The purpose of clinical trials is to find evidences for the effects of experimental new drugs or treatments on human. For the successful clinical trials, it is not sufficient to use statistics only for the analyses of collected data, but it is necessary to extend the usage of statistics in various ways. At the beginning of the study, one needs to use statistics for systematically and concretly planning the study. For this, we discussed the usage of statistics in defining the effect, determining the sample size, statistical analyses, and so on.
Humans ; Sample Size

Over the past several decades, the assessment of quality of life (QoL) has increasingly played a prominent role in both clinical practice and research regardless of the medical field. Palliative care is defined as an approach that improves the QoL of patients and their families and optimizing their QoL is the primary goal of palliative care. However, it is difficult to compare related studies due to several obstacles such as discrepancies in definitions for palliative medicine, lack of consensus on the central domains and diverse instruments. In this paper, we examined the current status of and challenges in QoL studies and discussed possible solutions. We are convinced this review will be helpful for further palliative care studies.
Consensus ; Humans ; Palliative Care ; Quality of Life

The purpose of this paper is to suggest a direction for future studies based on the analysis of the articles published in the Korean Journal of Hospice and Palliative Care from 1998 to 2012. A total of 240 articles (51 reviews, 189 original) were examined in three five-year groups. Categories of analysis include authors' background (profession, region) and general characteristics and qualitative aspects of the original paper (participants, topic, study design, data analysis, ethical consideration, multidisciplinary approach, research funds and sample size estimation). While the journal publishes more of articles than before, it is mainly due to the increase in the number of review articles, not original articles. As for study topics, healthcare industry and physical symptoms were most frequently studied. The disparity in authors' regional background is fading, and more articles are published by nurses than before. Moreover, more studies are funded while fewer papers tend to adopt a multidisciplinary approach or focus on care givers. Also, in terms of a study design, the number of experimental and methodological studies has slightly increased. In the qualitative aspect, studies considered ethical issues and collected participation consent, and fewer studies reported an estimated sample size. In data analysis, post-adjustment comparison decreased, and new analytical methods are increasingly used. Our results indicate the need to conduct research with more extensive scientific data in various fields of hospice and palliative care.
Caregivers ; Financial Management ; Health Care Sector ; Hospice Care ; Hospices ; Humans ; Palliative Care ; Sample Size ; Statistics as Topic

PURPOSE: Many clinical guidelines recommend apolipoprotein B (apoB) measurement, particularly in subjects with metabolic syndrome or type 2 diabetes. Recently, we developed a new equation to estimate serum apoB (apoBE). We validated the clinical relevance of apoBE and compared the performance of the equation with conventional lipid measurements and direct measurement of apoB. MATERIALS AND METHODS: Study subjects were recruited from patients who visited the Health Screening Center at Kangbuk Samsung Hospital between January and December 2009 for routine medical examinations (n=78125). For analysis of coronary calcium score, we recruited study subjects from the same institution between January 2007 and December 2010 (n=16493). RESULTS: apoBE was significantly correlated with serum high-sensitivity C-reactive level {r=0.18 [95% confidence interval (CI), 0.18–0.19]} in partial correlation analysis adjusted for age, sex, and body mass index. apoBE was associated with a Framingham risk score indicating more than moderate risk (10-year risk ≥10%), the presence of microalbuminuria, and the presence of coronary artery calcium in multivariate logistic regression analysis. These associations were comparable to those of directly-measured serum apoB [odds ratio per 1 SD 3.02 (2.75–3.27) vs. 2.70 (2.42–3.02) for a Framingham risk score indicating more than moderate risk, 1.31 (1.21–1.41) vs. 1.35 (1.25–1.45) for the presence of microalbuminuria, and 1.33 (1.26–1.41) vs. 1.31 (1.23–1.38) for the presence of coronary calcium score respectively]. These findings were also consistently observed in subgroup analysis for subjects with type 2 diabetes. CONCLUSION: The associations between cardiovascular surrogate markers and apoBE were comparable to those of directly-measured apoB.
Apolipoproteins B ; Apolipoproteins* ; Biomarkers* ; Body Mass Index ; Calcium ; Cardiovascular Diseases* ; Coronary Vessels ; Humans ; Logistic Models ; Mass Screening

Background: Many studies have assessed the risk factors for adverse drug reactions (ADRs) in elderly patients. However, most of these studies have focused on risk factors for ADRs, not serious ADRs (s-ADRs). s-ADRs are commonly found in hospitalized patients. s-ADRs warrant imminent but thorough investigations, given their critical impact on patient health. Therefore, this retrospective study aimed to assess the associated risk factors for s-ADRs in elderly hospitalized patients. Methods: In-patients aged >65 years having ADRs during hospitalization at a university hospital in Korea between 2010 and 2012 were included. Medical professionals spontaneously reported ADRs using an electronic submission system at the study hospital. Further, all descriptions of ADRs were characterized and categorized through the screening of electronic medical records. We compared the characteristics of patients having s-ADRs with those of patients not having s-ADRs. Results: There were 353 cases of ADRs, 67 of which were s-ADRs. Patients taking more than eight concomitant drugs showed the highest odds ratio (OR, 11.99; 95% confidence interval [CI], 3.42–42.03). The ratio of aspartate aminotransferase (AST)/alanine aminotransferase (ALT) was also significantly related to s-ADRs (OR, 2.78; 95% CI, 1.33–5.81). The use of antibiotics (OR, 2.39; 95% CI, 1.13–5.02) and antineoplastics (OR, 4.17; 95% CI, 1.09–15.94) were significant risk factors. Conclusion Our findings highlight the importance of polypharmacy. Liver function tests (AST/ALT ratio) must be monitored carefully within high-risk groups for ADRs.

Continuous deep sedation (CDS) is an extreme form of palliative sedation to relieve refractory symptoms at the end of life. In this study, we shared our experiences with CDS and examined the clinical characteristics associated with survival in patients with terminal cancer who received CDS. We conducted a chart audit of 106 consecutive patients with terminal cancer who received CDS at a single hospice care unit between January 2014 and December 2016. Survival was defined as the first day of admission to the date of death. The associations between clinical characteristics and survival were presented as hazard ratios and 95% confidence intervals using a Cox proportional hazard model. The mean age of participants was 65.2 years, and 33.0% (n=35) were women. Diazepam was the most commonly administered drug, and haloperidol or lorazepam were also used if needed. One sedative was enough for a majority of the patients. Stepwise multivariate analysis identified poor functioning, a high Palliative Prognostic Index score, hyperbilirubinemia, high serum ferritin levels, and a low number of sedatives as independent poor prognostic factors. Our experiences and findings are expected to be helpful for shared decision-making and further research on palliative sedation.

Background: We investigated whether metabolic dysfunction-associated fatty liver disease (MAFLD) is associated with an elevated risk of all-cause and cardiovascular mortality using a large-scale health examination cohort. Methods: A total of 394,835 subjects in the Kangbuk Samsung Health Study cohort were enrolled from 2002 to 2012. Participants were categorized by the presence of nonalcoholic fatty liver disease (NAFLD) and MAFLD as follows: normal subjects; patients with both NAFLD and MAFLD; patients with NAFLD only; and patients with MAFLD only. Cox proportional hazards models were used to analyze the risk of mortality. Results: During a median 5.7 years of follow-up, 20.69% was patients with both NAFLD and MAFLD, 1.51% was patients with NAFLD only, and 4.29% was patients with MAFLD only. All-cause and cardiovascular death was higher in patients with MAFLD than those without MAFLD (P<0.001, respectively). In patients with MAFLD only, the hazard ratio (HR) of all-cause and cardiovascular death was 1.35 (95% confidence interval [CI], 1.13 to 1.60) and 1.90 (95% CI, 1.26 to 2.88) after adjusting for age, which lost its statistical significance by multivariable adjustments. Compared to patients with less than two components of metabolic dysfunction, patients with more than two components of metabolic dysfunction were a higher risk of cardiovascular death (HR, 2.05; 95% CI, 1.25 to 3.38) and only women with more than two components of metabolic dysfunction were a higher risk of all-cause death (HR, 1.44; 95% CI, 1.02 to 2.03). Conclusion MAFLD criteria could identify a high-risk group for all-cause and cardiovascular death.

BACKGROUND: Many studies have attempted to develop relatively simple and easy noninvasive measurements of atherosclerosis (NIMA), and each NIMA assesses different atherosclerotic properties. We, therefore, investigated the association between metabolic syndrome (MetS) components and different NIMAs. METHODS: This study included 1,132 Korean subjects over 20 years of age who had visited a Health Promotion Center in Korea. Carotid injury (increased carotid intima-media thickness or plaques) was evaluated by ultrasonography and arterial stiffness by brachial-ankle pulse wave velocity. The MetS components were assessed according to the Asian criteria of the American Heart Association/National Heart, Lung, and Blood Institute. RESULTS: Both arterial stiffness and carotid injury gradually deteriorated with increase in the number of MetS components. Arterial stiffness and carotid injury were associated with different MetS components, each of which had varying impact. After adjustment for all possible confounders such as age, sex, and lifestyle, elevated blood pressure (BP) was found to have the strongest association with arterial stiffness, whereas central obesity, impaired fasting plasma glucose, and elevated BP had comparable connection with carotid atherosclerosis. CONCLUSION: Individual MetS components were related with subclinical atherosclerosis in different ways. Elevated BP showed the strongest association with arterial stiffness, while central obesity, impaired fasting plasma glucose, and elevated BP showed good correlation with carotid atherosclerosis.
Adult ; Asian Continental Ancestry Group ; Atherosclerosis ; Blood Pressure ; Carotid Artery Diseases ; Carotid Artery Injuries ; Carotid Intima-Media Thickness ; Fasting ; Glucose ; Health Promotion ; Heart ; Humans ; Korea ; Life Style ; Lung ; Obesity, Abdominal ; Plasma ; Pulse Wave Analysis ; Vascular Stiffness

The objective of the present study was to determine the relationship between serum uric acid (SUA) level and the presence of nonalcoholic fatty liver disease (NAFLD). We analyzed data of 9,019 Koreans who visited a health check up center. The SUA levels of all of these subjects were within the normal range. The participants were divided into 4 groups according to the quartiles of the SUA levels for both sexes. Hepatic steatosis was diagnosed on the basis of ultrasonographic findings. Multivariate logistic regression modeling was performed across the SUA quartiles. The presence of NAFLD and metabolic abnormalities were found significantly in subjects with high-normal SUA levels. After adjustment for age, metabolic components, and the liver-function test, the adjusted odds ratio (OR, 95% CIs) for the presence of NAFLD in the subjects with the highest SUA level was 1.46 (1.17-1.82) for men and 2.13 (1.42-3.18) for women, as compared to the subjects with the lowest SUA level. Our results suggest that increased SUA concentrations, even within the normal range, are independently associated with the presence of NAFLD.
Adult ; Fatty Liver/*blood/physiopathology ; Female ; Humans ; Liver Function Tests ; Logistic Models ; Male ; Middle Aged ; Republic of Korea ; Risk Factors ; Sex Characteristics ; Uric Acid/*blood

PURPOSE: Pain is the most common and influential symptom in cancer patients. Few studies concerning pain intensity in the terminally ill cancer patients have been done. This study aimed to identify factors related with more than moderate pain. METHODS: This study used secondary data of 162 terminal cancer inpatients at the palliative ward of six training hospitals in Korea. Physician-assessed pain assessment was by 10 point numeric rating scale. Substantial pain was defined more than moderate intensity by the Korean National Guideline for cancer pain. The Korean version of the MD Anderson Symptom Inventory was self-administered to assess symptoms. Survival prediction was estimated by the attending physicians at the time of admission. RESULTS: Less than six weeks of predicted survival and more than numeric rating of six for worst drowsiness in the previous 24 h were significantly related to substantial pain (P=0.012 and P=0.046, respectively). The dose of opioid analgesics was positively related to substantial pain (P=0.004). CONCLUSION: Factors positively related to substantial pain were less than six weeks of predicted survival and considerable drowsiness. Careful monitoring and active preparation for pain are required in terminal cancer patients having those factors.
Analgesics, Opioid ; Humans ; Inpatients ; Korea ; Pain Measurement ; Sleep Stages ; Terminally Ill