▢ 연구 배경
Ⅰ. 진료지침 개발 관련 현황
근거기반의학의 보급 이후 과학적이고 객관적인 최상의 근거를 임상에 받아들이고자 하는 수요와 맞물려 개발과 적용에 대한 관심이 높아졌고, 최근에는 신뢰도 높은(trustworthy) 임상진료지침의 개발이 더욱 중요한 이슈가 되고 있다.
국내의 경우 2014년 한국보건의료연구원의 진료지침 개발 현황 분석 결과 2009년 이후 신규직접 개발방식이 증가하고 방법론적인 향상이 보였으나, 여전히 진료지침에 체계적인 근거의 검색이나 합성, 근거활용에 대한 기술은 부족한 것으로 나타났다.
앞으로 국내 진료지침 역시 질적으로 ‘신뢰할 수 있는 진료지침’의 조건을 충족하는 것에 더욱 관심이 증가될 것이며, 최근 대규모의 근거기반 진료지침 개발 프로젝트의 경우 한국보건의료연구원의 공공성 측면과 그동안 축적된 근거기반 방법론을 적용한 연구성과 때문에 자문이나 협력요청이 증가하고 있는 추세이다. 따라서 구체적인 방법론적 지원 방안에 대한 대책 마련이 필요한 상황이다.
Ⅱ. 진료지침 적용 관련 현황
임상현장에서 생성된 근거는 진료지침이라는 도구를 통해 지식이 되고, 다시 현장에 적용되어 새로운 근거를 생성할 수 있어야 한다. 그러나 임상진료지침의 확산 및 실행에는 현실적으로 다양한 장애요인(barrier)가 존재하며, 임상진료지침이 실제 적용되어 진료행위의 변화가 일어나는 것은 쉽지 않다. 국내에서는 최근 선행 연구 결과(조희숙 등, 2013)에서는 2개 학회 대상 설문조사 결과 개발된 진료지침에 대한 인지도 및 접근성은 90~100%로 높았지만 활용도는 50% 미만이었다. 따라서 국내 상황에서 어떤 부분들이 실행의 장애요인으로 작용할 수 있는지 좀 더 자세한 조사가 필요하다.
▢ 연구 목적
본 연구는 신뢰도 높은 임상진료지침 개발의 확산을 위한 전문학회 및 유관기관과의 업무 협력 모형을 구축하고, 진료지침의 임상적용과 관련된 방법론연구의 심화 및 국내 임상진료지침의 적용성 평가를 통해 궁극적으로 환자진료의 질 향상에 기여하고자 한다.
구체적인 연구 목표는 다음과 같다.
1) 구조적 문헌고찰과 사례 조사로 신뢰도 높은 임상진료지침의 협력 과정의 개념 정립
2) 개별 협력 활동 방안의 구체화 및 예시 작성
3) 임상진료지침의 적용성 평가: 내적·외적 장애요인 파악
▢ 연구 방법
Ⅰ. 진료지침 개발 협력 프로토콜 개발
1. 구조적 문헌고찰(Structured Literature Review)
‘지침 개발에 있어 근거평가(또는 체계적 문헌고찰)와 관련한 협력이 일어나는 유형은 어떠한가?’라는 연구 질문에 답하기 위해 1) 지침 개발에 있어 우선순위 고려요소는 무엇인가? 2) 지침 개발에 있어 근거평가(또는 체계적 문헌고찰) 관련 협력 유형은 어떠한가? 라는 핵심질문을 선정하여 구조적 문헌고찰을 수행하였다.
2. 임상진료지침 개발 협력 사례 전문가 개별 심층면담 및 자문
임상진료지침 개발 과정에서 근거평가(evidence review)의 중요성 및 협력 형태를 확인하고 협력 개발의 모형을 도출하기 위하여 임상 전문가와 방법론 전문가의 협력을 통한 임상진료지침 개발 경험이 있는 전문가를 대상으로 개별 심층면담(in-depth interview) 또는 서면 자문을 수행하였다. 반구조화된 질문 문항을 토대로 진료지침 개발 시 근거평가 방법, 근거평가 시행 주체, 근거평가 범위, 근거평가에 소요된 인력 및 자원, 근거평가의 활용 계획 등에 대한 전문가들의 심층적인 의견을 질적으로 분석하였다.
Ⅱ. 임상진료지침의 적용성 평가
1. 진료지침의 내적 적용성 및 장애요인 평가
(1) Guideline Implementability Appraisal (GLIA) ver.2.0 도구의 한글 번역 및 실행가능성 검토
진료지침의 내적 적용성 및 장애요인을 평가하는 도구인 GLIA 도구의 ver.2.0 버전을 한글로 번역하기 위해 원저자로부터 한글 번역에 대한 승인을 받았다. 번역 과정은 영한 1차 번역, 한영 역번역, 역번역 검토 후 번역본 초안 와성, 외부 전문가 1차 검토 및 외부전문가 2차 검토를 거쳐 번역 최종본을 완성하였다. 1차 및 2차 외부전문가 검토를 통해 번역된 내용의 의미전달 일치에 대한 동의 정도(4점 척도) 및 국내 적용가능성에 대한 평가 항목을 5개로 구분하여 평가 받았다(7점 척도).
(2) GLIA ver.2.0 번역 도구를 이용한 국내 지침 시범 평가
번역된 도구를 국내 진료지침의 평가에 적용하고자 하였다. GLIA 도구를 적용하여 개발이 진행 중인 권고의 잠재적인 장애요인을 파악함으로써 개발자에게 실재적인 도움을 주는 것이 도구의 평가 목적에 더 적합하다는 점을 고려하여 평가 대상 지침을 선정하였다. 최종 선정된 대한외상·중환자외과학회의 ‘복부 외상환자에 대한 항생제 사용 지침’을 방법론 전문가 및 임상 전문가 7명이 번역된 도구를 이용하여 독립적 평가 후 의견이 불일치한 항목들에 대해 합의하였다.
2. 진료지침 적용의 외적 장애요인 확인을 위한 설문조사
본 연구에서는 진료지침의 대상 사용자에게 설문조사를 실시하여 기존 진료지침 적용 경험, 평소 지침 적용의 장애요인과 함께 GLIA 평가를 적용한 진료지침의 예상되는 외적 장애요인을 확인하고자 하였으며, ‘복부 외상환자에 대한 항생제 사용 지침’의 대상 사용자인 대한외상·중환자외과학회 회원 약 60명을 대상으로 설문조사를 시행하였다. 설문기간은 약 2주 동안 진행하였으며, 총 47명이 설문조사에 응답하였다.
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▢ Background
Ⅰ. Current Status related to Clinical Practice Guideline Development
In connection with the demand that would like to accept the best scientific and objective evidence to clinical practice, the interests in development and implementation of clinical practice guideline are getting increased. In the future, the domestic clinical practice guidelines will also increase the concern for satisfying the condition of ‘trustworthy clinical practice guideline’ in qualitative ways. Thanks to public aspects of National Evidence-based Healthcare Collaborating Agency (NECA) and study results to which evidence-based methodology accumulated so far are applied, requests for consulting or collaboration tend to increase. Therefore, it is now necessary to prepare measures for ways to support with specific methodology.
Ⅱ. Current Status related to Clinical Practice Guideline Implementation
The evidence generated in a clinical field should be applied to the field and generate new evidence. However, there are realistic, various barriers in proliferation and execution of clinical practice guidelines, and it is not easy to apply a clinical practice guideline to have changes in clinical practice. Therefore, there needs more detailed investigation to see which parts in domestic situation can be barriers of implementation.
▢ Objective
This study will build a task cooperation model with specialized academic societies and related organizations to increase clinical practice guidelines with high trustworthiness, and ultimately contribute to increase the quality of patient treatment through intensifying methodology studies related to clinical application of clinical practice guidelines and implementability evaluation of domestic clinical practice guidelines.
1) Establishment of concept of cooperation process of trustworthy clinical practice guidelines through structured literature review and case study
2) Actualization of individual cooperative activity methods and preparation of examples
3) Evaluation of implementability of clinical practice guidelines: understanding internal and external barriers
▢ Methods
Ⅰ. Clinical Practice Guideline Development Cooperation Protocol Development
1. Structured Literature Review
To answer research problem ‘What are types in which cooperations related to evidence review(or systematic review) in consultation development?’, key questions of 1) What are priority considerations in developing guidelines? and 2) What are types of cooperation related to evidence review(or systematic review) in developing guidelines? to perform the structured literature review.
2. Clinical Practice Guideline Development Cooperation Case Experts’ Individual In-depth Interview and Consultation
To identify the importance of evidence review and cooperation types in process of developing clinical practice guidelines and derive a model for cooperation development, in-depth interview or written consultation were conducted in experts with experience of development of clinical treatment guidelines through cooperation of clinical and methodological experts.
Ⅱ. Evaluation of Implementability of Clinical Practice Guideline
1. Evaluation of Internal Implementability of Clinical Practice Guideline and Barriers
(1) Review of Korean Translation and Implementability of Guideline Implementability Appraisal (GLIA) ver. 2.0
Version 2.0 of GLIA which is an instrument to evaluate internal implementability and barriers of clinical practice guidelines was translated into Korean. In the translation process, after completing the first draft of translation following English-Korean translation and Korea-English backward translation, and the final translation was completed after going through review of external experts twice. The consent degree on the consistency of meaning communication of the translated contents and domestic implementability were evaluated by the review of external experts.
(2) Demonstrative Evaluation of Domestic Guideline Using Translation Instrument of GLIA ver.2.0
After an independent evaluation of ‘Guideline to Use of Antibiotics in Patients with Abdominal Trauma’ of the Korean Society of Acute Care Surgery which is under development in Korea using the translated instrument, the items with inconsistent comments were settled.
2. Survey to Identify External Barriers of Clinical Practice Guideline Implementation
The survey was attempted to identify external barriers expected in the domestic development clinical practice guidelines applied by GLIA evaluation. The survey was conducted in about 60 members of the Korean Society of Acute Care Surgery who are the users of the ‘Guideline to Use of Antibiotics in Patients with Abdominal Trauma’.
▢ Results
⦁Building a task cooperation model of CPG development
⦁Korean Translation and Demonstrative Evaluation of Implementability of Guideline Implementability Appraisal (GLIA) ver. 2.0
⦁Survey to Identify External Barriers of Clinical Practice Guideline Implementation
Ⅰ. Development of Clinical Practice Guideline Development Cooperation Protocol
1. Structured Literature Review and Investigation of Domestic Status
A total of 13 pieces of literature were selected for structured literature review including 4 domestic articles and 9 overseas articles. To identify the form of cooperation related to evidence review in development of clinical practice guidelines, the literature was divided into (1) the subject of guideline development, (2) inclusion of experts related to evidence review in composition of guideline development group, (3) the subject conducting evidence review, and (4) the scope of evidence review and what suggested by each article was identified.
2. Clinical Practice Guideline Development Cooperation Case Expert's Individual In-depth Interview and Consultation Results
To suggest support cooperation system related to evidence review in development of clinical practice guidelines, it was attempted to collect various opinions of clinical practice guideline developers in the Society comprehensively. The interview contents were divided into difficulties related to guideline development and implementation experiences and opinions about cooperative activities with National Evidence-based Healthcare Collaborating Agency.
When analyzing the interview findings, in the suggestions for clinical practice guideline support and cooperation system, it was integrated into 32 subcategories from a total of 42 significant statements and descriptions, focusing on the 4 subjects. Based on them, it was structured with 10 categories.
3. Development Cooperation Model and Cooperation Protocol(Draft)
In this study, advanced research, overseas case study, structured literature review, and experts’ in-depth interview results were combined to suggest development cooperation model and protocol for division of task. In development of clinical practice guideline, the roles of National Evidence-based Healthcare Collaborating Agency were defined as 1) experts of evidence evaluation and 2) coordinator/moderator in cooperative business part and 1) methodology study/training and 2) expert network building, etc. in competence enhancement part. Regarding this, the types of development cooperation of clinical practice guideline were suggested by roughly dividing into 1) joint study with the Society as an expert team of methodology or 2) consulting role for methodology.
In addition, a role flow chart was presented according to development method of clinical practice guideline (de novo development or adaptation), and cooperation protocol(draft) according to development plan and schedule was suggested.
Ⅱ. The Evaluation of Implementability of Clinical Practice Guideline
1. GLIA ver.2.0 Instrument Translation, Implementability Review and Demonstrative Evaluation for Internal Implementability of Clinical Practice Guideline
The domestic applicability of GLIA ver.2.0 instrument translated into Korean was reviewed by external expert consultation. In the evaluation, utility item showed 5.75(±0.96) on average which was the highest score. In short-answer questions, despite the advantage of the instrument that it can evaluate specifically, there was an opinion that practical applicability judgment would be difficult since it seemed there would be much information that is not in domestic guidelines.
2. Understanding External Barriers of Implementation through Survey in Users of Clinical Practice Guideline
When identifying general barriers of implementation of clinical practice guideline, ‘does not receive the related compensation or incentive although the guideline is applied’ registered 6.1(±1.3), the highest score. With descriptive answer results, it was found that problems related to insurance fee or cutback were felt as the major obstructive factors of the implementation of guideline.
Also, in terms of the answer to expected barriers when implementing the development recommendations of the Korean Society of Acute Care Surgery, it was confirmed that environment aspects were largely expected as barriers including ‘I think that resources(manpower time, system, etc.) will be needed(4.8±1.6)’, ‘I think there will be difficulties in cooperating with other departments(4.5±1.7)’, etc.
▢ Conclusions
In this study, specific cooperation roles, flow chart by development method, and the cooperation protocol draft were first derived through multilateral techniques including the structured literature review, case review, qualitative interview, etc. In addition, it is suggested that internal and external competence enhancement through preparation of training programs, and systematic support systems by building an expert network are needed.
In the aspect of evaluation of implementability, internal and external barriers were evaluated by cooperating with academic societies that recently developed the recommendation for guideline for evaluation of implementability, and a monitoring index was suggested for actual implementation. Despite its utility of the contents, because the internal barrier evaluation instrument was considered to have difficulty in availability in use, it is necessary to develop a domestic instrument in the future. Also, when considering implementation situations by academic society and by guideline, the implementability evaluation study should be more expanded and carried out.
연구정보
연구보고서
한국보건의료연구원