Search

Critical analysis of studies with high level of evidence has relied on the significance set by the reported P values. However, this strategy steers readers toward categorical interpretation of the data; therefore, a more comprehensive approach of data analysis is warranted. The continuous fragility index (CFI) allows for frailty interpretation of any given study's continuous outcome results.To calculate the CFI of high-level quality studies reporting significant continuous outcomes on comparison of treatment modalities for management of femoroacetabular impingement syndrome.Meta-analysis; Level of evidence, 2.Three databases (PubMed, Embase, Cochrane) were queried from inception to February 2024 utilizing Boolean operators to combine variations of the following search terms: “femoroacetabular impingement, randomized controlled trials or prospective cohort.” Studies were included if level of evidence 1 or 2, and a statistically significant outcome was reported for any continuous outcome. CFI calculation was performed for all significant outcomes to obtain a study-specific mean CFI and also for the primary outcome of each study. Mean CFI was also calculated for outcomes reported to be significant in >3 studies. Additionally, multivariable linear regression was utilized for assessment of variables associated with achievement of a higher CFI.Thirteen studies totaling 1316 patients were included for analysis: 11 level of evidence 1 and 2 level of evidence 2 studies. A total of 48 outcomes reaching significance were extracted, with 8 representing primary outcomes. Study-specific mean (SD) CFI was 8 (9.3), whereas primary outcome mean CFI was 12.5 (12). In 4 of the 13 studies, the number of hips lost to follow-up was greater than the study CFI. Outcome-specific mean CFI was obtained for 5 outcomes reported in >3 studies. Multivariable linear regression revealed that larger sample size and greater journal impact factor had a significant positive association with a higher overall CFI value (P < .05).The mean (SD) number of patient outcome events needed to reverse the significance of a continuous outcome (ie, CFI) was 8.0 (9.3). Nearly one-third of studies had a CFI less than the reported loss to follow-up, reflecting the need for better patient compliance to attain less fragile statistical results. Larger sample size and greater journal impact factor were both predictive of a higher CFI. [ABSTRACT FROM AUTHOR]

Randomized controlled trials (RCTs) represent the highest level of evidence in guiding the management of clavicle fractures. They are conducted to ensure that evidence drives the basis of treatment algorithms. Relying solely on P values to assess orthopedic RCTs may be deceptive and challenge the validity of the studies.To evaluate the degree of statistical fragility in the clavicle fracture literature using the fragility index (FI) and fragility quotient (FQ).A systematic search strategy using the Medline, PubMed, and Embase databases was used to find all dichotomous data for randomized controlled trials (RCTs) in clavicle fracture research from 2000 to 2024. The FI of each outcome was calculated by reversing a single outcome event until significance was reversed. The FQ was calculated by dividing each fragility index by the study sample size. The interquartile range (IQR) was also calculated for the FI and FQ.Of the 3646 articles screened, 81 met the search criteria, with 30 RCTs evaluating clavicle fractures included for analysis. There were 250 total outcomes, where 62 significant and 188 nonsignificant outcomes were identified. The overall FI and FQ were 4 (IQR 3–5) and 0.045 (IQR 0.024–0.080). Statistically significant and nonsignificant outcomes had an FI of 3.5 (IQR 2–7) and 4 (IQR 3–5), respectively. Regarding loss to follow-up (LTF), 63.3% (19) reported LTF greater or equal to the overall FI of 4.When scrutinizing management algorithms relying on statistical analysis, we recommend including the FI and FQ alongside the P value. [ABSTRACT FROM AUTHOR]

Background: Fragility Index (FI) is increasingly used to assess robustness of statistically significant p-values reported in randomized controlled trials (RCTs). FI represents the lowest number of non-events changed to events that would make study findings non-significant. This methodological survey was designed to assess the fragility of the evidence for extended VTEp following major abdominopelvic surgery., Methods: MEDLINE, Embase, and CENTRAL were searched from inception to November 2023. RCTs with parallel, double-armed, superiority design comparing extended VTEp for patients undergoing major abdominopelvic surgery to controls with at least one statistically significant dichotomous outcome were included. Walsh et al.'s method of calculating FI was utilized., Results: After review of 611 citations, 6 RCTs were identified with 12 statistically significant outcomes between groups. The mean number of patients randomized per RCT was 419 (SD 176). The median FI was 1.5 (range: 1-4). The number of patients lost to follow-up was greater than the FI for 10/12 (83.3 ​%) outcomes., Conclusions: Statistically significant differences reported in RCTs evaluating extended VTEp following major abdominopelvic surgery are not robust., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)