국가연구개발성과
논문 (학술지)
Development of a survey form through Delphi study about adverse events associated with the miniscalpel needle, for application in prospective observational studies regarding safety of miniscalpel needles Study protocol
| 등록번호 | - | SCI 구분
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※구분 : SCI(SCIE포함), 비SCI |
SCI |
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| 저자명 (주·공동저자) | Yoon Sang-Hoon; Younghee Yun; Jae-Uk Sul; Geon-Mo k Lee; Sang-Hoon Yoon; 이준환 ; 외7 ※ 과제 참여정보와 일치하는 연구자 상세정보로 정확하지 않을 수 있습니다. 동일저자 논문보기 |
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| 논문구분 | 국외전문학술지 | 학술지명 | MEDICINE |
| ISSN | 0025-7974 | 학술지 출판일자 | - |
| 학술지 볼륨번호 | 97 | 논문페이지 | 0 ~ 0 |
| 학술지 임팩트팩터 | 2.028 | 기여율 | 100 % |
| DOI | 10.1097/MD.0000000000012736 | ||
| 초록 | Background: Despite the wide usage of miniscalpel-needles (MSNs), information about MSN treatment-related adverse events (AEs) is insufficient. As the definition of AE might vary among physicians, without an exact definition for pain and hemorrhage, it is difficult to provide accurate information about AEs in MSN treatment to physicians, researchers, and patients. The aim of our study is to reach a consensus about the items and definitions of AEs that should be included in the survey form for prospective observational multicenter studies to record MSN treatment-related AEs. We will especially focus on obtaining a consensus on the definition of pain and hemorrhage caused by MSN treatment. Methods: Our study protocol is composed of 6 steps. First, we will identify the aim of the study. Next, we will conduct a systematic review to investigate MSN treatment-related AEs reported till date in Korea. Third, we will conduct a pilot observational prospective single-center study on AEs in MSN treatment. We will develop a standardized case report form to record MSN treatment-related AEs, including the causality, severity, and details of the MSN procedure at every site. Next, based on the pilot study, the Delphi study questionnaire will be developed by a panel composed of 13 physicians. The Delphi study will have 4 rounds with open questions and 4-point Likert-scale closed questions. Through these rounds, we will develop a consensus about the items and definitions of AEs that should be included in the survey form for future multicenter studies about MSN treatment-related AEs. Following this, a face-to-face consensus meeting will be held for a final agreement of survey form. The final survey form will then be approved by the related academic society for dissemination. | ||
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