The Statistical Stability of Clavicle Fracture Management: A Systematic Review of Randomized Controlled Trials with Fragility Analysis

The Statistical Stability of Clavicle Fracture Management: A Systematic Review of Randomized Controlled Trials with Fragility Analysis | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article The Statistical Stability of Clavicle Fracture Management: A Systematic Review of Randomized Controlled Trials with Fragility Analysis Michael N. Megafu, Elisabeth Point Du Jour, Janet T. Nguyen, Emmanuel C. Megafu, and 4 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4132465/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Purpose This study applied the fragility index (FI) and fragility quotient (FQ) to evaluate the degree of statistical fragility in the clavicle fracture literature. Methods This review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A PubMed systematic search strategy was used to find all dichotomous data for randomized controlled trials (RCTs) in clavicle fracture research from 2000 to 2022. 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. Results Of the 2967 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. Conclusions Relying solely on P values to assess clavicle fracture RCTs may be deceptive and challenge the studies' validity. When scrutinizing management algorithms relying on statistical analysis, we recommend including the FI and FQ alongside the P value. statistical fragility fragility index clavicle fractures P value reverse fragility index Figures Figure 1 Figure 2 INTRODUCTION Clavicle fractures are among the most common upper extremity fractures, constituting an estimated 2–10% of all fractures in adults; they more commonly occur in younger, active individuals [ 1 ]. The mechanisms of these fractures vary in mechanisms such as traumatic falls, sports injuries, road traffic accidents, or even childbirth [ 2 , 3 ]. However, despite these various mechanisms, many clavicle fractures occur more frequently from falls [ 3 ]. Clavicle fractures usually present with symptoms such as shoulder pain and soft-tissue swelling, followed by decreased mobility of the affected arm, visible deformity, and a downward and forward sagging of the shoulder girdle [ 4 , 5 ]. While the incidence is usually higher in males in the first two decades of life, males and females tend to experience similar incident rates as age increases [ 6 ]. The anatomy of the clavicle comprises three portions: distal third, proximal third, and middle third (midshaft). Since the middle third of the clavicle is least supported, it is more prone to trauma compared to proximal third and distal third clavicle fractures [ 7 ]. The middle third of the clavicle, or midshaft, comprises 75% of clavicle fractures, while the distal third comprises 20% and the proximal third about 5% [ 5 ]. It is also essential to highlight the connections of the clavicle that primarily moves the shoulder girdle via rotational movements through the acromioclavicular (AC) and sternoclavicular (SC) joints [ 8 ]. In nonsurgical management, patients with clavicle fractures are typically prescribed pain medication and given a sling to maintain immobilization and facilitate osseous union [ 9 ]. However, when unstable clavicle fractures exist, such as open or tented skin, significant displacement and shortening, and specific-athletic involvement, the gold standard of treatment utilizes open reduction and internal fixation (ORIF) [ 10 ]. Despite the existing indications for nonsurgical and surgical management of clavicle fractures, there remains to be significant debate on the appropriate treatment algorithms. Randomized controlled trials (RCTs) represent the highest level of evidence in the guiding management of clavicle fractures and are conducted to ensure that evidence drives the basis of treatment algorithms. In evidence-based research in the orthopedic literature, the P value has been utilized to present statistical data supporting or challenging interventions and outcomes [ 11 , 12 ]. Clinicians must have a strong understanding and conceptualization of the P value, as the utilization of this statistical tool has consistently assessed the significance of a study's findings. The alpha value of 0.05 is commonly used, indicating that 5% of the data is probably due to chance, advocating for a significant difference being depicted. This arbitrary threshold is then used to reject or confirm a hypothesis. So, if the P value is more significant than this threshold of 0.05, the null hypothesis is accepted, indicating that there is no difference in the collected data and no evidence of a statistically significant outcome; on the other hand, a P value greater than 0.05 would indicate that there is a statistically significant outcome present and there is less than 5% chance that this is a finding by mere chance. Although the P value consistently has been used, it continues to be overvalued and neglects to address factors such as sample size, fails to account for loss to follow-up (LTF), and lacks sufficient power, study design, and randomization [ 13 – 15 ]. With the noticeable shortcomings of the P value, an approach to supplement this tool was needed so that clinicians could have a more conceptual and thorough understanding of the research presented in the orthopedic literature. The fragility index (FI) has been applied to randomized controlled trials to assess the robustness of clinical trial results [ 16 ]. The FI was first used as an epidemiologic tool to address the shortcomings of the P value and is calculated as the number of outcome event reversals necessary to convert a finding from significant to nonsignificant. The reverse fragility index (rFI) is the number of outcome event reversals required to convert a finding from nonsignificant to substantial. In most orthopedic studies, vent outcomes quantify the results, revealing the necessary event outcomes to shift a trial from high to low or no significance [ 17 ]. The fragility quotient (FQ) further evaluates the FI and its relationship to the sample size by dividing the FI by the sample size [ 18 ]. The FI and FQ complement the P value, instilling confidence that low fragility (higher fragility index) signifies genuinely impactful results [ 19 ]. Evidence-based medicine empowers physicians to deliver competent patient care using the most up-to-date literary evidence. This foundational model of evidence-based medicine utilizes the results from orthopedic RCTs and aids in the determination and treatment algorithms of clavicle fractures, ensuring that the optimal treatment is applied. Despite the research surrounding algorithms for treating clavicle fractures, much debate exists supporting the optimal treatment regimen [ 20 – 23 ]. Given these considerations, scrutinizing the literature results' robustness becomes imperative. This study aimed to investigate the degree of statistical fragility in clavicle fracture literature, hypothesizing that dichotomous outcomes within this literature are statistically fragile, as assessed by both the FI and FQ. METHODS This review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines (Figure 1) . A search of the PubMed database from 2000 to 2022 was conducted to retrieve all randomized controlled trials (RCTs) on clavicle fractures. The search used "clavicular fractures" OR "clavicle fractures" to pinpoint relevant RCTs. Inclusion criteria required RCTs to present dichotomous outcomes accompanied by associated P values. Exclusion criteria encompassed systematic reviews, meta-analyses, animal studies, cadaveric studies, biomechanical studies, case reports, studies with more than two intervention groups, and those reporting non-dichotomous outcomes. Each included study underwent extraction of the journal name, publication year, authors, PubMed Identifier, loss to follow-up (LTF), study design, dichotomous outcomes (categorized as primary or secondary), and associated P values for each outcome The following orthopedic journals met the search criteria: Journal of Orthopedic Science, Journal of Orthopedic Trauma, Journal of Bone and Joint Surgery (JBJS), Journal of International Medical Research (JIMR), Journal of Orthopedics, Acta Orthopedica Belgica, Journal of Injury, Journal of International Orthopedics, Journal of Shoulder and Elbow Surgery (JSES), Archives of Orthopaedic and Trauma Surgery, Journal of Orthopedics and Traumatology, Orthopaedics & Traumatology: Surgery & Research (OTSR), and Acta Orthopaedica et Traumatologica Turcica. The outcomes from the included studies were categorized as significant ( P < 0.05) or nonsignificant ( P ≥ 0.05). The FI for each outcome event was determined using a 2-by-2 contingency table containing the dichotomous outcome events from included comparative trials. Each outcome event was manipulated until the reversal of significance was achieved. The corresponding value was determined as the FI for that particular outcome event. An example of this process can be found in Table 1 . The number of reversals required to change the significance was calculated and recorded as the FI for each outcome. For this study, we reported the rFI as the FI of nonsignificant findings. The median FI incorporating all outcomes was reported as the overall FI for the entire study. The FQ of each outcome was determined by dividing the FI by the associated total sample size. The FI and the FQ were further defined for the following subgroups: outcome type (primary versus secondary), initial significance ( P < 0.05 vs P ≥ 0.05), complications, radiographic findings, patient satisfaction, shoulder evaluation, comparing outcomes FI to LTF (FI LFT), and year (Table 2) . Finally, the overall FI and FQ were determined by incorporating all outcome events. Fragility analyses were calculated via utilization of the 2-tailed Fisher exact test. Interquartile ranges (IQRs) were calculated and reported for each subgroup's FI and FQ to aid in interpreting statistical results. A Risk-of-bias assessment was also performed (Figure 2) . Table 1: Demonstration of Reversal Significance with a Fragility of 1 Outcome A Outcome B P Value Scenario 1 Treatment A 6 33 Treatment B 15 40 0.041 Scenario 2 Treatment A 7 32 Treatment B 15 40 0.078 RESULTS A total of 2967 studies were screened with 81 RCTs that met the search criteria; however, only 30 were included in the analysis (Figure 1). There were 250 events with 62 significant (p 0.05) outcomes were identified. The overall FI, incorporating all 250 outcome events from the 30 RCTs, was 4 (IQR, 3 to 5) (Table 2) . The overall FQ was 0.045 (IQR, 0.024 to 0.080), indicating that the reversal of 4.5 of 100 outcomes may change the significance of the included RCTs in the study. Of the 30 included studies, 19 RCTs reported LTF greater than or equal to the overall FI 4. Therefore, 63.3% of studies reported an LTF value greater than or equal to the overall FI. For the 62 outcomes that were reported as significant, the median number of events required to change significance was 3.5 (IQR 2-7). The FQ for significant outcomes was 0.036 (IQR 0.017-0.063). For the 188 outcomes reported as nonsignificant, the number of events required to change significance was 4 (IQR 3-5). The FQ for nonsignificant outcomes was 0.05 (IQR 0.026-0.085). Of the 250 outcomes, 18 (7.2%) were primary and 232 (92.8%) were secondary. The primary and secondary outcomes FI were 6 (IQR 4-8) and 4 (IQR 3-5), respectively. The associated FQ for primary and secondary outcomes had values of 0.085 (IQR 0.060-0.123) and 0.045 (IQR 0.022-0.076), respectively. For the outcomes where FI LTF (n = 77), the median FI was found to be 5 (IQR 4-6). The median FQs were 0.040 (IQR 0.020-0.067) and 0.072 (IQR 0.037-0.130), respectively. The outcomes evaluating complications reported an FI of 4 (IQR 3-5) and an associated FQ of 0.045 (IQR 0.022-0.045). The outcomes highlighting radiographic findings reported an FI and FQ of 4 (IQR 3-8) and 0.065 (IQR 0.039-0.123), respectively. The outcomes evaluating patient satisfaction reported an FI of 3 (IQR 2.5-6) and an associated FQ of 0.040 (IQR 0.017-0.061). The outcomes of the shoulder evaluation were reported as follows: an FI of 6 (IQR 3.5-8.5) and an FQ of 0.063 (IQR 0.036-0.105). Fragility subanalysis per year of publication identified a FI of 4 (IQR 3-6) from 2000 to 2007, a FI of 4 (IQR 3-5) from 2008 to 2015, and a FI of 4 (IQR 3-6) from 2016 to 2022, thus demonstrating consistent statistical fragility over the 22 years (Table 2) . Table 2: Overall Fragility Data and Analysis of Subgroups Characteristic Events Fragility Index (IQR) Fragility Quotient (IQR) All trials 250 4 (3-5) 0.045 (0.024-0.080) Outcome type Primary 18 6 (4-8) 0.085 (0.060-0.123) Secondary 232 4 (3-5) 0.045 (0.022-0.076) Complications 193 4 (3-5) 0.045 (0.022-0.045) Radiographic Findings 15 4 (3-8) 0.065 (0.039-0.123) Patient Satisfaction 29 3 (2.5-6) 0.040 (0.017-0.061) Shoulder Evaluation 13 6 (3.5-8.5) 0.063 (0.036-0.105) Outcome significance P 0.05 188 4 (3-5) 0.05 (.026-.085) Comparing outcome FI to LTF FI LTF 77 5 (4-6) 0.072 (0.037-0.130) Year of publication 2016 – 2022 115 4 (3-6) 0.041 (0.018-0.069) 2008 – 2015 109 4 (3-5) 0.060 (0.031-0.105) 2000 – 2007 26 4 (3-6) 0.045 (0.027-0.065) DISCUSSION This systematic review examined the surgical management of clavicle fractures and incorporated a fragility analysis that revealed an overall median FI and FQ of 4 and 0.045, respectively. A FI of 4 demonstrates that only four events were required for the statistical significance of orthopedic trials examining clavicle fractures. The FQ of 0.045 indicates that only 4.5 of 100 patients would be needed to reverse the statistical significance across 250 outcomes. The significant outcomes identified had a median FI of 3.5, while the remaining nonsignificant outcomes had a median FI of 4. The significant outcomes experienced less statistical stability and more fragility than the nonsignificant outcomes, posing a risk to the results received by RCTs studying clavicle fractures. More than half of the RCTs (19 RCTs out of 30 RCTs) reported an LTF value greater than or equal to the overall FI of 4. Subgroup fragility analysis by year revealed a stagnant and fragile FI of 4 over the past two decades, which this study evaluated. The results from this fragility analysis align with the existing literature and justify our hypothesis [ 24 – 47 ]. When examining the trauma literature, Megafu et al. examined 10 RCTs investigating orbital fractures and detected an FI of 5 among 58 outcomes [ 24 ]. Megafu et al. investigated 34 distal radius fracture RCTs and reported an FI of 9 among 151 outcomes [ 25 ]. A study exploring distal femur fractures [ 46 ] revealed an overall median FI of 5 in 98 outcomes, and another study examining distal fibula fractures [ 28 ] revealed an FI of 5 in 6 RCTs. Parisien et al. examined comparative trials in the trauma literature across 364 total outcomes and reported a similar FI of 5 [ 44 ]. In a recent study examining femoral neck fractures, Yendluri et al. examined 71 RCTs across 197 outcomes and reported a median FI of 2 [ 30 ]. Megafu et al. examined calcaneus fractures and reported an FI 6 among 19 RCTs and 79 total outcomes [ 26 ]. Across the other orthopedic subspecialties, Fackler et al. compared single-row vs. double-row anchoring for rotator cuff repairs in 10 RCTs and discovered an FI of 2 among 74 outcomes [ 32 ]. In a fragility analysis examining knee cartilage restoration, Parisien et al. revealed an FI of 4 across 60 total outcomes, similar to the FI of 4 we reported in this study [ 38 ]. Chan et al. examined RCTs evaluating platelet-rich plasma use for the treatment of knee osteoarthritis and reported an FI of 12 among significant outcomes [ 47 ]. These analyses demonstrate that incorporating an FI statistic provides a numerical measure to assess evidence strength in orthopedic trials concerning clinical significance. Inverse relationships were observed between the number of LTFs and the number of events required to alter results from significant to nonsignificant. Therefore, our hypothesis was supported, as our median FI of 4 aligns with the FI range reported in the current orthopedic literature. Statisticians have consistently used the P value as the core statistical tool to evaluate statistical significance in an outcome or result; with an arbitrary alpha level of 0.05, many researchers rely on this tool to display their research findings [ 48 ]. The P value is noted to have significant misuse and misinterpretation because many researchers justify their results as significant or nonsignificant but neglect to account for the many flaws of the P value (e.g., loss to follow-up, sample size, power, and effect size) [ 13 – 15 ]. While the P value is essential, researchers have many other tools. Confidence intervals (CIs) have been incorporated in many orthopedic trials and are generally more helpful than the P value alone because they consider the effect size of the particular outcome [ 49 ]. While variability is fundamental to interpreting data within the orthopedic literature, the data must be presented accordingly; confidence intervals help supplement this and overcome misleading data points that can be skewed by variability [ 49 ]. In addition to P values and confidence intervals, the fragility index and fragility quotient can complement the P values and CIs, effectively reporting the clinical data. Now, we can assess the effect size of the clinical data with CIs, detect a statistical significance with the P value, and assess the robustness or fragility of an orthopedic trial with an FI and FQ [ 50 ]. Therefore, incorporating the CI, FQ, and FI, along with the P value, can aid in interpreting the clinical data evaluating the management of clavicle fractures. This systematic review has several strengths, including a comprehensive review of published trials from 2000 to 2022, providing a cumulative overview of the data examining the management of clavicle fractures over 22 years. This study also includes the ability of the FI to identify the number needed to adjust nonsignificant outcomes to become significant outcomes and vice-versa. This study also incorporates strictly RCTs as this is the highest level of studies utilized to investigate how clavicle fractures are managed. However, limitations include focusing on dichotomous trials, potentially introducing bias toward the null hypothesis. Fragility analysis depends on dichotomous RCT calculations, and the FI concept is vulnerable to fragility with small sample sizes or many patient withdrawals for unknown reasons, impacting the study's confidence interval and statistical significance. This study offers a practical tool with FI analysis to understand trial results in orthopedic literature. Confirming our hypothesis, dichotomous outcomes in clavicle fracture literature are statistically unstable. The use of evidence in decision-making is facilitated by incorporating robust methods like the FI and FQ. Fragility analysis should complement, not replace, the P value, serving as a supplemental metric for clinicians to thoroughly assess the confidence to place in statistical findings, contributing to evidence-based clinical decision-making in clavicle fracture management. To enhance our understanding of the influence of the statistical conclusions on clinical outcomes, patient-reported outcome tools such as the minimal clinically significant difference (MCID), substantial clinical benefit (SCB), patient-acceptable symptomatic state (PASS), and maximal outcome improvement (MOI) can be utilized to achieve meaningful outcomes in patient care. In addition, using an FI for continuous outcomes can also be used to classify continuous outcomes that were missed in our study. CONCLUSIONS Relying solely on P values for assessing clavicle fracture RCTs may be deceptive, given the apparent fragility of statistical results, challenging the validity of the studies. When scrutinizing management algorithms relying on statistical analysis, we recommend including the FI and FQ alongside the P value. This comprehensive approach assists clinicians in interpreting the robustness of outcomes, thereby influencing clinical decision-making within the clavicle fracture literature. Declarations Competing Interests Robert L. Parisien, MD reports a relationship with the American Orthopaedic Society for Sports Medicine that includes: board membership. Robert L. Parisien, MD reports a relationship with the American Orthopaedic Society for Sports Medicine that includes: non-financial support. Robert L. Parisien, MD reports a relationship with the Arthroscopy Association of North America that includes: non-financial support. Robert L. Parisien, MD reports a relationship with The Society of Military Orthopaedic Surgeons that includes: non-financial support. Robert L. Parisien, MD reports a relationship with the Journal of Cartilage & Joint Preservation that includes: non-financial support. Robert L. Parisien, MD reports a relationship with Arthroscopy that includes: board membership. Robert L. Parisien, MD reports a relationship with Arthroscopy, Sports Medicine, and Rehabilitation that includes: board membership. Robert L. Parisien, MD reports a relationship with the Journal of Sport Rehabilitation that includes: board membership. Robert L. Parisien, MD reports a relationship with Arthrex Inc that includes: funding grants. Paul Tornetta III, MD reports receiving publishing royalties, financials, and material from Wolters Kluwer Health – Lippincott Williams & Wilkins. Paul Tornetta III, MD also receives royalties from Smith & Nephew. 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The Fragility of Statistical Significance in Patellofemoral Instability Research: A Systematic Review. Am J Sports Med [Internet]. 2022;50:3714–8. http://dx.doi.org/10.1177/03635465211039202 . Fackler NP, Karasavvidis T, Ehlers CB, Callan KT, Lai WC, Parisien RL et al. The Statistical Fragility of Operative vs Nonoperative Management for Achilles Tendon Rupture: A Systematic Review of Comparative Studies. Foot Ankle Int [Internet]. 2022;43:1331–9. http://dx.doi.org/10.1177/10711007221108078 . Parisien RL, Danford NC, Jarin IJ, Li X, Trofa DP, Vosseller JT. The Fragility of Statistical Findings in Achilles Tendon Injury Research: A Systematic Review. J Am Acad Orthop Surg Glob Res Rev [Internet]. 2021;5. http://dx.doi.org/10.5435/JAAOSGlobal-D-21-00018 . Parisien RL, Trofa DP, Cronin PK, Dashe J, Curry EJ, Eichinger JK et al. Comparative Studies in the Shoulder Literature Lack Statistical Robustness: A Fragility Analysis. Sports Med Arthrosc Rehabil Ther Technol [Internet]. 2021;3:e1899–904. http://dx.doi.org/10.1016/j.asmr.2021.08.017 . Pearsall C, Constant M, Saltzman BM, Parisien RL, Levine W, Trofa D. The Fragility of Statistical Significance in Sham Orthopaedic Surgery: A Systematic Review of Randomized Controlled Trials. J Am Acad Orthop Surg [Internet]. 2023;31:e994–1002. http://dx.doi.org/10.5435/JAAOS-D-23-00245 . Parisien RL, Constant M, Saltzman BM, Popkin CA, Ahmad CS, Li X et al. The Fragility of Statistical Significance in Cartilage Restoration of the Knee: A Systematic Review of Randomized Controlled Trials. Cartilage [Internet]. 2021;13:147S – 155S. http://dx.doi.org/10.1177/19476035211012458 . Parisien RL, Trofa DP, Dashe J, Cronin PK, Curry EJ, Fu FH et al. Statistical Fragility and the Role of P Values in the Sports Medicine Literature. J Am Acad Orthop Surg [Internet]. 2019;27:e324–9. http://dx.doi.org/10.5435/JAAOS-D-17-00636 . Parisien RL, Ehlers C, Cusano A, Tornetta P 3rd, Li X, Wang D. The Statistical Fragility of Platelet-Rich Plasma in Rotator Cuff Surgery: A Systematic Review and Meta-analysis. Am J Sports Med [Internet]. 2021;49:3437–42. http://dx.doi.org/10.1177/0363546521989976 . Parisien RL, Trofa DP, O’Connor M, Knapp B, Curry EJ, Tornetta P 3rd et al. The Fragility of Significance in the Hip Arthroscopy Literature: A Systematic Review. JB JS Open Access [Internet]. 2021;6. http://dx.doi.org/10.2106/JBJS.OA.21.00035 . Cordero JK, Lawrence KW, Brown AN, Li X, Hayden BL, Parisien RL. The Fragility of Tourniquet Use in Total Knee Arthroplasty: A Systematic Review of Randomized Controlled Trials. J Arthroplasty [Internet]. 2023;38:1177–83. http://dx.doi.org/10.1016/j.arth.2022.12.035 . Lawrence KW, Okewunmi JO, Chakrani Z, Cordero JK, Li X, Parisien RL. Randomized Controlled Trials Comparing Bone-Patellar Tendon-Bone Versus Hamstring Tendon Autografts in Anterior Cruciate Ligament Reconstruction Surgery Are Statistically Fragile: A Systematic Review. Arthroscopy [Internet]. 2024;40:998–1005. http://dx.doi.org/10.1016/j.arthro.2023.07.039 . Parisien RL, Dashe J, Cronin PK, Bhandari M, Tornetta P 3. rd. Statistical Significance in Trauma Research: Too Unstable to Trust? J Orthop Trauma [Internet]. 2019;33:e466–70. http://dx.doi.org/10.1097/BOT.0000000000001595 . Yendluri A, Gonzalez C, Cordero JK, Hayden BL, Moucha CS, Parisien RL. Statistical Outcomes Guiding Periprosthetic Joint Infection Prevention and Revision Are Fragile: A Systematic Review of Randomized Controlled Trials. J Arthroplasty [Internet]. 2024; http://dx.doi.org/10.1016/j.arth.2024.01.059 . Megafu M, Mian H, Megafu E, Singhal S, Lee A, Cassie R et al. The fragility of statistical significance in distal femur fractures: systematic review of randomized controlled trials. Eur J Orthop Surg Traumatol [Internet]. 2023;33:2411–8. http://dx.doi.org/10.1007/s00590-022-03452-3 . Chan JP, Vrla M, Thompson C, Trofa DP, Li X, Wang D et al. Statistical Fragility of Randomized Controlled Trials Evaluating Platelet-Rich Plasma Use for Knee Osteoarthritis: A Systematic Review. Orthop J Sports Med [Internet]. 2023;11:23259671231187894. http://dx.doi.org/10.1177/23259671231187894 . Weinberg CR. It’s time to rehabilitate the P-value. Epidemiology [Internet]. 2001;12:288–90. http://dx.doi.org/10.1097/00001648-200105000-00004 . Perry DC, Griffin XL, Dritsaki M, Costa ML, Parsons N, on behalf of the Bone & Joint Journal Research Methods Group*. Becoming confident about confidence intervals. Bone Joint J [Internet]. 2017;99-B:563–5. http://dx.doi.org/10.1302/0301-620X.99B5.BJJ-2017-0075 . Stern BZ, Poeran J. Statistics in Brief: The Fragility Index. Clin Orthop Relat Res [Internet]. 2023;481:1288–91. http://dx.doi.org/10.1097/CORR.0000000000002622 . Additional Declarations Competing interest reported. Robert L. Parisien, MD reports a relationship with the American Orthopaedic Society for Sports Medicine that includes: board membership. Robert L. Parisien, MD reports a relationship with the American Orthopaedic Society for Sports Medicine that includes: non-financial support. Robert L. Parisien, MD reports a relationship with the Arthroscopy Association of North America that includes: non-financial support. Robert L. Parisien, MD reports a relationship with The Society of Military Orthopaedic Surgeons that includes: non-financial support. Robert L. Parisien, MD reports a relationship with the Journal of Cartilage & Joint Preservation that includes: non-financial support. Robert L. Parisien, MD reports a relationship with Arthroscopy that includes: board membership. Robert L. Parisien, MD reports a relationship with Arthroscopy, Sports Medicine, and Rehabilitation that includes: board membership. Robert L. Parisien, MD reports a relationship with the Journal of Sport Rehabilitation that includes: board membership. Robert L. Parisien, MD reports a relationship with Arthrex Inc that includes: funding grants. Paul Tornetta III, MD reports receiving publishing royalties, financials, and material from Wolters Kluwer Health – Lippincott Williams & Wilkins. Paul Tornetta III, MD also receives royalties from Smith & Nephew. Paul Tornetta III, MD is currently on the editorial and governing board for the Journal of Orthopedic Trauma. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4132465","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":281672387,"identity":"3acdb4ce-61af-437a-a1bd-1a1e3181bb5f","order_by":0,"name":"Michael N. Megafu","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABBklEQVRIiWNgGAWjYBACg8MMbEDKgsHgAJCqqIAK8+DRYgnRIsFgCdJy5gyQRUiL/QGoFnuQlrNtRGgxO8787MGPCgkgo/3ih4Pz7OrkZyQwPnjbhkfLYTZzw54zQC1nzhRLHNyWLGFwI4HZcC5eLTxsErxtQC03chKkP25jljCQSGCT5sWjxQCoRfLvPwkGg/tvkn8cnFMvAXQY+29CWqR5G4BabrAfkzjYcFiC4UYCGzN+LWxm0jLHJHgMzuSwWRw4dlxyw5mHzZJzzuHRcv7wM8k3NTZyBsePP75xoKaaX749+eCHN2W4tcAAMCJ4DKBsxgbC6iGA/QGxKkfBKBgFo2CEAQD101VxntHErgAAAABJRU5ErkJggg==","orcid":"","institution":"A.T. Still Uuniversity Kirksville College of Osteopathic Medicine","correspondingAuthor":true,"prefix":"","firstName":"Michael","middleName":"N.","lastName":"Megafu","suffix":""},{"id":281672388,"identity":"de7854ba-d2a5-4010-a6d0-5462f50738d3","order_by":1,"name":"Elisabeth Point Du Jour","email":"","orcid":"","institution":"Geisinger Commonwealth School of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Elisabeth","middleName":"Point","lastName":"Du Jour","suffix":""},{"id":281672389,"identity":"c1b92870-4dbd-40e3-8a18-2f5093a1417f","order_by":2,"name":"Janet T. Nguyen","email":"","orcid":"","institution":"Geisinger Commonwealth School of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Janet","middleName":"T.","lastName":"Nguyen","suffix":""},{"id":281672390,"identity":"a3485673-012a-44bf-b99c-7cd063b063d0","order_by":3,"name":"Emmanuel C. Megafu","email":"","orcid":"","institution":"Geisinger Commonwealth School of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Emmanuel","middleName":"C.","lastName":"Megafu","suffix":""},{"id":281672391,"identity":"73fdaf29-8361-4416-9aa7-de6abe970ecc","order_by":4,"name":"Hassan S. Mian","email":"","orcid":"","institution":"University of Minnesota Medical School","correspondingAuthor":false,"prefix":"","firstName":"Hassan","middleName":"S.","lastName":"Mian","suffix":""},{"id":281672392,"identity":"36fdf712-f2e4-4a50-aac5-1b4750261e4b","order_by":5,"name":"Sulabh S. Singhal","email":"","orcid":"","institution":"Drexel University College of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Sulabh","middleName":"S.","lastName":"Singhal","suffix":""},{"id":281672393,"identity":"adc6eb06-74a4-4ab0-8b23-6a14191e4f2a","order_by":6,"name":"Paul Tornetta III","email":"","orcid":"","institution":"Boston University School of Medicine, Department of Orthopaedic Surgery","correspondingAuthor":false,"prefix":"","firstName":"Paul","middleName":"Tornetta","lastName":"III","suffix":""},{"id":281672394,"identity":"e760a33c-c3ab-4183-94d3-4a88afca0cd5","order_by":7,"name":"Robert L. Parisien","email":"","orcid":"","institution":"Mount Sinai Health System","correspondingAuthor":false,"prefix":"","firstName":"Robert","middleName":"L.","lastName":"Parisien","suffix":""}],"badges":[],"createdAt":"2024-03-19 18:51:46","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4132465/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4132465/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":53278171,"identity":"4c22097b-366a-4be9-8ad9-a64820b2b0fc","added_by":"auto","created_at":"2024-03-22 18:37:43","extension":"jpeg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":431369,"visible":true,"origin":"","legend":"\u003cp\u003ePRISMA Diagram of Included Studies\u003c/p\u003e","description":"","filename":"floatimage1.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-4132465/v1/29aeba2073951047c68f212f.jpeg"},{"id":53278170,"identity":"2249803e-1ba3-40e3-a4f7-f156cf5311e5","added_by":"auto","created_at":"2024-03-22 18:37:43","extension":"jpeg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":1233502,"visible":true,"origin":"","legend":"\u003cp\u003eRisk-of-Bias Assessment of Included Studies\u003c/p\u003e","description":"","filename":"floatimage2.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-4132465/v1/10446dbb38c9f2f46a31b235.jpeg"},{"id":53793660,"identity":"31767d40-7a3d-476c-926b-6943227c1202","added_by":"auto","created_at":"2024-03-30 21:22:39","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":615617,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4132465/v1/9d2f6224-48f5-4964-9082-2294f374fefa.pdf"}],"financialInterests":"Competing interest reported. Robert L. Parisien, MD reports a relationship with the American Orthopaedic Society for Sports Medicine that includes: board membership. Robert L. Parisien, MD reports a relationship with the American Orthopaedic Society for Sports Medicine that includes: non-financial support. Robert L. Parisien, MD reports a relationship with the Arthroscopy Association of North America that includes: non-financial support. Robert L. Parisien, MD reports a relationship with The Society of Military Orthopaedic Surgeons that includes: non-financial support. Robert L. Parisien, MD reports a relationship with the Journal of Cartilage \u0026 Joint Preservation that includes: non-financial support. Robert L. Parisien, MD reports a relationship with Arthroscopy that includes: board membership. Robert L. Parisien, MD reports a relationship with Arthroscopy, Sports Medicine, and Rehabilitation that includes: board membership. Robert L. Parisien, MD reports a relationship with the Journal of Sport Rehabilitation that includes: board membership. Robert L. Parisien, MD reports a relationship with Arthrex Inc that includes: funding grants. \nPaul Tornetta III, MD reports receiving publishing royalties, financials, and material from Wolters Kluwer Health – Lippincott Williams \u0026 Wilkins. Paul Tornetta III, MD also receives royalties from Smith \u0026 Nephew. Paul Tornetta III, MD is currently on the editorial and governing board for the Journal of Orthopedic Trauma.","formattedTitle":"The Statistical Stability of Clavicle Fracture Management: A Systematic Review of Randomized Controlled Trials with Fragility Analysis","fulltext":[{"header":"INTRODUCTION","content":"\u003cp\u003eClavicle fractures are among the most common upper extremity fractures, constituting an estimated 2\u0026ndash;10% of all fractures in adults; they more commonly occur in younger, active individuals [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. The mechanisms of these fractures vary in mechanisms such as traumatic falls, sports injuries, road traffic accidents, or even childbirth [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. However, despite these various mechanisms, many clavicle fractures occur more frequently from falls [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. Clavicle fractures usually present with symptoms such as shoulder pain and soft-tissue swelling, followed by decreased mobility of the affected arm, visible deformity, and a downward and forward sagging of the shoulder girdle [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. While the incidence is usually higher in males in the first two decades of life, males and females tend to experience similar incident rates as age increases [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. The anatomy of the clavicle comprises three portions: distal third, proximal third, and middle third (midshaft). Since the middle third of the clavicle is least supported, it is more prone to trauma compared to proximal third and distal third clavicle fractures [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. The middle third of the clavicle, or midshaft, comprises 75% of clavicle fractures, while the distal third comprises 20% and the proximal third about 5% [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. It is also essential to highlight the connections of the clavicle that primarily moves the shoulder girdle via rotational movements through the acromioclavicular (AC) and sternoclavicular (SC) joints [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. In nonsurgical management, patients with clavicle fractures are typically prescribed pain medication and given a sling to maintain immobilization and facilitate osseous union [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. However, when unstable clavicle fractures exist, such as open or tented skin, significant displacement and shortening, and specific-athletic involvement, the gold standard of treatment utilizes open reduction and internal fixation (ORIF) [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. Despite the existing indications for nonsurgical and surgical management of clavicle fractures, there remains to be significant debate on the appropriate treatment algorithms.\u003c/p\u003e \u003cp\u003eRandomized controlled trials (RCTs) represent the highest level of evidence in the guiding management of clavicle fractures and are conducted to ensure that evidence drives the basis of treatment algorithms. In evidence-based research in the orthopedic literature, the \u003cem\u003eP\u003c/em\u003e value has been utilized to present statistical data supporting or challenging interventions and outcomes [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. Clinicians must have a strong understanding and conceptualization of the \u003cem\u003eP\u003c/em\u003e value, as the utilization of this statistical tool has consistently assessed the significance of a study's findings. The alpha value of 0.05 is commonly used, indicating that 5% of the data is probably due to chance, advocating for a significant difference being depicted. This arbitrary threshold is then used to reject or confirm a hypothesis. So, if the \u003cem\u003eP\u003c/em\u003e value is more significant than this threshold of 0.05, the null hypothesis is accepted, indicating that there is no difference in the collected data and no evidence of a statistically significant outcome; on the other hand, a \u003cem\u003eP\u003c/em\u003e value greater than 0.05 would indicate that there is a statistically significant outcome present and there is less than 5% chance that this is a finding by mere chance. Although the \u003cem\u003eP\u003c/em\u003e value consistently has been used, it continues to be overvalued and neglects to address factors such as sample size, fails to account for loss to follow-up (LTF), and lacks sufficient power, study design, and randomization [\u003cspan additionalcitationids=\"CR14\" citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eWith the noticeable shortcomings of the \u003cem\u003eP\u003c/em\u003e value, an approach to supplement this tool was needed so that clinicians could have a more conceptual and thorough understanding of the research presented in the orthopedic literature. The fragility index (FI) has been applied to randomized controlled trials to assess the robustness of clinical trial results [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]. The FI was first used as an epidemiologic tool to address the shortcomings of the \u003cem\u003eP\u003c/em\u003e value and is calculated as the number of outcome event reversals necessary to convert a finding from significant to nonsignificant. The reverse fragility index (rFI) is the number of outcome event reversals required to convert a finding from nonsignificant to substantial. In most orthopedic studies, vent outcomes quantify the results, revealing the necessary event outcomes to shift a trial from high to low or no significance [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. The fragility quotient (FQ) further evaluates the FI and its relationship to the sample size by dividing the FI by the sample size [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. The FI and FQ complement the \u003cem\u003eP\u003c/em\u003e value, instilling confidence that low fragility (higher fragility index) signifies genuinely impactful results [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eEvidence-based medicine empowers physicians to deliver competent patient care using the most up-to-date literary evidence. This foundational model of evidence-based medicine utilizes the results from orthopedic RCTs and aids in the determination and treatment algorithms of clavicle fractures, ensuring that the optimal treatment is applied. Despite the research surrounding algorithms for treating clavicle fractures, much debate exists supporting the optimal treatment regimen [\u003cspan additionalcitationids=\"CR21 CR22\" citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. Given these considerations, scrutinizing the literature results' robustness becomes imperative. This study aimed to investigate the degree of statistical fragility in clavicle fracture literature, hypothesizing that dichotomous outcomes within this literature are statistically fragile, as assessed by both the FI and FQ.\u003c/p\u003e"},{"header":"METHODS","content":"\u003cp\u003eThis review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines \u003cstrong\u003e(Figure 1)\u003c/strong\u003e. A search of the PubMed database from 2000 to 2022 was conducted to retrieve all randomized controlled trials (RCTs) on clavicle fractures. The search used \u0026quot;clavicular fractures\u0026quot; OR \u0026quot;clavicle fractures\u0026quot; to pinpoint relevant RCTs. Inclusion criteria required RCTs to present dichotomous outcomes accompanied by associated \u003cem\u003eP\u003c/em\u003e values. Exclusion criteria encompassed systematic reviews, meta-analyses, animal studies, cadaveric studies, biomechanical studies, case reports, studies with more than two intervention groups, and those reporting non-dichotomous outcomes. Each included study underwent extraction of the journal name, publication year, authors, PubMed Identifier, loss to follow-up (LTF), study design, dichotomous outcomes (categorized as primary or secondary), and associated P values for each outcome The following orthopedic journals met the search criteria: \u003cem\u003eJournal of Orthopedic Science, Journal of Orthopedic Trauma, Journal of Bone and Joint Surgery (JBJS), Journal of International Medical Research (JIMR), Journal of Orthopedics, Acta Orthopedica Belgica, Journal of Injury, Journal of International Orthopedics, Journal of Shoulder and Elbow Surgery (JSES), Archives of Orthopaedic and Trauma Surgery, Journal of Orthopedics and Traumatology, Orthopaedics \u0026amp; Traumatology: Surgery \u0026amp; Research (OTSR), and Acta Orthopaedica et Traumatologica Turcica.\u003c/em\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe outcomes from the included studies were categorized as significant (\u003cem\u003eP\u003c/em\u003e \u0026lt; 0.05) or nonsignificant (\u003cem\u003eP\u003c/em\u003e \u0026ge; 0.05). The FI for each outcome event was determined using a 2-by-2 contingency table containing the dichotomous outcome events from included comparative trials. Each outcome event was manipulated until the reversal of significance was achieved. The corresponding value was determined as the FI for that particular outcome event. An example of this process can be found in \u003cstrong\u003eTable 1\u003c/strong\u003e. The number of reversals required to change the significance was calculated and recorded as the FI for each outcome. For this study, we reported the rFI as the FI of nonsignificant findings. The median FI incorporating all outcomes was reported as the overall FI for the entire study. The FQ of each outcome was determined by dividing the FI by the associated total sample size. The FI and the FQ were further defined for the following subgroups: outcome type (primary versus secondary), initial significance (\u003cem\u003eP\u003c/em\u003e \u0026lt; 0.05 vs \u003cem\u003eP\u003c/em\u003e \u0026ge; 0.05), complications, radiographic findings, patient satisfaction, shoulder evaluation, comparing outcomes FI to LTF (FI \u003cu\u003e\u0026lt;\u003c/u\u003e LFT vs FI \u0026gt; LFT), and year \u003cstrong\u003e(Table 2)\u003c/strong\u003e. Finally, the overall FI and FQ were determined by incorporating all outcome events. Fragility analyses were calculated via utilization of the 2-tailed Fisher exact test. Interquartile ranges (IQRs) were calculated and reported for each subgroup\u0026apos;s FI and FQ to aid in interpreting statistical results. A Risk-of-bias assessment was also performed \u003cstrong\u003e(Figure 2)\u003c/strong\u003e.\u0026nbsp;\u003c/p\u003e\n\u003cp style='margin:0in;font-size:16px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:15px;font-family:\"Times New Roman\",serif;color:black;'\u003eTable 1: Demonstration of Reversal Significance with a Fragility of 1\u003c/span\u003e\u003c/strong\u003e\u003cspan style='font-family:\"Times New Roman\",serif;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003ctable style=\"border: none;border-collapse:collapse;\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd style=\"padding: 0in 5.4pt;vertical-align: top;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"padding: 0in 5.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0in;font-size:16px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cstrong\u003e\u003cspan style='font-size:15px;font-family:\"Times New Roman\",serif;color:black;'\u003eOutcome A\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"padding: 0in 5.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0in;font-size:16px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cstrong\u003e\u003cspan style='font-size:15px;font-family:\"Times New Roman\",serif;color:black;'\u003eOutcome B\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"padding: 0in 5.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0in;font-size:16px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style='font-size:15px;font-family:\"Times New Roman\",serif;color:black;'\u003eP\u003c/span\u003e\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cspan style='font-size:15px;font-family:\"Times New Roman\",serif;color:black;'\u003e\u0026nbsp;Value\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"background: rgb(242, 242, 242);padding: 0in 5.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0in;font-size:16px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:15px;font-family:\"Times New Roman\",serif;color:black;'\u003eScenario 1\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"background: rgb(242, 242, 242);padding: 0in 5.4pt;vertical-align: top;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"background: rgb(242, 242, 242);padding: 0in 5.4pt;vertical-align: top;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"background: rgb(242, 242, 242);padding: 0in 5.4pt;vertical-align: top;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"padding: 0in 5.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0in;font-size:16px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:15px;font-family:\"Times New Roman\",serif;color:black;'\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; Treatment A\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"padding: 0in 5.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0in;font-size:16px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-size:15px;font-family:\"Times New Roman\",serif;color:black;'\u003e6\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"padding: 0in 5.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0in;font-size:16px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-size:15px;font-family:\"Times New Roman\",serif;color:black;'\u003e33\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"padding: 0in 5.4pt;vertical-align: top;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"background: rgb(242, 242, 242);padding: 0in 5.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0in;font-size:16px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:15px;font-family:\"Times New Roman\",serif;color:black;'\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; Treatment B\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"background: rgb(242, 242, 242);padding: 0in 5.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0in;font-size:16px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-size:15px;font-family:\"Times New Roman\",serif;color:black;'\u003e15\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"background: rgb(242, 242, 242);padding: 0in 5.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0in;font-size:16px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-size:15px;font-family:\"Times New Roman\",serif;color:black;'\u003e40\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"background: rgb(242, 242, 242);padding: 0in 5.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0in;font-size:16px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cstrong\u003e\u003cspan style='font-size:15px;font-family:\"Times New Roman\",serif;color:red;'\u003e0.041\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"padding: 0in 5.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0in;font-size:16px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:15px;font-family:\"Times New Roman\",serif;color:black;'\u003eScenario 2\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"padding: 0in 5.4pt;vertical-align: top;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"padding: 0in 5.4pt;vertical-align: top;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd style=\"padding: 0in 5.4pt;vertical-align: top;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"background: rgb(242, 242, 242);padding: 0in 5.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0in;font-size:16px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:15px;font-family:\"Times New Roman\",serif;color:black;'\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; Treatment A\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"background: rgb(242, 242, 242);padding: 0in 5.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0in;font-size:16px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cstrong\u003e\u003cspan style='font-size:15px;font-family:\"Times New Roman\",serif;color:red;'\u003e7\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"background: rgb(242, 242, 242);padding: 0in 5.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0in;font-size:16px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cstrong\u003e\u003cspan style='font-size:15px;font-family:\"Times New Roman\",serif;color:red;'\u003e32\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"background: rgb(242, 242, 242);padding: 0in 5.4pt;vertical-align: top;\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"padding: 0in 5.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0in;font-size:16px;font-family:\"Calibri\",sans-serif;'\u003e\u003cstrong\u003e\u003cspan style='font-size:15px;font-family:\"Times New Roman\",serif;color:black;'\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; Treatment B\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"padding: 0in 5.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0in;font-size:16px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-size:15px;font-family:\"Times New Roman\",serif;color:black;'\u003e15\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"padding: 0in 5.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0in;font-size:16px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cspan style='font-size:15px;font-family:\"Times New Roman\",serif;color:black;'\u003e40\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"padding: 0in 5.4pt;vertical-align: top;\"\u003e\n \u003cp style='margin:0in;font-size:16px;font-family:\"Calibri\",sans-serif;text-align:center;'\u003e\u003cstrong\u003e\u003cspan style='font-size:15px;font-family:\"Times New Roman\",serif;color:red;'\u003e0.078\u003c/span\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp style='margin:0in;font-size:16px;font-family:\"Calibri\",sans-serif;margin-bottom:12.0pt;'\u003e\u003cspan style='font-family:\"Times New Roman\",serif;'\u003e\u003cbr\u003e\u003c/span\u003e\u003c/p\u003e"},{"header":"RESULTS","content":"\u003cp\u003eA total of 2967 studies were screened with 81 RCTs that met the search criteria; however, only 30 were included in the analysis \u003cstrong\u003e(Figure 1).\u003c/strong\u003e There were 250 events with 62 significant (p \u0026lt; 0.05) outcomes and 188 with nonsignificant (p \u003cu\u003e\u0026gt;\u003c/u\u003e 0.05) outcomes were identified. The overall FI, incorporating all 250 outcome events from the 30 RCTs, was 4 (IQR, 3 to 5) \u003cstrong\u003e(Table 2)\u003c/strong\u003e. The overall FQ was 0.045 (IQR, 0.024 to 0.080), indicating that the reversal of 4.5 of 100 outcomes may change the significance of the included RCTs in the study. Of the 30 included studies, 19 RCTs reported LTF greater than or equal to the overall FI 4. Therefore, 63.3% of studies reported an LTF value greater than or equal to the overall FI. For the 62 outcomes that were reported as significant, the median number of events required to change significance was 3.5 (IQR 2-7). The FQ for significant outcomes was 0.036 (IQR 0.017-0.063). For the 188 outcomes reported as nonsignificant, the number of events required to change significance was 4 (IQR 3-5). The FQ for nonsignificant outcomes was 0.05 (IQR 0.026-0.085). Of the 250 outcomes, 18 (7.2%) were primary and 232 (92.8%) were secondary. The primary and secondary outcomes FI were 6 (IQR 4-8) and 4 (IQR 3-5), respectively. The associated FQ for primary and secondary outcomes had values of 0.085 (IQR 0.060-0.123) and 0.045 (IQR 0.022-0.076), respectively. For the outcomes where FI \u003cu\u003e\u0026lt;\u003c/u\u003e LTF (n = 173), the median FI was found to be 4 (IQR 3-5). For the outcomes where FI \u0026gt; LTF (n = 77), the median FI was found to be 5 (IQR 4-6). The median FQs were 0.040 (IQR 0.020-0.067) and 0.072 (IQR 0.037-0.130), respectively. The outcomes evaluating complications reported an FI of 4 (IQR 3-5) and an associated FQ of 0.045 (IQR 0.022-0.045). The outcomes highlighting radiographic findings reported an FI and FQ of 4 (IQR 3-8) and 0.065 (IQR 0.039-0.123), respectively. The outcomes evaluating patient satisfaction reported an FI of 3 (IQR 2.5-6) and an associated FQ of 0.040 (IQR 0.017-0.061). The outcomes of the shoulder evaluation were reported as follows: an FI of 6 (IQR 3.5-8.5) and an FQ of 0.063 (IQR 0.036-0.105). Fragility subanalysis per year of publication identified a FI of 4 (IQR 3-6) from 2000 to 2007, a FI of 4 (IQR 3-5) from 2008 to 2015, and a FI of 4 (IQR 3-6) from 2016 to 2022, thus demonstrating consistent statistical fragility over the 22 years \u003cstrong\u003e(Table 2)\u003c/strong\u003e. \u0026nbsp;\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 2: Overall Fragility Data and Analysis of Subgroups\u003c/strong\u003e\u0026nbsp;\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eCharacteristic\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eEvents\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eFragility Index (IQR)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eFragility Quotient (IQR)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eAll trials\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e250\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e4 (3-5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.045 (0.024-0.080)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eOutcome type\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Primary\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e18\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e6 (4-8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.085 (0.060-0.123)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Secondary\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e232\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e4 (3-5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.045 (0.022-0.076)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Complications\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e193\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e4 (3-5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.045 (0.022-0.045)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Radiographic Findings\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e15\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e4 (3-8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.065 (0.039-0.123)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Patient Satisfaction\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e29\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e3 (2.5-6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.040 (0.017-0.061)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Shoulder Evaluation\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e13\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e6 (3.5-8.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.063 (0.036-0.105)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eOutcome significance\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;P \u0026lt; 0.05\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e62\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e3.5 (2-7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.036 (0.017-0.063)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;P \u003cu\u003e\u0026gt;\u003c/u\u003e 0.05\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e188\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e4 (3-5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.05 (.026-.085)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eComparing outcome FI to LTF\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;FI \u003cu\u003e\u0026lt;\u003c/u\u003e LTF\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e173\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e4 (3-5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.040 (0.020-0.067)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;FI \u0026gt; LTF\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e77\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e5 (4-6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.072 (0.037-0.130)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eYear of publication\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\u003cbr\u003e\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;2016 \u0026ndash; 2022\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e115\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e4 (3-6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.041 (0.018-0.069)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;2008 \u0026ndash; 2015\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e109\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e4 (3-5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.060 (0.031-0.105)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;2000 \u0026ndash; 2007\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e26\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e4 (3-6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.045 (0.027-0.065)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eThis systematic review examined the surgical management of clavicle fractures and incorporated a fragility analysis that revealed an overall median FI and FQ of 4 and 0.045, respectively. A FI of 4 demonstrates that only four events were required for the statistical significance of orthopedic trials examining clavicle fractures. The FQ of 0.045 indicates that only 4.5 of 100 patients would be needed to reverse the statistical significance across 250 outcomes. The significant outcomes identified had a median FI of 3.5, while the remaining nonsignificant outcomes had a median FI of 4. The significant outcomes experienced less statistical stability and more fragility than the nonsignificant outcomes, posing a risk to the results received by RCTs studying clavicle fractures. More than half of the RCTs (19 RCTs out of 30 RCTs) reported an LTF value greater than or equal to the overall FI of 4. Subgroup fragility analysis by year revealed a stagnant and fragile FI of 4 over the past two decades, which this study evaluated.\u003c/p\u003e \u003cp\u003eThe results from this fragility analysis align with the existing literature and justify our hypothesis [\u003cspan additionalcitationids=\"CR25 CR26 CR27 CR28 CR29 CR30 CR31 CR32 CR33 CR34 CR35 CR36 CR37 CR38 CR39 CR40 CR41 CR42 CR43 CR44 CR45 CR46\" citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR47\" class=\"CitationRef\"\u003e47\u003c/span\u003e]. When examining the trauma literature, Megafu et al. examined 10 RCTs investigating orbital fractures and detected an FI of 5 among 58 outcomes [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]. Megafu et al. investigated 34 distal radius fracture RCTs and reported an FI of 9 among 151 outcomes [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]. A study exploring distal femur fractures [\u003cspan citationid=\"CR46\" class=\"CitationRef\"\u003e46\u003c/span\u003e] revealed an overall median FI of 5 in 98 outcomes, and another study examining distal fibula fractures [\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e] revealed an FI of 5 in 6 RCTs. Parisien et al. examined comparative trials in the trauma literature across 364 total outcomes and reported a similar FI of 5 [\u003cspan citationid=\"CR44\" class=\"CitationRef\"\u003e44\u003c/span\u003e]. In a recent study examining femoral neck fractures, Yendluri et al. examined 71 RCTs across 197 outcomes and reported a median FI of 2 [\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e]. Megafu et al. examined calcaneus fractures and reported an FI 6 among 19 RCTs and 79 total outcomes [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e]. Across the other orthopedic subspecialties, Fackler et al. compared single-row vs. double-row anchoring for rotator cuff repairs in 10 RCTs and discovered an FI of 2 among 74 outcomes [\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e]. In a fragility analysis examining knee cartilage restoration, Parisien et al. revealed an FI of 4 across 60 total outcomes, similar to the FI of 4 we reported in this study [\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e]. Chan et al. examined RCTs evaluating platelet-rich plasma use for the treatment of knee osteoarthritis and reported an FI of 12 among significant outcomes [\u003cspan citationid=\"CR47\" class=\"CitationRef\"\u003e47\u003c/span\u003e]. These analyses demonstrate that incorporating an FI statistic provides a numerical measure to assess evidence strength in orthopedic trials concerning clinical significance. Inverse relationships were observed between the number of LTFs and the number of events required to alter results from significant to nonsignificant. Therefore, our hypothesis was supported, as our median FI of 4 aligns with the FI range reported in the current orthopedic literature.\u003c/p\u003e \u003cp\u003eStatisticians have consistently used the \u003cem\u003eP\u003c/em\u003e value as the core statistical tool to evaluate statistical significance in an outcome or result; with an arbitrary alpha level of 0.05, many researchers rely on this tool to display their research findings [\u003cspan citationid=\"CR48\" class=\"CitationRef\"\u003e48\u003c/span\u003e]. The \u003cem\u003eP\u003c/em\u003e value is noted to have significant misuse and misinterpretation because many researchers justify their results as significant or nonsignificant but neglect to account for the many flaws of the \u003cem\u003eP\u003c/em\u003e value (e.g., loss to follow-up, sample size, power, and effect size) [\u003cspan additionalcitationids=\"CR14\" citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. While the \u003cem\u003eP\u003c/em\u003e value is essential, researchers have many other tools. Confidence intervals (CIs) have been incorporated in many orthopedic trials and are generally more helpful than the \u003cem\u003eP\u003c/em\u003e value alone because they consider the effect size of the particular outcome [\u003cspan citationid=\"CR49\" class=\"CitationRef\"\u003e49\u003c/span\u003e]. While variability is fundamental to interpreting data within the orthopedic literature, the data must be presented accordingly; confidence intervals help supplement this and overcome misleading data points that can be skewed by variability [\u003cspan citationid=\"CR49\" class=\"CitationRef\"\u003e49\u003c/span\u003e]. In addition to \u003cem\u003eP\u003c/em\u003e values and confidence intervals, the fragility index and fragility quotient can complement the \u003cem\u003eP\u003c/em\u003e values and CIs, effectively reporting the clinical data. Now, we can assess the effect size of the clinical data with CIs, detect a statistical significance with the \u003cem\u003eP\u003c/em\u003e value, and assess the robustness or fragility of an orthopedic trial with an FI and FQ [\u003cspan citationid=\"CR50\" class=\"CitationRef\"\u003e50\u003c/span\u003e]. Therefore, incorporating the CI, FQ, and FI, along with the P value, can aid in interpreting the clinical data evaluating the management of clavicle fractures.\u003c/p\u003e \u003cp\u003eThis systematic review has several strengths, including a comprehensive review of published trials from 2000 to 2022, providing a cumulative overview of the data examining the management of clavicle fractures over 22 years. This study also includes the ability of the FI to identify the number needed to adjust nonsignificant outcomes to become significant outcomes and vice-versa. This study also incorporates strictly RCTs as this is the highest level of studies utilized to investigate how clavicle fractures are managed. However, limitations include focusing on dichotomous trials, potentially introducing bias toward the null hypothesis. Fragility analysis depends on dichotomous RCT calculations, and the FI concept is vulnerable to fragility with small sample sizes or many patient withdrawals for unknown reasons, impacting the study's confidence interval and statistical significance. This study offers a practical tool with FI analysis to understand trial results in orthopedic literature. Confirming our hypothesis, dichotomous outcomes in clavicle fracture literature are statistically unstable. The use of evidence in decision-making is facilitated by incorporating robust methods like the FI and FQ. Fragility analysis should complement, not replace, the \u003cem\u003eP\u003c/em\u003e value, serving as a supplemental metric for clinicians to thoroughly assess the confidence to place in statistical findings, contributing to evidence-based clinical decision-making in clavicle fracture management. To enhance our understanding of the influence of the statistical conclusions on clinical outcomes, patient-reported outcome tools such as the minimal clinically significant difference (MCID), substantial clinical benefit (SCB), patient-acceptable symptomatic state (PASS), and maximal outcome improvement (MOI) can be utilized to achieve meaningful outcomes in patient care. In addition, using an FI for continuous outcomes can also be used to classify continuous outcomes that were missed in our study.\u003c/p\u003e"},{"header":"CONCLUSIONS","content":"\u003cp\u003eRelying solely on \u003cem\u003eP\u003c/em\u003e values for assessing clavicle fracture RCTs may be deceptive, given the apparent fragility of statistical results, challenging the validity of the studies. When scrutinizing management algorithms relying on statistical analysis, we recommend including the FI and FQ alongside the \u003cem\u003eP\u003c/em\u003e value. This comprehensive approach assists clinicians in interpreting the robustness of outcomes, thereby influencing clinical decision-making within the clavicle fracture literature.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eCompeting Interests\u003c/strong\u003e\u003cp\u003eRobert L. Parisien, MD reports a relationship with the American Orthopaedic Society for Sports Medicine that includes: board membership. Robert L. Parisien, MD reports a relationship with the American Orthopaedic Society for Sports Medicine that includes: non-financial support. Robert L. Parisien, MD reports a relationship with the Arthroscopy Association of North America that includes: non-financial support. Robert L. Parisien, MD reports a relationship with The Society of Military Orthopaedic Surgeons that includes: non-financial support. Robert L. Parisien, MD reports a relationship with the Journal of Cartilage \u0026amp; Joint Preservation that includes: non-financial support. Robert L. Parisien, MD reports a relationship with Arthroscopy that includes: board membership. Robert L. Parisien, MD reports a relationship with Arthroscopy, Sports Medicine, and Rehabilitation that includes: board membership. Robert L. Parisien, MD reports a relationship with the Journal of Sport Rehabilitation that includes: board membership. Robert L. Parisien, MD reports a relationship with Arthrex Inc that includes: funding grants. Paul Tornetta III, MD reports receiving publishing royalties, financials, and material from Wolters Kluwer Health \u0026ndash; Lippincott Williams \u0026amp; Wilkins. Paul Tornetta III, MD also receives royalties from Smith \u0026amp; Nephew. Paul Tornetta III, MD is currently on the editorial and governing board for the Journal of Orthopedic Trauma.\u003c/p\u003e\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eMNM: Conceptualization, Methodology, Software, Investigation, Writing-Original Draft, Writing-Review and Editing, Project administrationHSM: Data curation, Resources, Formal analysis, Methodology, Writing-Original DraftECM: Data curation, Resources, Formal analysis, Methodology, Writing-Original Draft, SoftwareSSS: Data curation, Resources, Formal analysis, Writing-Original DraftEP: Data curation, Resources, Formal analysisJTN: Data curation, Resources, Formal analysisPTIII: Conceptualization, Writing-Review and Editing, SupervisionRLP: Conceptualization, Writing-Review and Editing, Supervision\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eWiesel B, Nagda S, Mehta S, Churchill R. Management of Midshaft Clavicle Fractures in Adults. J Am Acad Orthop Surg [Internet]. 2018;26:e468\u0026ndash;76. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttp://dx.doi.org/10.5435/JAAOS-D-17-00442\u003c/span\u003e\u003cspan address=\"10.5435/JAAOS-D-17-00442\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePostacchini F, Gumina S, De Santis P, Albo F. Epidemiology of clavicle fractures. J Shoulder Elbow Surg [Internet]. 2002;11:452\u0026ndash;6. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttp://dx.doi.org/10.1067/mse.2002.126613\u003c/span\u003e\u003cspan address=\"10.1067/mse.2002.126613\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChen W, Zhu Y, Liu S, Hou Z, Zhang X, Lv H et al. 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Statistics in Brief: The Fragility Index. Clin Orthop Relat Res [Internet]. 2023;481:1288\u0026ndash;91. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttp://dx.doi.org/10.1097/CORR.0000000000002622\u003c/span\u003e\u003cspan address=\"10.1097/CORR.0000000000002622\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"statistical fragility, fragility index, clavicle fractures, P value, reverse fragility index","lastPublishedDoi":"10.21203/rs.3.rs-4132465/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4132465/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003ePurpose\u003c/h2\u003e \u003cp\u003eThis study applied the fragility index (FI) and fragility quotient (FQ) to evaluate the degree of statistical fragility in the clavicle fracture literature.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eThis review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A PubMed systematic search strategy was used to find all dichotomous data for randomized controlled trials (RCTs) in clavicle fracture research from 2000 to 2022. 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.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eOf the 2967 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\u0026ndash;5) and 0.045 (IQR 0.024\u0026ndash;0.080). Statistically significant and nonsignificant outcomes had an FI of 3.5 (IQR 2\u0026ndash;7) and 4 (IQR 3\u0026ndash;5), respectively. Regarding loss to follow-up (LTF), 63.3% (19) reported LTF greater or equal to the overall FI of 4.\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e \u003cp\u003eRelying solely on \u003cem\u003eP\u003c/em\u003e values to assess clavicle fracture RCTs may be deceptive and challenge the studies' validity. When scrutinizing management algorithms relying on statistical analysis, we recommend including the FI and FQ alongside the \u003cem\u003eP\u003c/em\u003e value.\u003c/p\u003e","manuscriptTitle":"The Statistical Stability of Clavicle Fracture Management: A Systematic Review of Randomized Controlled Trials with Fragility Analysis","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-03-22 18:37:38","doi":"10.21203/rs.3.rs-4132465/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"3ef0e3ad-3243-4734-be2a-8d613189c1de","owner":[],"postedDate":"March 22nd, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2024-03-30T21:14:25+00:00","versionOfRecord":[],"versionCreatedAt":"2024-03-22 18:37:38","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-4132465","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4132465","identity":"rs-4132465","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}