A Study Protocol for Developing a Consensus-Based Reporting Guideline for Case Reports on Acupuncture-Related Adverse Events

Case reports play a crucial role in identifying safety concerns related to new or rare complications and adverse events (AEs) associated with therapeutic interventions. Although acupuncture is generally considered safe when performed by trained professionals, the increasing number of case reports reporting acupuncture-related AEs has raised public safety concerns. A recent systematic review of case reports from 2010 to 2023 determined that many reports lacked the essential details necessary for assessing AE causality, treatment appropriateness, and contributing risk factors. These omissions may result in misinformation, and exaggerate the potential harm of acupuncture. The CAse REport guidelines (13 items) provide general guidance to improve the clarity, completeness, and transparency of case report findings, but they do not address the unique clinical features and factors specific to acupuncture-related AEs such as defective needles, practitioner malpractice, or patient-related factors. These limitations may hinder the educational value of such reports in preventing acupuncture-related AEs. To address this gap, a consensus-based reporting guideline tailored to acupuncture-related AEs is necessary to enhance the quality, transparency, and reliability of case reports, which will ultimately contribute to improved patient care. This article outlines a protocol, and approaches, for developing a reporting guideline for acupuncture-related AEs in case reports.