• Title/Summary/Keyword: Clinical safety

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Current Practices and Future Directions in Patient Safety Education and Curriculum in Medical Schools (의과대학에서의 환자안전 교육과정 도입을 위한 환자안전 교육현황조사 및 향후 운영방안)

  • Oh, Hae Mi;Lee, Won;Jang, Seung Gyeong;Kim, So Yoon
    • Korean Medical Education Review
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    • v.21 no.3
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    • pp.143-149
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    • 2019
  • In 2018, The Ministry of Health and Welfare announced its first comprehensive plan for patient safety, which included the imperative to develop a patient safety curriculum for students studying to become health professionals. The aim of this study is to assess current patient safety education and points of consideration for introducing new curriculum. An online survey was used to understand the status of patient safety education in medical schools, and key informant interviews and focus group interviews were used to collect qualitative data on the experience of patient safety education. The results of the online survey from 16 out of 40 medical schools (40% response rate) and the qualitative data analysis were integrated and analyzed. Twelve schools (75%) had established courses related to patient safety. The qualitative responses suggest that patient safety education is appropriate both before and after clinical training through a variety of educational methods, and that the topics should be linked with clinical training. The challenge of securing lecture time to address patient safety was mentioned as a realistic obstacle. When patient safety education is integrated in future curriculum, it is necessary to consider it as a priority. Moreover, in the early stages of introducing patient safety education, a step-by-step, policy-based approach is required for seamless adoption and settlement.

A Retrospective Study of the Safety and Effect of Co-administration of Glucose-lowering Medication and Bojungikgi-tang on Blood Glucose Level in Patients with Type 2 Diabetes Mellitus (제2형 당뇨병 환자에서 혈당강하제와 보중익기탕 병용 투여가 혈당 변화에 미치는 영향 및 안전성 연구)

  • Seung-hyun Oh;Woo-nyoung Jung;Mee-ryoung Song;Ji-won Noh;Young-min Ahn;Se-young Ahn;Byung-cheol Lee
    • The Journal of Internal Korean Medicine
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    • v.44 no.3
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    • pp.354-365
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    • 2023
  • Objective: This study aimed to assess the safety and effect on glucose level of Bojungikgi-tang in patients with type 2 diabetes mellitus. Methods: To review patients' clinical characteristics and laboratory tests retrospectively, we investigated 15 hospitalized patients with type 2 diabetes mellitus who took Bojungikgi-tang at Kyung Hee University Korean Medical Hospital for at least one day between January 2012 and December 2022. The blood glucose levels, including fasting blood sugar (FBS), 2-hour postprandial glucose (PP2) levels, and glycated hemoglobin level, were collected to determine the effect of the Bojungikgi-tang on blood sugar changes. Furthermore, to evaluate the safety of Bojungikgi-tang, hepatic function and renal function tests were implemented, including aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, γ-glutamyltransferase, blood urea nitrogen, creatinine, and Modification of Diet in Renal Disease estimated glomerular filtration rate. Results: When Bojungikgi-tang and a standard treatment for diabetes were administered for patients with type 2 diabetes, it was confirmed that there were no statistically significant changes in FBS and PP2 levels in the analysis of each medication taken. There was no significant difference in the safety profile after taking Bojungikgi-tang. Conclusions: The combined administration of Bojungikgi-tang with standard hypoglycemic medication for patients with type 2 diabetes may not affect blood glucose levels and safety.

Analysis of Existing Guidelines and Randomized, Controlled, Clinical Trials for Development of [Guideline of Clinical Trial with Herbal Medicinal Product for gastric cancer] (위암 한약제제 임상시험 가이드라인 개발을 위한 한약제제 무작위배정 대조군 임상시험 고찰)

  • Han, Gajin;Seong, Sin;Kim, Sungsu;Kim, Jinsung;Park, Jae-Woo
    • The Journal of Korean Medicine
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    • v.38 no.3
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    • pp.124-142
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    • 2017
  • Objectives: This study aimed to learn what should be considered in [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer)] by analyzing the existing guidelines and clinical trials. Methods: The development committee searched guidelines for herbal medicinal product or gastric cancer developed already. Then, clinical trials for gastric cancer using herbal medicine were searched. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of analysis with the regulations and guidelines of Ministry of Food and Drug Safety to suggest the issue that we will have to consider when making the [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer]. Results: As a result, few guidelines for anti-tumor agent and clinical trial with herbal medicinal product were searched in the national institution homepage. In addition, 10 articles were searched by using the combination following search term; 'stomach neoplasm', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional', 'TCM', 'TKM', 'trial'. Most trials included gastric cancer participants with medical history of operation. The type of intervention was various such as decoction, granules, and fluid of intravenous injection. Comparators were diverse such as placebo, conventional treatment including chemotherapy and nutritional supplement. The most frequently used outcome for efficacy was quality of life. Besides, the symptom score, tumor response, and survival rate were used. Safety was investigated by recording adverse events. Conclusion: We found out some issue by reviewing the existing guidelines and comparing it with clinical trials for gastric cancer and herbal medicinal products. These results will be utilized for developing [Guideline of Clinical Trial with Herbal Medicinal Product for Gastric Cancer].

Clinical Observation of Effect on Severity of Symptoms and Safety of Auto-microneedle Therapy in Patients with Peripheral Facial Paralysis (자동 미세침이 말초성 안면마비 환자의 증상 정도 및 안전성에 미치는 영향에 대한 임상 관찰)

  • Lee, Ung-In;Kwon, You-Jung;Kim, Hyun-Ho;Yoo, Je-Hyuk;Kim, Kyung-Wook;Kang, Jung-Won;Lee, Sang-Hoon
    • Journal of Acupuncture Research
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    • v.29 no.4
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    • pp.35-42
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    • 2012
  • Objectives : This study was to observe clinical application of auto-microneedle therapy system (AMTS) in patients with peripheral facial paralysis. Methods : 27 peripheral facial paralysis patients were observed after taking AMTS at Facial Palsy Center, Kyung Hee University Oriental Medicine Hospital from March 1, 2011 to January 9, 2012. We assessed the symptoms of facial paralysis with Yanagihara unweighted grading system, Sunnybrook facial grading system(SBGS) and facial disability index(FDI), and observed adverse events and total safety of the treatment. Results : The scores of facial palsy scales increased after AMTS in Yanagihara grading system and Sunnybrook facial grading system. AMTS-related adverse events were mild pain(5.9%) and fatigue(3.5%), which needed no extra treatment. The total safety evaluation was between 'safe' and 'nearly safe' level. There were no other serious adverse events. In addition, patients were satisfied with subjective improvement including facial tingling and numbness. Conclusions : AMTS can be applied as an adjunctive treatment for patients with peripheral facial paralysis due to its safety and clinical usefulness. It is easier to stimulate wide skin area in a short time. Further clinical research is required to investigate the effectiveness of ATMS in a more rigorous RCTs.

The effects of Inter-professional Patient Safety Education in clinical practice for healthcare college students (보건의료계열 대학생 대상 전문직 간 환자안전 교육프로그램이 임상실습에 미치는 효과)

  • Shin, Eunhee
    • Journal of Digital Convergence
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    • v.17 no.11
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    • pp.409-417
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    • 2019
  • This study was done to identify the effects of the inter-professional education program on the knowledge, attitude, and self-confidence of patient safety in the clinical practice of nursing, physical therapy and biomedical laboratory students. Each week for 6 weeks, a lecture and group discussion were given to twenty-nine students. Data were collected by self-administered questionnaire and interview. The knowledge and self-confidence were increased but the attitude was not changed. Students showed the increased their awareness of patient safety and the importance of collaboration with other occupational groups. It is necessary to establish a inter-professional education program between departments to enhance the ability to work collaboratively based on good communication along with knowledge, attitude in clinical settings.

Subacute(13-week) Inhalation Toxicity Study of Methyl Acrylate in Rats (랫드를 이용한 Methyl Acrylate의 아급성(13주) 흡입독성 연구)

  • Han, Jeong Hee;Park, Sang Yong;Kang, Min Gu;Chung, Yong Hyun;Yang, Jung Sun
    • Journal of Korean Society of Occupational and Environmental Hygiene
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    • v.22 no.4
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    • pp.316-328
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    • 2012
  • Objectives: This study was designed to provide the information regarding chemicals classification and health hazard by evaluating the toxicological effect through repeated inhalation exposure of methyl acrylate(MA) in Sprague-Dawley(SD) rat for 13 weeks. Methods: According to the notification with Ministry of Labor(No. 2009-68) and OECD Test Guideline 413, the rats were exposed to MA at concentration of 0, 56, 168, 280 ppm via whole body inhalation for 6 hours per day, 5 days per week, for 13 weeks. All animals were observed for mortality, morbidity and the change of body weight and food consumption were determined during the exposure period. Necropsy finding, organ weight, hematology, clinical biochemistry and histopathological examination following exposure were also performed. Results: There were no death and abnormal clinical signs relate to exposure MA. However, At 160 ppm and 280 ppm exposure groups, body weight and food consumption showed statistically significant decrease and histopathological changes in lung, trachea, nasal cavity, larynx were observed. Conclusions: MA was mainly affected respiratory tract. It is consequently provided to be classified as category 2(0.2 mg/L/6h < category 2 ${\leq}$ 1.0 mg/L/6h) for specific target organ toxicity following repeated exposure according to Standard for Classification and Labeling of Chemical Substance and Material Safety Data Sheet. The NOAEL(no observable adverse effect level) of MA was also determined to be lower than 56 ppm.

The knowledge and attitude toward radiation safety management in dental clinic worker (치과의료기관종사자의 방사선안전관리에 대한 지식 및 태도 조사)

  • Han, Ok-Sung;Woo, Seung-Hee;Kim, Seo-Yeon
    • Journal of Korean society of Dental Hygiene
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    • v.14 no.6
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    • pp.849-857
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    • 2014
  • Objectives: The aim of the study was to investigate the knowledge and attitude toward radiation safety management in dental clinic worker. Methods: A self-reported questionnaire was filled out by 294 dental clinic workers in dental hospitals and clinics in Gwangju and Jeonnam from February 17 to March 30, 2014. The questionnaire consisted of general characteristics of radiation safety(8 questions), knowledge of radiation safety(15 questions), and attitudes of radiation safety(16 questions). The survey was done by Likert 5 scale method. Results: In completion of the radiodontia courses, 84.0% of the learners were female workers. 88.0% of the learners took the theoretical and practical courses. Those who work in the university dental hospital accounted for 87.1% and those in dental clinics accounted for 83.2%. Majority of the workers took on Leaden protective clothing in order to protect the thyroid gland. Male workers had more knowledge toward the radiation safety management than the female workers. The attitude toward the radiation safety management revealed the significant differences between age, gender, academic careers, license, clinical careers and the mean number of patients per day(p<0.05). Conclusions: The radiation safety management is very important in dental clinical workers and it is necessary to enhance the attitude toward the radiation safety through continuous education.

Pilot Clinical Trial to Evaluate the Efficacy of Acupuncture Therapy on TEWL and Skin hydration (침시술이 경피수분 손실량과 피부 수분함유량에 미치는 임상적 연구)

  • Park, Soo Yeon
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.32 no.4
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    • pp.271-276
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    • 2018
  • The purpose of pilot clinical trial is to evaluate the efficacy and safety of acupuncture therapy on TEWL(Transepidermal Water Loss) and skin hydration. A total of 36 human who visited Dongshin University Oriental Medical Center from October 2nd, 2015 to July 31st, 2016 were included in the pilot clinical trial. Acupuncture therapy was performed at Gokji(LI11) and Daechu(GV14). We observed change of TEWL(Transepidermal Water Loss), skin hydration before and after acupuncture therapy. In the primary endpoint, index of TEWL showed a statistically significant decline($8.01{\pm}2.55{\rightarrow}6.58{\pm}1.97g/h/m2$, $7.40{\pm}2.65{\rightarrow}4.99{\pm}1.89g/h/m2$). Index of skin hydration showed statistical significance($52.83{\pm}6.53{\rightarrow}56.82{\pm}7.24$, $63.50{\pm}8.57{\rightarrow}64.96{\pm}8.48$). To evaluate the safety, vital sign check were conducted and showed no statistically significant result. And there were no severe adverse events during this study. According to the above pilot clinical trial, it is suggested acupuncture therapy were effective for skin moisturizing.

Post-Marketing Surveillance Study of the Safety and Efficacy of Mesoglycan Prescribed in Primary and Secondary Care of Patients with Vascular Disease (혈관질환 환자의 예방치료에 있어 메소글리칸의 안전성 및 유효성에 관한 시판 후 조사에 대한 연구)

  • Kim, Yoon-Hee;Jung, Young-Hye;Lee, Hwa-Jeong;Gwak, Hye-Sun
    • Korean Journal of Clinical Pharmacy
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    • v.15 no.2
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    • pp.94-99
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    • 2005
  • The aim of this study was to evaluate the safety and efficacy of treatment of mesoglycan. This study was conducted between September 2003 and May 2004. A total of 292 patients with vascular disorders including cerebral infarction were enrolled. The patients were administered with 50-100mg of mesoglycan by an oral route everyday for eight weeks. Subjective physicians' assessments of efficacy had ratings of 'improvement', 'invariability', 'exacerbation' and 'not being able to assess'. An improvement was observed in 241 patients out of 274; 18 patients were rules out. The efficacy rate was influenced statistically significantly by the duration of therapy (p=0.0392) and daily mean drug dose (p<0.0001). The adverse events were reported in 8 patients (9 cases) out of 292 patients: skin/appendages disorders (0.7%), liver/biliary system disorders (0.7%), cardiovascular system disorders (0.7%), neurologic disorders (0.3%). respiratory disorders (0.3%) and gastrointestinal system disorders (0.3%). There showed no serious adverse events. These results indicate that mesoglycan was well tolerated and effective for the prevention of vascular disorders.

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Manual Aspiration Thrombectomy Using Penumbra Catheter in Patients with Acute M2 Occlusion : A Single-Center Analysis

  • Park, Jung Soo;Kwak, Hyo Sung
    • Journal of Korean Neurosurgical Society
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    • v.59 no.4
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    • pp.352-356
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    • 2016
  • Objective : The efficacy and safety of manual aspiration thrombectomy using Penumbra in an acute occlusion of large intracranial arteries has been proven in many previous studies. Our study aimed to retrospectively assess the efficacy and safety of manual aspiration thrombectomy using Penumbra in patients with small vessel occlusions (M2 segment of the MCA). Methods : We conducted a retrospective review of 32 patients who underwent manual aspiration thrombectomy using the Penumbra 4 MAX Reperfusion Catheter for treatment of an M2 occlusion between January 2013 and November 2014. We evaluated immediate angiographic results and clinical outcomes through review of patient electronic medical records. Results : There were slightly more men in this study (M : F=18 : 14) and the median age was 72.5 (age range : 41-90). The rate of successful recanalization (TICI grade ${\geq}2b$) was 84% (27/32). NIHSS at discharge and favorable clinical outcomes at 3 months were significantly improved than baseline. Median initial NIHSS score was 10 (range : 4-25) and was 4 (range : 0-14) at discharge. Favorable clinical outcomes (mRS score ${\leq}2$ at 3 months) were seen in 25 out of 32 patients (78%). There were no procedure-related symptomatic intracerebral hemorrhages. One patient expired after discharge due to a cardiac problem. Conclusion : Manual aspiration thrombectomy might be safe and is capable of achieving a high rate of successful recanalization and favorable clinical outcomes in patients with distal cerebral vessel occlusion (M2).