PMID- 30313076
OWN - NLM
STAT- MEDLINE
DCOM- 20181029
LR  - 20221005
IS  - 1536-5964 (Electronic)
IS  - 0025-7974 (Print)
IS  - 0025-7974 (Linking)
VI  - 97
IP  - 41
DP  - 2018 Oct
TI  - 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.
PG  - e12736
LID - 10.1097/MD.0000000000012736 [doi]
LID - e12736
AB  - 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. DISCUSSION: 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. TRIAL REGISTRATION: Clinical Research 
      Information Service: KCT0002849.
FAU - Yoon, Sang-Hoon
AU  - Yoon SH
AD  - Chung-Yeon Medical Institute.
AD  - Chung-Yeon Korean Medicine Hospital, Gwangju.
FAU - Lee, Haebeom
AU  - Lee H
AD  - Department of Human Informatics of Korean Medicine, Interdisciplinary Programs, 
      Kyung Hee University.
AD  - Inae Korean Medicine Clinic, Seongdong-gu.
FAU - Kwon, Chan-Young
AU  - Kwon CY
AD  - Chung-Yeon Medical Institute.
AD  - Department of Clinical Korean Medicine, Graduate School, Kyung Hee University, 
      Dongdaemun-gu.
FAU - Jeon, Damin
AU  - Jeon D
AD  - Chung-Yeon Medical Institute.
FAU - Kim, Hyunho
AU  - Kim H
AD  - Chung-Yeon Medical Institute.
AD  - Dongshin Korean Medicine Hospital, Yangcheon-gu.
FAU - Jo, Hee-Geun
AU  - Jo HG
AD  - Chung-Yeon Medical Institute.
AD  - Chung-Yeon Korean Medicine Hospital, Gwangju.
FAU - Shin, Aesook
AU  - Shin A
AD  - Chung-Yeon Medical Institute.
FAU - Yun, Younghee
AU  - Yun Y
AD  - Chung-Yeon Medical Institute.
AD  - Research and Development Institute, CY Pharma Co, Gangnam-gu.
FAU - Sul, Jae-Uk
AU  - Sul JU
AD  - Chung-Yeon Medical Institute.
AD  - Chung-Yeon Korean Medicine Hospital, Gwangju.
FAU - Lee, Geon-Mok
AU  - Lee GM
AD  - Lee-Geonmok Wonli Korean Medicine Hospital, Seocho-gu, Seoul.
FAU - Lee, Jun-Hwan
AU  - Lee JH
AD  - Clinical Medicine Division, Korea Institute of Oriental Medicine.
AD  - Korean Medicine Life Science, University of Science and Technology (UST), Campus 
      of Korea Institute of Oriental Medicine, Daejeon, South Korea.
FAU - Leem, Jungtae
AU  - Leem J
AD  - Chung-Yeon Medical Institute.
AD  - Dongshin Korean Medicine Hospital, Yangcheon-gu.
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Medicine (Baltimore)
JT  - Medicine
JID - 2985248R
SB  - IM
MH  - Acupuncture Therapy/*adverse effects/*instrumentation
MH  - *Delphi Technique
MH  - Humans
MH  - *Physicians
MH  - Pilot Projects
MH  - Prospective Studies
MH  - Reproducibility of Results
MH  - Research Design
PMC - PMC6203508
COIS- The authors have no conflicts of interest to disclose.
EDAT- 2018/10/14 06:00
MHDA- 2018/10/30 06:00
PMCR- 2018/10/12
CRDT- 2018/10/14 06:00
PHST- 2018/10/14 06:00 [entrez]
PHST- 2018/10/14 06:00 [pubmed]
PHST- 2018/10/30 06:00 [medline]
PHST- 2018/10/12 00:00 [pmc-release]
AID - 00005792-201810120-00058 [pii]
AID - MD-D-18-06028 [pii]
AID - 10.1097/MD.0000000000012736 [doi]
PST - ppublish
SO  - Medicine (Baltimore). 2018 Oct;97(41):e12736. doi: 10.1097/MD.0000000000012736.