The Fragility of Statistical Findings in Distal Radius Fractures: A Systematic Review of Randomized Controlled Trials

Megafu, Michael; Megafu, Emmanuel

doi:10.1016/j.injury.2022.07.017

Cited by 20 publications

(8 citation statements)

References 25 publications

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“…These findings align with the emerging evidence in the orthopaedic literature. [21][22][23][24][25][26][27][28][29][30][31] Megafu and Megafu 22 found an FI of 4 for significant outcomes in their evaluation of dichotomous outcomes for distal radius fractures. In an analysis of distal femur fractures, an FI of 1 was demonstrated for significant outcomes.…”

Section: Discussionmentioning

confidence: 99%

“…Analyses within the orthopaedic literature consistently reveal fragility, with many authors reporting FI and FQ values similar to the overall median FI and FQ in this article. [21][22][23][24][25][26][27][28][29][30][31] As research in this area continues to develop, researchers can explore the integration of other statistical tools like the minimal clinically important difference, substantial clinical benefit, and patient-acceptable symptomatic state to establish recommended FI and FQ thresholds for statistically significant outcomes. In the meantime, including FI and FQ in the analysis of fragility in RCTs can provide clinicians with a more comprehensive and accurate understanding of the trial's significance and reported significant outcomes.…”

Section: Discussionmentioning

confidence: 99%

“…6 The FI has since been used widely in the orthopaedic literature to assess the stability across study findings. [7][8][9][10][11][12][13][14][15][16] The reverse fragility index (rFI) is a similar metric that evaluates the number of outcome event reversals needed to alter nonsignificant findings that has also been used widely. [17][18][19] A smaller FI or rFI value indicates that fewer outcome event reversals are needed to alter outcome significance and thus statistical fragility is appreciated.…”

Section: Introductionmentioning

confidence: 99%

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The Fragility of Statistical Findings in the Femoral Neck Fracture Literature: A Systematic Review of Randomized Controlled Trials

Yendluri,

Megafu,

Wang

et al. 2024

Journal of Orthopaedic Trauma

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Objectives: Randomized controlled trials (RCTs) in the femoral neck fracture literature frequently report p-values for outcomes which have substantial implications in guiding surgical management. This study utilized the fragility index (FI), reverse fragility index (rFI), and fragility quotient (FQ) to assess the statistical stability of outcomes reported in RCTs evaluating the management and treatment of femoral neck fractures. Methods: Data Sources: Pubmed, Emabse, and MEDLINE were queried for RCTs (January 1, 2010 to February 28th, 2023) that evaluated surgical management/treatment of femoral neck fractures. Study Selection: RCTs with two treatment arms reporting categorical dichotomous outcomes were included. Non-RCT studies, RCTs with greater than 2 treatment arms, and RCTs without a femoral neck fracture cohort were excluded. Data Extraction and Synthesis: The FI and rFI were calculated as the number of outcome event reversals required to alter statistical significance for significant (p<0.05) and non-significant (p≥0.05) outcomes, respectively. The FQ was calculated by dividing the FI by the sample size for the study. Results: 985 articles were screened with 71 studies included for analysis. The median FI across a total of 197 outcomes was 4 (IQR 2-5) with an associated FQ of 0.033 (IQR 0.017-0.060). 47 outcomes were statistically significant with a median FI of 2 (IQR 1-4) and associated FQ of 0.02 (IQR 0.014-0.043). 150 outcomes were statistically non-significant with a median rFI of 4 (IQR 3-5) and associated FQ of 0.037 (IQR 0.019-0.065). Conclusion: Statistical findings in femoral neck fracture RCTs are fragile with reversal of a median 4 outcomes altering significance of study findings. The authors thus recommend standardized reporting of p-values with FI and FQ metrics to aid in interpreting the robustness of outcomes in femoral neck fracture RCTs. Level of evidence: Level I. See Instructions for Authors for a complete description of levels of evidence.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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The Fragility of Statistical Findings in the Femoral Neck Fracture Literature: A Systematic Review of Randomized Controlled Trials

Yendluri,

Megafu,

Wang

et al. 2024

Journal of Orthopaedic Trauma

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“…Authors from Kirksville (Missouri, USA) have usefully reviewed the RCTs on distal radius fracture fixation to assess the fragility of the findings. 4 A Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) compliant search of 13 high-impact orthopaedic journals over a 21-year period to 2021 was performed. The resultant studies were screened for reporting dichotomous categorical outcomes with p-values, and studies with more than two treatment groups were excluded.…”

Section: How Certain Are Findings In Distal Radius Fractures: a Syste...mentioning

confidence: 99%

Wrist & Hand

2022

Bone & Joint 360

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The December 2022 Wrist & Hand Roundup360 looks at: Anti-tumour necrosis factor therapy for early-stage Dupuytren’s disease; Patient experiences of scaphoid waist fractures and their treatment; Postoperative complications following open a1 pulley release for a trigger finger or thumb; How certain are findings in distal radius fractures: a systematic review of randomized controlled trials; Partial wrist denervation in wrist osteoarthritis: patient-reported outcomes and objective function; Dorsal bridge plating versus bridging external fixation for management of complex distal radius fractures; How is reduction lost in distal radius fractures in females aged 50 years and older; The HAND-Q: psychometrics of a new patient-reported outcome measure for clinical and research applications.

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“…In recent years, this method has been applied throughout the surgical literature to better understand the fragility of RCTs in distinct subspecialties, including orthopedics, neurosurgery, colorectal surgery, and even plastic surgery. [8][9][10][11][12] However, these previous meta-analyses did not discuss the content or the impact of the articles they included, thus foregoing perspective on the true ramifications of their findings.…”

Section: Introductionmentioning

confidence: 99%

The Fragility of Landmark Randomized Controlled Trials in the Plastic Surgery Literature

Ormseth,

ElHawary,

Janis

2024

Plastic and Reconstructive Surgery - Global Open

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Background: Randomized controlled trials (RCTs) are integral to the progress of evidenced-based medicine and help guide changes in the standards of care. Although results are traditionally evaluated according to their corresponding P value, the universal utility of this statistical metric has been called into question. The fragility index (FI) has been developed as an adjunct method to provide additional statistical perspective. In this study, we aimed to determine the fragility of 25 highly cited RCTs in the plastic surgery literature. Methods: A PubMed search was used to identify the 25 highest cited RCTs with statistically significant dichotomous outcomes across 24 plastic surgery journals. Article characteristics were extracted, and the FI of each article was calculated. Additionally, Altmetric scores were determined for each study to determine article attention across internet platforms. Results: The median FI score across included studies was 4 (2–7.5, interquartile range). The two highest FI scores were 208 and 58, respectively. Four studies (16%) had scores of 0 or 1. Three studies (12%) had scores of 2. All other studies (72%) had FI scores of 3 or higher. The median Altmetric score was 0 (0–3). Conclusion: The FI can provide additional perspective on the robustness of study results, but like the P value, it should be interpreted in the greater context of other study elements.

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The Fragility of Statistical Findings in Distal Radius Fractures: A Systematic Review of Randomized Controlled Trials

Cited by 20 publications

References 25 publications

The Fragility of Statistical Findings in the Femoral Neck Fracture Literature: A Systematic Review of Randomized Controlled Trials

The Fragility of Statistical Findings in the Femoral Neck Fracture Literature: A Systematic Review of Randomized Controlled Trials

Wrist & Hand

The Fragility of Landmark Randomized Controlled Trials in the Plastic Surgery Literature

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