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van Leeuwen P.J.,Erasmus Medical Center | Kranse R.,Comprehensive Cancer Center the Netherlands | Hakulinen T.,Finnish Cancer Registry | Hugosson J.,Gothenburg University | And 7 more authors.
Journal of Medical Screening | Year: 2013

Objectives To assess the effect of screening in terms of excess mortality in the European Randomized Study of Screening for Prostate Cancer (ERSPC). Methods A total of 141,578 men aged 55-69 were randomized to systematic screening or usual care in ERSPC sections in Finland, Italy, the Netherlands and Sweden. The excess number of deaths was defined as the difference between the observed number of deaths in the prostate cancer (PC) patients and the expected number of deaths up to 31 December 2006. The expected number was derived from mortality of all study participants before a diagnosis with PC adjusted for study centre, study arm and study attendance. The excess mortality rates were compared between the two study arms. Results The PC incidence was 9.25 per 1000 person-years in the intervention arm and 5.49 per 1000 person-years in the control arm, relative risk (RR) 1.69 (95% confidence interval [CI] 1.62-1.76). The excess mortality among men with PC was 0.29 per 1000 person-years in the intervention arm and 0.37 per 1000 person-years in the control arm; the RR for excess mortality was 0.77 (95% CI 0.55-1.08). The absolute risk reduction in the excess mortality was 0.08 per 1000 person-years. The overall mortality was not significantly different between the intervention and the control arms of the study: RR 0.99 (95% CI 0.96-1.01). Conclusions Although the reduction in excess mortality was not statistically significant, the between-arm reduction in excess mortality rate was in line with the previously reported 20% reduction in the disease-specific mortality. This finding indicates that the reduction in PC mortality in the ERSPC trial cannot be due to a bias in cause of death adjudication.

Kranse R.,Erasmus Medical Center | Kranse R.,Comprehensive Cancer Center the Netherlands | van Leeuwen P.J.,Erasmus Medical Center | Hakulinen T.,Finnish Cancer Registry | And 9 more authors.
Journal of Medical Screening | Year: 2013

Objective In addition to disease-specific mortality, a randomized controlled cancer screening trial may be evaluated in terms of excess mortality, in which case no patient-specific information on causes of death is needed. We studied the effect of not accounting for attendance on the calculated excess mortality in a prostate cancer screening trial. Methods The numerator of the excess mortality rate related to prostate cancer diagnoses in each study arm equals the excess number of deaths observed in the cancer patients. The estimation of the expected number of deaths in the absence of the prostate cancer diagnoses has to account for the self-selection of those participating in the trial, particularly if the proportion of non-participants is substantial. Setting The European prostate cancer screening trial (ERSPC). Results In the screening arm, non-attendees had roughly twice the mortality rate of attendees. Approximately twice as many cancers were detected in the screening arm compared with the control arm, primarily in attendees. Unless attendance is properly accounted for, the expected mortality of prostate cancer patients in the screening arm is overestimated by 0.9-3.6 deaths per 1000 person-years. Conclusions Attendees have a lower all-cause mortality rate (are healthier) and a higher probability of a prostate cancer diagnosis than non-attendees and the men randomized to the control arm. If attendance is not accounted for, the excess mortality and the between-arm excess mortality rate ratio are underestimated and screening is considered more effective than it actually is. These effects may be sizeable, notably if non-attendance is common. Correcting for attendance status is important in the calculation of the excess mortality rate in prostate cancer patients that can be used in conjunction with a disease-specific mortality analysis in a randomized controlled cancer screening trial.

Mallone S.,Institute for Cancer Prevention | Stafoggia M.,Lazio Regional Health Service | Faustini A.,Lazio Regional Health Service | Paolo Gobbi G.,National Research Council Italy | And 2 more authors.
Environmental Health Perspectives | Year: 2011

Background: Outbreaks of Saharan-Sahel dust over Euro-Mediterranean areas frequently induce exceedances of the Europen Union's 24-hr standard of 50 μg/m 3 for particulate matter (PM) with aerodynamic diameter ≤ than 10 μm (PM 10). Objectives: We evaluated the effect of Saharan dust on the association between different PM fractions and daily mortality in Rome, Italy. Methods: In a study of 80,423 adult residents who died in Rome between 2001 and 2004, we performed a time-series analysis to explore the effects of PM2.5, PM 2.5-10, and PM10 on natural, cardiac, cerebrovascular, and respiratory mortality. We defined Saharan dust days by combining light detection and ranging (LIDAR) observations and analyses from operational models. We tested a Saharan dust-PM interaction term to evaluate the hypothesis that the effects of PM, especially coarse PM (PM 2.5-10), on mortality would be enhanced on dust days. Results: Interquartile range increases in PM 2.5-10 (10.8 μg/m 3) and PM10 (19.8 μg/m 3) were associated with increased mortality due to natural, cardiac, cerebrovascular, and respiratory causes, with estimated effects ranging from 2.64% to 12.65% [95% confidence interval (CI), 1.18-25.42%] for the association between PM 2.5-10 and respiratory mortality (0- to 5-day lag). Associations of PM 2.5-10 with cardiac mortality were stronger on Saharan dust days (9.73%; 95% CI, 4.25-15.49%) than on dust-free days (0.86%; 95% CI, -2.47% to 4.31%; p = 0.005). Saharan dust days also modified associations between PM10 and cardiac mortality (9.55% increase; 95% CI, 3.81-15.61%; vs. dust-free days: 2.09%; 95% CI, -0.76% to 5.02%; p = 0.02). Conclusions: We found evidence of effects of PM 2.5-10 and PM 10 on natural and cause-specific mortality, with stronger estimated effects on cardiac mortality during Saharan dust outbreaks. Toxicological and biological effects of particles from desert sources need to be further investigated and taken into account in air quality standards.

Faustini A.,Regional Health Service of Lazio | Stafoggia M.,Regional Health Service of Lazio | Berti G.,Regional Environmental Protection Agency of Piedmont | Bisanti L.,Epidemiology Unit | And 8 more authors.
European Respiratory Journal | Year: 2011

The association of air pollutants with natural and respiratory mortality has been consistently reported. However, several aspects of the relationship between particulate matter with a 50% cut-off aerodynamic diameter of 10 μm (PM 10) and respiratory mortality require further investigation. The aim of the present study was to assess the PM 10-respiratory mortality association in Italy and examine potentially susceptible groups. All deaths from natural (n=276,205) and respiratory (n=19,629) causes among subjects aged ≥35 yrs in 10 northern, central and southern Italian cities in 2001-2005 were included in the study. Pollution data for PM 10, nitrogen dioxide and ozone were also obtained. A time-stratified case-crossover analysis was carried out. Different cumulative lags were selected to analyse immediate, delayed, prolonged and best-time effects of air pollution. The shape of the exposure-response curve was analysed. Age, sex, chronic conditions and death site were investigated as potential effect modifiers. We found a 2.29% (95% CI 1.03-3.58%) increase in respiratory mortality at 0-3 days lag. The increase in respiratory mortality was higher in summer (7.57%). The exposure-response curve had a linear shape without any threshold. Sex and chronic diseases modified the relationship between particular matter (PM) and respiratory mortality. The effect of PM on respiratory mortality was stronger and more persistent than that on natural mortality. Females and chronic disease sufferers were more likely to die of a respiratory disease caused by air pollution than males and healthy people. Copyright©ERS 2011.

Schwartz J.L.,University of Illinois at Chicago | Schwartz J.L.,Institute for Cancer Prevention | Brunnemann K.D.,New York Medical College | Adami A.J.,University of Illinois at Chicago | And 4 more authors.
Journal of Oral Pathology and Medicine | Year: 2010

Background: Different compositions of smokeless tobacco (ST) are widely thought to cause oral carcinoma at different rates but there is little direct evidence for this hypothesis. Methods: We used a rat lip canal model to examine the mucosal changes induced by chronic daily exposure to four different brands of ST: Skoal, Copenhagen, Ettan Swedish Snus, and Stonewall, differing in measured levels of: tobacco specific nitrosamines (TSNAs), unprotonated nicotine, moisture, and pH. Results: Exposure to the lip canal for 12 months produced changes in the mucosa marked by increases in S phase and M phase cells for the Skoal and Copenhagen exposed rats. This correlated with the high level of TSNAs and nicotine in these products. All the tobacco products, to different degrees, induced sites of moderate to severe dysplasia some with extensive rete peg outgrowth from the oral mucosa not seen in the controls. Many of these sites showed a loss of p16 expression. Conclusions: While all ST products caused dysplasia, the products with lower levels of TSNAs and unprotonated nicotine caused less, consistent with the model that tobacco with low levels of nitrosamines might potentially induce fewer carcinomas in human users. © 2010 John Wiley & Sons A/S.

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