BACKGROUND All clinical research benefits from transparency and validity. Transparency and validity of studies may increase by prospective registration of protocols and by publication of statistical analysis plans (SAPs) before data have been accessed to discern data-driven analyses from pre-planned analyses. MAIN MESSAGE Like clinical trials, recommendations for SAPs for observational studies increase the transparency and validity of findings. We appraised the applicability of recently developed guidelines for the content of SAPs for clinical trials to SAPs for observational studies. Of the 32 items recommended for a SAP for a clinical trial, 30 items (94%) were identically applicable to a SAP for our observational study. Power estimations and adjustments for multiplicity are equally important in observational studies and clinical trials as both types of studies usually address multiple hypotheses. Only two clinical trial items (6%) regarding issues of randomisation and definition of adherence to the intervention did not seem applicable to observational studies. We suggest to include one new item specifically applicable to observational studies to be addressed in a SAP, describing how adjustment for possible confounders will be handled in the analyses. CONCLUSION With only few amendments, the guidelines for SAP of a clinical trial can be applied to a SAP for an observational study. We suggest SAPs should be equally required for observational studies and clinical trials to increase their transparency and validity.

中文翻译：

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用于观察研究的辩论统计分析计划。

背景技术所有临床研究都受益于透明度和有效性。研究的透明度和有效性可能会通过协议的前瞻性注册和发布统计分析计划（SAP）来增加，然后才能访问数据以从预先计划的分析中识别出数据驱动的分析。主要信息与临床试验一样，针对观察性研究的SAP的建议增加了结果的透明度和有效性。我们评估了最近开发的用于临床试验的SAP内容对于观察性研究的适用性。在推荐用于临床试验的SAP的32项中，有30项（94％）同样适用于我们的观察性研究的SAP。在观察性研究和临床试验中，多重性的功效估计和调整同等重要，因为这两种类型的研究通常都涉及多个假设。关于随机化问题和对干预措施依从性的定义，只有两个临床试验项目（6％）似乎不适用于观察性研究。我们建议在SAP中包括一个特别适用于观测研究的新项目，描述在分析中将如何处理可能的混杂因素的调整。结论只需进行少量修改，就可以将SAP的临床试验指南应用于SAP的观察性研究。我们建议观察性研究和临床试验同样需要SAP，以提高其透明度和有效性。