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SOFA and mortality endpoints in randomized controlled trials: a systematic review and meta-regression analysis
Harm-Jan de Grooth1, Irma L Geenen2, Armand R Girbes2
1Department of Intensive Care, VU University Medical Center, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands. h.degrooth@vumc.nl.
Critical Care (London, England)
|February 25, 2017
Summary
Delta SOFA, a measure of organ failure trajectory, is reliably associated with mortality in intensive care randomized controlled trials (RCTs). This contrasts with Fixed-day SOFA, which showed no significant mortality association, suggesting Delta SOFA is a better endpoint for future RCTs.
Area of Science:
- Critical Care Medicine
- Clinical Trials Methodology
- Biostatistics
Background:
- Sequential Organ Failure Assessment (SOFA) score is a common endpoint in intensive care randomized controlled trials (RCTs).
- Previous observational studies show serial SOFA scores correlate with mortality.
- The relationship between treatment effects on SOFA and mortality in RCTs remains unquantified.
Purpose of the Study:
- To quantify the association between treatment effects on SOFA and mortality in RCTs.
- To identify which SOFA derivative best reflects between-group mortality differences in RCTs.
Main Methods:
- A systematic literature search identified RCTs reporting both SOFA and mortality outcomes.
- Meta-regression analyzed the linear relationship between treatment effects on mortality (log odds ratio) and SOFA (standardized difference).
- Residual heterogeneity (consistency) was assessed using I-squared statistics.
Main Results:
- Analysis of 87 RCTs revealed a significant association between overall SOFA and mortality (slope=0.49, R-squared=9%).
- Fixed-day SOFA (n=58 RCTs) was not significantly associated with mortality (slope=0.35, R-squared=3%).
- Delta SOFA (n=25 RCTs) demonstrated a significant association with mortality (slope=0.70, R-squared=32%) with no heterogeneity.
Conclusions:
- Treatment effects on Delta SOFA are reliably and consistently associated with mortality in RCTs.
- Fixed-day SOFA, though frequently used, lacks significant association with mortality.
- Delta SOFA is recommended over Fixed-day SOFA as a more robust endpoint for future intensive care RCTs.
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