Introduction: Comparative trials evaluating categorical outcomes have important implications on surgical decision making. The purpose of this study was to examine the statistical stability of sports medicine research. Methods: Comparative clinical sports medicine research studies involving anterior cruciate ligament, meniscus, and knee instability were reviewed in two journals between 2006 and 2016. The statistical stability for each study outcome was determined by the number of event reversals required to change the P value to either greater or less than 0.05. The number of patients lost to follow-up was also determined. Results: Of the 1,505 studies screened, 102 studies were included for analysis, 40 of which were randomized controlled trials. There were 339 total outcome events, with 98 significant and 241 not significant. The Fragility Index, or the median number of events required to change the statistical significance of the overall study, was five (interquartile range, 3 to 8) or 5.4% of the total study population. In addition, the average number of patients lost to follow-up was 7.9, which is greater than the number needed to change the significance of each study arm and the entire study population. Conclusion: Results in the comparative sports medicine literature may not be as stable as previously thought, with only a small percentage of outcome events needed to change study significance. Outcomes research based on a single discreet P value cutoff may be misleading.

Objectives: To evaluate the stability of statistical findings in the fracture care literature based on minor changes in event rates and to determine the utility of applying both the Fragility Index (FI) and Fragility Quotient (FQ) to comparative orthopaedic trauma trials. Methods: All fracture care studies from 1991 to 2013 in the Journal of Bone and Joint Surgery and the Journal of Orthopaedic Trauma were screened. The FI was determined by altering the number of reported outcome events, a single event at time, until a reversal of statistical significance was determined. The associated FQ was determined by dividing the FI by the total sample size. Results: Of the 4040 studies evaluated, 198 comparative studies met inclusion criteria with a reported 253 primary and 522 secondary outcome events. There were 118 randomized controlled trials and 80 retrospective comparative studies. Of the 775 total outcome events, 235 were initially reported as significant. The median FI for the entire study was only 5 with an associated FQ of 0.046. This represents just 3.8% of the total study population. Conclusions: The robustness of comparative trials in the orthopaedic trauma literature may not be as stable as previously thought with only a few event reversals required to alter trial significance. We therefore recommend triple reporting of a P value, FI, and FQ to aid in the evaluation and interpretation of statistical stability and quantitative significance in comparative orthopaedic trauma trials.

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SLE patients with infection in the ICU had a higher mortality and a higher APACHE II score compared to SLE patients with noninfectious causes in the ICU. Their physiologic signs including temperature, HR, and SBP were more reflective of infection than their WBC count.

Background: There is limited evidence that syndesmotic implant removal (SIR) is beneficial. However, many surgeons advocate removal based on studies suggesting improved motion. Methodologic difficulties make the validity and applicability of previous works questionable. The purpose of this study was to examine the effect of ankle dorsiflexion after SIR using radiographically measured motion before and after screw removal utilizing a standardized load. Methods: All patients undergoing isolated SIR were candidates for inclusion. Dorsiflexion was measured radiographically: (1) immediately before implant removal intraoperatively, (2) immediately after removal intraoperatively, and (3) 3 months after removal. A standardized torque force was applied to the ankle and a perfect lateral radiograph of the ankle was obtained. Four reviewers independently measured dorsiflexion on randomized, deidentified images. A total of 29 patients met inclusion criteria. All syndesmotic injuries were associated with rotational ankle fractures. There were 11 men (38%) and 18 women (62%). The mean, and standard deviation, age was 50.3 ± 16.9 years (range 19-80). Results: The mean ankle dorsiflexion pre-operatively, post-operatively, and at a 3-month follow-up was 13.7 ± 6.6 degrees, 13.3 ± 7.3 degrees and 11.8 ± 11.3 degrees, respectively ( P = .466). For subsequent analysis, 5 patients were excluded because of the potential confounding effect of retained suture button devices. Analysis of the remaining 24 patients (and final analysis of 21 patients who had complete 3-month follow-up) demonstrated similar results with no statistically significant difference in ankle dorsiflexion at all 3 time points. Conclusion: Removal of syndesmotic screws may not improve ankle dorsiflexion motion and should not be used as the sole indication for screw removal. Level of Evidence: Level II, prospective cohort study.

Objectives: To determine whether a particular surgical approach or combination of approaches is a risk factor for infection. Design: Retrospective review. Setting: Two Level-1 trauma centers. Patients/Participants: Five hundred ninety pilon fractures in 581 patients (66% male) with a median age of 45 years were identified. Intervention: Open reduction internal fixation of pilon fractures. Main Outcome Measures: Postoperative deep surgical site infection and risk factors for postoperative deep infection. Results: The most common primary surgical approach was medial (54%), followed by anterolateral (25%), anteromedial (11%), posterolateral (8%), and posteromedial (2%). A dual approach to the distal tibia was used in 18% of the cases. The overall deep infection rate was 19%. There was no association between primary surgical approach and development of infection (P = 0.19–0.78). Independent risk factors for infection were smoking (hazard ratio, 2.1; P < 0.001) and need for soft tissue coverage (hazard ratio, 6.9; P < 0.001). Conclusions: Surgical approach does not appear to be a significant risk factor for postoperative infection after open reduction internal fixation of distal tibial pilon fractures. When treating tibial plafond fractures, surgeons should select the approach they feel best addresses the specific fracture pattern. Level of Evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Level V, expert opinion.

Purpose: Evidenced-based decision-making is rooted in comparative clinical studies; however, a small number of outcome event reversals have the potential to change study significance. The purpose of this study was to determine the utility of applying fragility analysis to comparative studies in the published orthopaedic shoulder literature. Methods: Comparative clinical shoulder research studies reporting 1:1 dichotomous categorical data were analyzed in 6 leading orthopaedic journals between 2006 and 2016. Statistical significance was defined as a P value of less than .05. The fragility index (FI) for each study outcome was determined by the number of event reversals required to change the P value to either greater or less than 0.05, thus changing the study conclusions. The associated fragility quotient (FQ) was determined by dividing the FI by the total population comprising a particular outcome. Results: Of the 23,897 studies screened, 3,591 met search criteria, with 198 comparative studies ultimately included for analysis, 67 of which were randomized controlled trials. There were 357 total outcome events with 74 reported as significant and 283 as not significant. The FI was 4 (IQR 2-6) with an associated FQ of 0.066 (interquartile range [IQR] 0.038-0.102). There was no difference in statistical fragility between randomized and nonrandomized trials with both revealing a FI of 4 and FQ of 0.068 (IQR 0.044-0.107) and 0.065 (IQR 0.031-0.101), respectively. Conclusions: This current analysis reveals that comparative shoulder studies published in six leading orthopaedic journals are at risk of statistical fragility. As such, contemporary clinical shoulder literature may not be as robust as traditionally perceived with the reversal of only a few outcome events required to change study significance. Therefore, we advocate the reporting of both FI and FQ in addition to the P value as statistical complements to all comparative investigations to provide a more comprehensive understanding of trial stability and significance in the published shoulder literature. Clinical Relevance: Comparative study designs are commonly employed in shoulder research. Several studies in both the general medical and orthopaedic literature have identified a lack of statistical robustness through comprehensive fragility analysis. Our findings demonstrate the P value may be an inadequate independent statistical metric requiring the complement of a FI and FQ to aid in the interpretation and understanding of study significance for clinical decision-making.T he primary objective of evidence-based medicine is to produce meaningful and clinically relevant information to help guide medical decision-making. 1 The viability of evidence-based medicine depends on validated research findings and an informed readership. Within the shoulder surgery literature, randomized controlled trials (RCTs) and dichotomous comparison studies are frequently used toward this end. 2 Statistical findings are typically reported in terms of a threshold probability value (P ...