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Alzheimer’s disease and other dementias affect >50 million individuals globally and are characterised by broad clinical and biological heterogeneity. Cohort and biobank studies have played a critical role in advancing the understanding of disease pathophysiology and in identifying novel diagnostic and treatment approaches. However, further discovery and validation cohorts are required to clarify the real-world utility of new biomarkers, facilitate research into the development of novel therapies and advance our understanding of the clinical heterogeneity and pathobiology of neurodegenerative diseases.
The Tallaght University Hospital Institute for Memory and Cognition Biobank for Research in Ageing and Neurodegeneration (TIMC-BRAiN) will recruit 1000 individuals over 5 years. Participants, who are undergoing diagnostic workup in the TIMC Memory Assessment and Support Service (TIMC-MASS), will opt to donate clinical data and biological samples to a biobank. All participants will complete a detailed clinical, neuropsychological and dementia severity assessment (including Addenbrooke’s Cognitive Assessment, Repeatable Battery for Assessment of Neuropsychological Status, Clinical Dementia Rating Scale). Participants undergoing venepuncture/lumbar puncture as part of the clinical workup will be offered the opportunity to donate additional blood (serum/plasma/whole blood) and cerebrospinal fluid samples for longitudinal storage in the TIMC-BRAiN biobank. Participants are followed at 18-month intervals for repeat clinical and cognitive assessments. Anonymised clinical data and biological samples will be stored securely in a central repository and used to facilitate future studies concerned with advancing the diagnosis and treatment of neurodegenerative diseases.
Ethical approval has been granted by the St. James’s Hospital/Tallaght University Hospital Joint Research Ethics Committee (Project ID: 2159), which operates in compliance with the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 and ICH Good Clinical Practice Guidelines. Findings using TIMC-BRAiN will be published in a timely and open-access fashion.
To assess the effects of an electronic health record (EHR) intervention that prompts the clinician to prescribe nicotine replacement therapy (NRT) at hospital admission and discharge in a large integrated health system.
Retrospective cohort study using interrupted time series (ITS) analysis leveraging EHR data generated before and after implementation of the 2015 EHR-based intervention.
Kaiser Permanente Northern California, a large integrated health system with 4.2 million members.
Current smokers aged ≥18 hospitalised for any reason.
EHR-based clinical decision supports that prompted the clinician to order NRT on hospital admission (implemented February 2015) and discharge (implemented September 2015).
Primary outcomes included the monthly percentage of admitted smokers with NRT orders during admission and at discharge. A secondary outcome assessed patient quit rates within 30 days of hospital discharge as reported during discharge follow-up outpatient visits.
The percentage of admissions with NRT orders increased from 29.9% in the year preceding the intervention to 78.1% in the year following (41.8% change, 95% CI 38.6% to 44.9%) after implementation of the admission hard-stop intervention compared with the baseline trend (ITS estimate). The percentage of discharges with NRT orders increased acutely at the time of both interventions (admission intervention ITS estimate 15.5%, 95% CI 11% to 20%; discharge intervention ITS estimate 13.4%, 95% CI 9.1% to 17.7%). Following the implementation of the discharge intervention, there was a small increase in patient-reported quit rates (ITS estimate 5.0%, 95% CI 2.2% to 7.8%).
An EHR-based clinical decision-making support embedded into admission and discharge documentation was associated with an increase in NRT prescriptions and improvement in quit rates. Similar systemic EHR interventions can help improve smoking cessation efforts after hospitalisation.
by Byungseok Kang, Youngjae Jo
Recently, Generative Adversarial Networks (GAN) has been greatly developed and widely used in image synthesis. A Style-Based Generator Architecture for Generative Adversarial Networks (StyleGAN) which is the foremost, continues to develop human face inversion domain. StyleGAN uses insufficient vector space to express more than one million pixels. It is difficult to apply in real business due to distortion-edit tradeoff problem in latent space. To overcome this, we propose a novel semantic segment encoder (SSE) with improved face inversion quality by narrowing the size of restoration latent space. Encoder’s learning area is minimized to logical semantic-segment units that can be recognized by humans. The proposed encoder does not affect other segments because only one segment is edited at a time. To verify the face inversion quality, we compared with the latest encoders both Pixel2style2Pixel and RestyleEncoder. Experimental result shows that the proposed encoder improved distortion quality around 20% while maintain editing performance.by Jin-Sung Yuk, Ji Young Park
ObjectiveTo determine whether menopausal hormone therapy (MHT) increases the risk of gallstones and gallbladder cancer.
DesignA retrospective cohort study.
Patients or other participantsData from the Korea National Health Insurance Corporation was obtained between January 1, 2002, and December 31, 2019.
InterventionsParticipants were divided into MHT and non-MHT groups; the MHT group was analyzed in detail by dividing participants into tibolone, combined estrogen plus progestin by the manufacturer (CEPM) or physician (CEPP), oral estrogen alone, and topical estrogen subgroups.
Main outcome measuresThe incidence of gallstones and gallbladder cancer was compared between the two groups.
ResultsThis study enrolled 1,004,034 and 381,711 patients in the non-MHT and the MHT groups, respectively. The incidence of gallstones was 2.6% in the non-MHT group and 3.4%, 2.6%, 3.4%, 3.2%, and 4.4% in the tibolone, CEPM, oral estrogen alone, CEPP, and topical estrogen groups, respectively. Cox proportional hazard analysis revealed that all hormones increased the risk of gallstones ([tibolone] hazard ratio [HR]: 1.347, 95% confidence interval [CI]: 1.309–1.387, [CEPM] HR: 1.146, 95% CI: 1.1–1.19, [oral estrogen alone] HR: 1.241, 95% CI: 1.18–1.305, [CEPP] HR: 1.164, 95% CI: 1.01–1.341, [topical estrogen] HR: 1.602, 95% CI: 1.295–1.983). However, the risk of gallbladder cancer did not change with any hormone therapy.
ConclusionsAll types of MHT including tibolone, increased the risk of gallstones. This risk was the highest with topical estrogen, which may be a result of selection bias due to concerns regarding the adverse effects of CEE and MPA.
by Young Min Hur, Jae Young Yoo, Young Ah You, Sunwha Park, Soo Min Kim, Gain Lee, Young Ju Kim
Preterm birth (PTB) refers to delivery before 37 weeks of gestation. Premature neonates exhibit higher neonatal morbidity and mortality rates than term neonates; therefore, it is crucial to predict and prevent PTB. Advancements enable the prediction and prevention of PTB using genetic approaches, especially by investigating its correlation with single nucleotide polymorphisms (SNPs). We aimed to identify impactive and relevant SNPs for the prediction of PTB via whole–genome sequencing analyses of the blood of 31 pregnant women with PTB (n = 13) and term birth (n = 18) who visited the Ewha Womans University Mokdong Hospital from November 1, 2018 to February 29, 2020. A genome-wide association study was performed using PLINK 1.9 software and 256 SNPs were selected and traced through protein-protein interactions. Moreover, a validation study by genotyping was performed on 60 other participants (preterm birth, n = 30; term birth, n = 30) for 25 SNPs related to ion channel binding and receptor complex pathways. Odds ratios were calculated using additive, dominant, and recessive genetic models. The risk of PTB in women with the AG allele of rs2485579 (gene name: RYR2) was significantly 4.82-fold increase, and the risk of PTB in women with the AG allele of rs7903957 (gene name: TBX5) was significantly 0.25-fold reduce. Our results suggest that rs2485579 (in RYR2) can be a genetic marker of PTB, which is considered through the association with abnormal cytoplasmic Ca2+ concentration and dysfunctional uterine contraction due to differences of RYR2 in the sarcoplasmic reticulum.by Su-Yeon Yu, Miyoung Choi, Seungeun Ryoo, Chelim Cheong, Kyungmin Huh, Young Kyung Yoon, Su Jin Jeong
Inhaled corticosteroids are known to be relatively safe for long-term use in inflammatory respiratory diseases and it has been repurposed as one of the potential therapies for outpatients with coronavirus disease 2019 (COVID-19). However, inhaled corticosteroids have not been accepted for COVID-19 as a standard therapy because of its lack of proven benefits. Therefore, this study aimed to evaluate the effectiveness of inhaled corticosteroids in patients with COVID-19. Randomized controlled trials comparing the efficacy of inhaled corticosteroid treatment in patients with COVID-19 were identified through literature electronic database searches up to March 10, 2023. Meta-analyses were conducted for predefined outcomes, and the certainty of evidence was graded using the grading of recommendations, assessment, development, and evaluation approach. Overall, seven trials (eight articles) were included in this systematic review. Compared with usual care, inhaled corticosteroids was associated with significantly improved clinical recovery at 7 and 14 days in patients with COVID-19. In subgroup analysis, only budesonide showed significant efficacy in clinical recovery, whereas no significant benefit was observed for ciclesonide. Moreover, inhaled corticosteroids use was not significantly associated with all-cause hospitalization, all-cause mortality, admission to intensive care unit, or the use of mechanical ventilation. Our systematic review used evidence with very low to moderate certainty. Although based on limited evidence, our results suggest that inhaled corticosteroids treatment, especially budesonide, improves the clinical recovery of patients with COVID-19. More trials and meta-analyses are needed to assess the efficacy of inhaled corticosteroids for COVID-19 treatment.by Choungwon Jung, Soyoung Park, Hyunah Kim
Nonalcoholic fatty liver disease (NAFLD) is a growing health concern with increasing prevalence and associated health impacts. Although no approved drugs are available for the NAFLD treatment, several hypoglycemic agents have been investigated as promising therapeutic agents. We aimed to compare the risk of occurrence of NAFLD with respect to the use of different hypoglycemic agents in patients with type 2 diabetes. This retrospective cohort study used data from the National Health Insurance Service–National Sample Cohort of South Korea. Participants newly diagnosed with type 2 diabetes (2003–2019) were included in this study. Two new user-active comparator cohorts were assembled: Cohort 1, new users of thiazolidinediones (TZD) and dipeptidyl peptidase-4 inhibitors (DPP-4i), and Cohort 2, new users of sodium-glucose cotransporter-2 inhibitors (SGLT-2i) and DPP-4i. The occurrence of NAFLD was defined based claims that include diagnostic codes. Hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated using Cox proportional hazard models in 1:3 propensity score (PS)-matched cohorts. For 65,224 patients newly diagnosed with type 2 diabetes, the overall prevalence of NAFLD was 42.6%. The PS-matched Cohort 1 included 6,351 and 2,117 new users of DPP-4i and TZD, respectively. Compared to DPP-4i, TZD use was associated with the decreased risk of NAFLD (HR, 0.66; 95% CI: 0.55–0.78). Cohort 2 consisted of 6,783 and 2,261 new users of DPP-4i and SGLT-2i, respectively; SGLT-2i use was associated with a decreased risk of NAFLD (HR, 0.93; 95% CI: 0.80–1.08). This population-based cohort study supports the clinical implications of prioritizing TZD and SGLT-2i over DPP-4i in reducing the risk of occurrence of NAFLD in patients with type 2 diabetes. However, the findings lacked statistical significance, highlighting the need for further verification studies.by Hyoung Nam Lee, Sangjoon Lee, Sung-Joon Park, Youngjong Cho, Hwan Hoon Chung
Bedside peripherally inserted central catheter (PICC) placement is sometimes required when the patient’s intrahospital transport is restricted, and the ideal catheter length prediction is needed. This study aimed to develop an updated formula that predicts the optimal length of a PICC based on anteroposterior chest radiographs (AP-CXRs). This retrospective study collected PICC procedure data as the training and validation sets in three hospitals, including cubital crease-puncture point distance (CP), the actual PICC length (aCL), and the approach side. Horizontal and vertical measurement variables were set on the AP-CXRs. Two dependent variables were ipsilateral upper arm length (AL) and ideal truncal catheter length (iTCL). Simple and multiple regression analyses were used for formula development, and it was applied to the test set to evaluate the length prediction performance. The study included 309 patients in the training and validation sets and 91 intensive care patients in the test set. The final derived formula was: (AL + iTCL = CP + estimated PICC length, cm) = 19.831 − 0.062 × (contralateral clavicle length, cm) + 0.255 × (2nd ribs horizontal distance, cm) + 0.720 × (humero-vertebral distance, cm) + 0.761 × (thoraco-carinal distance, cm) + 1.024 × (the vertical distance of two vertebral body units, cm). (If approaching from the left, add 2.843cm, and if female, subtract 0.821cm.) In the test set, there was no case of length prediction failure. Moreover, the catheter tip position was evaluated as optimal in 82 cases (90.1%). This study’s results suggest an updated formula to predict the ideal PICC length using only AP-CXRs for bedside placement.by Ki-Hoon Kim, Seol Whan Oh, Soo Jeong Ko, Kang Hyuck Lee, Wona Choi, In Young Choi
Numerous studies make extensive use of healthcare data, including human materials and clinical information, and acknowledge its significance. However, limitations in data collection methods can impact the quality of healthcare data obtained from multiple institutions. In order to secure high-quality data related to human materials, research focused on data quality is necessary. This study validated the quality of data collected in 2020 from 16 institutions constituting the Korea Biobank Network using 104 validation rules. The validation rules were developed based on the DQ4HEALTH model and were divided into four dimensions: completeness, validity, accuracy, and uniqueness. Korea Biobank Network collects and manages human materials and clinical information from multiple biobanks, and is in the process of developing a common data model for data integration. The results of the data quality verification revealed an error rate of 0.74%. Furthermore, an analysis of the data from each institution was performed to examine the relationship between the institution’s characteristics and error count. The results from a chi-square test indicated that there was an independent correlation between each institution and its error count. To confirm this correlation between error counts and the characteristics of each institution, a correlation analysis was conducted. The results, shown in a graph, revealed the relationship between factors that had high correlation coefficients and the error count. The findings suggest that the data quality was impacted by biases in the evaluation system, including the institution’s IT environment, infrastructure, and the number of collected samples. These results highlight the need to consider the scalability of research quality when evaluating clinical epidemiological information linked to human materials in future validation studies of data quality.by Angela Durante, Ahtisham Younas, Angela Cuoco, Josiane Boyne, Bridgette M. Rice, Raul Juarez-Vela, Valentina Zeffiro, Ercole Vellone
AimsTo develop a comprehensive understanding of caregiver burden and its predictors from a dyadic perspective.
MethodA convergent mixed methods design was used. This study was conducted in three European countries, Italy, Spain, and the Netherlands. A sample of 229 HF patients and caregivers was enrolled between February 2017 and December 2018 from the internal medicine ward, outpatient clinic, and private cardiologist medical office. In total, 184 dyads completed validated scales to measure burden, and 50 caregivers participated in semi-structured interviews to better understand the caregiver experience. The Care Dependency Scale, Montreal Cognitive Assessment, and SF-8 Health Survey were used for data collection. Multiple regression analysis was conducted to identify the predictors and qualitative content analysis was performed on qualitative data. The results were merged using joint displays.
ResultsCaregiver burden was predicted by the patient’s worse cognitive impairment, lower physical quality of life, and a higher care dependency perceived by the caregivers. The qualitative and mixed analysis demonstrated that caregiver burden has a physical, emotional, and social nature.
ConclusionsCaregiver burden can affect the capability of informal caregivers to support and care for their relatives with heart failure. Developing and evaluating individual and community-based strategies to address caregiver burden and enhance their quality of life are warranted.
by Win Lee Edwin Wong, Ryan Arathimos, Cathryn M. Lewis, Allan H. Young, Gavin S. Dawe
The relaxin-3/RXFP3 system has been implicated in the modulation of depressive- and anxiety-like behaviour in the animal literature; however, there is a lack of human studies investigating this signalling system. We seek to bridge this gap by leveraging the large UK Biobank study to retrospectively assess genetic risk variants linked with this neuropeptidergic system. Specifically, we conducted a candidate gene study in the UK Biobank to test for potential associations between a set of functional, candidate single nucleotide polymorphisms (SNPs) pertinent to relaxin-3 signalling, determined using in silico tools, and several outcomes, including depression, atypical depression, anxiety and metabolic syndrome. For each outcome, we used several rigorously defined phenotypes, culminating in subsample sizes ranging from 85,881 to 386,769 participants. Across all outcomes, there were no associations between any candidate SNP and any outcome phenotype, following corrections for multiple testing burden. Regression models comprising several SNPs per relevant candidate gene as exploratory variables further exhibited no prediction of outcome. Our findings corroborate conclusions from previous literature about the limitations of candidate gene approaches, even when based on firm biological hypotheses, in the domain of genetic research for neuropsychiatric disorders.The Re-Evaluating the Inhibition of Stress Erosions (REVISE) Trial aims to determine the impact of the proton pump inhibitor pantoprazole compared with placebo on clinically important upper gastrointestinal (GI) bleeding in the intensive care unit (ICU), 90-day mortality and other endpoints in critically ill adults. The objective of this report is to describe the rationale, methodology, ethics and management of REVISE.
REVISE is an international, randomised, concealed, stratified, blinded parallel-group individual patient trial being conducted in ICUs in Canada, Australia, Saudi Arabia, UK, US, Kuwait, Pakistan and Brazil. Patients≥18 years old expected to remain invasively mechanically ventilated beyond the calendar day after enrolment are being randomised to either 40 mg pantoprazole intravenously or an identical placebo daily while mechanically ventilated in the ICU. The primary efficacy outcome is clinically important upper GI bleeding within 90 days of randomisation. The primary safety outcome is 90-day all-cause mortality. Secondary outcomes include rates of ventilator-associated pneumonia, Clostridioides difficile infection, new renal replacement therapy, ICU and hospital mortality, and patient-important GI bleeding. Tertiary outcomes are total red blood cells transfused, peak serum creatinine level in the ICU, and duration of mechanical ventilation, ICU and hospital stay. The sample size is 4800 patients; one interim analysis was conducted after 2400 patients had complete 90-day follow-up; the Data Monitoring Committee recommended continuing the trial.
All participating centres receive research ethics approval before initiation by hospital, region or country, including, but not limited to – Australia: Northern Sydney Local Health District Human Research Ethics Committee and Mater Misericordiae Ltd Human Research Ethics Committee; Brazil: Comissão Nacional de Ética em Pesquisa; Canada: Hamilton Integrated Research Ethics Board; Kuwait: Ministry of Health Standing Committee for Coordination of Health and Medical Research; Pakistan: Maroof Institutional Review Board; Saudi Arabia: Ministry of National Guard Health Affairs Institutional Review Board: United Kingdom: Hampshire B Research Ethics Committee; United States: Institutional Review Board of the Nebraska Medical Centre. The results of this trial will inform clinical practice and guidelines worldwide.
by Jisu Kim, In-Whi Hwang, Jeong-Hui Park, Youngdeok Kim, Jung-Min Lee
The current study is to examine the disparities in physical activity (PA), sedentary behavior (SB), and stress levels in Korean adolescents concerning changes in their perception of family economic status (ES) during COVID-19. Among a total of 6144 Korean adolescents aged 12 to 18, the participants were categorized into two groups based on their responses regarding changes in their family ES due to COVID-19: Declined ES (n = 3072) and Non-changed ES (n = 3072), with matching in terms of age, gender, and BMI. All variables were assessed using the 16th year (2020) of the Korean Youth Risk Behavior Survey. Statistical analyses were conducted using the SPSS 26.0 version, employing independent t-tests to examine anthropometrics’ differences and multinominal logistic regression to predict the impact of perception of family ES on PA, SB, and stress while comparing the two groups. The significance level was set at α = 0.05. Adolescents in the Declined ES group were 1.2 times more likely to engage in MVPA for less than 420 mins/wk (OR = 1.16, p = 0.039), 1.7 times more likely to meet recommended muscular strength activities (i.e., ≥ 3 days/wk) (OR = 1.70, p p pby Jihun Ahn, HyeYon Yu, Seung-Woon Rha, Byoung Geol Choi, Dong Oh Kang, Cheol Ung Choi, Sangho Park, Jon Seo, Kichang Kim, Minung Kim, Yong Hoon Kim, Yong Seong Seo
This prospective, multicenter, randomized study aimed to compare the 1-year clinical outcomes after primary stenting with self-expanding bare metal nitinol stent (SENS) and plain old balloon angioplasty (POBA) in patients with critical limb ischemia (CLI) and below-the-knee (BTK) lesions. Overall, 119 patients with CLI and BTK lesions were randomized to POBA alone (POBA group, 61 patients) or primary stenting with SENS (stenting group, 58 patients) after achieving acceptable POBA results in target BTK lesions. Clinical outcomes including amputation and revascularization rates were prospectively compared for 1 year. After 1 year, similar incidence rates of individual clinical endpoints, including cardiac death (6.5% vs. 5.1%, p > 0.999), myocardial infarction (1.6% vs. 0.0%, p > 0.999), repeat revascularization (19.6% vs. 18.9%, p = 0.922), target lesion revascularization (13.1% vs. 17.2%, p = 0.530), and amputation (4.9% vs. 0.0%, p = 0.244), were observed. POBA appeared to have acceptable treatment outcomes compared with primary stenting with SENS after 1 year in CLI patients with BTK lesions undergoing percutaneous transluminal angioplasty (PTA).The increased peripheral arterial disease (PAD) incidence associated with aging and increased incidence of cardiovascular conditions underscores the significance of assessing lower limb perfusion. This study aims to report on the correlation and utility of two novel non-invasive instruments: transcutaneous oxygen pressure (TcPO2) and forward-looking infrared (FLIR) thermography. A total of 68 patients diagnosed with diabetic foot ulcer and PAD who underwent vascular studies at a single institution between March 2022 and March 2023 were included. Cases with revascularization indications were treated by a cardiologist. Following the procedure, ambient TcPO2 and FLIR thermography were recorded on postoperative days 1, 7, 14, 21 and 28. In impaired limbs, TcPO2 was 12.3 ± 2 mmHg and FLIR thermography was 28.7 ± 0.9°C. TcPO2 (p = 0.002), FLIR thermography (p = 0.015) and ankle–brachial index (p = 0.047) values significantly reduced with greater vascular obstruction severity. Revascularization (n = 39) significantly improved TcPO2 (12.5 ± 1.7 to 19.1 ± 2.2 mmHg, p = 0.011) and FLIR (28.8 ± 1.8 to 32.6 ± 1.6°C; p = 0.018), especially in severe impaired angiosomes. TcPO2 significantly increased immediately post-procedure, then gradually, whereas the FLIR thermography values plateaued from day 1 to 28 post-procedure. In conclusion, FLIR thermography is a viable non-invasive tool for evaluating lower limb perfusion based on angiosomes, comparable with TcPO2.
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