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

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  • 1Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.

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Summary
This summary is machine-generated.

This paper presents a statistical analysis plan (SAP) template for observational research to enhance transparency and reproducibility. Adopting this SAP template helps prevent questionable research practices and ensures more reliable scientific findings.

Keywords:
observational researchopen scienceresearch best practicesstatistical analysis planstudy planningtemplate

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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.