Mantel-Haenszel Test Research Articles

Echocardiographic evaluation of right ventricle to pulmonary artery coupling in patients undergoing transcatheter aortic valve implantation: a systematic review and meta-analysis

Abstract Background Right Ventricle to Pulmonary Artery (RV/PA) uncoupling, which depicts the inability of RV contractility to match the increasing RV afterload, has recently gained recognition as a simple echocardiography parameter to aid prognosis judgment in patients with RV dysfunction. In Aortic Stenosis (AS) patients, the extent of RV dysfunction and Pulmonary Hypertension (PH) has been linked with poor outcomes, but the prognostic value of RV/PA uncoupling in AS patients undergoing TAVI has not been well-defined. Purpose To investigate the prognostic value of RV/PA uncoupling and its association with echocardiographic parameters in AS patients undergoing TAVI. Methods We conducted a systematic search through Pubmed and Embase to include studies up to February 2024. Studies were eligible if they evaluated the prognostic performance of RV/PA uncoupling in AS patients undergoing TAVI. Random-effects model were employed to pool the adjusted Hazard Ratio (aHR) with inverse-variance weighting method or Relative Risk (RR) with 95% Confidence Interval (95% CI) using Mantel-Haenszel test for categorical outcomes or Weighted Mean Difference (WMD) for numerical outcomes. Risk of bias assessment was conducted using the Newcastle Ottawa Scale (NOS). Results Thirteen studies were included. Out of 4,146 patients, 55.21% were reported to have RV-PA uncoupling prior to TAVI. RV/PA uncoupling was customarily assessed with TAPSE/PASP ratio, with threshold for uncoupling ranging between <0.31–<0.63 mm/mmHg. Follow-up period ranged between 6–65 months. Patients with baseline RV/PA uncoupling had lower LVEF (WMD -9.94% [-4.36– -15.53%]; I2 = 78%), lower TAPSE (WMD -4.98 mm [95% CI -1.15– -8.80]; I2 = 95%), and higher PASP (WMD 19.77 [95% CI 17.02–22.51]; I2 = 0%) compared to patients with RV/PA coupling at baseline. Baseline RV-PA uncoupling was an independent predictor of all-cause mortality (pooled aHR = 2.26 (95% CI 1.36–3.76); I2 = 77%) and composite endpoint of mortality and adverse cardiac or cerebrovascular events (pooled aHR = 2.07 (1.30–3.29); I2 = 24%). However, RV/PA uncoupling was not significantly associated with a higher risk of permanent pacemaker implantation after TAVI (pooled Risk Ratio 1.02 [0.70–1.47]; I2 = 0%). Conclusion Pre-procedural RV/PA uncoupling emerges as an independent predictor of worse prognosis in AS patients undergoing TAVI, contributing to a better understanding of the impact of this parameter on patient outcomes.

A Risk Tool for Evaluating Overuse Injury and Return-to-Play Time Periods in Youth and Collegiate Athletes: Preliminary Study.

Overuse injuries in youth athletes are associated with risks, including sports specialization, biological maturation, female sex, and workload measures. As no assessment tool exists to evaluate risk accumulation, we developed a novel risk factor scoring system (Sport Training Assessment of Risk [STAR]) to assess participants' risk of overuse injury and explore association with return-to-play (RTP) time periods. (1) STAR will reach an acceptable predictive threshold in the assessment of overuse injury in youth athletes. (2) Higher STAR scores will be associated with increased RTP time periods after injury. Longitudinal cohort study. Level 3. Youth athletes with an injury sustained during competitive sport completed questionnaires. Association of questionnaire variables with injury risk type was evaluated via logistic regression analyses, and unweighted and weighted versions of a total risk score were developed. RTP was defined by physician clearance per electronic medical record review. Mantel-Haenszel chi-square tests and Kendall's rank correlation coefficients were used to assess the relationship between weighted total risk score and RTP time periods. The weighted STAR model was analyzed with receiver operating characteristic (ROC) curves. The weighted STAR model trended toward an acceptable level of prediction for overuse (nonserious + serious) injury (area under the ROC curve [AUC], 0.66; 95% CI, 0.61-0.71), but was less predictive for serious overuse injury (AUC, 0.63; 95% CI, 0.55-0.71). Weighted total risk score was weakly associated with return to full play (ρ = 0.11; P < 0.01), and potentially with return to modified play (ρ = -0.08; P = 0.04). STAR may be a feasible tool for assessing overuse injury risk and RTP time periods in youth athletes but requires further development, as it did not reach an acceptable predictive threshold in this preliminary study. Clinicians can use STAR to assess overuse injury risk in youth athletes.

Knowledge and Use of Social Networks in University Students from Mexico and Spain

&lt;p&gt;It is unclear how social networks can be utilized in educational settings. An exploratory study was conducted to examine the differences between university students in Mexico and Spain in terms of their perceptions of knowledge and utilization of networks in the university environment. An overall sample of 378 students was collected from two public universities, one in Mexico and one in Spain. This study utilized descriptive statistics as part of a contingency analysis, X&lt;sup&gt;2&lt;/sup&gt; with correction was used for the analysis of differences, Mann-Whitney U for the analysis of independence, Mantel-Haenszel test for association degree, Cramer's V for strength of association, Spearman's correlation coefficient for correlations. According to the results, the use of social networks is clearly related to country of origin, but not to gender. It seems that Instagram is a platform widely used by both Mexican and Spanish students, but it is not used in educational environments. Therefore, the use of social networks in higher education contexts differs by country, as does the knowledge of social bookmarking and the distribution of content to share information and resources.&lt;/p&gt;

Hurricane disasters and radiation treatment delays among patients diagnosed with non-small cell lung cancer.

98 Background: Hurricanes can disrupt cancer care and adversely affect health outcomes, especially for patients needing daily radiation therapy, which depends on stable electricity and safe facility access. Among patients diagnosed with locally advanced non-small cell lung cancer (NSCLC), disruptions in radiation can decrease survival. This study evaluates the associations of exposure to a hurricane disaster and radiation delays and total dose received among patients diagnosed with NSCLC. Methods: Patients aged ≥18 years who initiated radiation therapy for non-operable stage III NSCLC between 2004-2021 were identified from the National Cancer Database. Exposure was defined as a Federal Emergency Management Agency (FEMA) hurricane disaster declaration at the county of the treating facility during radiation treatment. Patients treated at the same facility, but at a time when no hurricane happened (i.e. unexposed) were propensity score matched in a 1:1 ratio with exposed patients on age at diagnosis, sex, lymph node involvement, comorbidity score, season, and era (radiation start year 2004 – 2009, 2010 – 2015, 2016 – 2021), to account for more active hurricane seasons in recent years. Delays in radiation treatment completion were defined as &gt; 8 weeks between date when radiation started and ended. A two-way t-test and Mantel-Haenszel test were used to examine associations of hurricane exposure and radiation dose and treatment delays respectively. Results: 6,260 matched patients were included, of whom 3,130 were treated at facilities exposed to hurricanes during radiation and 3,130 completed treatment at the same facilities but at a time when no hurricane exposure happened. Patients treated during hurricanes had 1.95 higher odds (95% confidence interval (CI): 1.71 – 2.24) of experiencing treatment delays compared to unexposed patients (23% of exposed patients experienced delays compared to 13% of unexposed patients). Exposed patients were more likely to have received higher radiation doses compared to unexposed patients (mean 5221.81 cGy vs. 4962.75 cGy; p &lt; 0.0001). Conclusions: Patients with locally advanced NSCLC who received radiation during a hurricane disaster were more likely to experience treatment completion delays. Patients treated during a hurricane were also more likely to receive higher total doses of radiation, possibly suggesting compensation to mitigate the detrimental biological impact of radiation delays. As severe weather events become more common, comprehensive emergency preparedness plans that incorporate evidence-based strategies for mitigating adverse effects of treatment delays are essential.

Characteristics and real-world medication persistence of people living with HIV treated with DTG/3TC or BIC/FTC/TAF: a hospital claims database study in Japan.

As the life expectancy of people living with human immunodeficiency virus (HIV) (PLWH) has improved, chronic disease burden and polypharmacy have increased in PLWH. Simplification of the antiretroviral therapy (ART) regimen for PLWH has become crucial. The real-world treatment patterns and medication persistence of the 2-drug single-tablet regimen (STR), dolutegravir/lamivudine (DTG/3TC), compared to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) prescribed were investigated. This retrospective, database study extracted data from a hospital-based medical claims database in Japan. The changes in ART distributions by year during the identification period between January 1, 2018 and December 31, 2021 were observed. Patients with disease record of HIV-1 infection and prescribed DTG/3TC or BIC/FTC/TAF as the first prescription of STR during the identification period were divided into two cohorts; DTG/3TC cohort and BIC/FTC/TAF cohort, respectively. Patient without medication records more than 3 months and no future data more than 6 months were excluded. Patients' characteristics were compared between the DTG/3TC cohort and the BIC/FTC/TAF cohort by Mantel-Haenszel test to adjust for age. Medication persistence was compared between the two cohorts by evaluating the continuation rates using Kaplan-Meier methods, using the log-rank test to assess the difference between the Kaplan-Meier curves. The median time-to-first prescription was compared between the two cohorts by Kaplan-Meier methods. Prescriptions of DTG/3TC and BIC/FTC/TAF increased steadily from 2019 to 2021 after the release year of each STR. There was no significant difference in the time-to-first prescription (p = 0.3). A total of 959 patients were included, with 120 patients and 839 patients on DTG/3TC and BIC/FTC/TAF, respectively. The proportion of dyslipidemia at baseline was significantly higher in the DTG/3TC cohort than in the BIC/FTC/TAF cohort after adjusting for mean age (p = 0.002). There was no significant difference in medication persistence between the two cohorts (p = 0.91). This study showed that DTG/3TC was likely to be selected for elderly patients and those with chronic disease in real-world clinical practice, which seems in accordance with the treatment strategy recommended by guidelines. Comparable medication persistence was observed with both regimens, aligning with findings from other countries. The 2-drug single-tablet regimen DTG/3TC may be an important ART regimen for PLWH with multiple morbidities and polypharmacy in an aging society. Due to the limitations of the database, further research to assess viral loads, emergence of resistance and adverse events will be encouraged.

Trans-fat labelling and potential presence of industrially produced trans-fat in the New Zealand packaged food supply: 2015–2019 & 2022

Background and aimThe World Health Organization (WHO) recommends that countries reduce industrially produced TFA (iTFA) in the food supply. However, New Zealand (NZ) has no mandatory regulation to control amounts of iTFA in foods. The objectives of this study were to assess within the NZ packaged food supply in recent years (2015-19 and 2022): i) the availability of products displaying information on TFA content on nutrition information panels (NIPs), ii) the content of TFA declared, and iii) the presence/potential presence of iTFA (n = 85,892 products). Methods and resultsA database of packaged foods from major NZ supermarkets was used. TFA contents declared on NIPs were benchmarked against limits recommended by the WHO and the Canadian Trans Fat Task Force. Proportions of products listing specific ingredients (containing iTFA) or non-specific ingredients (potentially containing iTFA) were examined. Trends in proportions were assessed (Mantel–Haenszel tests). Among all products and years examined (n = 81,591), 84.0 % did not display information on TFA content. Across all products declaring TFA contents and years 15.4 % and 6.4 %, respectively, were above the WHO and Canadian TFA limits. Across all products and years, 0.8 % and 13.6 % listed ingredients that contained or potentially contained iTFA, respectively. Across 2015–2019, there was a trend of decrease in the proportions of products listing specific (0.9 %–0.7 %; P = 0.018) and non-specific ingredients (15.1 %–12.8 %; P < 0.001). ConclusionInformation on the TFA content and ingredients containing iTFA in NZ packaged foods is lacking and ambiguous and government-led interventions to control and reduce TFA in the food supply are warranted.

The Impact of Traditional Children's Games on Internet Use, Social Skills, and Stress Level: A Cross-Sectional Design.

Traditional games are essential for children's social inclusion due to cultural values and beliefs. This study was conducted to measure the impact of traditional children's games on internet use, social skills, and stress levels. A cross-sectional design was carried out. Children who had parental approval and agreed to participate were included in the study (n = 314). The data were collected using a questionnaire, the Perceived Stress Questionnaire (8-11 years), and the Social Skills Assessment Scale. Linear regression and multinomial logistic regression were performed to analyze the data. Mantel-Haenszel chi-square test was performed to assess the confounding factors for playing traditional games. The children's mean age was 11.58 (SD = 0.49), and 56.1% were girls. Children who did not play traditional games were more likely to use the internet than those who played traditional games (odds ratio [OR] = 2.16, p = .014). The social skills were significantly associated with daily internet use time (β = 0.164, p = .003), playing traditional games (β = 0.155, p = .008), and frequency of gaming per week (β = 0.123, p = .035). The stress levels were associated with gender (β = 0.120, p = .033) and academic level (β = 0.111, p = .048). Traditional game playing reduced the duration of one sitting and daily internet use. Moreover, outdoor gaming, frequency of playing games, and daily internet use duration were predictors of social skills, whereas being a girl and sixth-grade student were predisposing factors of stress level. Nurses could benefit from traditional games in reducing internet use and stress and improving social skills in children.

Predicting Unfavorable Pregnancy Outcomes in Polycystic Ovary Syndrome (PCOS) Patients Using Machine Learning Algorithms.

Background and Objectives: Polycystic ovary syndrome (PCOS) is a complex disorder that can negatively impact the obstetrical outcomes. The aim of this study was to determine the predictive performance of four machine learning (ML)-based algorithms for the prediction of adverse pregnancy outcomes in pregnant patients diagnosed with PCOS. Materials and Methods: A total of 174 patients equally divided into 2 groups depending on the PCOS diagnosis were included in this prospective study. We used the Mantel-Haenszel test to evaluate the risk of adverse pregnancy outcomes for the PCOS patients and reported the results as a crude and adjusted odds ratio (OR) with a 95% confidence interval (CI). A generalized linear model was used to identify the predictors of adverse pregnancy outcomes in PCOS patients, quantifying their impact as risk ratios (RR) with 95% CIs. Significant predictors were included in four machine learning-based algorithms and a sensitivity analysis was employed to quantify their performance. Results: Our crude estimates suggested that PCOS patients had a higher risk of developing gestational diabetes and had a higher chance of giving birth prematurely or through cesarean section in comparison to patients without PCOS. When adjusting for confounders, only the odds of delivery via cesarean section remained significantly higher for PCOS patients. Obesity was outlined as a significant predictor for gestational diabetes and fetal macrosomia, while a personal history of diabetes demonstrated a significant impact on the occurrence of all evaluated outcomes. Random forest (RF) performed the best when used to predict the occurrence of gestational diabetes (area under the curve, AUC value: 0.782), fetal macrosomia (AUC value: 0.897), and preterm birth (AUC value: 0.901) in PCOS patients. Conclusions: Complex ML algorithms could be used to predict adverse obstetrical outcomes in PCOS patients, but larger datasets should be analyzed for their validation.

Preventive Effect of Neuromuscular Training on Chemotherapy-Induced Neuropathy

Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and clinically relevant adverse effect of chemotherapy, negatively impacting patient quality of life. The lack of effective preventive or therapeutic options regarding CIPN often requires changes in cancer therapy, potentially resulting in reduced survival. To determine whether sensorimotor training (SMT) and whole-body vibration (WBV) training reduce symptoms and decrease the onset of CIPN. This prospective multicenter randomized clinical trial (STOP) followed up patients over 5 years at 4 centers in or near Cologne, Germany. Patients undergoing treatment with oxaliplatin or vinca alkaloids were recruited. Participants were recruited from May 2014 to November 2020. Data were last analyzed in June 2021. Participants in the intervention groups performed supervised SMT or WBV training sessions twice a week, each lasting approximately 15 to 30 minutes, concomitant to medical therapy. The primary end point was the incidence of CIPN. Secondary end points included subjective neuropathy symptoms, balance control, physical activity levels, quality of life, and clinical outcome. For cross-stratum evaluations, the Mantel-Haenszel test (MH) was used, and within individual strata, Fisher exact test was used for analysis. A total of 1605 patients were screened, and 1196 patients did not meet all inclusion criteria, with 251 further excluded or declining participation. A total of 158 patients (mean [SD] age, 49.1 [18.0-82.0] years; 93 [58.9%] male) were randomized into 1 of 3 groups: 55 (34.8%) in SMT, 53 (33.5%) in WBV, and 50 (31.6%) in treatment as usual (TAU). The incidence of CIPN in participants was significantly lower in both intervention groups compared to the control group (TAU): (SMT, 12 of 40 [30.0%; 95% CI, 17.9%-42.1%] and WBV, 14 of 34 [41.2%; 95% CI, 27.9%-54.5%] vs TAU, 24 of 34 [70.6%; 95% CI, 58.0%-83.2%]; P = .002 for intention to treat-MH). Patients receiving vinca alkaloids and performing SMT benefited the most. Results were more pronounced in a per-protocol analysis (>75% participation in the intervention) (SMT, 8 of 28 [28.6%; 95% CI, 16.6%-40.5%] and WBV, 9 of 24 [37.5%; 95% CI, 24.4%-50.5%] vs TAU, 22 of 30 [73.3%; 95% CI, 61.6%-85.6%]). Improvements in favor of SMT compared to TAU were found for balance control bipedal with eyes open; bipedal with eyes closed; monopedal, vibration sensitivity, sense of touch, lower leg strength, pain reduction, burning sensation, chemotherapy dose reductions, and mortality. This randomized clinical trial provides initial evidence that neuromuscular training decreases the onset of CIPN. German Clinical Trials Register: DRKS00006088.

Radiomics based on HRCT can predict RP-ILD and mortality in anti-MDA5 + dermatomyositis patients: a multi-center retrospective study

ObjectivesTo assess the effectiveness of HRCT-based radiomics in predicting rapidly progressive interstitial lung disease (RP-ILD) and mortality in anti-MDA5 positive dermatomyositis-related interstitial lung disease (anti-MDA5 + DM-ILD).MethodsFrom August 2014 to March 2022, 160 patients from Institution 1 were retrospectively and consecutively enrolled and were randomly divided into the training dataset (n = 119) and internal validation dataset (n = 41), while 29 patients from Institution 2 were retrospectively and consecutively enrolled as external validation dataset. We generated four Risk-scores based on radiomics features extracted from four areas of HRCT. A nomogram was established by integrating the selected clinico-radiologic variables and the Risk-score of the most discriminative radiomics model. The RP-ILD prediction performance of the models was evaluated by using the area under the receiver operating characteristic curves, calibration curves, and decision curves. Survival analysis was conducted with Kaplan-Meier curves, Mantel-Haenszel test, and Cox regression.ResultsOver a median follow-up time of 31.6 months (interquartile range: 12.9–49.1 months), 24 patients lost to follow-up and 46 patients lost their lives (27.9%, 46/165). The Risk-score based on bilateral lungs performed best, attaining AUCs of 0.869 and 0.905 in the internal and external validation datasets. The nomogram outperformed clinico-radiologic model and Risk-score with AUCs of 0.882 and 0.916 in the internal and external validation datasets. Patients were classified into low- and high-risk groups with 50:50 based on nomogram. High-risk group patients demonstrated a significantly higher risk of mortality than low-risk group patients in institution 1 (HR = 4.117) and institution 2 cohorts (HR = 7.515).ConclusionFor anti-MDA5 + DM-ILD, the nomogram, mainly based on radiomics, can predict RP-ILD and is an independent predictor of mortality.

Analysis Of Risk Factors For The Incidence Of Sexually Transmitted Infections Of Gonorrhea In Male Patients At Hitam Putih Clinic In Gorontalo

Gonorrhea is a sexually transmitted infection (STI) that occurs most frequently throughout the world every year and is the second most common infection caused by bacteria. This study aimed to analyze the risk factors including education, employment, marital status, alcohol consumption status, sexual practices history, condom use behavior, and the most dominant risk factors for the incidence of sexually transmitted infections (STIs) of Gonorrhea in male patients at the Hitam Putih Clinic in Gorontalo. The research design employed was an analytical observational approach with a case-control design. The sample in this study comprised 33 male patients with gonorrhea and 66 male control patients with non-gonorrhea, matched based on patients’ age. Data were analyzed using Odds Ratio (OR) with a 95% Confidence Interval (CI) in the Mantel-Haenszel test. If the OR value was &gt; 1 and the p-value was ≤ α (0.05), it meant that the factor increased the risk. Factors include educational background (OR=1.963; p=0.120), employment status (OR=3.077; p=0.01), marital status (OR=2.870; p=0.02), alcohol consumption status (OR=4.080; p =0.03), sexual practices history (OR=21.350; p=0.000), condom use behavior (OR=4.389; p=0.007) were risk factors for gonorrhea, where sexual practices history (OR=35.704; p=0.000) stood out as the most dominant risk factor. Therefore, those variables represented significant risk factors for the occurrence of Gonorrhea among male patients in the Hitam Putih Clinic in Gorontalo. Educational background, employment status, marital status, alcohol consumption status, sexual practices history, and condom use behavior are the risk factors of gonorrhea where the sexual practices history stands out as the most dominant risk factor.

Prenatal predictors of ambulation without assistance by 30 months of age in children following prenatal repair of open spina bifida, a systematic review and meta‐analysis

AbstractObjectivesWe aimed to investigate prenatal predictors for ambulation without assistance in children following prenatal repair of open spina bifida (OSB).MethodsA systematic search was conducted in three databases until June 2022. We included articles reporting on prenatal repair of open spina bifida (OSB) and ambulation outcomes. The random‐effect model was used. Effect sizes are presented as odds ratio (OR), using the Mantel–Haenszel test, with 95% confidence interval (CI).ResultsFive studies encompassing 460 pregnancies that underwent prenatal repair of OSB of which a total of 234 had data on ambulation and were included. The follow‐up age for all included studies was 30 months. Two studies were open repairs, two were fetoscopic repairs, and one included both open and fetoscopic repairs. Of the 234 included population, ambulation without assistance occurred in 159/234, 68% (95% CI 58, 76), and ambulation with assistance occurred in 75/234, 32% (95% CI 23.6, 41.6). Significant prenatal preoperative predictors that are negatively associated with ambulation without assistance were lateral ventricle (LV) width ≥15 mm (OR: 0.29; 95% CI 0.12, 0.69, I2 = 0.0%; p &lt; 0.0001), lesion level T12‐L2 (OR: 0.22; 95% CI 0.07, 0.7; I2 = 65%, p = 0.01), and severe hindbrain herniation (OR: 0.28; 95% CI 0.1, 0.77; I2 = 0.0%; p = 0.01). Factors including gestational age at surgery (p = 0.5), Myeloschisis (p = 0.4), talipes (p = 0.29), and gestational age at birth (p = 0.95) were not significantly associated with ambulatory status.ConclusionFollowing the prenatal repair of OSB, preoperative factors that are negatively associated with walking without assistance were preoperative LV width ≥15 mm, lesion level T12‐L2, and preoperative severe hindbrain herniation. These results provide pertinent counselling points for parents with pregnancies affected by OSB considering a prenatal repair.

#1141 Chronic kidney disease in inflammatory bowel disease: systematic review and meta-analysis

Abstract Background and Aims Chronic kidney disease (CKD) is defined by a reduction in kidney function (estimated glomerular filtration rate &amp;lt; 60 mL/min/1.73 m2) and/or damage markers that are present for at least three months, regardless of the underlying aetiology. Case reports and cohort studies suggest that inflammatory bowel disease (IBD is associated with CKD. The extent and magnitude of a potential association between IBD and CKD is currently unknown. Method A comprehensive search was conducted in EMBASE, MEDLINE, Web of Science, the Cochrane database, and SCOPUS. Two separate reviewers were involved in the process of article selection and evaluation. In studies where a comparison between an IBD population and a non-IBD control population was available, odds ratios were calculated to quantify the association. To derive an overall estimate of the effect, the Mantel–Haenszel test was employed, utilising a random effect model. This systematic was registered with Prospero. Results Fifty-four articles were included in the review (Table 1). Eight articles compared an IBD population with a healthy control population and were included in the meta-analysis, although with high heterogeneity (I2 88%). An increased risk of CKD in the IBD population was observed, with an overall odds ratio of 1.59 (95% CI 1.31-1.93) (Fig. 1). Importantly, this effect was independent of 5-aminosalicylic acid use. Data on other therapies was sparse, except for known nephrotoxic medication like tacrolimus and cyclosporine. Interestingly, several studies reported a decreasing relative risk with increasing age, potentially reflecting an increased baseline risk in this ageing population. Conclusion The existing evidence on CKD in IBD was systematically reviewed, including all human epidemiological studies. An increased CKD prevalence in IBD was found; independent of medication. Hence, we suggest regular measurements of kidney function for all patients with IBD, irrespective of the therapeutic regimen. Measurements should include determination of the baseline creatinine, albumin/creatinine ratio and urinary sediment. For patients having a normal baseline function, we would recommend annual follow-up. A more systematic research approach regarding CKD and IBD is warranted

Associations Between Social Networks and COVID-19 Vaccine Uptake in 4 Rural Alabama Counties: Survey Findings.

The COVID-19 pandemic demonstrated how vaccination decisions are influenced by misinformation, disinformation, and social pressures, leading to varied and inequitable uptake rates. In this study, we examined how COVID-19 vaccine messages received via social networks were associated with vaccine uptake in rural Alabama. From November 2021 through March 2022, we collected 700 responses to a telephone survey administered in 4 rural Alabama counties. We asked respondents to indicate whether certain social relationships (eg, family, businesses) tried to influence them to (1) obtain or (2) avoid a COVID-19 vaccine. We used χ2 tests, Kruskal-Wallis tests, Mantel-Haenszel χ2 tests, and Fisher exact tests to examine the associations between vaccination status and survey responses. Respondents in majority-African American counties were significantly more likely than those in majority-White counties to have received ≥1 dose of COVID-19 vaccine (89.8% vs 72.3%; P < .001). Respondents who received ≥1 dose had a significantly higher mean age than those who had not (58.0 vs 39.0 years; P < .001). Respondents who were encouraged to get vaccinated by religious leaders were more likely to have received ≥1 dose (P = .001), and those who were encouraged to avoid vaccination by family (P = .007), friends (P = .02), coworkers (P = .003), and health care providers (P < .001) were less likely to have received ≥1 dose. Respondents with more interpersonal relationships that encouraged them to avoid vaccination were more likely to be unvaccinated (P < .001). Interpersonal relationships and demographic characteristics appeared to be important in COVID-19 vaccine decision-making in rural Alabama. Further research needs to identify how to facilitate vaccine-positive interpersonal relationships, such as peer mentoring and trusted messenger interventions.

Patient perspectives in adverse event reporting after vaginal apical prolapse surgery

BackgroundMany clinical trials use systematic methodology to monitor adverse events (AE) and determine grade (severity), expectedness, and relatedness to treatments as determined by clinicians. However, patient perspective in the process remains lacking. ObjectivesTo compare clinician versus patient grading of AE severity in a urogynecologic surgical trial. Secondary objectives were to estimate the association between patient grading of AEs with decision-making and quality of life outcomes and to determine if patient perspective changes over time. Study DesignThis was a planned supplementary study, “Patient-Perspectives in Adverse Event Reporting” (PPAR), to a randomized trial comparing 3 surgical approaches to vaginal apical prolapse. In the parent trial, AEs experienced by patients were collected per a standardized protocol every 6 months where clinicians graded AE severity (mild, moderate, severe/life threatening). In this sub-study, we obtained additional longitudinal patient perspectives for 19 predetermined “PPAR AEs”. Patients provided their own severity grading (mild, moderate, severe/very severe/ life threatening) at initial assessment and at 12 and 36 months postoperatively. Clinicians and patients were masked to each other’s reporting. The primary outcome was the interrater agreement (kappa statistic, κ) for AE severity between the initial clinician and patient assessment, combining patient grades of mild and moderate. Association between AE severity and the Decision-Regret Scale (DRS), Satisfaction with Decision Scale (SDS), the Short-Form Health Survey-12 (SF-12), and Patient-Global Impression of Improvement (PGI-I) scores were assessed utilizing Spearman’s correlation coefficient (ρ) for continuous scales, Mantel-Haenszel chi-squared test for PGI-I, and T-tests or chi-squared tests comparing assessments of severe vs other grades. To describe patient perspective changes over time, the intra-observer agreement was estimated for AE severity grade over time using weighted kappa-coefficients. ResultsOf 360 patients randomized, 219 (61%) experienced a total of 527 PPAR AEs (91% moderate and 9% severe/life threatening by clinician grading). Mean patient age was 67 years, 87% were White, and 12% Hispanic. Of patients reporting any PPAR event, the most common were urinary tract infection (61%), de novo urgency urinary incontinence (35%), stress urinary incontinence (22%), and fecal incontinence (13%).Overall agreement between clinician and participant grading of severity was poor (κ=0.24 (95%CI 0.14, 0.34). Of 414 AEs clinicians graded as moderate, patients graded 120 (29%) mild, and 80 (19%) severe. Of 39 AEs graded severe by clinicians, patients graded 15 (38%) mild or moderate. Initial patient grading of the most severe reported AE was mildly correlated with worse DRS (ρ=0.2, p=0.01), SF-12 (ρ=-0.24, p<0.01) and PGI-I (p<0.01). There was no association between AE severity and SDS. Patients with an initial grading of “severe” had more regret, lower quality of life, and poorer global impressions of health than those whose worst severity grade was mild (p<0.05). Agreement between the patients’ initial severity and later timepoints was fair at 12 months (κ=0.48 (95% CI 0.39, 0.58)) and 36 months (κ=0.45 (95% CI 0.37, 0.53)). ConclusionsClinician and patient perceptions of AE severity are discordant. Worse severity from the patient perspective was associated with patient-centered outcomes. Including the patient perspective provides additional information for evaluating surgical procedures.

Abstract PO2-02-07: Clinicopathological Features and Prognostic Role of HER2 Low in Early Breast Cancer: A real world study

Abstract Background: The definition of human epidermal growth factor receptor-2(HER2) low was proposed with the development of T-DXd, a novel antibody-drug conjugate (ADCs) targeting HER2 in the field of breast cancer (BC) treatments. However, whether HER2 low is a distinct subgroup is still an ongoing debate with mixed results. Current retrospective studies focused on HER2 low concentrated more on metastatic BC, less was known in early BC. The retrospective study was conducted based on HER2 low early BC to comprehensively analyze its clinicopathological features and prognostic roles compared with HER2 IHC0. Methods: This single institution retrospective study enrolled 999 early stage (stage I through III) HER2 negative invasive BC patients diagnosed at Chinese PLA General Hospital from January 2010 to December 2015. Tumors with HER2 immunohistochemical (IHC) score of 1+ or 2+ with negative in situ hybridization assay were defined as HER2 low. Clinicopathological characteristics s and survival outcomes including disease-free survival (DFS) and overall survival (OS) were compared between HER2 IHC0 and HER2 low groups. The correlations between HER2 expression and estrogen receptor (ER) status were determined by Mantel-Haenszel χ2 test. Cohen’s kappa coefficient (k) was adopted to evaluate the concordance between HER2 expression on primary tumors and matched biopsies. Results: 999 patients were eligible for inclusion criteria, among which the percentages of HER2 low in the whole cohort, HR positive group and HR negative group were 83.6%, 86.54%, 72.14% respectively. It was observed the presence of a significant higher proportion of ER level &amp;gt; 10% (p &amp;lt; 0.001), PgR positive (p &amp;lt; 0.001) and more patients who received endocrine therapy (p = 0.002). In HR positive group, clinicopathological features were balanced between HER2 IHC0 and HER2 low. In HR negative group, HER2 low manifested a higher proportion of invasive ductal type (p = 0.016) compared with HER2 IHC0. Survival analysis showed a significantly longer OS in HER2 low BC than HER2 IHC0. (HR: 0.458, 95%CI: 0.262-0.800, p = 0.0005). Nevertheless, the independent role was not reached in DFS. When stratified by HR status, patients with HER2 low in HR positive group demonstrated a longer OS than HER2 IHC0 (HR: 0.55, 95%CI: 0.273-1.105, p = 0.0385). The same trend was observed in HR negative group (HR: 0.385, 95%CI: 0.158-0.939, p = 0.0132). Neither the HR positive group nor the HR negative group achieved significant DFS. Besides, a positive correlation was observed between ER status and the rate of HER2 low (Mantel-Haenszel c2 test, p &amp;lt; 0.001, Pearson’s R = 0.159, P &amp;lt; 0.001). No regularity of survival differences between HER2 IHC0 and HER2 low was found in each ER level in the exploratory study. Finally, 119 patients who developed relapsed or metastatic disease were identified, with the most prevalent metastatic site being bone (31.1%), following by lung (16.80%) and lymph node (13.44%). Among 52 patients with matched biopsy samples, dynamic changes of HER2 IHC status were confirmed in both primary and relapsed statuses, with an discordance rate of 28.84% (K = 0.194, 95%CI: 0.168-0.219). conclusion: HER2 low expression breast cancer may not be regarded as a unique BC group in this real-world population due to similar clinicopathological features and prognostic roles especially in hormone-receptor positive cases. ER level was positively correlated with the rate of HER2 low population. Overall, whether HER2 low is a distinct subgroup remains to be supported and validated by more data both in clinical and molecular levels. Key words: HER2 low; Breast cancer; Clinicopathological Features; Prognosis; Molecular type Clinicopathological Features and Prognostic Role of HER2 Low in Early Breast Cancer: A real world study Citation Format: Ziqing Kong, Weihong Zhao. Clinicopathological Features and Prognostic Role of HER2 Low in Early Breast Cancer: A real world study [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-02-07.

Abstract PO1-12-09: Doublet or triplet antiemetic prophylaxis for trastuzumab deruxtecan-induced nausea and vomiting: An open-label, randomized, multicenter, exploratory phase 2 study

Abstract Background: Trastuzumab deruxtecan (T-DXd) is classified as an anticancer agent that poses a moderate emetic risk according to international guidelines for antiemetic therapy, which recommend emesis prophylaxis using a two-drug combination therapy comprising 5-hydroxytryptamine-3 receptor antagonist (5-HT3RA) and dexamethasone (DEX). The incidence rates of nausea and vomiting in patients in DESTINY BREAST01 and DESTINY BREAST03 were 77.7%, 45.7%, 72.8%, and 44%, respectively. However, no effective antiemetic therapy was observed. The high nausea and vomiting incidence associated with T-DXd is problematic. Hence, this exploratory phase 2 study aimed to assess the efficacy and safety of treatment with 5-HT3RA and DEX, with or without a neurokinin-1 receptor antagonist (NK1RA), in preventing T-DXd-induced nausea and vomiting. Methods: We conducted an open-label, randomized exploratory phase 2 study at 14 centers in Japan. Patients with breast cancer scheduled to receive T-DXd were enrolled in this study. Patients were randomly assigned to receive granisetron and dexamethasone (arm GD) or granisetron, dexamethasone, and aprepitant (fosaprepitant; arm GDA). Patients in both treatment arms were administered granisetron (1 mg i.v. 30 min before T-DXd on day 1). Those in the GD arm were administered DEX (6.6 mg i.v. 30 min before T-DXd on day 1 and 8 mg p.o. on days 2–3). The patients in the GDA arm were administered DEX (9.9 mg i.v. 30 min before T-DXd on day 1) and NK1-RA (125 mg of aprepitant p.o. 60 min before chemotherapy on day 1 and 80 mg p.o. on days 2 and 3, or 150 mg fosaprepitant i.v. 60 min before T-DXd on day 1). The primary endpoint was complete response (CR; no emesis or rescue therapy) during the overall phase (0–120 h after the start of T-DXd). The primary endpoint was estimated using the CR rate and 95% confidence intervals (CIs) following the Pearson–Clopper method. The Cochran–Mantel–Haenszel test was used to compare the exploratory results between the two treatment arms with age strata and previous experience with chemotherapy-induced nausea and vomiting. Logistic regression analyses were performed to determine the risk factors associated with the non-achievement of CR, non-achievement of complete control (CC), and non-achievement of total control (TC) in the overall and long-overall phases. Results: Between September 2020 and March 2023, 40 patients were enrolled and randomly assigned to either the GD (n = 19) or GDA (n = 21) arm. In the GDA group, one patient who did not complete the rescue medication listed in the diary was excluded from the efficacy analysis, including rescue medication use. The CR rates during the overall phase were 36.8% and 70.0% in the GD and GDA groups, respectively (odds ratio [OR], 0.1334; 95% confidence interval [CI], 0.0232–0.7672; P = 0.0190), with a difference of 33.2%. The CR rates during the long-overall phase were 31.6% in the GD arm and 70.0% in the GDA arm (OR, 0.1073; 95% CI, 0.0185–0.6239; P = 0.0087), a difference of 38.4%. NK1RA use was associated with a significant decrease in the non-achievement of CR, CC, and TC in the overall and long-overall phases. Only patients in the GDA arm (33.3%) reported being “very satisfied” with the treatment. No grade 3 or 4 toxicities related to antiemetic therapy were observed. Conclusions: Breast cancer patients receiving T-DXd require triple therapy, including mandatory NK1RA administration, for antiemetic prophylaxis. Further investigation is needed to explore the development of more appropriate combination therapies for T-DXd-induced nausea and vomiting. Citation Format: Manabu Futamura, Hirotoshi Iihara, Hiroko Bando, Yoshihiro Kawaguchi, Yutaka Mizuno, Akari Murakami, Masaaki Kawai, Tomokazu Iyoda, Kazshige Ishida, Kazuhiro Ishihara, Takumi Nakada, Makoto Takeuchi, Mika Kitahora, Yoshihisa Tokumaru, Mototsugu Shimokawa, Nobuhisa Matsuhashi. Doublet or triplet antiemetic prophylaxis for trastuzumab deruxtecan-induced nausea and vomiting: An open-label, randomized, multicenter, exploratory phase 2 study [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-12-09.

Clinical and epidemiological risk factors associated with hospitalization and mortality rate of COVID-19 patients in Banja Luka County: A retrospective observational cohort study on 40,000 patients.

Since beginning of the coronavirus disease (COVID-19) it became clear that severe forms of this infection have primarily affected patients with chronic conditions. The aim of the study was to explore clinical and epidemiological characteristics associated with COVID 19 outcomes. The retrospective observational study included 40,692 citizens of Banja Luka County, Bosnia and Herzegovina, who were confirmed as reverse transcriptase polymerase chain reaction (RT-PCR) positive on COVID-19 at a primary healthcare centre from March 2020 to September 2022. Epidemiological data were obtained from Web-Medic medical records of patients. The COVID-19 data were obtained from COVID-19 data sheets comprised of patients' RT-PCR testing forms, surveillance forms for severe acute respiratory syndrome coronavirus-2 status, and a map of their positive and isolated contacts. Differences regarding the distributions of patients between groups were analysed using the Pearson chi-square test and Mantel-Haenszel chi-square test for trends, while differences in mean values were compared using an independent sample t-test. The average age of hospitalised patients was significantly higher compared to the age of non-hospitalised patients (P < 0.001). The average age of patients with lethal outcomes was nearly twice as high in comparison to patients with non-lethal outcomes (P < 0.001). Male patients had a higher hospitalization and mortality rate (P < 0.001). The highest hospitalization rate was in patients with chronic renal failure (CRF), diabetes and cardiovascular diseases (CVDs), while the death rate was the highest among patients with CRF and hearth comorbidities. Patients with fatigue and appetite loss had a higher percentage of lethal outcomes. Vaccinated patients had a significantly lower rate of lethal outcome. Clinical symptoms, signs and outcomes, are posing as predictive parameters for further management of COVID-19. Vaccination has an important role in the clinical outcomes of COVID-19.

Quality Assessment and Comparison of 3D-Printed and Milled Zirconia Anterior Crowns and Veneers: In Vitro Pilot Study

AbstractThe esthetic rehabilitation of a patient is a demanding yet rewarding procedure, improving the form, function, and well-being of a patient. Three-dimensional (3D) printed, or additive manufactured, zirconia has recently entered the dental space, but without a thorough assessment or comparison. This pilot study utilized digital impressions of two demonstration casts: Cast 1 prepared both central incisors for full ceramic crown coverage, while cast 2 had a lateral incisor (#22) prepared for a ceramic veneer. Both casts underwent digital scanning (Straumann CARES 3, Straumann, Basel, Switzerland) to create virtual STL models. Cast 1 had two full zirconia anterior crowns digitally designed, and Cast 2 had a zirconia veneer digitally designed, using Exocad GmbH software by a certified dental technician at Schulich Dentistry. The STL files were used for fabricating six milled zirconia crowns for central incisor (#21) and six 3D-printed zirconia crowns for the other central incisor (#11). Similarly, for Cast 2, milled and 3D-printed zirconia veneers were made for the prepared lateral incisor (#22). Statistical analysis employed Minitab 16.1.0 software to construct a 2 × 2 table for cross-tabulation and chi-squared analysis. This statistical approach assessed the relationship between restoration design and processing method. Cochran–Mantel–Haenszel test evaluated categorical variables considering different classification variables. Milled restorations showed minor variations, while 3D-printed units displayed consistency. Statistical tests found no significant associations. This in vitro study suggests 3D-printed zirconia for crowns and veneers meets precementation standards akin to conventionally milled restorations. Further research can assess its potential benefits for dentistry's efficiency, cost, and sustainability.

Investigating Differential Item Functioning of an International Mathematics Competition Items across Gender Groups

Mathematical problem-solving competitions have existed for over a century. Scholars report the gender gap in these competitions. As a result, it is necessary to determine whether any score difference between gender groups is attributable to a genuine difference or is the result of the exam itself. Thus, the current study specifically examined bias in one of the well-known mathematics competitions: the Kangaroo Mathematics competition. Determining the fairness of Kangaroo mathematics competition items across gender groups is crucial for creating accurate comparisons and avoiding unintended construct irrelevant bias. To examine the bias, Differential Item Functioning (DIF) analyses were conducted using Logistic Regression, Mantel-Haenszel, and Item Response Theory Likelihood Ratio Test DIF detection methods. After a series of investigations, out of 336 items, it was concluded that these mathematics items were free of DIF and bias across the gender groups. Further implications were discussed in detail regarding the validity and bias.