A Demographic Analysis of Craniomaxillofacial Trauma in the Era of COVID-19.

Study Design: Retrospective cohort study. Objective: The challenges of COVID-19 could magnify socioeconomic vulnerability for craniomaxillofacial (CMF) trauma. This study compares subjects who presented with CMF fractures to a regional healthcare system during the pandemic with those in 2019. We hypothesized societal circumstances of 2020 would correlate with disproportionately more CMF fractures in vulnerable patients compared to pre-pandemic trends. Methods: An IRB approved retrospective study of CMF fracture presentations in 2019 and 2020 was performed. Demographics, injury details, and management details were collected. A residence-based poverty index was calculated for each subject utilizing census data. Pre-pandemic and pandemic cases were compared to identify differences between cohorts. Results: A large decrease in presentations was noted between pre-pandemic and pandemic cohorts. There was significantly greater poverty the pre-pandemic cohort as compared to the pandemic cohort (P = .026). Overall, there was a significant correlation between higher poverty and violent MOI (P < .001). This association was maintained pre-pandemic, (P = .001) but was insignificant in the pandemic cohort (P = .108). Difference between cohorts with respect to violent injury was non-significant (P = .559) with non-significant difference in demographics including age (P = .390), place of injury (P = .136), employment status (P = .905), insurance status (P = .580), marital status (P = .711), ethnicity (P = .068), and gender (P = .656). Management was not significantly different between cohorts including percent hospital admission (P = .396), surgical intervention (P = .120), and time to operation (P = .109). Conclusions: Contrary to our hypothesis, this analysis indicates that the societal changes brought on by the COVID-19 pandemic did not magnify vulnerable populations. Some changes were noted including in volume of presentation, demographic distribution, and injury detail.

Evaluating the Addition of Clinical and Staging Data to Improve the Pricing Methodology of the Oncology Care Model.

PURPOSE: The Oncology Care Model (OCM) is the largest value-based care model focusing on oncology, but the current pricing methodology excludes relevant data on the cancer stage and current clinical status, limiting the precision of the risk adjustment. METHODS: This analysis evaluated 15,580 episodes of breast cancer, lung cancer, and multiple myeloma, starting between July 1, 2016, and January 1, 2020, with data from a cohort of OCM practices affiliated with academic medical centers. The authors merged clinical data with claims for OCM episodes defined by the Center for Medicare and Medicaid Innovation to identify potential quality improvement opportunities. The regression model evaluated the association of the cancer stage at initial diagnosis and current clinical status with variance to the OCM target price. RESULTS: Cancer stage at the time of initial diagnosis was significant for breast and lung cancers, with stage IV episodes having the highest losses of -$6,700 (USD) for breast cancer (P < .001) and -$18,470 (USD) for lung cancer (P < .001). Current clinical status had a significant impact for all three cancers in the analysis, with losses correlated with clinical complexity. Breast cancer and multiple myeloma episodes categorized as recurrent or progressive disease had significantly higher losses than stable episodes, at -$6,755 (USD) for breast (P < .001) and -$19,448 (USD) for multiple myeloma (P < .001). Lung cancer episodes categorized as initial diagnosis had significantly fewer losses than stable episodes, at -$3,751 (USD) (P = .001). CONCLUSION: As the Center for Medicare and Medicaid Innovation designs and launches new oncology-related models, the agency should adopt methodologies that more accurately set target prices, by incorporating relevant clinical data within cancer types to minimize penalizing practices that provide guideline-concordant cancer care.

Prevalence and Morphology of the Coracoclavicular Joint: An Osteological Study of 2,724 Subjects Using Univariable and Multivariable Logistic Regression Analyses.

Background: The coracoclavicular joint (CCJ) is an anomalous articulation between the surfaces of the inferior clavicle and superior coracoid and its etiology is controversial. Reportedly, symptomatic patients demonstrate significant functional limitations including shoulder abduction loss and potential for brachial plexus compression and impingement. Purpose: To determine the prevalence of CCJ across age, gender and ethnicity, and to identify clinically useful morphological characteristics. Methods: 2,724 subjects with intact clavicles and scapulae from the Hamann-Todd Osteological Collection were evaluated for the presence of CCJ. Logistic regression was used to determine the effect of age, height, gender, and race on prevalence of CCJ. 354 clavicles with CCJ were measured for size and location of the CCJ facet. Results: CCJ was observed in 9% of subjects. CCJ was more prevalent in African-Americans (12%) than Caucasian-Americans (6%) (p < 0.001) and more prevalent in females (11%) than males (8%) (p = 0.055). Facet location along clavicle length was consistent (average 25%, range 15-35%). But, facet location along clavicle width varied (average 60%, range 10-90%), with males having a more posterior location. For every 10-year increase in age, facet elevation (p = 0.001) and surface area (p < 0.001) increased. Conclusions: CCJ prevalence was 9% in our large osseous population, found more commonly in African-Americans and females. Facet location is predictable with respect to clavicle length, but less so along clavicle width. The clavicular facet may develop at some point in life and continue to grow in size after its appearance. Clinical Relevance: Presence of a CCJ represents a potential overlooked source of anterior shoulder pain and supracoracoid impingement. Epidemiologic and morphological characteristics presented in our study can aid in the identification, clinical understanding, and surgical excision of a symptomatic CCJ. Level of Evidence: Level IV.

Piloting a Financial Counseling Intervention for Patients With Cancer Receiving Chemotherapy.

PURPOSE: National organizations encourage communication about costs of cancer care; however, few data are available on health system models for identifying and assisting patients with financial distress (FD). We report the feasibility and acceptability of a financial counseling (FC) intervention for patients who receive chemotherapy at a comprehensive cancer center. MATERIALS AND METHODS: Patients were randomly assigned 1:1 to FC or standard care. The FC arm received education, financial assistance screening, and an estimation tool with total billed charges and out-of-pocket (OOP) cost of one cycle of chemotherapy from a financial counselor through phone call and in-person visit. Participants completed measures of FD, health-related quality of life, and acceptability. RESULTS: Ninety-five participants enrolled (mean age, 61 years; 72% white; 50% commercially insured), with a 32% attrition rate between assessments. Rates of completion for the phone call, in-person, and entire intervention were 98%, 47%, and 30%, respectively. The OOP estimation tool was considered understandable and acceptable to the majority of participants. No significant changes in FD were found between arms. Emotional functioning was negatively associated with having high FD (95% CI, -0.13379 to -0.013; P = .0189). Being married was associated with a decrease in log-odds of having high FD (ß = -1.916; 95% CI, -3.358 to -0.475; P = .0092). CONCLUSION: Implementation of an FC program that provides transparent cost data is feasible and acceptable. Incorporation of FC into clinical workflow, including phone counseling, is important to improve feasibility. Additional work is needed to develop tailored educational materials that are patient specific.

Pilot randomized controlled trials in the orthopaedic surgery literature: a systematic review.

BACKGROUND: The primary objective of this systematic review is to examine the characteristics of pilot randomized controlled trials (RCTs) in the orthopaedic surgery literature, including the proportion framed as feasibility trials and those that lead to definitive RCTs. This review aim to answer the question of whether pilot RCTs lead to definitive RCTs, whilst investigating the quality, feasibility and overall publication trends of orthopaedic pilot trials. METHODS: Pilot RCTs in the orthopaedic literature were identified from three electronic databases (EMBASE, MEDLINE, and Pubmed) searched from database inception to January 2018. Search criteria included the evaluation of at least one orthopaedic surgical intervention, research on humans, and publication in English. Two reviewers independently screened the pool of pilot trials, and conducted a search for corresponding definitive trials. Screened pilot RCTs were assessed for feasibility outcomes related to efficiency, cost, and/or timeliness of a large-scale clinical trial involving a surgical intervention. The quality of the pilot and definitive trials were assessed using the Checklist to Evaluate a Report of a Non-Pharmacological Trial (CLEAR NPT). RESULTS: The initial search for pilot RCTs yielded 3857 titles, of which 49 articles were relevant for this review. 73.5% (36/49) of the orthopaedic pilot RCTs were framed as feasibility trials. Of these, 5 corresponding definitive trials (10.2%) were found, of which four were published and one ongoing. Based on author responses, the lack of a definitive RCT following the pilot trial was attributed to a lack of funding, inadequacies in recruitment, and belief that the pilot RCT sufficiently answered the research question. CONCLUSIONS: Based on this systematic review, most pilot RCTs were characterized as feasibility trials. However, the majority of published pilot RCTs did not lead to definitive trials. This discrepancy was mainly attributed to poor feasibility (e.g. poor recruitment) and lack of funding for an orthopaedic surgical definitive trial. In recent years this discrepancy may be due to researchers saving on time and cost by rolling their pilot patients into the definitive RCT rather than publish a separate pilot trial.

Mesangial cell apoptosis induced by stimulation of the adenosine A3 receptor: signaling and apoptotic events.

Mesangial cell apoptosis has been proposed as a means of resolution of glomerular hypercellularity in proliferative forms of glomerular disease. We previously demonstrated that adenosine causes mesangial cell apoptosis by stimulating the A3-type adenosine receptor. This is a G protein-coupled receptor shown to activate kinases involved in apoptotic signaling. In this work, we assessed changes in phosphorylation of the mitogen-activated protein kinase extracellular signal-regulated kinase (ERK)1/2 and in levels of specific pro- and antiapoptotic proteins following exposure of mesangial cells to the A3 adenosine receptor agonist N(6)-(3-iodobenzyl)-adenosine-5'-N-methyluronamide (IB-MECA). Cultured mesangial cells were incubated with IB-MECA for 30 minutes and 6, 24, and 48 hours. IB-MECA was used at a concentration (30 microM) that induces a reproducible degree of mesangial cell apoptosis. Changes in ERK1/2 phosphorylation and in protein levels of Bcl-2, Bax, and caspase 3 were assessed by Western blot analysis. IB-MECA markedly increased phosphorylation of ERK1/2. This effect peaked at 5 minutes, dissipated by 20 minutes, and was abolished by the inhibitor of ERK phosphorylation, compound U0126, in a dose-dependent manner. This inhibitor had no effect on the extent of IB-MECA-induced apoptosis. Bcl-2 levels progressively declined, whereas those of Bax and activated caspase 3 increased. These observations indicate that stimulation of the A3-type adenosine receptor causes mesangial cell apoptosis via mechanisms independent of ERK activation. The observations also point to an imbalance in the expression of antiapoptotic (Bcl-2) and proapoptotic (Bax, caspase 3) proteins as a potential mechanism underlying adenosine-induced mesangial cell apoptosis.