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Readability of Patient Information Leaflets in Clinical Trials (임상시험 시험대상자설명서의 가독성 평가)

  • Choi, Im-Soon;Yong, Chul-Soon;Lee, Iyn-Hyang
    • Korean Journal of Clinical Pharmacy
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    • v.26 no.1
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    • pp.33-39
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    • 2016
  • Background: Elements of informed consent including capacity, disclosure, understanding, voluntariness, and permission of the participant, are all crucial for clinical trials to be legally and ethically valid. During the informed consent process, the patient information leaflet is an important information source which prospective research subjects can utilize in their decision-making. In the adequate provision of information, KGCP guideline necessitate 20 specific items, as well as the use language that individuals can understand. This study measures the vocabulary level of patient information leaflets in an effort to provide an objective evaluation on the readability of such material. Methods: The word difficulty of 13 leaflets was quantitatively evaluated using Kim kwang Hae's vocabulary grading framework, which was compared to the difficulty level of words found in the $6^{th}$ grade Korean textbook. The quantitative outcomes were statistically analyzed using chi-squared tests and linear by linear association for ordinal data. Results: There was a statistically significant difference between the vocabulary level and frequency of words in leaflets and the 6th Korean textbook. The leaflets were on average 260 sentences and about roughly 15 pages long, including lay language (easier or equal to language used in primary school) of around 12% less; technical language of around 4.5% more. As the vocabulary grades increase, there was a distinct difference in vocabulary level between Korean textbook and each information leaflet (p < 0.001). Conclusion: Patient information leaflets may fail to provide appropriate information for self-determination by clinical trial subject through the difficulty level of its wording. Improvements in the degree of patients' understanding and appropriate use of information leaflets are collaboratively equipped to strengthen patient's autonomy and therefore guaranteeing participant's rights.

Changes in Perception of Consumers for Non-prescription Drug Policy since Sales Begins at the Outside of Pharmacy (일반의약품 약국 외 판매 이후의 일반의약품 정책에 대한 소비자의 인식 변화)

  • Kim, Eun Hee;Bang, Joon Seok
    • Korean Journal of Clinical Pharmacy
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    • v.24 no.3
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    • pp.183-192
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    • 2014
  • Purpose: This study was aimed to identify the status of utilization of healthcare services and self-care behaviors, knowledge level and influencing choice factors of non-prescription drugs (OTCs) on consumers since sales of OTCs at the outside of pharmacy in Korea, and to confirm the changes in perception of consumers for OTCs policy through check of perception level for current OTCs policy. Methods: Data was collected from April 2014 to May 2014 from questionnaires by 418 adults who are in university located in Seoul or live in Seoul Metropolitan area but not health science major and healthcare providers. Results: The female gender was 56.6% and University students were 73.9%. The ratio by age was as follows: below 25 (60.9%), 26-30 (18.2%), 30-40s (14.9%) and 50-60s (6.0%). The knowledge level of OTCs for use of medicine, dose and side effects was generally low and especially they knew little how to deal with side effects after taking OTCs on sale at the outside of pharmacy, even though over one year has passed since the policy. The proportion of those who thought the current OTCs policy has problems regarding safety issues since the policy was very high and it was also high that the study group thought there are problems with the current way to sale OTCs and educate employees. Conclusion: After selling OTCs at the outside of pharmacy, the consumers still lacked knowledge of OTCs and did not get correct information properly. Especially, they had little information about the way to deal with side effects after taking OTCs. Public policy should be based on the health of the people and the public health is a national health priority. When all these things are taken into consideration, the government has to strengthen the OTCs policy and provide a safer environment with the accurate drug information for people than developing OTCs policy in the future.

The Study on the improvement of dental technician practical examination I (치과기공사 실기시험 개선에 관한 조사 연구 I)

  • Bae, Eun-Jeong;Kim, Woong-Chul;Chung, In-Sung;Nam, Sang-Yong;Kim, Ji-Hwan
    • Journal of Technologic Dentistry
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    • v.34 no.4
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    • pp.413-421
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    • 2012
  • Purpose: The purpose of this study is to investigate the improvement measure of dental technician practical examination. Methods: A survey was performed on 111 dental technicians who were self-written questionnaire. The results were analyzed by SPSS 12.0. The collected data was analyzed by frequency and chi-square test. Results: Questions most necessary work tools with the articulator was the highest with 55.9%, Electric wax carver(16.2%), heating clear(14.4%), CAD/CAM program(9.0%) was in the order. The need for additional practical test in response to actions included maxillary and mandibular comments occlusal work that you have to wax up the highest rate of 63.8%. Items most in need of improvement was strengthen of clinically oriented(48.0%), separation of written and practical(14.6%), control the degree of difficulty(11.4%) were the next order. Conclusion: Based on the results of this study, the current dental technician did not show major problems in the practical test. However, clinicians should be strengthened mainly. To do this, the use of the articulator is essential.

A Study of the Cognition and the Requirement on the Key Competency of Dental Technology (치과기공분야에서의 직업기초능력수준과 요구도에 관한 연구)

  • Hwang, Jae Sun
    • Journal of Technologic Dentistry
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    • v.34 no.4
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    • pp.457-469
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    • 2012
  • Purpose: The purpose of this study is analyzing how much students of dental technology possess core competencies and cognition between dental technicians and students. Methods: The subjects of this study were dental technicians, dental technology students and a self-administered structured questionnaire survey wax conducted for 428 selected people. Collected data were analyzed using SPSS Win 20.0 statistics program and analysis techniques include the frequency, t-test, One-way ANOVA. Results: The results of the survey are as follows. The cognition of key competency according to the gender in the students showed differences in interpersonal ability, information ability and the requirement of key competency according to the gender in the students showed differences in speaking ability, listening ability, problem solving ability. The cognition of key competency according to the grade in the students showed difference in speaking ability, listening ability and the requirement of key competency according to the grade in the students showed difference in comprehension of organization ability. The speaking ability is the lowest in the cognition of key competency according to the gender, grade, experience of clinical training in the students and the skill ability is the highest in the requirement of key competency according to the gender, experience of clinical training in the students. The cognition of key competency according to the career in the dental technicians showed difference in problem solving ability, self-regulation and self-development ability, skill ability and the requirement of key competency according to the career in the dental technicians showed difference in writing ability. The cognition of key competency according to the educational background in the dental technicians showed difference in comprehension of organization ability. The foreign language ability is the lowest in the cognition of key competency according to the career, job in the dental technicians and the skill ability is the highest and the math ability is th lowest in the requirement of key competency according to the career, place of employment in the dental technician. Conclusion: This study can be used as basic data for dental technology that are available not only to field-oriented disciplines but also to overall higher education fields which aim to strengthen key competency.

Content Analysis of Debriefing after Simulation-based Nursing Education on Respiratory Distress Syndrome in the Neonatal Intensive Care Unit (간호학생이 경험한 시뮬레이션 기반 간호교육의 디브리핑에 대한 내용분석: 호흡곤란증후군 신생아 간호를 중심으로)

  • Kang, Kyung-Ah;Kim, Sunghee;Kim, Shin-Jeong;Lee, Myung-Nam
    • Child Health Nursing Research
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    • v.24 no.2
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    • pp.208-219
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    • 2018
  • Purpose: The purpose of this study was to explore nursing students' experiences of debriefing after simulation-based learning and to obtain fundamental data to support the development of effective teaching strategies. Methods: Sixty-seven nursing students participated in this study from April to May, 2017. This was a descriptive study analyzing the content of students' descriptions of structured questions in 3 stages (description, analysis, and application) based on recorded videos. Results: The description stage was classified into 3 categories for problem recognition, 4 categories for the nursing plan, and 6 categories for the nursing intervention. The analysis stage was classified into 6 categories for satisfactory practice, 3 categories for experience and 4 categories for what they learned through practice. The application stage was classified into 5 categories, that were to be mastered, and 6 categories, that were important to recognize. Conclusion: This study succeeded in charaterizing learners' experiences of debriefing. During the debriefing, students watched recorded videos, and we found that self-evaluation through structured questionnaires could be a very effective way to strengthen students' core competencies. Our content analysis of the debriefing is expected to contribute to the development of effective strategies in simulation-based education for students and nurses.

Current Status and Factors Affecting Prenatal Care by Married Immigrant Women (결혼이민여성의 산전관리 실태와 영향요인)

  • Jang, In-Sun;Hwang, Na-Mi;Yoon, Mi-Sun;Park, Seung-Mi
    • Women's Health Nursing
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    • v.16 no.4
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    • pp.326-335
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    • 2010
  • Purpose: The purpose of this study was to identify factors affecting prenatal care (PNC) by married immigrant women. Methods: This study was a secondary analysis of "Reproductive Health Status of Married Immigrant Women and Policy Directions in Korea" by the Korea Institute for Health & Social Affairs. The participants were 727 married immigrant women from Asia. Data were analysed using descriptive statistics, $x^2$ test and logistic regression with SPSS 14.0. Results: Of the 727 women interviewed, 91.7% visited prenatal clinic. However, first time for PNC was late and total number of PNC was lower (9.07) than the average of Korean women. Timing and number of PNC in rural area were later and fewer than those in urban area. PNC by these women was significantly lower in those who had lived in Korea longer and for those who the employed. However, PNC was significantly higher in those who attended health education during pregnancy and had not experienced premature delivery. Those who attended health education during pregnancy (OR=2.84, CI=1.49~5.40) or were unemployed (OR=0.51, CI=0.26~0.99) were more likely to have PNC. Conclusion: These findings illustrate the need to strengthen the public information and provide special services to their demands about PNC for married immigrant women.

Implementing and Evaluating a Nurse Led Hereditary Cancer Genetics Educational Program in a Korean Breast Cancer Surgery Clinic (한국형 유방 난소 종양유전상담 프로그램 적용 및 평가)

  • Choi, Kyung-Sook;Jun, Myung-Hee;Ahn, Sei-Hyun;Anderson, Gwen
    • Korean Journal of Adult Nursing
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    • v.20 no.6
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    • pp.815-828
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    • 2008
  • Purpose: This study was to develop and evaluate the clinical utility of the breast and ovarian cancer genetic counselling program specific for 20 Korean women(KBOCGP). Methods: The KBOCGP was developed using three types of approaches: an ethnography among Korean women who underwent BRCA1/2 test, designing and implementing one week clinical genetic educational course for clinical cancer nurses, educational observation visits to three American cancer genetic counselling programs. And then pre-experimental design was implicated to evaluate the change of the women's knowledge about the hereditary breast and ovarian cancer and the level of the satisfaction with genetic counselling. Results: The mean score of the knowledge has significantly increased from $7.45{\pm}3.86$ to $11.55{\pm}2.21$ (t = 5.63, p < .001). The level of the satisfaction with the counselling was very high ($27.47{\pm}1.35$). Because most of the subjects have young kids, they showed strong concerns about their kids' getting cancer. Conclusion: This new KBOCGP is the satisfactory program for the education and communication of the genetic information to the Korean women with HBOC. But it is needed more to strengthen the cultural sensitivity especially to Korean family relationships. Authors recommend that this program be provided by other nurses who are counselling women at high risk of breast cancer.

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Chronic Exposure to Chlorophenol Related Compounds in the Pesticide Production Workplace and Lung Cancer: A Meta-Analysis

  • Zendehdel, Rezvan;Tayefeh-Rahimian, Raana;Kabir, Ali
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.13
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    • pp.5149-5153
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    • 2014
  • Background: Chlorophenols (CPs) and related phenoxyacetic acids (PAs) are pesticide groups contaminated with highly toxic 2, 3, 7, 8-tetrachlorodibenzo-p-dioxin (TCDD) during production. PAs and CPs exposure is associated with risk of cancer, but the situation regarding lung cancer has not been clearly defined. We proposed a meta-analysis of published researches to evaluate relationship between chronic exposure to PAs and CPs in pesticide production workplaces and the risk of lung cancer. Materials and Methods: After searching PubMed, Scopus, Scholar Google, Web of Sciences until August 2013, the association between chronic PAs and CPs exposure in production workplace and lung cancer was studied in 15 cohort studies. The standardized mortality rate (SMR) and 95% confidence intervals (CI) were collected from the papers. We used random or fixed-effects models, Egger test, funnel plot and meta regression in our analysis. Results: Five papers with six reports were included in the final analysis. The standardized mortality rate for lung cancer from the random model was 1.18 (95% CI: 1.03-1.35, p=0.014) with moderate heterogeneity. Publication bias was not found for included studies in meta-analysis (p=0.9). Conclusions: Our findings has strengthen the evidence of lung cancer from chronic exposure to chlorophenol related compounds (PAs, CPs).

Knowledge about Risk Factors for Breast Cancer and Having a Close Relative with Cancer Affect the Frequency of Breast Self-Examination Performance

  • Freitas, Angela Gabrielly Quirino;Weller, Mathias
    • Asian Pacific Journal of Cancer Prevention
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    • v.17 no.4
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    • pp.2075-2081
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    • 2016
  • Background: Breast cancer incidence and mortality rates are increasing in North-Eastern Brazil and the patients with the disease often presented at advanced stages. The present study was focused on identifying variables that affect women's frequency of breast self- examination (BSE) performance. Materials and Methods: Data on BSE, socio-economic parameters and risk factors for breast cancer were obtained from 417 women from a community in North-Eastern Brazil by a self-informant method. To identify independent variables that affect frequency of BSE, nominal logistic regression analysis was performed. Results: Of 417 women, 330 (79.3%) reported performing BSE. Compared to high-income women, BSE performance by low-income women every month was 7.69 (OD=0.130; CI 95%: 0.044- 0.0386; p=0.000) times lower. Women who did not live in a stable union performed BSE each month 2.73 (OD=0.366; CI 95%: 0.171-0.782; p=0.010) less often than those living in a stable union. BSE performance every month and every six months or every year by women with poor knowledge about risk factors for breast cancer was 3.195 (OD=0.313; CI 95%: 0.141- 0.695; p=0.004) times and 2.028 (OD=0.493; CI 95%: 0.248- 0.979; p=0.043) times lower, compared to women with good knowledge. Participants who had a close relative with cancer performed BSE every month and every six months or every year 2.132 (OD=0.469; CI 95%: 0.220-0.997; p=0.049) times and 2.337 (OD=0.428; CI 95%: 0.219-0.836; p=0.013) times less often, compared to those women without close relatives with cancer. Conclusions: The results of this study indicated that income, marital status, knowledge about risk factors and having a close relative with breast cancer, affect the frequency of BSE performance. Information about risk factors in public health campaigns could additionally strengthen avoidance behaviour and also motivate BSE performance.

A Study on the Safety of Bangpungtongsung-san in Rats (랫드에서 방풍통성산의 안전성 연구)

  • Jung, Ko-Eun;Lee, Kyoung-Jin;Lee, Chul-Won;Kwak, In-Seok;Lee, Jang-Cheon;An, Won-Gun
    • Herbal Formula Science
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    • v.20 no.2
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    • pp.55-63
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    • 2012
  • Objectives : This study was conducted to investigate the safety of Bangpungtongsung-san in rats. Methods : The safety of this prescription on acute toxicity was evaluated by single dose toxicity study. Rats were orally administrated in a single dose of 0 and 2,000 mg/kg(limited dose) Bangpungtongsung-san. There were 7 rats in each groups. All animals were sacrificed after 14 days of treatment. After single administration, mortality, clinical signs, and body weight changes were observed for 14 days. Three parameters(autopsy finding, clinical chemistry, and hematology) were tested on the last day. Results : In this study with rats, Bangpungtongsung-san treatment did not show any acute toxicity. No mortality was noted for 14 days of treatment. There were no adverse effects on clinical signs, body weight changes, and autopsy finding at all treatment groups. The clinical chemistry parameters attesting to liver and kidney functions as well as the hematological parameters were within the normal ranges. Conclusions : It is considered that $LD_{50}$ of Bangpungtongsung-san is over 2,000 mg/kg in oral administration by rats. This finding of the safety of Bangpungtongsung-san is expected to strengthen the position of this prescription as nontoxic medicine.