Follow-up Study Research Articles

Abstract PO1-05-05: Overall survival (OS) and subsequent therapy patterns in Japanese patients with HR+/HER2− advanced breast cancer (ABC) treated with palbociclib (PAL) plus letrozole (LET) in first-line setting (1L)

Abstract Background: PAL is a first-in-class cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) for the treatment of HR+/HER2− ABC. In PALOMA-2 study, PAL plus LET demonstrated a numerically, not statistically significant, prolonged OS versus placebo plus LET (53.9 vs 51.2 months; HR, 0.956; 95% CI, 0.777–1.177) in patients with HR+/HER2− ABC in 1L. Subgroup analyses showed a similar trend in Asia/Pacific region (73.4 vs 55.1 months; HR, 0.744), however, data specific to Japanese subgroup have not been reported. An open-label, single-arm, multicenter Japanese phase 2 study (J-Ph2) investigated the efficacy and safety of PAL plus LET in postmenopausal Japanese women with HR+/HER2− ABC in 1L and showed a median progression-free survival (PFS) of 35.7 months (95% CI, 21.7–46.7) in the final analysis of PFS. However, OS data were immature at the data cutoff. Here, we report the findings from a follow-up study of J-Ph2 (NCT04735367) evaluating OS and subsequent therapy in these Japanese patients. Methods: Patients (N=42) who participated in J-Ph2 were enrolled in this follow-up study. The primary endpoint was OS, defined as the time from the first dose of PAL plus LET in J-Ph2 to date of death due to any cause. Secondary endpoints included chemotherapy-free survival (CFS) and type and duration of subsequent therapy. Median OS, CFS, duration of subsequent therapy and associated 95% CIs were estimated using the Kaplan–Meier method. Outcomes were also assessed for baseline demographic and disease characteristic subgroups including visceral or nonvisceral metastatic disease, disease-free interval (DFI; ≤12 months, >12 months, de novo metastatic), and duration of 1L PAL use (≤24 months or >24 months). Results: Patients had a median age of 62.5 years; 48% had visceral metastases; 33% had de novo disease; 48% had a TFI >12 months; 93% had an ECOG performance status (PS) of 0. At a median follow up of 89.7 months, the median OS was 85.4 months (95% CI, 64.3–not estimable [NE]). Median OS was longer in patients with nonvisceral versus visceral metastases (not reached [NR] vs 67.3 months), with TFI >12 months versus ≤12 months (85.4 vs 45.4 months), or with duration of 1L PAL use >24 months versus ≤24 months (NR vs 47.5 months). Median CFS was 69.1 months (95% CI, 24.2–85.4), and that was longer in patients with nonvisceral versus visceral metastases (77.5 vs 37.5 months). At the data cutoff, 3 patients (7.1%) were still receiving PAL plus LET (90.9–93.2 months). Subsequent therapy after disease progression was administered to 34 of 42 patients (81%). Of these patients, 28 (82%) received endocrine-based therapy, while 3 (9%) patients each received chemotherapy and other therapy, respectively. The median duration of the first subsequent therapy was 8.3 months (95% CI, 3.9–12.2), and that was similar among patients with nonvisceral versus visceral metastases (7.8 vs 8.3 months). Conclusion: This interim analysis showed a median OS of >7 years with 1L PAL plus LET. Patient demographics (geographic, racial factors), disease characteristics (ECOG PS, visceral metastases), and subsequent therapy decisions may have contributed to the extended median OS observed in this study. Further, this report provides insight into real-world subsequent treatment patterns following PAL plus ET. Table Citation Format: Masato Takahashi, Tomofumi Osako, Hiroyuki Yasojima, Kenichi Inoue, Masahiro Kawashima, Hideki Maeda, Mitsuya Ito, Yasuaki Sagara, Kan Yonemori, Masaya Hattori, Naohito Yamamoto, Eriko Tokunaga, Shozo Ohsumi, Yutaka Yamamoto, Akemi Ichikawa, Yasuaki Muramatsu, Norikazu Masuda. Overall survival (OS) and subsequent therapy patterns in Japanese patients with HR+/HER2− advanced breast cancer (ABC) treated with palbociclib (PAL) plus letrozole (LET) in first-line setting (1L) [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 PO1-05-05.

Insects as radar targets: size, form, density and permittivity

ABSTRACT To make biologically useful interpretations of the echo signals from an entomological radar (a radar designed and operated to observe insects in flight), it is necessary to relate basic properties of insects (i.e. their mass, size, and form) to their radio-wave scattering characters – e.g. their radar cross-section (RCS) and its variation with aspect or beam polarization. Measurements of RCSs of live or freshly dead specimens in laboratory rigs have played an important role in establishing such relationships, but it is desirable to develop and validate methods employing numerical computation, using electromagnetic calculation software, as a more widely applicable and generalizable alternative. In such computations, the insect is represented by a model with specified size, form, and composition; composition appears as the complex relative permittivity, with both polarizability (real) and loss (imaginary) terms. As a preliminary to investigating how adequately different types of electromagnetic model perform, we have collected and analysed morphometric data on adult, flight-capable specimens of a wide range of insect species, including many known to be migratory and to fly at heights where they would be detectable by radar. Our analyses reveal that appropriate densities for prolate-spheroid models of flying insects are in the range 0.60–0.76 g cm−3, which is about half that measured for air-free samples of the solids and liquids from which insect bodies are formed. From this, appropriate permittivities for the material filling the model are found to be in the range 7–11 (real component) and 2.0–3.5 (imaginary); again, these are much lower than measured values for pure insect-body material. These results enable construction of simple electromagnetic models of insects in which both spatial dimensions and masses are accurate. Computation of model RCSs and their aspect and polarization variations, and comparison of these with laboratory measurements, will be the topic of a follow-up validation study.

Abstract PO2-12-06: Comparative Study on Bone Mineral Density in Premenopausal Patients with Estrogen Receptor-Positive Breast cancer in ASTRRA study: a 5-year follow-up study

Abstract Background With the positive outcomes associated with Ovarian Function Suppression (OFS) treatment as reported in the ASTRRA study, which compare two therapeutic strategies, tamoxifen alone and ovarian function suppression (OFS) in premenopausal patients after chemotherapy, the role of OFS has getting important. However, considering the increased risk of bone density reduction associated with postmenopause in women, the understanding these effects is crucial in devising strategies that not only effectively combat the cancer but also concurrently safeguard the patients’ bone health. This study aimed to compare the impacts of two therapeutic strategies, tamoxifen alone and OFS on bone mineral density (BMD) in premenopausal patients after chemotherapy. Methods Of the 1483 premenopausal enrolled in ASTRRA study, we focused on a subset of 522 patients who had undergone BMD examinations at diagnosis, 3 years and 5 years after diagnosis. Patients were stratified into three categories: normal, osteopenia, osteoporosis, and we examined the changes in their classifications over the 3-year and 5-year periods from baseline to identify any deterioration in bone density. Also, Patients were examined ovarian function every 6 months for 2 years and have different randomization times. Further categorization was carried out according to the time of randomization, which means starting time of OFS after recovery of ovary function. Lastly, we conducted a subset analysis using data from the Asan Medical Center (AMC), specially focused on the absolute value of one density measured in g/cm3. Results The median age of 522 patients was 41.1 and at baseline, a higher incidence of osteopenia was observed in the OFS addition group (p=0.028). Both analysis of change in BMD categories of from baseline to 3-year and baseline to 5-year period showed no significant differences between TAM only and TAM+OFS group (3-year: p=0.567, 5-year: p=0.600). However, there was a significant increased risk of bone density deterioration in the OFS addition group, when randomization occurred at the first visit (HR= 2.970, p=0.008). Within the AMC subset, statistically significant decrease in BMD were observed in the OFS addition group at the spine (p=0.023) and femur (p=0.040) over a baseline to 3-year period. Although a decrease in BMD was also observed over a baseline to 5-year period at both the spine and femur, this change was not statistically significant. Conclusion This study revealed a deleterious impact on bone density associated with the addition of OFS, compared to tamoxifen-only treatment. Remarkably, our findings also indicated that early suppression of ovarian function exerts even more detrimental influence on bone health in premenopausal, estrogen receptor-positive breast cancer patients, who have recovered ovarian function. Change between baseline to 5 years according to randomization time interval The table shows the risk associated with bone health deterioration according to the duration of randomization, thus specifying the time interval between the recovery and suppression of ovarian function. Citation Format: Eunju Shin, Seung Il Kim, Min-ho Park, Hyun-Ah Kim, Yongsik Jung, Jai Min Ryu, Eun Hwa Park, Sung Yong Kim, Eun-Gyeong Lee, Min Hyuk Lee, Jung Ho Park, Seock-Ah Im, Soong June Bae, Su Hwan Kang, Woosung Lim, Hyun Jo Youn, Heung Kyu Park, Kyong Hwa Park, Tae-Hyun Kim, Shin-Young Park, Cheol wan Lim, Geum-Hee Kwak, Chanheun Park, Hyuk-Jae Shin, Young Bum Yoo, Sun Hee Kang, Bong Kyun Kim, Hee Jeong Kim. Comparative Study on Bone Mineral Density in Premenopausal Patients with Estrogen Receptor-Positive Breast cancer in ASTRRA study: a 5-year follow-up 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 PO2-12-06.

Survival, incidence, and predictors of diabetic neuropathy among type 2 diabetic patients in hospitals of Addis Ababa

BackgroundDiabetic neuropathy is a very common complication of diabetes mellitus. Thus, measuring the incidence of diabetic neuropathy is a key element in tracking the progress of epidemics of diabetes mellitus and an indication of early accessibility for healthcare in terms of type 2 diabetic patients.ObjectiveTo assess survival, incidence, and predictors of diabetic neuropathy among type 2 diabetic patients in hospitals of Addis Ababa from June 25 to August 25, 2023.MethodsAn institutional-based retrospective follow-up study design was used among newly diagnosed type 2 diabetic patients at hospitals of Addis Ababa. A chart review tool that contains socio-demographic, clinical, and comorbidity characteristics, biochemical characteristics, and the status of type 2 patients was used. A cleaned data was exported from Epi-data manager 4.6 version to SPSS version 25 for analysis. Bivariate Cox regression analysis was done to identify predictors of diabetic neuropathy at a 95% confidence level.ResultA total of 414 type 2 diabetic patients were included in the study. Of these, 97 (23.4%) developed diabetic neuropathy. Variables like having hypertension (AHR 11.25, 95% CI 3.73–33.93), anemia (AHR 4.18, 95% CI 1.78–9.82), high-density lipoprotein < 40 mg/dl (AHR 5.07, 95% CI 1.38–18.67), high creatinine level (AHR 14.67, 95% CI 4.27–50.40), diabetic retinopathy (AHR 4.32, 95% CI 1.32-14.18), and diabetic nephropathy (AHR 2.50, 95% CI 1.09–6.57) were associated with the incidence of diabetic neuropathy. The mean time to develop diabetic neuropathy was 4.94 years, CI (4.50–5.38), and the mean survival time was 6.61 years.ConclusionThe incidence of diabetic neuropathy was high relative to other studies. Variables like having hypertension, anemia, high-density lipoprotein, high creatinine level, diabetic retinopathy, and diabetic nephropathy were predictors of diabetic neuropathy. The mean time to develop diabetic neuropathy was 5 years, with a survival mean time of 7 years.

Abstract PO3-09-06: Role of Obesity-Related Biomarkers on Mortality Among Black Breast Cancer Survivors in the Women’s Circle of Health Followup Study

Abstract Background: Central obesity and higher adiposity have been recently associated with higher all-cause and breast cancer-specific mortality in Black breast cancer survivors participating in the Women’s Circle of Health Followup Study. Adipose tissue is a dynamic organ producing adipocytokines, including leptin, adiponectin, adipsin, resistin, lipocalin-2/NGAL, plasminogen-activator inhibitor type 1 (PAI-1) and CXCL11, TNFα, and IL-6, which modulate inflammatory markers in obesity, including the release of proinflammatory C-reactive protein (CRP). These circulating biomarkers play important roles linking obesity with insulin resistance, hyperinsulinemia, chronic inflammation, and altered immunity, which may impact overall and breast cancer mortality. The goal of this analysis was to determine if circulating adipocytokines and obesity-related biomarkers of systemic inflammation are associated with breast cancer and overall survival in Black breast cancer survivors. Methods: Circulating biomarkers were assayed for 460 Black breast cancer survivors who provided a blood sample 2 years post-diagnosis in the Women’s Circle of Health Followup Study, a population-based cohort of Black breast cancer survivors in New Jersey enrolled within 12 months of diagnosis. Associations between biomarkers (by tertiles) and overall survival were assessed using multivariable Cox regression models. Breast cancer specific survival was assessed based on competing risk analyses using the Fine and Gray subdistribution hazard model. Multivariable models were adjusted for age, body mass index as a measure of overall adiposity, education, menopausal status, stage, grade, subtype, and chemotherapy, hormonal therapy, and radiation treatments received. All tests were two-sided at Analyses were conducted at P=0.05. Results: In multivariable analyses, lipocalin-2, CXCL11, and CRP, biomarkers of adipose tissue inflammation closely related to insulin resistance, were associated with worse overall but not breast cancer specific survival. Compared to women in the lowest tertile of lipocalin-2, women in the highest tertile had a 3-fold increased risk of dying from any cause (T3 vs T1, HR=3.08, 95% CI: 1.29-7.39, p= 0.004) and a ~2-fold increased risk of dying from breast cancer, which was not statistically significant (HR= 1.84, 95% CI: 0.59-5.79, p=0.30). Similarly, women in the highest tertile of CXCL11 were at 2-fold increased risk of dying of any cause (HR: 2.10, 95% CI: 0.96-4.57, p=0.06) but no associations were observed with risk of dying from breast cancer (HR:1.31, 0.42-4.13, p=0.64). Circulating CRP, as a marker of systemic inflammation, was also associated with worse overall survival (T3 vs T1 HR: 2.51, 95% CI: 1.07-5.89, p=0.03), showing a borderline significant association with increased breast cancer specific survival (T3 vs T1 HR: 4.32, 95% CI: 0.87-21.38, p=0.07). No associations with overall or breast cancer specific mortality were observed for any of the other adipocytokines examined. Conclusion: In this population-based cohort study of Black breast cancer survivors, biomarkers associated with adipose tissue related inflammation and insulin resistance were associated with reduced overall survival. Relationships with breast cancer survival were not significant, possibly due to limited sample size. Citation Format: Shipra Gandhi, Chi-Chen Hong, Anthony George, Kristopher Attwood, Bo Quin, Nur Zeinomar, Yong Lin, Christine Ambrosone, Kitaw Demissie, Elisa Bandera. Role of Obesity-Related Biomarkers on Mortality Among Black Breast Cancer Survivors in the Women’s Circle of Health Followup 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 PO3-09-06.

Predictors of infective endocarditis associated in-hospital mortality in Ayder Comprehensive Specialized Hospital, Tigray, North Ethiopia: Microbiological,clinical features, and management profiles.

Infective endocarditis (IE) is a continuously evolving disease with a high mortality rate despite different advances in treatment. In Ethiopia, there is a paucity of data regarding IE. Therefore, this study is aimed at assessing IE-related in-hospital mortality and characterization of IE patients based on their microbiological, clinical features, and management profiles in the Ayder Comprehensive Specified Hospital (ACSH). We conducted a hospital-based prospective follow-up study with all consecutive sampling techniques for suspected infective endocarditis patients admitted to ACSH from January 2020 to February 2022. Echocardiography was performed, and three sets of blood samples for blood culture were taken as per the standard protocol. We also performed isolation of microbial etiologies and antimicrobial susceptibility tests. The data was analyzed using STATA version 16. Stepwise logistic regression was run to identify predictors of in-hospital mortality. Effects were measured through the odds ratio at the 5% level of significance. Seventy-four cases of suspected infective endocarditis were investigated; of these, 54 episodes fulfilled modified Duke's criteria. Rheumatic heart disease (RHD) (85.2%) was the most common underlying heart disease. Murmur (94.4%), fever (68.5%), and pallor (57.4%) were the most common clinical findings. Vegetation was present in 96.3% of episodes. Blood culture was positive only in 7 (13%) episodes. Complications occurred in 41 (75.9%) cases, with congestive heart failure being the most common. All patients were managed medically, with no surgical intervention. The in-hospital mortality was 14 (25.9%). IE-related in-hospital mortality was significantly associated with surgery recommendation and myalgia clinical symptoms. IE occurred relatively in a younger population, with RHD as the most common underlying heart disease. There was a high rate of culture-negative endocarditis, and the majority of patients were treated empirically. Mortality was high. The establishment of cardiac surgery and strengthening microbiology services should be given top priority.

Sustainability and impact of an intervention to improve initiation of tuberculosis preventive treatment: results from a follow-up study of the ACT4 randomized trial

In a cluster randomized trial (clinicaltrials.gov: NCT02810678) a flexible but comprehensive health system intervention significantly increased the number of household contacts (HHC) identified and started on tuberculosis preventive treatment (TPT). A follow-up study was conducted one year later to test the hypotheses that these effects were sustained, and were reproducible with a simplified intervention. We conducted a follow-up study from May 1, 2018 until April 30, 2019, as part of a multinational cluster randomized trial. Eight sites in 4 countries that had received the intervention in the original trial received no further intervention; eight other sites in the same countries that had not received the intervention (control sites in the original trial) now received a simplified version of the intervention. This consisted of repeated local evaluation of the Cascade of care for TB infection, and stakeholder decision making. The number of HHC identified and starting TPT were repeatedly measured at all 16 sites and expressed as rates per 100 newly diagnosed index TB patients. The sustained effect of the original intervention was estimated by comparing these rates after the intervention in the original trial with the last 6 months of the follow-up study. The reproducibility was estimated by comparing the pre-post intervention changes in rates at sites receiving the original intervention with the pre-post changes in rates at sites receiving the later, simplified intervention. With regard to the sustained impact of the original intervention, compared to the original post-intervention period, the number of HHC identified and treated per 100 newly diagnosed TB patients was 10 more (95% confidence interval: 84 fewer to 105 more), and 1 fewer (95% CI: 22 fewer to 20 more) respectively up to 14 months after the end of the original intervention. With regard to the reproducibility of the simplified intervention, at sites that had initially served as control sites, the number of HHC identified and treated per 100TB patients increased by 33 (95% CI:-32, 97), and 16 (-69, 100) from 3 months before, to up to 6 months after receiving a streamlined intervention, although differences were larger, and significant if the post-intervention results were compared to all pre-intervention periods. Up to one year after it ended, a health system intervention resulted in sustained increases in the number of HHC identified and starting TPT. A simplified version of the intervention was associated with non-significant increases in the identification and treatment of HHC. Inferences are limited by potential bias due to other temporal effects, and the small number of study sites. Funded by the Canadian Institutes of Health Research (Grant number 143350).

Use of melatonin supplements and risk of type 2 diabetes and cardiovascular diseases in the USA: insights from three prospective cohort studies.

Use of melatonin supplements has been increasing substantially in both children and adults in the USA; however, their long-term cardiometabolic effects remain unclear. We aimed to assess the associations between regular use of melatonin supplements and the risk of developing type 2 diabetes or cardiovascular disease in adults. In this study, we included individuals from three US cohorts: the Nurses' Health Study (women only), the Health Professionals Follow-up Study (men only), and the Nurses' Health Study II (women only). Women aged 25-55 years and men aged 45-75 years at baseline, who had no diagnosis of cancer at baseline, and who responded to the question about melatonin supplement use (yes or no) were included. We excluded baseline prevalent cardiovascular disease and baseline prevalent type 2 diabetes for the main analyses. The main outcomes were cardiovascular disease and type 2 diabetes incidence. In secondary analyses, we stratified by duration of rotating night shift work in the Nurses' Health Study and Nurses' Health Study II to examine whether the associations with melatonin supplement use differed by rotating night shift work. For the cardiovascular disease analysis, we included 67 202 women from the Nurses' Health Study (follow-up 1998-2019, mean age at baseline: 63·6 years [SD 7·1]), 26 629 men from the Health Professionals Follow-up Study (1998-2020, 62·9 years [8·8], and 65 241 women from the Nurses' Health Study II (2003-19, 48·2 years [4·7]). Follow-up for incident type 2 diabetes was from 1998 to June 30, 2021, for the Nurses' Health Study; 2003 to Jan 31, 2023, for the Nurses' Health Study II; and from 1998 to Jan 31, 2020, for the Health Professionals' Follow-up Study. Melatonin supplement use in the study cohorts doubled over recent decades from less than 2% in 1998-2007 to 4% or higher in 2014-15 (4·0% in men and 5·3% in women). We documented 16 917 incident cardiovascular disease events during 2 609 068 person-years of follow-up and 12 730 incident cases of type 2 diabetes during 2 701 830 person-years of follow-up. In a pooled analysis of the three cohorts, comparing users with non-users of melatonin supplements, the pooled multivariable-adjusted hazard ratios were 0·94 (95% CI 0·83-1·06, p=0·32) for cardiovascular disease and 0·98 (0·86-1·12, p=0·80) for type 2 diabetes. In secondary analyses, melatonin supplement use appeared to attenuate the positive association between long-term shift work (>5 years) and risk of cardiovascular disease (pinteraction=0·013) among the female nurses. With up to 23 years of follow-up of three large prospective cohorts of middle-aged and older men and women, self-reported melatonin supplement use was not associated with risk of type 2 diabetes or cardiovascular disease. Further research is warranted to assess if melatonin supplement use could mitigate the potential risks of type 2 diabetes and cardiovascular disease associated with rotating night shift work. US National Institutes of Health.

Mental health, COVID-19 burden and quality of life of kidney transplant recipients two years after the COVID-19 pandemic

IntroductionFew studies have evaluated the psychological distress of COVID-19 in kidney transplantation and the psychological impact that the COVID-19 pandemic has had on kidney transplant recipients is not yet well understood. The present study aimed to investigate the change in symptom burden and health-related quality of life in the two years after initial assessment, by outlining the change over time of symptoms at 12 and 24 months of follow-up.MethodsThis is a follow-up study. We performed a study published in 2021 (phase 1 of COVID-19); of the 89 kidney transplant recipients evaluated in this study, 60 completed the 12 months follow-up (March 2021 June 2021, phase 2 of COVID-19) and 57 completed the 24 months follow-up (March 2022 June 2022, post COVID-19). The same tools as in previous study were administered: the ad hoc questionnaire on emotional state and psychophysical well-being during COVID-19, the Middlesex Hospital Questionnaire (MHQ) to provide a simple and rapid quantification of the psychological and somatic symptoms and the Short Form Health Survey 36 (SF-36) was used to assess health-related quality of life.ResultsCompared to the first and second phase of COVID-19, the mean score of quality of life variables were higher in the post COVID-19 phase; thus the recipients physical health, mental health and their perception of their general health improved. Regarding the psychopathology variables the levels of Anxiety, Depression and Phobia in the Post COVID-19 phase decreased, while the Somatization score was higher. Lastly, burden of COVID-19 scores in the third phase, significantly decreased.DiscussionOur study highlights a significant association between mental health and the burden of COVID-19 pandemic in kidney transplant recipients. This study showed, a significant worsening, over time, of some specific symptoms, such as somatization and phobias. However, the results showed that depressive symptoms improved during the study period. Long-term monitoring of kidney transplant recipients therefore remains fundamental. These results confirmed the need to provide integrated multidisciplinary services to adequately address the long-term effects of the COVID-19 pandemic on the mental health of the most vulnerable subjects.

Estudio del índice de gravedad del síndrome metabólico como factor predictivo de un episodio cardiovascular mayor en mujeres premenopáusicas con lupus eritematoso sistémico

BackgroundPatients with systemic lupus erythematosus (SLE) have an increased risk of metabolic syndrome (MS) and cardiovascular (CV) disease. MS is evaluated binary, limiting the understanding of each component's severity individually. Therefore, severity scores for MS that evaluate them separately have been developed. This study aims to determine the prognosis between MS severity and the occurrence of major adverse cardiovascular events (MACE) in SLE patients. MethodsTen-year follow-up cohort study. Premenopausal>18-year-old women with a previous diagnosis of SLE were included. Patients with recent CV events, pregnancy, thyroid disease, and liposuction were excluded. The variables of interest were CV events; the confounding variables, and the MS severity indexes were examined. Hazard ratios and Kaplan-Meier survival curves were estimated through Cox regression. ResultsA total of 238 women were analyzed: 22 presented MACE, and 216 did not. MS prevalence, measured according to consensus and ATP-III criteria, was higher in MACE patients (50 and 40,95%, respectively). The MetSx-IMC severity index was higher within the MACE group. Cox analysis showed an increase in the MetSx-IMC associated with the risk of suffering MACE in a 1.107 ratio. ConclusionsThe MetSx-IMC severity index, contrary to the binary approaches, is recommended to evaluate MS as a predictor of MACE in SLE patients. Offering improved and more accurate prognosis in patients at risk of developing MCE.

Validating Thai translations of perceptual soundscape attributes: A non-Procrustean approach with a Procrustes projection

Measurement of a psychological construct across populations without a common linguistic medium often necessitates the development of multiple translations of the psychometric tool across multiple languages, dialects, or other population-specific variations. In this follow-up (Stage 2) study, a listening test using a shared set of 27 stimuli from the Soundscape Attribute Translation Project (SATP) was conducted with Thai-speaking participants using the set of Thai translations of the eight perceptual affective quality (PAQ) descriptors selected in earlier (Stage 1) work through a structured evaluation questionnaire. Principal component analysis was performed on the listening test data to obtain a rank-two reduction of the responses with maximal explained variance. In order to align the principal component space to the two-dimensional circumplex space, this work presents a simple and numerically stable method based on the orthogonal Procrustes projection, to find the optimal two-dimensional orthogonal transform that aligns the first two principal components with the axes corresponding to Pleasantness and Eventfulness as defined in ISO/TS 12913-3:2019. Analysis of the listening test responses indicated good to excellent interrater reliability, reflecting the general comprehensibility of the translations to laypersons. Subsequent analyses yielded a two-dimensional projection with ▪ explained variance and near-perfect alignment of the composite Pleasantness and Eventfulness axes. Angular locations of the individual translated PAQs are located within ▪ of their theoretically ideal locations and preserve angular ordering, albeit with imperfect equiangularity. Cross-analysis against the results from Stage 1 showed that the structured evaluation may be partially useful in anticipating potential imperfections of the PAQ translations and their angular locations in Stage 2.

North Atlantic Ocean–Originated Multicentennial Oscillation of the AMOC: A Coupled Model Study

Abstract Using a CESM1 control simulation, we conduct a follow-up study to advance our earlier theoretical research on the multicentennial oscillation (MCO) of the Atlantic meridional overturning circulation (AMOC). The modeled AMOC MCO primarily arises from internal oceanic processes in the North Atlantic, potentially representing a North Atlantic Ocean–originated mode of AMOC multicentennial variability (MCV) in reality. Specifically, this AMOC MCO is mainly driven by salinity variation in the subpolar upper North Atlantic, which dominates local density variation. Salinity anomaly in the subpolar upper ocean is enhanced by the well-known positive salinity advection feedback that is realized through anomalous advection in the subtropical to subpolar upper ocean. Meanwhile, mean advection moves salinity anomaly in the subtropical intermediate ocean northward, weakening the subpolar upper salinity anomaly and leading to its phase change. The salinity anomalies have a clear three-dimensional life cycle around the North Atlantic. The mechanism and time scale of the modeled AMOC MCO are consistent with our earlier theoretical studies. In the theoretical model, artificially deactivating either the anomalous or mean advection in the AMOC upper branch prevents it from exhibiting AMOC MCO, underscoring the indispensability of both the anomalous and mean advections in this North Atlantic Ocean–originated AMOC MCO. In our coupled model simulation, the South Atlantic and Southern Oceans do not exhibit variabilities synchronous with the AMOC MCO; the Arctic Ocean’s contribution to the subpolar upper salinity anomaly is much weaker than the North Atlantic. Hence, this North Atlantic Ocean–originated AMOC MCO is distinct from the previously proposed Southern Ocean–originated and Arctic Ocean–originated AMOC MCOs.

Causal Selection of Covariates in Regression Calibration for Mismeasured Continuous Exposure.

Regression calibration as developed by Rosner, Spiegelman, and Willett is used to adjust the bias in effect estimates due to measurement error in continuous exposures. The method involves two models: a measurement error model relating the mismeasured exposure to the true (or gold-standard) exposure and an outcome model relating the mismeasured exposure to the outcome. However, no comprehensive guidance exists for determining which covariates should be included in each model. In this article, we investigate the selection of the minimal and most efficient covariate adjustment sets under a causal inference framework. We show that to address the measurement error, researchers must adjust for, in both measurement error and outcome models, any common causes (1) of true exposure and the outcome and (2) of measurement error and the outcome. We also show that adjusting for so-called prognostic variables that are independent of true exposure and measurement error in the outcome model, may increase efficiency, while adjusting for any covariates that are associated only with true exposure generally results in efficiency loss in realistic settings. We apply the proposed covariate selection approach to the Health Professional Follow-up Study dataset to study the effect of fiber intake on cardiovascular disease. Finally, we extend the originally proposed estimators to a nonparametric setting where effect modification by covariates is allowed.

Survival Analysis of Glass Ionomer Cement and Resin-Based Sealant Retention: A 10-Year Follow-Up Study

Background and Objective: Sealant application is a proven method to prevent occlusal caries; however, long-term studies on this topic are scarce. This study aimed to assess the survival rate and clinical effectiveness of glass ionomer cement (GIC) and resin-based sealants (RBSs) on second permanent molars over a long-term follow-up period. Materials and methods: Sixteen patients aged 11–13 years with all four completely erupted permanent second molars were enrolled in the study. All patients attended 1-year and 3-year follow-ups; however, one participant did not respond after 10 years and was excluded from the final analyses. The oral health status evaluation was based on WHO criteria. A total of 32 teeth received an RBS (Clinpro), and a further 32 teeth were sealed with GIC (Fuji IX). The sealant retention was determined according to the Kilpatrick criteria after 1 year, 3 years, and 10 years, respectively. Statistical analysis included a chi-square test, the Kaplan–Meier method, and the Cox proportional hazard model. Results: At baseline, seven boys and eight girls participated in the study, with a mean age of 12.3 ± 0.9 years. The 1-year follow-up results revealed that 90% of the RBSs and 43.3% of the GIC sealants were completely retained, and no caries lesions were recorded (p = 0.01). The 3-year follow-up results showed that 23.3% of the RBSs and 0% of the GIC sealants demonstrated complete retention (p = 0.034). Moreover, 10.0% of the occlusal surfaces in the RBS group and 13.3% of the occlusal surfaces in the GIC group were filled (p > 0.05). A total of 6.7% of the RBSs showed complete retention. One-third of the sealed teeth (30.0% of the teeth sealed with RBSs and 36.7% of teeth applied with GIC) were filled after 10 years. The Kaplan–Meier analysis demonstrated a higher survival rate in the RBS group when compared with the GIC over the entire follow-up period (p = 0.001). Conclusions: Although the survival rate of RBSs was higher than GIC sealants, their effectiveness in preventing fissure caries in permanent second molars did not differ significantly over a 10-year follow-up.

Ultra-processed food consumption and mortality among patients with stages I–III colorectal cancer: a prospective cohort study

Ultra-processed foods (UPFs) are emerging as a risk factor for colorectal cancer (CRC), yet how post-diagnostic UPF intake may impact CRC prognosis remains unexplored. Data collected from food frequency questionnaires were used to estimate intakes of total UPFs and UPF subgroups (serving/d) at least 6 months but less than 4 years post-diagnosis among 2498 patients diagnosed with stages I-III CRC within the Nurses' Health Study and Health Professionals Follow-up Study during 1980-2016. Hazard ratios (HR) and 95% confidence intervals (CIs) of all-cause, CRC- and cardiovascular disease (CVD)-specific mortality in association with UPF consumption were estimated using an inverse probability weighted multivariable Cox proportional hazards regression model, adjusted for confounders. The mean (SD) age of patients at diagnosis was 68.5 (9.4) years. A total of 1661 deaths were documented, including 321 from CRC and 335 from CVD. Compared to those in the lowest quintile (median=3.6 servings/d), patients in the highest quintile (median=10 servings/d) of post-diagnostic UPF intake had higher CVD mortality (HR=1.65, 95% CI=1.13-2.40) but not CRC or all-cause mortality. Among UPF subgroups, higher consumption of fats/condiments/sauces was associated with a higher risk of CVD-specific mortality (highest vs. lowest quintile of intake, HR=1.96, 95% CI=1.41-2.73), and higher intake of ice cream/sherbet was associated with an increased risk of CRC-specific mortality (highest vs. lowest quintile, HR=1.86, 95% CI: 1.33-2.61). No statistically significant association was found between UPF subgroups and overall mortality. Higher post-diagnostic intake of total UPFs and fats/condiments/sauces in CRC survivors is associated with higher CVD mortality, and higher ice cream/sherbet intake is linked to higher CRC mortality. US National Institutes of Health and the American Cancer Society.

Mortality Among Low Birth Weight Neonates on Parenteral Feeding: A Prospective Follow-Up Study

Mortality Among Low Birth Weight Neonates on Parenteral Feeding: A Prospective Follow-Up Study

Time to Treatment Failure and Its Predictors Among Second-Line ART Clients in Amhara Region, Ethiopia: A Retrospective Follow-Up Study.

Second-line antiretroviral treatment failure has become a major public health issue, and the time to treatment failure among second-line ART clients varies globally, and the Sub-Saharan African region having a high rate of second-line ART treatment failures. In addition, after the ART treatment guideline changed there is limited information on Ethiopia. Therefore, this study aimed to assess time to treatment failure and its determinants among second-line ART clients in Amhara Region, Ethiopia. A multi-centered retrospective follow-up study was conducted. A random sample of 860 people on second-line ART was selected by using a computer-generated simple random sampling technique from January 30, 2016, to January 30, 2021, at the University of Gondar Compressive Specialized Hospital, Felege Hiwot Compressive Specialized Referral Hospital, and Debre Tabor Compressive Specialized Referral Hospital, in Amhara region, Ethiopia. Data was captured using a checklist. A total of 81 (9.4%) ART clients developed second-line treatment failure, with a median follow-up time of 29 months with an interquartile range (IQR: 18, 41]. The risk of second-line treatment failure is higher among patients aged 15 to 30 years (adjusted hazard ratio (AHR) = 2.01, 95% confidence interval (CI): [1.16, 3.48]). Being unable to read and write (AHR = 1.312, 95% CI: [1.068, 1.613]), and poor ART drug adherence (AHR = 3.067, 95% CI: [1.845, 5.099]) were significant predictors of second-line ART treatment failures. In the current study, the time to second-line ART treatment failure was high compared with a previous similar study in Ethiopia. Factors like being younger age, ART clients who are not being able to read and write, and having poor ART drug adherence was significant predictors of second-line ART treatment failure.

Effect of frailty status on mortality risk among chilean community-dwelling older adults

IntroductionThe study of frailty and its effect on the risk of mortality in older people is of utmost importance, but understanding the critical factors is still limited. Our main objective was to analyze the association of frailty with all-cause mortality in a prospective community cohort of older people. MethodsA five-year longitudinal follow-up study was conducted with 1,174 community-dwelling older adults (men and women≥65 years old) from different Family Health Centers and community groups from Chile. We evaluated the functional risk, socioeconomic status, and anthropometric variables. The frailty status was evaluated by modified Fried criteria. ResultsThe diagnosis of frailty was reached in 290 older adult participants, who had significantly increased 5-year all-cause mortality independently of age, sex, cognitive impairment, and socioeconomic status (adjusted HR 1.51, 1.06–2.15). ConclusionFrailty is a predictor of increased mortality independently of age, sex, socio-economic and cognitive factors.

Clinical Characteristics of Heavy Alcohol Consumption in Young and Middle-Aged Acute Cerebral Infarction: A 12-Month Follow-up Study

ObjectiveTo investigate the clinical characteristics and prognosis of heavy alcohol consumption among young and middle-aged patients with acute cerebral infarction (ACI). MethodsA total of 263 young and middle-aged ACI patients were included in the study from June 2018 to December 2020 and classified into heavy drinkers and non-heavy drinkers. Multivariate logistic regression analysis was conducted to assess the association between ACI and heavy alcohol consumption, considering clinical characteristics and one-year post-discharge prognosis. ResultsAmong the patients, 78 were heavy drinkers. Heavy drinkers were more likely to consume alcohol 24 hours before ACI onset (OR 4.03, 95% CI 2.26-7.20), especially in the form of liquor (OR 3.83, 95% CI 1.59-9.20), and had a higher risk of diastolic blood pressure ≥ 90 mmHg upon admission (OR 2.02, 95% CI 1.12-3.64). In the one-year post-discharge prognosis, heavy drinkers had a greater likelihood of poor prognosis at 3 months (OR 2.31, 95% CI 1.01-5.25), were less likely to quit drinking after discharge (OR 0.36, 95% CI 0.19-0.66), and had a higher risk of recurrent cerebral infarction (OR 2.79, 95% CI 1.14-6.84). ConclusionsOver the 12-month follow-up, young and middle-aged ACI patients with heavy alcohol consumption exhibited worse short-term prognosis. Controlling alcohol consumption levels may improve the prognosis of these patients.

MP06-20 Long term follow-up study of polytetrafluoroethylene (PTFE) coated self-expandable metallic urethral stents a management modality for recurrent bulbar urethral stricture

MP06-20 Long term follow-up study of polytetrafluoroethylene (PTFE) coated self-expandable metallic urethral stents a management modality for recurrent bulbar urethral stricture