Comment: In head and neck surgical oncology, we tend to take the findings of our relatively limited number of randomized trials as gospel because they are the “highest level of evidence.” However, these authors from Toronto found that, in most randomized surgical trials in our literature, changing one patient from a nonevent to an event in the treatment arm would change the result to a statistically nonsignificant result. In other words, in most studies, changing the outcome of a single patient completely changes the conclusions of the study. Additionally, the finding that the fragility index (FI) was less than the number of patients lost to follow-up in 71% of cases calls into question the quality and validity of many of these trials that we base critical treatment decisions on. —Andres Bur, MD
How robust are the statistically significant findings in randomized trials in the head and neck cancer literature where surgery was a primary intervention?