A Statistical Analysis Plan Template for Observational Studies: Promoting Quality and Rigor in Research

Area of Science:

• Biostatistics
• Epidemiology
• Research Methodology

Background:

• Trustworthy scientific findings rely on rigorous and transparent research practices, especially in observational studies.
• Observational research analyses carry risks of questionable research practices, highlighting a need for structured guidance.

Purpose of the Study:

• To introduce a statistical analysis plan (SAP) template tailored for observational research.
• To provide clear guidelines for prespecifying key analytical components and administrative details.

Main Methods:

• Development of a comprehensive SAP template for observational studies.
• Inclusion of essential components: study objectives, measures, variables, and analytical methods.
• Emphasis on administrative details for documentation and reproducibility.

Main Results:

• The SAP template offers structured guidance for prespecifying analyses in observational research.
• It aims to reduce ad hoc modifications and mitigate risks of questionable research practices like p-hacking.
• Facilitates enhanced study integrity and reproducibility.

Conclusions:

• The proposed SAP template strengthens study integrity in observational research.
• It supports researchers in avoiding questionable research practices and producing robust findings.
• Designed for broad usability across diverse research sectors and teams.