Noninferiority trials test whether a new experimental treatment is not unacceptably less efficacious than an active control treatment already in use. With continuous improvements in health technologies, standard care, and clinical outcomes, the incremental benefits of newly developed treatments may be only marginal over existing treatments. Sometimes assigning patients to a placebo is unethical. In such circumstances, there has been increasing emphasis on the use of noninferiority trial designs. Noninferiority trials are more complex to design, conduct, and interpret than typical superiority trials. This paper reviews the concept of noninferiority trials and discusses some important issues related to them.
Kang, Eun Sook;Tark, Kwan-Chul;Lee, Taewha;Kim, In Sook
Quality Improvement in Health Care
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v.9
no.2
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pp.116-133
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2002
Background : It is very common in Korea to take care of non-acute patients in an acute setting, due to the lack of long-term facilities. Long term hospitalization increase medical expenses and decreases the bed utilization, which can affect the urgent and emergent admissions, and eventually jeopardize the hospital financially. In this study, strategies for effective transfers to the lower levels of care, and to decrease the length of stay were presented by surveying and analyzing the patient's knowledge of the transfer needs, and the willingness to transfer those whose hospital length of stay was more than 30days. Method : The survey is subject to a group of 251 patients who have been hospitalized over 30 days in a general hospital in Seoul. Excluding those that were in the Intensive Care Unit and psychiatric ward, 214 in-patients were used as participants. They were surveyed from April 9, 2002 to April 17, 2002. One hundred and thirty seven out of 214 were responded which made the response rate 64%. Data were analyzed by SAS and SPSS. Result : Multi-variable Logistic Regression Analysis showed a significant effect in medical expenses, knowledge of referral system and the information of the receiving hospital. The financial burden in medical expenses made the patient 10.7 times more willing to be transferred, knowledge of the referral system made them 5 times more willing to be transferred, and the information of receiving hospital makes 6.5 times more willing to be transferred. Reasons for willing to be transferred to a lower level of care were the phase of physical therapy, the distance from home, the attending physician's advice and being unable to be treated as an out patient. Reasons for refusing to be transferred were the following. The attending physician's competency, not being ready to be discharged, not trusting the receiving hospital's competency due to the lack of information, or never hearing about the referring system by the attending physician. Conclusion : Based on this, strategies for the effective transfer to the lower levels of care were suggested. It is desirable for the attending physician to be actively involved by making an effort to explain the transfer need, and referring to the Healthcare Coordinating Center, which can help the patient make the right decision. Nationwide networking for the referral system is the another key factor that may need to be suggested as an alternative to decrease the medical expenses. Collaborating with the Home Health Agency for the early discharge planning and the Social Service Department for financial aid are also needed. It is recommended that the hospital should expedite the transfer process by prioritizing the cost and the information as medical expenses, knowledge of referring system and the information of the receiving hospital, are the most important factors to the willingness to transfer to a lower level of care.
Journal of the Korean Society for information Management
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v.37
no.2
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pp.71-93
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2020
Today, in order to more effectively cope with the emergence of various diseases and the rapidly-changing medical environment, several medical departments are conducting treatment collaborations within the university hospital. This collaborative care is very important and is already common in the medical field. Nevertheless, there is no research on this, especially how the departments are collaborating. Therefore, the purpose of this study is to investigate how the characteristics of the treatment collaboration networks vary by year and season by exploring the relationship between the medical departments within the university hospital. This study analyzed the collaboration networks of 29 medical departments of 'A' university in Korea by dividing the collaborative care by year and season. Directed networks were constructed in response to departments requesting and departments requested for collaborative care. Betweenness centrality, eigenvector centrality, closeness centrality analysis, ego network analysis, and faction analysis were also conducted. This study performed the first treatment collaboration network analysis among medical departments, and is expected to present new insights into the location and spatial composition of medical departments in consideration of the knowledge transfer paths within medical institutions.
Journal of Korean Academy of Fundamentals of Nursing
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v.21
no.4
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pp.423-432
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2014
Purpose: This study was done to evaluate effectiveness of deep breathing exercise as a postoperative intervention to prevent pulmonary complications. Methods: A search of databases from 1990 to 2012 was done including MEDLINE, EMBASE, CINAHL, Cochrane Library and eight Korean databases. Ten studies met eligibility criteria. Researchers trained in systematic review, independently assessed the methodological quality of selected studies using the Cochrane's risk of bias tool. Data were analyzed using RevMan 5.2 program. Results: Among ten RCTs in four studies, deep breathing exercise was compared with an instrument using interventions such as incentive spirometry, in the other four studies deep breathing exercise was compared with non-intervention, and in last two studies bundles of interventions including coughing and early ambulation were assessed. A significant difference was found between deep breathing exercise group and non-intervention group. The odds ratio (OR) of occurrence of pulmonary complications for deep breathing exercise versus non-intervention was 0.30. However, there was no significant difference between deep breathing exercise group and incentive spirometry group (OR=1.22). Conclusion: Deep breathing exercise is vital to improving cost-effectiveness and efficiency of patient care in preventing postoperative pulmonary complications. For evidence-based nursing, standardized guidelines for deep breathing in postoperative care should be further studied.
Jung, Seulgi;Kim, Yoojin;Park, Jeongok;Choi, Miyoung;Kim, Sue
Women's Health Nursing
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v.27
no.2
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pp.75-92
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2021
Purpose: This study aimed to analyze the content and effectiveness of psychosocial support interventions for women with gestational diabetes mellitus (GDM). Methods: The following databases were searched with no limitation of the time period: Ovid-MEDLINE, Cochrane Library, Ovid-Embase, CINAHL, PsycINFO, NDSL, KoreaMed, RISS, and KISS. Two investigators independently reviewed and selected articles according to the predefined inclusion/exclusion criteria. ROB 2.0 and the RoBANS 2.0 checklist were used to evaluate study quality. Results: Based on the 14 selected studies, psychosocial support interventions were provided for the purpose of (1) informational support (including GDM and diabetes mellitus information; how to manage diet, exercise, stress, blood glucose, and weight; postpartum management; and prevention of type 2 diabetes mellitus); (2) self-management motivation (setting goals for diet and exercise management, glucose monitoring, and enhancing positive health behaviors); (3) relaxation (practicing breathing and/or meditation); and (4) emotional support (sharing opinions and support). Psychosocial supportive interventions to women with GDM lead to behavioral change, mostly in the form of self-care behavior; they also reduce depression, anxiety and stress, and have an impact on improving self-efficacy. These interventions contribute to lowering physiological parameters such as fasting plasma glucose, glycated hemoglobin, and 2-hour postprandial glucose levels. Conclusion: Psychosocial supportive interventions can indeed positively affect self-care behaviors, lifestyle changes, and physiological parameters in women with GDM. Nurses can play a pivotal role in integrative management and can streamline the care for women with GDM during pregnancy and following birth, especially through psychosocial support interventions.
Purpose: This secondary data analysis study evaluated the effects of ICT enhanced home-visit nursing in long-term care insurance on health-related quality of life among community-dwelling older adults. Methods: This study included data of 131 older adults who had experienced a pilot service for ICT enhanced home-visit nursing. ICT enhanced home-visit nursing refers to a method of sharing health records and teleconference between a visiting nurse and a doctor during the home-visit nursing services to community-dwelling older adults. Health-related quality of life and influencing factors were analyzed by t-tests, logistic regression analysis using the Stata 17/SE program. Results: After a pilot service for ICT enhanced home-visit nursing, their health-related quality of life increased. The teleconferencing method had a significant effect on the increase in health-related quality of life. Conclusion: The findings indicate a pilot service for ICT enhanced home-visit nursing can be applied to the domestic community-based healthcare service model in terms of health management. In the future, the advanced service model of a pilot service for ICT enhanced home-visit nursing in which subjects conduct detailed for each health problem, and a well-designed evaluation system should be developed.
Background: This study aimed to explore factors associated with the non-use of beneficiaries of long-term care insurance services for the elderly in Jeollanam-do Province by analyzing a dataset obtained from National Health Insurance Service. Methods: The study sample consists of 1,663 individuals who were evaluated as eligible for long-term care insurance services in Jeollanam-do Province during the period of July 1, 2008 through June 30, 2009. As a dependent variable, the non-use of the service was defined as one when a beneficiary had used it once or more times during one year after he or she was evaluated as eligible and as zero otherwise. A proportion analysis was conducted to describe characteristics of study sample. Chi-square tests were used to compare general characteristics between beneficiaries who had used the services and those who had not used them. Multiple logistic regressions were performed by three models including additional sets of explanatory variables such as socio-demographic characteristics, health conditions, and economic status. Results: Main results are summarized as follows. The proportion of beneficiaries who had not used the service was 14.5% of all beneficiaries. According to the results from the model using all explanatory variables, the factors associated with the non-use of the services were residence location, dwelling place, type of desired service, level of care needs, and instrumental activities of daily life limitations. Conclusion: In particular, regarding the type of desired service, the cash benefit showed a high likelihood of the non-use of the service; it had an odds ratio (OR) of 50.212 (95% confidence interval [CI], 24.00-105.04) compared with home service. In case of dwelling place, a hospital showed also a high likelihood of the non-use with an OR of 20.71 (95% CI, 10.12-42.44) compared with home.
The purpose of this study is to analyze medical expenses by decedents in their last year of life and compare them with those by survivors during the year 2008. This study is conducted firstly in Korea, except some studies focusing on medical cost of decedents from specific diseases. To study this, national health insurance(NHI) claims data was used with medicaid claims data. The study group(decedents) was selected from the insurance entitlement file who were dropped out from January to December of 2008. The control group(survivors) was selected from the entitlement file by stratified sampling with keeping age-sex composition of the study group. The medical expenses of decedents during one year before death were measured and compared with those of survivors by sex and age. And the medical expenses were analyzed by causes of death, and also the expenses were examined by each item of medical services. On average, the medical expense amounted to 11 million Korean Won per decedent during their last year of life in 2008. The medical expense per decedent was 9.3 higher than that of survivor. The death-related expense of under the age 35 was about 16 million Won, compared with 4 million Won in the case of over the age 95, in average. The death-related expense is higher in younger ages. This means that more medical resources are put in to save life in younger ages. Total death-related expenditure took 8.3 percent in total NHI expenditures. Of the death-related medical expenses, the largest one was injection-related cost which shares twenty five percent, and the second largest one was hospitalization charges, and then the third one was surgery cost. The results of this study suggested that we should pay attention to the medical expenses in the last of year of life when we study health care expenditure in Korea. In addition, we have to deliberate health care policy to cope with medical expenditures before death in more efficient way.
Purpose: This study was to test a structural model of spirituality and the quality of life of stroke survivors' caregivers in order to provide guidelines for the development of intervention and strategies to improve their quality of life. Methods: Data were collected from 133 family caregivers of stroke patients who were hospitalized in C university hospital located in Seoul. Data collection using survey questionnaires was done from May, 2013 to February, 2014. Results: Fitness of the hypothetical model was appropriate. Physical component of quality of life of family caregivers is directly affected by two variables (51.5%), burden and depression. Mental component of quality of life of family caregivers is directly affected by three variables (77.6%), depression, burden, and functional dependence of patients. Depression as well as burden were directly affected by spirituality and functional dependence of patients respectively. Thus, spirituality directly affected depression and burden and indirectly affected the quality of life of family caregivers. Conclusion: Therefore, spiritual intervention to improve the stroke caregivers' quality of life might be necessary to support and strengthen their spirituality as a mediating variable that can contribute to decreasing their depression and burden.
Purpose: This study was conducted to synthesis the results of research on relationships of cognitive impairment with multi-dimensional correlates of rheumatic disease through a systematic literature review and meta-analysis. Methods: For the study purpose, 23 studies were selected through a systematic process of searching the literature. Results: The study results showed that among general characteristics, age and education were the variables having a significant relationship with cognitive impairment. Among health risk factors, obesity appeared to have a significant positive relationship with cognitive impairment. For past history, diabetes and hypertension were shown to have a significant positive relationship with cognitive impairment. It was noted also that aPL, one of the physiological factor, had significant association with cognitive impairment. None of the medication related factors had a significant relationship with cognitive impairment. Results showed that among disease related factors, disease activity had the highest relationship with cognitive impairment. Depression, among psychological factors, was the only variable having a significant relationship with cognitive impairment. Conclusion: The findings indicate that the variables strongly impacting on cognitive impairment in rheumatic disease are depression and disease activity.
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