Creation of a risk of harms informed consent form for dry needling: A nominal group technique.

BACKGROUND

When consenting patients to dry needling treatment, it is necessary to inform patients of potential risks of harms.

OBJECTIVES

The aim of this study was to identify elements and framework for an Informed Consent (IC) risk of harm statement to improve patient decision-making.

DESIGN

A virtual Nominal Group Technique (vNGT) methodology was used to achieve consensus among participants to identify what needs to be on a consent form, how it should be framed, and what it should state so patients understand the true risks.

METHODS

Eligible participants were identified as one of four groups: legal expert, policy expert, dry needling expert, or patient. The vNGT session consisted of 5 rounds of idea generation and final consensus voting which lasted for 2 h.

RESULTS

Five individuals consented to participate. Of the 27 original ideas, 22 reached consensus including ones specifically related to a risk of harms statement: identifying risks and discomforts, identify different sensations, and using a classification to order risks by severity. Consensus was achieved with percent agreement of ≥ 80%. The constructed risk of harm statement had a reading level of grade 7 and provided a list of stratified risks associated with dry needling.

CONCLUSION

The generated risk of harm statement can be incorporated on IC forms that require disclosure of risks in both the clinical and research setting. Additionally, further elements were identified by panel participants about defining the framework for an IC form outside of the risk of harm statement.

GOV REGISTRATION

NCT05560100 (29/09/22).