Thor Maria, Oh Jung Hun, Apte Aditya P, Deasy Joseph O
Department of Medical Physics, Memorial Sloan Kettering Cancer Center, New York, NY, United States.
Front Oncol. 2020 Jun 24;10:978. doi: 10.3389/fonc.2020.00978. eCollection 2020.
Public preregistration of study analysis plans (SAPs) is widely recognized for clinical trials, but adopted to a much lesser extent in observational studies. Registration of SAPs prior to analysis is encouraged to not only increase transparency and exactness but also to avoid positive finding bias and better standardize outcome modeling. Efforts to generally standardize outcome modeling, which can be based on clinical trial and/or observational data, have recently spurred. We suggest a three-step SAP concept in which investigators are encouraged to (1) Design the SAP and circulate it among the co-investigators, (2) Log the SAP with a public repository, which recognizes the SAP with a digital object identifier (DOI), and (3) Cite (using the DOI), briefly summarize and motivate any deviations from the SAP in the associated manuscript. More specifically, the SAP should include the (brief data and study description, co-investigators, hypotheses, primary outcome measure, study title), in addition to step-by-step details of the (handling of missing data, resampling, defined significance level, statistical function, validation, and variables and parameterization).
研究分析计划（SAPs）的公开预注册在临床试验中已得到广泛认可，但在观察性研究中的采用程度要低得多。鼓励在分析之前对SAPs进行注册，这不仅可以提高透明度和准确性，还能避免阳性结果偏倚，并更好地规范结果建模。最近，人们致力于对可基于临床试验和/或观察性数据的结果建模进行总体规范。我们提出了一个三步SAP概念，鼓励研究者：（1）设计SAP并在共同研究者之间传阅；（2）将SAP记录在公共知识库中，该知识库用数字对象标识符（DOI）识别该SAP；（3）在相关手稿中引用（使用DOI），简要总结并说明与SAP的任何偏差及其原因。更具体地说，除了（缺失数据处理、重采样、定义的显著性水平、统计函数、验证以及变量和参数化）的逐步细节外，SAP还应包括（简要的数据和研究描述、共同研究者、假设、主要结局指标、研究标题）。
