Randomized controlled trials (RCTs) are considered the most rigorous study design for testing hypotheses and the gold standard for evaluating intervention effectiveness. However, RCTs are often conducted under the assumption of ideal conditions that may differ from real-world scenarios in which various issues, such as loss to follow-up, mistakes in participant enrollment or intervention, and low subject compliance or adherence, may occur. There are various group-defining strategies for analyzing RCT data, including the intention-to-treat (ITT), as-treated, and per-protocol (PP) approaches. The ITT principle involves analyzing all participants according to their initial group assignments, regardless of study completion and compliance or adherence to treatment protocols. This approach aims to replicate real-world clinical settings in which several anticipated or unexpected conditions may occur with regard to the study protocol. For the PP approach, only participants who meet the inclusion criteria, complete the interventions according to the study protocols, and have primary outcome data available are included. This approach aims to confirm treatment effects under optimal conditions. In general, the ITT principle is preferred for superiority and inequality trials, whereas the PP approach is preferred for equivalence and non-inferiority trials. However, both analytical approaches should be conducted and their results compared to determine whether significant differences exist. Overall, using both the ITT and PP approaches can provide a more complete picture of the treatment effects and ensure the reliability of the trial results.

Evidence of the ethical appropriateness and clinical benefits of shared decision-making (SDM) are accumulating. This study aimed to not only identify physicians’ perspectives on SDM, and practices related to end-of-life care in particular, but also to gauge the effect of SDM education on physicians in Korea. Methods: A 14-item questionnaire survey using a modified Delphi process was delivered to nephrologists and internal medicine trainees at 17 university hospitals. Results: A total of 309 physicians completed the survey. Although respondents reported that 69.9% of their practical decisions were made using SDM, 59.9% reported that it is not being applied appropriately. Only 12.3% of respondents had received education on SDM as part of their training. The main obstacles to appropriate SDM were identified as lack of time (46.0%), educational materials and tools (29.4%), and education on SDM (24.3%). Although only a few respondents had received training on SDM, the proportion of those who thought they were using SDM appropriately in actual practice was high; the proportion of those who chose lack of time and education as factors that hindered the proper application of SDM was low. Conclusion: The majority of respondents believed that SDM was not being implemented properly in Korea, despite its use in actual practice. To improve the effectiveness of SDM in the Korean medical system, appropriate training programs and supplemental policies that guarantee sufficient application time are required.

Background/Aims: Although the incidence and mortality of tuberculosis are decreasing in South Korea, the number of applications for financial assistance with the cost of tuberculosis treatment made by individuals from vulnerable groups was 3.8 times higher in 2019 compared to 2017 (Tuberculosis Relief Belt Project, 2019). Methods: We analyzed the data of patients who received financial aid for tuberculosis treatment (in the period 2014-2018) from the Tuberculosis Relief Belt Project, which was designed to assist vulnerable groups. This study analyzed 137 subjects, and the independent variables included patient factors (age, gender, nationality, tuberculosis type, number of comorbidities, and place of residence) and treatment type (outpatient or inpatient). The dependent variable was the treatment outcome. Results: The likelihood of treatment success was significantly lower for patients with one (odds ratio [OR] 0.202), two (OR 0.147), or three or more (OR 0.070) comorbidities compared to those with no comorbidities. This was also the case for patients living alone (OR 0.097), and for those classified as homeless (OR 0.053). Korean patients (OR 8.512) had a significantly higher probability of a successful treatment outcome than foreigners. Conclusions Appropriate community-based management of individuals with tuberculosis from vulnerable groups, including foreigners, people with comorbidities, people living alone, and people with an unstable residential situation or homeless status, is important.

Most diseases have more than two interventions or treatment methods, and the application of network meta-analysis (NMA) studies to compare and evaluate the superiority of each intervention or treatment method is increasing. Understanding the concepts and processes of systematic reviews and meta-analyses is essential to understanding NMA. As with systematic reviews and meta-analyses, NMA involves specifying the topic, searching for and selecting all related studies, and extracting data from the selected studies. To evaluate the effects of each treatment, NMA compares and analyzes three or more interventions or treatment methods using both direct and indirect evidence. There is a possibility of several biases when performing NMA. Therefore, key assumptions like similarity, transitivity, and consistency should be satisfied when performing NMA. Among these key assumptions, consistency can be evaluated and quantified by statistical tests. This review aims to introduce the concepts of NMA, analysis methods, and interpretation and presentation of the results of NMA. It also briefly introduces the emerging issues in NMA, including methods for evaluation of consistency.

Most diseases have more than two interventions or treatment methods, and the application of network meta-analysis (NMA) studies to compare and evaluate the superiority of each intervention or treatment method is increasing. Understanding the concepts and processes of systematic reviews and meta-analyses is essential to understanding NMA. As with systematic reviews and meta-analyses, NMA involves specifying the topic, searching for and selecting all related studies, and extracting data from the selected studies. To evaluate the effects of each treatment, NMA compares and analyzes three or more interventions or treatment methods using both direct and indirect evidence. There is a possibility of several biases when performing NMA. Therefore, key assumptions like similarity, transitivity, and consistency should be satisfied when performing NMA. Among these key assumptions, consistency can be evaluated and quantified by statistical tests. This review aims to introduce the concepts of NMA, analysis methods, and interpretation and presentation of the results of NMA. It also briefly introduces the emerging issues in NMA, including methods for evaluation of consistency.

Background: Protease-activated protein-2 (PAR2) has been reported to regulate hepatic insulin resistance condition in type 2 diabetes mice. However, the mechanism of lipid metabolism through PAR2 in obesity mice have not yet been examined. In liver, Forkhead box O1 (FoxO1) activity induces peroxisome proliferator-activated receptor γ (PPARγ), leading to accumulation of lipids and hyperlipidemia. Hyperlipidemia significantly influence hepatic steatoses, but the mechanisms underlying PAR2 signaling are complex and have not yet been elucidated. Methods: To examine the modulatory action of FoxO1 and its altered interaction with PPARγ, we utilized db/db mice and PAR2-knockout (KO) mice administered with high-fat diet (HFD). Results: Here, we demonstrated that PAR2 was overexpressed and regulated downstream gene expressions in db/db but not in db+ mice. The interaction between PAR2/β-arrestin and Akt was also greater in db/db mice. The Akt inhibition increased FoxO1 activity and subsequently PPARγ gene in the livers that led to hepatic lipid accumulation. Our data showed that FoxO1 was negatively controlled by Akt signaling and consequently, the activity of a major lipogenesis-associated transcription factors such as PPARγ increased, leading to hepatic lipid accumulation through the PAR2 pathway under hyperglycemic conditions in mice. Furthermore, the association between PPARγ and FoxO1 was increased in hepatic steatosis condition in db/db mice. However, HFD-fed PAR2-KO mice showed suppressed FoxO1-induced hepatic lipid accumulation compared with HFD-fed control groups. Conclusion Collectively, our results provide evidence that the interaction of FoxO1 with PPARγ promotes hepatic steatosis in mice. This might be due to defects in PAR2/β-arrestin-mediated Akt signaling in diabetic and HFD-fed mice.

Purpose: Melanoma is a potentially fatal cutaneous malignancy and regional lymph node (LN) metastases are the most important predictors of mortality. This study aimed to analyze clinical features and risk factors of complications associated with inguinal LN dissection (LND) to establish treatment protocols. Methods: This single-center retrospective study (2000 to 2018) consisted of patients who underwent inguinal area sentinel LN biopsy (SLNB) or LND due to malignant melanoma. Risk factors and outcomes were analyzed. Results: One hundred patients underwent SLNB alone (n=67; patients with negative SLNB), complete LND (CLND) after positive SLNB (n=19), or radical LND without SLNB (n=14). Five-year overall survival and disease-free survival rates among these groups were 87.3%, 57.4%, and 61.9%, and 59.0%, 22.7%, and 28.1%, respectively. The complication rate in the SLNB alone group was lower than the other groups (22.4% vs. 47.4% and 35.7%, respectively; P=0.048). Seroma was the most common complication in the SLNB alone group (15.0%); lymphedema was most common in the CLND after SLNB group (21.1%). Multivariate analysis of risk factors for postoperative complications found the hazard ratio for body mass index >28 kg/m2 was 4.376 (95% confidence interval [CI], 1.243–15.401; P=0.022). The hazard ratio for LND (including CLND after SLNB and radical LND without SLNB) was 3.263 (95% CI, 1.248–8.529; P=0.016). Conclusion Inguinal LND is a higher risk procedure compared to SLNB and other sites for postoperative complications, irrespective of meticulous surgical techniques. More studies are needed to establish treatment protocols (e.g., observation vs. CLND after a positive SLNB result) and the risks and benefits in Asian populations.

Purpose: Melanoma is a potentially fatal cutaneous malignancy and regional lymph node (LN) metastases are the most important predictors of mortality. This study aimed to analyze clinical features and risk factors of complications associated with inguinal LN dissection (LND) to establish treatment protocols. Methods: This single-center retrospective study (2000 to 2018) consisted of patients who underwent inguinal area sentinel LN biopsy (SLNB) or LND due to malignant melanoma. Risk factors and outcomes were analyzed. Results: One hundred patients underwent SLNB alone (n=67; patients with negative SLNB), complete LND (CLND) after positive SLNB (n=19), or radical LND without SLNB (n=14). Five-year overall survival and disease-free survival rates among these groups were 87.3%, 57.4%, and 61.9%, and 59.0%, 22.7%, and 28.1%, respectively. The complication rate in the SLNB alone group was lower than the other groups (22.4% vs. 47.4% and 35.7%, respectively; P=0.048). Seroma was the most common complication in the SLNB alone group (15.0%); lymphedema was most common in the CLND after SLNB group (21.1%). Multivariate analysis of risk factors for postoperative complications found the hazard ratio for body mass index >28 kg/m2 was 4.376 (95% confidence interval [CI], 1.243–15.401; P=0.022). The hazard ratio for LND (including CLND after SLNB and radical LND without SLNB) was 3.263 (95% CI, 1.248–8.529; P=0.016). Conclusion Inguinal LND is a higher risk procedure compared to SLNB and other sites for postoperative complications, irrespective of meticulous surgical techniques. More studies are needed to establish treatment protocols (e.g., observation vs. CLND after a positive SLNB result) and the risks and benefits in Asian populations.

Among the different providers of health care big data in Korea, the data provided by the National Health Insurance Database include the medical information of all the citizens who have subscribed to medical insurance. As such, the data have representativeness and completeness. In order to conduct research using these National Health Insurance Database data, it is necessary to understand the characteristics of the claim data to avoid various biases, and to control confounding variables when making various operational definitions in the planning stage of the research. Moreover, without a proper understanding of the big data, it is possible during the analysis and data interpretation to mistakenly interpret the correlation between variables as a causal relationship. Therefore, in order to help advanced medical science, which reflects the medical reality such as medical expenses and number of hospital visits by clearly recognizing and analyzing the characteristics and limitations of health care big data, this author has dealt with the use of data sharing services provided by the National Health Insurance Database.

BACKGROUND: Terminally ill cancer patients suffer from refractory symptoms, and the last option of treatment is to consider sedatives. However, due to concerns that sedation may shorten survival time, some people prefer not to take sedatives. The purpose of this study was to investigate the effects of sedative administration on survival time among terminally ill cancer patients.METHODS: Two hundreds and thirty-seven patients who were hospitalized to the hospice care unit of public hospitals in Seoul from January, 2015 to March, 2016 were analyzed retrospectively. The univariate and multivariate Cox's proportional hazard regression model was used to determine independent factors related to survival time.RESULTS: The usage of sedation was necessary because the incidence of insomnia was 61.4% in the lorazepam only group, and the incidence of delirium was highest in the haloperidol group and the haloperidol with lorazepam group. Interestingly, multivariate analysis showed that male (HR, 1.766; P < 0.001), decreased consciousness (HR, 1.803; P=0.003), anorexia (HR, 1.506; P=0.012), resting dyspnea (HR, 1.757; P < 0.001), elevated serum bilirubin (HR, 1.657; P=0.001), and the haloperidol with lorazepam group (HR, 0.535, P < 0.001) were each significantly associated with survival time. Furthermore, patients in the haloperidol with lorazepam group survived longer than patients with no such medications.CONCLUSION: There is no evidence that treatment with sedative medication shortens the survival time of patients with terminally ill cancer with refractory symptoms.
Anorexia ; Bilirubin ; Consciousness ; Delirium ; Dyspnea ; Haloperidol ; Hospice Care ; Hospices ; Hospitals, Public ; Humans ; Hypnotics and Sedatives ; Incidence ; Lorazepam ; Male ; Multivariate Analysis ; Palliative Care ; Retrospective Studies ; Seoul ; Sleep Initiation and Maintenance Disorders ; Terminally Ill