Outcome measures in Stevens–Johnson syndrome/toxic epidermal necrolysis: a systematic review
摘要
Evidence supporting Stevens–Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) management strategies is limited by small sample sizes and heterogeneous, poorly defined outcomes. An improved understanding of the selection and definition of commonly reported SJS/TEN outcome measures may facilitate the adoption of more precise, clinically meaningful metrics for use in future studies. A systematic review was performed using searches of PubMed, Scopus, and Embase databases, according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. All English language articles with at least 10 patients that reported outcomes of SJS/TEN and met prespecified criteria were included. A total of 282 studies met inclusion criteria. Out of 304 primary outcomes identified, only 47 (15.5%) were explicitly stated. The most common primary outcome was mortality (231/304; 76.0%), the timing and cause of which was clearly defined in only 39.8% of cases (92/231). The next most common primary outcome was skin healing (6.9%; 21/304), which was poorly defined and extremely heterogeneous across studies. A wide variety of other primary and secondary outcome measures were reported, such as hospital length of stay and infectious, pulmonary, and other complications. In summary, in most SJS/TEN studies, reported outcomes needed to be inferred, were poorly defined, and varied widely across studies, limiting generalizability and posing significant barriers to understanding SJS/TEN natural history and response to therapy. Future studies should seek rigorous definition and validation of standardized outcome measures for use in SJS/TEN clinical trials.