• Title/Summary/Keyword: observational

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Sharing Experiences in Selecting Clinical Outcome and Approving Validated Questionnaires : Insights from an Elderly Registry Study (노인등록연구 사례를 통한 임상평가지표 선정 과정 및 검증된 설문도구 승인 경험의 공유)

  • Nahyun Cho;Hyungsun Jun;Won-Bae Ha;Junghan Lee;Mi Mi Ko;Young-Eun Kim;Jeeyoun Jung;Jungtae Leem
    • The Journal of Korean Medicine
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    • v.45 no.1
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    • pp.17-43
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    • 2024
  • Objectives: Underpinned by the context of a Korean traditional medicine cohort study on healthy aging, this research primarily aims to guide the selection of Clinical Outcome Assessments (COAs) for elderly healthy aging patient registry research, offering insights into the selection process; and secondly, to streamline the resource-intensive process of obtaining permissions for validated COAs, benefiting future traditional Korean medicine clinical researchers. Methods : In this study, we identified outcomes through a review of previous studies, followed by a process involving expert consultations to select the final outcomes. Subsequently, for the selected outcomes that were Clinical Outcome Assessments (COAs) developed tools, we searched in commercial databases to confirm the availability of Korean versions and the necessity of obtaining permissions. Finally, we obtained permissions for their utilization and, when needed, acquired the original instrument questionnaire through payment. Results: Through a literature review of existing observational studies, a total of 57 outcomes were selected, with 19 of them identified as COA instruments. Upon verifying usage permissions for these 19 instruments, it was found that 17 required author-specific permissions, and among these, 2 needed a purchase as they were commercially available. Conclusion: This study provides a detailed overview of outcome selection and permission acquisition for elderly patient registry research. It underscores the importance of Clinical Outcome Assessment (COA) tools and the rigorous approval process, aiming to enhance research reliability. Continuous verification of COA information is essential, and future research should explore Core Outcome Set (COS) development through consensus-building approaches like Delphi studies.

Vitamin D Attenuates Pain and Cartilage Destruction in OA Animals via Enhancing Autophagic Flux and Attenuating Inflammatory Cell Death

  • JooYeon Jhun;Jin Seok Woo;Ji Ye Kwon;Hyun Sik Na;Keun-Hyung Cho;Seon Ae Kim;Seok Jung Kim;Su-Jin Moon;Sung-Hwan Park;Mi-La Cho
    • IMMUNE NETWORK
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    • v.22 no.4
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    • pp.34.1-34.19
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    • 2022
  • Osteoarthritis (OA) is the most common form of arthritis associated with ageing. Vitamin D has diverse biological effect on bone and cartilage, and observational studies have suggested it potential benefit in OA progression and inflammation process. However, the effect of vitamin D on OA is still contradictory. Here, we investigated the therapeutic potential of vitamin D in OA. Six-week-old male Wistar rats were injected with monosodium iodoacetate (MIA) to induce OA. Pain severity, cartilage destruction, and inflammation were measured in MIA-induced OA rats. Autophagy activity and mitochondrial function were also measured. Vitamin-D (1,25(OH)2D3) and celecoxib were used to treat MIA-induced OA rats and OA chondrocytes. Oral supplementation of vitamin D resulted in significant attenuations in OA pain, inflammation, and cartilage destruction. Interestingly, the expressions of MMP-13, IL-1β, and MCP-1 in synovial tissues were remarkably attenuated by vitamin D treatment, suggesting its potential to attenuate synovitis in OA. Vitamin D treatment in OA chondrocytes resulted in autophagy induction in human OA chondrocytes and increased expression of TFEB, but not LC3B, caspase-1 and -3, in inflamed synovium. Vitamin D and celecoxib showed a synergistic effect on antinociceptive and chondroprotective properties in vivo. Vitamin D showed the chondroprotective and antinociceptive property in OA rats. Autophagy induction by vitamin D treatment may be a promising treatment strategy in OA patients especially presenting vitamin D deficiency. Autophagy promoting strategy may attenuate OA progression through protecting cells from damage and inflammatory cell death.

The Extent of Late Gadolinium Enhancement Can Predict Adverse Cardiac Outcomes in Patients with Non-Ischemic Cardiomyopathy with Reduced Left Ventricular Ejection Fraction: A Prospective Observational Study

  • Eun Kyoung Kim;Ga Yeon Lee;Shin Yi Jang;Sung-A Chang;Sung Mok Kim;Sung-Ji Park;Jin-Oh Choi;Seung Woo Park;Yeon Hyeon Choe;Sang-Chol Lee;Jae K. Oh
    • Korean Journal of Radiology
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    • v.22 no.3
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    • pp.324-333
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    • 2021
  • Objective: The clinical course of an individual patient with heart failure is unpredictable with left ventricle ejection fraction (LVEF) only. We aimed to evaluate the prognostic value of cardiac magnetic resonance (CMR)-derived myocardial fibrosis extent and to determine the cutoff value for event-free survival in patients with non-ischemic cardiomyopathy (NICM) who had severely reduced LVEF. Materials and Methods: Our prospective cohort study included 78 NICM patients with significantly reduced LV systolic function (LVEF < 35%). CMR images were analyzed for the presence and extent of late gadolinium enhancement (LGE). The primary outcome was major adverse cardiac events (MACEs), defined as a composite of cardiac death, heart transplantation, implantable cardioverter-defibrillator discharge for major arrhythmia, and hospitalization for congestive heart failure within 5 years after enrollment. Results: A total of 80.8% (n = 63) of enrolled patients had LGE, with the median LVEF of 25.4% (19.8-32.4%). The extent of myocardial scarring was significantly higher in patients who experienced MACE than in those without any cardiac events (22.0 [5.5-46.1] %LV vs. 6.7 [0-17.1] %LV, respectively, p = 0.008). During follow-up, 51.4% of patients with LGE ≥ 12.0 %LV experienced MACE, along with 20.9% of those with LGE ≤ 12.0 %LV (log-rank p = 0.001). According to multivariate analysis, LGE extent more than 12.0 %LV was independently associated with MACE (adjusted hazard ratio, 6.71; 95% confidence interval, 2.54-17.74; p < 0.001). Conclusion: In NICM patients with significantly reduced LV systolic function, the extent of LGE is a strong predictor for long-term adverse cardiac outcomes. Event-free survival was well discriminated with an LGE cutoff value of 12.0 %LV in these patients.

Long-term Efficacy of S-1 Monotherapy or Capecitabine Plus Oxaliplatin as Adjuvant Chemotherapy for Patients with Stage II or III Gastric Cancer after Curative Gastrectomy: a Propensity Score-Matched Multicenter Cohort Study

  • Lee, Chang Min;Yoo, Moon-Won;Son, Young-Gil;Oh, Sung Jin;Kim, Jong-Han;Kim, Hyoung-Il;Park, Joong-Min;Hur, Hoon;Jee, Ye Seob;Hwang, Sun-Hwi;Jin, Sung-Ho;Lee, Sang Eok;Park, Ji-Ho;Seo, Kyung Won;Park, Sungsoo;Kim, Chang Hyun;Jeong, In Ho;Lee, Han Hong;Choi, Sung Il;Lee, Sang-Il;Kim, Chan Young;Kim, In-Hwan;Son, Myoung-Won;Pak, Kyung Ho;Kim, Sungsoo;Lee, Moon-Soo;Min, Jae-Seok
    • Journal of Gastric Cancer
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    • v.20 no.2
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    • pp.152-164
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    • 2020
  • Purpose: To compare long-term disease-free survival (DFS) between patients receiving tegafur/gimeracil/oteracil (S-1) or capecitabine plus oxaliplatin (CAPOX) adjuvant chemotherapy (AC) for gastric cancer (GC). Materials and Methods: This retrospective multicenter observational study enrolled 983 patients who underwent curative gastrectomy with consecutive AC with S-1 or CAPOX for stage II or III GC at 27 hospitals in Korea between February 2012 and December 2013. We conducted propensity score matching to reduce selection bias. Long-term oncologic outcomes, including DFS rate over 5 years (over-5yr DFS), were analyzed postoperatively. Results: The median and longest follow-up period were 59.0 and 87.6 months, respectively. DFS rate did not differ between patients who received S-1 and CAPOX for pathologic stage II (P=0.677) and stage III (P=0.899) GC. Moreover, hazard ratio (HR) for recurrence did not differ significantly between S-1 and CAPOX (reference) in stage II (HR, 1.846; 95% confidence interval [CI], 0.693-4.919; P=0.220) and stage III (HR, 0.942; 95% CI, 0.664-1.337; P=0.738) GC. After adjustment for significance in multivariate analysis, pT (4 vs. 1) (HR, 11.667; 95% CI, 1.595-85.351; P=0.016), pN stage (0 vs. 3) (HR, 2.788; 95% CI, 1.502-5.174; P=0.001), and completion of planned chemotherapy (HR, 2.213; 95% CI, 1.618-3.028; P<0.001) were determined as independent prognostic factors for DFS. Conclusions: S-1 and CAPOX AC regimens did not show significant difference in over-5yr DFS after curative gastrectomy in patients with stage II or III GC. The pT, pN stage, and completion of planned chemotherapy were prognostic factors for GC recurrence.

AN OBSERVATIONAL MULTI-CENTER STUDY FOR EVALUATION OF EFFICACY, SAFETY AND PARENTAL SATISFACTION OF METHYLPHENIDATE-OROS IN CHILDREN WITH ADHD (주의력결핍과잉운동장애 아동에게 Methylphenidate-OROS 투여시 효용성과 안전성 및 부모 만족도를 평가하기 위한 다기관관찰연구)

  • Kim, Bong-Seog;Park, Eun-Jin
    • Journal of the Korean Academy of Child and Adolescent Psychiatry
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    • v.16 no.2
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    • pp.279-285
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    • 2005
  • Objectives : This study was performed to evaluate the efficacy and safety of MPH-OROS and parental satisfaction for treatment of children with ADHD Method : The 569 participants were clinically diagnosed for ADHD using DSM-IV criteria. We switched current medication to MPH-OROS or introduced MPH-OROS for treatment of ADHD. We assessed the clinical global impression severity of illness (CGI-S), the clinical global impression severity of improvement(CGI-I). And the parents of participants measured the Korean version of Conners rating scale at baseline, the 1 st week and the 3rd week after MPH-OROS trial. At the 3rd week, the parents measured the parent satisfaction questionnaire. Results : $13\%$ of participants dropped out because of several causes including side effects. The change of CGI-S was significantly decreased. Using CGI-I, the improvement was $72.3\%$ at the 1st week and $87.4\%$ at the 3rd week. The total score of the Korean version of Conners parent rating scale was significantly decreased. The participants complaining one or more of side effects were 119$(20.7\%)$, and the most common side effect was anorexia. The $94\%$ of parents replied that they were overall satisfied with MPH-OROS trial. Also the advantages of MPH-OROS of parental report were the long duration of the drug, the improvement of schoolwork and attitude, the improvement of home behavior and homework and the improvement of overactivity. Conclusion : MPH-OROS is effective and well-tolerated in actual clinical use for ADHD.

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Clinical Characteristics of Chronic Cough in Korea

  • An, Tai Joon;Kim, Jin Woo;Choi, Eun Young;Jang, Seung Hun;Lee, Hwa Young;Kang, Hye Seon;Koo, Hyeon-Kyoung;Lee, Jong Min;Kim, Sung-Kyung;Shin, Jong-Wook;Park, So Young;Rhee, Chin Kook;Moon, Ji-Yong;Kim, Yee Hyung;Lee, Hyun;Kim, Yong Hyun;Kim, Je Hyeong;Lee, Sang Haak;Kim, Deog Kyeom;Yoo, Kwang Ha;Kim, Dong-Gyu;Jung, Ki-Suck;Kim, Hui Jung;Yoon, Hyoung Kyu;Cough Study Group of the Korean Academy of Tuberculosis and Respiratory Diseases
    • Tuberculosis and Respiratory Diseases
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    • v.83 no.1
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    • pp.31-41
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    • 2020
  • Background: Chronic cough is defined as a cough lasting more than 8 weeks and socio-economic burden of chronic cough is enormous. The characteristics of chronic cough in Korea are not well understood. The Korean Academy of Tuberculosis and Respiratory Diseases (KATRD) published guidelines on cough management in 2014. The current study evaluated the clinical characteristics of chronic cough in Korea and the efficacy of the KATRD guidelines. Methods: This was a multi-center, retrospective observational study conducted in Korea. The participants were over 18 years of age. They had coughs lasting more than 8 weeks. Subjects with current pulmonary diseases, smokers, exsmokers with more than 10 pack-years or who quit within the past 1 year, pregnant women, and users of cough-inducing medications were excluded. Evaluation and management of cough followed the KATRD cough-management guidelines. Results: Participants with chronic cough in Korea showed age in the late forties and cough duration of more than 1 year. Upper airway cough syndrome was the most common cause of cough, followed by cough-variant asthma (CVA). Gastro-esophageal reflux diseases and eosinophilic bronchitis were less frequently observed. Following the KATRD cough-management guidelines, 91.2% of the subjects improved after 4 weeks of treatment. Responders were younger, had a longer duration of cough, and an initial impression of CVA. In univariate and multivariate analyses, an initial impression of CVA was the only factor related to better treatment response. Conclusion: The causes of chronic cough in Korea differed from those reported in other countries. The current Korean guidelines proved efficient for treating Korean patients with chronic cough.

Vitamin D and Risk of Respiratory Tract Infections in Children: A Systematic Review and Meta-analysis of Randomized Controlled Trials (비타민 D와 소아 호흡기 감염의 위험성: 무작위 대조 연구에 대한 체계적 문헌고찰 및 메타분석)

  • Ahn, Jong Gyun;Lee, Dokyung;Kim, Kyung-Hyo
    • Pediatric Infection and Vaccine
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    • v.23 no.2
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    • pp.109-116
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    • 2016
  • Purpose: Recent observational studies have found that vitamin D deficiency is associated with respiratory tract infections. However, randomized controlled trials (RCTs) regarding the efficacy of vitamin D in childhood respiratory tract infection (RTI) have yield inconsistent results. We performed a systematic review and meta-analysis to evaluate the association between vitamin D supplementation and the risk of RTI. Methods: A comprehensive search was conducted using MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trial. Randomized controlled trials of vitamin D supplementation for prevention of RTI in children were included for the analysis. Cochrane Collaboration's tool for assessing the risk of bias was used to assess the quality of the studies. Pooled risk ratios with 95% confidence intervals (CIs) were meta-analyzed using Review Manager 5.3. Results: A total of seven RCTs were included in the meta-analysis. According to a random-effects model, the risk ratio for vitamin D supplementation was 0.82 (95% CI: 0.69-0.98) and $I^2=62%$ for heterogeneity. On subgroup analysis, heterogeneity decreased in the subgroup with follow-up less than 1 year, participants ${\geq}5years$ of age, patients subgroup, and subgroup with dosing daily. Funnel plot showed that there might be publication bias in the field. Conclusions: The present meta-analysis supports a beneficial effect of vitamin D supplementation for the prevention of RTI in children. However, the result should be interpreted with caution due to limitations including a small number of available RCTs, heterogeneity among the studies, and potential publication bias.

The Characteristic and Implication of the View of Object in Oriental Medicine (한의학적(韓醫學的) 대상관(對象觀)의 특징과 성격)

  • Lee, Choong-Yeol
    • The Journal of Korean Medicine
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    • v.16 no.1 s.29
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    • pp.505-530
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    • 1995
  • Recently some people in learned circles of oriental medicine raised a Question about a terminological problem, i.e., 'oriental medical'. This question was thought as an attempt to find out the identity of oriental medicine which exists among the various current medical knowledge systems. In spite of same object, human body, there are diverse medical knowledge systems which has different concepts and theories. This come from the difference of a view of object which defines the experiences of that. The knowledge system of oriental medicine was established by the view of object in oriental medicine which depended on the way of thinking as Yin and Yang. The view of object in oriental medicine has come out in the special cultural soil, namely, the oriental world. Because of this the view of object in oriental medicine cannot be seperated from the oriental world view. What distintive feature does the oriental world view have? It can be summarized as the holistic, dynamical and organic ideas of the world. The term 'oriental medical' is being used to emphasize the characteristic and the peculiarity of the oriental medicine among the various medical knowledge systems. Can the current so called scientific method accept this peculiar and special method of oriental medicine? The efforts of philosophers who had been stimulated by the awful scientific achivements and had tried to find out the unified method penetrating through all the empirical science by mobilizing the logic and mathematics has became out of date for the raise of a question about the inductive method. On the contrary, the theses of theory-laden observation was accepted widely and the relativism was accepted as a new established theory. But the relativism has its own problem. The relativism was founded upon the concept, the incommensurability, which Khun and Feyerabend had proposed. This concept was criticized strongly by some of philosophers because of its own self-refuting. The view of object in oriental medicine has a relative characteristic in the aspect of its urge that in accordance with the perspective a different medical knowledge system can be possible. But our possible choice is the moderate conceptual relativism. Therefore if the view of object in oriental medicine includes the relative aspect, there is the 'conceptual relativity' between the knowledge system of oriental medicine and the western medicine. This preview an important aspect for the standardization and modernizing research of oriental medicine by lending the knowledge of the western medicine. And when we choose the moderate conceptual relativism, it means that we do not support the extreme relativism, that is, 'anything goes'. The concept of truth and rationality cannot be abandoned, and it plays the role of the norm on the knowledge system of oriental medicine and other knowledge systems of medicine in a limited meaning. And the view of object in oriental medicine has an organic view about the human body and the characteristic which wants to interpret the phenomena of human body by using the holistic method. But the availability of this method will be evaluated by the achievements of oriental medicine. Finally what relationship does the theory of oriental medicine have with the world the theory is applied to? It is recognized that the theory of oriental medicine has the instrumental characteristic. But it can be thought the instrumentalism is different from the oriental medical standpoint in the aspect that the instrumentalism seperates the theoretical existence from the observational existence sharply. Because in the oriental thinking way there is no seperation between the mind of observer and the object and no conflict between the idealism and the realism like the western world. For this problem there must be a further study.

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A Study of the Influence of Short-Term Air-Sea Interaction on Precipitation over the Korean Peninsula Using Atmosphere-Ocean Coupled Model (기상-해양 접합모델을 이용한 단기간 대기-해양 상호작용이 한반도 강수에 미치는 영향 연구)

  • Han, Yong-Jae;Lee, Ho-Jae;Kim, Jin-Woo;Koo, Ja-Yong;Lee, Youn-Gyoun
    • Journal of the Korean earth science society
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    • v.40 no.6
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    • pp.584-598
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    • 2019
  • In this study, the effects of air-sea interactions on precipitation over the Seoul-Gyeonggi region of the Korean Peninsula from 28 to 30 August 2018, were analyzed using a Regional atmosphere-ocean Coupled Model (RCM). In the RCM, a WRF (Weather Research Forecasts) was used as the atmosphere model whereas ROMS (Regional Oceanic Modeling System) was used as the ocean model. In a Regional Single atmosphere Model (RSM), only the WRF model was used. In addition, the sea surface temperature data of ECMWF Reanalysis Interim was used as low boundary data. Compared with the observational data, the RCM considering the effect of air-sea interaction represented that the spatial correlations were 0.6 and 0.84, respectively, for the precipitation and the Yellow Sea surface temperature in the Seoul-Gyeonggi area, which was higher than the RSM. whereas the mean bias error (MBE) was -2.32 and -0.62, respectively, which was lower than the RSM. The air-sea interaction effect, analyzed by equivalent potential temperature, SST, dynamic convergence fields, induced the change of SST in the Yellow Sea. In addition, the changed SST caused the difference in thermal instability and kinematic convergence in the lower atmosphere. The thermal instability and convergence over the Seoul-Gyeonggi region induced upward motion, and consequently, the precipitation in the RCM was similar to the spatial distribution of the observed data compared to the precipitation in the RSM. Although various case studies and climatic analyses are needed to clearly understand the effects of complex air-sea interaction, this study results provide evidence for the importance of the air-sea interaction in predicting precipitation in the Seoul-Gyeonggi region.

The KALION Automated Aerosol Type Classification and Mass Concentration Calculation Algorithm (한반도 에어로졸 라이다 네트워크(KALION)의 에어로졸 유형 구분 및 질량 농도 산출 알고리즘)

  • Yeo, Huidong;Kim, Sang-Woo;Lee, Chulkyu;Kim, Dukhyeon;Kim, Byung-Gon;Kim, Sewon;Nam, Hyoung-Gu;Noh, Young Min;Park, Soojin;Park, Chan Bong;Seo, Kwangsuk;Choi, Jin-Young;Lee, Myong-In;Lee, Eun hye
    • Korean Journal of Remote Sensing
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    • v.32 no.2
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    • pp.119-131
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    • 2016
  • Descriptions are provided of the automated aerosol-type classification and mass concentration calculation algorithm for real-time data processing and aerosol products in Korea Aerosol Lidar Observation Network (KALION, http://www.kalion.kr). The KALION algorithm provides aerosol-cloud classification and three aerosol types (clean continental, dust, and polluted continental/urban pollution aerosols). It also generates vertically resolved distributions of aerosol extinction coefficient and mass concentration. An extinction-to-backscatter ratio (lidar ratio) of 63.31 sr and aerosol mass extinction efficiency of $3.36m^2g^{-1}$ ($1.39m^2g^{-1}$ for dust), determined from co-located sky radiometer and $PM_{10}$ mass concentration measurements in Seoul from June 2006 to December 2015, are deployed in the algorithm. To assess the robustness of the algorithm, we investigate the pollution and dust events in Seoul on 28-30 March, 2015. The aerosol-type identification, especially for dust particles, is agreed with the official Asian dust report by Korean Meteorological Administration. The lidar-derived mass concentrations also well match with $PM_{10}$ mass concentrations. Mean bias difference between $PM_{10}$ and lidar-derived mass concentrations estimated from June 2006 to December 2015 in Seoul is about $3{\mu}g\;m^{-3}$. Lidar ratio and aerosol mass extinction efficiency for each aerosol types will be developed and implemented into the KALION algorithm. More products, such as ice and water-droplet cloud discrimination, cloud base height, and boundary layer height will be produced by the KALION algorithm.