Primary Study Research Articles

Masks and respirators for prevention of respiratory infections: a state of the science review.

SUMMARYThis narrative review and meta-analysis summarizes a broad evidence base on the benefits-and also the practicalities, disbenefits, harms and personal, sociocultural and environmental impacts-of masks and masking. Our synthesis of evidence from over 100 published reviews and selected primary studies, including re-analyzing contested meta-analyses of key clinical trials, produced seven key findings. First, there is strong and consistent evidence for airborne transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and other respiratory pathogens. Second, masks are, if correctly and consistently worn, effective in reducing transmission of respiratory diseases and show a dose-response effect. Third, respirators are significantly more effective than medical or cloth masks. Fourth, mask mandates are, overall, effective in reducing community transmission of respiratory pathogens. Fifth, masks are important sociocultural symbols; non-adherence to masking is sometimes linked to political and ideological beliefs and to widely circulated mis- or disinformation. Sixth, while there is much evidence that masks are not generally harmful to the general population, masking may be relatively contraindicated in individuals with certain medical conditions, who may require exemption. Furthermore, certain groups (notably D/deaf people) are disadvantaged when others are masked. Finally, there are risks to the environment from single-use masks and respirators. We propose an agenda for future research, including improved characterization of the situations in which masking should be recommended or mandated; attention to comfort and acceptability; generalized and disability-focused communication support in settings where masks are worn; and development and testing of novel materials and designs for improved filtration, breathability, and environmental impact.

Supported employment interventions with people who have severe mental illness: Systematic mixed-methods umbrella review.

Primary and review studies show that supported employment interventions showed promise in assisting people with severe mental illness (SMI) in achieving successful employment and health-related outcomes. This umbrella review synthesises evidence from across review studies on supported employment interventions for individuals with SMI, to identify key findings and implementation challenges in relation to five key outcomes: (1) employment, (2) quality of life, (3) social functioning, (4) clinical/service utilisation, and (5) economic outcomes. A systematic search of eleven databases and registers (CINAHL, Cochrane, EmCare, JBI EBP, ProQuest, PsycINFO, PubMed, Scopus, and Web of Science, and Prospero and Campbell) was conducted to identify meta-analyses and systematic reviews on supported employment interventions for individuals with SMI, peer reviewed and published in English. Quality assessment and data extraction were performed using standardised Joanna Briggs Institute (JBI) tools. A mixed-methods synthesis approach was employed to integrate both quantitative and qualitative evidence. The synthesis of 26 review studies primarily focused on the Individual Placement and Support (IPS) model among various supported employment interventions. Overall, combining supported employment with targeted interventions such as neurocognitive therapy and job-related social skill training showed a positive effect on employment (including job retention) and non-employment outcomes (e.g., health, quality of life, social functioning) relative to standard forms of supported employment for people with SMI. Contextual factors (intervention fidelity, settings, systemic barriers) were important considerations for intervention implementation and effectiveness. Significant overlap of primary studies across 26 review studies exposed considerable variations in interpretation and conclusions drawn by authors, raising questions about their reliability. High volume of overlap reporting from the USA on IPS interventions in review studies is likely to have biased perceptions of effectiveness. There is no one-size-fits-all solution for supporting individuals with SMI in obtaining and maintaining employment. Tailoring strategies based on individual needs and circumstances appears crucial to address the complexity of mental health recovery. We propose creating centralised registries or databases to monitor primary studies included in reviews, thus avoiding redundancy. This umbrella study was registered with PROSPERO (No. CRD42023431191).

Impact of Cerebral Embolic Protection Devices on Disabling Stroke after Transcatheter Aortic Valve Replacement: Updated Results from the STS/ACC TVT Registry.

Background: Cerebral embolic protection devices (EPDs) were developed to mitigate the risk of stroke during transcatheter aortic valve replacement (TAVR), but their benefit remains unproven. In the PROTECTED-TAVR trial, EPD use did not reduce periprocedural stroke (primary study outcome) but led to a 62% reduction in the secondary endpoint of disabling stroke. Given these results, the impact of EPDs during TAVR remains unclear. Methods: We used STS/ACC TVT registry data to examine the association between EPD use and a proxy for disabling stroke among transfemoral TAVR patients between 1/2018-6/2023. The primary outcome was in-hospital disabling stroke-defined as stroke associated with either in-hospital death or discharge to a non-home location. We evaluated the association between EPD use and disabling stroke using instrumental variable (IV) analysis with site-level preference for EPD use as the instrument-a quasi-experimental approach that can support causal inference. In addition, we performed a propensity-score based comparison using overlap weighting as a secondary analysis. Results: The study population consisted of 414,649 patients of whom 53,389 (12.9%) received an EPD. The unadjusted rate of in-hospital disabling stroke was 0.7% among the EPD group and 0.9% in the no EPD group. EPD use was associated with a reduction in disabling stroke in both IV analysis (RR 0.87; 95% CI: 0.73-1.00) and propensity-weighted (PW) analysis (OR 0.79; 95% CI: 0.70-0.90) but was not associated with a reduction in non-disabling stroke. In subgroup analyses, the benefit of EPD was greater among those with versus without prior stroke (interaction p<0.05 for IV and PW). Conclusions: In the largest study to date, among patients undergoing TAVR, EPD use was associated with a small, borderline significant reduction in stroke associated with death or a discharge to a non-home location (a proxy for disabling stroke) that is likely to be causal in nature. Taken together with previous mechanistic and clinical studies, these findings provide credible evidence that EPDs benefit patients undergoing TAVR.

Trends in acupuncture for infertility: a scoping review with bibliometric and visual analysis.

Unexplained recurrent implantation failure and the high cost of assisted reproductive techniques for those experiencing infertility have increasingly resulted in the use of acupuncture. However, the trends and research status of acupuncture on infertility resulting in natural conception have not been systematically summarized. This scoping review and knowledge graph analysis aimed to summarize existing clinical studies on acupuncture for infertility that resulted in natural conception. Seven databases, namely, PubMed, Embase, the Cochrane Library, CNKI, VIP, Wanfang Data, and SinoMed, were searched up to August 2023 (updated on 1 April). Two authors independently identified related clinical studies and systematic reviews, and extracted data from included studies on acupuncture for infertility; any discrepancies were resolved by discussion or judged by a third author. A meta-analysis was conducted based on randomized controlled trials (RCTs), and data were synthesized using risk ratios with 95% confidence intervals. Of the 310 articles meeting the inclusion criteria, 274 were primary studies, 7 were systematic reviews, and 29 were case reports. Reported adverse events included mild ovarian irritation and early signs of miscarriage. Out of the 274 primary studies, there were 40 (14.60%) cases of male infertility and 234 (85.40%) cases of female infertility. Current research highlights on acupuncture for infertility focused on female infertility caused by polycystic ovary syndrome, ovulation disorder, and luteinized unruptured follicle syndrome (LUFS), while acupuncture for male infertility was a hotspot in the early research stage. The meta-analysis also suggested that acupuncture was more effective than human chorionic gonadotropin (HCG) [RR = 1.89, 95% CI (1.47, 2.42), 11 RCTs, 662 participants]. Acupuncture combined with HCG was comparable to HCG [RR = 2.33, 95% CI (1.53, 3.55), four RCTs, 259 participants]. Compared with no treatment, acupuncture resulted in a higher pregnancy rate [RR = 22.12, 95% CI (1.39, 353.09), one RCT, 47 participants]. There was no statistical difference between acupuncture combined with HCG plus letrozole and HCG plus letrozole [RR = 1.56, 95% CI (0.84, 2.89), one RCT, 84 participants]. Current research highlights on acupuncture for infertility resulting in natural conception focused on female infertility caused by polycystic ovary syndrome, ovulation disorder, and LUFS, while studies on male infertility and female infertility caused by blockage in the fallopian tube, thin endometrium, and other factors were insufficient. Well-designed confirmatory clinical studies are still needed as the research hypotheses of most studies were unclear.

Effect of Treating Periodontal Disease in Pregnant Women to Reduce the Risk of Preterm Birth and Low Birth Weight: An Umbrella Review.

Background: The aim of this review was to evaluate the effects of periodontal disease (PD) treatment in pregnant women to reduce the risk of preterm birth (PB) and low birth weight (LBW) by conducting an umbrella review. Methods: A comprehensive search for the literature up to April 2024 was conducted across multiple databases including PubMed, Cochrane Library, Scopus, EMBASE, Scielo, Web of Science, Google Scholar, Proquest Dissertations and Theses, and OpenGrey. We specifically targeted systematic reviews (SRs) with or without meta-analyses, irrespective of language or time constraints, focusing on primary studies examining the effect of PD treatment in pregnant women to reduce the risk of PB and LBW. Various types of non-systematic reviews, intervention studies, observational studies, preclinical and basic research, summaries, comments, case reports, protocols, personal opinions, letters, and posters were excluded from consideration. The quality and overall confidence of the included studies were assessed using the AMSTAR-2 tool. Results: After the initial search, 232 articles were identified, of which only 24 met the selection criteria after exclusion. The majority of these studies indicated that periodontal treatment reduces the risk of PB and LBW. Conclusions: According to the findings and conclusions drawn from the SRs with a high overall confidence level, PD treatment in pregnant women reduces the risk of PB and LBW.

Reporting case studies in systematic literature studies—An evidential problem

Context:The term and label, “case study”, is not used consistently by authors of primary studies in software engineering research. It is not clear whether this problem also occurs for systematic literature studies (SLSs). Objective:To investigate the extent to which SLSs in/correctly use the term and label, “case study”, when classifying primary studies. Methods:We systematically collect two sub-samples (2010–2021 & 2022) comprising a total of eleven SLSs and 79 primary studies. We examine the designs of these SLSs, and then analyse whether the SLS authors and the primary-study authors correctly label the respective primary study as a “case study”. Results:76% of the 79 primary studies are misclassified by SLSs (with the two sub-samples having 60% and 81% misclassification, respectively). For 39% of the 79 studies, the SLSs propagate a mislabelling by the original authors, whilst for 37%, the SLSs introduce a new mislabel, thus making the problem worse. SLSs rarely present explicit definitions for “case study” and when they do, the definition is not consistent with established definitions. Conclusions:SLSs are both propagating and exacerbating the problem of the mislabelling of primary studies as “case studies”, rather than – as we should expect of SLSs – correcting the labelling of primary studies, and thus improving the body of credible evidence. Propagating and exacerbating mislabelling undermines the credibility of evidence in terms of its quantity, quality and relevance to both practice and research.

Safety and Efficacy of Laser Interstitial Thermal Therapy as Upfront Therapy in Primary Glioblastoma and IDH-Mutant Astrocytoma: A Meta-Analysis.

Although primary studies have reported the safety and efficacy of LITT as a primary treatment in glioma, they are limited by sample sizes and institutional variation in stereotactic parameters such as temperature and laser power. The current literature has yet to provide pooled statistics on outcomes solely for primary brain tumors according to the 2021 WHO Classification of Tumors of the Central Nervous System (WHO CNS5). In the present study, we identify recent articles on primary CNS neoplasms treated with LITT without prior intervention, focusing on relationships with molecular profile, PFS, and OS. This meta-analysis includes the extraction of data from primary sources across four databases using the Covidence systematic review manager. The pooled data suggest LITT may be a safe primary management option with tumor ablation rates of 94.8% and 84.6% in IDH-wildtype glioblastoma multiforme (GBM) and IDH-mutant astrocytoma, respectively. For IDH-wildtype GBM, the pooled PFS and OS were 5.0 and 9.0 months, respectively. Similar to rates reported in the prior literature, the neurologic and non-neurologic complication rates for IDH-wildtype GBM were 10.3% and 4.8%, respectively. The neurologic and non-neurologic complication rates were somewhat higher in the IDH-mutant astrocytoma cohort at 33% and 8.3%, likely due to a smaller cohort size.

Perceived stigma and depression among the HIV-positive adult people in Ethiopia: A systematic review and meta-analysis.

Depression is one of the most common psychiatric disorders, affecting approximately 60% of people infected with the human immunodeficiency virus (HIV). Low and middle-income countries (LMICs), including Ethiopia, bear a disproportionate burden of depression among HIV/AIDS patients. Several factors, including perceived stigma, have been linked to increased depression among HIV/AIDS patients. Therefore, we aimed to estimate the pooled effect of perceived stigma on depression among HIV/AIDS patients in Ethiopia. For this systematic review and meta-analysis, we systematically retrieved all relevant studies starting from January 1, 2000 to June 1, 2022 from PubMed, HINARI, and Google Scholar. This review included observational studies that reported the effect of perceived stigma on the prevalence of depression among HIV-positive adults in Ethiopia. The effect estimate of the pooled effect of perceived stigma on depression was conducted using DerSimonian-Laird's random effect model using STATA/MP version 16. An adjusted odds ratio (AOR), along with a 95% confidence interval (CI), was conducted to estimate the strength of the association between perceived stigma and depression. Eleven studies with a total of 4,153 HIV-positive adults were included for meta-analysis. The results of the meta-analysis revealed that the odds of depression were higher among patients with perceived stigma (AOR: 3.78, 95% CI: 2.73, 5.24). The pooled prevalence of depression among HIV/AIDS patients in Ethiopia was 39% (95% CI: 32%, 46%) (I2 = 98%, p ≤ 0.0001). The subgroup analysis revealed that the primary studies conducted in the Oromia region had the highest pooled prevalence of depression at 48% (95% CI: 32%, 63%). The pooled estimates of the meta-analysis revealed that perceived stigma and depression were strongly associated. Stigma and depression screenings should be carried out for additional treatments and prevention, and programs supporting Ethiopia's PLWHA population should be strengthened.

Racial and socioeconomic disparities in survival among patients with metastatic Non-Small cell lung cancer.

Immune checkpoint inhibitors (ICI) have profoundly impacted survival among patients with metastatic non-small cell lung cancer (NSCLC). However, population-based studies evaluating this impact on survival by race and socioeconomic factors are lacking. We utilized the SEER-Medicare database to identify patients with metastatic NSCLC diagnosed between 2015 and 2019. The primary study outcomes were the receipt of an ICI and overall survival (OS). Chi-square tests and logistic regression were utilized to identify demographic factors associated with receipt of ICI. The Kaplan-Meier method was used to calculate 2-year OS rates, and log-rank tests were used to compared survival by race/ethnicity. Out of 17,134 patients, approximately 39% received an ICI. Those diagnosed with cancer recently (in 2019), who are relatively younger (<85 years old), non-Hispanic white, non-Hispanic Asian, or Hispanic, living in high socioeconomic status or metropolitan areas, not Medicaid eligible, and with adenocarcinoma histology were more likely to receive ICI. The 2-year OS rate from diagnosis was 21% for the overall population. The 2-year OS rate from ICI initiation was 30%, among those who received at least one cycle and 11% among those who did not receive ICI. The 2-year OS rates were higher among non-Hispanic whites (22%) and non-Hispanic Asians (23%) compared to non-Hispanic Blacks (15%) and Hispanics (17%). There was no significant racial differences in survival for those who received ICI. ICI utilization rates and the resulting outcomes were inferior for certain vulnerable groups, mandating the need for strategies to improve access to care.

Global trend of nondrug and nonsedativehypnotic treatment forinsomnia: a bibliometric study.

To present a bibliometric analysis of global scientific publications on the nondrug and nonsedative hypnotic treatment of insomnia with regard to influential institutions, publications, countries, research hotspots, trends, and frontiers. A literature review was conducted by searching the Web of Science Core Collection (WoSCC) and China National Knowledge Infrastructure (CNKI) databases to identify all publications related to the nondrug and nonsedative hypnotic treatment of insomnia from 2000 to 2021. Eligible publications were reviewed, including annual publication increments, citation analyses, international collaborations, and keyword analyses. The data were analysed using CiteSpace (vers5.8.R3, 6.1.R2 and 6.1.6, College of Computing and Informatics, Philadelphia, PA, USA) and virtualized by knowledge maps. RESULTS：In total, 9832 publications were included in this analysis. The results from the WoSCC showed that the United States of America (Count = 2268, 40.33%), Stanford University (Count = 141, 2.51%), and the United States Department of Health and Human Services were the leading country, institute, and funding agency regarding the number of publications, respectively. 'Cognitive-behavioural therapy" was the most popular research topic generated from the cocited reference. The most frequently co-occurring keywords were insomnia, cognitive behavioural therapy, disorder, depression, quality of life, Meta-analysis, older adult, sleep, prevalence and efficacy, while keywords including clinical practice guideline, guideline, and Tai Chi remained popular after 2021. Circadian rhythm was the strongest research frontier for 2000-2021. In China, Chengdu University of Traditional Chinese Medicine (Count = 69, 4.79%) was the most productive institute in this field. The most frequently co-occurring keywords from Chinese literature were sleep disorder, sleep quality, acupuncture and moxibustion, Parkinson's disease, transcranial magnetic stimulation, health education, music therapy, chronic insomnia, quality of life, and nonmotor symptoms. Traditional Chinese medicine was the strongest research frontier for 2019-2021. This bibliometric study provides an exhaustive mapping encompassing pertinent institute, publications, influential articles, researchers and topics of the global trend of nondrug and nonsedative hypnotic treatment for insomnia. The results show that the research trend has shifted from primary studies on the efficacy and safety of nondrug and nonsedative hypnotic treatment for insomnia to comorbidity studies. Clinical practice guidelines will potentially become the research frontier for this field post-2021. The findings are important for researchers, clinicians, journal editors, and policy-makers working in the field of nondrug and nonsedative hypnotic treatment for insomnia to understand the strengths and potentials in the current studies and guide future clinical practice, research, and science policy.

Biopsychosocial risk factors for intimate partner violence perpetration and victimization in adolescents and adults reported after the COVID-19 pandemic onset: a scoping review protocol.

This scoping review aims to provide a comprehensive summary of the biological, psychological, and sociological risk factors for intimate partner violence (IPV) victimization and perpetration reported after the onset of the COVID-19 pandemic. IPV is a significant public health concern, characterized by various forms of violence inflicted by intimate partners. The onset of the COVID-19 pandemic significantly increased the global prevalence of IPV. While prior research has identified factors linked to IPV, the risk factors reported in the literature during this period have not been systematically mapped. Additionally, the similarities and differences in risk factors between perpetration and victimization have not been well delineated. This review will focus on individuals aged 12 years or older involved in dyadic romantic relationships. Primary studies and systematic reviews published from the year 2020 will be included. Full-text papers, preprints, theses, and dissertations published in English will be included. Studies focusing on factors unrelated to IPV risk will be excluded. Non-systematic reviews, opinion pieces, and protocols will also be excluded. Following the JBI methodology for scoping reviews, systematic searches will be conducted for both peer-reviewed and gray literature. Independent reviewers will screen records, select eligible studies, and extract data using a standardized form. Key risk factors will be mapped to explore their interplay. Open Science Framework https://osf.io/c2hkm.

Prevalence of depression and its associated factors among Ethiopian students: a systematic review and meta-analysis

ObjectivesThe objective of this study is to estimate the overall pooled prevalence of depression and its associated factors among high school, college and university students in Ethiopia.DesignSystematic review and meta-analysis.Data...

Effectiveness of COVID-19 vaccines administered in the 2023 autumnal campaigns in Europe: Results from the VEBIS primary care test-negative design study, September 2023–January 2024

In autumn 2023, European vaccination campaigns predominantly administered XBB.1.5 vaccine. In a European multicentre study, we estimated 2023 COVID-19 vaccine effectiveness (VE) against laboratory-confirmed symptomatic infection at primary care level between September 2023 and January 2024. Using a test-negative case–control design, we estimated VE in the target group for COVID-19 vaccination overall and by time since vaccination. We included 1057 cases and 4397 controls. Vaccine effectiveness was 40 % (95 % CI: 26–53 %) overall, 48 % (95 % CI: 31–61 %) among those vaccinated < 6 weeks of onset and 29 % (95 % CI: 3–49 %) at 6–14 weeks. Our results suggest that COVID-19 vaccines administered to target groups during the autumn 2023 campaigns showed clinically significant effectiveness against laboratory-confirmed, medically attended symptomatic SARS-CoV-2 infection in the 3 months following vaccination. A longer study period will allow for further variant-specific COVID-19 VE estimates, better understanding decline in VE and informing booster administration policies.

Hard drugs use and tooth wear: a scoping review.

This study aims to map evidence on the relationship between hard drug use and dental wear. The scoping review is guided by the question: What is the relationship between hard drug consumption and dental wear? Adhering to PRISMA-ScR guidelines, searches were conducted across PubMed, Embase, and four databases in March 2024. Inclusion criteria included studies investigating the association between hard drug use and dental wear, regardless of publication date or language. Data were presented through narrative exposition, tables, and a conceptual framework. Twenty-eight studies (four case-control, three cross-sectional, five case reports, and sixteen literature reviews) were included. Among case-control studies, 75% observed an association between drug use and dental erosion; however, no cross-sectional studies demonstrated this association. Despite questionable quality, reviews established connections between drug use and dental erosion. Studies aimed to elucidate potential causes for dental erosion. Analysis suggests a potential link between hard drug use and dental wear, though indirect. Factors like bruxism and reduced salivary pH may contribute to dental wear among drug users. Further investigation through primary studies exploring this relationship is necessary. Dentists should focus not only on clinical characteristics of dental wear but also on mediating factors such as bruxism and decreased salivary pH associated with drug use. This holistic approach allows for a deeper understanding of dental wear mechanisms, enabling targeted preventive and therapeutic interventions.

Factors Associated with Take Home Naloxone Refusal among Emergency Department Patients Participating in an Opioid Overdose Prevention Program

BackgroundIncreasing the equitable distribution of take home naloxone (THN) may result in reduced deaths from opioid overdose (OD). ObjectivesThe primary study objective is to describe the demographic and clinical characteristics of emergency department (ED) patients who decline THN. The findings of this descriptive study may generate new hypotheses for successful THN distribution. MethodsRetrospective chart review using prospectively collected program evaluation data from a single urban EDs Health Education THN database and electronic health record. Characteristics of participants who refused versus accepted THN were compared using Chi-square testing for categorical variables and t-tests for continuous variables. A multivariate model was built to assess associations of statistical and clinically relevant characteristics with THN refusal. ResultsA total of 711 ED patients were offered THN of which 334 (46%) declined. In unadjusted analysis, with the independent variable being refusal of the THN offer, being currently on medication for opioid use disorder (MOUD) was associated with a greater odds of refusal (OR 1.9, 95%CI 1.3-2.6) while any drug related overdose (OR 0.6, 95%CI 0.4-0.8) or being given a prescription for buprenorphine in the ED (OR 0.2, 95%CI 0.1-0.9) were both associated with a lower odds of refusal. ConclusionsDemographic characteristics did not differ between those who accept versus refuse THN. Patients already receiving MOUD were more likely to refuse THN while those starting MOUD in the ED were less likely to refuse THN. Further studies are needed to determine the root causes of patients’ declination of THN and develop targeted interventions to address these causes.

Menopausal hormone therapy and ovarian and endometrial cancers: Long-term follow-up of the Women’s Health Initiative randomized trials.

10506 Background: After decades of use,menopausal hormone therapy influence on ovarian and endometrial cancer remains unsettled. Therefore, we assessed the long-term influence of conjugated equine estrogen (CEE) plus medroxyprogesterone acetate (MPA) and CEE-alone use on ovarian and endometrial cancer incidence and mortality in long-term follow-up of the Women’s Health Initiative randomized, placebo-controlled clinical trials. Methods: Long-term follow-up of two placebo-controlled randomized clinical trials that recruited 27,347 postmenopausal women aged 50-79 years without prior breast cancer or invasive cancer within 10 years (and no baseline endometrial pathology in combined hormone trial participants) from 40 US centers from 1993-1998. In 16,608 women with a uterus, 8,506 were randomized to daily 0.625 mg/d of CEE plus 2.5 mg/d of MPA and 8,102, placebo. In 10,739 women with prior hysterectomy, 5,310 were randomized to daily 0.625 mg/d of CEE-alone and 5,429, placebo. Intervention was stopped for cause before the planned 8.5-year intervention after 5.6 years (CEE plus MPA) and after 7.2 years (CEE-alone). Cancers were verified by central pathology report review. Mortality findings were enhanced by serial National Death Index (NDI) queries. The primary study outcomes were ovarian cancer and endometrial cancer incidence and related mortality. Results: After 20-year follow-up, with mortality information for &gt; 98%; in the initial WHI report on CEE-alone influence on ovarian cancer, CEE-alone, versus placebo, significantly increased ovarian cancer incidence (35 cases [0.041% annualized rate] vs 17 [0.020%]; hazard ratio [HR], 2.04; 95% CI 1.14-3.65; P = 0.01) and ovarian cancer mortality (HR 2.79 95% CI 1.30-5.99, P = 0.006). KM-estimates and cumulative hazard ratios indicate a persistent CEE-alone adverse effect on ovarian cancer incidence that emerged after 12-years follow-up and did not diminish (P = 0.006). In contrast, use of CEE plus MPA, versus placebo, did not increase ovarian cancer incidence (75 cases [0.051%] vs 63 [0.045%]; HR, 1.14; 95% CI, 0.82-1.59; P = 0.44) or ovarian cancer mortality (HR 1.21 95% CI 0.84-1.74). CEE plus MPA did significantly lower endometrial cancer incidence (106 cases [0.073%] vs 140 [0.10%]; HR, 0.72; 95% CI, 0.56-0.92; P = 0.01), without statistically significant influence on endometrial mortality (HR 0.58 95% CI 0.29-1.16) Conclusions: In randomized, placebo-controlled, clinical trial settings, CEE-alone, in women with prior hysterectomy, significantly increased ovarian cancer incidence and increased ovarian cancer mortality while CEE plus MPA, in women with a uterus, in contrast to most observational studies, did not. However, CEE plus MPA reduced endometrial cancer incidence. These findings inform decisions regarding menopausal hormone therapy use. Clinical trial information: NCT00000611 .

Comparison of antitumor efficacy of first-line palbociclib, ribociclib, or abemaciclib in patients with HR+/HER2- aBC: Results of the multicenter, real-world, Italian study PALMARES-2.

1014 Background: The Cyclin Dependent Kinase 4/6 inhibitors (CDK4/6i) Palbociclib, Ribociclib and Abemaciclib in combination with Endocrine Therapy (ET) represent the standard-of-care, 1st line treatment for patients with Hormone Receptor-positive, Human Epidermal growth factor Receptor 2-negative, advanced Breast Cancer (HR+/HER2- aBC). So far, no large real-world studies have compared the efficacy of the three CDK4/6i in this clinical setting. Methods: The multicenter, population-based study PALMARES-2 evaluated the antitumor efficacy of 1st line Palbociclib, Ribociclib or Abemaciclib in combination with ET in consecutive HR+/HER2- aBC patients treated in 18 Italian cancer centers between 1st January 2016 and 1st September 2023. The primary study endpoint was real-world Progression-Free Survival (rwPFS), as defined as the time interval between ET plus CDK4/6i initiation and disease progression. Multivariate Cox regression model was used to adjust the association between individual CDK4/6i and rwPFS for clinically relevant variables. Results: With a data cut-off date of January 1st, 2024, we enrolled 1850 patients, 750 (40.6%), 676 (36.5%) and 424 (22.9%) of whom received Palbociclib, Ribociclib and Abemaciclib, respectively. Among 1226 (66.3%) patients with endocrine-sensitive disease, 1087 (89%) received concomitant Aromatase Inhibitors, whereas 441 (70.7%) out of 624 (33.7%) patients with endocrine-resistant disease received concomitant Fulvestrant. Patients treated with Abemaciclib were more likely to have endocrine-resistant disease, liver metastases, lobular tumor histology and lower PgR tumor expression, and less likely to have de novometastatic disease (p&lt;0.001). Median rwPFS in the whole study cohort was 34.9 months (95% CI 32.0-37.4). Abemaciclib and Ribociclib were independently associated with better rwPFS when compared to Palbociclib (Table), whereas Abemaciclib and Ribociclib showed no significantly different efficacy (aHR 0.91, 95% CI 0.70-1.19; p=0.505). Other covariates independently associated with rwPFS are shown (Table). Conclusions: The real-world study PALMARES-2 revealed different antitumor efficacy of individual CDK4/6i in HR+/HER2- aBC patients. Longer follow-up is required to study if Palbociclib, Ribociclib and Abemaciclib are associated with different overall survival. [Table: see text]

A winding design for improving 3-phase induction motor performance

One of the most popular electric motors used today is the 3-phase induction motor, which has a sturdy design, is less expensive, and is simple to use. Improvements to the materials used in the rotor or stator of induction motors, raising the number of motor phases, and employing a 3-phase induction motor for 1-phase power are just a few of the ways the motor is now being developed to perform better. These studies are all pricey, though. The goal of this study is to determine how to enhance the motor's performance at a reasonable cost. The suggested remedy was to create a 3-phase induction motor winding with a 1-layer design that resembled a symmetrical 6-phase winding. The primary study topics were the motor's rotor speed, mechanical torque, efficiency, and winding current when it was powered by a three-phase power source. The results of the study show that, although consuming less winding current, the 3-phase induction motor with a new winding design outperforms a traditional 3-phase induction motor in terms of rotor speed, mechanical torque, and efficiency.

Design and Methods of the Early Age-Related Hearing Loss Investigation Randomized Controlled Trial.

Hearing loss has been identified as a major modifiable risk factor for cognitive decline. The Early Age-Related Hearing Loss Investigation (EARHLI) study will assess the mechanisms linking early age-related hearing loss (ARHL) and cognitive impairment. Randomized, controlled, single-site, early phase II, superiority trial. Tertiary academic medical center. One hundred fifty participants aged 55 to 75 years with early ARHL (severity defined as borderline to moderate) and amnestic mild cognitive impairment will be included. Participants will be randomized 1:1 to a best practice hearing intervention or a health education control. The primary study outcome is cognition measured by the Alzheimer Disease Cooperative Study-Preclinical Alzheimer Cognitive Composite. Secondary outcomes include additional measures of cognition, social engagement, and brain organization/connectivity. Trial enrollment will begin in early 2024. After its completion in 2028, the EARHLI trial should offer evidence on the effect of hearing treatment versus a health education control on cognitive performance, social engagement, and brain organization/connectivity in 55- to 75-year-old community-dwelling adults with early ARHL and amnestic mild cognitive impairment.

Fundamental LCZ Mapping with ArcGIS-Based Spatial and Correlational Analyses to Study the Impacts of Infrastructural Area- Maximum Volume (A-MV) Attributes on OTC – An Urban Aw Summer Case

The aim of this study is to map the study location stretches into 100mx100m local climate zones (LCZs) on the basis of primary observations and secondary photographic data for spatial analysis of various urban infrastructural elements (grey(G)-built structures, blue(B)-water bodies and green (Gr)-natural vegetation) and impact assessment of their estimated area (EA) and maximum volume (EMV)) on the air temperature (Ta) that characterizes the outdoor thermal comfort (OTC). Climate Modification by Urban Infrastructure, Fundamental Concepts of Urban Infrastructure Mensuration Parameters, Fundamental Concepts of Urban Grey Blue Green Infrastructure (UGBGI) and Concepts Of OTC, Koppen Classification and LCZs are the linked areas. Study locations are based on socio-economic and geophysical attributes. Initial 200 pilot survey responses regarding thermal sensation votes and other subjective details were used. Preferred values of Physiological Equivalent Temperature (PET) and optimum Ta have been used. After the mapping in ArcGIS and polygonal delineation of the areas, EA values were compiled in tabular format. Based on primary measurements and secondary studies, a maximum height (hmax) value was assigned to each sub-category for EMV evaluation. Statistically, the EA and estimated perimeter (EP) values were analyzed using QQ, scatter plots, histogram and generate near table tools in ArcGIS. EA and EMV values were correlated with mean Ta values by linear regression. The R-square values generated gave a clear idea about the extent of their impacts on Ta. From the established relationships and preferred PET and optimum Ta values, optimum EA, EMV and hmax values of the broader categories(G,B,Gr) required for preferred OTC levels were finally evaluated.