Department of Graduate Studies and Rehabilitation Sciences, Youngstown State University, Youngstown, OH, USA.
Department of Orthopaedics, Duke University, Durham ,NC, USA.
Physiother Theory Pract. 2024 Aug;40(8):1731-1743. doi: 10.1080/09593985.2023.2208668. Epub 2023 May 9.
Dry needling (DN) uses a monofilament needle to reduce pain and is performed by various healthcare professions. Due to the invasive needle puncture, adverse events (AEs) have been associated with DN. It is unclear, which AEs should be included in a risk statement for Informed Consent (IC). The purpose of this study was to identify which AEs should be included in a risk statement for IC.
A three-round e-Delphi study was undertaken using a panel of DN experts. Expert inclusion criteria included: (1) ≥5 years practice performing DN and one of the following secondary criteria: (A) certification in DN; (B) completion of a manual therapy fellowship that included DN training; or (C) ≥1 publication involving the use of DN. Participants rated their level of agreement using a 4-point Likert scale. Consensus was defined as either: 1) ≥80% agreement; or 2) ≥70% and <80% agreement with median ≥3, interquartile range ≤1, and standard deviation ≤1.
A total of 14 (28%) AEs achieved final consensus in Round 3 for inclusion on IC. Kendall's Coefficient () of agreement for Round 2 was 0.213 and improved to 0.349 after Round 3. Wilcoxon rank tests revealed statistically significant changes for 12 of the 50 AEs.
Consensus was attained for 14 AEs for inclusion on IC. The AEs identified can be used for the development of a shorter, more concise IC risk statement. A total of 93.6% of experts agreed on definitions for AE classification.
干针疗法（DN）使用单丝针来减轻疼痛，由各种医疗保健专业人员进行。由于侵入性的针刺，与 DN 相关的不良事件（AE）已经出现。目前还不清楚哪些 AE 应该包含在知情同意书（IC）的风险声明中。本研究的目的是确定哪些 AE 应该包含在 IC 的风险声明中。
采用专家小组进行了三轮电子德尔菲研究。DN 专家的纳入标准包括：（1）≥5 年的 DN 实践经验，以及以下标准之一：（A）DN 认证；（B）完成包括 DN 培训的手法治疗研究员课程；或（C）≥1 篇涉及 DN 使用的出版物。参与者使用 4 分李克特量表对其同意程度进行评分。共识定义为：1）≥80%的同意；或 2）≥70%且<80%的同意，中位数≥3，四分位距≤1，标准差≤1。
共有 14 项（28%）AE 在第 3 轮中达成最终共识，纳入 IC。第 2 轮的 Kendall 协调系数（）为 0.213，第 3 轮后提高到 0.349。Wilcoxon 秩检验显示，50 项 AE 中有 12 项的变化具有统计学意义。
达成了纳入 IC 的 14 项 AE 的共识。确定的 AE 可用于制定更简短、更简洁的 IC 风险声明。93.6%的专家对 AE 分类的定义达成一致。
