신의료기술평가의 주요 이슈와 개선 방안

장승경,안형식,이상일 한국보건의료기술평가학회 2020 보건의료기술평가 Vol.8 No.2

Objectives: This study reviewed the current major issues of New Health Technology Assessment Program (nHTA) in Korea and suggested ways to promote evidence-based approaches to nHTA. Methods: Data covered the list of all applications to nHTA from 2007 when nHTA was introduced to September 30, 2019. A total of 2539 application cases were analyzed. In addition 11 experts who had experience in the nHTA were surveyed and conducted 1:1 non-face-to-face interviews from June 18th to July 5th, 2020. The questionnaire for the expert survey was developed based on the 15 principles of the best HTA practice. Results: Of the 2539 applications, 891 were classified as new technologies, 440 existing technologies, 568 early stage technologies, 243 research stage technologies, and 397 others. Among the 891 new technologies, there were 320 in vitro diagnostic tests, 259 genetic tests, 194 treatments and procedures, and 128 others including one oriental medicine. The average time required for nHTA was 226 days (±96.8), and it took an average of 43.3 days (±22.7) from notification to the applicant to official release of the Ministry of Health and Welfare. Of the 243 cases classified as the research stage technologies, 124 cases were Grade I, which means that the potential benefit of clinical introduction was not significant. About 76% (435/568) of early stage technologies were Grade I. Among 567 cases of new technologies with Scottish Intercollegiate Guidelines Network recommendation grading Grade C was the most common with 236 cases, followed by Grade D 218, Grade B 87, and Grade A 47 in that order. Based on the result of the expert survey, we propose recommendations for improving nHTA. Conclusion: This study based on the analysis of nHTA database and expert survey results can help policy makers and health care professional societies to make better nHTA in Korea.

연명의료결정법과 의료기관윤리위원회: 현황, 경험과 문제점

최지연,장승경,김정아,이일학 한국의료윤리학회 2019 한국의료윤리학회지 Vol.22 No.3

Institutional Ethics Committees are responsible for reviewing, consulting, and educating about matters related to life-sustaining treatment, these committees should play a substantial role in implementing the Act in each hospital. However, there are few such committees and their operations have been limited in many respects. In this article we report on a survey that was carried out to assess the difficulties faced by 63 committee administrators. We also conducted focus-group interviews with seven medical professionals or administrators working in health care institutions in which a committee has been established. Subjects were asked about the difficulties these committees face in advising on foregoing life-sustaining treatment. The operational problems that were reported include the following: difficulties in accessing patients’ records of decisions concerning life-sustaining treatment, obstacles in using Shared Ethics Committees, legal and administrative complexities in diagnosing the end-of-life process, the lack of expertise of committee members and administrators, manpower shortages on the committees, and medical professionals’ negative views of the Act’s procedures for life-sustaining treatment decision-making. In order to deal with these problems, we suggest the following solutions: improving the accessibility of patients’ life-sustaining treatment decisions, encouraging the use of Shared Ethics Committees, defining the qualifications and training requirements for Committee members, establishing better communications among committee members; creating an educational system for medical professionals in order to improve their understanding of the committees’ role; and developing standard operating procedures for the committees. 연명의료결정법이 시행된 지 1년이 넘게 지났다. 연명의료결정법이 치료에 대한 자기결정을 확산하여생애 말기 치료 문화 및 관행에 변화를 가져올 것이라는 기대가 있었으나 아직 제도는 안착하지 않았고 개선되어야 할 다양한 과제들이 드러나고 있다. 특히 연명의료결정법이 규정하는 다양한 관련기관 중 연명의료중단등결정을 비롯하여 이행에 관한 심의, 상담, 교육의 실질적인 주체가 되는 의료기관윤리위원회의 경우, 이를 설치한 의료기관의 수도 적을 뿐 아니라 운영에 한계를 경험하고 있다. 이에 본 연구는 의료기관윤리위원회 행정간사 63명을 대상으로 위원회의 운영현황 및 업무상 어려움을 파악하는 설문조사를수행하였으며 의료기관윤리위원회 설치 의료기관의 의료인 및 행정간사 7명을 대상으로 초점집단면접을 수행하여 의료기관윤리위원회를 운영함에 있어 나타나는 연명의료중단등결정에 대한 실질적인 장애요인을 파악하여 이에 대한 해결책을 모색하고자 하였다. 본 연구에서 나타난 의료기관윤리위원회의 운영상 문제점은 환자의 연명의료정보열람에 따른 고충, 윤리위원회 미설치기관의 공용윤리위원회 활용 장벽, 연명의료중단 등 임종기 결정 관련 법적ㆍ행정적 절차의 복잡성, 행정간사 및 위원의 경험 및 전문지식 부족, 의료기관윤리위원회 실무인력 부족, 연명의료결정제도에 대한 의료인의 부정적 인식이었으며이를 해결하기 위하여 환자의 연명의료결정 정보 접근성 확보, 공용윤리위원회의 활성화의 가능한 방안, 의료기관윤리위원회 전담인력 규정 및 양성, 다른 의료기관에 있는 의료기관윤리위원회 간 소통 구조 형성, 의료인 인식개선을 위한 교육체계 수립, 의료기관 윤리위원회 표준운영지침 개발을 제시하였다.

변화된 연구 환경에 적합한 연구윤리 제도로서연구윤리자문 서비스의 제안

이은영,장승경,이일학 한국의료윤리학회 2018 한국의료윤리학회지 Vol.21 No.1

As biomedical research becomes more interdisciplinary and subjects more diversified, an increasing emphasis is being placed on the ethics of biomedical research. Conventional research ethics is based on the oversight of institutional review boards (IRBs), which are commonly criticized for being ineffective in today’s changing research environment. Although various suggestions have been made concerning how to improve IRB-based research ethics, relatively little attention has been given to the perspective of organizational ethics. Yet in order to improve the decision-making of individual researchers it is crucial to understand the structure of the organizations in which those decisions are made. Research ethics consultation(REC) takes a systemic approach to organizational ethics and assists the decisions and practices of both individuals as well as organizations. This article argues for the necessity of REC and describes how REC services should be structured. 오늘날 연구 프로그램의 수행과정에서 연구자 개인이 지켜야 하는 윤리적 책임이 점점 복잡해지고 그 기준도 강화되고 있다. 오늘날 연구윤리는 개인의 윤리적 감수성과 실천의지를 강조하고 있을 뿐 실천의 차원에서 개인에게 도움이 되지 않고 있다. 개인은 윤리적 결정과 실천 과정에서 상담, 자문뿐 아니라 위기 상황을 해결할 수 있는 중재를 필요로 하는 경우가 있고, 이러한 도움을 기관 차원에서 제공해야 연구 과정에서 발생하는 문제를 예방하고 신속하게 해결할 수 있다. 저자들은 이와 같이 연구윤리가 개인의 차원을 넘어 조직의 차원에서 이해되고 실천되는 조직윤리(organizational ethics)의 관점으로 접근해야 한다고 주장한다. 이는 연구윤리가 연구의 형식적인 측면을 감독하는 것을 넘어서야 조직 구성원의 윤리적 결정과 실천 과정을 이해하고 지원하는 데 이르러야 한다는 것이다. 본 연구는 조직윤리의 구성요소를 조율하고 실천으로 옮기도록 하는 방식을 고안하는 것을 목표하는 “연구윤리자문(research ethics consultation)”에 주목한다. 연구윤리자문은 연구의 이익을 최대화하고 연구에 대한 잠재적인 위해를 최소화하려는 전반적인 목표를 갖고 기관에서 서비스의 형태로 제공된다. 이러한 연구윤리자문 서비스에 참여하는 전문가의 독립적이고 투명한 공유된 의사결정(shared decision making) 과정을 통해 해당 사건에 적시에 개입하고, 축적된 자료는 교육 자료로 활용가능하다.

The Legal Doctrine on the Liability of Physicians in Medical Malpractice Lawsuits Involving Complex Regional Pain Syndrome

신수환,장승경,민경태,이원,김소윤 대한의학회 2018 Journal of Korean medical science Vol.33 No.9

Background: Complex regional pain syndrome (CRPS) involves severe pain and it is difficult to identify the exact cause or pathogenesis. Therefore, there are controversies regarding legal issues related to the establishment of damage in medical malpractice lawsuits involving CRPS. This study aimed to analyze malpractice lawsuits involving CRPS, which occurred after the disputed medical treatment, to provide information on the courts' opinion and characteristics of the cases. Methods: This study analyzed 23 lawsuit judgments involving CRPS that were sentenced from 2005 to 2015. Results: A total of 12 of the 23 cases were partially ruled in favor of the plaintiff. The average amount (KRW) claimed was 470,638,385 ± 860,634,092 (21,000,000 to 4,020,000,000), and that awarded was 72,906,843 ± 53,389,367 (15,000,000 to 181,080,803). Sixteen of the 23 cases had CRPS type I. In 11 of 23 cases, the site of the pain was located in the lower limb and in 14 cases there was no presence of trauma or event prior to medical treatment. Conclusion: Nerve injury was the most frequent reason for taking responsibility in compensating damage in malpractice cases involving CRPS. Physicians should consider various possibilities of such complications in medical practices. It is important to identify and improve areas which need to be improved for patient safety through analyzing the lawsuit judgment cases.

Analysis of closed medical litigation in urology

신수환,김소윤,장승경,이원 대한비뇨의학회 2017 Investigative and Clinical Urology Vol.58 No.5

Purpose: The objective of this study was to provide a descriptive understanding of the characteristics of malpractice litigation related to urology by examining court cases. Materials and Methods: A total of 6,074 court cases related to medical malpractice litigation filed between 2005 and 2010 were received from the Lower Courts, the Appellate Courts, and the Supreme Court of Korea. Of the received cases, 34 urology-related civil proceedings were analyzed. The following information was compiled and investigated from the cases: background, age and sex of patient, categorization of the defendant, opinion of the court, amount claimed and awarded in damages, type of medical treatment involved, and negative effects resulting from the medical accident. Results: The average amount in damages paid out to plaintiffs in this research was 27,186,504±32,371,008 Korean won (KRW) (range, 1,000,000–100,000,000 KRW). A total of 9 of the 34 analyzed cases (26.5%) ruled in favor of the plaintiff, with all 9 cases involving a surgery. An analysis of the surgery sites further revealed that the penis was the most frequently litigated over site of surgery, making up 14 of the 35 sites (40.0%). Conclusions: Information regarding urology malpractice lawsuits should be made available to help prevent further disputes and litigation. Continuous efforts must be expended in the prevention of accidents and disputes, alongside research into urology-related cases beyond 2010. Extensive cause analysis and recurrence prevention methods must also be researched to enhance overall patient safety.

환자안전 인식 향상을 위한 의과대학생 대상 환자안전 역할극 교육의 효과

이원,표지희,장승경,최은영,옥민수,조민우,이상일 건강보험심사평가원 2021 HIRA RESEARCH Vol.1 No.1

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환자안전사건을 경험한 의료진을 위한 제2의 피해자 지원 프로그램의 동향

최은영,표지희,장승경,이원,옥민수,이해영 한국의료질향상학회 2023 한국의료질향상학회지 Vol.29 No.1

Purpose: This study aimed to review second victim support programs to identify effective evidence-based strategies for supporting healthcare providers involved in patient safety incidents. Methods: A comprehensive review search was conducted, including a search of databases, gray literature, and a hand-search of related fields, with “second victim” as the main search term. Results: We reviewed nine second victim support programs, focusing on their development process, operating form, and performance. These were (a) Peer Support Services, (b) forYOU team, (c) YOU Matter, (d) Resilience in Stressful Events, (e) Clinician Peer Support Program, (f) SWADDLE, (g) Surgery Second Victim Peer Support Program, (h) Caring for the Caregiver, and (i) Code Lavender. Conclusion: Second victim support programs help solve the emotional problems of medical staff caused by patient safety incidents. Therefore, it is necessary to develop a second victim support program suitable for the medical environment in Korea.

미국의 사과법 및 디스클로져법의 의의와 그 시사점

이원,박지용,장승경 대한의료법학회 2018 의료법학 Vol.19 No.1

Recently in Korea, public interest about patient safety has increased because patient safety incidents occurred continuously. In addition, as the way of coping with medical personnel and medical institutions after occurrence of patient safety incident became controversial, the necessity of introducing apology law and disclosure law was raised. We analyzed the contents of apology law and disclosure law in U.S.A and critically examined the legislative movements in Korea. First, the Apology law requires that a medical personnel provide apology, consolation, sympathy to the patient for discomfort, pain, damage or death, and that the expression of apology shall be inadmissible as evidence of an admission of liability in civil action or administrative proceeding. The Apology law is divided into ‘full apology law’ and ‘partial apology law’ depending on whether mistake, error, fault, liability, and legal liability shall be inadmissible. Meanwhile, Disclosure law enforces or voluntarily enforces the law to communicate with the patient regarding the disclosure of the incident, the cause of incident, the compensation plan, and the measures to prevent the recurrence in the adverse incident that serious harm to the patient. In Korea, the concern about patient safety incidents has been amplified, and as the importance of communication between the medical personnel and patient has been recognized, the revision bill for the “Patient Safety Act”, which adopted the U.S.A apology or disclosure law, was submitted to the National Assembly. The purpose of this study was to critically review the contents of the revised legislation based on the analysis of the apology law and disclosure law in U.S.A. and to provide implications for future legislative direction. 최근 우리나라에서는 연속적으로 발생한 환자안전사건으로 인해 환자안전에 대한 사회적 관심이 높아졌다. 더불어 환자안전사건 발생 후 의료인 및 의료기관의 대응방식이 논란이 되면서, 사과법 및 디스클로져법 도입의 필요성이 제기되고 있다. 본 연구에서는 미국의 사과법과 디스클로져법 내용을 분석하고, 우리나라의 입법 움직임에 대하여 비판적으로 검토하고자 한다. 먼저 사과법은 의료인 등이 환자 측에게 불편감, 통증, 손상, 사망 등에 대해 사과나 위로, 공감 등을 표하는 경우, 사과 등의 표현은 민사재판 및 행정절차에서 법적인 증거로 사용할 수 없도록 하는 것을 그 주요 내용으로 한다. 사과법은 실수, 오류, 잘못, 책임, 법적 책임의 표현과 같은 규범적 평가요소를 증거법의 보호 범위에 포함하는지 여부에 따라 ‘완전한 사과법’과 ‘부분적 사과법’으로 구분된다. 한편, 디스클로져법은 의료기관이 심각한 위해가 발생한 사건 등에 있어 사건의 공개, 발생 원인, 보상계획, 재발방지대책 등에 관하여 환자 측과 소통하는 것을 법률상 강제하거나 자율적으로 유도하는 것을 그 주요 내용으로 한다. 한편, 최근 우리나라에서도 환자안전사고에 관한 관심이 증폭되고, 의료인 측과 환자 측의 의사소통의 중요성이 인식되면서, 위와 같은 미국의 사과법 또는 디스클로져법을 수용한 「환자안전법」 개정법률안이 국회에 제출되기도 하였다. 본 연구에서는 미국의 사과법 및 디스클로져법의 분석을 토대로 위 개정법률안의 내용을 비판적으로 검토함으로써 향후의 입법방향에 시사점을 제시하고자 한다.

의과대학에서의 환자안전 교육과정 도입을 위한 환자안전 교육현황조사 및 향후 운영방안

오혜미,이원,장승경,김소윤 연세대학교 의과대학 2019 의학교육논단 Vol.21 No.3

In 2018, The Ministry of Health and Welfare announced its first comprehensive plan for patient safety, which included the imperative to develop a patient safety curriculum for students studying to become health professionals. The aim of this study is to assess current patient safety education and points of consideration for introducing new curriculum. An online survey was used to understand the status of patient safety education in medical schools, and key informant interviews and focus group interviews were used to collect qualitative data on the experience of patient safety education. The results of the online survey from 16 out of 40 medical schools (40% response rate) and the qualitative data analysis were integrated and analyzed. Twelve schools (75%) had established courses related to patient safety. The qualitative responses suggest that patient safety education is appropriate both before and after clinical training through a variety of educational methods, and that the topics should be linked with clinical training. The challenge of securing lecture time to address patient safety was mentioned as a realistic obstacle. When patient safety education is integrated in future curriculum, it is necessary to consider it as a priority. Moreover, in the early stages of introducing patient safety education, a step-by-step, policy-based approach is required for seamless adoption and settlement.

환자안전사건을 겪은 일반인들은 경험한 환자안전사건 소통하기에 만족할 수 있을까?

표지희,이원,장승경,최은영,옥민수,이상일 한국의료윤리학회 2019 한국의료윤리학회지 Vol.22 No.4

This study examines people’s experiences with the disclosure of patient safety incidents (DPSI), which is known to be effective in decreasing medical disputes and improving the relationships between patients and medical professionals. Data on people’s experiences with, and the impacts of, patient safety incidents were collected by means of an online survey of 201 individuals. Only 30.3% (n=61) of participants had experienced full DPSI. The study found that those who experienced patient safety incidents with permanent disability or death were significantly less likely to report expressions of sympathy and regret from the relevant medical professionals than those who experienced patient safety incidents with a lower level of harm (p=0.003). The percentage of participants who reported sleep disorders was 35.3% for “no disclosure”, 28.1% for “partial disclosure”, and 31.3% for “full disclosure” (p=0.673). The results of the survey indicate that those who experience patient safety incidents do not in general receive proper responses from the relevant medical professionals. This in turn suggests that detailed guidelines and training programs for DPSI are required and that psychological and other forms of support should be provided to patients and caregivers who experience patient safety incidents. 이번 연구에서는 환자안전사건을 겪은 일반인들을 대상으로 환자안전사건 소통하기의 경험 여부를 알아보고 그 경험에 따라 환자안전사건으로 인한 어려움의 호소에 차이가 있는지 살펴보았다. 온라인 설문조사를 실시하여 경험한 환자안전사건의 특성(위해의 정도 등), 경험한 환자안전사건으로 인한 영향(수면장애, 식이장애 등), 환자안전사건 소통하기 경험(구성 요소별 경험까지), 인구사회학적 요인(성별, 연령대 등) 등의 자료를 수집하였다. 환자안전사건을 경험한 일반인 총 201명이 설문에 응답하였으며 환자안전사건 소통하기의 구성 요소 중 5가지 이상을 경험한 참여자는 30.3% (61명)에 불과하였다. 즉, 70% 에 가까운 참여자들이 환자안전사건 소통하기 과정을 부분적으로 경험하였거나 소통하기를 전혀 경험하지 못한 것으로 드러났다. 영구적 장애 또는 사망한 환자안전사건을 경험한 연구 참여자는 이보다 위해가 작은 사건을 경험한 연구참여자에 비하여 의료진이 발생한 환자안전사건에 대한 공감 및 유감을 표명하는 경우가 통계적으로 유의하게 낮았다(p=0.003). 환자안전사건 소통하기를 경험하지 못한 집단에서 수면장애를 호소한 분율은 35.3%였으나 부분적 소통하기나 완전한 소통하기를 경험한 집단은 그 분율이 각각 28.1%, 31.3%이었다(p=0.673). 이번 설문조사를 통하여 환자안전사건을 경험한 많은 환자 및보호자들이 의료진들로부터 제대로 된 환자안전사건 대응을 받지 못하고 있음을 확인할 수 있었다. 환자안전사건 소통하기의 가이드라인을 마련하고 교육을 진행할 때 환자안전사건의 위해 정도를 고려한 세부적 지침과 사례별 교육 및 훈련이 필요할 것으로 판단된다. 더불어 환자안전사건 소통하기 수행과는 별도로 환자안전사건을 경험한 환자 및 그 보호자를 위한 심리적, 신체적 지원책도 함께 제공될 필요가 있다.