Suchergebnisse

The extensive data from the Blairet al.(1)epidemiology study of occupational acrylonitrile exposure among 25,460 workers in eight plants in the United States provide an excellent opportunity to update quantitative risk assessments for this widely used commodity chemical. We employ the semiparametric Cox relative risk (RR) regression model with a cumulative exposure metric to model cause‐specific mortality from lung cancer and all other causes. The separately estimated cause‐specific cumulative hazards are then combined to provide an overall estimate of age‐specific mortality risk. Age‐specific estimates of the additional risk of lung cancer mortality associated with several plausible occupational exposure scenarios are obtained. For age 70, these estimates are all markedly lower than those generated with the cancer potency estimate provided in the USEPA acrylonitrile risk assessment.(2)This result is consistent with the failure of recent occupational studies to confirm elevated lung cancer mortality among acrylonitrile‐exposed workers as was originally reported by O'Berg,(3)and it calls attention to the importance of using high‐quality epidemiology data in the risk assessment process.

BACKGROUND: On April 23, 2014, US media outlets broadcast reports of excessive wait times and "secret" waitlists at some Veterans Affairs (VA) hospitals, precipitating legislation to increase Veterans' access to private sector health care. OBJECTIVE: The aims were to assess changes in Veterans' distrust in the VA health care system before and after the media coverage and explore sex and racial/ethnic differences in the temporal patterns. METHODS: Veterans completed semistructured interviews on health care satisfaction from June 2013 to January 2015, including a validated scale of health system distrust (range: 1–5). We used linear splines with knots at 90-day intervals to assess changes in distrust before and after April 23, 2014 ("day 0") in linear mixed models. To explore sex and racial/ethnic differences in temporal patterns, we stratified models by sex and tested for interactions of race/ethnicity with time. RESULTS: For women (n=600), distrust scores (mean=2.09) increased by 0.45 in days 0–90 (P<0.01), then decreased by 0.45 in days 90–180 (P<0.01). Among men (n=575), distrust scores (mean=2.05) increased by 0.18 in days 0–90 (P=0.059). Distrust levels were significantly higher for Black versus White women (time adjusted mean difference=0.21) and for Black and Hispanic versus White men (differences=0.26 and 0.18). However, the temporal patterns did not vary by race/ethnicity for women or men (interaction P=0.85 and 0.21, respectively). CONCLUSIONS: Health system distrust increased in women following media coverage of VA access problems and was higher in Black/Hispanic versus White Veterans at all time periods. Such perceptions could influence Veteran decisions to seek health care in the community rather than VA.

Institutional Review Boards (IRBs) are intended to protect those who participate in research. However, because there is no established measure of IRB quality, it is unclear whether these committees achieve their goal. The IRB Researcher Assessment Tool is a previously validated, internally normed, proxy measure of IRB quality that assesses 45 distinct IRB activities and functions. We administered this instrument to a sample of investigators and IRB members at a large urban VA Medical Center. We describe a systematic approach to analyze and interpret survey responses that can identify the IRB activities and functions most in need of quality improvement. The proposed approach to empirical data analysis and presentation could inform local initiatives to improve the quality of IRB review.

How well institutional review boards (IRBs) follow Common Rule criteria for levels of initial protocol review has not been systematically evaluated. We compared levels of review as determined using the Office for Human Research Protections (OHRP) human subject regulations decision charts of 313 protocols that had been approved by IRBs. There was a 97.8% agreement between 140 protocols that were reviewed by full board and the levels of review according to OHRP criteria. Likewise, there was a 93.8% agreement between 113 protocols that were reviewed using an expedited review procedure and OHRP criteria. However, there was only 75% agreement for exempt protocols. Specifically, 10 (16.7%) of the 60 exempt protocols were found to require IRB review, that is, six protocols requiring expedited review and four protocols requiring full board review. Conducting non-exempt research without prior IRB approval constitutes serious noncompliance. Our data suggest that exempt protocols need more scrutiny.