• Communications for Statistical Applications and Methods
• /
• v.24 no.6
• /
• pp.561-581
• /
• 2017

Bayesian statistics can play a key role in the design and analysis of clinical trials and this has been demonstrated for medical device trials. By 1995 Bayesian statistics had been well developed and the revolution in computing powers and Markov chain Monte Carlo development made calculation of posterior distributions within computational reach. The Food and Drug Administration (FDA) initiative of Bayesian statistics in medical device clinical trials, which began almost 20 years ago, is reviewed in detail along with some of the key decisions that were made along the way. Both Bayesian hierarchical modeling using data from previous studies and Bayesian adaptive designs, usually with a non-informative prior, are discussed. The leveraging of prior study data has been accomplished through Bayesian hierarchical modeling. An enormous advantage of Bayesian adaptive designs is achieved when it is accompanied by modeling of the primary endpoint to produce the predictive posterior distribution. Simulations are crucial to providing the operating characteristics of the Bayesian design, especially for a complex adaptive design. The 2010 FDA Bayesian guidance for medical device trials addressed both approaches as well as exchangeability, Type I error, and sample size. Treatment response adaptive randomization using the famous extracorporeal membrane oxygenation example is discussed. An interesting real example of a Bayesian analysis using a failed trial with an interesting subgroup as prior information is presented. The implications of the likelihood principle are considered. A recent exciting area using Bayesian hierarchical modeling has been the pediatric extrapolation using adult data in clinical trials. Historical control information from previous trials is an underused area that lends itself easily to Bayesian methods. The future including recent trends, decision theoretic trials, Bayesian benefit-risk, virtual patients, and the appalling lack of penetration of Bayesian clinical trials in the medical literature are discussed.

• Clinical and Experimental Pediatrics
• /
• v.50 no.8
• /
• pp.794-798
• /
• 2007

Hepatopulmonary syndrome is a triad that includes: hepatic dysfunction, intrapulmonary vascular dilatation and abnormal arterial oxygenation. The incidence of intrapulmonary vascular dilatations, in adults with end-stage liver disease, has been reported to be 13% to 47%, however the incidence in children is unclear and the cases in Korean children have never been reported. The hepatopulmonary syndrome may occur as a result of chronic liver disease following nonalcoholic steatohepatitis in children with hypothalamic or pituitary dysfunction. We report a case of hepatopulmonary syndrome in a 13-year-old child who had rapidly progressive liver dysfunction secondary to panhypopituitarism after craniopharyngioma resection. Careful monitoring and treatment of endocrine abnormalities and metabolic status, as well as liver function, are required in all children undergoing pituitary tumor resection.

• Journal of Korean Academy of Fundamentals of Nursing
• /
• v.12 no.3
• /
• pp.278-283
• /
• 2005

Purpose: The purpose of this study was to compare changes in learning objectives in Fundamentals of Nursing which were established between 2000 and 2004. Method: 2000, 2004 learning objectives were analyzed with frequencies and percents. Results: There was an increase in the total number of learning objectives used in 2004(n=534) over 2000(n=527). In 2004 compared to 2000, there was an increase in learning objectives related to nursing process, need of oxygenation, need of nutrition, need of temperature regulation, need of activity and exercise, need of comfort, medication, preoperative care. According to Bloom's taxonomy, learning objectives established in 2004, mainly consisted of three domains, 35.5% for comprehension, 23.6% for synthesis, 20.4% for knowledge Changes in learning objectives established in 2004 compared to 2000 decreases in the comprehension domain and increases in the synthesis domain. Conclusion: The learning objectives established in 2004 showed remarkable change when compared to those established in 2000. But the learning objective domains in Bloom's taxonomy were distributed unevenly. For better learning objectives in Fundamentals of Nursing, constant revision will be needed.

• Journal of Korean Academy of Fundamentals of Nursing
• /
• v.19 no.3
• /
• pp.322-333
• /
• 2012

Purpose: The purpose of this study was to evaluate the effects of a newly developed Introduction to Clinical Nursing (ICN) program on critical thinking skills, communication competence, self-efficacy, and clinical performance self-confidence in nursing students in their third year. Methods: One group pre-test and post-test design was used with three data collection time points (pre-test, post-test1 and post-test2). Participants were 74 third year nursing students approaching their first clinical practicum. The new program included (a) simulated clinical encounters regarding situations of assessing hospitalized patents and caring for patients with oxygenation needs, (b) objective structured clinical examination of skills, (c) lectures, and (e) field trips. Data were analyzed using paired t-tests. Results: After the ICN course, critical thinking skills(significant only between pretest and post-test2), communication competence, and clinical performance self-confidence improved significantly (p<.05). There was no improvement in the self-efficacy total score but there was significant improvement in the subscale, self-regulatory efficacy. Conclusions: The study results indicate that the ICN course may be effective in increasing critical thinking skills, communication competence, and clinical performance self-confidence in nursing students. However, the effect size was very small and modifications of this program should be considered to develop more cost-effective educational programs.

• Child Health Nursing Research
• /
• v.5 no.2
• /
• pp.198-210
• /
• 1999

The goal of respiratory management in high risk infants is to maintain proper oxygenation by supporting respiration, therefore to minimize the secondary complications and to promote the maximum growth and development. While on artificial ventilator to achieve this goal, the infants require endotracheal suctioning(ETS) to remove lung secretions. However, the negative effects of ETS in neoates have been documented and include hypoxia, bradycardia, mucosal damage, increased intracranial pressure, and death result. The purpose of the study was to investigate how ETS is currently performed in NICU, which would be beneficial to develop the standardized ETS protocol and to apply it to these population. A national-wide survey on clinical protocol of ETS was performed to 149 neonatal nurses with the average of 3 years and 6 months experience in neonatal nursing, 34.2% of whom was bachelor in nursing. The results showed that about 89% of the nurses initiate En primarily based on the need of the subjects. The aseptic regulation on ETS was used in 83.9% of the subjects. There was no regulation on the length of catheter in 32.9% and on ID/OD ratio in 17.4%. Many nurses administered hyperoygenation/hyperinflation/hyperventilation based on personal knowhow, rather than scientific rationals (77.2%, 40.9%, 75.2%, retrospectively). About 41% of the nurse regulate subjectively the suction power, while 73.8% of them rotate the sub ject's head during suctioning and the half of the nurses was favorable in adapting the closed-suctioning protocol. With the findings of the study, the current clinical application of E% in neonates appears to be based on adult care practices, or personal preference, rather than scientific validation of the safety and effectiveness of the procedure. This study support the needs for developing and applying the standardized ETS protocolin conjunction with the consideration given to the physiologic characteristics of the neonates in respiratory distress.

• Tuberculosis and Respiratory Diseases
• /
• v.45 no.4
• /
• pp.888-895
• /
• 1998

Malaria is one of the most common infectious diseases in the world. Plasmodium falciparum, accounting for nearly all malaria mortality, kills an estimated 1 to 2 million persons yearly and has several features that make it deadlist of malarias. While cerebral malaria is the most common presentation of severe disease, acute lung injury associated with malaria is uncommon but serious and fatal complication. We report two cases of severe malaria with ARDS and multi-organ failure. All two patients traveled to foreign countries, Kenya, Papua New Guinea where choroquine-resistant malaria is distributed. The first case, which developed cerebral malaria, hypoglycemia, multi-organ failure, and ARDS, treated with quinine and mechanical ventilator, but expired due to oxygenation failure. Autopsy showed acute necrotizing infiltration, diffuse eosinophilic fibrinoid deposits along the alveolar space, and alveolar macrophage with malaria pigment The second case also developed multi-organ failure, followed by ARDS, and was treated with quinine, exchange transfusion, plasmapheresis, and mechanical ventilator. He recovered with residual restrictive lung change after treatment.

• Journal of Home Health Care Nursing
• /
• v.11 no.1
• /
• pp.44-56
• /
• 2004

This study was conducted to investigate the evaluation of students on a practical performance of the home health care and to provide data for practical education on the home care nurse institution. Research was performed from March to December. 2002. 40 Respondents participated in the evaluation four times. The data were analysed by using the SPSS/PC + version 10. 0. The results of this study were as followings: 1. The average age of the subjects was 32. Majority of the subjects were interested in home health care. Majority of the subjects were staff nurse(57.5%) and workers at general hospitals(50%). 2. According to the result of the comparison of practical performances. performance evaluations of 20 items were higher when they admitted special practice than when they admitted any other practice. There was an positive increase in the evaluation of health assessment. nursing documentation. explanation. coping with emergency status. coordination and self assertion. In addition to health assessment. CPR. oxygenation. education & consultation. developmental assessment of child. nursing documentation. mastering nursing practice and consideration of client were significantly different. 3. The subjects were useful for practical circumference where they are working at. From these research findings. the following suggestions have been drawn: it is needed to manage practical curriculum variously and to include not only clinical aspect but also organic or administrational aspect and to reflect on students' needs and to choose to be reasonable items and to develop instruments for evaluation capability of home care nurse.

• Investigative Magnetic Resonance Imaging
• /
• v.2 no.1
• /
• pp.50-57
• /
• 1998

MR acoustic sound or noise due to gradient pulsings has been one of the problems in MRI, both in patient scanning as well as in many areas of psychiatric and neuroscience research, such as brain fMRI. Especially in brain fMRI, sound noise is one of the serious noise sources which obscures the small signals obtainable from the subtle changes occurring in oxygenation status in the cortex and blood capillaries. Therfore, we have studied the effects of acoustic or sound noise arising in fMR imaging of the auditory, motor and visual cortices. The results show that the acoustical noise effects on motor and visual responses are opposite. That is, for the motor activity, it shows an increased total motor activation while for the visual stimulation, corresponding(visual) cortical activity has diminished substantially when the subject is exposed to a loud acoustic sound. Although the current observations are preliminary and require more experimental confirmation, it appears that the observed acoustic-noise effects on brain functions, such as in the motor and visual cortices, are new observations and could have significant consequences in data observation and interpretation in future fMRI studies.

• Proceedings of the KSMRM Conference
• /
• 2002.11a
• /
• pp.111-111
• /
• 2002

Purpose： This study is to compare the distinct brain activation between implicit and explicit memory retrieval tasks using a non-invasive blood-oxygenation-level-dependent (BOLD) functional magnetic resonance imaging(fMRI). Materials ＆ Methods： We studied seven right-handed, healthy volunteers aged 21-25 years(mean；22 years) were scanned under a 1.5T Signa Horizon Echospeed MR imager(GE Medical Systems, Milwaukee, U.S.A.). During the implicit and explicit memory retrieval tasks of previously teamed words under the conceptual processing, we acquired fMRI data using gradient-echo EPI with 50ms TE, 3000ms TR, 26cm${\times}$26cm field-of-view, 128${\times}$128 matrix, and ten slices(6mm slice thickness, 1 mm gap) parallel to the AC-PC(anterior commissure and posterior commissure) line. By using the program of statistical parametric mapping(SPM99), functional activation maps were reconstructed and quantified.

• Journal of Chest Surgery
• /
• v.33 no.2
• /
• pp.125-131
• /
• 2000

Background: Hyperinflation during lung ischemia has been known to improve pulmonary functions after reperfusion which may be exerted through a pulmonary vasodilation and avoidance of atelectasis by an increased surfactant release and been known whether the improvement of pulmonary function was the effect of hyperinflation itself or the oxygen content in inflation gas. Therefore we attempted to clarify the effect of hyperinflation with oxygen in pulmonary inflation gas during warm ischemia on pulmonary function after reperfusion to solve the problem of ischemia-reperfusion injury after lung transplantation. Material and Method: sixteen mongrel dogs were randomly divided into two groups: the left lung was inflated to 30-35 cm H2O with 100% oxygen in oxygen group and 100% nitrogen in nitrogen group. The inflated left lung was maintained with warm ischemia for 100 minutes. Arterial and mixed venous blood gas analysis and hemodynamics were measured before ischemia and 30, 60, 120, 180 and 240 minutes afer reperfusion. Lung biopsy was taken for the measurement of lung water content after the end of reperfusion. Result: In oxygen group arterial oxygen tension the difference of arterial and mixed venous oxygen tension and the difference of alveolar-arterial oxygen tension at 30-minute after reperfusion were not significantly different from those before ischemia and were stable during the 40hour reperfusion. However in nitrogen group these values were significantly deteriorated at 30-minute after reperfusion. there was no significant difference between two groups in hemodynamic data peak airway pressure and lung water content. Conclusion : The results indicated that the oxygenation one of the most important pulmonary functions was improved by pulmonary inflation with 100% oxygen during warm ischemia but the hemodynamics were not. Oxygen as a metabolic substrate during warm ischenia was believed to make the pulmonary tissues to maintain aerobic metabolism and to prevent ischemic damage of alveoli and pulmonary capillary.