Current Status of Informed Consent Form for Acupotomy in Korean Medicine Hospitals and Development of a Standard Informed Consent Form Using Delphi Method

Jihun Kim; Bonhyuk Goo; Hyongjun Kim; Kyoungsuk Seo; Myungjin Oh; Myungseok Ryu; Sang-Hoon Yoon; Kwang Ho Lee; Hyun-Jong Lee; Jungtae Leem; Hyungsun Jun; Jeong Ihn Sook; Sung Woon Choi; Tae Wook Lee; Yeonhak Kim; Yoona Oh; Kunhyung Kim; Gi Young Yang; Eunseok Kim; Kim, Jihun; Goo, Bonhyuk; Kim, Hyongjun; Seo, Kyoungsuk; Oh, Myungjin; Ryu, Myungseok; Yoon, Sang-Hoon; Lee, Kwang Ho; Lee, Hyun-Jong; Leem, Jungtae; Jun, Hyungsun; Jeong, Ihn Sook; Choi, Sung Woon; Lee, Tae Wook; Kim, Yeonhak; Oh, Yoona; Kim, Kunhyung; Yang, Gi Young; Kim, Eunseok

doi:10.13048/jkm.24012

JKM > Volume 45(1); 2024 > Article

Kim, Goo, Kim, Seo, Oh, Ryu, Yoon, Lee, Lee, Leem, Jun, Sook, Choi, Lee, Kim, Oh, Kim, Yang, and Kim: Current Status of Informed Consent Form for Acupotomy in Korean Medicine Hospitals and Development of a Standard Informed Consent Form Using Delphi Method

Original Article

The Journal of Korean Medicine 2024; 45(1): 180-199.

Published online: March 1, 2024

DOI: https://doi.org/10.13048/jkm.24012

Current Status of Informed Consent Form for Acupotomy in Korean Medicine Hospitals and Development of a Standard Informed Consent Form Using Delphi Method

Jihun Kim¹

, Bonhyuk Goo²

, Hyongjun Kim³

, Kyoungsuk Seo⁴

, Myungjin Oh⁵

, Myungseok Ryu⁶^{, 13}

, Sang-Hoon Yoon⁷

, Kwang Ho Lee⁸

, Hyun-Jong Lee⁹

, Jungtae Leem¹⁰^{, 11}

, Hyungsun Jun¹¹

, Jeong Ihn Sook¹²

, Sung Woon Choi¹³

, Tae Wook Lee¹

, Yeonhak Kim¹

, Yoona Oh¹^{, 14}

, Kunhyung Kim¹^{, 14}

, Gi Young Yang¹^{, 14}

, Eunseok Kim¹^{, 14}^{, *}

¹Department of Acupuncture and Moxibustion Medicine, Pusan National University Korean Medicine Hospital

²Department of Acupuncture and Moxibustion Medicine, Kyung Hee University Korean Medicine Hospital at Gangdong

³Chunjin Korean Medicine Clinic

⁴Pusan National University Korean Medicine Hospital

⁵Keumkang Korean Medical Clinic

⁶Daemyung Korean Medicine Clinic

⁷Chung-Yeon Korean Medicine Clinic

⁸Lee Kwang Ho Medicine Clinic

⁹Department of Acupuncture and Moxibustion, College of Korean Medicine, Daegu Haany University

¹⁰Research Center of Traditional Korean Medicine, College of Korean Medicine, Wonkwang University

¹¹Department of Diagnostics, College of Korean Medicine, Wonkwang University

¹²College of Nursing, Pusan National University

¹³Korean Medical Society of Acupotomology

¹⁴Division of Clinical Medicine, School of Korean Medicine, Pusan National University

Correspondence to: Eunseok Kim, Division of Clinical Medicine, School of Korean Medicine, Pusan National University, 49, Busandaehak-ro, Mulgeum-eup, Yangsan-si, Gyeongnam, 50612, Republic of Korea, Tel: +82-55-360-5950, Fax: +82-55-360-5890, Email: eskim@pusan.ac.kr

Received January 22, 2024 Revised February 14, 2024 Accepted February 16, 2024

Abstract

Objectives

This study was conducted to develop a standard acupotomy consent form that takes into account the unique characteristics of Korean Medicine. The study was motivated by the increasing importance of patient autonomy and the growing number of legal disputes related to medical malpractice in the clinical field of Korean Medicine.

Methods

The analysis phase of the study involved a survey of the current status of acupotomy consent forms in Korean Medicine hospitals nationwide. The items of each form were analyzed based on the contents of the Medical law and the standard contract for medical procedures of the Fair Trade Commission (FTC). In the development and evaluation phase, the items and contents of the acupotomy consent form were evaluated using a 5-point Likert scale and content validity was assessed through two rounds of Delphi surveys. In the improvement phase, the contents of the consent form were revised based on the results of a survey of inpatient and outpatient patients in the Department of Acupuncture and Moxibustion at Pusan National University Korean Medicine Hospital, and real-time online meeting. The final version of the standard acupotomy consent form was completed after undergoing proofreading and corrections by a linguistics expert.

Results

Only 30% of Korean Medicine hospitals have implemented acupotomy consent forms. The items of the consent forms did not fully include the items presented in the Medical act and the standard contract for medical procedures of the FTC. To address this issue, two rounds of Delphi surveys and a real-time discussion were conducted with a panel of 12 experts on 27 preliminary items of consent forms. The items and contents that met the criteria for content validity ratio, convergence, and consensus were derived. Based on the derived items and content, a standard acupotomy consent form was developed.

Conclusions

The standard consent form for acupotomy is anticipated to ensure patient autonomy and enhance transparency and liability in acupotomy. Furthermore, it is expected to serve as evidence in case of medical disputes related to acupotomy and contribute as a reference document for the development of standard consents forms for various procedures of Korean Medicine. However, the limitations of the study include that the survey of consent forms was limited to only training hospitals of Korean Medicine, and the standard consent form is only applicable to adults in Korea. Future studies are needed to address these limitations.

Keywords: Acupotomy, Korean Medicine, Consent form, Delphi method, Standard consent form

Supplementary Information

jkm-45-1-180-Supplementary.pdf

Fig. 1

Examples of acupotome

(A) 0.40 x 30mm (B) 0.50 x 50mm (C) 0.50 x 50mm (D) 0.60 x 50mm (E) 0.75 x 50mm (F) 0.60 x 80mm (G) 0.75 x 80mm (H) 1.0 x 80mm

Fig. 2

Comparison of acupotome and acupuncture needle tips

Fig. 3

Flow chart of the study

Fig. 4

Availability of acupotomy consent forms

Fig. 5

How to manage acupotomy consent form storage

Table 1

Characteristics of the Delphi Panel

번호	성별	나이	직업	임상연차	침도 사용 연차
1	남	40대	대학한방병원 교수	23	8
2	남	30대	대학한방병원 교수	13	1
3	남	40대	유관학회 전문가	22	10
4	남	50대	유관학회 전문가	27	8
5	남	60대	유관학회 전문가	20	20
6	남	40대	유관학회 전문가	16	13
7	남	40대	한의과대학 교수	9	0.5
8	남	30대	로컬 임상 한의사	13	12
9	남	40대	로컬 임상 한의사	18	15
10	여	50대	간호대학 교수	-	-
11	여	40대	대학한방병원 수간호사	-	-
12	여	30대	한의학 박사과정	4	2

Table 2

Minimum Values of CVR^* for Delphi Panels (p=0.05)18)

Number of Panelists	Minimum values of CVR^*
5	.99
6	.99
7	.99
8	.75
9	.78
10	.62
11	.59
12	.56
13	.54
14	.51
15	.49
20	.42
25	.37
30	.33
35	.31
40	.29

* CVR; Content validity ratio

Table 3

Analysis of Acupotomy Consent Form Items in Korean Medicine Hospitals

Korean Medicine Hospitals	A	B	C	D	E	F	Inclusion (%)	Exclusion (%)
Items	A	B	C	D	E	F	Inclusion (%)	Exclusion (%)
진단명	X	X	X	X	O	X	1 (17)	5 (83)
시술명	O	O	O	O	O	O	6 (100)	0 (0)
시행(예정)일	O	X	X	X	X	X	1 (17)	5 (83)
환자의 현재상태	O	X	X	X	O	O	3 (50)	3 (50)
시술의 목적 및 필요성	O	X	X	X	O	O	3 (50)	3 (50)
시술의 과정 및 방법	O	O	O	O	O	O	6 (100)	0 (0)
시술의 부위 및 추정 소요시간	O	X	X	X	O	X	2 (33)	4 (67)
발현 가능한 합병증 내용 정도 및 대처방법	O	O	O	O	O	O	6 (100)	0 (0)
시술 관련 주의사항 (시술후 관리에 필요한 사항)	O	O	O	O	O	X	5 (83)	1 (17)
예정된 시술이외의 시행 가능한 다른 치료 방법	O	O	O	O	O	X	5 (83)	1 (17)
예정된 시술을 시행하지 않았을 때의 결과	O	O	O	O	O	X	5 (83)	1 (17)
시술 방법의 변경 또는 시술 범위의 추가 가능성	O	X	X	X	X	X	1 (17)	5 (83)
시술의의 변경 가능성	O	X	X	X	X	X	1 (17)	5 (83)
설명 한의사의 서명	O	O	O	O	O	O	6 (100)	0 (0)
시술 한의사의 서명	O	O	O	O	X	X	4 (67)	2 (33)
참여 의료진의 전문의, 일반의 여부	O	X	X	X	X	X	1 (17)	5 (83)
참여 의료진의 전문과목(전문의), 진료과목(일반의)	O	X	X	X	X	X	1 (17)	5 (83)
환자(또는 대리인)의 서명	O	O	O	O	O	O	6 (100)	0 (0)

Table 4

Items for Standard Acupotomy Consent Form from the First Delphi Survey (N=11)

Items (before)^†	Positive response rate	CVR^*	Consensus	Convergence	Items (after)^‡
시술명	10	0.82	1	0	시술명
환자의 진단명	10	0.82	1	0	진단명
시술 부위	9	0.64	1	0	시술 부위 (체크 박스로 구성)
시술의 목적	7	0.27	0.6	1	목적 및 필요성
시술의 필요성	6	0.09	0.5	1.25	목적 및 필요성
시술의 효과	8	0.45	0.7	0.75	효과
시술 과정	7	0.27	0.6	1	과정 및 방법, 부위 및 추정 소요시간
시술 방법	9	0.64	0.9	0.25
시술 소요시간	8	0.45	0.8	0.5
참여 의료진의 성명	10	0.82	1	0	참여 의료진의 성명
의사(시술의)의 서명	8	0.45	0.8	0.5	참여 의료진의 성명
참여 의료진의 전문의/일반의 여부	4	−0.27	0	1.5	참여 의료진의 전문의(전문과목), 일반의(진료과목)
참여 의료진의 전문과목 및 진료과목	4	−0.27	0	1.5	참여 의료진의 전문의(전문과목), 일반의(진료과목)
시행(예정)일	9	0.64	1	0	시행(예정)일
발현 가능한 합병증(후유증)의 내용, 정도	11	1	1	0	회복과정에서 발생할 수 있는 증상과 발현 가능한 합병증 (후유증)의 내용, 정도 및 대처방법
발현 가능한 합병증(후유증)의 대처방법	11	1	1	0
시술 후 발생할 수 있는 반응 및 불편감	11	1	1	0
시술 후 발생할 수 있는 반응 및 불편감의 대처방법	11	1	1	0
침도 외 시행 가능한 다른 방법(대안)	4	−0.27	0	1.5	침도 시술 외 시행 가능한 다른 방법(대안) 및 미시행시 결과
침도요법 미시행 시 결과	2	−0.64	0.5	0.5	침도 시술 외 시행 가능한 다른 방법(대안) 및 미시행시 결과
시술 관련 주의사항	11	1	1	0	시술 관련 주의사항 (시술 후 건강관리에 필요한 사항)
시술 후 (자가)건강관리	11	1	1	0	시술 관련 주의사항 (시술 후 건강관리에 필요한 사항)
시술 방법의 변경 가능성	8	0.45	0.6	1	시술 방법의 변경 또는 시술 범위의 추가 가능성
시술 범위의 추가 가능성	10	0.82	0.8	0.5	시술 방법의 변경 또는 시술 범위의 추가 가능성
시술의의 변경 가능성	7	0.27	0.5	1.25	시술의의 변경 가능성
환자(또는 대리인)의 서명	11	1	1	0	환자(또는 대리인)의 서명
설명한 의료인의 서명	10	0.82	1	0	설명한 의료인의 서명
					환자의 상태 점검 (표)^§
					서약 문구
					초음파 활용과 관련된 문구

* CVR; Content validity ratio

† Preliminary items derived in advance through the analysis stage

‡ Revised items based on the first Delphi survey

§ Added items based on the first Delphi survey

Table 5

Items for Standard Acupotomy Consent Form from the Second Delphi Survey (N=12)

Items	Positive response rate	CVR^*	Consensus	Convergence	Selection
시술명 Acupotomy Therapy Consent Form	11	0.83	1	0	Selected
시술 부위 (체크 박스로 구성)	11	0.83	0.8	0.5	Selected
참여 의료진의 전문의(전문과목), 일반의(진료과목)	9	0.5	0.69	0.63	pending
환자의 현재 상태 (표)	9	0.5	0.75	0.63	pending
목적 및 필요성	9	0.5	0.75	0.63	pending
효과 (첫번째 문장)	8	0.33	0.44	1.13	pending
효과 (두번째 문장)	9	0.5	0.75	0.63	pending
과정 및 방법, 부위 및 추정 소요시간	6	0	0.36	1.13	pending
회복과정에서 발생할 수 있는 증상과 발현 가능한 합병증 (후유증)의 내용, 정도 및 대처방법 (첫번째 문장)	11	0.83	0.8	0.5	Selected
회복과정에서 발생할 수 있는 증상과 발현 가능한 합병증 (후유증)의 내용, 정도 및 대처방법 (두번째 문장)	10	0.67	0.8	0.5	Selected
시술 관련 주의사항 (시술 후 건강관리에 필요한 사항) (첫번째 문장)	11	0.83	1	0	Selected
시술 관련 주의사항 (시술 후 건강관리에 필요한 사항) (두번째 문장)	11	0.83	1	0	Selected
시술 관련 주의사항 (시술 후 건강관리에 필요한 사항) (세번째 문장	10	0.67	0.8	0.5	Selected
시술 관련 주의사항 (시술 후 건강관리에 필요한 사항) (네번째 문장)	11	0.83	1	0	Selected
침도 시술 외 시행 가능한 다른 방법(대안) 및 미시행시 결과	10	0.67	0.78	0.5	Selected
시술 방법의 변경 또는 시술 범위의 추가 가능성	11	0.83	1	0	Selected
시술의의 변경 가능성	10	0.67	0.8	0.5	Selected
서약 문구	12	1	1	0	Selected
초음파 활용과 관련된 문구	11	0.83	1	0	Selected

* CVR; Content validity ratio

Table 6

Demographic characteristics of survey respondents

	항목	N (%)
성별	남	5 (25)
성별	여	15 (75)
연령	≤ 29	4 (20)
	30 - 39세	6 (30)
	40 - 49세	3 (15)
	50 - 59세	2 (10)
	60 - 69세	4 (20)
	70 ≤	1 (5)
결혼 유무	미혼	10 (50)
결혼 유무	기혼	10 (50)
최종학력	초등학교졸업	1 (5)
	중학교 졸업	0 (0)
	고등학교 졸업	3 (15)
	전문대학교 졸업	4 (20)
	대학교 졸업	8 (40)
	대학원 졸업	4 (20)
가계의 월 평균 세후소득	100만원 미만	3 (15)
	100 - 200만원 미만	5 (25)
	200 - 300만원 미만	2 (10)
	300 - 400만원 미만	2 (10)
	400 - 500만원 미만	5 (25)
	500 - 600만원 미만	2 (10)
	600만원 이상	1 (5)
총합		20 (100)

Table 7

Patients' Understanding of Acupotomy Consent Form Content

내용에 대한 이해도	의견
동의서 항목	의견
시술의 목적 및 필요성	의학, 전문용어에 대한 이해 어려움 : “고질적” (2건), “메스모양” (1건)
시술의 효과	의학, 전문용어에 대한 이해 어려움 : “미소순환” (3건), “단백분해” (2건)
시술의 과정 및 방법, 부위 및 추정 소요시간	의학, 전문용어에 대한 이해 어려움 : “연부조직” (2건), “경결점” (4건) 추정 소요시간에 대한 설명 부족 (2건)
회복과정에서 발생할 수 있는 증상과 발현 가능한 합병증 (후유증)의 내용, 정도 및 대처방법	침도 시술 부작용에 대한 두려움 (4건)
기타	한자 표현에 대한 이해 어려움 : “경항부, 견부, 요배부” (1건) 글자 크기 확대 (1건), 그림 추가 (2건)

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