University of Applied Sciences and Arts Bielefeld, Bielefeld, Germany.
PeerJ. 2023 Sep 25;11:e16015. doi: 10.7717/peerj.16015. eCollection 2023.
The registration of studies, especially in the case of clinical trials, is required by the declaration of Helsinki and the policies of various scientific journals. However, numerous analyses have found considerable discrepancies between published articles and accompanying trial registrations. The aim of this study is to assess such discrepancies for a sample of studies with recruiting locations in Germany. Additionally, the association between the adherence to registrations and possible involvement of Coordinating Centers for Clinical Studies (KKS) as well as Universities of Excellence was tested.
For a sample of 376 interventional or observational study registrations, we found 115 published articles. Subsequently, we searched for discrepancies in the study design, the key inclusion criteria, the interventions, the blinding, and a primary and a secondary outcome.
We found discrepancies in 26% of all studies, most frequently in the secondary outcomes, where 16.5% of the secondary outcomes per study that were registered in most detail had discrepancies. When running regression models for adherence discrepancies, the only variable that had a statistically significant association with better adherence was registration on ClinicalTrials.gov. The association of potential involvement of a KKS with adherence ratings was positive, too, but statistically insignificant.
In summary, the amount of discrepancies between registrations and published articles remains elevated.
赫尔辛基宣言和各种科学期刊的政策都要求对研究进行注册，但许多分析发现，已发表的文章和伴随的试验注册之间存在相当大的差异。本研究的目的是评估在德国有招募地点的研究样本中存在的这种差异。此外，还测试了对注册的遵守情况与可能涉及的临床研究协调中心（KKS）和卓越大学之间的关联。
我们对 376 个干预性或观察性研究注册进行了抽样，找到了 115 篇已发表的文章。随后，我们在研究设计、主要纳入标准、干预措施、盲法以及主要和次要结局方面寻找差异。
我们发现所有研究中有 26%存在差异，最常见的是次要结局，在注册时最详细的每个研究的 16.5%次要结局存在差异。当对遵守差异进行回归模型分析时，唯一与更好的遵守有统计学显著关联的变量是在 ClinicalTrials.gov 上的注册。与潜在参与 KKS 的关联也是积极的，但没有统计学意义。
总的来说，注册和已发表文章之间的差异仍然很高。
