• Title/Summary/Keyword: institutional review board

Search Result 209, Processing Time 0.197 seconds

Factors Influencing on Pressure Ulcer Incidence among Older Patients with Hip Fracture in a Hospital (고관절 골절로 입원한 노인 환자의 욕창 발생 위험요인)

  • Lee, Sun Jin;Jeong, Jae Shim;Lim, Kyung-Choon;Park, Eun Young;Kim, Hye Youn
    • Journal of Korean Biological Nursing Science
    • /
    • v.21 no.1
    • /
    • pp.54-61
    • /
    • 2019
  • Purpose: This study aimed to identify the incidence and risks for pressure ulcer among older patients with hip fracture. Methods: The subject were 215 older patients suffering from hip fracture who were admitted for surgical operation from January 1, 2012 to April 30, 2016 in a university-affiliated hospital. The incidence of pressure ulcer was collected retrospectively through medical record review and the risk factors were analyzed using Cox's proportional hazard model. Results: Out of the total, 32 patients (14.9%) developed pressure ulcer with the average occurrence period being 4.72 (${\pm}3.81$) days. Stage II pressure ulcer was the most common at 72.0%. Risk factors included ambulation status before injury (p= .039), spinal anesthesia (p= .029), and stay at intensive care unit after operation (p= .009). Conclusion: Despite pressure ulcer prevention efforts, the incidence remained relatively high. Considering the identified risk factors, more efforts is needed for early detection and prevention of pressure ulcers in such patients.

Legal Issues in Clinical Trial on Minor (미성년자 대상 임상시험에 관한 법적 문제점)

  • Song, Young-min
    • The Korean Society of Law and Medicine
    • /
    • v.17 no.2
    • /
    • pp.125-144
    • /
    • 2016
  • All forms of Clinical trial should be fully equipped with protection systems for experimental subjects considering their uncertainty and various risks. Existing laws have some regulations in pharmaceutical affairs act and medical device act. Nonetheless, there is a limit to protect the subjects considering law objective to perform administration of medicine. Furthermore, the clinical trial on minor has no direct regulations in pharmaceutical affairs act, but prescribes certain portion in clinical trial assessment guideline on infants or medicine clinical trial management standard, however there is a limit because that is just recommendation not having legal effectiveness. The legislative solution would be possible for legal problems of clinical trial on minor by examining treatment system on minor in organ transplant act and clinical trial on minor in other foreign laws stronger than usual medical practice in terms of degree of human body invasion. I suppose that the control system of clinical trial being done focusing on the pharmaceutical affairs act, medical device act and other guidelines in existing laws system should be resolved by legislating 'trial subject protection law', in addition, this would be well balanced in organ transplant act on protection system of minor organ donors. Furthermore, the judgement on the consent ability and spontaneity in clinical trial on minor should be judged considering maturity and mentality of minor by clinical trial institutional review board based on legislative solution mentioned above.

  • PDF

The Domestic Trends of Acupuncture Treatment on Lateral Epicondylitis : A literature review (주관절 외측상과염의 침치료에 대한 국내 연구 동향 분석)

  • Kim, Hyunseok;Lee, Chiho;Oh, Minseok
    • Journal of Haehwa Medicine
    • /
    • v.25 no.1
    • /
    • pp.1-13
    • /
    • 2016
  • Objectives : Lateral epicondylitis on elbow is one of the most common causes of elbow pain. Lateral epicondylitis can be managed with acupuncture, but the evidence for its effectiveness is uncertain. The purpose of this review is to investigate the trends of acupuncture treatments on lateral epicondylitis. Methods : We investigated the studies about acupuncture treatments for lateral epicondylitis via searching 5 Korean web databases(KTKP, RISS, OASIS, KCI, Kisti) The key search terms were 'Lateral epicondylitis', 'Tennis elbow', 'External epicondylitis'. 12 research papers(10 case reports, 1 RCT, 1NRCT) were found to be analyzed according to their published year, the titles of journals, published institution, the types of study, the number of cases, the types of treatments, the instruments for assessment and ethical approvals. The effectiveness of acupuncture treatment was classified. Results : 12 papers were published since 2003. The studies on acupuncture treatments about lateral epicondylitis were mainly published in The journal of pharmacopuncture. 10 case reports, 1 non-randomized controlled trials, 1 randomized controlled trials had been under research. In most of the research, the number of the cases were not enough. In 9 cases of the studies, various korean medicine treatments including acupuncture were used to treat the symptoms. In 3 cases of the studies single method was used to treat the symptoms. Visual analogue scale(VAS) and range of motion(ROM), grip strength were used as primary assessments. Among 12 clinical studies, 1 of them were accepted by institutional review board(IRB). Conclusions : In this study, we analyzed the trends of acupuncture treatments on lateral epicondylitis. Reviewing the domestic trends of studies on acupuncture treatments for lateral epicondylitis and examining the strong and weak points of those treatments are essential for the future studies.

A Review on Clinical Studies of Acupuncture and Moxibustion Therapy for Acute Herpes Zoster (급성기 대상포진의 침구치료에 대한 임상 연구 문헌 고찰)

  • Choi, Yoo Min;Kim, Seok Hee;Kim, Ju Yong;Park, Sang Hun;Yook, Tae Han;Kim, Jong Uk
    • Journal of Acupuncture Research
    • /
    • v.32 no.3
    • /
    • pp.147-161
    • /
    • 2015
  • Objectives : The purpose of this study was to review the effectiveness of acupuncture and moxibustion therapy for the treatment of acute herpes zoster. Methods : Data was collected by two researchers. Clinical trials on PubMed were retrieved using MeSH terms including "herpes zoster" combined with "acupuncture therapy", "moxibustion", "bloodletting", "electroacupuncture", and related keywords. We excluded irrelevant studies and included randomized and non-randomized controlled trials, case series and case reports. Finally, we selected a total of thirteen studies and conducted a literature analysis and an object quality assessment. Results : Twelve of thirteen studies were about acupuncture and moxibustion combined therapy. Only one study suggested that a single acupuncture therapy is expected to be equally as effective as a common western medicine therapy. There was some evidence related to the effectiveness of moxibustion, venesection and electroacupuncture, but it dealt with combining therapy and was insufficient, and with an inclusion of potential risk factors. Only one study was conducted under approval from an institutional review board. No severe treatment-related adverse events were observed. A quality assessment suggested that there was some weakness in the areas of blinding and concealment. Conclusions : There is some evidence that suggests the effectiveness and safety of acupuncture and moxibustion combined therapy as a treatment for acute herpes zoster.

Analyzing intervention research trends in animal-assisted therapy: a review on the Korean experimental researches from 1998 to 2022

  • Taeyoung Kil
    • Journal of Animal Science and Technology
    • /
    • v.65 no.6
    • /
    • pp.1111-1123
    • /
    • 2023
  • This study aims to present a more systematic and developmental research direction by classifying animal-mediation related research trends published in Korea. We analyzed the research trends of 68 domestic animal-mediation programs published in 26 journals over the past 24 years under the premise of the necessity of animal-assisted therapy, which considered a very effective intervention method in the practice areas of various subjects. Therefore, this study examines the year of publication of animal-mediation related research conducted in various academic fields from 1998 to 2022, research data sources, characteristics of research subjects, types of interventions and research topics, research design and intervention sessions, intervention methods, and ethical consideration statements. The results of this study are as follows: First, in the source of research and research trends by year, the number of papers published in animal-related societies was the highest at 34 (50%); the number of studies has been steadily increasing since the mid-2000s. Second, regarding research trends by subject, 45 (66%) were general subjects, 23 (34%) were medically diagnosed, 60 (88%) were selected through pre-evaluation, and 8 (12%) were requested. Third, regarding research trends by method, 27 (40%) of the pretests were conducted before and after the experiment-control group, and only 3 (4%) of the 68 papers were examined later. Fourth, regarding research trends by content, depression (25%) was the most frequently applied variable, and regarding intervention sessions, 53 (78%) were less than 12 sessions. Fifth, regarding research trends and ethical consideration statements by treatment approach method, 58 cases (85%) of individual treatment approaches and 10 cases (15%) of intervention approaches integrated with individual treatment approaches, and 23 cases (34%) of studies with ethical consideration statements or the Institutional Review Board's (IRB) approval. Based on the study results, the implications and research directions of animal-assisted therapy related research are discussed.

Predicting Factors of Smoking and Emotional Stress among Male Patients with Acute Coronary Syndrome (급성관상동맥증후군 남성 환자의 흡연과 스트레스에 영향을 미치는 요인)

  • Kim, Eun-Young;Hwang, Seon-Young
    • Korean Journal of Adult Nursing
    • /
    • v.23 no.1
    • /
    • pp.100-109
    • /
    • 2011
  • Purpose: This study was conducted to identify the factors that predict a current smoking behavior and higher emotional stress among male patients with acute coronary syndrome (ACS). Methods: The study was approved by an institutional review board from a university hospital, 2010. A face to face interview using questionnaires was performed with 185 first-time ACS male patients who were undertaken a percutaneous coronary intervention at a cardiovascular care unit. Data were analyzed using SPSS/WIN 15.0. Results: About 54% of the study subjects were currently smoking. The current smokers had dyslipidemia and reported bad eating habits compared to the non-smokers. The current smokers were younger, living alone, and reported lower perceived benefit on smoking cessation than the non-smokers, and 15% of them did not consider quitting (precontemplation stage). Smoking status was not significantly related to emotional stress. Logistic regression analysis revealed that being employed including professional or labor increased the odds of current smoking four or three times compared to the non-employed or retired. Low income or dyslipidemia also increased the likelihood of current smoking 2.8 and 2.1 times, respectively. Blue collar workers or heavy drinkers had 2.9 and 2.8 times more risks of having higher level of stress. Conclusion: An occupational background and health habits should be considered to develop an effective educational strategy for smoking cessation and stress reduction among male patients with ACS.

Structural Relationships among Job Embeddedness, Emotional Intelligence, Social Support and Turnover Intention of Nurses (간호사의 직무 배태성, 감성지능, 사회적지지, 이직의도 간의 구조적 관계)

  • Lee, So-Jung;Woo, Hye-Jong
    • Journal of Korean Academy of Nursing Administration
    • /
    • v.21 no.1
    • /
    • pp.32-42
    • /
    • 2015
  • Purpose: This study was done to elicit basic data for effective human resource management by identifying the relationships among job embeddedness, emotional intelligence, social support, and the turnover intention of Nurses. Methods: Research design was to build a hypothetical causal model between variables and to verify its fitness. The sample for this study was 283 nurses with careers of more than 6 months in one hospital of more than 800 beds located in Seoul. They agreed in writing and this study was approved by the Institutional Review Board. Data were analyzed using SPSS 18.0 and AMOS 18.0 program. Results: Differences in general characteristics for the variables were significant for age, marital status, education, work experience, job title, income, and department. Job embeddedness, emotional intelligence and social support were significantly correlated to turnover intention. Job embeddedness to emotional intelligence and social support showed positive effects and a negative effect to turnover intention. Emotional intelligence to turnover intention showed a positive effect, but social support was not significant. Conclusion: Organizations should provide ways to minimize voluntary turnover of a competent workforce and demonstrate their competency. Also it should develop training and management programs to effectively utilize emotional intelligence.

The Life of Adolescent Patients with Complex Congenital Heart Disease (복잡 심기형을 가진 환자의 청소년기 삶)

  • Lee, Sun-Hee;Kim, So-Sun
    • Journal of Korean Academy of Nursing
    • /
    • v.40 no.3
    • /
    • pp.411-422
    • /
    • 2010
  • Purpose: In the present study, an analysis of the life of adolescents with complex congenital heart disease (CHD) was done using grounded theory. Consideration was given to the socio-cultural context of Korea. Methods: After approval from the institutional review board of Y hospital, 12 patients ranging in age from 14 to 35 were recruited. Data were gathered using in-depth interviews. Theoretical sampling was performed until the concepts were saturated. Results: The results confirmed the life of adolescents with complex CHD as a 'journey to finding uniqueness of oneself as a person with CHD'. The life consisted of 3 stages. In the crisis stage, participants had a feeling of threat to self-existence, and made an effort to be the same as others. In the self-recognition stage, participants who had sufficient role-performance built self-esteem while those who did not fell into self-accusation. In the self-establishment stage, participants who reached sufficiency in independence and knowledge planned the future, whereas those who did not conformed to the realities of life. Conclusion: The results of present study provide help in understanding the experiences of adolescents with CHD and provide a basis for developing nursing intervention strategies for these patients.

A Study on The Resolution of Commercial Disputes under The South-North Korea Arbitration Rules (남북중재규정 에 따른 상사분쟁해결에 관한 소고)

  • Park Jong-Sam
    • Journal of Arbitration Studies
    • /
    • v.15 no.1
    • /
    • pp.67-93
    • /
    • 2005
  • To realize the spirit of South-North Joint Declaration of June 15, 2000, the authorities concerned of South and North Korea have reached agreements to settle commercial disputes as well as to set up a South-North arbitration rule which is becoming a problem of vital importance between South and North Korea. The purpose of this paper is to analyzed and review carefully the drafting of Commercial Arbitration Rule of the commercial Arbitration Committee of the South-North Korea so The South-North Korea Commercial Rule is an institutional organization for resolution of commercial disputes arising form trade and investment between south and north Korea. Under the situation, it is becoming a problem of vital importance how to manage and control the Arbitration Rule for prompt and effective resolution of South-North Korea of commercial disputes It is probable that the drafting of Commercial Arbitration Rule of the Commercial Arbitration Committee in South Korea should be written by the Commercial Arbitration Committee of South Korean arbitral body after these organizations are established and appointed. it's not recommendable that we the South-North Korea write the only enc South Korean draft of the Commercial Arbitration Committee of the South-Nonh Korea. The Korean Commercial Arbitration Board(KCAB) should be designated as the arbitration institution of South Korea because the KCAB is the only authorized institution in South Korea, statutorily empowered to settle any kind of commercial disputes at home and abroad.

  • PDF

Study on the Clinical Trial Practice of Drugs at the Designated Hospitals (국내 임상시험 실시기관의 의약품 임상시험 관리현황 분석)

  • Lee Eui-Kyoung;Jang Sun-Mee;Huh Soon-Im
    • Korean Journal of Clinical Pharmacy
    • /
    • v.5 no.2
    • /
    • pp.33-49
    • /
    • 1995
  • The purpose of this study is to understand present situation of clinical trials, and evaluate the preparedness of the desiRnated institutions to abide by GCP(Good Clinical Practice) standards during clinical trials. Survey on the status of clinical trials was conducted for the desienated 83 clinical trial hospitals, and response rate was $95.2\%$. The results showed that 39 hospitals have conducted clinical trials to obtain drug manufacturing approval from 1990 to 1994. Most of them were trials on Phase III. Only $46.8\%$ of the institutions had sufficient human resources to perform the clinical trials. Institutions which established IRB(Institutional Review Board) accounted for 41 or $51.9\%$, but those who have a protocol evaluation guideline, or Adverse Drug Reaction(ADR) reporting system were only 12, and 21 Places, respectively. Regarding supervision of the investigational drugs, less than 30 institutions designated pharmacist as a supervisor. In conducting clinical trials, $97.4\%$ of trials had high rates of prior consent of testees, but only part of them-$61.7\%$-gave written consent. The level of conducting GCP is found to be unsatisfactory. Institutions must build the appropriate infrastructure and government must prepare in order to protect testees' rights as well as to ensure validity of the results.

  • PDF