BACKGROUND The effectiveness of surgery versus observation for men with localized prostate cancer detected by means of prostate-specific antigen (PSA) testing is not known. METHODS From November 1994 through January 2002, we randomly assigned 731 men with localized prostate cancer (mean age, 67 years; median PSA value, 7.8 ng per milliliter) to radical prostatectomy or observation and followed them through January 2010. The primary outcome was all-cause mortality; the secondary outcome was prostate-cancer mortality. RESULTS During the median follow-up of 10.0 years, 171 of 364 men (47.0%) assigned to radical prostatectomy died, as compared with 183 of 367 (49.9%) assigned to observation (hazard ratio, 0.88; 95% confidence interval [CI], 0.71 to 1.08; P = 0.22; absolute risk reduction, 2.9 percentage points). Among men assigned to radical prostatectomy, 21 (5.8%) died from prostate cancer or treatment, as compared with 31 men (8.4%) assigned to observation (hazard ratio, 0.63; 95% CI, 0.36 to 1.09; P = 0.09; absolute risk reduction, 2.6 percentage points). The effect of treatment on all-cause and prostate-cancer mortality did not differ according to age, race, coexisting conditions, self-reported performance status, or histologic features of the tumor. Radical prostatectomy was associated with reduced all-cause mortality among men with a PSA value greater than 10 ng per milliliter (P = 0.04 for interaction) and possibly among those with intermediate-risk or high-risk tumors (P = 0.07 for interaction). Adverse events within 30 days after surgery occurred in 21.4% of men, including one death. CONCLUSIONS Among men with localized prostate cancer detected during the early era of PSA testing, radical prostatectomy did not significantly reduce all-cause or prostate-cancer mortality, as compared with observation, through at least 12 years of follow-up. Absolute differences were less than 3 percentage points. (Funded by the Department of Veterans Affairs Cooperative Studies Program and others; PIVOT ClinicalTrials.gov number, NCT00007644.)

Prostate cancer is the most common noncutaneous malignancy and the second leading cause of cancer death in men. In the United States, 90% of men with prostate cancer are more than age 60 years, diagnosed by early detection with the prostatespecific antigen (PSA) blood test, and have disease believed confined to the prostate gland (clinically localized). Common treatments for clinically localized prostate cancer include watchful waiting (WW), surgery to remove the prostate gland (radical prostatectomy), external-beam radiation therapy and interstitial radiation therapy (brachytherapy), and androgen deprivation. Little is known about the relative effectiveness and harms of treatments because of the paucity of randomized controlled trials. The Department of Veterans Affairs/National Cancer Institute/Agency for Healthcare Research and Quality Cooperative Studies Program Study #407:Prostate Cancer Intervention Versus Observation Trial (PIVOT), initiated in 1994, is a multicenter randomized controlled trial comparing radical prostatectomy with WW in men with clinically localized prostate cancer. We describe the study rationale, design, recruitment methods, and baseline characteristics of PIVOT enrollees. We provide comparisons with eligible men declining enrollment and men participating in another recently reported randomized trial of radical prostatectomy vs WW conducted in Scandinavia. We screened 13 022 men with prostate cancer at 52 US medical centers for potential enrollment. From these, 5023 met initial age, comorbidity, and disease eligibility criteria, and a total of 731 men agreed to participate and were randomized. The mean age of enrollees was 67 years. Nearly one-third were African American. Approximately 85% reported that they were fully active. The median PSA was 7.8 ng/mL (mean 10.2 ng/mL). In three-fourths of men, the primary reason for biopsy leading to a diagnosis of prostate cancer was a PSA elevation or rise. Using previously developed tumor risk categorizations incorporating PSA levels, Gleason histologic grade, and tumor stage, it was found that approximately 40% had low-risk, 34% had medium-risk, and 21% had high-risk prostate cancer based on local histopathology. Comparison to our national sample of eligible men declining PIVOT participation as well as to men enrolled in the Scandinavian trial indicated that PIVOT enrollees are representative of men being diagnosed and treated in the United States and quite different from men in the Scandinavian trial. PIVOT enrolled an ethnically diverse population representative of men diagnosed with prostate cancer in the United States. Results will yield important information regarding the relative effectiveness and harms of surgery compared with WW for men with predominately PSA-detected clinically localized prostate cancer.

With more studies consistently documenting effectiveness, PBT interventions have greater evidence of effectiveness than methylphenidate for treatment of preschoolers at risk for ADHD.

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The purpose of our study was to conduct a preliminary investigation into the experiences and mental health of Senegalese refugees. Although research has established that refugees are more prone to psychiatric illnesses than the general population, little has been written about West African refugees. Our focus was on adult refugees (18 years of age and older) from the Casamance region of Senegal. A total of 80 participants (39 women, 41 men) were randomly selected from refugee camps in The Gambia. The Harvard Trauma Questionnaire and the Hopkins Symptom Checklist-25 were used to assess levels of traumatization and mental health status. Typical of refugees of war, participants reported suffering a large number of various traumas. High prevalence rates of anxiety, depression, and posttraumatic stress disorder were also found in this group. A substantial mental health problem exists within the Senegalese refugee population that may signify a potential human crisis.

Cigarette smoking during pregnancy is an important, avoidable factor associated with low birth weight. Maternal age is also associated with variations in birth weight. Using birth certificate data from all 347,650 singleton births for which maternal age and birth weight were recorded during 1984-1988 in Washington State, this study investigated birth weight and smoking during pregnancy (yes/no) for mothers of different ages. In multiple linear regressions adjusted for race, marital status, parity, adequacy of prenatal care, and urban/rural residence, the decrement in mean birth weight associated with smoking grew steadily from 117 g for the youngest mothers (age less than 16 years) to 376 g for the oldest (age 40 years or more). Similarly, the adjusted relative risk of having a low weight birth (less than 2,500 g) for smokers compared with nonsmokers was lowest for mothers aged 16-17 years, at 1.43 (95% confidence interval 1.22-1.68), and increased steadily to 2.63 (95% confidence interval 1.77-3.90) for mothers aged 40 or more. This result suggests that the effect of exposure to cigarette smoking during pregnancy is modified by advancing maternal age. Further research using data that more precisely measure the exposure (cigarettes per day, years smoked) could help further clarify this issue and better address the public health question of whether smoking cessation programs ought to focus limited resources more selectively toward pregnant smokers in particular age groups.

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Preliminary studies of trauma and psychiatric sequelae among West African refugees have revealed the need to develop West African-sensitive assessment instruments. This article addresses the results of the first stage of such a process which involved two focus group discussions with nine traditional Mandinka practitioners. Various dimensions of the diagnoses required to adequately reflect the range of refugee experience are presented. Such dimensions include diagnostic labels, idioms of distress, causes, source, and seriousness. The findings of this pilot study suggest that the impact of trauma such as experienced by refugees is so complex that a unitary diagnostic label is insufficient.