Estimating relative risks and risk differences in randomised controlled trials: a systematic review of current practice
2025

Methods for Estimating Relative Risks and Risk Differences in Trials

Sample size: 308 publication Evidence: moderate

Author Information

Author(s): Thompson Jacqueline J.Y., Watson Samuel I., Middleton Lee, Hemming Karla

Primary Institution: Department of Applied Health Sciences, College of Medicine and Health, University of Birmingham

Hypothesis

What methods are used to estimate covariate-adjusted relative risks and risk differences in randomized controlled trials?

Conclusion

Approximately half of the RCTs report either a covariate-adjusted relative risk or risk difference, but many lack adequate details on the methods used.

Supporting Evidence

  • 49% of RCTs reported a covariate-adjusted relative risk or risk difference.
  • 65% of studies used the log-binomial model for adjusted relative risks.
  • 48% of studies used the binomial model for adjusted risk differences.

Takeaway

This study looked at how often trials report adjusted risks and found that about half do, but many don't explain how they calculated them.

Methodology

Systematic review of two-arm parallel RCTs published in high-impact journals from January 1, 2018, to March 11, 2023.

Potential Biases

Potential bias due to unclear reporting of methods and selection of covariates.

Limitations

The review only included trials from high-impact journals and may not represent all RCTs.

Participant Demographics

Most trials were multi-centre with an average sample size of 357 in the control arm and 367 in the intervention arm.

Statistical Information

Confidence Interval

95% CI: 43–54%

Digital Object Identifier (DOI)

10.1186/s13063-024-08690-w

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