The clinical clerkship focuses students on developing their ability to perform comprehensive diagnosis and management of patients with common undifferentiated problems by the integration of knowledge and clinical reasoning. Therefore, the clerkship evaluation system should assess their actual problem solving and professional behavior. However, concern remains that clerkship evaluations are imprecise and highly variable. This review is designed to provide faculty members with concepts, options, and a methodology to actively teach and evaluate the clinical clerkship, as well as offer encouragement and inspiration to medical students. We reviewed past and current clinical clerkship evaluations and discuss several tips to improve clinical excellence such as continuity, transparency of the evaluation process, a faculty development program, practical examination of clinical skills, implementation of a checklist for recording exposure and skills, providing prompt and constructive feedback to students, self-evaluation of professional performance, varying multi-faceted assessment combinations, being outpatient clinic-centered, and having dedicated faculty members who give students one-on-one contact with a preceptor.
This study focuses on the protection of trial subjects, who participate in clinical trials for new drug. It takes long time to develop new drugs and the clinical trials are required. Usually, pharmaceutical company, which develop new drug, request a research institution(usually, hospital) to investigate the examination of security and side effects of new drug. The institution recruit trial subject to participate in the trials. The contract for clinical research of investigational new drug is concluded between the pharmaceutical company and the institution. This thesis studies the legal regulations for protection of participants of clinical research for new drug. In this respect the first matter of this study is to seek which relation between pharmaceutical firm and participants of clinical trials. Especially, there is a question which the trial subject is entitled to demand the pharmaceutical company which requested clinical trials the institution to supply the investigational new drug, after the contract for clinical trials had terminated or cancelled. This study take into account the liability of the pharmaceutical company to trial subject. Secondly, it is researched the roles and authority of Institutional Review Board(IRB). IRB is Research Ethics Committee of the institution, in which clinical trials for new drug are conducted. According to the rule of Korea good clinical practice(KGCP), IRB is the mandatory organization which is authorized to approve, secure approval or disapprove the clinical trials for investigational new drug in the institution. The important roles are the review of ethical perspective of trial research and the protection of trial subject. Thirdly, this paper focuses if the participants are to be paid for the participation for clinical research. This is ethical aspect of clinical trials. It is resonable that the participant is reimbursed for expenditure such as travels, and other expenses incurred in participation in trials. It is not allowed that the benefit of clinical trials is paid to trial subject. The payment should not function as financial inducements for participations of trials. Finally, the voluntary consent of the trial subject is required. The institution ought to inform the subject, who would like to participate in trials, and it ought to received informed consent in writing for subject. In this regard, it is matter that trial subject has ability of consent. It is principle that the subject as severely psychogeriatric patient has not ability of consent. However, it is required that not only healthy people but also patients are allowed to take part in clinical trials of new drug, in order to confirm which the investigation new drug is secure. Therefore there are cases, in which the legal representative of subject consent the participation of the trials. In addition, it is very important that the regulations concerning clinical trials of new drug is to be systematically well-modified. The approach of legal and political approach is needed to achieve this purpose.
Yeonju Kim;Yigun Lim;Subin Ahn;Junyeop Oh;Yoonbyeong Chae;Yoomin Choi;Jong Uk Kim
Journal of Acupuncture Research
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제41권1호
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pp.29-52
/
2024
The aim of this review is to consolidate findings from clinical investigations spanning the past decade regarding the impact of acupuncture on Parkinson's disease (PD). The objective is to assess the efficacy of acupuncture as a therapeutic approach to PD, with the intention of informing future clinical practices and advancing the foundation for subsequent research endeavors in this area. A comprehensive literature search was conducted to identify clinical trials exploring the effects of acupuncture on PD between January 2014 and August 2023. Databases search included PubMed, EMBASE, CNKI, OASIS, KISS, KMBASE, RISS, and ScienceON. Quantitative evidence from randomized controlled trials (RCTs) was systematically reviewed, and the methodological quality of the included studies was assessed using Cochrane's risk of bias tool. Meta-analysis was performed using Review Manager (RevMan) 5.4.1 software. The systematic review encompassed a total of 38 RCTs involving 2,786 participants. Meta-analysis of 12 studies revealed that individuals treated with a combination of acupuncture and Western medicine exhibited notable improvements compared to those receiving Western medicine alone or sham acupuncture alongside Western medicine. However, the overall quality of the RCTs was deemed low, and no serious adverse events were reported. Across clinical investigations conducted in the past decade, acupuncture appears to hold promise as a complementary treatment for PD patients when administered alongside Western medicine. Nevertheless, this study identifies certain limitations that warrant consideration in future research endeavors. Enhanced emphasis on conducting high-quality RCTs is imperative to comprehensively evaluate the efficacy of acupuncture in managing PD.
Objectives: This review aims to report the efficacy and safety of electroacupuncture in the treatment of primary dysmenorrhea. Methods: We searched for randomized controlled studies (RCTs) using electroacupuncture on primary dysmenorrhea up to Dec 2016. The following databases were searched : OASIS, PubMED, EMBASE, CENTRAL. The results of the studies were analyzed and the risk of bias was assessed. Results: Five studies were included in this review. In most studies, the effect of electroacupuncture at Sameumgyo (SP6) was better than that of electroacupuncture at Hyeonjong (GB39), nonacupoint and no intervention about Visual analog scale (VAS), Verbal rating scale (VRS) and Retrospective symptom scale (RSS). But there were no significant effects on Resistance Index (RI) and S/D ratio (the ratio between peak systolic to end-diastolic flow velocity in uterine arteries). Serous adverse events were not reported. Conclusions: This review shows that electroacupuncture is effective on primary dysmenorrhea with no serious adverse events.
Objectives : It is necessary to monitor consumption of drugs in order to enhance promote appropriate use of drugs. Defined Daily Dose(DDD) of World Health Organization(WHO) has been used for evaluating the amount of medicine use. However, DDD of some drugs must be determined for drugs in Korea which are not listed by WHO. Our formulary follows ourself classification and DDD of some drugs must be determined since they exist only in Korea. This study was aimed to determine DDD value using RAND Appropriateness Methods and evaluate the amount of antibiotics use using DDD value. Methods : J01 antibiotics of WHO anatomical therapeutic chemical(ATC) classification were extracted from drug formulary. Antibiotics list without DDD was identified to determine their DDD with comprehensive review of references and recommendation of experts. defined. Review of reference was executed. of Expert panels were comprised of clinical pharmacist and clinical doctors. Modified Delphi Method was applied by survey and consensus meeting. Amount of antibiotic use was calculated by DDD/1000 inhabitants/day in the national level using health insurance claim data. Results : The result of 1 round, DDD values of 28 ingredients were determined from the first round of consensus meeting. With 2nd round meeting, 3 ingredients were deleted and DDD of 17 ingredients were decided. Analysis of antibiotic use in health insurance claim data showed 22.97 DDD/1000 inhabitants/day in 2003 year. Conclusion : This study can contribute to the establishment of DDD assignment and thus quantifying drug uses.
In this study, we examined whether the systematic literature review method used in the field of evidence-based medicine could be used for post-market clinical evaluation of medical devices by modifying them to fit the regulatory perspective of medical devices in Korea. For this purpose, systematic literature review was modified and applied to conduct a clinical literature survey on the ophthalmic electrosurgical system(Trabectome®, NeoMediX Corp) used for the treatment of glaucoma. A total of six documents were finally selected, and clinical safety and efficacy information on the indications of the ophthalmic electrosurgical system were effectively presented. In addition, general safety information and unexpected safety information could be distinguished through comparison with medical device adverse event reporting cases. The method used in this study is expected to be used in various ways throughout post-market medical device safety management system and for the purpose of regulation improvement, especially in the field of ophthalmic electrosurgical system.
Objectives : This work aimed to review clinical trial trend of Korean medicine's face rejuvenation and suggest future trial using embedded needle(Maesun) based on Evidence-based medicine's PICO Model. Methods : 46 papers were searched from Oasis and DBPia, then 8 papers were engaged in review of clinical trial trend. Based on PICO model, clinical trial's patient, intervention, and outcome measurement were suggested. Results : Evidence level of clinical trials is relatively low, because their study designs are almost case report or case series. No study have comparison groups. Outcome measurement is varied, however, 3D face scanner were used to measure before-after changes of face. Based on review, we suggested that necessity of intervention standardization, measuring of normal control group and 2D/3D combined outcome measurement of face. Conclusions : There are many demands for revealing efficacy and safety of Korean medicine's intervention, also for face rejuvenation using embedded needle. For meeting the level of demands, more rigorous works are needed.
Medical humanities education (MHE) is as essential as basic medical sciences and clinical medicine education. Despite the importance of MHE, MHE curriculum development (CD) has proven to be challenging. This critical review examines the MHE CD at one medical school. The critical review methodology was developed based on Kern's six step CD model to systematically examine the CD of "Doctoring and Medical Humanities (DMH)" at the Yonsei University College of Medicine. Five review questions were developed related to (1) necessity, (2) direction and purpose, (3) design, (4) operation, and (5) evaluation of CD based on Kern's model. The review showed that the process of DMH CD mapped to components of Kern's model. The DMH curriculum content selected was closely related to medical practice and aimed to combine the acquisition of understanding and skills by designing a student-participatory curriculum based on clinical cases. Assessment methods that emphasized students' reflections were actively introduced in the evaluation section. Since the regular committee for DMH continued the work of the special ad hoc committees for DMH CD, the CD was effectively completed. However, the planning and evaluation functions and responsibilities of the DMH committee need to be strengthened. Despite the apparent limitations, the fact that students showed a high satisfaction rate and preferred small group discussions based on clinical cases has significant implications in the instructional design of MHE, where changes in self-awareness and attitude are more important than the acquisition of information. It is necessary to systematically review and study students' reflection results produced by the changed assessment methods and to develop assessment indicators for MHE that reflect the achievements of the MHE competencies of students.
Background: Rehabilitations in subacute phase are different from acute treatments regarding the characteristics and required resource consumption of the treatments. Lack of accuracy and validity of the Korean Diagnosis Related Group and Korean Out-Patient Group for the acute patients as the case-mix and payment tool for rehabilitation inpatients have been problematic issues. The objective of the study was to develop the Korean Rehabilitation Patient Group (KRPG) reflecting the characteristics of rehabilitation inpatients. Methods: As a retrospective medical record survey regarding rehabilitation inpatients, 4,207 episodes were collected through 42 hospitals. Considering the opinions of clinical experts and the decision-tree analysis, the variables for the KRPG system demonstrating the characteristics of rehabilitation inpatients were derived, and the splitting standards of the relevant variables were also set. Using the derived variables, we have drawn the rehabilitation inpatient classification model reflecting the clinical situation of Korea. The performance evaluation was conducted on the KRPG system. Results: The KRPG was targeted at the inpatients with brain or spinal cord injury. The etiologic disease, functional status (cognitive function, activity of daily living, muscle strength, spasticity, level and grade of spinal cord injury), and the patient's age were the variables in the rehabilitation patients. The algorithm of KRPG system after applying the derived variables and total 204 rehabilitation patient groups were developed. The KRPG explained 11.8% of variance in charge for rehabilitation inpatients. It also explained 13.8% of variance in length of stay for them. Conclusion: The KRPG version 1.0 reflecting the clinical characteristics of rehabilitation inpatients was classified as 204 groups.
Background and Objective: The use of potentially inappropriate medications (PIMs) increases the risk of negative health outcomes, including drug-related admissions. Tools for structured medication review have been developed to ensure optimal medication use and safety. Here, we aimed to evaluate medication use review (MUR) tools for community-dwelling older patients. Methods: We performed a systematic review of the literature according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Statement (PRISMA). We searched PubMed, Embase, and the Cochrane Library from 1991 to 2020, excluding tools that are specifically applied to hospitalized patients or nursing home residents. We identified the most common inappropriate medications, drug-disease interactions, drug-drug interactions and prescribing omissions presented among tools. Results: From among 9,788 identified reports screened, 60 met our inclusion criteria; finally, 27 were eligible for data analysis considering originality and up-to-dateness. Most tools presented explicit criteria (93%), and only one was specific to community-dwelling elderly. The most common PIM was tricyclic antidepressants. Use of diltiazem and verapamil in patients with heart failure and the combination of nonsteroidal anti-inflammatory analgesics and warfarin were the most frequent disease-specific PIM and drug-interaction, respectively. Conclusions: Although several medication review tools have been developed for older adults, specific guidelines for community-dwelling populations remain limited. Furthermore, the list of PIMs differed among available tools. In future, specific but integrating MUR tools need to be developed for clinical practice considering this population.
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