• Title/Summary/Keyword: Multicenter clinical study

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A Web-based Platform for Managing Rehabilitation Outcome Measures

  • Sujin Kim;Jiwon Jeon;Haesu Lee
    • 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.

Extended Use of Extracorporeal Membrane Oxygenation for Acute Respiratory Distress Syndrome: A Retrospective Multicenter Study

  • Kim, Won-Young;Park, SeungYong;Kim, Hwa Jung;Baek, Moon Seong;Chung, Chi Ryang;Park, So Hee;Kang, Byung Ju;Oh, Jin Young;Cho, Woo Hyun;Sim, Yun Su;Cho, Young-Jae;Park, Sunghoon;Kim, Jung-Hyun;Hong, Sang-Bum
    • Tuberculosis and Respiratory Diseases
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    • v.82 no.3
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    • pp.251-260
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    • 2019
  • Background: Beyond its current function as a rescue therapy in acute respiratory distress syndrome (ARDS), extracorporeal membrane oxygenation (ECMO) may be applied in ARDS patients with less severe hypoxemia to facilitate lung protective ventilation. The purpose of this study was to evaluate the efficacy of extended ECMO use in ARDS patients. Methods: This study reviewed 223 adult patients who had been admitted to the intensive care units of 11 hospitals in Korea and subsequently treated using ECMO. Among them, the 62 who required ECMO for ARDS were analyzed. The patients were divided into two groups according to pre-ECMO arterial blood gas: an extended group (n=14) and a conventional group (n=48). Results: Baseline characteristics were not different between the groups. The median arterial carbon dioxide tension/fraction of inspired oxygen ($FiO_2$) ratio was higher (97 vs. 61, p<0.001) while the median $FiO_2$ was lower (0.8 vs. 1.0, p<0.001) in the extended compared to the conventional group. The 60-day mortality was 21% in the extended group and 54% in the conventional group (p=0.03). Multivariate analysis indicated that the extended use of ECMO was independently associated with reduced 60-day mortality (odds ratio, 0.10; 95% confidence interval, 0.02-0.64; p=0.02). Lower median peak inspiratory pressure and median dynamic driving pressure were observed in the extended group 24 hours after ECMO support. Conclusion: Extended indications of ECMO implementation coupled with protective ventilator settings may improve the clinical outcome of patients with ARDS.

Clinical Efficacy and Safety of Gyebutang Granules Combined with Acupuncture for the Treatment of Knee Osteoarthritis: Protocol for a Multicenter, Randomized, Assessor-blinded, 2-armed Parallel, Controlled Trial

  • Lee, Cham-Kyul;Kang, Ha-Ra;Lee, Yeon-Sun;Sung, Won-Suk;Lim, Chi-Yeon;Jung, Chan-Yung;Kim, Eun-Jung;Seo, Byung-Kwan;Baek, Yong-Hyeon;Kim, Kyung-Ho;Lee, Eun-Young
    • Journal of Acupuncture Research
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    • v.37 no.2
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    • pp.102-109
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    • 2020
  • Background: Due to the aging population in Korea, knee osteoarthritis (KOA) has become an increasingly common condition. Many patients with KOA prefer analgesics, herbal medicines, acupuncture, or exercise, rather than arthroscopic surgery or a knee replacement. Gyebutang (GB) granules are a herbal extract widely used to treat KOA in traditional Korean medicine, but there is insufficient evidence of its efficacy and safety. Methods: A multicenter, randomized, assessor-blinded, 2-armed parallel, controlled clinical trial has been designed to investigate the efficacy and safety of GB combined with acupuncture for the treatment of KOA. There will be 100 patients with KOA enrolled in the study from 3 traditional Korean medicine hospitals. The participants will be randomly allocated to an experimental group (GB and acupuncture) or a control group (celecoxib and acupuncture) in a 1:1 ratio. Both groups will receive acupuncture treatment once a week for 6 weeks; one group will receive GB and the other will receive celecoxib for the same duration. Results: The primary outcome will be the change of knee osteoarthritic pain, based on scores on a 100 mm visual analog scale. The secondary outcomes will be scores on a numeric rating scale, the Western Ontario and McMaster Universities osteoarthritis index, patient global assessment, European quality of life 5-dimension 5-level scale, and adverse events. Conclusion: The results of this study will provide evidence of efficacy and safety of GB as a treatment for patients with KOA.

The Comorbidity of Anxiety Disorder in Depressed Patients : A CRESCEND(Clinical Research Center for Depression in Korea) Cohort Study (우울증 환자에서 불안장애의 동반이환 : 우울증 임상연구센터 코호트연구)

  • Sakong, Jeong-Kyu;Lee, Do-Yun;Suh, Ho-Suk;Sung, Hyung-Mo;Kim, Jung-Bum;Jung, Young-Eun;Lee, Min-Soo;Kim, Jae-Min;Jo, Sunjin
    • Mood & Emotion
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    • v.9 no.1
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    • pp.30-36
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    • 2011
  • Purpose : Anxiety disorder and depressive disorder are often comorbid with each other, and the comorbidity is associated with poorer psychiatric outcome, resistance to treatment, increased risk for suicide, greater chance for recurrence. We aimed to investigate the comorbidity of anxiety disorder in Korea. Method : Subjects were total of 867 depressed patients recruited CRESCEND-K multicenter trial. We used SCID (Structured Clinical Interview for DSM - IV) to find comorbidity of anxiety disorders in depressed patient. Results : Of 867 patients, total 8.2% had anxiety disorder. Proportion of anxiety disorder Not Otherwise Specified was 3.5%, panic disorder was 1.7%, generalized anxiety disorder was 1.1%, post traumatic stress disorder was 0.9%, obsessive compulsive disorder was 0.6%, social phobia was 0.4%. Conclusion : In this study, anxiety disorder in depression were measured at a low comorbidity rate in compare to previous studies. Selection bias, use of antidepressants at registration, severity of depression symptoms, and point of SICD administration seems to have affected these results. It is probable that comorbidity evaluation would be more precise if shorter, structured interviews such as M. I.N.I.-Plus were used during first clinical interview for depression diagnosis.

A Multicenter Study of Pertussis Infection in Adults with Coughing in Korea: PCR-Based Study

  • Park, Sunghoon;Lee, Myung-Gu;Lee, Kwan Ho;Park, Yong Bum;Yoo, Kwang Ha;Park, Jeong-Woong;Kim, Changhwan;Lee, Yong Chul;Park, Jae Seuk;Kwon, Yong Soo;Seo, Ki-Hyun;Kim, Hui Jung;Kwak, Seung Min;Kim, Ju-Ock;Lim, Seong Yong;Sung, Hwa-Young;Jung, Sang-Oun;Jung, Ki-Suck
    • Tuberculosis and Respiratory Diseases
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    • v.73 no.5
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    • pp.266-272
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    • 2012
  • Background: Limited data on the incidence and clinical characteristics of adult pertussis infections are available in Korea. Methods: Thirty-one hospitals and the Korean Centers for Disease Control and Prevention collaborated to investigate the incidence and clinical characteristics of pertussis infections among adults with a bothersome cough in non-outbreak, ordinary outpatient settings. Nasopharyngeal aspirates or nasopharyngeal swabs were collected for polymerase chain reaction (PCR) and culture tests. Results: The study enrolled 934 patients between September 2009 and April 2011. Five patients were diagnosed as confirmed cases, satisfying both clinical and laboratory criteria (five positive PCR and one concurrent positive culture). Among 607 patients with cough duration of at least 2 weeks, 504 satisfied the clinical criteria of the US Centers for Disease Control and Prevention (i.e., probable case). The clinical pertussis cases (i.e., both probable and confirmed cases) had a wide age distribution ($45.7{\pm}15.5$ years) and cough duration (median, 30 days; interquartile range, 18.0~50.0 days). In addition, sputum, rhinorrhea, and myalgia were less common and dyspnea was more common in the clinical cases, compared to the others (p=0.037, p=0.006, p=0.005, and p=0.030, respectively). Conclusion: The positive rate of pertussis infection may be low in non-outbreak, ordinary clinical settings if a PCR-based method is used. However, further prospective, well-designed, multicenter studies are needed.

A multicenter clinical study of installed US II Plus/GS II Osstem implants after bone graft (골 이식술 후 Osstem Implant (US II Plus/GS II)의 다기관 임상연구)

  • Chung, Kwang;Oh, Chul-Jung;Ha, Ji-Won;Kook, Min-Suk;Park, Hong-Ju;Oh, Hee-Kyun;Kim, Su-Gwan;Kim, Young-Kyun;Kim, Woo-Cheol
    • The Journal of the Korean dental association
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    • v.50 no.12
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    • pp.743-754
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    • 2012
  • urpose : The purpose of this study was to evaluate the US II plus/GS II Osstem$^{(R)}$ implants through the study for the clinical success rate during the installation of the Osstem¢Á implants after bone graft. Materials and Methods : This study was researched in the 4 medical institutions: Chonnam National University, Chosun University, Bundang Seoul National University Hospital, and FM dental clinic from May, 2002 to September, 2009. Based on the total number of 60 patients whose treatment was the installation of the US II plus/GS II Osstem¢Á implants after bone graft, we evaluated success rate of implants. We analysis the distribution of patient's age and gender, edentulous area, bone type, fixture length and diameter, installation and loading time, donor site, bone graft material and method, antagonistic teeth, and survival and success rate. From these analyses we got the following results. Results : 1. In this study, the total number of patients who have been installed with US II plus implant was 27, and total of 52 implants were installed. The average age was 38.9, with 16 male, and 11 female patients. 2. The total number of patients who have been installed with GS II implant was 33, and total of 54 implants were installed. The average age was 49.7, with 24 male, and 9 female patients. 3. As for bone graft method, either autogenous bone or a mix of autogenous and heterogenous bone was used(88.4%) for US II plus. Chin, iliac, and Maxillary tuberosity were the donor sites for autogenous bone graft, and onlay method of bone graft was performed. 4. Allogenic bone or a mix of autogenous and heterogenous bone was used(77.8%) for GS II. Chin, ramus, and tibia were the donor sites for autogenous bone graft, and GBR method of bone graft was performed. 5. The duration from the installation of implants to setting of final prosthesis was average of 16 months and 10 months for US II plus and GS II respectively. Also, the final follow up period was average of 31 months and 28 months respectively. During this period, one GS II implant was removed from 1 patient due to failure of early osteointegration. 6. The survival rates were 100% and 98.1%, and success rates were 94.2% and 94.4% for US II plus and GS II implant respectively. Conclusion : On the evaluation of our clinical study, both US II plus and GS II Osstem¢Á implants showed the excellent clinical results after bone graft.

Analysis on Research Trend of Studies Related with Scutellariae Radix in Korea (황금(黃芩)에 관한 국내 연구 동향에 관한 소고)

  • Kim, Kang-San;Kim, Lae-Hee;Rhee, Yun-Jin;Lee, Su-Hyoun;Choi, Ji-Hye;Ko, Ha-Neul
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.25 no.6
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    • pp.1095-1101
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    • 2011
  • Scutellariae Radix has been used as a traditional medicine for anti-oxidant, anti-inflammatory, anti-allergic function. But most study methods were restricted to in vitro and in vivo. Therefore to perform for clinical trials further for a new natural drug development is necessary and this study will be used as a basis for it. The studies selected from domestic academic database included the following key words; '황금', '黃芩', 'skullcap', 'Scutellariae Radix', 'scutellaria baicalensis' and considered were those published from 1990 to July, 2011. All 1080 studies were found to include the keywords related to the study subjects either in their title of contents or abstracts. and 298 studies were finally selected as subjects for this study. 243 studies among 293 studies were published between 2000 to 2011. Classification was proceeded according to study subjects as followed; anti-Inflammatory effect and antiallergic and antihistamin effect(66), antibacterial and antivirus effect(61), antioxidant effect(51), neuronal cell apoptosis and neuronal cell protective effect(22), liver cell protective effect(20). According to method type of study, 194 studies practicing in vitro, 60 studies practicing in vivo, 37 studies practicing in both. and 5 studies on documentary records. Most study methods were restricted in vitro and in vivo. For developmenting of function of anti-inflammatory effect and antiallergic, antihistamin effect & atopic dermatitis effect, antibacterial and antivirus effect, antioxidant effect, case report on various fields and multicenter clinical trials is necessary.

The Concordance and Validity Assessment of Diagnosis for the Expert in Sasang Constitution (사상체질 전문가의 체질진단 일치도 및 타당도 평가)

  • Baek, Young-Hwa;Kim, Ho-Seok;Lee, Si-Woo;Jang, Eun-Su
    • Journal of Sasang Constitutional Medicine
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    • v.26 no.3
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    • pp.295-303
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    • 2014
  • Objectives It is very important to diagnose Sasang Constitution (SC) correctly. The aim of this study was to reveal the concordance and validity of the specialists in Sasang Constitutional Medicine (SCM). Methods Three experts who had more than 5 years of experience and used more than 90% of Sasang Constitutional prescription in clinical practice of SCM participated in this study. The data composed of body shape, face, voice, temperament and physio-pathological symptoms were collected in the Korea Constitutional Multicenter Bank and 81 subjects' data were extracted randomly. The experts reviewed all 81 subjects data independently. Kappa analysis was conducted. Results 1) The concordance is from 52.5% to 68.4% among three experts. 2) The validity between individual expert and gold standard is from 54.3% to 63% and Kappa's coefficients are from 0.283 to 0.421. 3) The validity is from 68.5% to 70.7% when two or three experts agree the Sasang constitution independently and 75.7% when all of experts agree it. Conclusions The concordance and validity of experts in SCM seems to be moderate. We think further study is needed.

Rationale, Design, and Interim Observations of the Steady Movement With Innovating Leadership for Heart Failure (SMILE HF) Registry: A Multicenter Prospective Cohort Registry for Patients With Acute Heart Failure

  • Jah Yeon Choi;Mi-Na Kim;Seongwoo Han;Sunki Lee;Myung Soo Park;Min Gyu Kong;Sung-Hea Kim;Yong-Hyun Kim;Sang-Ho Jo;Sungeun Kim;Seonghoon Choi;Jinsung Jeon;Jieun Lee;Byambakhand Battumur;Seong-Mi Park;Eung Ju Kim;SMILE HF Investigators
    • International Journal of Heart Failure
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    • v.6 no.3
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    • pp.129-136
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    • 2024
  • Background and Objectives: Heart failure (HF) is a leading cause of hospitalization and death worldwide. The Steady Movement with Innovating Leadership for Heart Failure (SMILE HF) aims to evaluate the clinical characteristics, management, hospital course, and long-term outcomes of patients hospitalized for acute HF in South Korea. Methods: This prospective, observational multicenter cohort study was conducted on consecutive patients hospitalized for acute HF in nine university hospitals since September 2019. Enrolment of 2000 patients should be completed in 2024, and follow-up is planned through 2025. Results: Interim analysis of 1,052 consecutive patients was performed to understand the baseline characteristics. The mean age was 69±15 years; 57.6% were male. The mean left ventricular ejection fraction was 39±15%. The prevalences of HF with reduced ejection fraction, HF with mildly reduced ejection fraction, and HF with preserved ejection fraction were 50.9%, 15.3%, and 29.2%. Ischemic cardiomyopathy (CMP) was the most common etiology (32%), followed by tachycardia-induced CMP (12.8%) and idiopathic dilated CMP (9.5%). The prescription rate of angiotensin-converting enzyme inhibitor/angiotensin receptor blockers/angiotensin receptor/neprilysin inhibitor, beta-blockers, spironolactone, and sodium-glucose cotransporter-2 inhibitors at discharge were 76.8%, 66.5%, 50.0%, and 17.5%, respectively. The post-discharge 90-day mortality and readmission rates due to HF aggravation were 2.0% and 6.4%, respectively. Our analysis reveals the current state of acute HF in South Korea. Conclusions: Our interim analysis provides valuable insights into the clinical characteristics, management, and early outcomes of acute HF patients in South Korea, highlighting the current state and treatment patterns in this population.

The Clinical Interchange between Western Medicine and Oriental Medicine: with the Stroke Patient Outcomes Research (일부 한.양방병원 뇌혈관질환 환자의 진료결과 및 만족도의 비교연구 -한양방협진 진료프로토콜의 적용을 중심으로-)

  • Park, Jong-Ku;Kang, Myung-Guen;Lee, Seong-Soo;Kim, Dal-Rae;Choi, Seo-Young;Han, Chang-Ho;Yoo, Jun-Sang;Kim, Min-Gi;Kim, Chun-Bae
    • 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.

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