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Identifying which adverse events associated with dry needling should be included for informed consent: A modified
Edmund C Ickert1, David Griswold1, Ken Learman1
1Department of Graduate Studies and Rehabilitation Sciences, Youngstown State University, Youngstown, OH, USA.
This study identified 14 adverse events (AEs) for inclusion in dry needling (DN) informed consent (IC) risk statements. These findings help create concise and clear IC documents for patients undergoing DN procedures.
Area of Science:
- Physical Therapy
- Pain Management
- Clinical Practice Guidelines
Background:
- Dry needling (DN) is a therapeutic modality utilizing monofilament needles for pain reduction.
- Adverse events (AEs) are associated with DN due to its invasive nature.
- Standardized risk statements for informed consent (IC) in DN are lacking.
Purpose of the Study:
- To identify specific adverse events (AEs) for inclusion in dry needling (DN) informed consent (IC) risk statements.
- To establish consensus among experts on essential AEs for patient disclosure.
Main Methods:
- A three-round electronic Delphi (e-Delphi) study was conducted with dry needling (DN) experts.
- Expert consensus was defined by specific agreement thresholds and statistical measures.
- Participants rated their agreement on a 4-point Likert scale.
Main Results:
- Fourteen adverse events (AEs) achieved final consensus for inclusion in informed consent (IC) risk statements.
- Expert agreement improved throughout the e-Delphi process (Kendall's w: 0.213 to 0.349).
- Statistically significant changes were observed for 12 of 50 evaluated AEs.
Conclusions:
- Consensus was reached on 14 adverse events (AEs) for dry needling (DN) informed consent (IC).
- The identified AEs facilitate the development of concise and informative IC risk statements.
- High expert agreement (93.6%) was achieved on AE classification definitions.
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