Background:
The practice of evidence-based medicine relies on objective data to guide clinical decision-making with specific statistical thresholds conveying study significance.
Purpose:
To determine ...the utility of applying the fragility index (FI) and the fragility quotient (FQ) analysis to randomized controlled trials (RCTs) evaluating the utilization of platelet-rich plasma (PRP) in rotator cuff repairs (RCRs).
Study Design:
Systematic review and meta-analysis.
Methods:
RCTs pertaining to the utilization of PRP in surgical RCRs published in 13 peer-reviewed journals from 2000 to 2020 were evaluated. The FI was determined by manipulating each reported outcome event until a reversal of significance was appreciated. The associated FQ was determined by dividing the FI by the sample size.
Results:
Of the 9746 studies screened, 19 RCTs were ultimately included for analysis. The overall FI incorporating all 19 RCTs was only 4, suggesting that the reversal of only 4 events is required to change study significance. The associated FQ was determined as 0.092. Of the 43 outcome events reporting lost to follow-up data, 13 (30.2%) represented lost to follow-up >4.
Conclusion:
Our analysis suggests that RCTs evaluating PRP for surgical RCRs may lack statistical stability with only a few outcome events required to alter trial significance. Therefore, we recommend the reporting of an FI and an FQ in conjunction with P value analysis to carefully interpret the integrity of statistical stability in future comparative trials.
Clinical Relevance:
Clinical decisions are often informed by statistically significant results. Thus, a true understanding of the robustness of the statistical findings informing clinical decision-making is of critical importance.
Selection of residents is a challenging process. The use of personality inventories to evaluate applicants has been validated in professions outside of healthcare. It has been shown that job ...applicants could not game the personality evaluation.
The purpose of this study was to determine if orthopaedic surgery residents could game the personality assessment to make themselves seem like a better fit for orthopaedic surgery residencies.
In 2017, 20 orthopaedic surgery residents at a single program were administered a validated personality assessment twice. On one occasion, they were instructed to answer honestly. On the other, they were instructed to shade their answers in a way that they would want a program to see them. Assessments were scored on 9 scales to determine how many were modified to a more desirable result based on previously determined results for desirability of orthopaedic residents.
Nineteen of 20 subjects had at least one of the nine scales that was “undesirable” when taking the test honestly. The average was 2.1. Forty-two out of a possible 180 results were “undesirable” when the test was taken honestly. 41 of the 42 became desirable when the subjects were instructed to shade their answers.
Orthopaedic surgery residents were able to modify their answers to a personality assessment enough to hide most “red flag” findings when they were instructed to shade questions toward answers they thought would be desirable by a program. This limits the utility of personality assessments as screening tools for residency applications.
Background:
Trochlear dysplasia is a known risk factor for patellar instability. Multiple radiographic measurements exist to assess trochlear morphology, but the optimal measurement technique and ...threshold for instability are unknown.
Purpose:
To describe the optimal measurements and thresholds for trochlear dysplasia on magnetic resonance imaging (MRI) that can identify knees with patellar instability in male and female patients.
Study Design:
Cohort study (diagnosis); Level of evidence, 3.
Methods:
Knee MRI scans of patients with patellar instability were compared with those of age- and sex-matched controls. Measurements of the sulcus angle, lateral trochlear inclination (LTI), and trochlear depth were performed on axial images using bony and cartilaginous landmarks. Receiver operating characteristic curve analysis was performed, with the area under the curve (AUC) describing the accuracy of each diagnostic test. Optimal cutoff values were calculated to distinguish between knees with and without patellar instability. AUC and cutoff values were reported for each measurement as well as for male and female subgroups.
Results:
A total of 238 knee MRI scans were included in this study (138 female, 100 male; age range, 18-39 years). Trochlear depth measurements had the greatest diagnostic value, with AUCs of 0.79 and 0.82 on bone and cartilage, respectively. All measurements (sulcus angle, LTI, trochlear depth) on bone and cartilage had an AUC ≥0.7 (range, 0.70-0.86), with optimal cutoff values of 145° (bone) and 154° (cartilage) for the sulcus angle, 17° (bone) and 13° (cartilage) for LTI, and 4 mm (bone) and 3 mm (cartilage) for trochlear depth. Optimal cutoff values in female patients varied from those in male patients for all measurements except for cartilaginous trochlear depth.
Conclusion:
Normal thresholds for trochlear dysplasia varied based on the use of bony versus cartilaginous landmarks. Cartilaginous trochlear depth measurements had the greatest ability to identify knees with patellar instability. Furthermore, optimal cutoff values for all measurements except for cartilaginous trochlear depth differed between female and male patients. These findings suggest that sex-specific parameters of normal values may be needed in the assessment of risk factors for patellofemoral instability.
There remains a compelling biological rationale for both reamed and unreamed intramedullary nailing for the treatment of tibial shaft fractures. Previous small trials have left the evidence for ...either approach inconclusive. We compared reamed and unreamed intramedullary nailing with regard to the rates of reoperations and complications in patients with tibial shaft fractures.
We conducted a multicenter, blinded randomized trial of 1319 adults in whom a tibial shaft fracture was treated with either reamed or unreamed intramedullary nailing. Perioperative care was standardized, and reoperations for nonunion before six months were disallowed. The primary composite outcome measured at twelve months postoperatively included bone-grafting, implant exchange, and dynamization in patients with a fracture gap of <1 cm. Infection and fasciotomy were considered as part of the composite outcome, irrespective of the postoperative gap.
One thousand two hundred and twenty-six participants (93%) completed one year of follow-up. Of these, 622 patients were randomized to reamed nailing and 604 patients were randomized to unreamed nailing. Among all patients, fifty-seven (4.6%) required implant exchange or bone-grafting because of nonunion. Among all patients, 105 in the reamed nailing group and 114 in the unreamed nailing group experienced a primary outcome event (relative risk, 0.90; 95% confidence interval, 0.71 to 1.15). In patients with closed fractures, forty-five (11%) of 416 in the reamed nailing group and sixty-eight (17%) of 410 in the unreamed nailing group experienced a primary event (relative risk, 0.67; 95% confidence interval, 0.47 to 0.96; p = 0.03). This difference was largely due to differences in dynamization. In patients with open fractures, sixty of 206 in the reamed nailing group and forty-six of 194 in the unreamed nailing group experienced a primary event (relative risk, 1.27; 95% confidence interval, 0.91 to 1.78; p = 0.16).
The present study demonstrates a possible benefit for reamed intramedullary nailing in patients with closed fractures. We found no difference between approaches in patients with open fractures. Delaying reoperation for nonunion for at least six months may substantially decrease the need for reoperation.
Narrative letters of recommendation are an important component of the residency application process. However, because narrative letters of recommendation are almost always positive, it is unclear ...whether those reviewing the letters understand the writer's intended strength of support for a given applicant.
(1) Is the perception of letter readers for narrative letters of recommendation consistent with the intention of the letter's author? (2) Is there inter-reviewer consistency in selection committee members' perceptions of the narrative letters of recommendation?
Letter writers who wrote two or more narrative letters of recommendation for applicants to one university-based orthopaedic residency program for the 2014 to 2015 application cycle were sent a survey linked to a specific letter of recommendation they authored to assess the intended meaning regarding the strength of an applicant. A total of 247 unstructured letters of recommendation and accompanying surveys were sent to their authors, and 157 surveys were returned and form the basis of this study (response percentage 64%). The seven core members of the admissions committee (of 22 total reviewers) at a university-based residency program were sent a similar survey regarding their perception of the letter. To answer our research question about whether letter readers' perceptions about a candidate were consistent with the letter writer's intention, we used kappa values to determine agreement for survey questions involving discrete variables and Spearman correlation coefficients (SCCs) to determine agreement for survey questions involving continuous variables. To answer our research question regarding inter-reviewer consistency among the seven faculty members, we compared the letter readers' responses to each survey question using intraclass correlation coefficients (ICCs).
There was a negligible to moderate correlation between the intended and perceived strength of the letters (SCC 0.26 to 0.57), with only one of seven letter readers scoring in the moderate correlation category. When stratifying the applicants into thirds, there was only slight agreement (kappa 0.07 to 0.19) between the writers and reviewers. There were similarly low kappa values for agreement about how the writers and readers felt regarding the candidate matching into their program (kappa 0.14 to 0.30). The ICC for each question among the seven faculty reviewers ranged from poor to moderate (ICC 0.42 to 0.52).
Our results demonstrate that the reader's perception of narrative letters of recommendation did not correlate well with the letter writer's intended meaning and was not consistent between letter readers at a single university-based urban orthopaedic surgery residency program.
Given the low correlation between the intended strength of the letter writers and the perceived strength of those letters, we believe that other options such as a slider bar or agreed-upon wording as is used in many dean's letters may be helpful.
Orthopaedic device-related infection is one of the most devastating complications in orthopaedic and trauma surgery. With increasing life expectancies as well as the lifelong risk of bacterial ...seeding on an implant, the prevention and treatment of device-related infection remains an important area for research and development. To facilitate information exchange and enhance collaboration among various stakeholders in the orthopaedic community, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) organized an inaugural workshop on orthopaedic device-related infections, exploring the regulatory challenges that are faced when proceeding from the bench level to marketing and clinical implementation of new infection-control devices and products. This article summarizes the perspectives of scientists, clinicians, and industry partners on the current regulatory approval process for orthopaedic anti-infective technologies as well as the proposed strategies to overcome these regulatory challenges.
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