The Statistical Fragility of Orbital Fractures: A Systematic Review of Randomized Controlled Trials

Megafu, Michael; Megafu, Emmanuel; Nguyen, Janet T.; Mian, Hassan; Singhal, Sulabh; Parisien, Robert L.

doi:10.1016/j.joms.2023.02.012

Cited by 9 publications

(5 citation statements)

References 32 publications

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“…Megafu and Megafu in examining the distal radius fracture literature reported an FI of 9, the highest FI within all orthopedic and spine literature to date [ 24 ]. Other trauma literature looking at fibula fractures, distal femur fractures, and orbital fractures reported a similar FI of 5 across all studies [ 25 – 27 ]. By the spine and orthopedic literature, the FI consistently demonstrates statistical fragility, thus confirming our hypothesis and continual evidence of fragile results within the spine and orthopedic literature.…”

Section: Discussionmentioning

confidence: 56%

The Fragility of Statistical Findings in Cervical Disc Arthroplasty: a Systematic Review of Randomized Controlled Trials

Megafu,

Nguyen

et al. 2024

Arch Orthop Trauma Surg

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Purpose This study employs both the fragility index (FI) and fragility quotient (FQ) to assess the level of robustness in the cervical disc arthroplasty (CDA) literature. We hypothesize that dichotomous outcomes involving CDA would exhibit statistical vulnerability. Methods A PubMed search was conducted to evaluate dichotomous data for randomized controlled trials (RCTs) in CDA literature from 2000 to 2023. The FI of each outcome was calculated through the reversal of 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. Results Of the 1561 articles screened, 111 met the search criteria, with 35 RCTs evaluating CDA included for analysis. Six hundred and ninety-three outcome events with 130 significant (P < 0.05) outcomes and 563 nonsignificant (P ≥ 0.05) outcomes were identified. The overall FI and FQ for all 693 outcomes were 5 (IQR 3–7) and 0.019 (IQR 0.011–0.043). Fragility analysis of statistically significant outcomes and nonsignificant outcomes both revealed an FI of 5. All of the studies reported loss to follow-up (LTF) data where 65.7% (23) did not report or reported an LTF greater or equal to 5. Conclusions The literature regarding CDA RCTs lacks statistical robustness and may misrepresent the conclusions with the sole use of the P value. By implementing the FI and FQ along with the P value, we believe the interpretation and contextualization of the clinical data surrounding CDA will be better understood.

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Section: Discussionmentioning

confidence: 56%

The Fragility of Statistical Findings in Cervical Disc Arthroplasty: a Systematic Review of Randomized Controlled Trials

Megafu,

Nguyen

et al. 2024

Arch Orthop Trauma Surg

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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%

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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“…Orbital floor fractures (OFFs) represent an interesting chapter of maxillofacial traumatology that is much debated in the scientific community regarding its epidemiological, clinical, and demographic characteristics [ 1 , 2 ]. Their incidence is increasing, probably due to the increase in road accidents, sporting accidents, and physical assaults.…”

Section: Introductionmentioning

confidence: 99%

Classical Orbital Floor Post-Traumatic Reconstruction vs. Customized Reconstruction with the Support of “In-House” 3D-Printed Models: A Retrospective Study with an Analysis of Volumetric Measurement

Kallaverja,

Barca,

Ferragina

et al. 2024

Diagnostics

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Background: Orbital floor fractures (OFFs) represent an interesting chapter in maxillofacial surgery, and one of the main challenges in orbit reconstruction is shaping and cutting the precise contour of the implants due to its complex anatomy. Objective: The aim of the retrospective study was to demonstrate, through pre- and postoperative volumetric measurements of the orbit, how the use of a preformed titanium mesh based on the stereolithographic model produced with 3D printers (“In-House” reconstruction) provides a better reconstruction volumetric compared to the intraoperatively shaped titanium mesh. Materials and Methods: The patients with OFF enrolled in this study were divided into two groups according to the inclusion criteria. In Group 1 (G1), patients surgically treated for OFF were divided into two subgroups: G1a, patients undergoing orbital floor reconstruction with an intraoperatively shaped mesh, and G1b, patients undergoing orbital floor reconstruction with a preoperative mesh shaped on a 3D-printed stereolithographic model. Group 2 (G2) consisted of patients treated for other traumatic pathologies (mandible fractures and middle face fractures not involving orbit). Pre- and postoperative orbital volumetric measurements were performed on both G1 and G2. The patients of both groups were subjected to the measurement of orbital volume using Osirix software (Pixmeo SARL, CH-1233 Bernex, Switzerland) on the new CT examination. Both descriptive (using central tendency indices such as mean and range) and regressive (using the Bravais–Pearson index, calculated using the GraphPad program) statistical analyses were performed on the recorded data. Results: From 1 January 2017 to 31 December 2021, of the 176 patients treated for OFF at the “Magna Graecia” University Hospital of Catanzaro 10 fulfilled the study’s inclusion criteria: 5 were assigned to G1a and 5 to G1b, with a total of 30 volumetric measurements. In G2, we included 10 patients, with a total of 20 volumetric measurements. From the volumetric measurements and statistical analysis carried out, it emerged that the average of the volumetric differences of the healthy orbits was ±0.6351 cm3, the standard deviation of the volumetric differences was ±0.3383, and the relationship between the treated orbit and the healthy orbit was linear; therefore, the treated orbital volumes tend to approach the healthy ones after surgical treatment. Conclusion: This study demonstrates that if the volume is restored within the range of the standardized mean, the diplopia is completely recovered already after surgery or after one month. For orbital volumes that do not fall within this range, functional recovery could occur within 6 months or be lacking. The restoration of the orbital volume using pre-modeled networks on the patient’s anatomical model, printed internally in 3D, allows for more accurate reconstructions of the orbital floor in less time, with clinical advantages also in terms of surgical timing.

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The Statistical Fragility of Orbital Fractures: A Systematic Review of Randomized Controlled Trials

Cited by 9 publications

References 32 publications

The Fragility of Statistical Findings in Cervical Disc Arthroplasty: a Systematic Review of Randomized Controlled Trials

The Fragility of Statistical Findings in Cervical Disc Arthroplasty: 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

Classical Orbital Floor Post-Traumatic Reconstruction vs. Customized Reconstruction with the Support of “In-House” 3D-Printed Models: A Retrospective Study with an Analysis of Volumetric Measurement

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