초록 ▼

○ 본 연구는 근거중심 한의임상진료지침 개발, 한의임상진료지침의 임상 적용성 연구, 한의임상진료지침 개발을 통해 요구된 근거 창출 연구, 그리고 국내외 전문가 네트워크 구축의 4가지의 성과목표로 연구가 수행되었음. 즉, 본 연구를 통해 한의학의 다빈도 질환에 대한 국제 수준의 근거중심의학 연구 방법론에 따라 한의임상진료지침을 개발하고 보급 및 확산, 국내외 네트워크를 구축함으로써 한의 의료의 질 향상에 기여하고자 하였음.
○ 연구 성과로는 총 7개의 질환 (안면신경마비, 아토피 피부염, 요추 추간판 탈출증, 족관절염좌, 견비통

○ 본 연구는 근거중심 한의임상진료지침 개발, 한의임상진료지침의 임상 적용성 연구, 한의임상진료지침 개발을 통해 요구된 근거 창출 연구, 그리고 국내외 전문가 네트워크 구축의 4가지의 성과목표로 연구가 수행되었음. 즉, 본 연구를 통해 한의학의 다빈도 질환에 대한 국제 수준의 근거중심의학 연구 방법론에 따라 한의임상진료지침을 개발하고 보급 및 확산, 국내외 네트워크를 구축함으로써 한의 의료의 질 향상에 기여하고자 하였음.
○ 연구 성과로는 총 7개의 질환 (안면신경마비, 아토피 피부염, 요추 추간판 탈출증, 족관절염좌, 견비통, 비만, 우울증) 한의임상진료지침 개발 및, 출판하였으며, 임상진료지침 개발을 위한 표준보고가이드 보급, 전문가 네트워크 협의체 구축을 완료하고 연례회의 및 국제심포지엄을 개최를 통해 한의임상진료지침의 우수성을 국내외에 널리 알림. 또한 임상진료지침 보급 및 확산, 그리고 임상진료지침의 장애요인을 도출하기 위해 진료지침개발 경험이 있는 임상의를 대상으로 설문 조사 및 리플렛화한 요추 추간판 탈출증과 견비통 임상진료지침의 임상현장 적용성 연구를 수행하였음. 또한 교육 모델 구축에 따른 임상진료지침 사용자 즉 관련 학회에서 사용자 및 개발자 대상 교육을 실시함. 마지막으로 개발된 임상진료지침에서 요구된 근거간격을 좁히기 위한 안면신경마비와 요추 추간판 탈출증 치료시 약침에 대한 근거확보 안전성 임상연구를 수행함.
○ 이러한 결과는 한의약 치료기술에 대한 질 높은 후속임상연구를 유도하고, 세계적으로 전통의학 근거 기반 및 창출 분야에서 선도적인 역할을 할 것으로 기대됨.

( 출처 : 보고서 초록 5p )

Abstract ▼

Ⅳ. Results of research
1. Development of evidence-based clinical practice guidelines for the treatment of frequently diagnosed diseases in traditional Korean medicine
(1) Development of standard reporting guidance for evidence-based clinical practice guidelines for traditional Korean medicine

Ⅳ. Results of research
1. Development of evidence-based clinical practice guidelines for the treatment of frequently diagnosed diseases in traditional Korean medicine
(1) Development of standard reporting guidance for evidence-based clinical practice guidelines for traditional Korean medicine (Preferred Reporting Items for DEvelopment of Clinical Practice Guideline in Korean Medicine, PRIDE-CPG-KM)
The PRIDE was to develop a unified methods platform with preferred reporting items for development of evidence based clinical practice guideline in traditional medicine. We searched the literature and guideline handbooks,collected information from methodological conferences. A group of expert edited drafts of the items, identifying for each item of one or more exemplars of good reporting, and developed text explaining the rationale and discussing relevant evidence. To develop, we also used general and various guideline checklists and drew on the experience gained from Oriental medical doctors and methodological experts. The PRIDE-CPG-KM, in the form of a checklist and description of items and example, were designed to improve reporting of CPG in TM, and hereby facilitating their interpretation and replication. The PRIDE included 5 items and 40 sub-items.

(2) Development and approval of evidence-based clinical practice guidelines for traditional Korean medicine (Development)
Through systematic, evidence-based approaches, evidence-based clinical practice guidelines for traditional Korean medicine have been developed for seven disease entities (facial palsy, herniation of the lumbar vertebra, atopic dermatitis, ankle sprain, shoulder-arm pain, obesity and depression). Following the preparation of the initial draft of evidence-based clinical practice guidelines, external reviews were performed by specialists in the relevant fields, as well as the academic societies.
This was followed by the official approval of evidence-based clinical practice guidelines by a group of experts in the relevant areas of specialization. Using the AGREE II tool, which was designed for the assessment of evidence-based clinical practice guidelines, we re-evaluated the level of the quality of the pre-existing evidence-based clinical practice guidelines for the treatment of facial palsy, atopic dermatitis and the herniation of the lumbar vertebra. This was followed, if applicable, by their re-publication.

2. Application of evidence-based clinical practice guidelines for traditional Korean medicine to their promotion and distribution in actual clinical settings (Implementation and adaptation)
(1) Analysis of the current status of the applicability of evidence-based clinical practice guidelines for traditional Korean medicine, and identification of the relevant factors affecting it

In an effort to spread and apply evidence-based clinical practice guidelines, it would be mandatory to analyze both the internal and external factors that are associated with the degree of acceptance of evidence-based clinical practice guidelines in an actual clinical setting. It would also be mandatory to pursue strategic approaches that are specific to traditional Korean medicine for the purpose of resolving each detrimental factor. Unfortunately, in the field of traditional Korean medicine, there is currently a paucity of data regarding the applicability of pre-existing evidence-based clinical practice guidelines and the relevant factors. Given this background, we conducted the current study with the goal of collecting baseline data for establishing a strategy to improve the applicability of evidence-based clinical practice guidelines prior to their development. To this end, we executed a self-reporting questionnaire survey to examine the rationale and the current status of the applicability of evidence-based clinical practice guidelines, and to identify factors that might affect the degree of their acceptance in a clinical setting among health care practitioners with experience in the development of evidence-based clinical practice guidelines.

Of the evidence-based clinical practice guidelines that have been developed thus far in the field of the traditional Korean medicine, we selected those that had been developed through a systematic literature review. Then, we received the recommendations of more than ten health care practitioners from each academic society with experience in the development of evidence-based clinical practice guidelines. Ultimately, we surveyed a total of 26 health care practitioners. The study period ran from September 1^st to 24^th, 2015. Using Survey Monkey, we collected their responses. The current study was designed to examine the current recognition of and attitudes towards evidence-based clinical practice guidelines among traditional Korean medical professionals with the experience of guideline development, and thus attempts to provide baseline data for establishing strategic approaches for the preparation, promotion and distribution of evidence-based clinical practice guidelines that are customized to the actual clinical setting in the field of traditional Korean medicine.

Most of the respondents recognized the necessity of evidence-based clinical practice guidelines. It is also presumed that there is a broad consensus that top-quality, evidence-based clinical practice guidelines for traditional Korean medicine should be developed through systematic education. In addition, such results might be significant in that they were obtained from the experience of developing evidence-based clinical practice guidelines. These results may vary depending on the type of evidence-based clinical practice guidelines. Overall,however, the proportion of respondents who recognized and agreed on the importance of evidence-based clinical practice guidelines was relatively high.

(2) Conducting clinical studies for the purpose of evaluating the applicability of evidence-based clinical practice guidelines for traditional Korean medicine
In the current study, leaflets describing evidence-based clinical practice guidelines were prepared. Then, respondents were divided into two groups: a group in which respondents did not use a leaflet (the non-leaflet group) and a group in which they did (the leaflet group). Thus, the applicability of evidence-based clinical practice guidelines was evaluated.

Based on evidence-based clinical practice guidelines for traditional Korean medicine, which had been developed to help health care practitioners specializing in traditional Korean medicine to diagnose and treat diseases through a decision-making process, we used a leaflet describing evidence-based clinical practice guidelines as a communication tool during the treatment of patients with HIVD. We carried out the current study with the aim of examining whether such a strategy would be helpful for increasing the degree of satisfaction from the perspective of both patients and health care practitioners, and increasing treatment compliance. To do this, we examined evidence-based clinical practice guidelines for the treatment of herniation of the lumbar vertebra and shoulder-arm pain. In patients with shoulder-arm pain, we performed an inter-group comparison to evaluate the degree of satisfaction with the use of a leaflet using 1-5 items of the questionnaire inquiries. In group 1, we used a leaflet for the first session of the assessment of the degree of satisfaction, but did not for the second one.

Conversely, in group 2, we did not use a leaflet for the first session of the assessment and did for the second one. In group 1, the mean degree of patient satisfaction was 23.32 points in the leaflet group, while it was 23.36 in the non-leaflet group. These results indicate that there was a slight increase in patient satisfaction. In group 2, the mean degree of patient satisfaction was 22.88 points in the non-leaflet group and 23.88 points in the leaflet group. These results indicate that patient satisfaction was increased by 1 point on average. With regard to the pattern shown in group 1, the effects due to the use of a leaflet might be associated with those in the second session of the assessment. With regard to the pattern shown in group 2, it was found that the use of a leaflet was associated with an increased degree of patient satisfaction. Based on studies about the applicability of evidence-based clinical practice guidelines for the treatment of the herniation of lumbar vertebra, we analyzed the degree of satisfaction with and understanding of traditional Korean medical professionals’ information and the resulting trustworthiness, the length of the time of medical examinations and the overall process of medical treatments. This showed that the mean degree of patient satisfaction was 88% to 96% in the leaflet group and 64% to 72% in the non-leaflet group, indicating that patient satisfaction was significantly higher in the leaflet group compared with the non-leaflet group.

(3) Establishment of an educational model for the promotion and distribution of evidence-based clinical practice guidelines for traditional Korean medicine
With regard to the establishment of an educational model for the improvement of the applicability of evidence-based clinical practice guidelines, promotional activities have been performed at the conference meetings of the relevant academic societies for the purpose of forming a consensus on the significance and applicability of evidence-based clinical practice guidelines, thereby improving treatment outcomes. Moreover, attempts were made to raise the degree of understanding of evidence-based medicine by implementing an educational program about the process of developing evidence-based clinical practice guidelines through evidence-based medical approaches in the field of traditional Korean medicine. Students attending traditional Korean medical schools can be characterized as holders of a relatively higher level of creativity, scholarly disciplines and transfer of learning effects. It can therefore be inferred that a higher degree of understanding and experience of evidence-based medicine during their undergraduate courses might be essential for increasing the degree of expertise of research activities as traditional Korean health care practitioners and decision-makers in an actual clinical setting. We therefore delivered lectures on the understanding of evidence-based clinical practice guidelines through evidence-based medical approaches to students attending traditional Korean medical schools.

(4) Education for users and developers involved in evidence-based clinical practice guidelines
For the purpose of increasing the degree of understanding of the process and methodology of the development of evidence-based clinical practice guidelines in the field of traditional Korean medicine, training for target audiences was performed a total of six times at each step of the developmental process. This is a step-by-step program that has been adjusted to the process of the development of evidence-based clinical practice guidelines. This training was performed to improve the expertise of developmental personnel, to enhance the quality of evidence-based clinical practice guidelines and to manage the overall process of developing evidence-based clinical practice guidelines through a consistent methodology.

3. Acquisition of clinical evidence for the development of evidence-based clinical practice guidelines for traditional Korean medicine
(1) Conducted study to acquire the clinical evidence required for the development and revision of evidence-based clinical practice guidelines
Based on the preliminary interviews with the developers, the level of priority and the requirement and possibility of conducting of clinical studies were determined. Following this, to collect clinical evidence, retrospective studies were conducted regarding the safety of pharmacopuncture. Of patients who had been diagnosed with facial palsy, through a retrospective analysis of the baseline data of those who underwent pharmacopuncture therapy and safety data, 1035 cases were collected from three traditional medical centers affiliated with the university in a multi-center setting. Moreover, safety data about the herniation of lumbar vertebra 51 cases were retrospectively collected from Semyung University hospital in a single-center setting. Thus, reports were made regarding the safety of pharmacopuncture in the treatment of two disease entities, facial palsy and the herniation of lumbar vertebra. Currently evidence of adverse events is far from sufficient for assessing a reliable, precise occurrence rate. This deserves further prospective safety studies, which will be used as baseline data for the relevant further clinical studies. Thus, we await well designed future studies of pharmacopuncture with more proper and strict harms reporting methods.

4. Establishment of a network of groups of experts from Korea or overseas countries for EB_KMCPG
In the current research, a multidisciplinary network of experts from Korea and other countries was formed beginning at the stage of study design in 2012. In an effort to establish evidence-based clinical practice guidelines and to discuss their future directions or other relevant issues, an annual meeting and symposium were held a total of four times. This network group of experts in the development of evidence-based clinical practice guidelines for traditional Korean medicine comprises a total of 16 experts from seven countries. It is also composed of principal investigators who will mainly be involved in the development of evidence-based clinical practice guidelines for traditional Korean medicine through evidence-based medical approaches. At symposia for the development of evidence-based clinical practice guidelines, held a total of four times, future issues and directions or implications were discussed in collaboration with specialists in the development of evidence-based clinical practice guidelines in the field of traditional medicine of each country. In addition, there will be further efforts to conduct collaborative studies in order to establish a platform for the development of evidence-based clinical practice guidelines based on a worldwide consensus.

Furthermore, since 2012, with the initiation of the workshop regarding the methodology of evidence-based medicine, there have been promising steps toward the future development of evidence-based clinical practice guidelines for traditional Korean medicine. Workshops have been held a total of eight times. Thus, attempts have been made to raise the degree of understanding of systematic literature reviews, which have served as a main methodology for the development of evidence-based clinical practice guidelines for traditional Korean medicine, and to form a consensus between the stakeholders. In particular, through collaboration with the Korean branch of the Cochrane Medical Review that provides the latest updates regarding the methodology of evidence-based medicine, a workshop for the systematic literature review was held. In 2015, at the International Congress on Complementary Medici

ne Research (ICCMR), a workshop for the methodology of evidence-based medicine was held. Thus, efforts have been made to increase the degree of understanding of evidence-based medicine in the field of traditional Korean medicine.

5. Plans for application of research results
The current study was conducted for the purpose of providing evidence and suggestions for both health care practitioners and patients during the development of evidence-based clinical practice guidelines through a methodology that is appropriate for the current status of traditional Korean medicine, which lacks clinical evidence from actual clinical settings. Specialists will be fostered and then spread or distributed through regular CPG education for traditional Korean medicine and the health care industry in Korea based on the expertise acquired from a group of experts from Korea and other countries.

In other words, with the development of evidence-based clinical practice guidelines for the treatment of major morbidities, it will become possible to objectively judge the current status of clinical therapeutic technology in the field of traditional Korean medicine. Thus, this would also be connected to the exploration of clinical research areas for which clinical support may be required henceforth. With the application of the rationale of the assessment of medical technology, traditional Korean medicine is subjected to the decision-making process to a considerable extent in the health care policy system. This may also apply to an actual clinical setting, which may be followed by an increased accessibility to traditional Korean medicine.

Moving forward, a methodology for medical treatment services in traditional Korean medicine should be established based on the development of evidence-based clinical practice guidelines for traditional Korean medicine, as implemented by our institution. This should be followed by a variety of studies and activities that will promote the propagation and pursuit of the development of evidence-based clinical practice guideline.

( 출처 : SUMMARY 22p )

목차 Contents

• 표지 ... 1
• 제 출 문 ... 3
• 보고서 초록 ... 5
• 요 약 문 ... 7
• SUMMARY ... 17
• Contents ... 31
• 목차 ... 33
• 표목차 ... 35
• 그림목차 ... 37
• 제1장 연구개발의 목적 및 필요성 ... 39
• 제2장 연구개발의 내용 및 범위 ... 45
• Ⅰ. 다빈도 질환 한의임상진료지침 개발 ... 47
• Ⅱ. 한의임상진료지침 보급 및 확산을 위한 임상현장 적용 (Implementation and adaptation) ... 63
• Ⅲ. 한의임상진료지침 개발을 위한 임상 근거 확보 (Evidencedevelopment) ... 70
• Ⅳ. 한의임상진료지침 개발을 위한 국내외 전문가 네트워크 구축 (EB_KMCPG Network) ... 72
• 제3장 연구개발 결과 ... 73
• Ⅰ. 다빈도 질환 한의임상진료지침 개발 ... 75
• Ⅱ. 한의임상진료지침 보급 및 확산을 위한 임상현장 적용 (Implementation and adaptation) ... 105
• Ⅲ. 한의임상진료지침 개발을 위한 임상 근거 확보 (Evidence development) ... 120
• Ⅳ. 한의임상진료지침 개발을 위한 국내외 전문가 네트워크 구축 (EB_KMCPG Network) ... 136
• 제4장 연구개발결과의 활용계획 ... 147
• Ⅰ. 기본방향 ... 149
• Ⅱ. 성과활용계획 및 기대효과 ... 151
• 제5장 연구의 의의 ... 153
• 참 고 문 헌 ... 157
• 부 록 ... 161
• 끝페이지 ... 217