Department of Intensive Care Medicine. Medical Faculty, RWTH Aachen University, Aachen, Germany.
Sci Rep. 2024 Jul 12;14(1):16160. doi: 10.1038/s41598-024-67089-4.
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.
序贯器官衰竭评估（Sequential Organ Failure Assessment），又称 SOFA 评分，用于评估危重症患者的器官功能障碍。然而，了解随机对照试验中缺失 SOFA 评分的影响，以及这如何影响 SOFA 评分作为预测死亡率的替代终点的有效性和适用性，一直是人们关注的问题。为了解决这个问题，对一项系统评价进行了二次分析，以量化 SOFA 评分与危重症成人随机对照试验（RCT）中死亡率预测之间的关系。所参考的系统评价包括 87 项 RCT，共纳入 12064 例危重症患者。该分析重点关注与 ICU 住院时间（length of stay on the intensive care unit，ICU）和处理缺失数据方法相关的缺失 SOFA 评分数据。纳入研究的 SOFA 评分测量值分为三个时间框架：早期（t ≤ 4 天）、中期（t = 5-10 天）和晚期（t > 10 天）测量。只有一项研究报告了完整数据集，用于计算早期测量的 SOFA 评分。当考虑所有用于处理缺失数据的方法时，32%的研究仍存在早期测量的缺失数据，而晚期测量的缺失数据百分比增加到 64%。这些发现表明，随着时间的推移，缺失数据集的研究数量一直在增加。患者在 ICU 接受治疗的时间越长，缺失数据的数量就越多，这可能会影响 SOFA 评分分析的有效性。对于缺失数据的补偿方法并没有明确的趋势。一个示例计算表明，忽略缺失数据可能会导致治疗效果的可变性被低估。这反过来又会影响政策制定者和临床决策者对研究结果的解释。总体而言，在将 SOFA 评分作为死亡率的替代终点使用时，存在几个需要考虑的限制。当作为结局使用时，SOFA 评分经常缺失，且大多数研究没有充分描述缺失数据的数量或性质，或者在分析中用于处理缺失数据的方法。
