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Background: Symptomatic rotator cuff tears often undergo surgical repair, which may be paired with various augmentation strategies to enhance structural healing rates. While many randomized controlled trials (RCTs) evaluate augmentation techniques, the statistical robustness of many findings in these studies is unknown. This systematic review aims to evaluate the continuous fragility index (CFI) of RCTs on augmentation techniques for rotator cuff repairs., Methods: MEDLINE, Embase, and CENTRAL databases were comprehensively searched from inception to September 2023 for RCTs assessing the efficacy of at least one augmentation strategy during rotator cuff repair. Eligible studies reported at least one statistically significant finding for a continuous outcome. The CFI for eligible outcomes was calculated, with median CFI presented by type of augmentation and outcome. Multivariable regression was performed to identify associations between CFI and other outcome variables., Results: Nineteen RCTs (1417 patients) were included in the final analysis. The median CFI for the 86 outcomes analyzed was 5.85 (IQR 2.3 - 14.4). Augmentation-specific analysis demonstrated variability in CFIs, with the most robust outcomes found in platelet-rich plasma studies (median 10.95, IQR 3.3 - 19.0) and suture-spanning augmentation studies (median 11.90, IQR 11.45 - 14.35). Outcome-specific analysis demonstrated range of motion outcomes as most robust (median 9.85, IQR 7.58 - 14.0) and strength-related outcomes as most fragile (median 2.00, IQR 1.0 - 16.3). Multivariable regression identified larger sample size as a statistically significant predictor of greater CFI. Notably, loss to follow-up exceeded the CFI in 31.4% of outcomes., Conclusion: The observed median CFI of 5.85 in augmentation trials is consistent with the CFI reported in orthopedic and sports medicine literature. However, almost a third of outcomes had a loss to follow-up exceeding their CFI, risking the reversal of study findings with more robust follow-up and outcomes. Clinicians and researchers should consider fragility in addition to p-values when assessing study results, especially in the context of high loss to follow-up. Future trials should report the fragility of their findings., Level of Evidence: Systematic Review; Research Methodology Study., (Copyright © 2024. Published by Elsevier Inc.)

Background: Reverse total shoulder arthroplasty (RTSA) has seen increasing utilization as an effective intervention for a wide variety of shoulder pathologies. The scope and indications for growth are often driven by findings from randomized controlled trials (RCTs) guiding surgical decision-making for RTSA. In this study, we utilized the fragility index (FI), reverse fragility index (rFI), and fragility quotient (FQ) to assess the robustness of outcomes reported in RCTs in the RTSA literature., Methods: PubMed, Embase, and MEDLINE were queried for RCTs (Jan. 1, 2010-Mar. 31, 2023) in the RTSA literature reporting dichotomous outcomes. The FI and rFI were defined as the number of outcome reversals required to alter statistical significance for significant and nonsignificant outcomes, respectively. The FQ was determined by dividing the FI by the sample size of each study. Subgroup analysis was performed based on outcome category., Results: One hundred seventy-six RCTs were screened with 18 studies included. The median FI across 59 total outcomes was 4 (interquartile range [IQR]: 3-5) with an associated FQ of 0.051 (IQR: 0.029-0.065). Thirteen outcomes were statistically significant with a median FI of 3 (IQR: 1-4) and FQ of 0.033 (IQR: 0.012-0.066). Forty-six outcomes were nonsignificant with a median rFI of 4 (IQR: 3-5) and FQ of 0.055 (IQR: 0.032-0.065). The most fragile outcome category was revision/reoperations with a median FI of 2.50 (IQR: 1.00-3.25), followed by clinical score/outcome (median FI: 3.00), complications (median FI: 4.00), "other" (median FI: 4.00), and radiographic findings (median FI: 5.00). Notably, the number of patients lost to follow-up was greater than or equal to the FI for 59% of outcomes., Conclusion: The statistical findings in RTSA RCTs are fragile and should be interpreted with caution. Reversal of only a few outcomes, or maintaining postoperative follow-up, may be sufficient to alter significance of study findings. We recommend standardized reporting of P values with FI and FQ metrics to allow clinicians to effectively assess the robustness of study findings., (Copyright © 2024 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.)

Background: The purpose of this present study was to perform a fragility analysis to assess the robustness of randomized controlled trials (RCTs) evaluating the distal biceps tendon repairs. We hypothesize that the dichotomous outcomes will be statistically fragile, and higher fragility will exist among statistically significant outcomes comparable to other orthopedic specialties., Methods: Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), randomized controlled trials from 4 orthopedic journals indexed on PubMed from 2000 to 2022 reporting dichotomous measures relating to distal biceps tendon repairs were included. The fragility index (FI) of each outcome was calculated through the reversal of a single outcome event until significance was reversed. The fragility quotient (FQ) was calculated by dividing each fragility index by study sample size. The interquartile range (IQR) was also calculated for the FI and FQ., Results: Of the 1038 articles screened, 7 RCTs containing 24 dichotomous outcomes were included for analysis. The fragility index and fragility quotient of all outcomes was 6.5 (IQR 4-9) and 0.077 (IQR 0.031-0.123), respectively. However, statistically significant outcomes had a fragility index and fragility quotient of 2 (IQR 2-7) and 0.036 (IQR 0.025-0.091), respectively. The average number of patients lost to follow-up was 2.7 patients, with 28.6% of the included studies reporting loss to follow-up (LTF) greater than or equal to 6.5., Conclusions: The literature surrounding distal biceps tendon repair may not be as stable as previously thought and presents a similar fragility index to other orthopedic subspecialties. We therefore recommend triple reporting the P value, fragility index, and fragility quotient to aid in the interpretation of clinical findings reported in biceps tendon repair literature., (Copyright © 2023 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.)

Background: Clinical decision-making often relies on evidence-based medicine. Our purpose was to determine the fragility index (FI) and fragility quotient (FQ) for studies evaluating rotator cuff repair (RCR) with graft augmentation. A lost to follow-up (LTF) value greater than the FI indicates statistical instability for the reported outcomes and conclusions., Methods: We performed a systematic review using Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines by searching PubMed, the Cochrane library, and Embase in June 2022 to identify studies of RCR with graft augmentation. Comparative studies with at least 1 statistically analyzed dichotomous outcome were included. Seventeen studies published in seven peer-reviewed journals from 2003 to 2019 were subsequently evaluated. The FI was determined by changing each reported outcome event within 2 × 2 contingency tables until statistical significance or nonsignificance was reversed. The associated FQ was determined by dividing the FI by the sample size. LTF values were also extracted from each included study., Results: The included studies had a total of 1098 patients with 36 dichotomous outcomes. The associated median FI was 4 (interquartile range 2-5), indicating that the reversal of 4 patients' outcomes would have reversed the finding of significant difference. The median FQ was 0.08 (interquartile range 0.04-0.15), indicating that in a sample of 100 patients, reversal of 8 patients' outcomes would reverse statistical significance. The median number of patients LTF was 3 (range 0-25), with 56% of reported outcomes having LTF greater than their respective FI., Conclusion: Studies of RCR with graft augmentation lack statistical stability, with few altered outcome events required to reverse statistical significance. Larger comparative studies with better follow-up will strengthen the statistical stability of the evidence for RCR with graft augmentation. For future investigations and reports, we recommend including FI and FQ along with traditional statistical significance analyses to provide better context on the strength of conclusions., (Copyright © 2023 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.)

Background: Proximal humeral fracture represents an increasingly common pathology with evaluation and treatment often guided by evidence from randomized controlled trials (RCTs), but the strength of an RCT must be considered in this process. The purpose of this study was to evaluate the strength of outcomes in RCTs on the management of proximal humeral fractures using the fragility index (FI), a method used with statistically significant dichotomous outcomes to assess the number of patients that would change an outcome measure from significant (P ≤ .05) to nonsignificant if the patient outcome changed. We also aimed to correlate the FI with other measures of study strength., Methods: A systematic review was performed using Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines to evaluate RCTs on the management of proximal humeral fractures. The PubMed, Ovid MEDLINE, Web of Science, and Embase databases were searched from database inception to May 2021. RCTs with at least 1 statistically significant (P ≤ .05) dichotomous outcome were included. The FI was calculated for each included trial using the Fisher exact test. The FI was correlated with the study sample size and journal impact factor., Results: Ten RCTs reporting on 656 patients and published between 2011 and 2020 were included. The median patient sample size was 67 (mean, 65.6; range, 40-86). Complications were the most commonly reported dichotomous statistically significant outcome. The median FI was 1 (mean, 2.6; range, 0-18), with 4 studies having an FI of 0. A median FI of 1 indicates that 1 patient experiencing an alternative outcome or having not been lost to follow-up could have changed the pertinent conclusions of the trial for a given outcome. The median number of patients lost to follow-up was 3 (mean, 4.9; range, 0-16) and exceeded the FI in 50% of studies. There was no correlation between the FI and sample size (Spearman coefficient = 0.0592, P = .865) or between the FI and journal impact factor (Spearman coefficient = -0.0229, P = .522)., Conclusion: In most studies of proximal humeral fractures, only 1 or 2 patients experiencing an alternative outcome or lost to follow-up would change the conclusions for the dichotomous outcome studied. Although the FI cannot be used to assess continuous variables, which are often the primary outcome variables of RCTs, it does offer an additional unique measure of study strength that surgeons should consider when evaluating RCTs., (Copyright © 2022 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.)

Background: The P value is a statistical tool used to assess the statistical significance of clinical trial outcomes in orthopedic surgery. However, the P value does not evaluate research quality or clinical significance. The Fragility Index (FI) is an alternative statistical method that can be used to assess the quality and significance of clinical research and is defined as the number of patients in a study intervention group necessary to convert an outcome from statistically significant to statistically insignificant or vice versa. The primary purpose of this study was to evaluate the statistical robustness of clinical trials regarding shoulder arthroplasty using the FI. The secondary goal was to identify trial characteristics associated greater statistical fragility., Methods: A systematic review of randomized clinical trials in shoulder arthroplasty was performed. The FI was calculated for all dichotomous, categorical study outcomes discussed in the identified studies. Descriptive statistics and the Pearson correlation coefficient were used to evaluate all studies and characterize associations between study variables., Results: A total of 13 randomized controlled trials were identified and evaluated; these trials had a median sample size of 47 patients (mean, 54 patients; range, 26-102 patients) and a median of 7 patients (mean, 5.8 patients; range, 0-14 patients) lost to follow-up. The median FI was 6 (mean, 5; range, 1-11), a higher FI than what has been observed in other orthopedic subspecialties. However, the majority of outcomes (74.4%) had an FI that was less than the number of patients lost to follow-up, and most outcomes (89.7%) were statistically insignificant., Conclusion: Randomized controlled trials in shoulder arthroplasty have comparable statistical robustness to the literature in other orthopedic surgical subspecialties. We believe that the inclusion of the FI in future comparative studies in the shoulder arthroplasty literature will allow surgeons to better assess the statistical robustness of future research., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Considered the gold standard of study designs, randomized controlled trials' (RCTs) results shape clinical practice, effect policy, and influence reimbursement. The fragility index (FI) can be used to quantitate the relative robustness of RCT results, with higher scores indicating more stout results. Unfortunately, most RCTs in surgery have fragile results. The aim of this study was to report on the FI in addition to a qualitative assessment of recent RCTs within the field of shoulder and elbow surgery., Methods: A systematic review was performed identifying recently published shoulder/elbow RCTs that included 1:1 allocated parallel study arms, dichotomous primary outcome variables, and statistical significance. The FI was calculated by sequentially modifying outcome groups by exchanging a nonevent in one group to an event until the P value for the outcome comparison, as calculated by the Fisher exact test, was increased above the .05 threshold., Results: Thirty RCTs were included. The median FI was 4. Sixty percent trials had a FI of 2 or less. Fifty-three percent studies reported that participants were lost to follow-up. In 87.5% of these studies, the losses to follow-up exceeded their respective FIs. Only 53% of studies defined a primary outcome variable and 60% studies performed a prestudy power analysis., Conclusions: The median FI reported in the recent shoulder/elbow literature is 4; however, a high proportion of included RCTs display significant methodological concerns. The FI is a useful adjunct to analyze RCT results, but careful analysis of trial methods should be employed in each circumstance before drawing conclusions., (Copyright © 2019 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.)

Background: Statistical significance, as reported by the P value, has traditionally been the most commonly reported way to determine whether a difference exists between clinical interventions. Unfortunately, P values alone confer little about the robustness of a study's conclusions. An emerging metric, the fragility index (FI), helps to address this challenge by quantifying the number of events per outcome group that would need to be reversed to the alternative outcome in order to raise the P value above the 0.05 threshold., Methods: Using systematic search strategy, we identified randomized controlled trials (RCTs) pertaining to clavicular fractures published in the last decade (2007-2017). Studies included for analysis involved 2 parallel arms, were published in English, allocated patients to treatment and control arms in a 1:1 ratio, and reported statistical significance (P < .05) for dichotomous variables. The FI was determined based on the Fisher exact test, using previously published methods., Results: Fifteen RCTs were included. The median FI was 2 (range, 0-17). Eleven studies (73.3%) had an FI of 2 or less. Seven of the trials (46.7%) reported that the number of patients lost to follow-up exceeded the FI., Conclusions: The median FI reported in the recent literature on clavicular fractures is only 2. The FI is a useful metric to analyze the robustness of study conclusions that should complement other methods of critical data evaluation, including the P value or effect sizes. Future efforts are needed to increase institutional collaboration and patient recruitment to strengthen the robustness of RCT conclusions, especially in the realm of clavicular fracture management., (Copyright © 2018 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.)