Department of Physical Therapy, Youngstown State University, 1 University Plaza, Youngstown, OH, 44555, USA.
Youngstown State University, USA.
Musculoskelet Sci Pract. 2023 Aug;66:102778. doi: 10.1016/j.msksp.2023.102778. Epub 2023 May 24.
When consenting patients to dry needling treatment, it is necessary to inform patients of potential risks of harms.
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.
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.
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.
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.
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.
NCT05560100 (29/09/22).
在同意患者接受干针治疗时，有必要告知患者潜在的伤害风险。
本研究旨在确定知情同意书（IC）伤害风险声明的要素和框架，以改善患者的决策。
采用虚拟名义群体技术（vNGT）方法，让参与者达成共识，确定同意书中需要包含哪些内容，应如何陈述，以及应如何陈述以便患者了解真实风险。
合格的参与者被确定为四个组之一：法律专家、政策专家、干针专家或患者。vNGT 会议由 5 轮想法生成和最终共识投票组成，持续 2 小时。
有 5 人同意参加。在最初的 27 个想法中，有 22 个达成共识，其中包括专门涉及伤害风险声明的想法：确定风险和不适、识别不同感觉，以及使用分类法按严重程度对风险进行排序。达成共识的百分比协议≥80%。构建的伤害风险声明的阅读水平为 7 级，并提供了与干针治疗相关的分层风险列表。
生成的伤害风险声明可以纳入临床和研究环境中需要披露风险的知情同意书中。此外，小组参与者还确定了在伤害风险声明之外定义知情同意书框架的其他要素。
NCT05560100（29/09/22）。
