Evaluation of Fatigue Behavior of Asphalt Field Cores Using Discrete Element Modeling.

Fatigue cracking is one of the primary distresses of asphalt pavements, which significantly affects the asphalt pavement performance. The fatigue behavior of the asphalt mixture observed in the laboratory test can vary depending on the type of fatigue test and the dimension and shape of the test specimen. The variations can make it difficult to accurately evaluate the fatigue properties of the field asphalt concrete. Accordingly, this study proposed a reliable method to evaluate the fatigue behavior of the asphalt field cores based on discrete element modeling (DEM). The mesoscopic geometric model was built using discrete element software PFC (Particle Flow Code) and CT scan images of the asphalt field cores. The virtual fatigue test was simulated in accordance with the semi-circular bending (SCB) test. The mesoscopic parameters of the contacting model in the virtual test were determined through the uniaxial compression dynamic modulus test and SCB test. Based on the virtual SCB test, the displacement, contact forces, and crack growth were analyzed. The test results show that the fatigue life simulated in the virtual test was consistent with that of the SCB fatigue test. The fatigue cracks in the asphalt mixture were observed in three stages, i.e., crack initiation, crack propagation, and failure. It was found that the crack propagation stage consumes a significant portion of the fatigue life since the tensile contact forces mainly increase in this stage.

Experimental Investigation of Water Vapor Concentration on Fracture Properties of Asphalt Concrete.

The effect of moisture on the fracture resistance of asphalt concrete is a significant concern in pavement engineering. To investigate the effect of the water vapor concentration on the fracture properties of asphalt concrete, this study first designed a humidity conditioning program at the relative humidity (RH) levels of 2%, 50%, 80%, and 100% for the three types of asphalt concrete mixtures (AC-13C, AC-20C, and AC-25C).The finite element model was developed to simulate the water vapor diffusion and determine the duration of the conditioning period. The semi-circular bending (SCB) test was then performed at varying temperatures of 5 °C, 15 °C, and 25 °C to evaluate the fracture energy and tensile strength of the humidity-conditioned specimens. The test results showed that the increasing temperature and the RH levels resulted in a lower peak load but greater displacement of the mixtures. Both the fracture energy and tensile strength tended to diminish with the rising temperature. It was also found that moisture had a significant effect on the tensile strength and fracture energy of asphalt concrete. Specifically, as the RH level increased from 2% to 100% (i.e., the water vapor concentration rose from 0.35 g/m3 to 17.27 g/m3), the tensile strength of the three types of mixtures was reduced by 34.84% on average, which revealed that the water vapor led to the loss of adhesion and cohesion within the mixture. The genetic expression programming (GEP) model was developed to quantify the effect of water vapor concentrations and temperature on the fracture indices.

The Variability of MCID, SCB, PASS, and MOI Thresholds for PROMs in the Reverse Total Shoulder Arthroplasty Literature: A Systematic Review.

BACKGROUND: Reverse total shoulder arthroplasty (RTSA) is a common procedure utilized to address degenerative pathologies of the glenohumeral joint and rotator cuff. Increased reliance on patient-reported outcome measures (PROMs) has placed emphasis on the utilization of the minimum clinically important difference (MCID), substantial clinical benefit (SCB), patient acceptable symptom state (PASS), and maximal outcome improvement (MOI) thresholds to assess the clinical efficacy of RTSA. In this study, we systematically reviewed the MCID, SCB, PASS, and MOI thresholds reported for PROMs following RTSA. METHODS: PubMed, Embase, MEDLINE, Cochrane Library, and Google Scholar were queried for articles from Jan. 1, 2000-Aug. 31, 2023 reporting MCID, SCB, PASS, or MOI values for PROMs following RTSA. Patient demographic data, study characteristics, MCID/SCB/PASS/MOI thresholds, and threshold calculation methods were extracted. RESULTS: 141 articles were screened with 39 ultimately included, comprising 11,984 total patients that underwent RTSA. 34 (87%) studies reported MCID thresholds, 20 (51%) reported SCB, 5 (13%) reported PASS, and 2 (5%) reported MOI. 25/39 (64%) studies referenced a previous study when reporting MCID, SCB, PASS, or MOI values, 11 (28%) used an anchor-based method to calculate threshold values, 1 (3%) used a distribution-based method, and 2 (5%) used both anchor and distribution methods. There were 19 newly calculated MCID (11), SCB (5), PASS (1), and MOI (2) thresholds. For five of the six most utilized PROMs (ASES, SST, Constant, UCLA, SPADI), the range of reported MCID values exceeded 50% of the most common threshold. For three of the six, the range of SCB values exceeded 25% of the most common threshold. CONCLUSION: There is substantial variability in the MCID and SCB threshold values reported in the RTSA literature. Standardizing the methodologic calculation and utilization of MCID, SCB, PASS, and MOI thresholds for RTSA may allow for improved assessment of PROMs.

Stratification of the Minimal Clinically Important Difference, Substantial Clinical Benefit, and Patient Acceptable Symptomatic State after Total Shoulder Arthroplasty by Implant Type, Preoperative Diagnosis, and Sex.

BACKGROUND: Clinical significance, as opposed to statistical significance, has increasingly been utilized to evaluate outcomes after total shoulder arthroplasty (TSA). The purpose of this study was to identify thresholds of the minimal clinically important difference (MCID), substantial clinical benefit (SCB), and patient acceptable symptomatic state (PASS) for TSA outcome metrics and determine if these thresholds are influenced by prosthesis type (anatomic or reverse TSA), sex, or preoperative diagnosis. METHODS: A prospectively collected international multicenter database inclusive of 38 surgeons was queried for patients receiving a primary aTSA or rTSA between 2003 and 2021. Prospectively, outcome metrics including ASES, shoulder function score (SFS), SST, UCLA, Constant, VAS Pain, shoulder arthroplasty smart (SAS) score, forward flexion, abduction, external rotation, and internal rotation was recorded preoperatively and at each follow-up. A patient satisfaction question was administered at each follow-up. Anchor-based MCID, SCB, and PASS were calculated as defined previously overall and according to implant type, preoperative diagnosis, and sex. The percentage of patients achieving thresholds was also quantified. RESULTS: A total of 5,851 total shoulder arthroplasties including aTSA (n=2,236) and rTSA (n=3,615) were included in the study cohort. The following were identified as MCID thresholds for the overall (aTSA + rTSA irrespective of diagnosis or sex) cohort: VAS Pain (-1.5), SFS (1.2), SST (2.1), Constant (7.2), ASES (13.9), UCLA (8.2), SPADI (-21.5), and SAS (7.3), Abduction (13°), Forward elevation (16°), External rotation (4°), Internal rotation score (0.2). SCB thresholds for the overall cohort were: VAS Pain (-3.3), SFS (2.9), SST 3.8), Constant (18.9), ASES (33.1), UCLA (12.3), SPADI (-44.7), and SAS (18.2), Abduction (30°), Forward elevation (31°), External rotation (12°), Internal rotation score (0.9). PASS thresholds for the overall cohort were: VAS Pain (0.8), SFS (7.3), SST (9.2), Constant (64.2), ASES (79.5), UCLA (29.5), SPADI (24.7), and SAS (72.5), Abduction (104°), Forward elevation (130°), External rotation (30°), Internal rotation score (3.2). MCID, SCB, and PASS thresholds varied depending on preoperative diagnosis and sex. CONCLUSION: MCID, SCB, and PASS thresholds vary depending on implant type, preoperative diagnosis, and sex. A comprehensive understanding of these differences as well as identification of clinically-relevant thresholds for legacy and novel metrics is essential to assist surgeons in evaluating their patient's outcomes, interpreting the literature, and counseling their patients preoperatively regarding expectations for improvement. Given that PASS thresholds are fragile and vary greatly depending on cohort variability, caution should be exercised in conflating them across different studies.

Sustainable Asphalt Mixtures with Enhanced Water Resistance for Flood-Prone Regions Using Recycled LDPE and Carnauba-Soybean Oil Additive.

This manuscript presents a comprehensive study on the sustainable optimization of asphalt mixtures tailored for regions prone to flooding. The research addresses the challenges associated with water damage to asphalt pavements by incorporating innovative additives. The study centers on incorporating recycled Low-Density Polyethylene (LDPE) and a tailored Carnauba-Soybean Oil Additive, advancing asphalt mixtures with a Control mix, LDPE (5%) + Control, and LDPE (5%) + 3% Oil + Control. A critical aspect of the research involves subjecting these mixtures to 30 wetting and drying cycles, simulating the conditions prevalent in tropical flood-prone areas. The incorporation of innovative additives in asphalt mixtures has demonstrated significant improvements across various performance parameters. Tensile Strength Ratio (TSR) tests revealed enhanced tensile strength, with the LDPE (5%) + 3% Oil-modified mixture exhibiting an impressive TSR of 85.7%. Dynamic Modulus tests highlighted improved rutting resistance, showcasing a remarkable increase to 214 MPa in the LDPE (5%) with a 3% Oil-modified mixture. The Semi-Circular Bending (SCB) test demonstrated increased fracture resistance and energy absorption, particularly in the LDPE (5%) with 3% Oil-modified mixture. Hamburg Wheel-Tracking (HWT) tests indicated enhanced moisture resistance and superior rutting resistance at 20,000 cycles for the same mixture. Cantabro tests underscored improved aggregate shatter resistance, with the LDPE (5%) + 3% Oil-modified mixture exhibiting the lowest weight loss rate at 9.820%. Field tests provided real-world insights, with the LDPE (5%) + 3% Oil mixture displaying superior stability, a 61% reduction in deflection, and a 256% improvement in surface modulus over the control mixture. This research lays the groundwork for advancing the development of sustainable, high-performance road pavement materials, marking a significant stride towards resilient infrastructure in flood-prone areas.

Predicting the Effect of the Loading Rate on the Fracture Toughness of Hydraulic Asphalt Concrete Based on the Weibull Distribution.

The cracking problem of asphalt concrete panels is a crucial consideration in the design of hydraulic asphalt concrete seepage control bodies. Panels experiencing uneven rises or falls of water levels during impoundment may exhibit loading rate effects. Investigating the fracture toughness value of asphalt concrete under varying loading rates is essential. This study employs a statistical method to calculate the fracture index KIC, using the semi-circular bending test (SCB) to examine the effect of loading rates on the Type I fracture mode of hydraulic asphalt concrete. The data are analyzed using the two-parameter Weibull distribution curve, offering insights into the minimum number of KIC test specimens. The results indicate an increase in KIC with loading rate, with greater data dispersion at faster rates. The Weibull distribution curve successfully fits the fracture behavior under different loading rates, providing valuable predictions. This study estimates the minimum number of SCB test specimens to be nine, based on a confidence level of 0.95 and a relative deviation not exceeding 5%.

SCB-2019 protein vaccine as heterologous booster of neutralizing activity against SARS-CoV-2 Omicron variants after immunization with other COVID-19 vaccines.

We assessed the non-inferiority of homologous boosting compared with heterologous boosting with the recombinant protein vaccine, SCB-2019, in adults previously immunized with different COVID-19 vaccines. Three equal cohorts (N ~ 420) of Philippino adults (18-80 years) previously immunized with Comirnaty, CoronaVac or Vaxzevria COVID-19 vaccines were randomized 1:1 to receive homologous or heterologous (SCB-2019) boosters. Neutralizing antibodies against prototype SARS-CoV-2 (Wuhan-Hu-1) were measured in all participants and against Delta variant and Omicron sub-lineages in subsets (30‒50 per arm) 15 days after boosting. Participants recorded solicited adverse events for 7 days and unsolicited and serious adverse events until Day 60. Prototype SARS-CoV-2 neutralizing responses on Day 15 after SCB-2019 were statistically non-inferior to homologous Vaxzevria boosters, superior to CoronaVac, but lower than homologous Comirnaty. Neutralizing responses against Delta and Omicron BA.1, BA.2, BA.4 and BA.5 variants after heterologous SCB-2019 were higher than homologous CoronaVac or Vaxzevria, but lower than homologous Comirnaty. Responses against Omicron BF.7, BQ.1.1.3, and XBB1.5 following heterologous SCB-2019 were lower than after homologous Comirnaty booster but significantly higher than after Vaxzevria booster. SCB-2019 reactogenicity was similar to CoronaVac or Vaxzevria, but lower than Comirnaty; most frequent events were mild/moderate injection site pain, headache and fatigue. No vaccine-related serious adverse events were reported. Heterologous SCB-2019 boosting was well tolerated and elicited neutralizing responses against all tested SARS-COV-2 viruses including Omicron BA.1, BA.2, BA.4, BA.5, BF.7, BQ.1.1.3, and XBB1.5 sub-lineages that were non-inferior to homologous boosting with CoronaVac or Vaxzevria, but not homologous Comirnaty booster.

Minimal clinically important difference (MCID), substantial clinical benefit (SCB), and patient-acceptable symptom state (PASS) in patients who have undergone total knee arthroplasty: a systematic review.

BACKGROUND: The present systematic review investigated the minimal clinically important difference (MCID), substantial clinical benefit (SCB), and patient-acceptable symptom state (PASS) of several frequent and established PROMs used to assess patients who have undergone TKA. This study was conducted according to the 2020 PRISMA statement. METHODS: In September 2023, PubMed, Web of Science, and Embase were accessed with no time constraint All clinical studies investigating tools to assess the clinical relevance of PROMs used to evaluate patients having received TKA were accessed. Only studies which evaluated the MCID, PASS, or SCB were eligible. The PROMs of interest were the Forgotten Joint Score-12 (FJS-12), the Oxford Knee Score (OKS), the Knee Injury and Osteoarthritis Outcome Score (KOOS) and its related subscales activity of daily living (ADL), pain, quality of life (QoL), sports and recreational activities, and symptoms, the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) score, the Knee Society Score (KSS) and related function score, and the Short Form-12 (SF-12) and Short Form-36 (SF-36). RESULTS: Data from 29,737 patients were collected. The overall risk of bias was low to moderate. The great variability of thresholds for MCID, SCB and PASS between questionnaires but also between investigated aspects was noted, whereby MCIDs for the SF-36 appear lower than for knee-specific questionnaires. CONCLUSION: Despite its critical role from a patient's perspective, the dimension of SCB is still neglected in the literature. Moreover, thresholds for the different concepts need to be condition-specific. We encourage authors to specifically report such data in future studies and to adhere to previously reported definitions to allow future comparison. Level of evidence Level IV, systematic review and meta-analysis.

Clinically significant outcome thresholds and rates of achievement by shoulder arthroplasty type and preoperative diagnosis.

BACKGROUND: Clinically significant outcome (CSO) benchmarks have been previously established for shoulder arthroplasty by assimilating preoperative diagnoses and arthroplasty types. The purpose of this study was to establish unique CSO thresholds and compare the time-to-achievement of these for reverse shoulder arthroplasty (RSA) for osteoarthritis (GHOA), RSA for rotator cuff arthropathy (RCA), and total shoulder arthroplasty (TSA) for GHOA. MATERIALS AND METHODS: Consecutive patients who underwent elective RSA for GHOA, TSA for GHOA, or RSA for RCA between February 2015 and May 2020, with 2-year minimum follow-up, were retrospectively identified from a prospectively maintained single surgeon registry. The American Shoulder and Elbow Surgeons (ASES) score was administered preoperatively and postoperatively at 2-week, 6-week, 3-month, 6-month, 1-year, and 2-year timepoints. Satisfaction and subjective overall improvement anchor questionnaires were administered at the time of final follow-up. Distribution-based methods were used to calculate the Minimal Clinically Important Difference (MCID), and anchor-based methods were used to calculate the Substantial Clinical Benefit (SCB) and the Patient Acceptable Symptom State (PASS) for each patient group. Median time to achievement, individual incidence of achievement at each time point, and cumulative incidence of achievement calculated using Kaplan-Meier survival curve analysis with interval censoring were compared between groups for each CSO. Cox-regression analyses were also performed to determine which patient factors were significantly associated with early or delayed achievement of CSOs. RESULTS: There were 471 patients eligible for study analysis: 276 RSA for GHOA, 107 TSA for GHOA, and 88 RSA for RCA. The calculated MCID, SCB, and PASS scores differed for each group. There were no significant differences in median time to achievement of any CSO between groups. Log-rank testing revealed that cumulative achievements significantly differed between groups for MCID (P = .014) but not for SCB (P = .053) or PASS (P = .620). On cox regression analysis, TSA patients had earlier achievement of SCB, whereas TSA and RSA for GHOA patients had earlier achievement of MCID. At 2-years, a significantly higher percentage of RSA for GHOA patients achieved MCID and SCB compared to RSA for RCA (MCID:100%, 95.5%, P = .003, SCB:94.6%, 86.4%, P = .036). CONCLUSION: Calculated CSO thresholds differ according to preoperative diagnosis and shoulder arthroplasty type. Patients undergoing TSA and RSA for GHOA achieve CSOs earlier than RSA for RCA patients, and a significantly higher percentage of RSA for GHOA patients achieve CSOs by 2 years compared to RSA for RCA patients.

Relationship between ozone and air temperature in future conditions: A case study in sichuan basin, China.

The Sichuan Basin (SCB) is located in southwestern China and has a unique topography where ozone (O3) pollution is frequent during summer. Few studies have clarified the relationship between O3 and air temperature in SCB. Here, the SCB was divided into four major urban agglomerations. The weather research and forecasting model-community multiscale air quality model (WRF-CMAQ) was used to analyze the meteorology, spatial distribution characteristics of pollutants, and interactions among the urban agglomerations in the SCB. WRF-CMAQ was used to study the historical changes in the climate penalty factor (CPF) from 2015 to 2020 and the climate pathways under the SSP2-4.5 CPF in values in 2030 for the ambitious pollution NDC-goal scenario (NDC) and current-goals scenario (Current). The results show that the SCB is warmer in the summer months with prevailing northeasterly winds. Ozone accumulated in the western part of the SCB, and a high CPF of O3 concentration was most prominent in NW urban agglomeration, where the O3 concentration increased by 4.12-5.40 ppb for every 1 °C increase in air temperature. The observed CPF in the SCB in 2020 averaged 3.64 ppb/°C. The average CPF in the SCB in 2030 was 1.152 ppb/°C under the NDC scenario and 1.269 ppb/°C under the current scenario. This study is critical for understanding the relationship between O3 concentration and air temperature in China.

Electronic Structure and Chemical Bonding of the First-, Second-, and Third-Row-Transition-Metal Monoborides: The Formation of Quadruple Bonds in RhB, RuB, and TcB.

Boron presents an important role in chemistry, biology, and materials science. Diatomic transition-metal borides (MBs) are the building blocks of many complexes and materials, and they present unique electronic structures with interesting and peculiar properties and a variety of bonding schemes which are analyzed here. In the first part of this paper, we present a review on the available experimental and theoretical studies on the first-row-transition-metal borides, i.e., ScB, TiB, VB, CrB, MnB, FeB, CoB, NiB, CuB, and ZnB; the second-row-transition-metal borides, i.e., YB, ZrB, NbB, MoB, TcB, RuB, RhB, PdB, AgB, and CdB; and the third-row-transition-metal borides, i.e., LaB, HfB, TaB, WB, ReB, OsB, IrB, PtB, AuB, and HgB. Consequently, in the second part, the second- and third-row MBs are studied via DFT calculations using the B3LYP, TPSSh, and MN15 functionals and, in some cases, via multi-reference methods, MRCISD+Q, in conjunction with the aug-cc-pVQZ-PPM/aug-cc-pVQZB basis sets. Specifically, bond distances, dissociation energies, frequencies, dipole moments, and natural NPA charges are reported. Comparisons between MB molecules along the three rows are presented, and their differences and similarities are analyzed. The bonding of the diatomic borides is also described; it is found that, apart from RhB(X1Σ+), which was just recently found to form quadruple bonds, RuB(X2Δ) and TcB(X3Σ-) also form quadruple σ2σ2π2π2 bonds in their X states. Moreover, to fill the gap existing in the current literature, here, we calculate the TcB molecule.

Revealing Inter-regional Environmental Inequities Hidden in China's Energy Transition.

Energy transition is an important way to control air pollution, but it may conflict with the economic goal of alleviating regional inequality due to its inherently different cost burdens. As one of the effective measures of energy transition, this paper takes small coal-fired boiler (SCB) upgrading as an example to explore the regional mismatch between upgrading costs and health benefits. Here, we construct a boiler-level inventory of SCB upgrades for the North China Plain (NCP) during 2013-2017 and propose an integrated modeling framework to quantify the spatial contribution of economic costs and health benefits associated with SCB upgrading. We find that although the total health benefits could offset the total costs for the entire region, the developed municipalities (Beijing and Tianjin) are likely to gain more health benefits from less-developed neighboring provinces at lower costs. These developed municipalities contribute only 14% to the total health benefits but gain 21% of the benefits within their territories, 56% of which come from neighboring provinces. Their benefits are approximately 5.6 times their costs, which is much higher than the 1.5 benefit-cost ratio in neighboring provinces. Our findings may be useful in shaping more equitable and sound environmental policies in China or other regions of the world with serious coal-related air pollution.

Engineering Characteristics and Microscopic Mechanism of Soil-Cement-Bentonite (SCB) Cut-Off Wall Backfills with a Fixed Fluidity.

Soil-cement-bentonite (SCB) backfill has been widely used in constructing cut-off walls to inhibit groundwater movement in contaminated sites. This study prepares SCB backfill with fixed fluidity. We conducted a series of experiments to investigate the engineering characteristics and microscopic mechanism of the backfill. The results indicate that the water content in the slurry was more sensitive to the bentonite content. The unconfined compression strength (UCS) value increased with an increase in the cement content, and the change with an increase in bentonite content was not noticeable. The permeability coefficient decreased distinctly with an increase in the cement and bentonite contents. The porosity of the SCB backfill increased with increasing bentonite content and decreased with increasing cement content. The UCS of SCB backfill was linearly and negatively correlated with the porosity; the permeability coefficient was not significantly related to the porosity. The percentage of micro- and small-pore throats in the backfill increased with increasing bentonite and cement contents. As cement and bentonite content increased by 6% in the backfill, the proportion of micro- and small-pore throats increased by 0.7% and 1.2%, respectively. The percentage of micro- and small-pore throats is deduced to be more suitable as a characterization parameter for the permeability of the SCB backfill. The overall results of this study show that the reasonably proportioned SCB backfill has potential as an eco-friendly and cost-effective material. Based on the requirements of strength and permeability coefficient (UCS > 100 kPa, 28 days permeability coefficient <1 × 10-7 cm/s), we suggested using a backfill with 12% bentonite and 9% cement as the cut-off wall mix ratio.

Superior Boosting of Neutralizing Titers Against Omicron SARS-CoV-2 Variants by Heterologous SCB-2019 Vaccine vs a Homologous Booster in CoronaVac-Primed Adults.

BACKGROUND: We compared homologous and heterologous boosting in adults in the Philippines primed with 2 or 3 doses of CoronaVac, with recombinant protein vaccine, SCB-2019. METHODS: CoronaVac-immunized adults (18-72 years) received a homologous or heterologous full or half dose SCB-2019 booster. We assessed all neutralizing antibody (NAb) responses against prototype SARS-CoV-2 after 15 days and NAb against SARS-CoV-2 Delta and Omicron variants in subsets (30‒50 per arm). Participants recorded adverse events. RESULTS: In 2-dose CoronaVac-primed adults prototype NAb geometric mean titers (GMT) were 203 IU/mL (95% confidence interval [CI], 182-227) and 939 IU/mL (95% CI, 841-1049) after CoronaVac and SCB-2019 boosters; the GMT ratio (4.63; 95% CI, 3.95-5.41) met predefined noninferiority and post-hoc superiority criteria. After 3-dose CoronaVac-priming prototype NAb GMTs were 279 IU/mL (95% CI, 240-325), 1044 IU/mL (95% CI, 898-1213), and 668 IU/mL (95% CI, 520-829) following CoronaVac, full and half-dose SCB-2019 boosters, respectively. NAb GMT ratios against Delta and Omicron comparing SCB-2019 with CoronaVac were all greater than 2. Mild to moderate reactogenicity was evenly balanced between groups. No vaccine-related serious adverse events were reported. CONCLUSIONS: Full or half dose SCB-2019 boosters were well tolerated with superior immunogenicity than homologous CoronaVac, particularly against newly emerged variants. Clinical Trials Registration. NCT05188677.

Minimal Clinically Important Difference (MCID), Substantial Clinical Benefit (SCB), and Patient Acceptable Symptom State (PASS) of the Shoulder Disability Questionnaire (SDQ) in Patients Undergoing Rotator Cuff Repair.

The Shoulder Disability Questionnaire (SDQ) is a Patient-Reported Outcome Measure (PROM) applied to evaluate shoulder surgery outcomes. The purpose of this study is to identify the accurate Minimal Clinically Important Difference (MCID), Substantial Clinical Benefit (SCB) and Patient Acceptable Symptom State (PASS) values for the SDQ score. A total of 35 patients (21 women and 16 men, mean age 76.6 ± 3.2 years) were followed up at 6 months postoperatively. To assess the patient's health satisfaction and symptoms, anchor questions were used. The MCID and SCB values of the SDQ score for patients who underwent arthroscopic rotator cuff repair from inception to final follow-up were 40.8 and 55.6, respectively. A change of 40.8 in the SDQ score at 6 months after surgery shows that patients achieved a minimum clinically important improvement in their state of health, and a 55.6 change in the SDQ score reflects a substantial clinically important improvement. The PASS cut-off of the SDQ score at 6 months postoperatively ranged from 22.5 to 25.8. If an SDQ score of 22.5 or more is attained after surgery, the health condition can be recognized as acceptable by the majority of patients. These cut-offs will help with understanding specific patient results and allow clinicians to personally assess patient improvement after rotator cuff repair.

Safety and immunogenicity of SCB-2019, an adjuvanted, recombinant SARS-CoV-2 trimeric S-protein subunit COVID-19 vaccine in healthy 12-17 year-old adolescents.

We previously demonstrated the efficacy of the COVID-19 vaccine candidate, SCB-2019, in adults in the SPECTRA phase 2/3 efficacy study. We extended the study to include 1278 healthy 12-17-year-old adolescents in Belgium, Colombia, and the Philippines who received either two doses of SCB-2019 or placebo 21 days apart, to assess immunogenicity as neutralizing antibodies against prototype SARS-CoV-2 and variants of concern, and safety and reactogenicity as solicited and unsolicited adverse events with a comparator group of young adults (18-25 years). In participants with no evidence of prior SARS-CoV-2 infection SCB-2019 immunogenicity in adolescents was non-inferior to that in young adults; respective geometric mean neutralizing titers (GMT) against prototype SARS-CoV-2 14 days after the second vaccination were 271 IU/mL (95% CI: 211-348) and 144 IU/mL (116-178). Most adolescents (1077, 84.3%) had serologic evidence of prior SAR-CoV-2 exposure at baseline; in these seropositive adolescents neutralizing GMTs increased from 173 IU/mL (135-122) to 982 IU/mL (881-1094) after the second dose. Neutralizing titers against Delta and Omicron BA SARS-CoV-2 variants were also increased, most notably in those with prior exposure. SCB-2019 vaccine was well tolerated with generally mild or moderate, transient solicited and unsolicited adverse events that were comparable in adolescent vaccine and placebo groups except for injection site pain - reported after 20% of SCB-2019 and 7.3% of placebo injections. SCB-2019 vaccine was highly immunogenic against SARS-CoV-2 prototype and variants in adolescents, especially in those with evidence of prior exposure, with comparable immunogenicity to young adults. Clinical trial registration: EudraCT 2020-004272-17; ClinicalTrials.gov NCT04672395.

Quantifying success after first revision reverse total shoulder arthroplasty: the minimal clinically important difference, substantial clinical benefit, and patient acceptable symptomatic state.

BACKGROUND: When patients require revision of primary shoulder arthroplasty, revision reverse total shoulder arthroplasty (rTSA) is most commonly performed. However, defining clinically important improvement in these patients is challenging because benchmarks have not been previously defined. Our purpose was to define the minimal clinically important difference (MCID), substantial clinical benefit (SCB), and patient acceptable symptomatic state (PASS) for outcome scores and range of motion (ROM) after revision rTSA and to quantify the proportion of patients achieving clinically relevant success. METHODS: This retrospective cohort study used a prospectively collected single-institution database of patients undergoing first revision rTSA between August 2015 and December 2019. Patients with a diagnosis of periprosthetic fracture or infection were excluded. Outcomes scores included the ASES, raw and normalized Constant, SPADI, SST, and University of California, Los Angeles (UCLA) scores. ROM measures included abduction, forward elevation (FE), external rotation (ER), and internal rotation (IR) score. Anchor-based and distribution-based methods were used to calculate the MCID, SCB, and PASS. The proportions of patients achieving each threshold were assessed. RESULTS: Ninety-three revision rTSAs with minimum 2-year follow-up were evaluated. Mean age was 67 years, 56% were female, and average follow-up was 54 months. Revision rTSA was performed most commonly for failed anatomic TSA (n = 47), followed by hemiarthroplasty (n = 21), rTSA (n = 15), and resurfacing (n = 10). The indication for revision rTSA was most commonly glenoid loosening (n = 24), followed by rotator cuff failure (n = 23), subluxation and unexplained pain (n = 11 for both). The anchor-based MCID thresholds (% of patients achieving) were as follows: ASES, 20.1 (42%); normalized Constant, 12.6 (80%); UCLA, 10.2 (54%); SST, 0.9 (78%); SPADI, -18.4 (58%); abduction, 13° (83%); FE, 18° (82%); ER, 4° (49%); and IR, 0.8 (34%). The SCB thresholds (% of patients achieving) were as follows: ASES, 34.1 (25%); normalized Constant, 26.6 (43%); UCLA, 14.1 (28%); SST, 3.9 (48%); SPADI, -36.4 (33%); abduction, 20° (77%); FE, 28° (71%); ER, 15° (15%); and IR, 1.0 (29%). The PASS thresholds (% of patients achieving) were as follows: ASES, 63.5 (53%); normalized Constant, 59.1 (61%); UCLA, 25.4 (48%); SST, 7.0 (55%); SPADI, 42.4 (59%); abduction, 98° (61%); FE, 110° (56%); ER, 19° (73%); and IR, 3.3 (59%). CONCLUSIONS: This study establishes thresholds for the MCID, SCB, and PASS at minimum 2-years after revision rTSA, providing physicians an evidence-based method to counsel patients and assess patient outcomes postoperatively.

Propensity for Clinically Meaningful Improvement and Surgical Failure After Anterior Cruciate Ligament Repair.

Background: Primary repair of the anterior cruciate ligament (ACL) confers an alternative to ACL reconstruction in appropriately selected patients. Purpose: To prospectively assess survivorship and to define the clinically meaningful outcomes after ACL repair. Study Design: Case series; Level of evidence, 4. Methods: Included were consecutive patients with Sherman grade 1-2 tears who underwent primary ACL repair with or without suture augmentation between 2017 and 2019. Patient-reported outcomes (Lysholm, Tegner, International Knee Documentation Committee, Western Ontario and McMaster Universities Osteoarthritis Index, and Knee injury and Osteoarthritis Outcome Score [KOOS] subscales) were collected preoperatively and at 6 months, 1 year, and 2 years postoperatively. The minimal clinically important difference (MCID) was calculated using a distribution-based method, whereas the Patient Acceptable Symptom State (PASS) and substantial clinical benefit (SCB) were calculated using an anchor-based method. Plain radiographs and magnetic resonance imaging (MRI) were obtained at 6 months, 1 year, and 2 years postoperatively. Results: A total of 120 patients were included. The overall failure rate was 11.3% at 2 years postoperatively. Changes in outcome scores required to achieve the MCID ranged between 5.1 and 14.3 at 6 months, 4.6 and 8.4 at 1 year, and 4.7 and 11.9 at 2 years postoperatively. Thresholds for PASS achievement ranged between 62.5 and 89 at 6 months, 75 and 89 at 1 year, and 78.6 and 93.2 at 2 years postoperatively. Threshold scores (absolute/change based) for achieving the SCB ranged between 82.8 and 96.4/17.7 and 40.1 at 6 months, between 94.7 and 100/23 and 45 at 1 year, and between 95.3 and 100/29.4 and 45 at 2 years. More patients achieved the MCID and PASS at 1 year compared with 6 months and 2 years. For SCB, this trend was also observed for non-KOOS outcomes, while for KOOS subdomains, more patients achieved the SCB at 2 years. High-intensity signal of the ACL repair (odds ratio [OR], 31.7 [95% CI, 1.5-73.4]; P = .030) and bone contusions on MRI (OR, 4.2 [95% CI, 1.7-25.2]; P = .041) at 1 year postoperatively were independently associated with increased risk of ACL repair failure. Conclusion: The rate of clinically meaningful outcome improvement was high early after ACL repair, with the greatest proportion of patients achieving the MCID, PASS, and SCB at 1 year postoperatively. Bone contusions involving the posterolateral tibia and lateral femoral condyle as well as high repair signal intensity at 1 year postoperatively were independent predictors of failure at 2 years postoperatively.

Six-month safety follow-up of an adjuvanted SARS-CoV-2 trimeric S-protein subunit vaccine (SCB-2019) in adults: A phase 2/3, double-blind, randomized study.

BACKGROUND: We evaluated the safety of SCB-2019, a protein subunit vaccine candidate containing a recombinant SARS-CoV-2 spike (S) trimer fusion protein, combined with CpG-1018/alum adjuvants. METHODS: This ongoing phase 2/3, double-blind, placebo-controlled, randomized trial is being conducted in Belgium, Brazil, Colombia, the Philippines, and South Africa in participants ≥ 12 years of age. Participants were randomly assigned to receive 2 doses of SCB-2019 or placebo administered intramuscularly 21 days apart. Here, we present the safety results of SCB-2019 over the 6-month period following 2-dose primary vaccination series in all adult participants (≥18 years of age). RESULTS: A total of 30,137 adult participants received at least one dose of study vaccine (n = 15,070) or placebo (n = 15,067) between 24 March 2021 and 01 December 2021. Unsolicited adverse events, medically-attended adverse events, adverse events of special interest, and serious adverse events were reported in similar frequencies in both study arms over the 6-month follow-up period. Vaccine-related SAEs were reported by 4 of 15,070 SCB-2019 recipients (hypersensitivity reactions in two participants, Bell's palsy, and spontaneous abortion) and 2 of 15,067 placebo recipients (COVID-19, pneumonia, and acute respiratory distress syndrome in one participant and spontaneous abortion in the other one). No signs of vaccine-associated enhanced disease were observed. CONCLUSIONS: SCB-2019 administered as a 2-dose series has an acceptable safety profile. No safety concerns were identified during the 6-month follow-up after the primary vaccination. CLINICAL TRIALS REGISTRATION: NCT04672395; EudraCT: 2020-004272-17.

MicroFPGA: An affordable FPGA platform for microscope control.

Modern microscopy relies increasingly on microscope automation to improve throughput, ensure reproducibility or observe rare events. Automation requires computer control of the important elements of the microscope. Furthermore, optical elements that are usually fixed or manually movable can be placed on electronically-controllable elements. In most cases, a central electronics board is necessary to generate the control signals they require and to communicate with the computer. For such tasks, Arduino microcontrollers are widely used due to their low cost and programming entry barrier. However, they are limiting in their performance for applications that require high-speed or multiple parallel processes. Field programmable gate arrays (FPGA) are the perfect technology for high-speed microscope control, as they are capable of processing signals in parallel and with high temporal precision. While plummeting prices made the technology available to consumers, a major hurdle remaining is the complex languages used to configure them. In this work, we used an affordable FPGA, delivered with an open-source and friendly-to-use programming language, to create a versatile microscope control platform called MicroFPGA. It is capable of synchronously triggering cameras and multiple lasers following complex patterns, as well as generating various signals used to control microscope elements such as filter wheels, servomotor stages, flip-mirrors, laser power or acousto-optic modulators. MicroFPGA is open-source and we provide online Micro-Manager, Java, Python and LabVIEW libraries, together with blueprints and tutorials.