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Abstract Epidermally mounted sensors using triaxial accelerometers have been previously used to monitor physiological processes with the implementation of machine learning (ML) algorithm interfaces. The findings from these previous studies have established a strong foundation for the analysis of high-resolution, intricate signals, typically through frequency domain conversion. In this study we integrate a wireless mechano-acoustic sensor with a multi-modal deep learning system for the real-time analysis of signals emitted by the laryngeal prominence area of the thyroid cartilage at frequency ranges up to 1 kHz. This interface provides real-time data visualization and communication with the ML server, creating a system that assesses severity of chronic obstructive pulmonary disease and analyzes the user’s speech patterns.

Abstract Background Rising digitalization and individualism in the workplace after the COVID-19 pandemic have increased loneliness and related problems in the working-age population. The potential effects of various forms of loneliness on suicidal ideation may differ depending on employment status. Method This is a cross-sectional study based on a national survey of mental health in the general Korean population. We classified occupations as “employed,” “self-employed,” or “unemployed.” Loneliness was assessed using the UCLA Loneliness Scale, which measures both qualitative and quantitative aspects of loneliness. Suicidal ideation was evaluated using the Patient Health Questionnaire-9. Results A total of 1770 participants aged 30–65 years (mean age: 47.7 years) were included. The mean loneliness score was 43.9 (SD = 10.4), and 28% of the participants experienced a high level of loneliness. The prevalence ratio for suicidal ideation in the group with high levels of loneliness was 3.06 (95% CI 2.57, 3.63) compared to the group with low levels of loneliness. In our subgroup analysis, we consistently observed an association between loneliness and suicidal ideation across the employed group; however, the employed was more related with qualitative loneliness, the self-employed and the unemployed were more related with quantitative loneliness. Conclusions Loneliness was associated with suicidal ideation. According to employment status, the associations were consistent, but there were interactions between type of loneliness and employment status. These findings suggest that interventions to reduce loneliness and prevent suicidal ideation should be tailored to specific employment groups, focusing on qualitative aspects for employed individuals and quantitative aspects for self-employed and unemployed individuals.

Abstract Anticancer drugs may affect the incidence of dementia by modulating the common pathophysiology between cancer and dementia. However, there is a paucity of research that focused on anticancer drugs with different mechanisms of action and their associations with subtypes of dementia. Therefore, we aimed to investigate the incidence of dementia according to various groups of anticancer drugs. From the Korea National Health Insurance Service database, our retrospective population-based cohort study enrolled 116,506 cancer patients aged 65 years and older who received anticancer drugs between January 1, 2008 and December 31, 2018. The hazard ratio was determined using Cox proportional hazards regression models, comparing each group of anticancer drugs to all other anticancer drugs, after adjusting for covariates. Antimetabolites (HR = 0.91; 95% CI 0.84–0.97) and molecular targeted therapies (HR = 0.60; 95% CI 0.49–0.74) were associated with a decreased incidence of dementia of the Alzheimer type (DAT), but not with vascular dementia. Among molecular targeted therapies, epidermal growth factor receptor inhibitors (HR = 0.60; 95% CI 0.46–0.79) and multikinase inhibitors (HR = 0.49; 95% CI 0.27–0.89) were associated with a low incidence of DAT only. Our findings highlight the potential for targeted repurposing of anticancer drugs to prevent dementia.

Objective To assess the influence of advanced maternal age on congenital malformations, short- and long-term outcomes in offspring of nulligravida. Methods A retrospective study was conducted using the Korean National Health Insurance Service database spanning from January 2005 to December 2019. All live-born offspring of nulligravida (n=3,685,817) were included. The maternal age was subdivided into the following subgroups: 44 years (n=9,296). Outcomes were assessed based on International Classification of Diseases-10 codes. Adjusted odds ratios (aOR) were calculated with the group of 25-29 years as a reference. Result Most congenital malformations showed an age dependent increase, but cleft lip and abdominal wall defect exhibited a U-shape curve, indicating an increase even in those 44 years old and 1.18 (95% CI, 1.11-1.25) and 1.19 (95% CI, 1.09-1.30) in

Background Continuous renal replacement therapy (CRRT) has become the standard modality of renal replacement therapy (RRT) in critically ill patients. However, consensus is lacking regarding the criteria for discontinuing CRRT. Here we validated the usefulness of the prediction model for successful discontinuation of CRRT in a multicenter retrospective cohort. Methods One temporal cohort and four external cohorts included 1,517 patients with acute kidney injury who underwent CRRT for >2 days from 2018 to 2020. The model was composed of four variables: urine output, blood urea nitrogen, serum potassium, and mean arterial pressure. Successful discontinuation of CRRT was defined as the absence of an RRT requirement for 7 days thereafter. Results The area under the receiver operating characteristic curve (AUROC) was 0.74 (95% confidence interval, 0.71–0.76). The probabilities of successful discontinuation were approximately 17%, 35%, and 70% in the low-score, intermediate-score, and high-score groups, respectively. The model performance was good in four cohorts (AUROC, 0.73–0.75) but poor in one cohort (AUROC, 0.56). In one cohort with poor performance, attending physicians primarily controlled CRRT prescription and discontinuation, while in the other four cohorts, nephrologists determined all important steps in CRRT operation, including screening for CRRT discontinuation. Conclusion The overall performance of our prediction model using four simple variables for successful discontinuation of CRRT was good, except for one cohort where nephrologists did not actively engage in CRRT operation. These results suggest the need for active engagement of nephrologists and protocolized management for CRRT discontinuation.

Abstract Background The cancer experienced in adolescent and young adult (AYA) could disturb developmental changes and long-term life. The current AYA guidelines and research for survivorship were developed and reported according to the general age range of 15–39 years; however, expected life events vary by diagnosed age. We aimed to examine the social, psychological, and physical well-being of AYA cancer survivors by age at diagnosis using a multinational representative dataset focusing on age at diagnosis. Methods We conducted a cross-sectional study using the US and Korean National Health and Nutrition Examination Surveys from 2007 to 2018. Participants diagnosed with any cancer aged 15–39 years and were aged > 18 years at the survey year were defined as AYA cancer survivors. AYA were classified into three groups based on their diagnosed age: adolescent survivors (diagnosed between the ages of 15 and 19, n = 45), young adult survivors (diagnosed between the ages of 20 and 29, n = 238), and late young adult survivors (diagnosed between the ages of 30 and 39, n = 539). We also selected an age-, sex-, race-, and survey year-matched general population with 1:5 ratio among participants without cancer (N = 4110). Results The average age of the survey was 29.1, 43.7, and 48.7 years for AYA survivors diagnosed during adolescence, young adulthood, and late young adulthood, respectively. Adolescent survivors had more non-couple marital status (adjusted odds ratio (aOR), 1.34; 95% CI, 1.10–1.64) and unemployed (aOR, 1.30; 95% CI, 1.05–1.61) compared to late young adult survivors. Comparing with the matched general, adolescent survivors were more in poor general health (aOR, 4.65; 95% CI, 2.09–10.38) and unemployed (aOR, 2.17; 95% CI, 1.12–4.24) and late young adult survivors were more non-couple (aOR, 1.40; 95% CI, 1.05–1.86). Conclusion This study provides evidence for future studies on long-term health, which may vary according to age at the time of diagnosis among AYA with cancer.

Introduction: Understanding human differences is essential for managing chronic diseases. To establish robust evidence for Eight Constitution Medicine (ECM), a Korean personalized medical system, it is necessary to identify the status of clinical research in ECM and develop validated measurements. This study aims to confirm the types of clinical research on ECM and how they have been conducted. Methods: A scoping review covered three international databases (PubMed, Embase, and Cochrane) and five domestic electronic databases (DataBase Periodical Information Academic, Research Information Sharing Service, Korean Studies Information Service System, National Digital Science Library, and Oriental Medicine Advanced Searching for Integrated System), using strategies such as reference searches and gray literature searches. Mapping was attempted, and subcategories were established, synthesized, and presented in tables. All relevant content in Korean and English was considered, excluding theses, dissertations, and editorials. Results: Sixty ECM studies were selected. There were 47 (78.3%) original studies, of which 39 (65.0%) were observational and eight (13.3%) were experimental. There were six eight constitution diet (ECD)-related studies (12.8%), much less than the 15 (31.9%) eight constitution acupuncture (ECA)-related studies. Original studies that measured the effectiveness of ECM used various methods of exposure/intervention and outcome measurement tools. Conclusions: The original research evidence for ECM mainly came from observational studies on ECA and eight constitution diagnosis. Active clinical research related to ECD and a tool that effectively measures adherence and target diseases are required. Furthermore, it is necessary to introduce electronic patient-reported outcome measurements that can be used in community-based clinical environments.

Abstract Background The association between longitudinal body mass index (BMI) change and clinical outcomes in patients with chronic obstructive pulmonary disease (COPD) has not fully investigated. Methods This retrospective cohort study included 116,463 COPD patients aged ≥ 40, with at least two health examinations, one within 2 years before and another within 3 years after COPD diagnosis (January 1, 2014, to December 31, 2019). Associations between BMI percentage change with all-cause mortality, primary endpoint, and initial severe exacerbation were assessed. Results BMI decreased > 5% in 14,728 (12.6%), while maintained in 80,689 (69.2%), and increased > 5% in 21,046 (18.1%) after COPD diagnosis. Compared to maintenance group, adjusted hazard ratio (aHR) for all-cause mortality was 1.70 in BMI decrease group (95% CI:1.61, 1.79) and 1.13 in BMI increase group (95% CI:1.07, 1.20). In subgroup analysis, decrease in BMI showed a stronger effect on mortality as baseline BMI was lower, while an increase in BMI was related to an increase in mortality only in obese COPD patients with aHRs of 1.18 (95% CI: 1.03, 1.36). The aHRs for the risk of severe exacerbation (BMI decrease group and increase group vs. maintenance group) were 1.30 (95% CI:1.24, 1.35) and 1.12 (95% CI:1.07, 1.16), respectively. Conclusions A decrease in BMI was associated with an increased risk of all-cause mortality in a dose-dependent manner in patients with COPD. This was most significant in underweight patients. Regular monitoring for weight loss might be an important component for COPD management.

Abstract Anemia is common in critically ill patients undergoing continuous renal replacement therapy (CRRT). We investigated the impact of anemia requiring red blood cell (RBC) transfusion or erythropoiesis-stimulating agents (ESAs) on patient outcomes after hospital discharge in critically ill patients with acute kidney injury (AKI) requiring CRRT. In this retrospective cohort study using the Health Insurance Review and Assessment database of South Korea, 10,923 adult patients who received CRRT for 3 days or more between 2010 and 2019 and discharged alive were included. Anemia was defined as the need for RBC transfusion or ESAs. Outcomes included cardiovascular events (CVEs) and all-cause mortality after discharge. The anemia group showed a tendency to be older with more females and had more comorbidities compared to the control group. Anemia was not associated with an increased risk of CVEs (adjusted hazard ratio [aHR]: 1.05; 95% confidence interval [CI]: 0.85–1.29), but was associated with an increased risk of all-cause mortality (aHR: 1.41; 95% CI 1.30–1.53). For critically ill patients with AKI requiring CRRT, anemia, defined as requirement for RBC transfusion or ESAs, may increase the long-term risk of all-cause mortality.

Abstract Background The effects of smoking reduction on the incidence of lung cancer in patients with chronic obstructive pulmonary disease (COPD) are not well known. This study aimed to investigate the effects of changes in smoking habits after COPD diagnosis on lung cancer development in patients who smoked less than 30 pack-years. Methods This nationwide retrospective cohort study included 16,832 patients with COPD who smoked less than 30 pack-years at the time of COPD diagnosis. Based on changes in smoking habits in the health screening examination data, smokers were categorized into three groups: quitters, reducers, and sustainers. The primary outcome was the risk of lung cancer development, which was estimated using the Cox proportional hazards model. We also modelled the amount of smoking reduction as a continuous variable. Results During a median follow-up of 4 years, the cumulative incidence of lung cancer was the highest among sustainers, followed by reducers and quitters. Compared with sustainers, reducers (adjusted HR 0.74, 95% CI:0.56–0.98) and quitters (adjusted HR 0.78, 95% CI:0.64–0.96) had a significantly lower risk of lung cancer. Incidence of lung cancer showed a decreasing trend with a decreasing amount of smoking (P for linearity

Abstract Limited information is available regarding the association between preoperative lung function and postoperative pulmonary complications (PPCs) in patients with esophageal cancer who undergo esophagectomy. This is a retrospective cohort study. Patients were classified into low and high lung function groups by the cutoff of the lowest fifth quintile of forced expiratory volume in 1 s (FEV1) %predicted (%pred) and diffusing capacity of the carbon monoxide (DLco) %pred. The PPCs compromised of atelectasis requiring bronchoscopic intervention, pneumonia, and acute lung injury/acute respiratory distress syndrome. Modified multivariable-adjusted Poisson regression model using robust error variances and inverse probability treatment weighting (IPTW) were used to assess the relative risk (RR) for the PPCs. A joint effect model considered FEV1%pred and DLco %pred together for the estimation of RR for the PPCs. Of 810 patients with esophageal cancer who underwent esophagectomy, 159 (19.6%) developed PPCs. The adjusted RR for PPCs in the low FEV1 group relative to high FEV1 group was 1.48 (95% confidence interval [CI] = 1.09–2.00) and 1.98 (95% CI = 1.46–2.68) in the low DLco group relative to the high DLco group. A joint effect model showed adjusted RR of PPCs was highest in patients with low DLco and low FEV1 followed by low DLco and high FEV1, high DLco and low FEV1, and high DLco and high FEV1 (Reference). Results were consistent with the IPTW. Reduced preoperative lung function (FEV1 and DLco) is associated with post-esophagectomy PPCs. The risk was further strengthened when both values decreased together.

Introduction There is a lack of evidence to support the effectiveness of prolonged β-blocker therapy after stabilisation of patients with acute myocardial infarction (AMI) without heart failure (HF) or left ventricular systolic dysfunction.Methods and analysis The SMart Angioplasty Research Team: DEcision on Medical Therapy in Patients with Coronary Artery DIsease or Structural Heart Disease Undergoing InterventiON (SMART-DECISION) trial is a multicentre, prospective, open-label, randomised, non-inferiority trial designed to determine whether discontinuing β-blocker therapy after ≥1 year of maintenance in stabilised patients after AMI is non-inferior to continuing it. Patients eligible for participation are those without HF or left ventricular systolic dysfunction (ejection fraction >40%) who have been continuing β-blocker therapy for ≥1 year after AMI. A total of 2540 patients will be randomised 1:1 to continuation of β-blocker therapy or not. Randomisation will be stratified according to the type of AMI (ie, ST-segment-elevation MI or non-ST-segment-elevation MI), type of β-blocker (carvedilol, bisoprolol, nebivolol or other) and participating centre. The primary study endpoint is a composite of all-cause death, MI and hospitalisation for HF over a median follow-up period of 3.5 years (minimum, 2.5 years; maximum, 4.5 years). Adverse effects related to β-blocker therapy, the occurrence of atrial fibrillation, medical costs and Patient-reported Outcomes Measurement Information system-29 questionnaire responses will also be collected as secondary endpoints.Ethics and dissemination Ethics approval for this study was granted by the Institutional Review Board of Samsung Medical Center (no. 2020-10-176). Informed consent is obtained from every participant before randomisation. The results of this study will be submitted for publication in international peer-reviewed journals and the key findings will be presented at international scientific conferences.Trial registration number ClinicalTrials.gov, NCT04769362.

Abstract Objective Although breast magnetic resonance imaging (MRI) is a valuable screening tool, breast MRI testing burden was associated with cancer worry and quality of life. We aimed to develop and validate the MRI‐related distress scale (MRI‐DS) to assess comprehensive distress specifically related to breast MRI. Methods We enrolled women aged above 18 years, diagnosed breast cancer, had MRI examination at least one time, and who could speak and read Korean in phase I and enrolled women aged above 18 years, visited outpatient clinic of breast general surgery, had undergone MRI examination at least once, and could speak and read Korean in phase II. We excluded patients who had any physical or psychiatric conditions in both phases. We recruited from a tertiary university‐based hospital in South Korea between April and August 2023. Results All 18 items had acceptable levels of item correlation (≥0.30) in the explanatory factor analysis with a four‐factor solution. The fit indices for the four‐factor solution model were good. The discriminant validity of the MRI‐DS had a moderate correlation with general anxiety or quality of life. In the known‐group analysis, those who reported MRI as the most burden breast examination had higher total scores. Conclusion The validity of the MRI‐DS has been confirmed as a scale for measuring the specific distress caused by breast MRI. The MRI‐DS is recommended to health professional to communicate with patients with MRI. Clinical Implications It can be used to assess the distress associated with MRI screening in breast cancer patients. Physician could use MRI‐DS to discuss the reasons for distress caused by breast MRI screening and to address specific sources of discomfort associated with it.

Abstract Background The obesity paradox in patients with advanced non‐small cell lung cancer receiving immune checkpoint inhibitor therapy has been observed, but its underlying mechanism is not fully understood. We aimed to investigate whether body composition affects the prognostic impact of obesity, as determined by body mass index (BMI), on survival. Methods This retrospective study evaluated the data collected from Asian patients who were treated with immune checkpoint inhibitors for advanced non‐small cell lung cancer between October 2015 and October 2021. We used abdominal cross‐sectional imaging to calculate the skeletal muscle and visceral fat indices (cm2/m2) by dividing the cross‐sectional areas of the skeletal muscle and visceral fat by the height squared. Cox proportional‐hazards regression was performed to determine the correlation between BMI according to the Asia‐Pacific classification, body composition metrics and overall survival. Results We analysed the data of 820 patients (630 men and 190 women, with a mean age of 64.3 years [standard deviation: 10.4 years]) and observed 572 (69.8%) deaths with the 1‐year mortality rate of 0.58 (95% confidence interval, 0.55–0.62). Obese BMI was associated with longer overall survival, independent of clinical covariates (hazard ratio, 0.64; 95% confidence interval: 0.52–0.80). The prognostic value of obese BMI remained after additional adjustments for skeletal muscle index (hazard ratio, 0.68; 95% confidence interval, 0.53–0.87) or visceral fat index (hazard ratio, 0.54; 95% confidence interval: 0.41–0.70). No association was observed between sex and the impact of BMI on overall survival (P‐value for interaction >0.05). Conclusions In Asian patients with advanced non‐small cell lung cancer who received immune checkpoint inhibitors, obese BMI was associated with favourable overall survival independent of skeletal muscle or visceral fat mass.

Introduction Symptoms due to chemotherapy are common in patients with cancer. Cancer-related symptoms are closely associated with the deterioration of physical function which can be associated with decreased quality of life and increased mortality. Thus, timely symptom identification is critical for improving cancer prognosis and survival. Recently, remote symptom monitoring system using digital technology has demonstrated its effects on symptom control or survival. However, few studies examined whether remote monitoring would contribute to retaining physical function among patients with cancer. Therefore, this study aimed to evaluate the effectiveness of mobile-based symptom monitoring in improving physical function among patients with cancer under chemotherapy.Methods and analysis This study is a multicentre, open-label, parallel-group, randomised controlled trial. We will recruit 372 patients at three tertiary hospitals located in Seoul, South Korea. Study participants will be randomly assigned to either an intervention group receiving the ePRO-CTCAE app and a control group receiving routine clinical practice only. The primary outcome is changes in physical function from commencement to completion of planned chemotherapy. A linear mixed model will be performed under the intention-to-treat principle. The secondary outcomes include physical activity level; changes in pain interference; changes in depressive symptom; unplanned clinical visits; additional medical expenditure for symptom management; completion rate of planned chemotherapy; changes in symptom burden and health-related quality of life; and 1-year overall mortality.Ethics and dissemination The study has been approved by the institutional review board and ethics committee at the three university hospitals involved in this trial. Written informed consent will be obtained from all the participants. The results of the trial will be submitted for publication in peer-reviewed academic journals and disseminated through relevant literatures.Trial registration number KCT0007220.

Abstract Objective To evaluate a psychometric validation of the endometrial cancer subscales (EnCS) in the Functional Assessment of Cancer Therapy‐Endometrial (FACT‐EN) among patients with endometrial cancer. Methods This cross‐sectional study was conducted at a tertiary university‐based hospital in South Korea between April and October 2022. Participants completed a survey questionnaire that included the FACT‐EN. Exploratory and confirmatory factor analyses (EFA, CFA) and the reliability were measured using the intraclass correlation coefficient (ICC) under a two‐way mixed model. Pearson's correlations were used to evaluate the validity. We also tested known‐group validity. Results In total, 240 patients with endometrial cancer participated in the survey. In EFA, we found EnCS included four domains. In CFA, four‐factor solution model was good: CFI = 0.659; SRMR = 0.066, and RMSEA = 0.073. The mean (SD) of total score of FACT‐EN was 122.84 (23.58). The floor and ceiling effects were 0.4% and 0.4%, respectively. Cronbach's α coefficients for the five scales of the EnCS ranged from 0.78 to 0.91. The ICC of EnCS was 0.76. The convergent and discriminant validity of EnCS was acceptable. In the group analysis, older age and lower ECOG performance scores were associated with higher EnCS scores. The stomach and vaginal domains in EnCS were higher in patients who had completed treatment for more than 1 year compared to those who were still undergoing treatment. Conclusions FACT‐EN has demonstrated its validity as an assessment tool with significant implications for capturing various symptoms in patients with endometrial cancer.

Abstract Background No randomized controlled trials have been completed to see whether statin can decrease hepatocellular carcinoma (HCC) risk in chronic hepatitis B (CHB) patients. We used large-scale, population-based, observational data to emulate a target trial with two groups, statin user and statin non-user. Methods Among 1,379,708 nonunique individuals from the Korean National Health Insurance Service data, 2,915 CHB patients with serum cholesterol level of 200 mg/dL or higher who started statin therapy and 8,525 propensity-score matched CHB patients with serum cholesterol level of 200 mg/dL or higher who did not start statin therapy were analyzed for the development of HCC. In addition, liver cancer or liver-related mortality and all-cause mortality were assessed. Results During follow-up, 207 participants developed HCC. Incidence rate of HCC was 0.2 per 1,000 person-years in the statin user group and 0.3 per 1,000 person-years in the statin non-user group. Fully adjusted hazard ratio (HR) for incident HCC comparing statin user group to statin nonuser group was 0.56 (95% confidence interval [CI]: 0.39 to 0.80). The association between statin use and decreased HCC risk was consistent in all subgroups analyzed. Fully adjusted HR comparing statin user to statin nonuser was 0.59 (95% CI: 0.35 to 0.99) for liver cancer or liver-related mortality and 0.93 (95% CI: 0.78 to 1.11) for all-cause mortality. Conclusions Statin might have a benefit for preventing HCC in CHB patients with elevated cholesterol levels. Statin should be actively considered for CHB patients with dyslipidemia.

Abstract Intracranial aneurysm (IA) is difficult to detect, and most patients remain undiagnosed, as screening tests have potential risks and high costs. Thus, it is important to develop risk assessment system for efficient and safe screening strategy. Through previously published research, we have developed a prediction model for the incidence risk of IA using cohort observational data. This study was designed to verify whether such a prediction model also demonstrates sufficient clinical performance in predicting the prevalence risk at the point of health screening, using cross-sectional data. The study population comprised individuals who visited the Chonnam National University Hwasun Hospital Health Promotion Center in Korea for voluntary medical checkups between 2007 and 2019. All participants had no history of cerebrovascular disease and underwent brain CTA for screening purpose. Presence of IA was evaluated by two specialized radiologists. The risk score was calculated using the previously developed AI model, and 0 point represents the lowest risk and 100 point represents the highest risk. To compare the prevalence according to the risk, age-sex standardization using national database was performed. A study collected data from 5942 health examinations, including brain CTA data, with participants ranging from 20 to 87 years old and a mean age of 52 years. The age-sex standardized prevalence of IA was 3.20%. The prevalence in each risk group was 0.18% (lowest risk, 0–19), 2.12% (lower risk, 20–39), 2.37% (mid-risk, 40–59), 4.00% (higher risk, 60–79), and 6.44% (highest risk, 80–100). The odds ratio between the lowest and highest risk groups was 38.50. The adjusted proportions of IA patients in the higher and highest risk groups were 26.7% and 44.5%, respectively. The median risk scores among IA patients and normal participants were 74 and 54, respectively. The optimal cut-off risk score was 60.5 with an area under the curve of 0.70. We have confirmed that the incidence risk prediction model built through machine learning also shows viable clinical performance in predicting prevalence risk. By utilizing this prediction system, we can effectively predict not only the incidence risk but also the prevalence risk, which is the probability of already having the disease, using health screening data. This may enable us to consider strategies for the early detection of intracranial aneurysms.

Abstract Background The current guidelines for survivorship in adolescents and young adults (AYA) cancer are based on studies conducted in the United States and European AYA survivors. However, previous studies have shown that the health-related quality of life in cancer survivors can vary depending on race, yet the long-term health differences among AYA survivors by race/ethnicity have not been fully explored. Therefore, our aim is to compare the psychosocial and physical health of AYA survivors and their matched controls across different racial and ethnic groups. Methods We conducted a cross-sectional study using US National Health and Nutrition Examination Survey (NHANES) and the Korea NHANES from 2007 to 2018. We included AYA cancer survivors who were diagnosed with any type of cancer aged between 15 and 39 years, and who were adult with aged over 18 years old at survey year. We then stratified the study population by race/ethnicity with Non-Hispanic White (NHW, n = 310), African American (AA, n = 42), Hispanic (n = 81) from NHANES, and Asian (n = 389) from the Korea NHANES. We also selected 5 times age-, sex-, race-, and survey year-matched general population among participants who had never been diagnosed with cancer (N = 4110). Variables were defined using questionnaire data, physical exams, and laboratory tests. Results Compared to NHW, Hispanics (aOR 1.15, 95% CI 1.00–1.32) had poor or fair general health, lower education (aOR 1.23, 95% CI 1.07–1.40), and lower household income (aOR 1.16, 95% CI 1.01–1.33). AA survivors were more likely to be non-coupled (aOR 1.35, 95% 1.15–1.60) and have hypertension (aOR 1.18, 95% CI 1.03–1.36). Asians were more former/current drinkers (aOR 1.21, 95% CI 1.05–1.40). NHW are more likely to experience psychological limitation. Compared to matched general, NHW and Asian survivors had poor general health and psychological health. Conclusions This study provides evidence for future studies concerning long-term health after AYA cancer survivorship that may vary according to race.

Abstract Insulin injections are stressful but necessary for people with diabetes. This study aimed to develop and validate the Distress of Self-Injection (DSI) scale for patients with diabetes aged ≥ 10 years. We created a questionnaire to evaluate DSI after examining each item following a literature review. The DSI scale with 20 questions in three domains (physical [4], psychosocial [7], and process [9]) was developed and tested at the Samsung Medical Center in Seoul, Korea, from April to September 2021. To verify structural validity, exploratory and confirmatory factor analyses (CFA) were conducted. Internal consistency was also calculated. To assess construct and criterion validity, the correlation between the DSI scale and Korean version of the Problem Areas in Diabetes (PAID-K) scale was obtained. Cronbach’s alpha varied from 0.69 to 0.87, and the DSI score was 0.90, demonstrating acceptable internal consistency. CFA fit indices (CFI = 0.980; RMSEA = 0.033) were favorable. DSI and pertinent PAID-K domains correlated strongly. For measuring self-injection distress, the DSI score had good accuracy. For patients with diabetes aged ≥ 10 years who self-inject insulin, the DSI was a viable and accurate method for quantifying discomfort associated with insulin injection. Health practitioners should use the DSI to communicate with patients about their suffering.

Abstract Background Numerous epidemiological studies investigating gender-dependent clinical outcomes in sepsis have shown conflicting evidence. This study aimed to investigate the effect of gender on in-hospital mortality due to sepsis according to age group. Methods This study used data from the Korean Sepsis Alliance, an ongoing nationwide prospective multicenter cohort from 19 participating hospitals in South Korea. All adult patients diagnosed with sepsis in the emergency departments of the participating hospitals between September 2019 and December 2021 were included in the analysis. Clinical characteristics and outcomes were compared between male and female. Eligible patients were stratified by age into 19–50 years, 50–80 years, and ≥ 80 years old individuals. Results During the study period, 6442 patients were included in the analysis, and 3650 (56.7%) were male. The adjusted odds ratio (OR) [95% confidence interval (CI)] for in-hospital mortality for male compared with female was 1.15 (95% CI = 1.02–1.29). Interestingly, in the age 19–50 group, the risk of in-hospital mortality for males was significantly lower than that of females [0.57 (95% CI = 0.35–0.93)]. For female, the risk of death remained relatively stable until around age 80 (P for linearity = 0.77), while in males, there was a linear increase in the risk of in-hospital death until around age 80 (P for linearity

BackgroundLung cancer diagnosis affects an individual’s quality of life as well as physical and emotional functioning. Information on survivorship care tends to be introduced at the end of treatment, but early intervention may affect posttreatment adjustment. However, to the best of our knowledge, no study has explored the effect of early information intervention on the return to work, family, and societal roles of lung cancer survivors. ObjectiveWe report the study protocol of a comprehensive care prehabilitation intervention designed to facilitate lung cancer survivors’ psychological adjustment after treatment. MethodsA comprehensive care program was developed based on a literature review and a qualitative study of patients with lung cancer and health professionals. The Lung Cancer Comprehensive Care Program consists of educational videos and follow-up visits by a family medicine physician. To prevent contamination, the control group received routine education, whereas the intervention group received routine care and intervention. Both groups completed questionnaires before surgery (T0) and at 1-month (T1), 6-month (T2), and 1-year (T3) follow-up visits after surgery. The primary outcome was survivors’ psychological adjustment to cancer 6 months after pulmonary resection. ResultsThe historical control group (n=441) was recruited from September 8, 2021, to April 20, 2022, and the intervention group (n=350) was recruited from April 22, 2022, to October 17, 2022. All statistical analyses will be performed upon completion of the study. ConclusionsThis study examined the effectiveness of an intervention that provided general and tailored informational support to lung cancer survivors, ranging from before to the end of treatment. Trial RegistrationClinicalTrials.gov NCT05078918; https://clinicaltrials.gov/ct2/show/NCT05078918 International Registered Report Identifier (IRRID)DERR1-10.2196/54707

Background & aimsA new nomenclature, Steatotic Liver Disease (SLD), has been proposed by consensus with sub-classifications and requires evidence-based validation. We assessed whether the presence and severity of SLD, as well as its sub-classifications, are associated with the progression of coronary atherosclerosis.MethodsThis longitudinal cohort study included 13,811 adults who participated in repeated regular health screening examinations between January 1, 2004 and December 31, 2021 that included assessments of their coronary artery calcium (CAC) scores. SLD was defined using abdominal ultrasonography and classified as metabolic dysfunction associated steatotic liver disease (MASLD), MASLD with increased alcohol intake (MetALD), and cryptogenic SLD. SLD severity was assessed using fibrosis-4 (FIB-4) scores. The progression of CAC scores was measured using multidetector CT scans.ResultsThe average duration of follow-up was 5.8 years. During follow-up, the annual rate of CAC progression in participants with and without SLD was 18% (95% CI 17%-19%) and 14% (95% CI 13%-14%) (p < 0.01), respectively. The multivariable ratios of progression rates when we compared participants with cryptogenic SLD, MASLD, or MetALD with those without SLD were 0.98 (95% CI 0.95-1.01), 1.03 (95% CI 1.03-1.04), and 1.07 (95% CI 1.04-1.09), respectively. The multivariable ratios of progression rates when we compared participants with SLD with FIB-4 score ConclusionsSLD was associated with a higher risk of coronary atherosclerosis, and the risk differed by sub-classifications and severity. These findings suggest that the newly proposed definition has clinical relevance in terms of stratifying cardiovascular disease risk.

Background Preserved ratio impaired spirometry (PRISm) is associated with increased cardiovascular disease (CVD) risk and mortality. However, a causal relationship between PRISm and CVD remains unclear. We investigated the progression of coronary artery calcium (CAC) scores based on the presence of PRISm and reduced forced vital capacity (FVC). Methods This retrospective cohort study included 11 420 participants aged ≥40 years with forced expiratory volume in 1 s (FEV1)/FVC ≥0.7 who underwent at least two health screening examinations with coronary computed tomography scan between 2003 and 2020, and were without a history of CVD or interstitial lung disease. Participants with PRISm, defined as FEV1/FVC ≥0.7 and FEV1

Olive leaf contains plenty of phenolic compounds, among which oleuropein (OP) is the main component and belongs to the group of secoiridoids. Additionally, phenolic compounds such as oleocanthal (OL) and oleacein (OC), which share a structural similarity with OP and two aldehyde groups, are also present in olive leaves. These compounds have been studied for several health benefits, such as anti-cancer and antioxidant effects. However, their impact on the skin remains unknown. Therefore, this study aims to compare the effects of these three compounds on melanogenesis using B16F10 cells and human epidermal cells. Thousands of gene expressions were measured by global gene expression profiling with B16F10 cells. We found that glutaraldehyde compounds derived from olive leaves have a potential effect on the activation of the melanogenesis pathway and inducing differentiation in B16F10 cells. Accordingly, the pro-melanogenesis effect was investigated by means of melanin quantification, mRNA, and protein expression using human epidermal melanocytes (HEM). This study suggests that secoiridoid and its derivates have an impact on skin protection by promoting melanin production in both human and mouse cell lines.

Abstract This nationwide population-based cohort study searched for demographic, comorbid, behavioral, and reproductive risk factors for idiopathic macular hole (MH) development using data provided by the Korean National Health Insurance Service. A total of 4,496,867 individuals aged 50–79 years who participated in the Korean National Health Screening Program in 2013 or 2014 were included. Participants were followed up until December 2018, and incident cases of idiopathic MH were identified. Prospective associations between incident idiopathic MH and various covariates were investigated using multivariable-adjusted Cox proportional hazard models. During an average follow-up period of 4.91 years, 3054 patients were newly diagnosed with idiopathic MHs. Women showed greater risk (hazard ratio of 1.71) and earlier presentation of idiopathic MH than men. Compared to the normal body mass index group, the obese group (≥ 25 kg/m2) showed a significantly lower risk of idiopathic MH. Among postmenopausal women, those with two or more children showed a greater risk of idiopathic MH than those who had not been pregnant, with a hazard ratio of 1.80. In conclusion, idiopathic MH occurred earlier and greater in women. Childbirth were associated with an increased risk of MH development, and obesity was associated with a lower risk of MH.

BackgroundBreast cancer is the most common cancer and the most common cause of cancer death in women. Although survival rates have improved, unmet psychosocial needs remain challenging because the quality of life (QoL) and QoL-related factors change over time. In addition, traditional statistical models have limitations in identifying factors associated with QoL over time, particularly concerning the physical, psychological, economic, spiritual, and social dimensions. ObjectiveThis study aimed to identify patient-centered factors associated with QoL among patients with breast cancer using a machine learning (ML) algorithm to analyze data collected along different survivorship trajectories. MethodsThe study used 2 data sets. The first data set was the cross-sectional survey data from the Breast Cancer Information Grand Round for Survivorship (BIG-S) study, which recruited consecutive breast cancer survivors who visited the outpatient breast cancer clinic at the Samsung Medical Center in Seoul, Korea, between 2018 and 2019. The second data set was the longitudinal cohort data from the Beauty Education for Distressed Breast Cancer (BEST) cohort study, which was conducted at 2 university-based cancer hospitals in Seoul, Korea, between 2011 and 2016. QoL was measured using European Organization for Research and Treatment of Cancer QoL Questionnaire Core 30 questionnaire. Feature importance was interpreted using Shapley Additive Explanations (SHAP). The final model was selected based on the highest mean area under the receiver operating characteristic curve (AUC). The analyses were performed using the Python 3.7 programming environment (Python Software Foundation). ResultsThe study included 6265 breast cancer survivors in the training data set and 432 patients in the validation set. The mean age was 50.6 (SD 8.66) years and 46.8% (n=2004) had stage 1 cancer. In the training data set, 48.3% (n=3026) of survivors had poor QoL. The study developed ML models for QoL prediction based on 6 algorithms. Performance was good for all survival trajectories: overall (AUC 0.823), baseline (AUC 0.835), within 1 year (AUC 0.860), between 2 and 3 years (AUC 0.808), between 3 and 4 years (AUC 0.820), and between 4 and 5 years (AUC 0.826). Emotional and physical functions were the most important features before surgery and within 1 year after surgery, respectively. Fatigue was the most important feature between 1 and 4 years. Despite the survival period, hopefulness was the most influential feature on QoL. External validation of the models showed good performance with AUCs between 0.770 and 0.862. ConclusionsThe study identified important factors associated with QoL among breast cancer survivors across different survival trajectories. Understanding the changing trends of these factors could help to intervene more precisely and timely, and potentially prevent or alleviate QoL-related issues for patients. The good performance of our ML models in both training and external validation sets suggests the potential use of this approach in identifying patient-centered factors and improving survivorship care.

Background: Pretreatment endocrine symptoms in premenopausal patients might be considered as a potential marker of poor prognosis. We conducted a cohort study to evaluate the association between endocrine symptoms prior to treatment and recurrence-free survival (RFS) among premenopausal patients with breast cancer aged ⩽40 years. Methods: Data were obtained from a prospective cohort study (NCT03131089) conducted at the Samsung Medical Center from 2013 to 2021. We included patients aged ⩽40 years who had been diagnosed with breast cancer. The primary outcome measure was RFS. Endocrine symptoms were measured using the Functional Assessment of Cancer Therapy – Endocrine Symptoms (FACT-ES). We also calculated the hazard ratio (HR) for recurrence or all-cause mortality by comparing the tertiles of the FACT-ES score at diagnosis. Results: Among the 977 participants, the mean (standard deviation) age was 35.3 (3.9) years. At diagnosis, 17.2% of the patients had at least one severe endocrine symptom. During 3512 person-years of follow-up, the high symptom group had a worse RFS than the low-symptom group [HR = 2.05; 95% confidence interval (CI) = 1.19–3.54]. In particular, hot flashes (HR = 5.59; 95% CI = 1.96–15.93) and breast sensitivity (HR = 1.82; 95% CI = 1.00–3.32) were associated with reduced RFS. Conclusion: Close monitoring of pretreatment endocrine symptoms may be important in patients diagnosed with breast cancer at a young age.

Background Hypertension is an important cause of morbidity, which predisposes patients to major cardiovascular events and mortality. The aim of this study was to explore the association between adherence to antihypertensive medication and clinical outcomes in adult patients with cancer. Methods and Results Using the 2002 to 2013 Korean National Health Insurance Service–National Sample Cohort, we extracted adult patients with cancer treated with antihypertensive medications. Based on the medication possession ratio value, participants were divided into 3 groups: good (medication possession ratio ≥0.8), moderate (0.5≤ medication possession ratio

Background: Evidence on whether long-term exposure to air pollution increases the mortality risk in patients with chronic obstructive pulmonary disease (COPD) is limited. Objectives: We aimed to investigate the associations of long-term exposure to particulate matter with diameter

Abstract We investigated the associations between serum lipid profiles and risk of early-onset vasomotor symptoms (VMSs) in premenopausal women. This cohort study comprised 2,540 premenopausal women aged 42–52 years without VMSs at baseline (median follow-up: 4.4 years). VMSs, including hot flashes and night sweats, were assessed using the Menopause-Specific Quality of Life questionnaire (Korean version). Early-onset VMSs were defined as VMSs that occurred premenopause; moderate/severe VMSs were defined as a score of ≥ 3 points (range: 0 to 6, 6 being most bothersome). Cox proportional hazard regression models were used to estimate hazard ratios with 95% confidence intervals (CI) for the development of VMSs across the lipid levels. Higher low-density lipoprotein (LDL) cholesterol levels were positively associated with increased risk of early-onset VMSs. Compared to the

Abstract Background While many studies investigated changes in working status in cancer survivors, most studies have been performed in survivors of breast cancer and few studies evaluated factors associated with changes in the working status of cancer survivors comprehensively. We aimed to evaluate the changes in the working status of cancer survivors after diagnosis and socio-demographic, clinical, work-related and psychological factors associated with it. Methods We conducted a cross-sectional survey of adult patients with cancer who were working at the time of diagnosis. A trained interviewer inquired about participants’ current working status, including leave of absence, discontinuing, continuing, and changing work. Sociodemographic, clinical, work-related and psychological factors were measured. Multinomial logistic regression was used to identify factors associated with changes in the working status. Results Among the 730 patients, 29%, 18% and 6% were currently on a discontinued working, leave of absence and had changed jobs, respectively. Patients who discontinued working after cancer diagnosis were more likely to be female, have ≥ $3,000 of monthly family income, not be the principal wage earners for their families and be blue-collar workers. In clinical characteristics, advanced-stage cancer and experienced cancer recurrence was associated with leave of absence and discontinued working. In work-related and psychological factors, stress due to insufficient job control (relative risk ratio [RRR] = 2.26), interpersonal conflict (RRR = 1.86), job insecurity (RRR = 2.63), organizational system (RRR = 3.49), and lack of reward (RRR = 11.76), and less meaning to work were more likely to discontinue working after a cancer diagnosis. Conclusion Occupational health care professionals and other stakeholders need to openly communicate with patients with cancer about potential barriers during the return-to-work trajectory.

Abstract Background Surgery is the mainstay of treatment for non-small cell lung cancer, but the decline in pulmonary function after surgery is noticeable and requires attention. This study aimed to evaluate longitudinal changes in pulmonary function and integrated patient-reported outcomes (PROs) after lung cancer surgery. Methods Data were obtained from a prospective cohort study, the Coordinate Approach to Cancer Patients’ Health for Lung Cancer. Changes in forced vital capacity (FVC) and forced expiratory volume in 1 s (FEV1) at 2 weeks, 6 months, and 1 year after surgery, and the corresponding modified Medical Research Council (mMRC) dyspnea scale and chronic obstructive lung disease assessment test (CAT) scores were evaluated. Mixed effects model was used to investigate changes in pulmonary function and PROs. Results Among 620 patients, 477 (76.9%) underwent lobectomy, whereas 120 (19.4%) and 23 (3.7%) were treated with wedge resection/segmentectomy and bilobectomy/pneumonectomy, respectively. Both FVC and FEV1 markedly decreased 2 weeks after surgery and improved thereafter; however, they did not recover to baseline values. The corresponding mMRC dyspnea scale and CAT scores worsened immediately after surgery. The dyspnea scale of the mMRC was still higher, while CAT scores returned to baseline one year after surgery, although breathlessness and lack of energy persisted. Compared to the changes from baseline of FVC and FEV1 in patients who underwent lobectomy, patients who underwent bilobectomy/pneumonectomy showed a greater decrease in FVC and FEV1, while wedge resection/segmentectomy patients had smaller decreases in FVC and FEV1 at 2 weeks, 6 months, and 1 year after surgery. Bilobectomy/pneumonectomy patients had the highest mMRC dyspnea grade among the three groups, but the difference was not statistically significant one year after surgery. Conclusions After lung cancer surgery, pulmonary function and PROs noticeably decreased in the immediate post-operative period and improved thereafter, except for dyspnea and lack of energy. Proper information on the timeline of changes in lung function and symptoms following lung cancer surgery could guide patient care approaches after surgery. Trial registration: ClinicalTrials.gov; No.: NCT03705546; URL: www.clinicaltrials.gov

Abstract Background A central venous catheter (CVC) is an important medical device, but it could be preceding infection and the risk of central line-associated bloodstream infection (CLABSI). CLABSI is a common healthcare-associated infection but results in high cost and mortality; therefore, various efforts to reduce CLABSI have been attempted. Methods This is a retrospective, observational, quasi-experimental study in the intensive care unit (ICU) of a single tertiary care hospital. We reviewed and analysed the data of CLABSI rates and days from the insertion to the removal of the temporary CVC between January 2018 and June 2021 with transient periods over 9 months. Sequentially, all patients with the CVC in the ICU underwent the following interventions: maximal barrier precaution, automatic notification of catheter days and 2% chlorhexidine gluconate bathing. A segmented regression analysis of interrupted time series was conducted to compare the CLABSI rates before and after the introduction of multimodal interventions. During study periods, the impact of interventions on CLABSI was evaluated using multivariate logistic regression analyses. Results A total of 76,504 patient-days, 28,312 catheter days and 66 CLABSI cases were reviewed in ICU-hospitalised patients. As additional interventions, the CLABSI rate declined from 3.1 per 1000 CVC days to 1.2 per 1000 CVC days in post-interventions. In the pre-intervention and post-intervention periods, 4146 patents had one more short-term CVC. In the multivariate logistic regression analyses, multimodal intervention was one of determinants reducing CLABSI rates (odds ratio (OR), 0.52 [95% confidence interval {CI}, 0.28–0.94]). Indwelling time of CVC over 10 days was the risk factor for CLABSI rates (OR, 6.27 [95% CI, 3.36–12.48]). Of the three interventions, the automatic notification of catheter days was associated with decreased median monthly total CVC days and duration of CVC days per patient. Conclusions Multidisciplinary and evidence-based interventions could lead to a decrease in the CLABSI rates. Moreover, the automatic notification of catheter days of the electronic medical healthcare system has shortened the time of indwelling CVC.

Abstract The role of anti-Müllerian hormone (AMH) levels in incident vasomotor symptoms (VMS) is largely unknown. This study aimed to investigate the relationship between AMH levels and the development of early-onset VMS among premenopausal women. Our cohort study comprised 2041 premenopausal women aged 42–52 years free of VMS at baseline whose AMH levels were measured. VMS, including hot flushes and night sweats, were assessed using the Korean version of the Menopause-specific Quality of Life questionnaire. Early-onset VMS was defined as the occurrence of VMS prior to menopause. Parametric proportional hazards models were used to estimate adjusted hazard ratios (HRs) and 95% CI. During a median follow-up of 4.4 years, 708 premenopausal women developed early-onset VMS (incidence rate, 8.0 per 100 person-years). Lower AMH levels were statistically significantly associated with an increased risk of early-onset VMS. After adjusting for age and other confounders, multivariable-adjusted HRs (95% CI) for incident VMS comparing AMH quintiles 4–1 to the highest quintile were 1.02 (0.78–1.33), 1.37 (1.06–1.76), 1.36 (1.04–1.76), and 2.38 (1.84–3.08), respectively (P for trend

BackgroundOver 90% of patients with cancer experience 1 or more symptoms caused directly by cancer or its treatment. These symptoms negatively impact on the completion of planned treatment as well as patients’ health-related quality of life (HRQoL). It often results in serious complications and even life-threatening outcomes. Thus, it has been recommended that surveillance of symptom burden should be performed and managed during cancer treatment. However, differences in symptom profiles in various patients with cancer have not been fully elucidated for use in performing surveillance in the real world. ObjectiveThis study aims to evaluate the burden of symptoms in patients with various types of cancers during chemotherapy or radiation therapy using the PRO-CTCAE (Patient-Reported Outcome Version of the Common Terminology Criteria for Adverse Events) and its impact on quality of life. MethodsWe performed a cross-sectional study of patients undergoing outpatient-based chemotherapy, radiation therapy, or both at the National Cancer Center at Goyang or at the Samsung Medical Center in Seoul, Korea between December 2017 and January 2018. To evaluate cancer-specific symptom burden, we developed 10 subsets for using the PRO-CTCAE-Korean. To measure HRQoL, we used the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Participants answered questions prior to their clinic appointments on tablets. Multivariable linear regression was used to analyze symptoms based on cancer type and to evaluate the association between the PRO-CTCAE items and the EORTC QLQ-C30 summary score. ResultsThe mean age (SD) of the patients was 55.0 (11.9) years, and 39.94% (540/1352) were male. Overall, symptoms in the gastrointestinal category were the most dominant in all cancers. Fatigue (1034/1352, 76.48%), decreased appetite (884/1352, 65.38%), and numbness and tingling (778/1352, 57.54%) were the most frequently reported. Patients reported more local symptoms caused by a specific cancer. In terms of nonsite-specific symptoms, patients commonly reported concentration (587/1352, 43.42%), anxiety (647/1352, 47.86%), and general pain (605/1352, 44.75%). More than 50% of patients with colorectal (69/127, 54.3%), gynecologic (63/112, 56.3%), breast (252/411, 61.3%), and lung cancers (121/234, 51.7%) experienced decreased libido, whereas 67/112 (59.8%) patients with gynecologic cancer and lymphoma/myeloma reported pain during sexual intercourse. Patients with breast, gastric, and liver cancers were more likely to have the hand-foot syndrome. Worsening PRO-CTCAE scores were associated with poor HRQoL (eg, fatigue: coefficient –8.15; 95% CI –9.32 to –6.97), difficulty in achieving and maintaining erection (coefficient –8.07; 95% CI –14.52 to –1.61), poor concentration (coefficient –7.54; 95% CI –9.06 to –6.01), and dizziness (coefficient –7.24; 95% CI –8.92 to –5.55). ConclusionsThe frequency and severity of symptoms differed by cancer types. Higher symptom burden was associated with poor HRQoL, which suggests the importance of appropriate surveillance of PRO symptoms during cancer treatment. Considering patients had comprehensive symptoms, it is necessary to include a holistic approach in the symptom monitoring and management strategies based on comprehensive patient-reported outcome measurements.

BackgroundIn recent decades, real-world evidence (RWE) in oncology has rapidly gained traction for its potential to answer clinical questions that cannot be directly addressed by randomized clinical trials. Integrating real-world data (RWD) into clinical research promises to contribute to more sustainable research designs, including extension, augmentation, enrichment, and pragmatic designs. Nevertheless, clinical research using RWD is still limited because of concerns regarding the shortage of best practices for extracting, harmonizing, and analyzing RWD. In particular, pragmatic screening methods to determine whether the content of a data source is sufficient to answer the research questions before conducting the research with RWD have not yet been established. ObjectiveWe examined the PAR (Preliminary Attainability Assessment of Real-World Data) framework and assessed its utility in breast cancer brain metastasis (BCBM), which has an unmet medical need for data attainability screening at the preliminary step of observational studies that use RWD. MethodsThe PAR framework was proposed to assess data attainability from a particular data source during the early research process. The PAR framework has four sequential stages, starting with clinical question clarification: (1) operational definition of variables, (2) data matching (structural/semantic), (3) data screening and extraction, and (4) data attainability diagramming. We identified 5 clinical questions to be used for PAR framework evaluation through interviews and validated them with a survey of breast cancer experts. We used the Samsung Medical Center Breast Cancer Registry, a hospital-based real-time registry implemented in March 2021, leveraging the institution’s anonymized and deidentified clinical data warehouse platform. The number of breast cancer patients in the registry was 45,129; it covered the period from June 1995 to December 2021. The registry consists of 24 base data marts that represent disease-specific breast cancer characteristics and care pathways. The outcomes included screening results of the clinical questions via the PAR framework and a procedural diagram of data attainability for each research question. ResultsData attainability was tested for study feasibility according to the PAR framework with 5 clinical questions for BCBM. We obtained data sets that were sufficient to conduct studies with 4 of 5 clinical questions. The research questions stratified into 3 types when we developed data fields for clearly defined research variables. In the first, only 1 question could be answered using direct data variables. In the second, the other 3 questions required surrogate definitions that combined data variables. In the third, the question turned out to be not feasible for conducting further analysis. ConclusionsThe adoption of the PAR framework was associated with more efficient preliminary clinical research using RWD from BCBM. Furthermore, this framework helped accelerate RWE generation through clinical research by enhancing transparency and reproducibility and lowering the entry barrier for clinical researchers.

Abstract We conducted a retrospective cohort study to evaluate the temporal pattern of incidence of chronic conditions after developing breast cancer using a population-based national registry. We selected 84,969 women with newly diagnosed breast cancer between 2002 and 2016 and a 1:10 sample of age-matched non-breast cancer controls (N = 1,057,674). The main study exposure was incident breast cancer, considered as a time-varying exposure. The outcomes were incident cases of leukemia, endometrial cancer, myeloma, cardiomyopathy, osteoporosis, end stage renal disease (ESRD), pulmonary fibrosis, hypothyroidism, type 2 diabetes, hypertension and hyperlipidemia. The development of breast cancer was associated with a significantly increased risk of all outcomes analyzed except for ESRD and hypertension. The fully-adjusted risks of leukemia (HR 3.09; 95% CI 2.11–4.51), cardiomyopathy (HR 2.65; 95% CI 1.90–3.68), endometrial cancer (HR 3.53; 95% CI 2.76–4.53), hypothyroidism (HR 1.29; 95% CI 1.19–1.40), pulmonary fibrosis (HR 1.84; 95% CI 1.12–3.02), and hyperlipidemia (HR 1.24; 95% CI 1.20–1.28) remained significantly elevated after more than 5 years since diagnosis. Optimal care for breast cancer survivors requires close collaboration between oncologists and allied health care professionals to identify and manage the long-term morbidity and mortality associated with these chronic conditions.

Abstract Objective Delirium in the intensive care unit (ICU) may be a preventable risk factor for cognitive impairment or psychiatric problems. We aimed to evaluate the association between the presence of delirium during hospitalization involving ICU care and post-discharge cognitive impairment or psychiatric problems. Design A retrospective cohort study. Setting A database of nationwide insurance claims data. Patients All adult patients aged 18 years or older who were admitted to an ICU between January 1, 2008, and May 31, 2015, and had no history of previous cognitive impairment or psychiatric problems were included in the study. Interventions None. Measurements and main results Of 306,011 patients who met the inclusion criteria, the proportion of those who experienced delirium during hospitalization was 55.0% (n = 168,190). The patients with delirium during hospitalization had significantly increased odds for cognitive impairment (adjusted hazard ratio [HR] 1.17; 95% confidence interval [CI] 1.05–1.29) and psychiatric problems (adjusted HR 1.78; 95% CI 1.67–1.90) after discharge compared with patients without delirium. In patients who had delirium, the incidence of cognitive impairment was 210.8 per 1000 person-years. In 19,496 patients who were diagnosed with cognitive impairment, depression (n = 3233, 16.5%), sleep disorder (n = 1791, 9.2%), and anxiety (n = 1683, 8.6%) were commonly co-diagnosed. The most common psychiatric problem was sleep disorder (148.7 per 1000 person-years), followed by depression (133.3 per 1000 person-years). Conclusions Among patients received ICU care, those who experienced delirium during hospitalization had an increased risk of developing cognitive impairment or psychiatric problems post-discharge. Many patients showed multiple cognitive impairment and psychiatric problems during the follow-up period. Efforts to decrease these problems should be made to increase the quality of life of these ICU survivors.

Health screening is an important component of health promotion programs, and countries have promoted general health screening targeting the prevention and early management of common chronic diseases. In Korea, a General Health Screening Program (GHSP) began with workers in the 1950s and continuously expanded its target population, and currently includes the adult population. The main target diseases are cerebroand cardiovascular diseases, including hypertension, diabetes mellitus, dyslipidemia, obesity, and related health behaviors. Other target conditions include other diseases (e.g., anemia, liver disease, visual/auditory impairment), mental health (e.g., depression), and geriatric disease and function (osteoporosis, dementia, risk of fall, etc.). The National Health Information Database, including GHSP information, is now extensively used in clinical and public health research. The participation rate is currently 70% to 80%, but varies according to age, disability, and the socioeconomic status. There is a need for a more systematic evaluation of the screening items, reducing disparity gaps in participation, and linking GHSP to actual health promotion.

Abstract Hemorrhoidal disease is a highly prevalent anorectal condition causing substantial discomfort, disability, and decreased quality of life. Evidence on preventable risk factors for hemorrhoidal disease is limited. We conducted a cross-sectional study of 194,620 healthy men and women who completed a health screening exam including colonoscopy in 2011–2017. We evaluated potential risk factors of hemorrhoidal disease, including lifestyle factors, medical history, birth history, gastrointestinal symptoms, and anthropometric measurements. The prevalence of hemorrhoidal disease was 16.6%, and it was higher in females than in males (17.2 vs. 16.3%; P

Abstract Background Social and hospital environmental factors that may be associated with hospital-acquired pneumonia (HAP) have not been evaluated. Comprehensive risk assessment for the incidence of HAP including sociodemographic, clinical, and hospital environmental factors was conducted using national health insurance claims data. Methods This is a population-based retrospective cohort study of adult patients who were hospitalized for more than 3 days from the Health Insurance Review and Assessment Service-National Inpatient Sample data between January 1, 2016 and December 31, 2018 in South Korea. Multivariable logistic regression analyses were conducted to identify the factors associated with the incidence of HAP. Results Among the 512,278 hospitalizations, we identified 25,369 (5.0%) HAP cases. In multivariable analysis, well-known risk factors associated with HAP such as older age (over 70 vs. 20–29; adjusted odds ratio [aOR], 3.66; 95% confidence interval [CI] 3.36–3.99), male sex (aOR, 1.35; 95% CI 1.32–1.39), pre-existing lung diseases (asthma [aOR, 1.73; 95% CI 1.66–1.80]; chronic obstructive pulmonary disease [aOR, 1.62; 95% CI 1.53–1.71]; chronic lower airway disease [aOR, 1.79; 95% CI 1.73–1.85]), tube feeding (aOR, 3.32; 95% CI 3.16–3.50), suctioning (aOR, 2.34; 95% CI 2.23–2.47), positioning (aOR, 1.63; 95% CI 1.55–1.72), use of mechanical ventilation (aOR, 2.31; 95% CI 2.15–2.47), and intensive care unit admission (aOR, 1.29; 95% CI 1.22–1.36) were associated with the incidence of HAP. In addition, poverty (aOR, 1.08; 95% CI 1.04–1.13), general hospitals (aOR, 1.54; 95% CI 1.39–1.70), higher bed-to-nurse ratio (Grade ≥ 5; aOR, 1.45; 95% CI 1.32–1.59), higher number of beds per hospital room (6 beds; aOR, 3.08; 95% CI 2.77–3.42), and ward with caregiver (aOR, 1.19; 95% CI 1.12–1.26) were related to the incidence of HAP. Conclusions The incidence of HAP was associated with various sociodemographic, clinical, and hospital environmental factors. Thus, taking a comprehensive approach to prevent and treat HAP is important.

Abstract Background Alanine aminotransferase (ALT) levels are widely used to screen liver disease, and many asymptomatic individuals show elevated ALT levels. As elevated ALT level indicates liver injury, even a small amount of alcohol intake may be harmful in subjects with elevated ALT levels, but there is limited evidence of the effect of light to moderate amount of alcohol intake in this subgroup. Methods A cohort of 367,612 men and women without established liver diseases (including chronic viral hepatitis, alcohol-associated liver disease, cirrhosis, liver transplantation, or rare forms of liver disease) who underwent at least 1 health screening exam between 2009 and 2015 were assessed for liver-related and all-cause mortality. Elevated ALT levels were defined as ≥ 34 U/L for men and 25 U/L for women. Results In participants with normal ALT levels, the fully-adjusted hazard ratios (95% CI) for liver-related mortality comparing light and moderate drinkers to non-drinkers were 0.73 (0.51–1.05), and 1.06 (0.73–1.52), respectively. In participants with elevated ALT levels, the corresponding hazard ratios were 1.57 (1.08–2.28), and 2.09 (CI 1.46–2.99), respectively (p value for alcohol intake by ALT interaction

ObjectiveNon-alcoholic fatty liver disease (NAFLD) is potentially reversible. However, whether improvement of NAFLD leads to clinical benefits remains uncertain. We investigated the association between regression of NAFLD and the risk of incident diabetes in a longitudinal way.MethodsA cohort of 11,260 adults who had NAFLD at in an initial exam, had the second evaluation for NAFLD status at 1~2 years from an initial exam were followed up for incident diabetes from 2001 and 2016. NAFLD was diagnosed with abdominal ultrasound.ResultsAt baseline, NAFLD was regressed in 2,559 participants (22.7%). During 51,388 person-years of follow-up (median 4 years), 1,768 participants developed diabetes. The fully adjusted hazard ratio (HR) for incident diabetes in participants with regressed NAFLD compared to those with persistent NAFLD was 0.81 [95% confidence interval (CI) 0.72-0.92]. When assessed by NAFLD severity, among participants with a low NAFLD fibrosis score (NFS) (< -1.455), participants with regressed NAFLD had a lower risk of incident diabetes than those with persistent NAFLD (HR 0.77, 95% CI 0.68-0.88). However, in participants with an intermediate to high NFS (≥ -1.455), the risk of incident diabetes was not different between NAFLD regression and persistence groups (HR 1.12, 95% CI 0.82-1.51).ConclusionsRegression of NAFLD was associated with decreased risk of incident diabetes compared to persistent NAFLD. However, the benefit was evident only for NAFLD patients with low NFS. This suggests that early intervention for NAFLD, before advanced fibrosis is present, may maximize the metabolic benefit from NAFLD regression.

BackgroundSymptom monitoring application (SMA) has clinical benefits to cancer patients but patients experience difficulties in using it. Few studies have identified which types of graphical user interface (GUI) are preferred by cancer patients for using the SMA.MethodsThis is a cross-sectional study aimed to identify preferred GUI among cancer patients to use SMA. Total of 199 patients were asked to evaluate 8 types of GUIs combining text, icon, illustration, and colors using mixed-methods. Subgroup analyses were performed according to age and gender.ResultsThe mean age of the patients was 57 and 42.5% was male. The most preferred GUI was "Text + Icon + Color" (mean = 4.43), followed by "Text + Icon" (mean = 4.39). Older patients (≥ 60 years) preferred "Text + Icon" than younger patients (p for interaction < 0.01). Simple and intuitive text and icons were the most useful GUI for cancer patients to use the SMA.ConclusionSimple and intuitive text and icons were the most useful GUI for cancer patients to use the SMA. Researchers need to be careful when applying realistic face drawings to cancer symptom monitoring applications because they can recall negative images of cancer.

Abstract Several studies have suggested that estrogens have a protective function against lymphomagenesis. The treatment of breast cancer is driven by subtype classification, and the assessment of hormone receptor status is important for treatment selection. Thus, we evaluated the association between breast cancer and the incidence of NHL. We conducted a retrospective cohort study using a population-based nationwide registry in South Korea. We selected all women with newly diagnosed breast cancer between January 1st, 2002 and December 31st, 2016 who received curative treatment (N = 84,969) and a 1:10 sample of age-matched non-breast cancer controls (N = 1,057,674). Incident breast cancer (time-varying exposure) was the exposure and development of any type of NHL, including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mature T/NK-cell lymphomas, anaplastic large cell lymphoma (ALCL), and unspecified types of NHL, was the outcome. During follow-up, 1564 incident cases of NHL occurred. The fully adjusted Hazard Ratio (HR) for NHL associated with the development of breast cancer was 1.64 (95% CI = 1.34–2.00) after adjusting for body mass index, alcohol intake, physical activity, smoking, income, and comorbidity. The adjusted HR for NHL was much higher in participants who were aged

Abstract Background Patients with lower extremity problems (LEP) commonly experience functional loss, pain, decreased range of motion, inadequacy in daily living activities, and structural change in radiographic evaluations. However, the traditional patient-reported outcome measurement which focused on symptoms, had a limited scope of applicability. This study aimed to validate the psychometric properties of the Korean version of PROMIS-29 Profile v2.1 (K-PROMIS-29 V2.1), a multi-dimensional measure for assessing generic profile health-related quality-of-life (HRQoL) in a sample of patients with lower extremity problems (LEP). Methods Participants were recruited from the orthopedic outpatient clinics at the Samsung Medical Center in Seoul, South Korea from September to October 2018. Participants completed a survey questionnaire that included the K-PROMIS-29 V2.1 and the SF-36v2. Principal component analysis (PCA) and confirmatory factor analysis (CFA) and Pearson’s correlations were used to evaluate the reliability and validity of the K-PROMIS-29 V2.1. Results A total of 299 participants were enrolled in the study and 258 (86%) completed the study questionnaire. The mean age (SD) of the participants was 56.6 (14.5) and 32.3%, 29.8, and 25.2% of the study participants visited outpatient clinics for foot, knee, and hip problems respectively. The Cronbach’s alpha coefficients of 7 sub-domains in K-PROMIS-29 V2.1 ranged from 0.80 to 0.95, indicating satisfactory internal consistency. In CFA, the goodness-of-fit indices were high (CFI = 0.937 and SRMR = 0.061). High to moderate correlations were found between comparable subscales of the K-PROMIS-29 V2.1 and subscales of the SF-36v2 (r = 0.55–0.70). Conclusions The K-PROMIS-29 V2.1 is a reliable and valid measure for assessing a broad range of health-related quality-of-life domains in patients with LEP. It would reflect the real-life symptoms experienced by patients with LEP.

The aim of this study is to identify the prevalence and predictors of unmet needs of non-small cell lung cancer (NSCLC) patients undergoing surgical resection in Seoul, South Korea. A total of 949 patients who completed survey questionnaires that included the Cancer Survivors’ Unmet Needs Korean version (CaSUN-K), fear of cancer recurrence (FCR) inventory-short form, and European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) were recruited from January to October 2020. Multivariable logistic regression was used to determine the potential correlation of significant unmet needs, defined as any moderate or strong need, for each domain of CaSUN-K. Of the 949 participants, the mean age was 63.4 ± 8.8 years old, and 529 (55.7%) were male. Overall, 91.8% of participants reported one or more unmet need. The highest domains of moderate-to-strong unmet needs were existential survivorship (59.1%), comprehensive cancer care (51.2%), and information (49.7%). High FCR and poor emotional function were associated with moderate-to-strong unmet needs across all domains of CaSUN-K. NSCLC survivors with a recent diagnosis had more frequent disease-related unmet needs. Interventions to reduce the unmet needs of NSCLC patients should focus on relieving FCR and improving emotional functioning. Furthermore, emphasis should be placed on decreasing disease-related needs, particularly for early survivors of lung cancer during the re-entry phase.

Introduction South Koreans continue to smoke at high rates. Tobacco manufacturers have a history of branding cigarettes with misleading descriptors including the introduction of low or ultra-low tar brand variants. The government bans traditional misleading descriptors (low, mild) but requires the presence of machine-assessed tar yields on cigarette packages. Literature suggests the presence of quantitative constituents can be misleading for smokers. We analyzed the machine-assessed tar value branding and the presence of additional branding that highlight tar levels on South Korean cigarette packs. Methods In August 2018, we analyzed 178 unique cigarette packs purchased in Seoul and Busan, South Korea using a systematic protocol. Cigarette packs were coded for tar levels and classified as ultra-low, low, mid, and high tar. The presence of misleading descriptors and any additional branding relating to tar or potentially indicating strength were also coded. Results Machine-assessed tar yields ranged from 0.1 to 8 mg. Cigarettes with a 1 mg machine-assessed tar yield accounted for 38% of all packs purchased. A majority (80%) of packs with tar values