Purpose: Following the withdrawal of propacetamol in Europe owing to safety issues, the regulatory authority of South Korea requested a post-marketing surveillance study to investigate its safety profile. Materials and Methods: We conducted nested case-control and case-time-control (CTC) analyses of cases and controls identified for outcomes of interest, including anaphylaxis, thrombosis, and Stevens–Johnson syndrome (SJS), using the claims database of South Korea, 2010–2019. Risk-set sampling was used to match each case with up to 10 controls for age, sex, cohort entry date, and follow-up duration. Exposure to anaphylaxis, thrombosis, and SJS was assessed within 7, 90, and 30 days of the index date, respectively. We calculated odds ratios (OR) with 95% confidence intervals (CIs) using conditional logistic regression to assess the risk of outcomes associated with propacetamol. Results: We identified cases of anaphylaxis (n=61), thrombosis (n=95), and SJS (n=1) and matched them to controls (173, 268, and 4, respectively). In the nested case-control analysis, the ORs for anaphylaxis and SJS were inestimable given the small number of propacetamol users during the risk period; meanwhile, the OR for thrombosis was 1.60 (95% CI 0.71–3.62). In the CTC design, the effect estimate was only estimated for thrombosis (OR 0.56, 95% CI 0.09–3.47). Conclusion In both nested case-control and CTC analyses, propacetamol was not associated with an increased risk of anaphylaxis, thrombosis, or SJS. The findings from this study, which used routinely collected clinical data, provide reassuring real-world evidence regarding the safety of propacetamol in a nationwide population to support regulatory decision-making.

Here we present a rare case of an adolescent with hypertension, concurrently diagnosed with fibromuscular dysplasia of the renal artery and Graves’ disease. Although fibromuscular dysplasia and Graves’ disease have distinct pathogenic mechanisms, it is possible to infer the potential correlation between the two from the perspective of vascular involvement. It is believed that transforming growth factor-β, as the shared element of both diseases, may contribute to their development and progression. The overactivation of the sympathetic nervous system in Graves’ disease may induce hyperplasia of vascular smooth muscle cells, similar to that observed in fibromuscular dysplasia. In Graves’ disease, the excessive synthesis and secretion of angiotensin II due to the overactivation of the renin-angiotensin system, along with the up-regulation of angiotensin II receptors, may also induce pathological changes in the vasculature throughout the body. In this regard, exploring the correlation between fibromuscular dysplasia and Graves’ disease is of significant clinical importance.

Purpose: This study investigated changes in attitudes toward marriage and childbearing assuming a BRCA1/2 mutation carrier status among healthy, unmarried individuals in Korea. Methods: A nationally representative sample of healthy, unmarried individuals aged 20–39 years was surveyed. A questionnaire on marriage and childbearing intentions was administered to the participants before and after providing them with information on BRCA1/2 mutation carriers’ breast and ovarian cancer risks and their autosomal dominant inheritance pattern. The participants were asked about their attitudes toward childbearing through preimplantation genetic diagnosis (PGD). Results: Of the participants who initially wanted to marry, the assumption that they or their partners had BRCA1/2 mutation caused 25.3% to no longer want to get married and 36.2% to change their attitude from wanting to bear children to no longer wanting them. Females were more likely than males to change their attitudes toward marriage and childbearing. The participants who had negative attitudes toward genetic testing were more likely to change their attitudes regarding marriage and childbearing than those who were favorable toward both disclosure and testing. More than 50% of the participants who did not want children were willing to bear children through PGD when it was assumed that they were BRCA mutation carriers. Conclusion On the assumption of being carriers, general, young, and healthy females were more likely than males to negatively change their attitudes toward marriage and childbearing. Public education on the implications of living with mutation carriers and reproductive options may be required.

Purpose: This study was done to investigate the experience of physical and emotional safety in nursing students during fundamentals of nursing practicum. Methods: A descriptive cross-sectional study was conducted from March to September 2019. A total of 553 nursing students, who had completed fundamental nursing laboratories, participated in this study. Data were collected using self-report questionnaires which included questions about general characteristics, physical and emotional safety during fundamental nursing laboratories along with an informed consent given prior to the practicum. Results: Of the students, 26 experienced physical safety accidents, and 18 reported emotional safety accidents. Students' mean stress score for physical safety was 1.95, and the mean score for emotional safety was 1.92. Of the students, more than 59.1% agreed to volunteer as practice models in certain nursing procedures’ training. Of the students, 55.8% were satisfied with using their bodies to train fundamental nursing skills. 61.8% of students reported that informed consent was obtained during the nursing laboratory, and 88.6% of students thought that informed consent needs to be obtained. Conclusion To prevent safety accidents during the fundamentals of nursing practicum and systematically manage accidents, standardized safety guidelines for nursing practicum should be developed. Establishing various training strategies using advanced models or simulators to increase education efficiency and satisfaction is necessary.

Purpose: To identify the discrepancies in the textbook of fundamentals of nursing in nutrition and elimination needs in terms of number, range, definition and etc. Methods: The 10 textbooks which are the most frequently used were selected and reviewed. After then compared it with the protocols of essential nursing skills of Korean Accreditation Board of Nursing Education and evidence-based clinical nursing practice guidelines of Korean Hospital Nurses’ Association. Results: The most significant discrepancies in nutrition domain were criteria of obesity, confirmation of nasogastric tube placement. In elimination domain, there were several mixed or miss uses of French and number unit in catheter size. And appropriate catheter size for urinary catheterization and enema is different to books and guidelines. Conclusion In order to conduct an effective resource in education of nursing, textbooks need to be revised constantly and contain the recent researches and guidelines.

Purpose: BRCA1/2 mutations are associated with risks of breast and ovarian cancer. In Korea, incidences of BRCA1/2 genetic testing and risk-reducing surgery (RRS) have increased with insurance coverage and the Angelina Jolie effect. The aim of this study was to identify trends in RRS performed in Korean women with the BRCA1/2 mutation. Methods: We retrospectively reviewed the medical records of BRCA1/2 mutation carriers with (affected carriers) and without (unaffected carriers) breast cancer until August 2018 from 25 Korean Hereditary Breast Cancer (KOHBRA)-affiliated hospitals. Results: The numbers of contralateral risk-reducing mastectomy (RRM) and risk-reducing bilateral salpingo-oophorectomy (RRBSO) in affected carriers have increased 5.8- and 3.6-fold, respectively, since 2013. The numbers of RRBSO in unaffected carriers has increased 8-fold since 2013. The number of institutions that perform RRS has increased gradually. The number of hospitals that perform contralateral RRM on affected carriers increased from 3 in 2012 to 11 in 2018, and that of those that perform RRBSO increased from 7 to 17. The number of hospitals that perform bilateral RRM on unaffected carriers increased from 1 in 2012 to 2 in 2018, and that of those that perform RRBSO increased from 1 to 8. However, the hospitals showed differences in the rates of RRM or RRBSO performed. Conclusion The incidence of RRS increased each year throughout the study period. However, in Korea, the rate of RRS procedures depended on the hospital.

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.
Adolescent ; Anaphylaxis ; Centers for Disease Control and Prevention (U.S.) ; Decision Making ; Humans ; Immunization ; Immunization Programs ; Incidence ; Influenza Vaccines ; Influenza, Human ; Korea ; Research Design ; United States ; Vaccination ; Vaccines

PURPOSE: The purpose of this study is to investigate the safety of nursing students during fundamentals of nursing practicum in Korea. METHODS: This study used a descriptive design. A total of 106 nursing instructors teaching fundamentals of nursing longer than one year participated in this study. Data were collected using self-report questionnaires from July 24 to August 28, 2018. The questionnaires consisted of general characteristics, characteristics of fundamentals of nursing course, physical and emotional safety issues during fundamentals of nursing practicum, and obtaining an informed consent prior to practicum. RESULTS: The average number of physical safety accidents during practicum of fundamentals of nursing in the past 5 years was 1.12±2.44. The most common safety accident was punctured wound. The mean score of the participants' stress on physical safety accidents was 3.53±1.12 out of 5. The average number of emotional safety accidents of fundamentals of nursing practicum in the past 5 years was 1.05±2.72. The mean score of stress on emotional safety accident was 3.00±1.09 out of 5. We found that 47.2% of the participants obtained an oral consent or a written consent for safety of fundamentals of nursing practicum. CONCLUSION: The results of this study indicate that it is necessary to establish safety strategies for fundamentals of nursing practicum for nursing students.
Human Body ; Humans ; Informed Consent ; Korea ; Nursing ; Students, Nursing ; Wounds and Injuries

OBJECTIVE: This study was aimed to determine effectiveness and tolerability of Osmotic-controlled Release Oral delivery (OROS) methylphenidate (MPH) and its optimal dose administered openly over a period of up to 12 weeks in drug naive Korean children with ADHD. METHODS: Subjects (n=143), ages 6 to 18-years, with a clinical diagnosis of any subtype of ADHD were recruited from 7 medical centers in Korea. An individualized dose of OROS-MPH was determined for each subject depending on the response criteria. The subjects were assessed with several symptom rating scales in week 1, 3, 6, 9 and 12. RESULTS: 77 of 116 subjects (66.4%) achieved the criteria for response and the average of optimal daily dose for response was to 30.05+/-12.52 mg per day (0.90+/-0.31 mg/kg/d) at the end of the study. Optimal dose was not significantly different between ADHD subtypes, whereas, significant higher dose was needed in older aged groups than younger groups. The average of optimal daily dose for response for the subjects aged above 12 years old was 46.38+/-15.52 per day (0.81+/-0.28 mg/kg/d) compared to younger groups (p<0.01). No serious adverse effects were reported and the dose did not have a significant effect on adverse effects. CONCLUSION: Optimal mean dose of OROS-MPH was significantly different by age groups. Higher dose was needed in older aged groups than younger groups. Effectiveness and tolerability of OROS-MPH in symptoms of ADHD is sustained for up to 12 weeks.
Aged ; Child ; Humans ; Korea ; Methylphenidate ; Weights and Measures

OBJECTIVES: This study was conducted to develop a Korean algorithm of pharmacological and non-pharmacological treatment strategies in attention-deficit hyperactivity disorder (ADHD) and its specific comorbid disorders (e.g. tic disorder, depressive disorder, anxiety disorder, bipolar disorder, and oppositional defiant disorder/conduct disorder). METHODS: Based on a literature review and expert consensus, both paper- and web-based survey tools were developed with respect to a comprehensive range of questions. Most options were scored using a 9-point scale for rating the appropriateness of medical decisions. For the other options, the surveyed experts were asked to provide answers (e.g., duration of treatment, average dosage) or check boxes to indicate their preferred answers. The survey was performed on-line in a self-administered manner. Ultimately, 49 Korean child & adolescent psychiatrists, who had been considered experts in the treatment of ADHD, voluntarily completed the questionnaire. In analyzing the responses to items rated using the 9-point scale, consensus on each option was defined as a non-random distribution of scores as determined by a chi-square test. We assigned a categorical rank (first line/preferred choice, second line/alternate choice, third line/usually inappropriate) to each option based on the 95% confidence interval around the mean rating score. RESULTS: Specific medication strategies for key clinical situations in ADHD and its comorbid disorders were indicated and described. We organized the suggested algorithms of ADHD treatment mainly on the basis of the opinions of the Korean experts. The suggested algorithm was constructed according to the templates of the Texas Child & Adolescent medication algorithm Project (CMAP). CONCLUSION: We have proposed a Korean treatment algorithm for ADHD, both with and without comorbid disorders through expert consensus and a broad literature review. As the tools available for ADHD treatment evolve, this algorithm could be reorganized and modified as required to suit updated scientific and clinical research findings.
Adolescent ; Anxiety Disorders ; Bipolar Disorder ; Child ; Comorbidity ; Consensus ; Depressive Disorder ; Humans ; Psychiatry ; Texas ; Tic Disorders ; Surveys and Questionnaires