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.

Five-Year Incidence of Progression to Osteoarthritis and Total Joint Arthroplasty in Patients Prescribed Glucagon-Like Peptide 1 Receptor Agonists.

BACKGROUND: Research has suggested that glucagon-like peptide-1 receptor agonists (GLP-1-RAs) may have therapeutic effects on osteoarthritis of the hip and knee, in addition to managing diabetes and obesity. However, there is a lack of understanding regarding the association between GLP-1-RA use and the diagnosis of osteoarthritis (OA) of the hip and knee. METHODS: A collaborative network analytics platform was queried for obese diabetic (n = 1,094,198), obese nondiabetic (n = 916,235), and nonobese diabetic (n = 157,305) patients who had an index visit between 2015 and 2017. Patients who had pre-existing hip and/or knee OA were excluded. A 1:1 propensity score matching was used to balance GLP-1-RA use in stratified cohorts for age, sex, race, body mass index, and hemoglobin A1c. The primary outcomes were rates of progression to hip OA, knee OA, major joint injections, total hip arthroplasty, and total knee arthroplasty. Cox proportional hazards models determined hazard ratios (HRs) between cohorts prescribed and not prescribed GLP-1-RAs. RESULTS: All patients had a five-year follow-up. Rates of progression to hip and knee OA were higher among the GLP-1-RA users in both obese diabetic (hip HR: 1.63, 95% confidence interval [CI]: 1.46 to 1.82; knee HR: 1.52, CI: 1.41 to 1.64) and nonobese diabetic (hip HR: 1.78, CI: 1.50 to 2.10; knee HR: 1.58, CI: 1.39 to 1.80) cohorts. These diabetic cohorts received higher rates of major joint injections, though there was no difference in rates of total hip arthroplasty or total knee arthroplasty. No differences in five-year outcomes were seen when comparing obese, nondiabetic patients who were prescribed GLP-1-RAs with obese, nondiabetic patients not exposed to GLP-1-RAs. CONCLUSIONS: This five-year analysis found a greater risk of progression to hip and knee OA among obese and non-obese diabetic GLP-1-RA users. Further studies should explore GLP-1-RA effects upon glucose management, weight loss, and lower extremity arthritis development. LEVEL OF EVIDENCE: III, retrospective cohort study.

Improved short-term outcomes for a novel, fluoroscopy-based robotic-assisted total hip arthroplasty system compared to manual technique with fluoroscopic assistance.

BACKGROUND: While robotic-assisted total hip arthroplasty (RA-THA) has been associated with improved accuracy of component placement, the perioperative and early postoperative outcomes of fluoroscopy-based RA-THA systems have yet to be elucidated. METHODS: This retrospective cohort analysis included a consecutive series of patients who received manual, fluoroscopy-assisted THA (mTHA) and fluoroscopy-based RA-THA at a single institution. We compared rates of complications within 90 days of surgery, length of hospital stay (LOS), and visual analog scale (VAS) pain scores. RESULTS: No differences existed between groups with respect to demographic data or perioperative recovery protocols. The RA-THA cohort had a significantly greater proportion of outpatient surgeries compared to the mTHA cohort (37.4% vs. 3.8%; p < 0.001) and significantly lower LOS (26.0 vs. 39.5 h; p < 0.001). The RA-THA cohort had a smaller 90-day postoperative complication rate compared to the mTHA cohort (0.9% vs. 6.7%; p = 0.029). The RA-THA cohort had significantly lower patient-reported VAS pain scores at 2-week follow-up visits (2.5 vs. 3.3; p = 0.048), but no difference was seen after 6-week follow visits (2.5 vs. 2.8; p = 0.468). CONCLUSION: Fluoroscopy-based RA-THA demonstrates low rates of postoperative complications, improved postoperative pain profiles, and shortened LOS when compared to manual, fluoroscopy-assisted THA.

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.

Is Social Deprivation Associated With Usage, Adverse Events, and Patient-reported Outcome Measures in Total Joint Arthroplasty? A Systematic Review.

BACKGROUND: To capture various social determinants of health, recent analyses have used comprehensive measures of socioeconomic disadvantage such as deprivation and vulnerability indices. Given that studies evaluating the effects of social deprivation on total joint arthroplasty (TJA) have yielded mixed results, a systematic review of this relationship might help answer questions about usage, complications, and results after surgery among patients in different socioeconomic groups and help guide targeted approaches to ensure health equity. QUESTIONS/PURPOSES: We asked: How is social deprivation associated with TJA (1) usage, (2) adverse events including discharge deposition and length of stay, and (3) patient-reported outcome measures (PROMs)? METHODS: A comprehensive review of the PubMed, EBSCO host, Medline, and Google Scholar electronic databases was conducted to identify all studies that evaluated social deprivation and TJA between January 1, 2000, and March 1, 2022. Studies were included if they evaluated comprehensive measures of socioeconomic deprivation rather than individual social determinants of health. Nineteen articles were included in our final analysis with a total of 757,522 patients. In addition to characteristics of included studies (such as patient population, procedure evaluated, and utilized social deprivation metric), we recorded TJA usage, adverse events, and PROM values as reported by each article. Two reviewers independently evaluated the quality of included studies using the Methodological Index for Nonrandomized Studies (MINORS) tool. The mean ± SD MINORS score was 13 ± 1 of 16, with higher scores representing better study quality. All the articles included are noncomparative studies. Given the heterogeneity of the included studies, a meta-analysis was not performed and results were instead presented descriptively. RESULTS: Although there were inconsistencies among the included articles, higher levels of social deprivation were associated with lower TJA usage even after controlling for various confounding variables. Similarly, there was agreement among studies regarding higher proportion of nonhome discharge for patients with more social deprivation. Although there was limited agreement across studies regarding whether patients with more social deprivation had differences in their baseline and postoperative PROMs scores, patients with more social deprivation had lower improvements from baseline for most of the included articles. CONCLUSION: These findings encourage continued efforts focusing on appropriate patient education regarding expectations related to functional improvement and the postoperative recovery process, as well as resources available for further information and social support. We suggest linking patient data to deprivation measures such as the Area Deprivation Index to help encourage shared decision-making strategies that focus on health literacy and common barriers related to access. Given the potential influence social deprivation may have on the outcome and utilization of TJA, hospitals should identify methods to determine patients who are more socially deprived and provide targeted interventions to help patients overcome any social deprivation they are facing. We encourage physicians to maintain close communication with patients whose circumstances include more severe levels of social deprivation to ensure they have access to the appropriate resources. Additionally, as multiple social deprivation metrics are being used in research, future studies should identify a consistent metric to ensure all patients that are socially deprived are reliably identified to receive appropriate treatment. LEVEL OF EVIDENCE: Level III, therapeutic study.

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 Is the Geographic Distribution and Density of Orthopaedic Advanced Practice Professionals in Rural Counties? A Large-database Study.

BACKGROUND: Advanced practice professionals, including physician assistants (PAs) and nurse practitioners (NPs), play an important role in providing high-quality orthopaedic care. This role has been highlighted by projections of nationwide shortages in orthopaedic surgeons, with rural areas expected to be most affected. Given that approximately half of rural counties have no practicing orthopaedic surgeons and that advanced practice professionals have been shown to be more likely to practice in rural areas compared to physicians in other medical disciplines, orthopaedic advanced practice professionals may be poised to address orthopaedic care shortages in rural areas, but the degree to which this is true has not been well characterized. QUESTIONS/PURPOSES: (1) What percentage of rural counties have no orthopaedic caregivers, including surgeons and advanced practice professionals? (2) Is the density of advanced practice professionals greater than that of orthopaedic surgeons in rural counties? (3) Do orthopaedic advanced practice professionals only practice in counties that also have practicing orthopaedic surgeons? (4) Are NPs in states with full practice authority more likely to practice in rural counties compared with NPs in restricted practice authority states? METHODS: We identified orthopaedic surgeons and advanced practice professionals using the 2019 Medicare Provider Utilization and Payment Data, as this large dataset has been shown to be the most complete source of claims data nationwide. Each professional's ZIP Code was matched to counties per the US Postal Service ZIP Code Crosswalk Files. The total number and density of physician and advanced practice professionals per 100,000 residents were calculated per county nationwide. Counties were categorized as urban (large central metropolitan, large fringe metropolitan, medium metropolitan, and small metropolitan) or rural (micropolitan and noncore) using the National Center for Health Statistics Urban-Rural Classification Scheme. Comparisons between rural and urban county caregivers were conducted with the chi-square test and odds ratios. Population densities were compared with the Wilcoxon rank sum test. A bivariate density map was made to visualize the nationwide distribution of orthopaedic caregivers and determine the percentage of rural counties with no orthopaedic caregivers as well as whether orthopaedic advanced practice professionals practiced in counties not containing any surgeons. Additionally, to compare states with NP's full versus restricted practice authority, each NP was grouped based on their state to determine whether NPs in states with full practice authority were more likely to practice in rural counties. We identified a group of 31,091 orthopaedic caregivers, which was comprised of 23,728 physicians, 964 NPs, and 6399 PAs (7363 advanced practice professionals). A total of 88% (20,879 of 23,728) of physicians and 87% (6427 of 7363) of advanced practice professionals were in urban counties, which is comparable to nationwide population distributions. RESULTS: A total of 39% (1237 of 3139) of counties had no orthopaedic professionals (defined as orthopaedic surgeons or advanced practice professionals) in 2019. Among these counties, 82% (1015 of 1237) were rural and 18% (222 of 1237) were urban. The density of advanced practice professionals providing orthopaedic services compared with the density of orthopaedic surgeons was higher in rural counties (18 ± 70 versus 8 ± 40 per 100,000 residents; p = 0.001). Additionally, 3% (57 of 1974) of rural and 1% (13 of 1165) of urban counties had at least one orthopaedic advanced practice professional, but no orthopaedic surgeons concurrently practicing in the county. There was no difference between the percentage of rural counties with an NP in states with full versus restricted practice authority for NPs (19% [157 of 823] versus 26% [36 of 141], OR 1.45 [95% CI 0.99 to 2.2]; p = 0.08). CONCLUSION: As advanced practice professionals tended to only practice in counties which contain orthopaedic surgeons, our analysis suggests that plans to increase the number of advanced practice professionals alone in rural counties may not be sufficient to fully address the demand for orthopaedic care in rural areas that currently do not have orthopaedic surgeons in practice. Rather, interventions are needed to encourage more orthopaedic surgeons to practice in rural counties in collaborative partnerships with advanced practice professionals. In turn, rural orthopaedic advanced practice professionals may serve to further extend the accessibility of these surgeons, but it remains to be determined what the total number and ratio of advanced practice professionals and surgeons is needed to serve rural counties adequately. CLINICAL RELEVANCE: To increase rural orthopaedic outreach, state legislatures may consider providing financial incentives to hospitals who adopt traveling clinic models, incorporating advanced practice professionals in these models as physician-extenders to further increase the coverage of orthopaedic care. Furthermore, the creation of more widespread financial incentives and programs aimed at expanding the experience of trainees in serving rural populations are longer-term investments to foster interest and retention of orthopaedic caregivers in rural settings.

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.

Readability of Online Patient Educational Materials in Pediatric Orthopaedics: A Systematic Review.

BACKGROUND: As most patients and their families utilize online education materials, ensuring that their readability is at or below the recommended reading level of sixth grade is imperative to enhance informed consent, patient involvement, and shared decision-making. We evaluated and compared the readability of online patient education materials (PEMs) about pediatric orthopaedics for academic-sponsored websites and search-engine result websites. METHODS: Following the PRISMA-P guidelines, we performed a systematic review to answer our study question (PROSPERO registration of the study protocol: CRD42022352323, August 8, 2022). PubMed, EBSCOhost, Medline, and Google Scholar electronic databases were utilized to identify all studies evaluating the readability of pediatric orthopaedic online PEMs between January 1, 2000 and September 9, 2022. We included studies with full-text manuscripts in English addressing the readability of pediatric orthopaedic online patient education materials. We excluded general reviews, papers, case reports, duplicate studies between databases, grey literature, and publications in languages other than English. The quality of included studies was assessed using the Joanna Briggs Institute (JBI) tool for cross-sectional studies. RESULTS: Our initial search yielded 196 candidate publications. Of these, 11 studies met inclusion criteria. These included a total of 893 PEMs assessed for readability between January 2001 to December 2021. The mean JBI score was 7.3±1.1. Each of the seven studies assessing PEMs from academic-sponsored sources reported mean readability scores of at least an eighth-grade level. Among the 5 studies assessing the readability of PEMs accessed through search engines, 3 studies reported ninth-grade reading level whereas the other 2 reported 10th-grade. Academic and search-engine website readability scores remained constant between 2001 and 2021. CONCLUSIONS: Our analysis showed poor readability scores for both academic-sponsored website PEMs and those accessed through search engines. In addition, the readability scores remained constant between 2001 and 2021, indicating that revisions to orthopaedic online PEMs are needed. Supplementation with visuals should be included to educate patients with lower health literacy. LEVEL OF EVIDENCE: III.

Implant Selection Strategies for Total Joint Arthroplasty: The Effects on Cost Containment and Physician Autonomy.

BACKGROUND: With continued declines in reimbursement for total joint arthroplasty, health systems have explored implant cost containment measures to generate sustainable margins. This review evaluated how implementation of (1) implant price control programs, (2) vendor purchasing agreements, and (3) bundled payment models affected implant costs and physician autonomy in implant selection. METHODS: PubMed, EBSCOhost, and Google Scholar were searched to identify studies that evaluated the efficacy of total hip or total knee arthroplasty implant selection strategies. The review included publications between January 1, 2002, and October 17, 2022. The mean Methodological Index for Nonrandomized Studies score was 18.3 ± 1.8. RESULTS: A total of 13 studies (32,197 patients) were included. All studies implementing implant price capitation programs found decreased implant costs, ranging 2.2 to 26.1% and increased utilization of premium implants. Most studies found bundled payments models reduced total joint arthroplasty implant costs with greatest reduction being 28.9%. Additionally, while absolute single vendor agreements had higher implant costs, preferred single vendor agreements had reduced implant costs. When given price constraints, surgeons tended to select more premium implants. CONCLUSION: Alternative payment models that incorporated implant selection strategies saw reduced costs and surgeon utilization of premium implants. The study findings encourage further research on implant selection strategies, which must balance the goals of cost containment with physician autonomy and optimized patient care. LEVEL OF EVIDENCE: Level III.

Is Penicillin Allergy a Clinical Problem? A Systematic Review of Total Joint Arthroplasty Procedures With Implications for Patient Safety and Antibiotic Stewardship.

BACKGROUND: Patients undergoing total joint arthroplasty (TJA) who report penicillin allergy (PA) are frequently administered second-line antibiotics, although recent evidence suggests that this may be unnecessary and could increase infection risk. Many institutions have aimed to improve antibiotic deployment via allergy testing and screening; however, there is little standardization to this process. This review aimed to evaluate (1) antibiotic selection in patients who report PA and assess the impact of screening and testing interventions, (2) rates of allergic reactions in patients who report PA, and (3) the association between reported PA and screening or testing programs and odds of surgical site infection or periprosthetic joint infection. METHODS: PubMed, EBSCOhost, and Google Scholar electronic databases were searched on February 4, 2023 to identify all studies published since January 1, 2000 that evaluated the impact of PA on patients undergoing TJA (PROSPERO study protocol registration: CRD42023394031). Articles were included if full-text manuscripts in English were available, and the study analyzed the impact of PA and related interventions on TJA patients. There were 11 studies evaluating 1,276,663 patients included. Interventions were compared via presentation of key findings regarding rates of clinically relevant or high-risk PA reported upon screenings or testings, cephalosporin utilizations, allergic reactions, and postoperative infections (surgical site infection and periprosthetic joint infection). RESULTS: All 6 studies found that PA screening and testing markedly increase the use of first-line antibiotics. Testing showed low rates of true allergy (0.7 to 3%) and allergic reaction frequency for patients who have reported PA receiving cephalosporins was between 0% and 2%. Although there were mixed findings across studies, there was a trend toward second-line antibiotic prophylaxis being associated with a slightly higher rate of infection in PA patients. CONCLUSIONS: Using PA screening and testing can promote antibiotic stewardship by safely increasing the use of first-line antibiotics in patients who have a reported PA. LEVEL OF EVIDENCE: Level III, Therapeutic Study.

Total Hip Arthroplasty Outcomes in Patients Who Have a History of Prior Radiation.

BACKGROUND: The purpose of this study was to assess the odds of developing medical and surgical adverse events following total hip arthroplasty (THA) in patients who have a history of radiation therapy (RT) for cancer. METHODS: A retrospective cohort study was conducted using a national database to identify patients who underwent primary THA (Current Procedural Terminology code 27130) from 2002 to 2022. Patients who had a prior RT were identified by International Classification of Diseases, Tenth Revision, Clinical Modification codes Z51.0 (encounter for antineoplastic RT), Z92.3 (personal history of irradiation), or Current Procedural Terminology code 101843 (radiation oncology treatment). One-to-one propensity score matching was conducted to generate 3 pairs of cohorts: 1) THA with/without a history of RT; 2) THA with/without a history of cancer; and 3) THA patients who have a history of cancer treated with/without RT. Surgical and medical complications were assessed at the 30-day, 90-day, and 1-year postoperative periods. RESULTS: Patients who have a history of RT had higher odds of developing anemia, deep vein thrombosis, pneumonia, pulmonary embolism, and prosthetic joint infection at all intervals. When controlling for a history of cancer, RT was associated with an increased risk of pulmonary embolism, heterotrophic ossification, prosthetic joint infection, and periprosthetic fracture at all postoperative time points. There was additionally an increased risk of aseptic loosening at 1 year (odds ratio: 2.0, 95% confidence interval: 1.2 to 3.1). CONCLUSION: These findings suggest that patients who have a history of antineoplastic RT are at an increased risk of developing various surgical and medical complications following THA.

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.

Mark-Up Trends in Contemporary Medicare Primary and Revision Total Joint Arthroplasty.

BACKGROUND: Understanding mark-up ratios (MRs), the ratio between a healthcare institution's submitted charge and the Medicare payment received, for high-volume orthopaedic procedures is imperative to inform policy about price transparency and reducing surprise billing. This analysis examined the MRs for primary and revision total hip and knee arthroplasty (THA and TKA) services to Medicare beneficiaries between 2013 and 2019 across healthcare settings and geographic regions. METHODS: A large dataset was queried for all THA and TKA procedures performed by orthopaedic surgeons between 2013 and 2019, using Healthcare Common Procedure Coding System (HCPCS) codes for the most frequently used services. Yearly MRs, service counts, average submitted charges, average allowed payments, and average Medicare payments were analyzed. Trends in MRs were assessed. We evaluated 9 THA HCPCS codes, averaging 159,297 procedures a year provided by a mean of 5,330 surgeons. We evaluated 6 TKA HCPCS codes, averaging 290,244 procedures a year provided by a mean of 7,308 surgeons. RESULTS: For knee arthroplasty procedures, a decrease was noted for HCPCS code 27438 (patellar arthroplasty with prosthesis) over the study period (8.30 to 6.62; P = .016) and HCPCS code 27447 (TKA) had the highest median (interquartile range [IQR]) MR (4.73 [3.64 to 6.30]). For revision knee procedures, the highest median (IQR) MR was for HCPCS code 27488 (removal of knee prosthesis; 6.12 [3.83-8.22]). While no trends were noted for both primary and revision hip arthroplasty, median (IQR) MRs in 2019 for primary hip procedures ranged from 3.83 (hemiarthroplasty) to 5.06 (conversion of previous hip surgery to THA) and HCPCS code 27130 (total hip arthroplasty) had a median (IQR) MR of 4.66 (3.58-6.44). For revision hip procedures, MRs ranged from 3.79 (open treatment of femoral fracture or prosthetic arthroplasty) to 6.10 (revision of THA femoral component). Wisconsin had the highest median MR by state (>9) for primary knee, revision knee, and primary hip procedures. CONCLUSION: The MRs for primary and revision THA and TKA procedures were strikingly high, as compared to nonorthopaedic procedures. These findings represent high levels of excess charges billed, which may pose serious financial burdens to patients and must be taken into consideration in future policy discussions to avoid price inflation.

Have all races experienced reductions in complication rates following total hip arthroplasty? A NSQIP analysis between 2011 and 2019.

INTRODUCTION: Despite numerous articles in the orthopedic literature evaluating racial and ethnic disparities, inequalities in total joint arthroplasty outcomes remain. While the National Surgical Quality Improvement (NSQIP) database has been previously utilized to highlight these disparities, no previous analysis has evaluated how the rate of various perioperative complications has changed over recent years when segregating by patient race. Specifically, we evaluated if all races have experienced decreases in (1) medical complications, (2) wound complications, (3) venous thromboembolism (VTE), and (4) readmission/reoperation rates following total hip arthroplasty (THA) over recent years? METHODS: Current Procedural Terminology (CPT) code 27,130 (total hip arthroplasty) was utilized to identify all THA procedures conducted between 2011 and 2019. Patients were segregated according to race and various demographics were collected. Linear regression was utilized to evaluate changes in each complication rate between 2011 and 2019. A multivariate regression was then conducted for each complication to evaluate whether race independently was associated with each outcome. RESULTS: Our analysis included a total of 212,091 patients undergoing primary THA. This included 182,681 (85.76%) White, 19,267 (9.04%) Black, 5928 (2.78%) Hispanic, and 4215 (1.98%) Asian patients. We found that for urinary tract infection (UTI), acute renal failure, superficial SSI, and readmission rates, White patients experienced significant reductions between 2011 and 2019. However, this was not consistent across all races. Black race was associated with a significantly increased risk of acute renal failure (OR: 2.03, 95% CI: 1.17-3.34; p = 0.008), renal insufficiency (OR: 2.33, 95% CI: 1.62-3.28; p < 0.001), deep vein thrombosis (DVT) (OR: 1.34, 95% CI: 1.07-1.66; p = 0.01), and pulmonary embolism (PE) (OR: 1.76, 95% CIL: 1.36-2.24; p < 0.001). CONCLUSION: Our analysis highlights specific complications for which further interventions are necessary to reduce inequalities across races. These include medical optimization, increased patient education, and continued efforts at understanding how social factors may impact-related care inequalities. Future study is needed to evaluate specific interventions that can be applied at the health systems level to ensure all patients undergoing THA receive the highest quality of care regardless of race.

Less Than One-third of Hospitals Provide Compliant Price Transparency Information for Total Joint Arthroplasty Procedures.

BACKGROUND: The Centers for Medicare and Medicaid Services (CMS) recently implemented price transparency legislation. As total joint arthroplasty (TJA) procedures are widely used, expensive, and generally are predictable in terms of cost and expected outcomes, these procedures are a proxy for assessing how hospitals provide price transparency for their services as a whole. Furthermore, cost estimates for TJA procedures represent some of the most commonly sought-after price transparency information among the orthopaedic surgery patient population. QUESTIONS/PURPOSES: We asked: (1) Are hospitals compliant with federal rules mandating transparency in pricing for primary TJA? (2) Are hospitals providing these data in a user-friendly format? (3) Is there a difference in prices quoted based on Current Procedural Terminology (CPT) codes compared with Diagnosis Related Group (DRG) codes? METHODS: Our cross-sectional retrospective analysis used the CMS's Hospital Compare database. This database includes information for 5326 Medicare hospitals nationally. We excluded children's, psychiatric, Veterans Affairs, and active military base hospitals as well as hospitals performing fewer than 100 TJAs annually. A total of 1719 hospitals remained after this selection process. Random sampling stratified across practice setting, hospital size, TJA volume, type, ownership, and Census region was performed to identify 400 facilities for our final analysis. Included hospitals were located predominately in urban areas (79% [317 of 400]) and were mostly medium-sized facilities (43% [171 of 400]). Most hospitals were classified as acute care (98% [392 of 400]) versus critical access. Three reviewers thoroughly searched each hospital website for a machine-readable file providing the following five datapoints: gross charges, payer-specific negotiated charges, deidentified minimum negotiated charges, deidentified maximum negotiated charges, and discounted cash prices. Hospitals that provided all five datapoints through a machine-readable file were considered compliant. Additionally, we considered hospitals with any gross price information pseudocompliant. The consumer-friendliness of the website was assessed based on the following criteria: (1) languages other than English were offered, (2) it took less than 15 minutes to locate pricing information, (3) a phone number or email address was provided for questions, and (4) there was a description of procedure in common terms. Pricing information was recorded and compared for CPT codes 27447 and 27130 and DRG codes 469 and 470. Data were sourced from December 1 through 20, 2021, to assess compliance in the first year since the legislation was implemented. RESULTS: Only 32% (129 of 400) of the sampled hospital websites were compliant with all six requirements under the CMS rule for transparency in pricing. When segregating by individual procedures, 21% (84 of 400), 18% (72 of 400), 18% (71 of 400), and 19% (74 of 400) of hospitals provided CMS-compliant pricing information for CPT codes 27447 and 27130 and DRG codes 469 and 470, respectively. For each code, rates of pseudocompliance were 36% (143 of 400), 31% (125 of 400), 34% (135 of 400), and 50% (199 of 400) for the included codes, respectively. Most included hospitals provided at least some of their pricing data in a user-friendly format. Prices quoted using a DRG search were higher overall than prices quoted using a procedure-specific CPT code. CONCLUSION: Although the CMS implemented a price transparency mandate at the beginning of 2021, our analysis demonstrated that most hospitals either do not provide TJA price estimates or are noncompliant when presenting related information. Specifically, approximately half of evaluated hospitals provided a gross charge for any TJA code, and less than one-third of these institutions were fully compliant with all CMS mandates for these procedures. CLINICAL RELEVANCE: Given the potential influence compliance and price sharing may have on empowering patients' healthcare decisions and reducing healthcare expenditures, hospitals should use our analysis to identify where their compliance is lacking and to understand how to make their pricing information more readily available to their patients. In addition to ensuring that all six CMS mandates are met, this should include providing information in easy-to-understand formats and making related services identifiable across all levels of health literacy. Furthermore, we advocate for the use of CPT codes and layman terms when identifying provided services as well as a price estimator tool that allows for the download of a machine-readable file specific to the procedure of interest.

The Epidemiology of Posttraumatic Osteoarthritis of the Knee in the United States: An Analysis of 948,853 Patients From 2000 to 2022.

INTRODUCTION: Posttraumatic osteoarthritis of the knee (PTOAK) is a known sequela of bony and soft-tissue articular knee injuries, although its historically reported prevalence is highly variable with no recent population-based studies. METHODS: The TriNetX/US Collaborative Network database was queried to identify adult patients diagnosed with a history of knee trauma using ICD-10-CM coding. Primary outcomes measured were yearly incidence proportion (IP), incidence rate (IR), and prevalence of knee osteoarthritis in the United States from 2000 to 2022. Chi square analyses were conducted to compare outcomes across categorical data. Regression modeling was performed to project PTOAK epidemiology to 2030. Statistical significance was held at P < 0.05 for all analyses. RESULTS: Nine hundred forty-eight thousand eight hundred fifty-three patients meeting criteria were identified. As of 2022, the IP of PTOAK was 5.93%, IR was 2.26 × 10 -4 cases/person-day, and prevalence was 21.1%. By strata in 2022, posttraumatic knee OA is most prevalent among the 54 to 59-year-old age group (50.9%), 60 to 64-year-old age group (50.3%), 50 to 54-year-old age group (49.7%), female patients (24.2%), and White patients (23.1%). Regression analyses revealed that the IP, IR, and prevalence of PTOAK have increased exponentially from 2000 to 2022. By 2030, the model predicts that the IP will further increase to 10.7% (95% PI = 9.79% to 11.7%), IR will be 3.79 × 10 -4 cases/person-day (95% PI = 3.28 × 10 -4 to 4.29 × 10 -4 ), and prevalence of PTOAK in the United States will be 40.6% (95% PI = 39.1% to 42.0%). DISCUSSION: These findings echo earlier, smaller scale studies but reveal an alarming rise in PTOAK prevalence, potentially doubling by 2030. The financial burden of knee OA treatment in the United States is already substantial, costing between $5.7 and $15 billion USD annually. This projected increase in prevalence could further increase healthcare expenditures by $1 to 3 billion by 2030. These results emphasize the need for additional research into factors contributing to PTOAK, evidence-based preventive public health interventions, and the development of multidisciplinary system-based care delivery optimization pathways.

What is the long-term survivorship, complication profile, and patient reported outcomes after Birmingham hip resurfacing?

Introduction: When indicated, Birmingham Hip Resurfacing (BHR) presents a viable alternative to total hip arthroplasty (THA), but there remain questions about the long-term outcomes of BHR. Therefore, we asked: 1) what are the long-term patient-reported outcomes and 2) survivorship rates following BHR; 3) what are the causes for revision surgery after BHR? and 4) how have these outcomes compared to THA at long-term follow-up. Methods: A query of PubMed, MEDLINE, Scopus, and Cochrane in September 2023 was performed. Articles were included if they reported BHR survivorship rates at ≥10 years. Survivorship was defined as an all-cause revision of any BHR component. This review encompasses 26 articles, totaling 13,103 hips. Mean follow-up ranged from 6.0 to 20.9 years, but each study had at least a subgroup analysis for ≥10-year follow-up. Results: Five studies compared preoperative and postoperative PROs for BHR, with four reporting improvement in at least one PRO after 10-year follow-up. Overall, survivorship rates ranged from 83% to 100% across diverse long-term timeframes, with 25 of 26 studies reporting 10-year survivorship rates greater than 87%. The primary reasons for revisions were implant loosening (22%), adverse reactions to metal debris (21.2%), and fractures of any kind (17.2%). In the six studies that compared BHR to THA, long-term survivorship was similar while BHR exhibited slightly superior activity levels. Conclusion: The findings from this study suggested favorable long-term survivorship and postoperative outcomes of BHR. In studies comparing long-term BHR and THA, survivorship was comparable, with BHR potentially providing enhanced postoperative activity levels.

Use of a fluoroscopy-based robotic-assisted total hip arthroplasty system resulted in greater improvements in hip-specific outcome measures at one-year compared to a CT-based robotic-assisted system.

BACKGROUND: The purpose of this study was to compare one-year patient reported outcome measures between a novel fluoroscopy-based robotic-assisted (FL-RTHA) system and an existing computerised tomography-based robotic assisted (CT-RTHA) system. METHODS: A review of 85 consecutive FL-RTHA and 125 consecutive CT-RTHA was conducted. Outcomes included one-year post-operative Veterans RAND-12 (VR-12) Physical (PCS)/Mental (MCS), Hip Disability and Osteoarthritis Outcome (HOOS) Pain/Physical Function (PS)/Joint replacement, and University of California Los Angeles (UCLA) Activity scores. RESULTS: The FL-RTHA cohort had lower pre-operative VR-12 PCS, HOOS Pain, HOOS-PS, HOOS-JR, and UCLA Activity scores compared with patients in the CT-RTHA cohort. The FL-RTHA cohort reported greater improvements in HOOS-PS scores (-41.54 vs. -36.55; p = 0.028) than the CT-RTHA cohort. Both cohorts experienced similar rates of major post-operative complications, and had similar radiographic outcomes. CONCLUSIONS: Use of the fluoroscopy-based robotic system resulted in greater improvements in HOOS-PS in one-year relative to the CT-based robotic technique.