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Incomplete Intervention Description, Incorrect Exploratory Outcome Data, and Incorrect Axis Labels.

analysis of the modified SOFA (mSOFA) scores in the CITRISALI trial.1 de Grooth and colleagues suggest that our analysis had survivorship bias, focusing on the mSOFA scores of patients surviving while ignoring data from the remainder of the population (ie, mSOFA scores of the patients who died). Debate continues concerning the correct statistical techniques required for accurate interpretation of clinical trial results, especially in trials such as CITRIS-ALI in which patients are critically ill.3 de Grooth and colleagues were surprised by a lack of mSOFA score differences between placeboand vitamin C–treated patients yet a significant difference in survival at 96 hours. What was not considered were the mSOFA scores of patients who died during the 96-hour treatment period. We performed a post hoc analysis assigning a maximum mSOFA score of 20 in patients who had missing mSOFA elements because of death on the same day and a minimum score of 0 for patients who were discharged from the intensive care unit and had missing mSOFA scores. The treatment caused the missing data, which thus were not missing at random or normally distributed. We applied the Mann-Whitney rank sum test4 to compare the ranked mSOFA scores at 0, 48, and 96 hours. We found no statistically significant differences in mSOFA scores between the vitamin C and placebo groups at 0 and 48 hours (P = .32 and P = .17, respectively) (Figure). However, we found a statistically significant difference in the mSOFA scores at 96 hours (P = .03). There was a 60% probability that any random patient from the placebo group had a higher mSOFA score than any random patient from the vitamin C group. Although the result at 96 hours differs from the primary analysis, this analysis is post hoc and exploratory and does not change the conclusion of the study.