• Title/Summary/Keyword: observational clinical study

Search Result 308, Processing Time 0.033 seconds

Development and Lessons Learned of Clinical Data Warehouse based on Common Data Model for Drug Surveillance (약물부작용 감시를 위한 공통데이터모델 기반 임상데이터웨어하우스 구축)

  • Mi Jung Rho
    • Korea Journal of Hospital Management
    • /
    • v.28 no.3
    • /
    • pp.1-14
    • /
    • 2023
  • Purposes: It is very important to establish a clinical data warehouse based on a common data model to offset the different data characteristics of each medical institution and for drug surveillance. This study attempted to establish a clinical data warehouse for Dankook university hospital for drug surveillance, and to derive the main items necessary for development. Methodology/Approach: This study extracted the electronic medical record data of Dankook university hospital tracked for 9 years from 2013 (2013.01.01. to 2021.12.31) to build a clinical data warehouse. The extracted data was converted into the Observational Medical Outcomes Partnership Common Data Model (Version 5.4). Data term mapping was performed using the electronic medical record data of Dankook university hospital and the standard term mapping guide. To verify the clinical data warehouse, the use of angiotensin receptor blockers and the incidence of liver toxicity were analyzed, and the results were compared with the analysis of hospital raw data. Findings: This study used a total of 670,933 data from electronic medical records for the Dankook university clinical data warehouse. Excluding the number of overlapping cases among the total number of cases, the target data was mapped into standard terms. Diagnosis (100% of total cases), drug (92.1%), and measurement (94.5%) were standardized. For treatment and surgery, the insurance EDI (electronic data interchange) code was used as it is. Extraction, conversion and loading were completed. R language-based conversion and loading software for the process was developed, and clinical data warehouse construction was completed through data verification. Practical Implications: In this study, a clinical data warehouse for Dankook university hospitals based on a common data model supporting drug surveillance research was established and verified. The results of this study provide guidelines for institutions that want to build a clinical data warehouse in the future by deriving key points necessary for building a clinical data warehouse.

  • PDF

Domestic Occupational Therapist Awareness Survey for the Need to Apply Artificial Intelligence Measurement Technology for Clinical Observation Evaluation Based on Sensory Integration (감각통합에 기초한 임상 관찰 평가의 AI 측정 기술 적용 필요성을 위한 국내 작업치료사 인식 조사)

  • Cho, Sun-Young;Jung, Young-Jin;Kim, Jung-Ran
    • Therapeutic Science for Rehabilitation
    • /
    • v.12 no.1
    • /
    • pp.23-35
    • /
    • 2023
  • Objective : This study is to examine the practical use of clinical observational evaluation of sensory integration therapy and the difficulty and importance of measuring results for each sub-item, and through this, to confirm the usefulness of the application of Artificial Intelligence measurement technology in clinical observational measurement and the need for application. Methods : The questionnaire consisted of the actual use of the sensory integration evaluation tool, the difficulty of measurement for each detailed item of clinical observation, the usefulness of AI measurement technology, the importance of evaluation for each detailed item, and the need for developing AI measurement technology. Results : The detailed items that were difficult to measure during clinical observation were the Finger-to-Nose Test and Postural control (71.0%), followed by Eye movement and Protective Extension Test (67.7%). 83.9% of the study subjects answered that it would be useful to apply AI measurement technology when observing images. Postural control (on the ball) (90.3%) was the highest item that answered that AI measurement technology was needed, followed by Eye movement (83.9%), and Prone Extension and Protective Extension Test (77.4%). Conclusion : The results confirmed the desire of therapists that clinical observation is an important evaluation tool in the field of child occupational therapy in Korea.

Musculoskeletal Ultrasound Findings of Shoulder Pain Patients: A Retrospective Observational Study (근골격계 초음파 진단기기를 활용한 견관절 통증 환자의 초음파 소견: 후향적 관찰 연구)

  • Hyun-Tae Kim;Hye-Jin Park;Yeon-Woo Lee;Sun-Young Park;In Heo;Eui-Hyoung Hwang;Byung-Cheul Shin;Man-Suk Hwang
    • Journal of Korean Medicine Rehabilitation
    • /
    • v.33 no.2
    • /
    • pp.77-85
    • /
    • 2023
  • Objectives The aim of this study is to retrospectively evaluate the shoulder lesions in patients experiencing shoulder pain through the use of musculoskeletal ultrasound during Korean medicine intervention treatments. Methods A total of 20 cases were collected, including biceps tendinitis (n=4), calcification (n=3), SASD bursitis (n=4), partial tear (n=2), full-thickness tear (n=1), tendinopathy (n=5), and impingement syndrome (n=1). Musculoskeletal ultrasound was used by Korean medicine doctors to perform real-time scanning and to explain the patient's condition during treatment sessions. Results The use of musculoskeletal ultrasound allowed Korean medicine doctors to perform treatments such as pharmacoacupuncture, acupotomy, and acupuncture more safely and effectively. Patients were able to better understand their conditions through real-time imaging and explanations provided by the doctors. Conclusions Musculoskeletal ultrasound has the potential to enhance the safety and efficacy of Korean medicine intervention treatments for patients with shoulder pain. Institutional or governmental support is needed to further promote the use of medical devices by Korean medicine doctors, ultimately leading to an increase in cases and clinical evidence.

Effects of Sweet Bee Venom on the Central Nervous System in Rats -using the Functional Observational Battery- (Sweet BV 시술이 Rat의 중추신경계에 미치는 영향 - 기능관찰 종합평가를 이용하여-)

  • An, Joong-Chul;Kwon, Ki-Rok
    • Journal of Pharmacopuncture
    • /
    • v.14 no.3
    • /
    • pp.19-45
    • /
    • 2011
  • Objectives: This study was performed to analyse the effects of Sweet Bee Venom(Sweet BV-pure melittin, the major component of honey bee venom) on the central nervous system in rats. Methods: All experiments were conducted at Biotoxtech Company, a non-clinical studies authorized institution, under the regulations of Good Laboratory Practice (GLP). Male rats of 5 weeks old were chosen for this study and after confirming condition of rats was stable, Sweet BV was administered in thigh muscle of rats. And checked the effects of Sweet BV on the central nervous system using the functional observational battery (FOB), which is a neuro-toxicity screening assay composed of 30 descriptive, scalar, binary, and continuous endpoints. And home cage observations, home cage removal and handling, open field activity, sensorimotor reflex test/physiological measurements were conducted. Results: 1. In the home cage observation, there was not observed any abnormal signs in rats. 2. In the observation of open field activity, the reduction of number of unit areas crossed and rearing count was observed caused by Sweet BV treatment. 3. In the observation of handling reactivity, there was not observed any abnormal signs in rats. 4. In the observation of sensorimotor reflex tests/physiological measurements, there was not observed any neurotoxic signs in rats. 5. In the measurement of rectal temperature, treatment of Sweet BV did not showed great influences in the body temperature of rats. Conclusions: Above findings suggest that Sweet BV is relatively safe treatment in the central nervous system. But in the using of over dose, Sweet BV may the cause of local pain and disturbance of movement. Further studies on the subject should be conducted to yield more concrete evidences.

Ribavirin and Interferon Treatment for MERS-CoV Infection: A Clinical Literature Review (메르스 감염에서 리바비린과 인터페론 사용에 대한 임상 문헌 고찰)

  • Lim, Mi-sun
    • YAKHAK HOEJI
    • /
    • v.59 no.6
    • /
    • pp.245-250
    • /
    • 2015
  • Middle East respiratory syndrome - coronavirus infection has posed substantial threat to public health with extremely high mortality rate in 2015. Although there are no approved novel medications for coronavirus, several antiviral agents such as ribavirin and interferon have been tried to MERS patients according to the in-vitro inhibitory effect, therapeutic effect on the animal model and experience from the severe acute respiratory syndrome - coronavirus infection. The aim of this study is to evaluate the clinical evidence of the antiviral treatment for MERS-CoV infection. After systematically searching the medical literature databases, I found five studies described the clinical efficacy of antiviral treatment on MERS patients. All of them were about the combination therapy of ribavirin and interferon (IFN). Two of them were retrospective cohort studies with quality of evidence (QOE) II and the others were observational study and case reports with QOE III. As a result of critical appraisal, it is concluded that none of those studies represented confirmatory clinical evidence of the efficacy of ribavirin and interferon combination therapy on MERS patients. Although Omrani et al. represented that ribavirin and IFN treatment had significantly improved survival at 14 days, it was not enough time to conclude the effect.

Clinical Characteristics of Patients after Aryloxyphenoxy Propionate Herbicide Ingestion (Aryloxyphenoxy propionate 계열 제초제 중독환자의 임상 양상)

  • Lim, Junyeong;Moon, Jeongmi;Chun, Byeongjo
    • Journal of The Korean Society of Clinical Toxicology
    • /
    • v.14 no.2
    • /
    • pp.71-77
    • /
    • 2016
  • Purpose: No studies have been conducted to investigate the acute toxicity of aryloxyphenoxypropionate herbicides in humans following ingestion. Therefore, this study was conducted to investigate the clinical characteristics of aryloxyphenoxypropionate herbicide poisoning and provide guidance for physicians treating patients who have ingested these types of herbicides. Methods: A retrospective observational case series was conducted using ten patients with history of aryloxyphenoxy propionate herbicide. Data were collected for clinical manifestation, management and final outcome. Results: The most common symptoms were gastrointestinal irritation and an altered mental state (Glasgow Coma Scale<15). An elevated lactate level was a common laboratory abnormality, and prolonged QTc interval was commonly observed. These clinical features normalized within one day of supportive treatment. Conclusion: The acute toxicity of aryloxyphenoxypropionate herbicides in humans is manageable with supportive treatment. However, physicians should take into account depressed consciousness, the possibility of arrhythmia, and an elevated lactate level when planning their treatment strategy.

Analysis on Statins for The Treatment of Bone Fracture (스타틴계 고지혈증치료제의 골절치료효과에 대한 분석)

  • Choi, Byung-Chul
    • YAKHAK HOEJI
    • /
    • v.53 no.4
    • /
    • pp.206-216
    • /
    • 2009
  • 3-Hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (Statins) are potent inhibitors of cholesterol biosynthesis. Cholesterol-lowering therapy using statins significantly reduces the risk of coronary heart disease. Various discovery of statins as bone anabolic agents has spurred a great deal of interest among both basic and clinical bone researchers. In-vitro and some animal studies suggest that statins increase the bone mass by enhancing bone morphogenetic protein-2 (BMP-2)-mediated osteoblast expression. Clinical and animal test results of statins focusing on the prevention and treatment of bone fractures was collected. Three independent literature searches were performed by using from January 1, 2002 to September 2008 for clinical and animal test results. Search term included statins, HMG-CoA reductase inhibitors, pleiotropic effects, fracture, osteoporosis and clinical and animal test. No consensus has been reached whether clinical use of statins has beneficial effects on bone health, partly due to lower statin concentrations because of first-pass metabolism by the liver. Experimental use of statins as stimulators of bone formation suggests that they may have widespread applicability in the field of orthopaedics. With their combined effects on osteoblasts and osteoclasts, statins have the potential to enhance resorption of synthetic materials and improve bone ingrowth. In conclusion, The use of statins in the prevention and treatment of bone fractures requires further study. But observational studies suggest that statins for decreasing bone fractures including osteoporosis have to be considered local direct administration like transdermal or subcutaneous type over oral adminstration.

Clinical Research Trends in Respiratory Diseases Related to Particulate Matter (미세먼지 관련 호흡기질환 임상연구 동향)

  • Lyu, Yee Ran;Kim, JinHoo;Yang, Won-kyung;Kim, Seung-hyeong;Park, Yang-Chun
    • The Journal of Internal Korean Medicine
    • /
    • v.40 no.3
    • /
    • pp.443-457
    • /
    • 2019
  • Objectives: This study aimed to review the clinical research trends in respiratory diseases related to particulate matter (PM) to help design clinical studies on herbal medicine that protects against PM. Methods: We searched three international databases (Pubmed, EMBASE, and CENTRAL) to investigate clinical studies on respiratory diseases related to PM and to analyze their study design, respiratory-related disease, inclusion/exclusion criteria, study period, outcome measure, study results, measurement method of PM and range of PM. Results: A total of 18 studies were finally selected, including 13 observational studies and 5 randomized controlled trials. The selected studies showed an increasing trend from 1985 to 2018 and were conducted mostly in North America, followed by Europe and Asia. Subject disease and age were decided in variety by each study objective, although asthma accounted for the majority. For the outcome assessment, pulmonary function test was mostly used for lung function. Quality of life questionnaires and biomarkers in blood and sputum were also used. Conclusion: A well-designed clinical study on herbal medicine that protects against PM is needed, and this study is expected to be used as base data.

Efficacy and Safety of Sirolimus-Eluting Stent With Biodegradable Polymer UltimasterTM in Unselected Korean Population: A Multicenter, Prospective, Observational Study From Korean Multicenter Ultimaster Registry

  • Soohyung Park;Seung-Woon Rha;Byoung Geol Choi;Jae-Bin Seo;Ik Jun Choi;Sung-Il Woo;Soo-Han Kim;Tae Hoon Ahn;Jae Sang Kim;Ae-Young Her;Ji-Hun Ahn;Han Cheol Lee;Jaewoong Choi;Jin Soo Byon;Markz RMP Sinurat;Se Yeon Choi;Jinah Cha;Su Jin Hyun;Cheol Ung Choi;Chang Gyu Park
    • Korean Circulation Journal
    • /
    • v.54 no.6
    • /
    • pp.339-350
    • /
    • 2024
  • Background and Objectives: UltimasterTM, a third-generation sirolimus-eluting stent using biodegradable polymer, has been introduced to overcome long term adverse vascular events, such as restenosis or stent thrombosis. In the present study, we aimed to evaluate the 12-month clinical outcomes of UltimasterTM stents in Korean patients with coronary artery disease. Methods: This study is a multicenter, prospective, observational registry across 12 hospitals. To reflect real-world clinical evidence, non-selective subtypes of patients and lesions were included in this study. The study end point was target lesion failure (TLF) (the composite of cardiac death, target vessel myocardial infarction [MI], and target lesion revascularization [TLR]) at 12-month clinical follow up. Results: A total of 576 patients were enrolled between November 2016 and May 2021. Most of the patients were male (76.5%), with a mean age of 66.0±11.2 years. Among the included patients, 40.1% had diabetes mellitus (DM) and 67.9% had acute coronary syndrome (ACS). At 12 months, the incidence of TLF was 4.1%. The incidence of cardiac death was 1.5%, MI was 1.0%, TLR was 2.7%, and stent thrombosis was 0.6%. In subgroup analysis based on the presence of ACS, DM, hypertension, dyslipidemia, or bifurcation, there were no major differences in the incidence of the primary endpoint. Conclusions: The present registry shows that UltimasterTM stent is safe and effective for routine real-world clinical practice in non-selective Korean patients, having a low rate of adverse events at least up to 12 months.

Histopathological Features of Lymphoma in Yogyakarta, Indonesia

  • Dwianingsih, Ery Kus;Indrawati, Indrawati;Hardianti, Mardiah Suci;Malueka, Rusdy Ghazali;Iswar, Riezka Rivani;Sutapa, Stefani APPG;Triningsih, FX Ediati
    • Asian Pacific Journal of Cancer Prevention
    • /
    • v.17 no.9
    • /
    • pp.4213-4216
    • /
    • 2016
  • The incidence and prevalence, the second most common lymphoid malignancy after leukemia, are both increasing. The distribution of lymphoma varies among sexes, age groups, and sites. In Indonesia, information about the incidence of lymphoma and its characteristics are insufficient. Therefore, this study was performed to evaluate the incidence of lymphoma and features based on age group, sex, site, clinical diagnosis, and histopathological type in Indonesia. This study is an observational analytical study with a cross-sectional design aimed to evaluate the histopathological profile of lymphoma in Yogyakarta from 2010-2014. It was based on secondary data from Anatomic Pathology Department's medical records from several hospitals and laboratories. The result showed an increased incidence of lymphoma in Yogyakarta in 2010-2014 (p=0.039). Lymphoma mostly occurred in age range 45-64 years (p=0.004), dominated by male with ratio 1.6:1. DLBCL was found to be the most common histopathological type (44.4%). Sex, age, and clinical diagnosis demonstrated statistically significant correlations with the histopathological type (p<0.001). In conclusion, the incidence of lymphoma has significantly increased from 2010-2014. There are statistically significant correlations between gender, age, and clinical diagnosis with the histopathological type of lymphoma.