Abstract：
Parkinson\'s Disease (PD) affects more than 10 million individuals, with increasing incidence worldwide. As PD\'s incidence rises, research funding is increasing substantially. PD\'s core outcome set (COS) provides standardization for PD clinical trial outcomes, improves research quality, and study comparability. Our study aimed to analyze COS uptake rate before and after the PD COS publication.
We searched ClinicalTrials.gov to retrieve phase III/IV adult PD trials published between 2013 and 2023. Screening for inclusion and data extraction occurred in a masked, duplicate fashion. Trial characteristics and COS uptake rate were extracted from this sample.
In our 111 included trials, the COS uptake rate was highest for the \'Walking and Balance\' outcome and lowest for the \'Hospital Admissions\' outcome. Overall, there was a non-significant monthly increase of 0.26 % (P = 0.266, CI = [-0.20, 0.72]) in \"COS-defined outcome\" measurement when comparing pre- and post-COS publication.
Our study found no significant increase in COS uptake in PD clinical trials. We found multiple outcomes to be vastly unmeasured and heterogeneity among the measurement instruments used. These findings complicate standardizing and comparing RCT outcomes. Overcoming these barriers is vital to improving the usefulness of PD research.
We searched ClinicalTrials.gov to retrieve phase III/IV adult PD trials published between 2013 and 2023. Screening for inclusion and data extraction occurred in a masked, duplicate fashion. Trial characteristics and COS uptake rate were extracted from this sample.
In our 111 included trials, the COS uptake rate was highest for the \'Walking and Balance\' outcome and lowest for the \'Hospital Admissions\' outcome. Overall, there was a non-significant monthly increase of 0.26 % (P = 0.266, CI = [-0.20, 0.72]) in \"COS-defined outcome\" measurement when comparing pre- and post-COS publication.
Our study found no significant increase in COS uptake in PD clinical trials. We found multiple outcomes to be vastly unmeasured and heterogeneity among the measurement instruments used. These findings complicate standardizing and comparing RCT outcomes. Overcoming these barriers is vital to improving the usefulness of PD research.
摘要：
背景：帕金森病（PD）影响超过1000万人，随着全球发病率的增加。随着PD的发病率上升，研究经费正在大幅增加。PD的核心结果集(COS)为PD临床试验结果提供了标准化，提高研究质量，研究可比性。我们的研究旨在分析PDCOS发表前后的COS摄取率。
方法：我们搜索了ClinicalTrials.gov，以检索2013-2023年间发表的III/IV期成人PD试验。筛选纳入和数据提取发生在一个蒙面，重复的时尚。从该样品中提取试验特征和COS摄取率。
结果：在我们的111项纳入试验中，“行走和平衡”结局的COS摄取率最高，“住院”结局的COS摄取率最低。总的来说,比较COS发表前和发表后的"COS定义结局"测量值,无显著性月增长0.26%(P=0.266,CI=[-0.20,0.72]).
结论：我们的研究发现在PD临床试验中COS摄取没有显著增加。我们发现，在使用的测量工具中，多个结果是无法测量的，并且存在异质性。这些发现使RCT结果的标准化和比较变得复杂。克服这些障碍对于提高PD研究的有用性至关重要。
方法：我们搜索了ClinicalTrials.gov，以检索2013-2023年间发表的III/IV期成人PD试验。筛选纳入和数据提取发生在一个蒙面，重复的时尚。从该样品中提取试验特征和COS摄取率。
结果：在我们的111项纳入试验中，“行走和平衡”结局的COS摄取率最高，“住院”结局的COS摄取率最低。总的来说,比较COS发表前和发表后的"COS定义结局"测量值,无显著性月增长0.26%(P=0.266,CI=[-0.20,0.72]).
结论：我们的研究发现在PD临床试验中COS摄取没有显著增加。我们发现，在使用的测量工具中，多个结果是无法测量的，并且存在异质性。这些发现使RCT结果的标准化和比较变得复杂。克服这些障碍对于提高PD研究的有用性至关重要。
