Objective: 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.
Methods: 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.
Results: A total of 14 (28%) AEs achieved final consensus in Round 3 for inclusion on IC. Kendall's Coefficient (w) 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.
Conclusion: 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.
Keywords: Adverse events; Delphi; dry needling; informed consent.