To explore a suitable research design for evaluating the long-term effects of vaccines, taking into account the heterogeneity caused by individual susceptibility, vaccination status, vaccination timing, and the confounding effects of healthcare-seeking behavior.
This study employed a Monte Carlo simulation method to extend the Test-Negative Design (TND),considering constant vaccine efficacy and two types of time-dependent vaccine efficacy under a fixed study duration model. A multivariable logistic regression model and a semi-parametric generalized additive model based on restricted cubic splines were constructed to evaluate the long-term effects of vaccines.
When only considering changes in vaccine efficacy, the estimated vaccine effectiveness (VE) curves from both models accurately fit the actual decay trend of VE, being only slightly higher than the true VE (approximately 1%-3%). The VE curves were minimally affected by vaccination rates, the mean probability of influenza-like illness in the entire population, and the probability of influenza-like illness in the vaccinated population.
The extended TND under a fixed study duration model provides a feasible new approach for evaluating long-term vaccine effectiveness, with the potential for application to other types of vaccines. Both models demonstrated good fitting performance over time with no significant differences. However, further exploration is needed to comprehensively consider other heterogeneous influencing factors and to conduct simulation experiments with the extended TND after group assignment.
| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |