OBJECTIVE: To analyse neonatal outcomes of the very low birthweight infants born to women who underwent an indicated preterm delivery and spontaneous preterm delivery. METHODS: We performed an observational study of 150 very low birthweight(<1500 grams) infants delivered at Samsung Medical Center. The study population was limited to singleton infants without major congenital anomalies. The primary reason for delivery was categorized as indicated preterm delivery or spontaneous preterm delivery. Selected neonatal outcomes were compared between infants born to women in each of these groups. RESULTS: Univariate analyses showed some survival benefits in infants born to women who underwent indicated preterm delivery. Selected neonatal outcomes, however, did not differ between the groups in the multiple logistic regression analysis. CONCLUSION: There was no survival advantage to the very low birthweight infants born to women who underwent an indicated preterm delivery compared to those born to women with spontaneous preterm delivery.
Female ; Humans ; Infant* ; Logistic Models ; Observational Study

No abstract available.
Anticoagulants ; Observational Study ; Venous Thrombosis ; Warfarin

OBJECTIVE: To determine if the physical design and organizational structure of rehabilitation stroke unit (RSU) is related to the amount of patients' activity pattern. METHOD: An observational study was conducted using behavioral mapping method. Time samples of the motor activity of patients following stroke were taken at 10-minute interval, between 7 AM and 7 PM both on weekdays and weekends. At each observation, physical activity patterns, location in which the patients spent their time, and other person present were recorded. RESULTS: RSU patient spent less time in non-therapeutic activity and more time in therapeutic activity (p<0.05). There were significant differences in the locations of patient's position between the two types of ward (p<0.05). RSU patients had significantly more interaction with formal carerand less time disengaged (p<0.05). The proportion of time in therapeutic activity was low in all location, with patients spending many hours in bed and doing nothing. There was no significant differences in total Functional Independence Measure (FIM) scores at admission and on discharge, FIM gain, and FIM efficiency between RSU and mixed rehabilitation ward (p<0.05). CONCLUSION: In spite of quantitative difference, the two wards had similar patterns of treatment activity and deployment of staff. These maybe resulted in similar treatment experiences for patient and no functional differences between two wards. It appears that strategies are required so that patients can be practicing at an more appropriate level.
Humans ; Motor Activity ; Observational Study ; Rehabilitation* ; Stroke*

Introduction: There is an ever-increasing prevalence of type 2 diabetes mellitus (T2DM) in the Philippines. This observational study aimed to evaluate the effectiveness and safety of vildagliptin as monotherapy or combination therapy in patients with T2DM in a real-life setting from the Philippines. Methods: This 24-week, non-interventional study enrolled adult T2DM patients, receiving vildagliptin either as monotherapy or dual/triple combination therapy. The primary endpoint was change in HbA1c from baseline to week 24. The secondary endpoints included proportion of patients achieving the glycemic goals HbA1c ≤6.5% and ≤7.0%, and safety assessment at week 24. Results: Of the 385 patients enrolled, 267 (69.35%) completed the study. The mean±standard deviation age was 54.72±11.06 years, HbA1c, body mass index, and diabetes duration were 8.54±1.81%, 27.35±5.58 kg/m2 and 3.04±4.88 years, respectively. Overall, treatment with vildagliptin resulted in HbA1c reduction of 2.02±1.68 (p<0.0001) from baseline to week 24. At week 24, 60.64% and 74.47% of the patients achieved the glycemic target of HbA1c ≤6.5% and ≤7.0% respectively. Seven serious adverse events (AEs) unrelated to the study drug were reported, most of which (24/28) were mild or moderate in severity; 85.71% of the AEs reported were not drug related. One hypoglycemic event (with vildagliptin/metformin single pill combination [SPC]) and one death (with vildagliptin/metformin free dose and SPC, due to severe pneumonia) were reported at week 12. Discussion: This observational study showed that treatment with vildagliptin monotherapy or combination therapy for 24 weeks in patients with T2DM in the Philippines provided statistically significant reductions in HbA1c. Overall, vildagliptin (mono or dual/triple therapy) was well-tolerated and demonstrated a favorable safety profile with no new safety signal. Conclusion Treatment with vildagliptin as monotherapy or in combination with other antihyperglycemic agents resulted in good glycemic control and was well-tolerated in patients with T2DM in the Philippines, under real-world settings.
Diabetes Mellitus, Type 2 ; Observational Study

A case control study is a type of observational study. In this study design, participants are selected to participate depending on their outcome status. Cases are participants with outcome of interest whereas controls are participants who do not have the outcome of interest. These studies estimate the odds ratio or the odds between the exposure and health outcome, however they cannot prove causality. Advantages of case control studies include the following: inexpensive, easy to design and implement, and are used to study rare outcomes. Case control studies are prone to certain research bias but can be addressed by the investigator through careful designing and planning. This paper describes the case control studies, their advantages, bias in case control studies and how to address them, and discuss the steps in how to conduct this type of study design.

BACKGROUND: Pre-procedural lumbar ultrasound scanning is a reliable tool to estimate the skin to epidural distance (SED). We conducted an observational study to compare the SED between the sitting position and lateral position using pre-procedural ultrasound imaging of the lumbar spine in parturients. METHODS: Using a 2–5 MHz curvilinear transducer, we obtained images of the lumbar interspaces from L2-3 to L5-S1 in the paramedian sagittal oblique view. The individual distance from the skin to the ligamentum flavum-dura mater unit was measured at the level of L2-3, L3-4, L4-5, and L5-S1 in the left lateral position (distance in lateral position; D-lat). Subsequently, participants were placed in the sitting position, and the distance was measured in the same manner (distance in sitting position; D-sit). Data were grouped according to body mass index (BMI; kg/m²) measurements of ≥ 25 or < 25 and analyzed. The primary outcome was the change determined by ultrasound between D-lat and D-sit at the same lumbar level according to position. RESULTS: Thirty parturients were studied. The difference between D-lat and D-sit in the same lumbar level was not statistically significant. The mean changes between D-lat and D-sit in the same lumbar level were less than 0.18 cm. In BMI ≥ 25 group, the difference between D-lat and D-sit were greater than that of BMI < 25 group at L3-4 level (P = 0.042). CONCLUSIONS: It is important for clinicians to consider that position change is associated with greater differences in SED in obese parturients (BMI ≥ 25) compared with thin parturients (BMI < 25). For obese parturients, the sitting position may be helpful.
Body Mass Index ; Observational Study ; Skin ; Spine ; Transducers ; Ultrasonography*

BACKGROUND AND PURPOSE: Left ventricular (LV) diastolic dysfunction, developed in relation to myocardial dysfunction and remodeling, is documented in 15%-25% of the population. However, its role in functional recovery and recurrent vascular events after acute ischemic stroke has not been thoroughly investigated. METHODS: In this retrospective observational study, we identified 2,827 ischemic stroke cases with adequate echocardiographic evaluations to assess LV diastolic dysfunction within 1 month after the index stroke. The peak transmitral filling velocity/mean mitral annular velocity during early diastole (E/e') was used to estimate LV diastolic dysfunction. We divided patients into 3 groups according to E/e' as follows: <8, 8-15, and ≥15. Recurrent vascular events and functional recovery were prospectively collected at 3 months and 1 year. RESULTS: Among included patients, E/e' was 10.6±6.4: E/e' <8 in 993 (35%), 8-15 in 1,444 (51%), and ≥15 in 378 (13%) cases. Functional dependency or death (modified Rankin Scale score ≥2) and composite vascular events were documented in 1,298 (46%) and 187 (7%) patients, respectively, at 3 months. In multivariable analyses, ischemic stroke cases with E/e' ≥15 had increased odds of functional dependence or death at 3 months (adjusted OR [95% CI]: 1.73 [1.27-2.35]) or 1 year (1.47 [1.06-2.06]) and vascular events within 1 year (1.65 [1.08-2.51]). Subgroups with normal ejection fraction or sinus rhythm exhibited a similar overall pattern and direction. CONCLUSIONS: LV diastolic dysfunction was associated with poor functional outcomes and composite vascular events up to 1 year.
Diastole ; Echocardiography ; Humans ; Observational Study ; Prospective Studies ; Retrospective Studies ; Stroke*

PURPOSE: Rotavirus vaccine (RV) was introduced in Korea since 2007, and intussusception (IS) remains an important safety concern. This study investigated the trend of IS occurrence related to RV as well as the temporal relevance between vaccination and IS in children. METHODS: We collected data of the patient aged ≤18 years with IS admitted to Gachon University Gil Medical Center, 2003 to 2015. For the patients that have occurred since 2008, the immunization records of RV were collected. The proportion of cases <1 year was calculated by the year and the temporal relationship between vaccination and IS occurrence was analyzed. RESULTS: A total of 696 IS cases were noted. The cases <1 year were 30.7% (214/696). Although the incidence of all IS has increased over the 13-year period (from 74.1 in 2003 to 89.5 in 2015, linear by linear association, P=0.003), the incidence of IS <1 year has not increased (from 56.9 in 2003 to 53.3 in 2015, P=0.910), and the proportion of cases <1 year has decreased (from 35.4 in 2003 to 18.8 in 2015, P=0.000). Of 128 cases <1 year since 2008, 53.9% received RV. In the vaccinated group, 10 cases of IS occurred within 30 days, and eight cases did within 31 to 60 days. Numbers of IS after first, second, and third dose were three, 10, and five cases, respectively. CONCLUSIONS: Occurrence of IS in children <1 year of age did not increase since the introduction of RV. Further monitoring is essential for evaluation of vaccine safety.
Child ; Humans ; Immunization ; Incidence ; Intussusception* ; Korea ; Observational Study* ; Rotavirus* ; Vaccination

PURPOSE: The purpose of this study is to measure the range of normal eye movement and to evaluate the effect of age on the range of ocular movement in a normal population. METHODS: We conducted a prospective observational study of 85 subjects aged between 5 and 91 years. Photographs were taken of the cardinal position, and these images were analyzed using an image analysis software (Adobe Photoshop 6.0, Adobe, San Jose, CA, USA). To measure the range of eye movement, the preprocessed images were analyzed using the Image J program. The range of movement of the eyeball was quantitatively measured using corneal limbal analysis. Specifically, the ranges of ocular movement according to adduction, abduction, elevation, and depression were measured. RESULTS: The normal movement ranges were 44.4 ± 6.9° in adduction, 44.8 ± 5.5° in abduction, 27.7 ± 7.6° in elevation, and 46.7 ± 8.4° in depression. Adduction, abduction, and elevation were negatively correlated with age (R² = 0.220, R² = 0.126, and R² = 0.304, respectively, all p < 0.001). However, there was no significant correlation between age and depression (R² = 0.030, p = 0.113). CONCLUSIONS: For all ages, the range of normal ocular movement in the horizontal direction was symmetric, while the range of ocular movement in elevation was smaller than that of depression. As age increased, the range of ocular movement decreased in all directions except depression, but depression did not decrease with age. When assessing eye movement, it is necessary to consider the range of ocular movements relative to both the movement direction and changes in the ocular movement range according to age.
Aging ; Depression ; Eye Movements* ; Observational Study ; Prospective Studies

Sorafenib, the first-approved molecular targeted agent (MTA), is actively used in patients with advanced hepatocellular carcinoma (HCC) worldwide. Accumulating experiences suggest that the efficacy of this drug is modest and the adverse events are not minimal, although those are manageable. Given that newer drugs targeting various molecules involved in hepatocarcinogenesis have been failed to show efficacy compared with sorafenib, the perspectives regarding development of novel MTA appear to be gloomy. Nonetherless, it is necessary to maximize the efficacy of sorafenib by combining this drug with locoregional therapies and by finding biomarkers predicting the outcomes of patients treated with sorafenib. A series of data indicate that combining sorafenib and locoregional therapies including transarterial chemoemolization could improve patients outcome. Unfortunately, there has been no biomarkers identified which could predict the response to sorafenib. Global investigation of therapeutic decisions in HCC and of its treatment with sorafeNib (GIDEON) is a global, non-interventional, observational study to evaluate the safety and efficacy of sorafenib, particularly in patients with Child-Pugh B. The final report of GIDEON study is going to be published soon, and the Korean GIDEON data suggest that sorafenib in patients with decreased liver function might be safe and effective as in patients with Child-Pugh A. The way to conquer HCC using molecular approach is still long and the era of immune-oncology seems to get started.
Biomarkers ; Carcinoma, Hepatocellular* ; Humans ; Liver ; Observational Study ; Pemetrexed