Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)
Comparison of alpha-spending plans for near real-time monitoring for Guillain-Barré Syndrome after influenza vaccination during the 2010/11 influenza season.
Vaccine ( IF 5.5 ) Pub Date : 2020-01-10 , DOI: 10.1016/j.vaccine.2019.12.032 Sukhminder K Sandhu 1 , Wei Hua 1 , Thomas E MaCurdy 2 , Riley L Franks 3 , Armen Avagyan 3 , Yoganand Chillarige 3 , Michael Wernecke 3 , Jeffrey Kelman 4 , Robert Ball 1
Vaccine ( IF 5.5 ) Pub Date : 2020-01-10 , DOI: 10.1016/j.vaccine.2019.12.032 Sukhminder K Sandhu 1 , Wei Hua 1 , Thomas E MaCurdy 2 , Riley L Franks 3 , Armen Avagyan 3 , Yoganand Chillarige 3 , Michael Wernecke 3 , Jeffrey Kelman 4 , Robert Ball 1
Affiliation
BACKGROUND
Near real-time surveillance of the influenza vaccine, which is administered to a large proportion of the US population every year, is essential to ensure safety of the vaccine. For efficient near real-time surveillance, it is key to select appropriate parameters such as monitoring start date, number of interim tests and a scheme for spending a pre-defined total alpha across the entire influenza season. Guillain-Barré Syndrome, shown to be associated with the 1976 influenza vaccine, is used to evaluate how choices of these parameters can affect whether or not a signal is detected and the time to signal. FDA has been monitoring for the risk of GBS after influenza vaccination for every influenza season since 2008.
METHODS
Using Medicare administrative data and the Updating Sequential Probability Ratio Test methodology to account for claims delay, we evaluated a number of different alpha-spending plans by varying several parameters.
RESULTS
For relative risks of 5 or greater, almost all alpha-spending plans have 100% power; however, for relative risks of 1.5 or lower, the constant and O'Brien-Fleming plans have increasingly more power. For RRs of 1.5 and greater, the Pocock plan signals earliest but would not signal at a RR of 1.25, as observed in prior influenza seasons. There were no remarkable differences across the different plans in regards to monitoring start dates defined by the number of vaccinations; reducing the number of interim tests improves performance only marginally.
CONCLUSIONS
A constant alpha-spending plan appears to be robust, in terms of power and time to detect a signal, across a range of these parameters, including alternate monitoring start dates based on either cumulative vaccinations or GBS claims observed, frequency of monitoring, hypothetical relative risks, and vaccine uptake patterns.
中文翻译:
比较2010/11流感季节接种流感疫苗后Guillain-Barré综合征的近乎实时监测的alpha支出计划。
背景技术对流感疫苗的近实时监视是确保疫苗安全性的关键,每年对美国大部分人口进行这种监视。为了进行有效的近实时监视,选择合适的参数(例如监视开始日期,临时测试的数量以及在整个流感季节中使用预先定义的总alpha值的方案)至关重要。格林-巴利综合症(Guillain-BarréSyndrome)与1976年流感疫苗相关,可用于评估这些参数的选择如何影响是否检测到信号以及发出信号的时间。自2008年以来,FDA一直在每个流感季节监测流感疫苗接种后GBS的风险。方法使用Medicare管理数据和更新的顺序概率比率测试方法来解决索赔延迟,我们通过改变几个参数来评估许多不同的alpha支出计划。结果对于5或更大的相对风险,几乎所有alpha支出计划都具有100%的功效;但是,对于1.5或更低的相对风险,恒定计划和O'Brien-Fleming计划的权力越来越大。对于RR等于或大于1.5的情况,Pocock计划最早发出信号,但RR值为1.25则不会发出信号,就像以前的流感季节观察到的那样。在不同计划之间,在监测由接种数量确定的开始日期方面没有显着差异;减少临时测试的数量只能稍微提高性能。结论恒定的Alpha支出计划似乎是可靠的,
更新日期:2020-01-11
中文翻译:
比较2010/11流感季节接种流感疫苗后Guillain-Barré综合征的近乎实时监测的alpha支出计划。
背景技术对流感疫苗的近实时监视是确保疫苗安全性的关键,每年对美国大部分人口进行这种监视。为了进行有效的近实时监视,选择合适的参数(例如监视开始日期,临时测试的数量以及在整个流感季节中使用预先定义的总alpha值的方案)至关重要。格林-巴利综合症(Guillain-BarréSyndrome)与1976年流感疫苗相关,可用于评估这些参数的选择如何影响是否检测到信号以及发出信号的时间。自2008年以来,FDA一直在每个流感季节监测流感疫苗接种后GBS的风险。方法使用Medicare管理数据和更新的顺序概率比率测试方法来解决索赔延迟,我们通过改变几个参数来评估许多不同的alpha支出计划。结果对于5或更大的相对风险,几乎所有alpha支出计划都具有100%的功效;但是,对于1.5或更低的相对风险,恒定计划和O'Brien-Fleming计划的权力越来越大。对于RR等于或大于1.5的情况,Pocock计划最早发出信号,但RR值为1.25则不会发出信号,就像以前的流感季节观察到的那样。在不同计划之间,在监测由接种数量确定的开始日期方面没有显着差异;减少临时测试的数量只能稍微提高性能。结论恒定的Alpha支出计划似乎是可靠的,