Efficacy of Messenger RNA-1273 Against Severe Acute Respiratory Syndrome Coronavirus 2 Acquisition in Young Adults From March to December 2021.

Background: The efficacy of messenger RNA (mRNA)-1273 against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is not well defined, particularly among young adults. Methods: Adults aged 18-29 years with no known history of SARS-CoV-2 infection or prior vaccination for coronavirus disease 2019 (COVID-19) were recruited from 44 US sites from 24 March to 13 September 2021 and randomized 1:1 to immediate vaccination (receipt of 2 doses of mRNA-1273 vaccine at months 0 and 1) or the standard of care (receipt of COVID-19 vaccine). Randomized participants were followed up for SARS-CoV-2 infection measured by nasal swab testing and symptomatic COVID-19 measured by nasal swab testing plus symptom assessment and assessed for the primary efficacy outcome. A vaccine-declined observational group was also recruited from 16 June to 8 November 2021 and followed up for SARS-CoV-2 infection as specified for the randomized participants. Results: The study enrolled 1149 in the randomized arms and 311 in the vaccine-declined group and collected >122 000 nasal swab samples. Based on randomized participants, the efficacy of 2 doses of mRNA-1273 vaccine against SARS-CoV-2 infection was 52.6% (95% confidence interval, -14.1% to 80.3%), with the majority of infections due to the Delta variant. Vaccine efficacy against symptomatic COVID-19 was 71.0% (95% confidence interval, -9.5% to 92.3%). Precision was limited owing to curtailed study enrollment and off-study vaccination censoring. The incidence of SARS-CoV-2 infection in the vaccine-declined group was 1.8 times higher than in the standard-of-care group. Conclusions: mRNA-1273 vaccination reduced the incidence of SARS-CoV-2 infection from March to September 2021, but vaccination was only one factor influencing risk. Clinical Trials Registration: NCT04811664.

Using time-weighted average change from baseline of SARS-CoV-2 viral load to assess impact of hydroxychloroquine as postexposure prophylaxis and early treatment for COVID-19.

Two randomized controlled trials demonstrated no clinical benefit of hydroxychloroquine (HCQ) for either postexposure prophylaxis or early treatment of SARS-CoV-2 infection. Using data from these studies, we calculated the time-weighted average change from baseline SARS-CoV-2 viral load and demonstrated that HCQ did not affect viral clearance.

Metabolic and inflammatory risk reduction in response to lipid-lowering and lifestyle modification in the medically underserved individuals.

INTRODUCTION: Medically underserved (US) populations have an increased level of atherosclerotic cardiovascular disease (ASCVD) risk, however, few studies investigated ASCVD risk reduction in US. METHODS: Of 217 subjects with ApoB ≥120 mg/dL and carotid atherosclerosis (≥15% stenosis by ultrasound) enrolled in the Carotid Plaque Composition by MRI (CPC) study between 2005 and 2011, US (n=33) was defined as those without adequate healthcare insurance, while AS (n=184) included those with adequate healthcare coverage. All subjects received atorvastatin-based lipid therapies and lifestyle intervention for 2 years. Metabolic and inflammatory risk factors were compared between AS and US. RESULTS: At baseline, compared to AS, US displayed higher levels of metabolic and inflammatory risk including systolic blood pressure (140±27 vs. 131±18 mmHg, p=0.04), fasting glucose (125±59 vs. 102±22 mg/dL, p=0.03) and fasting insulin (39±33 vs. 28±20 µU/dL, p=0.03) which resulted in higher insulin resistance (HOMA-IR 2.2±0.4 vs. 1.3±0.1, p=0.03), and hsCRP (5.6±1.5 vs. 2.8±0.2 mg/L, p=0.03). Over 2 years of intervention, US and AS showed similar reductions in LDL-C (-10.7% vs. -16% per year, p=0.2), triglycerides (-16.7% vs. -15.9% per year, p=0.4), and hsCRP (-0.11% vs. -0.04% per year, p=0.1). However, US continued to show significantly higher levels of fasting blood glucose (115±6.0 vs. 101±2.0 mg/dL, p=0.03) and HOMA-IR (1.9±0.2 vs. 1.5±0.1, p=0.047), and hsCRP (3.9±0.7 vs. 1.9±0.2 mg/L, p<0.001) than AS following 2 years of interventions. CONCLUSIONS: US displayed higher ASCVD risk than AS at baseline and over 2 years despite similar reductions following the intervention. These findings highlight the unmet needs for improved intervention strategies and implementation methods for ASCVD risk reduction in US. CLINICAL TRIAL REGISTRATION: NCT00715273 at ClinicalTrials.gov.

mRNA vaccination boosts cross-variant neutralizing antibodies elicited by SARS-CoV-2 infection.

Emerging SARS-CoV-2 variants have raised concerns about resistance to neutralizing antibodies elicited by previous infection or vaccination. We examined whether sera from recovered and naïve donors collected prior to, and following immunizations with existing mRNA vaccines, could neutralize the Wuhan-Hu-1 and B.1.351 variants. Pre-vaccination sera from recovered donors neutralized Wuhan-Hu-1 and sporadically neutralized B.1.351, but a single immunization boosted neutralizing titers against all variants and SARS-CoV-1 by up to 1000-fold. Neutralization was due to antibodies targeting the receptor binding domain and was not boosted by a second immunization. Immunization of naïve donors also elicited cross-neutralizing responses, but at lower titers. Our study highlights the importance of vaccinating both uninfected and previously infected persons to elicit cross-variant neutralizing antibodies.

Assessing pregnancy and neonatal outcomes in Malawi, South Africa, Uganda, and Zimbabwe: Results from a systematic chart review.

A systematic chart review was performed to estimate the frequency of pregnancy outcomes, pregnancy complications and neonatal outcomes at facilities in Blantyre, Malawi; Johannesburg, South Africa; Kampala, Uganda; and Chitungwiza and Harare, Zimbabwe to provide comparisons with estimates from an ongoing clinical trial evaluating the safety of two biomedical HIV prevention interventions in pregnancy. A multi-site, cross-sectional chart review was conducted at Maternal Obstetric Units and hospitals where women participating in the ongoing clinical trial would be expected to deliver. All individuals delivering at the designated facilities or admitted for postpartum care within seven days of a delivery elsewhere (home, health clinic, etc.) were included in the review. Data were abstracted for pregnancy outcomes, pregnancy complications, maternal and neonatal death, and congenital anomalies. Data from 10,138 records were abstracted across all four sites (Blantyre n = 2,384; Johannesburg n = 1,888; Kampala n = 3,708; Chitungwiza and Harare n = 2,158), which included 10,426 pregnancy outcomes. The prevalence of preterm birth was 13% (range across sites: 10.4-20.7) and 4.1% of deliveries resulted in stillbirth (range: 3.1-5.5). The most commonly noted pregnancy complication was gestational hypertension, reported among 4.4% of pregnancies. Among pregnancies resulting in a live birth, 15.5% were low birthweight (range: 13.8-17.4) and 2.0% resulted in neonatal death (range:1.2-3.2). Suspected congenital anomalies were noted in 1.2% of pregnancies. This study provides systematically collected data on background rates of pregnancy outcomes, pregnancy complications and neonatal outcomes that can be used as a reference in support of ongoing HIV prevention studies. In addition, estimates from this study provide important background data for future studies of investigational products evaluated in pregnancy in these urban settings.

A single mRNA immunization boosts cross-variant neutralizing antibodies elicited by SARS-CoV-2 infection.

Emerging SARS-CoV-2 variants have raised concerns about resistance to neutralizing antibodies elicited by previous infection or vaccination. We examined whether sera from recovered and naive donors collected prior to, and following immunizations with existing mRNA vaccines, could neutralize the Wuhan-Hu-1 and B.1.351 variants. Pre-vaccination sera from recovered donors neutralized Wuhan-Hu-1 and sporadically neutralized B.1.351, but a single immunization boosted neutralizing titers against all variants and SARS-CoV-1 by up to 1000-fold. Neutralization was due to antibodies targeting the receptor binding domain and was not boosted by a second immunization. Immunization of naïve donors also elicited cross-neutralizing responses, but at lower titers. Our study highlights the importance of vaccinating both uninfected and previously infected persons to elicit cross-variant neutralizing antibodies.

Atherosclerosis, its risk factors, and cognitive impairment in older adults.

OBJECTIVE: To examine the association of atherosclerotic cardiovascular disease (ASCVD) and its risk factors with cognitive impairment in older adults. METHODS: Six hundred and fourteen subjects, aged ≥ 65 years, from one center (2016-2018) underwent clinical, laboratory assessments and the Montreal Cognitive Assessment (MoCA). Using regression analysis, the relationship between ASCVD and its risk factors was evaluated in subjects with and without cognitive impairment (MoCA score < 26). RESULTS: Older age (ß = -1.3 per 5 years, 95% CI: -1.7 to -0.9, P < 0.001), history of stroke (ß = -1.6, 95% CI: -3.0 to -0.3, P = 0.01), and myocardial infarction (MI; ß = -2.2, 95% CI: -3.6 to -0.8, P = 0.003) were independently associated with lower MoCA scores, whereas more education (ß = 1.5 per 3 years, 95% CI: 1.1 to 1.9, P < 0.001), higher body mass index (BMI; ß = 0.5 per 3 kg/m2, 95% CI: 0.0 to 1.0, P = 0.04), higher estimated glomerular filtration rate (eGFR; ß = 0.8 per 15 U, 95% CI: 0.1 to 1.4, P = 0.03), left ventricular ejection fraction (LVEF; ß = 0.4 per 5%, 95% CI: 0 to 0.8, P = 0.04) and statin use (ß = 1.3, 95% CI: 0.3 to 2.3, P = 0.01) were associated with a higher MoCA score. Cognitive impairment was independently associated with older age (OR = 1.51 per 5 yrs, 95% CI: 1.28 to 1.79, P < 0.001), less education (OR = 0.55 per 3 years, 95% CI: 0.45 to 0.68, P < 0.001), lower BMI (OR = 0.78 per 3 kg/m2, 95% CI: 0.62 to 0.98, P = 0.03) and higher levels of high sensitivity c-reactive protein (hsCRP; OR = 1.08 per 1 mg/L, 95% CI: 1.02 to 1.15, P = 0.01). CONCLUSIONS: Beyond age, cognitive impairment was associated with prior MI/stroke, higher hsCRP, statin use, less education, lower eGFR, BMI and LVEF.

Echocardiographic and hemodynamic indices of myocardial contractility simultaneously evaluated in telemetered beagle dogs: A HESI-sponsored cross-company evaluation.

INTRODUCTION: Alterations in cardiac contractility can have significant clinical implications, highlighting the need for early detection of potential liabilities. Pre-clinical methods to assess contractility are typically invasive and their translation to human measures of cardiac function are not well defined. Clinically, cardiac function is most often measured non-invasively using echocardiography. The objective of these studies was to introduce echocardiography into standard large animal cardiovascular safety pharmacology studies and determine the feasibility of this combination. METHODS: A consortia of laboratories combined their data sets for evaluation. At each site, telemetered beagle dogs, in a 4 × 4 Latin square crossover study design (n = 4), were administered either pimobendan (positive inotrope) or atenolol (negative inotrope) orally at clinically relevant dose levels. Standard telemetry parameters were collected (heart rate, mean arterial blood pressure, etc.) continuously over 24 h, as well as derived contractility endpoints: QA interval and LV +dP/dtmax. At Tmax, echocardiography was performed in conscious dogs with minimal restraint to collect contractility parameters: ejection fraction (EF) and fractional shortening (FS). RESULTS: Correlations between telemetry and echo contractility endpoints showed that, in general, a change in LV +dP/dtmax of 1000 mmHg/s translates to a 5.2% change in EF and a 4.2% change in FS. Poor correlations were shown between QA interval derived simultaneously, to both EF and FS. DISCUSSION: Comparing data from telemetry-only groups to those that included echocardiography collections showed no effect in the ability to interpret test article-related effects, providing the foundation for the inclusion of echocardiography without compromising standard telemetry data quality.

Patterns of Hospital Bypass and Interhospital Transfer Among Patients With Heart Failure.

BACKGROUND: We describe how patient characteristics influence hospital bypass, interhospital transfer, and in-hospital mortality in patients with heart failure in Washington. Rural patients with heart failure may bypass their nearest hospital or be transferred for appropriate therapies. The frequency, determinants, and outcomes of these practices remain uncharacterized. METHODS AND RESULTS: Mean excess travel times based on hospital and patient residence ZIP codes were calculated using published methods. Hospitals and servicing areas were coded based on bed size and ZIP code, respectively. Transfer patterns were analyzed using bootstrap inference for clusters. Analysis of mortality and transfer-associated factors was performed using logistic regression with generalized estimating equations. There were 48,163 patients, representing 1106 instances of transfer, studied. The mean excess travel time increased 7.14 minutes per decrease in population density (metropolitan, micropolitan, small town, rural; P < .0001). The rural mean excess travel time was greatest at 28.56 minutes. Transfer likelihood increased with younger age, male gender, admitting hospital rurality, higher Charlson Comorbidity Index, and stroke. Transfer was less likely among women (odds ratio [OR], 0.82; 95% confidence interval [CI], 0.72-0.94) and patients over 70 years old (OR, 0.15-0.46; 95% CI, 0.10-0.65). Adjusting for comorbidities and transfer propensity, transfer exhibited a stronger association with mortality than any other measured patient risk factor (OR, 2.15; 95% CI, 1.69-2.73), excluding stroke (OR, 7.09; 95% CI, 4.99-10.06). CONCLUSIONS: Rural hospital bypass is prevalent among patients with heart failure, although its clinical significance is unclear. Female and older patients were found to have a lesser likelihood of transfer adjusted for other factors. Interhospital transfer is associated with increased mortality when adjusted for comorbidities.

Effects of Air Pollution and Other Environmental Exposures on Estimates of Severe Influenza Illness, Washington, USA.

Ecologic models of influenza burden may be confounded by other exposures that share winter seasonality. We evaluated the effects of air pollution and other environmental exposures in ecologic models estimating influenza-associated hospitalizations. We linked hospitalization data, viral surveillance, and environmental data, including temperature, relative humidity, dew point, and fine particulate matter for 3 counties in Washington, USA, for 2001-2012. We used negative binomial regression models to estimate the incidence of influenza-associated respiratory and circulatory (RC) hospitalizations and to assess the effect of adjusting for environmental exposures on RC hospitalization estimates. The modeled overall incidence rate of influenza-associated RC hospitalizations was 31/100,000 person-years. The environmental parameters were statistically associated with RC hospitalizations but did not appreciably affect the event rate estimates. Modeled influenza-associated RC hospitalization rates were similar to published estimates, and inclusion of environmental covariates in the model did not have a clinically important effect on severe influenza estimates.

Impact of previous non-arthroplasty surgery on clinical outcomes after primary anatomic shoulder arthroplasty.

BACKGROUND: The objectives of this study were to address the following questions regarding previous non-arthroplasty surgery prior to primary anatomic shoulder arthroplasty (either total shoulder arthroplasty [TSA] or ream-and-run arthroplasty): (1) To what degree is primary anatomic shoulder arthroplasty after prior non-arthroplasty surgery associated with inferior clinical outcomes and higher revision rates compared with arthroplasty without previous surgery? (2) Does type, approach, or timing of previous surgery affect outcomes after anatomic arthroplasty? METHODS: A retrospective review of a primary shoulder arthroplasty database was performed and identified 640 patients undergoing anatomic shoulder arthroplasty (345 TSAs and 295 ream-and-run arthroplasties). Of these patients, 183 (29%) underwent previous non-arthroplasty surgery. Baseline and demographic information, 2-year postoperative outcome scores, and revision surgical procedures with associated culture results were collected. RESULTS: In patients undergoing TSA, previous non-arthroplasty surgery was associated with a significantly lower 2-year Simple Shoulder Test (SST) score (P = .010), percentage maximum possible improvement (MPI) (P = .024), and Single Assessment Numeric Evaluation (SANE) score (P < .001) and a higher rate of reoperation (P < .001). In patients undergoing ream-and-run arthroplasty, previous non-arthroplasty surgery was associated with a nonsignificantly lower 2-year SST score, percentage MPI, and SANE score and higher reoperation rate. Prior fracture surgery carried a higher risk of reoperation than other types of surgery including rotator cuff repair and instability surgery. Among TSA and ream-and-run arthroplasty cases with prior non-arthroplasty surgery, prior open surgery and the time interval from most recent surgery were associated with nonsignificant differences in the 2-year SST score, percentage MPI, SANE score, and revision risk. CONCLUSION: Previous surgery is associated with inferior clinical outcomes and higher revision rates in patients undergoing index TSA but not in those undergoing the ream-and-run procedure. Patients with previous fracture surgery carry the highest risk of reoperation.

Forecasting a Crisis: Machine-Learning Models Predict Occurrence of Intraoperative Bradycardia Associated With Hypotension.

BACKGROUND: Predictive analytics systems may improve perioperative care by enhancing preparation for, recognition of, and response to high-risk clinical events. Bradycardia is a fairly common and unpredictable clinical event with many causes; it may be benign or become associated with hypotension requiring aggressive treatment. Our aim was to build models to predict the occurrence of clinically significant intraoperative bradycardia at 3 time points during an operative course by utilizing available preoperative electronic medical record and intraoperative anesthesia information management system data. METHODS: The analyzed data include 62,182 scheduled noncardiac procedures performed at the University of Washington Medical Center between 2012 and 2017. The clinical event was defined as severe bradycardia (heart rate <50 beats per minute) followed by hypotension (mean arterial pressure <55 mm Hg) within a 10-minute window. We developed models to predict the presence of at least 1 event following 3 time points: induction of anesthesia (TP1), start of the procedure (TP2), and 30 minutes after the start of the procedure (TP3). Predictor variables were based on data available before each time point and included preoperative patient and procedure data (TP1), followed by intraoperative minute-to-minute patient monitor, ventilator, intravenous fluid, infusion, and bolus medication data (TP2 and TP3). Machine-learning and logistic regression models were developed, and their predictive abilities were evaluated using the area under the ROC curve (AUC). The contribution of the input variables to the models were evaluated. RESULTS: The number of events was 3498 (5.6%) after TP1, 2404 (3.9%) after TP2, and 1066 (1.7%) after TP3. Heart rate was the strongest predictor for events after TP1. Occurrence of a previous event, mean heart rate, and mean pulse rates before TP2 were the strongest predictor for events after TP2. Occurrence of a previous event, mean heart rate, mean pulse rates before TP2 (and their interaction), and 15-minute slopes in heart rate and blood pressure before TP2 were the strongest predictors for events after TP3. The best performing machine-learning models including all cases produced an AUC of 0.81 (TP1), 0.87 (TP2), and 0.89 (TP3) with positive predictive values of 0.30, 0.29, and 0.15 at 95% specificity, respectively. CONCLUSIONS: We developed models to predict unstable bradycardia leveraging preoperative and real-time intraoperative data. Our study demonstrates how predictive models may be utilized to predict clinical events across multiple time intervals, with a future goal of developing real-time, intraoperative, decision support.

Cutaneous microbiology of patients having primary shoulder arthroplasty.

BACKGROUND: Shoulder periprosthetic infections are predominantly caused by bacteria residing in the skin of healthy individuals. Knowledge of the factors associated with the loads of the different cutaneous bacteria in individuals having shoulder arthroplasty may help identify patients at higher risk of periprosthetic infection and help guide preventive measures. For this reason, we tested the hypothesis that easy-to-obtain preoperative characteristics were significantly associated with the cutaneous microbiology and the loads of specific bacteria in shoulders having joint replacement. METHODS: This study identified the microbiology of the unprepared epidermal skin surface and of the dermal edge freshly incised at surgery in 332 patients having primary shoulder arthroplasty. The load of bacteria in each sample was characterized as a value based on the laboratory report: 0 for "no growth"; 0.1 for "one colony only" or for "broth only"; and 1, 2, 3, and 4 for 1+, 2+, 3+, and 4+ growth, respectively. The relationships between preoperative patient characteristics and these semiquantitative results of the cutaneous cultures were analyzed. RESULTS: Cultures of the unprepared epidermal skin surface showed positive results for a wide variety of organisms, including Cutibacterium in 72%, coagulase-negative Staphylococcus in 61%, and a spectrum of other organisms in 32%. By contrast, cultures of the freshly incised dermal edge showed a great preponderance of Cutibacterium (34%) in comparison to low levels of coagulase-negative Staphylococcus (8%) and other organisms (2%). An increased dermal load of Cutibacterium was significantly associated with male sex, younger patient age, American Society of Anesthesiologists class 1, use of testosterone supplements, prior shoulder surgery, and higher Cutibacterium loads on the unprepared skin surface. CONCLUSIONS: Although the microbiology of the unprepared skin surface is diverse, the same is not true for the freshly incised dermis, where Cutibacterium is the predominant organism. Readily available preoperative patient characteristics are significantly associated with the load of Cutibacterium in the incised dermis. Preoperative cultures of the unprepared skin surface appear to be a new method for predicting the type and load of bacteria found in the freshly incised dermis at the time of surgery. Additional studies are needed to determine whether preoperative cultures of the unprepared epidermal skin surface can provide a method for identifying patients at increased risk of shoulder periprosthetic infections.

The validation of a new scoring method for assessing ego development based on three dimensions of language.

We describe research on the validity of a new theoretical framework and scoring methodology, called STAGES, for sentence completion tests of meaning-making maturity or complexity (also called ego development or perspective-taking capacity). STAGES builds upon research on the substantially validated Washington University Sentence Completion Test of Jane Loevinger as updated by Susanne Cook-Greuter. STAGES proposes an underlying structural explanation for the Cook-Greuter system based on three dimensions. Two of these are polar factors: individual/collective, and passive/active; and the third is a categorization of the sophistication of the types of objects referred to (i.e. as concrete, subtle/abstract, or "metaware"). We describe two validation studies for the STAGES scoring method and model. The first is a replication study of concurrent validity, using 73 inventories to test the hypothesis that the STAGES scoring method replicates the Cook-Greuter scoring method. Using the weighted Kappa statistic, we demonstrate a very strong match between the two methods, confirming the first hypothesis. This study includes levels up to and including Strategist (i.e. a substantial percentage of test-takers from most populations). Levels above Strategist were validated using another method because (1) there is less Cook-Greuter data available at these levels, and (2) the two scoring methods diverge sufficiently, making comparison difficult. The second study, of 71 inventories, attempts to validate the STAGES scoring method at levels above Strategist by testing the inter-rater reliability among four scorers. The inter-rater reliability above Strategist, using the weighted Kappa statistic, was found to be moderate to substantial, indicating that the instrument and scoring method has internal validity for these four, rare higher levels. Additionally, the inter-rater reliability over all STAGES levels were found to be very strong.

High-resolution MRI assessed carotid atherosclerotic plaque characteristics comparing men and women with elevated ApoB levels.

Previous studies demonstrated that men were more likely to have plaque rupture and are at greater risk for myocardial infarction and stroke than women. We evaluated differences in carotid plaque characteristics by MRI between men and women with mild-moderate atherosclerosis and elevated ApoB levels. One hundred eighty-two subjects (104 men and 78 women) with CAD or carotid stenosis (≥ 15% by ultrasound), ApoB ≥ 120 mg/dL and carotid MRI scan were included. Percent wall volume (%WV) was calculated as (wall volume/total vessel volume) × 100%. Three major plaque compositions, fibrous tissue (FT), calcification (CA) and lipid rich necrotic core (LRNC), were identified and quantified using published MRI criteria. Adventitial and plaque neovascularization as fractional plasma volume (Vp) and permeability as transfer constant (Ktrans) were analyzed using kinetic modeling. These characteristics were compared between men and women. Men, compared to women, were younger (54 ± 8 vs. 58 ± 8 years, p = 0.01), had higher rate of previous MI (46 vs. 26%, p = 0.005) but lower proportions of metabolic syndrome (37 vs. 59%, p = 0.003). After adjusting for between-gender differences, men were significantly more likely to have LRNC (OR 2.22, 95% CI 1.04-4.89, p = 0.04) and showed significantly larger %LRNC than women (diff = 4.3%, 95% CI 1.6-6.9%, p = 0.002), while %WV, FT, and CA were similar between men and women. There were no statistically significant differences in adventitial and plaque Vp or Ktrans. Men were significantly more likely to have LRNC and had larger LRNC than women. However, men and women showed relatively similar levels of adventitial and plaque neovascularization and permeability.Trial registration: NCT00715273 at ClinicalTrials.gov. Registered 15 July 2008, retrospectively registered.

Industry payments to authors of Journal of Shoulder and Elbow Surgery shoulder arthroplasty manuscripts are accurately disclosed by most authors and are not significantly associated with better reported treatment outcomes.

BACKGROUND: Author transparency in disclosing potential conflicts of interest when reporting outcomes for shoulder arthroplasty implants is important. Using the Centers for Medicare & Medicaid Services Open Payments Program (OPP) database, we analyzed articles in the Journal of Shoulder and Elbow Surgery to evaluate (1) discrepancies between the stated conflicts of interest and associated payments recorded in the database, (2) the magnitude and types of payments received, and (3) possible relationships between industry financial support and positive study outcomes. METHODS: Articles reporting clinical outcomes of shoulder arthroplasty from 2016 and 2017 were reviewed. Articles identifying a specific shoulder arthroplasty implant and having at least 1 author based in the United States were included. Payment types, amounts, and sources were extracted from disclosure statements in the manuscript and considered relevant if they were received from the implant manufacturer. Published disclosure statements were compared against the OPP database. Study outcomes demonstrating a clinical benefit were considered "positive." Payments to authors reporting positive outcomes were compared with those reporting nonpositive outcomes. RESULTS: Implant manufacturers provided $16,051,261 to authors of shoulder arthroplasty publications over a 2-year period. Approximately half of senior authors (46%) received royalty payments, more than 90% of which ($14,910,873; 93%) were reported in disclosure statements. Although authors of articles with positive outcomes received greater payments than those reporting nonpositive outcomes, these differences were not statistically significant. CONCLUSION: The majority of author disclosure statements accurately reflected the OPP data. Payments were not significantly associated with positive outcomes reported for the specific implant.

Factors predictive of Cutibacterium periprosthetic shoulder infections: a retrospective study of 342 prosthetic revisions.

BACKGROUND: Cutibacterium are the most common cause of periprosthetic shoulder infections, as defined by ≥2 deep cultures. Established Cutibacterium periprosthetic infections cannot be resolved without prosthesis removal. However, the decision for implant removal must be made from an assessment of infection risk before the results of intraoperative cultures are finalized. We hypothesized that the risk for a Cutibacterium infection is associated with characteristics that are available at the time of revision arthroplasty. METHODS: In a retrospective review of 342 patients having prosthetic revisions between 2006 and 2018 for whom definitive deep culture results were available, we used univariate and multivariate analyses to compare the preoperative and intraoperative characteristics of 101 revisions with Cutibacterium periprosthetic infections to the characteristics of 241 concurrent revisions not meeting the definition of infection. RESULTS: Patients with definite Cutibacterium periprosthetic infections were younger (59 ± 10 vs. 64 ± 12, P < .001), were more likely to be male (91% vs. 44%, P < .001), were more likely to have had their index procedure performed for primary osteoarthritis (54% vs. 39%, P = .007), were more likely to be taking testosterone supplements (8% vs. 2%, P = .02), had lower American Society of Anesthesiologists scores (1.9 ± 0.7 vs. 2.3 ± 0.7, P < .001), and had lower body mass indices (29 ± 5 vs. 31 ± 7, P = .005). Patients with definite Cutibacterium periprosthetic infections also had significantly higher preoperative loads of Cutibacterium on their unprepared skin surface (1.7 ± 0.9 vs. 0.4 ± 0.8, P < .001) and were more likely to have the surgical finding of synovitis (41% vs. 16%, P < .001). CONCLUSIONS: The risk of definite Cutibacterium periprosthetic infections is associated with observations that can be made before or at the time of revision arthroplasty.

Pain Patterns and Treatment Among Nursing Home Residents With Moderate-Severe Cognitive Impairment.

OBJECTIVES: To examine the frequency and severity of pain and use of pain therapies among long-term care residents with moderate to severe dementia and to explore the factors associated with increased pain severity. DESIGN: Prospective individual data were collected over 1 to 3 days for each participant. SETTING: Sixteen long-term care facilities in Alabama, Georgia, Pennsylvania, and New Jersey. PARTICIPANTS: Residents with moderate to severe cognitive impairment residing in a long-term care facility for at least 7 days were enrolled (N = 205). Residents were 47% female, predominantly white (69%), and 84 years old, on average (SD = 10 years). MEASUREMENTS: A comprehensive pain assessment protocol was used to evaluate pain severity and characteristics through medical record review, interviews with nursing home staff, physical examinations, as well as pain observation tools (Mobilization-Observation-Behavior-Intensity-Dementia Pain Scale and Pain Intensity Measure for Persons With Dementia). Known correlates were also assessed (agitation, depression, and sleep). RESULTS: Experts' pain evaluations indicated that residents' usual pain was mild (mean = 1.6/10), and most experienced only intermittent pain (70%). However, 45% of residents experienced moderate to severe worst pain. Of residents, 90% received a pain therapy, with acetaminophen (87%) and opioids (32%) commonly utilized. Only 3% had a nondrug therapy documented in the medical record. The only resident characteristic that was significantly associated with pain severity was receipt of an opioid in the past week. CONCLUSION: Using a comprehensive pain assessment protocol, we found that most nursing home residents with moderate to severe dementia had mild usual, intermittent pain and the vast majority received at least one pain therapy in the previous week. Although these findings reflect improvements in pain management compared with older studies, there is still room for improvement in that 45% of the sample experienced moderate to severe pain at some point in the previous week. J Am Geriatr Soc 68:794-802, 2020.

Radiographic outcomes of impaction-grafted standard-length humeral components in total shoulder and ream-and-run arthroplasty: is stress shielding an issue?

BACKGROUND: The purpose of this study was to evaluate humeral stress shielding in shoulder arthroplasties performed with a smooth, standard-length humeral stem fixed with impaction autografting. METHODS: Two-year outcomes were evaluated for 48 ream-and-run arthroplasties and 78 total shoulder arthroplasties (TSAs) performed at a single institution. Postoperative radiographs were analyzed for adaptive changes, calcar osteolysis, and component shift or subsidence. Radiographic outcomes were analyzed for associations with patient demographic characteristics, humeral stem filling ratios, and glenoid loosening; clinical outcomes were assessed using the Simple Shoulder Test. RESULTS: At 2 years after surgery, the ream-and-run procedures showed partial calcar osteolysis in 9 cases (19%). The TSAs showed partial calcar osteolysis in 19 cases (24%) and complete calcar osteolysis in 2 (3%). Humeral component subsidence or component shift was observed in 3 ream-and-run procedures (6%) and in 8 TSAs (10%). These radiographic findings were not significantly associated with patient demographic characteristics, canal-filling ratios, or clinical outcomes. CONCLUSION: When inserted with impaction autografting, a smooth, standard-length humeral stem offers a secure bone-preserving approach for humeral component fixation in shoulder arthroplasty. These results with a conventional prosthesis can serve as a basis for comparison for new component designs and fixation methods.