• 제목/요약/키워드: Multicenter studies

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MANAGEMENT OF MULTICENTER CONTROLLED CLINICAL TRIALS

  • Raub William F.
    • 대한예방의학회:학술대회논문집
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    • 대한예방의학회 1994년도 교수 연수회(역학)
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    • pp.336-341
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    • 1994
  • Multicenter controlled clinical trials require It synthesis of the scientific method and the precepts of modern management. The management tasks associated with these studies are akin to those found in other kinds of complex corporate endeavors. It is recommended that clinical investigators become more knowledgeable about management concepts and methods and management specialists be given a major role in the planning and conduct of large-scale clinical trials.

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임상연구에서 사용되고 있는 NRS에 대한 분석 : 무작위대조군연구를 중심으로 (Analysis of the Numeric Rating Scale (NRS) Used in Clinical Studies Based on Randomized Controlled Studies)

  • 이찬;조임학;허기윤;강희경;김민화;한창우;김소연;최준용;박성하;윤영주;홍진우;권정남;이인
    • 대한한방내과학회지
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    • 제42권4호
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    • pp.510-531
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    • 2021
  • Objectives: The purpose of this study was to review the status of numeric rating scale (NRS) usage and suggest the potential for use in multicenter retrospective studies of various diseases. Methods: Articles published from 2011 to 2021 that used the keywords "NRS", "Multi-center", and "RCT" were identified in foreign databases, including EMBASE, PubMed, CENTRAL. The articles were analyzed according to their use of "NRS" by symptoms and by disease group using the major classifications of the Korean Standard Classification of Diseases (KCD-7). Results: Classification by symptom in a total of 288 articles illustrates that the NRS was not only commonly used in pain evaluation but also for non-pain symptoms. In usage with non-pain symptoms, chief complaint of patients was the most common at 79%, and other factors included treatment satisfaction, evaluation of daily life, and sleep quality. In disease classification according to the KCD-7, the NRS was commonly used in connection with musculoskeletal and connective tissue diseases but was also utilized in various other disease groups. Conclusions: This study confirms usage of the NRS in multi-center RCTs, as the NRS was widely used in all types of diseases and symptoms. Considering the result and the advantages of the NRS, it is recommended for use as a daily evaluation tool for the collection of common data in multicenter retrospective studies.

Association Between Insomnia and Constipation: A Multicenter Three-year Cross-sectional Study Using Shift Workers' Health Check-up Data

  • Yun, Byung-Yoon;Sim, Juho;Yoon, Jin-Ha;Kim, Sung-Kyung
    • Safety and Health at Work
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    • 제13권2호
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    • pp.240-247
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    • 2022
  • Background: Although insomnia and constipation are highly prevalent worldwide, studies examining a possible association between them are lacking. We examined the relationship between insomnia and constipation in shift workers who have a high prevalence of insomnia and other diseases. Methods: This study had a multicenter cross-sectional design and conducted using health examination data including self-reported questionnaires. In total, 12,879 and 4,650 shift workers were enrolled in Severance Hospital and Wonju Severance Hospital, respectively, during 2015-2017. Multivariate logistic regression models and subgroup analysis were performed in each center with the same protocol, using a common data model. Results: The mean age of the total population was 44.35 (standard deviation = 8.75); the proportion of males was 56.9%. Female sex, being underweight and non-smoker were strongly associated with an increased risk of constipation symptom (p < 0.001). Pooled odds ratios (ORs) were calculated using ORs of both centers with weights; there was a significant dose-response relationship (sub-threshold 1.76 [95% confidence interval [CI] 1.62-1.91]; moderate 2.28 [95% CI 2.01-2.60]; severe 4.15 [95% CI 3.18-5.41] in the final model, p for trend < 0.001). Subgroup analysis performed by stratifying sex and pooled ORs showed a similar trend to that of the entire group. Conclusion: We observed a strong correlation between insomnia and constipation in this population. Our findings may help in formulating guidelines and policies to improve quality of life in shift workers through the management of sleep quality and proper bowel function. This study is the first to report this relationship among people working in shifts.

COVID-19 and Cancer: Questions to Be Answered

  • Hong, Young Seon
    • Journal of Hospice and Palliative Care
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    • 제24권1호
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    • pp.66-68
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    • 2021
  • The World Health Organization (WHO) declared the coronavirus disease 2019 (COVID-19) outbreak to be a pandemic on March 12, 2020. In Korea, there have been 24,027 confirmed cases of COVID-19 and 420 deaths as of October 3, 2020. The clinical spectrum of COVID-19 ranges from asymptomatic infection to death. Cancer care in this pandemic has radically changed. The literature was reviewed. The COVID-19 pandemic has made it urgently necessary to profoundly re-organize cancer patients' care without compromising cancer outcomes. Several important questions in regard to COVID-19 infection in cancer patients have emerged. Are patients with cancer at a higher risk of COVID-19 infection? Are they at an increased risk of mortality and severe illness when infected with COVID-19? Does anticancer treatment affect the course of COVID-19? Based on the existing research, cancer patients with immunosuppression are vulnerable to COVID-19 infection, and cancer patients are more likely to experience severe COVID-19. However, chemotherapy and major surgery do not seem to be predictors of hospitalization or severe disease. Korean background data on patients with cancer and COVID-19 are lacking. Prospective multicenter studies on the outcomes of patients with cancer and COVID-19 should be conducted.

Treatment of Unruptured Intracranial Aneurysms in South Korea in 2006 : A Nationwide Multicenter Survey from the Korean Society of Cerebrovascular Surgery

  • Kim, Jeong-Eun;Lim, Dong-Jun;Hong, Chang-Ki;Joo, Sung-Pil;Yoon, Seok-Mann;Kim, Bum-Tae
    • Journal of Korean Neurosurgical Society
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    • 제47권2호
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    • pp.112-118
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    • 2010
  • Objective : There have been no clinical studies regarding the epidemiology and treatment outcome for unruptured intracranial aneurysm (UIA) in South Korea yet. Thus, The Korean Society of Cerebrovascular Surgery (KSCVS) decided to evaluate the clinical and epidemiological characteristics, and outcome of the treatment of UIA in 2006, using the nationwide multicenter survey in South Korea. Methods : A total of 1,696 cases were enrolled retrospectively over one year at 48 hospitals. The following data were obtained from all patients : age, sex, presence of symptoms, location and size of the aneurysm, treatment modality, presence of risk factors for stroke, and the postoperative 3D-day morbidity and mortality. Results : The demographic data showed female predominance and peak age of seventh and sixth decades. Supraclinoid internal carotid artery was the most common site of aneurysms with a mean size of 5.6 mm. Eight-hundred-forty-six patients (49.9%) were treated with clipping, 824 (48.6%) with coiling, and 26 with combined method. The choice of the treatment modalities was related to hospital (p=0.000), age (p=0.000), presence of symptom (p=0.003), and location of aneurysm (p=0.000). The overall 30-day morbidity and mortality were 7.4% and 0.3%, respectively. The 30-day mortality was 0.4% for clipping and 0.2% for coiling, and morbidity was 8.4% for clipping and 6.3% for coiling. Age (p=0.010), presence of symptoms (p=0.034), size (p=0.000) of aneurysm, and diabetes mellitus (p=0.000) were significant prognostic factors, while treatment modality was not. Conclusion : This first nation-wide multicenter survey on UIAs demonstrates the epidemiological and clinical characteristics, outcome and the prognostic factors of the treatment of UIAs in South Korea. The 30-day postoperative outcome for UIAs seems to be reasonable morbidity and mortality in South Korea.

High-flow nasal cannula oxygen therapy in children: a clinical review

  • Kwon, Ji-Won
    • Clinical and Experimental Pediatrics
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    • 제63권1호
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    • pp.3-7
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    • 2020
  • High-flow nasal cannula (HFNC) is a relatively safe and effective noninvasive ventilation method that was recently accepted as a treatment option for acute respiratory support before endotracheal intubation or invasive ventilation. The action mechanism of HFNC includes a decrease in nasopharyngeal resistance, washout of dead space, reduction in inflow of ambient air, and an increase in airway pressure. In preterm infants, HFNC can be used to prevent reintubation and initial noninvasive respiratory support after birth. In children, flow level adjustments are crucial considering their maximal efficacy and complications. Randomized controlled studies suggest that HFNC can be used in cases of moderate to severe bronchiolitis upon initial low-flow oxygen failure. HFNC can also reduce intubation and mechanical ventilation in children with respiratory failure. Several observational studies have shown that HFNC can be beneficial in acute asthma and other respiratory distress. Multicenter randomized studies are warranted to determine the feasibility and adherence of HFNC and continuous positive airway pressure in pediatric intensive care units. The development of clinical guidelines for HFNC, including flow settings, indications, and contraindications, device management, efficacy identification, and safety issues are needed, particularly in children.

TESS 보고 양식을 활용한 대전 지역의 중독 양상 (The Toxic Exposure Patients of Daejon Province by Modified TESS Style)

  • 박정규;정성필;김승환;유인술;박준석;유진현;양영모;정시경
    • 대한임상독성학회지
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    • 제2권1호
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    • pp.1-6
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    • 2004
  • Purpose: A number of reports about the intoxicated patients have been introduced, but there were few multicenter studies. The purpose of this study was to analyse the patients with toxic exposure in the Daejon province. Methods: The patients who were presented to the four academic emergency departments in Daejon with toxic exposure were enrolled from January to June 2003. The collected variables were according to the form which modified from the Toxic Exposure Surveillance System (TESS) of the American Association of Poison Control Centers. Results: The toxic exposure patients were 362 cases which is $0.78\%$ of total patients presented to the emergency department. The most common exposure site was home ($84\%$). Eighteen percent of cases were exposed by two or more substances. The most common substance was the pesticides ($34.8\%$), and the non-prescription drugs ($32.6\%$) was followed. The suicidal attempt was the top reason for exposure ($67.1\%$). The route of exposure other than ingestion was $3.6\%$. Although the most patients left the hospital within a day, the average treatment period was 4.4 days. Thirty-one patients ($8.6\%$) were expired, and 22 among them were exposed to the paraquat. Conclusion: We reported the current status of toxic exposure in Daejon province by modified TESS style.

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Factors Associated with Gastric and Duodenal Neuroendocrine Tumor Development

  • Kwangwoo Nam;Su Youn Nam
    • Journal of Digestive Cancer Research
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    • 제12권1호
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    • pp.1-5
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    • 2024
  • The incidence and prevalence of upper gastrointestinal neuroendocrine tumors (NETs), including gastric NETs (GNETs) and duodenal NETs (DNETs), have been gradually increasing. These trends may be associated with the increased use of health checkups, which includes upper endoscopy, in conjunction with better disease recognition. However, the clinical factors associated with GNETs and DNETs remain unknown; previous studies revealed discrepancies. Recently, metabolic disorders have been indicated as potential factors that are associated with GNETs and DNETs. This review summarizes the results of previous studies and briefly introduces the results of a recent Korean multicenter study on the factors associated with GNETs and DNETs.

Effect of Sihogayonggolmoryeo-Tang on Hwa-byung: A Multicenter, Randomized, Double-Blinded, Placebo-Control Trial

  • Choi, Woo-Chang;Lee, Hun-Soo;Kim, Ju-Yeon;Kang, Wee-Chang;Park, Yang-Chun;Kim, Geun-Woo;Kim, Jong-Woo;Jung, In Chul
    • 동의신경정신과학회지
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    • 제31권3호
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    • pp.135-147
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    • 2020
  • Objectives: Hwa-byung is a mental illness. It is also known as a Korean culture-related syndrome. In traditional Korean medicine, Sihogayonggolmoryeo-tang is used to treat Hwa-byung related neuropsychiatric symptoms. The purpose of this research was to examine the effect of Sihogayonggolmoryeo-tang on Hwa-byung. Methods: A multicenter, randomized, double-blinded, placebo-controlled study was performed for 160 patients with Hwa-byung. Patients were divided into a Sihogayonggolmoryeo-tang group and a placebo group. Treatment period was 8 weeks. Hamilton Rating Scale for Anxiety (HAM-A), Likert scale for major symptoms of Hwa-byung, Hwa-byung Scale (HBS), Korean Beck Depression Inventory (K-BDI), Korean State-Trait Anxiety Inventory (K-STAI), Korean State-Trait Anger Expression Inventory (K-STAXI), and Korean WHO Quality of Life Scale Abbreviated Version (WHOQOL-BREF) were used to evaluate the effect of Sihogayonggolmoryeo-tang on Hwa-byung. We also used an Instrument of Pattern Identification for Hwa-Byung to evaluate different responses for six patterns of patients. Results: Scores of all the measurements improved significantly for each group, showing no significant differences between the two groups. In the case of deficiency of both Qi and blood pattern, the Sihogayonggolmoryeo-tang group showed a significant decrease in the HAM-A score compared to the placebo group. Conclusions: The effect of Sihogayonggolmoryeo-tang on Hwa-byung did not exceed that of the placebo. Further studies involving more elaborate pattern identification are needed.

Do Degree Programs Affect Health Profession Students' Attitudes and Opinions Toward Vaccinations? An Italian Multicenter Study

  • Voglino, Gianluca;Barbara, Andrea;Dallagiacoma, Giulia;Santangelo, Omar Enzo;Provenzano, Sandro;Gianfredi, Vincenza
    • Safety and Health at Work
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    • 제13권1호
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    • pp.59-65
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    • 2022
  • Background: Healthcare workers' attitudes toward vaccination have been widely described in the literature, but a restricted amount of studies assessed healthcare students' knowledge, attitudes, and opinions on this issue. This study aimed to estimate the influence of a degree course on knowledge and immunization behavior among healthcare students and to compare medical students with students from other health profession degree programs to identify possible differences. Methods: A multicenter, cross-sectional study was performed in 2018 in 14 Italian Universities (3,131 students were interviewed). A validated questionnaire was used to assess knowledge, attitudes, and opinions toward vaccinations, with a specific focus on influenza vaccine and attitudes toward mandatory vaccination policies. Statistical software STATA® 14 was used. Results: Significant differences were recorded between medical students and other healthcare students. The intention to get vaccinated against influenza during the next season and having been vaccinated in the previous season was higher in the medical group (p < 0.001). In the group of students of other health professions, we registered a lower probability of identifying themselves as a high-risk group for contracting infectious diseases as a consequence of their profession and health status (aOR 0.49; CI95%: 0.40-0.60) and an increased likelihood of defining their level of knowledge on vaccine-preventable diseases and related vaccinations as "insufficient/sufficient/fair" (aOR 1.31; CI95%: 1.11-1.56). Conclusions: Results show several differences between medical students and students of other health professions when it comes to vaccination knowledge, attitudes, and perceptions, as well as a general low tendency to be vaccinated against influenza.