• Title/Summary/Keyword: clinical assessment guideline

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Assessment of Inappropriate Medication Use and Dosage in Elderly Patients (입원 노인환자의 부적절 약물사용현황 및 용량적절성 평가)

  • Hong, Yu-Rhee;Lee, Suk-Hyang
    • YAKHAK HOEJI
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    • v.54 no.3
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    • pp.205-214
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    • 2010
  • This study aimed to evaluate the patterns of inappropriate medication use and inappropriate dosage in elderly patients in Korea. A retrospective study was performed for the elderly 65 years or older admitted from January 2007 to December 2007 in a medical center, Seoul, Korea. Potentially inappropriate medication (PIM) use in the elderly was evaluated using Beers criteria. Eighteen drugs out of Beers criteria were included in the formulary of the institute. Inappropriate dosage was set using Beers criteria, CMS (the Centers for Medicare& Medicaid Services) guideline, Geriatric Dosage Handbook. As results, the patients with PIM were 2,172 during the study period. The commonly used inappropriate medications were drugs for the nervous system (n=1237, 44.78%), the alimentary System (n=663, 24.54%) and the cardiovascular system (n=494, 18.28%). The elderly patients with prescription of inappropriate dosage were 10% out of patients with PIMs. The commonly inappropriate dosage drugs were digoxin (n=75, 27.27%), diazepam (n=70, 22.55%) and ferrous sulfate (n=66, 24.00%). Logistic regression analysis showed the number of PIM, days of hospital stay as predictors related to inappropriate dosage use. In conclusion, CNS drugs were frequently prescribed as PIM and inappropriate dosages were identified. It is needed to develop a means of decreasing adverse drug events in elderly.

Development and validation of a nutrition literacy assessment tool for young adults (젊은 성인의 영양정보이해력 평가도구 개발 및 타당성 검증)

  • Ahn, Seokyoung;Kim, Bogyeong;Um, Mihyang;Park, Yookyung;Kye, Seunghee
    • Journal of Nutrition and Health
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    • v.53 no.2
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    • pp.175-189
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    • 2020
  • Purpose: This study was conducted to develop, validate, and assess the reliability of a questionnaire for nutritional literacy among young Korean adults. Methods: The draft questionnaire contained 65 items in 7 domains (i.e., dietary guideline, nutrition and health, nutrients, 5 food groups [food bicycle], nutrition labeling, portion size, and nutrition management for disease prevention). The authors developed a draft questionnaire based on a literature review. After multiple drafts, 52 items were retained and 13 were eliminated in the 7 domains according to professional advice from 5 nutrition experts. A panel of experts (n = 20) comprised of clinical dietitians and nutrition professors completed the content validity assessment, including quantitative and qualitative feedback. As the results, all items of the portion size were eliminated from the questionnaire. A sample of 211 young adults completed the test-retest reliability assessment. Test-retest reliability was evaluated using intra-class correlation coefficient (ICC) and inter-item reliability by Cronbach α coefficient. Results: The final questionnaire contained 30 items with 5 questions each on the dietary guideline, nutrition and health, nutrients, 5 food groups (food bicycle), nutrition labeling, and nutrition management for disease prevention. The Lawshe content validity ratio for domains ranged from 0.60 to 1.00. The ICC scores for questions ranged from 0.64 to 0.86. Cronbach's α for domains ranged from 0.83 to 0.90 and for the overall questionnaire was 0.87. Conclusion: The questionnaire showed strong content validity, test-retest reliability, and high inter-item reliability, indicating that it is a useful tool for assessing nutritional literacy of young adults.

Investigation of the Study Plan and Statistical Method of Functional Cosmetics on Human Skin (기능성 화장품의 인체시험 설계 및 통계적용 방법에 대한 고찰)

  • Seo, Young Kyoung;Koh, Jae Sook;Lee, Won Chul
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.39 no.2
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    • pp.105-115
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    • 2013
  • In Korea, the human skin tests to evaluate the anti-wrinkles and whitening effect have been accomplished in accordance with the KFDA guideline. Regarding the data of the visual assessment and machinery evaluation of the results for the human skin test, unpaired t-test have been used in order to compare between the test and the control groups and paired t-test for the comparison of effects for before and after. Descriptive statistics such as frequency analyses was used for the questionnaire evaluation data. In many cases of the European and American clinical test centers, the methodology and the statistical analysis were similar to ours. But, the documentation obtained by repeated application from identical individual has high relation. For this reason, it is desirable to apply RM ANCOVA and RM ANOVA to a visual assessment and machinery evaluation. We suggested that RM ANCOVA and RM ANOVA is the new approach to statistical analysis of human test data of functional cosmetics.

A Quality Evaluation Study of Case Reports in the Journal of Korea CHUNA Manual Medicine for Spine & Nerves According to the CARE(CAse REport) Guidelines (CARE(CAse REport) 지침에 의거한 척추신경추나의학회지 증례보고의 질 평가 연구: 2013년 이후 증례보고를 중심으로)

  • Choi, Seung-Kwan;Oh, Kyeong-Jin;Lee, Jung-Han
    • The Journal of Churna Manual Medicine for Spine and Nerves
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    • v.16 no.1
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    • pp.91-105
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    • 2021
  • Objectives A case report is a detailed medical description of previously unreported observations or complications of medical conditions, unique use cases of tests, or new side effects. The purpose of this study was to evaluate the quality of case reports published in the Journal of Korea CHUNA Manual Medicine for Spine & Nerves (JKCMSN). Methods Case reports published in the JKCMSN from January 2013 to December 2020 were selected using the Oriental Medicine Advanced Searching Integrated System (OASIS). The quality of the reports was assessed based on the Consensus-based Clinical Case Reporting Guideline Development (CARE) guidelines. Results Sixty case reports that met the inclusion criteria were included in the assessment. Our analysis revealed that 71.42% of the case reports included all the necessary information and their level of reporting was good. However, their scores in the qualitative subdivisions of the reporting level parameters showed that the quality level was uneven. More than 65% of the papers did not report in the following categories: "Keywords," "Patient information," "Timeline," "Diagnostic assessment," "Therapeutic interventions," "Follow-up and outcomes," "Patient perspective," and "Informed consent." Conclusions Our analysis shows that CARE guidelines need to be followed more rigorously to improve the quality of reporting in the JKCMSN. Further efforts are necessary to develop reporting guidelines and evaluation tools relevant to the Korean clinical context.

An Improvement Plan with Assessment of Therapeutic Drug Monitoring Service for Vancomycin (Vancomycin Therapeutic Drug Monitoring 운영 실태 조사와 업무 개선 방안)

  • Kim, Hae-Sook;Lee, Suk-Hyang
    • Korean Journal of Clinical Pharmacy
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    • v.19 no.2
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    • pp.120-130
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    • 2009
  • The objective of this study was to analyze and to improve therapeutic drug monitoring(TDM) service of vancomycin in a local hospital. Patients with TDM service between September 2005 and December 2008 were included and the data were collected for vancomycin use and components of TDM. During that period, 421 cases of TDM service of vancomycin in 236 patients were retrospectively reviewed. The first dosages of vancomycin were appropriate in 135(57.2%) patients and administration of vancomycin was discontinued in 126(53.4%) patients due to therapeutic failure or adverse drug reaction. MRSA was identified in 191(80.9%) patients and 135(70.7%) samples for the identification were sputum. According to the TDM reports, 232(55.1%) serum samples were obtained at the steady-state conditions and 55.5% of the samples that were drawn before the steady-state was due to the physician's inappropriate knowledge about the steady-state. Based on the time of vancomycin administration, 35.8% of the samples were not obtained at the recommended sampling time. For the patients in general wards, the most common reason for the incorrect samples was routine serum sampling by the laboratory medicine phlebotomists between 6 and 8 a.m. except sunday. In contrast, samples drawn by nurses or physicians at inappropriate time were the most common reason for the incorrect samples with patients in the intensive care units. Physicians accepted 68.5% of the recommendations for vancomycin dosage and administration. In conclusion, TDM service of vancomycin needs to be improved in inappropriate sampling time and vancomycin dosage. For solving these problems, current team made of TDM pharmacists and physicians of laboratory medicine can be expanded to include a physician of infectious diseases, nurses and laboratory medicine phlebotomists as new members. Through the TDM service of vancomycin by the new team, we can settle the problems and make the guideline for the scientific controversies associated with therapeutic monitoring of vancomycin.

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A Review on Reporting Quality of Acupuncture Intervention for Visceral Pain: Assessment with STRICTA (내장 통증에 사용된 침 중재 분석 및 보고의 질 평가)

  • Lee, In-Seon;Cheon, Soyeon;Park, Ji-Yeun
    • Korean Journal of Acupuncture
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    • v.36 no.1
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    • pp.19-35
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    • 2019
  • Objectives : The purpose of this study is to review which acupoints and meridians are selected to treat visceral pain in articles published in international journals and to investigate quality of reporting acupuncture intervention according to the STRICTA guidelines. Methods : Electrical and hand search were conducted in PubMed, EMBASE, MEDLINE, and Cochrane Library for acupuncture studies on visceral pain in human and animals. Reporting quality of intervention was evaluated using the revised STRICTA guidelines. Results : We included 51 articles (7 clinical studies and 44 animal studies) in this study. The most frequently adopted meridians and acupoints were Stomach meridian, Spleen meridian, Conception Vessel meridian, and ST36, CV4, SP6, LI4, PC6, SP9, ST25, ST37 in clinical studies. In animal studies, Stomach meridian, Conception Vessel meridian, Pericardium meridian and ST36, ST37, CV12, PC6 were most frequently used. Animal studies showed significantly lower quality of reporting compared to clinical studies. According to the analysis on the effect of year of publication of articles, announcement of STRICTA guidelines did not improve the quality of reporting for studies on visceral pain. Conclusions : These results suggest that both proximal and distal acupoints based on meridian theory were used to study the underlying mechanisms of visceral pain both in human and animal studies. Guidelines of acupuncture intervention reporting for animal study is necessary to improve the quality of evidence, and it will also allow us the integrative understanding of the mechanisms and clinical effects of acupuncture treatment in human and animal.

A Systematic Review on the Reporting Quality of Acupuncture Treatment for Carpal Tunnel Syndrome (손목터널증후군에 사용된 침 치료 보고의 질 평가)

  • Hyun, Ji-Yoon;Shin, Joo-eun;Im, Chae-Jeong;Park, Ji-Yeun
    • Korean Journal of Acupuncture
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    • v.37 no.3
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    • pp.131-144
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    • 2020
  • Objectives : The aim of this study is to analyze the details of acupuncture treatment methods and the reporting quality of acupuncture on Carpal Tunnel Syndrome (CTS). Methods : Search was conducted in Pubmed, EMBASE, and Cochrane Library for acupuncture studies on CTS. The reporting quality of acupuncture treatment was assessed using the following guidelines: Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) for analyzing the method of acupuncture treatment, Consolidated Standards of Reporting Trials (CONSORT) for analyzing study design and study process, and Risk of Bias (ROB) for analyzing bias. The number of reported items was calculated and evaluated as a proportion. The reported proportion of each study was classified into three grades: Grade A (% score ≥75), Grade B (50≤ % score <75), and Grade C (% score <50). Results : A total of 9 Randomized Controlled Trials (RCTs) were included in this study. All trials reported 12 items (66.67%) on average in STRICTA guidelines. Five studies were conducted with manual acupuncture and 3 studies were conducted with electroacupuncture. PC7 (Daereung) was most frequently used to treat CTS. In STRICTA guideline evaluation, 3 studies were classified as Grade A, 5 studies were classified as Grade B, and 1 study was classified as Grade C. In the CONSORT statement assessment, all trials reported an average of 20.56 items. Of the 9 RCTs, 6 studies were classified as Grade B and 3 studies were classified as Grade C. In ROB assessment, most studies showed a low (63.49%) or unclear (26.98%) risk of bias. The selective reporting bias and the incomplete outcome data bias were found to have the lowest risk of bias, and the allocation concealment of selection bias was found to have the most unclear risk of bias. Conclusions : Recent acupuncture studies on CTS showed moderate reporting quality. However, more detailed reports on acupuncture are still needed to establish more solid evidence of acupuncture treatment.

Part 4. Clinical Practice Guideline for Surveillance and Imaging Studies of Trauma Patients in the Trauma Bay from the Korean Society of Traumatology

  • Chang, Sung Wook;Choi, Kang Kook;Kim, O Hyun;Kim, Maru;Lee, Gil Jae
    • Journal of Trauma and Injury
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    • v.33 no.4
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    • pp.207-218
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    • 2020
  • The following recommendations are presented herein: All trauma patients admitted to the resuscitation room should be constantly (or periodically) monitored for parameters such as blood pressure, heart rate, respiratory rate, oxygen saturation, body temperature, electrocardiography, Glasgow Coma Scale, and pupil reflex (1C). Chest AP and pelvic AP should be performed as the standard initial trauma series for severe trauma patients (1B). In patients with severe hemodynamically unstable trauma, it is recommended to perform extended focused assessment with sonography for trauma (eFAST) as an initial examination (1B). In hemodynamically stable trauma patients, eFAST can be considered as the initial examination (2B). For the diagnosis of suspected head trauma patients, brain computed tomography (CT) should be performed as an initial examination (1B). Cervical spine CT should be performed as an initial imaging test for patients with suspected cervical spine injury (1C). It is not necessary to perform chest CT as an initial examination in all patients with suspected chest injury, but in cases of suspected vascular injury in patients with thoracic or high-energy damage due to the mechanism of injury, chest CT can be considered for patients in a hemodynamically stable condition (2B). CT of the abdomen is recommended for patients suspected of abdominal trauma with stable vital signs (1B). CT of the abdomen should be considered for suspected pelvic trauma patients with stable vital signs (2B). Whole-body CT can be considered in patients with suspicion of severe trauma with stable vital signs (2B). Magnetic resonance imaging can be considered in hemodynamically stable trauma patients with suspected spinal cord injuries (2B).

Legal Issues in Clinical Trial on Minor (미성년자 대상 임상시험에 관한 법적 문제점)

  • Song, Young-min
    • The Korean Society of Law and Medicine
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    • v.17 no.2
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    • pp.125-144
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    • 2016
  • All forms of Clinical trial should be fully equipped with protection systems for experimental subjects considering their uncertainty and various risks. Existing laws have some regulations in pharmaceutical affairs act and medical device act. Nonetheless, there is a limit to protect the subjects considering law objective to perform administration of medicine. Furthermore, the clinical trial on minor has no direct regulations in pharmaceutical affairs act, but prescribes certain portion in clinical trial assessment guideline on infants or medicine clinical trial management standard, however there is a limit because that is just recommendation not having legal effectiveness. The legislative solution would be possible for legal problems of clinical trial on minor by examining treatment system on minor in organ transplant act and clinical trial on minor in other foreign laws stronger than usual medical practice in terms of degree of human body invasion. I suppose that the control system of clinical trial being done focusing on the pharmaceutical affairs act, medical device act and other guidelines in existing laws system should be resolved by legislating 'trial subject protection law', in addition, this would be well balanced in organ transplant act on protection system of minor organ donors. Furthermore, the judgement on the consent ability and spontaneity in clinical trial on minor should be judged considering maturity and mentality of minor by clinical trial institutional review board based on legislative solution mentioned above.

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Development of Clinical Protocol for Acquisition of Change of Radial Pulse Wave Signal in the Cold-Heat Intervention: Explanatory, Randomized, 2×2 cross-over design (냉온 부하에 따른 요골동맥 맥파의 변화 특성을 파악하기 위한 무작위 배정·2×2교차설계 탐색적 임상시험계획서 개발)

  • Yu, Hana;Kim, Jihye;Ku, Boncho;Kim, Hyunho;Jeon, Youngju
    • The Journal of the Society of Korean Medicine Diagnostics
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    • v.19 no.2
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    • pp.91-100
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    • 2015
  • Objectives The aim of this study is to develop a structured clinical protocol related with acquisition of radial pulse wave in the randomized, $2{\times}2$ cross-over design, and cold-heat intervention trial for a pilot and preliminary study. Methods The protocol was contrived based on wide ranging literature searches for cold-heat intervention experiments and radial pulse diagnoses. Results Sample size of 60 subjects was calculated based on an effect size derived from the previous study designed to detect the pre-post cold-heat differences in the radial pulse. Each subjects will be randomly assigned to the cold (first) to heat (last) group (n=30) or heat (first) to cold (last) group (n=30). All subjects will fill out a case report form and questionnaires related with pattern identification, dietary patterns, sleep quality, and physical activity will be surveyed and used as a secondary outcomes. Safety assessment will be reported at the final stage. Conclusions This protocol will provide an additional reference to future studies related with observation of radial pulse during any interventions and also expect to be used as a guideline for acquisition of reliable radial pulse wave data.