Assessing the Readability of Clinical Trial Consent Forms for Surgical Specialties.

INTRODUCTION: To evaluate the readability of surgical clinical trial consent forms and compare readability across surgical specialties. METHODS: We conducted a cross-sectional analysis of surgical clinical trial consent forms available on ClinicalTrials.gov to quantitatively evaluate readability, word count, and length variations among different specialties. The analysis was performed between November 2022 and January 2023. A total of 386 surgical clinical trial consent forms across 14 surgical specialties were included. RESULTS: The main outcomes were language complexity (measured using Flesch-Kincaid Grade Level), number of words (measured as word count), time to read (measured at reading speeds of 240 per min), and readability (measured by Flesch Reading Ease Score, Gunning Frog Index, Simple Measures of Gobbledygook Index, FORCAST, and Automated Readability Index). The surgical consent forms were a mean (standard deviation) of 2626 (1668) words long, with a mean of 12:53 min to read at 240 words per min. None of the surgical specialties had an average readability level of sixth grade or lower across all six indices, and only 16 out of 386 (4%) clinical trials met the recommended reading level. Furthermore, there was no significant difference in reading grade level between surgical specialties based on the Flesch-Kincaid Grade Level and Flesch Reading Ease indices. CONCLUSIONS: Our findings suggest that current surgical clinical trial consent documents are too long and complex, exceeding the recommended sixth-grade reading level. Ensuring readable clinical trial consent forms is not only ethically responsible but also crucial for protecting patients' rights and well-being by facilitating informed decision-making.

Impact of external beam radiation on total shoulder arthroplasty outcomes: a propensity-matched cohort study.

BACKGROUND: External beam radiation therapy has a number of deleterious effects on the body, and a number of post-operative complications have been reported for several surgeries including total knee arthroplasty. However, few studies have investigated the impact of external beam radiation therapy for total shoulder arthroplasty (TSA). Our study aimed to assess the systemic and joint complications associated with TSA in patients with prior radiation exposures, as well as evaluate the surgical outcomes of radiation patients compared to non-radiation TSA patients. MATERIALS AND METHODS: A retrospective cohort analysis was conducted using the TriNetX Analytics Network. A 1:1 propensity score matching function was utilized to create two cohorts with matched baseline characteristics within the TriNetX network. Comparisons of the primary and secondary outcomes between the two cohorts were made using odds ratios. A p value of < 0.05 was determined to be significant. RESULTS: A total of 75,510 patients that received TSA were identified with 1505 having a history of radiation therapy (RT) and 73,605 with no radiation therapy (non-RT). After propensity matching, both groups contained 1484 patients. RT patients were at higher risk for developing prosthetic joint infection, acute renal failure, altered mental state, cerebrovascular event, DVT, PE, pneumonia, respiratory failure, and UTI compared to non-RT patients at different time points (p < 0.5). CONCLUSION: Patients with prior history of external beam radiation undergoing TSA had a higher risk of systemic complications and prosthetic joint infection compared to patients without a prior history. These complications suggest a more complicated post-operative management course for these patients.

Comparing outcomes in revision total hip arthroplasty in inpatient versus outpatient setting: a matched cohort analysis.

BACKGROUND: As the population ages, revision total hip arthroplasty (rTHA) is becoming more common. However, there is a paucity of literature regarding perioperative outcomes following inpatient versus outpatient rTHA. Our study aims to compare perioperative complications and readmission rates associated with rTHA in a large national cohort. METHODS: A retrospective, propensity-matched cohort study was conducted using the National Surgical Quality Improvement Program database from 2006 to 2020. Patients undergoing rTHA in the inpatient setting were propensity matched to patients receiving rTHA in the outpatient setting. Following 1:1 matching, multivariate analyses were performed to compare perioperative complications and readmission. RESULTS: A total of 207,102 patients were identified, including 181,164 outpatient primary THA, 25,466 inpatient rTHA, and 492 outpatient rTHA patients. Following propensity matching, outpatient primary THA versus outpatient rTHA had 210 patients and inpatient rTHA versus outpatient rTHA had 214 patients. Patients in the outpatient rTHA had a significantly higher operative time (132.4 ± 73.2 versus 90.9 ± 32.7, p < 0.001) and length of stay (1.6 ± 1.6 vs. 0.9 ± 1.0, p < 0.001) compared to outpatient primary THA. When comparing inpatient versus outpatient rTHA, the outpatient cohort had lower operative time (131.1 ± 70.9 vs. 145.4 ± 71.5, p = 0.038), total length of stay (1.7 ± 1.8 vs. 3.6 ± 4.1, p < 0.001), and bleeding complications (6% vs. 18%, p < 0.001). CONCLUSION: There were no difference in the odds of complications between outpatient primary and revision THA. Additionally, rTHA performed in an outpatient setting did not show any increase in immediate compared to inpatient settings. These findings suggest that rTHA can be safely performed on certain patients.

Amygdala subfield and prefrontal cortex abnormalities in patients with functional seizures.

BACKGROUND: Functional seizures (FS) are paroxysmal episodes, resembling epileptic seizures, but without underlying epileptic abnormality. The aetiology and neuroanatomic associations are incompletely understood. Recent brain imaging data indicate cerebral changes, however, without clarifying possible pathophysiology. In the present study, we specifically investigated the neuroanatomic changes in subregions of the amygdala and hippocampus in FS. METHODS: T1 MRI scans of 37 female patients with FS and 37 age-matched female seizure naïve controls (SNC) were analyzed retrospectively in FreeSurfer version 7.1. Seizure naïve controls included patients with depression and anxiety disorders. The analysis included whole-brain cortical thickness, subcortical volumes, and subfields of the amygdala and hippocampus. Group comparisons were carried out using multivariable linear models. RESULTS: The FS and SNC groups did not differ in the whole hippocampus and amygdala volumes. However, patients had a significant reduction of the right lateral amygdala volume (p = 0.00041), an increase of the right central amygdala, (p = 0.037), and thinning of the left superior frontal gyrus (p = 0.024). Additional findings in patients were increased volumes of the right medial amygdala (p = 0.031), left anterior amygdala (p = 0.017), and left dentate gyrus of the hippocampus (p = 0.035). CONCLUSIONS: The observations from the amygdala and hippocampus segmentation affirm that there are neuroanatomic associations of FS. The pattern of these changes aligned with some of the cerebral changes described in chronic stress conditions and depression. The pattern of detected changes further study, and may, after validation, provide biomarkers for diagnosis and treatment.

What is the Association Between Clinically Diagnosed Psychiatric Illness and Total Joint Arthroplasty? A Systematic Review Evaluating Outcomes, Healthcare Use, and Patient-reported Outcome Measures.

BACKGROUND: Studies evaluating the effects of a psychiatric illness on orthopaedic surgical outcomes have yielded mixed results. Because awareness of patient comorbid mental health disorders has become increasingly important to tailor treatment plans, the aim of our systematic review was to present the findings of all studies reporting on the association between clinically diagnosed psychiatric illnesses and total joint arthroplasty (TJA) outcomes and evaluate the quality of evidence to provide a comprehensive summary. QUESTION/PURPOSE: Is there a consistently reported association between comorbid psychiatric illness and (1) complication risk, (2) readmission rates, (3) healthcare use and discharge disposition, and (4) patient-reported outcome measures (PROMs) after TJA? METHODS: The PubMed, EBSCO host, Medline, and Google Scholar electronic databases were searched on April 9, 2022, to identify all studies that evaluated outcomes after TJA in patients with a comorbid clinically diagnosed mental health disorder between January 1, 2000, and April 1, 2022. Studies were included if the full-text article was available in English, reported on primary TJA outcomes in patients with clinically diagnosed mental health disorders, included patients undergoing TJA without a psychiatric illness for comparison, and had a minimum follow-up time of 30 days for evaluating readmission rates, 90 days for other perioperative outcomes such as length of stay and complications, and 1-year minimum follow-up if assessing PROMs. Studies that used a mental health screening examination instead of clinical diagnoses were excluded to isolate for verified psychiatric illnesses. Additionally, systematic reviews, case reports, duplicate studies between the databases, and gray literature were excluded. Twenty-one studies were included in our final analysis comprising 31,023,713 patients with a mean age range of 57 to 69 years. Mental health diagnoses included depression, anxiety, bipolar disorder, schizophrenia, major personality disorder, and psychosis as well as concomitant mental disorders. Two reviewers independently evaluated the quality of included studies using the Methodological Index for Nonrandomized Studies (MINORS) tool. The mean MINORS score was 19.5 ± 0.91 of 24, with higher scores representing better study quality. All the articles included were retrospective, comparative studies. Given the heterogeneity of the included studies, a meta-analysis was not performed, and results are instead presented descriptively. RESULTS: Patients with schizophrenia were consistently reported to have higher odds of medical and surgical complications than patients without psychiatric illness, particularly anemia and respiratory complications. Among studies with the largest sample sizes, patients with depression alone or depression and anxiety had slightly higher odds of complications. Most studies identified higher odds of readmission among patients with depression, schizophrenia, and severe mental illness after TJA. However, for anxiety, there was no difference in readmission rates compared with patients without psychiatric illness. Slightly higher odds of emergency department visits were reported for patients with depression, anxiety, concomitant depression and anxiety, and severe mental illness across studies. When evaluating healthcare use, articles with the largest sample sizes reporting on depression and length of stay or discharge disposition found modestly longer length of stay and greater odds of nonhome discharge among patients with depression. Although several studies reported anxiety was associated with slightly increased total costs of hospitalization, the most robust studies reported no difference or slightly shorter average length of stay. However, the included studies only reported partial economic analyses of cost, leading to relatively superficial evidence. Patients with schizophrenia had a slightly longer length of stay and modestly lower odds of home discharge and cost. Likewise, patients with concomitant depression and anxiety had a slightly longer average length of stay, according to the two articles reporting on more than 1000 patients. Lastly, PROM scores were worse in patients with depression at a minimum follow-up of 1 year after TJA. For anxiety, there was no difference in improvement compared with patients without mental illness. CONCLUSION: Our systematic review found that individuals with psychiatric illness had an increased risk of postoperative complications, increased length of stay, higher costs, less frequent home discharge, and worse PROM scores after TJA. These findings encourage inclusion of comorbid psychiatric illness when risk-stratifying patients. Attention should focus on perioperative interventions to minimize the risk of thromboembolic events, anemia, bleeding, and respiratory complications as well as adequate pain management with drugs that do not exacerbate the likelihood of these adverse events to minimize emergency department visits and readmissions. Future studies are needed to compare patients with concomitant psychiatric illnesses such as depression and anxiety with patients with either diagnosis in isolation, instead of only comparing patients with concomitant diagnoses with patients without any psychiatric illnesses. Similarly, the results of targeted interventions such as cognitive behavioral therapy are needed to understand how orthopaedic surgeons might improve the quality of care for patients with a comorbid psychiatric illness.

What Are the Trends in Research Publication Misrepresentation Among Orthopaedic Residency and Fellowship Applicants From 1996 to 2019? A Systematic Review.

BACKGROUND: Because research experience is increasingly important in ranking orthopaedic residency and fellowship applicants, determining the accuracy of candidates reporting their scholarly activity is essential. However, disparate and inconsistent findings have made it difficult to draw meaningful conclusions from individual studies. QUESTIONS/PURPOSES: In this systematic review, we asked: (1) What percentage of research publications are misrepresented among orthopaedic residency and fellowship applicants? (2) What percentage of applications contain one or more example of academic misrepresentation? (3) Is research misrepresentation associated with any individual applicant characteristics? (4) What is the publication status of articles listed by applicants as having been submitted to journals? METHODS: A systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. PubMed, EBSCOhost, Medline, and Google Scholar electronic databases were searched on March 10, 2022, to identify all studies that evaluated research misrepresentation in orthopaedic residency and fellowship applications between January 1, 1995, and March 1, 2022. Articles were included if full-text articles in English were available and the study reported on research misrepresentation among orthopaedic residency or fellowship applicants. Studies investigating nonorthopaedic publications, systematic reviews, case studies, duplicate studies among databases, and gray literature were excluded. Two reviewers independently evaluated the quality of included studies using the Methodological Index for Nonrandomized Studies (MINORS) tool. This is a validated assessment tool that grades noncomparative studies from 0 to 16 and studies with control groups from 0 to 24, based on eight criteria related to study design, outcomes assessed, and follow-up. All included articles were noncomparative studies, so the maximum score here was 16, with higher scores indicating better study quality. The mean MINORS score was 13 ± 1 in the studies we included. The final analysis included 10 studies with 5119 applicants. Eight studies evaluated orthopaedic residency applicants and two evaluated fellowship applicants. The applicant classes ranged from 1996 to 2019. Research misrepresentation was defined among studies as nonauthorship of an existing article, claimed authorship of a nonexistent article, or incorrect listing of authorship order for an existing article. Each study's findings and definition of research misrepresentation were considered to allow for a discussion of overall trends. The percentage of misrepresentation was further broken down by the misrepresentation type. Applicant characteristics and destination of submitted articles were also evaluated. Given the potential overlap between applicants among the studies, no pooled analysis was conducted, and results are presented as a narrative summary. RESULTS: The percentage of overall publication misrepresentation was estimated to range between 1% (13 of 1100) and 21% (27 of 131), with more-recent studies reporting a lower proportion of overall articles misrepresented. Most studies we found claimed that authorship of a nonexistent article was the most common type of misrepresentation. Nonauthorship of an existing article and incorrect authorship order were less common. The percentage of applications with at least one misrepresentation was approximately 20% between 1998 and 2017. Most studies found no applicant characteristics, such as match outcomes, demographic markers, or academic records, that were consistently associated with a higher odds of the candidate misrepresenting his or her research credentials. Finally, approximately half of the articles listed as submitted to journals went on to publication, with one-third going to a different journal with a lower Impact Factor. CONCLUSIONS: Our systematic review found that the percentage of overall publication misrepresentations among orthopaedic residency and fellowship applicants has generally been low over the past 20 years. However, approximately one-fifth of applications had at least one research misrepresentation, with 2% having multiple misrepresentations on reported publications. There were no consistent applicant characteristics associated with higher odds of research misrepresentation. Additionally, most of the articles listed as submitted to journals for publication were ultimately published. CLINICAL RELEVANCE: Although the decrease in overall publication misrepresentation is encouraging, our finding that one-fifth of applicants have research misrepresentation is a cause for concern. In light of a continually evolving application process, orthopaedic residency and fellowship programs must ensure there is integrity related to information that is self-reported by applicants. These findings also serve to encourage faculty members involved in the application screening and decision process to limit biases related to applicant demographics perceived to be associated with a high odds of misrepresentation. Furthermore, governing agencies and program leadership should evaluate methods of verifying unpublished work and provide opportunities for applicants to give publication updates throughout the application cycle.

What Are the Trends in Women's Representation Among Lead Investigators of Orthopaedic Clinical Trials?

BACKGROUND: Serving as a principal investigator for a clinical trial can bring national visibility and recognition to physicians, and it can have a substantial impact on their promotion and tenure. In the field of orthopaedics, there is a well-known gender gap in terms of representation and leadership. Examining the representation of women in clinical trial leadership may help to inform and enable the design of targeted interventions and policies to foster a more inclusive and diverse environment in clinical trial leadership. QUESTIONS/PURPOSES: (1) What is the proportion of women principal investigators in orthopaedic clinical trials, and has this changed over time? (2) Are there trial characteristics (trial phase, status, funding source, and intervention) associated with women principal investigators? (3) What is the geographic distribution globally and regionally within the United States of clinical trials led by women principal investigators? METHODS: A cross-sectional survey of clinical trials using the ClinialTrials.gov registry and results database provided by the NIH was performed on August 22, 2022. Trial characteristics included principal investigator names and gender, trial phase, type, funding source, intervention, and location (defined by continent and US Census region). Our primary outcome was the overall proportion of women orthopaedic principal investigators over time. We assessed this by comparing the proportion of women principal investigators from 2007 to 2022. Our secondary outcomes were trial characteristics (trial phase, status, funding source, and intervention) and geographic distribution (globally and within the United States) associated with women principal investigators. Baseline characteristics of the clinical trials were calculated using frequencies and percentages for categorical variables. Fisher exact tests were conducted to evaluate differences in gender proportions based on the included clinical trial characteristics. Univariate linear regression was applied to analyze trends in the annual proportion of women principal investigators over time. RESULTS: The overall proportion of women principal investigators was 18% (592 of 3246), and this proportion increased over the study period. Specifically, the proportion of women leading clinical trials was 13% (16 of 121) in 2007 and 22% (53 of 242) in 2022 (r2 = 0.68; p < 0.001). This trend was also observed when evaluating only US women principal investigators (r2 = 0.47; p = 0.003) and non-US women principal investigators over the study period (r2 = 0.298; p = 0.03). There was no difference in the distribution of trial phases between men and women principal investigators. Most men and women were involved in "not applicable" or Phase IV trials. Similarly, there was no difference in trial status or funding source. However, women principal investigators had a higher proportion of studies involving behavioral interventions (11% [67 of 592]) compared with men principal investigators (3% [74 of 2654]; p = 0.03). The proportion of women principal investigators over the study period by world region revealed a higher proportion of women principal investigators in Asia (23% [88 of 391]), followed by South America (24% [12 of 49]), North America (18% [306 of 1746]), and Europe (16% [136 of 833]). Among all US trials over the study period, the proportion of women principal investigators across the US Census region was Northeast (19% [62 of 329]), South (18% [90 of 488]), West (20% [97 of 492]), and Midwest (13% [22 of 168]). CONCLUSION: Although there has been a notable increase in the proportion of women principal investigators over time, the overall representation remains relatively low. The disparities observed in trial characteristics and geographic distribution of women principal investigators further emphasize the need for targeted interventions and policies to foster a more inclusive and diverse environment in clinical trial leadership. CLINICAL RELEVANCE: These results underscore the importance of adopting practices and strategies that foster gender equity in the leadership of orthopaedic clinical trials. By establishing mentorship and sponsorship programs, early-career women surgeons can be connected with experienced leaders, cultivating a supportive network and offering valuable career guidance. Additionally, addressing geographic disparities in the representation of women principal investigators can involve the implementation of mentorship and sponsorship programs in regions with lower representation.

Complications in Osteonecrosis Patients Following Total Knee Arthroplasty: A Propensity-Matched Cohort Study.

BACKGROUND: Several studies have demonstrated high complication rates in osteonecrosis (ON) patients undergoing total hip arthroplasty. However, there is a paucity of literature regarding outcomes of total knee arthroplasty (TKA) in ON patients. Our study aimed to assess preoperative risk factors associated with the development of ON and determine the incidence of postoperative complications up to one year following TKA. METHODS: A retrospective cohort study was conducted using a large national database. Patients who had a primary TKA and ON were isolated using Current Procedural Terminology code 27447 and ICD-10-CM code M87, respectively. A total of 185,045 patients were identified, including 181,151 patients who had a TKA and 3,894 patients who had a TKA and ON. After propensity matching, both groups each contained 3,758 patients. Intercohort comparisons of primary and secondary outcomes after propensity score matching were made using the odds ratio. A P value of < .01 was determined to be significant. RESULTS: The ON patients were found to have an increased risk for prosthetic joint infection, urinary tract infection, deep vein thrombosis, pulmonary embolism, wound dehiscence pneumonia, and the development of heterotopic ossification at different time points. Osteonecrosis patients had an increased risk of revision at the 1-year time point (odds ratio = 2.068, P < .0001). CONCLUSION: The ON patients had a higher risk of systemic and joint complications than non-ON patients. These complications suggest a more complicated management course for patients who have ON prior to and after TKA.

Readability of Online Patient Education Materials for Total Joint Arthroplasty: A Systematic Review.

BACKGROUND: As the demand for total joint arthroplasty continues to grow, patients increasingly turn to internet sources for accessible orthopaedic health information. We sought to evaluate the readability of online hip and knee arthroplasty patient education materials (PEMs). METHODS: Our systematic review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses-P guidelines (PROSPERO registration of the study protocol: CRD42022358872, September 19th, 2022). PubMed, EBSCOhost, Medline, and Google Scholar electronic databases were utilized to identify all studies evaluating online PEMs related to total joint arthroplasty between January 1, 2000, and August 1, 2022. The quality of studies was assessed with the Joanna Briggs Institute scale. RESULTS: Our initial search yielded 360 publications which were then screened for appropriate studies aligned with our review's purpose. A total of eleven cross-sectional studies were included. The total sample size across the studies consisted of 662 PEMs. Five studies evaluated professional or academic orthopaedic websites, six evaluated PEMs through web engines, and three evaluated apps or commercial websites. Most included studies found PEMs to be well above the recommended 6th-grade reading level. CONCLUSION: Arthroplasty PEMs produced by orthopaaedic websites, web searches, and apps have readability scores well above the recommended levels. Given the importance of health literacy on patient outcomes and satisfaction, work needs to be done to improve the readability of these materials.

Clinical MRI morphological analysis of functional seizures compared to seizure-naïve and psychiatric controls.

PURPOSE: Functional seizures (FS), also known as psychogenic nonepileptic seizures (PNES), are physical manifestations of acute or chronic psychological distress. Functional and structural neuroimaging have identified objective signs of this disorder. We evaluated whether magnetic resonance imaging (MRI) morphometry differed between patients with FS and clinically relevant comparison populations. METHODS: Quality-screened clinical-grade MRIs were acquired from 666 patients from 2006 to 2020. Morphometric features were quantified with FreeSurfer v6. Mixed-effects linear regression compared the volume, thickness, and surface area within 201 regions-of-interest for 90 patients with FS, compared to seizure-naïve patients with depression (n = 243), anxiety (n = 68), and obsessive-compulsive disorder (OCD, n = 41), respectively, and to other seizure-naïve controls with similar quality MRIs, accounting for the influence of multiple confounds including depression and anxiety based on chart review. These comparison populations were obtained through review of clinical records plus research studies obtained on similar scanners. RESULTS: After Bonferroni-Holm correction, patients with FS compared with seizure-naïve controls exhibited thinner bilateral superior temporal cortex (left 0.053 mm, p = 0.014; right 0.071 mm, p = 0.00006), thicker left lateral occipital cortex (0.052 mm, p = 0.0035), and greater left cerebellar white-matter volume (1085 mm3, p = 0.0065). These findings were not accounted for by lower MRI quality in patients with FS. CONCLUSIONS: These results reinforce prior indications of structural neuroimaging correlates of FS and, in particular, distinguish brain morphology in FS from that in depression, anxiety, and OCD. Future work may entail comparisons with other psychiatric disorders including bipolar and schizophrenia, as well as exploration of brain structural heterogeneity within FS.

Reliability of additional reported seizure manifestations to identify dissociative seizures.

PURPOSE: Descriptions of seizure manifestations (SM), or semiology, can help localize the symptomatogenic zone and subsequently included brain regions involved in epileptic seizures, as well as identify patients with dissociative seizures (DS). Patients and witnesses are not trained observers, so these descriptions may vary from expert review of seizure video recordings of seizures. To better understand how reported factors can help identify patients with DS or epileptic seizures (ES), we evaluated the associations between more than 30 SMs and diagnosis using standardized interviews. METHODS: Based on patient- and observer-reported data from 490 patients with diagnoses documented by video-electoencephalography, we compared the rate of each SM in five mutually exclusive groups: epileptic seizures (ES), DS, physiologic seizure-like events (PSLE), mixed DS and ES, and inconclusive testing. RESULTS: In addition to SMs that we described in a prior manuscript, the following were associated with DS: light triggers, emotional stress trigger, pre-ictal and post-ictal headache, post-ictal muscle soreness, and ictal sensory symptoms. The following were associated with ES: triggered by missing medication, aura of déjà vu, and leftward eye deviation. There were numerous manifestations separately associated with mixed ES and DS. CONCLUSIONS: Reported SM can help identify patients with DS, but no manifestation is pathognomonic for either ES or DS. Patients with mixed ES and DS reported factors divergent from both ES-alone and DS-alone.

Objective score from initial interview identifies patients with probable dissociative seizures.

OBJECTIVE: To develop a Dissociative Seizures Likelihood Score (DSLS), which is a comprehensive, evidence-based tool using information available during the first outpatient visit to identify patients with "probable" dissociative seizures (DS) to allow early triage to more extensive diagnostic assessment. METHODS: Based on data from 1616 patients with video-electroencephalography (vEEG) confirmed diagnoses, we compared the clinical history from a single neurology interview of patients in five mutually exclusive groups: epileptic seizures (ES), DS, physiologic nonepileptic seizure-like events (PSLE), mixed DS plus ES, and inconclusive monitoring. We used data-driven methods to determine the diagnostic utility of 76 features from retrospective chart review and applied this model to prospective interviews. RESULTS: The DSLS using recursive feature elimination (RFE) correctly identified 77% (95% confidence interval (CI), 74-80%) of prospective patients with either ES or DS, with a sensitivity of 74% and specificity of 84%. This accuracy was not significantly inferior than neurologists' impression (84%, 95% CI: 80-88%) and the kappa between neurologists' and the DSLS was 21% (95% CI: 1-41%). Only 3% of patients with DS were missed by both the fellows and our score (95% CI 0-11%). SIGNIFICANCE: The evidence-based DSLS establishes one method to reliably identify some patients with probable DS using clinical history. The DSLS supports and does not replace clinical decision making. While not all patients with DS can be identified by clinical history alone, these methods combined with clinical judgement could be used to identify patients who warrant further diagnostic assessment at a comprehensive epilepsy center.

Women's Representation as Principal Investigators Among Pediatric Orthopaedic Clinical Trials: An Analysis of ClinicalTrials.Gov.

INTRODUCTION: Despite recent efforts to increase the participation of women in orthopaedic surgery, there remains a gender gap, particularly when compared with other medical specialties. Acting as a principal investigator (PI) in a clinical trial can give physicians notable exposure and national recognition, which can improve their chances of promotion and tenure. This study aims to assess the proportion of women serving as PIs in pediatric orthopaedic clinical trials, examine associated trial characteristics, and explore geographic distribution. METHODS: A cross-sectional analysis of clinical trials was conducted using data from the ClinicalTrials.gov registry. Specific search terms were used to identify pediatric orthopaedic trials. Data on trial characteristics, including phase, status, funding source, and intervention type, were collected. PI sex was determined using Genderize.io, an application program interface that predicts the sex of individuals based on their name, and the geographic distribution of women PIs was examined. RESULTS: From 2007 to 2022, women PIs increased from zero to 26.86%. The United States saw no significant increase (ß = 1.553; P = 0.125), but international trials did (ß = 2.845; P = 0.008). Women PIs led more active/completed trials and trials with behavioral/other interventions. Geographic analysis showed higher representation in North America (38.47%), especially the Northeast (28.17%) and West (25.35%). The United States had 28.74% women PIs, with California (15.49%) leading. CONCLUSION: Progress toward gender parity in pediatric orthopaedic research is evident; however, disparities still exist. Efforts to provide additional research opportunities for women in orthopaedics may be crucial in attracting and retaining diverse talent in the field. Targeted initiatives may have potential in achieving equal representation in orthopaedics.

Accuracy of machine learning to predict the outcomes of shoulder arthroplasty: a systematic review.

BACKGROUND: Artificial intelligence (AI) uses computer systems to simulate cognitive capacities to accomplish goals like problem-solving and decision-making. Machine learning (ML), a branch of AI, makes algorithms find connections between preset variables, thereby producing prediction models. ML can aid shoulder surgeons in determining which patients may be susceptible to worse outcomes and complications following shoulder arthroplasty (SA) and align patient expectations following SA. However, limited literature is available on ML utilization in total shoulder arthroplasty (TSA) and reverse TSA. METHODS: A systematic literature review in accordance with PRISMA guidelines was performed to identify primary research articles evaluating ML's ability to predict SA outcomes. With duplicates removed, the initial query yielded 327 articles, and after applying inclusion and exclusion criteria, 12 articles that had at least 1 month follow-up time were included. RESULTS: ML can predict 30-day postoperative complications with a 90% accuracy, postoperative range of motion with a higher-than-85% accuracy, and clinical improvement in patient-reported outcome measures above minimal clinically important differences with a 93%-99% accuracy. ML can predict length of stay, operative time, discharge disposition, and hospitalization costs. CONCLUSION: ML can accurately predict outcomes and complications following SA and healthcare utilization. Outcomes are highly dependent on the type of algorithms used, data input, and features selected for the model. LEVEL OF EVIDENCE: III.

Neighborhood Deprivation is Associated With Hospital Length of Stay, Discharge Disposition, and Readmission Rates for Patients Who Survive Hospitalization With Traumatic Brain Injury.

BACKGROUND AND OBJECTIVES: Traumatic brain injury (TBI) is a leading cause of disability in the United States. Limited research exists on the influence of area-level socioeconomic status and outcomes after TBI. This study investigated the correlation between the Area Deprivation Index (ADI) and (1) 90-day hospital readmission rates, (2) facility discharge, and (3) prolonged (≥5 days) hospital length of stay (LOS). METHODS: Single-center retrospective review of adult (18 years or older) patients who were admitted for TBI during 2018 was performed. Patients were excluded if they were admitted for management of a chronic or subacute hematoma. We extracted relevant clinical and demographic data including sex, comorbidities, age, body mass index, smoking status, TBI mechanism, and national ADI. We categorized national ADI rankings into quartiles for analysis. Univariate, multivariate, and area under the receiver operating characteristic curve (AUROC) analyses were performed to assess the relationship between ADI and 90-day readmission, hospital LOS, and discharge disposition. RESULTS: A total of 523 patients were included in final analysis. Patients from neighborhoods in the fourth ADI quartile were more likely to be Black (P = .007), have a body mass index ≥30 kg/m2 (P = .03), have a Charlson Comorbidity Index ≥5 (P = .004), and have sustained a penetrating TBI (P = .01). After controlling for confounders in multivariate analyses, being from a neighborhood in the fourth ADI quartile was independently predictive of 90-day hospital readmission (odds ratio [OR]: 1.35 [1.12-1.91], P = .011) (model AUROC: 0.82), discharge to a facility (OR: 1.46 [1.09-1.78], P = .03) (model AUROC: 0.79), and prolonged hospital LOS (OR: 1.95 [1.29-2.43], P = .015) (model AUROC: 0.85). CONCLUSION: After adjusting for confounders, including comorbidities, TBI mechanism/severity, and age, higher ADI was independently predictive of longer hospital LOS, increased risk of 90-day readmission, and nonhome discharge. These results may help establish targeted interventions to identify at-risk patients after TBI.

Phenotyping of Review-of-Systems Responses to Differentiate Functional Seizures From Epilepsy.

Objective: Although the populations of patients with functional seizures (FS) and epileptic seizures (ES) are extremely heterogeneous with multiple etiologies and phenotypes, patients with FS have increased somatic sensitivity and report more positive complaints on review-of-systems questionnaires (ROSQs). We evaluated if data-driven clustering and projection analysis could identify symptom phenotypes that could differentiate between patients with FS and ES.Methods: The dataset included all adult patients admitted from January 2006 to March 2020 for video-electroencephalography with available ROSQs (N = 877). Latent clusters and axes of variation in ROSQ responses were evaluated using multiple well-established methods. Leave-one-out cross-validation was used to evaluate if logistic regression using information could differentiate patients with FS from ES.Results: When evaluating individual symptom response and proportion of positive responses, the area under the receiver operating curve (AUC) was 62% (95% CI, 53%-69%) and 72% (CI, 65%-78%), respectively. The best AUC achieved by phenotyping methods was 74%. The patterns of clusters and components reflected properties of each analysis and did not correlate with assigned "system" from the ROSQ or other interpretations.Discussion: The overall proportion of positive responses was the most informative metric to differentiate patients with FS compared to ES. While both FS and ES are heterogeneous populations with multiple subgroups, these subgroups were not meaningfully identified based on ROSQ symptoms. The limited overall predictive accuracy and AUC suggests that, in absence of other supporting data, ROSQ responses in patients with FS and ES were not clinically useful for screening.

Self-Reported Severity and Causes of Traumatic Brain Injury in Patients With Epileptic or Functional Seizures.

Background and Objectives: Although moderate and severe traumatic brain injury (TBI) can cause posttraumatic epilepsy (PTE), many patients with functional seizures (FS) also report a history of mild TBI. To determine whether features of TBI history differ between patients with epileptic seizures (ES) and FS, we compared patient reports of TBI severity, symptoms, and causes of injury. Methods: We recruited patients undergoing video-EEG evaluation for the diagnosis of ES, FS, mixed ES and FS, or physiologic seizure-like events at an academic, tertiary referral center. Patients and their caregivers were interviewed before final video-EEG diagnosis regarding their TBI histories, including concussive symptoms and causes of injury. Results: Of 506 patients, a greater percentage of patients with FS reported a history of TBI than patients with ES (70% vs 59%, aOR = 1.75 [95% CI: 1.00-3.05], p = 0.047). TBI with loss of consciousness (LOC) lasting less than 30 minutes was more frequently reported among patients with FS than with ES (27% vs 13%, aOR = 2.38 [1.26-4.47], p < 0.01). The proportion of patients reporting other neurologic symptoms immediately after TBI was not significantly different between FS and ES (40% vs 29%, p = 0.08). Causes of TBI were found to differ, with TBIs caused by falls from a height (17% vs 10%, aOR = 2.24 [1.06-4.70], p = 0.03) or motor vehicle collisions (27% vs 11%, aOR = 2.96 [1.54-5.67], p < 0.01) reported more frequently in FS than ES. Discussion: Our findings further the association of mild TBI with FS and prompt reconsideration of typical assumptions regarding the significance of a reported TBI history in patients with previously undifferentiated seizures. Although common in both groups, TBI with LOC less than 30 minutes and causes of injury that are commonly believed to be more severe were reported more frequently in FS than ES. This suggests that a patient or caregiver reporting of these features does not imply that PTE is a more probable diagnosis than FS. Although a history of TBI with LOC and presumed high-risk causes of injury intuitively raises suspicion for PTE, clinicians should be cautioned that these historical factors also were a frequent finding in patients with FS.

Title: Functional seizures across the adult lifespan: female sex, delay to diagnosis and disability.

OBJECTIVE: The clinical characteristics of functional seizures may vary based on age-of-onset or age-of-presentation. Description of age-related differences has focused on three categories: pediatric, young-adult, and older-adult. We evaluated how factors continuously varied based on age-of-presentation across the adult lifespan. METHODS: Based on cross-sectional data from 365 adult (18 to 88 years old) patients with documented diagnoses of functional seizures, we evaluated how the quantity and prevalence of specific ictal behaviors, historical factors, and comorbidities varied based on patient age-of-presentation using sequential weighted averages. RESULTS: Four factors changed prominently with age-of-presentation: female predominance decreased at two inflection points - ages 35 and 62; the prevalence of work disability was higher until age-of-presentation 30 then plateaued at 80%; there was greater delay to diagnosis in older patients; and comorbidities was higher with age-of-presentation, starting from early adulthood. The proportion of patients who presented with functional seizures decreased after 50. Ictal behavior did not substantially vary with age-of-presentation. CONCLUSION: The time from onset to diagnosis increased with age-of-presentation, which may be related to increased comorbidities and the misconception that FS do not start in older age. The female predominance decreased nonlinearly with age. By age 30, most patients' seizures already had substantial association with unemployment. These findings emphasize that patients can develop functional seizures at any age. The rapid development of disability relatively early in life, which then stays at a high prevalence rate, demonstrates the need for prompt referral for definitive diagnosis and treatment.

A minority of patients with functional seizures have abnormalities on neuroimaging.

OBJECTIVE: Functional seizures often are managed incorrectly as a diagnosis of exclusion. However, a significant minority of patients with functional seizures may have abnormalities on neuroimaging that typically are associated with epilepsy, leading to diagnostic confusion. We evaluated the rate of epilepsy-associated findings on MRI, FDG-PET, and CT in patients with functional seizures. METHODS: We studied radiologists' reports from neuroimages at our comprehensive epilepsy center from a consecutive series of patients diagnosed with functional seizures without comorbid epilepsy from 2006 to 2019. We summarized the MRI, FDG-PET, and CT results as follows: within normal limits, incidental findings, unrelated findings, non-specific abnormalities, post-operative study, epilepsy risk factors (ERF), borderline epilepsy-associated findings (EAF), and definitive EAF. RESULTS: Of the 256 MRIs, 23% demonstrated ERF (5%), borderline EAF (8%), or definitive EAF (10%). The most common EAF was hippocampal sclerosis, with the majority of borderline EAF comprising hippocampal atrophy without T2 hyperintensity or vice versa. Of the 87 FDG-PETs, 26% demonstrated borderline EAF (17%) or definitive EAF (8%). Epilepsy-associated findings primarily included focal hypometabolism, especially of the temporal lobes, with borderline findings including subtle or questionable hypometabolism. Of the 51 CTs, only 2% had definitive EAF. SIGNIFICANCE: This large case series provides further evidence that, while uncommon, EAF are seen in patients with functional seizures. A significant portion of these abnormal findings are borderline. The moderately high rate of these abnormalities may represent framing bias from the indication of the study being "seizures," the relative subtlety of EAF, or effects of antiseizure medications.

Factors associated with delay to video-EEG in dissociative seizures.

PURPOSE: While certain clinical factors suggest a diagnosis of dissociative seizures (DS), otherwise known as functional or psychogenic nonepileptic seizures (PNES), ictal video-electroencephalography monitoring (VEM) is the gold standard for diagnosis. Diagnostic delays were associated with worse quality of life and more seizures, even after treatment. To understand why diagnoses were delayed, we evaluated which factors were associated with delay to VEM. METHODS: Using data from 341 consecutive patients with VEM-documented dissociative seizures, we used multivariate log-normal regression with recursive feature elimination (RFE) and multiple imputation of some missing data to evaluate which of 76 clinical factors were associated with time from first dissociative seizure to VEM. RESULTS: The mean delay to VEM was 8.4 years (median 3 years, IQR 1-10 years). In the RFE multivariate model, the factors associated with longer delay to VEM included more past antiseizure medications (0.19 log-years/medication, standard error (SE) 0.05), more medications for other medical conditions (0.06 log-years/medication, SE 0.03), history of physical abuse (0.75 log-years, SE 0.27), and more seizure types (0.36 log-years/type, SE 0.11). Factors associated with shorter delay included active employment or student status (-1.05 log-years, SE 0.21) and higher seizure frequency (0.14 log-years/log[seizure/month], SE 0.06). CONCLUSIONS: Patients with greater medical and seizure complexity had longer delays. Delays in multiple domains of healthcare can be common for victims of physical abuse. Unemployed and non-student patients may have had more barriers to access VEM. These results support earlier referral of complex cases to a comprehensive epilepsy center.