Yoon Sang-Hoon, Lee Haebeom, Kwon Chan-Young, Jeon Damin, Kim Hyunho, Jo Hee-Geun, Shin Aesook, Yun Younghee, Sul Jae-Uk, Lee Geon-Mok, Lee Jun-Hwan, Leem Jungtae
Chung-Yeon Medical Institute.
Chung-Yeon Korean Medicine Hospital, Gwangju.
Medicine (Baltimore). 2018 Oct;97(41):e12736. doi: 10.1097/MD.0000000000012736.
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.
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.
The aim of this protocol is to develop a survey form for future prospective observational multicenter studies on MSN treatment-related AEs. This protocol will present the research methodology for developing a survey form, which will improve consistency and reliability between MSN treatment studies. We believe that this protocol can evaluate the safety of MSN treatment.
Clinical Research Information Service: KCT0002849.
尽管微型针刀（MSN）的使用广泛，但关于MSN治疗相关不良事件（AE）的信息并不充分。由于不同医生对AE的定义可能存在差异，且缺乏疼痛和出血的确切定义，因此难以向医生、研究人员和患者提供关于MSN治疗中AE的准确信息。我们研究的目的是就前瞻性观察性多中心研究的调查问卷中应包含的AE项目和定义达成共识，以记录MSN治疗相关的AE。我们将特别专注于就MSN治疗引起的疼痛和出血的定义达成共识。
我们的研究方案包括6个步骤。首先，我们将确定研究目的。其次，我们将进行系统评价，以调查韩国迄今报道的与MSN治疗相关的AE。第三，我们将对MSN治疗中的AE进行一项试点观察性前瞻性单中心研究。我们将制定一份标准化的病例报告表，以记录与MSN治疗相关的AE，包括每个部位MSN操作的因果关系、严重程度和详细信息。接下来，根据试点研究，由13名医生组成的小组将制定德尔菲研究问卷。德尔菲研究将包括4轮开放式问题和4点李克特量表封闭式问题。通过这些轮次，我们将就未来关于MSN治疗相关AE的多中心研究调查问卷中应包含的AE项目和定义达成共识。在此之后，将举行一次面对面的共识会议，以最终确定调查问卷。然后，最终调查问卷将由相关学术协会批准发布。
本方案的目的是为未来关于MSN治疗相关AE的前瞻性观察性多中心研究制定一份调查问卷。该方案将展示制定调查问卷的研究方法，这将提高MSN治疗研究之间的一致性和可靠性。我们相信该方案能够评估MSN治疗的安全性。
临床研究信息服务：KCT0002849。
