Publication
Title
How robust are clinical trials in primary and secondary ankle sprain prevention?
Author
Abstract
Objectives: Determine the statistical stability of RCTs examining primary and secondary prevention of ankle sprains.Methods: Databases were searched to August 2023. We included parallel design RCTs, using conservative interventions for preventing ankle sprain, reporting dichotomous injury event outcomes. Statistical stability was quantified using Fragility Index (FI) and Fragility Quotient (FQ). Subgroup analyses were undertaken to test if FI varied based on by study objective, original approach to analysis (frequency vs time to event), follow-up duration, and pre-registration.Results: 3559 studies were screened with 45 RCTs included. The median number of events required to change the statistical significance (FI) was 4 (IQR 1-6). FI was similar regardless of study objective, original analysis, followup duration, and pre-registration status. Median (IQR) FQ was 0.015 (0.005-0.046), therefore reversing events <2 patients/100 would alter significance. In 80% of studies the number of patients lost to follow-up was greater than the FI.Conclusion: RCTs informing primary and secondary prevention of ankle sprain are fragile. Only a small percentage of outcome event reversals would reverse study significance, and this is often exceeded by the number of drop outs. Robust reporting of dichotomous outcomes requires the use P values and key metrics such as FI or FQ.
Language
English
Source (journal)
Physical therapy in sport. - London
Publication
London : 2023
ISSN
1466-853X
DOI
10.1016/J.PTSP.2023.08.005
Volume/pages
64 (2023) , p. 85-90
ISI
001092036500001
Pubmed ID
37801794
Full text (Publisher's DOI)
Full text (open access)
The author-created version that incorporates referee comments and is the accepted for publication version Available from 04.04.2024
Full text (publisher's version - intranet only)
UAntwerpen
Faculty/Department
Research group
Publication type
Subject
Affiliation
Publications with a UAntwerp address
External links
Web of Science
Record
Identifier
Creation 04.12.2023
Last edited 08.12.2023
To cite this reference