• The Journal of KAIRB
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• v.5 no.1
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• pp.21-32
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• 2023

Purspose: The purpose of this study is to examine the meaning and definition of vulnerable subjects in clinical trials in light of domestic and international regulations and guidelines, to analyze the contents of standard operation procedures (SOPs) among advanced general hospitals in Korea that conduct clinical trials, and to examine deliberation procedures for operation plans. Methods: The study examined how vulnerable research subjects were defined and described in related regulations and the classification of vulnerable research subjects presented in the IRB/HRPP SOPs of 18 clinical trial institutions, including 11 AAHRPP-accreditated general hospitals in Korea, as well as the operation of the IRB deliberation. Results: Among all domestic and international regulations and guidelines, only the The Council for International Organization of Medical Sciences (CIOMS) guidelines explain why vulnerability is related to judgments on the severity of physical, psychological, and social harm, why individuals are vulnerable, and for what reasons. However, the classification of vulnerable subjects by institutions differed from the classification by the International Conference on Harmonization-Good Clinical Practice (ICH-GCP). A total of the 16 institutions classified children and minors as vulnerable research subjects. 14 institutions classified subjects who cannot consent freely were classified as vulnerable subjects. 15 institutions classified sujects who can be affected by the organizational hierarchy were classified as vulnerable subjects. Subjects in emergency situations were regarded as vulnerable research subjects in 8 of institutions, while people in wards, patients with incurable diseases, and the economically poor including the unemployed were categorized as vulnerable research subjects in 7, 4, and 4 of institutions, respectively. Additionally, some research subjects were not classified as vulnerable by ICH-GCP but were classified as vulnerable by domestic institutions 15 of the institutions classified pregnant women and fetuses as vulnerable, 11 classified the elderly as vulnerable, and 6 classified foreigners as vulnerable. Conclution: The regulations and institutional SOPs classify subjects differently, which may affect subject protection. There is a need to improve IRBs' classifications of vulnerable research subjects. It is also necessary to establish the standards according to the differences in deliberation processes. Further, it is recommended to maintain a consistent review of validity, assessment of risk/benefit, and a review using checklists and spokeperson. The review of IRB is to be carried out in a manner that respects human dignity by taking into account the physical, psychological, and social conditions of the subjects.

• Journal of Korean Academy of Nursing Administration
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• v.1 no.2
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• pp.246-267
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• 1995

Recently the request of the patients to participate in the medical courses has been expanding due to the elevated sense of right on the people's health, merchandised medical treatment by mass supply, human right declaration of the patients, generalized medical informations by the mass media and the change of human relation between the medical personnels and the patients. Under these phenomena the patients have been in the thought of solving such accidents only by regulation of the laws which they think to be all powerful, Such trends are same in the area of nursing service. Also today the accident by the nurses have been increasing by the area of the nurses having been expanded and their independent roles having been increased. Such nursing accidents are the important subject which the professional occupation of the nurse has been facing but legal protective capability of the nurses has been very weak. Therefore this study has examined the degree of the experience of the nursing accident that happens in the clinical nursing scenes in the general hospital to provide the basic materials for the protection and the counter measures of the nursing accident. The following is the conclusion based by the above examination. 1) The experience degree of the whole nursing accidents has been appeared as 1.90 in average. And the degree according to service area has been 1.77 in the area of supervising management of patients, 1.54 in the area of the same management of patients by head-nurses, 1.84 in the area of doctors' treatment performances, 14 in the enforcement and education areas of the nursing technology, 2.04 in the area of observing patients and judgement and 2.07 in the area of nursing records and maintaining confidentials. Accordingly there has been higher degree of accidental experiences in the independent service areas of the patients than in the dependent ones directed by the doctors. 2) The perception of the nurses showed that the cause of the nursing accident has been due to the heavy work of the nurses with the 60.4% of the response rate, the highest rate. They report the accident to the head nurse first by 2/3 nurses after accident. And the hour of the accident has been frequently happened regardless of service hours with 48.1% in response rate, the highest rate, and the nursing accident happens in the night more than the daytime with the rate of 37.5% at night while 14. 4% daytime. 3) The nurses are in the perception that the patients are responsible for the accident with 48.2% response rate while 43.9% rate in response showed that it has been caused by many people. They are in the perception that 41.7% when the nursing power was lacking, 46.7% lower recognition of actual state about indivitual patient in the section of technical speciality and 35.8% when the patients were not cooperative and 37.8% when the wards were dirty and in disorder. 4) the attitude of the patients after the various nursing accidents has been violent words in 72.7%, violence in 17.4% and 3.9% in attending the court by the sue of the patient's side(18 nurses). 5) The action of the hospital has been : requesting the submission of the story of the accident in 22.8%, the report of the accidents in 14.4%, thus the written statement disposal was most, 4.5% was the transfer to the other departments when the accident was larger or the patients' guardians protested strongly and 0.6% of the dismissals of the nurses. 6) In regard to the responsiblity of the nurse accidents, 78.9% was the highest rate of supplying the nursing manpowers, 48.4% of mutual cooperation of the medical personnels, 37.2% of strengthening the education for the nurses and hospital facilities reformation in 32.7%. 7) The review of relation between the general characters of the object of the study and the degree of experience of nursing accidents showed the significant differences in ages (F=4.04, p=0.000).

• Pediatric Infection and Vaccine
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• v.4 no.1
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• pp.64-72
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• 1997

Purpose : The incidence of tuberculous meningitis in Korean children has been markedly decreased after 1980s, but this disease has still occurred with low rate. Therefore, it may be suspected that delayed diagnosis and treatment will be happened because of lacking of clinical experiences and indistinguishable other meningitis, so it is important to make early diagnosis and treatment of tuberculous meningitis concerning with the prognosis. In this aspect, we conducted study to concern and investigate sustainly about the diagnostic criteria, clinical characteristics, radiological findings, complications, and prognosis of typical or atypical tuberculous meningitis in children. Methods : Forty four children who were hospitalized and treated due to tuberculous meningitis in pediatric wards of Our Lady of Mercy Hospital, St. Holy Hospital, St. Vincent Hospital and Uijungbu St. Mary Hospital from January 1985 to June 1996 were included in this study. We reviewed medical records of these patients retrospectively. Results : 1) The tuberculous meningitis has occured continuosly since mid-1980s. The highest 2) The diagnosis was made by contact history of active tuberculous patients, positive tuberculin test, responses of antituberculous antibiotics and discovery of Mycobacterium tuberculosis from CSF or other specimens. Among patients, 7 children(16%) were not vaccinated with BCG, and only 18 children(40%) were positive in tuberculin test. 3) The symptoms and signs of our patients on initial examinations were fever, vomiting, headache, lethargy, poor feeding, weight loss, neck stiffness, convulsion, abdominal pain and motor deficits. 4) The findings of initial CSF samples revealed leukocyte $239.5/mm^3$(mean) with lymphocyte predominant, elevated protein levels(mean;259.5mg%) and low sugar level(mean;40.7mg%). And the ratio of CSF/blood sugar was 0.407. But, atypical CSF findings were seen in 31.8% patients. 5) On brain imaging study, 34 out of 39 children had findings of hydrocephalus, basilar meningeal enhancement, infarction and subarachnoidal inflammations etc. On chest X-ray, the findings of miliary tuberculosis(34.1%), normal finding(29.5%), parenchymal infiltrations (11.4%) and calcifications(9.1%) were showed. 6) In neurological clinical stage, there were twenty-six children(59%) in stage 1, fourteen children(32%) in stage 2 and four children(9%) in stage 3. The late sequeles were encountered by 29.5% with mild and 4.6% with severe neurological injury. The most common neurological injury was quadriplegia and the mortality rate was 6.8%. 7) The SIADH was developed in 20 children(45.5%) after the 4th hospital day. Half of all SIADH patients were symptomatic. Conclusion : Tuberculosis meningitis is still an important extrapulmonary disease with high morbidity and mortality. Early diagnosis with clinical contact history of active tuberculosis and radiological imaging examinations and early treatments are essential in order to prevent and decrase the rate of late sequeles and death.

• Journal of Oral Medicine and Pain
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• v.31 no.3
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• pp.199-210
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• 2006

The epidemiological researches on the inpatients hospitalized at the oral medicine ward have been continuously carried out since 1970, and most researches have been performed by centering around the oral medicine wards of college hospitals. Numerous specialists have been produced after the establishment of oral medicine, and they have been active in various fields. As dental clinics have gotten bigger, the function of oral medicine in the secondary clinics is being brought out. As admissive channel, case features, case composition and otherwise have not been researched for a long time, the related researches should be carried out from now on. Hereupon, this study was carried out by targeting the 100 inpatients hospitalized at the oral medicine ward of Sun Hospital located in Daejeon Korea, through questionnaire. As the result, the following results were derived. 1. The ages of the inpatients in Sun Hospital were $29.21{\pm}11.31$ on the average; 71 females' mean average was $29.63{\pm}11.29$ and 29 males' mean average was $28.17{\pm}11.48$. In regard of school career, the patients who finished high-school course or higher accounted for 78%; the patients' school career seemed to be relatively high. The patients who complained of temporomandibular pain accounted for the highest proportion with 65%. In motivation to visit this hospital, internet surfing was 11%, mass media was 10%, acquaintance's introduction was 38%. The patients, who were hospitalized at another hospital due to the same symptom, accounted for 56%. The dental clinics, which made the patients visit this hospital, accounted for 20%. The patients, who were previously aware that the present symptom should be treated by oral medicine, accounted for 38%. The patients, who were not aware of the fact in advance, were 62%. The respondents of 51% answered that they were aware of the fact one month or below before hospitalization. 2. The patients, who complained of craniocervical ache, accounted for 58%; the patients, whose ache aches affect dailylife, were 22%. Continuous ache was 14% and intermittent ache was 68%, and dull pain was 23%. 3. Life variations were compared with each other by using SRRS (Social Readjustment Rating Scale). In consequence, the variation within 3 years indicated a significant difference in the both groups but the variation within 6 months did not indicate any differences. 4. In regard of the questionnaire on the incidents happened for a week, the ache-group was compared with the group free from the ache. As the result, the number of strain arisen for a week, the decrease of favorite works and sudden fear indicated a significant difference. Pleasant feeling and the decrease of interests in looks did not indicate a significant difference, but came close to the significance. 5. In the questionnaire on impatience, the ache-group indicated higher value but there was not a significant difference. 6. In the questionnaire on the symptoms caused by stress, the two groups indicated significant differences in the item of 'the teethridge itches and feels a tooth rising' and 'the occiput or the nape is stiff.' In the item 'the inside of the cheek or the teethridge are widely peeled off, accompanied with ache and hemorrhage', 'the face has acne or pimple' and 'headache frequently attacks', a significant difference was not observed but the two groups came close to the significance.

• Journal of Korean Academy of Nursing
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• v.19 no.1
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• pp.40-62
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• 1989

This study was conducted to measure the effects of clinical application of a Nursing Diagnosis Protocol. The dependent variables were the degree of patient's satisfaction and the degree of nurse's satisfaction with the nursing activity. Analysis of the effect of the use of the nursing diagnosis protocol was based on the nursing record. The subjects for this study were 61 nurses(experimental group 31, control group 30) and 155 patients (experimental group 55, control group 100) on four internal medicine wards in K University Hospital in Seoul. Data collection was done from August to October 12,1988. The results obtained in this study can be summarized as follows, 1, Effect of the clinical application of the nursing diagnosis protocol. 1) The first hypothesis ; “nurses who use the nursing diagnosis protocol will have higher degrees of satisfaction than those who use traditional methods” was rejected (t＝.54, df＝58, p＝.59). 2) The second hypothesis ; “patients nursed by nurses using the nursing diagnosis protocol will have higher degrees of satisfaction than those nursed with traditional methods” was supported(t＝1.93, df＝154, p＝.05). 3) The third hypothisis : Major hypothesis ; “the nursing records of the experimental group, who used the nursing diagnosis protocol, will be more detailed than those of the control group” was supported (t＝6.40, df＝79.90, p＝.000). (1) The first subhypothesis ; “The recorded data collection of the experimental group will be more detailed than that of the control group” was rejected (t＝1.79, df＝118, p＝.07). (2) The second subhypothesis ; “The recorded patient's problem statement of the experimental group will be more detailed than that of the control group”, was supported. (3) The third subhypothesis ; “The nursing record of the experimental group will be more convenient for implementation than that of the control group” was supported. 2. Factors related to the nurse's degree of satisfaction with protocol. 1) No general characteristics(age, religion, education level, duty career, present duty career) were related to the nurse's degree of satisfaction. 2) Variables related to the nurse's degree of satisfaction were “satisfaction as a nurse” and “consider nursing as lifelong job” (t＝-2.6, df＝13.22, p＝.02, t＝2.41, df＝23.85, p＝.02). 3. Factors related to the patient's degree of satisfaction. 1) General characteristics related to the patient's degree of satisfaction with nurses using the protocol were age, educational level, and being married.(F＝5.17, df＝3/153, p＝.00, t＝ -2.39, df＝154, p＝,01, f＝5.91, df＝2/153, p＝.00) 2) The variables previous hospitalization, duration of hospitalization, the hospital unit presence of a relative, medical insurance, or medical diagnosis were not related to the patient's degree of satisfaction. 1. The experimental group's nursing record was more detailed than the control group's record with regard to the physical and psychological state of the patients. As noted above, the experimental group nurses, who use a nursing diagnosis had protocol were less satisfied than the control group who used traditional methods of the recording, but experimental group patients had a higher degree of satisfaction than the control group patients. The nursing records of experimental group, using the nursing, diagnosis protocol was more detailed than that of the control group. If the nursing diagnosis protocol is used in clinical nursing practice, the quality of nursing care may be improved.

• Journal of Korean Academy of Nursing Administration
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• v.7 no.2
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• pp.265-284
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• 2001

The case management has been applied to improve the quality of care and the cost-effectiveness in the most health care institutions. In a way of case management, the critical pathway(CP) has been executed in many acute care settings, focused on the diagnoses with high cost, high volume, and high risk. This study was conducted to develop a case management program using CP as an intervention of patients with lumbar spinal stenosis for the surgery of posterolateral fusion, and to find out the effects of the critical pathway on the quality of nursing care, patient satisfaction as an outcome of care, length of stay and medical charge, and nurses' job satisfaction. At the same time, patients' functional states were checked with the Oswestry Low Back Pain Index, to show that the CP would not decrease the patients' function compared to the control group. The subjects were 25 control patients with a usual operation of lumbar fusion and 25 experimental patients with CP. They were all female, aged $50s{\sim}70s$, admitted in the Orthopedic surgery ward of a university hospital. Also nurses on the floor using CP were asked to respond to measurement tool of job satisfaction before and after the application of CP, and compared with other nurses on the different wards. Data were analyzed with t-test for continuous variables and chi-square for non-parametric variables in addition to the reliability test of the measurement tools. The results of this study were as followings: 1. Patients' functional states The differences in Oswestry scores of the experimental and control groups assessed at preoperation and at discharge were not statistically significant. The change in scores of the experimental group measured at preoperation and at discharge was larger than that of the control group, however the difference was not statistically significant. The results indicate that the CP did not decrease the patients' functional status. 2. The quality of nursing care The total of quality of nursing care given to the experimental group was better than that of the control group(P=.000). In addition, the experimental group showed better scores of quality of every item of care than the control group(P=.000 -.004). 3. Patient satisfaction Patients of the experimental group were not more satisfied with general care than the control group. But they were more satisfied with discharge care of 'explanation about medication, body posture, and brace application' and 'explanation about the adjustment of daily living and exercise during recovery'(P= .047, P=.028). 4. Nurses' job satisfaction Nurses working with the CP showed more job satisfaction than before the CP introduction(P=.048). But the control group of nurses on a different floor showed no change in job satisfaction at the same period of time. 5. Length of stay and medical charge The mean length of stay of the experimental group was shorter than that of the control group without statistical significance. The charge of medication and treatment of the experimental group were smaller than that of the control group(P=.011, P=.000). The results of the study support that the case management using critical pathway enables to improve the quality of care and job satisfaction, to reduce the medical charge, and consequently to increase satisfaction with care. However, the case management should be instituted focusing on the quality improvement of nursing and the client satisfaction, not just for the purpose of cost-effectiveness of health care facilities.

• Korean Journal of Psychosomatic Medicine
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• v.27 no.2
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• pp.130-137
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• 2019

Objectives : When a patient who attempts suicide visits the emergency room, it is important that the departments of emergency medicine, internal medicine, and psychiatry communicate with each other and prioritize treatment. This study was conducted to verify the effectiveness of the multidisciplinary emergency consultation system (ECS) for drug intoxicated patients. Methods : We retrospectively analyzed the data from medical records prior to the ECS, from July 2017 to May 2018, and after the ECS, from July 2018 to May 2019, to verify the effectiveness of the system. Results : After the ECS, admission to open wards was significantly higher than to the intensive care units (χ²=8.567, p=0.014). In addition, the proportion of consultations to the department of psychiatry among patients admitted to other departments tended to increase (χ²=4.202, p=0.053), and the time required for consultation response decreased (Z=-2.031, p=0.042). As a result of the consultation, the proportion of the patients who had been transferred to the department of psychiatry was increased (χ²=4.692, p=0.043), and the time spent to transfer tended to decrease (Z=-1.941, p=0.052). Conclusions : After implementing the ECS for drug intoxicated patients, unnecessary intensive care unit admissions, consultation response time, and the time spent to transfer were reduced, and the rate of consultation referrals and transfer rates increased. This means that the multidisciplinary consultation system rapidly provided essential medical services to patients at lower medical costs.

• Journal of Korean Academy of Nursing
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• v.5 no.2
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• pp.74-91
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• 1975

A purpose of this study was to compare the breast massage and manual expression of the breast before engagement after delivery with the time of engagement, the throbbing pain in breast, the first amount of breast milk and involution of the uterus. The subjects selected for this study were 138 women (experimental group;69, control group :69) who were admitted to the Dept. of Obtest. and Gyneco. of Kyung Hee University Hospital from Jan. 5 to June 5, 1975. The results of study were as follows; 1 The average age of the women 26.9 years old in the experimental group and 27.6 years old in the control group. As to religion, the number of those who had no religion was 58.0 percent and 62.4 percent respectively. Classified according to occupation, there were 87.0 percent in house wives of the booths group. Educational background; 87.0 percent of high school graduates or above, 78.3 percent respectively. The occupation of husband 53.7 percent of company employees stood highest and 42.0 percent respectively. In according to the grade of wards, 55.1 percent and 52.2 percent of four-men room stood highest. 2. Physical condition: Body weight before this Pregnancy(T=0.4962, N.S.), the size of breast(X²df2 = 0.1728, N.S.), the shape of nipple(X²df3 =1.3804, N.S.), hemoglobin's level of the first day after delivery(T=1.2572, N.S.), the above were showed non significant between the experimental group and control group The investigator found any difference between the two groups of the health condition during the pregnancy, 3. The rate of no experience of breast massage during pregnancy was 85 percent and 75.4 percent (X²df1=2.2562, N.S.). 4. As to the meal during hospitalization after delivery: The booth of the groups in ordinary food took usually of meyer soup and milk(X²df8=2.5957, N.S.). 5. The relation between the first step of breast massage, second step of the manual expression of breast before engagement after delivery and time of engagement : average time of engagement in the experimental group (2.1 days±0.8) was shortened than the control group (3.3 days±1.2). (T=-6.9045, P< 0.005). It toot less time in the experimental group of primipara(2.2days±0.7) than in the control group (3.1day±1.2) and it also took less time in the experimental group of multipara (2.0 days±0.9) than in the control group (3.5days±1.4). (Primipara T=-3.9266, 0< 0.005. Multipara T= 5.2356, P<0.005). 6. The relationship between the first step of the massage and second step of manual expression and the throbbing pain at the time of engagement: The experimental group showed less effect than control group (X²df4= 27.3342 P<0.005). The separate study of primipara and multipara showed remarkable difference in the group of primipara)X²df4=20.7285, p<0.005) and little difference in the multipara group (X²df4=8.8351, p< 0. 10). 7. The relationship between the first step of the breast massage, second stop of the manual expression and first amount of breast milk: The average amount of breast milk increased more conspicuously in the experimental group (33.8㎖±23.4) than in the control(29.8㎖±25.3) (T=0.8262, N.S.). No remarkable difference was found in the respective groups that investigated in the groups of primipara and of multipara. (Primipara T=1.1467, N.S., Multipara T=-0.0354, N.S.). 8. The relationship between the first step of breast massage and second step of manual expression of breast and involution of uterus : Average time needed for uttering involution was sooner in the experimental group of primipasa(-3.3 F.B.±1.1), than the control group of primipara (-2.5F. B.±1.2), and it was sooner in the experimental group of muitipara (-3.0 F. B.±l..3), than the control group of multipara(-2.3 F.B±0.9). Primipara T=-2.9272, p< 0.005, Multipara T=2.5557, p< 0.01).

• The Korean Journal of Nuclear Medicine Technology
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• v.17 no.1
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• pp.30-35
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• 2013

Purpose: One of the current services, providing information to the patients and their guardians by using promotion materials induces positive responses and contributes to the improvement of the hospital reliability. Therefore, the objective of this study is to evaluate the effectiveness of audio visual materials, one of the means of promotion, as a way to give accurate medical information to resolve patient's curiosity about purpose and procedure of their examination and deplete complains about waiting which attributes negative effect to service quality assessment. Materials and Methods: 60 patients(mean age $53.97{\pm}12.24$, male : female = 26 : 34) who had $^{18}F-FDG PET/CT$ scan from July 2012 to August 2012 in Seoul Asan Medical Center were referred to the study. All of the patients having PET/CT scan were asked to watch an informative video material before the injection of radiopharmaceutical ($^{18}F-FDG$) and to fill in a questionnaire. Results: As a result of analyzing the contents of questionnaire, 52% of 60 patients had PET/CT scan for the first time and 72.4% of the patients read the PET/CT guidebook offered from their outpatient department or inpatient wards before their scan. After we searched the level of previous knowledge of the purpose and method of PET/CT scan, the patients answered 25.1% "know well", 34% "not sure", 40.9% "don't know" respectively. And 84.7% of the patients answered that watching the PET/CT guide video before the injection helps understanding what exam they were having and 15.3% of the patients did not. For the question asking ever the patients have experienced using our homepage or smart phone QR code to see the guide video before they visit out PET center, only 3.3% of them answered "yes". Lastly, the patients answered 60.1% "yes", 31.4% "so so" and 8.5% "no" respectively for the question asking whether watching the video makes the patients to fill the waiting time short. Conclusion: It is found that understanding of objective and method of the PET/CT scan and level of satisfaction was improved after the patients watched the guide video whether they had PET/CT scan before and read the PET/CT guidebook or not. Also, watching the video was effective for the reduction of perceptible waiting time. But while displaying the PET/CT guide video is useful for providing information about the scan and shortening the waiting time as one of the medical service, utilization of service was actually very poor because of the passive promotion and indifference of the patients about their examination. Therefore, from now on, it is necessary to construct the healthcare system which can be offered to more patients through the active promotion.

• Neonatal Medicine
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• v.18 no.1
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• pp.137-142
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• 2011

Purpose: In relation to perinatal healthcare, medical institutions and resources are limitative and also are in a state of flux due to the therapeutic specialty. We analyzed requests for interhospital transfers received by Busan 1339 Emergency Medical Information Center (EMIC) to grasp the state of perinatal healthcare delivery system. Methods: This study was conducted on the basis of data inputted into the computing system of Busan 1339 EMIC, between January 1 and December 31, 2009. In connection with 378 pregnant women and 136 newborns who were required to transfer, retrospective analyses were made of the success rate of transfer (SR), the number of contacted hospitals, the time required for transfer and the reason of transfer and refusal. Results: In the case of pregnant women, the SR were 65.5%. They came in contact with 2.7 hospitals, and it took 24.4 minutes. As for the reason of transfer, preterm labor accounted for the highest proportion. In the case of newborns, the SR were 71.3%. They came in contact with 2.4 hospitals, and it took 15.6 minutes. The most common reason of transfer were respiratory symptoms. In the reason of refusal with pregnant women and newborn, the lack of medical staff, medical equipments and wards accounted for great. Conclusion: Many pregnant women and newborns have been transferred to hospitals by EMIC, but the SR has not been higher yet. Accordingly, there is a need to evaluate the propriety of perinatal treatment system, as well as to set up effective perinatal healthcare delivery system.