• Korean Journal of Adult Nursing
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• v.29 no.2
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• pp.154-165
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• 2017

Purpose: This study was designed to evaluate a patient safety application in the prevention of adverse event among surgical patients. Seventy three surgical patients with thirty six of them using the patient safety application and the rest (N=37) were provided educational booklet. Further, the instrument would measure patients' right to know, knowledge about patient safety, and attitude toward patient safety. Methods: The patient safety application was developed by the ADDIE along with input from experts, patients and an extensive literature review. Data were collected from 7 September through 20 October 2015. Results: The experimental group had significantly higher scores in patients' right to know (t=2.01, p=.024), knowledge on patient safety (t=3.80, p<.001) and attitude toward patient safety (t=2.74, p=.004) than those of the control group. Conclusion: The patient safety application developed using Smartphone could be an effective tool enhancing patient involvement in preventing adverse events that may occur to patients. Further studies are recommended with diverse subjects with varying medical conditions.

• Translational and Clinical Pharmacology
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• v.26 no.3
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• pp.118-127
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• 2018

The safety and efficacy of fimasartan have been evaluated through post-marketing surveillance in real world clinical practice. The multi-center, prospective, open-label and non-interventional study. A total of 3,945 patients (3,729 patients for safety assessment and 3,473 patients for efficacy assessment) were screened in patients with essential hypertension in 89 study centers from 9 September 2010 through 8 September 2016. Among the total patients, 2,893 patients (77.6%) were administered fimasartan for 24 weeks or longer and were classified as 'patients with long-term follow-up', and the additional safety and efficacy analysis were performed. The improvement was defined as systolic blood pressure (SBP) controlled to ${\leq}140mmHg$ or decreased SBP differences ${\geq}20mmHg$ after treatment or diastolic blood pressure (DBP) controlled to ${\leq}90mmHg$ or decreased DBP differences ${\geq}10mmHg$ after treatment. Adverse drug reactions (ADRs) were reported in 3.8% patients; dizziness, and hypotension were the most frequently reported ADRs in total patients. The results of patients with long-term follow-up were comparable with total patients. The overall improvement rate in all efficacy assessment at the last visit was 87.1% (3,025/3,473 patients). The overall improvement rate of the patients with long-term follow-up was 88.9%. Fimasartan was well tolerated, with no new safety concerns identified and an effective treatment in the real world clinical practice for Korean patients with hypertension.

• Quality Improvement in Health Care
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• v.17 no.1
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• pp.89-105
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• 2011

Background : The purpose of study in to grasp the level of perception of hospital workers on the patient safety culture, consider the difference in perception of patients safety culture according to medical service and finally find out a way to establish patient safety culture in hospital. Methods : As for the data, the analysis on frequency, t-test, ANOVA and tukey test were carried out by using SPSS 12.0. Result : The results of comparison among the positive response ratios on the patients culture of hospital workers showed that the subjects had perceived the teamwork within units most positively(74.1%), and perceived most negatively on the non-punitive response to error(16.2%)and the staffing(26.2%). 68.6% of subjects answered that the medical error were mostly of always reported. when daytime working hours are longer, perception of patient safety culture ranked low. In general, departments for direct medical service than departments for indirect medical service assessed patient safety culture high. Conclusion : Organizational learning and teamwork within units, communication openness, active support of hospital management for patient safety, and cooperation across the units would be crucial to promote the overall perceptions of patients safety of hospital workers and the level of patients safety in the units and to improve the quality of the event reporting system.

• Tuberculosis and Respiratory Diseases
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• v.80 no.1
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• pp.52-59
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• 2017

Background: Inhaled indacaterol (Onbrez Breezhaler), a long-acting ${\beta}_2$-agonist, is approved in over 100 countries, including South Korea, as a once-daily bronchodilator for maintenance and treatment of chronic obstructive pulmonary disease (COPD). Here, we present an interim analysis of a post-marketing surveillance study conducted to evaluate the real-world safety and effectiveness of indacaterol in the Korean population. Methods: This was an open-label, observational, prospective study in which COPD patients, who were newly prescribed with indacaterol (150 or $300{\mu}g$), were evaluated for 12 or 24 weeks. Safety was assessed based on the incidence rates of adverse events (AEs) and serious adverse events (SAEs). Effectiveness was evaluated based on physician's assessment by considering changes in symptoms and lung function, if the values of forced expiratory volume in 1 second were available. Results: Safety data were analyzed in 1,016 patients of the 1,043 enrolled COPD patients receiving indacaterol, and 784 patients were included for the effectiveness analysis. AEs were reported in 228 (22.44%) patients, while 98 (9.65%) patients reported SAEs. The COPD condition improved in 348 patients (44.4%), while the condition was maintained in 396 patients (50.5%), and only 40 patients (5.1%) exhibited worsening of ailment as compared with baseline. During the treatment period, 90 patients were hospitalized while nine patients died. All deaths were assessed to be not related to the study drug by the investigator. Conclusion: In real-life clinical practice in South Korea, indacaterol was well tolerated in COPD patients, and can be regarded as an effective option for their maintenance treatment.

• Quality Improvement in Health Care
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• v.25 no.1
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• pp.2-10
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• 2019

Purpose: The purpose of this study was to share program and/or resource on patient safety education for patients and families conducted overseas agency. This study will help the patient safety officer establish and implement an educational plan for patients and families. Methods: We searched the Internet for patient safety related organizations. We chose an institution that provided education for patients and families. Results: Most of the program and/or resource was about patient and family involvement; Taking Care of Myself, My Questions for This Visit, Patient Prep Card, 20 Tips to Help Prevent Medical Errors, Ask Me 3(R), Health and Safety Passport, My Medication log etc. Conclusions: It is necessary to distribute educational materials for patients and families in the country through the results of this study. For patient safety, education and publicity are needed so that developed educational materials can be actively used.

• Quality Improvement in Health Care
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• v.25 no.2
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• pp.2-15
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• 2019

Purpose: The purpose of this study is to provide basic data for the development of the most appropriate and effective educational materials for patients and their caregivers through the educational experiences of patient safety officer. Methods: This study is a qualitative analysis that involves using the focus group interview to understand the patient safety education experience of the patient safety officer. Results: The patient safety education experience of the patient safety officer is divided into four topics: (1) patient safety education content (2) patient safety education method (3) patient safety education status (4) activation and improvement of patient safety education. Additionally, the study incorporated twelve subtopics: (a) falls (b) speak up (c) patient safety campaign (d) patient safety rounding and a one on one training (e) education through medical staff (f) education using broadcast, video, post, among others (g) a lot of education in patient (h) patients not interested in patient safety education (i) patient safety education is less effective (j) human and medical expenses support (k) provision of standardized educational materials (l) patient safety culture for patient participation. Conclusions: This study indicate that education for patients and the caregivers should be inclusive and protective of stakeholders from the risks involved in patient safety events. The experience of patient safety officer is necessary for patient safety education for both patients and the caregivers since it is the source of basic data for the future development of patient safety education.

• Asian Pacific Journal of Cancer Prevention
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• v.15 no.22
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• pp.9875-9877
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• 2014

Objective: To access the safety of chemotherapy for elderly cancer patients complicated with hypertension. Methods: Elderly cancer patients who were complicated with hypertension and treated by chemotherapy were recruited. All patients were treated by chemotherapy after an intervention on hypertension by psychotherapy, exercise guidance, salt regulation and nutrition support, therapy on hypertension, as well as prevention on hypertension associated complications. Results: In 68 eligible patients, two suspended chemotherapy because of adverse reactions and 4 because of disease progression. The remaining 62 patients completed chemotherapy smoothly based on good hypertension control. Conclusion: With effective control of blood pressure, chemotherapy for elderly cancer patients complicated with hypertension is generally safe.

• Quality Improvement in Health Care
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• v.28 no.2
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• pp.50-60
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• 2022

Purpose: To examine the degree of recognition regarding the concept of patient safety, as perceived by the patient, using a focus group discussion. Methods: A focus group discussion was conducted with a patient group comprising seven patients. Results: When the participants heard the term "patient safety" they seemed to understand it to be related to the hospital environment or satisfaction with the overall hospitalization experience. The participants emphasized communication between the medical staff and the patients in relation to the explanation of treatments, as well as the provision of information regarding prevention, experience, and the treatment of incidents with patient safety. They agreed on the need for indicators reported by patients. However, they emphasized that additional items and a questionnaire method that considers the patients' point of view are needed. Conclusion: It is necessary to establish and implement various strategies that can raise the awareness of patient safety using patient safety indicators and increase participation in patient safety activities.

• Korean Journal of Biological Psychiatry
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• v.3 no.1
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• pp.102-108
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• 1996

This was an open trial to evaluate the efficacy and safety of moclobemide twice daily for treatment of Korean patients with major depressive disorder(DSM-III-R). The duration of the trial was 6 weeks with the initial dose of moclobemide being fixed lor the first two weeks at 300mg/day(150mg twice daily, each token after morning and evening meals). Thereafter, when necessary, the dose was allowed to increase to 600mg/day or decrease to 150mg/day according to the seventy of the depression and/or the tolerability of the drug. Hypnotics and/or sedatives from a benzodiazepine group could be concomitantly administered at usual dosage. Patients were assessed at baseline and at days 14, 28 and 42. Efficacy was primarily judged on the Hamilton Rating Scale for Depression(HAM-D) and Beck Depression Inventory(BDI). Patients had to score at least 17 respectively an both scales to enter the trial. Secondary efficacy parameters included Clinical Global Impression(CGI) for severity of illness and improvement. Safety and tolerability were judged on reported adverse events, vital signs and laboratory parameters. In addition, there was a series of questions and assessments for the psychiatrists and patients to complete at the end of the trial Twenty nine patients completing trial were included in the analysis of efficacy : of thirty one patients participating in the safety and tolerability analysis, those who withdraw voluntarily without particular reasons or violated the treatment schedule were not included. The efficacies as determined by HAM-D, BDI or CGI were found to be significant compared to baseline. The number of responders defined as patients with a total score of 10 or less or with a total score of 50% or less of the baseline score on HAM-D and BDI were 17(59%) and 18(62%) respectively. Regarding safety and tolerability, nine patients(29%) reported mild adverse events probably related to moclobemide : of these one patient dropped out because of poor tolerability : however, there were no appreciable changes in blood pressure, pulse rate, body weight or laboratory parameters for all patients over the trial period. Furthermore, the physicians' and patients' opinions at final evaluation showed that moclabemide has a good antidepressant effect as well as a favorable tolerability. In conclusion, a twice-daily dosage schedule with maclobemide is recommendable for the treatment of Korean patients with major depressive disorder since its efficacy and safety were demonstrated in this study.

• Tuberculosis and Respiratory Diseases
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• v.86 no.1
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• pp.33-46
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• 2023

Background: Umeclidinium/vilanterol (UMEC/VI; ANORO ELLIPTA, GSK) is a commonly used dual bronchodilator. This study evaluated the safety and effectiveness of UMEC/VI in Korean patients with chronic obstructive pulmonary disease (COPD) over a 6-year period. Methods: This was an open-label, multicentre, observational, post-marketing surveillance study. A total of 3,375 patients were enrolled consecutively in 52 hospitals, by 53 physicians, between July 2014 and July 2020. Patients who were administered UMEC/VI (fixed-dose 62.5 ㎍/25 ㎍) at least once and were monitored for safety and effectiveness were included in the analysis. Incidence and severity of adverse events (AEs) reported after administrating at least one dose of UMEC/VI were monitored, including unexpected adverse events (UAEs) and adverse drug reactions (ADRs). Effectiveness of UMEC/VI after 24 weeks of administration was also assessed using physician's evaluation (effective, ineffective/no change, worsening, indeterminable) and lung function improvement. Results: Of 3,375 patients, 3,086 were included in the safety assessment group (mean age±standard deviation: 69.76±8.80 years; 85.9% male [n=2,652]; 73.1% aged ≥65 years [n=2,255]). The overall incidence of AEs was 28.8% (n=890), of which 2.2% (n=67) were ADRs. Serious AEs and UAEs were reported in 181 (5.9%) and 665 (21.6%) patients, respectively, and two patients (<0.1%) reported unexpected severe ADR. Of the 903/3,086 patients analysed for effectiveness, most (82.8%, n=748) showed overall disease improvement after UMEC/VI treatment. Conclusion: This study confirmed UMEC/VI administered to Korean patients according to the prescribing information was well-tolerated and can be considered an effective option for COPD treatment.