Patient Safety during Live Demonstrations: An International Delphi Consensus
Live demonstrations are a hallmark of aesthetic training, with common characteristics including complimentary treatment for patient volunteers, educational and/or promotional objectives, and direct or indirect industry support. Demonstrations of injectables (fillers and botulinum toxins) are commonly performed and cited as low-risk procedures with high-yield educational value. Although intended to empower attendees to treat patients themselves, demonstration conditions invariably do not replicate clinical settings.
The purpose of this initiative was to frame guidelines for live injectables demonstrations from the suggestions of a group of core aesthetic faculty with experience in organization and execution of educational programs. Objectives were to define existing concerns, and to provide recommendations to minimize complications, facilitate consistent and ethical practice, and maximize educational benefits. To our knowledge, this is the first initiative to develop adaptable best practices for multinational implementation. The consensus guidelines have applicability to all aesthetic demonstrations, and other situations of non-standard/discontinuous patient care, including itinerant practice and medical tourism.
Methods/Technique
:The Global Aesthetics Alliance Procedural Safety Consensus Group comprised 40 plastic surgeons and dermatologists from 25 countries and territories: 15 faculty who convened a facilitated meeting in Singapore in March 2018, plus 25 additional respondents of commensurate qualifications and experience, who shared responses primarily via structured interviews with a trained facilitator (Table 1). The consensus questionnaire addressed experiences serving as injectors, faculty, chairs, conference organizers, workshop instructors and audience members at live injectables demonstrations, as well as strategies for improvement. In accordance with established consensus methodology, group review and revision of these suggestions in a Delphi process yielded recommendations (suggestions that received a minimum of 66% support), and position statements (suggestions that did not meet this threshold).
To develop a statement of need, faculty provided case reports on significant adverse events or deviations from standard of care. After sufficient information was provided to remove duplicate reports, incidents were de-identified and tabulated. For all case reports, the respondent was directly present during the event, or personally verified details with other faculty in attendance.
Results/Complications
:Case reports fell into four non-exclusive categories: (1) Procedural Complication including sequelae; (2) Potential for Procedural Complication, as established through Delphi process; (3) Treatment Planning & Implementation (logistical and methodological issues); and/or (4) Patient Welfare (Table 2). Thirty-nine case reports were documented, including similar incidents confirmed to have occurred at different demonstrations. Two incidents of vascular compromise and four incidents of intravascular entry without sequelae were reported. Overtreatment was the most common methodological issue. Compromises of patient welfare ranged from pain and acute distress to seizure, loss of consciousness, and death.
Consistent disparities between live demonstrations and in-clinic standard of care were summarized (Table 3). Faculty reported which aspects of demonstrations had concerned them in the past (Figure 1). 57.1% of faculty respondents reported addressing concerns with demonstration organizers or company representatives and characterized their experiences (Figure 3). The consensus group identified barriers to addressing concerns in demonstration settings.
77.4% and 83.9% of respondents stated concerns with demonstration rooms and facilities. 100% identified immediate needs for general and procedure-specific emergency equipment and protocols, based on in-clinic standards and adverse events at demonstrations during which equipment was unavailable. Relationships with local hospitals and specialists were also recommended. Pre-treatment concerns included recruitment, history-taking, informed consent, and clinical indication for the planned procedure. 93.6% of respondents reported inadequate pre-treatment consultation. Recommendations were framed to standardize recruitment and informed consent. 93.55% of faculty members reported suboptimal/nonexistent post-procedural communication. Guidelines were developed to foster continuity of care and routinize follow-up for all patients.
80% of respondents cited concerns regarding injector qualifications and provision of evidence of competency. Some respondents recommended existing demonstration staff/faculty to serve as patient liaisons during consent, treatment and follow-up, while others supported creating a formal, separate position. 77.1% of respondents supported a “code word” to halt demonstrations, but opinions varied regarding who should be aware of this word. Suggestions to delineate procedure- versus results-focused demonstrations were provided to minimize discrepancies between educational objectives and audience impact.
Conclusion
:Divergence from standard of care raises questions regarding live aesthetic demonstrations as they currently exist. This consensus identified numerous strategies to facilitate more effective education and ensure ethical and appropriate treatment of patients.
All consensus faculty serve as industry consultants, clinical investigators, speakers, etc. Recommendations strove to balance the important role of industry in aesthetic education with faculty concerns regarding extent of involvement. Industry representatives have expressed support for this initiative, to reinforce and actualize their existing commitments, and to minimize situations with medicolegal implications.
This work initiates a multistage initiative to address challenges specific to live aesthetic demonstrations. The feasibility of these evidence-based guidelines across variable settings will be investigated in a global pilot project, for which sites have already been identified. Further consideration of the legal and liability aspects of international practice and the uses of technology to promote patient safety is also needed.