Neurosurgical Evidence and Randomized Trials: The Fragility Index.
Effect size measures
Evidence
Fragility index
Neurosurgical trials
Randomized clinical trials
Study design
Journal
World neurosurgery
ISSN: 1878-8769
Titre abrégé: World Neurosurg
Pays: United States
ID NLM: 101528275
Informations de publication
Date de publication:
05 2022
05 2022
Historique:
received:
30
11
2021
accepted:
26
12
2021
entrez:
4
5
2022
pubmed:
5
5
2022
medline:
6
5
2022
Statut:
ppublish
Résumé
Neurosurgical randomized controlled trials (RCTs) are difficult to carry out due to the low incidence of certain diseases, heterogeneous disease phenotypes, and ethical issues. This results in a weak evidence base in terms of both the number of trials and their robustness. The fragility index (FI) measures the robustness of an RCT and is the minimum number of patients in a trial whose status would have to change from a nonevent to an event to change a statistically significant result to a nonsignificant result. The smaller the FI, the more fragile the trial's outcome. RCTs that have influenced neurosurgical practice were included in this analysis. Simulations were run to calculate the FI. To determine associations with a high or low FI, multivariable logistic regression was used to calculate adjusted odds ratios and 95% confidence intervals adjusting for baseline confounders. Of 2975 papers screened, 74 were included. The median FI was 4.5 (interquartile range: 1.5-10). RCTs included a median of 165 patients (interquartile range: 75-330), with a maximum of 10,008. A total of 38 trials had lost to follow-up patients that might have impacted the robustness of the results (51%). Results of neurosurgical RCTs on which we base our clinical decision-making and treatment guidelines are often fragile. Improved methodologies, international collaboration, and cooperation between specialties might improve the evidence base in the future.
Sections du résumé
BACKGROUND
Neurosurgical randomized controlled trials (RCTs) are difficult to carry out due to the low incidence of certain diseases, heterogeneous disease phenotypes, and ethical issues. This results in a weak evidence base in terms of both the number of trials and their robustness. The fragility index (FI) measures the robustness of an RCT and is the minimum number of patients in a trial whose status would have to change from a nonevent to an event to change a statistically significant result to a nonsignificant result. The smaller the FI, the more fragile the trial's outcome.
METHODS
RCTs that have influenced neurosurgical practice were included in this analysis. Simulations were run to calculate the FI. To determine associations with a high or low FI, multivariable logistic regression was used to calculate adjusted odds ratios and 95% confidence intervals adjusting for baseline confounders.
RESULTS
Of 2975 papers screened, 74 were included. The median FI was 4.5 (interquartile range: 1.5-10). RCTs included a median of 165 patients (interquartile range: 75-330), with a maximum of 10,008. A total of 38 trials had lost to follow-up patients that might have impacted the robustness of the results (51%).
CONCLUSION
Results of neurosurgical RCTs on which we base our clinical decision-making and treatment guidelines are often fragile. Improved methodologies, international collaboration, and cooperation between specialties might improve the evidence base in the future.
Identifiants
pubmed: 35505538
pii: S1878-8750(21)01941-0
doi: 10.1016/j.wneu.2021.12.096
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
224-229.e14Informations de copyright
Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.