• Physical Therapy Korea
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• v.31 no.2
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• pp.174-181
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• 2024

Background: Effective management of clinical assessment tools is critical in stroke and brain injury rehabilitation research. Managing rehabilitation outcome measures (ROMs) scores and training therapists in multicenter randomized clinical trials (RCTs) is challenging. Objects: The aim of this study was to develop a web-based platform, the Korean Rehabilitation Outcome Measurement (KoROM), to address these limitations and improve both therapist training and patient involvement in the rehabilitation process. Methods: The development of the KoROM spanned from June 2021 to July 2022, and included literature and web-based searches to identify relevant ROMs and design a user-friendly platform. Feedback from six physical therapy and informatics experts during pilot testing refined the platform. Results: Several clinical assessment tools categorized under the International Classification of Functioning, Disability, and Health (ICF) model are categorized in the KoROM. The therapist version includes patient management, assessment tool information, and data downloads, while the patient version provides a simplified interface for viewing scores and printing summaries. The master version provides full access to user information and clinical assessment scores. Therapists enter clinical assessment scores into the KoROM and learn ROMs through instructional videos and self-checklists as part of the therapist standardization process. Conclusion: The KoROM is a specialized online platform that improves the management of ROMs, facilitates therapist education, and promotes patient involvement in the rehabilitation process. The KoROM can be used not only in multi-site RCTs, but also in community rehabilitation exercise centers.

• Journal of Periodontal and Implant Science
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• v.46 no.6
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• pp.382-395
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• 2016

Purpose: Alendronate has been proposed as a local and systemic drug treatment used as an adjunct to scaling and root planing (SRP) for the treatment of periodontitis. However, its effectiveness has yet to be conclusively established. The purpose of the present meta-analysis was to assess the effectiveness of SRP with alendronate on periodontitis compared to SRP alone. Methods: Five electronic databases were used by 2 independent reviewers to identify relevant articles from the earliest records up to September 2016. Randomized controlled trials (RCTs) comparing SRP with alendronate to SRP with placebo in the treatment of periodontitis were included. The outcome measures were changes in bone defect fill, probing depth (PD), and clinical attachment level (CAL) from baseline to 6 months. A fixed-effect or random-effect model was used to pool the extracted data, as appropriate. Mean differences (MDs) with 95% confidence intervals (CIs) were calculated. Heterogeneity was assessed using the Cochrane ${\chi}^2$ and $I^2$ tests. Results: After the selection process, 8 articles were included in the meta-analysis. Compared with SRP alone, the adjunctive mean benefits of locally delivered alendronate were 38.25% for bone defect fill increase (95% CI=33.05%-43.45%; P<0.001; $I^2=94.0%$), 2.29 mm for PD reduction (95% CI=2.07-2.52 mm; P<0.001; $I^2=0.0%$) and 1.92 mm for CAL gain (95% CI=1.55-2.30 mm; P<0.001; $I^2=66.0%$). In addition, systemically administered alendronate with SRP significantly reduced PD by 0.36 mm (95% CI=0.18-0.55 mm; P<0.001; $I^2=0.0%$) and increased CAL by 0.39 mm (95% CI=0.11-0.68 mm; P=0.006; $I^2=6.0%$). Conclusions: The collective evidence regarding the adjunctive use of alendronate locally and systemically with SRP indicates that the combined treatment can improve the efficacy of non-surgical periodontal therapy on increasing CAL and bone defect fill and reducing PD. However, precautions must be exercised in interpreting these results, and multicenter studies evaluating this specific application should be carried out.

• Clinical and Experimental Pediatrics
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• v.52 no.4
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• pp.476-480
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• 2009

Purpose : The purpose of this study was to investigate the polymorphisms of the TNF-alpha promotor gene, its susceptibility to Kawasaki disease (KD) and to assess whether the TNF-alpha promotor gene polymorphism was related the risk of coronary artery lesions (CALs). Methods : From January 2003 to January 2007, 51 children (30 boys and 21 girls) with KD and 48 children forming an age-matched control group were studied. DNA from the peripheral blood of all the children was sampled, and the DNA polymorphisms of the 5' flanking regions of the TNF-alpha promoter gene at position -308 [guanine (G) to adenine (A)] were determined by polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP). Then, the relationship between KD and the TNF-alpha promotor gene polymorphisms was evaluated. Results : The A allele frequency of the -308 site of the TNF-alpha promotor gene was 17.6% (9/51) for children with KD and 6.8% (3/48) for the control group children, but this result was not statistically significant. Twenty-four patients experienced CALs within 60 days after the onset of symptoms. KD children with TNF-alpha -308 A allele had lower frequencies of CALs (12.5% versus 22.2%, P>0.05). Conclusion : The DNA polymorphism of the -308 site TNF-alpha gene was not associated with susceptibility to KD and a risk of CALs. Multicenter, large-scale randomized controlled trials are needed for further study.

• The Journal of Internal Korean Medicine
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• v.22 no.4
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• pp.691-702
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• 2001

Objectives : This study was done to assess the effects of the clinical interchange between the Western Medicine and the Oriental Medicine for ischemic stroke patients. The patient outcomes include changes in neurologic function by modified NIH stoke scale, stroke pattern identification scale, and patient satisfaction, Methods : For the assessment of effects, this study was performed with 178 inpatients who had undergone the stroke care at three hospitals (W Hospital adopted western therapy, S Oriental Hospital adopted Sasang constitution medicine therapy, and H Oriental Hospital adopted mixed therapy according to a joint protocol on Western Oriental medical care) from November 1997 to December 1998. Patients were interviewed or written with self-entered questionnaire forms, and clinical data were obtained, Physicians or oriental doctors wrote clinical questionnaire forms according to the care process. Results : The patient outcomes within three hospitals at 2 stages (at admission and discharge in the modified NIH stroke scale. at admission and second weeks during admission in the stroke pattern identification scale) were found to be decreased, Especially in the results of hierarchical multiple regression analysis, the degree of improvement of modified NIH stroke scale of the stroke patients at W Hospital was significant large than it at S Oriental Hospital. Also, the degree of improvement of stroke pattern identification scale at W Hospital was significantly large than it at other two hospitals. However, the patient's satisfaction score at three hospitals wasn't significantly different. Conclusions : The result of this study suggested that the joint clinical research of Western & Oriental medical practitioners was possible even if there was a conflict between Western Medicine and Oriental Medicine. Therefore Western & Oriental medical practitioners share a mutual responsibility to apply evidence-based practice, to seek scientific empirical proof through randomized clinical trials between the multicenter.

• Asian Pacific Journal of Cancer Prevention
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• v.15 no.2
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• pp.925-928
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• 2014

Background: Gestational trophoblastic neoplasia (GTN) is a spectrum of disease with abnormal trophoblastic proliferation. Treatment is based on FIGO stage and WHO risk factor scores. Patients whose score is 12 or more are considered as at extremely high risk with a high likelihood of resistance to first line treatment. Optimal therapy is therefore controversial. Objective: This study was conducted in order to summarize the regimen used for extremely high risk or resistant GTN patients in our institution the in past 10 years. Materials and Methods: All the charts of GTN patients classified as extremely high risk, recurrent or resistant during 1 January 2002 to 31 December 2011 were reviewed. Criteria for diagnosis of GTN were also assessed to confirm the diagnosis. FIGO stage and WHO risk prognostic score were also re-calculated to ensure the accuracy of the information. Patient characteristics were reviewed in the aspects of age, weight, height, BMI, presenting symptoms, metastatic area, lesions, FIGO stage, WHO risk factor score, serum hCG level, treatment regimen, adjuvant treatments, side effects and response to treatment, including disease free survival. Results: Eight patients meeting the criteria of extremely high risk or resistant GTN were included in this review. Mean age was 33.6 years (SD=13.5, range 17-53). Of the total, 3 were stage III (37.5%) and 5 were stage IV (62.5%). Mean duration from previous pregnancies to GTN was 17.6 months (SD 9.9). Mean serum hCG level was 864,589 mIU/ml (SD 98,151). Presenting symptoms of the patients were various such as hemoptysis, abdominal pain, headache, heavy vaginal bleeding and stroke. The most commonly used first line chemotherapeutic regimen in our institution was the VAC regimen which was given to 4 of 8 patients in this study. The most common second line chemotherapy was EMACO. Adjuvant radiation was given to most of the patients who had brain metastasis. Most of the patients have to delay chemotherapy for 1-2 weeks due to grade 2-3 leukopenia and require G-CSF to rescue from neutropenia. Five form 8 patients were still survived. Mean of disease free survival was 20.4 months. Two patients died of the disease, while another one patient died from sepsis of pressure sore wound. None of surviving patients developed recurrence of disease after complete treatment. Conclusions: In extremely high risk GTN patients, main treatment is multi-agent chemotherapy. In our institution, we usually use VAC as a first line treatment of high risk GTN, but since resistance is quite common, this may not suitable for extremely high risk GTN patients. The most commonly used second line multi-agent chemotherapy in our institution is EMA-CO. Adjuvant brain radiation was administered to most of the patients with brain metastasis in our institution. The survival rate is comparable to previous reviews. Our treatment demonstrated differences from other institutions but the survival is comparable. The limitation of this review is the number of cases is small due to rarity of the disease. Further trials or multicenter analyses may be considered.

• Journal of Physiology & Pathology in Korean Medicine
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• v.24 no.3
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• pp.361-366
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• 2010

This study was practiced to investigate the existing study trends for Injinho that is numerously used for hepatobiliary diseases in oriental medicine. The studies selected from the domestic academic database included the following keywords in the title or abstract; 'Artemisia capillaris', 'Artemisia iwayomogi', 'Artemisia scoparia'. The studies considered were those published from January 1990 to May 2009. 198 studies were found to include the keywords related to the study subjects either in their title of contents or abstracts, and 104 studies among them were finally selected as subjects for this study. 81 studies among 104 studies(78%) were published between 2000 and 2009, while 23 studies(22%) were published between 1990 and 1999. Classification was proceeded according to study subjects as followed; 23 studies confirming hepatoprotective effect after artificial liver damage in a number of cells or the organ itself, 18 studies on anti-tumor effect, 12 studies on hyperlipidemia and fatty liver disease, and 4 studies on liver cirrhosis and hepatocyte regeneration. Furthermore, classification was conducted according to study methods as followed; 56 studies practicing in vitro, 33 studies practicing in vivo, 11 studies practicing both in vitro and in vivo. 2 studies on specific cases and 1 study on documentary records. The majority of studies report the affirmative effects of Injinho. However most study methods were restricted to in vitro and in vivo. Hereafter, case reports on various fields and multicenter clinical trials on Injinho is necessary.

• Dementia and Neurocognitive Disorders
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• v.22 no.3
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• pp.100-108
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• 2023

Background and Purpose: The efficacy and safety of GV1001 have been demonstrated in patients with moderate-to-severe Alzheimer's disease (AD). In this study, we aimed to further demonstrate the effectiveness of GV1001 using subscales of the Severe Impairment Battery (SIB), which is a validated measure to assess cognitive function in patients with moderate-to-severe AD. Methods: We performed a post hoc analysis of data from a 6 month, multicenter, phase 2, randomized, double-blind, placebo-controlled trial with GV1001 (ClinicalTrials.gov, NCT03184467). Patients were randomized to receive either GV1001 or a placebo for 24 weeks. In the current study, nine subscales of SIB-social interaction, memory, orientation, language, attention, praxis, visuospatial ability, construction, and orientation to name-were compared between the treatment (GV1001 1.12 mg) and placebo groups at weeks 12 and 24. The safety endpoints for these patients were also determined based on adverse events. Results: In addition to the considerable beneficial effect of GV1001 on the SIB total score, GV1001 1.12 mg showed the most significant effect on language function at 24 weeks compared to placebo in both the full analysis set (FAS) and per-protocol set (PPS) (p=0.017 and p=0.011, respectively). The rate of adverse events did not differ significantly between the 2 groups. Conclusions: Patients with moderate-to-severe AD receiving GV1001 had greater language benefits than those receiving placebo, as measured using the SIB language subscale.

• Clinical and Experimental Pediatrics
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• v.52 no.2
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• pp.181-186
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• 2009

Purpose : Inflammation plays a potential role in the pathogenesis of bronchopulmonary dysplasia (BPD). Strategies for preventing BPD include respiratory management, antioxidants, nutritional treatment, and others such as anti-inflammatory agents. We aimed to assess the safety, tolerability, and efficacy of montelukast (MK), a cysteinyl leukotriene 1 receptor antagonist, as an add-on therapy in BPD. Methods : In addition to currently available standard measures such as oxygen supplementation, bronchodilators, nutritional support, and/or diuretics, montelukast was administered to 15 preterm infants with BPD. MK was given orally (1 mg/kg/d) for a mean period of 12 weeks. We compared safety and efficacy parameters with historical controls. Results : All 15 patients survived, and no differences were found in the incidence of adverse reactions between the 2 groups. The ventilation index was significantly improved after 2 weeks in MK group compared with historical controls. There were no significant differences in other respiratory parameters (MAP, oxygen dependency, and ventilator dependency) between the groups, but the MK group showed trends of greater improvement. Conclusion : Administration of MK 1 mg/kg/d was well tolerated in preterm BPD patients as an add-on therapy. We demonstrated that after 2 weeks of MK administration of 1 mg/kg/d, MK had beneficial therapeutic effects on BPD patients as an add-on to the standard therapy. Further multicenter randomized controlled clinical trials are needed to confirm the efficacy and safety of MK as a useful supplement to standard therapy for BPD patients.

• The Korean journal of helicobacter and upper gastrointestinal research
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• v.18 no.4
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• pp.247-257
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• 2018

Background/Aims: The aim of this study was to analyze the trend of the prevalences of atrophic gastritis (AG) and intestinal metaplasia (IM) from 2011 to 2016~2017 in Korea. And, the risk factors of AG and IM were compared between 2011 and 2016~2017. Materials and Methods: A total of 4,023 subjects in 2011 and 2,506 subjects in 2016~2017 were enrolled. AG and IM were diagnosed on the basis of endoscopic findings. Multivariate analysis was performed for risk factors of AG and IM. Seventeen factors were analyzed. Results: The seroprevalence of Helicobacter pylori decreased from 2011 (59.8%; 2,407/4,023) to 2016~2017 (51.6%; 1,293/2,506; P<0.001). The prevalence of AG decreased from 2011 to 2016~2017 (P=0.018), but that of IM increased (P<0.001). The risk factors of AG in 2011 were male sex, old age, H. pylori immuoglobulin G (IgG) positivity, family history of gastric cancer (GC), and high-salt diet. For IM in 2011, the risk factors were male sex, old age, H. pylori IgG positivity, and family history of GC. Risk factors of AG in 2016~2017 were old age, H. pylori IgG positivity, and country of residence. For IM in 2016~2017, the risk factors were male sex, old age, family history of GC, high fasting glucose level (${\geq}126mg/dL$), H. pylori IgG positivity, and low income level. Conclusions: The difference in prevalence trends of AG and IM between 2016~2017 and 2011 could be the result of the different risk factors of AG and IM, such as decreased prevalence of H. pylori infection.

• The Journal of KAIRB
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• v.6 no.1
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• pp.5-16
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• 2024

Purpose: The purpose of this study is to investigate the current status of pediatric assent in nationwide hospitals and to assess the children's comprehension for pediatric assent by interviewing pediatricians/pediatric neurologists to determine whether children of the age (elementary and middle school students) can understand the purpose, risks, benefits, and concepts of voluntary participation in clinical research described in the assent form, and to help improve the administrative efficiency of multicenter clinical trials. Methods: The status of pediatric assent was surveyed online using Google Forms at 141 university hospitals with administrative staff who are members of the Institutional Review Board (IRB) administrative staff subcommittee with in Korean Association of Institutional Review Boards (KAIRB). Additionally, face-to-face interviews were conducted with 7 pediatricians/pediatric neurologists. Survey and interview responses were summarized using descriptive statistics. Results: Out of the 141 institutions surveyed, 35 institutions (24.8%) responded. Among them, 30 institutions (85.7%) reported having age criteria for acquiring pediatric assent forms in the case of children. The age range for pediatric assent acquisition have been from 7 years old to 12 years old (15 institutions, 50%), and from 7 years old to 15 years old (7 institutions, 23.3%). Nine institutions (25.7%) have had criteria for obtaining both parents' consent in cases involving the participation of children. Nineteen institutions (54.3%) have had checklists or guidelines available for use by IRB members in study protocols involving vulnerable research subjects. Three pediatricians/pediatric neurologists have believed that upper-grade elementary school students (5th-6th grade) could comprehensively understand informed consent forms. Two have believed that middle school students would be able to understand them if they included personal information. Two pediatricians/pediatric neurologists have believed that even lower-grade elementary school students (1st-4th grade) could understand the explanations if they were made simpler. Conclusion: It is suggested that not only elementary school students (7-12 years old) but also middle school students (13-15 years old) should receive pediatric assent forms, as it would facilitate a comprehensive understanding of the forms. To enhance the comprehension of assent form content, it is necessary to use age-appropriate words, language, and expressions in the forms hospital. It is also recommended to create comics or videos to make the content of the assent forms more accessible for children.