Limitations
sepsis
SEPSIS, CRITICAL ILLNESS, DISORDERS, SECONDARY
This study has several limitations. First, interpretation was restricted to those who survived sepsis. How survivorship influenced the interpretation of results was unclear, although understanding the differences in patient-reported outcomes based on survivorship remains valuable. Second, a common problem among studies of cognitive and psychological outcomes after critical illness is the unplanned nature of inclusion and the resultant difficulty in adequately assessing for premorbid cognitive and psychological disorders. Despite randomization, there could be baseline differences in cognitive measures among participants in the follow-up cohort that cannot be quantified or controlled in the analysis. We did not collect baseline cognitive or psychological data, which warrants the cautious interpretation of the results.Third, 40 of 303 eligible participants (13.2%) did not consent to follow-up assessment. The fact that trial participants were not automatically included in this secondary analysis and had to express willingness to participate may have increased attrition. Furthermore, the VICTAS trial was administratively terminated due to withdrawal of funding, leading to a truncated follow-up window for a small proportion (4.6%) of eligible participants. Nonetheless, we were able to obtain at least partial follow-up assessments for approximately 85% of eligible participants, and these sepsis survivors did not differ in characteristics from those who withdrew, refused assessment, or were ultimately lost to follow-up. Some participants were unable or unwilling to complete a few of the assessments, and the rates of missing data reached nearly 25% for several assessments. Among participants who were included in the follow-up cohort, the most common reason for failure to complete an assessment was patient refusal (eTable 2 in 