This paper estimates the dose-response relationship between air pollution and the number of work loss days for the Netherlands.
The study is based on illness data (work loss days) for the Dutch labour population and average year concentrations of air
pollution in 29 districts. The dose-response relationship has been estimated by means of two different techniques: the ordinary
least squares method (OLS) and the one-way fixed-effects method (OWFEM), which we consider to be more adequate. In general
health effects are much smaller when OWFEM is applied than if OLS is used. With OWFEM a significant relationship is found
between sulphate aerosol (SO4), ammonia (NH3) and the number of work loss days (WLDs). Particulates (TSP), O3 and SO2 have no significant effect on the number of WLDs. These results differ from those obtained in studies in the United States,
which indicate that particulates (TSP) and other small particles, ozone (O3) and to a lesser extent SO4 and SO2 significantly influence the number of WLDs. 相似文献
Background: Validation of overall survival (OS) extrapolations of immune-checkpoint inhibitors (ICIs) during the National Institute for Health and Care Excellence (NICE) Single Technology Assessment (STA) process is limited due to data still maturing at the time of submission. Inaccurate extrapolation may lead to inappropriate decision-making. The availability of more mature trial data facilitates a retrospective analysis of the plausibility and validity of initial extrapolations. This study compares these extrapolations to subsequently available longer-term data.
Methods: A systematic search of completed NICE appraisals of ICIs from March 2000 to December 2017 was performed. A targeted search was also undertaken to procure published OS data from the pivotal clinical trials for each identified STA made available post-submission to NICE. Initial Kaplan-Meier curves and associated extrapolations from NICE documentation were extracted to compare the accuracy of OS projections versus the most mature data.
Results: The review identified 11 STAs, of which 10 provided OS data upon submission to NICE. The extrapolations undertaken considered parametric or piecewise survival models. Additional data cut-offs provided a mean of 18 months of OS beyond the end of the original data. Initial extrapolations typically under-estimated OS from the most mature data cut-off by 0.4–2.7%, depending on the choice of assessment method and use of the manufacturer- or ERG-preferred extrapolation.
Conclusion: Long-term extrapolation of OS is required for NICE STAs based on initial immature OS data. The results of this study demonstrate that the initial OS extrapolations employed by manufacturers and ERGs generally predicted OS reasonably well when compared to more mature data (when available), although on average they appeared to underestimate OS. This review and validation shows that, while the choice of OS extrapolation is uncertain, the methods adopted are generally aligned with later-published follow-up data and appear appropriate for informing HTA decisions. 相似文献
1. Introduction Development of human industrial civilization and predatory exploitation of natural resources have in- duced tremendous changes of ecological environment. In recent years, territorial and global environmental problems have increased, such as greenhouse effect, depletion of ozone, global warming, water scarcity, water pollution, acid rain, decrease of biodiversity, soil erosion desertification etc. These changes seriously intimidate the health and security of ecosystems, and dist… 相似文献