Randomized Trials in Head Neck are Statistically Nonrobust

Study design: Potential articles were identified in PubMed, Embase, and Cochrane without publication date restrictions.

Synopsis: Two reviewers independently screened eligible RCTs reporting at least one dichotomous and statistically significant outcome. The data from each trial were extracted and the FI scores were calculated. Associations between trial characteristics and FI were determined.

In total, 27 articles were identified. The median sample size was 67.5 (interquartile range [IQR] = 42–143) and the median number of events per trial was eight (IQR = 2.25–18.25). The median FI score was one (IQR = 0–2.5), meaning that changing one patient from a nonevent to an event in the treatment arm would change the result to a statistically nonsignificant result, or P > .05. The FI score was less than the number of patients lost to follow-up in 71% of cases. The FI score was found to be moderately correlated with P value (ρ = −0.52, P = .007) and with journal impact factor (ρ = 0.49, P = .009) on univariable analysis. On multivariable analysis, only the P value was found to be a predictor of FI score (P = .001).

Citation: Noel CW, McMullen C, Yao C, Monteiro E, et al. The fragility of statistically significant findings from randomized trials in head and neck surgery [published online ahead of print April 23, 2018]. Laryngoscope. doi: 10.1002/lary.27183.