• 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
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• v.54 no.2
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• pp.237-249
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• 2024

Purpose: This study aimed to examine the adequacy of current nurse staffing levels by identifying nursing activities and workload. Methods: The study used a mixed-method design. A nursing activity survey was conducted using the work sampling method over 2 working days with 119 general ward nurses. A focus group interview was conducted with 12 nurses. Quantitative and qualitative data were analyzed using SPSS 20.0 and content analysis, respectively. Results: The most amount of time was spent on medication (in direct nursing) and electronic medical record documentation (in indirect nursing). The appropriate nurse-to-patient ratio is 1:7.7 for the day shift, 1:9.0 for the evening shift, and 1:11.9 for the night shift. However, the current nurse-to-patient ratio is 1:9.4, 1:11.0, and 1:13.8 for the day, evening, and night shifts, respectively. Therefore, the current nurse staffing level is insufficient for the workload. In the focus group interview, the main reasons cited for being unable to complete tasks within working hours were communication and coordination, and the nursing electronic medical record. The essential nursing activities of basic nursing and emotional support were overlooked owing to a heavy workload. Therefore, an adequate nurse staffing level should be higher than the measured quantitative workload. Conclusion: These results suggest the general wards of tertiary hospitals should evaluate the adequacy of their current nurse staffing and allocate sufficient nurses to improve patient safety and nursing care quality.

• The Journal of Korean Physical Therapy
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• v.4 no.1
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• pp.27-42
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• 1992

The purpose of this study is to investigate the occurence properties of the complications in spinal cord injured patients. Clinical observation were for 116 cases in and out wards, were carried out during one year from july, 1990 to June, 1991 at 4 general hospitals in Taegu, Korea. The results of this study is summarized as follows : 1. Among the 116 cases, $67.7\%$ was male and $35.3\%$ was female. The largest groups were noted in $60.7\%$, of the forties by age, in $34.5\%$ of the middle school by educational career, in $27.6\%$ of the administer by professional division. 2. The number of complications in a patient in the largest group was two-type. The next groups were three-type, $23.3\%$ and five-type, $20.7\%$. Of each factors, the largest numbers of two-type recorded tuberculosis of spine$(71.4\%)$, thoracic cord injury$(63.4\%)$, incomplete paraplegia$(48.4\%)$, and inwards during 1-2 months $(47.4\%)$. 3. Total number of the complications were counted to 367 cases. The largest group of complications was pain, $24.8\%$. The next groups were pressure sores, $19.9\%$. spasticity, $12.5\%$, and urinary tract infection, $9.3\%$. 4. The number of the 4 major complications(pain, pressure sores, joint contracture, spasticity) was counted to 280 cases. The largest group of the major complications was pain, $32.5\%$. The next groups were pressure sores, $26.1\%$, joint contracture, $25.9\%$ and spasticity, $16.4\%$. Of each factors, the largest numbers of the pain recorded female$(40.5\%)$, thirties$(49.2\%)$, non-educate $(53.8\%)$, labor$(38.2\%)$, traffic accidents$(32.8\%)$, thoracic cord injury$(34.4\%)$, complete paraplegia$(58.1\%)$, and inwards during above 13 months$(37.5\%)$. 5. The largest group of the pain portion was shoulder. $49.4\%$. The non groups were lower extremity, $25.2\%$, hip, $11.0\%$, and all bodies, $4.3\%$. The largest numbers of the shoulder pain recorded thirties$(59.4\%)$, traffic accidents $(52.7\%)$, cervical cord injury$(67.2\%)$. complete quadriplegia$(81.8\%)$, and inwards during above 13 months$(100.0\%)$. 6. The largest group of the pressure sores sites was sacral portion, $83.6\%$. The next groups were hip, $6.8\%$, maleollus, $4.1\%$. The largest numbers of pressure sores formation in the sacral portion recorded below 19 and above $60(100.0\%)$, falling objects$(100.0\%)$, lumbar cord injury$(100.0\%)$, incomplete paraplegia$(100.0\%)$, and in wards during 3-4 months$(95.9\%)$. 7. The largest group of the joint contracture portion was lower extremity, $61.4\%$, follows was upper extremity, $38.6\%$. The largest numbers of the joint contrcture portions recorded thirties$(100.0\%)$, traffic accidents$(86.1\%)$, cervical cord injury$(80.4\%)$, complete quadriplegia$(86.7\%)$, and inwards during 3-4 months $(82.2\%)$ 8. The largest group of spasticity portion was lower extremity, $53.0\%$. The next groups were hip. 23.9, 23.9, ankle, $8.7\%$, and elbow, $4.3\%$. The largest numbers of the spasticity portions recorded above $60(100.0\%)$, falling $(100.0\%)$, cervical cord injury$(71.4\%)$, incomplete quadriplegia$(71.4\%)$, and inwards during 1-2 months $(100.0\%)$.

• Journal of Convergence for Information Technology
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• v.10 no.9
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• pp.43-52
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• 2020

The purpose of this study is to develop video exercise education for patients with shoulder-joint and evaluate the effects on range of motion, pain and quality of life. This study was conducted in 30 experimental groups and 26 control groups among shoulder-joint patients who were admitted to orthopedic outpatient clinics at university hospitals in G city from January to June 2020. For data analysis, SPSS was used to analyze the general characteristics of the two groups and the pre-homogeneity test for the dependent variables by 𝑥²-test and t-test. As a result of the study, the subject's pre-post score change was found to have a significant difference in the degree of internal rotation of the range of motion and pain score, but there was no significant difference in the flexion, abduction degree of the range of motion and quality of life. In this study, clinical application of video education can be suggested as a way to improve nursing practice as it saves time spent on patient education of nurses not only in outpatients but also in wards.

• The Journal of the Korea Contents Association
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• v.20 no.11
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• pp.676-685
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• 2020

This study attempted to examine the subjectivity of early postpartum mothers' perceptions of comprehensive nursing care services targeting at early postpartum mothers hospitalized at general wards, and applied Q methodology to find types of subjectivity and characteristics of the types. P-sample 21 subjects were asked to read Q sample 25 statements about comprehensive nursing care services and indicate their level of agreement to those statements on a 9-point scale. The data were collected during the period from March 16 to March 31, 2020, and the collected data were analyzed using PC-QUANL program. The results of the study showed differences in the respondents' perceptions, which led to the classification into three types. "Type 1" is "those calling for continuous emotional management for early postpartum mothers." "Type 2" is "those seeing the role of a family in the recovery period as important." The respondents of this type considered a bond of sympathy should be formed in the family in relation to the new tasks of the mother's recovery and the child's birth. "Type 3" is "those calling for differentiated operation guidelines according to the motivation for hospitalization." The respondents of this type recognized that the operation guidelines limiting the residing of guardians need to be improved for early postpartum mothers.

• Journal of Korean Academy of Nursing
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• v.15 no.1
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• pp.17-29
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• 1985

This study was to explore on the rank of stressful events related to the experience of hospitalization. 180 hospitalized patients on surgical and medical wards were asked to rate 49 stress-producing events associated with the experience of hospitalization. Two university hospitals was used as the setting for this study. Because the nature of the events in the stress scale pertain mainly to general short term hospitalizations, patients in the rehabilitation and psychiatric units of the hospital were not included. Prior to the beginning of the study, three times meeting were held with 12 head nurses and 3 investigators for discussing with the ethics subject related to the study. The pretest was done to determine whether items to use were pertinent or not. According to the result of the pretest, Volicer's Hospital Stress Rating Scale was selected as a study tool for this study. Data collection was used an interview and a card-sorting method. The interviewing was done by two authors and three graduate nursing students. A total 125 completed the card-sorting procedure. The stressful items were ordered from most to least stressful within the categories. Additional information such as: age, sex, marital status, and diagnosis was obtained from the kardex file. The ordered list of items, with mean values, as scored by the total of 125 respondents was significantly accepted at 1% level by Friedman test. (X²=1448.339) The event,“knowing you have a serious illness.”was rated highest stressful and (M=41.54) “Being awakened in the night by the nurse”least stressful. (M=14.73) Highly rated items were orderly “Thinking you might have cancer”“Thinking you might lose a kidney or some other organ”“Not being told what your diagnosis is. “Not knowing for sure what illness you have,”five lowerly rated items were orderly “Having to eat at different times than you usually do”“net being able to call family or friends on the phone”“Not having friends visit you,”“Having strangers sleep in the same room with you.”Futher analysis of the data was done to ascertain tao degree of similarity of judgment between different groups in the sample as to how events should be rated. The sample was divided into two groups according to the demographic characteristics and the degree of seriousness of illness. The rank order correlation was calculated for the two sets of ranks as a measure of consensus between the two groups. The correlations ranged from .85∼.99 all indicating a high degree of consensus.

• Journal of Hospice and Palliative Care
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• v.23 no.3
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• pp.103-113
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• 2020

A clinical practice guideline for patients in the dying process in general wards and their families, developed through an evidence-based process, is presented herein. The purpose of this guideline is to enable a peaceful death based on an understanding of suitable management of patients' physical and mental symptoms, psychological support, appropriate decision-making, family care, and clearly-defined team roles. Although there are limits to the available evidence regarding medical issues in patients facing death, the final recommendations were determined from expert advice and feedback, considering values and preferences related to medical treatment, benefits and harms, and applicability in the real world. This guideline should be applied in a way that takes into account specific health care environments, including the resources of medical staff and differences in the available resources of each institution. This guideline can be used by all medical institutions in South Korea.

• Quality Improvement in Health Care
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• v.2 no.2
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• pp.156-171
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• 1996

Background: Nosocomial infection control is one of important means to assure the quality of medical care in the hospital, however, it has been neglected by most of the hospital personnels. Of nosocomial infections, urinary tract infection is the highest incidence, which is related to the indwelling catheter. It is, therefore, necessary to pay primary attention to the patients with the indwelling catheter in intensive care unit in order to control nosocomial Infection and to improve the quality of medical care in the hospital. Methods : The subjects of this study were patients with indwelling catheter who were admitted to the ICU of Pusan Paik Hospital from March 1994 to May 1995. The author calculated UTI rate among the subjects through the cultivation of the urine, identified the related factors of the UTI through brain storming of study team and head nurses working at ICU, and analized the effectiveness of the proposed approaches through comparing the infection rates of before and after activities. Results : The major activities carried out by the study team were to conduct in-service education programs for the staffs working at ICU about the importance of the nosocomial infection control in QA, and nursing intervention to reduce the UTI rate among the patients with indwelling catether. 1. The major nursing interventions that the study team had implemented were as follows ; 1) Drainage system was changed from partial open system to completely closed system. 2) Bladder irrigation which was routinely practised in all patients stopped among the noninfected patients. 3) Bladder irrigation set was changed to the disposable one. 4) Catheter was inserted under the anesthesia for patients to be operated. 5) Male patient receiving wrapped with gauze after perineal care was not wrapped. 6) Clamp which had not been before was newly attached to drainage tube. 7) Urine bag which had been packed into a lot of pieces was done into each piece. 8) The interval of change of indwelling catheter had regularly been four weeks, however it was used continously until it worked well. 9) Catheter was attached well at the defined site. 10) Paper towel was used instead of cotton towel. 11) Mats at the entrance were removed and cleansing of wards was enhanced. 2. The UTI rate by month was 34.4% in maximum and 9.8% in minimum during the period of this study, however it had gradually decreased. After 6 months from initiating infection control activities, the trend of rates was relatively stable. It was identified that UTI rate was different by season 12.5% in winter and 27.2% in summer. 3. Utilization rate of indwelling catheter was maintained at under 50%, but it was increased above 57% from April 1995. 4. The number of bladder irrigation sets used per day was 33.3 sets in maximum and 2.8 sets in minimum. The number used per day were also remarkably deceased. Conclusion : It was found that a program to control UTI could contribute to nosocomial infection control, and it was, in turn, a mean to assure the quality of medical care in the hospital. The nursing interventions which this study team had implemented were effective in the reduce of UTI rates.

• Korea Journal of Hospital Management
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• v.6 no.3
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• pp.109-129
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• 2001

The purpose of this study was the acquisition of the optimum scale of the apportionment of standard & high-class bed for the maximum profit representative of the desire of customers in a General Hospital with 1,100 beds located in Seoul. This investigation was proceeded by the analysis of the result of the simulation with the survey of both the patients' needs for bed and the degree of the medical service by the grade of the ward. And finally the consequence was obtained as follows: 1. The result of the investigation of the inpatients' preference for the grade of ward classes shows that a private ward reflected 4.3 percent, a semi-private ward 1.7 percent, a three-bed ward 0.1 percent, and a ward with six beds 93.9 percent each other. 2. A questionnaire poll was paralleled of service terms of a medical doctor and a nurse by ward class, the data were used for the standard of the allotment of labor cost by the ward class. The poll shows that the service tenn of a medical doctor and a nurse based on a ward with six beds by ward class showed 1.7 times in internal medicine and 1.9 times in surgery at a private ward; 1.4 times in internal medicine and 1.7 times in surgery at a semi-private room; and 1.2 times both in internal medicine and in surgery at a three-bed ward 3. The resultant findings revealed the most profit per bed and per patient in a private ward. However, an analysis of profit with a standard of unit area by ward class represented a higher profit in both the internal medicine and the surgery semi-private ward than other ward classes. 4. The result of the analysis through simulation based on the data of the prime cost per the ward class proved the optimum scale of the distribution of beds by class as follows: sixteen beds of the internal medicine and twenty three beds of the surgery in the private ward; two hundreds and two of the internal medicine and one hundred and ninety eight of the surgery in the semi-private room; three of both the internal medicine and the surgery each other in the three-bed ward; one hundred and ninety eight of the internal medicine and two hundred and fifty two of the surgery in the ward with six beds. The result of this research exhibits that the income and expenditure of the hospital could be improved by changing parts of wards into private ones(containing the maximum profit per a unit of width) in case the scale of the number of beds is reset with the consideration of the profit per the unit width. In the near future it's strongly expected that the research for the more scientific standard of the allotment of labour cost by ward class and for definition of the optimum scale of the number of beds that actualize the maximum profit with the change of the three elements of the prime cost: cost of materials; labor costs; management expenses.

• Journal of Korean Academy of Nursing
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• v.15 no.3
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• pp.5-20
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• 1985

The purpose of this study was to assess the value-of post-operative treatment in terms of nursing care in the allevation of pain. More specifically, the effects of supportive touch and patient education were examined. On the date before each patient's operation, the Bevels of anxiety, depression and affiliation were examined. The post-operative treatment was adminis. tered after an initial measurement of the patient's fain, according to the experimental category for the three days following the operation. On the final day, the level of anxiety and depression were again measured. The subjects of this study were 138 patient from the general surgical and gynecological wards in H university Hospital in Seoul. The study was conducted over a three-month period from June 24, 1984 to September 18, 1984. All patients had undergone laparatomies. Various standard instruments were used to measure the pain, anxiety, depression and affiliation levels. for pain, 5 grate Simple Descriptive Scale, and the Mclachlan four-range Observational Pain Scale were employed. For anxiety and depression, respectively the Spielberger State Anxiety Inventory and Beck Depression Inventory (B.D.I.) were used. Lastly, the affiliation was determined by the Mehrabian Affiliation Scale. The outcome of the research was as follows: 1. The first hypothesis concerning the existence of lower pain levels of Experimental Group A and Experimental Group B than the pain levels of Control Croup C was not supported. 2. The second hypothesis concerning the existence if lower anxiety levels of Experimental Group A and Experimental Group B than the anxiety levels of Control Group C was supported at the level of F=3.58 (p=.03). 3. The third hypothesis concerning the existence of lower depression levels of Experimental Group A and Experimental Group B than the depression levels of Control Group C was not supported. 4. The fourth hypothesis concerning the existence of different levels of pain in accordance with the levels of affiliation in Experimental Group A was not supported. 5. A positive correlation did exist between pain and anxiety after surgery (r=.34, p=.0001). Thus, the fifth hypothesis was supported. 6. A positive correlation did exist between pain and depression following surgery(r=.36, p=.0001). Thus, the sixth hypothesis was supported. Based on the above results, it was found that supportive touch and patient education either through human sources or via tape recorder do influence the anxiety of a patient after surgery, that a Positive correlation between pain, anxiety and deparession exist, that affiliation does not alter the influence of supportive touch, and that the graph on which pain levels were depicted indicates the possibility of development even if the effects of supportive touch did not reach a meaningful level. Thus it can be concluded that patient education, regardless of its form, is essential for the patient after surgery and that supportive touch, when reasonably modified and supplemented, can be an effective method of alleviating pain.