Epidemiology, Health Services, The Dow Chemical Company, P.O. Box 444, 4530 AK Terneuzen, The Netherlands.
J Clin Epidemiol. 2011 May;64(5):481-6. doi: 10.1016/j.jclinepi.2010.04.009.
To evaluate the need for the creation of a system in which observational epidemiology studies are registered; an Observational Studies Register (OSR).
The current scientific process for observational epidemiology studies is described. Next, a parallel is made with the clinical trials area, where the creation of clinical trial registers has greatly restored and improved their credibility and reliability. Next, the advantages and disadvantages of an OSR are compared.
The advantages of an OSR outweigh its disadvantages.
The creation of an OSR, similar to the existing Clinical Trials Registers, will improve the assessment of publication bias and will provide an opportunity to compare the original study protocol with the results reported in the publication. Reliability, credibility, and transparency of observational epidemiology studies are strengthened by the creation of an OSR. We propose a structured, collaborative, and coordinated approach for observational epidemiology studies that can provide solutions for existing weaknesses and will strengthen credibility and reliability, similar to the approach currently used in clinical trials, where Clinical Trials Registers have played a key role in strengthening their scientific value.
评估创建一个观察性流行病学研究注册系统的必要性，即观察性研究注册处（OSR）。
描述了当前观察性流行病学研究的科学流程。接下来，与临床试验领域进行了平行比较，在临床试验领域，创建临床试验登记处极大地恢复和提高了其可信度和可靠性。接下来，比较了 OSR 的优缺点。
OSR 的优点超过了其缺点。
创建 OSR，类似于现有的临床试验登记处，将改善对发表偏倚的评估，并提供机会将原始研究方案与出版物中报告的结果进行比较。创建 OSR 可增强观察性流行病学研究的可靠性、可信度和透明度。我们提出了一种结构化、协作和协调的方法，用于观察性流行病学研究，可以为现有弱点提供解决方案，并将加强可信度和可靠性，类似于目前在临床试验中使用的方法，临床试验登记处在加强其科学价值方面发挥了关键作用。
