Observational study of missing SOFA score data frequency in RCTs relative to ICU length of stay

Abstract

Abstract The Sequential Organ Failure Assessment, also known as SOFA score, was introduced to assess organ dysfunction of critical ill patients. However, understanding the impact of missing SOFA scores in randomized controlled trials and how this affect the validity and applicability of the SOFA score as a surrogate endpoint for predicting mortality has been a matter of interest. To address this, a secondary analysis of a systematic review was conducted to quantify the relationship between SOFA scores and the prediction of mortality in critically ill adults in randomized controlled trials (RCTs). The systematic review being referred to included 87 RCTs with a total of 12,064 critically ill patients. This analysis focused on missing SOFA score data in relation to the length of stay on the intensive care unit (ICU) and the methods used to handle missing data. SOFA score measurements from the included studies were categorized into three time frames: Early (t ≤ 4 days), Intermediate (t = 5–10 days) and Late (t > 10 days) measurement. Only one study reported a complete data set for calculating the SOFA score for an Early measurement. When considering all methods used to address missing data, 32% of studies still had missing data for Early measurements, and this percentage increased to 64% for Late measurements. These findings suggested that, over time, the number of studies with incomplete data sets has been increasing. The longer a patient is treated on the ICU, the higher the number of missing data which can impact the validity of SOFA score analyses. There was no clear trend towards a specific method for compensating missing data. An exemplary calculation demonstrated that ignoring missing data may lead to an underestimated variability of the treatment effect. This, in turn, could bias the interpretation of study results by policy- and clinical decision-makers. Overall, there are several limitations that need to be considered when using SOFA score as a surrogate endpoint for mortality. When employed as an outcome, the SOFA score is frequently missing and most studies do not adequately describe the amount or nature of missing data, or the methods used to handle missing data in the analysis.