Mantel-Haenszel Test Research Articles

Comparison of Transcatheter Arterialization of Deep Veins to Standard of Care in Patients with No-Option Chronic Limb Threatening Ischemia

Patients with no-option chronic limb-threatening ischemia (no-option CLTI) have limited therapeutic options. The PROMISE II study evaluated, transcatheter arterialization of deep veins (TADV) as a treatment option for no-option CLTI. In the current study patients from PROMISE II were compared to patients from a registry of untreated no-option CLTI patients (CLariTI: Natural Progression of High-Risk Chronic Limb-Threatening Ischemia). We used propensity matching to compare patients from the PROMISE II prospective study of the TADV intervention with simultaneously enrolled CLTI patients that were note candidates for PROMISE II but were enrolled in to CLariTI natural history registry. Untreated no-option CLTI (CLariTI) patients could either be no-option or patients who did not meet PROMISE II entry criteria. Risk difference between groups was calculated using common risk difference and P values were provided by propensity-score stratified Mantel-Haenszel test. The primary endpoint was amputation-free survival (AFS). Diabetes was present in over 75% of patients. All patients had tissue loss and 35-46% had extensive tissue loss (Rutherford 6). The unadjusted AFS at 6months, was 66.1% by Kaplan-Meier estimate for PROMISE II patients (n=105) compared to 39.1% in the no-option cohort of CLariTI (n=121) and 44.0% in the full cohort (no-option and patients not meeting entry criteria combine, n=180). The treatment group who underwent TADV for no-option CLTI had an absolute difference of 29% improved (P<0.0001) propensity-adjusted risk difference in AFS and a relative event rate reduction of 45% compared to the no-option control patients. Transcatheter arterialization of deep veins (TADV) resulted in improved 6month AFS in no-option CLTI patients and appears to be a promising therapy in patients with no-option CLTI.

Factors That Influence the Life Satisfaction of Afghan Refugees Living in Eastern Turkey: The Role of Their Migration Causes

In this study, the impact of the reasons for leaving their country (such as social, economic, and political) of Afghan asylum seekers who illegally entered Turkey from the eastern border on their life satisfaction in the country of destination was analyzed. The sample comprised 500 individuals (54.8% women; 42.4% &lt; 30 age) who came as refugees from Turkey’s eastern border. Three-stages of analysis were carried out in the study: the Mantel–Haenszel test, ordered logit, and CART (Classification and Regression Trees) decision tree. The main findings obtained from these analyses show that individuals leaving their country for economic reasons and because of war/terrorism are happier, while those leaving their country because of religious and cultural pressures are unhappier. According to the results of the CART analysis, the most frequently repeated variables are economic and life satisfaction of individuals who are satisfied with their household income and save money is at its highest level. In the analysis it is also seen that the life satisfaction level of individuals who are not satisfied with their household income, leave their country for reasons other than economic reasons, and make a living on debt is very low. This study also focuses on the relationship between happiness and sustainable development (SD). It has associated the reasons for migrants leaving their countries with the Sustainable Development Goals (SDGs), highlighting the significance of happiness studies in achieving the SDGs.

Trends in the Use of Recombinant Activated Factor VII and Prothrombin Complex Concentrate in Heart Transplant Patients in Virginia

To explore trends in intraoperative procoagulant factor concentrate use in patients undergoing heart transplantation (HTx) in Virginia. Secondarily, to evaluate their association with postoperative thrombosis. Patients who underwent HTx were identified using a statewide database. Trends in off-label recombinant activated factor VII (rFVIIa) use and on-label and off-label prothrombin complex concentrate (PCC) use were tested using the Mantel-Haenszel test. Multivariate logistic regression was used to test for an association between procoagulant factor concentrate administration and thrombosis. Virginia hospitals performing HTx. Adults undergoing HTx between 2012 and 2022. None. Among 899 patients who required HTx, 100 (11.1%) received off-label rFVIIa, 69 (7.7%) received on-label PCC, and 80 (8.9%) received off-label PCC. There was a downward trend in the use of rFVIIa over the 10-year period (p = 0.04). There was no trend in on-label PCC use (p = 0.12); however, there was an increase in off-label PCC use (p < 0.001). Patients who received rFVIIa were transfused more and had longer cardiopulmonary bypass time (p < 0.001). Receipt of rFVIIa was associated with increased thrombotic risk (odds ratio [OR] 1.92; 95% CI 1.12-3.29; p = 0.02), whereas on-label and off-label PCC use had no association with thrombosis (OR 0.98, 95% CI 0.49-1.96, p = 0.96 for on-label use; and OR 0.61, 95% CI 0.29-1.30, p = 0.20 for off-label use). Use of rFVIIa in HTx decreased over the past decade, whereas off-label PCC use increased. Receipt of rFVIIa was associated with thrombosis; however, patients who received rFVIIa were more severely ill, and risk adjustment may have been incomplete.

Association between Benign Paroxysmal Positional Vertigo and Thyroid Diseases: Systematic Review and Meta-Analysis.

Introduction Benign paroxysmal positional vertigo (BPPV) is the peripheral vestibular dysfunction that most affects people worldwide, but its etiopathogenesis is still not fully understood. Considering the etiological diversity, some studies highlight the association between BPPV and thyroid diseases. Objective To investigate the association between thyroid diseases and BPPV. Data Synthesis Systematic review and meta-analysis of epidemiological studies searched in the PubMed, Web of Science, Embase, Cochrane Library, and Scopus databases. Studies that were fully available and investigated the association between BPPV and thyroid diseases were selected. The articles that composed the meta-analysis were analyzed using the dichotomous model, the Mantel-Haenszel statistical test, odds ratio (OR), and a 95% confidence interval (CI). Of the 67 articles retrieved from the databases, 7 met the eligibility criteria of the systematic review, and 4 had data necessary to perform the meta-analysis. Qualitative analysis revealed that the studies were conducted in the European and Asian continents. The predominant methodological design was the case-control type, and thyroid dysfunctions, hypothyroidism, and Hashimoto thyroiditis occurred more frequently. The meta-analysis showed no association between hypothyroidism and BPPV; however, there was a statistically significant relationship between Hashimoto thyroiditis and BPPV. Conclusion The meta-analysis results suggest a possible association between BPPV and Hashimoto thyroiditis. Nevertheless, we emphasize the need for further studies to elucidate the evidence obtained.

Analgesic Efficacy and Safety of Tapentadol Immediate Release in Bunionectomy: A Meta-Analysis.

The aim of this systematic review and meta-analysis was to evaluate the analgesic effect of different doses of tapentadol immediate release (IR) and its adverse effects after a bunionectomy. Pubmed, Cochrane, Lilacs, Medline, and Imbiomed were used to identify abstracts of scientific publications related to the keywords of this systematic review (PROSPERO ID CRD42023437295). Moreover, the risk of bias in all included articles was assessed using the Cochrane Collaboration risk of bias tool. Data on the sum of pain intensity, total pain relief, global assessment, and adverse effects were extracted. The statistical method of inverse variance with means difference was used to evaluate the numerical data and the Mantel-Haenszel and Odd Ratio test to analyze the dichotomous data. In addition, the number needed to treat, the number needed to harm, and the 95% confidence intervals were calculated. A qualitative evaluation (n = 2381) was carried out according to the conclusions of the authors. Tapentadol (n = 1772) was more effective in relieving postoperative pain than the placebo (n = 609) after a bunionectomy. In addition, the analgesic efficacy of IR tapentadol (n = 1323) versus the placebo (n = 390) was evaluated in a total of 1713 patients using a global evaluation of the treatments. All three doses of IR tapentadol showed better results compared to the placebo after a bunionectomy. Finally, the adverse effects have a direct relationship with the dose, and the greatest number of adverse effects are most observed with tapentadol IR 100 mg (n = 2381). It is concluded that tapentadol IR (100 mg) leads to the best satisfaction score in this meta-analysis.

The effectiveness of dental water jet in reducing dental plaque and gingival bleeding in orthodontic patients: A systematic review and meta-analysis of randomized clinical trials.

This systematic review and meta-analysis tests the effectiveness of dental water jet (DWJ) with manual toothbrushes (MTB) compared to MTB alone in oral health maintenance in orthodontic patients. Four databases were systematically searched: PubMed, Scopus, Web of Science (WoS) and Cochrane Library until 6 January 2022 using a combination of medical subject heading (MeSH) terms and keywords. Randomized clinical trials (RCTs) were only included and critically appraised using the Cochrane Risk of Bias (ROB) tool. The mean difference (MD) effect measure was calculated using the Mantel-Haenszel statistical test (95% confidence interval [CI]) to compare both study groups (p-value < 0.05). After reviewing 5881 studies from a systematic search, six were selected for inclusion, with four involved in the quantitative analysis. The risk of bias was low in two studies, moderate in two studies and high in the remaining two studies. The meta-analysis showed a significant improvement in plaque index and bleeding scores in DWJ + MTB group compared MTB alone group in orthodontic patients with generalized gingivitis (MD = -0.75, 95% CI [-1.29, -0.22], p = 0.006) and (MD = -0.17, 95% CI [-0.27, -0.08], p = 0.0003), respectively. However, no significant improvement was detected between both groups in the gingival index. The use of DWJ as an adjunctive device in addition to MTB can be an effective strategy for maintaining oral hygiene in orthodontic patients with gingivitis. However, more high-quality RCTs are needed to confirm the findings.

THE EFFECT OF LOW BIRTH WEIGHT (LBW) ON NEONATAL DEATH IN GORONTALO CITY

Indonesia is a developing country with high maternal and infant mortality rates. One of the causes of infant mortality in Indonesia is the incidence of Low Birth Weight (LBW) of 38.85%. The number of neonatal deaths in Gorontalo City between 2018 - 2021 is 83 cases. The novelty of this research is the effect of LBW on neonatal death. This study aims to see the impact of LBW on neonatal mortality in Gorontalo City after controlling for maternal risk factors in the form of a history of complications and the frequency of ANC. The research design used was analytic with a case-control approach. The sample in this study consisted of 30 cases and 60 controls. The results of the survey show that from the effects of bivariate analysis, the history of complications variable has an Odds Ratio Crude value of 55 and an Odds Ratio Adjusted of 13 and the Mantel-Haenszel test value: p-value α (0.000 0.05). In contrast, Antenatal Care has an Odds Ratio Crude value of 28 and Odds Ratio Adjusted by 17 and the value of the Mantel-Haenszel test: p-value α (0.000 0.05). The Odds Ratio value for LBW is 20 with a p-value α (0.000 0.05). This study concludes that LBW has a 20 times risk of neonatal death (95% CI = 6.506 – 61.485)

Eight-Year Trends in the Effect of the Great East Japan Earthquake on Obstetrics Outcomes: A Study from the Fukushima Health Management Survey.

Information regarding the longitudinal effects of natural/environmental disasters on obstetrics outcomes is limited. This study aimed to analyze the longitudinal changes in obstetrics outcomes over 8 years after the Great East Japan Earthquake and the Fukushima power plant accident. We used data from the first 8 years of the Pregnancy and Birth Survey by the Fukushima prefectural government, launched in 2011. We compared data on obstetrics outcomes by year and divided Fukushima Prefecture into six districts based on administrative districts. Longitudinal changes in the occurrence of preterm birth before 37 gestational weeks, low birth weight, and anomalies in newborns were accessed using the Mantel-Haenszel test for trends in all six districts. Overall, 57,537 participants were included. In 8 years, maternal age, conception rate after sterility treatment, and cesarean section delivery incidence increased. Although significant differences were observed in preterm birth and low birth weight occurrence among districts, there was no significant trend in the occurrence of preterm birth, low birth weight, and anomalies in newborns in all six districts of Fukushima Prefecture. The Great East Japan Earthquake and Fukushima power plant accident were associated with increased cesarean section delivery incidence but had no significant adverse effects on obstetrics outcomes.

Correlation Between Intranodular Vessels and Tumor Invasiveness of Lung Adenocarcinoma Presenting as Ground-glass Nodules: A Deep Learning 3-Dimensional Reconstruction Algorithm-based Quantitative Analysis on Noncontrast Computed Tomography Images.

To evaluate the role of quantitative features of intranodular vessels based on deep learning in distinguishing pulmonary adenocarcinoma invasiveness. This retrospective study included 512 confirmed ground-glass nodules from 474 patients with 241 precursor glandular lesions (PGL), 126 minimally invasive adenocarcinomas (MIA), and 145 invasive adenocarcinomas (IAC). The pulmonary blood vessels were reconstructed on noncontrast computed tomography images using deep learning-based region-segmentation and region-growing techniques. The presence of intranodular vessels was evaluated based on the automatic calculation of vessel prevalence, vascular categories, and vessel volume percentage. Further comparisons were made between different invasive groups by the Mantel-Haenszel χ 2 test, χ 2 test, and analysis of variance. The detection rate of intranodular vessels in PGL (33.2%) was significantly lower than that of MIA (46.8%, P = 0.011) and IAC (55.2%, P < 0.001), while the vascular categories were similar (all P > 0.05). Vascular changes were more common in IAC and MIA than in PGL, mainly in increased vessel volume percentage (12.4 ± 19.0% vs. 6.3 ± 13.1% vs. 3.9 ± 9.4%, P < 0.001). The average intranodular artery and vein volume percentage of IAC (7.5 ± 14.0% and 5.0 ± 10.1%) was higher than that of PGL (2.1 ± 6.9% and 1.7 ± 5.8%) and MIA (3.2 ± 9.1% and 3.1 ± 8.7%), with statistical significance (all P < 0.05). The quantitative analysis of intranodular vessels on noncontrast computed tomography images demonstrated that the ground-glass nodules with increased internal vessel prevalence and volume percentages had higher possibility of tumor invasiveness.

An analysis of changes in the prevalence and patterns of intimate partner violence against women in seven Asian countries

BackgroundAssessments of changes in prevalence and patterns of violence against women are critical to inform prevention and response approaches and to monitor progress towards elimination. Most countries in the Asia Region have data on violence and several have completed second and third waves of surveys. This study sought to assess and compare the prevalence and patterns of physical and/or sexual partner violence in seven Asian countries with at least two rounds of comparable national-level data.MethodsWe conducted primary descriptive analyses using Demographic and Health data from India, Nepal, and Pakistan (South Asia), and from Cambodia, the Philippines, Timor-Leste, and extracted data from reports from Vietnam (Southeast Asia). We examined differences in partner violence by type of violence, reference periods, severity of violence, and age group. Pearson chi-square tests and Mantel-Haenszel test for trend were used to assess whether differences between time points were significant (p < 0.05).ResultsPrevalence and patterns of violence vary across countries and sub-regions. In Southeast Asia, women in Cambodia and Vietnam experienced increasing and relatively high levels of sexual violence alongside declining physical violence. Reported levels of violence were lowest in the Philippines and prevalence showed consistent declines. Timor-Leste stands out as having the highest prevalence of physical partner violence, and there were consistently significant increases in estimates. Women in South Asia experienced predominantly physical violence and there were consistent declines in all three countries, though physical violence increased among older women in India.ConclusionsData from Asian countries where more than one prevalence survey had been done provided a unique opportunity to analyse differences in estimates of violence against women at two time points. Deeper analyses into types and severity of violence revealed that overall prevalence estimates hid more complex patterns. There are clear limitations in using survey data to understand the nuances which highlighted the need for depth analysis identifying contextual factors of violence to inform situation specific policies and interventions for the greatest impact. It is also clear that more than two data points are necessary to identify change over time, and interventions driving or preventing that change.

Scholarly activity following National Institutes of Health Women’s Reproductive Health Research K12 training—a cohort study

National Institutes of Health funding to address basic reproductive health for common female conditions remains disproportionately low, in part because of low success rates of grant applications by obstetrician-gynecologists. This study aimed to evaluate the scholarly productivity of individuals supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Women's Reproductive Health Research K12 career development award, created to advance careers of obstetrician-gynecologist physician-scientists. We performed a cohort study of individuals who completed at least 2 years of Women's Reproductive Health Research training by June 30, 2015, and had at least 5-year follow-up. Earliest training start date was December 1, 1998. Primary outcomes from public data sources (National Institutes of Health RePORTER, PubMed, iCite) were (1) number of total and R01 National Institutes of Health grants as principal investigator; (2) numbers of total and first and last author publications; and (3) median and highest publication impact factor measured by the relative citation ratio. Secondary outcomes from an email survey subcohort were total number of research grants, federally funded grants, and number of National Institutes of Health grants as coinvestigator; institutional promotions and academic appointments, national and National Institutes of Health leadership roles; and career and mentorship satisfaction. Outcomes were recorded at 5, 10, and 15 years postgraduation, and aggregate anonymized data were divided into 3 groups using Women's Reproductive Health Research completion dates: June 30 of 2005, 2010, and 2015. Temporal trends were assessed. Results were stratified by gender, number of awarded grant cycles (1-2 vs 3-4), and specialty type. Analyses used Fisher exact or Pearson chi-square tests, and Mantel-Haenszel tests of trend. The distribution of the cohort (N=178) by graduation completion date was: on or before June 30, 2005 (57 [32%]); July 1, 2005 to June 30, 2010 (60 [34%]); and July 1, 2010 to June 30, 2015 (61 [34%]). Most participants were female (112 [64%]) and maternal-fetal medicine trained (53 [30%]), followed by no fellowship (50 [28%]). Of the 178 participants, 72 (40%) received additional National Institutes of Health funding as a principal investigator, 45 (25%) received at least 1 R01, and 23 (13%) received 2 to 5 R01s. There were 52 (31%) scholars with >10 first author publications, 66 (39%) with >10 last author publications, and 108 (63%) with ≥25 publications. The highest relative citation ratio was a median of 8.07 (interquartile range, 4.20-15.16). There were 121 (71%) scholars with relative citation ratio ≥5, indicating >5-fold greater publication impact than that of other National Institutes of Health-funded scientists in similar areas of research. No differences by gender, institution, or temporal trends were observed. Of the full cohort, 69 (45.7%) responded to the survey; most self-identified as women (50 [73%]) and White (51 [74%]). Our findings suggest that the infrastructure provided by an institutional K award is an advantageous career development award mechanism for obstetrician-gynecologists, a group of predominantly women surgeons. It may serve as a corrective for the known inequities in National Institutes of Health funding by gender.

Multidrug-Resistant Organism Infections of Inpatients in a Hospital in Eastern China from 2015 to 2021.

The prevalence of multidrug-resistant organisms (MDRO) is gradually increasing in the global scope, causing serious burden to patients and society, which is an important public health problem. To analyze the distribution and trend of MDROs and provide a reference for hospital infection control. Collected data on MDROs infections among inpatients in a Grade III Level A hospital in Suzhou from 2015 to 2021, including drug-resistant bacteria strains and specimen sources, etc. Mantel-Haenszel χ2 test was used to evaluate the trend of infection rates over the years and SPSS version 26.0 was used for statistics analysis. The hospital infection rate showed an overall downward trend across the seven-year period, ranging from 1.53% to 2.10%. According to the analysis of change of drug-resistant bacteria strains, the highest infection rate was carbapenem-resistant Acinetobacter baumannii (CRABA) (63.74%), followed by methicillin-resistant Staphylococcus aureus (MRSA) (46.37%), carbapenem-resistant Pseudomonas aeruginosa (CRPAE) (24.87%), carbapenem-resistant Enterobacteriaceae (CRE) (13.14%) and vancomycin-resistant Enterococcus (VRE) (0.42%). The results of Mantel-Haenszel χ2 test showed that there was a linear relationship between the detection rate of CRE and CRPAE and the time (P<0.001), but the correlation was not strong (R = 0.136; R = 0.139). The overall detection rate of the five pathogens also increased (P<0.001). The majority of the specimens, mainly from sputum, airway secretions, and midstream urine, had a detection rate of over 70%. Our data showed that the detection rate of MDROs generally increased from 2015 to 2021, although the hospital infection rate displayed a declining trend. Among the detection rate MDROs, the highest was CRABA, and the lowest was VRE. It is necessary to enhance the prevention, control, and management of MDROs infections in the clinical practice.

425 Effect of upadacitinib on SCORAD intensity items: analysis from the Measure Up 1 and Measure Up 2 studies

Abstract Atopic dermatitis (AD) is a chronic, inflammatory disease characterized by typical clinical signs (erythema, edema/papulation, oozing/crusting, excoriation, lichenification and dryness) and prominent itch that can markedly impact a patient’s sleep and quality of life (QoL). Upadacitinib is a selective oral Janus kinase (JAK) inhibitor with greater inhibitory potency for JAK1 vs. JAK2, JAK3 and tyrosine kinase 2. The SCORing Atopic Dermatitis (SCORAD) measure is a validated assessment tool that evaluates the extent of disease based on the area of the body affected, intensity of clinical signs of AD, and itch and sleeplessness due to AD. In this integrated post hoc analysis of the Measure Up 1 and Measure Up 2 studies, we compared the effects of upadacitinib (15 and 30 mg) vs. placebo on the intensity of the individual signs assessed by the SCORAD at Week 2 and Week 16. Measure Up 1 and Measure Up 2 are replicate phase 3 multicenter, randomized, double-blind studies comparing the safety and efficacy of upadacitinib 15 mg and upadacitinib 30 mg to placebo in adolescent and adult patients with moderate-to-severe AD. Patients were randomized to upadacitinib 15 mg, upadacitinib 30 mg or placebo orally once daily. All patients received additive-free, bland emollient twice daily for at least 7 days before baseline and during the study until week 16. The current study assessed the intensity of the six clinical signs assessed by the SCORAD (erythema, edema/papulation, oozing/crusting, excoriation, lichenification and dryness with a 4-level rating scale of none, mild, moderate and severe). The proportions of patients achieving resolution (i.e. an intensity rating of ‘none’) of each clinical sign at Week 2 and Week 16 were evaluated among patients with mild, moderate or severe intensity at baseline. Resolution rates were compared using the Mantel–Haenszel test. Missing data were handled using nonresponder imputation. A total of 1679 participants (placebo, 558; upadacitinib 15 mg, 557; upadacitinib 30 mg, 564) were included in the analysis of integrated data from the Measure Up 1 and Measure Up 2 studies. Differences in the proportion of patients achieving resolution for both upadacitinib doses (15 mg/30 mg) vs. placebo were observed at Week 2 (P &amp;lt; 0.0001) for erythema (3.1%/6.0% vs. 0.0%), edema/papulation (13.1%/16.6% vs. 1.3%), oozing/crusting (49.8%/59.1% vs. 15.6%), excoriation (26.9%/34.6% vs. 3.1%), lichenification (9.6%/13.5% vs. 1.4%) and dryness (8.6%/11.9% vs. 1.8%). Resolution rates were also higher with upadacitinib (15 mg/30 mg) vs. placebo at Week 16 (P &amp;lt; 0.0001) for erythema (22.2%/29.7% vs. 2.2%), edema/papulation (33.6%/42.8% vs. 4.9%), oozing/crusting (62.1%/72.0% vs. 20.5%), excoriation (43.3%/54.6% vs. 8.5%), lichenification (30.8%/40.7% vs. 5.2%) and dryness (28.7%/35.9% vs. 4.4%). Greater proportions of patients treated with upadacitinib 15 mg or upadacitinib 30 mg achieved resolution of erythema, edema/papulation, oozing/crusting, excoriation, lichenification or dryness compared with placebo at Week 2 and Week 16. Complete resolution of these clinical signs of AD may correspond to reductions in disease burden that translate to improved QoL. Consideration of the clinical signs of AD as assessed by the SCORAD may help inform physicians as they tailor their treatment choices specifically to the unique skin manifestations of each individual patient.

Personal Adaptations to Remote Working in the Post-Pandemic City and Its Potential Impact on Residential Relocations: The Case of Istanbul

A forced and rapid increase in remote working because of the COVID-19 pandemic has afforded today’s megacities several important opportunities for reducing traffic congestion, energy consumption, greenhouse gas emissions, and certain threats such as the promotion of urban sprawl. The way in which employees have adapted to working remotely during the pandemic and the potential it offers for improving their work/life balance provide indicators for developing urban policies in the post-pandemic city. The present study aims to examine the potential impact the increase in remote working during the first phase of the COVID-19 pandemic has had on residential relocations in Istanbul by investigating how employees have adapted to remote working and their thoughts about leaving the city after the pandemic. To do so, an online survey was conducted between June 1 and June 5, 2020 with 186 employees living in the city of Istanbul. The survey consisted of investigations into changes in work life during the pandemic. The differences between participants’ responses were analyzed and interpreted with respect to their personal characteristics and leisure-time preferences using Pearson’s chi-squared test and the Mantel–Haenszel test of trends (linear-by-linear association). The study finds significant relationships between personal/social characteristics and how people adapt to remote working and provides important indicators of the effects these adaptation processes have on residential relocations.

Association between cognitive diagnosis and a range of significant life events in an elderly essential tremor cohort: a longitudinal, prospective analysis.

Although essential tremor (ET) patients have greater odds of mild cognitive impairment (MCI) and dementia than age-matched controls, the functional consequences of these enhanced odds are unknown. We examined associations between cognitive diagnosis and the occurrence of near falls, falls, use of a walking aid or a home health aide, non-independent living, or hospitalizations within a prospective, longitudinal study of ET patients. A total of 131 ET patients (mean baseline age = 76.4 ± 9.4 years) completed a battery of neuropsychological tests and questions about life events and were assigned diagnoses of normal cognition (NC), MCI, or dementia at the baseline and at 18-, 36-, and 54-month follow-ups. Kruskall-Wallis, chi-square, and Mantel-Haenszel tests assessed whether the diagnosis was associated with the occurrence of these life events. Patients with final diagnoses of dementia were more often reported as living non-independently than NC or MCI patients and more often used walking aids than NC patients, with a p-value of <0.05. Patients with a final MCI or dementia diagnosis more often employed a home health aide than NC patients, with a p-value of <0.05. Moreover, Mantel-Haenzsel tests revealed linear associations between the occurrence of these outcomes and the level of cognitive impairment, with a p-value of <0.001 (i.e., dementia > MCI > NC). Cognitive diagnosis was associated with reported life events of ET patients, including the use of a mobility aid, employment of a home health aide, and removal from an independent living situation. These data provide rare insights into the important role cognitive decline plays in the experiences of ET patients.

Can prenatal ultrasound predict adverse neonatal outcomes in SARS-CoV-2–affected pregnancies?

On the basis of available data, at least 1 ultrasound assessment of pregnancies recovering from SARS-CoV-2 infection is recommended. However, reports on prenatal imaging findings and potential associations with neonatal outcomes following SARS-CoV-2 infection in pregnancy have been inconclusive. This study aimed to describe the sonographic characteristics of pregnancies after confirmed SARS-CoV-2 infection and assess the association of prenatal ultrasound findings with adverse neonatal outcomes. This was an observational prospective cohort study of pregnancies diagnosed with SARS-CoV-2 by reverse transcription polymerase chain reaction between March 2020 and May 2021. Prenatal ultrasound evaluation was performed at least once after diagnosis of infection, with the following parameters measured: standard fetal biometric measurements, umbilical and middle cerebral artery Dopplers, placental thickness, amniotic fluid volume, and anatomic survey for infection-associated findings. The primary outcome was the composite adverse neonatal outcome, defined as ≥1 of the following: preterm birth, neonatal intensive care unit admission, small for gestational age, respiratory distress, intrauterine fetal demise, neonatal demise, or other neonatal complications. Secondary outcomes were sonographic findings stratified by trimester of infection and severity of SARS-CoV-2 infection. Prenatal ultrasound findings were compared with neonatal outcomes, severity of infection, and trimester of infection. A total of 103 SARS-CoV-2-affected mother-infant pairs with prenatal ultrasound evaluation were identified; 3 cases were excluded because of known major fetal anomalies. Of the 100 included cases, neonatal outcomes were available in 92 pregnancies (97 infants); of these, 28 (29%) had the composite adverse neonatal outcome, and 23 (23%) had at least 1 abnormal prenatal ultrasound finding. The most common abnormalities seen on ultrasound were placentomegaly (11/23; 47.8%) and fetal growth restriction (8/23; 34.8%). The latter was associated with a higher rate of the composite adverse neonatal outcome (25% vs 1.5%; adjusted odds ratio, 22.67; 95% confidence interval, 2.63-194.91; P<.001), even when small for gestational age was removed from this composite outcome. The Cochran Mantel-Haenszel test controlling for possible fetal growth restriction confounders continued to show this association (relative risk, 3.7; 95% confidence interval, 2.6-5.9; P<.001). Median estimated fetal weight and birthweight were lower in patients with the composite adverse neonatal outcome (P<.001). Infection in the third trimester was associated with lower median percentile of estimated fetal weight (P=.019). An association between placentomegaly and third-trimester SARS-CoV-2 infection was noted (P=.045). In our study of SARS-CoV-2-affected maternal-infant pairs, rates of fetal growth restriction were comparable to those found in the general population. However, composite adverse neonatal outcome rates were high. Pregnancies with fetal growth restriction after SARS-CoV-2 infection were associated with an increased risk for the adverse neonatal outcome and may require close surveillance.

B7H3 expression in sarcoma.

e23517 Background: Targeted therapy development in sarcoma has been burdened by the heterogeneity of this rare group of tumors. B7H3 is an immune checkpoint molecule in the same family as PD-L1 (also known as B7H1). Its limited expression in non-cancerous tissues and over-expression in numerous tumor types makes it an attractive target for cancer immunotherapy. Available data suggests high expression of B7H3 in certain sarcoma subtypes, including rhabdomyosarcoma, osteosarcoma, liposarcoma, Ewing sarcoma, synovial sarcoma and chondrosarcoma. This study was conducted to further explore B7H3 expression patterns across sarcoma subtypes and the relationship, if any, with PD-1 and PD-L1 expression. Methods: This single-institution, retrospective analysis evaluated soft tissue sarcoma Formalin-Fixed Paraffin-Embedded tumor specimens in patients with a variety of different subtypes. Specimens were evaluated for expression of B7H3, vessel positivity for B7H3, B7H3 staining pattern, and expression of PD-L1 and PD-1. The association between B7H3 expression and baseline and tumor factors was tested using the Mantel Haenszel test or two-sample T-test. Overall survival was estimated using the Kaplan-Meier method where survival time was calculated from diagnosis to death (or last follow-up for those last known to be alive). Results: 156 sarcoma specimens encompassing 16 subtypes were included. B7H3 was broadly expressed across sarcoma subtypes, with some degree of expression found in 91% of samples and 61% demonstrating high levels of B7H3 expression. All tumor samples expressing B7H3 exhibited the biomarker in at least 80% of tumor cells per sample (with a mean of 92.34% of cells testing positive for B7H3). All samples positive for B7H3 showed both cytoplasmic and membranous expression, and B7H3 vessel positivity was found in 90% (137/152) of samples. There were no significant differences in expression or level of expression when stratified by sarcoma subtype, prior treatment(s), tumor size, tumor grade or patient age. No significant difference in overall survival was seen regardless of B7H3 expression or expression levels across sarcoma subtypes. There was no correlation between B7H3 expression and expression of PD-L1 or PD-1 in tumor cells. Conclusions: This is the most comprehensive analysis of B7H3 expression in sarcoma to date. This data shows high levels of B7H3 expression across sarcoma subtypes, suggesting its feasibility as a therapeutic target for future sarcoma treatments. Future clinical trials are needed to evaluate its numerous actions and if manipulation of B7H3 can be employed to improve outcomes in sarcoma. [Table: see text]

Perioperative PD-1 antibody toripalimab plus SOX or XELOX chemotherapy versus SOX or XELOX alone for locally advanced gastric or gastro-oesophageal junction cancer: Results from a prospective, randomized, open-label, phase II trial.

4001 Background: The combination of PD-1 antibody and chemotherapy was shown to be effective in advanced gastric or gastro-oesophageal junction (GEJ) cancer, but has not yet been investigated in the context of locally advanced patients. In this study, we conducted a prospective, randomized, open-label phase II trial to evaluate the effectiveness of adding PD-1 antibody to perioperative chemotherapy in patients with locally advanced resectable gastric or GEJ cancer. Methods: In this randomized, open-label, phase II study, patients with resectable gastric or GEJ cancer clinically staged as cT3-4a N+M0 were randomized (1:1) to three preoperative and five postoperative 3-week cycles of SOX/XELOX (C arm) or PD-1 antibody toripalimab plus SOX/XELOX, followed by toripalimab monotherapy for 6 months (C+T arm). The primary endpoint was pathological complete regression/moderate regression rate (TRG 0/1). The secondary endpoints were pathological complete response (pCR), R0 resection rate, recurrence-free survival, event-free survival, objective response rate, disease control rate, overall survival and treatment safety. The study had been completed enrollment, and here, we analyzed the primary endpoint. Mantel-Haenszel test was used to test the difference of pathological regression between the two arms. The trial was registered at ClinicalTrials.gov, identifier: NCT04250948. Results: Between Oct 2019 and June 2022, 108 patients (C+T arm, n=54; C arm, n=54) were enrolled and assessed using intention-to-treat analysis. Patients in the toripalimab plus chemotherapy arm achieved higher proportion of TRG 0/1 than those in the chemotherapy arm (44.4% [24/54, 95% CI: 30.9%-58.6%] vs 20.4% [11/54, 95% CI: 10.6%-33.5%]; P=0.009). A higher pCR rate was observed in the C+T arm (24.1% [13/54, 95% CI:13.5%-37.6%] vs 9.3% [5/54, 95% CI: 3.1%-20.3%]; P=0.039). Preoperative therapies (3 cycles) were completed in 96.3% of patients and postoperative cycles (&gt;3 cycles) in 81.5%, with no significant differences observed between these two arms. A higher proportion of downstaging was observed in the C+T arm (ypT0-2: 46.3% vs 22.2% [P=0.002]; ypstage 0-1: 38.9% vs 16.7% [P=0.024]). Surgical morbidity (11.8% in the C+T arm vs 13.5% in the C arm) and mortality (1.9% vs 0%) and treatment-related grade 3-4 adverse events (27.8% vs 25.9%) were comparable between the arms. Conclusions: Perioperative PD-1 antibody toripalimab plus chemotherapy demonstrated a significantly improved pathological regression and might be a promising option for patients with locally advanced resectable gastric or GEJ cancer. Clinical trial information: NCT04250948 .

Postoperative acute pain management with duloxetine as compared to placebo: A systematic review with meta-analysis of randomized clinical trials.

Duloxetine has been used as an adjunct in multimodal analgesia for acute postoperative pain in clinical studies. This meta-analysis aims to conclude whether oral duloxetine, when given perioperatively, is any better than a placebo in managing postoperative pain. Effects of duloxetine on postoperative pain scores, time to first rescue analgesia, postoperative rescue analgesia consumption, side effects attributable to duloxetine, and patient satisfaction profile were assessed. MEDLINE, Web of Science, EMBASE, Scholar Google, and the Cochrane Central Register of Controlled Trials (CENTRAL) were searched with keywords including "Duloxetine" AND "postoperative pain", "Duloxetine" AND "acute pain" and with "Duloxetine" till October 2022. This meta-analysis included randomized clinical trials in which perioperative duloxetine 60 mg per oral was administered not more than 7 days before surgery and for at least 24 after surgery but not more than 14 days after surgery. All RCTs in which the comparator is placebo and outcomes related to analgesic efficacy like pain scores, opioid consumption, and side effects of duloxetine until 48 h postoperatively were included. Data were extracted from the studies and a risk of bias summary was formed using the Cochrane Collaboration tool. Effect sizes were given as standardized mean differences for continuous outcomes and risk ratios (RR) by the Mantel-Haenszel test for the categorical outcome. Confirmation of publication bias was done by Egger's regression test (p < 0.05). If publication bias or heterogeneity was detected, the trim-and-fill method was used to calculate the adjusted effect size. Sensitivity analysis was done by leaving one out method after excluding the study with a high risk of bias. Subgroup analysis was done based on the type of surgery and gender. The study was prospectively registered in the PROSPERO under the registration number CRD42019139559. 29 studies with 2043 patients met the inclusion criteria and were reviewed for this meta-analysis. Postoperative pain scores at 24 h [Std. Mean Difference (95% CI); -0.69 (-1.07, -0.32)] and at 48 h [-1.13 (-1.68, -0.58)] are significantly less with duloxetine (p-value < 0.05). Time to first rescue analgesia was significantly more in patients where duloxetine was administered [1.27 (1.10, 1.45); p-value > 0.05]. Opioid consumption up to 24 h [-1.82 (-2.46, -1.18)] and 48 h [-2.48 (-3.46, -1.50)] was significantly less (p-value < 0.05) in patients who received duloxetine. Complications and recovery profiles were similar in patients receiving either duloxetine or a placebo. Based on GRADE findings, we conclude that there is low to moderate evidence to advocate the use of duloxetine for managing postoperative pain. Further trials are needed to replicate or refute these results based on robust methodology.

A Psychometric Framework for Evaluating Fairness in Algorithmic Decision Making: Differential Algorithmic Functioning

As algorithmic decision making is increasingly deployed in every walk of life, many researchers have raised concerns about fairness-related bias from such algorithms. But there is little research on harnessing psychometric methods to uncover potential discriminatory bias inside decision-making algorithms. The main goal of this article is to propose a new framework for algorithmic fairness based on differential item functioning (DIF), which has been commonly used to measure item fairness in psychometrics. Our fairness notion, which we call differential algorithmic functioning (DAF), is defined based on three pieces of information: a decision variable, a “fair” variable, and a protected variable such as race or gender. Under the DAF framework, an algorithm can exhibit uniform DAF, nonuniform DAF, or neither (i.e., non-DAF). For detecting DAF, we provide modifications of well-established DIF methods: Mantel–Haenszel test, logistic regression, and residual-based DIF. We demonstrate our framework through a real dataset concerning decision-making algorithms for grade retention in K–12 education in the United States.