• Title/Summary/Keyword: observational clinical study

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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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Does Process Quality of Inpatient Care Serve as a Guide to Reduce Potentially Preventable Readmission (PPR)? (의료서비스의 과정적 질과 잠재적으로 예방 가능한 재입원율과의 관계)

  • Choi, Jae-Young
    • Korea Journal of Hospital Management
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    • v.23 no.1
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    • pp.87-106
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    • 2018
  • Objective: The objective of this study is to examine the association between process quality of inpatient care and risk-adjusted, thirty-day potentially preventable hospital readmission (PPR) rates. Data Sources/Study Setting: This was an observational cross-sectional study of nonfederal acute-care hospitals located in two states California and Florida, discharging Medicare patients with a principal discharge diagnosis of heart failure, acute myocardial infarction, or pneumonia January through December 31, 2007. Data were obtained from the Healthcare Cost and Utilization Project State Inpatient Database of the Agency for Healthcare Research and Quality, Centers for Medicare and Medicaid Services Hospital Compare database, and the American Hospital Association Annual Survey of Hospitals. Study Design: The dependent variable of this study is condition-specific, risk-adjusted, thirty-day potentially preventable hospital readmission (PPR). 3M's PPR software was utilized to determine whether a readmission was potentially preventable. The independent variable of this study is hospital performance for process quality of inpatient care, measured by hospital adherence to recommended processes of care. We used multivariate hierarchical logistic models, clustered by hospitals, to examine the relationship between condition-specific, risk-adjusted, thirty-day PPR rates and process quality of inpatient care, after taking clinical and socio-demographic characteristics of patients and structural and operational characteristics of hospitals into account. Findings: Better performance on the process quality metrics was associated with better patient outcome (i.e., low thirty-day PPR rates) in pneumonia, but not generally in two cardiovascular conditions (i.e., heart failure and acute myocardial infarction). Practical Implication: Adherence to the process quality metrics currently in use by CMS is associated with risk-adjusted, thirty-day PPR rates for patients with pneumonia, but not with cardiovascular conditions. More evidence-based process quality metrics closely linked to 30-day PPR rates, particularly for cardiovascular conditions, need to be developed to serve as a guideline to reduce potentially preventable readmissions.

Effect of Self-gravity Acupressure on Varus Knee Correction: Retrospective Observational Study (자가 중력 지압에 의한 내반슬 교정 효과: 후향적 관찰 연구)

  • Sung Kwon Park;Seong Chan Kim;Geum Na Hong;Min Joo Choi
    • Journal of Naturopathy
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    • v.12 no.1
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    • pp.1-6
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    • 2023
  • Background: Despite the positive effects of the self-gravity acupressure program on genu varum correction, no systematic observation has yet to be made. Purpose: In this study, the effect of the self-gravity acupressure program on varus knee correction was confirmed retrospectively by comparing the medial angle of the knee before and after the self-gravity acupressure program. Methods: Fifty people with varus knees were subjected to a 75-minute acupressure program while lying on an acupressure tool, and then the medial knee angles were compared before and after the program. Results: The average angle of the inside of the knee of the study subjects increased by 7.29±3.85° (p<.000) on the left side and 7.08±3.86° (p<.000) on the right side after the acupressure program was implemented, indicating that the study subject's varus knee significantly improved even after applying for a short period time. It was confirmed. Conclusion: This study confirmed that the self-gravity acupressure is a valuable program for correcting the genus varus. However, to use the results of this study clinically in the future, further studies are required to optimize the mechanism and clinical effects of the self-gravity acupressure program on the improvement of the genu varus knee.

Observational Study of Glossodynia (설통에 대한 관찰연구)

  • Shim, So-Ra;Kim, Min-Kyung;Lee, Ji-Hyun;Lu, Hsu-Yuan;Cho, Seung-Yeon;Park, Seong-Uk;Park, Jung-Mi;Bae, Hyung-Sup;Ko, Chang-Nam
    • The Journal of Internal Korean Medicine
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    • v.33 no.4
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    • pp.476-484
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    • 2012
  • Objectives : The purpose of this study was to report the clinical characteristics of glossodynia patients and effects of traditional Korean treatment on glossodynia and to gather data in order to carry out future study. Methods : We surveyed 40 glossodynia patients visiting the Department of Korean Internal Medicine of Stroke and Neurological Disorders Center, Kyung Hee University Hospital at Gangdong and analyzed their glossodynia questionnaires, examination results, and progression of symptoms. Results : In Glossodynia patients the average age was 62.4 years old. Glossodynia was more prevalent in females than males (5.67:1). Red tongue color, white fur, and fissured tongue were observed most often. The average glossodynia duration was 36.1 months and the average glossodynia degree was VAS 5.6. The most commonly appearing symptom was burning sense, and dryness of tongue. In Korean medicine diagnosis, Yin, deficiency, Tae-eum was most commonly diagnosed. In herbal medicine, Gamichungsim-tang was the most frequently prescribed. In laboratory tests, zinc deficiency was the most common result. In heart rate variability (HRV), average SDNN was 34.03 and average LF/HF ratio was 2.11. Of 40 patients, 23 completed treatment and their pain was relieved from average VAS 5.52 to VAS 3.63. Pre-and post-treatment results showed a significant difference. The average duration of treatment was 34.91 days. Conclusions : The results of this study suggest that Korean medical approach and treatment for glossodynia could be effective. Further study should be conducted for more valuable information.

Recovery of lingual nerve injury: retrospective observational study (설신경 손상 환자의 회복에 대한 후향적 연구)

  • Hong, Dong-Hwan;Lim, Ho-Kyung;Kim, Soung-Min;Kim, Myung-Jin;Lee, Jong-Ho
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • v.37 no.5
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    • pp.355-364
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    • 2011
  • Introduction: This study evaluated nerve recovery through retrospective study of patients with lingual nerve damage. Patients and Methods: The patients who visited Seoul National University Dental Hospital for an injury to the lingual nerve from April 1988 to August 2009 were enrolled in this study (n=41). The relevance of various factors including the causes of damage, age, etc. was analyzed by the subjective improvement based upon questionnaires and the clinical records. The evaluation variants were a subjective assessment and neurosensory examination composed of the direction, contact threshold, two-point discrimination, pin prick, thermal discrimination and current perception threshold. Results: The causes of lingual nerve damage were an extraction of the lower third molar (75.6%), local anesthesia (9.7%), incision and drainage (4.88%), trauma (2.44%). The evaluation of subjective prognosis exhibited no difference in sensory improvement depending on the cause, age and gender. Based upon the subjective evaluation, 44.7% of patients showed sensory improvement. The first hospital visit from injury was shorter in the group showing subjective improvement (3.41 months) than those showing no improvement (5.24 months) (P=0.301). Thirty six out of 41 patients were treated with only conservative therapy and 5 patients were treated by surgical intervention. Neurosensory examinations revealed improvement, although not statistically significant, and the degree was higher in the subjectively improved group. The contact threshold discrimination showed the highest correlation with subjective improvement (P=0.069). Most of the sensory recovery was gained within 12 months and the degree of improvement at the tip of the tongue was higher than that of the dorsum (P<0.001). Conclusion: The damaged lingual nerve improved at a rate of 44.7% and mostly within 12 months after the incident. There was no difference between the subjective prognosis and neurosensory examination depending on the cause of damage, age and gender, whereas the contact threshold discrimination was the best variant that reflected the subjective prognosis statistically.

Strategic Direction and Road Map of Expanding Prevention of Winter Disease in the Summer (동병하치 확산을 위한 전략적 방향과 이행방안)

  • Song, Ho-Sueb
    • Journal of Acupuncture Research
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    • v.27 no.3
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    • pp.147-157
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    • 2010
  • Objectives : The purpose of this study was to propose appropriate strategic directions and road maps for successful achievement of programs preventing winter disease in the summer. Methods : Details on programs preventing winter disease in the summer such as clear concept, theoretical basis, current status, intervention or available prescriptions and indication/contraindication/caution were prepared through the related journal review, upon which an observational study was devised and done for simulation to find out even a trivial problem and to guarantee the safety beforehand. The experimental group was divided into 5 groups by the size of pill and the way ginger is treated; 1cm pill with ginger group, 3cm pill group without ginger, 3cm pill group dipped into ginger, 3cm pill group applying ginger to acupoints and 3cm pill group with ginger Results 1. program preventing winter disease in the summer was defined as representative winter diseases such as common cold, influenza, chronic asthma, chronic bronchitis, allergic rhinitis, emphysema, chronic gastritis and rheumatoid arthritis, and preventive care in the summer, reinforcing deficient yang qi of five viscera by using exuberant yang qi from summer heat. 2. It was based upon historically established theories which is 'nourishing yang qi in the spring and summer', 'long summer, namely rainy spell in the summer overwhelms the winter, because of earth winning water according to the five phases theory' and 'To replenish yang qi is major principle to treat winter diseases, which can be most appropriately and timely applied to the patient with deficient yang qi of five viscera inherently, especially in the three dog days of the summer, because of exuberant exterior yang qi and deficient interior yang qi in the five viscera'. 3. In the adjacent China and Taiwan, acupoint applying method in the three dog days named 'San Fu Tie' have been stirring a boom throughout the nation, in which Xiaochuan Gao was used as a basic prescription and it mainly was applied at bilateral $BL_{13}$, $_{15}$ and $_{17}$ for about 4 hours. As far as domestic current status, the necessity of adopting the above method prior to Herbal formula was also recognised, because not a few koreans have apprehension for the safety of it including medicinal herbs and are reluctant to take it any more due to negative advertisement of narrow minded doctors' association. 4. Indication of acupoint applying method in the three dog days included most of winter diseases such as common cold, influenza, chronic asthma, chronic bronchitis, allergic rhinitis, emphysema, chronic gastritis. contraindication was pregnant woman and the weak such as infants and the old. More attention was paid to grasp firmly the normal reaction following the treatment for preventing side effect and teasing blister. recommendation was also given to abstain from food inducing phlegm and dampness such as meat, shrimp and crab as well as cold drinks and foods 5. In the simulation observational study based upon the above findings following review the related articles, no blister was shown on the acupoints icluding bilateral $BL_{13}$, $_{15}$ and $_{17}$ in every experimental group during 24hr observation following the acupoint applying treatment with pills made by modified and devised prescription. At 4 hr, the effectiveness of it reached a peak showing redness and mild tenderness and there is little difference between groups 3cm pills groups regardless of the way ginger was treated. abdominal distention and growling was found in all the volunteers during the treatment at CV 8. Strategic directions and road maps : Through successful fulfillment of the program preventing winter disease in the summer, Korean traditional medicine should be integrated into mainstream national health care services. Cultural access was thought to be as important as Scientific EBM approach. First of all, To evoke potential cultural homogeneity from campaigns and press advertisement was needed for promoting public awareness about preventing winter disease in the summer by enhancing immunity via acupoint applying treatment in the three dog days, and then indigenous name as Sambokcheop, protocol, Clinical Research Form for data collection of it should be developed and prepared. Once the first step was taken this summer, through a thorough data collection and scrutinized scientific evaluation, drawbacks should be compensted for and the efficacy and safety should be substantiated.

Gefitinib in Selected Patients with Pre-Treated Non-Small-Cell Lung Cancer: Results from a Phase IV, Multicenter, Non-Randomized Study (SELINE)

  • Lee, Kwan-Ho;Lee, Kye-Young;Jeon, Young-June;Jung, Maan-Hong;Son, Choonhee;Lee, Min-Ki;Ryu, Jeong-Seon;Yang, Sei-Hoon;Lee, Jae-Cheol;Kim, Young-Chul;Kim, Sun-Young
    • Tuberculosis and Respiratory Diseases
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    • v.73 no.6
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    • pp.303-311
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    • 2012
  • Background: This study was designed to analyze the efficacy of gefitinib as a second-line therapy, according to the clinical characteristics in Korean patients with non-small-cell lung cancer (NSCLC). Methods: In this Phase IV observational study, we recruited patients, previously failed first-line chemotherapy, who had locally advanced or metastatic NSCLC, and who were found to be either epidermal growth factor receptor (EGFR) mutation-positive or satisfied 2 or more of the 3 characteristics: adenocarcinoma, female, and non-smoker. These patients were administered with gefitinib 250 mg/day, orally. The primary endpoints were to evaluate the objective response rate (ORR) and to determine the relationship of ORRs, depending on each patient's characteristics of modified intent-to-treat population. Results: A total of 138 patients participated in this study. One subject achieved complete response, and 42 subjects achieved partial response (ORR, 31.2%). The subgroup analysis demonstrated that the ORR was significantly higher in patients with EGFR mutation-positive, compared to that of EGFR mutation-negative (45.8% vs. 14.0%, p=0.0004). In a secondary efficacy variable, the median progression-free survival (PFS) was 5.7 months (95% confidence interval, 3.9~8.4 months) and the 6-month PFS and overall survival were 49.6% and 87.9%, respectively. The most common reported adverse events were rash (34.4%), diarrhea (26.6%), pruritus (17.5%), and cough (15.6%). Conclusion: Gefitinib was observed in anti-tumor activity with favorable tolerability profile as a second-line therapy in these selected patients. When looking at EGFR mutation status, EGFR mutation-positive showed strong association with gefitinib by greater response and prolonged PFS, compared with that of EGFR mutation-negative.

Usefulness of End-tidal Carbon Dioxide as a Predictor of Emergency Intervention in Major Trauma Patients (중증 외상 환자에서의 응급중재술 시행 예측 인자로서의 호기말 이산화탄소 분압의 유용성)

  • Kim, Sung Ho;Kim, Seunghwan;Lee, Jae Gil;Chung, Sung Phil;Kim, Seung Ho
    • Journal of Trauma and Injury
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    • v.27 no.4
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    • pp.133-138
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    • 2014
  • Purpose: If the survival of patients suffering from severe blunt trauma is to be improved, appropriate interventions should be taken immediately. The purpose of this study is to evaluate the clinical utility of end-tidal carbon dioxide ($ETCO_2$) as a surrogate marker for predicting both the need for intervention and the prognosis. Methods: This is a prospective observational study. Nasal cannula was applied to measure $ETCO_2$, and the following parameters, which are known to be related to the prognosis for a patient, were recorded: injury severity score (ISS), revised trauma score (RTS), arterial blood gas (ABG), lactate, and hemoglobin (Hb). To evaluate the outcome, we investigated the details of emergent interventions and expired patients. Results: A total of 93 patients were enrolled in this study. Emergent intervention was significantly associated with systolic blood pressure (sBP, p-value=0.001), $ETCO_2$ (p-value<0.001), serum lactate level (p-value<0.001), pH (p-value< 0.003), $HCO_3$ (p-value=0.004), base excess (p-value<0.002), ISS (p-value<0.001) and RTS (p-value=0.005). In the multivariate logistic regression, only $ETCO_2$ (odds ratio (OR): 0.897, 95% confidence interval (CI): 0.792-0.975, p-value= 0.048) and ISS (OR: 1.132, 95% CI: 1.053-1.233, p-value=0.002) were associated with emergent intervention whereas $ETCO_2$ (p-value=0.973) and ISS (p-value=0.511) were not statistically significant in predicting the survival of patients in the univariate analysis. An optimal ETCO cut-off of 29 mmHg on the ROC curve was determined, with the area under the ROC curve (AUC) being 0.824 (0.732-0.917)]. Conclusion: This study has revealed that $ETCO_2$, which can be rapid and easily measured through a nasal cannula, and the ISS may be prognostic indicators of emergent interventions in Emergency Departments.

The Factors Affecting the Registration Rates for Emergency Department Based Post-suicidal Care Program (응급실 기반 자살 시도자 사후 관리사업의 등록률에 영향을 미치는 인자)

  • Lee, Junchul;Kang, Hyung Goo;Kim, Changsun;Oh, Jaehoon;Lim, Taeho;Ahn, Dong Hyun;Lee, Jung Im;Park, Min Hee;Kim, Kyung Hee
    • Journal of The Korean Society of Clinical Toxicology
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    • v.13 no.1
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    • pp.25-32
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    • 2015
  • Purpose: The aim of this study was to investigate the independent factors associated with the registration rate for the community-based post suicidal care program in the emergency department (ED). Methods: This prospective observational study was conducted between March and December 2013 at the academic ED at the tertiary urban hospital. During the study period, the pre-designed registry was recorded. The variables examined included the following: patients' demographic data (Sex, age, address, type of insurance, marital status, level of education, and history of previous psychiatric disease), suicide-related data (suicidal methods, combined drink of alcohol and number of previous attempts), and management-related data (disposition at ED, physician's training level, etc.). Univariated and multivariated logistic regression analyses were performed for identification of factors affecting the registration rate for the community-based post suicidal care program. Results: A total of 163 suicides were included during the study period. Of these, 33 (20.2%) patients were registered in the post-suicide care program. Factors including a patient's address (OR: 14.92, 95% CI: 3.606-61.711), immediate intervention by psychiatric healthcare center (OR: 5.05, CI: 1.688-15.134), admissions in hospital (OR: 3.69, CI: 1.286-10.605), and history of previous psychiatric disease (OR: 3.52, CI: 1.216-10.201) showed significant association with registration for the program. Conclusion: The community-based post-suicidal care program, which is available 24 hours a day, should be operated in each district in order to increase the registration rate. Emergency physicians should actively consider the inpatient treatment program for suicidal patients and strongly recommend registration to the program, particularly for patients without previous history of psychiatric disease.

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An Experimental Study for Performance Evaluation in Dogs of Preventive Contrast Media Extravasation with a Strain Gage Based Prototype Extravasation Detection Accessory System (잡견에서 조영제 혈관외유출 예방을 위한 스트레인 게이지 기반의 EDA 시스템 성능 평가를 위한 실험적 연구)

  • Kweon, D.C.;Yoo, B.G.;Lee, J.S.;Cho, M.S.;Yang, S.H.
    • Journal of Biomedical Engineering Research
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    • v.29 no.1
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    • pp.66-72
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    • 2008
  • The major risk associated with the use of automated power injectors is the well known complication of contrast material extravasation at the injection site. Automated injection of computed tomography (CT) contrast media can produce the compartment syndrome. The purpose of this study was to assess the ability of this device during clinically important episodes of extravasation. The extravasation detection accessory (EDA) system was composed of a strain gage, an amplifier and a computer based system. A strain gage pliable adhesive patch was applied to the skin aver the intravenous catheter and the catheter was connected to the power injector with a cable to monitor the resolution data. If the programmed monitoring, which was developed with MS Visual C++, at the extravasation occurred, then the injection was interrupted the auto injector. CT was used to demonstrate the clinically important extravasation. This study was a prospective, observational study in which the EDA system was used to monitor the automated mechanical injection of contrast material in 7 dogs. There were two true-positive cases (range of extravasation volumes: $18{\sim}22ml$), twenty three true-negative cases, three false-positive cases and no false-negative cases. The EDA system had a sensitivity of 100% and a specificity of 88% for the detection of clinically important extravasation. The EDA system had good sensitivity for the detection of clinically important extravasation and the EDA system has the clinical potential for the early detection of extravasation of the contrast medium that is administered with power injectors. The EDA system is easy to use safe and accurate for the monitoring extravasation of the intravenous injections, and this system may prove especially useful in CT applications.