• Title/Summary/Keyword: IRB

Search Result 223, Processing Time 0.028 seconds

Research to Establish a Common Standard for Assent by Assessing the Current State of the Assent Process and Conducting Interviews with Pediatrician/Pediatric Neurologist (소아승낙 현황조사와 소아청소년과/소아신경과 전문의를 대상으로 면담조사를 통한 소아승낙서 공통기준 수립 연구)

  • Yoon Jin Lee;Sun Ju Lee;Su Jin Kang;Dae Ho Lee;Kyun-Seop Bae;Jong Woo Chung;Byung Soo Kim;Jin Seok Kim;Myung Ah Lee
    • The Journal of KAIRB
    • /
    • v.6 no.1
    • /
    • pp.5-16
    • /
    • 2024
  • Purpose: The purpose of this study is to investigate the current status of pediatric assent in nationwide hospitals and to assess the children's comprehension for pediatric assent by interviewing pediatricians/pediatric neurologists to determine whether children of the age (elementary and middle school students) can understand the purpose, risks, benefits, and concepts of voluntary participation in clinical research described in the assent form, and to help improve the administrative efficiency of multicenter clinical trials. Methods: The status of pediatric assent was surveyed online using Google Forms at 141 university hospitals with administrative staff who are members of the Institutional Review Board (IRB) administrative staff subcommittee with in Korean Association of Institutional Review Boards (KAIRB). Additionally, face-to-face interviews were conducted with 7 pediatricians/pediatric neurologists. Survey and interview responses were summarized using descriptive statistics. Results: Out of the 141 institutions surveyed, 35 institutions (24.8%) responded. Among them, 30 institutions (85.7%) reported having age criteria for acquiring pediatric assent forms in the case of children. The age range for pediatric assent acquisition have been from 7 years old to 12 years old (15 institutions, 50%), and from 7 years old to 15 years old (7 institutions, 23.3%). Nine institutions (25.7%) have had criteria for obtaining both parents' consent in cases involving the participation of children. Nineteen institutions (54.3%) have had checklists or guidelines available for use by IRB members in study protocols involving vulnerable research subjects. Three pediatricians/pediatric neurologists have believed that upper-grade elementary school students (5th-6th grade) could comprehensively understand informed consent forms. Two have believed that middle school students would be able to understand them if they included personal information. Two pediatricians/pediatric neurologists have believed that even lower-grade elementary school students (1st-4th grade) could understand the explanations if they were made simpler. Conclusion: It is suggested that not only elementary school students (7-12 years old) but also middle school students (13-15 years old) should receive pediatric assent forms, as it would facilitate a comprehensive understanding of the forms. To enhance the comprehension of assent form content, it is necessary to use age-appropriate words, language, and expressions in the forms hospital. It is also recommended to create comics or videos to make the content of the assent forms more accessible for children.

  • PDF

The relationship between radiological features and clinical manifestation and dental expenses of keratocystic odontogenic tumor

  • Min, Jung-Hyun;Huh, Kyung-Hoe;Heo, Min-Suk;Choi, Soon-Chul;Yi, Won-Jin;Lee, Sam-Sun;Bae, Kwang-Hak;Choi, Jin-Woo
    • Imaging Science in Dentistry
    • /
    • v.43 no.2
    • /
    • pp.91-98
    • /
    • 2013
  • Purpose: This study was performed to identify correlations between keratocystic odontogenic tumor (KCOT) data from CT sections, and data on the KCOT clinical manifestation and resulting dental expenses. Materials and Methods: Following local Institutional Review Board (IRB) approval, a seven-years of retrospective study was performed regarding patients with KCOTs treated at the Seoul National University Dental Hospital. A total of 180 KCOT were included in this study. The following information was collected: age, gender, location and size of the lesion, radiological features, surgical treatment provided and dental expenses. Results: There was no significant association between the size of the KCOT and age, gender, and presenting preoperative symptoms. In both jaws, it was unusual to find KCOTs under 10 mm. The correlation between the number of teeth removed and the size of the KCOT in the tooth bearing area was statistically significant in the mandible, whereas in the maxilla, no significant relationship was found. Dental expenses compared with the size of the KCOT were found to be significant in both jaws. Conclusion: The size of KCOT was associated with a significant increase in dental expenses for both jaws and the number of teeth removed from the mandible. These findings emphasize the importance of routine examinations and early detection of lesions, which in turn helps preserving anatomical structures and reducing dental expenses.

The Survey on the Influence of Clinical Nurse's Critical Thinking Disposition, Problem-solving Skill and Self-efficacy on Patients Safety Competencies (간호사의 비판적 사고성향, 문제해결능력 및 자기효능감이 환자안전역량에 미치는 영향)

  • Kim, Hyo-Sun;Han, Suk-Jung
    • Journal of the Korea Academia-Industrial cooperation Society
    • /
    • v.17 no.6
    • /
    • pp.598-608
    • /
    • 2016
  • This study examined the relationships among patient safety competence, critical thinking disposition, problem-solving competence, and self-efficacy of clinical nurses to identify the factors influencing the patient safety competence. A convenience sample of 373 nurses working in 4 general hospitals in a Metropolitan area in Korea was selected. After obtaining IRB approval, data collection was done with a structured self-administered questionnaire from October 14th to November 4th, 2014. The data were analyzed using descriptive statistics, t-test, ANOVA, Pearson's correlation coefficient and multiple regression analysis using the SPSS WIN 21.0 program. The participants showed a moderate level of patient safety competence ($3.75{\pm}0.37$), of critical thinking disposition ($3.43{\pm}0.27$), of problem solving competence ($3.54{\pm}0.30$), and of self-efficacy ($3.58{\pm}0.47$). The patient safety competence of the participants showed a significant correlation with the critical thinking disposition (r=.493, p<.001), problem solving competence (r=.616, p<.001), and self-efficacy (r=.475, p<.001). The significant factors influencing the patient safety competence were problem solving competence (${\beta}=.403$, p<.001), self-efficacy (${\beta}=.156$, p=.005), critical thinking disposition (${\beta}=.130$, p=.018), and having the experience of reporting patient safety accidents (${\beta}=.137$, p=.002). The results suggest that educational programs to enhance the critical thinking disposition, problem-solving competence, and self-efficacy would develop the patient safety competence of clinical nurses. In addition, more effort should be placed into reinforcing the patient safety competence by activating the report of patient safety accidents.

Analysis of Factors Affecting Breakfast Eating Behavior of Children in Indonesia: An Application of the Health Belief Model (인도네시아 아동들의 아침식사하기에 영향을 미치는 요인 분석 -건강신념모델을 이용하여-)

  • Kang, Ran Yi;Lee, Soo Jin;Ryu, Ho Kyung
    • Korean Journal of Community Nutrition
    • /
    • v.25 no.1
    • /
    • pp.1-12
    • /
    • 2020
  • Objectives: This study investigates the current state of consuming breakfast among elementary school students residing in Malang, East Java, Indonesia, and to identify factors that influence breakfast behavior. Methods: The research model was set up as per the health belief model, and slightly modified by adding the subjective normative factors of the theory of planned behavior. The survey was conducted from July 17 to August 15, 2017 using a questionnaire, after receiving the permission PNU IRB (2017_60_HR). Results: The subjects were 77 boys (49.4%) and 79 girls (50.6%) suffering from malnutrition with anemia (21.2%) and stunting ratio of Height for Age Z Score (HAZ) (11.5%). Furthermore, moderate weakness (14.8%) and overweight and obesity (12.3%) by Body Mass Index for Age Z Score (BMIZ) were coexistent. According to the results obtained for breakfast, 21.8% did not eat breakfast before school, with 18.8% of the reasons for skipping breakfast being attributed to lack of food. Even for subjects partaking breakfast, only about 10% had a good balanced diet. The average score of behavioral intention on eating breakfast was 2.60 ± 0.58. The perceived sensitivity, perceived severity, perceived benefits, and self-efficacy of the health belief model correlated with breakfast behavior. Of these, self-efficacy (β=0.447, R2=0.200) and perceived sensitivity (β=0.373, R2=0.139) had the greatest effect on breakfast behavior. Mother was the largest impact person among children. Conclusions: In order to increase the level of breakfast behavior intention among children surveyed in Indonesia, we determined the effectiveness by focus on education which helps the children recognize to be more likely to get sick when they don't have breakfast, and increase their confidence in ability to have breakfast on their own. We believe there is a necessity to seek ways to provide indirect intervention through mothers, as well as impart direct nutrition education to children.

Trends in Research on Hospice Care in Korea (호스피스 간호 관련 국내 연구 동향)

  • Lee, Young-Eun;Choi, Eun-Joung
    • Journal of Hospice and Palliative Care
    • /
    • v.14 no.3
    • /
    • pp.152-162
    • /
    • 2011
  • Purpose: This study was conducted to analyze a trend in studies of hospice care in Korea and to suggest future research directions. Methods: This study analyzed a total of 183 studies related to hospice care which were found at http://www.riss.kr. Results: Of the 183 studies, 62 (33.9%) were for thesis studies for a degree, 121 (66.1%) for academic journals. There were 159 (87.8%) quantitative studies, 18 (8.9%) qualitative studies, and 6 (3.3%) Q-Method studies. The most frequently used study design was a descriptive study. The majority of study participants were terminal cancer patients, patients' family members and health care personnel. The thesis articles were searched by using key words as follows: health, nursing, environment, children's hospice, and others. Conclusion: The number of studies of hospice care has increased, and research key words varied. Furthermore, more experimental research is needed on nursing intervention such as pain relief, alternative therapies and hospice care for children.

Feasibility of Photodynamic Diagnosis for Challenging TUR-Bt Cases Including Muscle Invasive Bladder Cancer, BCG Failure or 2nd-TUR

  • Takai, Tomoaki;Inamoto, Teruo;Komura, Kazumasa;Yoshikawa, Yuki;Uchimoto, Taizo;Saito, Kenkichi;Tanda, Naoki;Kouno, Junko;Minami, Koichiro;Uehara, Hirofumi;Takahara, Kiyoshi;Hirano, Hajime;Nomi, Hayahito;Kiyama, Satoshi;Azuma, Haruhito
    • Asian Pacific Journal of Cancer Prevention
    • /
    • v.16 no.6
    • /
    • pp.2297-2301
    • /
    • 2015
  • Background: Despite widely adopted standard methods for follow-up including cystoscopy plus cytology, recurrence rates of non muscle-invasive bladder cancer (NMIBC) have not improved over the past decades, still ranging from 60% through 70%. Hence, widely acceptable surveillance strategies with excellent sensitivity are needed. Early recurrence has led to the development of a novel cystoscopy technique utilizing photodynamic diagnosis (PDD). Although, no studies have evaluated the efficacy of PDD for patients of MIBC, BCG failure or 2nd-transurethelial resection (TUR). Materials and Methods: The present study was performed from October 2012 through May 2013. IRB approved 25 patients initially underwent a cystoscopy examination of white light and blue light followed by the resection of tumors identified. Resections were performed from bladder mucosa areas considered suspicious at PDD, along with PDD negative normal bladder mucosa area resected by random biopsy. Specimens were divided into two groups, PDD positive and negative. Primary endpoints were sensitivity and specificity. Results: A total of 147 specimens extracted from 25 patients were included in the analysis. Some 45 out of 92 PDD-positive specimens were confirmed to have bladder cancer, and 51 out of PDD-negative 55 specimens were confirmed to be cancer negative. The sensitivity of PDD was 91.8% (45/49) and specificity was 52.0% (51/98). The sensitivity:specificity was 89.5% (17/19) : 47.6% (30/63) in 12 2nd-TUR patients, 90.5% (19/21) : 61.1% (11/18) in seven MIBC patients, and 95.0% (19/20) : 48.5% (16/33) in eight failed BCG cases. Conclusions: PDD-TURBT has high sensitivity to diagnose BC even for 2nd-TUR, MIBC or BCG failure cases.

Sugar composition and glycemic indices of frequently consumed fruits in Korea (우리나라 다빈도 섭취 과일의 당 함량 및 혈당지수에 관한 연구)

  • Ryu, Ji-Hyun;Yim, Jung-Eun;Suk, Wan-Hee;Lee, Han-Song-Yi;Ahn, Hye-Jin;Kim, Young-Seol;Park, Cheon-Seok;Choue, Ryo-Won
    • Journal of Nutrition and Health
    • /
    • v.45 no.2
    • /
    • pp.192-200
    • /
    • 2012
  • Fruits are generally recommended for a balanced meal, as they are good sources of vitamins, minerals, and fiber, which may improve blood glucose control. However, fruits have simple sugars with a wide glycemic index (GI) range. The purpose of this study was to analyze the sugar content and composition and to determine the glycemic indices of the most frequently consumed fruits in Korea, including apple, tangerine, pear, water melon, persimmon, grape, oriental melon, and peach. The sugar content and composition of the fruits were analyzed by high performance anion-exchange chromatography (Dinonex model DX-600). The GI of the fruits was measured in 13 healthy subjects (seven females and six males) after permission was received from the University Hospital institutional review board (KHU-IRB 1114-06). The subjects consumed 50 g of glucose as a reference and carbohydrate portions of eight fruits. Blood samples were collected at 0, 30, 60, 90, and 120 min after consuming the fruits. The GI values for the fruits were calculated by expressing the increase in the area under the blood glucose response curve for each subject. As a result, the total sugar contents of 100 g fruits were: grape (13.9 g), apple (12.3 g), persimmon (11.9 g), oriental melon (11.2 g), watermelon (9.3 g), tangerine (8.9 g), peach (8.6 g), and pear (8.3 g). The GI values of the fruits were as follows: GI value of peach ($56.5{\pm}14.17$), watermelon ($53.5{\pm}18.07$), oriental melon ($51.2{\pm}18.14$), tangerine ($50.4{\pm}15.16$), grape ($48.1{\pm}14.05$), persimmon ($42.9{\pm}18.92$), pear ($35.7{\pm}14.38$), and apple ($33.5{\pm}11.92$). These findings will help individuals choose fruit for controlling blood sugar.

The Effects of Semi-Fowler's position on Post-Operative Recovery and Pain for Patients with Laparoscopic Abdominal Surgery (복강경 수술 후 반좌위가 수술회복성과 통증에 미치는 영향)

  • Choi, Un Jong;Ha, Tae Uk;Kang, Ji Sook
    • Journal of the Korea Academia-Industrial cooperation Society
    • /
    • v.18 no.5
    • /
    • pp.412-419
    • /
    • 2017
  • Purpose:This study was conducted to identify the effects of theSemi-Fowler's position on post-operative recovery and pain for patients with laparoscopic abdominal surgery Methods: This study utilized a non-equivalent control group non-synchronized design to validate the effects of theSemi-Fowler's position. After IRB approval, 56 patients took part in this study, 29 in the experimental group and 27 in the control group. Consent was obtained from the participants. The Semi-Folwer's position was applied to experimental group and the supine position was applied to the control group for 24 hours after surgery. All data were reviewed retrospectively from April to June 2016. Collected data, frequency, percentage, average, standard deviation, chi-squared test, independent t-test and repeated measures ANOVA were conducted using SPSS 20.0. Results: There was no significant difference between the experimental and control group with regard to recovery outcomes; however, there was a significance differencebetween groups and among check times with regard to post operational pain. Conclusion:The results of this study provide information that will be usefulto the development of strategies for improving recovery outcomes and pain for laparoscopic operation patients.

Reports on 'Meeting on the Revision of Guidelines for Clinical Research on Acupuncture' (WHO 침구임상 지침서 개정을 위한 국제회의 보고)

  • Park, Hi-Joon;Seo, Jung-Chul;Kim, Se-Hyun;Kim, Sang-Woo;An, Kyung-Eh;Lim, Sabina;Kim, Yong-Suk;Choi, Do-Young;Kang, Sung-Keel
    • Journal of Acupuncture Research
    • /
    • v.22 no.5
    • /
    • pp.195-199
    • /
    • 2005
  • The Working Group on the revision of Clinical Research Methodology for Acupuncture met in Seoul, Republic of Korea from 24 to 26 August 2005. The main objectives of the meeting were to review the regional publication guidelines for Clinical Research on Acupuncture, to make necessary revisions in the guidelines, to make recommendations on further collaboration and activities in the field of research on acupuncture, and to discuss scientific evidence-based approaches in the clinical research on acupuncture. Fourteen members from the eight Member States, one secretariat staff from the WHO Regional Office for the Western Pacific and ten observers from the Republic of Korea attended the meeting. The members presented their papers to review the current status of clinical research on acupuncture. The drafts of proposed revision to the previous guidelines for clinical research methodology on acupuncture were discussed extensively. The issues covered during the discussion included: the definition of the new terms; reorganization of clinical research design; revision and update of contents (e.g., control group); introduction of Institutional Review Board (IRB) on the section of ethical approval; additional outcomes including health-related quality of life (HRQOL), qualitative measures, etc. In the course of these discussions, the working group developed the revised guidelines for clinical research on acupuncture and made recommendations for promoting the dissemination of the revised guidelines.

  • PDF

Report of the 3rd Japan-Korea Workshop on Acupuncture and EBM;Protocol development for the acupuncture trial on the osteoarthritis of the knee

  • Jang, Jun-Hyouk;Kenji, Kawakita;Hahn, Seo-Kyung;Park, Hi-Joon;Lee, Seung-Deok;Kim, Yong-Suk;Norihito, Takahashi;Toshiyuki, Shichidou;Kazunori, Itoh;Eiji, Sumiya;Eiji, Furuya;Hitoshi, Yamashita;Hiroshi, Tsukayama
    • Journal of Acupuncture Research
    • /
    • v.23 no.6
    • /
    • pp.239-254
    • /
    • 2006
  • The 3rd Japan-Korea Workshop on Acupuncture and EBM was held at Kanazawa on June $16^{th}$. From Korea team, 4 papers were presented. Dr. Hahn introduced a new approach of data analysis on series of n-of-1 trials using the Bayesian statistics. It offered important information for the future n-of-1 trials. Dr. Park clearly demonstrated the significance of various sham devices proposed and stressed the importance of research questions when we choose the control intervention in RCT. Dr. Lee reported the results of survey in Korean Medical Doctors (KMD) for their point selection and techniques to the distal and local points. Dr. Kim presented the results of face to face survey on the KMD with 28 items for acupuncture treatment on the knee OA. Finally, a draft of protocol was introduced by Dr. Kim. The title was "multi-center, a randomized, single blinded, two arms, parallel-group study to compare the effectiveness and safety of 'individualized acupuncture' and 'standardized minimal acupuncture' in Korean and Japanese patients with knee osteoarthritis (Phase IV)". From Japan team, 7 speakers presented their comments and proposals on the protocol. Dr. Takahashi introduced several issues regarding n-of-1 trials and pointed out the importance of obtaining generalizability from n-of-1 trials. Dr. Shichidou pointed the importance of research design, selection of outcome measures and reduction of biases. Dr. Itoh presented the results of point selection for the knee OA based on the literature survey. Dr. Sumiya introduced several differences between KMD and Japanese acupuncturists based on the questionnaire used in KMD survey. Dr. Furuya demonstrated a result of press tack needle and its sham device on shoulder stiffness. Dr. Yamashita introduced the results of literature survey regarding adverse events occurred by acupuncture on knee OA. Dr.Tsukayama stressed the importance of responsibility of Institutional Review Board (IRB) for the conduction of clinical trials. After several issues were discussed, the need of continued meeting for final protocol development was agreed, then the workshop was closed.

  • PDF