Registering Study Analysis Plans (SAPs) Before Dissecting Your Data—Updating and Standardizing Outcome Modeling

Abstract

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 scope (brief data and study description, co-investigators, hypotheses, primary outcome measure, study title), in addition to step-by-step details of the analysis (handling of missing data, resampling, defined significance level, statistical function, validation, and variables and parameterization).