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Development of a survey form through Delphi study about adverse events associated with the miniscalpel needle, for

Sang-Hoon Yoon1,2, Haebeom Lee3,4, Chan-Young Kwon1,5

  • 1Chung-Yeon Medical Institute.

Medicine
|October 14, 2018
PubMed
Abstract

Insights

This study aims to standardize the reporting of adverse events (AEs) from miniscalpel-needle (MSN) procedures by developing a consensus-based survey form. This will improve the accuracy and reliability of safety data for MSN treatments.

Area of Science:

  • Dermatology and minimally invasive procedures.
  • Clinical research methodology and patient safety.

Background:

  • Miniscalpel-needle (MSN) procedures are widely used, but data on treatment-related adverse events (AEs) are insufficient.
  • Lack of standardized definitions for AEs, particularly pain and hemorrhage, hinders accurate reporting and patient information.
  • Existing information on MSN AEs lacks consistency, impacting clinical decision-making and patient safety.

Purpose of the Study:

  • To establish a consensus on the specific items and definitions for adverse events (AEs) related to miniscalpel-needle (MSN) treatment.
  • To develop a standardized survey form for recording MSN treatment-related AEs in future prospective observational multicenter studies.
  • To enhance the consistency and reliability of safety data collection in MSN treatment research.

Main Methods:

  • A systematic review of reported MSN AEs in Korea was conducted.
  • A pilot observational prospective single-center study was performed to inform the development of a standardized case report form.
  • A Delphi study involving 13 physicians across 4 rounds was employed to reach consensus on AE definitions and survey items, followed by a face-to-face meeting.

Main Results:

  • The study protocol outlines a systematic approach to developing a consensus-based survey form for MSN AEs.
  • The methodology includes a systematic review, pilot study, Delphi technique, and consensus meeting.
  • The developed survey form aims to standardize the recording of AEs, including causality, severity, and procedure details.

Conclusions:

  • The developed protocol provides a robust methodology for creating a standardized survey form for MSN treatment-related AEs.
  • This standardized form will improve the consistency and reliability of data in future multicenter studies.
  • The research is expected to significantly contribute to evaluating the overall safety profile of MSN treatments.

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