Quality assurance may be defined as the complete set of systemic actions that is required to achieve a better treatment result by standardizing treatment and by using various audit programs. In general, application of a quality assurance program in surgery is considered to be more difficult than it is in chemotherapy or radiotherapy. However, recently, the importance of quality assurance in the surgical field has been emphasized in clinical trials comparing different surgical procedures and evaluating the role of postoperative adjuvant therapy. In the case of gastric cancer surgery, excellent quality assurance programs have rarely been applied in most large prospective clinical trials. Although the quality assurance in Dutch trial was conducted very systemically and strictly, the situation is quite different from ours. On the other hand, several quality assurance programs in Japanese trials comparing D2 and D2 plus para-arotic lymph node dissection seem to be applicable to Korean clinical trials. Several factors, including selection of appropriate surgeons based on personal experience and annual number of operations, standardization of surgical procedures by education and consensus, development of a unified database program, application of standardized perioperative management, and standardization of pathologic examination, are required to guarantee a successful multi-institutional prospective clinical trial. In contrast, one needs to realize that protocols that are too strict and sophisticated can make the enrollment of patients and surgeons more difficult and can promote protocol violation during the clinical trials. (J Korean Gastric Cancer Assoc 2005;5:79-88)
BACKGROUND/OBJECTIVES: The purpose of this study was to investigate the overall effects of a tailored Dietary Approaches to Stop Hypertension (DASH) nutritional intervention program which included omega-3 fatty acids supplementation, on dietary self-efficacy, dietary knowledge, and dietary behaviors in Korean elderly women with abdominal obesity. Furthermore, we investigated the effects of the program on metabolic syndrome parameters including the antioxidant capacities in these subjects. SUBJECTS/METHODS: A randomized, controlled trial was conducted for 8 weeks. The experimental group (n = 21) received a weekly tailored nutritional program for 8 weeks and the control group (n = 18) received only one educational session. The clinical survey was conducted before and after the intervention period. RESULTS: After the intervention, dietary self-efficacy (P = 0.023), frequency of fruit intake (P = 0.019), and dietary fiber intake (P = 0.044) were higher in the experimental group than in the control group. The oxidative stress (P < 0.001) was lower in the experimental group than in the control group. Moreover, low density lipoprotein (LDL) cholesterol (P = 0.023) had significantly decreased in the experimental group but not in the control group after the intervention. CONCLUSIONS: The intervention program including omega-3 fatty acid supplementation had a positive effect on dietary self-efficacy, dietary behaviors, and oxidative stress among aged women with abdominal obesity.
Baek, Ji Hyun;Heo, Jung-Yoon;Fava, Maurizio;Mischoulon, David;Choi, Kwan Woo;Na, Eun Jin;Cho, Hana;Jeon, Hong Jin
Journal of Ginseng Research
/
v.43
no.3
/
pp.402-407
/
2019
Background: To investigate the neurobiological evidence supporting the adaptogenic effects of Korean Red Ginseng in reducing the harmful consequences of stress using a double-blind, placebo-controlled trial. Method: Sixty-three subjects with high stress levels were randomized to receive an orally administered, double-blind, 6-week treatment with Korean Red Ginseng (n = 32) or placebo (n = 31). All participants underwent a comprehensive psychological evaluation using Beck Depression Inventory and Stress Response Inventory, cognitive evaluation using the continuous performance test, biological evaluation by measuring blood levels of lipids, catecholamines, inflammation markers, and heart rate variability at baseline and after 6 weeks. Results: At baseline, both groups showed no significant differences in age, sex, years of education, Beck Depression Inventory, and Stress Response Inventory. After 6 weeks, triglyceride levels were significantly increased within the normal limit in the Korean Red Ginseng group (F = 4.11, p = 0.048), and the epinephrine level was decreased in this group (F = 4,35, p = 0.043). The triglyceride increase was significantly associated with epinephrine decrease (B = 0.087, p = 0.041), suggesting that Korean Red Ginseng may stabilize the sympathetic nervous system. In addition, we detected a significant group by time effect in the visually controlled continuous performance test, suggesting positive effects of Korean Red Ginseng on cognition. Conclusion: Korean Red Ginseng might help to stabilize the sympathetic nervous system and improve cognition in individuals with high stress.
Purpose: Nurses play an important role in ensuring patient rehabilitation and are involved in all aspects of multidimensional rehabilitation. Therefore, strengthening rehabilitation nursing education is vital to ascertain high-quality rehabilitation and optimum outcomes. This study examined the effectiveness of a new teaching reform-a modified Six-Sigma-based training program-against a conventional educational program on rehabilitation specialist nurses' core competencies, post-training performance, and satisfaction. Methods: A quasi-randomized controlled trial was conducted to assess the effectiveness of the modified training program. We recruited 56 learners from the 2020 training course at the Hunan Rehabilitation Specialist Nurse Training Base as the control group. Sixty learners from the base's 2021 training course were recruited as the intervention group. Data were collected in a consistent manner from both groups after the training program was implemented. Results: Those who underwent the modified training program showed better improvement in all core competencies than those who underwent the conventional training program (p < .05); the scores for theoretical knowledge, clinical nursing lectures, reviews, and nursing case management improved significantly following the teaching reform (p < 0.05). Further, overall satisfaction as well as base management and theoretical teaching satisfaction improved significantly (p < .05). Conclusion: The modified training program strengthens rehabilitation nurses' base management abilities; enhances their core competencies; expands their interest in and breadth, depth, and practicability of theoretical courses; and updates the teaching methods.
Maeng, Chi Hoon;Lee, Sun Ju;Cho, Sung Ran;Kim, Jin Seok;Rha, Sun Young;Kim, Yong Jin;Chung, Jong Woo;Kim, Seung Min
The Journal of KAIRB
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v.2
no.2
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pp.37-48
/
2020
Purpose: The purpose of this study is to assess the operational status and level of understanding among IRB and HRPP staffs at a hospital or a research institute to the HRPP guideline set by the Ministry of Food and Drug Safety (MFDS) and to provide recommendations. Methods: Online survey was distributed among members of Korean Association of IRB (KAIRB) through each IRB office. The result was separated according to topic and descriptive statistics was used for analysis. Result: Survey notification was sent out to 176 institutions and 65 (37.1%) institutions answered the survey by online. Of 65 institutions that answered the survey; 83.1% was hospital, 12.3% was university, 3.1% was medical college, 1.5% was research institution. 23 institutions (25.4%) established independent HRPP offices and 39 institutions (60.0%) did not. 12 institutions (18.5%) had separate IRB and HRPP heads, 21 (32.3%) institutions separated business reporting procedure and person in charge, 12 institutions separated the responsibility of IRB and HRPP among staff, and 45 institutions (69.2%) had audit & non-compliance managers. When asked about the most important basic task for HRPP, 23% answered self-audit. And according to 43.52%, self-audit was also the most by both institutions that operated HRPP and institutions that did not. When basic task performance status was analyzed, on average, the institutions that operated HRPP was 14% higher than institutions that only operated IRB. 9 (13.8%) institutions were evaluated and obtained HRPP accreditation from MFDS and the most common reason for obtaining the accreditation was to be selected as Institution for the education of persons conducting clinical trial (6 institutions). The most common reason for not obtaining HRPP accreditation was because of insufficient staff and limited capacity of the institution (28%). Institutions with and without a plan to be HRPP accredited by MFDS were 20 (37.7%) each. 34 institutions (52.3%) answered HRPP evaluation method and accreditation by MFDS was appropriate while 31 institutions (47.7%) answered otherwise. 36 institutions answered that HRPP evaluation and accreditation by MFDS was credible while 29 institutions (44.5%) answered that HRPP evaluation method and accreditation by MFDS was not credible. Conclusion: 1. MFDS's HRPP accreditation program can facilitate the main objective of HRPP and MFDS's HRPP accreditation program should be encouraged to non-tertiary hospitals by taking small staff size into consideration and issuing accreditation by segregating accreditation. 2. While issuing Institution for the education of persons conducting clinical trial status as a benefit of MFDS's HRPP accreditation program, it can also hinder access to MFDS's HRPP accreditation program. It should also be considered that the non-contact culture during COVID-19 pandemic eliminated time and space limitation for education. 3. For clinical research conducted internally by an institution, internal audit is the most effective and sole method of protecting safety and right of the test subjects and integrity for research in Korea. For this reason, regardless of the size of the institution, an internal audit should be enforced. 4. It is necessary for KAIRB and MFDSto improve HRPP awareness by advocating and educating the concept and necessity of HRPP in clinical research. 5. A new HRPP accreditation system should be setup for all clinical research with human subjects, including Investigational New Drug (IND) application in near future.
This study aimed to pilot test a newly developed bilateral upper limb rehabilitation training program for improving the upper limb function of individuals with chronic stroke using a visual feedback method. The double-group pretest-posttest design pilot study included 10 individuals with chronic stroke (age >50 years). The intervention (four weekly meetings) consisted of five upper limb training protocols (wrist extension; forearm supination and pronation; elbow extension and shoulder flexion; weight-bearing shift; and shoulder, elbow, and wrist complex movements). Upper limb movement function recovery was assessed with the FuglMeyer Assessment of the Upper Extremity, the Wolf Motor Function Test, the Trunk Control Test, the modified Ashworth Scale, and the visual analog scale at baseline, immediately after, and four weeks after the intervention. The Fatigue Severity Scale was also employed. The Fugl-Meyer Assessment of the Upper Extremity and Wolf Motor Function Test showed significant improvement in upper limb motor function. The Trunk Control Test results increased slightly, and the modified Ashworth Scale decreased slightly, without statistical significance. The visual analog scale scores showed a significant decrease and the Fatigue Severity Scale scores were moderate or low. The bilateral upper limb training program using the visual feedback method could result in slight upper limb function improvements in individuals with chronic stroke.
Purpose: This study was designed to evaluate the perception of cancer in aspirants for hospice volunteer. Methods: Aspirants for hospice volunteer were surveyed by questionnaire before education of hospice program in September 2005 at Pyongan Hospice Center of Sam Anyang Hospital. The questionnaire was composed of total 28 items. Ten items were general characteristics and the remaining 18 items knowledge, attitude and practice of cancer and cancer pain. The data were analyzed by SPSS WIN 11.0 program using frequency, mean, percentage. Results: Eighty nine questionnaires were returned. There were 6 males and 83 females, and median age of aspirants was 46 years. Forty five aspirants(51%) had a cancer patient in th family or relatives and the others 44(49%) not. Forty eight(54%) had favorable attitude about modern clinical medicine for cancer treatment and the others 39(44%) unfavorable. Fifty eight(65%) had favorable attitude about complementary and alternative medicine for cancer treatment and the others 20(23%). In response to the question about 'How illness is a cancer', 25 aspirants(25%) responded to chronic disease, 42(47%) suffering incurable disease, the others 17(19%) death sentence, respectively. A number of aspirants had wrong knowledge and understanding of cancer, cancer pain and opioid analgesics. Seventy one percent aspirants feared cancer pain. Conclusion: The credibility to modern clinical medicine for cancer treatment was relatively low in aspirants for hospice volunteer compared with complementary and alternative medicine. They recognized a cancer as suffering incurable disease and death sentence than chronic disease. A number of aspirants had wrong knowledge of cancer, cancer pain and opioid analgesics. Therefore, further studies and trial will be warranted to evaluated the causes of these results and improve the credibility of modern clinical medicine for cancer treatment in general population.
The Journal of Korean Academic Society of Nursing Education
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v.23
no.1
/
pp.15-26
/
2017
Purpose: This study evaluated the efficacy of a communication ability enhancement program for nursing students in Korea through a systematic review of literature and meta-analysis. Methods: The researchers searched data-bases, including the Data Base Periodical Information Academic, Research Information Sharing Service, National Digital Science Library and National Assembly Library. The key words used included 'communication' and 'nursing student'. The researchers evaluated articles published up to July 2016. Out of 381 selected articles, 20 clinical trial studies were meta-analyzed. Each article was evaluated in accordance with the Checklist of Scottish Intercollegiate Guideline Network. The effect size of communication ability, self-efficacy and interpersonal relations were synthesized by a random effects model from analysis software (R 3.2.3). The heterogeneity of effect size was analyzed by exploratory and confirmatory moderator analysis. Results: The overall effect size of the program was of a moderate level (SMD=0.78, 95% CI: 0.49~1.07) along with each outcome of self-efficacy (SMD=0.80, 95% CI: 0.23~1.37), and interpersonal relations (SMD=0.47, 95% CI: 0.14~0.80). For heterogeneity, moderator analysis was performed, by grade, and a statistically significant moderator was found. Conclusion: It is evident that a communication ability enhancement program for nursing students is moderately effective in improving communication ability, self-efficacy and interpersonal relations.
BACKGROUND/OBJECTIVES: Nutrition is a determinant factor of health in elderly people. Independent living in elderly people can be maintained or enhanced by improvement of nutritional behavior. Hence, the present study was conducted to determine the impact of Health Belief Model (HBM)-based intervention on the nutritional behavior of elderly women. SUBJECTS/METHODS: Cluster-random sampling was used to assess the sample of this clinical trial study. The participants of this study attended a 12-week nutrition education program consisting of two (2) sessions per week. There was also a follow-up for another three (3) months. Smart PLS 3.5 and SPSS 19 were used for structural equation modeling, determination of model fitness, and hypotheses testing. RESULTS: The findings indicate that intervention had a significant effect on knowledge improvement as well as the behavior of elderly women. The model explained 5 to 70% of the variance in nutritional behavior. In addition, nutritional behavior was positively affected by the HBM constructs comprised of perceived susceptibility, self-efficacy, perceived benefits, and barriers after the intervention program. CONCLUSION: The results of this study show that HBM-based educational intervention has a significant effect in improving nutritional knowledge and behavior among elderly women.
Objectives This study reviewed the effects of a combined treatment with Kampo and Western medicine for Developmental disability in Japan, and the provision of education programs in clinical care. Methods The search database includes J-STAGE. To narrow the search, the following key words were used: 'pervasive developmental disorders, Attention-Deficit/Hyperactivity Disorder, Learning Disorders or Learning Disabilities, Intellectual Disability, and Kampo'. The search was limited to the publication date from 2001 to 2019. Results 1. Japan analyzed five sections: The usage of the Kampo medicine ranges from 25.2% to 71.6%, and the Kampo medicine was highly used in large cities. 2. In Japan, the educational programs were provided for the caregiver and special educational programs were available for children with disabilities. 3. In Japan, there were 9 studies regarding developmental disability treating with herbal remedies. There were seven clinical trial reports, and two were published in a review or report form. 4. The results showed benefits of using Kampo for patients with lack of Yin in blood in treatment of developmental disorder. It is also important to control the liver qi and Yin in blood. 5. Seven papers reported no side effects or abnormal findings. They have reduced the use of antipsychotics. Conclusions These review studies in regards to the combined treatment of Kampo and Western medicines can be helpful to improve long term side effects of the antipsychotics used in developmental disorders.
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