• 대한기관윤리심의기구협의회지
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• 제5권1호
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• pp.14-20
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• 2023

Purpose: To obtain fundamental data on selection tools for an internal audit and develop a new guideline. We scored the indicated points from the internal audit, identified the research progress and problems that occurred, and confirmed the validity of the risk factors involved. Methods: Of the 63 internal audits conducted by Keimyung University Dongsan Hospital from 2014 to 2021, we analyzed 55 clinical trials with an inspection checklist. We excluded 8 that failed to transfer data and refused to comply with the internal audit. The statistical summary of the collected data was verified and interpreted by using frequency analysis and a chi-square test. Result: Of total 55 cases included in the internal audit, sponsor-initiated trial (SIT) was 63.6% (vs. investigator-initiated trial [IIT]), clinical trial for investigational drug was 71.0% (vs. nonclinical or clinical trial for investigational device), domestic multicenter trial was 60.0% (vs. single center or multinational multicenter trial), and trial requisition for MFDS approval was 69.1% (vs. exception for MFDS approval). The 10 areas of the clinical trial inspection checklist (reports, protection of subjects, compliance with protocols, records, management of investigational drug and/or device, delegation of duties, qualification of investigators, management of specimen, contract-agreement and approval of protocols, and preservation of recorded documents) were weighted between 2 to 5 points. The average of the total points was 16.09±13.2 and 20 clinical trials were above the average. As a result of comparing the average of the total points weighted by year, the highest score was in 2020. The 4 factors that play significant roles in determining the internal quality were (1) principal subjects that initiated the clinical trials (p=0.049), (2) type (p=0.003), (3) phase of clinical trials (p=0.024), and (4) number of registered subjects reported at the time of continuing deliberation (p=0.019). Of the 10 areas of the clinical trial inspection checklist, 'record' was the most inappropriate and insufficient. We found more indicated points; the quality of performance declined in IIT, nonclinical trials, and other clinical trials that were not in phase I1-IV4, and the study of more than 30 registered subjects at the time of continuing review. Conclusion: If an institution has an internal audit selection tool that reflects the aforementioned risk factors, it will be possible to effectively manage high-risk studies; thereby, contributing to an efficient internal audit and improving the quality of clinical trials.

• 임상간호연구
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• 제20권2호
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• pp.147-161
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• 2014

Purpose: This study was aimed to modify and adapt the previously developed, high-quality enteral tube feeding guidelines for the usage in clinical settings in Korea. Methods: Guideline adaptation process was undertaken according to the guideline adaptation manual version 2.0 developed by NECA (Kim, et al., 2011) and the standardized methodology for nursing practice guideline adaptation (Gu, et al. 2012). Results: The modified and adapted enteral tube feeding guidelines were consisted of 11 domains and 95 recommendations. The domains and numbers of recommendations in each domain were: 4 on general issues, 2 on enteral nutrition indication and discontinue, 6 on enteral nutrition device selection, 12 on enteral tube feeding device insertions, 3 on enteral nutrition formular and choices, 16 on enteral tube feeding start and progress, 20 on enteral tube feeding maintenance and management, 15 on monitoring enteral tube feeding administration, 10 on prevention of error, 5 on medication administration, and 2 on documentation and report. There were 16.1% of the recommendations marked as A grade, 17.8% of B grade, and 66.1% of C grade. Conclusion: The adapted enteral tube feeding nursing practice guideline is to be added to the evidence-based practice guidelines for fundamentals of nursing practice. The guideline is hoped to be disseminated to nurses nationwide in order to improve the efficiency of enteral tube feeding practice.

• 대한한방내과학회지
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• 제37권6호
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• pp.940-948
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• 2016

Objectives: This exploratory trial evaluated the possibility of quantitatively measuring several aspects during the "abdominal examination" of traditional Korean medicine. The main results of this study will be used to develop a new diagnostic device for abdominal examinations. Methods: Fifteen healthy volunteers were recruited for this study. Three certified Korean medical doctors assessed the existence of pressure pain, the elasticity of the abdominal muscle, and the tonus at CV12 as gold standards. Then, 2 well-trained investigators measured the pressure pain threshold (PPT), the indentation depth of a bar, and repelling force by pressing CV12. Each investigator measured the above 3 variables 2 times at 1 min intervals using a modified digital algometer. Reliability and validity tests of the 3 variables were performed. Results: There were statistically significant coefficients of intraclass correlation on the 3 variables both between and within the investigators (P<0.001). Also, PPT and repelling force showed statistically significant high sensitivity and specificity in a ROC curve. However, the indentation depth of the bar presented relatively low sensitivity. Conclusions: This new diagnostic method using a modified digital algometer could be a useful tool for quantitative measurement in "abdominal examinations". However, future rigorous clinical studies with a large population will be needed for the verification of its usefulness.

• 동의신경정신과학회지
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• 제31권2호
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• pp.89-99
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• 2020

Objectives: The purpose of this study was to identify the needs of bio-signal devices for the diagnosis, assessment, and analysis of neurocognitive disorder in Korean medicine (KM) hospitals and clinics. Methods: A questionnaire was developed to survey the current status of medical device use, and diagnosis and interventions for patients with cognitive disorders in KM hospitals and clinics. November 11~December 2, 2019, 114 responses (71.9% completed) were collected by internet-based questionnaires from the members of the Korean society of Oriental Neuropsychiatry. Results: The clinical requests were in the descending order of hematology analyzer, ultrasound imaging system, and electroencephalography among the 15 most commonly used devices of which research would support for their clinical usability. The biosignal-based devices showed the highest research demands for patients with mild cognitive impairment rather than more severe stages of cognitive impairment. Prevention rather than diagnosis, or several treatment regimens was the strongest clinical area of the KM for patients with neurodegenerative cognitive impairment. Many responded that five to 10 minutes of test duration and 20,000 won to 30,000 won of cost would be appropriated for a new device to be developed. Conclusions: There were strong demands for the development of bio-signal devices for neurocognitive disorders among the KM doctors. Specifically, it showed high needs for the technology that can be used in the prevention area of cognitive disorders. Additionally, new medical devices to assess cognitive functions and to obtain KM pattern-related information were the high needs.

• Journal of the Korean Association of Oral and Maxillofacial Surgeons
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• 제37권2호
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• pp.133-136
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• 2011

Cystic lesions on the jaws with expansion can invade the adjacent anatomical structure, infiltrate and expand the jaws, cause facial deformity, etc. There is great potential for pathologic fractures after cyst enucleation, and damage to the major structures like the nerve, artery. For these reasons, marsupialization and decompression are commonly used to reduce the cystic size. In 1947, Thomas first mentioned decompression that reduces the osmotic pressure in a cyst by making a hole in the cyst and insert a drain. In our cases, a large sized cystic lesion was treated with a specific device made from an orthodontic band and spinal needle. This device is easy and effective for applications and self irrigation.

• 대한의용생체공학회:의공학회지
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• 제44권4호
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• pp.255-263
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• 2023

Clinical ultrasound (US) is a widely used imaging modality with various clinical applications. However, capturing a large field of view often requires specialized transducers which have limitations for specific clinical scenarios. Panoramic imaging offers an alternative approach by sequentially aligning image sections acquired from freehand sweeps using a standard transducer. To reconstruct a 3D volume from these 2D sections, an external device can be employed to track the transducer's motion accurately. However, the presence of optical or electrical interferences in a clinical setting often leads to incorrect measurements from such sensors. In this paper, we propose a deep learning (DL) framework that enables the prediction of scan trajectories using only US data, eliminating the need for an external tracking device. Our approach incorporates diverse data types, including correlation volume, optical flow, B-mode images, and rawer data (IQ data). We develop a DL network capable of effectively handling these data types and introduce an attention technique to emphasize crucial local areas for precise trajectory prediction. Through extensive experimentation, we demonstrate the superiority of our proposed method over other DL-based approaches in terms of long trajectory prediction performance. Our findings highlight the potential of employing DL techniques for trajectory estimation in clinical ultrasound, offering a promising alternative for panoramic imaging.

• Journal of Veterinary Science
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• 제24권4호
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• pp.34.1-34.12
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• 2023

Background: There has not been a thoroughly reported study of the comparison between spectral domain-optical coherence tomography (SD-OCT) with both ultrasound biomicroscopy (UBM) and gonioscopy on the evaluation of the iridocorneal angle (ICA) in dogs. Objectives: To investigate the diagnostic value of SD-OCT for the early detection of narrowing ICA by comparing and assessing inter-device agreement in anterior chamber angle (ACA) measurements obtained by SD-OCT and UBM, and ICA evaluations by gonioscopy. Methods: A total of 28 eyes from 28 client-owned dogs with normal intraocular pressure were included for examination. The ACA and angle opening distance (AOD) were measured from the SD-OCT and UBM images, and gonioscopy images were analyzed using the ICA grade and ZibWest angle index. Results: The mean ACA and AOD for SD-OCT were 28.31° ± 5.37° and 658.42 ± 219.90 ㎛, and for UBM, 28.34° ± 5.82° and 859.29 ± 221.80 ㎛, respectively. The mean difference in ACA between the average values of SD-OCT and UBM measurements was 0.03° with a 95% limit of agreement (LoA) span of 16.2°, indicating positive agreement; that in AOD was 200.85 ㎛ with a 95% LoA span of 1,110.95 ㎛, indicating poor agreement. The Pearson correlation coefficient of the ACA of SD-OCT and ZibWest indices of gonioscopy was 0.624, indicating strong agreement; that of UBM and gonioscopy was 0.43, indicating moderate agreement. Conclusions: SD-OCT is well tolerated by canine patients due to its non-contact method and might be an alternative option for early screening of ICA narrowing in clinical settings.

• 한국의학물리학회:학술대회논문집
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• 한국의학물리학회 2003년도 제27회 추계학술대회
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• pp.63-63
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• 2003

Purpose: Planning target volume (PTV) for tumors in abdomen or thorax includes enough margin for breathing-related movement of tumor volumes during treatment. We developed a simple and handy method, which can reduce PTV margins in patients with moving tumors, respiratory motion reduction device system (RMRDs). Materials and Methods: The patients clinical database was structured for moving tumor patients and patient setup error measurement and immobilization device effects were investigated. The system is composed of the respiratory motion reduction device utilized in prone position and abdominal presser (strip device) utilized in the supine position, moving phantom and the analysis program, which enables the analysis on patients setup reproducibility. It was tested for analyzing the diaphragm movement and CT volume differences from patients with RMRDs, the magnitude of PTV margin was determined and dose volume histogram (DVH) was computed using a treatment planning software. Dose to normal tissue between patients with RMRDs and without RMRDs was analyzed by comparing the fraction of the normal liver receiving to 50% of the isocenter dose(TD50). Results: In case of utilizing RMRDs, which was personally developed in our hospital, the value was reduced to $5pm1.4 mm$, and in case of which the belt immobilization device was utilized, the value was reduced to 3$pm$0.9 mm. Also in case of which the strip device was utilized, the value was proven to reduce to $4pm.3 mm$0. As a result of analyzing the TD50 is irradiated in DVH according to the radiation treatment planning, the usage of the respiratory motion reduction device can create the reduce of 30% to the maximum. Also by obtaining the digital image, the function of comparison between the standard image, automated external contour subtraction, and etc were utilized to develop patients setup reproducibility analysis program that can evaluate the change in the patients setup. Conclusion: Internal organ motion due to breathing can be reduced using RMRDs, which is simple and easy to use in clinical setting. It can reduce the organ motion-related PTV margin, thereby decrease volume of the irradiated normal tissue.

• 한국방사선학회논문지
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• 제13권4호
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• pp.605-611
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• 2019

본 연구의 목적은 여러 가지 하지입식검사에 적용할 수 있는 Multi-Function Device(MFD)를 제작하여 기존에 사용하던 Weight Bearing Platforms(WBPs)들과 X 선 영상의 비교를 통해 임상 활용을 제안하고자 한다. MFD는 단상(보조기구)를 이용한 Weight Bearing Foot/Ankle, Hindfoot Alignment View 검사시 X선 장치의 X선 관구의 최하 조절 높이를 고려하여 제작하였다. 그리고 Foot/Ankle Phantom으로 MFD와 WBPs에서 Weight Bearing Lateral Foot과 Hindfoot Alignment View를 검사하여 X선 영상의 해상력을 Quick MTF(modulation transfer function)프로그램으로 비교하였다. 연구결과 MFD와 WBPs에서 검사한 두 가지 영상 모두 MTF 50(50% Contrast Spatial Frequency)과 10-90%(10-90% of Maximum Energy Rise Distance) Rise의 C/P(Cycles Per Pixel)평균과 LPH(Lines Per Image Height)평균 모두 유의한 차이는 없었다(p>0.05). 연구에서 제작한 MFD는 환자의 안전과 여러 가지 검사를 복합적으로 수행 할 수 있는 유용한 보조기구로 임상 활용을 제안한다. 또한 정책적으로 보조기구의 활용을 권장한다면 전문 업체의 활성화를 돕는 길이며 의료의 질도 더욱 향상할 수 있을 것이다.

• 의료법학
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• 제17권2호
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• pp.125-144
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• 2016

모든 형태의 임상시험은 시험 자체가 불확실하며, 리스크가 다양하므로 피험자를 보호하기 위한 제도가 완비되어 있어야 한다. 그럼에도 불구하고 현행 임상시험에 관한 법률은 약사법과 의료기기법에서 일정한 규정을 두고 있으나 이는 '의약행정'을 원활하게 수행하기 위한 법목적에 비추어 피험자 보호에는 일정한 한계가 있다. 더 나아가 미성년 피험자를 대상으로 하는 임상시험은 약사법 등에서 직접적인 규정을 두지 않고, '소아를 대상으로 하는 임상시험 평가 가이드라인'이나 '의약품임상시험관리기준' 등에서 일정 부분 규율하고 있으나 이는 법적 효력이 없는 권고사항이라는 점에서 일정한 한계가 있다. 미성년자 대상 임상시험에 대한 법흠결 문제는 인체침습의 정도 면에서 통상적인 의료행위의 경우보다 강한 장기이식법상의 미성년자 취급제도와 기타 외국법상의 미성년자 임상시험 제도를 검토함으로서 입법적 해결이 가능하다고 할 것이다. 그러나 근본적으로는 현행법 체계상 약사법, 의료기기법 기타 가이드라인을 중심으로 이루어지고 있는 임상시험 규율체계를 이른바 "피험자보호법"이라는 법률제정을 통해 해결하는 것이 바람직하다고 본다.