별첨１	자료추출 및 비뚤림위험 평가

비뚤림위험 평가 (택1)

연번(Ref ID)		1(565)
1저자(출판연도)		Meng(2010)
영역	비뚤림위험	사유
Adequate sequence generation (무작위 배정순서 생성)	□ 낮음 □ 높음 ■ 불확실	100 consecutive premenopausal women with 138 symptomatic uterine fibroids (diameters ranging from 2–7.8 cm) were randomly divided into two groups and received HIFU or RF treatment.
Allocation concealment (배정순서 은폐)	□ 낮음 □ 높음 ■ 불확실	언급 없음
Blinding of participants and personnel (연구 참여자, 연구자에 대한 눈가림)	□ 낮음 □ 높음 ■ 불확실	언급 없음
Blinding of outcome assessment (결과평가에 대한 눈가림)	□ 낮음 □ 높음 ■ 불확실	언급 없음
Incomplete outcome data addressed (불충분한 결과자료)	■ 낮음 □ 높음 □ 불확실	결측치 없이 결과 보고됨
Free of selective reporting (선택적 보고)	■ 낮음 □ 높음 □ 불확실	프로토콜에 정의한 대로 결과 모두 보고됨
Other bias : Funding (그 외 비뚤림)	■ 낮음 □ 높음 □ 불확실	Conflicts of interest statement The authors declare that they have no conflict of interest. 민간연구비 지원 없음

RoB(Risk of Bias) 7편

연번(Ref ID)		2,3,4(207,363,477)
1저자(출판연도)		Brucker(2014) Hahn(2015) Kramer(2016)	NCT01750008 하나의 연구에서 발표된 문헌임
영역	비뚤림위험	사유
Adequate sequence generation (무작위 배정순서 생성)	■ 낮음 □ 높음 □ 불확실	All participants were women who desired uterine preservation and who were willing to be randomized 1:1 to RFVTA or LM (Fig. 1). Once a patient’s fibroids were mapped, classified, and recorded on the treatment case report form, an envelope was drawn that contained the patient’s treatment assignment. An independent third-party statistician (Innovative Analytics, Kalamazoo, MI, USA) performed a computer generation of the randomization assignments in blocks of 6 or 4; the patient and the surgeon were blinded to the treatment assignment.
Allocation concealment (배정순서 은폐)	■ 낮음 □ 높음 □ 불확실	Once a patient’s fibroids were mapped, classified, and recorded on the treatment case report form, an envelope was drawn that contained the patient’s treatment assignment. An independent third-party statistician (Innovative Analytics, Kalamazoo, MI, USA) performed a computer generation of the randomization assignments in blocks of 6 or 4; the patient and the surgeon were blinded to the treatment assignment.
Blinding of participants and personnel (연구 참여자, 연구자에 대한 눈가림)	■ 낮음 □ 높음 □ 불확실	the patient and the surgeon were blinded to the treatment assignment.
Blinding of outcome assessment (결과평가에 대한 눈가림)	□ 낮음 □ 높음 ■ 불확실	환자가 응답하는 결과보고가 많은데, 환자의 눈가림이 깨지지 않았을것으로 확신할 수 없음
Incomplete outcome data addressed (불충분한 결과자료)	□ 낮음 ■ 높음 □ 불확실	3개 문헌에서 보고한 동일한 지표 값이 상이함
Free of selective reporting (선택적 보고)	■ 낮음 □ 높음 □ 불확실	프로토콜에 정의한 대로 결과 모두 보고됨
Other bias : Funding (그 외 비뚤림)	□ 낮음 ■ 높음 □ 불확실	민간연구비 지원받음 Conflict of Interest; Halt Medical, Inc. (Brentwood, California USA) sponsored the study and provided materials and funding for the described procedures and for independent third-party monitoring, statistical analyses, and writing support. None of the authors have other commercial disclosures.

연번(Ref ID)		5(645)
1저자(출판연도)		Rattray(2018)
영역	비뚤림위험	사유
Adequate sequence generation (무작위 배정순서 생성)	■ 낮음 □ 높음 □ 불확실	The consent process included the participant’s willingness to be randomized (1:1) to one of two groups as follows: Group 1 offered randomization to either Lap-RFA or myomectomy, whereas Group 2 offered randomization to either Lap-RFA or UAE. An independent, third-party biostatistician (Innovative Analytics) randomized subjects in each site based on their group assignment in a 1:1 ratio in blocks of either four or six. A unique subject number was allocated to each randomization assignment, and the enrolled subjects were randomized to the lowest available subject number at each investigative site. Neither study participants nor surgeons were blinded to the randomization assignments.
Allocation concealment (배정순서 은폐)	■ 낮음 □ 높음 □ 불확실	A unique subject number was allocated to each randomization assignment, and the enrolled subjects were randomized to the lowest available subject number at each investigative site. Neither study participants nor surgeons were blinded to the randomization assignments.
Blinding of participants and personnel (연구 참여자, 연구자에 대한 눈가림)	■ 낮음 □ 높음 □ 불확실	Neither study participants nor surgeons were blinded to the randomization assignments.
Blinding of outcome assessment (결과평가에 대한 눈가림)	□ 낮음 □ 높음 ■ 불확실	환자가 응답하는 결과보고가 많은데, 환자의 눈가림이 깨지지 않았을것으로 확신할 수 없음
Incomplete outcome data addressed (불충분한 결과자료)	□ 낮음 ■ 높음 □ 불확실	수술 후 합병증 발생에 대한 자세한 언급 없음
Free of selective reporting (선택적 보고)	■ 낮음 □ 높음 □ 불확실	프로토콜에 정의한 대로 결과 모두 보고됨
Other bias : Funding (그 외 비뚤림)	□ 낮음 ■ 높음 □ 불확실	민간연구비 지원 받음 Acessa Health, Inc. provided funding for research, independent data collection and management, and third-party statistical analysis and editorial support related to this study.

연번(Ref ID)		6(810)
1저자(출판연도)		Yu(2022)
영역	비뚤림위험	사유
Adequate sequence generation (무작위 배정순서 생성)	■ 낮음 □ 높음 □ 불확실	This was a secondary analysis of the original postmarket, randomized, multicenter, longitudinal, comparative TRUST US trial to evaluate the health outcomes of LAP-RFA vs the standard uterine- conserving procedure, myomectomy. The study participants were randomized 1:1 to receive either LAP-RFA or myomectomy (laparoscopic, robotic, or abdominal) procedures. An independent, third-party biostatistician (Innovative Analytics) randomized subjects in each site on the basis of their group assignment in a 1:1 ratio in blocks of either 4 or 6. After consent, a unique subject number was allocated to each randomization assignment, and the enrolled subjects were randomized to the lowest available subject number.
Allocation concealment (배정순서 은폐)	■ 낮음 □ 높음 □ 불확실	After randomization, if participants preferred not to move forward with the procedure assigned or chose to opt for the alternate treatment, they were excluded from the study.
Blinding of participants and personnel (연구 참여자, 연구자에 대한 눈가림)	■ 낮음 □ 높음 □ 불확실	Neither study participants nor surgeons were blinded to the randomization assignments.
Blinding of outcome assessment (결과평가에 대한 눈가림)	□ 낮음 □ 높음 ■ 불확실	환자가 응답하는 결과보고가 많은데, 환자의 눈가림이 깨지지 않았을것으로 확신할 수 없음
Incomplete outcome data addressed (불충분한 결과자료)	□ 낮음 ■ 높음 □ 불확실	탈락된 환자가 있고(2명, 6명), 이에 대한 설명이 없음
Free of selective reporting (선택적 보고)	■ 낮음 □ 높음 □ 불확실	프로토콜에 정의한 대로 결과 모두 보고됨
Other bias : Funding (그 외 비뚤림)	□ 낮음 ■ 높음 □ 불확실	민간연구비 지원 받음 Barbara Levy is currently serving as a consultant to Hologic, Inc. Steve Yu, Bala Bhagavath, David Eisenstein, and S. Abbas Shobeiri are Acessa-trained physicians and were investigators in the TRUST randomized trial. Funding for this research study, independent data collection and management, third-party statistical analysis, and manuscript development was provided by Hologic, Inc. Hologic was not involved in the interpretation and presentation of the analysis nor the development of the manuscript.

연번(Ref ID)		7(736)
1저자(출판연도)		Hadisaputra(2006)
영역	비뚤림위험	사유
Adequate sequence generation (무작위 배정순서 생성)	□ 낮음 □ 높음 ■ 불확실	Randomization was done to allocate subjects to myolysis or resection group.
Allocation concealment (배정순서 은폐)	□ 낮음 □ 높음 ■ 불확실	언급 없음
Blinding of participants and personnel (연구 참여자, 연구자에 대한 눈가림)	□ 낮음 □ 높음 ■ 불확실	언급 없음
Blinding of outcome assessment (결과평가에 대한 눈가림)	□ 낮음 □ 높음 ■ 불확실	언급 없음
Incomplete outcome data addressed (불충분한 결과자료)	■ 낮음 □ 높음 □ 불확실	결측치 없이 결과 보고됨
Free of selective reporting (선택적 보고)	■ 낮음 □ 높음 □ 불확실	프로토콜에 정의한 대로 결과 모두 보고됨
Other bias : Funding (그 외 비뚤림)	□ 낮음 □ 높음 ■ 불확실	민간 연구비 지원에 대한 언급 없음

RoBANS ver2.0 (3편)

연번(Ref ID)		8(201)
1저자(출판연도)		Brooks(2020)
영역	비뚤림위험	사유
대상군 비교 가능성	□ 낮음 □ 높음 ■ 불확실	Patients for the myomectomy arm were identified by case-matching to TFA arm participants at the same centers. TFA patients were compared with myomectomy patients on the demographic characteristics of age, BMI, race, and ethnicity. Because age was a matching characteristic, we expected the groups to be similar in this regard. However, some study centers had difficulty identifying myomectomy patients within the original age range requested, and in these instances the centers could extend the age range for matching patients to younger ages. 연령, BMI는 두 군간 차이가 있음(대상군 선정의 한계로 보임)
대상군 선정	□ 낮음 □ 높음 ■ 불확실	기존 연구에 부합하는 사람들을 후향적으로 모집하여 적절한지 불확실함 Key patient eligibility criteria included women who were premenopausal and between 25 and 50 years of age, had experienced heavy menstrual bleeding associated with fibroids for at least the previous three months, had 1–10 fibroids of International Federation of Gynecology and Obstetrics (FIGO) types 1, 2, 3, 4, and/or type 2–5 with diameter between 1 and 5 cm, and had at least one fibroid that indented or abutted the endometrial cavity. Patients for the myomectomy arm were identified by case-matching to TFA arm participants at the same centers.
교란변수	□ 낮음 □ 높음 ■ 불확실	연구 참여자를 후향적으로 매칭하여 모집함 The data in the myomectomy arm were collected retrospectively, and proper IRB approval or waiver was given by each site that provided data to the study.
노출 측정	■ 낮음 □ 높음 □ 불확실	입원당시, 30일 후 재입원 등 측정. EMR으로 데이터 확인 Data on perioperative complications and readmissions for patients enrolled in the myomectomy arm were obtained from each facility’s EMR.
평가자의 눈가림	□ 낮음 □ 높음 ■ 불확실	평가자의 눈가림에 대한 언급 없음
결과 평가	■ 낮음 □ 높음 □ 불확실	30일이내 발생한 안전성 결과만 보고함
불완전한 결과자료	■ 낮음 □ 높음 □ 불확실	결측치 없음
선택적 결과 보고	■ 낮음 □ 높음 □ 불확실	방법에서 제시한 결과변수 모두 보고함

연번(Ref ID)		8(16)
1저자(출판연도)		최지현(2010)
영역	비뚤림위험	사유
대상군 비교 가능성	■ 낮음 □ 높음 □ 불확실	Table.1. 군 간 유의한 차이가 없음
대상군 선정	■ 낮음 □ 높음 □ 불확실	선택배제기준 기술되어있음 2006년 1월 1일부터 2009년 3월 31일까지 조선대학교 병원 산부인과에서 동일한 집도의에 의해 복강경보조 질식 자궁절제술 (laparoscopic-assisted vaginal hysterectomy, LAVH)과 미세내시경하 자궁근종용해술 (minilaparoscopic radiofrequency myolysis, MLRFM)을 받은 환자 중 각각 125명씩 250명을 대상으로 하였다. MLRFM은 향후 출산계획이 없는 경우에 한해서 시행하 였으며, 근종의 크기가 10 cm 이상 되는 경우는 연구대상 에서 제외하였다.
교란변수	□ 낮음 □ 높음 ■ 불확실	교란변수 보정에 대한 언급 없음
노출 측정	■ 낮음 □ 높음 □ 불확실	면담을 통한 시술/수술 만족도 조사(구조화된 설문지 언급x) 기타 이상반응이나, 수술관련 결과는 객관적 지표임(min, mL 등)
평가자의 눈가림	□ 낮음 □ 높음 ■ 불확실	평가자 눈가림에 대한 언급 없음
결과 평가	■ 낮음 □ 높음 □ 불확실	기타 이상반응이나, 수술관련 결과는 객관적 지표임(min, mL 등)
불완전한 결과자료	■ 낮음 □ 높음 □ 불확실	결측치 없음
선택적 결과 보고	■ 낮음 □ 높음 □ 불확실	방법에서 제시한 결과변수 모두 보고함

연번(Ref ID)		10(736)
1저자(출판연도)		Ti(2018)
영역	비뚤림위험	사유
대상군 비교 가능성	□ 낮음 ■ 높음 □ 불확실	주요기저특성을 연령 외에 판단할 수 없으며, 연령도 군간 유의한 차이가 있는 것으로 제시됨(table2., p<0.001)
대상군 선정	■ 낮음 □ 높음 □ 불확실	선택배제기준 제시됨 All patients had clinical symptoms of varying degrees, as dysmenorrhea, increased menstrual flow, menstruation, lower abdominal pain dur- ing menstruation, etc. Patients were without menopausal symptoms, without coagulation disorders, liver and kidney dysfunction, hypertension, diabetes, and coronary heart disease history. According to the different treatment groups of patients
교란변수	□ 낮음 □ 높음 ■ 불확실	교란변수 보정에 대한 언급 없음
노출 측정	□ 낮음 □ 높음 ■ 불확실	노출측정 등에 대한 언급없음 (신뢰할수 있는 의무기록, 표준화 등 x)
평가자의 눈가림	□ 낮음 □ 높음 ■ 불확실	눈가림에 대한 언급 없음
결과 평가	■ 낮음 □ 높음 □ 불확실	VAS, menstrual flow rate, B ultrasonic 검사, 혈액검사 등으로 평가
불완전한 결과자료	□ 낮음 ■ 높음 □ 불확실	결과값에 대한 정확한 자료, 단위 제시되어 있지 않음
선택적 결과 보고	□ 낮음 ■ 높음 □ 불확실	결과값에 대한 정확한 자료, 단위 제시되어 있지 않음