• 동의생리병리학회지
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• 제28권6호
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• pp.662-667
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• 2014

The purpose of this clinical study is to develop structured clinical trial protocol and guideline for improvement of safety, useful and effective of pulse diagnosis devices. As a first step, papers on pulse diagnosis and pulse diagnosis devices from 2001 and 2013 were systematically reviewed. In the next step, we have collected the opinions from the specialists, companies, and statistician in pulse diagnosis to evaluate the current condition, the state and problem of domestic clinical trial cases of pulse diagnosis device. And we have to created protocol and case report form (CRF) in regards to site condition and characteristics of pulse diagnosis devices, and showed the guideline of eligibility criteria, operation process, investigation items, evaluation items and so on. This clinical protocol will become a basic information for a researcher in designing or performing a clinical study of pulse diagnosis devices, and be used as a useful material during acquisition of good clinical data. Furthermore, we hope to enhance the invigoration of pulse diagnosis clinical trials and the performance improvement of pulse diagnosis devices.

• 사상체질의학회지
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• 제20권3호
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• pp.118-132
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• 2008

1. Introduction This study aims to survey knowledge and attitude of Sasang constitution investigators on the Sasang constitution clinical study. 2. Methods We have made up list of 24 Sasang constitution investigators who have conducted Sasang constitution clinical study before. The study has been surveyed for 20 investigators who has been experiencing clinical study bye-mail or interview. 3. Results 1) The recognition degree on clinical study for sasang constitutional investigators was relatively lower than that for non-oriental investigators. 2) Most investigators have difficulty in designing a Protocol and they thought Protocol is most important in clinical study. 3) The investigators has stressed the need of diagnosis guideline on Sasang Constitution in performing clinical study. 4. Conclusions Special course of clinical study for sasang constitutional investigators should be prepared to activate Sasang constitution clinical study. This course may set up the guideline of sasang constitution clinical study and designing protocol. Also it is urgent to develop constitution diagnosis guideline for clinical study.

• Journal of Acupuncture Research
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• 제32권2호
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• pp.11-21
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• 2015

Objectives : To improve quality of clinical research for acupuncture and moxibustion, a guideline for clinical research protocol is needed. While developing a guideline for acupuncture and moxibustion clinical research, we reviewed the ethical and scientific aspects of protocols pointed out by the institutional review board. This will offer practical assistance to the researchers. Methods : Ethical and scientific aspects of acupuncture and moxibustion research protocols reviewed by Kyung Hee University Korean Medicine Hospital Institutional Review Board were gathered and reviewed. Results : Ethical and scientific aspects of protocol review was reported. Conclusions : The example of review will be helpful for new researchers when developing acupuncture and moxibustion clinical research protocol.

• 기본간호학회지
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• 제15권1호
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• pp.34-44
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• 2008

Purpose: The purpose of this study was to develop an eye care protocol for intensive care unit (ICU) patients. Method: A systematic review was conducted to develop an eye care protocol for ICU patients. Searches were performed using computerized databases (CINAHL, MEDLINE, EBM Review) and citation search from 1996 to January 2007. For the keywords, "eye care", and "randomized controlled trial" were used to identify experimental studies regarding eye care for ICU patients. After reviewing the collected studies, a preliminary eye care protocol algorithm was created. Then, content validity was examined with ophthalmologists and ICU nurses. Results: Six studies were included to serve as a basis for framing of the preliminary algorithm. The final eye care protocol was completed after verifying the preliminary algorithm's content validity. The final eye care protocol was organized in the following manner: 3 items in the assessment stage, 7 items in the no-risk stage, 4 items in the low-risk stage, and 5 items in the high-risk stage. Conclusion: The results indicate that, for ICU patients, nurses can broaden their knowledge regarding ocular diseases, as well as improve their practice-based eye care nursing performance.

• 한국의료질향상학회지
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• 제27권1호
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• pp.20-25
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• 2021

Purpose: The ability to access clinical trials for cancer treatment is important. This study investigated whether regional differences exist in oncologic clinical trial protocols conducted in South Korea. Methods: Records of all approved oncologic clinical trials conducted in 2019 were downloaded from the Republic of Korea Ministry of Food and Drug Safety. The study covered Seoul, the capital area, other metropolitan cities, and provincial areas. Descriptive statistics summarized the distribution patterns of clinical trials by region. Results: A total of 202 oncologic clinical trials were conducted in 63 institutions in 2019. Of these protocols, 186 (92%) were available in Seoul, 120 (59%) in the capital area, 64 (32%) in metropolitan cities, and 66 (33%) in provincial areas. More regional differences in protocol availability were observed in domestic trials, investigator-initiated trials, phase 1 and 2 trials, and smaller-scale trials. Conclusion: Most oncologic clinical trials were conducted in medical institutions located in Seoul, with the rest conducted in the capital area, metropolitan cities, and provincial areas. The findings reveal clear differences in protocol availability between Seoul and the other regions. Measures designed to improve geographical access to oncologic clinical trials may be needed given their growing importance in cancer treatment.

• 한방재활의학과학회지
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• 제33권4호
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• pp.203-213
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• 2023

Objectives This study aimed to develop a Korean medicine (KM) clinical practice guideline for myofascial pain syndrome (MPS) via the collaboration of clinical and methodological experts. Methods The study will include an initial survey to establish a common understanding of MPS. To develop the clinical guideline, a multidisciplinary development group was formed. The group will finalize the clinical questions based on a preliminary draft. The GRADE methodology is going to be applied to determine the level of evidence and grading of the recommendations. Finally, approval from the relevant medical societies will be obtained. Results A protocol for developing a KM clinical guideline for MPS was presented. Before finalizing the clinical key questions, a literature search was conducted according to the protocol, and a draft of 19 clinical key questions was established. Conclusions An evidence-based KM clinical guideline for MPS is expected to contribute to the management of MPS. This may also serve as a reference for the development of other KM clinical practice guidelines in the future.

• 대한간호학회지
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• 제44권3호
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• pp.280-293
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• 2014

Purpose: The study was done to develop an evidence-based enteral nutrition (EN) protocol for effective nutritional support for dysphagia in patients with acute stroke, and to evaluate effects of this protocol on clinical outcomes. Methods: A methodological study was used to develop the EN protocol and a quasi-experimental study to verify the effectiveness of the protocol. The preliminary EN protocol was drawn by selecting recommendations from previous well-designed EN guidelines, and then developing additional recommendations based on high-quality evidence. Content validation was assessed by an expert group, and clinical applicability by care providers and patients. The scale-level content validity index of the final EN protocol was 0.99. Assessment was done of differences in percentage of caloric goals achieved and presence of undernutrition, aspiration pneumonia, and gastrointestinal (GI) complications after application of the EN protocol. Results: In the EN protocol group, the percentage of caloric goals achieved ($R^2=.24$, p=.001) and the reduction of GI complications (p=.045) were significantly improved, but the presence of undernutrition (p=.296) and aspiration pneumonia (p=.601) did not differ from the usual care group. Conclusion: Results indicate that the new EN protocol for dysphagia in patients with acute stroke significantly increased their nutritional intake and reduced GI complications.

• 한국한의학연구원논문집
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• 제8권2호통권9호
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• pp.37-46
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• 2002

Clinical trials are experimental studies with human subjects in which various limitations and variables exist by their nature. As a preparatory stage for designing clinical trials in Oriental medicine, this study considers a virtual protocol to show guideline regarding tasks necessary when writing a trials protocol. Clinical trials have many difficulties in planning, procedure, and interpretation of results, and these may be influenced by various biases that are difficult to predict and eliminate. To deal with these issues, clinical trials need a collaboration between medical experts and biostatisticians from the beginning, through the entire trial, until the final analysis. Therefore, the first stage of clinical trials is to write out a trial plan among the experts in each field to derive the best design for the trial.

• 한국임상수의학회지
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• 제34권1호
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• pp.1-6
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• 2017

Heartworm disease (HWD) in dogs is a life-threatening mosquito-borne disease resulting in right-sided congestive heart failure and inflammatory pulmonary disease. Due to complications from adulticidal therapy with melarsomine, slow kill protocol either with preventive dose of ivermectin or combined with doxycycline has been proposed for an alternative adultcidal therapy in dogs with HWD. Therefore, this study evaluated the clinical outcome of adultcidal therapy in dogs with class II stage of HWD after treating either American Heartworm Society (AHS) or slow kill protocol for 10 months. Clinical outcome after therapy was evaluated by clinical, radiographic and echocardiographic examination along with hematology before (D0) and after therapy (D300). Although clinical signs associated with HWD were all resolved after therapy in both groups, the infection was not cleared out 67% of dogs treated by slow kill protocol at the end of therapy. Furthermore, pulmonary arterial flow of acceleration time to ejection time ratio (AT/ET) and the right pulmonary artery distensibility index (RPADI) have been firstly used for detecting pulmonary hypertension in this study group. The pulmonary hypertension was more common in dogs with mild clinical signs, although tricuspid and pulmonary regurgitation were not detectable in most dogs in this study. Our study findings suggested that the slow kill protocol might not be efficacious enough to clear out HWD in dogs and more attention on the presence of pulmonary hypertension might be necessary for effective management of HWD in dogs.

• 한국임상약학회지
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• 제30권3호
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• pp.161-168
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• 2020

Background: Recently, a study comprising adult patients with sepsis admitted in the intensive care unit (ICU) was conducted. The patients were treated with high doses of intravenous ascorbic acid, thiamine, and hydrocortisone; the clinical outcomes demonstrated significant therapeutic benefits. The mortality rate in children with sepsis is approximately 25%. However, the effects of additional treatment with ascorbic acid and thiamine ("vitamin protocol") in children are rarely investigated. Methods: A retrospective analysis was performed using medical records of patients diagnosed with sepsis and admitted to the pediatric ICU (PICU) between September 2016 and June 2019. The control group received treatment only as per sepsis protocol, whereas the treated group received both sepsis protocol and the vitamin protocol. The primary endpoint was change in Vasoactive-Inotropic Score (VIS) for 5 days. The secondary endpoints included the length of stay in the PICU, duration of using mechanical ventilators and vasopressors, and mortality rate. Results: The number of patients in the treated and control groups was 33 and 24, respectively. The treated group showed greater decrease in their VIS for 5 days than the control group (44.4 vs 18.6); however, the difference was not statistically significant. The length of stay in the PICU was significantly longer for the treated group than for the control group [10.0 days (Interquartile range (IQR), 6-18) vs 4.5 days (IQR, 4-10.3); p=0.004]. Conclusions: No significant treatment benefits were observed following vitamin protocol administration to the pediatric patients with sepsis. Further studies are necessary for improving the efficacy and safety of the vitamin protocol.