Development of an Informed Consent Statement Which Communicates the Risk of Adverse Events Associated With Dry Needling (DNICNGT)

Development of an Informed Consent Statement Which Communicates the Risk of Adverse Events Associated With Dry Needling Using an Online Nominal Group

As Dry Needling (DN) continues to see increased use in the clinic, there is a need to establish adverse events that could occur as a result of DN intervention. The adverse events are important to consider when an individual needs to make an informed decision regarding their care. It is important to consider how such information should be presented during the informed consent process to improve an individual's ability to make a sound decision regarding their own personal care.

Study Overview

• Status: Completed
• Conditions: Dry Needling
• Intervention / Treatment: Other: Nominal Group Technique - 2 to 3 hour virtual meeting

Detailed Description

Dry Needling (DN) has been defined by a Task Force organized by the Federation of State Boards of Physical Therapy (FSBPT) as "a skilled intervention performed by a physical therapist using filiform needles to penetrate the skin and/or underlying tissues to affect change in body structures and functions for the evaluation and management of neuromusculoskeletal conditions, pain, movement impairments, and disability". As DN interest continues to expand and studies continue to show the feasibility of applying DN to a wider range of pathological conditions, there is a need to understand the risks related to the use of DN. Understanding the risks associated with DN will allow for improvements in clinical decision making regarding it's application in the clinic.

Enhancing patient choice is a central theme of medical ethics and law. Informed consent (IC) is the legal process used to promote patient autonomy while concepts of shared decision making (SDM) is a widely promoted ethical approach. IC is a means of respecting the autonomous preferences of persons seeking health care or participation in research. Empowerment of the patient is important in healthcare and can lead to improvements in overall quality of patient care and outcomes.

To date, there has been little research conducted that explored the topic of how risks should be presented during the IC process. The purpose of this study will be to utilize expert consensus to establish a risk statement for adverse events associated with DN that an be used during IC.

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Youngstown, Ohio, United States, 44555
      • Youngstown State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 96 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Dry Needling Experts, Legal Experts, Policy Experts, and Patients (Defined with inclusion criteria above).

Description

Inclusion Criteria:

Participants must be 18 years old or above and be able to read/write in English Participants must provide informed consent Participants must meet the criteria of one of the previously defined cohort groups used in the study

Dry Needling Experts

(1) Must have >= 5 years of clinical practice performing dry needling and at least ONE of the following secondary criteria:

1. Certification in Dry Needling
2. Completion of a manual therapy fellowship that included dry needling training
3. >= 1 total scholarly product (poster presentation, author of a peer-reviewed publication) involving the use of dry needling

Legal Expert

An individual who is an attorney and who has had training in health law as evidenced by at least ONE of the following criteria:

1. Training in health law as evidenced by ONE of the following:

   1. Concentration/Certification in Health Law
   2. L.L.M in health or medical law
   3. SJD in health law
2. Experience in litigating medical malpractice cases involving failure to obtain informed consent
3. Published scholarship on informed consent in an academic journal (>= 1) Policy Expert

An individual who has a degree in bioethics with at least ONE of the following criteria:

1. >= 5 years of experience in obtaining informed consent or an advanced graduate degree in bioethics
2. Has served on ethics related committee in a healthcare institution or healthcare society/professional association
3. Is or has been a member of a state licensing board

Patient Must have participated in >= 1 session of dry needling treatment and not be a healthcare provider

Exclusion Criteria:

Participants who did not provide informed consent Participants who did not meet the inclusion criteria of one of the four cohort groups defined in the study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; Must have participated in >= 1 session of dry needling treatment and not be a healthcare provider.	Other: Nominal Group Technique - 2 to 3 hour virtual meeting; Participants will be invited to a 2-3 online virtual online meeting with the goal of constructing and defining elements for producing a risk statement for dry needling that can be used for informed consent.
Dry Needling Experts; (1) Must have >= 5 years of clinical practice performing dry needling and at least ONE of the following secondary criteria: Certification in Dry Needling; Completion of a manual therapy fellowship that included dry needling training; >= 1 total scholarly product (poster presentation, author of a peer-reviewed publication) involving the use of dry needling	Other: Nominal Group Technique - 2 to 3 hour virtual meeting; Participants will be invited to a 2-3 online virtual online meeting with the goal of constructing and defining elements for producing a risk statement for dry needling that can be used for informed consent.
Policy Experts; An individual who has a degree in bioethics with at least ONE of the following criteria: >= 5 years of experience in obtaining informed consent or an advanced graduate degree in bioethics; Has served on ethics related committee in a healthcare institution or healthcare society/professional association; Is or has been a member of a state licensing board	Other: Nominal Group Technique - 2 to 3 hour virtual meeting; Participants will be invited to a 2-3 online virtual online meeting with the goal of constructing and defining elements for producing a risk statement for dry needling that can be used for informed consent.
Legal Experts; An individual who is an attorney and who has had training in health law as evidenced by at least ONE of the following criteria: Evidence of training based on ONE of the follow:Concentration/Certification in Health LawL.L.M in health or medical lawSJD in health law; Experience in litigating medical malpractice cases involving failure to obtain informed consent; Published scholarship on informed consent in an academic journal (>= 1)	Other: Nominal Group Technique - 2 to 3 hour virtual meeting; Participants will be invited to a 2-3 online virtual online meeting with the goal of constructing and defining elements for producing a risk statement for dry needling that can be used for informed consent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic Information Form	Contains questions about the characteristics of the participants	Up to 2 hours
Ranking of Statements	Participants will rank statements generated during the meeting to determine which statement best meets consensus within the group	A 2 hour virtual meeting for participants to rank statements

Collaborators and Investigators

• Sponsor: Youngstown State University
• Investigators: Principal Investigator: Edmund C Ickert, PhD, Youngstown State University

Publications and helpful links

General Publications

• Whitney SN, McGuire AL, McCullough LB. A typology of shared decision making, informed consent, and simple consent. Ann Intern Med. 2004 Jan 6;140(1):54-9. doi: 10.7326/0003-4819-140-1-200401060-00012.

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2022
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: September 21, 2022
• First Submitted That Met QC Criteria: September 28, 2022
• First Posted (Actual): September 29, 2022

Study Record Updates

• Last Update Posted (Estimated): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: informed consent; adverse event; nominal group technique
• Other Study ID Numbers: 2022-173

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No