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
The purpose of this study is to examine the airport service quality dimensions based on the ASQ survey and investigate the best predictor for overall satisfaction. The context of this study is the klia2 terminal passengers, which are predominantly users of the low-cost carriers at Kuala Lumpur International Airport. Secondary data obtained from the airport operator on the 2016 ASQ survey for the klia2 terminal was analysed using the PLS-SEM method. The grouping and impact of the thirty-three service quality elements from the ASQ survey were tested against the overall satisfaction element. The findings indicated that twenty-two out of the thirty-three elements were valid measures for the klia2 terminal users which forms the eight dimensions i.e. access, airport environment, airport facilities, arrival services, check-in, finding your way, passport and security. Airport environment was found as the best predictor in determining passengers’ overall satisfaction at klia2 terminal and should be given particular focus by the airport operator for continuous improvements. 相似文献
The purpose of this research is to explain the relationships among overall quick-casual restaurant image, perceived value, customer satisfaction, and behavioral intentions in the quick-casual restaurant industry. The findings indicate that overall quick-casual restaurant image significantly influences perceived value, and overall quick-casual restaurant image and perceived value had a significant role in influencing customer satisfaction. Additionally, overall quick-casual restaurant image, perceived value, and customer satisfaction are significant predictors of customers’ behavioral intentions. Finally, customer satisfaction can act as a partial mediator in the relationship between overall quick-casual restaurant image/perceived value and behavioral intentions. Furthermore, we discuss the theoretical and managerial implications of the findings and future research ideas. 相似文献