Two-tailed Significance Level Research Articles

Reducing Limb Asymmetry in Females Collegiate Basketball: A Randomized Trial

Background and Aim: Interlimb strength asymmetry has garnered significant attention in the field of sports science for its potential to influence both athletic performance and injury risk. Despite this, there is a noticeable gap in the literature concerning its impact on elite female collegiate basketball players. The study aims to assess the effectiveness of targeted weaker limb strength training in reducing jump strength asymmetry among elite female college basketball players. Materials and Methods: A randomized controlled design was used, involving 24 elite female college basketball players from Guangzhou Sports University. The Experimental Group underwent specialized training for the weaker limb, while the Control Group followed balanced training. The primary outcome was the change in the maximum ground reaction force (GRF) during single-leg jumps. Linear Mixed-Effects models were used for statistical analysis, with a two-tailed significance level of p<0.05. Result: The intervention was effective in reducing Countermovement Jump Asymmetry and Horizontal Jump Asymmetry with statistical significance (p-values 0.0045 and 0.029, respectively) but did not significantly impact Lateral Jump Asymmetry (p-value 0.2733). These findings were consistent when comparing the Experimental and Control groups post-intervention (p-values 0.0055 and 0.0474 for Countermovement and Horizontal, respectively; 0.3995 for Lateral). Time and group interaction analyses were significant but not universally consistent across all measures after the Bonferroni correction. Overall, the intervention had a mixed but generally positive effect on jump asymmetry. Conclusion: The study demonstrates that targeted weaker limb strength training can effectively reduce jump strength asymmetry in elite female collegiate basketball players. These findings have implications for athletic training regimens aimed at both improving performance and reducing the risk of injury.

Prevalence and factors associated with dry socket following routine dental extractions.

Dry socket (DS) or fibrinolytic osteitis is a relatively common complication that can occur following tooth extraction. This study aimed to determine the prevalence of DS and identify its associated predictive and mediating variables. This study is classified as prospective observational, cross-sectional, and multicenter. Patients were consecutively selected in accordance with established criteria for tooth extraction. Data on patient demographics, surgical procedures and postoperative outcomes were collected. Nominal variables were analyzed using the Chi-Square Test, while associations involving ordinal values or considering counts or layers were examined using the Kendall's Tau-B Test or Mantel-Haenszel Test for trend. The GLM Mediation Model was employed to investigate potential mediation or indirect effects or potential underlying mechanisms of predictive variables on the development of DS. Two-tailed significance level of p ≤0.05 was considered statistically significant. A total of 1,357 patients undergoing routine dental extractions were included. DS was observed in 13 patients (prevalence of 1%). DS was associated with younger patients (under 50 years old), longer procedures, and the presence of surgical accidents, but only when mediated by surgical complexity. Smoking, particularly in combination with complex surgeries and surgical accidents, was associated with DS. Postoperative pain for more than two days and reported at moderate to high levels, emerged as a potential warning sign for DS. The use of antibiotics was found to significantly reduce the risk of DS (RR reduction of 36% and absolute risk reduction of 0.63%). Routine dental extractions revealed a 1% prevalence of dry socket. The obtained results suggests that DS is a multifactorial condition influenced by various factors, including gender, age, smoking, antibiotic prescription and surgical factors such as length, technique and accidents, nevertheless, those associations were observed mainly considering the influence of one variable on another.

Major depressive disorders in patients with inflammatory bowel disease and rheumatoid arthritis.

Various immune-mediated inflammatory diseases consisting of inflammatory bowel disease (IBD) and rheumatoid arthritis (RA), are found to have a substantial societal burden, increased healthcare costs, and progressive disability. Studies suggest that patients with vs without comorbid depression have a more significant disability, a lower likelihood of remission, and reduced adherence to therapy. Elevated interleukin (IL)-1β, tumor necrosis factor-α, and IL-6 contribute to developing depression by the impaired physiological responses to stress, resulting in increased pain, fever, fatigue, and lack thereof of interest, and thus poor long-term outcomes. This study emphasizes the timely recognition of the prevalence of major depressive disorder (MDD) in patients with RA and IBD combined, thus preventing disability. To identify the prevalence level and temporal trends of depression in hospitalized IBD-RA patients. All adult hospitalized patients from January 2000 to December 2019 in the nationwide inpatient sample (NIS) were captured. The study population included all patients with a primary or secondary IBD-RA overlap disease using corresponding international classification of diseases (ICD)-9 and ICD-10 codes. IBD includes Crohn's disease and ulcerative colitis. The study population was divided into IBD-RA without MDD (controls) and IBD-RA with MDD (cases). For group comparison between MDD vs no MDD, we used Student's t-test for continuous variables and Rao-Scott Chi-square tests for categorical variables. For univariate analyses, we used logistic regression, and for multivariate analysis, we used a weighted multi-level mixed-effects model. We attested all hypotheses with two-tailed significance level of 0.05 (P < 0.05 was considered significant). The outcome is to examine the temporal trends and prevalence of depression in patients with IBD-RA by gender, race, and age. A total of 133315 records were identified with IBD-RA overlap, of which 26155 patients (19.62%) had MDD. Among the IBD-RA patients, those who had MDD were younger [mean age of 56 years (SD ± 15)] to IBD-RA without MDD patients with a P < 0.0001, more females (80% among cases vs 73% among controls) than males with a P < 0.0001, frequent in the white race (79% among cases vs 73% among controls) than black race. Over the 19 years, the number of patients with MDD in IBD-RA increased from 153 (the year 2000) to 2880 (the year 2019) in weighted NIS, representing a 1782% increase compared to the year 2000 with a P < 0.001. Factors associated with higher MDD included younger age, female gender, white race, alcohol, opioids, esophageal disorders, peptic ulcer disease, chronic pancreatitis, paralysis, dementia, menopausal disorders, obesity, nutritional deficiencies, diabetes mellitus with chronic complications, and osteoarthritis. There is a rise in the prevalence of depression in younger patients with IBD-RA combined compared to their counterparts. These patients are also at higher risk for the increased cost of care and poor treatment compliance. It is crucial to educate the involved clinicians to identify the early signs and symptoms of depression in patients with IBD or RA or IBD-RA combined and treat them to have a better overall prognosis.

Interobserver agreement between eight observers using IOTA simple rules and O-RADS lexicon descriptors for adnexal masses

PurposeTo evaluate interobserver agreement in assigning imaging features and classifying adnexal masses using the IOTA simple rules versus O-RADS lexicon and identify causes of discrepancy.MethodsPelvic ultrasound (US) examinations in 114 women with 118 adnexal masses were evaluated by eight radiologists blinded to the final diagnosis (4 attendings and 4 fellows) using IOTA simple rules and O-RADS lexicon. Each feature category was analyzed for interobserver agreement using intraclass correlation coefficient (ICC) for ordinal variables and free marginal kappa for nominal variables. The two-tailed significance level (a) was set at 0.05.ResultsFor IOTA simple rules, interobserver agreement was almost perfect for three malignant lesion categories (M2-4) and substantial for the remaining two (M1, M5) with k-values of 0.80–0.82 and 0.68–0.69, respectively. Interobserver agreement was almost perfect for two benign feature categories (B2, B3), substantial for two (B4, B5) and moderate for one (B1) with k-values of 0.81–0.90, 0.69–0.70 and 0.60, respectively. For O-RADS, interobserver agreement was almost perfect for two out of ten feature categories (ascites and peritoneal nodules) with k-values of 0.89 and 0.97. Interobserver agreement ranged from fair to substantial for the remaining eight feature categories with k-values of 0.39–0.61. Fellows and attendings had ICC values of 0.725 and 0.517, respectively.ConclusionO-RADS had variable interobserver agreement with overall good agreement. IOTA simple rules had more uniform interobserver agreement with overall excellent agreement. Greater reader experience did not improve interobserver agreement with O-RADS.Graphical abstract

Multidimensional Dynamics and Forecast Models of Network Public Opinions Based on the Fusion of Smart Transportation and Big Data

With the increase of the world’s population, the means of transportation and vehicles that adapt to the times are still difficult to cope with the increase in traffic volume. The traffic problem can be said to be a worldwide problem. However, with the development of artificial intelligence, the emergence of smart transportation has brought new development to modern transportation, and the application of smart transportation and big data is inseparable. In contemporary society, the widespread use of the Internet allows the public to fully exercise their rights to participate in social management and conduct public opinion supervision, which provides a great impetus for the development of online public opinion. However, due to the huge scale of information, some false and harmful information and opinions will inevitably be mixed into it, which will make the network public opinion unable to perform its due function smoothly. Therefore, it is necessary to carry out highly effective management activities on the network public opinion. This paper studies the multidimensional dynamics and prediction model of network public opinion based on the integration of smart transportation and big data; the aim is to design a simple and effective forecasting model to provide traffic management departments with good public opinion forecasting and analysis methods so as to make better decisions. This paper analyzes the related technologies of smart transportation and network public opinion and designs a prediction model of smart transportation network public opinion. Finally, this paper uses rough set theory to optimize the model and compares the data before and after optimization. The results are as follows: the data correlation coefficient before and after optimization is 0.988, and the two-tailed significance level is 0.471, which proves that the results before and after processing are highly correlated, and the two sets of data have no significant difference, proving that the optimization of the model is effective, simplifies the analysis process, and does not change the results.

Изменение лабораторных показателей липидного обмена у пациентов с ВИЧ-инфекцией при церебральном инсульте

The article reflects the results of assessing the state of the blood lipid spectrum in HIV-positive patients with various types of stroke. Objective: to study laboratory parameters of lipid metabolism in patients with cerebral stroke against the background of HIV infection. Materials and methods. We examined 77 patients with ischemic and 32 patients with hemorrhagic stroke against the background of comorbid HIV infection, who received treatment in hospitals in the Tyumen Region. The study of lipid metabolism parameters was carried out on the Beckman Coulter AU480 analyzer (USA). Blood sampling was carried out on the day of the patients’ admission. The control group consisted of 116 patients. The significance of differences was determined at a two-tailed significance level of p&lt;0.05. Results. The study found lower levels of total cholesterol and low-density lipoproteins in the patients with ischemic stroke against the background of HIV infection. In the patients with hemorrhagic stroke, only a decrease in the level of total cholesterol was noted. Conclusions. The state of the plasma lipid spectrum in patients with HIV infections and ischemic stroke, in comparison with those with hemorrhagic stroke, indicates a lower probability of atherosclerotic genesis of acute vascular cerebrovascular disorder. English version of the article is available at URL:https://panor.ru/articles/changes-in-laboratory-parameters-of-lipid-metabolism-in-hiv-infected-patients-with-cerebral-stroke/80579.html

A Study on Performance-Related Musculoskeletal Disorders During Chinese Opera Training

The goal of this research approach is to achieve training effectiveness as great as in olden times using modern methods of performance-related musculoskeletal disorders (PRMDs), mental models, and ergonomic analysis. The purpose of this study explored the situation of PRMDs among Chinese opera performers and assessed the severity, frequency, continuance, and locations of PRMDs. This study also identified the treatments used for PRMDs, contributing factors to PRMD development, and the perceptions of the Chinese opera community regarding PRMDs. This research used a questionnaire modified from the Nordic Musculoskeletal Questionnaire (NMQ). The questionnaire involved a total of 108 responses from 43 professionals and 65 students. For the nonparametric methods, independent-samples kruskal-wall is test, a one-way ANOVA (k samples), was used at multiple comparisons (all pairwise) significance level of .05. Chi-square tests were used to distinguish differences and relationships among the variables in self-report questionnaires between participants. Cross tabulations were applied to describe the univariate relationships among the items of independent and dependent variables for comparison of nominal and interval variables. For the parametric methods, the independent sample t-test was used at a two-tailed significance level of .05 for comparison of nominal and interval variables. One-way ANOVA and linear regression analysis was used to identify the relationship among variables and predicted factor between regions of the body with PRMDs and other self-report independent variables. The results indicate the most significant and frequent PRMD symptoms experienced after training and working for the nine body regions (neck: increased 41.7%, shoulders: increased 46.3%, upper back: increased 33.3%, elbows: increased 24.1%, wrists/hands: increased 50.0%, lower back/hips: increased 44.4%, thighs: increased 24.1%, knees: increased 52.8%, ankles/feet: increased 25.9%). According to our knowledge, this is the first research to examine the relationship among the self-reports severity and frequency of PRMDs in Chinese opera population. Therefore, the Chinese opera performing arts population requires more information regarding PRMDs for developing treatment and prevention strategies according to scientific methods. Hopefully, the PRMD-related problems from traditional Chinese opera training and work places reported in this study can be mitigated in the near future.

Randomized clinical trial to evaluate two methods of caries risk assessment in schoolchildren: the CARDEC-PEL 04 study protocol

BackgroundCaries risk assessment is an essential element for managing and preventing dental caries in children. Individual caries risk assessment can be conducted to evaluate the presence or absence of single factors, or using multivariate models, a combination of factors. The subject has been extensively studied, but no previous research has compared whether a more elaborate and individualized method of caries risk benefits the patient than more straightforward strategies. Thus, this protocol evaluates the efficacy of two risk assessment methods for caries control in children, a simplified method based on caries experience evaluation and a multivariate method described in the literature.MethodsThis is a randomized, double-blind, controlled, parallel-treatment trial protocol. Two groups will be tested for two forms of caries risk assessment: an individualized and detailed multivariate method based on the guidelines of the Caries Care International 4D and another simplified process, based only on caries experience in primary and/or permanent dentition, considering the presence of decayed, missing and filled teeth using the DMFT/dmft index. Participants will be children aged 8 to 11 years, followed up at 12 and 24 months. The primary outcome will be a composite outcome representing the number of tooth surfaces requiring operative intervention (account variable). In addition, the Shapiro–Wilk normality test and Student's t-test will be performed. A multivariate analysis using negative binomial regression will compare groups in the intention-to-treat population, considering a two-tailed significance level of 5%.DiscussionThis is the first randomized clinical trial aiming to compare dental caries-related treatment and follow-up based on a detailed, multivariate and individualized assessment of caries risk in school-age children to a simpler risk assessment strategy based on caries experience. This study will define whether there are essential benefits to the patient that justify the choice of one method over the other.Trial registration Clinicaltrials.gov registration: NCT03969628. Registered on May 31th, 2019.

Elective cesarean delivery at term and its effects on respiratory distress at birth in Japan: The Japan Environment and Children's Study.

Background and AimsEarly‐term birth between 37 and 38 weeks of gestation increases the risk of mortality and morbidity. This study investigated the status and impact of early‐term birth among neonates born by cesarean section in Japan.MethodsAll singleton live births that had data of gestational age at birth available in the Japan Environment and Children's Study (JECS), a nationwide birth cohort study launched in 2011, were eligible for this study. Neonates born by cesarean delivery at term without indications for early delivery were included to examine the association between early‐term birth and respiratory distress at birth. The gestational age at birth was categorized as 37 weeks 0 day to 38 weeks 6 days (early‐term), 39 weeks 0 day to 40 weeks 6 day (full‐term), and 41 weeks 0 day to 41 weeks 6 days (late‐term). Respiratory distress at birth included respiratory distress syndrome, transient tachypnea, and difficulty in breathing after birth. Univariable and multivariable analyses were performed using logistic regression models with a two‐tailed significance level of 5%. All statistical analyses were performed using SAS, version 9.4, for Windows (SAS Institute, Cary, NC).ResultsIn total, 32 078 of 100 011 (32.1%) neonates had early‐term birth. At 37 gestational weeks, 49.7% of the deliveries were via cesarean section, and half of the cesarean deliveries were due to a previous cesarean section. Among the 10 051 neonates born by elective cesarean delivery at term, neonates with early‐term births were more likely to have respiratory distress at birth (adjusted odds ratio: 4.19; 95% confidence interval, 1.70, 10.34) than those born at full term.ConclusionsEarly‐term birth is associated with a high risk of respiratory distress in births involving cesarean delivery without indication for early delivery. There is a need for guidelines for early delivery considering adverse effects of early‐term births.

Postural stability is a valid and meaningful disability metric in progressive MS with potential for use in neuroprotective therapy trials

BackgroundBalance impairment is observed in up to 70% of people with MS (pwMS) and worsens with disease progression. Posturography using a force platform is the current gold standard in the measurement of balance. However, posturography has not been adequately studied or widely accepted for use as a disability outcome measure for pwMS. Importantly, the recent emergence of both successful and failed neuroprotective therapy trials in progressive MS has emphasised the need for new disability outcome measures for people with progressive MS. The main objectives of this study were to evaluate the clinical validity, reliability and feasibility of posturography as a disability metric in progressive MS. MethodsThis was a prospective cross-sectional study. We recruited 73 people with progressive MS (age 18–65 years, EDSS 3.5–6.0). Participants stood in the centre of a force platform, feet comfortably apart, under various conditions: (i) eyes open (EO), (ii) eyes closed (EC) – a single task, each lasting ninety seconds; and simultaneous EO with a cognitive test: (iii) N-Back, a three-minute test whereby participants were instructed to click the mouse when two identical letters were displayed consecutively on a screen, (iv) Sustained Attention Response Task, a five-minute test whereby participants were instructed to click the mouse for every number “1″ to “9″ except “3″ – i.e., dual-tasks. Additionally, we performed a battery of validated physical and cognitive outcome measures. Posturographic data was processed using Matlab. Statistical analysis was performed using SPSS version 26. We used multiple linear regression modelling to determine whether significant univariate correlations between posturography and clinical metrics were independent of covariates that may influence the associations seen. A two-tailed significance level of 0.05 was used. ResultsOf 73 participants, mean age 52.4 (8.5) years, mean MS disease duration 13.8 (10.3) years, median EDSS 5.0 (IQR 4.0–6.0), 44 (60.4%) were female. EO-Path-Length independently predicted upper extremity function (9-Hole-Peg-Test) with a larger effect size (adjusted R2=20.0%, p = 0.001) than that for walking measures (Timed 25-Foot Walk, adjusted R2=1.6%, p = 0.01; Two-Minute Walk Test, adjusted R2=7.2%, p = 0.002), while controlling for age, disease duration, height, weight, and sex. The addition of EO-Mediolateral-Displacement to the MS Functional Composite (MSFC) created a four-component z-score that increased the variance explained for quality of life (QOL) by 62.1%. Postural stability was significantly lower with mediolateral vs anteroposterior direction of sway, removal of vision, increased body weight, male sex, and fampridine use. Postural stability improved during dual-tasks compared to EO single task. Posturography detected significant worsening of balance over a single prolonged stance. ConclusionPostural stability independently predicted a wide range of clinical metrics including upper extremity function, walking ability, cognition and QOL, therefore establishing construct and concurrent validity as a disability outcome measure for people with progressive MS. Additionally, posturography is a quantitative, non-invasive, quick-and-easy-to-administer, and highly sensitive device, demonstrating its high feasibility for use as a time- and resource-efficient disability metric in neuroprotective therapy trials for progressive MS.

Risk Factors for Severe Form of COVID-19 after Allogeneic Hematopoietic Stem Cell Transplantation: A SFGM-TC Multicentre Cohort Study

COVID-19 greatly affected Europe between March and May 2020. Initial reports suggest cancer and haematological malignancies as risk factors for severity and mortality, but the role of allogeneic stem cell transplantation (alloHSCT) remains unclear. The Société Francophone de Greffe de Moelle et Thérapie Cellulaire conducted a multicentre retrospective study of alloHSCT recipients diagnosed with COVID-19. We described the COVID-19 disease characteristics in this population and examined risk factors for severity and mortality.Data were collected retrospectively from the patients’ charts and the ProMISe database. Diagnosis was retained only if a reverse transcription polymerase chain reaction assay test from a nose swab was positive for SARS-CoV-2. Patients were classified as severe if they were transferred to an intensive care unit (ICU) due to COVID-19 or died of COVID-19, and non-severe in other cases. Comparisons of characteristics were performed using student’s t-tests and Mann-Whitney U tests for normally and abnormally distributed data, respectively, for continuous variables and χ2 or Fisher’s exact tests, when appropriate for categorical variables. Risk factors associated with a severe form of COVID-19 were assessed using both univariate and multivariate logistic regressions. All analyses were performed using SAS version 9.4.6 (SAS Institute Inc., Cary, NC, USA. A two-tailed significance level p<0.05 was used.Fifty-four patients were diagnosed, including 21 with severe forms (intensive care transfer and/or death). Haematological characteristics did not vary between patients with severe or non-severe forms of COVID-19. Patients with a severe form of COVID-19 were more likely to be diagnosed earlier after alloHSCT (0.78 vs. 2.1 years, p=0.01), to have comorbidities (80.9% vs. 54.5%, p=0.05) and to receive immunosuppressive treatment (81% vs. 51.5%, p=0.03). Severe COVID-19 patients were more likely to have symptoms at COVID-19 diagnosis (100% vs. 81.8%, p=0.04), especially pneumonia and symptoms other than respiratory or digestive (asthenia, neurological symptoms, myalgia, dysgeusia, skin lesions and arthralgia), and to experience co-infection during the course of the disease (52.4% vs. 21.2%, p= 0.001).At COVID-19 diagnosis, patients with a non-severe form were more likely to have a higher platelet count (226 G/L vs. 98 G/L, p= 0.01), while other biological characteristics did not vary between the two cohorts. In univariate analysis, shorter time from transplant to COVID-19 (before 211 days, p=0.01), pneumonia (OR 12.21 [95% CI 2.43 - 61.46], p=0.002), symptoms other than pulmonary or digestive (OR 1.21 [95% CI 1.02 - 11.16], p=0.04), immunosuppressive treatment (OR 5.97 [95% CI 0.75 - 47.42], p=0.03) , co-infection (OR 5.84 [95% CI 1.65-20.63], p=0.006) and comorbidity (OR 3.54 [95% CI 0.98-12.83], p=0.05) were associated with severe COVID-19. The only biological parameter associated with severity was a lower platelet count <71G/L (OR 28.00 [95% CI 2.07-379.25]), p=0.008. In multivariate analysis, pneumonia and other symptoms retained a significant association with severe COVID-19.Thirteen patients died of COVID-19: in univariate analysis, risk factors for death from COVID-19 were similar to the risk factors for severe COVID-19 (i.e. shorter time from alloHSCT, p=0.03; pneumonia, p=0.01; co-infection during the course of COVID-19, p<0.01, and lower platelet count, p<0.01). In multivariate analysis, none of the above mentioned factors remained significantly associated with death from COVID-19.As SARS-CoV-2 continues to spread internationally, given the lack of vaccine or treatment, alloHSCT recipients should maintain a high level of awareness to avoid contamination.FigureDisclosuresDalle:Incyte: Consultancy, Membership on an entity's Board of Directors or advisory committees; Gilead: Honoraria; Bellicum: Consultancy, Honoraria; AbbVie Pharmacyclics: Membership on an entity's Board of Directors or advisory committees; Orchard: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; bluebird bio: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Sanofi-Genzyme: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees; Medac: Consultancy, Honoraria; Jazz Pharmaceuticals: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. Rubio:MSD: Honoraria; Novartis: Honoraria; Neovii: Research Funding; Medac: Consultancy; Gilead: Honoraria.

Correlation between weather and COVID-19 pandemic in India: An empirical investigation.

This study is an attempt to find and analyze the correlation between Covid‐19 pandemic and weather conditions in Indian context. Secondary data analysis of surveillance data of COVID‐19 is taken from Wikipedia (updating information from World Health Organization) & statista.com and weather data through Power Data Access Viewer (DAV) (power.Iarc.nasa.gov) from NASA after mentioning latitude and longitude of India. The minimum temperature (°C) at 2 metre, maximum temperature (°C) at 2 metre, temperature (°C) at 2 metre and relative humidity (%) are taken as component of weather. To find the association, Spearman's rank correlation test was applied. The minimum, maximum temperature (°C) at 2 m, temperatures (°C) at 2 m and humidity at 2 m are significantly correlated with COVID‐19 pandemic cases (r = 0.93, 0.94, 0.83, and 0.30) at 99% two‐tailed significance level. The findings serve as an initial evidence to reduce the incidence rate of COVID‐19 in India and useful in policy making.

O04 Clinical and cost-effectiveness of ultrasound-guided intra-articular corticosteroid and local anaesthetic injection for hip OA: a randomised controlled trial (HIT)

Abstract Background Evidence of the effectiveness of intra-articular corticosteroid injection for hip osteoarthritis (OA) is limited. The HIT trial compared the clinical and cost-effectiveness of an ultrasound-guided intra-articular hip injection (USGI) of 40mg triamcinolone acetonide and 4ml 1% lidocaine hydrochloride combined with best current treatment (BCT) with (i) BCT alone (primary objective) and (ii) an USGI of 5ml 1% lidocaine only combined with BCT (EudraCT:2014-003412-37). Methods This was a pragmatic, three-parallel arm, single-blind, randomised controlled trial in adults with moderate-severe painful hip OA recruited from community musculoskeletal services and primary care. Participants were randomised equally to: (1) BCT alone, (2) BCT plus USGI triamcinolone/lidocaine, or (3) BCT plus USGI lidocaine only. Outcomes were collected postally at 2 weeks, 2, 4 and 6 months. The primary outcome was self-reported current hip pain intensity (0-10 numeric rating scale (NRS)) over 6 months (repeated measures analysis). Secondary outcomes included function (WOMAC), and, for cost-utility analysis, general health (EQ-5D-5L) and healthcare utilisation. 204 participants were required to detect a minimum difference of 1 point in mean pain NRS score between arms (1) and (2) with 80% power (5% two-tailed significance level, 15% loss to follow-up). Analysis was by intention-to-treat. Results 199 participants were recruited (43% male, mean age 63 years), 67 to arm (1) and 66 each to arms (2) and (3). Primary outcome completion rates were 95% at 2 weeks, 94% at 2 months, 90% at 4 months, and 89% at 6 months. Greater mean improvement in hip pain intensity (0-10 NRS) over 6 months was seen with BCT plus USGI triamcinolone/lidocaine compared with BCT alone: -1.43 (95%CI -2.15,-0.72). Greater mean improvement in pain intensity was seen at 2 weeks (-3.17; -4.06,-2.28) and 2 months (-1.81;-2.71,-0.92), but not at 4 (-0.86;-1.78,0.05) or 6 months (0.12; -0.80,1.04). Participants treated with BCT plus USGI triamcinolone/lidocaine compared with BCT alone had greater mean improvement in function (WOMAC-F -5.47;(-9.41,-1.53)) over 6 months. There was no statistically significant difference in hip pain intensity over 6 months between BCT plus USGI triamcinolone/lidocaine compared with BCT plus USGI lidocaine (-0.52;-1.21,0.18). There was one possible treatment-related serious adverse event: a participant with no signs of infection at randomisation died from endocarditis four months after USGI triamcinolone/lidocaine. BCT plus USGI triamcinolone/lidocaine was less costly (mean cost difference per participant £-161.59) and associated with significantly higher quality-adjusted life-years (QALYs) than BCT only over 6 months (mean difference 0.0477 (0.0257,0.0699). Conclusion USGI triamcinolone/lidocaine plus BCT leads to greater improvements in pain and function over 6 months in adults with hip OA than BCT alone, and was highly cost-effective. There was no significant difference in hip pain intensity between the groups receiving USGI triamcinolone/lidocaine and USGI lidocaine only, raising the possibility of a degree of placebo effect. Disclosures Z. Paskins None. K. Bromley None. M. Lewis None. G. Hughes None. E. Hughes None. A. Cherrington None. A. Hall None. M. Holden None. R. Oppong None. J. Kigozi None. K. Stevenson None. A. Menon None. P. Roberts None. G. Peat None. C. Jinks None. N.E. Foster None. C.D. Mallen None. E. Roddy None.

Clinical and cost-effectiveness of ultrasound-guided intra-articular corticosteroid and local anaesthetic injection for hip osteoarthritis: a randomised controlled trial (HIT)

Purpose: Evidence of the effectiveness of intra-articular corticosteroid injection for hip osteoarthritis (OA) is limited. The HIT trial compared the clinical and cost-effectiveness of an ultrasound-guided intra-articular hip injection (USGI) of 40mg triamcinolone acetonide and 4ml 1% lidocaine hydrochloride combined with best current treatment (BCT) with (i) BCT alone (primary objective) and (ii) an USGI of 5ml 1% lidocaine only combined with BCT (EudraCT: 2014-003412-37). Methods: This was a pragmatic, three-parallel group, single-blind, randomised controlled trial in adults with moderate to severe painful hip OA recruited from community musculoskeletal services and primary care. Participants were randomised equally to: (1) BCT alone, (2) BCT plus USGI triamcinolone/lidocaine, or (3) BCT plus USGI lidocaine only. BCT comprised written information and individualised advice regarding weight loss, exercise, footwear, walking aids and analgesia. Outcomes were collected postally at 2 weeks, 2, 4 and 6 months. The primary outcome was self-reported current hip pain intensity (0-10 numeric rating scale (NRS)) over 6 months (repeated measures analysis). A wide range of secondary outcomes were measured at each follow-up point including pain and physical function (Western Ontario and McMaster University Arthritis Index, WOMAC), pain self-efficacy, participant’s global impression of change, general health (EQ-5D-5L) and healthcare utilisation. Participants and clinicians were not blind to allocation to BCT alone or injection, however participants randomised to either injection arm were blind to the nature of injection. The research nurse involved in data collection and study statistician were blind to treatment allocation. 204 participants were required to detect a minimum difference of 1 point in mean pain NRS score between arms (1) and (2) with 80% power (5% two-tailed significance level, 15% loss to follow-up). Analysis was by intention-to-treat. To determine the cost-effectiveness of BCT plus USGI triamcinolone/lidocaine compared with BCT alone, a cost-utility analysis was conducted, adopting an NHS perspective. QALYs were calculated over a period of 6 months using the area under the curve approach. Results: 199 participants were recruited (43% male, mean age 63 years), 67 to arm (1) and 66 each to arms (2) and (3). Primary outcome completion rates were 95% at 2 weeks, 94% at 2 months, 90% at 4 months, and 89% at 6 months. Greater mean improvement in hip pain intensity (0-10 NRS) over 6 months was seen with BCT plus USGI triamcinolone/lidocaine compared with BCT alone: -1.43 (95% CI -2.15, -0.72). Greater mean improvement in pain intensity was seen at 2 weeks (-3.17; -4.06, -2.28,) and 2 months (-1.81; -2.71, -0.92,), but not at 4 months (-0.86; -1.78, 0.05) or 6 months (0.12; -0.80, 1.04). Participants treated with BCT plus USGI triamcinolone/lidocaine compared with BCT alone had greater mean improvement in function (WOMAC-F -5.47; (-9.41, -1.53)) and pain self-efficacy (5.87; 2.30, 9.45) over 6 months. More participants reported being completely recovered/much better at 2 months with BCT plus USGI triamcinolone/lidocaine than with BCT alone (45.4% v 6.9%; relative risk=6.7; 2.5, 17.9). There was no statistically significant difference in hip pain intensity over 6 months between BCT plus USGI triamcinolone/lidocaine compared with BCT plus USGI lidocaine only (-0.52; -1.21, 0.18). However, a statistically significant difference was seen in favour of the group receiving USGI triamcinolone/lidocaine in comparison to USGI lidocaine alone for a range of secondary outcome measures, over 6 months (e.g. pain self-efficacy, function, and work presenteeism). There was one possible treatment-related serious adverse event: a participant with no signs of infection at randomisation died from endocarditis four months after USGI triamcinolone/lidocaine. BCT plus USGI triamcinolone/lidocaine was less costly (mean cost difference per participant £-161.59) and associated with significantly higher quality-adjusted life-years (QALYs) than BCT only over 6 months (mean difference 0.0477 (0.0257, 0.0699). Increased number of visits to NHS consultants and hip-related surgery in the BCT only group accounted for the majority of cost difference. Conclusions: USGI triamcinolone/lidocaine combined with BCT leads to greater improvements in pain and function over 6 months in adults with hip OA than BCT alone, and was highly cost-effective. There was no significant difference in hip pain intensity over 6 months between the groups receiving USGI triamcinolone/lidocaine and USGI/lidocaine only raising the possibility of a degree of placebo effect.

Effects of inspiratory muscle training in advanced multiple sclerosis

BackgroundRespiratory training using Threshold Inspiratory Muscle Trainer (IMT) has not been examined adequately in multiple sclerosis (MS). The primary objective in this study of persons with advanced MS was to investigate the training effect of IMT. The secondary objective was to evaluate the retention of IMT benefits. MethodsThis study was a repeated measures within-subject design (before-after trial).. Participants were recruited from a long-term care facility specialized in progressive neurologic conditions. Thirty-six non-ambulatory persons with advanced MS volunteered. Inspiratory muscle exercise using the threshold IMT were performed daily for 10 weeks at 3 sets of 15 repetitions per day. Resistance was progressed weekly based on perceived rate of exertion and symptoms. Primary outcome measures were maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) that were measured at baseline, after 5 and 10 weeks of IMT exercises (training period), and at 4 and 8 weeks after the IMT training ended (retention). Linear mixed-effect regression models with time (i.e. weeks from baseline) as the fixed factor and participants as the random effect factor were applied separately to test each hypothesis. Effect size was calculated using partial eta square (η2p). Two-tailed significance level was p < 0.05. ResultsParticipants were 60.5 ± 8.6 years old. Expanded Disability Status Scale was 8.5 ± 0.4. Baseline MIP were 25.9 ± 16.4 cmH2O (33.2% %± 19.8% of predicted values) and MEP were 23.5 ± 15.7 cmH2O (25.8% %± 14.4% of predicted values). Compared to the baseline, MIP increased significantly to 30.1 ± 17.9 cmH2O (38.9% %± 22.4% of predicted values) and 30.6 ± 17.6 cmH2O (39.6% %± 22.3% of predicted values) after 5 (p < 0.05) and 10 weeks (p < 0.05) of IMT exercises. MIP improvements were retained in an 8-week washout period. MEP did not differ significantly by time. ConclusionIn persons with advanced MS, 10-week IMT training increased inspiratory muscle strength. This study is the first to demonstrate the retention of benefits following daily IMT exercises at 8 weeks after training ended.

Impact of Splanchnic Vein Thrombosis on Mortality in Patients with Advanced Pancreatic Cancer

Abstract BACKGROUND: The incidence of venous thromboembolism in pancreatic cancer is high. Pancreatic cancer patients who develop deep venous thrombosis (DVT) or pulmonary embolism (PE) have increased mortality compared to those without. Pharmacological anticoagulation mitigates the increased mortality in these patients thus providing rationale for treatment. The incidence of splanchnic vein thrombosis (SVT) in pancreatic cancer is also high ~8% (Pachon JCO 2015, Sogaard Blood 2015). However, the correlation between SVT and mortality in pancreatic cancer is not well established. Current guidelines recommend anticoagulation for SVT on a case-to-case basis, assessing the risk-benefit of treatment and patient prognosis (Khorana J Thromb Thrombolysis 2016). Hence, we conducted the largest study to date to evaluate the impact of SVT on mortality in a cohort of United States Veterans with advanced pancreatic cancer. METHODS: Study Population: We identified patients in the Veterans Administration Central Cancer Registry (VACCR) diagnosed with unresectable or metastatic pancreatic cancer (stage II, III, IV) between October 1st, 1998 and December 31st, 2014 using ICD-O3 codes. We then identified the pancreatic cancer patients who developed SVT using ICD-9/10 codes and the CPT codes for relevant diagnostic imaging. Patients with DVT, PE and atrial fibrillation were excluded. Statistical Analyses: We compared baseline patient characteristics between pancreatic cancer patients with SVT and those without using Chi-square and Cochrane-Mantel-Haenszel tests for categorical variables, and unpaired Student's t-tests for continuous variables. Using Cox proportional hazard models, we assessed the association between SVT and overall survival in patients with pancreatic cancer while adjusting for significant prognostic indicators including: age, gender, body mass index (BMI), Charlson comorbidity index, stage of cancer (stage IV vs. stage II/III), white blood cell count (WBC), estimated glomerular filtration rate (eGFR), use of radiation or chemotherapy. A two-tailed alpha significance level of 0.05 was used for all analyses. Statistical analyses were performed using SAS version 9.2 (SAS Institute, Cary, NC). RESULTS: We identified 6296 patients with unresectable or metastatic pancreatic cancer within the VACCR, of whom 170 were diagnosed with SVT. Baseline demographics of patients with and without SVT are shown in Table 1. The median OS of the patients with SVT was 140 days as compared to 92 days for those without SVT, Figure 1. After adjusting for potential confounders, patients with SVT had a 16% reduction in mortality compared to those without (HR 0.84, p = 0.03). In addition, increasing age, male gender, BMI &lt; 18.5, increasing comorbidities, eGFR &lt; 45 mL/min, WBC &gt; 10 x 109/L, metastatic disease (stage IV) were associated with increased risk of death, while receipt of chemo or radiation therapy and BMI ≥ 25 were associated with a reduced risk of death. DISCUSSION/CONCLUSION: In this large retrospective study of patients with advanced pancreatic cancer, we found no association between SVT and increased mortality in patients with pancreatic cancer. A significant number of SVTs are detected incidentally on surveillance scans, and are thus asymptomatic at diagnosis. Anticoagulation is associated with an increased risk of hemorrhage which can be fatal in some cases. Given the lack of association between SVT and death in pancreatic cancer, future studies should assess the impact of anticoagulation on outcomes in this population with consideration given to observation only to reduce the risk of hemorrhage. Disclosures Sanfilippo: BMS/Pfizer: Speakers Bureau.

Effect of the treatment of periodontal disease on the outcome of pregnancy

Correlations between periodontitis and its effects on the outcome of pregnancies are actually more focused topics. Maternal motivation for a good oral hygiene and preventive dental treatment must be highlighted tasks during pregnancy care. The authors analysed the effect of the preventive dental treatment during pregnancy and its obstetrical effects. In a prospective randomised study, including pregnant women observed for threatening preterm deliveries, patients with dental examination (n = 71) were compared with patients undergoing dental treatment at the same time (n = 79). Univariate comparisons for categorical variables were assessed by χ2 tests and independent Student's t-tests for continuous variables. ORs were compared with Mantel-Haenszel tests. Multivariable logistic regression was performed to evaluate the factors determining the poor periodontal parameters and gingivitis separately. The two-tailed statistical significance level was set at 5%. In the dental treatment group, the neonatal birth weight was significantly higher than in the non-treated group, in case of patients with periodontitis (2990 ± 582.3 g vs 2568.1 ± 699.1 g, p = 0.005). Also the average age at delivery was significantly higher in the treated vs non-treated groups (37.3 ± 1.9 vs 36.0 ± 2.9 weeks, p = 0.027), and the treatment had a beneficial effect on the prolongation of pregnancy, with a higher level of significance in the gingivitis group vs patients with periodontitis groups (p = 0.02 vs p = 0.043). Dental treatment of expecting women has a beneficial effect on the prolongation of pregnancy by decreasing the rate of prematurity and perinatal complications. Orv Hetil. 2018; 159(24): 978-984.

Effectiveness of monotherapy and combined therapy with calcitonin and minodronic acid hydrate, a bisphosphonate, for early treatment in patients with new vertebral fractures: An open-label, randomized, parallel-group study.

Evidence related to the effectiveness of combination drug therapy for the treatment of osteoporosis is currently considered insufficient. Therefore, this study was performed to clarify the effects of monotherapy, and combination therapy, with a bisphosphonate (minodronic acid hydrate), a bone resorption inhibitor, and calcitonin (elcatonin), which is effective for the alleviation of pain due to vertebral fractures in osteoporotic patients. Study participants comprised of 51 female subjects with post-menopausal osteoporosis, whose main complaint was acute lower back pain caused by vertebral fractures. Subjects were randomly allocated into three groups and then administered with either intramuscular injections of elcatonin at a dose of 20 units weekly, minodronic acid hydrate at a dose of 1mg daily, or a combination of these two drugs. As primary endpoints, time-dependent changes in levels of pain were assessed using a visual analog scale from baseline to 6 months of duration. In addition, we examined the effects of monotherapies, and a combination therapy on bone resorption, with changes in bone mineral density at 4 sites and advanced hip assessment parameters from baseline to 6 months. A two-tailed significance level of 5% was used for hypothesis testing. Elcatonin monotherapy showed some alleviation of pain immediately after any vertebral fractures, which was more than in the minodronic acid hydrate monotherapy group. In addition, the minodronic acid hydrate monotherapy group experienced more effective inhibited bone resorption than the elcatonin monotherapy group. In the combination therapy, the efficacy for alleviating pain and inhibiting bone resorption was equivalent to the effect observed in the elcatonin and minodronic acid hydrate monotherapy groups respectively, with further improved values of bone mineral density observed in the femoral neck and lumbar vertebrae, and in parameters of advanced hip assessment compared with both monotherapy groups. Combination therapy with elcatonin and minodronic acid hydrate appears to be an effective treatment for osteoporosis patients with lower back pain, caused by fresh vertebral fractures.

Inflammation-Related Gene Polymorphisms Associated with Susceptibility to Primary Immune Thrombocytopenia

INTRODUCTIONPrimary immune thrombocytopenia (ITP) is an acquired autoimmune disease characterized by a reduced platelet count and an increased risk of bleeding. Although immense research has improved our understanding of ITP and led to impressive therapeutics, the pathogenesis is still not completely clear and a large subset of patients are refractory to first- and second-line therapies.In this study, we investigated the involvement of a cluster of inflammation-related genes, including CD24, FCRL3, CD226, IL2, IRF5, ITGAM, NLRP3, CARD8, PTPN22, SH2B3, STAT4, TNFAIP3, and TRAF1 genes.METHODSIn this case-control study, 261 ITP inpatients (92 males and 169 females) with a mean age of 39.59 ± 17.52 years were recruited from Qilu Hospital, Shandong University between January 2007 to April 2016. In addition, 154 healthy participants (60 males and 94 females) with a mean age of 44.82 ± 13.63 years were enrolled as a control group. Inflammation-related single nucleotide polymorphism (SNP) genotyping was performed on the Sequenom MassARRAY iPLEX platform. SNPs included CD24 rs8734/rs52812045, FCRL3 rs11264799, rs7528684, rs945635, rs3761959, CD226 rs763361, IL2 rs6822844, IRF5 rs2004640, rs2280714, rs10954213, ITGAM rs1143679, NLRP3 rs35829419, rs4353135, rs10754558, CARD8 rs2043211, PTPN22 rs33996649, rs1310182, SH2B3 rs3184504, STAT4 rs7574865, rs10181656, TNFAIP3 rs6920220, rs10499194, rs2230926, rs5029939, TRAF1 rs10818488. SPSS (Ver 22.0, Chicago, IL) was used to perform statistical analysis. The results of genotyping were analyzed with t or ¦Ö2 tests. A Fisher’s exact test was performed when expected frequencies were less than 5. Univariate and multivariate analyses were then performed by non-conditional logistic regression adjusting for age and gender. P values < 0.05 were considered significant. The two-tailed significance level was set at 0.05.RESULTSGenotype frequencies of these inflammation-related SNPs in healthy controls were consistent with the Hardy-Weinberg equilibrium (p > 0.05). Genotype distributions in ITP patients and controls are detailed in Table 1. Statistical analysis revealed a significant difference in TNFAIP3 rs10499194 and CD24 rs52812045 between patients and controls (Table 1). Genotype frequencies of other SNPs were not significantly different (p > 0.05). However, when allelic frequencies were compared, significant differences were not found in any genotyped SNPs (p > 0.05).ITP is classified by duration into newly diagnosed (less than 3-month duration), persistent (3- to 12-month duration) and chronic (1-year duration). According to ordinal logistic regression, the genotype frequency of IRF5 rs2004640 was significantly different between the 3 ITP phases. Compared with heterozygous carriers, homozygous carriers of major allele were found in higher frequency in newly diagnosed patients. The OR for GG vs. GT was 0.472 (95%CI = 0.289-0.770, p = 0.003).Patients with clinically relevant bleeding who require mandated treatment or additional therapeutic intervention are defined as having severe ITP. The inflammation-related SNPs were not significantly different between severe and non-severe patients (p > 0.05).Interestingly, genotype frequency distribution of CARD8 rs2043211 was significantly higher in refractory patients than in non-refractory patients (OR = 4.191, 95%CI = 1.026-14.567, p = 0.040), while allelic frequencies were not significantly different. We also compared corticosteroid-sensitive and corticosteroid-resistant ITP patients. We found that the genotype frequency of NLRP3 rs4353135 was significantly different between the two groups, and heterozygous genotype was more frequent in corticosteroid-sensitive patients (OR = 0.413, 95%CI = 0.203-0.841, p = 0.015). No significant difference was observed in other polymorphisms.CONCLUSIONSOur study identifies SNPs that differ based on the presence of ITP (TNFAIP3 rs10499194 and CD24 rs52812045), the phase of ITP (IRF5 rs2004640), refractoriness (CARD8 rs2043211), and corticosteroid sensitivity (NLRP3 rs4353135) in Chinese Han population. These important findings may lead to more tailored treatment strategies for ITP patients. Further study will dissect how these SNPs exert their roles to affect the pathogenesis of ITP. [Display omitted] DisclosuresNo relevant conflicts of interest to declare.

Effectiveness of elcatonin for alleviating pain and inhibiting bone resorption in patients with osteoporotic vertebral fractures.

Elderly patients with osteoporotic vertebral fractures often experience severe pain that reduces their quality of life (QOL). Calcitonin, a bone resorption inhibitor, has been reported to alleviate pain in such patients; however, few clinical studies have demonstrated this effect. The objective of this study was to compare changes in pain scores, activities of daily living (ADL), QOL, bone resorption, bone mineral density (BMD), and fracture healing among patients with new vertebral fractures who received different treatment modalities. We conducted an open-label, multicenter, randomized, parallel control group study comprising 107 female patients ≥55years old with acute back pain from vertebral fracture. All subjects received either intramuscular injections of elcatonin, a derivative of calcitonin, or an oral nonsteroidal antiinflammatory drug (NSAID) combined with an active vitamin D3 (VD3) analogue for 6months. The pain was assessed using a visual analogue scale, and ADL and QOL were assessed using questionnaires. BMD was measured using dual-energy X-ray absorptiometry. A two-tailed significance level of 5% was used. The elcatonin IM group had significantly higher QOL score at 2weeks and later, and significantly lower VAS and ADL scores than those in the NSAID+VD3 group at 1month and later. The elcatonin IM group had significantly reduced TRACP-5b levels compared with those in the NSAID+VD3 group at 3months and later and significantly higher percent changes in BMD than the NSAID+VD3 group. These results suggest that elcatonin significantly alleviated pain, inhibited bone resorption, and improved ADL, QOL, and BMD compared with NSAID+VD3.