• Journal of Biomedical Engineering Research
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• v.44 no.6
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• pp.428-442
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• 2023

In this study, we have a goal to develop usability evaluation guidelines for heuristic-based artificial intelligence-based Software as a Medical Device (SaMD) in the medical field. We conducted a gap analysis between medical hardware (H/W) and non-medical software (S/W) based on ten heuristic principles. Through severity assessments, we identified 69 evaluation domains and 112 evaluation criteria aligned with the ten heuristic principles. Subsequently, we categorized each evaluation domain into five types, including user safety, data integrity, regulatory compliance, patient therapeutic effectiveness, and user convenience. We proposed usability evaluation guidelines that apply the newly derived heuristic-based Software as a Medical Device (SaMD) evaluation factors to the risk management process. In the discussion, we also have proposed the potential applications of the research findings and directions for future research. We have emphasized the importance of the judicious application of AI technology in the medical field and the evaluation of usability evaluation and offered valuable guidelines for various stakeholders, including medical device manufacturers, healthcare professionals, and regulatory authorities.

• Journal of the Korean Society of Radiology
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• v.81 no.1
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• pp.231-236
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• 2020

Duodenal varices can develop in patients with portal hypertension secondary to liver cirrhosis. Although upper gastrointestinal bleeding is often severe and fatal, the definite treatment or guideline has not been established. Although endoscopy is the primary therapeutic modality, the use of radiologic interventions, such as transjugular intrahepatic portosystemic shunt, balloon or vascular plug-assisted retrograde transvenous obliteration, and percutaneous transhepatic variceal obliteration, can be considered alternative treatment methods for duodenal varices. Herein, we report a case of duodenal varix in a patient with poor hepatic functional reserve and vascular anatomy, which are contraindications for an occlusion balloon or a vascular plug, successfully treated with coil-assisted retrograde transvenous obliteration.

• The Journal of Korean Obstetrics and Gynecology
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• v.37 no.1
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• pp.40-59
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• 2024

Objectives: Since infertility has been big social issue in Korea, this study aims to analyze the domestic study trends in Korean Medicine (KM) for female infertility treatment. Methods: Case studies applying KM treatment on female infertility were selected through 5 domestic journal databases. General characteristics, interventions, outcomes and results and the quality of the reports were analyzed. Especially, the quality assessments of studies were made using CAse REport (CARE) guideline and Joanna Briggs Institute (JBI) critical appraisal checklist. Results: 14 studies (22 cases) were finally selected for the analyzation. The mean age of the participants was 35.1 and the most common factor of female infertility in this study was Uterine factor. Herbal medicine was applied in all studies, and acupuncture was also used frequently. Most cases reported pregnancy of the participants. According to quality assessment, 'Diagnostic challenges', 'Intervention adherence and tolerability', 'Adverse and unanticipated events', 'Patient perspective' and 'Informed consent' were showed low reporting rates. Conclusions: Korean Medicine treatment for female infertility is expected to be effective. In quality evaluation, there were some items with low reporting rates. Further clinical studies have to be conducted to establish the evidence for the treatment.

• The Journal of Korean Academy of Prosthodontics
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• v.53 no.1
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• pp.51-57
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• 2015

When an implant-supported maxillary full-arch fixed prosthesis is planned for patients with the horizontal and vertical bone resorption induced by periodontal disease, it is necessary to consider the masticatory function, esthetics and phonetics when placing implants. For this reason, thorough clinical and radiological diagnosis is necessary. Extensive bone and soft tissue grafting may be required as well. Since there is no clear guideline for proper number of implants, segment or splinting of substructure and method of retaining prosthesis, these should be considered during diagnostic process. This clinical report describes a patient who has experienced several tooth extractions and periodontal treatment due to severe periodontitis on maxilla and mandible. With bone and soft tissue graft before dental implant placement, the patient have satisfactory result in esthetic and functional aspect with the implant-supported maxillary full-arch fixed prosthesis opposing mandibular natural dentition.

• Journal of the Korean Data and Information Science Society
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• v.28 no.5
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• pp.1027-1041
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• 2017

Hyperlipidemia, the status of blood with high level of low-density lipoprotein cholesterol (LDL-C), is known as a main cause of coronary artery diseases such as myocardiac infarction or brain infarct. Statin is the representative prescription to hyperlipidemia and the effects of it depend on the patient's individual conditions such as health-caring habits or adherence to medication. The main effect of statin is reducing LDL-C, which should reach the target range based on National Cholesterol Education Program-Adult Treatment Panel III (NCEP-ATP III) guideline. In this research, the reduction of LDL-C and attainment to patient's target range are considered effects of statin. The association between factors - individual conditions and adherence to medication of patients - and the effects of statin is analyzed with National Health Insurance Service-National Sample Cohort (NHIS-NSC).

• Asian Pacific Journal of Cancer Prevention
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• v.15 no.6
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• pp.2523-2527
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• 2014

Background: Serum thyroglobulin detection plays an essential role during the follow-up of thyroid cancer patients treated with total/near total thyroidectomy and radioiodine ablation. The aim of this retrospective study was to evaluate the relationship between stimulated serum thyroglobulin (Tg) level at the time of high dose $^{131}I$ ablation and risk of recurrence, using a three-level classification in patients with differentiated thyroid cancer (DTC) according to the ATA guidelines. Also we investigated the relationship between postoperative stimulated Tg at the time of ablation and DxWBS results at 8-10 months thereafter. Materials and Methods: Patients with radioiodine accumulation were regarded as scan positive (scan+). If there was no relevant pathological radioiodine accumulation or minimal local accumulation in the thyroid bed region, this were regarded as scan negative (scan-) at the time of DxWBS. We classified patients in 3 groups as low, intermediate and high risk group for assessment of risk of recurrence according to the revised ATA guidelines. Also, we divided patients into 3 groups based on the stimulated serum Tg levels at the time of $^{131}I$ ablation therapy. Groups 1-3 consisted of patients who had Tg levels of ${\leq}2ng/ml$, 2-10 ng/ml, and ${\geq}10ng/ml$, respectively. Results: A total of 221 consecutive patients were included. In the high risk group according to the ATA guideline, while 45.5% of demonstrated Scan(+) Tg(+), 27.3% of patients demonstrated Scan(-) Tg(-); in the intermediate group, the figures were 2.3% and 90.0% while in the low risk group, they were 0.6% and 96.4%. In 9 of 11 patients with metastases (81.8%), stimulated serum Tg level at the time of radioiodine ablation therapy was over 10, however in 1 patient (9.1%) it was <2ng/mL and in one patient it was 2-10ng/mL (p=0.005). Aggressive subtypes of DTC were found in 8 of 221 patients and serum Tg levels were ${\leq}2ng/ml$ in 4 of these 8. Conclusions: We conclude that TSH-stimulated serum thyroglobulin level at the time of ablation may not determine risk of recurrence. Therefore, DxWBS should be performed at 8-12 months after ablation therapy.

• Journal of radiological science and technology
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• v.39 no.4
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• pp.483-491
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• 2016

The conditions after exposure to digital mammography and digital breast tomosynthesis were analyzed. The examinations for the ACR phantom were done using manual exposure, not auto exposure, to examine image discrimination and patient dose. As a result, the following results were derived: In the CC exposure, the kVp was 2kVp higher while mAs decreased to 58.6% for the 3D tomography. Such result showed an approximate decrease of 60mAs. At that time, the patients' Average Glandular Dose (AGD) was 1.65mGy in 2D and 1.87mGy in 3D; thus, AGD of 3D was shown to have about 1.13times higher. The result of the manual exposure revealed a reduced mAs of up to 80%; there was no effect in the assessment standard in terms of image discrimination, resulting in more than 10 points. When mAs was reduced to 80% in the manual exposure for ACR phantom, AGD was decreased to 0.66mGy. The diagnostic values of images were maintained and patients dose was reduced in the manual exposure in the AEC condition for 3D. Since the use of 3D has recently increased, using the manual exposure has been recommended in this study to improve the diagnostic value, while, simultaneously reducing patients dose.

• Journal of Radiation Protection and Research
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• v.36 no.3
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• pp.140-147
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• 2011

Our purpose is to specify behavior and environmental factors aimed at reducing the exposed dosage caused by PET-CT and to develop radiation safety management guidelines adequate for domestic circumstances. We have used a multistep-multimethod as the methodological approach to design and to carry out the research both in quality and quantity, including an analysis on previous studies, professional consultations and a survey. The survey includes responses from 139 practitioners in charged of 109 PET-CTs installed throughout Korea(reported by the Korean Society of Nuclear Medicine, 2010). The research use 156 questions using Cronbach's ${\alpha}$ (alpha) coefficients which were: 0.818 for "the necessity of setting and installing the radiation protective environment"; 0.916 for "the necessity of radiation protection", "setting and installing the radiation protective environment"; and 0.885 for "radiation protection". The check list, derived from the radiation safety management guidelines focused on behavior and environment, was composed of 20 items for the radiation protective environment: including 5 items for the patient; 4 items for the guardian; 3 items for the radiologist; and 8 items applied to everyone involved; for a total of 26 items for the radiation protective behavior including: 12 items for the patient; 1 item for the guardian, 7 items for the radiologist; and 6 items applied to everyone involved. The specific check list is shown in(Table 5-6). Since our country has no safety management guidelines of its own to reduce the exposed dosage caused by PET-CTs, we believe the guidelines developed through this study means great deal to the field as it is not only appropriate for domestic circumstances, but also contains specific check lists for each target who may be exposed to radiation in regards to behavior and environment.

• The Korean Society of Law and Medicine
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• v.13 no.1
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• pp.359-395
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• 2012

In a broad term, health and medical data means all patient information that has been generated or circulated in government health and medical policies, such as medical research and public health, and all sorts of health and medical fields as well as patients' personal data, referred as medical data (filled out as medical record forms) by medical institutions. The kinds of health and medical data in medical records are prescribed by Articles on required medical data and the terms of recordkeeping in the Enforcement Decree of the Medical Service Act. As EMR, OCS, LIS, telemedicine and u-health emerges, sharing and protecting digital health and medical data is at issue in these days. At medical institutions, health and medical data, such as medical records, is classified as "sensitive information" and thus is protected strictly. However, due to the circulative property of information, health and medical data can be public as well as being private. The legal grounds of health and medical data as such are based on the right to informational self-determination, which is one of the fundamental rights derived from the Constitution. In there, patients' rights to refuse the collection of information, to control recordkeeping (to demand access, correction or deletion) and to control using and sharing of information are rooted. In any processing of health and medical data, such as generating, recording, storing, using or disposing, privacy can be violated in many ways, including the leakage, forgery, falsification or abuse of information. That is why laws, such as the Medical Service Act and the Personal Data Protection Law, and the Guideline for Protection of Personal Data at Medical Institutions (by the Ministry of Health and Welfare) provide for technical, physical, administrative and legal safeguards on those who handle personal data (health and medical information-processing personnel and medical institutions). The Personal Data Protection Law provides for the collection, use and sharing of personal data, and the regulation thereon, the disposal of information, the means of receiving consent, and the regulation of processing of personal data. On the contrary, health and medical data can be inspected or delivered of the copies, based on the principle of restriction on fundamental rights prescribed by the Constitution. For instance, Article 21(Access to Record) of the Medical Service Act, and the Personal Data Protection Law prescribe self-disclosure, the release of information by family members or by laws, the exchange of medical data due to patient transfer, the secondary use of medical data, such as medical research, and the release of information and the release of information required by the Personal Data Protection Law.

• Journal of the Korean Society of Radiology
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• v.10 no.3
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• pp.161-169
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• 2016

In this study, the proposal to seek ways to reduce the amount of radiation is drawn by comparing and analyzing CT Dose Index(CTDI) on the pediatric head CT which was performed at the busan regional hospitals, to the national diagnostic reference levels. As a result, it was appeared to exceed the amount of the dose recommendation in order of hospital, general hospital and senior general hospital in the hospital-specific classification and from 2 to 5 year, from 1 month to 1 year and from 6 to 10 year in the age-specific classification. In addition, the amount of the dose recommendation was exceed in order of helical, axial and volume in the scan-specific classification. As the results of the scan range reset to match the diagnostic reference level, the dose reduction showed 11.68%, 15.79% and 20.66% in senior general hospital, general hospital and hospital respectively. In the results of analysing patient average scan ranges which does not deviate from the guideline of patient dose recommendation, there was age of 1 month to 1 year, 2 to 5 year and 6 to 10 year of $03.2{\pm}11.8mm$, $110.5{\pm}14.5mm$, and $117.8{\pm}17.2mm$ respectively.