Despite long-term research achievements, the development of cell therapy (CT) products remains challenging. This is because the risks experienced by the subject and therapeutic effects in the clinical trial stage are unclear due to the various uncertainties of CT when administered to humans. Nevertheless, as autologous cell products for systemic administration have recently been approved for marketing, CT product development is accelerating, particularly in the field of unmet medical needs. The human experience of CT remains insufficient compared with other classes of pharmaceuticals, while there are countless products for clinical development. Therefore, for many sponsors, understanding the rationale of human application of an investigational product based on the consensus and improving the ability to apply it appropriately for CT are necessary. Thus, defining the level of evidence for safety and efficacy fundamentally required for initiating the clinical development and preparing it using a reliable method for CT. Furthermore, the expertise should be strengthened in the design of the first-in-human trial, such as the starting dose and dose-escalation plan, based on a sufficiently acceptable rationale. Cultivating development professionals with these skills will increase the opportunity for more candidates to enter the clinical development phase.

OBJECTIVES: This study examined whether depressive symptoms and social isolation were independent predictors of 2-year all-cause mortality among the elderly using data from a population-based cohort study. METHODS: In total, 1,033 participants (320 men and 713 women) older than 60 years of age participated in this study. Depressive symptoms, social isolation status, and socio-demographic and health-related covariates were assessed at baseline. The primary outcome measure was 2-year all-cause mortality. Data were collected through in-person interviews by trained interviewers. The GENMOD procedure was used to calculate relative risks (RRs). RESULTS: Of the 1,033 participants, 102 (40 men and 62 women) died within the follow-up period of 2 years. During the 2-year follow-up period, 17.8% of depressed men and 12.3% of depressed women died, and 29.8% of socially isolated men and 14.9% of socially isolated women died. Social isolation was an independent predictor of mortality in elderly men (adjusted relative risk [aRR], 4.6, 95% confidence interval [CI], 2.0 to 10.2), while depressive symptoms were an independent predictor of mortality in elderly women (aRR, 2.0; 95% CI, 1.2 to 3.6) when controlling for potential confounding factors. However, the depressive symptoms detected using the geriatric depression scale were not associated with mortality in men, and social isolation was not associated with mortality in women. CONCLUSIONS The effects of depressive symptoms and social isolation on 2-year all-cause mortality within an elderly population differed according to gender. Gender-specific community-based interventions must be developed to potentially reduce 2-year all-cause mortality among the elderly.

OBJECTIVES: The reported effects of digital media overuse on physical activity among adolescents are inconsistent. This study examined the association between hours of digital media use and lack of moderate-intensity physical exercise (mPE) according to the type of digital media. METHODS: This study included 1,837 middle school students from the iCURE (Internet user Cohort for Unbiased Recognition of gaming disorder in Early Adolescence) study conducted in Korea. Hours spent using digital media were measured by self-reported daily usage time for Internet games, messengers, social media, and watching game streaming on weekdays. Lack of mPE was defined as performing a minimum of 30 minutes at a time less than twice weekly. Multivariable logistic regression analysis stratified by sex was performed. RESULTS: Among male students, the group with the highest hours of using either Internet games or watching game streaming was more likely to lack mPE than each non-user group. In contrast, among male students, the group using either messengers or social media had a higher rate of mPE compared to each non-user group. Female students showed no association between hours spent using Internet games, messengers, social media, or watching game streaming and a lack of mPE. CONCLUSIONS Among male middle school students in Korea, the excessive use of Internet games or watching game streaming was associated with a lack of mPE. Thus, guidelines should be established regarding adolescent use of internet games and watching game streaming.

Objectives: Adhering to management guidelines, including routine follow-up and education, is crucial for the effective management of chronic diseases such as diabetes. Uncontrolled diabetes is linked to poor sleep quality. We used nationally representative data from community-dwelling Koreans to investigate potential associations between non-adherence to diabetes management and poor sleep quality. Methods: Of the 228 340 participants in the 2018 Korea Community Health Survey, we analyzed data from 68 246 participants aged 65 years and older. Based on their diabetes status and adherence to diabetes-related tests (glycated hemoglobin, fundus examination, and urine microalbuminuria) and management education, study participants were divided into 3 groups: no diabetes, adherence, and non-adherence. Outcome variables included poor overall sleep quality and sleep disturbances, as measured by the Pittsburgh Sleep Quality Index. Results: The study included 934 participants in the adherence group (2.0%) and 13 420 in the non-adherence group (20.2%). Participants displaying non-adherence were significantly more likely to report poor overall sleep quality (adjusted odds ratio [aOR], 1.09; 95% confidence interval [CI], 1.04 to 1.13) and to experience sleep fragmentation, nocturia, pain during sleep, and difficulty falling asleep compared to participants without diabetes. Even in the earlier stage of diabetes, non-adherent participants were more likely to report poor sleep quality (aOR, 1.06; 95% CI, 1.00 to 1.18). Conclusions Patients with diabetes who do not follow management guidelines are more likely to experience poor sleep quality than those without diabetes. Emphasizing diabetes management and increasing awareness of management strategies may improve sleep quality among patients with this disease.

Objectives: Adhering to management guidelines, including routine follow-up and education, is crucial for the effective management of chronic diseases such as diabetes. Uncontrolled diabetes is linked to poor sleep quality. We used nationally representative data from community-dwelling Koreans to investigate potential associations between non-adherence to diabetes management and poor sleep quality. Methods: Of the 228 340 participants in the 2018 Korea Community Health Survey, we analyzed data from 68 246 participants aged 65 years and older. Based on their diabetes status and adherence to diabetes-related tests (glycated hemoglobin, fundus examination, and urine microalbuminuria) and management education, study participants were divided into 3 groups: no diabetes, adherence, and non-adherence. Outcome variables included poor overall sleep quality and sleep disturbances, as measured by the Pittsburgh Sleep Quality Index. Results: The study included 934 participants in the adherence group (2.0%) and 13 420 in the non-adherence group (20.2%). Participants displaying non-adherence were significantly more likely to report poor overall sleep quality (adjusted odds ratio [aOR], 1.09; 95% confidence interval [CI], 1.04 to 1.13) and to experience sleep fragmentation, nocturia, pain during sleep, and difficulty falling asleep compared to participants without diabetes. Even in the earlier stage of diabetes, non-adherent participants were more likely to report poor sleep quality (aOR, 1.06; 95% CI, 1.00 to 1.18). Conclusions Patients with diabetes who do not follow management guidelines are more likely to experience poor sleep quality than those without diabetes. Emphasizing diabetes management and increasing awareness of management strategies may improve sleep quality among patients with this disease.

Objectives: Adhering to management guidelines, including routine follow-up and education, is crucial for the effective management of chronic diseases such as diabetes. Uncontrolled diabetes is linked to poor sleep quality. We used nationally representative data from community-dwelling Koreans to investigate potential associations between non-adherence to diabetes management and poor sleep quality. Methods: Of the 228 340 participants in the 2018 Korea Community Health Survey, we analyzed data from 68 246 participants aged 65 years and older. Based on their diabetes status and adherence to diabetes-related tests (glycated hemoglobin, fundus examination, and urine microalbuminuria) and management education, study participants were divided into 3 groups: no diabetes, adherence, and non-adherence. Outcome variables included poor overall sleep quality and sleep disturbances, as measured by the Pittsburgh Sleep Quality Index. Results: The study included 934 participants in the adherence group (2.0%) and 13 420 in the non-adherence group (20.2%). Participants displaying non-adherence were significantly more likely to report poor overall sleep quality (adjusted odds ratio [aOR], 1.09; 95% confidence interval [CI], 1.04 to 1.13) and to experience sleep fragmentation, nocturia, pain during sleep, and difficulty falling asleep compared to participants without diabetes. Even in the earlier stage of diabetes, non-adherent participants were more likely to report poor sleep quality (aOR, 1.06; 95% CI, 1.00 to 1.18). Conclusions Patients with diabetes who do not follow management guidelines are more likely to experience poor sleep quality than those without diabetes. Emphasizing diabetes management and increasing awareness of management strategies may improve sleep quality among patients with this disease.

OBJECTIVES: To test the hypothesis that tobacco exposure is associated with elevated blood pressure (EBP) in Korean adolescents, and that the association is dose dependent. METHODS: This cross-sectional study used data from the 2011-2020 Korea National Health and Nutrition Survey (KNHANES). Subjects were eligible if they were 13-18 years at the time of participation in KNHANES. Tobacco exposure was defined by urine cotinine level. The main outcomes were EBP and hypertension. Statistical analyses were conducted using SAS version 9.4 with appropriate sampling weights to account for the complex survey design, stratification, and cluster variable. RESULTS: A total of 2,518 adolescents was included in the analysis, representing 2.5 million Korean adolescents. The mean± standard deviation participant age was 15.3±1.7 years, and 55.3% were male. The number of participants with active tobacco smoke exposure was 283 (11.2%), passive tobacco smoke exposure was 145 (5.8%), and no smoke exposure was 2,090 (83.0%). Analysis of the 2,518 urine-cotinine-verified participants showed that tobacco smoke exposure had a significant effect on EBP: with an odds of elevated blood pressure of 3.00 (95% confidence interval [CI], 1.14 to 7.89). The odds of hypertension were 3.61 (95% CI, 1.13 to 11.49) in the active smoking group compared with the no tobacco exposure group after adjustment for potential confounders. CONCLUSIONS It is necessary to present a range of public health plans to reduce tobacco exposure that affects adolescents’ blood pressure, and further research with a larger number of participants using urine cotinine as a biomarker is needed.

OBJECTIVE: To prospectively compare technical success rate and reliable measurements of virtual touch quantification (VTQ) elastography and elastography point quantification (ElastPQ), and to correlate liver stiffness (LS) measurements obtained by the two elastography techniques. MATERIALS AND METHODS: Our study included 85 patients, 80 of whom were previously diagnosed with chronic liver disease. The technical success rate and reliable measurements of the two kinds of point shear wave elastography (pSWE) techniques were compared by χ2 analysis. LS values measured using the two techniques were compared and correlated via Wilcoxon signed-rank test, Spearman correlation coefficient, and 95% Bland-Altman limit of agreement. The intraobserver reproducibility of ElastPQ was determined by 95% Bland-Altman limit of agreement and intraclass correlation coefficient (ICC). RESULTS: The two pSWE techniques showed similar technical success rate (98.8% for VTQ vs. 95.3% for ElastPQ, p = 0.823) and reliable LS measurements (95.3% for VTQ vs. 90.6% for ElastPQ, p = 0.509). The mean LS measurements obtained by VTQ (1.71 ± 0.47 m/s) and ElastPQ (1.66 ± 0.41 m/s) were not significantly different (p = 0.209). The LS measurements obtained by the two techniques showed strong correlation (r = 0.820); in addition, the 95% limit of agreement of the two methods was 27.5% of the mean. Finally, the ICC of repeat ElastPQ measurements was 0.991. CONCLUSION: Virtual touch quantification and ElastPQ showed similar technical success rate and reliable measurements, with strongly correlated LS measurements. However, the two methods are not interchangeable due to the large limit of agreement.
Elasticity Imaging Techniques* ; Humans ; Liver Cirrhosis ; Liver Diseases ; Liver* ; Methods* ; Prospective Studies*

Depression is a highly prevalent mental health disease that, fortunately, can easily be treated. However, depression is often inadequately managed because only some depressive patients seek professional help, and even when they do, they often discontinue their treatments. Research has shown that there is a high association between suicide and depression. Proper depression management plans help depressive patients adhere to treatment medication and support them in continuing treatment. These efforts for treating depression may reduce suicidal ideation and behavior. Simply giving screening results to clinicians was not enough to have treatment outcomes. Besides informing clinicians of patients' screening results, staff-assisted care, including educating patients, following-up on assessments and treatment schedules, helping patients adhere to prescribed antidepressant medications, and referring to mental health care professionals would be critical to achieving successful treatment outcomes. A higher level of staff-assisted care has been reported to have higher treatment outcomes. Future studies in Korea are needed to establish a depression screening system, including post-screening management programs in primary care or community care settings, and to assess the effectiveness of this system. Attaining a higher depression diagnosis rate through screening and running post-screening management programs with sufficient staffing for treatment adherence will reduce depression relapse and suicidal attempts.
Appointments and Schedules ; Depression ; Humans ; Korea ; Mass Screening ; Mental Health ; Primary Health Care ; Recurrence ; Running ; Suicidal Ideation ; Suicide

OBJECTIVES: Little is known about the influence of urinary incontinence and depression on individual's QOL(Quality of life). We aimed to clarify how the interaction between urinary incontinence and depression influences one's QOL. METHODS: A total of 1262 patients were enrolled in this study from April, 2011 to July, 2011. We estimated the severity of depressive symptoms and QOL, using SGDS-K, EQ-5D. We also investigated the morbidity of urinary incontinence for each patient in person or by questionnaire. Comparisons of QOL between groups with or without depression, with or without urinary incontinence were established using t-test, ANOVA and Scheffe's post hoc analysis. The interaction between urinary incontinence and depression was analyzed by each domain of QOL, using multiple regression analysis. RESULTS: Patients with depression and urinary incontinence showed significantly higher EQ-5D scores on every domain of QOL than other patients, which means significantly lower QOL. Patients with depression, no urinary incontinence reported lower QOL, especially in the domain of ‘usual activity’, ‘anxiety’ and ‘visual analogue scale(VAS)’, whereas those with urinary incontinence, no depression showed lower QOL in ‘motility’, ‘usual activities’ and ‘pain’ domain. Statistically significant interaction effects of two diseases were observed in the domain of ‘VAS’, ‘self care’ and ‘anxiety’. CONCLUSIONS: Comorbidity of urinary incontinence and depression showed significantly lower QOL of patients, compared with urinary incontinence or depression respectively, which implies additive interaction effects of the two diseases. Optimal diagnosis and treatment of depression should be emphasized for patients with urinary incontinence.
Aged ; Comorbidity ; Depression ; Diagnosis ; Humans ; Quality of Life ; Urinary Incontinence