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Survey of Operation and Status of the Human Research Protection Program (HRPP) in Korea (2019) (임상시험 및 대상자보호프로그램의 운영과 현황에 대한 설문조사 연구(2019))

  • Maeng, Chi Hoon;Lee, Sun Ju;Cho, Sung Ran;Kim, Jin Seok;Rha, Sun Young;Kim, Yong Jin;Chung, Jong Woo;Kim, Seung Min
    • The Journal of KAIRB
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    • v.2 no.2
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    • pp.37-48
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    • 2020
  • Purpose: The purpose of this study is to assess the operational status and level of understanding among IRB and HRPP staffs at a hospital or a research institute to the HRPP guideline set by the Ministry of Food and Drug Safety (MFDS) and to provide recommendations. Methods: Online survey was distributed among members of Korean Association of IRB (KAIRB) through each IRB office. The result was separated according to topic and descriptive statistics was used for analysis. Result: Survey notification was sent out to 176 institutions and 65 (37.1%) institutions answered the survey by online. Of 65 institutions that answered the survey; 83.1% was hospital, 12.3% was university, 3.1% was medical college, 1.5% was research institution. 23 institutions (25.4%) established independent HRPP offices and 39 institutions (60.0%) did not. 12 institutions (18.5%) had separate IRB and HRPP heads, 21 (32.3%) institutions separated business reporting procedure and person in charge, 12 institutions separated the responsibility of IRB and HRPP among staff, and 45 institutions (69.2%) had audit & non-compliance managers. When asked about the most important basic task for HRPP, 23% answered self-audit. And according to 43.52%, self-audit was also the most by both institutions that operated HRPP and institutions that did not. When basic task performance status was analyzed, on average, the institutions that operated HRPP was 14% higher than institutions that only operated IRB. 9 (13.8%) institutions were evaluated and obtained HRPP accreditation from MFDS and the most common reason for obtaining the accreditation was to be selected as Institution for the education of persons conducting clinical trial (6 institutions). The most common reason for not obtaining HRPP accreditation was because of insufficient staff and limited capacity of the institution (28%). Institutions with and without a plan to be HRPP accredited by MFDS were 20 (37.7%) each. 34 institutions (52.3%) answered HRPP evaluation method and accreditation by MFDS was appropriate while 31 institutions (47.7%) answered otherwise. 36 institutions answered that HRPP evaluation and accreditation by MFDS was credible while 29 institutions (44.5%) answered that HRPP evaluation method and accreditation by MFDS was not credible. Conclusion: 1. MFDS's HRPP accreditation program can facilitate the main objective of HRPP and MFDS's HRPP accreditation program should be encouraged to non-tertiary hospitals by taking small staff size into consideration and issuing accreditation by segregating accreditation. 2. While issuing Institution for the education of persons conducting clinical trial status as a benefit of MFDS's HRPP accreditation program, it can also hinder access to MFDS's HRPP accreditation program. It should also be considered that the non-contact culture during COVID-19 pandemic eliminated time and space limitation for education. 3. For clinical research conducted internally by an institution, internal audit is the most effective and sole method of protecting safety and right of the test subjects and integrity for research in Korea. For this reason, regardless of the size of the institution, an internal audit should be enforced. 4. It is necessary for KAIRB and MFDSto improve HRPP awareness by advocating and educating the concept and necessity of HRPP in clinical research. 5. A new HRPP accreditation system should be setup for all clinical research with human subjects, including Investigational New Drug (IND) application in near future.

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The Differences of Rice Growth and Yield at Various Agroclimatic Regions in Chungnam Province (충남지역 농업기후 지대별 벼 생육 및 수량 변이)

  • Choi, N.G.;Park, J.H.
    • Journal of Practical Agriculture & Fisheries Research
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    • v.20 no.1
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    • pp.163-174
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    • 2018
  • Rice cultivation is immensely affected by many climatic factors including temperature, precipitation, etc, and imbalanced climatic conditions negatively affect the growth of rice. In this study, we investigated the effects of different agroclimatic zones of Chungnam Province on rice quality and examined the correlations between climatic characteristics and rice yield components. Average temperatures and rainfall were higher in 'Western Sobaek Inland' than those in the 'South Western coastal zone, and precipitation records showed a wide variation among counties due to typhoons during the examined periods. The average accumulative temperature affecting the magnitude of production during reproductive growth periods was higher in "Cheon-An", "Gong-Ju", "Yeon-Gi (Se-Jong)", "Bo-Ryeong", and "Dang-Jin" counties than those in other counties. The plant height was higher in 'Western Sobaek Inland' counties such as "Yeon-Gi(Se-Jong)" and "Cheon-An", and 'Southern Charyeong Plain' counties such as "Cheong-Yang", "Dang-Jin", and "A-San", than those in other counties. The number of tillers during the 40 days after rice transplantation in "Seo-Cheon" and "Bo-Ryeong" counties increased compared to other counties. This result was relevant to the fact that the date of rice transplantation in those counties was 3 to 4 days later than those in other counties of Chung-Nam Province. The average yield (milled rice basis) was the highest in 'Western Sobaek Inland' zone, showing 3,756 kg ha-1, followed by 'Southern Charyeong Plain' zone showing 3,621kg ha-1, and was the lowest in 'South Western coastal zone by 3,315kg ha-1. "Yeon-Gi(Se-Jong)" and "Dang-Jin" counties showed the highest yields of 4,100kg ha-1. "Seo-San", "Seo-Cheon", and "Tae-An" counties were relatively lower yields of 3,240~3,280kg ha-1 in comparison of other counties.

Radiation Dose Reduction in Digital Mammography by Deep-Learning Algorithm Image Reconstruction: A Preliminary Study (딥러닝 알고리즘을 이용한 저선량 디지털 유방 촬영 영상의 복원: 예비 연구)

  • Su Min Ha;Hak Hee Kim;Eunhee Kang;Bo Kyoung Seo;Nami Choi;Tae Hee Kim;You Jin Ku;Jong Chul Ye
    • Journal of the Korean Society of Radiology
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    • v.83 no.2
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    • pp.344-359
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    • 2022
  • Purpose To develop a denoising convolutional neural network-based image processing technique and investigate its efficacy in diagnosing breast cancer using low-dose mammography imaging. Materials and Methods A total of 6 breast radiologists were included in this prospective study. All radiologists independently evaluated low-dose images for lesion detection and rated them for diagnostic quality using a qualitative scale. After application of the denoising network, the same radiologists evaluated lesion detectability and image quality. For clinical application, a consensus on lesion type and localization on preoperative mammographic examinations of breast cancer patients was reached after discussion. Thereafter, coded low-dose, reconstructed full-dose, and full-dose images were presented and assessed in a random order. Results Lesions on 40% reconstructed full-dose images were better perceived when compared with low-dose images of mastectomy specimens as a reference. In clinical application, as compared to 40% reconstructed images, higher values were given on full-dose images for resolution (p < 0.001); diagnostic quality for calcifications (p < 0.001); and for masses, asymmetry, or architectural distortion (p = 0.037). The 40% reconstructed images showed comparable values to 100% full-dose images for overall quality (p = 0.547), lesion visibility (p = 0.120), and contrast (p = 0.083), without significant differences. Conclusion Effective denoising and image reconstruction processing techniques can enable breast cancer diagnosis with substantial radiation dose reduction.

Construction of a Standard Dataset for Liver Tumors for Testing the Performance and Safety of Artificial Intelligence-Based Clinical Decision Support Systems (인공지능 기반 임상의학 결정 지원 시스템 의료기기의 성능 및 안전성 검증을 위한 간 종양 표준 데이터셋 구축)

  • Seung-seob Kim;Dong Ho Lee;Min Woo Lee;So Yeon Kim;Jaeseung Shin;Jin‑Young Choi;Byoung Wook Choi
    • Journal of the Korean Society of Radiology
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    • v.82 no.5
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    • pp.1196-1206
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    • 2021
  • Purpose To construct a standard dataset of contrast-enhanced CT images of liver tumors to test the performance and safety of artificial intelligence (AI)-based algorithms for clinical decision support systems (CDSSs). Materials and Methods A consensus group of medical experts in gastrointestinal radiology from four national tertiary institutions discussed the conditions to be included in a standard dataset. Seventy-five cases of hepatocellular carcinoma, 75 cases of metastasis, and 30-50 cases of benign lesions were retrieved from each institution, and the final dataset consisted of 300 cases of hepatocellular carcinoma, 300 cases of metastasis, and 183 cases of benign lesions. Only pathologically confirmed cases of hepatocellular carcinomas and metastases were enrolled. The medical experts retrieved the medical records of the patients and manually labeled the CT images. The CT images were saved as Digital Imaging and Communications in Medicine (DICOM) files. Results The medical experts in gastrointestinal radiology constructed the standard dataset of contrast-enhanced CT images for 783 cases of liver tumors. The performance and safety of the AI algorithm can be evaluated by calculating the sensitivity and specificity for detecting and characterizing the lesions. Conclusion The constructed standard dataset can be utilized for evaluating the machine-learning-based AI algorithm for CDSS.

On the Secret Scripture of Dragon and Tiger (Yong-Ho-Bi-Gyeol)-a Jungian Commentary (용호비결 연단술의 분석심리학적 의미)

  • Yong-Wook Shin
    • Sim-seong Yeon-gu
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    • v.33 no.2
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    • pp.141-194
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    • 2018
  • The article is about Yong-Ho-Bi-Gyeol(龍虎秘訣), which is one of the most important Taoist text in Korea written by Jeong-Ryum, a Taoist and alchemist in the Chosun Dynasty. The article deals with the alchemical and psychological meanings of Yong-Ho (龍虎, Dragon-Tiger), the way of nurturing cinnabar (修丹之道), the closing of the qi (閉氣), the method of alchemical breathing, the Dantian (丹田, cinnabar-field), and the Mysterious Female's One Opening (玄牝一竅), in addition to the brief introduction of the life of Jeong-Ryum and the bibliography of the book. The Yong-Ho (龍虎) meaning the dragon and tiger is the archetype of transformation in the form of their opposites, rooted in the psychoid system of the human psyche. The unified Yong-Ho makes Dan and the Dan, literally indicating cinnabar, has many alchemical connotations such as Mercurius, the rubedo state of the alchemical process, and the philosopher's stone. In the book, Jeong-Ryum emphasized the slow and subtle way of breathing in and out of Dantian to develop neidan (内丹, inner cinnabar or inner alchemy). The refining of neidan begins by the closing of the qi, which symbolizes the radical introversion and withdrawal of all the projections on the outer objects. The Dantian located at the lower part of the abdomen has been known to preserve jing (精), the vital essence of life, which can be refined into qi and spirit (神). In Jungian perspective, the Dantian is a mandala where an individual's mind can stay and focus at the center of psyche detached from ego and related to the Self. The long-nurtured introverted energy makes the Mysterious Female's One Opening (玄牝一竅), a pit or cavity in the transcendental space, through which the meditator can have a relationship with the great female principle of the universe. The current article has introduced the contents of the Yong-Ho-Bi-Gyeol in the perspective of analytical psychology. However, it has not dealth with the remaining topics including Taesik (胎息, embryonic breathing) and Juchenhwahu (周天火候, the great Celestial circuit firing), due to the lack of author's sufficient knowledge and experience. The unexplored areas of Yong-Ho-Bi-Gyeol will be studied in the future.

A Study on the Hot Springs(Tangsil Building) of Temporary Palace(Onyanghaenggung) according to the <Oncheonhaenggungdo>(1795) (<온천행궁도(溫泉行宮圖)>(1795)의 온천(탕실) 건축 고찰)

  • LEE Jeongsoo;KIM Ilhwan;LEE Kyeongmi;JI Wonku;CHOI Jaeseong
    • Korean Journal of Heritage: History & Science
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    • v.57 no.1
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    • pp.110-123
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    • 2024
  • Onyanghaenggung Palace(temporary palace at Onyang) is an important cultural heritage that can substantially confirm the king's visiting at hot springs based on literature records such as <Ongungyeonggoedae(溫宮靈槐臺)>, <Oncheonhaenggungdo(溫泉行宮圖)> of 『Ongungsasil(溫宮事實)』, <Younggoedaedo(靈槐臺圖)>, 『Younggoedaegi(靈槐臺記)』 and cultural properties such as Yeonggoedae(靈槐臺) and Shinjeong Monument(神井碑). Through a photo taken by Hermann Sander in 1906, it can be confirmed that the hot springs(Tangsil building) at Onyanghaenggung Palace during the Joseon Dynasty was maintained until the early Japanese colonial period. The purpose of this study is to estimate the compositions of the hot springs(Tangsil building) in Onyanghaenggung Palace based on literature records and <Oncheonhaenggungdo>(1795). To achieve these purposes, we firstly examined the changes in Onyanghaenggung Palace and the hot springs (Tangsil building); secondly, the bathing behaviors of kings were reviewed; thirdly, we organized the architectural composition of the hot springs (Tangsil building) according to "Ongung Repair" of 『Ongungsasil (溫宮事實)』; and fourthly, by comparing Sander's photo in the early days of Japanese colonial rule, the architectural composition of the hot springs (Tangsil building) in the late Joseon Dynasty was examined. The results of this study are as follows. First, the hot springs(Tangsil building) of Onyanghaenggung Palace were continuously connected to the Onjeongsil(溫井室) in the reign of King Hyeonjong and maintained until 『Hoseo-eupji』 (1871) in the late Joseon Dynasty. It matches the photograph taken by Hermann Sander(1906) and <1912 Onyang Hot Springs in Asan City>(1912) of Korea Copyright Commission during the early Japanese colonial period. Second, the various king's bathing methods during the Joseon Dynasty were adopted such as washing, spilling and bathing head while sitting on a bathing platform or chair, or exposing the steam of hot spring water, dipping feet into the water and a half-body soaking bath below the navel immersed in water. Third, the stone bathtubs of hot springs(Tangsil building) are composed of the upper bath which was hot spring water gushes out from the northwest, bends to the east, enters the middle bath, and bends to the south to come out to the outside to gather in the lower bath. Around the stone bathtubs, pebble stones brought in from Taean were laid on the floor of the hot springs(Tangsil building). From the above considerations, the compositions of the Tangsil building in Onyang Temporary Palace is based on the king's approach from the main royal building, the king's bathing method and bathing tools, the bathing behavior of enlisted medical officers and bathing assistants, and each rooms mentioned in "Ongung Repair". By comparing it with Hermann Sander's photo, the architectural compositions of the hot springs(Tangsil building) can be estimated.

CT-Derived Deep Learning-Based Quantification of Body Composition Associated with Disease Severity in Chronic Obstructive Pulmonary Disease (CT 기반 딥러닝을 이용한 만성 폐쇄성 폐질환의 체성분 정량화와 질병 중증도)

  • Jae Eun Song;So Hyeon Bak;Myoung-Nam Lim;Eun Ju Lee;Yoon Ki Cha;Hyun Jung Yoon;Woo Jin Kim
    • Journal of the Korean Society of Radiology
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    • v.84 no.5
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    • pp.1123-1133
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    • 2023
  • Purpose Our study aimed to evaluate the association between automated quantified body composition on CT and pulmonary function or quantitative lung features in patients with chronic obstructive pulmonary disease (COPD). Materials and Methods A total of 290 patients with COPD were enrolled in this study. The volume of muscle and subcutaneous fat, area of muscle and subcutaneous fat at T12, and bone attenuation at T12 were obtained from chest CT using a deep learning-based body segmentation algorithm. Parametric response mapping-derived emphysema (PRMemph), PRM-derived functional small airway disease (PRMfSAD), and airway wall thickness (AWT)-Pi10 were quantitatively assessed. The association between body composition and outcomes was evaluated using Pearson's correlation analysis. Results The volume and area of muscle and subcutaneous fat were negatively associated with PRMemph and PRMfSAD (p < 0.05). Bone density at T12 was negatively associated with PRMemph (r = -0.1828, p = 0.002). The volume and area of subcutaneous fat and bone density at T12 were positively correlated with AWT-Pi10 (r = 0.1287, p = 0.030; r = 0.1668, p = 0.005; r = 0.1279, p = 0.031). However, muscle volume was negatively correlated with the AWT-Pi10 (r = -0.1966, p = 0.001). Muscle volume was significantly associated with pulmonary function (p < 0.001). Conclusion Body composition, automatically assessed using chest CT, is associated with the phenotype and severity of COPD.

The Association between Patient Characteristics of Chungnam-do and External Medical Service Use Using Health Insurance Cohort DB 2.0 (건강보험 코호트 자료를 활용한 충청남도 지역 환자의 특성에 따른 관외 의료이용과의 연관성)

  • Yeong Jun Lee;Se Hyeon Myeong;Hyun Woo Moon;Seo Hyun Woo;Sun Jung Kim
    • Health Policy and Management
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    • v.34 no.1
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    • pp.48-58
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    • 2024
  • Background: The purpose of this study was to investigate the association between external medical service use and the characteristics of Chungcheongnam-do patients. We aimed to provide evidence of external medical service use enhance the healthcare delivery system in Chungcheongnam-do. Methods: We used the Health Insurance Cohort DB 2.0 of 2016-2019, and 2,570,439 patients were included in the study. Multivariate logistic regression and multinomial logistic regression were used to identify the association between external medical service use and each patient characteristic. Generalized linear model was used to identify the association between medical costs and external medical service use area. Results: During the study period, 32.2% of inpatients and 12.5% of outpatients had external medical service use in Chungcheongnam-do. In comparison to patients living in Cheonan and Asan, the odds ratio (OR) for external medical services use was higher across all regions. Specifically, hospitalized patients from Gyeryong, Nonsan, and Geumsan (OR, 116.817) and Gongju, Buyeo, and Cheongyang (OR, 72.931) demonstrated extremely high likelihood of external medical service use in the Daejeon area. Furthermore, compared to medical expenses incurred within Chungcheongnam-do, patients with external medical service use in the capitol area (outpatient=17.01%, inpatients=22.11%) and Daejeon area (outpatient=16.63%, inpatients=15.41%) spent more on healthcare services. Conclusion: This study found the evidence of external medical service use among Chungcheongnam-do patients. Further study should be conducted taking into account variables including satisfaction of local medical services, different types of patient diseases, and others. The study's findings may serve as a foundation for policy proposals aimed at ensuring the financial stability of our health insurance system, ensuring the efficient delivery of medical care, and localization of medical care.

Multi-classification of Osteoporosis Grading Stages Using Abdominal Computed Tomography with Clinical Variables : Application of Deep Learning with a Convolutional Neural Network (멀티 모달리티 데이터 활용을 통한 골다공증 단계 다중 분류 시스템 개발: 합성곱 신경망 기반의 딥러닝 적용)

  • Tae Jun Ha;Hee Sang Kim;Seong Uk Kang;DooHee Lee;Woo Jin Kim;Ki Won Moon;Hyun-Soo Choi;Jeong Hyun Kim;Yoon Kim;So Hyeon Bak;Sang Won Park
    • Journal of the Korean Society of Radiology
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    • v.18 no.3
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    • pp.187-201
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    • 2024
  • Osteoporosis is a major health issue globally, often remaining undetected until a fracture occurs. To facilitate early detection, deep learning (DL) models were developed to classify osteoporosis using abdominal computed tomography (CT) scans. This study was conducted using retrospectively collected data from 3,012 contrast-enhanced abdominal CT scans. The DL models developed in this study were constructed for using image data, demographic/clinical information, and multi-modality data, respectively. Patients were categorized into the normal, osteopenia, and osteoporosis groups based on their T-scores, obtained from dual-energy X-ray absorptiometry, into normal, osteopenia, and osteoporosis groups. The models showed high accuracy and effectiveness, with the combined data model performing the best, achieving an area under the receiver operating characteristic curve of 0.94 and an accuracy of 0.80. The image-based model also performed well, while the demographic data model had lower accuracy and effectiveness. In addition, the DL model was interpreted by gradient-weighted class activation mapping (Grad-CAM) to highlight clinically relevant features in the images, revealing the femoral neck as a common site for fractures. The study shows that DL can accurately identify osteoporosis stages from clinical data, indicating the potential of abdominal CT scans in early osteoporosis detection and reducing fracture risks with prompt treatment.

Clinical Usefulness and the Accuracy of Korean Reference Equation for Diffusing Capacity (한국인 폐확산능 정상예측식의 임상적 유용성과 정확성)

  • Ra, Seung Won;Park, Tai Sun;Hong, Yoonki;Hong, Sang-Bum;Shim, Tae Sun;Lim, Chae-Man;Lee, Sang-Do;Koh, Younsuck;Kim, Woo Sung;Kim, Dong-Soon;Kim, Won Dong;Oh, Yeon-Mok
    • Tuberculosis and Respiratory Diseases
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    • v.64 no.2
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    • pp.80-86
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    • 2008
  • Background: Park et al. developed the Korean reference equation for the measurement of diffusing capacity in 1985. However, the equation has not been widely used in Korea and foreign reference equations have been popularly used. We intended to compare the clinical usefulness and the accuracy of the the Korean reference equation (Park's equation) with that of the foreign equation (Burrows' equation) that is commonly used in Korea. Methods: 1. Evaluation of clinical usefulness; Among 1,584 patients who underwent diffusing capacity ($D_LCO$) at the Asan Medical Center from July to December 2006, group A subjects included 276 patients who had different interpretations of $D_LCO$ in trials employing Burrows' equation and Park's equation. Clinical assessment was decided by consensus of two respiratory physicians. In order to evaluate the clinical usefulness of Burrows' equation and Park's equation, agreement of clinical assessment and $D_LCO$ interpretation were measured. 2. Evaluation of accuracy; Group B subjects were 81 patients with interstitial lung disease (ILD) and 39 normal subjects. The 81 ILD patients were diagnosed following a surgical lung biopsy. The accuracy of diagnosing ILD as well as sensitivity and specificity were evaluated according to the use of the reference equations (Burrows' equation and Park's equation) for $D_LCO$. Results: Agreement between clinical assessment and interpretation of $D_LCO$ was 22% for the use of Burrows' equation and 78% for the use of Park's equation. The sensitivity and specificity of the Burrows' equation for diagnosing ILD were 64.2% and 100%. The sensitivity and specificity of the Park's equation for diagnosing ILD were 90.1% and 100%. The sensitivity of the Park's equation for diagnosing ILD was significantly higher than that of Burrows' equation (p<0.001). Conclusion: The Korean reference equation (Park's equation) was more clinically useful and had higher sensitivity for diagnosing ILD than the foreign reference equation (Burrows' equation).