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The fragility of statistically significant findings from randomized trials in head and neck surgery
Author(s) -
Noel Christopher W.,
McMullen Caitlin,
Yao Christopher,
Monteiro Eric,
Goldstein David P.,
Eskander Antoine,
de Almeida John R.
Publication year - 2018
Publication title -
the laryngoscope
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.181
H-Index - 148
eISSN - 1531-4995
pISSN - 0023-852X
DOI - 10.1002/lary.27183
Subject(s) - medicine , interquartile range , randomized controlled trial , sample size determination , head and neck cancer , statistical significance , meta analysis , head and neck , surgery , radiation therapy , statistics , mathematics
Objectives The Fragility Index (FI) is a novel tool for evaluating the robustness of statistically significant findings in a randomized control trial (RCT). It measures the number of events upon which statistical significance depends. We sought to calculate the FI scores for RCTs in the head and neck cancer literature where surgery was a primary intervention. Data Sources Potential articles were identified in PubMed (MEDLINE), Embase, and Cochrane without publication date restrictions. Review Methods 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. Results 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 8 (IQR = 2.25–18.25). The median FI score was 1 (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). Conclusions Randomized trials in the head and neck cancer literature where surgery is a primary modality are relatively nonrobust statistically with low FI scores. Laryngoscope , 128:2094–2100, 2018