RAND 방법으로 합의한 임상진료지침의 정의와 질 평가 기준

지선미,김수영,신승수,허대석,김남순 한국보건행정학회 2010 보건행정학회지 Vol.20 No.2

background : Clinical practice guidelines are an increasingly familiar part of clinical practice. Moreover, rigorously developed evidence based guidelines has been widely used. However, in Korea, some of published documents as clinical practice guidelines have shown considerable disparity in structure, contents and quality. This is mainly because there is no consensus on the definition and quality standard of clinical practice guidelines. The purpose of this study was to draw consensus on the definition and the quality standard about clinical practice guidelines. Methods : We developed a questionnaire about the definition of clinical practice guidelines with inclusion criteria(23 items) and the quality standard(30 items). We selected 9 experts who had prior experience in developing and implementing guidelines. Rating methods for appropriateness of items were adopted from the RAND method. Consensus was drawn in three rounds. Result ; Of the 47 items agreed, 40 items were determined to be appropriate. Clinical practice guidelines were defined as "scientifically and systematically developed statements to assist practitioners and patients on making decisions about appropriate health care for specific clinical circumstances." Narrative reviews,systematic reviews or health technology assessment without recommendations,translation of foreign guidelines, guidelines for patients only and training manuals were not considered as clinical practice guidelines. For the quality standard of clinical practice guidelines, 27 items were deemed necessary. Conclusion : The consensus on the definition with inclusion criteria and the quality standard of clinical practice guidelines carries an important meaning as the first attempt to draw a general agreement in our society. The unique achievement of the consensus reflects the current status of clinical practice guidelines that there has been a high tendency to adapt foreign guidelines. We hope efforts of this kind will continue to bring improvement in clinical practice guidelines.

의료와 司法의 협력-일본에서의 진료가이드라인의 역할에 대한 논의를 중심으로-

송영민 대한의료법학회 2022 의료법학 Vol.23 No.2

There are two aspects of clinical practice guidelines that act as non-legal control before medical practice and as legal control standards after medical practice. The essential purpose of clinical practice guidelines is the former, but the latter action cannot be excluded. The clinical practice guidelines are a means of linking law and medical care. The negative perception of clinical practice guidelines that medical professionals' autonomy can be violated by the enactment of clinical practice guidelines is an excessive negative evaluation of clinical practice guidelines. Rather, judicial judgment based on clinical practice guidelines plays a role in respecting the autonomy of medical professionals. In other words, the clinical practice guidelines suppress legal regulations on medical care as much as possible and are based on doctors' professional ethics and self-discipline, and patient awareness and cooperation. In order to establish an ideal relationship of cooperation between doctors and patients, 'medical ethics' must be incorporated as a legal means. Clinical practice guidelines are the most appropriate means for incorporating such medical ethics into legal procedures. The lawyer solves the case with a legal syllogism that establishes a norm and applies facts to it to conclude. For the resolution of medical disputes, Clinical practice guidelines are used to establish norms that doctors should perform for specific diseases, and conclusions are drawn by applying the established norms to specific medical practices. When it is not easy to apply the established norms to specific medical practices, medical judgments by experts, such as emotions, expert testimony, and explanations by expert members, are used. As such, the Law respects the autonomy of medical care even in the establishment of norms and the application of norms. In particular, Clinical practice guidelines prepared independently by the medical community are referred to in establishing norms, which are the prerequisites for legal syllogism. This shows that doctors participate in the formation of precedents and contribute to the formation of norms. The use of clinical practice guidelines in trials is respect and consideration for the autonomy of medical care. Although there may be an aspect in which the autonomy of individual doctors is limited by clinical practice guidelines, it should be considered that the autonomy of doctors as a group is respected. In this way, the clinical practice guidelines play a role in protecting the autonomy of the "medical" group from the logic of the "law." 진료가이드라인은 의료행위 전의 비법적 통제로서 작용하는 측면과 의료행위 후의 법적인 통제기준으로 작용하는 두 가지 측면이 있다. 진료가이드라인의 본질적 목적은 전자이지만, 후자의 작용을 배제할 수 없다. 진료가이드라인은 법과 의료를 연결하는 수단이다. 진료가이드라인의 제정에 의해 의료전문가의 자율성이 침해될 수 있다는 진료가이드라인에 대한 부정적 인식은 진료가이드라인에 대한 지나친 부정적 평가이다. 오히려 진료가이드라인에 의한 사법판단은 의료전문가의 자율성을 존중하는 역할을 한다. 즉 진료가이드라인은 의료에 대한 법적 규제를 최대한 억제하고, 의사의 직업윤리 및 자기규율과 환자의 자각 및 협력을 바탕으로 하는 것이다. 의사와 환자의 협력이라는 이상적인 관계를 정립하기 위해서는 「의료윤리」를 법적 수단으로 편입해야 한다. 이러한 의료윤리의 법적 절차에의 편입작업에 가장 적절한 수단이 의료가이드라인이다. 법률가는 규범을 정립하고, 그것에 사실을 적용하여 결론을 내리는 법적 삼단논법으로 사안을 해결한다. 의료분쟁의 해결은, 의사가 특정 질환에 어떠한 의료행위를 해야 하는가라는 규범을 정립할 때에 진료가이드라인을 사용하며, 정립된 규범을 구체적인 진료행위에 적용하여 결론을 도출한다. 정립된 규범을 구체적인 진료행위에 적용하는 것이 쉽지 않은 때에는 감정이나 전문가 증언, 전문위원의 설명과 같은 전문가의 의학적 판단을 이용한다. 이처럼 司法은 규범의 정립이나 규범의 적용에도 의료의 자율성을 존중하고 있다. 특히 법적 삼단논법의 대전제인 규범의 정립에는 의료계가 자주적으로 작성한 진료가이드라인을 참고하고 있다. 이는 의료인이 판례의 형성에 참가하여 규범형성에 기여하는 모습이다. 진료가이드라인이 재판에 이용되는 것은 의료의 자율성에 대한 존중과 배려이다. 진료가이드라인에 의해 개개의 의사의 자율성이 제약되는 측면은 있을 수 있지만, 집단으로서의 의사의 자율성은 존중된다고 보아야 한다. 이처럼 진료가이드라인은 「법」의 논리에서 보면, 「의료」 집단의 자율성을 보호하는 역할을 한다.

병원단위의 임상진료지침 개발과정

신영수,김창엽,오병희,한규섭,윤병우,한준구,강영호 한국의료QA학회 1997 한국의료질향상학회지 Vol.4 No.1

Background : With increased concerns about variation among physician a practice pattern and their impact on the quality of care, clinical practice guidelines have been developed by many different organizations, with differing aims and incentives. From the same point of view, there is growing interest in the development of clinical practice guidelines in Korea, but with only a few examples. As a result, there is not much exploration on the incentive and barrier to development guidelines as well as description on the development process. The purposes of this study are to describe the process of the four different clinical practice guidelines in a hospital setting, and to identify incentives and barriers in the development of guidelines. Methods : For this research, a clinical practice guideline development committee and four clinical practice guideline development teams were organized in a university hospital which has more than 1,200 beds. Twenty eight doctors, three nurses, and one technician participated as members of development teams for eight months. Four to six meetings were held, and three to seven departments in the hospital were involved. Results : The topics which developed into clinical practice guidelines were cardiopulmonary resuscitation(CPR), blood transfusion, anticoagulation, and angiography. The main goals set by teams were education(CPR, angiography), risk management(blood transfusion), and to enhance quality of care(anticoagulation). Among four teams, only in the team for anticoagulation guideline medical record review and pilot-testing were performed. Also literature review was not carried out systematically. However, all the guidelines were developed by multidisciplinary participation by personnels of related departments. All the team expected guidelines to be used as standard protocols in the practice. Conclusion : Experience and skill in developing process has to be improved to have a more valid and useful practice guideline. In particular, literature review and problem identification by examining medical record should be emphasized. Also further studies of the clinical outcomes of the guidelines application and changes in physicians behaviors would be required.

Development and Implementation of Clinical Practice Guidelines: Current Status in Korea

안형식,김현정 대한의학회 2012 Journal of Korean medical science Vol.27 No.-

Documentation of unexplained geographic variations in medical practices and use of inappropriate interventions has led to the proliferation of clinical practice guidelines. With increased enthusiasm for guidelines, evidence exists that clinical practice guidelines often influence clinical practices or health outcomes. Their successful implementation may improve the quality of care by decreasing in appropriate variation and expediting the application of effective advances to healthcare practices. In Korea, physicians and healthcare professionals have begun to take interests in clinical practice guidelines. Currently, over 50 practice guidelines have been developed through professional academic organizations or via other routes; however, the quality of the guidelines is unsatisfactory,implementation in clinical settings is incomplete, and there is insufficient infrastructure to develop clinical practice guidelines. Korea must develop policies and invest resources to enhance the development and implementation of clinical practice guidelines.

전립선비대증의 진료지침 개발

유승흠,채수응,김춘배,강명근,송재만,이은식,이정구,이춘용,홍성준,Yu, Seung-Hum,Chai, Soo Eung,Kim, Chun-Bae,Kang, Myung Geun,Song, Jae Mann,Lee, Eun Sik,Lee, Jung Gu,Lee, Tchun Yong,Hong, Sung Joon 한국의료질향상학회 1997 한국의료질향상학회지 Vol.3 No.2

Background : Clinical practice guidelines define "systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances" and help to improve patient care. The purpose of this study is to develop a clinical practice guideline for the most effective diagnoses and treatments of benign prostatic hyperplasia based on patient preference and clinical need. Methods : For this research project, extensive literature searches (208 articles) were conducted. As well, critical reviews and syntheses (meta-analysis) were used to evaluate empirical evidence and significant outcomes of the BPH literature. Questionnaires about clinical practice for BPH patients were distributed and consensus meetings were undertaken to grasp variations in clinical practice and to reach agreement on the guideline's development. The guideline was promoted under the sponsorship of the Korean Medical Association and the Korean urological Cancer. Society. For the task, the Benign Prostatic Hyperplasia Guideline Panel was composed of multidisciplinary experts in the field. Results : BPH is a disease that affects a patient's quality of life. This Clinical Practice Guideline was developed for the typical man over age 50 with symptoms of prostatism, but with no significant medical morbidities such as diabetes or other known causes of voiding dysfunction, such as urethral stricture or neurogenic bladder. The guidelines detail the relative benefits and obstacles associated with all diagnostic and treatment approaches, including watchful waiting. Conclusion : This guideline provides a cornerstone for our medical association. It represents the most current scientific knowledge regarding the development, diagnosis, and treatment of BPH. It will be revised and updated as needed.

태음인·태양인체질병증 임상진료지침: 총론

이의주,고병희,김달래,김종열,김종원,박성식,송일병,송정모,안택원,장현진,조황성,Lee, Eui-Ju,Koh, Byung-Hee,Kim, Dal-Rae,Kim, Jong-Yeol,Kim, Jong-Won,Park, Seong-Sik,Song, Il-Byung,Song, Jeong-Mo,Ahn, Taek-Won,Jang, Hyun-Jin,Cho, Hwang-S 사상체질의학회 2015 사상체질의학회지 Vol.27 No.1

Objectives This study was aimed to develop the clinical practice guideline for Taeeumin, Taeyangin symptomatology. This was the second clinical practice guideline, which focuses on symptomatology. Methods Donguisusebowon and many articles were reviewed and examined for developing clinical practice guidelines. Among the previous guidelines, we assessed the guidelines by Appraisal of Guidelines for Research and Evaluation (AGREE II). After AGREE II assessment, we chose and revised the clinical practice guideline. Results and Conclusions By researching and discussing the Taeeumin, Taeyangin symptomatology, we make the principle of the clinical practice guideline, including classification, definition, algorithm, and treatment assessing tool.

체계적 고찰 방법을 이용한 임상진료지침 정책효과 평가

이선희,하귀염,김주혜,서주현,김현미 한국병원경영학회 2009 병원경영학회지 Vol.14 No.1

A systematic review of the literatures was conducted to evaluate the effect of clinical practice guideline. The 77 studies were identified from a computerized search of published research on MEDLINE, Science-Direct and Blackwell synergy from January, 1997 to October, 2007. The main search terms were “clinical practice guideline" and “effectiveness", “clinical practice guideline" and “impact", “clinical practice guideline" and “evaluation". These studies were assessed the quality twice by one qualified expert and converted into weighted scale. The 63 studies were eligible inclusion criteria and subdivided into type of effect. Final indicator using for policy effect of clinical practice guidelines were classified as 4 categories; "improvement of outcomes" in 81 studies, "betterment in practice patterns" in 68 studies, "rationalization in resource utilization" in 84 studies and "cost containment" in 31 studies. The vote-counting method, one of meta-analysis method, was applied to summarized the effect of clinical practice guidelines and test statistically. From results of meta analysis, all indices were statistically significant. In conclusion, this meta-analysis showed that introduction of clinical practice guidelines were resulted positive outcomes in health policy.

한방임상진료지침 개발에 대한 연구

정만진 ( Man Jin Jeong ),권오곤 ( O Gon Kwon ),우창훈 ( Chang Hoon Woo ),안희덕 ( Hee Duk An ) 한방재활의학과학회 2012 한방재활의학과학회지 Vol.22 No.2

Objectives :This study is intended to understand the developmental needs and directions of oriental medicine clinical practice guideline. Methods :Looking through previous studies, reported guideline and bibliography, we could find out the current state of oriental medicine clinical practice guideline. Results & Conclusions :1. Standardized oriental medicine clinical practice guideline is needed based on evidence-based medicine(EBM). 2. At the current state of oriental medicine clinical practice guideline, development through formal consensus is needed, which is one of methodology of clinical practice guideline. 3. More studies are needed to develop oriental medicine clinical practice guideline.

자폐스펙트럼장애의 치료에 대한 한의 임상 가이드라인 개발을 위한 기초연구 -기존에 개발된 자폐스펙트럼장애 가이드라인을 중심으로-

김상민,이진용,이선행,장규태,Kim, Sang Min,Lee, Jin Yong,Lee, Sun Haeng,Chang, Gyu Tae 대한한방소아과학회 2017 대한한방소아과학회지 Vol.31 No.1

Objectives The purpose of this study is to review pre-existing clinical practice guidelines for autism spectrum disorders, and refer those in developing a new practice guideline. Methods A total of 9 existing clinical practice guidelines for autism spectrum disorder developed from 2010 to 2016 were searched by Google scholar and Pubmed, and were reviewed those literatures in three parts: general, diagnosis & evaluation, and intervention. Results There were no consistency in the recommendation methods of 9 clinical care guidelines (such as the method of rating and recommendation intensity for diagnosis, evaluation, and treatment). However, in the diagnosis and evaluation section, frequently used evaluation and diagnostic tools are mentioned in most clinical practice guidelines, and the types of pharmacologic and non-pharmacological treatments that are mainly recommended in treatment are equally mentioned in most clinical practice guidelines could confirm. Conclusions 1. Some guideline recommendations are graded according to each criterion. Recommendations presented in various databases were based on systematic reviews or other literatures. The most utilized database were PsycINFO, CINAHL, Cochrane. 2. DSM-5 and ICD-10 were the most common used diagnostic criteria, and DSM-IV was used as a diagnostic standard in the guideline published before 2013. The tools used for diagnosis and evaluation were also varied. However, most recommended ones were ADI-R, ADOS-G, and DISCO. 3. Treatment was largely divided into pharmacological intervention and non-pharmacological intervention. In some guideline, the interventions were divided into pediatric and adult. Most of the pharmacological interventions were not recommended due to lack of evidence, but in cases in which specific symptoms were aimed, they recommended to seek professional help. 4. In addition to interventions, each guideline referred to supportive interventions that may be helpful in the daily life of patients with ASD, which may need to be addressed in future clinical guidelines.

표준 치료 지침서(Clinical Practice Guideline)의 의료법학적 의의

배현아 대한의료법학회 2008 의료법학 Vol.9 No.2

With recent emphasis on evidence based medicine, clinical practice guidelines are seen as a potential mechanism by which unify various managerial and professional approaches to improving the quality of care. The development process of guidelines has been the subject of much research. and it is need translating the medical evidence of research into a clinical practice guidelines. the gathered evidence needs to be interpreted into a clinical, public health, policy, or payment context. The term 'clinical practice guidelines' can evoke a diverse range of responses from healthcare personnel. Clinical practice guidelines are increasingly used in patient management but some clinicians are not familiar with their origin or appropriate applications. Understanding the limitations as well as benefits of CPG could enable clinicians to have clearer view of the place of guidelines in every practice. In the context of increasing complaints and litigation in healthcare, the legal implications of clinical practice guidelines are of increasing importance. Clinical practice guidelines could, in theory, influence the manner in which the courts establish negligence by suggesting the doctor breached the duty of care by failing to provide the required standard of medical care. In several studies, the CPGs were relevent to and played a pivotal role in the proof of negligence. Much depends on the quality of guidelines and the tools developed and the authoritativeness of a guideline. Recently, there are several opinions the court also should review the validity and reliability of expert testimony including medical evidence. and widespread use of guidelines in malpractice lawsuit could lead the physicians to greater compliance with guidelines in the long term. In conclusion, Health care reformers, physicians as well as guidelines developers should understand that guidelines have both medical and legal aspects as a double-edges sword. so clinicians, legal representatives and decision-makers should not defer unduly to guidelines.