function (P=0.01) and hormonal bother (P=0.03). ADT users had better urinary function and less bother than non-ADT users among the Other group, while the opposite was true for whites and Hispanics. For hormonal bother, ADT use was associated with worse outcomes across all three race/ethnicity groups; however, Hispanics were less bothered by their hormonal symptoms than whites or Others. CONCLUSION: Men of disadvantaged backgrounds on hormone therapy for prostate cancer experience declines in sexual and hormonal HRQOL. Whites and non-whites on ADT have significantly different HRQOL outcomes.

From bad to worse: comorbidity severity and quality of life after treatment for early-stage prostate cancer.

Commonly used measures of comorbidity assess comorbidity number and type but not severity. We sought to evaluate the impact of comorbidity severity on longitudinal health-related quality of life (HRQOL) in men treated with radical prostatectomy (RP) or radiation therapy (RT) using the Total Illness Burden Index for prostate cancer (TIBI-CaP). We sampled 738 men with non-metastatic prostate cancer treated with RP or RT from the Cancer of the Prostate Strategic Urologic Research Endeavor registry. We examined the impact of comorbidity severity on generic and disease-specific HRQOL at baseline and at 6, 12, 18 and 24 months post-treatment. Men with worse TIBI-CaP comorbidity had significantly lower baseline and post-treatment HRQOL in all domains at all time points. In a multivariate model, men with moderate or severe TIBI-CaP comorbidity had significantly worse HRQOL scores at 12 and 24 months after treatment in all domains except sexual and urinary function (P<0.05); in these domains, severe comorbidity was predictive of lower HRQOL (P<0.05). Comorbidity groups had similar absolute declines in HRQOL from baseline to 6 and 24 months after treatment. Although comorbidity groups experienced similar long-term declines from baseline HRQOL after treatment, men with more severe comorbidity had significantly lower baseline scores and therefore poorer long-term HRQOL.

Rescoring the NIH chronic prostatitis symptom index: nothing new.

The National Institutes of Health-chronic prostatitis symptom index (NIH-CPSI) is a commonly used 13-item questionnaire for the assessment of symptom severity in men with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). For each item, score ranges are 0-1 (6 items), 0-3 (2 items), 0-5 (3 items), 0-6 (1 item) and 0-10 (1 item). This scoring system is straightforward, but items with wider score ranges are de facto weighted more, which could adversely affect the performance characteristics of the questionnaire. We rescored the NIH-CPSI so that equal weights were assigned to each item, and compared the performance of the standard and rescored questionnaires using the original validation dataset. Both the original and revised versions of the scoring algorithm discriminated similarly among groups of men with CP (n=151), benign prostatic hyperplasia (n=149) and controls (n=134). The internal consistency of the questionnaire was slightly better with the revised scoring, but values with the standard scoring were sufficiently high (Cronbach's >or=0.80). We conclude that although the rescored NIH-CPSI provides better face validity than the standard scoring algorithm, it requires additional calculation efforts and yields only marginal improvements in performance.

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.

Primary care physician practices in the diagnosis, treatment and management of men with chronic prostatitis/chronic pelvic pain syndrome.

To describe practice patterns of primary care physicians (PCPs) for the diagnosis, treatment and management of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), we surveyed 556 PCPs in Boston, Chicago, and Los Angeles (RR=52%). Only 62% reported ever seeing a patient like the one described in the vignette. In all, 16% were 'not at all' familiar with CP/CPPS, and 48% were 'not at all' familiar with the National Institutes of Health classification scheme. PCPs reported practice patterns regarding CP/CPPS, which are not supported by evidence. Although studies suggest that CP/CPPS is common, many PCPs reported little or no familiarity, important knowledge deficits and limited experience in managing men with this syndrome.

Education as a predictor of quality of life outcomes among disadvantaged men.

Higher educational levels along with other factors such as literacy and communication with physicians have been associated with better outcomes for men with prostate cancer, but little research has focused on the relationship of educational attainment to self-efficacy for interacting with physicians been conducted on its effect on self-efficacy and health-related quality of life (HRQOL) among low-income, uninsured men. Data from 425 low-income, uninsured men with prostate cancer enrolled in UCLA's Men's Health Study were examined. We found that men with higher and lower education levels, including those who did not complete high school, had similar HRQOL and self-efficacy outcomes. Because of the close relationship between income and education, broader studies into the associations of these variables and prostate cancer outcomes are needed.

Distress and social dysfunction following prostate cancer treatment: a longitudinal cross-cultural comparison of Japanese and American men.

We assessed the impact of bother with urinary and bowel dysfunction on social activities among men in Japan and the United States following primary therapy for localized prostate cancer. In paired longitudinal outcomes studies, we measured general and disease-specific health-related quality of life in 400 Japanese and 427 American men who underwent radical prostatectomy or brachytherapy for localized prostate cancer. Outcomes included the social function domain of the Medical Outcomes Study Short Form-36 and the University of California, Los Angeles Prostate Cancer Index, all of which are scored 0-100. Participants completed the questionnaires before and 1, 12 and 24 months after treatment. Among men who reported any urinary bother, Japanese men had slightly better urinary function than American men (84 vs 77, P<0.01). Before brachytherapy, urinary bother was weakly correlated with social function in both the countries; after brachytherapy, urinary bother was strongly correlated with social function in American but not Japanese men. After brachytherapy, bowel dysfunction had a stronger correlation with social function in American than Japanese men (P<0.05). The bother associated with urinary and bowel dysfunction after surgery or brachytherapy for prostate cancer has a greater impact on social function in American men than in Japanese men.

Sexual function following radical prostatectomy: a prospective longitudinal study of cultural differences between Japanese and American men.

We conducted a cross-cultural comparison of the recovery of sexual function and bother during the first 2 years after radical prostatectomy (RP) between American and Japanese men. A total of 275 Japanese and 283 American men who underwent RP alone were prospectively enrolled into longitudinal cohort studies of health-related quality of life outcomes. Sexual function and bother (distress) were estimated with English and validated Japanese versions of the UCLA Prostate Cancer Index before RP and 1, 2-3, 4-6, 12, 18 and 24 months after RP. Each subject served as his own control. Japanese men reported lower sexual function scores at baseline, even after adjusted for age, prostate-specific antigen (PSA) and comorbidity (38 vs 61, P<0.001). The two groups had similar baseline sexual bother (70 vs 69, P=0.84). Japanese men had a smaller improvement in sexual function (beta=0.8 vs beta=5.3) and bother (beta=0.2 vs beta=2.9) over time than did the American men postoperatively, after adjusting for baseline score, age, baseline PSA and nerve-sparing. American men were more likely than Japanese men to regain their baseline sexual function by 24 months after surgery (hazard ratio (HR)=1.60; 95% confidence interval (CI)=1.06-2.42). In contrast, American men were less likely than Japanese men to return to baseline sexual bother (HR=0.57; 95% CI=0.44-0.75). This study demonstrates that Japanese and American men experience different patterns of recovery of their sexual function and bother after RP. Ethnicity may be a contributing factor.

Quality of life in young men after radical prostatectomy.

Urinary and sexual function and bother are important outcomes following radical prostatectomy (RP). Since urinary and sexual function are age-related, post-operative bother may vary by age. This study explores the disease-specific quality-of-life outcomes in young men compared with older men undergoing RP. Using CaPSURE data, we identified men who underwent RP and completed the UCLA Prostate Cancer Index (PCI) before and 1-year post-RP. Men were stratified by age (< 55 years, 55-64, > or = 65). Multivariate regression models were created: a linear model for predictors of PCI scores and a logistic model for predictors of severe declines in PCI domains. Younger men scored significantly better than older men in urinary function (P=0.04), urinary bother (P=0.02) and sexual function (P<0.0001) 1-year post-RP. Severe declines in urinary bother (odds ratio (OR)=1.54, 1.01-2.35) and sexual function (OR=3.20, 1.97-5.19) were more common in men > or = 65 years. Men with relationships had less urinary bother (P=0.03) and were less likely to experience severe worsening of urinary bother (OR=0.32, 0.17-0.60) while having a greater risk of severe worsening of sexual bother (OR=2.74, 1.28-5.89). The use of sexual aids was associated with worse sexual bother (P<0.0001) and greater risk of severe worsening of sexual bother (OR=2.29, 1.54-3.30). Baseline PCI scores were independent predictors in all models. One year after RP, younger men (age < 55) have similar, or better, urinary and sexual function and bother. Baseline scores are strongly associated with post-RP scores and severity of declines. Current relationships and use of sexual aids have significant roles in post-RP bother.

Responsiveness of the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI).

OBJECTIVES: The NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) was developed to assess symptoms and quality of life in men with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). We assessed the responsiveness of the NIH-CPSI to change over time and defined thresholds for changes perceptible to patients. METHODS: We studied 174 men with CP/CPPS who participated in a placebo-controlled randomized clinical trial. Changes from baseline to six weeks in the NIH-CPSI total score and pain, urinary, and quality of life subscores were compared to a global response assessment (GRA). Effect sizes and Guyatt statistics were calculated to evaluate responsiveness; 95% confidence intervals were produced using bootstrapping. RESULTS: All scores decreased over time with the largest decrease in subjects who reported on the GRA that they were markedly improved. The NIH-CPSI total, pain, and quality of life scores were highly responsive in the improved groups; the urinary score showed minimal responsiveness. There was no evidence of responsiveness among those subjects who worsened on the trial. ROC curves identified a 6-point decline in the NIH-CPSI total score as the optimal threshold to predict treatment response. CONCLUSIONS: The NIH-CPSI total score and pain and quality of life subscores are responsive to change over time.

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.

Quality of life after radical treatment of prostate cancer: validation of the Italian version of the University of California-Los Angeles Prostate Cancer Index.

OBJECTIVES: To validate an Italian version of the University of California-Los Angeles Prostate Cancer Index (UCLA-PCI). METHODS: Men with prostate cancer treated with radical retropubic prostatectomy (RRP) or external beam radiation (EBR) were retrospectively selected. Each subject was asked to complete the UCLA-PCI short form and the 36-item short-form health survey (SF-36) questionnaires (principal sample); a subgroup completed both questionnaires twice (retest sample). A linguistic translation and validation was performed. Psychometric properties were analyzed. RESULTS: A total of 595 men were included in the study: 394 from the Department of Urology (treated with RRP) and 201 from the Department of Radiotherapy (treated with EBR). Of these, 75 patients (50 from the RRP group and 25 from the EBR group) were selected as the retest cohort. Internal consistency reliability of the SF-36 and UCLA-PCI for the primary sample of the surgery and radiotherapy populations ranged from 0.82 to 0.94; the mean values of sexual function were superior in the principal urology group, whereas the principal radiotherapy group demonstrated superior mean values of urinary function and urinary bother. A strong correlation between urinary function and sexual and bowel function, and between urinary function and all bother scales, was reported only for patients treated with RRP. The expected correlation between sexual function and sexual bother was reported for the EBR group but not for the RRP group. CONCLUSIONS: Our study demonstrated the excellent psychometric properties of the Italian version of the UCLA-PCI; the Italian version of the UCLA-PCI questionnaire will allow cross-cultural comparative studies in men with 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.

Measuring disease specific quality of life in localized prostate cancer: the Dutch experience.

OBJECTIVE: We aimed at developing and testing a Dutch health-related quality of life measure for localized prostate cancer patients. METHODS: Scales on urinary and bowel function and bother from the UCLA Prostate Cancer Index (PCI) underwent formal linguistic and cultural translation. PCI sexual scales were replaced by an existing Dutch sexual activities module (SAc). After qualitative pilot testing 389 patients with localized prostate cancer (mean age 67 +/- 7 years) completed the measure before and at 2 time points after primary treatment. Psychometric properties (feasibility, score distribution, reliability, construct validity and responsiveness to change) of the new instrument were analyzed. RESULTS: Response rates ranged from 93% at baseline to 87% after treatment. Urinary and bowel function scales showed Cronbach's alphas >0.7. Urinary function and bother, and bowel function and bother were significantly correlated. Pre- vs. post-prostatectomy effect sizes were >0.9 only for urinary scales; while pre- vs. post-radiotherapy effect sizes were >0.75 only for bowel scales. Six months after baseline erectile dysfunction was reported by 64% of respondents, either as a problem in sexual activity or as a reason for not being sexually active. CONCLUSION: The Dutch PCI and SAc performed well in men treated for early stage prostate cancer.

Health-related quality of life in men with metastatic prostate cancer: the misleading effect of lead-time bias.

OBJECTIVE: To ascertain whether the difference in health-related quality of life, which appears to be worse in men with metastatic prostate cancer when the metastases are noted at initial diagnosis than during follow-up after treatment for clinically localized disease, can be attributed to previous local control or to some form of measurement bias. PATIENTS AND METHODS: We analysed by univariate and multivariate methods 375 men with metastatic prostate cancer who were enrolled in CaPSURE, a national observational cohort of patients with prostate cancer treated in community and academic settings throughout the USA. In particular, we assessed whether group differences in health-related quality of life were explained by the timing of metastatic diagnosis in the course of their disease. Health-related quality of life was measured with the RAND 36-Item Health Survey (SF-36). RESULTS: After controlling for relevant covariates (age, comorbidity and ethnicity), multivariate models suggested that men whose metastases were noted at the time of initial diagnosis scored 5-15 points worse in all eight domains of the SF-36. CONCLUSION: Men who are diagnosed with metastatic prostate cancer during the follow-up after treatment for clinically localized disease report a better quality of life than those who are metastatic at the time of diagnosis, not because the primary treatment confers any benefit but because they are followed more closely over time and diagnosed with metastases earlier in the course of their disease. This apparent difference in quality of life is an effect of lead-time bias in the diagnosis of metastasis.

Improvement in emotional well-being and relationships of users of sildenafil.

PURPOSE: We estimated the association of sildenafil use with erectile function, relationship with sexual partner, functional status and emotional well-being in men with erectile dysfunction. MATERIALS AND METHODS: Letters were mailed to eligible patients at a university hospital urology and internal medicine clinic, and university affiliated community primary care clinics by the primary care provider or urologist inviting them to participate in the study. Of the eligible sample 124 men (53%) completed and returned a survey, including 85 who reported current sildenafil use. Change scores in these patients were calculated using the International Index of Erectile Function, marital interaction scale from the Cancer Rehabilitation Evaluation System Short Form, 5-item emotional well-being scale of the RAND 36-Item Health Survey and 12-Item Short Form Health Survey. RESULTS: Sildenafil users reported an 88% increase in erectile function scores, 60% increase in overall sexual satisfaction and 36% increase in intercourse satisfaction related to the use of sildenafil (p <0.001). Of the respondents 38% indicated that using sildenafil had definitely improved quality of life. Likewise 29% of respondents indicated that using sildenafil had definitely improved the relationship with their partner. With sildenafil there was a statistically significant improvement in the scores of erectile and sexual function (p <0.001), sexual partner relationship (p = 0.007) and emotional well-being (p <0.001). In a multivariate model improved erectile function and sexual partner relationship were each significantly associated with improved emotional well-being (R2 = 0.20, p <0.001). CONCLUSIONS: Sildenafil users reported significant improvements in erectile and sexual function that were associated with positive changes in emotional well-being and the sexual partner relationships with their sexual partner.