• Title/Summary/Keyword: Adverse events

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Patient Safety Education for Medical Students: Global Trends and Korea's Status (의과대학생을 위한 환자안전 교육의 국제적 동향 및 국내 현황)

  • Roh, HyeRin
    • Korean Medical Education Review
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    • v.21 no.1
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    • pp.1-12
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    • 2019
  • This study is a narrative review introducing global trends in patient safety education within medical schools and exploring the status of Korean education. Core competences for patient safety include patient centeredness, teamwork, evidence- and information-based practice, quality improvement, addressing medical errors, managing human factors and system complexity, and patient safety knowledge and responsibility. According to a Korean report addressing the role of doctors, patient safety was described as a subcategory of clinical care. Doctors' roles in patient safety included taking precautions, educating patients about the side effects of drugs, and implementing rapid treatment and appropriate follow-up when patient safety is compromised. The Korean Association of Medical Colleges suggested patient safety competence as one of eight essential human and society-centered learning outcomes. They included appropriate attitude and knowledge, human factors, a systematic approach, teamwork skills, engaging with patients and carers, and dealing with common errors. Four Korean medical schools reported integration of a patient safety course in their preclinical curriculum. Studies have shown that students experience difficulty in reporting medical errors because of hierarchical culture. It seems that patient safety is considered in a narrow sense and its education is limited in Korea. Patient safety is not a topic for dealing with only adverse events, but a science to prevent and detect early system failure. Patient safety emphasizes patient perspectives, so it has a different paradigm of medical ethics and professionalism, which have doctor-centered perspectives. Medical educators in Korea should understand patient safety concepts to implement patient safety curriculum. Further research should be done on communication in hierarchical culture and patient safety education during clerkship.

Selecting the Priority Research Topics Addressing Unmet Post-immunization Safety Needs: A Model for Generating Research Proposal and Designing a Questionnaire for the Clinical Experts (설문조사를 통한 전문가 대상 예방접종 후 이상반응 관련 우선순위 연구주제 선정 기준모델 제시)

  • Kim, Hyun Jeong;Lee, Hyesung;Kim, Ju Hwan;Yoon, Dongwon;Noh, Yunha;Shin, Ju-Young
    • Korean Journal of Clinical Pharmacy
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    • v.29 no.3
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    • pp.173-185
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    • 2019
  • Objective: To gather inputs from clinical experts on selecting and prioritizing research topics, to address unmet vaccine safety needs. Methods: A questionnaire containing 15 vaccine safety assessment research proposals was sent to 28 vaccine experts chosen from various domestic medical association boards, and the rationale for each of the proposals was provided by presenting the following information: 1) a brief summary of the clinical safety studies on the vaccine, conducted by the Clinical Immunization Safety Assessment (CISA) project group, supervised by the United States Center for Disease Control (U.S. CDC), and 2) a summary of recently published studies that address vaccine safety issues. The experts were instructed to select and rank 5 topics in the order of preference, and the preference score for each proposed topic was calculated by assigning points on a scale of 1 to 5. Results: All 28 experts responded to the questionnaire, and the following topics were selected according to their calculated preference scores: 1) Human papillomavirus vaccine safety profile in the Korean female adolescents; 2) A signal detection of adverse events following Influenza vaccination: comparison between the US and South Korea; 3) Incidence of anaphylaxis following National Immunization Program vaccines between 2008 and 2017; 4) Safety of quadrivalent influenza vaccines compared to trivalent influenza vaccines; and 5) Pneumococcal vaccine safety profile in the general population. Conclusion: Five research topics addressing vaccine safety were selected, for which well-constructed research protocols need to be promptly developed to address current unmet vaccine safety needs in South Korea.

Meditation for Alzheimer's Disease: Systematic Review and Meta-Analysis

  • Lee, Go eun;Kim, Sang ho;Jung, In chul;Kang, Hyung won
    • Journal of Oriental Neuropsychiatry
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    • v.30 no.3
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    • pp.237-249
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    • 2019
  • Objectives: Interest in the use of complementary and alternative treatments to treat dementia. Meditation is used to treat various symptoms of physical and psychological diseases. Some studies suggest that meditation might have positive effects on cognitive functions, especially attention, in the elderly. However, how meditation affects Alzheimer's disease (AD) patients remains unclear. In this review, we assessed the effectiveness of practicing meditation in combination with standard care in AD. Methods: We searched the CCRCT, MEDLINE, EMBASE, AMED and CINAHL databases on 30 May 2017. We included randomized controlled trials (RCTs) that used meditation in adult patients diagnosed with AD. We allocated patients to a meditation combined with standard care or a standard care-only group. Results: The two RCTs met the inclusion criteria. A total of 98 patients were included in the meditation with standard care and standard care-only groups in this review. All meditation programs in the included trials were based on practicing mindfulness. The results of our meta-analysis indicatedthat adjunctive mindfulness meditation programs exerted favourable but non-significant effects on cognitive function on the Mini Mental State Examination (MMSE) (MD=4.68, 95% CI -0.11 to 9.46; Z=1.92, p=0.06). Only one study assessed depression, anxiety, quality of life and stress. No adverse events related to meditation were reported in the included studies. Conclusions: Insufficient data iscurrently available to determine the effectiveness of practicing meditation on patients diagnosed with AD. Hence, further RCTs with high methodological quality and larger sample sizes are needed to effectively estimate the effects of meditation on AD.

Recommended immunization schedule for children and adolescents: Committee on Infectious Diseases of the Korean Pediatric Society, 2018

  • Choi, Eun Hwa;Park, Su Eun;Kim, Yae-Jean;Jo, Dae Sun;Kim, Yun-Kyung;Eun, Byung-Wook;Lee, Taek-Jin;Lee, Jina;Lee, Hyunju;Kim, Ki Hwan;Cho, Hye-Kyung;Cho, Eun Young;Kim, Jong-Hyun
    • Clinical and Experimental Pediatrics
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    • v.62 no.7
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    • pp.252-256
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    • 2019
  • The Committee on Infectious Diseases of the Korean Pediatric Society recommended immunization schedule for children and adolescents aged 18 years or younger in the 9th (2018) edition of Immunization guideline. This report provides the revised recommendations made by the committee and summarizes several changes from the 2015 guideline. National immunization program (NIP) launched a human papillomavirus (HPV) immunization for girls aged 12 years in 2016. NIP has also expanded age indication for inactivated influenza vaccine (IIV) to 12 years of age in the 2018-2019 season. Quadrivalent IIVs with a full dose (0.5 mL) are approved for all children of 6 months or older. Recommendations of live attenuated influenza vaccine were removed. For inactivated Japanese encephalitis vaccine, first 2 doses are considered as the primary series. Recommendations for use of newly introduced vaccines (diphtheria-tetanus-acellular pertussis/inactivated poliovirus/Haemophilus influenzae type b, 9-valent HPV, new varicella vaccine, new quadrivalent IIV, and attenuated oral typhoid vaccine) were added. Lastly, monitoring system for adverse events following immunization was updated. Other changes can be found in the 9th edition of Immunization guideline in detail.

Association between Korean Medicine Hospital Utilization and Cardiovascular Risks in Patients with Hypertension: a National Korean Cohort Study (고혈압 환자에서 한방의료기관 이용과 심혈관 위험 요소와의 관계: 국민건강보험공단 표본코호트 DB)

  • Cho, Hyunjoo;Jung, Hyejin;Lim, Sabina
    • The Journal of Korean Medicine
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    • v.40 no.3
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    • pp.1-20
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    • 2019
  • Objectives: This study aims to investigate the effects of Korean Medicine Hospital Utilization (KMHU) on major adverse cardiovascular events (MACE), myocardial infarction (MI), stroke, and death in hypertensive patients taking antihypertensives. Methods: Using the Korean National Health Insurance Service-National Sample Cohort database, this study identified and diagnosed 68,457 hypertensive patients taking antihypertensives between 2003 and 2006. They were divided into KMHU and non-KMHU groups. The follow-up period ended with the diagnosis of myocardial infarction, stroke, or death. After propensity score matching (PSM), there were 18,242 patients each in the non-KMHU and KMHU groups. We calculated the incidence rate, hazard ratio (HR), and 95% confidence interval (CI) for MACE, myocardial infarction, stroke, and death in patients with hypertension using a stratified Cox proportional hazard model. In addition, secondary outcome analyses for stroke and cardiovascular mortality were performed. Results: After PSM, the HRs for MACE (HR: 0.84, 95% CI: 0.81-0.87), all-cause mortality (HR: 0.75, 95% CI: 0.72-0.79), and myocardial infarction (HR: 0.90, 95% CI: 0.83-0.97) were significantly lower in the KMHU group than in the non-KMHU group. Moreover, the HRs for stroke-related mortality, haemorrhage and ischaemic stroke-related mortality, and ischaemic heart disease-related and circulatory system disease-related mortality were significantly lower in the KMHU group than in the non-KMHU group. Conclusions: On long-term follow-up observation, this study supported the effect of KMHU for managing hypertension and reducing the burden of cardiovascular diseases.

Evaluation of the Quality of Case Reports of the Journal of Korean Medicine for Obesity Research from 2013 to 2018 According to the CARE (CAse REport) Guidelines (CARE (CAse REport) 지침에 의한 한방비만학회지 증례 논문에 대한 보고의 질 평가: 2013년~2018년 증례보고를 중심으로)

  • Park, Kyung Moo;Choi, Sung Youl;Lee, Ju Ah;Song, Yun Kyung
    • Journal of Korean Medicine for Obesity Research
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    • v.18 no.2
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    • pp.144-151
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    • 2018
  • Objectives: The purpose of this study is to evaluate the quality of case reports of the Journal of Korean Medicine for Obesity Research by the Case Report (CARE) guidelines. Methods: Case reports published in the Journal of Korean Medicine for Obesity Research from January 2013 to July 2018 were searched from Oriental Medicine Advanced Searching Integrated System (OASIS). We assessed the quality of reporting based on CARE guidelines. Results: A total of 8 case reports were finally included for the assessment. There was a deviation in the sub-item reporting rate by a maximum 75% and a minimum 57.14% in case reports. The 10 sub-items mentioned below, such as 'Timeline', 'Diagnostic challenges', 'Diagnostic reasoning including other diagnoses considered', 'Prognostic characteristics', 'Changes in intervention', 'Important follow-up diagnostic evaluations and other test results', 'Intervention adherence and tolerability', 'Adverse and unanticipated events', 'Patient perspective' and 'Informed consent' were reported below 30%. Conclusions: Efforts to diversify the subject of the case study and to apply appropriate reporting guidelines are needed to improve the quality of the case report contributed to the Journal of Korean Medicine for Obesity Research.

Analysis of Existing Guidelines and Randomized, Controlled, Clinical Trials for Development of [Guideline of Clinical Trial on Herbal Medicinal Product for Liver Cancer] (간암 한약제제 임상시험 가이드라인 개발을 위한 한약제제 무작위배정 대조군 임상시험 고찰)

  • Han, Ga-jin;Kim, Dong-hun;Park, Eun-joo;Seong, Sin;Kim, Sung-su;Leem, Jung-tae
    • The Journal of Internal Korean Medicine
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    • v.40 no.1
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    • pp.89-116
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    • 2019
  • Objective: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer," by analyzing existing guidelines and clinical trials. Methods: Committee for the development of a guideline, consisting of 6 Korean medicine doctors, reviewed guidelines and clinical trials on using herbal medicine for treating liver cancer. The trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparators, outcomes, and trial design. We then compared the results of our analysis with the guidelines to identify issues we must to consider when following the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer." Several guidelines for antitumor agents and clinical trials on herbal medicine were obtained from the Ministry of Food and Drug Safety homepage, etc. The search terms were as follows: "liver neoplasms"; "herbal medicine"; "medicine, Korean traditional"; and "medicine, Chinese Traditional.". Results: Ten articles were obtained from pubmed and Embase. There was no guideline for clinical trials on using herbal medicine for treating liver cancer. All the participants in the reviewed articles had primary liver cancer, and the type of intervention varied (e.g., decoction, patches, and capsules. The comparators included placebos and conventional treatments such as chemotherapy. The outcome assessment methods were tumor response, quality of life, survival, and liver function tests. Adverse events occuring during the trial were also evaluated. Conclusion: Findings were derived by reviewing existing guidelines and comparing them with clinical trials on liver cancer and herbal medicinal products. These results will be utilized in the development of the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer."

Albumin-Bilirubin Score Predicts Tolerability to Adjuvant S-1 Monotherapy after Curative Gastrectomy

  • Miwa, Takashi;Kanda, Mitsuro;Tanaka, Chie;Kobayashi, Daisuke;Hayashi, Masamichi;Yamada, Suguru;Nakayama, Goro;Koike, Masahiko;Kodera, Yasuhiro
    • Journal of Gastric Cancer
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    • v.19 no.2
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    • pp.183-192
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    • 2019
  • Purpose: Due to adverse events, dose reduction or withdrawal of adjuvant chemotherapy is required for some patients. To identify the predictive factors for tolerability to postoperative adjuvant S-1 monotherapy in gastric cancer (GC) patients, we evaluated the predictive values of blood indicators. Materials and Methods: We analyzed 98 patients with pStage II/III GC who underwent postoperative adjuvant S-1 monotherapy. We retrospectively analyzed correlations between 14 parameters obtained from perioperative routine blood tests to assess their influence on the withdrawal of postoperative adjuvant S-1 monotherapy, within 6 months after discontinuation. Results: Postoperative adjuvant chemotherapy was discontinued in 21 patients (21.4%) within 6 months. Univariable analysis revealed that high preoperative albumin-bilirubin (ALBI) scores had the highest odds ratio (OR) for predicting the failure of adjuvant S-1 chemotherapy (OR, 6.47; 95% confidence interval [CI], 2.08-20.1; cutoff value, -2.696). The high ALBI group had a significantly shorter time to failure of postoperative adjuvant S-1monotherapy (hazard ratio, 3.48; 95% CI, 1.69-7.25; P=0.001). Multivariable analysis identified high preoperative ALBI score as an independent prognostic factor for tolerability (OR, 10.3; 95% CI, 2.33-45.8; P=0.002). Conclusions: Preoperative ALBI shows promise as an indicator associated with the tolerability of adjuvant S-1 monotherapy in patients with pStage II/III GC.

Propofol with and without Midazolam for Diagnostic Upper Gastrointestinal Endoscopies in Children

  • Akbulut, Ulas Emre;Kartal, Seyfi;Dogan, Ufuk;Akcali, Gulgun Elif;Kalayci, Serap;Kirci, Hulya
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.22 no.3
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    • pp.217-224
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    • 2019
  • Purpose: Various publications on the use of sedation and anesthesia for diagnostic procedures in children have demonstrated that no ideal agent is available. Although propofol has been widely used for sedation during esophagogastroduodenoscopy in children, adverse events including hypoxia and hypotension, are concerns in propofol-based sedation. Propofol is used in combination with other sedatives in order to reduce potential complications. We aimed to analyze whether the administration of midazolam would improve the safety and efficacy of propofol-based sedation in diagnostic esophagogastroduodenoscopies in children. Methods: We retrospectively reviewed the hospital records of children who underwent diagnostic esophagogastroduodenoscopies during a 30-month period. Demographic characteristics, vital signs, medication dosages, induction times, sedation times, recovery times, and any complications observed, were examined. Results: Baseline characteristics did not differ between the midazolam-propofol and propofol alone groups. No differences were observed between the two groups in terms of induction times, sedation times, recovery times, or the proportion of satisfactory endoscopist responses. No major procedural complications, such as cardiac arrest, apnea, or laryngospasm, occurred in any case. However, minor complications developed in 22 patients (10.7%), 17 (16.2%) in the midazolam-propofol group and five (5.0%) in the propofol alone group (p=0.010). Conclusion: The sedation protocol with propofol was safe and efficient. The administration of midazolam provided no additional benefit in propofol-based sedation.

Diagnostic value of magnetic resonance imaging using superparamagnetic iron oxide for axillary node metastasis in patients with breast cancer: a meta-analysis

  • Lee, Ru Da;Park, Jung Gu;Ryu, Dong Won;Kim, Yoon Seok
    • Kosin Medical Journal
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    • v.33 no.3
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    • pp.297-306
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    • 2018
  • Objectives: Identification of axillary metastases in breast cancer is important for staging disease and planning treatment, but current techniques are associated with a number of adverse events. This report evaluates the diagnostic accuracy of superparamagnetic iron oxide (SPIO)-enhanced magnetic resonance imaging (MRI) techniques for identification of axillary metastases in breast cancer patients. Methods: We performed a meta-analysis of previous studies that compared SPIO enhanced MRI with histological diagnosis after surgery or biopsy. We searched PubMed, Ovid, Springer Link, and Cochrane library to identify studies reporting data for SPIO enhanced MRI for detection of axillary lymph node metastases in breast cancer until December 2013. The following keywords were used: "magnetic resonance imaging AND axilla" and "superparamagnetic iron oxide AND axilla". Eligible studies were those that compared SPIO enhanced MRI with histological diagnosis. Sensitivity and specificity were calculated for every study; summary receiver operating characteristic and subgroup analyses were done. Study quality and heterogeneity were also assessed. Results: There were 7 publications that met the criteria for inclusion in our meta-analysis. SROC curve analysis for per patient data showed an overall sensitivity of 0.83 (95% Confidence interval (CI): 0.75-0.89) and overall specificity of 0.97 (95% CI: 0.94-0.98). Overall weighted area under the curve was 0.9563. Conclusions: SPIO enhanced MRI showed a trend toward high diagnostic accuracy in detection of lymph node metastases for breast cancer. So, when the breast cancer patients has axillary metastases histologically, SPIO enhanced MRI may be effective diagnostic imaging modality for axillary metastases.