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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

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 ab...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Wolters Kluwer Health 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6203508/
https://www.ncbi.nlm.nih.gov/pubmed/30313076
http://dx.doi.org/10.1097/MD.0000000000012736
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author 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
author_facet 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
author_sort Yoon, Sang-Hoon
collection PubMed
description 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.
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spelling pubmed-62035082018-11-07 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 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 Medicine (Baltimore) Research Article 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. Wolters Kluwer Health 2018-10-12 /pmc/articles/PMC6203508/ /pubmed/30313076 http://dx.doi.org/10.1097/MD.0000000000012736 Text en Copyright © 2018 the Author(s). Published by Wolters Kluwer Health, Inc. http://creativecommons.org/licenses/by/4.0 This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/4.0
spellingShingle Research Article
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
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6203508/
https://www.ncbi.nlm.nih.gov/pubmed/30313076
http://dx.doi.org/10.1097/MD.0000000000012736
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