Delphi study for developing a checklist of adverse events associated with acupotomy

Area of Science:

• Integrative and Complementary Medicine
• Medical Device Safety
• Clinical Research Methodology

Background:

• Acupotomy, a needle-knife procedure, is more invasive than acupuncture, necessitating safety research.
• Adverse events (AEs) associated with acupotomy require standardized identification and reporting.

Purpose of the Study:

• To define relevant adverse events (AEs) for acupotomy.
• To develop a standardized checklist for acupotomy-related AEs, named ACUPOCHECK.

Main Methods:

• A systematic review and pilot prospective study were conducted to identify AEs.
• The Delphi method, involving 13 Korean doctors, was used over four rounds to achieve consensus on AEs.
• Consensus was defined as a critical value for the content validity ratio meeting or exceeding 0.538.

Main Results:

• The ACUPOCHECK includes 12 local AEs (e.g., pain, hemorrhage, infection) and 14 systemic AEs (e.g., disease aggravation, syncope).
• Specific criteria were established for pain, hemorrhage, and bruising.
• Severity and causality of AEs were assessed using established criteria.

Conclusions:

• ACUPOCHECK offers a standardized framework for researching acupotomy safety.
• This checklist will aid in developing rational safety guidelines for acupotomy techniques.