Disparities Associated With Total Joint Arthroplasty Transfusion Rates.

BACKGROUND: Infections, readmissions, and mortalities after total joint arthroplasty (TJA) are serious complications, and transfusions have been associated with increased complication rates following TJA. Certain populations, including women, Black patients, patients who have public insurance and older adults have higher risks of transfusion. Recently, there has been a decline in transfusion rates and a greater emphasis on equity in medicine. This study examined whether disparities in transfusion rates still exist and what variables influence rates over time. METHODS: We used a health care system database to identify 5,435 total knee arthroplasty (TKA) and 2,105 total hip arthroplasty (THA) patients from 2013 to 2021. Transfusion rates were 2.9 and 3.1% in the TKA and THA arthroplasty groups, respectively. White race represented 67.1 and 69.8% of the TKA and THA groups, respectively. Fisher exact and Wilcoxon rank sum tests were used to compare categorical and continuous variables. Multivariable logistic regressions were performed to predict transfusion rates within 5 days of surgery and adjust for potential confounders. RESULTS: Transfusion rates declined over time. However, Black patients had a higher rate of transfusion than White patients despite similar hemoglobin levels, 5.1 versus 1.8% (P < .001) in the TKA group and 4.1 versus 2.7% (P = .103) in the THA group. Following adjustment, the biggest factor associated with a higher transfusion risk in the TKA group was being Black (adjusted odds ratio = 2.2, 95% confidence interval = 1.55 to 3.13). CONCLUSIONS: Transfusion rates for TJA patients are declining; however, Black patients continued to receive transfusions at higher rates in patients receiving TKA.

Is Bipolar Radiofrequency-Assisted Liposuction Equivalent to Open Anterior Platysmaplasty in Facelift Surgery?

BACKGROUND: During facelift surgery, anterior platysmaplasty (AP) has been used for decades, but it limits lateral advancement and can induce contour irregularities. Radiofrequency (RF)-assisted-liposuction in the anterior neck can avoid these disadvantages by tightening skin without open surgery. PURPOSE: The purpose of the study was to compare the esthetic outcomes of facelift surgery with those of AP and RF. STUDY DESIGN, SETTING, SAMPLE: A 5-year retrospective cohort study was performed on facelift patients treated by a single surgeon. Exclusions were single-side surgery, previous facelift, chin/lip augmentation/reduction, and inadequate data. PREDICTOR VARIABLE: The predictor variable was neck management technique (AP vs RF). MAIN OUTCOME VARIABLES: The primary outcome variable was the change in cervicomental angle (CMA) following surgery as measured on facial photographs. Secondary outcomes included distance changes from the central CMA point in vertical and horizontal planes to repeatable reference planes. COVARIATES: Covariates were age, body mass index, American Society of Anesthesiologists classification, smoking, and simultaneous procedures. ANALYSES: The statistical analysis was performed using Wilcoxon rank-sum, Fisher's exact, Kruskal-Wallis tests, Pearson's correlation, and linear regressions. The level of statistical significance was P < .05. RESULTS: There were 132 patients included in the study; 67 received AP and 65 received RF. AP trended toward better performance in CMA change in the unadjusted analysis (-18.7° ± 13.8° vs -22.3° ± 13.7°, respectively, P = .08). AP and RF performed similarly in the adjusted analysis (P = .29). Techniques were similar in horizontal distance change to the CMA (P = .31). RF was associated with less change in the vertical distance to the CMA in the unadjusted analysis (-11.9 mm ± 11.0 mm vs -6.7 mm ± 8.7 mm, respectively, P = .01) and adjusted analysis (ß = 4.3 mm, 95% confidence interval .8 to 7.9 mm, P = .02). CONCLUSION AND RELEVANCE: Utilization of the RF technique for management of the anterior neck in facelift surgery is associated with similar outcomes to the AP technique in horizontal distance to the CMA, but AP performed better in CMA change and vertical distance to the CMA.

Novel Clinical Trial Designs with Dose Optimization to Improve Long-term Outcomes.

Conventional designs for choosing a dose for a new therapy may select doses that are unsafe or ineffective and fail to optimize progression-free survival time, overall survival time, or response/remission duration. We explain and illustrate limitations of conventional dose-finding designs and make four recommendations to address these problems. When feasible, a dose-finding design should account for long-term outcomes, include screening rules that drop unsafe or ineffective doses, enroll an adequate sample size, and randomize patients among doses. As illustrations, we review three designs that include one or more of these features. The first illustration is a trial that randomized patients among two cell therapy doses and standard of care in a setting where it was assumed on biological grounds that dose toxicity and dose-response curves did not necessarily increase with cell dose. The second design generalizes phase I-II by first identifying a set of candidate doses, rather than one dose, randomizing additional patients among the candidates, and selecting an optimal dose to maximize progression-free survival over a longer follow-up period. The third design combines a phase I-II trial and a group sequential randomized phase III trial by using survival time data available after the first stage of phase III to reoptimize the dose selected in phase I-II. By incorporating one or more of the recommended features, these designs improve the likelihood that a selected dose or schedule will be optimal, and thus will benefit future patients and obtain regulatory approval.

Comparative polar and lipid plasma metabolomics differentiate KSHV infection and disease states.

BACKGROUND: Kaposi sarcoma (KS) is a neoplastic disease etiologically associated with infection by the Kaposi sarcoma-associated herpesvirus (KSHV). KS manifests primarily as cutaneous lesions in individuals due to either age (classical KS), HIV infection (epidemic KS), or tissue rejection preventatives in transplantation (iatrogenic KS) but can also occur in individuals, predominantly in sub-Saharan Africa (SSA), lacking any obvious immune suppression (endemic KS). The high endemicity of KSHV and human immunodeficiency virus-1 (HIV) co-infection in Africa results in KS being one of the top 5 cancers there. As with most viral cancers, infection with KSHV alone is insufficient to induce tumorigenesis. Indeed, KSHV infection of primary human endothelial cell cultures, even at high levels, is rarely associated with long-term culture, transformation, or growth deregulation, yet infection in vivo is sustained for life. Investigations of immune mediators that distinguish KSHV infection, KSHV/HIV co-infection, and symptomatic KS disease have yet to reveal consistent correlates of protection against or progression to KS. In addition to viral infection, it is plausible that pathogenesis also requires an immunological and metabolic environment permissive to the abnormal endothelial cell growth evident in KS tumors. In this study, we explored whether plasma metabolomes could differentiate asymptomatic KSHV-infected individuals with or without HIV co-infection and symptomatic KS from each other. METHODS: To investigate how metabolic changes may correlate with co-infections and tumorigenesis, plasma samples derived from KSHV seropositive sub-Saharan African subjects in three groups, (A) asymptomatic (lacking neoplastic disease) with KSHV infection only, (B) asymptomatic co-infected with KSHV and HIV, and (C) symptomatic with clinically diagnosed KS, were subjected to analysis of lipid and polar metabolite profiles RESULTS: Polar and nonpolar plasma metabolic differentials were evident in both comparisons. Integration of the metabolic findings with our previously reported KS transcriptomics data suggests dysregulation of amino acid/urea cycle and purine metabolic pathways, in concert with viral infection in KS disease progression. CONCLUSIONS: This study is, to our knowledge, the first to report human plasma metabolic differentials between in vivo KSHV infection and co-infection with HIV, as well as differentials between co-infection and epidemic KS.

Does Preoperative Surgical Delay Lead to Increased Postsurgical Length of Stay or Reoperation in Patients With Severe Odontogenic Infections?

BACKGROUND: While severe odontogenic infections can be life-threatening and emergent surgery can be required more often, surgical management in the operating room (OR) is completed as soon as feasible. However, provider schedules and OR availability can occasionally lead to longer delays before surgery, but their effect on outcomes is unknown. PURPOSE: The purpose of this study was to determine the association of preoperative surgical delay with postsurgical length of stay (LOS) and reoperation in patients with severe odontogenic infections. STUDY DESIGN, SETTING, SAMPLE: The authors conducted a retrospective cohort study consisting of all adult patients treated in the OR with incision and drainage for odontogenic infections from 1/1/2015 to 7/30/2021 at a large, urban academic hospital. PREDICTOR VARIABLE: The primary predictor variable was the length of presurgical delay-the number of hours between arrival in the emergency department and the start of surgery. MAIN OUTCOME VARIABLES: The primary outcome variable was the postsurgical LOS and the secondary outcome variable was the rate of reoperation. COVARIATES: Demographics, medical history, exam findings, diagnosis, and treatment-related variables were also analyzed. ANALYSES: Descriptive and bivariate analyses were performed along with multivariable linear and logistic regression. A P value of < .05 was considered significant. RESULTS: There were 401 patients included in the study with 50.9% men and a mean age of 39.1 years. Increased length of presurgical delay (hours) was associated with a decreased postsurgical LOS (ß = -0.05 days, P = .01) and length of presurgical delay was not associated with reoperation (P = .51) in the unadjusted analyses. However, length of presurgical delay was not found to be associated with either LOS (ß = -0.02, 95% confidence interval (CI) -0.05 to 0.01, P = .12) or reoperation (adjusted odds ratio (aOR) 1.0, 95% CI 0.96 to 1.02, P = .67) in the adjusted analyses. CONCLUSIONS AND RELEVANCE: The association of decreased length of presurgical delay with increased postsurgical LOS in the unadjusted analysis could reflect the practice of rapid intervention for the most ill patients. After adjusting for number of spaces, a primary indicator of infection severity, length of presurgical delay was not associated with either LOS or return to the operating room.

Do Antibiotics Prevent Infectious Complications in Critically Injured Patients With Blunt Nonoperative Midfacial Trauma?

BACKGROUND: While recent literature suggests antibiotics are not needed in patients with nonoperative facial fractures involving sinuses, the existing studies do not focus on critically injured patients who are known to be at higher risk for sinusitis and ventilator-associated pneumonia, which could be exacerbated by facial fractures. PURPOSE: The purpose of this study was to determine if antibiotics reduce the rate of infectious complications in critically injured patients who have blunt midfacial trauma treated nonoperatively. STUDY DESIGN, SETTING, SAMPLE: The authors conducted a retrospective cohort study consisting of patients admitted to the trauma intensive care unit who sustained blunt midfacial injuries managed nonoperatively at an urban Level 1 trauma center from August 13th, 2012, to July 30th, 2020. Adults who were critically injured on admission and sustained a midfacial fracture involving a sinus were included in the study. Patients who underwent operative repair of any facial fracture were excluded. PREDICTOR VARIABLE: The predictor variable was the use of antibiotics. MAIN OUTCOME VARIABLE: The primary outcome variable was the development of infectious complications, such as sinusitis, soft tissue infection, or any type of pneumonia, including ventilator-associated pneumonia (VAP). ANALYSES: The data were analyzed using Wilcoxon rank sum tests, Fisher exact tests, and multivariable logistic regression as appropriate for analysis type with significance level set at <0.05. RESULTS: The study included 307 patients, with a mean age of 40.6 years. Men accounted for 85.0% of the study population. Antibiotics were administered to 229 (74.6%) of the study population. Complications developed in 13.6% of the patients, which included sinusitis (0.3%), VAP (7.5%), and other types of pneumonia (5.9%). Clostridioides difficile colitis developed in 2 patients (0.6%). Antibiotics were not associated with a decrease in infectious complications in either the unadjusted analysis (13.1% in antibiotic group, 15.4% in no antibiotic group, RR = 0.85 [95% confidence interval = 0.5 to 1.6], P = .7) or the adjusted analysis (odds ratio 0.74 [0.34 to 1.62]). CONCLUSIONS AND RELEVANCE: Even in this critically injured patient population thought to be at elevated risk for infectious complications from their midfacial fractures, the rates of infectious complications in those who received antibiotics and those who did not were no different. These results suggest that consideration of more judicious use of antibiotics is warranted in critically ill patients with nonoperative midface fractures.

Total Joint Arthroplasty Patient Demographics Before and After Coronavirus Disease 2019 Elective Surgery Restrictions.

Background: In 2020, the coronavirus disease 2019 (COVID-19) pandemic caused the cessation of nonemergent total joint arthroplasty (TJA, referring to total hip and total knee arthroplasty) operations between mid-March and April 2020. The purpose of this study is to analyze the effects and potential disparities in access to care due to the COVID-19 restrictions. Methods: A database was used to examine the demographics of patients undergoing TJA from May to December 2019 (pre-COVID-19) and from May to December 2020 (post-COVID-19 restrictions). Categorical covariates were summarized by reporting counts and percentages and compared using Fisher exact tests. Continuous covariates were summarized by reporting means and standard deviations. Two-sample t-tests were used for continuous covariates. The equality of TJA counts by year was tested using a test of proportions. Results: There were more TJA procedures performed during the post-COVID-19 period in 2020 than in the pre-COVID-19 period (1151 vs 882, P < .001). There was an increase in the relative percentage of THAs vs TKAs performed in 2020 vs 2019 (26.9% vs 18.8%, P < .001) and an increase in patients with Medicaid with a decrease in private insurance (P = .043). The average length of stay was shorter in 2020 with a greater percentage of TJAs performed outpatient (P < .001). There were no differences in patient sex, race, body mass index, smoking status, or age between the 2 periods. Conclusions: A relative increase in THA procedures, an increase in patients with Medicaid and decrease in private insurance, and a a decreased length of stay were seen after COVID-19 restrictions. These trends may reflect pandemic-related changes in insurance status as well as the growing shift to same-day discharge.

Disparities in Elective and Nonelective Total Hip Arthroplasty.

BACKGROUND: Prior studies have shown disparities in utilization of primary and revision total hip arthroplasty (THA). However, little is known about patient population differences associated with elective and nonelective surgery. Therefore, the aim of this study was to explore factors that influence primary utilization and revision risk of THA based on surgery indication. METHODS: Data were obtained from 7,543 patients who had a primary THA from 2014 to 2020 in a database, which consists of multiple health partner systems in Louisiana and Texas. Of these patients, 602 patients (8%) underwent nonelective THA. THA was classified as "elective" or "nonelective" if the patient had a diagnosis of hip osteoarthritis or femoral neck fracture, respectively. RESULTS: After multivariable logistic regression, nonelective THA was associated with alcohol dependence, lower body mass index (BMI), women, and increased age and number of comorbid conditions. No racial or ethnic differences were observed for the utilization of primary THA. Of the 262 patients who underwent revision surgery, patients who underwent THA for nonelective etiologies had an increased odds of revision within 3 years of primary THA (odds ratio (OR) = 1.66, 95% Confidence Interval (CI) = 1.06-2.58, P-value = .025). After multivariable logistic regression, patients who had tobacco usage (adjusted odds ratio (aOR) = 1.36, 95% CI = 1.04-1.78, P-value = .024), alcohol dependence (aOR = 2.46, 95% CI = 1.45-4.15, P-value = .001), and public insurance (OR = 2.08, 95% CI = 1.18-3.70, P-value = .026) had an increased risk of reoperation. CONCLUSION: Demographic and social factors impact the utilization of elective and nonelective primary THA and subsequent revision surgery. Orthopaedic surgeons should focus on preoperative counseling for tobacco and alcohol cessation as these are modifiable risk factors to directly decrease reoperation risk.

Does a Short Period of Maxillomandibular Fixation Decrease Complications in Open Reduction Internal Fixation of Mandibular Angle Fractures?

PURPOSE: A short duration of postoperative maxillomandibular fixation (MMF) has the potential to reduce complications following open reduction and internal fixation (ORIF) of mandibular angle fractures. The purpose of this study was to determine if a short duration of MMF is associated with a reduced rate of postoperative inflammatory complications (POICs) in patients with mandibular angle fractures undergoing ORIF. METHODS: The authors conducted a retrospective cohort study consisting of patients treated with ORIF for mandibular angle fractures from August 1, 2015 to May 31, 2020 at an urban, level 1 trauma center. Patients under the age of 18 years, bilateral angle fractures, those with MMF periods of more than 3 weeks, and those patients without documentation of the duration of MMF were excluded from the study. The primary predictor variable was the use of a short duration (less than 2 weeks) of postoperative MMF. The outcome variable of interest was the presence of POICs. Categorical covariates were compared using Fisher's exact tests, while continuous variables were compared using Wilcox rank-sum tests. Multivariable logistic regression adjustment was also performed. RESULTS: There were 307 patients included in the study, 84.4% of which were men. The average age was 32.5 years. Patients with a short duration of MMF had a POIC rate of 8.3% compared to 18.2% for no MMF (P = .08). In the adjusted analysis, patients with a short duration of MMF time had a significant decrease in POIC risk compared to no MMF (adjusted odds ratio [aOR] = 0.32, 95% confidence interval [CI] = 0.11 to 0.97). Other significant variables in the regression analysis included plating type and noncompliance. Inferior border rigid fixation was associated with decreased POIC risk compared to ladder plates and lateral border plates (aOR 5.8, 95% CI = 1.8 to 18.4 and aOR 5.1, 95% CI = 1.4 to 18.7, respectively). CONCLUSION: The findings from our study suggest that a short duration of postoperative MMF may reduce POICs following ORIF of mandibular angle fractures.

Lack of Demographic Information in Total Hip Arthroplasty/Total Knee Arthroplasty Randomized Controlled Trial Publications.

BACKGROUND: The impact of social determinants of health (SDOH) has been documented in orthopaedic literature. However, there is a lack of data on the inclusion of these variables in orthopaedic studies. Our aim was to investigate how many total hip arthroplasties and total knee arthroplasties randomized controlled trials report SDOH variables such as race, ethnicity, insurance, income, and education within the manuscript. METHODS: A systematic review was conducted on a PubMed search for randomized controlled trials published from 2017 to 2019 in the Journal of Bone and Joint Surgery, Journal of Arthroplasty, Clinical Orthopaedics and Related Research, and Osteoarthritis and Cartilage. Data collected included publication year, type of surgery, and the inclusion of race, ethnicity, insurance, income, and education. RESULTS: Of the 72 manuscripts included in the study, 5.6% of the manuscripts mentioned race, 4.2% included race within the demographic table, and 1.4% included ethnicity in the demographic table. Overall, only 5 studies discussed any one of the variables studied and none included any SDOH variables in their multivariable regressions. There were no statistically significant differences on inclusion across journal year (P value = .78), journal name (P value = 1.00), or surgery type (P value = .555). CONCLUSION: Our findings identify a major shortcoming in the inclusion of SDOH variables in total knee arthroplasty/total hip arthroplasty publications. Their exclusion may be indirectly perpetuating disparities if research that does not use representative patient samples is used in creating health policies and national standards. LEVEL OF EVIDENCE: Level V.

Are Delayed Dermal Filler Granulomas More Common Since COVID-19?

PURPOSE: Granuloma and delayed inflammatory reaction to hyaluronic acid facial esthetic fillers occurs rarely. More recently, these reactions have been reported with increasing frequency and have been associated with COVID-19 infection. The purpose of the study is to determine if delayed filler granulomas are more common after the start of the COVID-19 pandemic. MATERIALS AND METHODS: A retrospective cohort study including of all patients treated with dermal filler at 4 offices of a single cosmetic surgery practice between August 1, 2018 and October 31, 2021 was performed. The primary outcome variable was granuloma formation. The primary predictor variable was time period, either pre-COVID (8/1/18 to 2/29/20) or post-COVID (3/1/20 to 10/31/21). Other study variables recorded were age, amounts of dermal fillers used, and types of dermal filler used. Data were analyzed using chi-squared test, t-tests, and logistic regression. RESULTS: Over the study period, 3,255 patients receiving 8,067 syringes of filler over 6,800 sessions were reviewed. The average patient age was 46.8 ± 13.7 years and 2,583 sessions were performed in the pre-COVID time period and 4,217 sessions in the post-COVID time period. There were 11 granulomas in 9 subjects receiving filler in the post-COVID time period and 0 granulomas in the pre-COVID time period (0.3% vs 0.0%, respectively, P = .009). Juvederm Vollure was used in 64% of patients who developed granulomas but only accounted for 26% of filler administrations in the post-COVID time period and 28% in the cohort overall (P = .02). CONCLUSIONS: Granuloma formation is a rare complication of hyaluronic acid filler injection that appears to be occurring with more frequency following the COVID-19 pandemic. Practitioners who administer dermal fillers should be aware of this complication and its apparent increased incidence.

Systematic Review and Meta-Analysis of Perioperative Administration of Acetazolamide for Management of Postoperative Pain after Laparoscopy.

Background and Objective: To perform a systematic review and meta-analysis to evaluate the efficacy of perioperative acetazolamide (ACTZ) administration with laparoscopy for reducing postoperative referred pain. Methods: The following databases were searched from inception to March 1, 2020: Cochrane, PubMed, PubMed Central, Ovid, and Embase. Electronic search used: Acetazolamide AND (laparoscopy OR laparoscopic OR Celioscopy OR Celioscopies OR Peritoneoscopy OR Peritoneoscopies). No limits or filters were used. We included only studies of patients who underwent abdominal laparoscopy (LSC), had a pain assessment at approximately 24 hours postoperatively, and included a treatment with ACTZ group and a no-treatment or minimal-treatment comparison group. Results: Five studies met inclusion criteria, with a combined total of 253 participants, 116 in the ACTZ group and 137 in the control group. A Bayesian hierarchical model was assumed for the study specific treatment effects. Posterior sampling was conducted via Markov Chain Monte Carlo methods, and posterior inference carried out on the hierarchical treatment effect. ACTZ significantly decreased average pain scores compared to control group by -0.726 points (95% confidence interval -1.175-0.264). The posterior probability that ACTZ decreases mean pain scores by ≥ 0.5 was 0.846. Conclusion: Current available evidence demonstrates that perioperative ACTZ may provide a modest improvement in postoperative referred pain following LSC.

Clinical Advantages of Immediate Posterior Implants With Custom Healing Abutments: Up to 8-Year Follow-Up of 115 Cases.

PURPOSE: Proper management of the soft tissues around dental implants is crucial to their long-term function and esthetics. The purpose of this article is to report the survival rate of immediate posterior implants when using an immediate chair-side technique for custom healing abutments. MATERIALS AND METHODS: The investigator implemented a retrospective case series analysis of a sample of 115 consecutive patients with 1 posterior dental implant placed between February 1, 2012 and December 9, 2014, in the author's private practice who underwent the previously published technique for immediate custom chair-side healing abutment fabrication. In this descriptive analysis, the primary outcome variable was implant survival. Other variables included patient gender and age. RESULTS: Of the 115 patients in this cohort, 66 were female and 49 were male, with a mean age of 58 years, with 73% of the sites being first molars and 27% second molars. This study sample had a 98.26% overall implant survival rate with 3 implant failures. Median follow-up time was 1 year with identical 1-year and 5-year survival rates. Follow-up at up to 8 years demonstrated a 98.26% overall survival rate with 100% survival in the maxilla and 96.08% in the mandible. CONCLUSIONS: This case series demonstrates that the Anatomic Harmony Abutment technique, by applying principles of flapless posterior immediate implant surgery with immediate custom healing abutment placement, can lead to highly successful implant outcomes.

ERAS implementation in an urban patient population undergoing gynecologic surgery.

BACKGROUND: Enhanced recovery after surgery (ERAS) protocols improve outcomes. We investigated ERAS implementation in a population with comorbid conditions, inadequate insurance, and barriers to healthcare undergoing gynecologic surgery. OBJECTIVE: To investigate ERAS implementation in publicly insured/uninsured patients undergoing gynecologic surgery on hospital length of stay (LOS), 30-day hospital readmission rates, opioid administration, and pain scores. STUDY DESIGN: Data were obtained pre- and post-ERAS implementation. Patients undergoing gynecologic surgery with private insurance, public insurance, and uninsured were included (N = 589). LOS, readmission <30 days, opioid administration, and pain scores were assessed. RESULTS: Implementation of ERAS led to shorter LOS 1.75 vs. 1.49 days (p = 0.008). Average pain scores decreased from 3.07 pre-ERAS vs. 2.47 post-ERAS (p = <0.001). Opioid use decreased for ERAS patients (67.22 vs. 33.18, p = <0.001). Hospital readmission rates were unchanged from 8.2% pre-ERAS vs. 10.3% post-ERAS (p = 0.392). CONCLUSIONS: ERAS decreased pain scores and opioid use without increasing LOS or readmissions.

Low Rates of Reporting Race, Ethnicity, and Socioeconomic Status in Studies Published in Top Orthopaedic Journals.

BACKGROUND: Although there have been calls for the routine reporting of patient demographics associated with health disparities, including race, ethnicity, and socioeconomic status (SES), in published research, the extent to which these variables are reported in orthopaedic journals remains unclear. METHODS: We identified and examined all research articles with human cohorts published in 2019 in the 2 highest-ranked U.S. general orthopaedics journals, Clinical Orthopaedics and Related Research and The Journal of Bone & Joint Surgery. Excluded from analysis were studies with no U.S.-based institution and those that did not report any demographic data. Articles were reviewed to determine study type; reporting of race, ethnicity, and any of 3 SES variables (i.e., income, education, and health-care insurance); and the inclusion of these demographics in multivariable analyses. RESULTS: A total of 156 articles met the inclusion criteria. Of these, 56 (35.9%) reported patient race and 24 (15.4%) reported patient ethnicity. Income was reported in 13 (8.3%) of the articles, education in 23 (14.7%), and health insurance in 18 (11.5%). Of the 97 papers that reported results of multivariable analyses, 30 (30.9%) included race in the analysis and 21 (21.6%) reported significance associated with race. Income, education, and health insurance were included in multivariable analyses in 7 (7.2%), 11 (11.3%), and 10 (10.3%) of the articles, respectively. CONCLUSIONS: Race, ethnicity, and SES were infrequently reported and analyzed within articles published in 2 of the top orthopaedic journals. This problem may be remedied if orthopaedic journals impose standards for the reporting and analysis of patient demographics in studies with human cohorts. CLINICAL RELEVANCE: Failure to report key demographics makes it difficult for practitioners to determine whether study results apply to their patient populations. In addition, when orthopaedic interventions are evaluated without accounting for potential disparities by demographics, clinicians may incorrectly assume that the overall benefits and risks reported in studies apply equally to all patients.

Two-stage subgroup-specific time-to-event (2S-Sub-TITE): An adaptive two-stage time-to-toxicity design for subgroup-specific dose finding in phase I oncology trials.

For phase I trials, the subgroup-specific time-to-event (Sub-TITE) design identifies the maximum tolerated dose (MTD) separately in 2+ heterogeneous patient subgroups. Sub-TITE allows borrowing strength and dynamic clustering across subgroups from the trial's start, but delaying the initiation of borrowing and clustering may improve trial accuracy. We propose the 2-stage Sub-TITE (2S-Sub-TITE) design in which the trial starts by estimating separate models per subgroup, and then initiates the Sub-TITE design at some pre-specified point of patient accrual. We evaluate the operating characteristics of the 2S-Sub-TITE design using simulations. Nine configurations of the 2S-Sub-TITE design (varying in timing of initiation of borrowing/clustering and prior probability of subgroup heterogeneity, p_hetero) and three control methods were compared across 1000 randomly-generated true toxicity probability scenarios. Effects of priors, sample size, escalation rules, target toxicity probability, accrual rate, and number of subgroups were evaluated. Metrics included: proportion of correct selection (PCS) of the true MTD, and average number of toxicities incurred. Among the 5 2S-Sub-TITE configurations (out of 9 total) with the highest PCS (45%) when the subgroup heterogeneity assumption is correct (all of which out-perform the control methods by 2%-6%), the configuration which enables borrowing and clustering allowance with p_hetero = 0.7 starting at 75% patient accrual best minimizes toxicities as well as losses in accuracy if the heterogeneity assumption is incorrect. For trials with high confidence in subgroup heterogeneity, the 2S-Sub-TITE configuration enabling borrowing/clustering with p_hetero = 0.7 starting at 75% patient accrual exhibits superior dose-finding accuracy compared to existing methods.

Subgroup-specific dose finding for phase I-II trials using Bayesian clustering.

In most models and algorithms for dose-finding clinical trials, it is assumed that the trial participants are homogeneous-the optimal dose is the same for all those who qualify for the trial. However, if there are heterogeneous populations who may benefit from the same treatment, it is inefficient to conduct dose-finding separately for each group, and assuming homogeneity across all subpopulations may lead to identification of the incorrect dose for some (or all) subgroups. To accommodate heterogeneity in dose-finding trials when both efficacy and toxicity outcomes must be used to identify the optimal dose (as in immunotherapeutic oncology treatments), we utilize an adaptive Bayesian clustering method which borrows strength among similar subgroups and clusters truly homogeneous subgroups. Unlike methodology already described in the literature, our proposed methodology does not require the assumption of exchangeability between subgroups or a priori ordering of subgroups, but does allow for specification of different subgroup-specific priors if prior information is available. We provide a comparison of operating characteristics between our method and Bayesian hierarchical models for subgroups in a variety of relevant scenarios. After simulation studies with four a priori subgroups, we observed that our method and the hierarchical models both outperform separate subgroup-specific models when all subgroups have the same dose-efficacy and dose-toxicity curves. However, our method outperforms hierarchical models when one subgroup has a different dose-efficacy or dose-toxicity curve from the other three subgroups.

Equity in visual representation of vulvar conditions in major gynecology textbooks.

OBJECTIVES: To evaluate images of vulvar conditions (VCs) in major gynecologic textbooks and describe the skin tone representation. METHODS: Images of VCs in gynecological textbooks for medical students, obstetrics and gynecology (OBG) residents, and fellows were compiled. Texts were categorized into education levels (medical student, resident, or fellow) and selected based on the recommendations of OBG attendings and fellows at LSUHSCNew Orleans. Skin tones were scored according to the Fitzpatrick Scale (FS) and categorized as benign, infectious, inflammatory, and dysplasia/cancerous. Publishing and primary author demographics were collected. Proportional odds regression (POR) predicted FS based on image pathologies and book titles. RESULTS: Of 512 images selected from 21 textbooks, 77.0% [N = 395] were lighter skin tones (FS I-III). VCs were represented by the darkest skin tone (FS of VI) in 19.6% of images in texts targeting residents, compared to 8.5% and 4.5% in fellow and student textbooks, respectively (p <0.001). Compared to a cornerstone surgical atlas, the pediatric and adolescent gynecology text consisted of lighter skin tones. A prominent general gynecology text used darker skin tones. Images of infectious conditions were more likely to be darker skin tones than other VCs (p = 0.010). CONCLUSIONS: Most textbook images of VCs represent lighter skin tones, and women with darker skin are more underrepresented in texts geared at fellows and students. Inadequate exposure to the appearance of VCs on darker skin promotes and propagates racial inequities in healthcare. Medical textbooks should present visually diverse images of vulvar pathologies to train physicians to be well versed in caring for patients of all skin tones.

Increased inflammatory low-density neutrophils in severe obesity and effect of bariatric surgery: Results from case-control and prospective cohort studies.

BACKGROUND: Low-density neutrophils (LDN) are increased in several inflammatory diseases and may also play a role in the low-grade chronic inflammation associated with obesity. Here we explored their role in obesity, determined their gene signatures, and assessed the effect of bariatric surgery. METHODS: We compared the number, function, and gene expression profiles of circulating LDN in morbidly obese patients (MOP, n=27; body mass index (BMI) > 40 Kg/m2) and normal-weight controls (NWC, n=20; BMI < 25 Kg/m2) in a case-control study. Additionally, in a prospective longitudinal study, we measured changes in the frequency of LDN after bariatric surgery (n=36) and tested for associations with metabolic and inflammatory parameters. FINDINGS: LDN and inflammatory markers were significantly increased in MOP compared to NWC. Transcriptome analysis showed increased neutrophil-related gene expression signatures associated with inflammation, neutrophil activation, and immunosuppressive function. However, LDN did not suppress T cells proliferation and produced low levels of reactive oxygen species (ROS). Circulating LDN in MOP significantly decreased after bariatric surgery in parallel with BMI, metabolic syndrome, and inflammatory markers. INTERPRETATION: Obesity increases LDN displaying an inflammatory gene signature. Our results suggest that LDN may represent a neutrophil subset associated with chronic inflammation, a feature of obesity that has been previously associated with the appearance and progression of co-morbidities. Furthermore, bariatric surgery, as an efficient therapy for severe obesity, reduces LDN in circulation and improves several components of the metabolic syndrome supporting its recognized anti-inflammatory and beneficial metabolic effects. FUNDING: This work was supported in part by grants from the National Institutes of Health (NIH; 5P30GM114732-02, P20CA233374 - A. Ochoa and L. Miele), Pennington Biomedical NORC (P30DK072476 - E. Ravussin & LSU-NO Stanley S. Scott Cancer Center and Louisiana Clinical and Translational Science Center (LACaTS; U54-GM104940 - J. Kirwan).

Race and Age Impact Osteoporosis Screening Rates in Women Prior to Hip Fracture.

Bone mineral density screening and clinical risk factors are important to stratify individuals for increased risk of fracture. In a population with no history of fractures or baseline bone density measurement, black women were less likely to be screened than white counterparts prior to hip fracture. PURPOSE: To evaluate overall BMD (bone mineral density) screening rates within two years of hip fracture and to identify any disparities for osteoporosis screening or treatment in a female cohort who were eligible for screening under insurance and national recommendations. METHODS: Data were obtained from 1,109 female patients listed in the Research Action for Health Network (REACHnet) database, which consists of multiple health partner systems in Louisiana and Texas. Patients < 65 years old or with a history of hip fracture or osteoporosis diagnosis, screening or treatment more than 2 years before hip fracture were removed. RESULTS: Only 223 (20.1%) females were screened within the two years prior to hip fracture. Additionally, only 23 (10%) of the screened patients received treatment, despite 187 (86.6%) patients being diagnosed with osteoporosis or osteopenia. Screening rates reached a maximum of 27.9% in the 75-80 age group, while the 90 + age group had the lowest screening rates of 12%. We found a quadratic relationship between age and screening rates, indicating that the screening rate increases in age until age 72 and then decreases starkly. After adjusting for potential confounders, we found that black patients had significantly decreased screening rates compared to white patients (adjusted OR = .454, 95% CI = .227-.908, p value = .026) which held in general and for patient ages 65-97. CONCLUSION: Despite national recommendations, overall BMD screening rates among women prior to hip fracture are low. If individuals are not initially screened when eligible, they are less likely to ever be screened prior to fracture. Clinicians should address racial disparities by recommending more screening to otherwise healthy black patients above the age of 65. Lastly, treatment rates need to increase among those diagnosed with osteoporosis since all patients went on to hip fracture.