• 생물정신의학
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• 제19권4호
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• pp.159-163
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• 2012

An appropriate research design for hypotheses and purposes leads to a good quality of research results. In this review article, we summarized the types of research methods and described the characteristics of clinical trials. Research designs are categorized into observational studies and experimental ones, depending on data collecting methods. In an observational study, there are cross-sectional, cohort and case-control studies. Parallel groups design and crossover trial studies are representative designs in a randomized controlled trial study, a kind of experimental study. Clinical researchers should understand the characteristics of clinical research designs including advantages and disadvantages and choose the suitable design according to their study purposes and the nature of collected data or subjects.

• 대한간호학회지
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• 제27권4호
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• pp.892-900
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• 1997

The purpose of this study was to use phenomenological perspectives to identify the meaning and structure of the observational experience of labor and delivery by student nurses in the clinical setting. The participants were 115 junior and senior students from Christian College of Nursing in Kwang Ju. The students were asked to write about their observational experience in the delivery room. Colaizzi's method was used for phenomenological analysis. The investigator analysed the data to identify and categorize themes and basic structural elements. Twelve themes and eight basic structure were identified. The process of the observational experience in labor and delivery has three proposed phases : anticipatory, observational and post-observational. In the anticipatory phase, nursing students were related only to the event of anticipated labor and delivery of clients. Structure 1, feeling of expectation and fear, was identified. In the observational phase, students were related to the labor and delivery situation, a woman delivered and a newborn. Structure 2, shock and suffering, was identified in relation to the labor and delivery situation. Structure 3, need for caring and satisfaction, was identified in relation to the woman delivered. Structure 4, feeling of mystery and joy, was identified in relation to the newborn. In the post-observational phase, relations between students and the life of a human being, students and self in the future, students and their mothers and students and women and God appeared. And in these relations 〈structure 5, valuable〉, 〈structure 6, feeling of expectation and fear〉, 〈structure 7, love and appreciation〉 and 〈structure 8, greatness〉 were identified.

• Communications for Statistical Applications and Methods
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• 제30권1호
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• pp.1-19
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• 2023

Observational data with missing or incomplete data are common in biomedical research. Multiple imputation is an effective approach to handle missing data with the ability to decrease bias while increasing statistical power and efficiency. In recent years propensity score (PS) matching has been increasingly used in observational studies to estimate treatment effect as it can reduce confounding due to measured baseline covariates. In this paper, we describe in detail approaches to competing risk analysis in the setting of incomplete observational data when using PS matching. First, we used multiple imputation to impute several missing variables simultaneously, then conducted propensity-score matching to match statin-exposed patients with those unexposed. Afterwards, we assessed the effect of statin exposure on the risk of heart failure-related hospitalizations or emergency visits by estimating both relative and absolute effects. Collectively, we provided a general methodological framework to assess treatment effect in incomplete observational data. In addition, we presented a practical approach to produce overall cumulative incidence function (CIF) based on estimates from multiple imputed and PS-matched samples.

• 생물정신의학
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• 제19권4호
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• pp.172-178
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• 2012

Data from clinical studies are needed for psychiatrists to make quick and scientific decisions based on the best available evidence in clinical settings. Various methods of clinical studies are useful for clinicians to have reliable answers to unmet clinical needs. Although randomized controlled trials may provide high-quality information about major issues, well-designed, naturalistic and observational studies often give us unbiased explanation for real-world phenomena. Adequate selection of clinical variables and appropriate number of participants are key factors of well-designed clinical studies. Statistical methods can add an extra dimension to initial design of clinical studies. Given ethical issues in clinical studies on psychiatric disorders, special regards should be paid to participants' ability to provide informed consents. New strategies of clinical studies need to be developed to meet clinical needs and protect the rights and welfare of study participants.

• Korean Journal of Acupuncture
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• 제31권4호
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• pp.158-167
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• 2014

Objectives : The results from randomized controlled trials on traditional medicine have been negative or ambiguous. The appropriateness of the research methodology started to be questioned. However, the research methodology appropriate for studying traditional medicine has not been well-established. This study aims to explore the appropriate research methodologies for clinical studies on acupuncture. Methods : Clinical researches evaluating the efficacy and effectiveness of acupuncture for back pain were systematically searched and evaluated focusing on research methodology. The acupuncture treatment protocol is evaluated by 9 items which is individual treatment based on diagnosis, combining proximal and distal acupoints, exact location of acupoint, De Qi, adequate stimulation, duration of acupuncture, treatment sessions, treatment interval, and establishing relationship between patients and doctors. Results : Systematic review of acupuncture researches on low back pain suggested that observational studies and pragmatic trials rather than explanatory studies could incorporate these elements. Qualitative studies also could help understanding complex characteristics of acupuncture treatment which could not be evaluated by quantitative studies. Conclusions : In designing clinical researches on acupuncture, various study designs, especially observational study and pragmatic study, should be considered according to research objectives and subjects. The efforts to incorporate the core characteristics of acupuncture practiced in everyday clinical setting are also essential.

• Korean Journal of Acupuncture
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• 제40권2호
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• pp.44-53
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• 2023

Objectives : This study was conducted to reveal the relationship between multiple factors of traditional Korean Medicine diagnosis and consider the further probabilities of treating people with physical and mental problems not defined as diseases, which is called 'Mibyeong' in traditional Korean Medicine. Methods : 40 healthy participants were included in the observational clinical trial. The participants were asked to complete health questionnaires (e.g. State-Trait Anxiety Inventory, Pittsburgh Sleep Quality Index, Stress Response Inventory) and they went through a traditional diagnosis process, including four stages of diagnosis (looking, listening/smelling, inquiring, and pulse taking), by a Korean Medicine doctor. Both the Korean Medicine doctor and an artery tonometry device performed the pulse diagnosis. Results : Although all participants were healthy people with no history of disease, more than half of participants had a problem related with severe level of fatigue (n=19), sleep disturbance (n=26) and stress (n=27) status according to the related questionnaires. Participants diagnosed with phlegm syndrome by the Korean Medicine doctor showed significantly greater score in phlegm pattern questionnaires than participants who were not. However, there was little agreement between the doctor's pulse diagnosis and radial artery tonometry results. Conclusions : We conducted a pulse diagnosis and measured health-related information along with the traditional Korean Medicine diagnose procedure, including four stages of diagnosis, and we found a linkage between diagnosis of phlegm and the phlegm pattern questionnaire score. The results suggest that a number of healthy participants, with no disease diagnosed, have Mibyoung symptoms which need further clinical management. Thus, we suggest that Mibyoung management programs based on qualified diagnosis tools and traditional Korean medicine diagnosis procedures be developed, and that future research using various diagnostic tools be carried out on a large population.

• 동의신경정신과학회지
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• 제31권2호
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• pp.63-76
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• 2020

Objectives: The purpose of this study was to verify the clinical effects of herbal medicines on patients with depressive disorder. Methods: A prospective observational study on patients with depressive disorder was conducted. The patients were treated with herbal medicines for eight weeks. The Korean Hamilton Depression Rating Scale (K-HDRS) was evaluated as the primary outcome and the Korean Beck's Depression Inventory (K-BDI), Instrument on Pattern Identification for Depression, Korean Symptom Checklist-95 (KSCL-95), Insomnia Severity Index (ISI), Korean State-Trait Anxiety Inventory (STAI-K), Korean State-Trait Anger Expression Inventory (STAXI-K), EuroQol five-dimensional Questionnaire (EQ-5D), Minnesota Multiphasic Personality Inventory-2 (MMPI-2), Heart Rate Variability (HRV) were measured as the secondary outcome. Adverse events were assessed for safety. Results: A total of 35 participants were observed for 12 weeks. The K-HDRS improved significantly in four, eight, and 12 weeks and the K-BDI showed significant differences in four, and eight weeks. There were no significant improvements in other evaluation scales. Gyejibongnyeong-hwan was the most frequently and continuously prescribed, showing significant improvements of K-HDRS after eight weeks of treatment. Conclusions: In our observational study, herbal medicine was effective for relieving the depression of patients with depressive disorder and Gyejibongnyeong-hwan showed the most significant effectiveness.

• 대한관절경학회:학술대회논문집
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• 대한관절경학회 2006년도 제15차 추계학술대회 심포지움
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• pp.9-11
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• 2006

• 대한한방내과학회지
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• 제45권1호
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• pp.1-10
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• 2024

Objectives: This study investigated the pattern identification (PI) and clinical index of Parkinson's disease (PD) for personalized diagnosis and treatment. Methods: This prospective observational multi-center study recruited 100 patients diagnosed with PD from two Korean medicine hospitals. To cluster new subtypes of PD, items on a PI questionnaire (heat and cold, deficiency and excess, visceral PI) were evaluated along with pulse and tongue analysis. Gait analysis was performed and blood and feces molecular signature changes were assessed to explore biomarkers for new subtypes. In addition, unified PD rating scale II and III scores and the European quality of life 5-dimension questionnaire were assessed. Results: The clinical index obtained in this study analyzed the frequency statistics and hierarchical clustering analysis to classify new subtypes based on PI. Moreover, the biomarkers and current status of herbal medicine treatment were analyzed using the new subtypes. The results provide comprehensive data to investigate new subtypes and subtype-based biomarkers for the personalized diagnosis and treatment of PD patients. Ethical approval was obtained from the medical ethics committees of the two Korean medicine hospitals. All amendments to the research protocol were submitted and approved. Conclusions: An objective and standardized diagnostic tool is needed for the personalized treatment of PD by traditional Korean medicine. Therefore, we developed a clinical index as the basis for the PI clinical evaluation of PD. Trial Registration: This trial is registered with the Clinical Research Information Service (CRIS) (KCT0008677)

• Asian Pacific Journal of Cancer Prevention
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• 제15권23호
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• pp.10273-10276
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• 2015

Objective: To explore the clinical effects of nimotuzumab combined with chemotherapy in the treatment of late gastric cancer. Methods: A total of 34 reoccurrence or metastatic patients with late stage gastric cancer who were confirmed by histopathology and/or cytology were selected and randomly divided into observational and control groups, of 17 cases each. Patients in the control group were treated with the standard DCF plan, while patients in observational group additionally received nimotuzumab. The short-term and long-term efficacy and adverse reactions in the 2 groups were followed. Results: The objective response rate (ORR) and disease control rate (DCR) were 64.7% (11/17) and 82.4% (14/17) in observational group and 25.0%(4/16) and 37.5%(6/16) in the control group(ORR and DCR between 2 groups, ${\chi}^2=5.2412$, P=0.0221 and ${\chi}^2=6.9453$, P=0.0084). The median progression-free survival (PFS) time and median overall survival (OS) time were 6.50 months and 12.50 months in observational group and 4.50 months and 8.25 months in the control group (P=0.0212; P=0.0255). The main toxic and side effects in the 2 groups were reduced leukocytes and hemoglobin, gastrointestinal reactions and hair loss and these were relieved after symptomatic treatment and nutrition support therapy. There were no differences in the occurrence of toxic and side effects between the 2 groups. Conclusions: Nimotuzumab combined with DCF plan is effective in treating late stage gastric cancer. A larger scale study is now warranted for confirmation of the findings.